IIMT Pharmacy, Greater Noida

PHARMACOTHERAPEUTICS

CHAPTER-1 Ms. Bharti

SUBJECT NAME- PHARMACOTHERAPEUTICS (LECTURER)

D.PHARM 2ND YEAR

 PHARMACOTHERAPEUTICS
 It is applied science(Applied science is a discipline that is used to apply existing scientific
knowledge to develop more practical applications)
 Pharmacotherapeutics (PT) is the application of pharmacological information together with
the knowledge of the disease for its prevention, mitigation, or cure.
 Pharmacotherapy is included as drug therapy to treat the disease after surgical, radiation, or
physical therapy.
 In the modern day, different types of chemical constituted medicine or available which show
the effect (may be positive or negative), to correct this problem (according to the demand or
patient need) Pharmacotherapeutics play a major role in the Indian system of medicine.
 PHARMACOTHERAPEUTICS

Pharmacology Therapeutics
Science of drug Branch of medicine

• Provide scientific data about drugs • It is concerned with the prevention and cure
• How they act, where they act of disease or relief of symptoms with drug
therapy and non-drug measures
• Formulations in which they are available
• Routes and doses, frequency, duration
• Adverse effects
• How to use them safely
 IMPORTANT TERMS

• Etiopathogenesis- The cause and subsequent development of an abnormal condition

of a disease
• Clinical manifestation- A clinical manifestation is the physical result of some type
of illness or infection
• Non-pharmacological management of disease- Non-pharmacological therapies
(non-medication treatments): Referring to therapies that do not involve drugs
• Pharmacological management of disease- therapies that involve drugs
 PRINCIPLES OF
PHARMACOTHERAPEUTICS
1. Establish a goal for therapy
2. Every ill does not require a pill
3. Prescribe rationally and not fashionably
4. Integrate drug information with relevant knowledge from other subjects.
5. Safe prescribing all the times
6. Problems can arise at any stage: Beware of them
7. Adopt strategies to maximize adherence.
8. Keep your drug knowledge current.
9. Know your patient well: Avoid prescribing cascade(Prescribing cascade is defined as the
situation in which a first drug administered to a patient causes adverse event signs and
symptoms, that are misinterpreted as a new condition, resulting in a new medication being
prescribed.)
 OBJECTIVE OF
PHARMACOTHERAPEUTICS
• The main objectives of Pharmacotherapy study as follows:
1. Provide complete pathophysiology of selected disease states and the rationale for drug
therapy.
2. The therapeutic approach to management of these diseases
3. The importance of preparation of individualised therapeutic plans based on diagnosis.
4. Needs to identify the patient-specific parameters relevant in initiating drug therapy, and
monitoring therapy (including alternatives, time course of clinical and laboratory indices
of therapeutic response and adverse effects.)
5. Minimize adverse effect.
 SCOPE OF
PHARMACOTHERAPEUTICS
• Pharmacotherapeutics provides the knowledge and skills required for the quality use of medicine.
• Pharmacotherapeutics covers the pathophysiology and therapeutics of disease. This will enable us to
understand the pathophysiology of the disease and its management.
• Selection of the most appropriate drug, dose, dosage form and duration of action and route of
administration depends on the particular disease, its state, and patient condition.
• Pharmacokinetic and pharmacodynamics of drugs alter with the disease state and patient condition
and concurrently administered drugs.
• The change in the ADME of the drug will result in a change in the bioavailibilty of the drugs which
can modify the effect of drugs and may result in adverse effects of the drug.
• After complete study of pharmacotherapeutics, an individual has an extensive understanding of how
the pharmacokinetics and pharmacodynamics can be correlated with treatment and disease and how
drugs can interact with each other and this will be helpful to him to select best individual therapy.
