PHARMACY PRACTICE STANDARDS

Question 1

What are the core roles of a pharmacist in Botswana?

Answer 1

Dispensing medicines with counselling; Compounding and manufacturing; Stock control & procurement; Clinical pharmacy & patient monitoring; Public health promotion; Rational use of medicines; ADR monitoring and reporting; Supervising other healthcare personnel.

Question 2

What are the key responsibilities in pharmaceutical care?

Answer 2

Assess patient needs; Identify/resolve drug-related problems; Ensure safe, effective, rational therapy; Document interventions; Monitor outcomes.

Question 3

What must be present in a pharmacy’s Standard Operating Procedures (SOPs)?

Answer 3

Dispensing procedures; Compounding instructions; Storage & temperature monitoring; Expiry management; Infection control; Emergency procedures; ADR reporting; Documentation & record keeping.

Question 4

Storage requirements for medicines in health facilities

Answer 4

Temperature log twice daily; Cold chain maintained (2–8°C); FIFO/FEFO stock rotation; Secure, locked HFD cabinet; No expired items on shelves; Fire and hazard safety compliance.

Question 5

What documents must a pharmacy keep for controlled/HFD medicines?

Answer 5

HFD register; Requisition forms; Issue vouchers; Prescription copies; Returned/expired drug forms.

Question 6

How often must the emergency trolley be checked?

Answer 6

Regularly (daily/each shift depending on institution); Checklist must be signed, dated; Expiry dates reviewed; Seal must be intact.

Question 7

What is medicine use evaluation (MUE)?

Answer 7

Systematic review of how medicines are used to detect patterns, irrational use, or safety concerns.

Question 8

What are common dispensing errors?

Answer 8

Look-alike/sound-alike drugs
Wrong dose/strength
Poor handwriting
Mix-ups in paediatric vs adult dosing

Prevention includes SOPs, Tall-Man lettering, double checks, and pharmacist verification.

Question 9

What are the key counselling points required by standards?

Answer 9

• Dose & administration
• Purpose of medication
• Side effects
• Missed dose instructions
• Storage
• Duration of treatment
• Warning signs for referral

These points ensure patients understand their medication and its use.

Question 10

What are Good Manufacturing Practice (GMP)essentials?

Answer 10

• Trained personnel
• Clean environment
• Accurate batch records
• Quality assurance oversight
• Proper documentation
• Validated processes
• Product testing & release system

GMP ensures the quality and safety of pharmaceutical products.

Question 11

What is the main objective of the Botswana Health Professions Council?

Answer 11

• Promote high standards of health care
• Protect public welfare and interest

The Council aims to ensure quality health services in Botswana.

Question 12

What are the functions of the Council?

Answer 12

• Register/licence practitioners
• Maintain registers
• Oversee ethics & standards
• Investigate misconduct
• Advise Minister on public health issues
• Inspect private practice premises
• Promote professional conduct & training

These functions help maintain professional standards in health care.

Question 13

Who must be registered under BHPA to practice?

Answer 13

• Medical practitioners
• Pharmacists
• Dentists
• Interns
• Allied health professionals
• Associated medical professionals

Registration is mandatory for various health practitioners in Botswana.

Question 14

What documents are required for registration?

Answer 14

• Proof of identity
• Qualifications
• Certificate of good standing (Form 2)
• Oath declaration (Form 3)
• Payment of prescribed fees

These documents ensure the legitimacy of practitioners.

Question 15

When may the Council remove a name from the register?

Answer 15

• Absence from Botswana >3 years (non-citizen)
• Failure to respond to Registrar within 3 months
• Practitioner requests removal
• Failure to pay annual fees
• False documents used for registration

These conditions help maintain an accurate register of practitioners.

Question 16

What is the penalty for submitting false qualifications?

Answer 16

Immediate cancellation of registration & removal from register

This penalty ensures integrity in the registration process.

Question 17

What is temporary registration?

Answer 17

• Permission for practitioners from another country to practise:
  
  • Visiting specialist
  • Locum
  • Fully registered practitioner for limited period
  • Under specific conditions

Temporary registration allows foreign practitioners to work in Botswana under certain circumstances.

Question 18

Requirements to open private practice?

Answer 18

• Must obtain licence from Director of Health Services
• Must submit application in the prescribed form
• Premises must meet inspection standards
• Must be fully registered and compliant

These requirements ensure that private practices adhere to health regulations.

Question 19

What are the disciplinary powers of the Council?

Answer 19

• Caution or reprimand
• Suspension
• Removal from register
• Fines (as per Act)
• Conditions on practice
• Referral for criminal prosecution if needed

These powers help enforce professional standards and accountability.

Question 20

Who can appeal disciplinary decisions?

Answer 20

A practitioner may appeal to the High Court

This provides a legal avenue for practitioners to contest decisions made by the Council.

Question 21

What registers must the Council maintain?

Answer 21

• Medical/dental/pharmacy/intern register
• Supplementary medical professions
• Associated medical professions

Maintaining these registers is essential for tracking qualified practitioners.

