Suggestion of a form for outpatient reporting of suspected adverse drug reactions in Colombia

Abstract

Introduction: Obtaining accurate and timely information related to adverse drug reactions is key; uses strategy as voluntary reporting by health professionals or to the competent authority. Objective: To design a proposal of format for reporting adverse drug reactions (ADRs) by outpatients in Colombia based on recommendations from other countries and definite minimum requirements for this type of format. Methodology: We completed a structured review in PubMed/MEDLINE database of articles published in English or Spanish, using the terms Pharmacovigilance AND Patients, and Pharmacovigilance reporting and patient report. Articles with information about patients reporting ADR where included. With the support of the information from the review, as with the requirements established in the guidelines from the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2A and E2B (R3). We developed a checklist, and then we contrasted the items with the information registered in the format for reporting by patients from 50 countries belonging to the Uppsala Monitoring Center with. Finally, we defined the items to be included in the proposed format. Results: From structured review, we identified 104 articles, of which five met the inclusion criteria. We developed a checklist with 34 items, and then we confronted the 34 items with information registered in 33 of the 50 formats of the countries that we may accessed. We defined the contents of the ADR report format by patients. Conclusion: We design and develop a proposal of ADR reporting format by outpatient in Colombia, which has the information identified as key. The format requires a process of validation and evaluation of its functionality in contributing to achieving the objectives of pharmacovigilance.