Interventions that help to improve spontaneous adverse drug reaction reporting by patients: a protocol of a scoping review

Abstract

AbstractWhen a new medical product is released to the market, a continuous pharmacovigilance process is initiated to guarantee patient safety by collecting and analyzing adverse drug reaction (ADR) reports. These ADRs are noxious and unintended responses to a medicine and are collected and analyzed in databases like EudraVigilance to determine safety profiles of the products and signal detection. The spontaneous reporting of suspected ADR could be performed by both health care workers and patients/consumers. However, the under-reporting is well known. Different initiatives have been developed to encourage reporting by health professionals, however, further work is required to support patients in taking a more active role in reporting adverse drug reactions. In this context, we will conduct a Scoping Review of the literature to inquire about what is known about actions or strategies to improve pharmacovigilance engagement by patients. We will conduct searches in MEDLINE/PubMed, Scielo, Latindex, DOAJ, CINAHL, LILACS, IAM, IMEMR, IMSEAR, WPRO, and Cochrane Library databases. Two reviewers will screen all identified records for relevance. Conflicts between reviewers will be solved by consensus. We will chart the data using data-charting forms. Findings will be reported according to PRISMA for Scoping Reviews (PRISMA-ScR). No quality assessment will be performed.