Toward standardized reporting of drug interactions: the READI checklist for anecdotal reports

Abstract

Anecdotal reports contribute 30% of the literature on adverse drug reactions and interactions. However, the quality of such reports has not been uniformly high. Standardized reporting of clinical studies is of increasing interest, including the CARE guidelines on reporting anecdotal cases in general. Although there are guidelines on evaluating and managing drug–drug interactions, there are none recommending methods for reporting suspected drug interactions. Here, based on published guidelines for reporting suspected adverse drug reactions, I propose a checklist for reporting details of suspected drug interactions, the REporting Anecdotal Drug Interactions (READI) checklist, hoping to stimulate discussion and improve reporting of suspected drug interactions. The checklist includes items relating, among others, to the patient affected, the drugs involved, and the outcome.

Keywords:

• adverse drug reactions
• case reports
• drug–device interactions
• drug–drug interactions
• drug–food interactions
• drug–herb interactions
• reporting guidelines

Financial & competing interests disclosure

JK Aronson was a member of the Cochrane Adverse Effects Methods Group and of the CARE Group; he is a member of the Advisory Board of the British National Formularies and of a technology appraisal committee of NICE, and an Honorary Fellow of the British Pharmacological Society and of the Faculty of Pharmaceutical Medicine. He has edited textbooks and published papers on drug interactions. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Key issues

• Anecdotal reports contribute about 30% of the published literature on adverse drug reactions and interactions.

• Although anecdotal reports are generally regarded as being of poor evidential quality, they form an important part of the evidence on adverse drug reactions and interactions, are important for data mining in pharmacovigilance signal detection, and, in some cases, can provide definitive evidence of an association.

• The evaluation of drug interactions requires detailed, high-quality information on how they occur, and the quality of published reports, which has not hitherto been uniformly high, is therefore important.

• There is increasing interest in standardized reporting of clinical studies, including the CARE guidelines on reporting anecdotal cases in general and the PHARMA and ISoP/ISPE guidelines on reporting suspected adverse drug reactions.

• Although there are guidelines on the publication of strategies for evaluating and managing drug interactions, there are no guidelines that recommend methods for reporting suspected adverse drug interactions.

• To start a discussion, I offer a proposed checklist for reporting suspected drug interactions, the REporting Anecdotal Drug Interactions checklist (READI), based on the PHARMA and ISoP/ISPE guidelines for reporting adverse drug reactions.

• Guidelines on reporting suspected drug interactions in case series, observational studies, randomized studies, and systematic reviews are also needed.