Pharmacovigilance within a centralised procurement system

Abstract

In the effort to ensure access to medications that are not registered on the Maltese market, the Central Procurement Unit (CPSU) within the Ministry for Health is responsible for registering medicines via Article 126a of the EU Directive 2000/83/EC. The registration process requires a pharmacovigilance (PV) framework. This research aimed to identify and establish a robust framework of PV for medicines registered by CPSU and propose action plans for implementation of the framework. The study employed a qualitative research design. As part of the background study, literature review, and observation sessions at CPSU were completed. Focus group discussion and interviews with CPSU, medicines regulatory agency management (Medicines Authority), and staff were executed. Subsequently, a framework was developed within the context of the quality management system of CPSU. This study classified five gaps in a PV system through systematic literature review including underreporting of adverse drug reactions (ADR) and quality of report, lack of streamlined system, weaknesses in training and awareness, moderate monitoring and evaluation, inadequate training and awareness of PV, and need for a stronger collaboration among stakeholders. The focus group discussion revealed five major themes specifically, supply and availability which include product registration and outsourcing of medicinal product, pharmacovigilance and ADR reporting, barriers to PV described through the impact of importation due to market size, Brexit and barriers to ADR reporting, pharmacists’ contributions, challenges and mitigating measures, and continuous improvement. Following the identification of the themes that required addressing, a framework was developed to implement PV in CPSU. The developed framework targeted the inclusion of ADR and medication error reporting, registration status of medicinal products under Article 126a, risk minimization measures, monitoring and evaluation of PV system in CPSU, and qualifications and skills of a PV staff. Validation of the framework was conducted via a focus group and the optimized system was launched within CPSU. The establishment of a PV in CPSU is a patient safety-focused system ensuring access to medicines for which there are a shortage and access issues whilst ensuring quality, safety, and efficacy of the medicinal products.