Question 22

When must practitioners notify the Council of changes?

Answer 22

Within 1 month of changes in:
* Address
* Qualifications
* Circumstances affecting eligibility

Timely notification ensures the accuracy of the Council’s records.

Question 23

Composition of the Council (high yield)?

Answer 23

• Director of Health Services
• Dean of UB Faculty of Medicine
• 3 medical practitioners
• 2 dentists
• 2 pharmacists
• 6 allied health professionals
• 1 associated health professional
• 1 member of the public
• Attorney General representative (legal advisor)

This diverse composition ensures a broad representation of health professions.

Question 24

How often must the Council meet?

Answer 24

At least 4 ordinary meetings per year

Special meetings can be called as needed.

Question 25

What is quorum?

Answer 25

50% of members ## Footnote Quorum is necessary for the Council to conduct official business.

Question 26

What happens when a member has conflict of interest?

Answer 26

* Must declare * Must recuse if Council requires * Failure is an offence (liable to caution or reprimand) ## Footnote This ensures transparency and integrity in Council decisions.

Question 27

What committees can the Council create?

Answer 27

* Executive Committee * Conduct & Ethics * Grievance & Disciplinary * Registration & Certification * Private Practice & Licensing * Health Institution Inspection * Standards of Care * Health Education & Publicity * Research & Publication * Others as needed ## Footnote Committees help manage various aspects of health professions regulation.

Question 28

What are offences under the Act?

Answer 28

* Practising without registration * Using fraudulent documents * Failing to declare conflict of interest * Violating disciplinary sanctions ## Footnote Penalties include fines or imprisonment (as specified in Section 17).

Question 29

What is the role of the Registrar?

Answer 29

* Secretary to Council * Maintain registers * Handle applications * Send notices * Keep Council records ## Footnote The Registrar plays a crucial administrative role in the Council.

Question 30

When can an itinerant practitioner be registered?

Answer 30

Under very exceptional circumstances—Council’s discretion ## Footnote This allows for flexibility in unique situations.

Question 31

37. Proper documentation requirements A manufacturing facility must maintain:

Answer 31

Master formulae Batch manufacturing records Standard Operating Procedures (SOPs) Specifications for raw materials and packaging Cleaning and maintenance logs Sampling and testing records Validation records

Question 32

Documentation submitted to HPC According to the Standards, the preceptor must submit:

Answer 32

Assessment forms (Form A and Form B) including: Quality of work Attitude to patients and colleagues Personal behaviour Professional knowledge Periodic progress reports as required by HPC. Final internship completion report confirming competence in all core roles

Question 32

Steps for dealing with HFD register discrepancies

Answer 32

If morphine records do not match: Immediately initiate an investigation. Verify physical stock against register entries. Check all documentation: Requisitions Issue vouchers Administration sheets Returned drug records Inform the Pharmacist-in-Charge and Hospital Superintendent. If suspected loss or diversion → report to Medicines Regulatory Authority or relevant oversight committee. Correct the register with proper annotations, date, signature—no overwriting allowed. Reinforce staff training on HFD handling procedures.

Question 32

When confidentiality may be broken (expand your answer)

Answer 32

The pharmacist may disclose information only if: It is in the best interest of the patient (e.g., immediate threat to life). It is in the public interest (e.g., notifiable diseases, danger to community). When required by law, e.g.: Court order Police investigations involving controlled substances Disclosure to another health professional involved in the patient’s care. Otherwise confidentiality must not be breached

Question 33

Goals of the internship (full answer)

Answer 33

Dispensing and pharmaceutical care Clinical pharmacy practice Drug information and education Drug distribution and stock management Compounding and manufacturing Public health promotion

Question 34

Function of the Quality Assurance (QA) Unit

Answer 34

Approving or rejecting raw materials, packaging, in-process and finished products. Ensuring all production follows SOPs and GMP. Reviewing and approving batch manufacturing records. Investigating complaints, deviations, and non-conformances. Oversight of validation, calibration, and quality audits. Ensuring final product quality, safety, and efficacy.

Question 35

Proper documentation requirements A manufacturing facility must maintain:

Answer 35

Master formulae Batch manufacturing records Standard Operating Procedures (SOPs) Specifications for raw materials and packaging Cleaning and maintenance logs Sampling and testing records Validation records

Question 36

Stages of drug registration (full answer)

Answer 36

Application submission with full dossier Quality, safety, and efficacy evaluation Assessment of GMP compliance Laboratory testing (if required) Committee review (Drug Registration Committee) Decision by Medicines Regulatory Board Issuance of marketing authorization Post-marketing surveillance obligations

Question 37

Role of pharmacovigilance

Answer 37

Monitoring adverse drug reactions (ADRs) Detecting, assessing, and preventing harmful effects Maintaining risk–benefit balance of medicines Collecting and analysing reports from healthcare workers Triggering safety alerts, label changes, or product recalls Protecting the public from unsafe medicines