GPP v1 2010 ev A - MM3 Admin

1 GOODGOODPHARMACY PRACTICE IN SOUTH AFRICAGood PharmacyPractice in South AfricaFourth Edition, 2010 FOREWORDGood Pharmacy Practice ManualFourth edition, 2010 PRODUCED BY:The South African Pharmacy Council591 Belvedere StreetPO Box 40040 ARCADIA00070861 7272 00 (Customer Care line)+27 (0) 12 321 1492 (Fax)COMPILED AND EDITED BY:Office of the RegistrarDESIGN AND LAYOUT BY:Office of the RegistrarCOVER DESIGN BY:Office of the RegistrarENQUIRIES TO:The South African Pharmacy CouncilCopyright by the South African Pharmacy CouncilIn keeping with the vision of the South African Pharmacy Council, which is to ensure quality pharmaceutical services for all the people in South Africa, Council has developed the Good Pharmacy Practice standards. The aim of the GPP standards is to ensure that all practising pharmacists and other health care professionals provide a service of high quality for the public and private sector alike.

2 Council therefore encourages every health care profes-sional providing medicine to the public, to embrace the document and sup-port its implementation. Comments or any other constructive criticism of this document that will contribute to the improvement thereof must be send to us help each other to uplift the image of pharmacy."Reading make'th a man, learning make'th difference."What we have discovered today is a Gift,Yesterday is History andTomorrow remains a mystery."Knowledge comes from learning but,Wisdom comes from GOD"TA MASANGOREGISTRARC opyright 2010 The South African Pharmacy Council. All rights reservedAkCNOWLEDGEMENTSC ouncil would like to thank all members of Council, the Office of the Registrar and all other people who helped in the compilation and formulation of the Good Pharmacy Practice Standards. Council is especially grateful to Prof PFK Eagles for the good leadership in ensuring that Council fulfills its mandate, in respect of the GPP, of establishing, developing and controlling universally acceptable stand-ards of practice of the various categories of persons required to be registered in terms of the Pharmacy MembersMr L Ambler Mr W BannatyneMs V J Beaumont Ms M Cassimjee (Treasurer)Prof CM Dangor Prof PFK Eagles (President) Ms M Hela Mr KA JohnsonMr GM K hn Ms S Lebeko-RatlhaganeProf MMJ Lowes Mr MJV MolotoMs S Mthiyane Ms L Osman Prof DW Oliver Ms LN Peteni (Vice-President)

3 Mr OMB Pharasi Mr S Ramasala Mr CB Shabalala Mr F Shaikhnag Mr MS Shuping Ms V ThompsonMs M Thupana Mr GN Van der Vyver Office of the RegistrarMr VN Mokoena Mr TA MasangoMs HN Masiza Mr V M TlalaMs E Venter Other staff membersContributorsMs SJ Putter (Rational Pharmaceutical Management Plus Programme)Prof JS du Toit The South African Pharmacy Council strives continuously to ensure that the highest standards are maintained in the manner in which pharmaceutical serv-ices are provided and that any new amendments or additions to the Good Pharmacy Practice regulations are brought to the attentions of all pharmacists and other healthcare professionals at the earliest this new manual is produced in line with Council s desire to routinely update the manual whenever new developments necessitate this, it is also significant that the current amendments, relating to matters of confidential maintenance and disposal of patient information as they do, coincide with two issues that are likely to dominate the healthcare landscape in South Africa for a long time into the future.

4 The first is the scaling up of the battle against HIV and AIDS which will require that stigma and lack of confidentiality do not continue to be impediments to more people living with HIV seeking to utilize the healthcare system, be it in the public or the private second issue is occasioned by the fact that Government has decided to move along with plans to prepare for the implementation of a national health insurance (NHI) system. Whatever forms it takes, all health facilities, including community and hospital pharmacies, will have to meet certain standards if they are to be accredited to supply services to the NHI authority. It is thus important that all our pharmacy facilities continue to strive to be compliant with the requirements of is for this reason that we wish to reiterate the call made previously for pharmacists, pharmacist's Assistants and other health care professionals to boldly take ownership of the GPP document as its contents will always be influenced by our joint efforts to improve pharmacy in our us rise to the occasion and do the right thing!

