GOOD PHARMACY PRACTICE IN SOUTH AFRICA
Good Pharmacy Practice Manual and Associated SAPC rulesGOOD PHARMACY PRACTICEIN SOUTH AFRICAGood Pharmacy Practice in South Africa references the following: Part 1: Rules relating to the code of conduct; Part 2: Rules relating to good pharmacy practice; Part 3: Rules relating to the services for which a pharmacist may levy a fee andguidelines for levying such a fee or fees; and Part 4: Rules relating to acts or omissions in respect of which the Council make takedisciplinary steps.RulePart 1: Rules relating to the code of conduct for pharmacistsand other persons registered in terms of the Pharmacy ActPublication detailsBN 108 in GG 31534 of 24 October 2008BN 129 in GG 27112 of 17 December 2004, asamendedPart 2: Rules relating to good pharmacy practiceChapter 2, paras. 2.13.6 to 2.13.9 and 2.26 to 2.31inclusive sourced fromhttp://www.pharmcouncil.co.za/G PublicationsD.aspon 14 November 2016Part 3: Rules relating to the services for which a pharmacistmay levy a fee and guidelines for levying such a fee or feesGenN 432 in GG 40892 of 6 June 2017Part 4: Rules relating to acts or omissions in respect of whichthe Council make take disciplinary stepsGN R599 in GG 11792 of 31 March 1989, as amendedby GN R1549 in GG 13382 of 5 July 1991, GN R339 inGG 13747 of 31 January 1992 and GN R1547 inGG 15067 of 20 August 19932018: South African Pharmacy Council1
Good Pharmacy Practice Manual and Associated SAPC rulesContentsPART 1:RULES RELATING TO THE CODE OF CONDUCTIntroduction1.1Well-being of the patient1.2Honour and dignity of the profession1.3Confidentiality1.4Continuing professional development (CPD)1.5Co-operation with health care professionals1.61.71.5.1Maintain relationships1.5.2The health care team1.5.3Respect for other competencies1.5.4Referrals1.5.5Assist colleagues1.5.6Not criticise colleaguesProfessional independence1.6.1General Guidelines1.6.2Multi-professional (group) practice(s)1.6.3Perverse Incentives1.6.4Undesirable business practicesAdvertising1.7.1General guidelines1.7.2Publicity for services1.7.3Newspaper features1.7.4Directories1.8Professional appearance and nature of pharmacy1.9Control over medicines1.9.1General guidelines1.9.2Counterfeit and stolen medicines1.9.3Foil or blister packs1.9.4Re-use of medicines1.9.5Medicine misuse1.9.6Medicines used to reduce intoxication1.9.7Indirect supply of medicine (mail order/courier pharmaceutical service)2018: South African Pharmacy Council2
Good Pharmacy Practice Manual and Associated SAPC rules1.9.8Emergency supply of medicine or scheduled substances1.10 Chemicals sold/provided in a pharmacy1.11 Dual registration1.12 The use of trading titles, brand names and logosPART 2:RULES RELATING TO GOOD PHARMACY PRACTICEIntroductionThe underlying philosophyThe scope of practice of pharmacistsGood pharmacy practice requirementsGeneral objectives and requirements of pharmaceutical servicesChapter 1Professional Standards for PremisesMinimum standards for pharmacy premises, facility and equipment1.1Introduction1.2Minimum standards for pharmacy premises, facilities and equipment1.2.1Appearance of pharmacy premises1.2.2Another business or practice in a pharmacy or a pharmacy in another business1.2.3Security in pharmacy premises1.2.4Control of access to pharmacy premises1.2.5Safety of pharmacy premises1.2.6Condition of pharmacy premises1.2.7Construction of pharmacy premises1.2.8Environment in pharmacy premises1.2.9Hygiene in pharmacy premises1.2.10Storage areas in pharmacy premises1.2.11Dispensary1.2.11.1Size of dispensary1.2.11.2Suitability of dispensary1.2.11.3Waste disposal1.2.11.4Dispensing equipment1.2.11.5Reference sources1.2.12Waiting area1.2.13Areas for counselling and the furnishing of advice2018: South African Pharmacy Council3
