Analysis of the Drivers for the Proliferation of Unregistered Medicines in Harare, 2023

Abstract

Medicines are required to have prior assessment of their quality, safety and effectiveness before they are used by the public. This is the mandate of national medicines regulatory authorities, as recommended by the World Health Organisation. Some medicines, however, bypass this evaluation process and are marketed without having been evaluated. This risks substandard and falsified medicines being used by the public which threatens public health. The purpose of this study was to assess the reasons for unregistered medicines proliferation in Harare, Zimbabwe. A descriptive cross-sectional study was conducted in the Harare Metropolitan Province. Health workers from both private and public sectors were recruited. Stratified sampling was used to recruit 136 participants. Questionnaires were used to collect data, identify sources of unregistered medicines and evaluate if there is genuine need of these unregistered medicines. Epi Info version 7 was used to generate frequencies, proportions and means. The most commonly cited channel through which unregistered medicines were finding their way to the local market was cross border traders (56.6%). Other commonly cited sources were professionals with a know-how of pharmacy practice (10.3%) and people who work in the pharmaceutical sector (4.4%). Sixty-four percent of the respondents indicated that they had encountered circumstances where they needed unregistered medicines to diagnose, treat and manage their patients. A comparison of retail and wholesale prices indicated that 78.57% and 66.67%, respectively, of the registered medicines were more expensive than similar unregistered medicines. The study established that unregistered medicine outlets are sprouting due to inconsistent supply chain systems, unethical practices and economic recession. However, it was also revealed that the health system is in need of some of these unregistered medicines, and that not all unregistered medicines are of poor quality. The study recommended that registration of medicines be harmonised at regional level so that it becomes easier for manufacturers to enter and stay in the market. Capacitation and decentralisation of the regulatory authorities was also recommended so that they effectively execute their duties.