WHO Opens Its Database Of Medicines Side Effects To The Public

The World Health Organization has announced that its Global Medicines Safety Database is now open to the general public. The database named VigiAccess can now be accessed on any computer or smartphone in the world.

Speakers at a 17 April press briefing said VigiAccess can be access through a user-friendly platform but cannot be used to assess if a medicine is bad or good. According to the VigiAccess website, the database provides suspected side-effects from various medicinal products. The WHO global database for adverse drug reactions is maintained by the Uppsala Monitoring Center (UMC), in Uppsala, Sweden.

Marie-Paule Kieny, WHO assistant director-general, said the database contains some 10 million reports of adverse drug reactions across 110 countries. She said the WHO issued a position statement earlier calling for greater transparency of clinical trials results and now is launching an open access database on adverse drug reactions. Research and knowledge related to health products should become global public goods, she said.

The information about adverse drug reactions is vital for governments in public health decision-making, she said, as it is among the top ten causes of death in some countries, she added. The “incredible wealth of information” contained in the database is invaluable for public health actors as well as the public at large, and it is a “moral responsibility” to make sure that the world can access this information, she said. It can also drive innovation and lead to better patient care and treatment.

Relevant safeguards have been put into place to make sure that the database is not misused, she said. The WHO’s ultimate goal with this initiative is twofold, she said. One is to minimise health risks associated to medical products. The second is to ensure that governments make sound public health decision and that patients are able to take informed decisions about their own health, Kieny said.

One of the other goals of opening the database to the public is to raise awareness about pharmacovigilance, she said, and hopefully increase the reporting. Opening the database further serves to increase transparency in the field. The pros and cons to taking particular drugs are known to the public, she added.

Gerald Dal Pan, director, Office of Surveillance and Epidemiology, United States Food and Drug Administration, said when drugs are used on a large population, after their approval, new side effects can appear. They can relate to the manner in which drugs are used or to rare side effects. None of those side effects can be foreseen during clinical trials, he said. This is why countries have pharmacovigilance programmes.

Marie Lindquist, director/CEO of UMC said knowledge about risks attached to medicines is very limited in some parts of the world. She said VigiAccess can now be searched by anyone in the world, and comes with an easy to use interface accessible through a smart phone, computer or any internet connected device.

No individual case details can be found in the database, she said. However for any given drugs, the number of reports for each suspected adverse effect is indicated. Lindquist said the database does not indicate whether a drug is dangerous or safe. Users can input any product name and it will be translated into the active pharmaceutical ingredients. It is not the answer to drug safety, she said, but “just a small step.”

The UMC is also launching a pharmacovigilance global campaign named “take & tell – Together for safer medicines,” to encourage patients to talk to their doctors about suspected drug adverse effects, she said.

Dialogue with Pharmaceutical Companies

According to Lindquist, the UMC has maintained a dialogue with pharmaceutical companies for many years. One important feature of the work of the WHO, she said, is that the information that is fed into the database comes from national pharmacovigilance centres in over 100 countries. This data is analysed and screened by UMC to see if potential problems need to be investigated further, she said.

Many years ago, the content of the database was only available to regulators, she said, but for the last 20 years, pharmaceutical companies have been contacted about potential problems, if the product is still under patent as it is easy to identify the manufacturer. The company is then invited to produce comments, which are later published. Since 2012 summaries of findings are also published in the WHO pharmaceuticals newsletter, she further explained.

According to Janis Bernat, associate director, Biotherapeutics & Scientific Affairs, at the International Federation of Pharmaceutical Manufacturers & Associations, “Pharmacovigilance is an important measure by which the safety of medicines for, and treatment of, patients worldwide can be improved.”

“Everyone should understand the value in reporting side effects of medicines, and pharmacovigilance systems are widely recognised as important tools in the regulatory process for medicines, for protecting public health, and [as] an integral component of patient healthcare,” she told Intellectual Property Watch. “We recognise and support WHO’s continued work in this important area.”