5 BADA PHARASIPRESIDENTC opyright 2010 The South African Pharmacy Council. All rights reservedCopyright 2008 The South African Pharmacy Council. All rights reservedMESSAGE FROM THE SAPC PRESIDENTCONTENTS INTRODUCTION .. 1 THE UNDERLYING PHILOSOPHY .. 2 THE SCOPE OF PRACTICE OF PHARMACISTS .. 3 GOOD PHARMACY PRACTICE REQUIREMENTS .. 4 GENERAL OBJECTIVES AND REQUIREMENTS OF PHARMACEUTICAL SERVICES .. 61. INTRODUCTION .. MINIMUM STANDARDS FOR PHARMACY PREMISES, FACILITIES AND EQUIPMENT.. APPEARANCE OF PHARMACY PREMISES.. ANOTHER BUSINESS OR PRACTICE IN PHARMACY PREMISES OR A PHARMACY IN ANOTHER BUSINESS .. SECURITY IN PHARMACY PREMISES .. CONTROL OF ACCESS TO PHARMACY PREMISES.. SAFETY OF PHARMACY PREMISES .. CONDITION OF PHARMACY PREMISES .. CONSTRUCTION OF PHARMACY PREMISES .. ENVIRONMENT IN PHARMACY PREMISES .. HYGIENCE IN PHARMACY PREMISES .. STORAGE AREAS IN PHARMACY PREMISES.

6 DISPENSARY.. Size of dispensary .. Suitability of dispensary .. Waste disposal .. Dispensing equipment.. Reference sources .. 17 CHAPTER 1 PROFESSIONAL STANDARDS FOR PREMISESMINIMUM STANDARDS FOR PHARMACY PREMISES, FACILITIES ANDEQUIPMENTPage 9iABBREVIATIONS AIDS Acquired Immune Deficiency SyndromeCHC Community Health CentreCCMs Cold Chain MonitorsDOH Department of HealthEDL Essential Drug ListEPI Expanded Programme on ImmunisationGPP Good Pharmacy PracticeGMP Good Manufacturing PracticeHIV Human Immune VirusHEPA High Efficiency Particulate AirMCC Medicine Control CouncilMDR Mims Desk ReferenceMTCT Mother-to-Child TransmissionNDOH National Department of HealthPEP Post Exposure ProphylaxisPIN Personal Identification NumberPHC Primary Health ClinicPTC Pharmacy and Therapeutics CommitteeRBC Red Blood CellsSAMF South African Medicines FormularySAPC South African Pharmacy CouncilSOP Standard Operating ProcedureSTG Standard Treatment GuidelinesSTIs Sexually Transmitted InfectionsTPN Total Parenteral NutritionVVMs Vaccine Vial MonitorsVCT Voluntary Counselling

7 And Testing WDTC Wards, Departments, Theatres and ClinicsWHO World Health OrganisationCopyright 2010 The South African Pharmacy Council. All rights reservedCopyright 2010 The South African Pharmacy Council. All rights MINIMUM STANDARDS SPECIFICALLY RELATING TO A STORAGE AREA FOR PHARMACEUTICALS OUTSIDE THE PHYSICAL PREMISES OF A PHARMACY .. MANAGEMENT OF STORAGE FACILITY .. CONDITION OF THE STORAGE AREA .. CONTROL OF ACCESS TO THE STORAGE AREA .. INTRODUCTION .. MINIMUM STANDARDS FOR MANUFACTURING OF ANY MEDICINE OR SCHEDULED SUBSTANCE.. MINIMUM STANDARDS FOR PROCUREMENT, STORAGE AND DISTRIBUTION.. RESPONSIBILITY FOR PROCUREMENT .. SOURCES OF SUPPLY .. SAFE SYSTEMS OF WORK .. MEDICAL GASES .. COLD STORAGE OF PHARMACEUTICALS .. MAINTENANCE OF THE REFRIGERATOR .. STORAGE OF VACCINES .. MINIMUM STANDARDS RELATING SPECIFICALLY TO INSTITUTIONAL PHARMACIES.