Good Pharmacy Practice Manual and Associated SAPC rules1.2.13.1Types of areas for the furnishing of information and advice andthe counselling of patients1.2.13.2Semi-private area1.2.13.3Separate private area1.2.13.4Consultation area for the provision of screening and pment1.3Minimum standards relating specifically to institutional pharmacies1.4Minimum standards for community or institutional pharmacies providingpharmaceutical services from a mobile unit1.51.61.71.4.1Purpose1.4.2General considerations1.4.3Pre-requisites for conducting pharmaceutical services from a mobile unit1.4.4Mobile unit, facilities and equipment within the mobile unitMinimum standards for community or institutional pharmacies operating websites1.5.1Introduction1.5.2Purpose1.5.3General considerations1.5.4Standards for community or institutional pharmacies operating websitesMinimum standards for the supply of medicines in a primary health care clinic1.6.1Classification and management of facility1.6.2Designation of dispensary or medicine room1.6.3Condition of a dispensary or medicine room1.6.4Storage areas in dispensary or medicine room1.6.5Equipment for dispensary or medicine room or consulting room1.6.6Reference sources1.6.7Control of access to dispensary or medicine roomMinimum standards specifically relating to the medicine room of a person licensed todispense medicine in terms of the medicines act1.7.1Designation of the medicine room1.7.2Condition of the medicine room1.7.3Storage areas in the medicine room1.7.4Equipment in the medicine room or premises1.7.5Reference sources in the medicine room or premises1.7.6Control of access to the medicine room2018: South African Pharmacy Council4
Good Pharmacy Practice Manual and Associated SAPC rules1.81.9Minimum standards specifically relating to a storage area for pharmaceuticals outsidethe physical premises of a pharmacy1.8.1Management of storage facility1.8.2Condition of the storage area1.8.3Control of access to the storage areaMinimum standards relating to automated dispensing units for the purpose ofdispensing medicines and medical devices1.9.1Introduction1.9.2Purpose1.9.3General considerations1.9.4Dispensing of medicines using an ADU1.9.5The stocking and management of the ADU1.9.6The responsibilities of a responsible pharmacist of a pharmacy approved tooperate an ADU1.9.7Security, location, connectivity and features of an ADU1.9.8Record keeping1.9.9Information to be submitted in support of an application for the installation ofthe ADU in a pharmacy1.10 Minimum standards for a drive-through facility in a pharmacy1.10.1Features of a pharmacy with a drive-through facility1.10.2Minimum requirements1.11 Minimum standards for institutional public pharmacy operating a remote automateddispensing unit (RADU)1.11.1Introduction and background1.11.2Definitions of terms1.11.3Purpose1.11.4General considerations1.11.5Dispensing of medicines using a RADU1.11.6The responsibilities of a responsible pharmacist of the pharmacy approved byCouncil to operate a RADU1.11.7Record keeping1.11.8Security, location, connectivity and features of a RADU1.11.9Documentation and information displayed conspicuously at the RADU1.11.10 Information to be submitted in support of an application for installation andoperation of a RADUChapter 2Professional Standards for ServicesMinimum standards for services received in a pharmacy2018: South African Pharmacy Council5
Good Pharmacy Practice Manual and Associated SAPC rules2.1Introduction2.2Minimum standards for manufacturing of any medicine or scheduled substance2.3Minimum standards for procurement, storage and distribution2.42.52.3.1Responsibility for procurement2.3.2Sources of supply2.3.3Safe systems of work2.3.4Medical gases2.3.5Minimum standards for the procurement, storage and distribution ofthermolabile pharmaceutical products2.3.6Maintenance of the refrigerator2.3.7Storage of vaccinesMinimum standards relating specifically to institutional pharmacies2.4.1Selection of pharmaceuticals2.4.2Procurement and storage2.4.3Distribution of pharmaceuticals to wards, departments, theatres, clinics(WDTC) and other outletsMinimum standards relating specifically to mobile pharmaceutical services2.5.1Storage and control of medicine and scheduled substances2.6Minimum standards relating specifically to wholesale pharmacies2.7Minimum standards for the dispensing of medicine or scheduled substances on theprescription of an authorised prescriber2.7.1Dispensing procedures2.7.1.1Phase 1: Interpretation and evaluation of the prescription2.7.1.2Phase 2: Preparation and labelling of the prescribed medicine2.7.1.32.7.1.2.1Selecting or preparing the medicine2.7.1.2.2Labels2.7.1 2.3Record keeping regarding the supply of medicine2.7.1.2.3.1Schedule 1 record2.7.1.2.3.2Prescription bookPhase 3: Provision of information and instructions to the patientto ensure the safe and effective use of medicine2.7.1.3.1Supply to the patient2.7.1.3.2.1.12.7.2Supervision of dispensing and sales/supply2.7.3Safety in dispensing procedures2.7.3.1Interpretation of prescription2.7.3.2Forged prescriptions2018: South African Pharmacy CouncilMonitoring patient outcomes6
