An evaluation of safety quality control of drugs at National Drug Authority

Abstract

The study examined the determinants of safety quality controls on drugs delivered on the market. National Drug Authority implements safety quality controls to prevent harmful health products from entering the market for consumption by the end users. The administrative theory supports the implementation of safety quality controls of drugs on the market. The study was guided by three research objectives; to assess the determinants of quality drugs on the market in Uganda through measures taken by National Drug Authority in Uganda; to examine the challenges of implementing safety quality controls on drugs at National Drug Authority in Uganda; and to propose strategies of improving safety quality controls on drugs on market by National Drug Authority in Uganda. The study used a qualitative research design and the unit of analysis was National Drug Authority (NDA). The unit of inquiry was staff at NDA. Primary data was collected from 25 participants using the interview guide and analyzed with ATLAS.ti: Version 20 Qualitative Data Analysis. Results revealed that the determinants of safety quality controls of drugs on the market include; pre-market controls like product dossier assessment, inspection of manufacturing sites to establish if drugs are produced in accordance with WHO Good Manufacturing practices; Post market surveillance, which includes random visits and inspection of drug outlets, tracking suspicious vendors; Pharmacovigilance which includes interaction with doctors and patients to establish any occurrence of unknown drug reactions, drug med-safety app to promote NDA’s interaction with the drug consumers and issuing operating licenses to drug outlets. Factors were clients demand and preference, quality stock control, quality packaging and manufacturing technology of drugs. NDA ensures the quality of drugs on the market in Uganda by testing drug samples, adoption of international quality standards, use of quality control laboratories, tougher criminal penalties, training the herbalist and engaging stakeholders to ensure delivery of safe quality drugs to customers. Challenges were weak enforcement, limited quality diagnostic skills, insufficient funding for post-marketing surveillance, limited pharmacological reviews and clinical pattern variation. Strategies were sensitizing stakeholders on relevance of producing safe quality drugs, periodic inspection of drug manufacturing sites and dispensing drug outlets, verification of all imported drugs at the ports of entry.

The study recommends that NDA should strengthen the post-marketing surveillance network through periodical drug inspection, pharmacological reviews/ test drug samples in quality control laboratories and evaluating information on drug med-safety app to ensure delivery of quality drugs on the market.