Forensic

pharmacy

FORENSIC PHARMACY

0 |P a g
e
Forensic pharmacy

Contents
GENERAL INTRODUCTION
Introduction to forensic pharmacy and forensic pharmacist
02
History of legislation and pharmacy profession in Pakistan
06
National health policy

07a National drug policy

08b Essential drug list

16
Prescription handling in retail and record keeping
28
ROLE OF FORENSIC PHRMACIST
Forensic drug measurement ............................................................
.................................................................................................41
Post mortem ................................................................................
.................................................................................................47
Medication error ..........................................................................
.................................................................................................51
Prescription frogery .........................................................................
....................................................................................................53
Product tampering ........................................................................
.................................................................................................56
Insurance fraud ............................................................................
.................................................................................................61 Use
of alcohol in car accidents...............................................................64
Legal and illegal pharmaceutical evidence in investigations.........................66
Use of abused drug in work place..........................................71
Professional malpractice...................................................73
Quackery health care fraud..................................................76
PHARMACEUTICAL ETHICS:
Patents and generics.....................................................78

1 |P a g
e
Forensic pharmacy
Ethics in sale...........................................................79
Ethics in industry........................................................84
Ethics in research...............................................................89

THANK YOU

2 |P a g
e
Forensic medicine
Forensic or legal medicine (forensic = of or used in Courts of Law) deals with
the application of medical knowledge to aid in the administration of justice. It
is used by the legal authorities for the solution of legal problems. Some
examples are: applying the medical knowledge in deciding cases of injuries,
murder, suicide, accidents, sexual offences, poisoning, etc. In short, it deals
with medical aspect of law.

Aims of Forensic medicine

 To aid the administration of justice by correlating much medical
knowledge and applying it to the purposes of law.

 Truth or nearest reasonable approach to it that is possible from what is

observed is the sole aim of Forensic Medicine.

 Its particular field of activity is judicial investigation, both civil & criminal.
Though it does not itself prove the case of prosecution. It corroborates
medical evidence in all cases of crime involving person, e.g.
homicide, suicide, assault, sexual offences, traffic accidents, poisoning
etc.

 It finds out the medical evidence in all cases of crime involving the
person and it deals with medical aspects of law.

Forensic medicine is subdivided into branches, such as

 Forensic pathology: Branch of Forensic Medicine which deals with the
study & application of medical & pathological principles in determining
the cause & manner of death in case of violence, suspicious,
unexplained, unexpected, sudden & medically unattended deaths.

 Forensic Toxicology: Important subdivision of forensic

medicine, dealing with the comprehensive study of poisons, as
regards to their sources, characters & properties, signs & symptoms
they produce, their fatal dose & fatal period, the details about the
treatment to be undertaken for combating the effects of individual
poison & the postmortem appearances in the event of death.

 Forensic Ballistics: Branch of forensic medicine concerned with the

investigation of firearms ammunition & of the problems arising from
their use.
  Forensic Serology: It is the branch of forensic medicine which deals
with the examination of blood, saliva, urine or other body fluids and
seminal staining & their specific tests to detect crimes

 Forensic Radiology(X- ray): Branch of forensic medicine which deals

with X-ray examination for determination of age in various criminal cases,
detection of foetus, missile, diagnosis of head injuries, live birth etc.

 Forensic Dactylography: It is the branch of Forensic medicine which

deals with finger print system, which can be regarded as the most
characteristic datum for establishment of absolute identity of an
individual.

 Forensic Thanatology: Branch of Forensic medicine dealing with the

medical & legal aspects of death.

 Forensic Psychiatry: It deals with the application of psychiatry for

evaluations in legal purposes.

 Forensic Obstetrics: Branch of Forensic medicine dealing normal &

abnormal deliveries.

 Forensic Odontology: Branch of Forensic medicine which deals with

the science of dentistry as it relates to the law.

 Forensic Criminology: Branch of Forensic medicine which deals with

the crimes & criminals.

 Clinical Forensic Medicine: Deals with living person.

Scope of Forensic medicine

 Forensic medicine deals with those aspects of medical science which are
needed for application of scientific facts in legal matter, both civil &
criminal.

 It embraces all those aspects of medicine including its fundamental,

physical, chemical & biological principles such as specialties like forensic
pathology & toxicology in order to bring it into partnership with the
process of law.

 It deals with the application of principles and knowledge of facts of

medicine to the purposes of law, both civil & criminal.
Difference between Forensic medicine & Medical jurisprudence:

Forensic Medicine Medical Jurisprudence

1. It deals with medical aspects of law. 1. It deals with the legal aspects of

medical practice.

2. It brings the medical personnel into 2. It brings relationship between doctor

contact with courts of law. & patient, also doctor & society.

3. It deals with the application of 3. It deals with legal responsibilities

medical & para-medical knowledge of doctors with particular reference

in the administration of justice. to those arising from:

Doctor-patient

relationship Doctor-state

relationship Doctor-doctor

relationship

Medical negligence cases.

4. It has some subdivisions. 4. No such subdivisions.

5. Can be applied to all. 5. Applied only to the medical

practitioners
Forensic pharmacy

Forensic Pharmacist
A forensic pharmacist's job responsibilities are slightly different than a forensic
scientist's duties because a forensic pharmacist specifically applies the science of
drugs to legal matters. Forensic pharmacists spend much of their time researching,
testing and analyzing drug-related evidence for lawyers to use in litigation as
part of the criminal justice system.

Required Education
Forensic pharmacists typically have an advanced degree, at least at the master's
level, in forensic science or forensic pharmacy. For example, you may have a
doctorate in pharmacy along with master's degrees in relevant specializations,
such as clinical nutrition. Some universities offer a master's of science degree in
forensic science within the school's college of pharmacy. These typically cover
topics such as biological analysis, trace evidence analysis, toxicology, pattern
evidence and drug chemistry.

1. Legal Cases
Forensic pharmacists have expert skills evaluating drug-related evidence for
court cases. According to the U.S. National Library of Medicine, some
forensic pharmacists are employees of local, state and federal governments, and
some work as freelance forensic-litigation consultants. These professionals offer
valuable advice in legal situations involving drunken driving, drug-related
suicides, drug- induced criminal activity, malpractice and poisoning. Forensic
pharmacists test blood samples, examine human tissue and asses drug
interactions to determine how drugs were connected to criminal activity, including
murder.

Most forensic pharmacists work full-time in regular pharmacy jobs and provide
legal consultancy or expert witness services on a part-time basis. They may
review an attorney's case and relevant medical records, then provide an expert
opinion on the role that a drug played in a case. Cases might involve a car
accident or a death attributed to a drug's side effect. They can testify in court
about their findings or prepare a detailed report for trial. A forensic pharmacist
might also testify about a medication error made by a hospital and how it
contributed to a person's injury. Forensic pharmacists can work for the defendant
or the plaintiff.

2. Death Investigations
In cases where the cause of death is unknown, forensic pharmacists often asses a
victim's medical records, legal and illegal drug habits, prescription
medication history and lifestyle habits to determine if drugs were influential in
5 |P a g
e
Forensic pharmacy
the person's death. One drug alone might not cause death, but a combination of
drugs might be

6 |P a g
e
fatal, so forensic pharmacists study how drugs interact with each other. For
example, in some high-profile celebrity deaths, a mixture of alcohol and drugs was
found to be responsible for the deaths. Forensic pharmacists can also determine
whether drugs in a victim's system were regulated by the U.S. Food and Drug
Administration or obtained illegally.

3. Specific Job Responsibilities

Forensic pharmacists often serve as officers on drug-testing assignments.
According to Forensic Nursing Chronicles, some forensic pharmacists serve on
drug
-testing crews for the Olympics, as safety officers for the FDA or as FBI
investigators. Some prisons employ forensic pharmacists to address drug-related
problems, often involving hazardous drug combinations or overdoses. In addition,
police departments hire forensic pharmacists to work as criminologists, examining
drug-related evidence and criminal behavior.

4. Research
As a forensic pharmacist, you'll likely spend a large amount of time researching
hazardous drug combinations, the human body's response to pharmaceuticals and
previous scientific findings. Without a strong educational background, usually
consisting of an advanced degree in forensic science or pharmaceutical science,
you won't have the necessary expertise to analyze drug-related evidence.
Forensic pharmacists also spend much of their time in laboratories testing human
blood and tissue samples for adverse drug effects. A forensic pharmacist's
findings are often valuable to pathologists or medical doctors who perform
autopsies

5. Non-Legal Cases
You may work as a forensic pharmacist for non-attorneys. You may help hospitals
create systems for detecting drug abuse, or consult with a police department to
teach officers how to better detect drug abuse in suspects. A forensic pharmacist
might also offer his services to college sports teams, helping to detect drug use in
players.

6. Government Work
Some forensic pharmacists work full-time in the field, typically with state or
federal governments or regulatory agencies. For example, some work specifically
with state governments on Medicaid fraud cases. They may work for the Drug
Enforcement Agency creating drug-detection methods or help the Food and Drug
Administration determine dangerous side effects of new drugs.

History of pharmacy profession in Pakistan

 Poison Act 1919
 The Factories Act 1934
 West Pakistan dangerous Drugs Rules 1958

 The Pakistan Medical and Dental Council Ordinance 1962

 Allopathic System Ordinance 1962

 Unani ,Ayurvedic and Homeopathic Practitioners Acts 1965

 Dangerous Drug Rules 1967

 The West Pakistan Shops and Establishments Ordinance 1969

 Drug( Generic Names) Act 1972

 The Drug(Generic Names) Rules 1973

 Drug ( Appellate Board) Rules 1976

 The Drug ( Federal Inspectors Federal Drug Laboratories and Federal

Government Analysts) Rules 1976

 Drugs (Imports and Exports) Rules 1978

 The Drugs Act 1976

 Drug (Research)Rules 1978

 Sindh Drug Rules 1979

 National Institute of Health Ordinance 1980

 Unani ,Ayurvedic and Homeopathic System of Medicinal Rules 1980

 The Medical and Dental Degree Ordinance 1982

 National Institute of Health’s Employees Regulations 1986

 The Drugs ( Labelling and Packing) Rules 1986

 Medical Officers(Regularizations of Appointments) Act 1992

 Pharmaceutical Industry (Cost Accounting Records)Order 1995

 Anti-Narcotics Force Act 1997

 Control of Narcotic Substance Act 1997

 University of Health Sciences Ordinance 2002

 Health Services Academy Ordinance 2002

 Punjab Medical and Health Institution Act 2003

 Pharmacy Council of Pakistan (Doctor of Pharmacy Degree

Course)Regulations 2005

 The Punjab Drug Rules 2007

  The Punjab Healthcare Commission Act 2010

 The Drug Regulatory Authority of Pakistan Act 2012

 The Punjab Drugs Act 2017



National health policy

1. Vision Statement
To improve the health of all Pakistanis, particularly women and children, through
universal access to affordable quality essential health services, and delivered
through resilient and responsive health system, ready to attain Sustainable
Development Goals and fulfill its other global health responsibilities.

Background
The 2011 devolution of health to the provinces has created challenges as well as
opportunities for action. It is envisaged that the health benefits gained through
the federal support can lead to more equitable health system coverage, au
milieu de provincial priorities1. The provincial health departments and the re-
established Ministry of National Health Services, Regulation and Coordination
[MoNHSRC] are taking up their new found roles as provided for in the federal
legislative list part I & II2.

Political devolution within Pakistan provides a formidable opportunity for

healthcare systems to address issues related to systems, planning health
care delivery structures, programmes, and services3. This assumes greater
significance as the targets of health related MDGs were not completely
achieved, and far more effortsare required to work towards the even more
challenging targets of the Sustainable Development Goals (SDGs)4.
A significant gap after July 2011 has been lack of a consensus national vision that
reflects the shared aspirations for better health of the people of the country as a
whole. A national vision document on health that is aligned with the country’s
vision 20255, international health priorities and based on provincial realities, is thus
needed, which lies within the framework of post 18th Amendment Constitutional
roles/responsibilities.

The purpose of this document is to provide an overarching national vision and

agreed upon common direction, harmonizing provincial, federal, inter-provincial and
inter-sectoral efforts for achieving the desired health outcomes and to create an
impact on health..

The word “national” depicts common political aspirations of the provincial and
the federal governments. It has consonance with federal vision, provincial
strategies, and international commitments.
Moving beyond the health sector, it builds convergence with important
national programs and policy settings such as the Pakistan Vision 2025, Poverty
Reduction Strategy, and pro-poor social protection initiatives.

Pakistan at the Cross Roads for Health: Challenges

Despite several social, economic, political and cross border challenges

compounded by successive natural catastrophes, the health indicators of
Pakistan have shown improvement in the last 25 years; however it still lags
behind some regional countries.

The average life expectancy has increased from 59 years by 1990 to 67 years by
2015. The last maternal mortality ratio recorded was 276 per 100,000 live births
[2006-07]6, but it has improved significantly in the past decade, owing to
wide outreach of national LHW program, and better skilled birth attendance
availability7. Similarly, infant and under 5 mortality rates have improved [from
72/1000 to 66/1000 live births]; but neonatal mortality rate has remained
stagnant; and so has the rising toll of stillbirths [43/1000 live births.

Pakistan is facing a double burden of disease (BoD), the burden is higher in the
poor, and many of these conditions can be controlled at relatively low cost
interventions and best practices through primary and secondary care levels.
Communicable diseases, maternal

health issues and under-nutrition dominate and constitute about half of the BoD9.
In young children, diarrhoea and respiratory illness remain as the major
killers10. Maternal deaths due to preventable causes like sepsis,
haemorrhage and hypertensive crises are common. Pakistan is one of the three
remaining countries where Polio is still endemic11. Moreover, Pakistan has an
endemicity of hepatitis B and C in the general population with 7.6% affected
individuals; the 5th highest tuberculosis burden in the world13, has focal
geographical area of malaria endemicity14, and an established HIV
concentration among high risk groups15. Other vaccine preventable diseases and
new emerging infections call for strengthening disease surveillance and response
system uniformly across the country. Pakistan has one of the highest prevalence
of under-weight children in South Asia. Similarly stunting, micro nutrient
deficiencies and low birth weight babies contribute to already high level of
mortality in mothers and children16.

Non-Communicable Diseases along with Injuries and Mental health issues, now
constitute other half of the BoD, causing far more disabilities and premature deaths
among an economically productive adult age group 17. The common underlying
factors for non-communicable diseases including lifestyle, nutrition and
smoking have not been addressed adequately. Injuries account for more than 11%
of the total BoD, and are likely to rise with increasing road traffic, urbanization
and conflict18. Pakistan is ranked 7th highest in the world for diabetes
prevalence19. One in four adults over 18 years of age is hypertensive, and
smoking levels are high (38%
Forensic pharmacy
among men and 7% among women). . Rising but still unestimated burden of
cancers and COPD remain a largely unaddressed area. Poverty, low literacy,
unemployment, gender discrimination, and huge treatment gap have led to an
invisible burden of mental health problems in the society. Disability due to
blindness or other causes is also high, and services for disabled population are
limited, including provision of assist devices to improve their quality of life.

Population Explosion: The BoD is rendered worse by an increasing population,

with Pakistan now the sixth most populous country in the world 20. Decline in
population growth rate has been slow, and the current population growth rate of
1.9% per annum is driven by increasing age at marriage in urban areas;
while contraceptive prevalence of only 35% is far below than other regional
countries. Unmet need for birth spacing is around 25%21, and the health
system has to strategize to address this gap.

Health Access and Inequities: Pakistan has seen progress in access to health
care services; however, the gains are uneven across different service areas as out
of pocket expenditure is still around 70% despite having network of (primary,
secondary and tertiary) health care system in place. Though skilled birth
attendance (SBA) has improved from 18% in late 1990s’ to 58% in 2015, but only
one third of women make the required minimum number of antenatal visits and
the number decreases further for postnatal visits (2% after 1-2 days of delivery).
Despite reduction in Polio cases due to high vertical accountability, the rates of

routine immunization remain unacceptably low at 54% 21. Access to and

affordability of essential medicines is low22. Moreover, there are geographical
disparities in coverage between provinces, districts and rural-urban area23.
Evidence shows that low income groups are likely to have lower levels of health,
nutrition, immunization and family planning coverage.

Health Systems: Pakistan has a mixed health system, which includes government
infrastructure, para-statal health system, private sector, civil society and
philanthropic contributors25. A major strength of government’s health care system
in Pakistan is an outreach primary health care, delivered at the community level
by 100,000 Lady Health Workers (LHWs) and an increasing number of
community midwives (CMWs), and other community based workers who have
earned success and trust in the communities. Complementary, alternative and
traditional system of healing is also quite popular in Pakistan.
Health system faces challenges of vertical service delivery structures and low
performance accountability within the government, creating efficiency and quality
issues. Largely unregulated for quality care and pricing, there is also duplication of
services by the private sector 27. Although having the potential, private sector
contributes least towards preventive and promotive health services. The public
sector is inadequately staffed and job satisfaction and work environment need
improvement28. The overall health sector also faces an imbalance in the number,
10 | P a g
e
skill mix and deployment of health workforce, and inadequate resource allocation
across different levels of health care i.e. primary, secondary and tertiary. In
order to produce quality workforce for health sector, the quality of medical
and allied education both in public and private sector needs to be looked into. A
range of actions is needed, acting upon the social determinants within the health
and social sectors, if a wider impact is to be achieved

Purpose
The purpose of this document is to provide an overarching national vision an
agreed upon common direction, harmonizing provincial &federal efforts, inter-
provincial efforts and inter-sectoral efforts for achieving the desired health
outcomes and to create an impact. It provides a jointly developed account of
strategic directions to achieve the common vision, and which gives a guideline of
best practices for the provinces/ areas to carve their respective policies and
initiatives within their domains.

The word ‘national’ depicts common political aspirations of the provincial and
the federal governments. It has consonance with provincial & federal health
policy frameworks, post devolution health sector strategies, and with international
health treaties, commitments and regulations to which Pakistan is a signatory.

Guiding Values
The National Health Vision strives to provide a responsive unified national
direction to confront various health challenges, while ensuring adherence to
Universal Health Coverage as its ultimate goal. The principle values include:

 Good governance

 Innovation and Transformation

 Equity and pro-poor approach

 Responsiveness

 Transparency and Accountability

 Integration and cross sectoral synergies

The delivery of quality health care services is a provincial responsibility and the
priority actions emanating from this vision document would be in concert with
the provincial needs, expectations and priorities. The national health vision
aims to resonate with the ideals and expectations of provinces. The Federal
government will support and facilitate the provinces in developing and
implementing their strategies by providing the overall vision and by
facilitating/advocating for financial and technical resource mobilization to
ensure that essential health services are accessible to all citizens.
Objectives
The National Health Vision has adopted the following objectives in order to
improve the health and well-being of the Pakistani society:

Provide a unified vision to improve Health while ensuring provincial autonomy and
diversity
Build coherence to Federal & Provincial efforts in consolidating the progress, learning
from experiences and moving towards the universal health coverage.

Facilitate synchronization for commonality across international reporting and

international treaties

Facilitate coordination for regulation, information collection, surveillance, and research

for improved health systems

Provide a foundational basis for charting and implementing SDGs, in partnership with
other sectors.

Thematic Pillars
National Health Vision builds its narrative on the following thematic pillars. These
eight pillars will pave a way for ensuring access, coverage, quality and safety,
which are essential requisites for achieving the ultimate goals of health system:
improved health, responsiveness, social protection, and efficiency.

1. Health Financing

2. Health Service Delivery

3. Human Resource for Health

4. Health Information Systems

5. Governance

6. Essential Medicines & Technology

7. Cross-sectoral linkages

8. Global Health Responsibilities

Each thematic pillar or domain is critically analyzed for the challenges faced, and a
strategic vision for which an over-arching technical support to the provinces will be
offered and coordinated by the Federal government

1. Health Financing
1a. Challenges

Government spending on health has always been less than optimal (0.6% of GDP).
Most part of the allocations to health is consumed by the secondary and tertiary care,
leaving merely 15% for the preventive and primary health care.
Forensic pharmacy

There are inefficiencies in the public health spending due to weak management
systems, resulting in low utilization and eventual lapse of funds. Payments are
not linked to performance.

Donor funding has been minimal (<2% of total national health expenditure). The
official donor assistance (ODA) is far less than that committed in the Paris
declaration, and that too could be better aligned and coordinated with governments’
strategies.

Many population sub-groups lack financial protection, and face risk of catastrophic
health expenditure.

1b. Strategic Vision

Government is cognizant that adequate, responsive and efficient health financing

is the cornerstone of a country’s well-functioning health systems. The spending on
health will be advocated as “investment” with the line ministries, finance
departments and international development partners.

Federal and Provincial governments will increase allocation to health as pledged in

Pakistan vision 2025 to 3% of GDP, to maximize the pay-offs from investing in health.

Priorities for health allocations will be revisited, and a higher share for essential health
service delivery, preventive programs, communication, capacity building of
frontline health workers, and governance will be ensured.

Pro-poor social protection initiatives (including the recent national health

insurance scheme) will continue to be financed and new initiatives (CCT,
vouchers) will be launched, facilitating access to essential primary, secondary health
services and priority diseases.

There will be a progressive movement towards universal health coverage. RMNCAH

and nutrition investments will be increased in a phased manner.

Governments will develop mechanism to build capacity for implementing fiscal

discipline, revisit formulae for district allocations to maintain parity, and grant financial
autonomy to health institutions.

Federal and provincial governments will develop joint strategies aimed to enhance
resource mobilization for health from official development assistance
(ODA)/international development partners, private sectors’ engagement, and
through taxes such as sin tax.

2. Packaging Health Services

2a. Challenges

1 |P a g
e
Forensic pharmacy

2 |P a g
e
There is now an established and increasing double burden of disease including non-
communicable diseases, mental health and injuries as well as communicable
and infectious diseases such as TB, HIV/AIDS and Hepatitis B and C.

Inadequate infrastructure and standards along with poor quality of services have
shaken the trust of the public, resulting in hardly 20% population utilizing the first level
care in public sector.Progress has been constrained by fragmented delivery of
services, inadequate resource commitment to preventive and promotive care, human
resource imbalance, and lack of skill mix.

Inequitable access, urban-rural disparities, lack of regulation of private sector,

non- conformity of

essential services packages have made the healthcare delivery being non

-responsive. 2b. Strategic Vision

Governments will be working to improve the coverage and functionality of primary

and promotive health services, while ensuring the widening of essential service
packages by introducing family medicine, newborn survival, birth spacing and
contraceptives supply, non-communicable diseases, mental health, under-
nutrition, disabilities, problems of ageing population and other issues. Quality of
services will be ensured by implementing Minimal Standards for Delivery of Service
at all levels

Government will be encouraging and supporting the integration of vertical

programmes at the provincial level for optimal and efficient utilization of resources
and better performance.

