Assessment of the state of pharmacovigilance in the South-South zone of Nigeria using WHO pharmacovigilance indicators

Abstract

BackgroundWHO pharmacovigilance indicators have been recommended as a useful tool towards improving pharmacovigilance activities. Nigeria with a myriad of medicines related issues is encouraging the growth of pharmacovigilance at peripheral centres. This study evaluated the status of pharmacovigilance in tertiary hospitals in the South-South zone of Nigeria with a view towards improving the pharmacovigilance system in the zone.MethodsA cross-sectional descriptive survey was conducted in six randomly selected tertiary hospitals in the South-South zone of the country. The data was collected using the WHO core pharmacovigilance indicators. The language of assessment was phrased and adapted in this study for use in a tertiary hospital setting. Data is presented quantitatively and qualitatively.ResultsA total of six hospitals were visited and all institutions had a pharmacovigilance centre, only three could however be described as functional or partially functional. Only one centre had a financial provision for pharmacovigilance activities. Of note was the absence of the national adverse drug reaction reporting form in one of the hospitals. The number of adverse drug reaction reports found in the databases of the centres ranged from none to 26 for the previous year and only one centre had fully committed their reports to the National Pharmacovigilance Centre. There were few documented medicines related admissions ranging from 0.0985/1000 to 1.67/1000 and poor documentation of pharmacovigilance activities characterised all centres.ConclusionThis study has shown an urgent need to strengthen the pharmacovigilance systems in the South-South zone of Nigeria. Improvement in medical record documentation as well as increased institutionalization of pharmacovigilance may be the first steps to improve pharmacovigilance activities in the tertiary hospitals.Electronic supplementary materialThe online version of this article (10.1186/s40360-018-0217-2) contains supplementary material, which is available to authorized users.

Establishment and implementation of hospital-based health technology assessment at King Hussein Cancer Center: can our model be an example?

“…As stated by other hospital-based HTA experiences (2;3;12), we also learned during these years that political will and leadership support are the prime success factors for the establishment and implementation of an HTA. At the KHCC, the higher administration and the pharmacy department administration supported the initiation and the development of HTA.…”

“…Our results showed that our HTA program is functional and effective. As stated by the best practices of hospital-based HTA and key principles for conducting HTA (2;3;12), the minimum core requirements for a hospital-based HTA program are available. The KHCC has embedded HTA activities within the organizational structure of the KHCC, which makes it more structured than hospital-based activities in other countries (24;30–32).…”

“…In comparison with the AdHopHTA guiding principles (2;3), our selected indicators addressed the recommended requirements for founding and running HB-HTA units by the AdHopHTA project. Our assessment methodology is based on best practices (2;3;12) and can be seen as a complementary to AdHopHTA core principles as it facilitates the transition of HB-HTA development through phases. Therefore, the AdHopHTA can be used as a starting point for hospitals to assess their baseline situation and set their action plan.…”

“…The assessment was based on three types of indicators: structural, process, and outcome indicators. These types of indicators were selected because they are frequently used for assessing the performance of public health programs and in accreditation standards (10–12). As we are assessing a hospital-based HTA program, using indicators that are frequently used in hospitals and public health will be more engaging for stakeholders who are familiar with such type of indicators.…”

Evaluation of Pharmacovigilance System in Iran

“…17,18 Evaluating a pharmacovigilance system will facilitate actions to remedy the identified deficiencies to improve ADR reports' quantity and quality, leading to more rigorous decision-making in pharmacovigilance. 19 Currently, the assessment of pharmacovigilance has mainly been carried out at the national level using different tools, including the WHO Minimum Requirements for a Functional Pharmacovigilance System, 5 and the Indicator based Pharmacovigilance Assessment Tool. 20 WHO pharmacovigilance indicators were introduced in 2015.…”