Good Pharmacy Practice Manual and Associated SAPC rules2.82.92.7.3.3Dispensing containers2.7.3.4Reuse of containers2.7.3.5Reuse of .8Personal hygiene2.7.3.9Expiry dates2.7.3.10Adverse drug reaction reporting2.7.3.11Generic substitution2.7.4Pricing of prescriptions and services2.7.5Minimum standards specifically relating to the collection and the delivery ofmedicines to patients from a community or institutional pharmacyMinimum standards for patient information and advice2.8.1Purpose2.8.2General considerationsMinimum standards for record keeping procedures2.9.1Patient medication records2.9.2Documentation of professional activities2.10 Minimum standards for dispensing specifically in institutional pharmacies2.10.1Individual patient dispensing (IPD)2.10.2Emergency medicine trolley2.11 Minimum standards for clinical pharmaceutical services in institutional pharmacies2.11.1Introduction2.11.2Ward pharmacy services2.11.3Prescription monitoring2.11.4Provision of drug information and advice2.11.4.1 Minimum requirements for a drug information service2.12 Minimum standards for pharmacist-initiated therapy2.12.1Services relating to a specific patient2.12.1.1Response to symptoms2.12.1.2Self-care products, including the supply of Schedule 0, Schedule 1and Schedule 2 medicines2.12.1.3Follow up2.13 Minimum standards for screening and monitoring services in pharmacies2.13.1Minimum standards on promotion of public health2.13.1.12018: South African Pharmacy CouncilPhysical facilities7
Good Pharmacy Practice Manual and Associated SAPC rules2 13.22.13.32.13.42.13.52.13.62.13.1.2Documentation and record keeping2.13.1.3Professional and ethical aspectsMinimum standards regarding testing2.13.2.1Minimum standards regarding test materials and instruments2.13.2.2Minimum standards regarding the taking of samplesMinimum standards for blood pressure monitoring services2.13.3.1Equipment2.13.3.2Procedure and interpretation of results2.13.3.3Documentation and record keepingMinimum standards for the performance of peak flow tests2.13.4.1Equipment2.13.4.2Procedure and interpretation of results2.13.4.3Documentation and record keepingMinimum standards for the performance of HIV tests2.13.5.1Physical facilities and equipment2.13.5.2Collecting of samples2.13.5.3Informed consent2.13.5.4Counselling2.13.5.5Interpretation of results2.13.5.6Collecting and sending blood samples to a laboratory2.13.5.7Documentation and record keeping2.13.5.8Ethical aspects2.13.5.9Training2.13.5.10Advertising the serviceMinimum standards for cholesterol monitoring service2.13.6.1Physical facilities2.13.6.2Equipment2.13.6.3Procedure for carrying out the test2.13.6.4Interpretation of results2.13.6.5Documentation and record keeping2.13.6.6Confidentiality2.13.6.7Waste disposal2.13.6.8Counter infection measures[2.13.6 sourced from http://www.pharmcouncil.co.za/G PublicationsD.asp on 4 September 2017.]2.13.7Minimum standards for glucose monitoring2.13.7.12018: South African Pharmacy CouncilPhysical facilities8
