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Good Pharmacy Practice Manual
Contents
RULES RELATING TO GOOD PHARMACY PRACTICE
Introduction
The underlying philosophy
The scope of practice of pharmacists
Good pharmacy practice requirements
General objectives and requirements of pharmaceutical services
Chapter 1
Professional Standards for Premises
Minimum standards for pharmacy premises, facility and equipment
1.1 Introduction
1.2 Minimum standards for pharmacy premises, facilities and equipment
1.2.1 Appearance of pharmacy premises
1.2.2 Another business or practice in a pharmacy or a pharmacy in another business
1.2.3 Security in pharmacy premises
1.2.4 Control of access to pharmacy premises
1.2.5 Safety of pharmacy premises
1.2.6 Condition of pharmacy premises
1.2.7 Construction of pharmacy premises
1.2.8 Environment in pharmacy premises
1.2.9 Hygiene in pharmacy premises
1.2.10 Storage areas in pharmacy premises
1.2.11 Dispensary
1.2.11.1 Size of dispensary
1.2.11.2 Suitability of dispensary
1.2.11.3 Waste disposal
1.2.11.4 Dispensing equipment
1.2.11.5 Reference sources
1.2.12 Waiting area
1.2.13 Areas for counselling and the furnishing of advice
1.2.13.1 Types of areas for the furnishing of information and advice and
the counselling of patients
1.2.13.2 Semi-private area
1.2.13.3 Separate private area
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Good Pharmacy Practice Manual
1.2.13.4 Consultation area for the provision of screening and monitoring
services
1.2.13.4.1 Location
1.2.13.4.2 Equipment
1.3 Minimum standards relating specifically to institutional pharmacies
1.4 Minimum standards for pharmacies providing mobile pharmaceutical services
1.4.1 Pre-requisites for conducting mobile pharmaceutical services
1.4.2 Mobile unit, facilities and equipment
1.5 Minimum standards for pharmacies operating internet sites
1.6 Minimum standards for the supply of medicines in a primary health care clinic
1.6.1 Classification and management of facility
1.6.2 Designation of dispensary or medicine room
1.6.3 Condition of a dispensary or medicine room
1.6.4 Storage areas in dispensary or medicine room
1.6.5 Equipment for dispensary or medicine room or consulting room
1.6.6 Reference sources
1.6.7 Control of access to dispensary or medicine room
1.7 Minimum standards specifically relating to the medicine room of a person licensed to
dispense medicine in terms of the medicines act
1.7.1 Designation of the medicine room
1.7.2 Condition of the medicine room
1.7.3 Storage areas in the medicine room
1.7.4 Equipment in the medicine room or premises
1.7.5 Reference sources in the medicine room or premises
1.7.6 Control of access to the medicine room
1.8 Minimum standards specifically relating to a storage area for pharmaceuticals outside
the physical premises of a pharmacy
1.8.1 Management of storage facility
1.8.2 Condition of the storage area
1.8.3 Control of access to the storage area
1.9 Minimum standards relating to automated dispensing units for the purpose of
dispensing medicines and medical devices
1.10 Minimum standard for a drive-through facility in a pharmacy
1.10.1 Features of a pharmacy with a drive-through facility
1.10.2 Minimum requirements
Chapter 2
Professional Standards for Services
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Good Pharmacy Practice Manual
Minimum standards for services received in a pharmacy
2.1 Introduction
2.2 Minimum standards for manufacturing of any medicine or scheduled substance
2.3 Minimum standards for procurement, storage and distribution
2.3.1 Responsibility for procurement
2.3.2 Sources of supply
2.3.3 Safe systems of work
2.3.4 Medical gases
2.3.5 Minimum standards for the procurement, storage and distribution of
thermolabile pharmaceutical products
2.3.6 Maintenance of the refrigerator
2.3.7 Storage of vaccines
2.4 Minimum standards relating specifically to institutional pharmacies
2.4.1 Selection of pharmaceuticals
2.4.2 Procurement and storage
2.4.3 Distribution of pharmaceuticals to wards, departments, theatres, clinics
(WDTC) and other outlets
2.5 Minimum standards relating specifically to mobile pharmaceutical services
2.5.1 Storage and control of medicine and scheduled substances
2.6 Minimum standards relating specifically to wholesale pharmacies
2.7 Minimum standards for the dispensing of medicine or scheduled substances on the
prescription of an authorised prescriber
2.7.1 Dispensing procedures
2.7.1.1 Phase 1: Interpretation and evaluation of the prescription
2.7.1.2 Phase 2: Preparation and labelling of the prescribed medicine
2.7.1.2.1 Selecting or preparing the medicine
2.7.1.2.2 Labels
2.7.1 2.3 Record keeping regarding the supply of medicine
2.7.1.2.3.1 Schedule 1 record
2.7.1.2.3.2 Prescription book
2.7.1.3 Phase 3: Provision of information and instructions to the patient
to ensure the safe and effective use of medicine
2.7.1.3.1 Supply to the patient
2.7.1.3.2.1.1 Monitoring patient outcomes
2.7.2 Supervision of dispensing and sales/supply
2.7.3 Safety in dispensing procedures
2.7.3.1 Interpretation of prescription
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Good Pharmacy Practice Manual
2.7.3.2 Forged prescriptions
2.7.3.3 Dispensing containers
2.7.3.4 Reuse of containers
2.7.3.5 Reuse of medicines
2.7.3.6 Confidentiality
2.7.3.7 Recalls
2.7.3.8 Personal hygiene
2.7.3.9 Expiry dates
2.7.3.10 Adverse drug reaction reporting
2.7.3.11 Generic substitution
2.7.4 Pricing of prescriptions and services
2.7.5 Delivery of medicines
2.8 Minimum standards for patient information and advice
2.8.1 Purpose
2.8.2 General considerations
2.9 Minimum standards for record keeping procedures
2.9.1 Patient medication records
2.9.2 Documentation of professional activities
2.10 Minimum standards for dispensing specifically in institutional pharmacies
2.10.1 Individual patient dispensing (IPD)
2.10.2 Emergency medicine trolley
2.11 Minimum standards for clinical pharmaceutical services in institutional pharmacies
2.11.1 Introduction
2.11.2 Ward pharmacy services
2.11.3 Prescription monitoring
2.11.4 Provision of drug information and advice
2.11.4.1 Minimum requirements for a drug information service
2.12 Minimum standards for pharmacist-initiated therapy
2.12.1 Services relating to a specific patient
2.12.1.1 Response to symptoms
2.12.1.2 Self-care products, including the supply of Schedule 0, Schedule 1
and Schedule 2 medicines
2.12.1.3 Follow up
2.13 Minimum standards for screening and monitoring services in pharmacies
2.13.1 Minimum standards on promotion of public health
2.13.1.1 Physical facilities
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