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

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

Inflammation-mediated Phenoconversion: A Potential Threat to COVID-19 Pharmacotherapy

“…It is understandable since clinical studies regarding the topic is still limited and hard to translate to clinically actionable medication management. Yet, Van Tongeren et al (2020) have recently published a standardized guideline to help the translation of the available clinical information of drug-disease interactions to applicable clinical action (Van Tongeren et al 2020).…”

“…Nevertheless, exploration of the clinical relevance of inflammation-mediated phenoconversion should still be further pursued. Since patients with comorbidities are commonly not included in randomized clinical trials, the evidence regarding the potential impact of drug-disease interactions is often lacking (Van Tongeren et al 2020). Therefore, we need an alternative method that can be used to predict the clinical impact of inflammation on drug pharmacokinetics.…”

Management of drug-disease interactions: a best practice from the Netherlands

“…These statements are not always optimal in practice, as advice concerning DDSIs in SmPCs are sometimes not clearly motivated or give impractical recommendations. Other sources for recommendations than the SmPC, are available for some comorbidities and conditions such as renal impairment, cirrhosis and pregnancy/lactation [7]. As far as we are aware, guidelines or practical recommendations for DDSIs covering a wide range of comorbidities are uncommon.…”

“…In the Netherlands, pharmacists have developed a practice over several decades to analyse and evaluate possible DDSIs based on pharmacological considerations, and formulated practice recommendations for specific drugs [7]. This practice has resulted in a set of motivated, clinically relevant DDSIs and practice recommendations.…”

Modelling bioactivities of combinations of whole extracts of edibles with a simplified theoretical framework reveals the statistical role of molecular diversity and system complexity in their mode of action and their nearly certain safety

“…Polypharmacology science as well as long standing drug screening observations evidenced that any chemical compound is interacting to some extent (from significant to negligible) with every constituent of an organism, resulting in desired and undesired effects [14,15]. In order to be administrated to humans (more broadly, to animals of interest to humans), whether for therapeutic or nutritional usage, the undesired effects of chemical compounds found in foods, feeds and drugs, need to be negligible, at least with an acceptable risk/benefit ratio, at the dose where the desired effect is significant [16].…”