A qualitative exploration of the strengths and weaknesses of Jordan’s pharmacovigilance system

Introduction: Pharmacovigilance (PV) plays a vital role in ensuring medicines’ safety. Although PV is generally well established in developed nations, it remains largely underdeveloped in the Arab World. In an initiative to unify PV practice across the Arab World, the ‘guideline on good PV practices (GPVP) for Arab countries’ was created by the League of Arab States’ Higher Technical Committee for Medicines1. Four years have since passed, yet little is known about how countries in the region have implemented the guideline. A better understanding of the strengths and weaknesses of the more developed systems within the Arab World will improve policy development and implementation in lesser developed ones.

Aim: As part of a wider programme to inform the implementation of the GPVP for Arab countries in Arab countries with nascent pharmacovigilance systems; this study aimed to identify the main strengths and weaknesses of the PV system in Jordan, an Arab country which has a well‐established national PV centre (NPVC) as part of its drug regulatory authority.

Methods: Semi‐structured face‐to‐face interviews were conducted with individuals involved in the implementation of the PV policy in the Jordan Food and Drug Administration (JFDA), regional PV centres, and pharmaceutical companies operating in the country. Following JFDA and university ethics committee approval, purposive and snowball sampling was used to recruit eligible participants, who were emailed study details via a gatekeeper at the JFDA. Interviews were audio‐recorded with written consent, transcribed verbatim, and analysed using thematic framework analysis.

Results: Sixteen participants were interviewed: five from the JFDA, two from regional PV centres, and nine from pharmaceutical companies. The major perceived strengths of Jordan's PV system can be grouped into three main themes: 1) the NPVC, (2) the country's PV policy and guideline, and (3) other general factors. In terms of the NPVC, this included its early establishment and membership in the WHO Programme for International Drug Monitoring (PIDM). Regarding the country's PV policy, examples were its use of the Arab and EU GPVP guidelines as a basis, feasibility in terms of implementation, and domestic focus. With respect to other general factors, these included the presence of regional PV centres covering the entire country as well as increasing awareness levels amongst reporters regarding PV. The perceived weaknesses centred on five themes: (i) reporting‐related issues, (ii) lack of resources, (iii) NPVC deficiencies, (iv) regional PV centres’ issues, and (v) pharmaceutical companies‐related issues. One example of reporting‐related issues was under‐reporting. Lack of resources included both human and financial. NPVC deficiencies included its lack of independence from the JFDA, and its staff's lack of continuous training. Examples of regional PV centres’ issues were lack of interconnectivity and autonomy. Finally, with respect to pharmaceutical company‐related issues, these included the absence of a dedicated PV department and personnel.

Conclusions: This study offers detailed insights into the strengths and weaknesses of Jordan's PV system, which will provide valuable insights for other Arab countries with nascent PV systems to design or improve their PV systems. Future work will involve exploring the strengths and weaknesses in two other Arab countries with less well‐developed PV systems than Jordan's in order to compare and contrast the differences between the three countries. This will facilitate making recommendations for the development of a more robust PV system in Arab World countries with nascent PV systems.