Governments will be enforcing the public health laws promulgated, related to smoking,
drug safety, organ donation and transplant, safe blood transfusion,
environmental protection, food safety etc.

Efforts would be geared toward building synergies with the private sector in
essential health services delivery (preventive and curative), reporting on key
indicators and for understanding its functioning, composition and possible
outreach for the under- privileged.

Entire health care system will be made resilient to disasters (climate change, natural
disasters, disease outbreak etc) in terms of both disaster mitigation response
and continued provision of services during acute crisis / emergencies.
3. Human Resource for Health
3a. Challenges

Human Resource in health is the most critical factor in provision of quality

preventive, promotive and curative services. Pakistan has one of the lowest
doctors, dentists, nurses and paramedics to population ratios. Other pressing issues
in Human resource include maldistribution of HR, retention issues and low work-place
satisfaction levels. This results in significant brain drain at all levels.

Professional education in health is run at sub-optimal level without synchronizing

the curriculum with modern pedagogic techniques, international standards and the
local requirements.

Licensing and renewal of licensing of health practitioners is weak, and is not linked
with improved qualification, competence, performance and continuous
professional development. There are weak institutional levers for gauging the
performance of health staff. There is an apparent stagnancy in the coverage of
community health workers, and their numbers, coverage and quality are far from the
required standards.

3b. Strategic Vision

Medical and allied health education will be tailored according to the health needs of
the population, focusing on social determinants of health, ethics and public health
laws. Continuous Professional Development will be institutionalized across both
public and private sectors in conjunction with associations, and linking up with re-
licensing of the health professionals.

Owing to the rapidly growing population, disease patterns and the health needs, further
expansion and strengthening of existing workforce will be done.

Governments will focus towards appropriate and adequate skill mix of human
resource production and task shifting where required. Fields of Public health, Allied
health institutions and Family Medicine will be nurtured and institutionalized to
increase the cadre of managers, regulators, administrators, specialized allied health
staff and family physicians.

Responsive management will be brought in the health departments, and incentives will
be given to boost the performance and to make the rural appointments attractive.

HR database at provincial and national level will be created for the sake of
forecasting and developing workforce.

Developing a comprehensive National HR strategy, Nursing strategy and other allied

health work force strategies may also be considered based on National Health Vision.

4. Health Information Systems and Research

4a. Challenges

Health information systems currently in use in Pakistan are fragmented and

vertical. They respond to or serve primarily the health programmes that created
them. Consequently, health indicator data collated through various systems
sometimes give conflicting results.

Demographic Health or the Social and Living Measurement Surveys cannot fully
compensate for the lack of reliable ongoing monitoring data. Furthermore, even
these surveys require ability for analysis which has been limited to date.

It is critical to use the information systems for planning, resource allocation, and
health care delivery system; however it is impractical because it lacks accuracy,
quality, reliability and absence of linkages with decision makers.

Though research is conducted in Pakistan, it is carried out in silos, does not

have relevance to local issues, and quality is often compromised because of
capacity and resources. There is a disconnect between researchers, implementers and
policy makers. Evidence to policy link hence is weak.

4b. Strategic Vision

Innovative technologies will be incorporated to provide speedy and reliant

information to support evidence based decision making at the district level through
District Health Information System (DHIS). Platforms at provincial and national level
for transforming evidence into policy advice will be encouraged including dedicated
units at federal and provincial levels (HPSIU and HSRUs/PSPU).

Governments will be building coherence across health information systems, and will
be investing in key missing areas for monitoring the SDGs as well as national health
targets, and information on vital events such as births and deaths.

The national health vision calls for a transition from medical research to national
health research prioritizing areas as per local requirements. Central hub for
information repository, standardization and quality will be developed at national
level with the assistance of provinces. This will serve to promote evidence based
decision making, policy formulation and health systems research.

Strengthening of information systems at national, provincial and district levels

eventually leading to an effective, integrated disease surveillance and response
system, with a particular focus on Early Warning System.

5. Governance
5a. Challenges
Governance has been a constant challenge undermining service delivery and
budgetary investments. At times patronage plays a significant role in determining
the agenda for health policies and administration in Pakistan, as in other sectors.

The capacity to regulate public and the private sector health market i.e. medical
practice, pharmaceutical, and diagnostics is weak.

There is no uniform approach for managing the governance of health institutions and
the capacity for contracting in and contracting out of services is not optimal.

5b. Strategic Vision

It appears necessary for federal and provincial health authorities to rebuild their
stewardship of the health system through professional independent advice and
technical governance of health services planning, and strive to become the forefront
provider of essential health services provision and delivery.

A steady and purposeful stewardship role of the provinces should bring about
structural changes in the health system. It is envisaged to have sector wide
strategic planning, regulation, purchasing and financing and moving towards
separation of service provision from its stewardship function.

Health services reforms which are already underway should focus more on
performance strengthening of government provided services. Innovative
management models of PHC are envisaged to be tried out with an emphasis for
alignment with preventive health targets.

Private sector should be seen as a partner in healthcare delivery and should be

engaged/regulated through appropriate mechanisms. They should also be engaged
for meeting national SDG targets. Increasing share of public sector budgets
commitment for governance strengthening, and

establishing dedicated structures within provincial and federal ministries. Both

government and private service providers will be involved in performance
accountability and target oriented service delivery arrangements.

Accountability mechanisms at all levels are envisaged to be put in place.

Development of key performance indicators and output based measures would be
helpful in gradual progression towards performance based models.

6. Essential Medicines & Technology

6a. Challenges

The current technologies being utilized in the health sector have not evolved through
a rigorous needs assessment process, leading to misuse of
such
equipment/technologies. Current mechanisms to determine the appropriateness of
supplies, diagnostics, medicines and laboratory reagents are not evidence based.

Package of essential services does not identify the type and quantum of equipment,
supplies and medicines needed to deliver the defined services for a specific health
facility. This encourages irrational procurements, use and spending on technologies
resulting in loss of precious resources.

There are issues related to quality and price of drugs and their prescriptions.
Medicines pricing is a contentious issue between the regulators and the industry.

Health Technology Assessment employing multidisciplinary approaches including

Pharmaco-economics, Pharmaco-epidemiology and Pharmaco-vigilance remains as un-
initiated concepts.

6b. Strategic Vision

Health Technology Assessment (HTA) capacity will be created at federal, provincial

and district level. Governments will be vigilantly monitoring the selection, quality, price
and use of technologies, equipment and medicine, as per international standards.

More evidence and best practices will be collected with regard to medicines related
policies, legislations and operative guidelines; and to translate the same into standard
treatment guidelines. Setting up an entity (e.g. NICE-UK) is another need to
adherence to the standard treatment guidelines and best practices.
The federal and provincial governments will ensure that appropriate regulations are in
place for the control of drugs, devices, diagnostics and biological reagents across the
country, ensuring quality control and patient safety.

Pharmaceutical industry will be encouraged to provide innovative and affordable

solutions to the patients. Pharmaco-vigilance program will be introduced at
federal level and collection centers at provinces.

Drug pricing policy will be implemented, protecting public interest by regulating

prices of essential medicines while allowing long term predictability. Appropriate
policies for Orphan Drugs, Alternative medicine and Medical Devices will also be put
in place.

Strengthening of DRAP and effective Legislation is required for efficient regulation

of drugs, human organs donations, blood transfusions and all therapeutic goods will
be revisited and implemented in spirit.

7. Cross-Sectoral Linkages
7a. Challenges
There is growing awareness amongst public health professionals that their universe is
impacted by the political, social, economic and developmental milieu in which
they operate.

Factors such as illiteracy, unemployment, gender inequality, food insecurity, rapid

urbanization, environmental degradation, natural disasters and the lack of access to
safe water and sanitation all have the potential to aggravate the state of health of
individuals and communities.

A large number of preventable deaths and disabilities among children,

pregnant/ lactating women, young adults and aging population can be averted but
action lies beyond the scope of

and mandate of health

sector. 7b. Strategic Vision

There will be a renewed and synergistic focus on cross-sectoral action for advancing
health, with a particular focus on communicable and non-communicable disease
including mental health and under-nutrition. The concept of “One Health” and
“Health in all policies” will be promoted.

Government will be striving to develop a common vision, framework and a platform

with multiple stakeholders from across the sectors to work for health, for instance
education, food security, agriculture and livestock, housing, sanitation,
water, environment, IT, local government, social protection etc.

In order to gear up its efforts towards SDGs. Government will embark upon advocacy,
planning, legislation, regulation, behavioral change communication, information
exchange, and evidence based decision through joint efforts of different sectors.

Efforts will be geared towards recognition of community involvement, women

empowerment, and local/ rural development being the key channels for cross-
sectoral action, and health will be an inclusive partner.

8. Global Health Responsibilities

8a. Challenges

Sustainable Development Goals (SDGs) and the broader sustainability agenda, need far
more efforts than employed in MDGs, addressing the root causes of poverty and the
universal need for development that works for all people. Achieving international
public health security is one of the main challenges arising from the new and
complex landscape of public health. Treaties like International Health Regulations
(IHR-2005) and Global Health Security Agenda (GHSA) require certain core capacities
that are not yet
appropriately developed at federal and provincial levels.

Progress against other treaties and commitments like FCTC, mHGAP, RMNCAH, FP
2020 and

others gets hindered because of a lack of coordination.

8b. Strategic vision

New global sustainable development agenda will be reflected in all health

strategies and plans, for which governments will be provided technical support and
appropriate expertise.

Mechanisms will be established for coordination across sectors and between

provinces and federal ministry, to prevent, detect, and provide a coordinated response
to events that may constitute a public health emergency of both national and
international concern, including integrated disease surveillance and response, as
laid down by the IHR 2005 and GHSA.

Determining systematically the assets and best practices of polio eradication to be

transitioned and mainstreamed over time to support other priorities, particularly
immunization and vaccine-preventable disease surveillance.

Adherence to other international treaties would warrant a strategic and

coordinated approach to achieve the targets of newly adopted SDGs.

9. Monitoring and Evaluation

A monitoring and evaluation (M&E) mechanism will be developed for the National
Health Vision 2016-2025. It would be in the shape of an M&E Framework and Plan,
linked and coordinated with the Planning Commission for SDG reporting, provincial and
area/region health departments for alignment with strategies, and other stake holders.
. The MoNHSRC will coordinate for these functions.

The M&E plan would describe in detail the specific roles of different facets of the
health system; the processes of data acquisition, flow, analysis, use and feedback;
resource requirements; institutional/organizational infrastructure needs (at
different levels); analysis of currently available competencies and capacities and
specific indicators and their time-lines for gauging performance and results. It will
also define how different levels of government can utilize the data and information
from such a system and even suggest corrective actions where needed.

The M&E framework and its operational plan will focus on progress towards
outcomes and impact, by developing an appropriate balance of M&E tools and
approaches relevant to the proposed objectives, activities, and targets.
Monitoring data will be
verified independently (via third parties). Much of the monitoring will be executed
by the provincial health systems strengthening units (or equivalent entities).
Together these units will track the progress of the health of the nation.

A national body (high level Interprovincial health and population council) will have
the responsibility of oversight of the implementation of the national health vision. It
will endorse the reports for presentation to the parliament on annual basis.

National Drug Policy

A national drug policy is a comprehensive framework in which each component plays
an important role in achieving one or more of the general objectives of the policy
(access, quality and rational use). The policy should balance the various goals
and objectives, creating a complete and consistent entity.

Introduction
Essential drugs are not used to their full potential

Essential drugs play a crucial role in many aspects of health care. If available,
affordable, of good quality and properly used, drugs can offer a simple, cost-
effective answer to many health problems. In many countries drug costs account for a
large share of the total health budget. Despite the obvious medical and economic
importance of drugs there are still widespread problems with lack of access, poor
quality, irrational use and waste. In many settings essential drugs are not used to their
full potential.

Lack of access to essential drugs

Many people throughout the world cannot obtain the drugs they need, either
because they are not available or too expensive, or because there are no adequate
facilities or trained professionals to prescribe them. Millions of children and adults
die each year from diseases that could have been prevented or treated with cost-
effective and inexpensive essential drugs.

Poor quality

In many countries drug quality assurance systems are inadequate because they lack
the necessary components. These components include adequate drug legislation and
regulations, and a functioning drug regulatory authority with adequate resources and
infrastructure to enforce the legislation and regulations. Without these,
substandard and counterfeit products can circulate freely.
Forensic pharmacy

Irrational use of drugs

Even people who have access to drugs may not receive the right medicine in the right
dosage when they need it. Many people buy, or are prescribed and dispensed, drugs
that are not appropriate for their needs.

A national drug policy as a common framework to solve problems in

pharmaceuticals

Experience in many countries has shown that these complicated and interdependent
problems can best be addressed within a common framework, as piecemeal
approaches can leave important problems unsolved and often fail. In addition, the
different policy objectives are sometimes contradictory, and so are the interests
of some of the stakeholders. On the basis of this experience, WHO recommends that
all countries formulate and implement a comprehensive national drug policy (NDP).

What is a national drug policy?

A commitment to a goal and a guide for action

A national drug policy is a commitment to a goal and a guide for action. It expresses
and prioritizes the medium- to long-term goals set by the government for the
pharmaceutical sector, and identifies the main strategies for attaining them. It provides
a framework within which the activities of the pharmaceutical sector can be
coordinated. It covers both the public and the private sector.

Why is a national drug policy needed?

A national drug policy is needed for many reasons. The most important are:

•to present a formal record of values, aspirations, aims, decisions and medium- to
long- term government commitments;

• to define the national goals and objectives for the pharmaceutical sector, and
set priorities;

• to identify the strategies needed to meet those objectives, and identify the various
actors responsible for implementing the main components of the policy;

•to create a forum for national discussions on these issues.

10 | P a g
e
Objectives of a national drug policy

In the broadest sense a national drug policy should promote equity and sustainability
of the pharmaceutical sector.

The general objectives of a national drug policy are to ensure:

•Access: equitable availability and affordability of essential drugs

•Quality: the quality, safety and efficacy of all medicines

• Rational use: the promotion of therapeutically sound and cost-effective use of

drugs by health professionals and consumers.

Importance of the essential drugs concept

The essential drugs concept is central to a national drug policy because it promotes
equity and helps to set priorities for the health care system. The core of the concept
is that use of a limited number of carefully selected drugs based on agreed clinical
guidelines leads to a better supply of drugs, to more rational prescribing and to lower
costs.

The reasons are clear. Essential drugs, which are selected on the basis of safe and cost
-effective clinical guidelines, give better quality of care and better value for money. The
procurement of fewer items in larger quantities results in more price competition
and economies of scale. Quality assurance, procurement, storage,
distribution and dispensing are all easier with a reduced number of drugs. Training
of health workers and drug information in general can be more focused, and
prescribers gain more experience with fewer drugs and are more likely to recognize
drug interactions and adverse reactions.

There is substantial evidence that the use of national lists of essential drugs has
contributed to an improvement in the quality of care and to a considerable saving in
drug costs.

Key components of a national drug policy

A national drug policy is a comprehensive framework in which each component plays
an important role in achieving one or more of the general objectives of the policy
(access, quality and rational use). The policy should balance the various goals and
objectives, creating a complete and consistent entity. For example, access to
essential drugs can
only be achieved through rational selection, affordable prices, sustainable financing
and reliable health and supply systems. Each of the four components of the “access
framework” is essential but not sufficient in itself to ensure access. Similarly, rational
drug use depends on many factors, such as rational selection, regulatory measures,
educational strategies and financial incentives.

Table 1 lists the key components of a national drug policy and shows how they relate
to the three main objectives of the policy.

Table 1. Components of a national drug policy, linked to key policy objectives

Components: Objectives: Acce Quality Rational

ss use

Selection of essential drugs X (X) X

Affordability X

Drug financing X

Supply systems X (X)

Regulation and quality X X

assurance

Rational use X

Research X X X

Human resources X X X

Monitoring and evaluation X X X

X = direct link; (X) = indirect link

As can be seen from the Table, most components cannot be linked to one objective
only. The components are briefly summarized below and are discussed in detail in
Part II (Chapters 4-12).

Selection of essential drugs

Drug selection, preferably linked to national clinical guidelines, is a crucial step
in ensuring access to essential drugs and in promoting rational drug use,
because no public sector or health insurance system can afford to supply or
reimburse all drugs that are available on the market. Key policy issues are:
• the adoption of the essential drugs concept to identify priorities for government
involvement in the pharmaceutical sector, and especially for drug supply in the public
sector and for reimbursement schemes;

•procedures to define and update the national list(s) of essential drugs;

•selection mechanisms for traditional and herbal medicines.

Affordability
Affordable prices are an important prerequisite for ensuring access to essential drugs
in the public and private sectors. Key policy issues are:

•government commitment to ensuring access through increased affordability;

•for all drugs: reduction of drug taxes, tariffs and distribution margins; pricing policy;

• for multi-source products: promotion of competition through generic policies, generic

substitution and good procurement practices;

• for single-source products: price negotiations, competition through price information

and therapeutic substitution, and TRIPS-compliant measures such as compulsory
licensing, “early workings” of patented drugs for generic manufacturers and
parallel imports.

Drug financing
Drug financing is another essential component of policies to improve access to
essential drugs. Key policy issues are:

•commitment to measures to improve efficiency and reduce waste;

•increased government funding for priority diseases, and the poor and disadvantaged;

• promotion of drug reimbursement as part of public and private health insurance

schemes;

•use and scope of user charges as a (temporary) drug financing option;

•use of and limits of development loans for drug financing;

•guidelines for drug donations.

Supply systems
The fourth essential component of strategies to increase access to essential drugs is
a reliable supply system. Key policy issues are:

•public-private mix in drug supply and distribution systems;

•commitment to good pharmaceutical procurement practices in the public sector;

•publication of price information on raw materials and finished products;

•drug supply systems in acute emergencies;

•inventory control, and prevention of theft and waste;

•disposal of unwanted or expired drugs.

Regulation and quality assurance

The drug regulatory authority is the agency that develops and implements most of
the legislation and regulations on pharmaceuticals, to ensure the quality, safety
and efficacy of drugs, and the accuracy of product information. Key policy issues are:

• government commitment to drug regulation, including the need to ensure a sound

legal basis and adequate human and financial resources;

• independence and transparency of the drug regulatory agency; relations between

the drug regulatory agency and the ministry of health (MoH);

• stepwise approach to drug evaluation and registration; definition of current

and medium-term registration procedures;

•commitment to good manufacturing practices (GMP), inspection and law enforcement;

•access to drug control facilities;

•commitment to regulation of drug promotion;

•regulation of traditional and herbal medicines;

•need and potential for systems of adverse drug reaction monitoring;

•international exchange of information.

Rational use
The rational use of drugs means that patients receive medicines appropriate for
their clinical needs, in doses that meet their individual requirements, for an adequate
period of time, and at the lowest cost to them and their community. Irrational drug
use by prescribers and consumers is a very complex problem, which calls for the
implementation of many different interventions at the same time. Efforts to
promote rational drug use should also cover the use of traditional and herbal
medicines. Key policy issues are:

• development of evidence-based clinical guidelines, as the basis for

training,
prescribing, drug utilization review, drug supply and drug reimbursement;

•establishment and support of drugs and therapeutics committees;

• promotion of the concepts of essential drugs, rational drug use and generic
prescribing in basic and in-service training of health professionals;

•the need and potential for training informal drug sellers;

• continuing education of health care providers and independent, unbiased drug

information;

•consumer education, and ways to deliver it;

•financial incentives to promote rational drug use;

•regulatory and managerial strategies to promote rational drug use.

Research
Operational research facilitates the implementation, monitoring and evaluation of
different aspects of drug policy. It is an essential tool in assessing the drug policy’s
impact on national health service systems and delivery, in studying the economics of
drug supply, in identifying problems related to prescribing and dispensing, and
in understanding the socio-cultural aspects of drug use. Key policy issues are:

• the need for operational research in drug access, quality and rational use;
•the need and potential for involvement in clinical drug research and development.

Human resources development

Human resources development includes the policies and strategies chosen to ensure
that there are enough trained and motivated personnel available to implement the
components of the national drug policy. Lack of motivation and appropriate
expertise has been a decisive factor in the failure to achieve national drug policy
objectives. Key policy issues are:

•government responsibility for planning and overseeing the development and

training of the human resources needed for the pharmaceutical sector;

•definition of minimum education and training requirements for each category of staff;

•career planning and team building in government service;

•the need for external assistance (national and international).

Monitoring and evaluation

Monitoring and evaluation are essential components of a national drug policy, and the
necessary provisions need to be included in the policy. Key policy issues are:

•explicit government commitment to the principles of monitoring and evaluation;

•monitoring of the pharmaceutical sector through regular indicator-based surveys;

•independent external evaluation of the impact of the national drug policy on all
sectors of the community and the economy.

2-The National Drug Policy of Pakistan

Introduction
Pakistan is committed to the goal of Health for all by the year 2000 which was
inspired by the principle of social equity. To achieve this, the
Government is taking all possible measures in the field of health services at
large and drugs in particular. Formulation of the national drug policy thus
forms an integral component of its national health policy, purpose of which is
to ensure regular availability of essential drugs of acceptable efficacy,
safety and quality at affordable prices to all irrespective of their socio-
economic status or place of living. Essential Drugs are those which meet the
health care needs of the majority of the population. Hence they will help in
combating disease and maintaining and improving the health of population.
The goal in nutshell is to develop, within the resources of the country
potential through the availability of drugs to control common diseases and to
alleviate pain and suffering.

Towards achieving this goal, Pakistan has drug legislation, a quality

control system, and certain other elements of a drug policy in fragmented
form, but to meet the challenges of the day, a more comprehensive drug policy
is necessary.

This document outlines the National Drug Policy encompassing all aspects of
drugs which has been formulated for the first time in Pakistan to serve as a
future guide.

Objectives
The specific objectives of the National Drug Policy are, as under

To develop and promote the concept of essential drugs and to ensure regular,
uninterrupted and adequate availability of such drugs of acceptable quality
and at reasonable prices.

To inculcate in all related sectors and personnel the concept of rational use of
drugs with a view to safeguarding public health from over-use, misuse or
inappropriate use of drugs.
 To encourage the availability and accessibility of drugs in all parts of the
country with emphasis on those which are included in the National Essential
Drugs List?

To attain self-sufficiency in formulation of finished drugs and to encourage

production of pharmaceutical raw materials by way of basic manufacture of
active ingredients.

To protect the public from hazards of substandard, counterfeit and unsafe drugs.

To develop adequately trained manpower in all fields related to drugs

management.

To develop a research base particularly for operational and applied research

with a view to achieving the above mentioned objectives.

To develop the pharmaceutical industry in Pakistan with a view to meeting the

requirement of drugs within the country and with a view to promoting their
exports to other countries.

