Week 7 - PHR514-Pharmacy Law and Regulatory Affairs

PHR514-Pharmacy Law and Regulatory Affairs
Lecture 7
Dr Shaouki Munir
MBBS (DU), MGMP (UTS), MPH (UNSW)
Module Contents
This module covers the following topics:
a) Code of conduct, ethics and laws

b) how to make a successful pharmacist workforce
c) Drug delivery system in BD
d) Clinical pharmacists: functions, level of actions, scopes & status in BD
e) Retail pharmacist: Roles, key skills, pharmacy mechanism in BD
f) Retail pharmacy design, standards, and pharmacy mechanism abroad
What is a code of conduct?
A code of conduct is a set of conventional principles and expectations that are
considered binding on any person who is a member of a particular group.
Specific codes of conduct: GPP (Good Pharmacy Practice):
• Dispensing • Minor ailments
• Health information • Medication therapy

management
• Patient education
• Disease management programs
• Monitoring
• Screening • Public health programs
• Therapeutic drug monitoring • Health campaigns

Making a
successful
pharmacist
workforce
Drug delivery system in Bangladesh
1. Direct method
Pharmaceutical companies directly
supply medicine to the consumer by
prescription order, which is written by
a physician
Drug delivery system in Bangladesh
2. Indirect method
Pharmaceutical companies supply
medicines to the consumer through
various intermediaries, Such as
agents, wholesalers, retailers, etc.
Function of Clinical Pharmacist
• Taking the medical history of the patient • Order and store medicines, keeping
• Patient Education them safe, pure and effective
• Patient Care • Formulation and management of drug
• Research and development policies
• Patient counselling • Drafts formation
• Drug interaction monitoring • Teaching and training medical and
• Safe use of the drug paramedical staff
• Specialize in dispensing drugs prescribed • Participation in drug utilisation studies
by physicians • Adverse drug reaction reporting
• Disease management cases
Level of action of clinical pharmacists
1. Before the prescription 2. During the prescription
• Clinical trials • Counselling activity
• Formularies • Influence the attitudes and priorities of the
• Drug information prescribers to choose the drug for the
• Drug-related policies treatment
• Monitor, detect, and prevent the medication-
related problem by giving special attention to
the drug dosages
3. After the prescription Information Source
• Counselling ✓ Medical record
• Preparation of personalised ✓ Patient
formulation ✓ Family
• Drug use evaluation ✓ Health care team
• Outcome research
• Pharmaco-economic studies
Clinical pharmacy practice areas
▪ Critical care
▪ Drug information
▪ Geriatrics and long-term care
▪ Internal medicines and subspecialties
▪ Different branches of medicine specialisations
▪ Nutrition
▪ Surgery
▪ Nuclear pharmacy
▪ Ambulatory care
Scope of clinical pharmacy in Bangladesh
There are several types of sector

• Drug information
• Drug utilisation
• Drug Evaluation and Selection
• Medication Therapy Management
• Formal Education and training programs
• Disease State Management
• Application of Electronic Data Processing
• Others [Drug Testing Laboratories, community
Status of clinical pharmacy in Bangladesh
• Pharmacy education structure in Bangladesh has a greater concentration on

industrial pharmacy practice, which is obviously a good sign when we have observed
tremendous development in the pharmaceutical manufacturing sector
• We have to be very careful and serious to ensure that those pharmaceutical products
are stored and administered properly at the end user point
• Our pharmacy council is not designing the syllabus in such a way that it will facilitate
a pharmacy student to become competent in the hospital and clinical sector, and a
future career in Bangladesh is one of them
• Only 2 or 3 tertiary and sophisticated private hospitals in Bangladesh (LABAID,
SQUARE etc.) have placed graduate pharmacists to run Pharmacy Department as a
Global standard requirement
• For now, we have quite a good number of Graduate Pharmacists in Bangladesh who
can be placed in hospitals to ensure that pharmaceutical services are available.
Proper training is required
Retail pharmacists work at a pharmacy in a store, typically a large
chain store such as CVS or Walgreens, while clinical pharmacists work
directly with physicians and patients in a hospital or other healthcare
facility.
Retail pharmacy & Retail
community pharmacy
❖Retail pharmacy is a pharmacy in

which drugs are sold to patients, as
opposed to a hospital pharmacy. Also
known as a community pharmacy
❖The term ‘retail community

pharmacy’ means an independent
pharmacy, a chain pharmacy, a
supermarket pharmacy, or a mass
merchandiser pharmacy that is
licensed as a pharmacy by the state
and that dispenses medications to the
general public at retail prices
Role of a retail pharmacists
✓Providing advice about health issues, symptoms and

