The Epidemic of Substandard and Falsified Medications in Iraq: Evaluating the Effectiveness of National Pharmacovigilance Alerts to Community Pharmacies

BACKGROUND: Assessing Iraqi experience with the impact of substandard and falsified (S/F) medicines can help other countries deal comprehensively with the underlying causes of this multifactorial problem. The tools used in this study to assess strategies to prevent the use of S/F medications can be used in other developing countries. This study investigated the problem of S/F medications at three levels: the Ministry of Health (MOH), pharmaceutical company representatives, and community pharmacists. OBJECTIVES: Study objectives were to evaluate the effectiveness of alerts about S/F medications issued by the national Iraqi Pharmacovigilance Center (IqPhvc) to community pharmacies and to explore the reasons and potential solutions for this problem from the perspective of both pharmaceutical companies and pharmacists. METHODS: This was an exploratory mixed-method study. The qualitative phase comprised seven 1-h semi-structured interviews and one focus group conducted via Zoom. Thematic analysis was used to analyse the qualitative data. The findings of the qualitative phase were then used to develop the survey items. The quantitative phase included an electronic survey distributed among pharmacists via two professional Facebook groups between 23 April and 19 May 2020. The Kruskal–Wallis test was used to measure differences in pharmacists’ knowledge of and ability to detect S/F medications according to their years of experience in the private sector. RESULTS: Over the last 5 years (2016–2020), the IqPhvc received 183 reports about S/F medications from representatives of 25 international companies. Only 29 (15.8%) of the reports were about falsified medications; the majority were about substandard (parallel) medicines. We interviewed 12 pharmacists (11 male, 1 female) representing ten large international pharmaceutical companies. We also received surveys from 590 pharmacists, of whom 475 (80.9%) were women. Although 72% of the participants had not received any training in the identification of S/F medications, 59.4% of them easily identified S/F medications. Likewise, approximately three-quarters of the participating pharmacists recognized genuine registered medications through three means: medication price sticker, cost, and packaging features. Although 61% of the pharmacists followed-up alerts about S/F medications, only 25.6% were willing to report S/F medications. CONCLUSIONS: Most reports to the IqPhvc were about substandard medications. Participants of the two study phases agreed on several reasons for the problem of S/F medications, including their low prices, the unavailability of registered medications, the lengthy medicine registration process, and inadequate awareness of S/F medications among healthcare providers and the public. They also agreed that national alerts and price stickers are helpful in the identification of S/F medications. Community pharmacists can increase their efforts to report S/F medicines, but they need training, awareness, and tools. The study highlighted the need for a track-and-trace system to detect S/F medicines in the supply chain. In brief, the problem of S/F medication is multifaceted. Reducing it will require effective collaboration among different entities, including health officials, border agencies, healthcare providers, and registered pharmaceutical companies.