To highlight the importance of spontaneous reporting programs in post marketing surveillance of medicines. Authors also aimed at providing various dimensions of spontaneous programs, including the strengths and weakness, and providing an insight on the future prospects of pharmacovigilance systems. Methods: Various literature related to post marketing surveillance and spontaneous reporting programs were reviewed and the relevant ones highlighting the strengths and weaknesses are summarized. A balance of information on strengths and weaknesses is listed. The health professionals’ awareness regarding existing spontaneous reporting programs is highlighted. Future prospects of pharmacovigilance are discussed. Results: Though beneficial, spontaneous reporting programs encounter several limitations and difficulties in diagnosing adverse drug reaction. Under-reporting and bias are major challenges. Online signal detection tools and innovative methods are needed to strengthen the spontaneous reporting programs. We provide the various issues to be considered while depending on spontaneous reporting programs as a method of post marketing surveillance. Conclusion: To strengthen the spontaneous reporting programs as an effective post marketing surveillance method, more awareness among health professionals and innovative strategies is needed. Integrating pharmacogenetic data can be a potential aspect of future pharmacovigilance.
To highlight the importance of spontaneous reporting programs in post marketing surveillance of medicines. Authors also aimed at providing various dimensions of spontaneous programs, including the strengths and weakness, and providing an insight on the future prospects of pharmacovigilance systems. Methods: Various literature related to post marketing surveillance and spontaneous reporting programs were reviewed and the relevant ones highlighting the strengths and weaknesses are summarized. A balance of information on strengths and weaknesses is listed. The health professionals’ awareness regarding existing spontaneous reporting programs is highlighted. Future prospects of pharmacovigilance are discussed. Results: Though beneficial, spontaneous reporting programs encounter several limitations and difficulties in diagnosing adverse drug reaction. Under-reporting and bias are major challenges. Online signal detection tools and innovative methods are needed to strengthen the spontaneous reporting programs. We provide the various issues to be considered while depending on spontaneous reporting programs as a method of post marketing surveillance. Conclusion: To strengthen the spontaneous reporting programs as an effective post marketing surveillance method, more awareness among health professionals and innovative strategies is needed. Integrating pharmacogenetic data can be a potential aspect of future pharmacovigilance.