Legislation
In order to ensure availability of safe, effective and quality products at
reasonable prices. Pakistan has a fairly modern legislation namely the
Drugs Act, 1976. Under this law comprehensive rule have also been framed on
various aspects of drug control. The law provides a system of licensing of each
manufacturing house and registration of all finished drugs with a view to
ensuring efficacy, safety and quality of the drugs sold in the market. For
licensing and registration Central Licensing and Registration Board comprising
of experts from the field of medicines and pharmacy are established. Quality
Control is ensured through inspection and laboratory services. The law also
provides for compliance of Good Manufacturing Practice by the manufacturers,
for fixing drug prices and for regulation of imports, export, and sale of
drugs. Under this Act, the manufacturing, registering and import/export
are regulated by the Federal Government whereas the sale is regulated by
the Provincial Governments.

These laws have been considered to be fairly modern with correct philosophy
for public safety. These laws shall be modified as and when necessary to keep
them up-to-date as well as to provide legal basis for the support and
implementation of the National Drug Policy.

The manufacture and trade of medicine of traditional systems of medicines

are not being properly regulated resulting in problems of public health. These
shall therefore be regulated by law with a view to their rationalization, to
improve their standards and for the protection of the public from any the
health hazard.
National Essential Drugs List (NEDK):
Preparation of NEDL: The Federal Government and each provincial
government until 1993 had their on lists of drugs for purchases for the
government institutions and thus there was lack of uniformity in these lists.
The concept if graded system if these lists for various levels of Health
Institutions was also not distinctly defined. There was, therefore, an urgent need
to prepare a National list of Essential Drugs of Pakistan with graded lists for
various levels to be implemented uniformly both at the Federal and Provincial
levels. A National Essential Drugs List of Pakistan was thus prepared in 1994 in
view of the health needs of the country with the help of specialists
organizations in the field of medicines and pharmacy from all over the
country. This has already been published and circulated widely throughout the
country.

Bulk purchases for Health Institutions: Future bulk purchases of drugs for
all government and semi-government health institutions shall be made in
accordance with this list. The NEDL has specified the health care levels at
which each essential drug is to be used. Effective and well organized
operating systems shall be developed for procurement and distribution of such
drugs for the population. This shall envisage quantification of the actual
needs for drugs and effective logistics for supply.

Promotion of Essential Drugs Concept: The Essential Drug Concept and

the National Essential Drug List will be promoted in the public and private
sector. Policy will be geared to increase share of essential drugs in local
production and to make such drugs available at affordable prices where-ever
needed. Efforts will also be made to promote rationality in essential drug
prescribing and use. To encourage this, Drug Information Sheets in line
with those of WHO model providing concise, accurate and comprehensive
information shall be prepared and widely circulated.

Comprehensive public information shall be launched to enhance

understanding and acceptance of the Essential Drugs Concept by the
patient and the health care personnel.

In order to promote the concept of Essential Drugs, the doctors in the public
sector shall be persuaded to prescribe rationally cost-effective drugs from the
Essential Drugs List. In order to encourage such practices, unbiased information
about drugs shall be published and widely circulated to the Federal and
Provincial Health Institutions.

A system of audit and accountability shall also be introduced for monitoring the
 prescribing practices. Procurement of drugs in the public sector shall also be
subject to similar audit and accountability.

Review of NEDL: The National Essential Drugs List will be periodically

reviewed and revised every year and made more pragmatic by a committee
that includes competent specialists in clinical medicine, pharmacology and
pharmacy and from other related fields and published.

Criteria for selection of E Ds : For the selection of essential drugs and for
establishing a national program for the use of essential drugs, the guidelines
and criteria recommended by the WHO shall be followed.

Availability of E Ds: The availability of essential drugs which could be in

short supply shall be ensured through the establishment of hospital pharmacy
for manufacture of such drugs and also by providing incentives to the local
industry”’

Constitution of Hospital Pharmacy and Therapeutic Committee ; All

teaching divisional and district hospitals shall constitute “Pharmacy and
Therapeutic Committees” to monitor and promote rational use of drugs in the
hospitals.

Generic names for E Ds: Only generic names will be used for drugs in the
NEDL all public sector drug lists, inventory sheets and tender
documents.
Drug Production
Pakistan has always been following the policy of encouraging manufacture of
drugs within the country. Consequently whereas there was virtually no
pharmaceutical manufacturing in Pakistan at the time of its independence in
1947, today about 80% of the drugs market is from local production by some
285 companies including 25 multinationals. However the industry still depends
largely on imported raw materials and that there is no assessment of the
actual requirement of drugs according to the health needs of the country.

Situational Analysis; In order to have realistic assessment of the real

demand of essential drugs corresponding to our health needs with
quantification of requirements as far as possible, the Government shall
arrange for an in-depth technical, economic, marketing study and critical
analysis of the existing situation in this behalf with a view to find ways and
means to meet this demand.

Measures shall be taken to enhance the formulations, of pharmaceutical

products to facilitate the availability of quality drugs at reasonable prices and
to
bring a high level of self-sufficiency in the country, coupled with a gradual up-
stream integration in the manufacture of active ingredients thorough
exploitation of local flora and fauna, fermentation, synthesis, semi-synthesis,
and application of modern method of bio-technology and genetic engineering.
These measures will include incentives for transfer of technology and import
substitution.

In view of the existing system for creating and stimulating the demand for
medicines and their consumption, options shall be exercised to ensure effective
quality control, to encourage the rational use of medicines, for the
human resources development, as well as for the conduct of operational and
applied research studies in order to produce quality medicines of high
standards meeting the actual health needs.

Pakistan shall try to be self-sufficient in the basic manufacture of

drugs.
Self-reliance in drug manufacture: With a view to creating self-reliance in
the country by encouraging manufacture of pharmaceuticals raw materials by
way of basic/semi-basic manufacture, the following incentives shall be given:

Concessional rates of import duty and sales tax on the import of plant,
machinery equipment which is not produced locally and is required for basic
and semi-basic manufacture of drugs.

Import of all raw materials, chemicals and other consumables required for the
basic / semi-basic manufacture of drugs at Concessional rates of duty and sale
tax.

Tariff protection against imports as and when the production starts

satisfactorily.

For the establishment of basic / semi-basic manufacturing plants the loan

advanced shall be with a dept. equity ratio of 70:30.

Adequate tariff protection to the basic / semi basic manufacture shall be

extended against import of finished drugs on the merits of each case. In case
of general decline in import duty regime, the same level of protective duty shall
be maintained as before, both in respect of import of raw materials and the
finished drugs.

The manufactures shall be made responsible for adequate and timely supply of
raw materials to formulators at reasonable prices.

The quality of the locally produced raw materials shall be of international

standards.
In Semi basic manufacture, there will be a gradual upstream integration towards
 basic manufacture.

In order to encourage introduction of high technology in the country as well as

to bring relative self-sufficiency, the tariff regime shall be so made that it is in
favor of basic manufacture compared to semi basic manufacture so that there
is gradual upstream integration from the later to the former and taking into
account the effect on process and factors of value addition ad foreign
exchange saving.

Basic manufacture of drugs included in the National Essential Drug List shall
be given preferred treatment in tariff rates and in drug prices as compared to
semi basic manufacture or manufacture of other drugs.
National Industry and Export:
To encourage exports of drugs, incentive similar to those available to other
value added export industries shall be made available.

Where a multinational company and a national collaborator partnership split

up, the former shall be permitted either to set up an independent unit or to
enter into a joint venture project only with another national company.

Where a pharmaceutical company has set up its own manufacturing facilities.

It shall be allowed import, if necessary, of products not otherwise
manufactured locally, only for a limited period after which the company shall be
required to start local manufacture of that product.

An institutional mechanism shall be developed so that the national units are

brought at par with the international standards. Transfer of technology shall
be encouraged by allowing contract manufacture by a multinational with
national companies.

Registration of Drugs:
Under the Drug Act, 1976, all finished drugs ready for use are required to be
registered through the Drugs Registration Board. Presently some 13000
products are registered including some 10000 locally produced and 3000
imported products.

The registration shall be granted and reviewed on the basis of established

criteria of acceptable safety, efficacy, in terms of significant therapeutic
value, quality and keeping in view real health needs of the country and the
public interest.

All irrational, unsafe and obsolete formulations and combinations shall be de-
registered.
Fixed ratio combinations products will be registered only when the dosage of
each ingredient meets the requirements of a defined population group and
when the combination has proven advantage over single compounds
administered separately in therapeutic effect, safety or compliance.

Drugs or any indication of a drug which are banned for safety reasons either in
USA, Canada, European Union, Japan, Australia, China, and Switzerland or in the
country of origin shall not be allowed sale in Pakistan.

The present identification number of drugs shall be rationalized on the basis

of various basic entities.

Action has already been initiated to computerize data in respect of drug

registrations. The sphere of activity in this field shall be expanded to. Efforts
shall be made to compute all necessary information relating to registered
products and their procedure for quick retrieval. A more comprehensive drug
information system shall be established in the Ministry of Health in each
Province in respect of registered drugs with facility of retrieval in relation to
medical pharmacological, pharmaceutical and economic aspects.

Information in respect of every registered drug shall be compiled and

published by the Ministry of Health.

For products of foreign companies with parent offices abroad, the indications,
adverse effects, dosing information etc. that were approved in the country of
origin will be accepted. Any other indications would require a separate and
detailed justification. In the labeling of drugs the use of generic names with
at least the same prominence as brand names and necessary information in
national language shall be made as a mandatory requirement.

A system for monitoring of adverse reactions shall be established.

For the registration of a new drug the fact that the drug is registered in one
of certain specified countries (USA, UK, European Union, Switzerland,
Japan and China) would be necessary.

When a MNC or subsidiary of MNC wishes to manufacture a drug already

registered in Pakistan it may be allowed to do this regardless the fact whether
it produces the drug in question in its country of origin.

The import of drugs is allowed to ensure availability and fair pricing through
competition.

Anti-dumping laws shall be enforced in order to prevent dumping when

necessary.
Drug Pricing
Efforts will be made to make availability of much needed drugs at reasonable
prices. In doing so the element of price competition between similar products
shall also be introduced.

The grant of patent protection for drugs shall be only of process and not for
the product. Further after the expiry of initial period provided in the law, no
extension shall be granted in case of drugs. The patent law shall be amended
accordingly. After the expiry of a patent, a fresh pricing exercise shall be
undertaken and a maximum of 15% allowance for R&D may be allowed over
the international prices for the raw materials. Thus transfer pricing over and
above the margin of 15% shall not be allowed the expiry of patent of a
product.

The pricing formula may be revised on the basis of international competitive

prices of raw materials, taking into account the cost of production and
reasonable margin of profit.

Prices of existing registered drugs which are higher shall be revised on the
basis of the revised formula. An annual review shall also be conducted on the
basis of feedback from the provincial governments about the actual sales
prices.

A system for monitoring and evaluation of drug prices shall be developed.

Adequate powers shall be made available under the Drug laws for fixing and
revising drug prices of both finished drugs and their active ingredient.

Drug Supply System:

The drug supply system in both public and private sector is the legacy of the
pre- independence era. Efforts shall be made to bring rationality in these
systems both at the government level and in the private sector.

It will be the policy objective of the Government that the scheme scientific
hospital pharmacy shall be introduced in the country both under the Federal
and Provincial Governments. In order to provide efficient health care service,
hospital pharmacists shall be appointed in all the hospitals of the country at
the rate of one pharmacist for each fifty beds. Efforts will be made to
increase the availability of qualified pharmacists for this purpose. The
Hospital Pharmacy System will be properly organized on scientific lines under
the supervision of graduate pharmacists. They will be assigned with specific
duties to provide an
efficient drug supply system and where possible a limited production of
pharmaceuticals. Model Hospital Pharmacies shall be set up in each Federal
and Provincial Government teaching hospital in line with the system in any
developed country to set an example for the others to follow.

The Federal and Provincial drugs supply system for the hospitals and
dispensaries etc. will be modernized and strengthened and will be managed to
ensure correct ordering, efficient procurement, proper packaging, storage,
distribution and inventory control with less waste through deterioration and
loss. The system will ensure the availability of essential drugs in health
facilities according to their level. Allocated drug schedules for different
categories of hospitals and health units will be followed as far as possible.

In the public sector the procurement of drugs shall be based on reliable

quantification of drug needs. The drugs shall generally be procured under
generic names through competitive tenders and a system shall be developed
for monitoring supplier performance. The average lead time form order to
receipt shall be minimized. The provinces would coordinate and exchange
information on costs in order to ensure reasonable purchase prices. All bulk
supplies of drugs to health institutions shall be obtained in government
approved special packs.

All drugs supplied to the health institutions shall be monitored for quality at
the time of purchases. The provincial government shall also share the results
of their drug testing with Federal Government. Companies supplying any
substandard drug shall not only be required to compensate for compensate for
the loss and shall be debarred for future supplies but their license for
manufacture or as the case may be for sale shall be reviewed and cancelled
where necessary.

In the Private Sector, a system of scientific retail pharmacy service shall

be introduced in a gradual manner and following specific steps shall be taken:

as recommended by the WHO, pharmacists shall be made to play their

recognized in all activities relating to drugs management supply and
distribution. Their services shall be effectively utilized in management of
prescription drugs. To implement this, to begin with. The drug sellers /
distributors having certain turn-over.

Future policy for issuance of drug sales license shall be developed and in view
of the size of the community to be served in the catchment area or on the
basis of area instead of concentrating on one place.

The sale of all potent drugs shall be restricted only on prescription of

registered
 medical practitioner. To begin with all psychoactive drugs, hormonal and
steroidal preparations and antibiotics shall be so restricted. In order to
maintain uniformity throughout the country the Federal Government being so
authorized shall notify such drugs or classes of drugs from time to time.

Training Courses for the existing qualified persons on licenses for retail and
whole-sale shall be conducted in collaboration with the Pharmacy Council,
Pakistan Pharmaceutical Manufacturing Association, Pharmacists
Association and Pakistan Chemists and Druggists Association at the district
level for their orientation on the modern concepts of pharmacy services.

The market intelligence shall be strengthened and import may be resorted in

case

Quality Assurance
Quality assurance, one of the main objectives of this policy, is covered under its
various heading viz: a viz LEGISLATION, REGISTEATION OF DRUGS and DRUG
SUPPLY SYSTEM. However, a well-defined quality control program with special
reference to the inspection and laboratory services exists at both the Federal
and Provincial levels of the country which shall also be strengthened as under.
Inspection Services:

At the Federal level 8 inspectors are working to monitor compliance of Good

Manufacturing Practices at the manufacturing level whereas, at the Provincial
level 81 regular inspectors of drugs in various grades as district, divisional and
chief inspectors have been appointed but in most places without proper
hierarchy. In addition, the DHOs have also been appointed as ex-officio
inspectors in some provinces who are supervise the district drug inspectors. In
some areas separate inspectors have been appointed for factory inspections
and for inspection of sale outlets but without any chain of command. In most
cases they lack facility of transport and funds for purchase of samples,

Under the Federal Government additional posts of Federal Inspectors shall be

created for ensuring compliance of Good Manufacturing practices and to act as
adviser to the industry to improve their standards in a satisfactory manner.
Under the Provincial set up, uniformity in their set up and a hierarchy shall be
created with proper chain of command and clearly defined duties for each
level and efficient system of management and control. Additional inspectors
shall be appointed to check specifically the sale of spurious drugs.

Both at the federal and provincial levels these services shall be equipped with
necessary logistics and communication facilities with a view to ensuring
effective regulatory controls. The inspectors shall also be provided with
regular training to keep abreast of latest quality control techniques and
inspections for compliance of Good Manufacturing Practices (GMPs) and Good
Sales Practices (GPs).

Good Manufacturing Practices: The Good Manufacturing Practices laid down

under the law shall be up-dated from time to time keeping in view the
recommendations of WHO and recent developments in the field of Quality
Control.

With a view to improving Good Manufacturing Practices at the manufacture

level, the number of pharmacists to supervise production in the
pharmaceutical manufacturing houses shall be required in accordance with the
size of the manufacturing facilities. Similar requirements shall be laid for
Quality Control Department also.

Good Storage and Distribution Practices: The existing conditions of

storage both in the public sector and the private sector require a lot of
improvement. For that the Good Procurement, Distribution and Storage
Practices shall be developed and implemented. In case of thermo labile
drugs, cold chain shall be ensure from the level of manufacturer to the end-
user in order to maintain the quality and potency of the product the
importers, manufacturers, distributors, wholesalers and retailers shall be
required to ensure storage facilities which would maintain the quality of the
drug in accordance with Good Storage Practices for each level. Facilities of all
the licensees shall be reviewed carefully in accordance with the Good Storage
Practices at the time of the renewal of their license.

Inspection and Sampling: An inspection and sampling policy shall be

developed so that all essential potent, lifesaving and fast moving drugs are
monitored on priority keeping in view testing facilities available in the
country.

Check lists shall be prepared for self-audit as well as for carrying out
inspections for different types of pharmaceutical establishments by the
inspection services.

Organized Market Surveillance: A program for organized market

surveillance shall be established for monitoring the quality of various products
which are of common use and of and actions will be taken to remove
products of doubtful efficacy from the market. Information regarding products
of standard quality shall be widely disseminated to medical and pharmacy
profession to build their confidence on all competitive products available in
the country.

Spurious Drugs: Manufacture and trade of spurious drugs is a cognizable

 offence special high level teams shall be constituted to monitor the market
and take action to eradicate this menace. The Drugs Act, 1976 shall be
amended so that the seller of such drugs is also made equally responsible as
that of the manufacturer and that the punishment for this offence shall be
enhanced .The manufacturers, sellers and importers or the distributors shall
be responsible to ensure the quality and efficacy of the drugs in accordance
with the requirements of law.

Presently there are five drug testing laboratories in the country. Four are for
routine analysis out of which one is under the Federal Government at Karachi
as Central Drugs Laboratory (CDL) and one each under the Provincial
Governments of Punjab, Sindh and NWFP at Lahore, Karachi and Peshawar
respectively the law provides that anyone who is not satisfied with the results
of the these laboratories can appeal requesting for retesting of the sample by
an Appellate Laboratory. Thus the drug Control and Traditional Medicines
Division at the National Institute of Health.As the most modern laboratory is
assigned with the functions of Appellate Testing. This however lacks necessary
manpower and The Central Drug Laboratory, Karachi is housed in an old
dilapidated army barracks and this along with the Provincial Laboratory are
also deferent in well qualified staff and equipment. The said Drug Testing
Laboratory, Karachi is also not properly housed. There is no laboratory in
Baluchistan and thus the CDI is performing test on behalf of that province.

10. Measure OT Promote Rational Drug Use:

10.1 Drug Information Bulletin: The Drugs Act, 1976, provides for regulation of
promotional activities of the pharmaceutical industry and to allow correct
information to be supplied to the medical profession. From the Government
platform, a Drug information Bulletin is issued from time to time to provide
unbiased information to the medical profession. This shall be published on regular
basis and distributed to all doctors, pharmacists and other health professionals.
Apart from providing these with accurate and timely information, the bulletin will
endeavor to promote the concept to essential drug and their rational use.
10.2 Ethical Criteria for Medical Drug Promotion: The pharmaceutical industry and
all other concerned shall be required to follow the Ethical Criteria for Medical Drug
Promotion which has been developed on the basis of
WHO guidelines will be to allow sales promotion only
through the health institutions though a well-defined system as in practice in some
other parts of the world.
10.3 National Formulary: A National Formulary shall be published in a new
context so as to serve as reliable prescribing and dispensing guide to all doctors and
pharmacists of the country and as an effective teaching aid. Similarly Standard
Treatment Guidelines in important areas shall be prepared and published and made
available for wider circulation.
10.4 Drug Information and A.D.R Monitoring: A computerized Drug Information and
poison Centre and an Adverse Drug Reaction Monitoring Centre will be established
and provided with a comprehensive library and literature search facilities. On the
basis of world-wide information monitoring, these Centers will also undertake post-
marketing surveillance studies of newly registered drug products containing newly
developed drug substance. These Centers shall also provide regular information on
drug to prescribers and pharmacists.

11. Human Resources Development

11.1 There is an urgent need for development of manpower for an efficient
drug supply system and to encourage rational use of Drugs.
11.2 The government will encourage and support facilities in Medical and
Pharmacy Schools to strengthen their curricula in Clinical Pharmacy and Clinical
pharmacology, Therapeutics, Hospitals Pharmacy and Pharmaceutical Technology. The
curricula shall be revised to include promotion of concept of essential drugs, rational
drug use and related subject, e.g., supply management, communication technique and
drug utilization studies.
11.3 Formal and training curricula for ancillary health workers and nurses will
similarly be revised and s strengthened. Facilities of foreign training shall be
provided to pharmacists working in the Drug Control Organization to keep them
abreast of the latest knowledge in the field.
11.4 In-service training courses in rational use of drugs, drug
supply management, communication technique etc., will be organized for pharmacists,
medical officer, graduate nurses and ancillary health workers so as to improve skills
in their respective areas of activity related to drugs.
11.5 Facilities for post graduate studies in pharmacy shall be strengthened
including creating of facilities for the same at the Quaid-e-Azam University.
11.6 Refresher and continuous education courses, seminars and lecturers
to promote the concept of essential drugs and rational drug use will be organized on
a regular basis at the national and provincial levels.
11.7 As recommended by WHO, pharmacists shall be made to play their
recognized role in all activities relating to drug control, management, supply
and distribution. Their services shall be effectively utilized in management of
prescription drugs in particular with the objective of their rational use. The teaching
curricula for pharmacy student shall be revised to provide adequate training to
prepare pharmacists to render efficient health care service with special emphasis on
hospital pharmacy and community pharmacy service.
12. Research and Development
12.1 In the field of research, Drugs Act, 1976 requires the manufacturers
to contribute a certain percentage of their profit (1 %) towards a Drug Research
Fund. These funds will be spent for conducting researches on the development of
new drugs and encouraging rational drug therapy.
12.2 A comprehensive national drug research program will be jointly developed
by the universities and research institutes active in this field according to national
health priorities to ensure coordination and collaboration in drug research.
13. Drug Control Organization
13.1 The Drug and Quality Control Organization at the Federal Level shall be
strengthened as per recommendations of the Management Services Division of the
Cabinet Secretariat and the E.C.C. Committee on ‘Pharmaceutical Regulation’ in
addition to the organizational requirements for implementing the policy. Similarly
the Provincial Drug Control Organization shall be organized in line with the
recommendation of the Senate Committee on health to set up Provincial Directorates
of Pharmacy. By doing so the system of drug licensing, registration and pricing and
quality control shall be made more objective and efficient.
13.2 The existing facilities of manpower in the drugs control administration
and for drug registration are presently inadequate even for day to day work
Additional expert technical staff shall be provided to attend to each of the activities
identified above.

