Implementation of the guideline for safe disposal of unfit medicines: a case of regional referral and regional hospitals and regulatory authorities in Dar es salaam.

Abstract

ABSTRACT Background: Unfit medicines includes expired, improperly sealed, damaged, unexpired but improperly stored, improperly labelled, counterfeit, substandard and adulterated, prohibited and unauthorized. To prevent accumulation and unsafe/ improper disposal of unfit medicines in Tanzania, Tanzania medicines and Medical Devices Authority (TMDA) formulated the guideline for safe disposal of unfit medicines. However, studies done after the introduction of the guideline in Tanzania has shown that unsafe/ improper disposal of unfit medicines is still rampant. The aim of the study: To assess how hospitals in Dar es Salaam implement the guideline for safe disposal of unfit medicines and regulatory authorities (Local Government Authorities (LGA’S) and TMDA) ensure adherence to the guideline. Materials and Methods: This study was conducted in Dar es Salaam region. A total of 18 participants were interviewed, a study design was a descriptive cross-sectional study using a mixed-method approach both qualitative (in-depth interview) and quantitative (observational). Quantitative data were analysed by Microsoft excel and qualitative data by thematic analysis. Results: The findings of this study revealed that in handling unfit medicines before disposal; hospitals register them in the book for unfit medicines, segregate from usable medicines, separate according to dosage forms, keep in the separate area for storage of unfit medicines and label them properly. And before disposal, they request for disposal from hospital management and others from respective authority (TMDA). The study also explored various disposal methods such as incineration, returning to the supplier, and outsourcing and based on TMDA guideline. Moreover, the study revealed inspection, supportive supervision, provision of education and dissemination of the guideline as measures applied by TMDA and LGA’S in ensuring adherence to the guideline. Conclusions: The study has shown non-adherence to some of the procedures in the guideline for safe disposal of unfit medicine and measures used by regulatory authorities in ensuring adherence to the guideline. Recommendations: Enough budgets should be allocated to regulatory authorities to ensure effective implementation of their roles in ensuring adherence to the guidelines, enough space for storage of unfit medicines and continuous education to hospitals on the importance of implementing the TMDA guideline and the impact of improper disposal of unfit medicines.