✓Medications in response to customer enquiries
✓Recruiting, training and managing staff
✓Processing prescriptions and dispensing medication
✓Ordering and selling medicines and other stock
✓Meeting medical representatives
✓Managing budgets
✓Keeping statistical and financial records
✓Preparing publicity materials and displays
✓Marketing services
Key skills for retail pharmacists
• Maturity
• Attentiveness
• Responsibility
• Excellent interpersonal skills
• Organizational skills
• Verbal communication skills
• Confidence
• Commercial awareness
Two organizations regulate drugs & pharmacies in
Bangladesh-
1. The Directorate General of Drug Administration (DGDA)
2. The Pharmacy Council of Bangladesh(PCB)

Mechanism of retail pharmacy in BD
Primary Hospital /
Supplier Manufacturer
Pharmacy
Patient
wholesale
distributor
Secondary
Re-packager
wholesale
distributor
Retail pharmacy design in abroad
(mostly first world countries )
Retail Pharmacy Design

Solutions customised for
business & drug
dispensing system
Retail pharmacist’s salary - abroad
The national average salary for a Retail Pharmacist is $119,000/year in the

United States.
Mechanism of retail
pharmacy in abroad
1. Accept and check prescription details
• Prescriber details
• Patient details
• Medicare
• Confirm items to be dispensed
• Preference for generic medicine
2. Review and process
Script validity
I. meets legal requirements
II. Pharmaceutical Benefits Scheme eligibility
Safety and appropriateness

I. safe dosage
II. contra-indications (not appropriate with certain medical
conditions)
III. appropriateness of prescription for age, weight etc.
2. Review and process (contd.)
Review the patient’s dispensing history.

I. new or changed therapy
II. duplication
III. interactions (drug-drug, drug-disease state, drug-herb)
IV. compliance issues (is medicine being taken as prescribed?)
V. unusual use
VI. misuse/abuse issues
Patient-specific factors
I. age
II. allergies
III. other health conditions
3.Select/prepare and check
Select product
I. appropriate drug, brand, strength, form, quantity
II. repack if needed (non-standard quantity)
III. prepare where needed (reconstitute or compound from raw
ingredients)
Dispensing check
I. correct drug, brand, strength, form, quantity
II. correct formula/methodology for compounded products
III. confirm Pharmaceutical Benefits Scheme processing
4. Label and assemble
Label and assemble dispensed products

I. review expiry, instructions, cautionary labels
II. conduct barcode scan check
III. complete documentation and records
IV. organise counselling aids (e.g. written materials)
5. Supply and counsel
Supply medicine To a patient

I. correct patient?
II. correct medicines?
III. Is documentation present?
IV. unusual storage/discard requirements?
V. Does the patient/caregiver understands directions/advisories?
VI. clarify patient/ carer issues
VII. obtain the patient/carer’s signature for the supply
Counsel patient/ caregiver on the safe and appropriate use

References
• Doucette, W., 2008. [online] Available at:

<https://www.researchgate.net/publication/51400603_Retail_Pharmacy_Market_Structure_and_Perfo
rmance> [Accessed 17 March 2022].
• Pcb.portal.gov.bd. 1988. [online] Available at:

<http://pcb.portal.gov.bd/sites/default/files/files/pcb.portal.gov.bd/download/9e9eb2bf_b46d_432e_8
b33_79e4f7d9cb93/Pharmacist%20Code%20of%20Ethics.pdf> [Accessed 17 March 2022].
• Reddy, V., 2019. INTRODUCTION OF CLINICAL PHARMACY. [online] Slideshare.net. Available at:
<https://www.slideshare.net/BVSubbaReddy/introduction-of-clinical-pharmacy> [Accessed 17 March
2022].

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PHR514-Pharmacy Law and Regulatory Affairs

This module covers the following topics:

a) Code of conduct, ethics and laws

• Dispensing • Minor ailments

• Health information • Medication therapy

• Therapeutic drug monitoring • Health campaigns

There are several types of sector

• Pharmacy education structure in Bangladesh has a greater concentration on

❖Retail pharmacy is a pharmacy in

❖The term ‘retail community

✓Providing advice about health issues, symptoms and

1. The Directorate General of Drug Administration (DGDA)

2. The Pharmacy Council of Bangladesh(PCB)

Retail Pharmacy Design

The national average salary for a Retail Pharmacist is $119,000/year in the

Safety and appropriateness

Review the patient’s dispensing history.

Label and assemble dispensed products

Supply medicine To a patient

Counsel patient/ caregiver on the safe and appropriate use

• Doucette, W., 2008. [online] Available at:

• Pcb.portal.gov.bd. 1988. [online] Available at:

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