14. Master Plans

In line with this policy Master Plans shall be prepared as follows:
1. a master Plan shall be prepared every five years on the basis of current situation
analysis. The planshall:
(a) Identify the basic problems and the measures to be taken.
(b) Identify the targets to be achieved in quantitative terms in a specified time.
(c) Prepare an estimate of the resources needed to implement the PLAN.

National Essential Drug List

Introduction
The WHO Model List of Essential Medicines (EML), published by the World
Health Organization (WHO), contains the medications considered to be most effective
and safe to meet the most important needs in a health system. The list is frequently
used by countries to help develop their own local lists of essential medicine
  Anesthetics

General Anesthetics and

Oxygen Local Anesthetics

Neuromuscular Blocking Agents

Miscellaneous

 Analgesics, Antipyretics, Non-Steroidal Anti-Inflammatory Drugs

and Drugs Used to Treat Gout

Opioid Analgesics

Non-Opioid Analgesics and

NSAIDS Local Analgesics

Drugs used to treat Gout

 Anti-Allergic and Drugs Used in Anaphylaxis

 Anti-Epileptic

 Anti-infective

Drugs Anthelmintics

Antibacterials

Antituberculosis Drugs

Antifungal Drugs

Antamoebic Drugs

Antiviral Drugs

Antimalarial Drugs and

Prophylactics Antileishmanial Drugs

 Antimigraine Drugs

 Antiparkinsonism Drugs

 Drugs Affecting

Blood Antianaemic Drugs

Drugs Affecting Coagulation

  Blood Products And Plasma Substitutes

 Cardiovascular Drugs

 Dermatological Drugs

 Diuretics

 Gastrointestinal Drugs

 Hormones, Other Endocrine Drugs and Contraceptives

 Immunological

s Diagnostics

Sera and Immunologicals

Vaccines for Universal

Immunization Vaccines for

Specific Use Immunosuppressants

 Muscle Relaxants (Peripherally Acting) and Cholinesterase Inhibitors

 Ophthalmological

Preparations Antiinfective Agents

Miotics and Antiglaucoma Drugs

Mydriatics and Cycloplegics Drugs

Corticosteroids

Non-steroidal Antiallergic/Decongestants

Topical Anaesthetics

Others

Oxytocics and

Antioxytocictocics Peritoneal

Dialysis Solution

Psychotherapeutics Drugs

Drugs Acting on the Respiratory Tract

Solutions Correcting water, Electrolytes AND ACID BASE Disturbance/s
 Vitamins and Minerals

E.N.T. Preparation

Antiseptics and Dis-

Infectants Antiseptics

Disinfectants

 Dental Preparation

 Dispensayy Item

 Drugs for Local Purchase

Antidotes and other substances used in

poisoning Antileprosy Drugs

Antineoplastics, Immunosuppressives and Drugs used in palliative

care Immunosuppressive

Drugs
Diagnostic Agents

 Drugs for Specialized

Centers Antiretroviral Drugs

Prescription Handling a Retail Setup and Record Keeping

Prescription Handling
Steps:
Receiving

Dosage

Calculation

Compounding

Finishing

Pricing

Deliverin

g
-Receiving the Prescription

The Pharmacist must himself receive the prescription. After receiving, the pharmacist
must check for any errors that may appear in the prescription or made by the

physician. It includes two steps:

Reading the prescription

Checking the

prescription

Reading the prescription: The prescription must be thoroughly and carefully read,
from top to bottom.

Checking the prescription: The prescription must be checked for any error or any
incompatibility.

For example, acetylsalicylic acid intensifies the action of codeine. So if such

combination is prescribed, it must be pointed out.

-Dosage Calculation
The Pharmacist must calculate the dose for every patient. If there is a child, his dose
should be calculated using the “Young’s rule” or the “Fried’s rule”. Similarly,
dose calculation for geriatric patients should also be calculated.

-Compounding

The pharmacist must compound the medicines very carefully. The ingredients must
be compounded accurately.

For weighing, electronic apparatus should be used and it should be validated

and caliberated.

Finishing
It includes:

 Packaging

 Labeling

 Rechecking

 Recording

Packaging: It comes after the compounding. For packaging, following containers are
used:

 Round vials

 Oval bottles
  Wide mouth bottles

 Colored bottles

 Collapsible tubes

 Paper wrappers

 Dropper Bottles

Labeling: The packaged container should be properly labeled. The label should be
affixed on the smooth surface of the bottle

Label’s information:
 Type of prescription

 Name, age and sex of the patient

 Date of dispensing

 Storage condition

 Name and address of the pharmacy

 Auxiliary label(In case of liquid preparation)

 Shake well before use

 Route of administration

Rechecking: After labeling, the prescription should be rechecked. Also polish the
container to remove the finger prints.

Recording: A variety of prescription files are available which serve to maintain and
preserve the original prescription in numerical manner.

-Pricing
The prescription should be priced immediately after receiving and the patient should
be informed about it. It should be done before compounding to avoid any dispute.

-Delivering
Finally the order supplies are delivered to the patients either at the pharmacy or
Home deliver.

Record Keeping
Draft Guidelines on Record Keeping for Medicinal Products in a Retail Pharmacy
Business.

1. Introduction
The purpose of these guidelines is to facilitate compliance with Regulation 12 of the
Regulation of Retail Pharmacy Businesses Regulations 2008, which details the records
to be kept in respect of medicinal products when conducting a retail pharmacy
business (i.e. a pharmacy). The requirements for some other important records that
ensure safe pharmacy practice are also detailed.

Pharmacists are the healthcare professionals authorized in legislation to be

responsible for the safe keeping and supply of medicinal products to patients. The
keeping of accurate records which clearly show when prescription-only medicines
are supplied, and to whom, is a key requirement of this role. The keeping of
appropriate records also supports the provision of safe services, continuity of care,
evidence-based healthcare, good professional practice and management of the
medicines supply chain.

This guideline does not cover record keeping requirements pertaining to the sale or
supply of medicinal products intended for use in animals, for information on this topic
please refer to the PSI website.

2. Legislative Basis
The operation of a registered pharmacy is governed by the Pharmacy Act 2007 and
the Regulation of Retail Pharmacy Businesses Regulations 2008 (S.I. No. 488 of 2008).

These guidelines focus on the requirements of Regulation 12 of the Regulation of

Retail Pharmacy Businesses Regulations 2008, the full text of which is set out
below. The need to keep records in respect to medicinal products, when conducting a
pharmacy, is set out under a number of different legislative requirements, including
Regulation 10 of the Medicinal Products (Prescription and Control of Supply)
Regulations 2003 (S.I. 540 of 2003) (as amended) and Regulation 16 of the Misuse of
Drugs Regulations 1988 (S.I. No. 328 of 1988) (as amended) which are included in the
appendix for reference.

It should be noted that in addition to pharmacy and medicines legislation, records

must comply with the provisions of the Data Protection Acts 1988 and 2003. Further
information on the general principles of data protection can be found in the
PSI’s ‘Guidance on Data Protection for Pharmacists’, and on the Data
Protection Commissioner’s website www.dataprotection.ie.

All legislation can be accessed in full through the PSI website or

www.irishstatutebook.ie.
Keeping of records in respect of medicinal products
12. (1) A person carrying on a retail pharmacy business shall keep— (a) such
records as are prescribed under Regulation 10 of the Medicinal Products
(Prescription and Control of Supply) Regulations 2003 (S.I. No. 540 of 2003) (as
amended); (b) such register as is prescribed under Regulation 16 of the Misuse
of Drugs Regulations 1988 (S.I. No. 328 of 1988) (as amended); and (c) such other
records in electronic form as will enable the patient in respect of whom a
medicinal product has been supplied on foot of a medical prescription to be
identified together with the said patient’s medication record in respect of his
or her previous supplies of such products made by the pharmacy.
(2) Where the records referred in paragraph (1)(a) are retained in electronic format,
the computer software in use for the retention of such records shall have been
independently validated and certified as being suitable for the retention of such
records, having regard to the purpose of such controls under the Medicinal
Products (Prescription and Control of Supply) Regulations 2003 (S.I. No. 540 of
2003). Such certification shall appropriately show the version of the software to
which the certificate relates and the date on which it was last updated1.
(3) The person responsible for the conduct of such validation and for the issue
of the required certification shall be a person approved by the Minister for Health and
Children.
(4) A person carrying on a retail pharmacy business shall—
1 Regulation 12(2) allows the prescription register
to be kept solely in electronic format if the computer software has been
independently validated by a body approved by the Minister for Health and
certified as suitable for the retention of such records. However to date, the
Minister for Health has not approved a body to carry out this function. Therefore,
a hard copy print out of these records must be made to meet the requirements
of the legislation.
(a) in the case of records referred to in paragraph (1)(a), keep such records readily
available for inspection as required under Regulation 10(3) of the Medicinal
Products (Prescription and Control of Supply) Regulations 2003 (S.I. No. 540 of 2003),
and (b) in the case of the certificate referred to in paragraph (2), keep a certified copy
of the said certificate readily available for inspection.
3. Guidance

The following guidance outlines the record keeping requirements when a

prescription- only medicine, including a controlled drug, is supplied to a patient.
Record keeping requirements for supply of medicines in other circumstances are also
detailed.
Records Related to Supply of a Prescription-Only Medicine
Regulation 10 of the Medicinal Products (Prescription and Control of Supply)
Regulations 2003, (as amended) specifies the details that must be recorded in
a register when a prescription-only medicine is supplied on foot of a prescription and
when supplied without a prescription as an emergency supply.

Supply of a Prescription-Only Medicine on foot of a Prescription

When a Prescription-Only Medicine is supplied on foot of a legally valid prescription,

the following must be recorded in a register:

 date on which the product is supplied,

 name, quantity, and except where it is apparent from the name, the
pharmaceutical form and strength of the product,

 name of the prescriber and, where they are not known to the pharmacist,
their address,

 name and address of the patient,

 date written on the prescription.

Supply of a Prescription-Only Medicine on foot of a Repeat

Prescription
Where the prescription is repeatable the following must be recorded in the register
on the second or subsequent supply of a prescription-only medicine:

Either:

 date on which the product is supplied,

 name, quantity, and except where it is apparent from the name, the
pharmaceutical form and strength of the product,

 name of the prescriber and where they are not known to the pharmacist,
their address,

 name and address of the patient,

 date written on the prescription,

 where the supply on the previous occasion was at another pharmacy,

 the name and address of that pharmacy, and the reference to the entry in
the register for that pharmacy in respect of the supply, where available.

Or:
date on which the product is supplied, and a reference to the entry in the register
 made on the first occasion the product was supplied against that prescription.

This Regulation also specifies that prescriptions, (in the case of a health prescription4
the duplicate copy of that prescription) must be retained for a period of two years
on the pharmacy premises and be readily available for inspection. The retention
period begins from the date on which the medicinal product was supplied, or for
repeatable prescriptions from the date on which the prescription was dispensed for
the last time.

When a prescription which is not completely dispensed is returned to the patient for
future supplies, it is recommended to keep a copy of the prescription for reference, in
the event that there is a query with the supply or the patient’s care.

Emergency Supply of a Prescription-Only Medicine

Where an emergency supply of a prescription-only medicine is made without a
prescription at the request of a patient, the following must be recorded in the
register:

 date on which the product is supplied,

 name, quantity, and except where it is apparent from the name, the
pharmaceutical form and strength of the product,

 name and address of the patient,

 nature of the emergency which made it necessary to supply the product

without a prescription,

 name of the prescriber who prescribed the product on the previous

occasion and where they are not known to the pharmacist, their address,

 where the supply on the previous occasion was at another pharmacy, the
name and address of that pharmacy and the reference to the entry in
the register for that pharmacy in respect of the supply, where available.

Where an emergency supply of a prescription-only medicine is made without a

prescription, at the request of a doctor, dentist or nurse prescriber the following must
be recorded in the register:

 date on which the product is supplied,

 name, quantity and, except where it is apparent from the name, the
pharmaceutical form and strength of the product,

 name of the prescriber and where they are not known to the pharmacist,
their address,
  name and address of the patient,

 date written on the prescription,

 date on which the prescription is received.

Further information on the legal requirements for the emergency supply of

prescription- only medicines is available in the PSI ‘Guidelines on Counseling and
Medicine Therapy Review in the Supply of Prescribed Medicinal Products from a
Retail Pharmacy Business’.

Records for Supply to a Person for Administration in their

Professional Practice and other Circumstances
Legislation provides exemptions to the prescription requirement for the supply of
prescription-only medicines, by a pharmacist, to specified persons. For example
a pharmacist can supply a prescription-only medicine to a registered medical
practitioner, registered dentist or registered veterinary surgeon, for administration to
patients in the course of their professional practice or service. A pharmacist can also
supply a medicinal product in other circumstances, for example to a University
or other institution concerned with higher education or scientific research for the
purposes of such education or research.

The practitioner/person making the request for such a supply should provide a
written order/requisition to the pharmacist.8 Every order or invoice, or copy of these,
relating to the supply of a medicinal product under these Regulations must be kept
for a period of two years on the pharmacy premises, and be readily available for
inspection.

Where an order or invoice, or copy of these, is not retained by the supplying pharmacy,
the following must be recorded in a register kept for that purpose:

 date product is supplied,

 name, quantity, and except where it is apparent from the name, the
pharmaceutical form and strength of the product

 name, address and trade, business or profession of the person to whom

the product is supplied

 purpose for which the product is supplied.

A pharmacist who supplies medicinal products under these regulations should be

satisfied, in so far as is possible, that the medication will be used appropriately. If a
pharmacist receives a request for a supply of a medicinal product, and is unsure if it is
legally permitted, or what records need to be made, they can contact the PSI for
further
guidance.

Requirements for the Register/Daily Dispensing Report

The requirements outlined above in 3.1 and 3.2, must be made in a physical, hard copy
register kept for that purpose or can be kept as computerized records provided that
this record is also retained in the form of a print-out for each day that the pharmacy
is open. This register is often referred to as the ‘prescription register’, ‘daily
dispensing report’, ‘daily audit’ or ‘daily print-out’.

Where these records are made electronically and printed each day, the print-out
must be dated and signed by the pharmacist on duty on the day to which the print-out
relates, or within 24 hours. The print out should provide an accurate record of
prescription-only medicines supplied from the pharmacy on a given day and it should
be clear and legible.

The register, (i.e. the daily dispensing report, signed and dated) must be kept
for a period of two years from the date of the last entry made in the register, or the
date the print out was signed by the pharmacist on duty. This record must be kept on
the pharmacy premises and be readily available for inspection.

The legislation provides an exception to the requirements to keep the records

detailed in sections 3.1 and 3.2, where the medicinal product is supplied in
accordance with a health prescription, as the duplicate part of the prescription is
retained, and also where a separate record of the supply has been made in the
controlled drugs register. However in order to maintain a complete and accurate
record of all medicines dispensed on a given day it is recommended that these
supplies are also included in the prescription register/daily dispensing report.

Records Relating to Supply and Administration of Medicinal Products

in Emergencies, Supply and Administration of Vaccines and Supply
of Emergency Medicines to Listed Organizations
Regulation 10A of the Medicinal Products (Prescription and Control of Supply)
Regulations 2003 (as amended), details the particulars that must be recorded when a
pharmacist administers an emergency medicine or vaccine in the course of his or her
professional practice. These requirements are detailed in the PSI’s ‘Guidance for
Pharmacists on the Safe Supply and Administration of prescription-only medicines for
the Purpose of Saving Life or Reducing Severe Distress in an Emergency’ and
‘Guidance on the Provision of Vaccination Services by Pharmacists in Retail Pharmacy
Businesses’. Regulation 10B details the particulars that must be recorded when
a pharmacist supplies a prescription-only medicine to a listed organization for
administration in an emergency situation (guidance on supply under this provision
will be published shortly).

Patient Medication Record

Regulation 12(1)(c) of the Regulation of Retail Pharmacy Businesses Regulations 2008
requires an electronic record to be kept to enable identification of a patient’s
medication history. A record of supply must be made each time a medicinal product
is supplied to a patient on foot of a prescription. This record is commonly known as
the Patient Medication Record (PMR). This record allows the pharmacist to check the
patient’s previous medication history when dispensing medicines and helps to inform
their decisions, for example with regard to potential interactions or contraindications.
The PMR should contain all information that the pharmacist deems necessary for the
accurate identification of a patient and the safe supply of their medicinal products, for
example the patient’s date of birth, any known allergies or adverse drug reactions and
full contact details for the patient, and the practitioner who prescriber the
medicinal product.

Recording professional advice and care provided by the pharmacist in the PMR,
or similar programme, can also improve patient care by demonstrating the reasons
behind the pharmacist’s actions, and help to demonstrate that the appropriate
standard of care was provided. Documenting all relevant information also enables
effective communication between different pharmacists and healthcare professionals
caring for a patient. Information documented can include details of a conversation
with another healthcare professional or particular advice that the pharmacist
provided to the patient. Information should be recorded in a clear, concise and
consistent manner which can be easily understood by colleagues and does not create
ambiguity.

Controlled Drugs
Records for Receipt and Supply of Schedule 2 Controlled Drugs
Regulation 16 of the Misuse of Drugs Regulations 1988 (as amended) details the
requirements for the keeping of registers for Schedule 2 controlled drugs.
Pharmacists have a responsibility to supervise the supply of controlled drugs and
ensure that these medicinal products are supplied safely and within the
requirements of the legislation. In order to fulfil this role the legislation requires
that an accurate and contemporaneous record of the receipt and supply of Schedule
2 controlled drugs from the pharmacy is made in a controlled drugs register. The
controlled drugs register is defined in legislation as ‘a bound book and does not
include any form of loose leaf register or card index’; Schedule 6 and 7 of the Misuse
of Drugs Regulations 1988 (as amended), provides details of the form that the
register must take i.e. headings for details to be
recorded. The legislation does not permit the controlled drugs register to be kept
electronically.

The PSI provided a Register of Controlled Drugs to all pharmacies to assist in meeting
the requirements of the legislation.

The following are the requirements for completing the controlled drugs register:

 Entries must be in chronological order, and include particulars of every

quantity of such a drug obtained and of every quantity of such a drug
supplied from the pharmacy.

 Where a portion of a prescription is dispensed, only the actual amount

supplied is to be entered in the controlled drugs register. Any
outstanding balance on the prescription should only be entered in the
register on the date it is supplied.

 There must be a running stock balance maintained for each drug.

 A separate register or separate part of the register must be used for

each class of drug (i.e. each drug name).

 Only one register must be kept at one time for each class of drug and
there must only be one entry in the register for each individual
product.

 The class of drug must be specified at the head of each page.

 A separate page should be used for each controlled drug product i.e. for
each dosage form (tablet, capsule, ampoule, suppository, syrup etc.) and
each strength.

 Each entry must be made on the day the drug is obtained or supplied, or
if not reasonably practicable the following day.

 Following the supply of methadone in installments, each installment

should be entered on the prescription and when the full prescription
has been dispensed the total amount supplied must be entered in the
controlled drugs register and the entry dated with the date of final
supply.

 Cancellation, obliteration or alteration of any entry must not be made. A

correction of an entry can only be made using a marginal note or
footnote which must include the date on which the correction is made.
This note should be signed by the relevant pharmacist.

 Each entry, or correction of an entry, must be made in ink or otherwise

so as to be indelible.
  The register must not be used for any purpose other than recording the
receipt and supply of controlled drugs.

 Only one register must be kept at one time in respect of each class of
drug.

 A separate register must be kept in respect of each pharmacy premises.

 Where the business is carried on in separate departments within a

premises, a separate register may be kept in respect of each such
department with the approval of the Minister.

 The register must be kept at the premises to which it relates and be

readily available for inspection.

 The controlled drugs register must be preserved for a period of two

years from the date of the last entry made in the register.

It is recommended that the supervising pharmacist should regularly review the

register and satisfy themselves that the register has been completed correctly, by
reconciling the register’s running stock balances for each product with the
contents of the controlled drugs safe.

The record keeping requirements for the destruction and disposal of controlled drugs
are detailed in the PSI’s ‘Guidelines on the Disposal of Medicinal Products for a Retail
Pharmacy Business’.

Retention of Other Controlled Drugs Records

Every order, prescription or requisition against which a controlled drug is supplied
must be kept for a period of two years on the pharmacy premises and be readily
available for inspection. In the case of a health prescription, or health service
requisition, the duplicate copy must be retained for two years. The retention period
begins from the date on which the last supply of a controlled drug was made against
the order, prescription or requisition.

It should also be noted that there is a legal requirement to keep every invoice, or other
like record issued in respect of a schedule 3 controlled drug obtained or supplied
from the pharmacy, and in respect of every schedule 5 controlled drug obtained, for a
period of two years.

Supply of Exempt Medicinal Products

Legislation permits a pharmacist to supply an ‘exempt’ (i.e.
unauthorised/unlicensed) medicinal product against a legally valid prescription.
When an exempt medicinal product is sold or supplied, a record showing the following
details must be kept:
  source from which the product is obtained,

 name of the patient,

 date on which the product is supplied,

 quantity of each product supplied,

 batch number of the product,

 details of any suspected adverse reactions to the product supplied,

of which the pharmacist is aware.

This record must be retained for at least 5 years17 and be readily available for
inspection. Further information on sourcing exempt medicinal products can be found
in the PSI’s ‘Guidelines on the Sourcing of Medicinal Products for Sale or Supply by a
Retail Pharmacy Business’

Other Important Records to be kept to Ensure Safe Practice

When operating a pharmacy, in addition to recording the supply of medicinal products,
there are other important records that must be kept in order to demonstrate that
the pharmacy is operating safely. For example, a record of the registered
pharmacist, responsible for the pharmacy, or for the personal supervision of the sale
and supply of medicinal products at the premises (i.e. the Duty Register), records for
the preparation of extemporaneously prepared medicinal products, for the
delivery of medicinal products to patients, medicinal product recalls in response to a
recall notifications, the recording of fridge temperatures and records for professional
services provided in the pharmacy. Many of these records are detailed in other PSI
guidance. It is the responsibility of the pharmacy owner, in partnership with the
superintendent and supervising pharmacist, to identify all necessary records
which relate to the safe operation of their business and ensure these are being
made and kept.

It is recommended that records to show the safe operation of the pharmacy are kept
for a minimum period of two years.

Ensuring Accuracy of Pharmacy Records

It is important that records are complete, accurate and up to date. Full details for the
patient and the prescriber should be recorded so that they can be clearly identified
and contacted if needed. Pharmacists should be alert to any errors or discrepancies
in pharmacy records. This may be anything from the incorrect doctor or an old
address recorded on the PMR, to a dose recorded in the patient’s history which differs
from that which is on their current prescription. Discrepancies or errors in records
should not be ignored, as this can have serious consequences for the patient,
and also in certain
circumstances for colleagues and the safe operation of the pharmacy. It should be
clear when an amendment has been made to a record. All errors and discrepancies in
records should be followed up and investigated further as needed.

