Background: The continuing uncertainty around Brexit has caused concern in the pharmaceutical industry and among healthcare professionals and patients. The exact consequences of Brexit on the UK pharmaceutical supply chain will depend on whether a deal is reached and what it entails, but it is likely to be affected by the withdrawal of the UK from the EU. Regulatory issues and delays in supply have the potential to seriously negatively affect the ability of UK residents to receive an adequate and timely supply of necessary medicines. Objective: The purpose of this protocol is to provide an overview and critical analysis of current perspectives on the effect of Brexit on the UK pharmaceutical supply chain. Methods: The PRISMA extension for Scoping Reviews (PRISMA-ScR) will be used to structure this protocol. A systematic search of Medline, Embase, PsycINFO, HMIC, Cochrane, Web of Science, Business Source Complete, EconLit, and EIU.com and a Google and Nexis.UK search for grey literature such as reports, opinion pieces, and press releases will be conducted. Two reviewers will independently screen the titles and abstracts of identified references and select studies according to the eligibility criteria. Any discrepancies will then be discussed and resolved. One reviewer will extract data from included studies into a standardised form, which will be validated by a second reviewer. Risk of bias will be assessed using the Cochrane Collaboration Risk of Bias tool for any randomized controlled trials, quality will be assessed using the relevant Critical Appraisal Skills Programme (CASP) checklists, and grey literature will be assessed using the Authority, Accuracy, Coverage, Objectivity, Date, Significance (AACODS) Checklist. Outcomes include the agreement between sources on the potential, likelihood, and severity of these consequences. Results: Results will be included in the scoping review which will be published in 2020. Conclusions: This scoping review will summarize the currently expected consequences of Brexit on the UK pharmaceutical supply chain.
JMIR Research Protocols