National Drug Information Systems

In the mid-sixties, Uppsala Biomedical Centre (BMC) was founded on the proposal of Bror Rexed, then Professor at the Anatomical Department of Uppsala University, and later Director General of the National Board of Health and Welfare. Gradually a number of departments were moved to BMC, such as the drug department at the National Board of Health and Welfare.

The first director of BMC, Karl-Johan Öhnebrink, decided in 1971 to investigate the need for a common computer center for all of BMC. One would think that it would be natural to turn to UDAC, the established computer center at Uppsala University and its dynamic director, but it wasn’t that simple.

The drug department at the National Board of Health and Welfare had their computer contacts at the Stockholm computer center as well as at several of the departments that had now been moved to Uppsala, and the Department of Engineering Sciences at Uppsala University had plans to develop a computer system independent of UDAC. There were some people who thought they could handle it themselves. However, Schneider made inquiries about how they had intended to do it, and soon found out that it wasn’t perfectly clear. For instance, they were not knowledgeable about the programs of interest in this context, like SIMULA, an object related program of simulation, and LISP=LISt Processor.

Per Manell, in charge of IT at the drug department of the National Board of Health and Welfare, says his supervisor, Håkan Mandahl, got the brilliant idea to call Schneider and ask for advice for further computerization of drug related data. Mandahl had, when he was the administrative manager of Linköping University College, been involved with the computer system for paying employees at universities and colleges developed by UDAC. Mandahl and Manell therefore paid Schneider a visit and asked for advice. In retrospect it was a coincidence that the forming of a computer center at BMC was administered from Uppsala and not from Stockholm.

The original idea was to build a main frame computer, to which everyone involved could have access. However, Schneider realized that it would run more smoothly if there were several terminals in the different departments. These terminals would then be connected to a mainframe computer through a sort of switch board.

Furthermore, through the switch board one would be able to connect to other terminals, and several terminals could share the same printer, in order to save money. This might not sound extraordinary today, with our access to computers all over the world through the internet, but at the time it was a revolutionary idea.

It all ended with UDAC developing a terminator network for asynchronous terminals. The network was named Upnet, the terminals were called upnoder and the switchboards were made and sold by a newly founded company, UPNOD Technology.

At the drug department of the National Board of Health and Welfare there was already an embryonic registry of drugs, and now help to systemize the information with computers was available. In connection with the solemn 500 year anniversary of Uppsala University 1977, there was a terminal in a closet at UDAC, where people could go with questions about different drugs. This service was a huge success and many people sought it out get information about their medications. Per Manell says elderly ladies arrived with their purses full of medications and asked to get information about them and about possible side effects etc. It was actually the first time this kind of information was made available to the public.

As there evidently was a big demand for drug information it seems natural that the terminal system expanded in order for all involved parties to have access to the information. However, there were difficulties because the grants were very small, partly because this was a new type of activity. In addition it was almost impossible to redirect grants from other, less urgent activities.

At the Stockholm computer center (QZ) data about drugs had been collected on magnetic tape, and the data was now transferred to UDAC. It was a big advantage that the material was already digitalized, because it made the work much faster and cheaper.

One could say that the drug department played an important role as a pioneer. Many other institutions were interested, but no one wanted to be the guinea pig in this field. Another problem was that many thought governmental agencies shouldn’t create new systems of this kind. Consequently UDAC and the Medical Products Agency formed a new virtual company, SWEDIS (Swedish Drug Information System), with Per Manell as its leader.

In order to discover rare adverse events in drugs, large amounts of data must be collected from several countries. As early as 1968, many countries had agreed to collaborate, and a large central database was created in Geneva in which data was stored on magnetic tapes. In 1976, the WHO announced a goal with the heading “Health for all by the year 2000”. The goal, though striking, was generally considered too optimistic. A mocking version was “Better weather for all in 2000.”

At this point there was a proposition from the WHO to phase out activities which were considered to focus on developed nations, like the international system for reporting of adverse events. As there was already a computerized drug database in Uppsala, Sweden offered to manage the reporting. However, other countries were slightly offended, and the Netherlands and Britain, among others, suddenly wanted to take over the database.