Policies and Procedures, as well as practice within the pharmacy should be reviewed
following the identification of a discrepancy or error in the pharmacy records, and staff
retrained to minimize the chance of a similar incident happening again.

Access to Records
A system should be in place to enable the timely and efficient retrieval of
records, registers and dispensed completed prescriptions when they are needed,
whether records are maintained in paper or electronic form. Where records are held
electronically regular back-ups should be made, and the back-up process regularly
verified. Any area where paper records are stored should ensure that security and
confidentiality is maintained at all times to protect patient privacy. As records held
in the pharmacy often contain personal data about patients’ medication history
and medical conditions, there should be systems in place to ensure that records are
only accessed by authorized persons in the course of their professional practice or
duty within the pharmacy.

On ceasing the operation of a pharmacy,
transfer of pertinent records to another
data as required by patients. For
‘Guidelines on Managing the Closure and
Pharmacy Business’.
appropriate provision must be made for the
pharmacy and for the retrieval of personal
further guidance please see the PSI’s
Cancellation of the Registration of a Retail

4. Staff Training

Staff members dealing with records should be competent and trained on the creation,
maintenance and use of records. They should understand the importance of records
being accurate, complete and made in a timely fashion. This training should include an
understanding of:

 what is being recorded,

 how it should be recorded,

 why it needs to be recorded,

 what the records are used for,

 when to access records,

 how to report any errors or discrepancies found in pharmacy records to

 the pharmacist.

All Staff members should also be trained on the importance of confidentiality with
regards to patient records and other information which they see and use in the
course of the business of the pharmacy.

5. Policies and Procedures

The pharmacy owner, superintendent pharmacist and supervising pharmacist have

overall responsibility for ensuring that appropriate records are being made and kept
securely in line with medicines and pharmacy legislation, Data Protection legislation
and PSI guidance.

Policies and Procedures should be in place detailing all records that need to be made
in the course of the business of the pharmacy and to ensure that the correct records
are consistently made. Procedures must ensure that records are kept in a secure and
confidential manner, and access to the records is restricted to trained staff members
in the course of their duties in the pharmacy.

There should be a defined retention period for all records which is clearly
documented. When considering how long to retain a particular record, as well as the
requirements set out in legislation, it is important to consider whether it is necessary to
retain the record to ensure the provision of safe services to patients or for other legal
or insurance purposes.

The superintendent pharmacist and supervising pharmacist must be satisfied that all
pharmacists practising in the pharmacy, and relevant staff members, are trained on,
and are following, the policies and procedures relevant to their role.
Compliance with policies and procedures should be regularly evaluated and training
records should be maintained.

6. Self-assessment Checklist

This self-assessment checklist is a practical tool intended to aid compliance with

these guidelines and to assist superintendent and supervising pharmacists in drawing
up the relevant policies and SOPs. The checklist captures many important elements
of the guidelines; it is not exhaustive and should only be used to assess pharmacy
practice in combination with these guidelines and all other relevant guidance and
requirements.

Ask Yourself Ye N N Required

s o / Action
A
Is an electronic record made on the Patient Medication
Record each time a prescription only medicine is
supplied to a patient?

Is a prescription register maintained, or a daily

dispensing report printed, dated and signed by the
pharmacist, for each day the pharmacy
operates, detailing all prescription-only medicine’s
supplied from the pharmacy?

Are all schedule 2 controlled drugs received by, and

supplied from, the pharmacy recorded in the
controlled drugs register?
Are records made when an exempt medicinal product is
supplied against a legally valid prescription to a
patient?

Are written policies and procedures in place detailing

all records that need to be made in the course of the
business of the pharmacy?
Are the retention periods for all records
clearly documented?

Are all records kept in compliance with the provisions

of the Data Protection Acts 1988 and 2003?
Is the pharmacy owner, superintendent pharmacist and
supervising pharmacist satisfied that all pharmacists in
the pharmacy, and relevant staff members, are trained
on, and following the policies and procedures?

Forensic drug measurement

Forensic science:
It is application of science to find the truth and help in matters of law. Other
related definitions of forensic may include

(1) The use of science to aid in the resolution of legal matters and

(2) A scientific analysis for the purpose of judicial resolve.

Forensic Scientist:

A person, who with his scientific knowledge, educational background ,training and
experience analyses evidence and interprets the results for legal purposes.

Role of forensic scientist:

In the field of forensic science forensic pharmacist plays an important role in the
investigation of crime in the laboratory. As a forensic pharmacist they don’t directly
solve the crime they first analyze the evidence collected by police officer or or
specially trained crime science investigator and these evidence are not limited to
those which is send to the laboratory by inspector but there are some other evidence
which also very helpful in determination of chemical substance or in solving of crime
scenes and these evidence includes eye victims of crime, police reports, crime
scene notes and sketches.[3]

Forensic drug chemistry:

In order to investigate the substance physical and chemical chemistry of drug
substance is an important tool in the determination of chemical substance because
without these e chemistry principle it will be difficult to investigate the drug
compound involve in the crime case.

Application:

It is use for the examination of all illegal substance and poison of plant origin and
other products and for the analysis of contraband materials

Two types of test are performed for the identification of substance

Preliminary test confirmative

Color tests. GC-MS

UV, VIS Spectrophotometric methods. FTIR

TLC GC-IR

GC. NMR

HPLC. . Ms-MS ICP-Ms,

Crystal tests. NAA, XRD

Polarimetry

These types of analysis or test is used to identifies the "question sample”

Presumptive analysis or preliminary test:

It is relatively quicker as compare to the confirmative analysis and performed to

test the physical and chemical characteristic of the drug to reduce the chances of
error in identification of the drug

Confirmative analysis:

This type of forensic analysis is used to performed a confirmative test to identify the
exact substance

THEORY OF FORENSIC ANALYSIS:

This figure shows the theory of forensic analysis performed by forensic specialist
After getting all the evidence from the, police officer forensic chemist is then
perform different analysis test to identify the exact substance .the chemist follows
the specific scientific method for the edification of sample. Sample which is
collected is unknown because its identity and origin is unknown and this unknown
sample is called as a Question sample which is then compare with reference sample
following are the different reason for which forensic analysis is performed

(1) To identify the question sample

(2) and to compare the sample or questioned sample with the known sample to
identify its origin as a result of this comparison these samples are compare with class
of substance with different origin or to individual of known origin to perform these
analysis forensic pharmacist or chemist will follow the order as mentioned in the
given figure 1)identification 2)classification n 3)individualization

Identification:

when questioned sample is given or submitted to the forensic laboratory for the
identifition of substance various test will perform to test the physical or chemical
characteristics of drug such as color odor if powder is seems white or suspected that
it is a control substance then various types of chemical tests are also performed to
identify the exact compound or to reduce the chance of error in identifying exact
substance

General method which is involve in analysis of substance is based on scientific

method which you can see in the picture
1) Observation

2) Suggest the hypothesis

3) Device a plan

Explanation:

in the first step of scientific method scientist make some observation about the
properties of sample by analyzing its chemical and physical properties and in the
second step scientist will suggest a hypothesis that tentavily explain what is being
observed and then plan is devise to test the hypothesis

as mentioned in the scientific method how the analysis are performed in the
identifition of unknown compound to identify the substance or to identify the exact
compound two types of analysis will perform by forensic scientist 1)presumptive or
preliminary test 2)confirmative test

presumptive test used to test the chemical and physical characteristics of substance
which are not known this will help in narrowing the chemical test to identify the
exact chemical substance in the given figure presumptive analysis of
methamphetamine as we know that methamphetamine will react with sodium
nitroprusside and give blue color indication and hence identified in this way as
presumptive analysis is quicker as compare to the confirmative analysis because it is
more complex as compare to pre lenitive test and required a trained specialized
personal for the performing it on some complex instruments which is listed above
and one of them is shown in figure below infrared spectra photometry it will detect
the question sample by measuring its interaction with infra red light this fraction
of interaction which is function of
wavelength is sometime called as chemical figure printing and this type of technique
is unique in the detection of the pure substance as question sample is not pure may
contained ore than one substance so another technique as separation technique is
required busing instruments called gas’s chromatography -mass spectrometer

The compound which is separated by gas’s chromatography is then separated into the
fragments and these mass of each fragments is measure by mass spectrometer

Comparitive analysis classification and individualization

The purpose of comparative analysis is to link the question sample with known
sample to know the origin of unknown compound . The origin may be broad resulting
in classification, or exclusive resulting in individualization

Test performed in forensic toxicology department : following are the test

performed in forensic toxicology department few of them are

TEST no 1:

Alcohol panel test liquor: used for screening and quantification of (ethanol) ethyl
alcohol and other volatile substances

Specimen: 2-3 ounce sample or blood or urine or other specimen for drunken alcohol

TEST no 2:
Individual drug analysis: individual testing can be requested for the for the
following drug classes and include screening confirmation and quantification Name of
the drugs cannas binoids ,cocain,opiates,amphetamines ,benzodiazepines etc
Specimen: Blood or urine or other specimen

Test no 3:
Drug of abuse panel:

Includes screening confirmation and quantification for the following drugs or

chemicals opiates, amphetamines, barbiturates, benzo dizepines, cannabinoids, cocain,
fentanyle, methamphetamine etc

Specimen: blood or urine or other specimen

Test no 4:

Comprehensive drug screen:

Including screening confirmation and qualification for a drug of abuse, most therapeutic
drugs and compound also include an alcohol panel and sedative and hypnotic drugs.

Specimen: blood or urine or other specimen

Test no 5:
Carbon mono oxide: including screening confirmation and qualification of carbon
mono oxide

Specimen: blood

Test no 6:
Clinical chemistry: include quantization Na*, K*, Cl*, GLUCOSE, CARBON DI OXIDE,
BUN, keratinize

Specimen: vitreous humor

References:

1-NFSA NATIONAL forensic science agency guidence about toxicology department

working for the investigation of unknown compound and tests
2-2-PFSA GUIDElines( punjab forensic science agency guidelines for the forensic toxicological
analysis

3-PJA (punjab judicial acedmy ) information about the role of forensic

pharmacist 4-RESEARCHGATE) (overview of forensic pharmacist

practice)
Postmortem Redistribution

Introduction:

"Post mortem (after the death) also called autopsy or necropsy" it is usually performed
by specialized medical doctor called pathologist

Following are the different types of autopsy which are performed

1) medico-logo autopsy or forensic autopsy: it is carried out when the cause of

death may be criminal matter.

2) Clinical or pathological autopsy: are usually performed to diagnose the

particular disease or for the research purpose.

3) Anatomical or academic autopsy: these type of autopsy are performed by the

anatomy students for the study purpose

4) Virtual or medical imaging autopsy:

These types of autopsy are performed by using different types of imaging technology
for example MRI magnetic resonance imaging and CT computed tomography.

Definition:

"Drug movements within the body after death which cause time-dependent variations
in blood and tissue drug concentrations prior to autopsy."

In forensic toxicology during postmortem of death body it is difficult to find out the
exact concentration of lethal or toxic dug form the dead body. Because during
sampling this concentration may vary according to the sampling site and interval
between the collections of sample at time of death so this type of time -site variation
is called postmortem redistribution. According to research of various scientist

1) There are certain organs which acts as source of such PMR

2) pharmacokinetics properties of molecule(like Pka, volume of distribution and

protein binding etc) is an important factor in determine the concentration of drug in
postmortem and also helps in identifying the mechanism which is involved in PMR

3) Cell or tissues modification during putrefaction process may also involve in this

1) Sources of postmortem redistribution:

Many drugs are categories as ante mortem drug in organ which acts as a drug reservoir
for that drug but after the death they are redistributed to surrounded tissues.

so there are various organs which acts as reservoir of drug for example
gastrointestinal tract or viscera with high concentration power such as liver, lungs (the
myocardium also
).

There are two mechanism which are involve in PMR

1) Diffusion through the blood vessels

2) Transperietal diffusion towards the surrounding organs

Explanation:

Mechanism which is involve in the redistribution of drug is listed above and let
explain it with brief explanation that how it will occur in the body to understand it
more clearly after the death there is a post mortem diffusion of drug along the
concentration gradient from site of higher concentration in solid organ into the
blood. that why higher drug concentration were found in the central vessels such as
pulmonary artery and vein and lowest drug concentration were found in peripheral
vein such as sub Clarian and femoral vein.

It is recommended that drug should be collected from the at least two areas of the
body at autopsy one is peripheral and second is central area using a cardiac blood as
a central sit and femoral drug as peripheral site so that comparison can be made.

Within the torso major organ constitute the potential drug pools, and gastro intestinal
trac contain the unabsorbed drug so central blood is subjected to redistribution
from these organ while the peripheral drug (femoral blood) subjected to re
constitute from local tissues for example muscles and Fat. and generally
redistribution of drug of central site is greater than that of peripheral sit and
comparison of both sample is called as central to peripheral ratio C/P. so sometimes
pathologist is requested to tell the concentration of drug or quantity of drug and it
was assume that concentration of drug in post mortem examination is reliable to
that concentration of drug which is present at a time of death of person because of
lack of evidence these estimation are performed but sometimes entemoterm and
post mortem data are also compare as entemoterm drug concentration from various
sites are present from a lot of research but these types of comparison studies are
not performed more extensively because a lot of of entemoterm sample are not
available . And as a pharmacist we have a complete knowledge of pharmacokinetics
of drugs for example ph, pka, volume of
distribution, lip solubility these are the factors which in flounce the drug blood or tissue
concentration weather person is alive or dead. But after the dead of a person what
will happen digestion, metabolism, blood flow breathing stops and decomposition will
start [1]

Cell death:

after the death breathing is stop and there is no longer supply of oxygen to the cell
which is import in the production of ATPs from NADH hence no ATP production in the
cell then it will lead towards the cell death and more lactic acid accumulation will
results in decrease in intracellular ph which is responsible for inverse gradient in non
ionize form for basic molecule and cause the movement of basic molecule in blood
stream out of the cell. Hence it will cause difficulty while sampling a fluid or blood
from the body of dead person

Putrefaction:

Putrefaction is a process of decay. Bacteria and micro flora effect the drug
concentration and must be considered and it can cross the cell wall and intestinal
wall to the blood vessels and lymph vessels. Which will cause difficulty while
sampling of a drug? .

List of recommended specimen for the post mortem

toxicology examination:
Specimen of choice with quantity:

1) Heart blood: 50 - 100 ml in plastic or glass container (add sodium fluoride

as a preservative and potassium oxalate as an anti coagulant )seal the lid/ cap
with an evidence tap and sign across the seal

2) Peripheral blood: 10 - 20 ml in plastic or glass container (add sodium fluoride

as a preservative and potassium oxalate as an anti coagulant))seal the lid/ cap with
an evidence tap and sign across the seal

3) Urine: all available up to 100ml in plastic or glass container (do not add
any preservative)) seal the lid/ cap with an evidence tap and sign across
the seal

4) Vitreous humor: all available in plastic or glass container (do not add
any preservative) seal the lid/ cap with an evidence tap and sign across
the seal
Other specimen:
BRAIN: 100 G IN PLASTIC OR GLASS CONTAINER) seal the lid/ cap with an
evidence tap and sign across the seal

Liver: 100g in plastic or glass container) seal the lid/ cap with an evidence tap and
sign across the seal

BIle: all available in plastic or glass container (do not add any preservative) seal the
lid/ cap with an evidence tap and sign across the seal

Cerebrospinal fluid:

All available in plastic or glass container (do not add any preservative )seal the lid/
cap with an evidence tap and sign across the seal

Gastric content:

All available (or 100g and record total present in stomach)) seal the lid/ cap with an
evidence tap and sign across the seal

Crime scene sample:

collect case related evidence found at crime sceneries drugs , )seal the lid/ cap with
an evidence tap and sign across the seal , cups or bottle, and suspicious household
product )seal the lid/ cap with an evidence tap and sign across the seal
 this pic shows how to seal the evidence

References:
1- BMJ journal (journal of clinical pathology)
2- PbMED.Gov US National library of medicine NATIONAL INSTITUTE OF HEALTH Mechanisms
underlying postmortem redistribution of drugs: a review
3--(RESEARCHGATE) (overview of forensic pharmacist

practice) 4- PFSA guidelinesPUNJAB FORENSEC

SCIENCE AGENCY and

5- NFSA(NATIONAL FORENSIC SCIENCE AGENCY )

Medication error
Definition:

A medication error is a preventable event that may cause r lead to in

appropriate medication use or patient arm while the medication is in the
control of heath care professional
Introduction:
It is a responsibility of law maker and forensic toxicologist experts for the
safety of patient, professionals’ and heath care citizen

Medication error is recognizer for the significant cause of tea morbidity

or mortality in the patient for which it is prescribed. As we know
medication is use for the prevention, diagnosis and treatment of tea
disease if any error occur then t will cause severe side effect or may
results n hundreds of thousand s of the death. medication error is not
only error occur during prescribing the medication to the patient but it
also includes those error occur in otter procedure which are involve in
the rational medication use for example ordering, transcribing ,
dispensing administration ad monitoring of therapeutic response in
patient which may lead to the negligence if there any negligence occur
by healthcare professionals’ .
Then they will be responsible for the legal action of court against them.
[1]
Forensic analysis and legal responsibility :

Common consequences after the miss use or medication error by

physisaca include civil action or criminal charges and medical board
discipline. Among the in appropriate prescribing the medication error is
an important or in top position of reason for the physical to be sued for
medication malpractice. As many heath care professionals’ are in ordering
, transcribing, dispensing and administration of medication if an error
occur in it then they found liable with civil and crime punishment

Preventive measurement

Following are the different preventive meanest which will be helpful

in the Performing all the function efficiently.

1) Ordering: physician select the appropriate or optimize die for the

individualize patient status and should use computerize ordering
technique by following the guidelines for the appropriates ordering of
medication

2) transcribe : pharmacist carefully interprets the physician order

and also utilize his own and to perform that function there should be
an computerize system knowledge to check the error in medication
3) Administration:

It is a possibility of a nurse to perform that function for right patient

barcode method should be utilize to minimize the error cancel and check
system must also be in place for the calculation of the dose

Drugs recall an medication withdrawn from the market:

It Is a situation when the error occur in manufacturing of a drug by

manufacturer due to which these drugs are recall or withdrawn from the
market by manufacturer or by order f FDA

These recall of medication are classified into following classes

Class 1:

Those drugs are included in the that class which have serious adverse drug
events or death in the individual due to label or concentration mix up on
drug

Class 2: class 2 includes those drugs which have temporarily or reverse

adverse events.

Class3: For those drugs which are unlikely to cause the adverse drug
events this recalls may be for batches or lot no

References :
1- ResearchGate Forensic Analysis of Medication Errors, Adverse Drug Events, and
Drug Labeling Changes

2- NCBI (british journl of clinical pharmacology )

Prescription forgery

Introduction:

The most common way to gain illegal access to narcotics or controlled substances is
through the use of legitimate prescriptions and forgeries. The Narcotic Monitoring
System (NMS) may temporarily reduce forgeries; however, those seeking narcotics or
controlled substances can be very creative in developing new methods for obtaining
these drugs. Advances in technology and the sophistication of equipment such as
photocopiers and faxes makes detecting forgeries or prescription copies an even
more daunting task. Fax numbers and points of origin can be manipulated, making it
essential for members to be able to recognize or verify the authenticity of all
prescriptions.

Forged and fraudulent computer-generated prescriptions are as prevalent as

handwritten prescriptions and are often more difficult to identify; computer-
generated forgeries fall into three main categories

Scanned copies or colour photocopies of genuine prescriptions; these

prescriptions often lack the perforated edges that are evident on genuine
prescriptions and can often be detected by careful examination.

Forgeries that are printed with a PC using stolen prescription pages; on some of these
forgeries, the prescriber's information on the prescription does not match the
pre- printed information on the back of the prescription. Spelling errors may also be
apparent upon closer examination.

Manual alterations to the quantity or number of repeats prescribed;

medical practitioners are not authorised to make manual alterations to computer-
generated prescriptions; the 'Criteria for computer-generated prescriptions' can be
found in the summary document, for multiple categories of health practitioner,
'Handwritten and computer-generated prescriptions'.[]

Strategies to address possibly forged prescriptions

1. Examine all prescriptions critically:

Many offenders create fraudulent prescriptions by copying information from a

genuine prescription but, when doing so, they use incorrect spelling for the name of a
medicine or incorrectly copy something that they don’t understand (e.g an incorrect
abbreviation for directions).[1]

2. Comply with regulatory requirements

Regulation 51 requires pharmacists to verify prescriptions for Schedule 8 medicines if

the prescriber’s handwriting is not familiar. This requirement applies to all
prescriptions (including repeats) for Schedule 8 medicines; not only if a pharmacist is
suspicious.

Many offenders attend pharmacies at times when it is difficult to contact prescribers

or otherwise verify that a prescription is genuine. This is why the regulations allow
for the provision of up to two-days’ supply of a Schedule 8 medicine if the
authenticity of a
prescription cannot be confirmed.

3. Record details of communications with prescribers

Recording all intervention communications ensures colleagues are aware of relevant

matters. Do not assume that one of your colleagues has confirmed that a
prescription is genuine unless there is evidence to support that belief.

There are a number of factors that can be assessed to determine whether a

prescription is authentic or a potential forgery. Although the prescription itself is
normally the main focus, assessing other elements of the transaction can also
provide information useful in determining the authenticity of a prescription. Consider
the following:

1. The Patient:

1)Do you know the patient?

2)Is there a patient medication history?

3)Is this medication consistent with the treatment history on file?

4)Is it reasonable for the patient to be visiting your pharmacy, given where the patient
lives?

5)Is the patient on vacation or visiting a friend or relative?

2. The Prescriber:

1)Do you know the prescriber, including their practice or specialty?

2)Is it reasonable for the patient to be seeing this prescriber?

3)Is the prescriber from out of town?

4)Are the drugs prescribed tailored to the individual or do all the prescribers’ patients
appear to receive the same drugs?

3. The Prescription:

1) Looks too good, i.e. handwriting, format, patient information.

2) Quantities or directions differ from the normal pattern.

3) Unusual symbols, terminology, or abbreviations are used.

4) Directions are fully written out.

5) Use of white-out, smudging, or different cooler ink on prescription.

6) Alterations to quantities.

7) Spelling errors.

8) Prescription appears to be a photocopy and not an original.

9) For electronically generated prescriptions, font size is different from normal

4. Suspicious Situations

1) Patient is in a hurry and unable to return later.

2) Patient presents the prescription late in the evening, or on weekends, when

it’s difficult to confirm Rx with doctor.

3) Date prescription written is not consistent with urgency to fill the prescription.

4) A diversion is used to distract the member and pressure them to fill the Rx as
quickly as possible, e.g. crying baby or feigned illness.

