Intervention | Study design | Characteristics |
---|---|---|
Laws and regulations (13 studies with 16 units of analysis) | ||
Drug registration25–29 | 5 cross-sectional studies | A form of regulation to ensure access to effective and safe medicines. It involves assessments by relevant drug regulatory authorities of manufacturers of all components of drugs to ensure they are certified as meeting the international standards for GMP before authorising the drug for sale. |
WHO-prequalification of drugs25 30 31 | 3 cross-sectional studies | A service provided by the WHO to “facilitate access to medicines that meet unified standards of quality, safety and efficacy primarily for HIV/AIDS, malaria TB and reproductive health”.31 |
Licensing of drug outlet25 28 32–37 | 8 cross-sectional studies | This refers to the authorisation of pharmaceutical establishments by drug regulatory authorities with the aim of ensuring that the supply and sale of drugs are carried out by qualified personnel on premises that meet regulatory requirements. |
Technological innovations (1 study) | ||
Product authentication technology38 | 1 retrospective study | This involved the deployment of six handheld laser (Raman) spectrometers by the National Agency for Food and Drug Administration and Control for immediate authentication of drugs at the point of sale. |
Awareness and communication (2 studies) | ||
Increased public information24 | 1 cross-sectional study | A public awareness campaign, mainly using TV and radio announcements, to promote public awareness of the dangers of counterfeit medicine from the illicit drug market. The campaign was designed based on previous survey data collected to evaluate the purchasing practices of consumers. |
Local and international collaboration39 | 1 case study | An international cross-disciplinary model of interaction and collaboration between WHO officials, physicians, pharmacists and scientists, and the Interpol, to investigate the source of counterfeit drugs in South East Asia. |
Multifaceted interventions (5 studies with 6 units of analysis) | ||
The PQM Program40–43 | 4 pre–post studies | A mechanism for MQM funded by the USAID and implemented by the USP. It is characterised by (1) early detection of poor-quality medicines (substandard and counterfeit) using a three-level testing approach of increasingly complex levels of analysis, (2) collaborations with a country's medicine regulatory authorities and international partners, and (3) strengthening of regulatory authorities’ capacities for enforcement of actions based on field evidence. |
Quality assurance system within the NDPP23 | 1 pre–post study | The system encompassed three main features: (1) development of regulations, for example, improvement of drug registration system and increased requirement for imported drugs, (2) training of drug inspectors in good manufacturing and pharmacy practice, and (3) implementation of legal actions, for example, fines and product recall. |
Regulatory intervention on private pharmacy services23 | 1 randomised trial | The regulatory interventions focused on improving the quality of private pharmacy services. The regular intervention package consisted of four high-quality annual inspections, sanctions for any violation, distribution of regulation documents to the private pharmacies and provision of information to the drug sellers about particular areas needing improvement. The active intervention package included these components, and was actively promoted through intensified supervision and additional training for the district drug inspectors. |
GMP, good manufacturing practice; MQM, Medicine Quality Monitoring; NDPP, National Drug Policy Programme; USAID, US Agency for International Development; USP, US Pharmacopeia; TB, tuberculosis.