About the same time, Schneider attended a conference on statistics in Göttingen and stayed in the same hotel as a number of representatives from German pharmaceutical companies. They told Schneider about their fears that Sweden might take over the adverse event database. They knew the risk that such a database, as well as many other things, would be public. They had discussed the matter and concluded that if Professor Schneider, who after all was Swiss, would be in charge, he would keep the database private. One can only reflect that this probably wasn’t a priority of Schneider’s…

WHO eventually choose Sweden in 1978, and the motivation was that the drug department at the National Board of Health and Welfare and UDAC already had the competence necessary and already had a modern adverse event database, for cases reported in Sweden.

When Sweden became the main responsible country for registering the reports, Manell in 1978 could collect the tapes in Switzerland and fly home. He was allowed to take the tapes as carry-on luggage. However, he was stopped on Arlanda airport. He tried to pass customs with nothing to declare, but a an alert customs agent wanted to know what was in the box. Manell truthfully explained its contents, which made the customs agent more suspicious. He probably wasn’t very well informed in these matters. Supervisors were called, but no one dared to let Manell come through. The problem was eventually solved by contacting Manell’s supervisor, Åke Liljestrand.

In Uppsala the drug department and UDAC transferred the information from the magnetic tapes to a modern database like the one that already existed for reported Swedish adverse events.

In the treaty between the Swedish government and WHO there was a strange clause which stated that the printing of the table with all the adverse event reports, which was called “Document A”, should be done at the WHO computer center in Geneva. This would happen before the annual meeting of all the countries who took part in the collaboration. The year after the move to Uppsala, the meeting was held in Geneva. Document A was at this time a key document. When Manell was headed to Geneva to participate in the meeting he knew Document A wasn’t printed out on paper. He also knew that people didn’t want to print it at all, as it would be difficult administratively to distribute the document to all countries involved. Consequently in Uppsala he copied Document A to microfiche and put the films in different envelopes, one for each country.

Once Manell arrived in Geneva in did indeed turn out there were no paper prints and that no one wanted to get any. Then Manell handed out the envelopes with the microfiche and also obtained a microfiche from Xerox. In this way the countries could see which equipment was needed to read Document A. It made Per Manell less popular in some circles in the WHO.

To manage the database naturally cost quite a lot, and to strengthen the finances Manell suggested that the pharmaceutical industry should pay much higher fees in order to access the database with terminology and drugs. The influx increased rapidly and a special foundation was created to handle the operations. It was called Uppsala Monitoring Centre (UMC) and also included WHO Collaborating Center for International Drug Monitoring. Both exist still today and currently employ approximately fifty people.

In 2011 UMC received more than one million adverse events reports from more than 130 countries.

Through a refined computer analysis, UMC could discover serious drug related adverse events and consequently could assist pharmaceutical agencies and companies in taking action.

FASS (Farmaceutiska Specialiteter i Sverige) was published in Sweden for the first time in 1966. It is a compilation of drug facts from the pharmaceutical industry for prescribing health care professionals, primarily physicians and pharmacists.

For the public there is Patient-FASS, first published in 1983. To give everyone access to information on drugs had been prohibited outside the Nordic countries for a long time. It can be said that Sweden was a pioneer in this area.

In 2000 Per Manell received an inquiry from LIF – the research-based pharmaceutical industry – if he would be in charge of the work with making FASS (in all its varieties) available on the internet. He accepted, and as soon as 2001 there was fass.se on the internet. Apparently this filled a large demand, because at the time this is being written (2012) there are between four and five million visitors on the web site every month. FASS is also available in braille and it is possible to get the text read out loud. Fass.se is regarded as the gold-standard for information to patients on medications within the EU.

In conclusion it can be said that the ideas from SWEDIS have stayed relevant, but that the central registration of drugs have moved on to other forms. A prerequisite has been that there has always been a need for both registration and information of adverse events, just as information to health care professionals and the public. Entrepreneurs at the drug department of the National Board of Health and Welfare and UDAC developed a new way to handle information on drugs that is still relevant today.