Members are advised to develop and implement routine dispensing procedures that
reflect the standards of practice. Compromises or shortcuts may lead to errors in
judgemen

Fraudulent prescriptions to be reported to police:

Pharmacists must notify the police when they suspect or have reason to believe that
a person has obtained or attempted to obtain the medication according to Pakistan
law Forgery is the process of making or adapting documents with the intention to
deceive. It is a form of fraud and is often a key technique in the execution of
identity theft. Questioned document examination is a scientific process for
investigating many aspects of various documents and is often used examine the
provenance and verity of a suspected forgery. Section 420, 468 and 471 of the
Pakistan Penal Code deal exclusively with these offences and are the most common
offences committed in Pakistan.

Reference:
1) Ontario college of pharmacist identification of forgery and redolence in
prescription 2)Victoria state gov Health.VIC Forged prescriptions and other scams
perpetrated on
pharmacists

Product tampering
On occasion, a telephone call may be received or an individual may come into the
office concerning possible tampering of a food product, over-the-counter drug or
cosmetic. Most reports have proven to be false, with the claimants seeking attention
and/or profit. Another common trend are “copy cat” reports on the heels of a widely
publicized tampering incident, e.g. syringe in a can of soft drink. A “red flag” indicating
a possible false report is when the environmental public health specialist is
contacted about the incident by an attorney or news reporter, rather than by the
alleged victim.Tampering, threat of tampering, and false reporting of tampering of food
products, over-the counter drugs, or cosmetics is a federal crime. Whenever a
report of possible or actual tamperingis received, referral must be made to the
U.S. Food & Drug Administration (FDA) via the DHSS/BERL central office.

Authority
o FDA is authorized to investigate reports of tampering:

o Federal Anti-Tampering Act (FATA), Title 18, USC, Section 1365; and

o Federal Food, Drug and Cosmetic Act.

o The lead agency is FDA’s Office of Criminal Investigations (FDA/OCI).

o FDA/OCI will coordinate notifications with appropriate law

enforcement agencies, including the Federal Bureau of Investigation
(FBI).
 The goal of the FDA/OCI investigation is to:

o Determine if tampering has occurred;

o Determine the seriousness of the problem;

o Determine the quantity of the affected products on the market;

o If possible, determine the source of the tampering;

o Quickly remove any contaminated products from consumers or

commerce; and

o Seek to identify and initiate criminal prosecution of those persons

responsible for criminal activity associated with the tampering/threat
incident.
In some cases, the FDA/OCI may decide not to follow up on reports of
tampering because of resource limitations. They will then consult with the FDA
district office to determine proper follow up, which may include referral to state or
local agencies, which may include DHSS/BERL. Any information on matters under
investigation by federal agencies must not be released without prior discussion and
concurrence of the FDA/OCI.

Method
Reports of tampering may be received directly from the victim, perpetrator,
news reporter or attorney; or by referral from the FDA. Timely communication with
FDA is important for purposes of coordination and investigation.

When information is received directly from the field:

o Information from the initial contact should be recorded:

o Name, address, telephone number of the victim;

o Product information of the item involved;

o Product brand;

o Flavor, variety, etc.;

o Size of container; and

o Lot number, production code, UPC and/or other descriptive identifiers.

o Problem with the product:

o Off quality (off-color, off-odor, etc); and/or

o Foreign objects.

o If there has been resulting injury/illness:

o Has physician and/or medical center been consulted?

o Have the police been contacted?

o Has victim volunteered that an attorney has been contacted?

o Has victim volunteered that news media has been contacted?

o If product or product container can be secured, arrange to assume

custody of the

 product/container:
 o Do not forward to DHSS Laboratory Services unless instructed; and

o Notify FDA/OCI for disposition of product/container.

o Attempt to answer the following concerns as quickly as feasible:

o Has tampering occurred, or can the condition of the product be explained

by other means?

o Is death, injury, or illness associated with the report and if so,

does it appear to be isolated, or widespread?

o Does the incident appear to be isolated or widespread?

o Is it likely that other similarly affected products remain in distribution

and if so, what is the extent and magnitude of the distribution?

o If not isolated, could the product tampering have occurred at the

production facility or in the distribution chain?

o Does the report seem plausible; does the victim’s story stay consistent?

Upon request or invitation from FDA to DHSS/BERL, personnel may inspect retail stores,
distribution points and/or manufacturers relative to a tampering incident
investigation.

 The request or invitation shall be from FDA to DHSS/BERL central office.

 In most cases, the request of invitation will be routed to

appropriate DHSS/BERL regional personnel

 Depending on circumstances, central office and regional personnel may

be involved with the field work associated with the incident;

 DHSS/BERL personnel should concentrate their efforts on identifying

possible avenues that products could become contaminated; and

 Matters concerning security at these sites, e.g. employee and visitor logs,
employees with potential grudges, labor disputes, etc., should be left to
the law enforcement agencies.

 Retail Store Inspection

 For an isolated incident, visit the retail store where the suspect product
was obtained. To help determine if the tampering occurred after
stocking of the shelves or before arrival to the store:

 Examine other containers of the same lot number for visible signs of
 tampering;

 Inspect what is on the store shelves; and

 Inspect what is in the stock room.

 Obtain the relevant information about the distribution source of the

product;

 If in Missouri, arrange for a visit to the facility for further inspection; or

 If out of state, inform DHSS/BERL Central Office, who will notify FDA.

 The regulatory agency for the affected area will be informed, either by
FDA, or DHSS/BERL, for an inspection of the facility.

 For known tampering that presents an immediate health threat, e.g.

cyanide in Tylenol, visits to retail outlets known to have the product
should be made immediately.

 The products suspected of being involved shall be placed under embargo

and secured.

 DHSS/BERL will inform FDA/OCI of the quantity of product placed under

embargo, the current location, and the site where the product was found.

 Distribution Point

 Determine if the product was received from another distributor or

directly from the manufacturer

 Determine if product with the implicated lot number is on hand;

 If so, the amount should be noted;

 Try to learn the amount of suspect product received and any variations
from the amount consigned to the facility;

 Try to ascertain if the accounts are wholesale, retail or both, and if they
handle any cash and carry orders;

 The distribution area covered by the facility is also needed. If possible, a

listing of accounts likely to have received shipments of the product with
the implicated lot number should be made; and

 Stock rotation practices should be noted.

 Determine if returns are accepted and how they are handled; and
 If returns of implicated products are made, are they segregated so they
will not inadvertently be re-distributed?

 Note if there are any practices or opportunities that would allow for
tampering of the product.

 Manufacturer

 Inspection of a manufacturing facility can be time-consuming and

exhausting. The objective is to determine if contamination of the
product could have occurred at the facility. Thus, inordinate time
should not be given to other sanitation aspects of the facility, e.g. don’t
document rodent activity by the loading dock if the tampering concern
is glass shards in packages of cookies. The rodent activity should be
noted, but not pursued until the next routine inspection of the facility.
With the implicated product in mind:

 Obtain the names, titles, addresses, and telephone numbers of company

representatives;

 If there are any contract packagers, obtain the name, location and
products handled;

 List other facilities that may produce the product;

 Determine the production dates of the lot number of the affected

product;

 Describe the lot numbering system and any plant identification numbers
and expiration dates placed on product containers and cases;

 Find the lot size and history of production beginning with date of
receiving raw material and the dates and description of processing steps;

 Note the storage history of containers of raw material and whether

there are containers partially full; and

 Determine distances between production areas or between processing

equipment at critical points.

 Obtain a listing of the facility’s source for raw material for the implicated
product;

 Note any locations where an employee could have access to the

contaminant being investigated;

 Describe the security for the suspected contaminant including

limitations of access, where it is stored, and responsibility for
controlling access to
 the material;

 Describe what legitimate use, if any, the facility has for the
suspected contaminant in each of the locations found; and

 Determine if there is a log for the material used and, if so, obtain a copy
of the log.

 Describe any laboratory control tests and in-process tests performed on

the finished packaged product and in-process materials. Determine
whether reserve samples are retained of all lots;

 Determine how rejects and re-worked materials are handled; and

 Describe any unusual events that may have taken place during the
period when the suspect material was in the facility.

Record Requests – Occasionally, the investigation may require a request for

information, which is considered proprietary or otherwise not normally requested or
made available.

 Under general authority of FATA, federal investigators or DHSS/BERL

personnel that are FDA commissioned officers may request certain data
from manufacturers, distributors, or other parties involved in
the investigation if, in the opinion of supervisory personnel it is
necessary, or if the following criteria are met.

 The apparent tampering incident may be serious and is assigned a high

priority by FDA or FBI;

 The data sought are normally of the type that FDA authorized personnel
are trained to evaluate and have access to in other areas of routine
activities, e.g. production records, formulae, distribution records, etc.;

 The requested data are likely to be necessary to the successful

resolution of the investigation; and

 Other alternatives to obtain the information are not as readily available.

 If an FATA request for data is made, the DHSS/BERL FDA commissioned

officer should direct a verbal request to the most responsible individual
at the location;

 Explain clearly and concisely your need for the data under the general
authority of the FATA; and

 Any refusal encountered during a tampering investigation should be

documented and include that the above listed criteria were met and
that
 the firm was aware of the non-routine nature of the request.
Consultation will be necessary with DHSS General Counsel and a search
warrant, subpoena or court order may be appropriate in some
circumstances.

Sampling in tampering incidents will have precautions above and in addition to those
described in the Food Sampling subsection of the Communicable Disease Investigation
Reference Manual Section 4 Disease Conditions pages 18-19.

 Whenever a sample is collected for suspect tampering:

 Collect an authentic sample of the same product;

 If possible, collect from the same lot and code; and

 At least 6 intact units should be obtained.

 Any containers that a tamperer may have handled in placing the

tampered product on the shelf should be collected:

 If law enforcement or FDA personnel are present, let them collect

the containers as they have training and equipment for collecting
evidence;

 If these personnel are not present, determine if the area where the
containers are located can be secured until these personnel arrive; and

 If these personnel are not expected to be on-scene and/or it is likely

the container evidence will be compromised, then the on-scene
environmental public health specialist should collect the containers with
the following precautions;

 Take care to avoid adding or smearing fingerprints;

 Wear cotton gloves, use tongs, forceps, or pick up the container

by opposing corners;

 Carefully place an identifying mark, e.g. your initials and date, on

product containers in as small an area as possible (this will be
important if you are called to testify); and

 Do not open outer containers to identify inner containers or inserts.

 When sampling or handling product;

 Be alert for traces of evidence such as hair, dust, paint chips, glass

 Secure such evidence in a separate container such as a glass vial, small

manila envelope or plastic bag.
  Take caution in packaging samples to avoid smearing and/or removing
fingerprints.

 Paper bags work best;

 Samples should be packed to avoid movement of the product container

within the bag; and

 Place samples in a secured area, such as your locked car, until they are
transferred to another responsible official.

Reporting – Reports must be submitted on a timely basis to keep affected offices in

DHSS and FDA informed of latest developments.

The on-scene investigator shall submit at least verbal reports to DHSS/BERL

central office periodically during the investigation;

As needed during the investigation and at the conclusion of the investigation, a

written report shall be submitted to DHSS/BERL central office; and

Central office staff will forward information to the DEH/CDP director’s office and
DHSS/OPI.

Reference

http://health.mo.gov/atoz/ehog/pdf/Ch_3.7.pdf

Insurance
fraud
Definitions
Insurance fraud refers to any duplicitous act performed with the intent to obtain an
improper payment from an insurer. Insurance fraud occurs most often when an
insured individual or entity makes a false or exaggerated insurance claim,
seeking compensation for injuries or losses that were not actually suffered.
Insurance fraud can also be committed upon customers, through 1) the sale of
unlicensed or bogus insurance coverage to unsuspecting clients, or 2) an
insurance broker or agent's diversion or theft of insurance premiums paid by
clients.

Types of Insurance Fraud

Police and prosecutors typically refer to an insurance fraud scheme as either "hard
fraud" or "soft fraud."
Hard Fraud: Someone deliberately fakes an accident, injury, theft, arson or other loss to
collect money illegally from insurance companies. Crooks often act alone, but
increasingly, organized crime rings stage large schemes to steal millions of dollars.

Soft Fraud: Normally honest people often tell "little white lies" to their insurance
company for the purposes of filing or maximizing a claim. Many people think it's just
harmless fudging. But soft fraud is a crime, and raises everyone's insurance costs. [1]

Other common examples of insurance fraud include:-

 Automobile Collision

 Swoop & Squat

 Backing

 Right of Way

 Hit& Run

 Organized Ring

 Sudden Stop

 Pedestrian Vs Auto

 Phantom Vehicle

 Paper Collision

 Medical Provider

 Automobile Property

 Faked Damages

 Vehicle Theft

 Auto Property/Vandalism

 Embezzlement

 Trailered Watercraft Arson

 Inflated Damages

 Vehicle Arson

 Agent/Broker

 Trailered Watercraft/Theft Damage

 Other Auto Property

 Medical

 Slip & Fall

 Disability

 Pharmacy

 Embezzlement

 Inflated Billing

 Food Contamination

 Dental

 Other Medical

 Life

 Questionable Death

 Suspicious/False Policy Application

 Workers' Compensation

 Claimant Fraud

 Legal Provider

 Pharmacy

 Under Reported Wages (Premium Fraud)

 Embezzlement

 Employer Defrauding Employee

 Medical Provider

 Misclassification (Premium Fraud)

 X-Mod Evasion (Premium Fraud)

 Uninsured Employer

 Fire

 Commercial Fire

 Residential Fire

 Arson for Hire

  Inflated Fire Loss

 Property

 Theft Residential

 Theft Commercial Carrier

 Watercraft/Aircraft Arson

 Property Theft from Vehicle

 Mold Related

 Theft Commercial

 Watercraft/Aircraft Theft

 Vandalism

 Agent/Broker

 Other Property Damage

 Embezzlement

 Unlawful Solicitations/Referral

 Immunization Fraud

 Surgery Center Fraud

 Identity Theft

 Billing Fraud

 Pharmacy

 Disability

 Other

 Casualty

 Agricultural/Livestock [2]

Penalty for insurance fraud

Fraud crimes may result in long prison terms and enormous fines, depending on the
circumstances surrounding the charges and the amount of money at issue.

Refernces
[1]http://criminal.findlaw.com/criminal-charges/insurance-fraud.html

[2] https://www.insurance.ca.gov/0300-fraud/0100-fraud-division-overview/05-ins-
fraud/

Use of abused drugs in the work

place Introduction
Using drugs or alcohol can lead to employee impairment while at work. Poor
concentration, carelessness, risk-taking behaviour and errors in judgement can occur.
Alcohol and drug abuse not only affects work performance and productivity, but also
results in higher rates of injuries, fatalities and absenteeism. Where possible
employers should work proactively with employees on policies and processes relating
to the management of the effects of alcohol and drugs in the workplace. Policies and
processes are often more effective when these are mainly focused on prevention and
protection (minimising the risks) rather than punishment. [1]

Federal laws and regulations

Federal statutes on drug-free workplace policies can be divided into two broad groups,
or categories, of legislation.

One category includes laws such as the Drug-free Workplace Act of 1988. These laws
are designed explicitly to target workplace substance use. They legally compel
certain types of employers to take action against drug use in the workplace,
such as by developing a written policy.

The other category includes laws designed to protect the basic civil rights of
American workers. These statutes provide special legal protections to certain kinds
of employees. They set clear limits on how far an employer can go in investigating
and establishing consequences for employee drug use. The most important federal
laws and regulations of this type to consider are:

The Americans with Disabilities Act (ADA) of

1990 The Civil Rights Act of 1964

The Family and Medical Leave Act (FMLA) of 1993

The National Labor Relations Act (NRLA) of 1935

Americans With Disabilities Act (ADA) of

1990
The Americans With Disabilities Act (ADA) is perhaps the most important federal civil
rights legislation that affects employers when developing and implementing drug-
free workplace policies. It prohibits all U.S. employers with more than 15 employees
from discriminating against qualified job applicants and employees because of a
physical disability.

Civil Rights Act of 1964

The Civil Rights Act (PL 88-352) is a landmark law that prohibits private employers
with 15 or more employees from discriminating against individuals on the basis of
race, sex, religion, or nationality. Employers implement a drug-free workplace policy
need to keep in mind Title VII of the Civil Rights Act.

Family and Medical Leave Act (FMLA) of 1993

The Family and Medical Leave Act (FMLA) (PL 103-3) applies to all public agencies
and to private employers with more than 50 workers. Under FMLA, these employers
must allow employees who have worked for the employer for at least one year and
who have worked at least 1,250 hours in the past 12 months to take up to 12 weeks of
unpaid, job- protected leave because of their own serious health condition or to care
for a spouse, child, or parent who has a serious health condition.

The National Labor Relations Act (NRLA) of 1935

Employers implementing drug-free workplace policies in unionized workplaces need
to be aware of the requirements of the National Labor Relations Act (NRLA). Passed
in 1935, this law provides a legal framework for all management and labor
negotiations. Under NRLA, any drug-testing program affecting unionized workers must
be negotiated and agreed on with the union through a formal collective bargaining
process. Even when an employer is required to implement a drug-testing program by
another federal mandate, such as the Omnibus Transportation Employee Testing
Act of 1991, the employer must negotiate with the union to determine exactly
when testing will be conducted and what penalties should apply to workers who test
positive for drug or alcohol use. [2]

Safety considerations
Drug testing may be reasonable if it is done with a view to protecting the safety of
employees or the general public, for example:

if the employee works in a safety sensitive area

if the employee’s work directly impacts the safety of others (eg other employees
or the public).
Random testing vs specific testing

Testing a specific employee for a specific purpose may be more reasonable than
random ‘suspicion-less’ testing of all employees.

A specific purpose may be where the employee:

 shows signs of being affected by drugs or alcohol.

 has recently been involved in a workplace accident or a near-miss.

If an alcohol or drug test is positive

The policy should set out clearly the procedure to be followed in the event of a
positive test result. This must involve discussion of the results with the employee,
and may involve having the sample retested. That procedure will depend on the
nature of the industry or work activity, and the health and safety, or reputational, risks
in the situation.

A positive test result does not automatically mean that a drug has impaired that
employee's performance while at work. However, a positive test is one of the facts that
an employer can take into account to determine whether, on balance, there are
reasonable grounds for believing that the employee is guilty of misconduct. [1]

References

https://www.employment.govt.nz/workplace-policies/tests-and-checks/drugs-
alcohol-and-work/

https://www.samhsa.gov/workplace/legal/federal-laws

Legal and illegal pharmaceutical evidence in criminal investigation

Introduction:

Crime scene:

: It is any place where the evidences may be located and gathered to help explain
events. When processing a crime scene the deductive and inductive reasoning should
be used in order to gain knowledge of the events occurred at the crime scene. The
objectives of crime scene investigation are to collect, preserve, package, transport and
document all physical evidence found at crime scene
Contemporary law enforcement has greatly expanded its ability to solve crimes by
the adoption of forensic techniques and procedures. Today, crimes often can be
solved by detailed examination of the crime scene and analysis of forensic evidence.
The work of forensic scientists is not only crucial in criminal investigations and
prosecutions, but is also vital in civil litigations, major man-made and natural disasters,
and the investigation of global crimes. The success of the analysis of the forensic
evidence is based upon a system that emphasizes teamwork, advanced investigative
skills and tools (such as GPS positioning, cell phone tracking, video image
analysis, artificial intelligence and data mining), and the ability to process a crime
scene properly by recognizing, collecting and preserving all relevant physical evidence

Role of forensic scientist in investigation of crime scene:

Forensic science applies scientific technology to supply accurate

information’s reflecting the events that occurred at the crime scene. Forensic
scientists are required to appear in court as expert witnesses. The DNA analysis may
be used for identification from small amounts of evidence which deposited for long
time or currently at crime scene before recovery by law enforcement. The disciplines
of forensic science have an essential contribution to investigate the crime

Evidence collection:

Because there is rarely more than one opportunity to obtain evidence from a crime
scene, the investigation by the CSIs must be methodical and complete. In keeping with
Locard’s exchange principle, CSIs collect evidence from the crime scene that may have
been touched or microscopically “contaminated” by the suspect or suspects They also
take samples of fibers’, dirt, and dust .Evidence can range from body fluids, to
weapons, to witnesses and DNA.

After a preliminary search, the crime scene is photographed; some police departments
also make a videotape of the scene. CSIs take careful measurements, make detailed
notes, and draw sketches. Evidence is collected and carefully catalogued. Scientific
and technological advances have resulted in the development of laser and
alternative-light sources that can reveal latent fingerprints, stains, hairs, fibers’, and
other trace evidence. For example, luminal, a substance that fluoresces when in
contact with blood, is capable of detecting blood traces that have been diluted up to
10,000 times, making it useful for searching crime scenes that were cleaned in order
to conceal evidence.

In Pakistan:
NFSA (NATIONAL FORENSIC SCIENCE AGENCY)
Provide guidelines for submission of evidence to ensure that the chain of custody of
evidence is properly maintained. Evidence Receiving Unit (ERU) is fully prepared to
aid the correct submission of evidence.

Evidence Receiving Unit:

National Forensic Science Agency has established its Evidence Receiving Unit (ERU)
with the following objectives:

1) To work as a bridge and barrier between case submitting authorities and

laboratories in NFSA

2) To avoid direct correspondence between analysts/experts and investigating

officers or offender/accused/grieves/victim

3) To scrutinize the documents

4) To scrutinize the evidence/samples

5) To ensure integrity of internal/external chain of custody

6) Correspondence with the case submitting authorities

7) Dispatch of reports/Evidence disposition to the case submitting departments

8) To keep evidence in safe custody(where applicable)

9) To maintain case file record

1requirements for case submission:

1DOCUMENTAL REQUIREMENTS:

Following documents are checked /verified on recipient of case at ERU

1) Covering letter

2) Copy of First Information Report (FIR)

3) Road Certificate

4) Medico Legal Certificate/ Post Mortem Report

5) Service card/original CNIC of special messenger

6) Original CNIC of victim/accused in cases where blood sample/buccal swabs taken

by NFSA technician at its premises
7) Recovery Memo

8) Statement of abductee’s victim u/s 164 Cr.P.C.

9) Bomb Disposal Inspection report and clearance certificate

10) Specimen seal pattern

11) Full record of chain of custody

12) Court Order

Note: Additional information/documents may be required depending upon the case

type. Any of the documents is checked/verified wherever applicable

2 Covering letter:

Covering letter is mandatory for case submission, duly issued by Gazette rank
Government official or above. The following contents of covering letter are verified:

1) Letter/Diary number, Issue date, Signature and Stamp of the issuer

2) Seal pattern

3) Special messenger name and designation

4) Number of sealed parcels/samples/evidence

5) Description of each of the parcel/sample/evidence

6) Explicit questioned request OR examination requested

7) Case FIR number, date, PPC section clause imposed, police station (If FIR
is registered against the case)

8) Name and CNIC number of victim/accused physically sent to NFSA in cases where
blood sample/buccal swab collection is requested at NFSA. Furthermore, name and
designation of official accompanying the said individuals in custody

Note: If time gap between date of issue of letter and date of receiving at ERU is large,
preservation/possession of the evidence during that period is inquired from the
concerned quarters before acceptance of the case.