8 SELECTION OF PHARMACEUTICALS.. PROCUREMENT AND STORAGE .. DISTRIBUTION OF PHARMACEUTICALS TO WARDS, DEPARTMENTS, THEATRES, CLINICS (WDTC) AND OTHER OUTLETS.. MINIMUM STANDARDS RELATING SPECIFICALLY TO MOBILE PHARMACEUTICAL SERVICES.. STORAGE AND CONTROL OF MEDICINE AND SCHEDULED SUBSTANCES .. MINIMUM STANDARDS RELATING SPECIFICALLY TO WHOLESALE PHARMACIES.. 58 CHAPTER 2 PROFESSIONAL STANDARDS FOR SERVICESMINIMUM STANDARDS FOR SERVICES PROVIDED IN A PHARMACY Page WAITING AREA .. AREAS FOR COUNSELLING AND THE FURNISHING OF ADVICE .. Types of areas for the furnishing of information and advice and the counselling of patients .. Semi-private area .. Separate private area .. Consultation area for the provision of screening and monitoring services .. Location.. Equipment .. MINIMUM STANDARDS RELATING SPECIFICALLY TO INSTITUTIONAL PHARMACIES.

9 MINIMUM STANDARDS FOR PHARMACIES PROVIDING MOBILE PHARMACEUTICAL SERVICES .. PRE-REQUISITES FOR CONDUCTING MOBILE PHARMACEUTICAL SERVICES .. MOBILE UNIT, FACILITIES AND EQUIPMENT .. MINIMUM STANDARDS FOR PHARMACIES OPERATING INTERNET SITES .. MINIMUM STANDARDS FOR THE SUPPLY OF MEDICINES IN A PRIMARY HEALTH CARE CLINIC.. CLASSIFICATION AND MANAGEMENT OF FACILITY .. DESIGNATION OF DISPENSARY OR MEDICINE ROOM.. CONDITION OF A DISPENSARY OR MEDICINE ROOM .. STORAGE AREA IN DISPENSARY OR MEDICINE ROOM .. EQUIPMENT FOR DISPENSARY OR MEDICINE ROOM .. REFERENCE SOURCES .. CONTROL OF ACCESS TO DISPENSARY OR MEDICINE ROOM .. MINIMUM STANDARDS SPECIFICALLY RELATING TO THE MEDICINE ROOM OF A PERSON LICENSED TO DISPENSE MEDICINE IN TERMS OF THE MEDICINES ACT .. DESIGNATION OF THE MEDICINE ROOM .. CONDITION OF THE MEDICINE ROOM.

10 STORAGE AREAS IN THE MEDICINE ROOM .. EQUIPMENT IN THE MEDICINE ROOM OR PREMISES .. REFERENCE SOURCES IN THE MEDICINE ROOM OR PREMISES .. CONTROL OF ACCESS TO THE MEDICINE ROOM .. 40 Copyright 2010 The South African Pharmacy Council. All rights reservedCopyright 2010 The South African Pharmacy Council. All rights MINIMUM STANDARDS FOR DISPENSING SPECIFICALLY IN INSTITUTIONAL PHARMACIES .. INDIVIDUAL PATIENT DISPENSING (IPD) .. EMERGENCY MEDICINE TROLLEY.. MINIMUM STANDARDS FOR CLINICAL PHARMACEUTICAL SERVICES IN INSTITUTIONAL PHARMACIES .. INTRODUCTION .. WARD PHARMACY SERVICES .. PRESCRIPTION MONITORING .. PROVISION OF DRUG INFORMATION AND ADVICE .. Minimum requirements for a drug information service .. MINIMUM STANDARDS FOR PHARMACIST INTITIATED THERAPY .. SERVICES RELATING TO A SPECIFIC PATIENT .. Response to symptoms.