Medicines reclassification from a pharmaceutical industry perspective: An international qualitative study

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Show simple item record Gauld, Natalie en Kelly, FS en Emmerton, LM en Kurosawa, N en Bryant, LJM en Buetow, Stephen en 2020-05-08T00:24:32Z en 2019-04 en
dc.identifier.issn 1551-7411 en
dc.identifier.uri en
dc.description.abstract BACKGROUND:Widening access to medicines through reclassification ('switching') of medicines from prescription to non-prescription is an international trend generally welcomed by community pharmacists. Research has focused on scheduling and committee deliberations affecting reclassification, rather than industry aspects, despite industry's role in driving reclassifications. The research aimed to identify how pharmaceutical industry and product-related factors influence reclassification, and to explore stakeholder acceptability of government or third-party driven reclassifications. METHODS:Sixty-five in-depth, semi-structured interviews were conducted with 80 key informants (including representatives from regulatory bodies, industry, pharmacy and medicine) in developed countries including the United States, the United Kingdom, Japan, Australia, and New Zealand. The questions explored barriers and enablers to reclassification at the local (micro-), regional (meso-) and global (macro-) levels. Analysis of transcribed interviews entailed descriptive and thematic approaches. RESULTS:Pharmaceutical industry decisions to drive medicine reclassification reflect characteristics of the company, product, and external environment at all levels. For the company, financial factors, company focus (e.g. on prescription business versus non-prescription business), and capability in non-prescription medicines and reclassification were common influences. Products with significant non-prescription market potential and a well-known prescription medicine brand name most suited reclassification, usually near patent expiry. Barriers included immediate generic entry post-reclassification, and a short-term profitability and/or prescription business focus. Some countries allow government or a third-party (including pharmacy) to drive reclassifications, with examples of successful reclassifications ensuing. Some industry and other participants held concerns about this practice, particularly in the United States. Concerns included insufficient resourcing, and the pharmaceutical company's business, potentially encouraging product withdrawal or legal challenge. CONCLUSIONS:This study is the first to explore both pharmaceutical industry factors affecting reclassification and acceptability of alternate drivers of reclassification. Factors beyond clinical safety and efficacy and the local reclassification environment can influence reclassification. Pharmacy-driven reclassification might be one alternative. en
dc.format.medium Print-Electronic en
dc.language eng en
dc.publisher Elsevier en
dc.relation.ispartofseries Research in Social and Administrative Pharmacy en
dc.rights Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher. en
dc.rights.uri en
dc.subject Humans en
dc.subject Qualitative Research en
dc.subject Drug Industry en
dc.subject United States en
dc.subject Japan en
dc.subject Australia en
dc.subject New Zealand en
dc.subject Nonprescription Drugs en
dc.subject Prescription Drugs en
dc.subject United Kingdom en
dc.title Medicines reclassification from a pharmaceutical industry perspective: An international qualitative study en
dc.type Journal Article en
dc.identifier.doi 10.1016/j.sapharm.2018.06.004 en
pubs.issue 4 en
pubs.begin-page 387 en
pubs.volume 15 en
dc.rights.holder Copyright: The author en
pubs.end-page 394 en
pubs.publication-status Published en
dc.rights.accessrights en
pubs.subtype Article en
pubs.elements-id 747831 en Medical and Health Sciences en Population Health en Gen.Practice& Primary Hlthcare en
dc.identifier.eissn 1934-8150 en
pubs.record-created-at-source-date 2020-01-13 en
pubs.dimensions-id 30917892 en

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