If the evidence/samples mentioned in the letter are incomplete or improper or not

upto the minimum requirements as per NFSA guidelines, case may be partially
accepted or returned.
3 Copy of FIR:

1) When the analysis is requested by Police, an attested copy of police FIR is required
at the time of case submission.

2) FIR No., Date, PPC section clause imposed and Police station are checked against
those mentioned in covering letter.

3) If more than one FIR’s are registered against a case, the same are demanded.

4) Copy of FIR is not mandatory for the cases coming from other Government
Departments, Intelligence agencies or referred by Honorable courts.

4 Road Certificate:

Road certificate is also mandatory at the time of case submission in order to

maintain the external chain of custody. The following things are verified from the
road certificate:

1) Name, designation and belt number of special messenger

2) Description of evidence/parcels

3) Date of departure/arrival

If a carrier physically bringing the case is not the same as appointed on the road
certificate, the case is not entertained. Any other inconsistency found on the
road certificate and covering letter is clarified before acceptance of the case.

5 Medico Legal Certificates/ Post Mortem Report:

A Medico Legal Certificate (MLC)/Post Mortem Report complete in all respects are
mandatory in cases in which samples are taken by Medico-Legal Officer. The
following contents of an MLC are checked:

1) Name, Signatures and stamp of the MLO who took the samples, sealed and handed
over

2) Description of the samples

3) Preservative material used for storage of sample (if any)

4) Purpose of the samples taken (DNA, Chemical examination etc.)

5) Date and time of medical examination

6) Time between last sexual activity and Date of medical examination in sexual assault
cases

7) Last Menopause in sexual assault cases

8) Information about stool passes, if any, in sodomy cases

9) Description of the interview, MLO has taken from victim

10) Preliminary Opinion of the MLO

Investigational facilities in Pakistan:

I. National Forensic Science Agency, Islamabad

(DNA)

2. Kadir Khan Research Laboratory,

Islamabad (DNA)

3. Forensic Science Laboratory, Islamabad

4. Center for Applied Molecular Biology

(CAMB), Lahore (DNA)

5. Forensic Science Laboratory, Lahore

6. Chief Chemical Examiner, (Punjab), Lahore

7. Chemical Examiner, Multan

8. Chemical Examiner, Rawalpindi

9. Forensic Science Laboratory, Karachi

10. Chief Chemical Examiner, (Sindh), Karachi

11. Chief Chemical Examiner,(Sindh), Rohri

References:

1) Research journal of forensic science (The role of Forensic science in Criminal

investigation in Rwanda )

2) NFSA(NATIONAL FORENSIC SCIENCE AGENCY ) Evidence Receiving Unit

3)UNODC(UNITED NATIONS OF DRUG and crime ) guidence about the investigation in
crime scene
Use of drugs or alcohol in car accidents or violent
actions DUI
It means Driving Under the Influence. DWI, an acronym for Driving While
Impaired. “OMVI,” an acronym for Operating a Motor Vehicle Impaired. The current
acronym that refers to driving under the influence is “OVI” (Operating a Vehicle
Impaired). All these words refers to the same thing.

DUI, typically relates to alcohol intoxication. But alcohol is just one of

countless substances that can impair one's ability to operate a motor vehicle. Mixing
drugs and driving, whether it's medicinal marijuana or legally prescribed muscle
relaxers, is just as illegal as driving drunk and can also constitute a DUI offense.

Impairing Effects of Various Illegal Drugs

Marijuana: Relaxation, euphoria, disorientation, altered time and space perception,
drowsiness, paranoia, image distortion, increased heart rate.

Cocaine: Euphoria, excitation, dizziness, increased focus and alertness

(initially), confusion and disoriented behavior, irritability, paranoia, aggressiveness,
increased heart rate.

Methamphetamine: Euphoria, excitation, hallucinations, delusions, insomnia,

poor impulse control, increased heart rate, increased blood pressure.

Morphine & Heroin: Intense euphoria, drowsiness, relaxation, sedation,

disconnectedness, mental clouding, analgesia, depressed heart rate, nausea and
vomiting, diminished reflexes.

LSD: Hallucinations, altered mental state, delusions, impaired depth, time and
space perception, hypertension, tremors.
Prescription & Over-the-Counter Drugs

Below are some common prescription and OTC drugs that can impair drivers:

Antidepressants: Some sedating antidepressants cause impairment similar to drunk

driving.

Valium: 10 mg of the popular tranquilizer can cause impairment similar to having a

blood-alcohol concentration of 0.10 percent.

Antihistamines: Many of them slow reaction time and impair coordination.

Decongestants: Many over-the-counter decongestants can cause drowsiness,

anxiety and dizziness.
Sleeping Pills: Even in the morning, the residual effects of these drugs can
impair drivers.

Hydrocodone: This common pain reliever, the main component of Vicodin, is similar to
opiates and causes impairment similar to morphine and codeine (oxycodone has
similar effects).

Drug recognition experts

(DREs) specially trained police officers who follow specific guidelines to determine
drug impairment in motorists. DREs closely examine a person's eye movements,
behavior and other cues pointing to drug influence.

Measuring Drug Impairment

Driving with a blood-alcohol concentration (BAC) above a certain level, typically 0.08
percent or higher, is illegal. Alcohol is flushed from the body rapidly, so it's relatively
easy to measure a motorist's BAC at the time of a traffic stop. Breathalyzer tests are
quite accurate, with readings of 0.08 percent or higher. The psychoactive component
of marijuana (THC) is detectable in a person's urine or bloodstream for up to four or
five weeks after use and there is no way to conclusively detect actual impairment at
a particular time. Cocaine, on the other hand, typically leaves the body after just a day
or two.

References

http://dui.findlaw.com/dui-charges/driving-under-the-influence-of-drugs.html

Quackery and health care fraud

Introduction:

A “quack” is someone who pretends to be a physician or who claims to have medical

knowledge that they do not possess. They often promise quick results or painless
cures for serious conditions. They often advise patients to use specific devices or
medicines with secret formulas. Many advertised their products in newspapers and
drug stores or sold them through the mail. Others traveled from town to town,
selling their products and Health care fraud is a type of white-collar crime that
involves the filing of dishonest health care claims in order to turn a profit

An analytical approach to health care fraud :

One of the common phrases you hear regarding the detection of suspect billing
behavior is the ability to “find a needle in a haystack”. In terms of detecting
improper payments in healthcare, be they intentional fraud, or accidental waste, the
idea being conveyed is that amidst a large amount of information, you need to
find a small, seemingly imperceptible, anomaly. Indulge the cliché just a bit longer.
In order to find that needle in a barn full of haystacks, one of the most critical, but
often overlooked steps, is first finding the right haystack in which that elusive needle
may be hiding.

What if there was a reliable technique that could tell investigators the location of a
needle in a haystack, or for this purpose, where to look for suspect behavior? In the
detection and discovery of healthcare fraud, waste and abuse, or more
generally, improper payments, there is such a method; a method that tells you where to
look for a needle in a barn of haystacks.

Understanding the Nature of Fraud, Waste and Abuse:

In order to uncover fraud, waste and abuse, we must first understand what a fraudster
needs in order to be successful. First, and most importantly, we should be clear on a
key point, fraud is a financial crime. Second, we need to understand that fraud
(waste or abuse) changes the factual data in some way. This means in order to be
successful, a fraudster must make some type of material misrepresentation of actual
events. Making a change that does not provide a benefit would be ineffective to the
fraudster, and of little, to no harm to the payer. What does this mean to the
investigator? He or she needs to find that change, which enables the fraudster to
gain a financial advantage that, absent that change, would not exist.

Methodology:

There are thousands of procedure codes and thousands of diagnosis codes; when you
mix in places of service, and modifiers, things get pretty complicated very
quickly. Remember, in order to be successful, fraudsters must create a change that
facilitates their financial gain. If we consider what that means, in an operational
sense, there are really only a select number of ways to do this. What we want to be
very careful to avoid, is only looking for the specific codes and schemes we expect to
find. Fraud is dynamic and often appears in unusual places, including previously
unmonitored areas of healthcare. To find the right “haystack”, behavioral analysis
must be performed, across ALL behaviors. Thankfully, there are only a few risk
classifications, regardless of the code(s) used.

Frequency:
A provider, be it a licensed provider, or someone impersonating a provider, can bill
for more of something. These can be services that are provided but unnecessary, or
what’s called “ghost services”, that were not provided. For example, billing for three
visits, but the patient was only seen once. Common Frequency Schemes: Billing for
Services not Rendered, Unnecessary Services, Medical Identity Theft.

Density:

Density takes on two (2) different manifestations. In both cases, it describes an issue
related to a quantity per unit measure, with the unit being different for each of
the conditions.

a) Visits: This is when there is an unusually high volume (density) of services during a
single visit. This is often the result of unbundling (breaking composite procedures
into component parts) and/or billing of extra, likely non-necessary services.

b) Patients: This is where there is an unexpected percentage (density) of patients

having the same service. A simple example would be all, or a very high percentage of
the patients having the same level of E&M (Evaluation and Management code), or the
same diagnostic test. Of course, both of these manifestations can occur
simultaneously, and can also combine with other risk categories, such as frequency,
increasing the impact, and complexity of the behavior. Common Density
Schemes: Unbundling, Services not Rendered, Unnecessary services

Intensity:

In simple terms, intensity describes increasing the level of service. There are
many instances where the level of service provided, increases the reimbursement. A
dermatology related example would be when a provider has an abnormally high
percentage of complex wound repairs as compared to simple and intermediate
repairs. In addition to increasing the level of procedure codes, intensity risk can also
been seen with unit billing. For example, when a service, such as administering
a drug, is reimbursed via units, by simply submitting overstated units, the
reimbursement is increased. Common Intensity Schemes: Up coding

Velocity:

The last risk classification is velocity. Velocity typically measures an abnormal or

unexpected increase, or in some cases a decrease, in behavior. This can identify either
spikes (point increase/decrease), or surges (slope increase/decrease).

Typically, these behavior changes fall into any combination of the following:
•Patients: An unexpected change in the number of patients

•Visits: An unexpected change in the number of visits submitted

• Procedures: An unexpected change in the billing of a specific procedure, or series of

procedures

• Billed/Paid $$: This is typically the manifestation of the above, where an unusual
and unexpected change in the total dollars billed or paid is observed Common
Velocity Schemes: Services not Rendered, Unnecessary Services, and Medical Identity
Theft

The Value of Forensic Analytics:

Identifying an anomaly in any of the four (4) above risk classifications can enable the
investigator to very quickly spot unusual behaviors. Further inspection will reveal to
what extent, if any, suspect billing and improper payment is a risk. Analytics can
help identify the anomalies more quickly than searching for only what you think you
will find. The best part is you are not looking for evidence that may not exist.
Instead, the data can tell you what is actually there and help guide the direction of
your investigation by revealing anomalies – letting you know where the needle is in
the haystack. In the content that follows, there are simple examples of how an
investigator can use analytics to identify each of the above risk classifications in
order to uncover active and early insight into anomalies. In order to illustrate these
metrics in action, actual case examples in the world of healthcare fraud are
highlighte

Reference:

1- emedion (The value of forensic analytic in detecting suspects)

2-(LII) Legal information institute (information about health care

frauds ) 3- Melnick Medical Museum Blog of the Melnick Medical (history)

Museum Professional malpracticing.

Introduction:

Definition:

Medical malpractice in penal law is defined as an adverse event (injury, harm) that is
caused by medical negligence.

Medico-legal malpractice assessments are an important part of the work of forensic

pathologists. Physicians of all clinical subjects are involved, especially in charges
claiming a malpractice leading to death. In most participating institutes,
forensic
pathologists already have access to the relevant clinical records before autopsy.
When a comprehensive written report is needed, all clinical data are available since
they are necessary for subsequent clinic-pathological correlations. The main task of a
forensic pathologist is to give an opinion on the cause, manner and causation of
death. Based on the autopsy findings and medical report analysis, the forensic
pathologist is often able to rule out medical negligence In all cases, reports of clinical
experts in the appropriate specialty are recommended. In all cases, the forensic
pathologist raises the questions which should be addressed by the clinicians, based
on the autopsy findings. [1]

The types of medical malpractice are classified as follows:

Group 1: negligence / therapeutic omissions.

Group 2: complications during, and / or after surgery (preoperative

Complications).

Group 3: wrong treatment or inappropriate management.

Group 4: mistakes in patient care (suboptimal care).

Group 5: medication errors

Occupational groups and medical specialties:

The criminal proceedings were mainly against public hospital doctors, and nearly one
third of the cases were against private hospitals, with a small percentage (3%) of
cases involving doctors in private practice. Surgery is at the top of the medical
specialties involved, since after an operation–using the terms of criminology–time and
location of the crime and the name of the perpetrator are obvious. And although
surgical specialties are at the top of accusations, the cause of accusation is
usually a conservative procedure. According to the classification of accusations,
most medical malpractice claims were on the account of negligence, complications
within surgical therapy, medication errors or mistakes in care.

Cause of preliminary proceeding/confirmation of medical malpractice

In all cases, the causes of the preliminary proceeding were complaints by the relatives.
While 25% of all cases (61 out of 243) were proven instances of medical malpractice.
The number of cases with proven medical negligence is higher than that of cases with
additionally confirmed causality between medical malpractice and death.

Although surgery is at the top of all medical disciplines where medical malpractice is
claimed, medical malpractice is confirmed only in 18.18% (12 out of 66) of cases. In
obstetrics specialty, 35% (18 out of 51) of claimed cases is confirmed, and medical
malpractice is confirmed in 29% (9 out of 31) of claimed cases in anesthesiology

Discussion:

Autopsy is nowadays an efficient method of clarifying medical malpractice claims

[20- 22]. The great value of autopsies for verifying medical malpractice becomes also
evident by a recent study from the UK [23]. The National Confidential Enquiry into
Peri- Operative Deaths (NCEPOD) has been auditing data on deaths within 30 days of
any surgical operation or invasive diagnostic procedure under local or general
anesthesia in England and Wales since 1987. Autopsy often yields findings not
suspected in living persons. For instance, major discrepancies between clinical
diagnosis and postmortem findings are encountered in 20.3% (81 of 346) of
autopsies. Similar results are known from other studies [20-22]. Twenty-one percent
of surgeons receiving a copy of the autopsy report indicate that clinically unexpected
findings had emerged.

Lethal cases represent the most dramatic events that can occur during medical care.
Without autopsies, these cases cannot be properly clarified. Investigating lethal cases
of medical malpractice and their objective clarification by autopsies as additional
sources for the evaluation and prevention of errors, requires sampling of cases, not
only on a local but also on a national, or better, international level. The special
value of objective data in forensic pathology and toxicology becomes also evident
from the study of adverse drug events.

References:
1- journal of forensic research (Alleged Medical Malpractice: A Retrospective
Study of Forensic Evaluation of Cases in Cairo and Giza regions-Egypt(2009-2011))
2- NCBI ( Introduction to Medical Malpractice in the United States)

What are ethics or codes of conduct?

When most people think of ethics (or morals), they think of rules for
distinguishing between right and wrong, such as the Golden Rule ("Do unto others as
you would have them do unto you"), a code of professional conduct like the
Hippocratic Oath ("First of all, do no harm"), a religious creed like the Ten
Commandments ("Thou Shalt not kill..."), or a wise aphorisms like the sayings of
Confucius. This is the most common way of defining "ethics": norms for conduct that
distinguish between acceptable and
unacceptable behavior.

All people recognize some common ethical norms but interpret, apply, and balance
them in different ways in light of their own values and life experiences. For
example, two people could agree that murder is wrong but disagree about the
morality of abortion because they have different understandings of what it means to
be a human being.

Another way of defining 'ethics' focuses on the disciplines that study standards of
conduct, such as philosophy, theology, law, psychology, or sociology. For example, a
"medical ethicist" is someone who studies ethical standards in medicine. One may
also define ethics as a method, procedure, or perspective for deciding how to act
and for analyzing complex problems and issues. For instance, in considering a
complex issue like global warming, one may take an economic, ecological,
political, or ethical perspective on the problem. While an economist might examine
the cost and benefits of various policies related to global warming, an environmental
ethicist could examine the ethical values and principles at stake.

Many different disciplines, institutions, and professions have standards for

behavior that suit their particular aims and goals. These standards also help members
of the discipline to coordinate their actions or activities and to establish the public's
trust of the discipline. For instance, ethical standards govern conduct in
medicine, law, engineering, and business. Ethical norms also serve the aims or goals
of research and apply to people who conduct scientific research or other scholarly or
creative activities. There is even a specialized discipline, research ethics, which
studies these norms.

Patents and Generics

Patents and exclusivities are forms of protection for drug makers that may affect
how and when a generic drug is approved and can be sold. New brand-name drugs
are usually protected by patents (issued by the U.S. Patent and Trademark Office)
that prohibit others from selling generic versions of the same drug

When a pharmaceutical company first develops a new drug to be used for a disease
condition, it is initially sold under a brand name by which the clinicians can prescribe
the drug for use by patients. The drug is covered under patent protection, which means
that only the pharmaceutical company that holds the patent is allowed to
manufacture, market the drug and eventually make profit from it.

In most cases, the drug patent is awarded for around twenty years. The lifetime of the
patent varies between countries and also between drugs. Since the company applies
for a patent long before the clinical trial to assess a drug’s safety and efficacy
has
commenced, the effective patent period after the drug has finally received approval is
often around seven to twelve years.

Once the patent has expired, the drug can be manufactured and sold by other
companies. At this point, the drug is referred to as a generic drug. According to
guidelines in most countries, including those from the FDA, generic drugs have to be
identical to the branded drug in terms of efficacy, safety, usage, route of drug
administration, pharmacokinetics and pharmacodynamics.

Therefore, a drug can be manufactured as a generic drug when the following

apply: Its patent has expired

The company that would manufacture the generic drug certifies that the patents held
on the drug are either unenforceable, are invalid or would not be infringed upon

There has never been any patents on the drug

before In countries where the drug has no patent

protection

Once the generic drug is on the market, the monopoly of the patent holder is
removed. This encourages competition and results in a significant drop in drug
costs, which ensures that life-saving and important drugs reach the general
population at comparative prices.

The company holding the initial patent may, however, renew the patent by forming
a new version of the drug that is significantly changed compared to the original
compound. However, this may require new clinical trials and re-application of the
patent. Furthermore, the new compound may have to compete with the original
generic molecule on the market, unless the drug regulators find faults and remove
the original from the market altogether.

Ethics in Sales
Science development of health-care management and health-care services
necessitate more involvement of pharmacists in the patient care. Previously, the
pharmacists were the sole holders of the knowledge of pharmacy with special skills
in compounding and dispensing medications, but industrialization changed their role
and they now retreat themselves by dispensing despite “over-qualification.” In
fact, pharmacists are supposed to be medicine experts, but mostly in the
community pharmacy work as a drug dispenser. Of course, this is the viewpoint of
authors based on what is happening at the time of writing this paper.

Although pharmacy is a science based and value based profession, its practice values
are rarely defined. This means that those credits that show the pharmacy as a
worthwhile profession are lacking. The conflict between different practice values is
important. The interface between invisible values and interests is sometimes the
origin of ethical dilemmas, which mostly is not sensible by pharmacy practitioners.
Hence, not only the raised conflict is not fully understood, but also it remains
unresolved and therefore providing a guideline as well as teaching those
professional values is of special importance.

In Pakistan, pharmacists are trained in an almost 5-years education program

(Doctorate of Pharmacy) with emphasis on applied therapeutics and patient centered
care. The graduated pharmacists mostly go to common pharmacies or pharmaceutical
companies and all must complete continuous medical education (CME) courses to
take annual score and allowance to work. The feedbacks coming from Pakistani
associations, regulatory organizations or common sources confirm the major need to
have a national pharmaceutical code of conduct.

Health-care in Pakistan is governed by both private and public sector, but the
predominant model in pharmacy is private. Unfortunately, community pharmacy
ownership is not limited to pharmacists and stakeholders sometimes hire pharmacists
for their community pharmacy. At the moment, the high amount of money exchange
in especially community pharmacies has converted the profession of pharmacy to a
business. Although this is not limited to pharmacies, the matter raises special ethical
challenges in dealing with patients or other health professionals.

It is believed that the essence of health-care is changing, and patients are more
actively participating in their own care. Therefore, more ethical concerns raise and
necessitates having guidelines for pharmacists to deal with such cases.

In some developed countries, there is a better understanding of the role of

pharmacists in the health-care management and use of their knowledge and skill. In
those countries, especially the US and UK, community pharmacies are
increasingly involved in the primary care service sector and some pharmacists have
some special prescription rights. Thus, they are faced with new concerns and
responsibilities, which need technical skills as well as consideration of values and
relationships.

Our former investigations in Iran showed that pharmacists have no big attitude
toward professionalism as well as ethical issues and confirmed the necessity of
teaching the principles of professionalism in addition to providing an ethical
guideline.

Therefore, the experts from Medical Ethics and History of Medicine Research Center
(MEHMRC) and the Pharmaceutical Sciences Research Center from Tehran University
of Medical Sciences (TUMS) aimed to provide the code of ethics for national
pharmaceutical system containing different workplaces where pharmacists play their
role as a health-care professional. To provide that aim, firstly a working group
consisted
of experts in the field of pharmacy, medicine, medical ethics, and the law was formed.
A thorough search into finding codes and guidelines of developed countries using
keywords such as pharmacy, ethics, ethical issues, code of conduct, etc., or
their combination was carried out. The resulted codes and guidelines were reviewed
and the most useful points were extracted, compiled, and compared to local rules and
context. The draft was submitted to review of pharmaceutical experts in various
workplaces and then comments were gathered and discussed in several meetings to
reach a consensus. The final code of ethics consists of five code and ethical
guidelines useful for pharmacy practitioners working in different fields
including pharmacy, pharmaceutical manufacturers, pharmaceutical importing
companies, pharmaceutical distributer companies, and policy making or
regulatory organizations. The food and drug organization (FDO) of Iranian
Ministry of Health and Medical Education is almost the only policy maker in the
pharmaceutical system. The document is centered at patients’ interests and
patients oriented pharmaceutical care and the pharmacists’ responsibilities
were directed toward.

Professional CODE of Ethics for Pharmacists

The code consists of 8 articles originated from principles of bioethics and

professionalism in pharmacy; each one containing special notes. Those articles
included respect for patient's dignity and autonomy, beneficence, non-
maleficence, justice, empathy, honesty, cooperation, and excellence. In addition, the
proper ethical relationship between pharmacists and patients, pharmacists and
physicians, and other health-care providers were considered. The main themes of the
provided code of conduct are brought in the next sections.

