BACKGROUND: Pharmacovigilance involves the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs), nationally and internationally. Effective communication, which relies increasingly on the Internet, is a crucial aspect of pharmacovigilance activities. AIM: The aim of this study was to perform an exploratory survey of national pharmacovigilance websites and compare their contents. METHODS: Of 99 international pharmacovigilance organizations known to us (listed in the Side Effects of Drugs Annual 30), 45 included website addresses and 35 provided some or all of the information in English. We reviewed 10 of these 35 websites in order to identify their contents. The 10 sites that we selected contained the most extensive information on pharmacovigilance of those that we were able to access. Reviewing these sites, we identified 32 items of information that we used to assess the scope of each website systematically, using a scoring system based on the presence or absence of those items. RESULTS: All the websites gave clear descriptions of national pharmacovigilance requirements and the reporting systems for ADRs, and all included devices. Beyond this, there was great variability in content from site to site. Few websites allowed access to raw pharmacovigilance data, such as individual case reports. CONCLUSIONS: Online drug safety communication from the selected national websites we examined is highly variable from site to site, although a wider study is needed to confirm this. Agreement on the key components of pharmacovigilance websites would facilitate the development of a standardized format to improve online communication.
BACKGROUND: Pharmacovigilance involves the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs), nationally and internationally. Effective communication, which relies increasingly on the Internet, is a crucial aspect of pharmacovigilance activities. AIM: The aim of this study was to perform an exploratory survey of national pharmacovigilance websites and compare their contents. METHODS: Of 99 international pharmacovigilance organizations known to us (listed in the Side Effects of Drugs Annual 30), 45 included website addresses and 35 provided some or all of the information in English. We reviewed 10 of these 35 websites in order to identify their contents. The 10 sites that we selected contained the most extensive information on pharmacovigilance of those that we were able to access. Reviewing these sites, we identified 32 items of information that we used to assess the scope of each website systematically, using a scoring system based on the presence or absence of those items. RESULTS: All the websites gave clear descriptions of national pharmacovigilance requirements and the reporting systems for ADRs, and all included devices. Beyond this, there was great variability in content from site to site. Few websites allowed access to raw pharmacovigilance data, such as individual case reports. CONCLUSIONS: Online drug safety communication from the selected national websites we examined is highly variable from site to site, although a wider study is needed to confirm this. Agreement on the key components of pharmacovigilance websites would facilitate the development of a standardized format to improve online communication.
Authors: A Vitry; J Lexchin; L Sasich; T Dupin-Spriet; T Reed; V Bertele; S Garattini; L Toop; E Hurley Journal: Intern Med J Date: 2008-03-11 Impact factor: 2.048