Strengthening Pharmacovigilance System to Capture Safety Data from HIV Clients on ART in Tanzania: Identification of Gaps in Safety Reporting System

Abstract

In Tanzania, pharmacovigilance system is implemented by Tanzania Food and Drugs Authority (TFDA) that monitors drug use countrywide. TFDA is the main national custodian for recording, analyzing and disseminating safety information that is generated through conventional health care facilities. Since the introduction of Care and Treatment Centre (CTC) in the health care system, little has been achieved on translating safety information from these facilities to the TFDA. Since the inception of national pharmacovigilance framework in 2003 there has been no systematic operational research to map the gaps in the existing pharmacovigilance system. Furthermore, it is not clear if there is adequate training and supervision. It is, therefore, important to strengthen antiretroviral therapy (ART) related adverse drug reactions (ADRs) reporting by mapping gaps in implementation of pharmacovigilance (PV) system. Information obtained will assist in addressing training needs to ensure effective reporting of ADRs through coordinated approach involving TFDA and National AIDS Control Program (NACP) in Tanzania. A cross-sectional study was conducted in four regions (Tanga, Singida, Dodoma and Mtwara) in two PV zones. Qualitative and quantitative data collection techniques with triangulation design were used. These included; desk document review of PV recording and reporting of drug safety information; in-depth interviews with various implementation stakeholders, exit interviews with patients, in-interviews with care takers and community based organizations (CBOs) involved in the provision of care and treatment of HIV/AIDS. A total of 801 respondents participated in the quantitative data component which included; 545 exit interviews to CTC clients, 177 health service providers, 62 in-depth interviews to CTC in-charges and 17 regional and district pharmacists. Ownership of these CTCs included 83.9% government, 12.9% faith based organizations and 3.2% co-owned by the government and faith based organizations. High proportions (97.2%) of the CTC health care providers had wide knowledge on ART related ADRs. However, more than half (53.4%) of the CTC service providers had not attended any training on ART related ADRs. Among the service providers, majority (67.8%) mentioned there was no guideline in place for reporting ART related ADRs. Only, 32.1% of health care providers indicated to be aware of the tool used for collection of ART related ADRs events. Of those, 37.5% mentioned that the forms were mainly obtained from district or regional pharmacists. The ADR reports were submitted to district and regional pharmacists 48.3%, TFDA 7.0%, and NACP 7.0%. Of those who indicated to have filled and submitted ADR form, only 7.4% received feedback. The proportion of ART clients who provided information was significantly different between urban and rural in Dodoma region (p=0.002). There was variation in proportions of ART clients who had mentioned seen/heard of ART related ADR by regions and difference was significant between rural and urban for all regions except Tanga (p<0.05). Majority (47.9%) of the ART clients reported ART related ADRs to the health provider for duration ranging from 3-7 days. The qualitative results revealed that that most of the guidelines from TFDA were not known and unavailable according to most of the respondents at national level (NACP), regional, district, and at health facility level. It was surprising that one of the district pharmacists interviewed was unaware of existence of guidelines in place for ADR and PV for use in the districts. It was also found that Sometimes even when available at health facilities, there was inadequate knowledge on how to fill the ADR forms according to Key Informant at national level. Moreover, several health workers admitted that that they were not reporting ADR due to a lack of forms according to some CTC in-charges interviewed. This study has shown that despite the established PV system in Tanzania, the frequency of reporting of ART related ADRs to TFDA is low. This is due to inadequate training of health care providers on ADR reporting, shortage of staff, unavailability of TFDA ADR reporting forms and lack of regular supportive supervision. Based on these results therefore we recommend TFDA should ensure that ADR reporting forms as well as guidelines are adequately supplied and utilized at CTC level NACP should ensure sharing of safety information with TFDA and recommend dedicated focal person liable for documenting and reporting ART related ADRs recorded in CTC II patient file. Regular training, supportive supervision and feedback on ART related ADR reporting system for health care providers is needed. The financial support was provided by the Global Fund Round 8. The total budget for the project was Tsh. 69,993,000/-