PT  - JOURNAL ARTICLE
AU  - Wagnild, Janelle M.
AU  - Lee, Diana
AU  - Jayeola, Babatunde
AU  - Lukito, Penny K.
AU  - Fimbo, Adam
AU  - Hampshire, Kate
TI  - Can a Smartphone Application Help Address Barriers to Reporting Substandard/Falsified Medical Products? A Pilot Study in Tanzania and Indonesia
AID  - 10.9745/GHSP-D-23-00034
DP  - 2023 Aug 28
TA  - Global Health: Science and Practice
PG  - e2300034
VI  - 11
IP  - 4
4099  - http://www.ghspjournal.org/content/11/4/e2300034.short
4100  - http://www.ghspjournal.org/content/11/4/e2300034.full
SO  - GLOB HEALTH SCI PRACT2023 Aug 28; 11
AB  - Key FindingsTraining and roll-out of a smartphone application for reporting suspected substandard or falsified medical products by health care professionals was effective, resulting in the recall of 8 medical products in a 6-month pilot period.The convenience of the smartphone application made it easier for health care professionals to report suspect products, but some barriers to reporting, such as fears of repercussions, were not addressed by the application.This study confirms the importance of 3 prerequisites for effective reporting: ability to identify suspect products, easy access to appropriate reporting tools, and protection from possible reprisals or other repercussions.Key ImplicationsNational stakeholders should pilot similar smartphone applications for reporting substandard and falsified medical products within their own contexts.A key to this pilot’s success was the development of standard operating procedures for reporting with the national medicine regulatory authorities before the application roll-out. Future applications should fit within existing standard operating procedures for reporting wherever possible.Introduction:Reporting is an essential component of efforts to combat the distribution and circulation of substandard and falsified (SF) medical products worldwide. However, little is known about why health care professionals (HCPs) do not report suspect products to the national medicine regulatory authority (NMRA) and what measures might address this. This pilot study aimed to assess the utility of a smartphone application for reporting SF medical products in Tanzania and Indonesia.Methods:At baseline, in 2017, HCPs completed a survey describing perceived barriers to reporting and received training in the identification of SF products and received use of the smartphone reporting application (N=309). The application reporting system was piloted for 6 months. Evaluations took place with HCPs and NMRA staff at the midpoint and endline of the pilot study (2018).Results:At baseline, HCPs surveyed (n=254) identified the following key barriers to reporting: difficulties identifying SF products, frustrations with existing reporting systems, and fears that reporting may have personal or reputational repercussions. During the pilot period, HCPs submitted a total of 36 reports of 27 products to the NMRAs in their respective countries; of these, 8 products were determined to be SF and 2 were unregistered. In all 10 cases, appropriate regulatory action was taken. Feedback from HCPs and NMRA staff was positive in both countries, suggesting that the application addressed several barriers to reporting as it was convenient and, importantly, opened a line of communication between HCPs and the NMRA. However, the application did not address all barriers to reporting, such as concerns of repercussions.Conclusion:The findings suggest that this smartphone application may be useful for improving HCPs’ reporting of suspected SF products. Developing and piloting similar reporting applications in other countries and contexts is required.