title: A qualitative exploration of the major challenges facing pharmacovigilance in Saudi Arabia.
abstract: OBJECTIVE
  To explore the challenges facing pharmacovigilance in Saudi Arabia and formulate recommendations to improve it from the perspective of healthcare professionals in Saudi Arabia.
  
  
  METHODS
  This was a qualitative study of 4 focus group discussions with pharmacists, physicians, and academicians held under the auspices of the King Saud University School of Pharmacy and the Center for Medicine in the Public Interest, Riyadh, Saudi Arabia. A total of 29 eligible healthcare professionals were invited to participate in the discussion. The predefined themes of the study were the current practice and major challenges facing pharmacovigilance in regulatory bodies, hospitals, the community, and academia, as well as recommendations to improve pharmacovigilance practice.
  
  
  RESULTS
  Of the 29 participants invited, 27 attended the discussion. Challenges facing regulatory bodies included complicated adverse drug reactions (ADR) reporting forms, lack of feedback on ADRs submitted to the Saudi Food and Drug Authority, lack of decisions from the local authority to withdraw medications, and lack of data on pharmacovigilance. The challenges to pharmacovigilance in hospitals included the lack of knowledge of the significance of ADR reporting, workload, blaming culture, and lack of collaboration between regulatory bodies and hospitals. However, challenges facing pharmaceutical industries included the lack of drug manufacturers in Saudi Arabia and lack of interest in pharmacovigilance. Recommendations to improve pharmacovigilance included the need for communication, stronger regulatory requirements, the need for research, the need for unified ADRs reporting, and continuous education and training.
  
  
  CONCLUSIONS
  The study has identified the challenges facing pharmacovigilance in Saudi Arabia and made certain recommendations to overcome them. These recommendations might be helpful for regulatory bodies to enhance spontaneous reporting and promote pharmacovigilance.
authors: Medication Safety Research Chair, College of Pharmacy, King Saud University, Riyadh, Kingdom of Saudi Arabia. E-mail. haljadhey@ksu.edu.sa.
authors: Hisham
authors: H
authors: Aljadhey
authors: Mansour A
authors: MA
authors: Mahmoud
authors: Thamir M
authors: TM
authors: Alshammari
authors: Mohammed
authors: M
authors: Al-Dhaeefi
authors: Herve
authors: H
authors: Le Louet
authors: Susana
authors: S
authors: Perez-Gutthann
authors: Peter J
authors: PJ
authors: Pitts
mesh_terms: D064420:Drug-Related Side Effects and Adverse Reactions; D017144:Focus Groups; D006801:Humans; D060735:Pharmacovigilance; D036301:Qualitative Research; D012529:Saudi Arabia