A qualitative exploration of the major challenges facing pharmacovigilance in Saudi Arabia

We read with great interest the article by Hisham AlJadhey et al1 regarding the major challenges facing pharmacovigilance in the Kingdom of Saudi Arabia (KSA). We have been associated with pharmacovigilance in Nepal for many years. The first author was involved with the establishment and the operation of 2 regional pharmacovigilance centers in the country, and the second author is the chief pharmacovigilance officer at a regional center affiliated to a medical school in the country. We found many similarities and certain differences between the observed situation in KSA and the one in Nepal, a landlocked developing country in South Asia. The authors describe the respondents’ perception regarding the complicated nature of the form designed by the Saudi Food and Drug Administration. In Nepal the form designed by the Department of Drug Administration (DDA), the national regulatory agency is simple and easy to use. However, many regional centers as in KSA have created their own forms based on the DDA form. The issue of providing feedback to the doctors, nurses, and other personnel who report adverse drug reactions (ADRs) mentioned by the respondents is an important one. Health workers may be more motivated to report ADRs if they understand that reporting ADRs can improve their prescribing. A similar situation is noticed in Nepal, and all prescribers in Nepal should be informed regarding the present safety status of different marketed medicines, which would enable prescribing and dispensing decisions to be modified according to the national data.2 Unrestricted access to medicines from community pharmacies is a big problem in Nepal as well, and patients can purchase any medicine without a prescription. Community pharmacists can play an important role in pharmacovigilance in Nepal and other developing countries, and should be trained to report ADRs.3 The issues mentioned by respondents regarding ADR reporting in the KSA setting are of relevance to Nepal. Increased workload, which reporting ADRs would entail and heavy patient load are reasons commonly offered for reluctance to report. In Nepal, many health professionals had a wrong perception that they should be confident that a particular ADR was associated with a medicine before they could report. In educational sessions conducted for health professionals, we emphasized that many ADRs may only be possibly, or probably associated with a particular medicine, and it is not necessary to be sure and only to be suspicious while reporting ADRs. Respondents mentioned teaching health science students of pharmacovigilance as an important initiative. Like in KSA, most health science students in Nepal lack knowledge about pharmacovigilance. At KIST Medical College in Nepal, we have been conducting sessions on pharmacovigilance for medical students.4 In many countries, patients and consumers are involved in ADR reporting. Consumer pharmacovigilance has many advantages, which have been explored in a recent article. Consumer reporting can reinforce ADR reporting systems, and partly address the problems of under-reporting.5 Consumer reporting could be another approach, which could be tried to strengthen pharmacovigilance systems in both Nepal and Saudi Arabia. The authors must be congratulated on an important study, which highlights the challenges facing the pharmacovigilance program in KSA. Similar challenges exists in Nepal and other countries in South Asia, and a similar study conducted in Nepal may yield important and relevant results.