Last week, the World Health Organization (WHO) boosted its transparency efforts with the launch of a new, open access drug safety database called VigiAccess.
The practice of postmarket drug monitoring, or pharmacovigilance, is an important part of ensuring patient safety after a product has been approved. During clinical trials, it is not possible to determine every possible side effect or reaction to a drug or vaccine. By monitoring drugs and collecting reports of suspected adverse drug reactions (ADRs), companies, regulators and healthcare providers can continue to assess a product's safety using real world data.
WHO has promoted the collection of ARDs on an international level since 1968, when it formed the Programme for International Drug Monitoring (PIDM). According to WHO, 120 countries are PIDM members, with 29 additional countries awaiting full membership.
The goal of PIDM is to identify emerging adverse reaction signals using individual case safety reports (ICSRs) by analyzing individual case study reports (ICSR) submitted by member countries. These ICSRs are catalogued in VigiBase, WHO's ADR database, which is maintained by the Uppsala Monitoring Centre (UMC).
To date, VigiBase has received more than 10 million ADRs related to 150,000 medicines and vaccines from around the world. According to WHO, VigiBase is the "largest and most comprehensive [pharmacovigilance] database in the world," and is "the only global database that contains safety reports from both high- and low-income countries."
VigiAccess gives users access to statistical data from the 10 million-plus ADRs contained in VigiBase. WHO says it designed VigiAccess to be user friendly to "promote medicine awareness," and hopes that sharing its data will encourage greater ARD reporting.
To use the site, users are asked to enter the trade name of a drug they wish to see ADR data for. Once the name of a drug or vaccine is entered, the database returns the active pharmaceutical ingredient (API) contained in the product and the total number of records related to that API.
From there, users can see the types of reactions that were reported for the product, broken down by category and frequency, geographical distribution, age group, patient sex and the number of ADRs per year. To ensure confidentiality, the data contained in VigiAccess is aggregated, and cannot be broken down by country, as some countries may have very few reported ADRs for any particular product.
Promoting Open Access
Recently, WHO has taken several strides to increase transparency and promote open access to information.
Earlier this month, WHO published a statement to its website calling for the public disclosure of clinical trial results. The move was made to address concerns that many clinical trials with poor results were not being published. In its statement, WHO asks that the main findings of clinical trials be submitted to a peer review journal within a year of the trial's end date. Additionally, WHO says that the key outcomes of the trial should be published to a clinical trial registry within the same one-year timeframe.
In July 2014, WHO updated its open access policy to require all articles authored or co-authored by WHO staff to be publically available, and to encourage the use of open licenses such as the Creative Commons license, for such publications.