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

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    Access Status
    Open access
    Authors
    Gauld, N.
    Kelly, F.
    Emmerton, Lynne
    Kurosawa, N.
    Bryant, L.
    Buetow, S.
    Date
    2018
    Type
    Journal Article
    
    Metadata
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    Citation
    Gauld, N. and Kelly, F. and Emmerton, L. and Kurosawa, N. and Bryant, L. and Buetow, S. 2018. Medicines reclassification from a pharmaceutical industry perspective: An international qualitative study. Research in Social and Administrative Pharmacy. 15 (4): pp. 387-394.
    Source Title
    Research in Social and Administrative Pharmacy
    DOI
    10.1016/j.sapharm.2018.06.004
    ISSN
    1551-7411
    School
    School of Pharmacy and Biomedical Sciences
    URI
    http://hdl.handle.net/20.500.11937/69958
    Collection
    • Curtin Research Publications
    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.

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