 RATIONAL USE OF MEDICINES
RUM is an important, vital, and caretaker aspect/subject included in the pharmacodynamics
because- Body mechanism of persons varies individually (obese, thin, male-female, age of
the person, etc.) due to the involvement of RUM we decide that- the correct medicine for the
correct individual at the correct time for correct diseases.
According to WHO- “The rational use of drugs requires the patient to receive medication
appropriate to their clinical needs, in doses that meet their own individual requirements for
an adequate period of time and at the lowest cost to them and their community”.
Factors responsible for the RUM
A. Arises during manufacturing procedures— It is the initial step/factor responsible for the
RUM because during the manufacturing drug quantity and measure are the important aspects
regarding the drug formulation, it is avoided by the involvement of-
1. Correct platform.
 2. Correct equipment.
3. Correct procedure.
B. Arise due to the individual— The body physiology of an individual varies from person to person
so chemical requirement also varies person to person for treating any disease. It depends on the
different factors-
1. Body structure.
2. Sex of person.
3. Age of person.
4. Prior disease history.
5. Drug contraindication and allergy.
6. Drug tolerance or resistance.
C. Environmental effects— Environmental condition also varies place to place so, they also act as
the factor-
1. Seasonal variation.
2. Any pandemic.
3. Any mutations.
Ideally, therapeutically sound and cost-effective use of medicines by health professionals and
consumers is achieved at all levels of the health system, and in both the public and the private
sectors. A sound rational drug use program in any country has three elements:
Rational use of medicines strategy and monitoring -- advocating rational medicine use,
identifying and promoting successful strategies, and securing responsible medicines
promotion.
Rational use of medicines by health professionals -- working with countries to develop and
update their treatment guidelines, national essential medicines lists, and formularies, and
supporting training programs on rational use of medicines.
Rational use of medicines by consumers -- supporting the creation of effective systems of
medicines information, and empowering consumers to take responsible decisions regarding
their treatment.
 IRRATIONAL USE OF THE DRUGS
• Irrational use of medicines is a major problem worldwide. WHO estimates that more
than half of all medicines are prescribed, dispensed, or sold inappropriately, and that
half of all patients fail to take them correctly. 
• Irrational use of drugs means, the use of medicines in an improper manner and
improper formulation it involves as-
1. By selection of wrong medicine.
2. By selection of wrong doses.
3. By selection of the wrong person.
4. By selection of wrong time.
 REASON FOR IRRATIONAL USE OF DRUGS
• The use of too many medicines prescribed per patient (polypharmacy); often, these result in cross-
reactions between different drugs prescribed.
• Inappropriate prescription of antimicrobials, often in inadequate dosage, for nonbacterial infections.
• Over-prescription of injections when oral formulations would be more appropriate.
• Failure to prescribe in accordance with clinical guidelines: Wrong choice of drugs, inadequate dosages,
incorrect frequency of administration of a drug, improper duration of therapy, or failure to observe
drug contraindications.
• Choice of more expensive drugs when less expensive drugs would be equally or more effective.
• Prescription of drugs that have no use, only for their placebo effect or for impressing the patient, or for
vested interests in the prescribed drugs.
• Inadequate consulting time and dispensing time along with poor communication of information
regarding drugs to a patient in a verbal or written form leading to incorrect use by patients is of great
public health concern too. Worldwide, more than 50% of all medicines are prescribed, dispensed, or
sold inappropriately, while 50% of patients fail to take them correctly.
• Inappropriate self-medication of prescription-only medicines.
 IMPACT OF IRRATIONAL USE OF MEDICINES
• Ineffective treatment leading to serious morbidity and mortality.
• Iatrogenic diseases: It is defined as a disease induced by a drug prescribed by a physician, or
after a medical or surgical procedure
• Inappropriate use and overuse of medicines leading to high out-of-pocket payments by
patients. This results in patient harm in terms of adverse drug reactions and impoverishment of
the patient.
• Inappropriate use and overuse in the public sector facility, where the government pays the
bills, leads to wastage of meager resources, and a shift of funds away from necessary
expenditures to unnecessary areas.
