Pharmacy Law and Regulatory Affairs

Lecture - 9

Dr Shaouki Munir
MBBS (DU), MGMP(UTS), MPH (UNSW)
 Module Contents

This module covers the following topics:

a) Model pharmacy concept in Bangladesh
b) Basics of dispensing: practices, importance, process and errors
c) Basics of prescription: parts, handling, dose calculation,
d) Importance of the interpretation of the prescription
f) Professional standards for hospital pharmacy services
Model pharmacy

Model pharmacy is a patient care service designed to improve

medication adherence and build efficiencies in pharmacy operations.

Reasons for establishing model pharmacy:

• Lack of knowledge of drug
• Low-quality of drugs and antibiotics
• Reduce to sell the fake drug
• Reduce the illegal business of drug
Model pharmacy initiatives

➢In Bangladesh availability of quality medicines and services in

retail pharmacies is one of the major problems affecting public
health. To address this issue, MSH has initiated a project titled
Designing Implementation Strategy for Accredited Drug Seller
(ADS) and BPMI program

➢Through this program, MSH aims to ensure improved access to

and appropriate use of quality medicines and services. MSH has
selected Visual Communication Ltd. (VISCOM) as a consultant to
develop a consumer engagement strategy, including marketing of
model pharmacies
Target Audience

✓Primary Audience – Consumers of medicines and

potential consumers (mass people)

✓Secondary Audience- Medicine sellers and medicine

shop owners in both rural and urban

✓Tertiary Audience- Stakeholders at 3 levels such as

Central, District and Upozilla
Design of model pharmacy

• Air conditioning system

• Registered graduate pharmacist
• Consistent care
• Drug therapy
• Scheduled work – 24-hour service
• Area of at least 300 sq. ft.

*YouTube video link: https://www.youtube.com/watch?v=80vG8a-NuCM

DRUG DISPENSING PRACTICES

Dispensing refers to
“process of preparing medicines and distributing them to
users with provision of an appropriate information,
counselling and follow-up”
DRUG DISPENSING PROCESS
DRUG DISPENSING PROCESS
DISPENSING ENVIRONMENT

A good dispensing environment includes the following:

• Staff

• Physical surrounding

• Equipment and other facilities

Examples of dispensing errors
• Dispensing medicines to the wrong patient
• Dispensing the wrong medicine to the patient
• Dispensing the wrong drug strength
• Dispensing at the wrong time
• Dispensing the wrong dosage form
• Dispensing an expired medicine
• Omission ( failure to dispense )
• Dispensing of medicine of inferior quality
• Dispensing an incorrectly compounded medicine
• Dispensing with the wrong information on the label
• Dispensing with wrong verbal information to the patients
INVESTIGATING DRUG DISPENSING PRACTICES

Quality indicators: Good drug dispensing guidelines of WHO

recommended following indicators to investigate drug dispensing
practices:
1. Average dispensing communication time
2. Percentage of prescribed items actually dispensed
3. Percentage of prescribed medication that are adequately labelled
4. Patient knowledge provided to patient
Average dispensing communication time

Purpose:
To measure the average time that personnel dispensing drugs
spend with patient.
Formula:
Percentage of prescribed medicines actually dispensed
Purpose:
To measure the degree to which health facilities can
provide the drugs which are prescribed.
Formula:
 Percentage of prescribed medication that are adequately
labelled

Purpose:
To measure the degree to which dispensers record essential
information on the drug package they dispense
Percentage of patient knowledge of correct dosage

Purpose:
To measure the effectiveness of the information given to patient on the
dosage schedule of the drugs they received.
Prescription legality in professional practice

“Prescription” means the written direction given by the doctor to the

chemist for the compounding of medicine suitable to a patient’s case.
 Recent legislation has legalised the electronic communication of
prescriptions
New technology has also made it easier to alter or forge prescriptions
It is, therefore, important for pharmacists and pharmacist’s assistants
to develop good pharmacy practice habits in handling, interpreting,
authenticating and recording prescriptions
It is equally important for doctors and patients to understand their
rights and obligations regarding prescriptions
PARTS OF PRESCRIPTION

1) Prescriber information
2) Patient information
3) Date of prescription
4) Superscription
5) Inscription
6) Subscription
7) Direction to patient (Transcription)
8) Signature of prescriber
Handling of Prescription

• Receiving
• Dosage calculation
• Compounding
• Finishing
• Pricing
• Delivering
Receiving the prescription

The pharmacist should receive the prescription.

It includes,
➢Reading the prescription
➢Checking the prescription
•
 Compounding

• The ingredients are compounded by the accurate method

• For weighing, electrical machines should be used

Finishing the prescription

It includes,
✓Packaging
✓Filling
✓Labelling
✓Rechecking
IMPORTANCE OF THE INTERPRETATION OF PRESCRIPTION

➢Drug use is a complex process, and there are many drug-related

challenges at various levels, involving prescribers, pharmacists and
patients
➢While medication misadventure can occur anywhere in the health
care system, from prescriber to dispenser to administration and
finally to patient use, the simple truth is that many errors are
preventable, and pharmacists assume an active role in the
appropriate use of drugs
Professional Standards for Hospital Pharmacy Services
Purpose of the standards

• The professional standards describe quality pharmacy services (or

‘what good looks like)

• They provide a broad framework to support pharmacists and their

teams to continually improve services, shape future services and
roles, and deliver high-quality patient care across all settings and
sectors

• Ultimately, they will enable all providers to improve and develop

pharmacy services that are safe and put the needs of patients first
Broad applicability

• Models of service delivery increasingly cut across the traditional

boundaries of care, and new care models are continuously developing

• The standards have broad applicability and can be used to ensure that
quality pharmacy services develop regardless of the care setting

• The standards can be used to support the development of quality

services in hospitals, community services, mental health services,
secure environments and ambulance services
▪ Pharmacists should ensure that the “right ” patient is
receiving the “right” drug in a “right” dose

▪ Pharmacists and other health care professionals involved in

the medication use process must work together to develop
a systems approach to medication use & error reduction
 References
• Who.int. 2011. [online] Available at:
<https://www.who.int/medicines/areas/quality_safety/quality_assurance/FIPWHOGuideline
sGoodPharmacyPracticeTRS961Annex8.pdf> [Accessed 30 March 2022].

• National Association of Boards of Pharmacy. 2013. Prescription Medication Distribution – The

Five Percent Rule for Resale (Resolution 109-2-13) - National Association of Boards of
Pharmacy. [online] Available at: <https://nabp.pharmacy/news/news-releases/prescription-
medication-distribution-the-five-percent-rule-for-resale-resolution-109-2-13/> [Accessed 30
March 2022].
•
• Rpharms.com. 2022. Hospital Pharmacy Standards Handbook. [online] Available at:
<https://www.rpharms.com/recognition/setting-professional-standards/professional-
standards-for-hospital-pharmacy/hospital-pharmacy-standards-handbook> [Accessed 30
March 2022].
Thank you