Pharmacovigilance in India, Uganda and South Africa with reference to WHO’s minimum requirements

Abstract

Background: Pharmacovigilance (PV) data are crucial for ensuring safety and effectiveness of medicines after drugs have been granted marketing approval. This paper describes the PV systems of India, Uganda and South Africa based on literature and Key Informant (KI) interviews and compares them with the World Health Organization's (WHO's) minimum PV requirements for a Functional National PV System. Methods: A documentary analysis of academic literature and policy reports was undertaken to assess the medicines regulatory systems and policies in the three countries. A gap analysis from the document review indicated a need for further research in PV. KI interviews covered topics on PV: structure and practices of the system; current regulatory policy; capacity limitations, staffing, funding and training; availability and reporting of data; and awareness and usage of the systems. Twenty interviews were conducted in India, 8 in Uganda and 11 in South Africa with government officials from the ministries of health, national regulatory authorities, pharmaceutical producers, Non-Governmental Organizations (NGOs), members of professional associations and academia. The findings from the literature and KI interviews were compared with WHO's minimum requirements. Results: All three countries were confronted with similar barriers: lack of sufficient funding, limited number of trained staff, inadequate training programs, unclear roles and poor coordination of activities. Although KI interviews represented viewpoints of the respondents, the findings confirmed the documentary analysis of the literature. Although South Africa has a legal requirement for PV, we found that the three countries uniformly lacked adequate capacity to monitor medicines and evaluate risks according to the minimum standards of the WHO. Conclusion: A strong PV system is an important part of the overall medicine regulatory system and reflects on the stringency and competence of the regulatory bodies in regulating the market ensuring the safety and effectiveness of medications. National PV systems in the study countries needed strengthening. Greater attention to funding is needed to coordinate and sustain PV activities. Our study highlights a need for developing more systematic approaches to regularly monitoring and evaluating PV policy and practices. Implications for policy makers• Given that similar barriers: insufficient funding, limited trained staff, inadequate training programs, unclear roles and poor coordination of activities confronted the Pharmacovigilance (PV) systems of India, Uganda and South Africa, the use of greater capacity-building within the three countries and in other countries with similar levels of healthcare system development would be useful to coordinate and sustain PV activities.• Having a clear structure of legal PV requirements with corresponding regulations in place where compliance and enforcement could be ensured, would be more effective than reliance on guidelines and normative practice which are not specifically bind...

Differences in VigiBase® reporting of aminoglycoside and capreomycin‐suspected ototoxicity during tuberculosis treatment

“…The observed geographic differences in the reporting of ototoxicity across the globe could be related to the global epidemiologic distribution of TB cases; differences in the relative use of specific aminoglycosides or capreomycin in TB treatment according to national clinical guidelines; the strength of the pharmacovigilance systems in the countries comprising the regional blocks, and the quality of ICSRs from these countries. For example, although sub‐Sahara Africa has a large burden of TB, there were disproportionately too few ICSRs reported in VigiBase® from this region, presumably because of the nascent or weak pharmacovigilance systems in many of the countries in sub‐Saharan Africa . For Europe, where most countries have functional pharmacovigilance systems, most ICSRs came from the Eastern countries like Romania and the Czech Republic where the burden of TB is still high .…”

“…For example, although sub-Sahara Africa has a large burden of TB, there were disproportionately too few ICSRs reported in VigiBase® from this region, presumably because of the nascent or weak pharmacovigilance systems in many of the countries in sub-Saharan Africa. [31][32][33][34] For Europe, where most countries have functional pharmacovigilance systems, most ICSRs came from the Eastern countries like Romania and the Czech Republic where the burden of TB is still high. 35,36 Asia reported the most cases of vertigo because of the predominant use of streptomycin by some of the countries in this region as reported in VigiBase®, while the Americas reported relatively more cases of deafness in VigiBase® because of the disproportionately greater use of amikacin and kanamycin compared to streptomycin or capreomycin.…”

Identifying medication errors in the neonatal intensive care unit and paediatric wards using a medication error checklist at a tertiary academic hospital in Gauteng, South Africa

“…[15] These programmes aim to detect, assess, manage and prevent drug-related problems. [15,16] The importance of the presence of a clinical pharmacist in a paediatric unit to monitor drug treatment and prevent medication errors is well established in some countries. [7,9,17] Clinical pharmacists monitoring medication orders might prevent more than half (58%) of all errors, including 72% of potentially harmful errors.…”

Strengthening Bolivian Pharmacovigilance system: new therapeutic strategies to improve health of Chagas Disease and Tuberculosis patients

“…Pharmacovigilance programme is an important component of National Healthcare Systems (NHS). Data coming from Pharmacovigilance programme is essential to ensure safety and effectiveness of drugs and to provide information concerning regulatory actions [18]. The efforts of the Bolivian Ministry of Health to increase access to treatment for CD and TB require strengthening the Pharmacovigilance system.…”

“…Information about the characteristics of presented ADRs in terms of severity, affected organ-system, clinical suspicion of recurrence, and health care intervention is collected in the CRF proposal. Better designed, user-friendly and standardized reporting forms would improve the process of capturing accurate information about ADR events [18]. New tools adapted to the reality of health care workers are needed in order to strengthen the current Bolivian ADR reporting system.…”