Pharmacovigilance Rapid Alert System for Consumer Reporting (PRASCOR): A Look at Its Quantitative Contribution to Spontaneous Reporting in Nigeria from August 2012 to February 2017

Background Direct patient reporting (DPR) is a system where patients report suspected adverse drug reactions (ADRs) directly to competent bodies. Studies have shown the added advantages of DPR of ADRs. In August 2012, the National Pharmacovigilance Centre (NPC) commenced implementation of a Pharmacovigilance Rapid Alert System for Consumer Reporting (PRASCOR) under the spontaneous reporting system, with the aim of facilitating direct consumer reporting of suspected ADRs to the drug regulatory authority. Objectives This study aims to examine the performance of PRASCOR by determining its quantitative contribution to spontaneous reporting of ADRs in Nigeria from inception in August 2012 to February 2017. Method In the PRASCOR system, consumers of medicines who experience an untoward effect are encouraged to send a prepaid short text message with the name of the medicine and the reaction to a short code (20543). This message with the consumer’s phone number is forwarded as an email alert to the National Agency for Food and Drug Administration and Control (NAFDAC) for follow-up. Logs of text messages from the PRASCOR system obtained from the service provider were reviewed to determine the number of consumer alerts and ‘reportable alerts’ received during the review period. Furthermore, the NPC local database was reviewed to determine the number of individual case safety reports (ICSRs) from PRASCOR and characterize them. Results A total of 47,071 hits were logged by the PRASCOR server. There were 3594 ‘consumer complaints’, of which 94% were ‘reportable alerts’. Fifty-two per cent ( n = 1758) of ‘reportable alerts’ contained information on both a medicine and a suspected ADR. A total of 353 ICSRs in the local database were attributed to PRASCOR, but only 247 (70%) of these were successfully matched to the originating PRASCOR alert. For the period under review, PRASCOR contributed 3.9% of reports in the NPC local database. Conclusion We conclude that, quantitatively, PRASCOR contributed minimally to the number of ADR reports received under the spontaneous reporting system, but has potential for performing better and adding value to the reporting of ADRs and pharmacovigilance in Nigeria.