Respect for patient's dignity and autonomy

Although patients get much of their information about the disease and medications
from their physicians, but still physicians do not meet all patient's needs. Patients need
more information about their medications and prefer to discuss drug-related issues
with physicians as primary health-care provider, but lack of enough time and in some
occasion knowledge about medications provide a good chance for pharmacists to
show their abilities and expertise. Fairly, it is a pharmacist's responsibility to fulfill
the information gap, but often patients are not aware of pharmacist's capacities. A
study in the US confirmed that realization of pharmacist's role in providing drug
information results in lowering the cost of treatment. Pharmacists should try on
renovating their relationship with patients to attract their trust to the pharmacy
system.

Patient consultation has been mentioned as the most important ethical issue in the
pharmacy practice on the way to help better treatment of patients with lower costs.
The patients’ privacy and exceptions, desire, and their rights for refusing treatment
have
been considered.

Providing drug information for patients not only includes drug usage, dosage,
and indication, but also it should contain information on adverse drug reactions,
(ADR) warnings, interactions, contraindications, and drug storage. Community
pharmacies in less developed countries do not pay enough attention to provide
sufficient drug information for patients, which has a detrimental effect on the
scientific position of community pharmacies. Counseling take times and it may not
be possible for pharmacists to counsel all patients. In addition, counseling is
considered as the temptation factor of the conflict between the financial income and
patients interests. In order to overcome this obstacle in the US, the congress
passed the Omnibus Budget Reconciliation Act of 1990 (OBRA 90) as a standard of
pharmacy care in 1993. According to OBRA 90, pharmacists have to offer drug
counseling to patients, which may be declined by patients. Most studies reported an
increase in counseling frequency after OBRA 90 in USA. Hussain and Ibrahim reported
unpleasant process of patient counseling in Pakistan where mostly unqualified
salespersons dispense the medications and wish legislative support for providing
patient-oriented services in the community pharmacies.

Beneficence
The second article of this code has been provided regarding beneficence to the
patients at the aim of optimizing drug therapy according to the patient's interests.
Providing the best health-care services needs efficient pharmacist-patient
relationships, confirming the accuracy of the prescription and documentation of
every professional function carried out in the pharmacy. One of the most important
issues in this code is the pharmacists’ responsibilities for selling every drug
including supplements, herbal products, over the counter medications, etc., The
second article emphasizes on the pharmacists duty and accountability.

The patient's best interests and respect for medicines have been defined as the two
core values in a study consisting qualitative interviews with 38 selected
practitioners. Another study in Canada demonstrated that 71% of Canadians take
natural health products and supplements on a routine basis. Their availability and
high demand should not mean they are safe as even these products may cause serious
side-effects in special populations. Furthermore, their potential interaction with
other medications should not be neglected. Therefore, pharmacists are recognized as
the most eligible healthcare professionals to advise patients on health products and
to provide evidence- based drug information. The potential responsibility of
pharmacists in counseling consumers about the harms/benefits of natural products
and their interactions was stated previously. It is believed that pharmacists are
obliged to get the ability of counseling patients about the natural health products. In
accordance with some codes,
the Iranian code emphasizes that a pharmacist cannot refuse drug delivery unless
offering an alternative although in the pharmacy code of ethics of France, refusal of
delivering oral emergency contraceptives is forbidden. In term of informed objection,
our code states that if there is no possibility to fill a prescription, the pharmacist
should redirect patient to substituted sources.

Non-maleficence
In the third article, it has been emphasized that a pharmacist should not harm
the patient. This article describes the situation in which a pharmacist is not able to
do his/her tasks and guides the pharmacist how to assign his/her duty to the
technician. Furthermore, quality of the drugs, drug dispensing in the pharmacy were
mentioned as the pharmacists’ responsibility. Furthermore, the way in which a
pharmacist faces medical error, serious ADR, and drug abuse was described.

In order to prevent quackery, providing sufficient and efficient drug information

to patients regardless of financial benefits is highly recommended in this code.
American Pharmacists Association (APhA) in its early codes of ethics stated passive
agreement of prevention from quackery then urges the discontinuance of quackery
and later put an obligation on discouraging objectionable nostrums for the sake of
profit. Patient safeguarding and drug safety is of the most important issues in
health-care which principally decrease morbidity, mortality, and health-care costs.
The development of new technologies complicated drug delivery process more than
before and accordingly medication error is inevitable. A study determined that
prescription and administration account for about 80% of the errors. Therefore, the
way we approach medication error is an essential element in preventing harms and
assuring patients safety. Therefore, in this code, direct supervision of a registered
pharmacist on every function in the pharmacy has been considered obligatory.

Justice
Justice was stated as the fourth article that mandates fair resource allocation in
pharmacies and guides the pharmacists at the condition of drug shortage.
Furthremore, this article took a brief look at the conflict of interests of pharmacists.

Gouveia and Shane believed that regardless of market forces and financial problems,
pharmacists ought to play a critical role in reducing the cost of treatment and
improving the quality of health-care. They proposed a model of pharmacy practice
consisting of 3 elements including the pharmacy practice across the continuum
of care, the major elements of pharmacy practice, and evolution of pharmacy.
Sporrong et al. evaluated moral distress in all staffs of 3 pharmacies and found some
distressing issues such as prioritizing between customers as very stressful issue in
pharmacy. They concluded
that ethical codes are not enough for alleviating moral distress and supportive
measures should be provided by management and work organization.

Empathy and excellence

Showing empathy with patients in cooperation with physicians and other health-care
providers are of major concerns, which were indicated in the fifth and sixth articles.

Fostering a shared responsibility and better therapeutic consequences needs

empathy, kindness and compassion in service to build up a proper relationship with
patients. Updating knowledge, pharmacists can develop their professional
patients oriented services based on patients interests and develop better cooperation
with physicians and other health-care providers, which lessen the confusion in
patients mind. Well- organized pharmaceutical care programs were shown to amend
therapeutic outcomes especially in chronic diseases such as diabetes. Public
confidence and the pharmacy reputation were regarded as two considerable goals,
which need to be supported. Both topics have been regarded in our code as well as
the code of UK. Faults including dispensing controlled drugs, drug trafficking, and
inappropriate self-medication may cause loss of public confident to pharmacists.

Honesty

The next article emphasizes on honesty that describes the situation in which gifts
are given to the pharmacists. In this part, much stress has been put on a pharmacist's
attendance in work days, banning buy and selling of special products which threatens
the profession, body piercing, etc.

APhA in its pharmacist's code of ethics states that a pharmacist should not allow his
name to be used in connection with advertisements for promotion of unworthy
products. Later in 1969 and 1981, APhA indicated absolute banning of dispensing,
promoting or distributing non-therapeutic products although the last updated code
insists on telling the truth to the patient and lacks any reference to this type of
medications; however, it indicates honesty, integrity, and ethical and transparent
manner of pharmacists. Some pharmacies in the world sell tobacco and alcohol that
is not a good message to consumers, but this has never happened in Iran. In the
recent decades, pharmacy profession showed its opposition against selling non-
medications harmful products such as cigarette and alcohol. In spite of apparent
opposition of pharmacy to selling tobacco, some pharmacies do not pay enough
attention to this fact. A study has shown that 93% of non-clinically affiliated
pharmacies in San Francisco sell cigarettes, which are in agreement with the other
studies. Although Corelli et al. reported lower contributions, they state that if
pharmacists have a choice, they choose not to sell cigarette or alcohol.
Cooperation

In the last article, pharmacists are encouraged to respect his/her colleagues and other
health-care providers. It is believed that pharmacists challenge to increase their
visibility in the health-care team as well as providing rational high level care and
modifying their relationship with other health-care providers. In the last decade,
developed countries like Canada revised the relationships between pharmaceutical
companies and health- care providers and exposed some special issues in this regard
including conflict of interest between pharmaceutical companies and health-care
professionals.

References

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3810583/

Ethics in research:

There are several reasons why it is important to adhere to ethical norms in research.

First, norms promote the aims of research, such as knowledge, truth, and avoidance of
error. For example, prohibitions against fabricating, falsifying, or misrepresenting
research data promote the truth and minimize error.

Second, since research often involves a great deal of cooperation and

coordination among many different people in different disciplines and institutions,
ethical standards promote the values that are essential to collaborative
work, such as trust, accountability, mutual respect, and fairness.

Third, many of the ethical norms help to ensure that researchers can be held
accountable to the public. For instance, federal policies on research
misconduct, conflicts of interest, the human subjects protections, and animal
care and use are necessary in order to make sure that researchers who are funded
by public money can be held accountable to the public.

Fourth, ethical norms in research also help to build public support for research.
People are more likely to fund a research project if they can trust the quality and
integrity of research.

Finally, many of the norms of research promote a variety of other important moral
and social values, such as social responsibility, human rights, animal welfare,
compliance with the law, and public health and safety. Ethical lapses in research can
significantly
harm human and animal subjects, students, and the public.

Principles of ethics in research:

The following is a rough and general summary of some ethical principals that various
codes address*:

1. Honesty

Strive for honesty in all scientific communications. Honestly report data, results,
methods and procedures, and publication status. Do not fabricate, falsify,
or misrepresent data. Do not deceive colleagues, research sponsors, or the public.

2. Objectivity

Strive to avoid bias in experimental design, data analysis, data interpretation,

peer review, personnel decisions, grant writing, expert testimony, and other
aspects of research where objectivity is expected or required. Avoid or minimize
bias or self- deception. Disclose personal or financial interests that may affect
research.

3. Integrity

Keep your promises and agreements; act with sincerity; strive for consistency of
thought and action.

4. Carefulness

Avoid careless errors and negligence; carefully and critically examine your own work
and the work of your peers. Keep good records of research activities, such as data
collection, research design, and correspondence with agencies or journals.

5. Openness

Share data, results, ideas, tools, resources. Be open to criticism and new ideas.

6.Respect for Intellectual Property

Honor patents, copyrights, and other forms of intellectual property. Do not use
unpublished data, methods, or results without permission. Give proper
acknowledgement or credit for all contributions to research. Never plagiarize.

7. Confidentiality

Protect confidential communications, such as papers or grants submitted

for publication, personnel records, trade or military secrets, and patient records.

8. Responsible Publication
Publish in order to advance research and scholarship, not to advance just your own
career. Avoid wasteful and duplicative publication.

9. Responsible Mentoring

Help to educate, mentor, and advise students. Promote their welfare and allow them to
make their own decisions.

10. Respect for colleagues

Respect your colleagues and treat them

fairly. 11.Social Responsibility

Strive to promote social good and prevent or mitigate social harms through research,
public education, and advocacy.
12. Non-Discrimination

Avoid discrimination against colleagues or students on the basis of sex, race, ethnicity,
or other factors not related to scientific competence and integrity.

13. Competence

Maintain and improve your own professional competence and expertise through
lifelong education and learning; take steps to promote competence in science as a
whole.

14. Legality

Know and obey relevant laws and institutional and governmental policies.

15.Animal Care

Show proper respect and care for animals when using them in research. Do not conduct
unnecessary or poorly designed animal experiments.

16. Human Subjects Protection

When conducting research on human subjects, minimize harms and risks and
maximize benefits; respect human dignity, privacy, and autonomy; take special
precautions with vulnerable populations; and strive to distribute the benefits and
burdens of research fairly.

Ethical decision making in research

Although codes, policies, and principals are very important and useful, like any set of
rules, they do not cover every situation, they often conflict, and they require
considerable interpretation. It is therefore important for researchers to learn how to
Forensic pharmacy

interpret, assess, and apply various research rules and how to make decisions and to
act ethically in various situations. The vast majority of decisions involve the
straightforward application of ethical rules.

Unethical activities in research:

There are many other activities that the government does not define as "misconduct"
but which are still regarded by most researchers as unethical. These are sometimes
referred to as "other deviations" from acceptable research practices and include:

Publishing the same paper in two different journals without telling the editors

Submitting the same paper to different journals without telling the editors

Not informing a collaborator of your intent to file a patent in order to make sure that
you are the sole inventor

Including a colleague as an author on a paper in return for a favor even though the
colleague did not make a serious contribution to the paper

Discussing with your colleagues confidential data from a paper that you are reviewing
for a journal

Using data, ideas, or methods you learn about while reviewing a grant or a
papers without permission

Trimming outliers from a data set without discussing your reasons in paper

Using an inappropriate statistical technique in order to enhance the significance of

your research

Bypassing the peer review process and announcing your results through a press
conference without giving peers adequate information to review your work

Conducting a review of the literature that fails to acknowledge the contributions of

other people in the field or relevant prior work

Stretching the truth on a grant application in order to convince reviewers that your
project will make a significant contribution to the field

Stretching the truth on a job application or curriculum vita

Giving the same research project to two graduate students in order to see who can do
it the fastest

Overworking, neglecting, or exploiting graduate or post-doctoral students

Failing to keep good research records

100 | P a g
e
Failing to maintain research data for a reasonable period of time

Making derogatory comments and personal attacks in your review of author's

submission

Promising a student a better grade for sexual

favors Using a racist epithet in the laboratory

Making significant deviations from the research protocol approved by your

institution's Animal Care and Use Committee or Institutional Review Board for
Human Subjects Research without telling the committee or the board

Not reporting an adverse event in a human research

experiment Wasting animals in research

Exposing students and staff to biological risks in violation of your institution's

biosafety rules

Sabotaging someone's work

Stealing supplies, books, or data

Rigging an experiment so you know how it will turn out

Making unauthorized copies of data, papers, or computer programs

Owning over $10,000 in stock in a company that sponsors your research and
not disclosing this financial interest

Deliberately overestimating the clinical significance of a new drug in order to obtain

economic benefits

Ethics in pharmaceutical industry

Pharmaceutcial industry
The pharmaceutical industry develops, produces, and market drugs
or pharmaceutical licensed for use as medication.

Pharmaceutical companies are allowed to deal in generic and/or brand

medication and medical devices.

They are subject to variety of laws and regulations regarding the

patenting,
 testing and ensuring safety and efficacy and marketing of drugs.

New innovation (1960s)

The industry expanded rapidly in the sixties, benefiting from new discoveries.

Attempts were made by the U.S. Food and Drug Administration (FDA) increase
regulation of pharmaceutical industries and to limit financial links between
companies and prescribing physician.

World medical association set standards for clinical research.

Pharmaceutical companies were required to prove efficacy and safety of the
drug in clinical trials before marketing them.

Regulation (1970s)
Tighter regulatory controls were introduced.

The new regulations revoked permanent patents and established fixed periods
on patent protection for branded products.

Legislation was enacted to test and approve drugs and to require appropriate
labelling .

Prescription and non prescription drugs became legally distinguished from one
another as the pharmaceutical industry matured.

Future out look

The chemical and drug industry has a promising future. With an aging
population consuming three times as many drugs as younger people, demand is
expected to rise and opportunities to increase. Drug spending is expected to
triple from 2000 to 2050.
Many new drugs are expected to be developed in the coming years. Advances
in technology and the knowledge of how cells work will allow pharmaceutical
and medicine manufacturing makers to become more efficient in the drug
discovery process. Further, there is a direct relationship between gene
discovery and identification of new drugs- the more gene identified the more
paths available for drug discovery.

New genetic technology is being explored to develop vaccines to prevent or

treat diseases that have eluded traditional vaccines such as AIDS, malaria.

Ethical business practices

Investors: Ensuring safety of their money and timely payment of interest.
 Employee: Provision of fair opportunities in promotion and training, good
working conditions and timely payment of salaries.

Customer: Complete information of service and product should made

available. Personal information of the customers should not be used for
personal gain.

Competition: Unscrupulous tactics and methods should be avoided while

handling competitors.

Government: Rules and regulations regarding taxes, duties, restrictive and

monopolistic trade practices and unlawful activities like corruption and
bribing should be adhered to.

Environment: Polluting industries should ensure compliance with the

government norms regarding air, water and noise pollution

Unethical business practices

Resorting to dishonesty, trickery or deception.

 Distortion of facts to mislead or confuse.

 Manipulating people emotionally by exploiting their vulnerabilities.

 Greed to amass excessive profit.

 Creation of false documents to show increased profits.

 Avoiding penalty or compensation for lawful act.

 Lack of transparency and resistance to investigation.

 Harming the environment by exceeding the government prescribed

norms for pollution.

 Invasion of privacy used as leverage, for obtaining personal or profession

gains.

Ethical Behaviour
o Integrity

o Information sharing

o Accurate prescription

o Transparency

o Objectivity
 o Fairness

o Care for and about people

Unethical behaviour
 Misleading advertisement

 Personal interest

 Misguiding prescription

 Subjectivity

 Partiality

 Selling of samples to public

 Uncontrolled testing

Laws in pharmaceutical industry

The pharmaceutical industry is an investment industry driven by the profits of
its shareholders. Improving human health is not the driving force of this
industry.

The pharmaceutical investment industry was artificially created and

strategically developed over an entire century by the same investment groups
that control the global petrochemical and chemical industries.

The huge profits of the pharmaceutical industry are based on the patenting of
new drugs. These patents essentially allow drug manufacturers to arbitrarily
define the profits for their products.

The marketplace for the pharmaceutical industry is the human body – but
only for as long as the body hosts diseases. Thus, maintaining and
expanding diseases is a precondition for the growth of the pharmaceutical
industry.

A key strategy to accomplish this goal is the development of drugs that merely
mask symptoms while avoiding the curing or elimination of diseases. This
explains why most prescription drugs marketed today have no proven efficacy
and merely target symptoms.

To further expand their pharmaceutical market, the drug companies are

continuously looking for new applications (indications) for the use of drugs
they already market. For example, Bayer’s pain pill Aspirin is now taken by 50
million healthy US citizens under the illusion it will prevent heart attacks.
Another key strategy to expand pharmaceutical markets is to cause new
diseases with drugs. While merely masking symptoms short term, most of the
prescription drugs taken by millions of patients today cause a multitude of
new diseases as a result of their known long-term side effects. For example,
all cholesterol-lowering drugs currently on the market are known to increase
the risk of developing cancer – but only after the patient has been taking the
drug for several years.

The known deadly side effects of prescription drugs are the fourth leading
cause of death in the industrialized world, surpassed only by the number of
deaths from heart attacks, cancer and strokes (Journal of the American Medical
Association, April 15, 1998). This fact is no surprise either, because drug patents
are primarily issued for new synthetic molecules. All synthetic molecules need
to be detoxified and eliminated from the body, a system that frequently fails
and results in an epidemic of severe and deadly side effects.

While the promotion and expansion of diseases increase the market of the
pharmaceutical investment industry - prevention and root cause treatment of
diseases decrease long-term profitability; therefore, they are avoided or even
obstructed by this industry.

Worst of all, the eradication of diseases is by its very nature incompatible

with and diametrically opposed to the interests of the pharmaceutical
investment industry. The eradication of diseases now considered as potential
drug markets will destroy billions of investment dollars and eventually will
eliminate this entire industry.

Vitamins and other effective natural health therapies that optimize cellular
metabolism threaten the pharmaceutical “business with disease” because they
target the cellular cause of today’s most common diseases - and these natural
substances cannot be patented.

Throughout the more than one hundred year existence of the pharmaceutical
industry, vitamins and other essential nutrients, with defined functions as
cofactors in cellular metabolism, have been the fiercest competition and
the greatest threat to the long-term success of the pharmaceutical investment
business.

Vitamins and other effective natural health therapies that effectively prevent
diseases are incompatible with the very nature of the pharmaceutical
“business with disease.”

To protect the strategic development of its investment business against the

threat from effective, natural and non- patentable therapies, the pharmaceutical
 industry has – over an entire century - used the most unscrupulous methods,
such as:

Withholding life-saving health information from millions of people. It is simply

unacceptable that today so few know that the human body cannot produce
vitamin C and lysine, two key molecules for connective tissue stability
and disease prevention.

Discrediting natural health therapies. The most common way is through global
PR campaigns organized by the Pharma-Cartel that spread lies about the
alleged side effects of natural substances – molecules that have been used by
Nature for millennia.

Banning by law the dissemination of information about natural health

therapies. To that end, the pharmaceutical industry has placed its lobbyists in
key political positions in key markets and leading drug export nations.

The pharmaceutical “business with disease” is the largest deception and fraud
business in human history. The product “health” promised by drug companies
is not delivered to millions of patients. Instead, the “products” most often
delivered are the opposite: new diseases and frequently, death.

The survival of the pharmaceutical industry is dependent on the elimination by any

means of effective natural health therapies. These natural and non-patentable
therapies have become the treatment of choice for millions of people despite the
combined economic, political and media opposition of the world’s largest investment
industry

Patent
When a pharmaceutical company first develops a new drug to be used for a
disease condition, it is initially sold under a brand name by which the clinicians
can prescribe the drug for use by patients. The drug is covered under patent
protection, which means that only the pharmaceutical company that holds the
patent is allowed to manufacture, market the drug and eventually make profit
from it.

In most cases, the drug patent is awarded for around twenty years in the United
States. The lifetime of the patent varies between countries and also between
drugs. Since the company applies for a patent long before the clinical trial to
assess a drug’s safety and efficacy has commenced, the effective patent period
after the drug has finally received approval is often around seven to twelve
years.
Generics
A generic drug is an agent that is similar to a branded or reference-listed drug
in terms of dosage, administration and performance. A generic drug is
marketed when the original patent protection that was applied to the drug
expires or when the owner of the patent waives its rights.

Once the patent has expired, the drug can be manufactured and sold by other
companies. At this point, the drug is referred to as a generic drug. According
to guidelines in most countries, including those from the US FDA, generic
drugs have to be identical to the branded drug in terms of efficacy, safety,
usage, route of drug administration, pharmacokinetics and pharmacodynamics.

Good manufacturing practice guidelines provide guidance for

manufacturing, testing, and quality assurance in order to ensure that a food or
drug product is safe for human consumption. Many countries have legislated
that food and pharmaceutical and medical device manufacturers follow GMP
procedures and create their own GMP guidelines that correspond with their
legislation.

All guidelines follow a few basic principles:

Manufacturing facilities must maintain a clean and hygienic manufacturing

area.

Controlled environmental conditions in order to prevent cross contamination

of food or drug product from adulterants that may render the product unsafe
for human consumption.

GMPS
 Manufacturing processes are clearlydefined and
controlled. All critical processes are validated to
ensure consistency and compliance with specifications.

 Manufacturing processes are controlled, and any changes to the process

are evaluated. Changes that affect the quality of the drug are validated
as necessary.

 Instructions and procedures are written in clear and unambiguous

language. (Good Documentation Practices)

 Operators are trained to carry out and document procedures.

 Cross contamination with unlabeled major allergens is prevented.

 Records are made, manually or by instruments, during manufacture that

demonstrate that all the steps required by the defined procedures.