Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Meta-Analysis
. 2016 Mar 1:16:27.
doi: 10.1186/s12911-016-0265-8.

How to promote adverse drug reaction reports using information systems - a systematic review and meta-analysis

Inês Ribeiro-Vaz  1   2 , Ana-Marta Silva  3   4 , Cristina Costa Santos  5   6 , Ricardo Cruz-Correia  7   8
Affiliations
Meta-Analysis

How to promote adverse drug reaction reports using information systems - a systematic review and meta-analysis

Inês Ribeiro-Vaz et al. BMC Med Inform Decis Mak. .

Abstract

Background: Adverse drug reactions (ADRs) are a well-recognized public health problem and a major cause of death and hospitalization in developed countries. The safety of a new drug cannot be established until it has been on the market for several years. Keeping drug reactions under surveillance through pharmacovigilance systems is indispensable. However, underreporting is a major issue that undermines the effectiveness of spontaneous reports. Our work presents a systematic review on the use of information systems for the promotion of ADR reporting. The aim of this work is to describe the state of the art information systems used to promote adverse drug reaction reporting.

Methods: A systematic review was performed with quantitative analysis of studies describing or evaluating the use of information systems to promote adverse drug reaction reporting. Studies with data related to the number of ADRs reported before and after each intervention and the follow-up period were included in the quantitative analysis.

Results: From a total of 3865 articles, 33 articles were included in the analysis; these articles described 29 different projects. Most of the projects were on a regional scale (62 %) and were performed in a hospital context (52 %). A total of 76 % performed passive promotion of ADR reporting and used web-based software (55 %). A total of 72 % targeted healthcare professionals and 24 % were oriented to patient ADR reporting. We performed a meta-analysis of 7 of the 29 projects to calculate the aggregated measure of the ADR reporting increase, which had an overall measure of 2.1 (indicating that the interventions doubled the number of ADRs reported).

Conclusions: We found that most of the projects performed passive promotion of ADR reporting (i.e., facilitating the process). They were developed in hospitals and were tailored to healthcare professionals. These interventions doubled the number of ADR reports. We believe that it would be useful to develop systems to assist healthcare professionals with completing ADR reporting within electronic health records because this approach seems to be an efficient method to increase the ADR reporting rate. When this approach is not possible, it is essential to have a tool that is easily accessible on the web to report ADRs. This tool can be promoted by sending emails or through the inclusion of direct hyperlinks on healthcare professionals' desktops.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Flowchart of the study selection
Fig. 2
Fig. 2
Number of publications by year
Fig. 3
Fig. 3
Rate (ADR reports after/ADR reports before) of ADR report increase (95 % IC)
See this image and copyright information in PMC

References

    1. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA J Am Med Assoc. 1998;279(15):1200–1205. doi: 10.1001/jama.279.15.1200. - DOI - PubMed
    1. Lasser K, Allen P, Woolhandler S, Himmlstein F, Wolfe S, Bor D. Timing of New black Box warnings and withdrawals for prescription medications. JAMA J Am Med Assoc. 2002;287(17):2215–2220. doi: 10.1001/jama.287.17.2215. - DOI - PubMed
    1. Estatuto do Medicamento. Decreto-Lei n.º 176/2006, de 30 de Agosto.
    1. Walker R, Edwards C. Clinical Pharmacy and Therapeutics. 3ª ed. Scotland: Churchill Livingstone; 2003
    1. McGettigan P, Golden J, Conroy RM, Arthur N, Feely J. Reporting of adverse drug reactions by hospital doctors and the response to intervention. Br J Clin Pharmacol. 1997;44(1):98–100. doi: 10.1046/j.1365-2125.1997.00616.x. - DOI - PMC - PubMed

LinkOut - more resources