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.