Good Pharmacy Practice Manual and Associated SAPC rules2.13.7.2Equipment2.13.7.3Performance of the test2.13.7.4Interpretation of results2.13.7.5Documentation and record keeping2.13.7.6Confidentiality[2.13.7 sourced from http://www.pharmcouncil.co.za/G PublicationsD.asp on 4 September 2017.]2.13.8Minimum standards for pregnancy testing service2.13.8.1Physical facilities2.13.8.2Procedure, interpretation and provision of results2.13.8.3Documentation and record keeping2.13.8.4Confidentiality[2.13.8 sourced from http://www.pharmcouncil.co.za/G PublicationsD.asp on 4 September 2017.]2.13.9Minimum standards for urine analysis2.13.9.1Physical facilities2.13.9.2Equipment2.13.9.3Procedure for carrying out the test2.13.9.4Obtaining a Clean-Catch Urine Sample2.13.9.5Storage and testing of samples2.13.9.6Interpretation of results2.13.9.7Documentation and record keeping2.13.9.8Confidentiality[2.13.9 sourced from http://www.pharmcouncil.co.za/G PublicationsD.asp on 4 September 2017.]2.14 Minimum standards for immunisation services2.14.1Physical facilities and equipment2.14.2Procedure2.14.3Documentation and record keeping2.14.4Ethical aspects2.14.5Training2.15 Minimum standards for reproductive health services2.15.1Physical facilities and equipment2.15.2Procedure2.15.3Documentation and record keeping2.15.4Legal and ethical aspects2.15.5Training2.16 Minimum standards for other health care services2.16.1Residential and nursing homes2018: South African Pharmacy Council9
Good Pharmacy Practice Manual and Associated SAPC rules2.16.2Smoking cessation2.16.3Nutrition advice2.16.4Baby and child health2.17 Minimum standards for aseptic dispensing service2.17.1Intravenous additive service2.17.2Total parenteral nutrition (TPN) preparation service2.17.3Cytotoxic preparation and reconstitution service2.18 Compounding2.19 Pre-packing2.19.1Minimum standards for pre-packing2.20 Minimum standards for a total parenteral nutrition (TPN) consultation service2.21 Minimum standards for therapeutic medicine monitoring service2.22 Minimum standards for the provision of complementary medicine2.23 Minimum standards for animal health care services2.24 Minimum standards for AIDS resource centres in a pharmacy2.24.1Facilities2.24.2Services that may be performed in an AIDS resource centre in a pharmacy2.24.3Responsibilities2.25 Review of the overall medication requirements of a patient2.25.1Patient ent of a care plan (taking appropriate actions)2.25.4Follow-up evaluation2.26 Minimum standards for emergency postcoital contraception (EPC)2.26.1Introduction2.26.2Before testing (pharmacist must consider the following before supplying EPC)2.26.3Emergency contraception regimens2.26.4Use of EPC when breastfeeding2.26.5Professional and ethical responsibility of pharmacists in the provision of EPC2.26.6Confidentiality2.26.7Patient counselling2.26.7.1 General principles2.26.7.2 Continued contraception2.26.7.3 Referral2.26.7.4 Repeated use of emergency contraception2.26.7.5 HIV & sexually transmitted infections (STIs)2018: South African Pharmacy Council10
Good Pharmacy Practice Manual and Associated SAPC rules2.26.7.6 Alcohol/drugs2.26.7.7 Dealing with children and parents[2.26 sourced from http://www.pharmcouncil.co.za/G PublicationsD.asp on 14 November 2016.]2.27 Control of Schedule 6 medicines or substances[2.27 sourced from http://www.pharmcouncil.co.za/G PublicationsD.asp on 14 November 2016.]2.28 Approval of tutors and premises for training of pharmacist interns and pharmacist'sassistants2.28.1Criteria for approval of tutors of pharmacist interns2.28.2Criteria for the approval of premises2.28.3Internship programme in hospital complexes (public sector hospitalcomplexes)[2.28 sourced from http://www.pharmcouncil.co.za/G PublicationsD.asp on 14 November 2016.]2.29 Products which may not be sold in a pharmacy[2.29 sourced from http://www.pharmcouncil.co.za/G PublicationsD.asp on 14 November 2016.]2.30 Minimum standards regarding maintenance and disposal of confidential informationrelating to patients2.30.1 Introduction2.30.2 Purpose2.30.3 General considerations2.30.3.1 Maintenance of patient's records2.30.3.2 Computer records2.30.3.3 Disposal of the patient's records[2.30 sourced from http://www.pharmcouncil.co.za/G PublicationsD.asp on 14 November 2016.]2.31 Information relating to compliance with good pharmacy practice to be submitted insupport of an application for a licence for a pharmacy premises2.31.1Supporting documentation2.31.2Floor plan2.31.3Trading title(s)2.31.4General[2.31 sourced from http://www.pharmcouncil.co.za/G PublicationsD.asp on 14 November 2016.]2.32 Minimum standards regarding destruction and disposal of medicines and 2.32.3General considerations2.32.4Legislative requirements2.32.5Minimum requirements for the destruction of medicines and scheduledsubstances2018: South African Pharmacy Council11