• Increasing antimicrobial resistance:
▪ Inappropriate use of antimicrobials is leading to increased antimicrobial resistance.
▪ Antimicrobial resistance (AMR) is one of the most serious public health problems globally
resulting in prolonged illness and hospitalization, mortality, and higher costs.
▪ Use of drugs other than first-line drugs(a drug that is the first choice for treating a
particular condition because it is considered a very effective treatment for that condition
with the least likelihood of causing side effects.) in such situations may increase costs
(sometimes as high as 100-fold), makes treatment unaffordable for many
governments/health systems, especially in developing countries, and increase in out-of-
pocket expenditure by patients.
▪ Development and spread of antimicrobial resistance are due to:
→ overuse, misuse, and irrational use by doctors;
→ self-medication by patients; and
→ use in animal husbandry, aquaculture, and agriculture.
Common examples of irrational prescribing seen in day-to-day practice include the use
of:
• drugs when no drug therapy is indicated, e.g., antibiotics for viral upper respiratory
infections
• wrong drug for a specific condition requiring drug therapy, e.g. an antibiotic in childhood
viral diarrheas requiring ORS
• drugs with doubtful/unproven efficacy, e.g. antimotility agents in acute infective diarrhea
• correct drugs but incorrect administration, dosages, or duration, e.g., use of IV
metronidazole when an oral formulation would be appropriate
• unnecessarily expensive drugs, e.g., a third generation, broad-spectrum antimicrobial when a
first-line, narrow spectrum, an agent would suffice
• multivitamins and ‘tonics’ and so forth. The list could go on and on.
 WHO ADVOCATES 12 KEY INTERVENTIONS
TO PROMOTE MORE RATIONAL USE
• Establishment of a multidisciplinary national body to coordinate policies on medicine use
• Use of clinical guidelines
• Development and use of national essential medicines list
• Establishment of drug and therapeutics committees in districts and hospitals
• Inclusion of problem-based pharmacotherapy training in undergraduate curricula
• Continuing in-service medical education as a licensure requirement
• Supervision, audit, and feedback
• Use of independent information on medicines
• Public education about medicines
• Avoidance of perverse financial incentives
• Use of appropriate and enforced regulation
• Sufficient government expenditure to ensure the availability of medicines and staff.
EVIDENCE BASED MEDICINE
• Evidence-based medicine, as it follows, is the conscientious, explicit, and judicious
use of current best evidence in making decisions about individual patients.
• Therefore, EBM’s praxis encompasses two components: a combination of medical
expertise with the best available external clinical evidence from systematic research. 
• according to EBM’s concept, medical treatment decisions must be based on the best
available evidence.
• The expertise and experience of the clinical who understands the disease are crucial
in determining whether the external evidence applies to the patient and whether it
should be integrated in the therapeutic plan.
• Best research evidence may come from basic medical sciences, but more often it
arises from patient-centered clinical research.
 5 steps of
evidence based
practice
• Ask a question
Converting the need for information (about prevention, diagnosis, prognosis, therapy,
causation, etc) into an answerable question
• Find information/evidence to answer question
Tracking down the best evidence with which to answer that question 
• Critically appraise the information/evidence
Critically appraising that evidence for its validity (closeness to the truth), impact (size of the
effect), and applicability (usefulness in our clinical practice) 
• Integrate appraised evidence with own clinical expertise and patient’s preferences
Integrating the critical appraisal with our clinical expertise and with our patient's unique
biology, values and circumstances 
• Evaluate
Evaluating our effectiveness and efficiency in executing Steps 1-4 and seeking ways to
improve them both for next time
LEVEL OF EVIDENCE PYRAMID
1. Editorials and Expert Opinions
This is evidence based on the opinions of a panel of experts
2. Case-Series and Case-Reports
• Case series are descriptive studies following one small group of people.
• They are additions or supplements of case reports.
