Quality Of Medicines in South Africa: Perceptions Vs. Reality A Patel 1,3 R Gauld 2 P Norris 3 T Rades 3 1 = Health Research for Action (HERA) 2 = Social and Preventive Medicine, University of Otago, New Zealand 3 = School of Pharmacy, University of Otago, New Zealand

INTRODUCTION WHO Defn: Essential Medicine available, affordable, safe, effective, quality- assured, information - outcomes. Quality: manufacture, registration, distribution, and pharmacovigilance. Access to affordable medicines: generic medicines policies.

South Africa NMP Generic Medicines Policy Pricing Regulations Regulatory Authority: MCC

AIM To compare the actual Quality of Selected Medicines to peoples’ understanding of medicine quality

Design Qualitative: Focus Groups (n=12) & key informant interviews (n=25) Purposive sampling of providers (n=25) & consumers (n= 73) Quantitative assessment of medicines: identity (FTIR), dissolution and uniformity of weight: BP Medicines: hydrochlorothiazide, amoxycillin and paracetamol (n= 135) Settings: Johannesburg, Cape Town and Durban

FINDINGS IN-vitro TESTRESULTS IDENTITY100% passed DISSOLUTION100% passed WEIGHT87% passed

QUALITY: PERCEPTIONS PROVIDERS’ & CONSUMERS’ VIEWS 1 QUALITY – “MEASURED” ON EFFECT PRODUCED “FREE”, STATE MEDICINES – “This body does not want mahala medicines” - SUSPICION GENERICS – MANUFACTURER NAME “REPUTATION”, SUPPLIER COUNTRY SELECTION – DEPENDENT ON PROVIDER (Dr preferred) 1 A Patel, R Gauld, P Norris, T Rades (2010) “This body does not want free medicines”: South African consumer perceptions of drug quality. Health Policy and Planning, 25 (1):

DISCUSSION In-vitro tests – positive results Providers – supplier origin & reputation; willingness to accept Consumers – depend on provider for information; confuse quality of care with quality of medicines

LESSONS PHARMACOLOGICAL THEORY – QUALITY & USE – BIOMEDICAL FRAMEWORK PEOPLE: SOCIAL & CULTURAL FRAMEWORKS GENERIC MANUFACTURERS – PROVIDERS OF INFORMATION

RECOMMENDATIONS REGULATOR: PRO-ACTIVELY MANAGE COMPLAINTS NMP IMPLEMENTATION: BIOMEDICAL AND THE SOCIO-CULTURAL WORLDS GENERIC SUBSTITUTION: MANAGE DEMAND

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