Good Pharmacy Practice Manual and Associated SAPC rules2.32.6Minimum requirements for the disposal of medicines and scheduledsubstances2.32.7DefinitionsChapter 3Professional Standards for Pharmacy Human ResourcesMinimum standards for human resource in a pharmacy3.1Scope of practice of pharmacy personnel3.2Recommended standards regarding staff selection, appraisal and training3.33.2.1Staff selection3.2.2Staff appraisal and development3.2.3Staff trainingLegislative requirements regarding the training of pharmacist interns and pharmacist'sassistants3.3.13.4Pharmacist interns/pre-registration experience3.3.1.1Objectives of the internship3.3.1.2Prerequisites for training3.3.2Pharmacists assistants3.3.2.1Prerequisites for trainingMinimum standards for pharmaceutical human resource development3.4.1Standards for continuing professional development of f-assessment (self-audit)3.4.1.3Legislative changes3.4.1.4New services3.4.1.5Other health care professionals3.5Professional indemnity3.6Minimum standards for locum/relief pharmacists3.7Minimum standards for the management of human resources in wholesale andmanufacturing pharmacies3.7.1General3.7.2Pharmacy support personnel3.7.3Responsible s and responsibilities of the responsible pharmacistMinimum standard relating to the supervision of pharmacy support personnel2018: South African Pharmacy Council12
Good Pharmacy Practice Manual and Associated SAPC ose3.8.4General considerations applicable to all sectors3.8.5Supervision of pharmacy support personnel in community and institutionalpharmacy3.8.6Supervision of pharmacy support personnel in manufacturing and wholesalepharmacy3.8.7Supervisory support at a primary health care clinicScope of practice of pharmacy personnel3.9.13.9.2Pharmacy human resources3.9.1.1Pharmacist's assistant (basic)3.9.1.2Pharmacist's assistant (post-basic)3.9.1.3Pharmacy student3.9.1.4Pharmacist intern3.9.1.5Pharmacist3.9.1.5.1Services and/or acts specially pertaining to apharmacist3.9.1.5.2Scope of practice of a pharmacistAuthority, duties and responsibilities of a responsible pharmacist3.9.2.1Duties and responsibilities of the responsible pharmacist3.9.2.1.1Circumstances and conditions under which aresponsible pharmacist may be absent from ConditionsChapter 4Professional Standards for Pharmacy ManagementMinimum standards for management of the pharmaceutical services4.1Introduction4.2Minimum standards for pharmacy administration and management4.2.1Pharmacy management4.2.1.14.2.24.2.3Pharmacy planningQuality standards for pharmacy4.2.2.1Quality management4.2.2.2Pharmacy effectivenessEthics and professional standards2018: South African Pharmacy Council13
Good Pharmacy Practice Manual and Associated SAPC rules4.34.2.3.1Inter-professional relationships4.2.3.2Closure of pharmacies4.2.3.3Standard operat
Good Pharmacy Practice Manual and Associated SAPC rules 2018: South African Pharmacy Council 3 1.9.8 Emergency supply of medicine or scheduled substances 1.10 Chemicals sold/provided in a pharmacy 1.11 Dual registration 1.12 The use of trading titles, brand names and logos PART 2: RULES RELATING TO GOOD PHARMACY PRACTICE Introduction
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The Emergence of Modern Pharmacist Roles The Modern Pharmacy William Procter Jr. is considered the father of American pharmacy. He graduated from the Philadelphia College of Pharmacy in 1837. In addition to having operated a retail pharmacy, Procter was a professor of pharmacy for 20 years at the college from which he graduated.
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36-11-71 Central pharmacy, remote pharmacy, and telepharmacy practice defined. 36-11-72 Telepharmacy--Promulgation of rules. 36-11-1. Public interest in regulation of practice. The practice of pharmacy in South Dakota is hereby declared to be a professional prac
Layout of the Book The Substance Abuse & Recovery Workbook is designed to be used either independently or as part of an integrated curriculum. You may administer one of the assessments and the journaling exercises