• A case report is a detailed report of the symptoms, signs, diagnosis, treatment, and
follow-up of an individual patient.
3. Case control study
The observational epidemiologic study of persons with the disease (or other outcome
variable) of interest and a suitable control (comparison, reference) group of persons
without the disease.
The relationship of an attribute to the disease is examined by comparing the diseased
and nondiseased with regard to how frequently the attribute is present or, if
quantitative, the levels of the attribute, in each of the groups. (OCEBM Table of
Evidence Glossary)
3. Cohort Studies
• The modern definition of a ‘cohort’ in clinical studies is a group of people with
defined characteristics who are followed in order to determine health-related
outcomes.
• The Framingham Heart study is an example of the use of a cohort study to answer an
epidemiological question. The study found high blood pressure and high blood
cholesterol to be major risk factors for cardiovascular disease
• Another example of a cohort study that has been ongoing for many years is the
National Child Development Study (NCDS), the most widely researched of the
British birth cohort studies. By following you throughout your lives, researchers are
able to understand:
→ how our experiences as children affect how we turn out as adults
→ how different areas of our lives, such as health, wealth, family, education, and
employment, are linked
→ how these aspects of life vary for people from different walks of life.
4. Randomised Clinical Trial (RCT)
• An RCT in clinical research typically compares a proposed new treatment against an
existing standard of care; these are then termed the 'experimental' and 'control'
treatments, respectively.
• A randomized clinical trial is one that uses randomization when allocating people to
different arms of the study.
• This means that the treatment groups are chosen by chance using a formal system
and each participant has an equal chance of being selected for each arm.
5. Meta-analysis
• Meta-analysis is a systematic, statistics-based review of data that contrasts and
combines results from different but related studies, in an attempt to identify patterns,
disagreements, and other relationships across multiple studies.
• A meta-analysis can support a stronger conclusion than any individual study but may
be flawed because of publication bias.
➢ Importance of EBM
• EBM gives physicians a way to keep up with evidence-based protocols
• EBM enables healthcare teams to make personalized decisions based on global
evidence
• EBM creates greater transparency and accountability
• EBM improves the quality of care and outcomes
➢ Limitations of EBM
• Time-consuming
• Require access to the medical literature
• Require some knowledge of statistics
• Publication bias
 ESSENTIAL MEDICINES LIST
According to WHO, Essential medicines are those that satisfy the priority healthcare
needs of the population.
• They are selected on the basis of disease prevalence, evidence of efficacy, safety, and
comparative cost-effectiveness.
• Essential medicines are intended to be available in functioning health systems at all
times in adequate amounts, in the appropriate dosage forms, with assured quality, and
at a price the individual and the community can afford.
• Which medicines are regarded as essential remains the responsibility of states within
a national framework.
• The International Conference on Primary Health Care (6–12 September 1978) was
held in Alma Ata, Kazakhstan, expressing the need for urgent action by all
governments, all health and development workers, and the world community to protect
and promote the health of all the people of the world
Impact of essential medicines: A limited range of carefully selected essential
medicines leads to
→ better health care,
→ better drug management and health outcome (including procurement, storage and
distribution, and improved quality of prescribed medicines),
→ cost-effective use of health resources.
• The WHO Model List of Essential Medicines is a list of essential medicines created by the World
Health Organization (WHO) which serves as a guide for the development of national and institutional
Essential Medicine Lists (EML).
• It is updated and revised every 2 years by the WHO Expert Committee on Selection and Use of
Medicines.
• The list was first published in 1977.
• Since 2007, a separate list for children up to 12 years (WHO Model List of Essential Medicines for
Children) is being brought out.
e.g. ibuprofen 200 mg/5 mL , pcm 125 mg/ml or suppositories 100mg tablet 100 mg or 250mg
• Initially in 1977, the WHO EML had 204 molecules and the current is the 20th list (2017) which has
433 medicines, including 25 fixed dose drug combinations (FDCs).
