The whole experience of public hospital physicians from several specialties with biopharmaceutical effectiveness, safety, adverse drug reactions and interchangeability: A qualitative study.

Background: Although there is increasing support for biosimilar medicines by the Iraqi Ministry of Health (MOH), there is scarce information about whether physicians accept these medicines and support movement toward replacing reference medicines with their biosimilar counterparts. Objectives: The study objectives were to 1) explore in-depth the perceptions of Iraqi physicians working in public hospitals about the difference in effectiveness and safety between biosimilar medicines and their reference biological counterparts, 2) evaluate physicians' barriers to prescribing biosimilar medicines, 3) assess the adherence of physicians to the new pharmacovigilance regulations on reporting biopharmaceutical adverse drug reactions (ADRs) and 4) identify any barriers facing physicians to reporting biopharmaceutical- ADRs. Methods: This qualitative study included face-to-face and virtual semi-structured interviews involving physicians from different disciplines who had experience with biological or biosimilar medicines. The interviews were conducted between November 6, 2020, and February 7, 2021. Thematic analyses were used to analyze qualitative data generated from the interviews. Results: The study sample included 36 physicians (6 women and 30 men) from seven different specialties at ten governmental hospitals mainly in Baghdad, and one physician was from Mosul, Iraq. Because most physicians had insufficient experience with biosimilar medications and were not sure about their effectiveness, the majority were hesitant to prescribe them. Most physicians preferred to prescribe reference biological medicines initially. However, the initial prescribing and switching between a reference and counterpart biosimilar relies on its availability. They chose biosimilar medications that have been approved by the U.S. FDA or EMA. Most physicians were unaware about the new pharmacovigilance regulations to report adverse biopharmaceutical reactions. The physicians tended to underreport biopharmaceutical ADRs and believed that inadequate physician-pharmacist collaboration negatively impacts preventing and reporting ADRs. Conclusions: Medicine procurement in healthcare settings should focus on sustainably securing high-quality biopharmaceuticals rather than looking only at costs to enhance physician experience and patient clinical outcomes. Promoting documentation, monitoring, and physician-pharmacist collaboration is pivotal to prevent, monitor, and treat biopharmaceutical ADRs.

Pharmaceutical regulations in Iraq: from medicine approval to postmarketing.

BACKGROUND: Recent information on regulation of the pharmaceutical sector in Iraq is scarce. AIMS: This report summarizes the regulations governing pharmaceutical products in Iraq, assesses the challenges faced and makes recommendations to tackle these issues. METHODS: The Iraq pharmaceutical country profile 2020, prepared by the Iraqi Ministry of Health in collaboration with the World Health Organization (WHO) in 2020, was the main source of information. RESULTS: Despite all the efforts by the Ministry of Health to provide adequate and safe medicines, the Iraqi pharmaceutical sector has several challenges, including inadequate budget allocated to the ministry, shortages in essential medicines, underutilization of electronic technologies in the management of regulation-related work, a large number of substandard and falsified medications in the private sector and a stagnant national pharmaceutical industry. CONCLUSION: The Ministry of Health needs more financial support from the federal government to fund its activities and technical support from international health organizations to provide training and resources.

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.