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

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/-

Adverse drug events resulting from use of drugs with sulphonamide-containing anti-malarials and artemisinin-based ingredients: findings on incidence and household costs from three districts with routine demographic surveillance systems in rural Tanzania.

BACKGROUND: Anti-malarial regimens containing sulphonamide or artemisinin ingredients are widely used in malaria-endemic countries. However, evidence of the incidence of adverse drug reactions (ADR) to these drugs is limited, especially in Africa, and there is a complete absence of information on the economic burden such ADR place on patients. This study aimed to document ADR incidence and associated household costs in three high malaria transmission districts in rural Tanzania covered by demographic surveillance systems. METHODS: Active and passive surveillance methods were used to identify ADR from sulphadoxine-pyrimethamine (SP) and artemisinin (AS) use. ADR were identified by trained clinicians at health facilities (passive surveillance) and through cross-sectional household surveys (active surveillance). Potential cases were followed up at home, where a complete history and physical examination was undertaken, and household cost data collected. Patients were classified as having 'possible' or 'probable' ADR by a physician. RESULTS: A total of 95 suspected ADR were identified during a two-year period, of which 79 were traced, and 67 reported use of SP and/or AS prior to ADR onset. Thirty-four cases were classified as 'probable' and 33 as 'possible' ADRs. Most (53) cases were associated with SP monotherapy, 13 with the AS/SP combination (available in one of the two areas only), and one with AS monotherapy. Annual ADR incidence per 100,000 exposures was estimated based on 'probable' ADR only at 5.6 for AS/SP in combination, and 25.0 and 11.6 for SP monotherapy. Median ADR treatment costs per episode ranged from US$2.23 for those making a single provider visit to US$146.93 for patients with four visits. Seventy-three per cent of patients used out-of-pocket funds or sold part of their farm harvests to pay for treatment, and 19% borrowed money. CONCLUSION: Both passive and active surveillance methods proved feasible methods for anti-malarial ADR surveillance, with active surveillance being an important complement to facility-based surveillance, given the widespread practice of self-medication. Household costs associated with ADR treatment were high and potentially catastrophic. Efforts should be made to both improve pharmacovigilance across Africa and to identify strategies to reduce the economic burden endured by households suffering from ADR