VigiAccess: Promoting public access to VigiBase

Sir,

Adverse drug reactions (ADRs) are an important cause of morbidity and mortality. The thalidomide tragedy in the late 1950s and early 1960s provided a strong impetus to initiating an international system of pharmacovigilance. The international drug monitoring system officially started in 1968 with ten countries pooling ADR data from their respective national systems.[1] As of March 2007, the system held 3,800,000 individual case safety reports (ICSRs) contributed by national centers. By October 2014, the number of ICSRs had increased to over 10 million reports to over 150,000 medicines and vaccines.[2]

Recognizing the increasingly important role of the general public in pharmacovigilance and medicine safety a platform for the general public to access VigiBase, called VigiAccess was launched on April 17, 2015. This is a powerful initiative to promote medicine safety and enables the public to be more informed about the adverse effects of medicines. Informed patients can play a more active and important role in their own treatment. The database can be accessed through the URL http://www.vigiaccess.org. After clicking on the disclaimer and accepting the terms and conditions of the database, you can enter and search the database.

There is a simple search bar, and drugs can be searched using either the generic name or the brand name. The author tried the search function using a variety of brand names, and the database returned a response in all cases. Brand names search result in a mention of the drug using its generic name. The total number of records related to the drug in the database is also shown. ADRs to each drug are displayed under five drop down lists. These are ADRs, geographical distribution, age group distribution, patient sex distribution, and ADR reports per year. ADRs are broadly grouped according to the system, and each major heading has drop down subheadings. The effect of the medicine on particular laboratory and other investigations and on pregnancy, lactation, and perinatal conditions can also be searched. Product issues, lifestyle issues, and legal issues are all mentioned if these are related to the drug, and these can be searched. The number of ADR reports under each category and subcategories are also mentioned. To maintain patient and health-care professional confidentiality, the geographic distribution of ADRs is limited to the continent level. The age distribution and the gender distribution provide the number of reported ADRs and the percentage of the total for various subgroups. The number of ADR reports per year provides an interesting historical snapshot about ADRs to the drug.

The “about” section provides interesting information about VigiAccess and the International Pharmacovigilance Program. Among the questions answered are: What is pharmacovigilance? What is VigiAccess? What is VigiBase? What is the Uppsala Monitoring Center (UMC)? What is the WHO program for international drug monitoring? Questions about the ADR reporting process, why it is important to report ADRs, functions of national pharmacovigilance centers, what happens to an ADR after it has been reported and information on using the VigiAccess system is also answered.

The UMC has produced a booklet about VigiAccess which can be downloaded from http://www.who-umc.org/graphics/29621.pdf. The database offers quick, hassle-free access to the VigiBase database of ADRs which has been built up over nearly the last 50 years. One possible problem for laypersons is the use of technical terms in the description of ADRs. The standard terminology used in the database is the medical dictionary for regulatory activities. In addition to lay persons, medical professionals will find access to the authoritative VigiBase database very useful. Health professions students can use the database to obtain information about possible ADRs to the medicines they are learning about. Opening access to the VigiBase database through VigiAccess fulfills a long-standing need, and health-care practitioners will be able to obtain practical information with the potential to influence prescribing and drug use. This can underline the practical importance of spontaneous and other ADR reporting programs and could improve ADR reporting rates. This is a powerful initiative to empower patients and promote the more rational use of medicines and should be strongly encouraged.

Financial Support and Sponsorship

Nil.

Conflicts of Interest

There are no conflicts of interest.