• India produced its National Essential Drugs List in 1996, and has revised it in 2011, and now in 2015
with the title “National List of Essential Medicines”. The latest list includes 376 medicines, of which 20
are FDCs.
The WHO has laid down criteria to guide selection of an essential medicine.
i) Only those medicines should be selected for which adequate data on efficacy and
safety are available from clinical studies and for which evidence of performance in
terms of efficacy, suitability, safety, and cost effectiveness has been obtained.
ii) Each selected medicine must be available in a form in which adequate quality,
including bioavailability, can be assured, its stability under the storage conditions and
use must be established.
iii) When two or more medicines appear to be similar in the above respects, the choice
between them should be made on the basis of a careful evaluation of their relative
efficacy, safety, quality, price, and availability.
iv) In cost comparison between medicines, not only the cost of the total treatment but
also the unit cost of the medicine must be considered. In cases where drugs are not
similar, the selection should be made on the basis of a cost-effectiveness analysis.
v) In some cases, the choice may also be influenced by other factors, such as
pharmacokinetic properties, or by local considerations, such as the availability of
facilities for storage or manufacturer.
vi) Most essential medicines should be formulated as single compounds. Fixed-ratio
combination products are acceptable only when the dosage of each ingredient meets
the requirements of a defined population and when the combination has a proven
advantage over single compounds administered separately in therapeutic effect and
safety.
vii) Drugs are specified by the international nonproprietary name (INN) or generic
name without reference to brand names or specific manufacturers.
 STANDARD TREATMENT
GUIDELINES(STG)
• The Standard Treatment Guidelines are prepared as a tool to assist and guide doctors,
pharmacists, dispensers, and other healthcare staff who prescribe at primary care
facilities in providing quality care to patients.
• The guidelines list the preferred treatments for common health problems experienced
by people in the health system.
• The guidelines are designed to be used as a guide to treatment choices and as a
reference book to help in the overall management of patients and are meant for use at
all levels within the health system, both public and private.
Definition:
A standard Treatment Guideline has been defined as a systematically developed
statement designed to assist practitioners and patients in making decisions about
appropriate health care for specific clinical circumstances.
Advantages
1. For Patients:
i) Consistency among prescribers reduced confusion and increased compliance.
ii) Most effective treatments prescribed
iii) Improves the availability of drugs
iv) It provides cost-effective optimal therapy.
2. For Healthcare Providers:
i) Gives expert consensus on the most effective, economical treatment for a specific
setting
ii) Provider can concentrate on correct diagnosis.
iii) Provide a standard to assess the quality of care.
iv) Provide a simple basis for monitoring and supervision.
3. For Supply Management Staff:
i) There should be sufficient quantities of drugs available for the most commonly
treated problems
ii) Facilitates pre-packaging, of course, of-therapy quantities of commonly prescribed
items for common conditions
iii) Drug demand is more predictable, so forecasting more reliable.
 Key features of the standard treatments include:
1. Simplicity:
• The number of health problems is limited. For each health problem, a few key clinical
diagnostic criteria are listed. Finally, drug and dosage information is clear and concise.
2. Credibility:
• The treatments are initially developed for patients by the most eminent clinicians.
• Revisions based on actual experience will further add to the credibility.
3. Same standard for all levels:
• The first choice of treatment of a patient depends on the patient’s diagnosis and condition.
• Doctors and other health care providers can use the same standard treatment. If a patient
attends a primary level or secondary level or tertiary level hospital, with a common condition
the treatment will be exactly the same.
4. Drug Supply based on Standards:
• The standard treatment guidelines must match the supply of drugs.
5. Pre-service Training:
• Standard treatment manuals are introduced and distributed during pre-service training and
their use becomes a habit.
6. Regular Updates:
• A change or alteration in the therapeutic preferences is incorporated and updated, and the
standards should be revised to reflect current recommendations.
