There is an organization that has done basic, pioneering work in drug safety and pharmacovigilance and that today continues to play a unique role in this field. This organization is called the Uppsala Monitoring Centre (a name that really does not describe its role).
The UMC was set up in1978 after the thalidomide disaster. It is a collaborating centre of the World Health Organization (WHO). WHO Collaborating Centres are institutions, institutes, academic or university divisions designated by the WHO to support WHO programs but are not actually part of the WHO.
The UMC is actually an independent foundation without regular financial support from any government or the WHO. They do, however, sell products and services to industry and others, to self-finance. More on this below.
They are a very interesting and unique organization that does three things: research in drug safety (and there is, alas, not much of that done in the world), public service and PV training, and selling products and services many of which we use in our everyday work (e.g. the WHO Drug Dictionary Enhanced – see below).
A look at the three areas:
Research
Research is focused on three areas primarily: data-driven discovery. This is the very “hot” area in drug safety in which large databases are being “mined” for signals and safety issues. In particular, the UMC is working on various statistical techniques, including disproportionality analyses as well as detection of interactions, event patterns over time and duplicate case detection (something that sounds simple but as anyone who does case processing can tell you, is not!).
The UMC is also active in safety surveillance and signaling with a focus on drug dependence and pediatric signal detection – another area that everyone knows is critical and wants to improve but remains a true challenge and problem.
Finally, another “hot” area of research is benefit risk analysis (or for the pessimists in the audience: risk-benefit analysis). They are looking at current methodology and trying to develop quantitative techniques. Perhaps someday we really will have a “benefit-risk ratio” – a numerical/statistical way of measuring risk. As the engineers say, “if you can measure it, you can fix it”.
They have been very active in publishing in the medical literature and some seminal works have come from the UMC. See the publication list (with free pdfs available) at https://www.who-umc.org/DynPage.aspx?id=100740&mn1=7347&mn2=7259&mn3=7296.
Public Service & Training https://www.who-umc.org/
One of the most interesting areas the UMC works in is public service, particularly sending the PV message to countries where drug safety has not be a focus at all. For example, in July 2012 the UMC ran a two day training course in Accra, Ghana on drug safety. They do various training sessions around the world with the next major course set for late May 2013 in Uppsala covering pharmacovigilance and vaccine vigilance.
A most interesting set of free publications (aimed primarily at governments) is “Setting Up a PV Programme” and “Minimum Requirements for a Functional National PV System” and a very high level paper on “The Basics on PV” all at https://www.who-umc.org/DynPage.aspx?id=98088&mn1=7347&mn2=7252&mn3=7253&mn4=7329.
There is also a lovely paper, available free as a pdf, on “The Importance of PV” which probably should be read by everyone in the pharmaceutical industry who is NOT involved in PV so that they can see what we are doing and why it is so important! See: https://www.who-umc.org/DynPage.aspx?id=105882&mn1=7347&mn2=7259&mn3=7298&mn4=7506.
They have multiple publications in many areas of PV. Perhaps the most interesting and useful is the free Uppsala Reports sent out quarterly as a pdf. Well worth subscribing and reading. Have a look at the latest copies at https://www.who-umc.org/DynPage.aspx?id=105825&mn1=7347&mn2=7259&mn3=7297. Requests to be put on the mailing list should be sent to info@who-umc.org.
Commercial Services (https://www.umc-products.com/)
This is the area where most of us involved in day-to-day pharmacovigilance encounter the UMC. They have three products:
WHO Drug Dictionary Enhanced (WHO DDE). https://www.umc-products.com/DynPage.aspx?id=73588&mn1=1107&mn2=1139
This is a drug dictionary that really is the only major drug dictionary that exists. The EU has its product dictionary but it is limited primarily to EU approved products. The WHO DDE is used by many companies and governments either directly or in an internally modified form to code, classify and search for drugs in their safety databases. The need for a dictionary of all drugs is obvious: we need to communicate globally with companies, governments, health care professionals, patients and without an agreed on set of drug names and classifications this would be a hopeless task. There are tools for using the dictionary in the Japanese and Chinese languages. There is also a WHO Herbal Dictionary. Although it is not possible to have all names from all countries for all drugs, this is about as close as one can get. The dictionary is updated quarterly. The WHO DDE has about 400,000 unique drug and herbal names as of 2012. Information at https://www.umc-products.com/DynPage.aspx?id=73551&mn1=1107&mn2=1139&mn3=6040.
WHO-ART. https://www.umc-products.com/DynPage.aspx?id=73589&mn1=1107&mn2=1664
This is an adverse event/reaction coding terminology. It was widely used until MedDRA was developed. Although there are still users of WHO-ART, it has largely been replaced by MedDRA. There is a mapping of WHO-ART preferred terms to MedDRA.
Vigibase. https://www.umc-products.com/DynPage.aspx?id=73590&mn1=1107&mn2=1132
This is a very large (probably the largest) drug safety database in the world. It has over 7 million individual case safety reports from 100 plus countries. It covers primarily marketed products and receives its data primarily from individual health agencies worldwide. Companies do not submit cases directly.
What is most interesting and useful is that the UMC provides safety data from Vigibase to companies, governments and other interested parties. They are quite refreshingly frank in stating that they help pharmaceutical companies “extract valuable information about the safety profile of their drug products as well as their competitors’”! Detailed information (customized searches) is available directly from the UMC or through commercial companies that have web access. There are certain limitations in the data. For example, not all countries allow their data to be included in reports sent out to companies or others. In addition, there are usually no narratives available. Nonetheless, a valuable resource for signaling, benefit-risk analyses etc.
Conclusions and Comments
The UMC has played and continues to play a vital role in the world of drug safety and PV. They have not been without controversy over the years and have at one point made various health agencies, companies and others rather unhappy or even angry with their reports and critiques on drug safety and particular products.
Nevertheless, they have always been open and easy to deal with for the most part and have been willing to talk to everyone: not just health agencies but also pharmaceutical companies, the public and other players in the pharmaceutical world. Their outreach to the third world and other areas where PV is not well handled or even handled at all is exemplary.
One of the global criticisms of drug safety and PV is that, like many things in the world, there is no one global organization that can centralize drug safety and its functions. For example there are hundreds, if not thousands, of drug safety databases around the world. Every drug company and health agency has a database. Many other NGOs, foundations, poison control centers etc. have drug safety databases. There is enormous duplication and enormous waste in doing this. Obviously if a single entity could maintain a global database as well as centralizing dictionaries, coding and other related items this would be an obvious benefit for the world. The UMC is a logical candidate for this role – obviously changes in governance and global participation would be needed. But this could be done.
However, this goal is obviously utopian and the world’s track record with global organizations to solve international problems has not been sterling (The League of Nations, the UN etc.). One can understand why wars, religious, ideologic, and political disputes are very hard to settle at a global level. But safer medicines is far less controversial and ideological and one can (naively?) hope that this will be amenable to international agreement. Perhaps not likely but, nevertheless, one can hope. The UMC is the obvious candidate for this role.
