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. 2020 May 15:11:707.
doi: 10.3389/fphar.2020.00707. eCollection 2020.

The Development of Practice Recommendations for Drug-Disease Interactions by Literature Review and Expert Opinion

Justine M Z van Tongeren  1 , S Froukje Harkes-Idzinga  2 , Heleen van der Sijs  3 , Roya Atiqi  4 , Bart J F van den Bemt  5   6 , L Willem Draijer  7 , Deline Hiel  8 , Adrian Kerremans  9 , Bart Kremers  10 , Marc de Leeuw  2 , Marleen V Olthoff  1 , T Kim-Loan Pham  1 , Ricky Valentijn-Robertz  11 , Kayan Tsoi  1 , Iris Wichers  12 , Maaike de Wit  2 , Sander D Borgsteede  1   3
Affiliations

The Development of Practice Recommendations for Drug-Disease Interactions by Literature Review and Expert Opinion

Justine M Z van Tongeren et al. Front Pharmacol. .

Abstract

Background: Drug-disease interactions negatively affect the benefit/risk ratio of drugs for specific populations. In these conditions drugs should be avoided, adjusted, or accompanied by extra monitoring. The motivation for many drug-disease interactions in the Summary of Product Characteristics (SmPC) is sometimes insufficiently supported by (accessible) evidence. As a consequence the translation of SmPC to clinical practice may lead to non-specific recommendations. For the translation of this information to the real world, it is necessary to evaluate the available knowledge about drug-disease interactions, and to formulate specific recommendations for prescribers and pharmacists. The aim of this paper is to describe a standardized method how to develop practice recommendations for drug-disease interactions by literature review and expert opinion.

Methods: The development of recommendations for drug-disease interactions will follow a six-step plan involving a multidisciplinary expert panel (1). The scope of the drug-disease interaction will be specified by defining the disease and by describing relevant effects of this drug-disease interaction. Drugs possibly involved in this drug-disease interaction are selected by checking the official product information, literature, and expert opinion (2). Evidence will be collected from the official product information, guidelines, handbooks, and primary literature (3). Study characteristics and outcomes will be evaluated and presented in standardized reports, including preliminary conclusions on the clinical relevance and practice recommendations (4). The multidisciplinary expert panel will discuss the reports and will either adopt or adjust the conclusions (5). Practice recommendations will be integrated in clinical decision support systems and published (6). The results of the evaluated drug-disease interactions will remain up-to-date by screening new risk information, periodic literature review, and (re)assessments initiated by health care providers.

Actionable recommendations: The practice recommendations will result in advices for specific DDSI. The content and considerations of these DDSIs will be published and implemented in all Clinical Decision Support Systems in the Netherlands.

Discussion: The recommendations result in professional guidance in the context of individual patient care. The professional will be supported in the decision making in concerning pharmacotherapy for the treatment of a medical problem, and the clinical risks of the proposed medication in combination with specific diseases.

Keywords: clinical decision support; drug-disease interactions; expert opinion; literature review; practice recommendations; study protocol.

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Figures

Figure 1
Figure 1
Flow chart of the evaluation plan.
Figure 2
Figure 2
Key questions in drug-disease interactions.
See this image and copyright information in PMC

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References

    1. Addis A., Sharabi S., Bonati M. (2000). Risk classification systems for drug use during pregnancy: are they a reliable source of information? Drug Saf. 23, 245–253. 10.2165/00002018-200023030-00006 - DOI - PubMed
    1. Ashley C., Dunleavy A. (2018). The Renal Drug Handbook, 5th ed. Boca Raton: CRC Press.
    1. Bingel U. (2014). For the Placebo Competence Team Avoiding Nocebo Effects to Optimize Treatment Outcome. JAMA 312, 693–694. 10.1001/jama.2014.8342 - DOI - PubMed
    1. Borgsteede S. D., Van-Donselaar-Pham K. L., Eimermann V. M., De Klerk S., Van Tongeren J. M. Z., Tsoi K. Y. Commentaren Medicatiebewaking Online. Health Base Foundation 2019. http://www.commentarenmedicatiebewaking.nl Accessed 6 November 2019.
    1. Boyd C. M., Vollenweider D., Puhan M. A. (2012). Informing evidence-based decision-making for patients with comorbidity: availability of necessary information in clinical trials for chronic diseases. PloS One 7, e41601. 10.1371/journal.pone.0041601 - DOI - PMC - PubMed