7. Pocket manuals:
• The standard treatments are published as small, durable pocket manuals, which makes them
convenient to carry and use.
 Development of Standard Treatment Guidelines
• Standard Treatment Guidelines, also termed as clinical guidelines and clinical
protocols are component of health services provisioning to ensure evidence based
medicine and quality of care.
• Understanding its importance, Ministry of Health & Family welfare commissioned a
Taskforce on Standard Treatment Guidelines Which comprised of eminent clinicians
and representations from important stakeholders such as Indian Council of Medical
Research (ICMR), Director General of Health Services (DGHS), Federation of Indian
Chambers of Commerce and Industry(FICCI), civil society organizations and
academic institutions.
• National Health Systems Resource Centre (NHSRC) was designated as secretariat
for this taskforce.
• The objective of this taskforce was to compare and review the existing standards
treatment guidelines as well as identify the procedures/ conditions where fresh
development of Standard treatment Guidelines is required
 Process of STG Development
1. STG writing group
• Taskforce decided to work on limited no. of guidelines in the first phase. 10 clinical
specialty subgroups were formed with each group initially to focus one disease condition.
• To make guideline group multidisciplinary each group was directed to recruit members
from diverse background apart from domain experts. This includes allied health workers
(Nursing/Paramedic/Rehabilitation), Physician, private practitioners, primary care doctors,
public health/ health system experts, methodology experts and patients or patients right
organization.
• In each the senior most expert was usually designated as facilitator
• Writing group members were trained for the guideline development methodology in a
two day workshop with technical support of National Institute for Health and Care
Excellence (NICE), UK.
• Each subgroup was allocated some financial resources by NHSRC for conducting
subgroup meetings and covering other incidental cost.
 2. Topic Selection Process
• Each subgroup was requested to propose 5 disease conditions of their respective clinical
specialty.
• These disease conditions were prioritized on a criteria based on burden of disease, non
availability of Indian guidelines and policy importance.
• The disease conditions on which MoHFW already have issued guidelines were excluded.
Total 14 disease condition Were, selected for the first phase
3. Guideline Development
• Guidelines were developed using agreed ‘Hybrid’ methodology
• Scope of Guidelines was defined before starting the search for guidelines.
• As a strategy reputed repositories of guidelines such National Guideline Clearinghouse and
NICE were searched for existing guidelines as these have been already screened for quality.
• For guidelines from other sources a screening of guidelines against AGREE II tool was done
before considering them for adoption/adaption.
4. Documentation
Once the recommendations were finalized following documents were developed.
i) Full Background document
Contains the detailed recommendations along with reference to source guidelines. Document
also describes the process of development of guideline, details of writing group members, and
decision taken on specific recommendations.
ii) Quick Reference Guide
A concise version of full document consists of key recommendations and clinical pathways
more targeted for frontline clinicians.
• Apart from these, implementation tools such as Quality Standards, Patient Information Sheet
and Formulary were also developed for each set of guidelines.
5. Review Process
• All the documents went through three tier review process.
• First Internal review was done by a designated internal harmonization group. This
group reviewed the document for consistency and adherence to agreed methodology.
• Once the internal review suggestions were incorporated documents were submitted
to DGHS for external review, who in turn appointed prominent expert for external
review of the documents.
• Finally documents were uploaded on MoHFW and NHM website for one month for
open consultation and comments from public.
• Finally revised documents were submitted to MoHFW for final approval and
commissioning.
Disadvantage
i) It is difficult lengthy and time taking
ii) Need regular updation
iii) It loses reliability if not updated iv) It should be brief and small enough to carry easily
 REFERENCES
• Verma BK, Pant NC, Ojha A. Pharmacotherapeutics. 1st edition. Meerut: Sarthak
publication; 2022.
• https://www.who.int/activities/promoting-rational-use-of-medicines#:~:
text=Irrational%20use%20of%20medicines%20is,fail%20to%20take%20them%20correctly.