ADR - Adverse Drug Reactions.
In 1971 the Ministry of Health and Care Services in Poland created the Center for Adverse Drug Reactions Monitoring (OMDUL). Since the very beginning it has worked within the framework of WHO Program for International Drug Monitoring as a Polish National Center.
Nowadays the unit works within the framework of the office for Registration of Medicinal Products, Medical Devices and Biocidal Products as a Department for Adverse Drug Reactions Monitoring. The Department collects the reports from individual persons as well as from medicinal products manufacturers and marketing authorization holders.
After the EU accession of Poland the Department for Adverse Drug Reactions Monitoring is obliged to electronic reporting of suspected serious adverse reactions to the European Medicines Agency (EMEA) in London in the framework of EudraVigilance.
Before the new medicine is marketing, many clinical researches are done on relatively small group of people - on average 1500 for a new drug. Whereas after marketing the drug is used by millions of patients. Clinical researches are done in special conditions, different from everyday medical practice. They take too less time to enable monitoring the distant effects of using medicinal substance. In medical researches it is possible to find adverse drug reactions which occur often and usually can be explained by the drug activity mechanism. But adverse drug reactions that occur rarely, drug-drug interactions or drug-food interactions, reactions that cannot be explained by drug activity mechanism, are found only when the drug is on the market for a longer time. The medicinal product is used by all groups of people, including elderly people, people with different nutritional habits, children, patients with accompanying disease, of different physical condition, exposed to different environmental factors, with specific risk factors, with different addictions.
Monitoring and reporting adverse reactions is vital. To report ADR you can use a special form - "yellow card" worked out by Monitoring Adverse Drug Reactions Department or an international CIOMS card (a form for reporting individual cases of adverse drug reactions, worked out by Council for International Organizations of Medical Sciences). Very important is to pay special attention to adverse drug reactions that were not observed before as well as enlarging knowledge about the known ones. When we know the action spectrum of the drug, we can compare its value to other drugs used in therapy of the same disease.
As soon as the reports are obtained, they are assessed regarding form and substance. The group of people in Department analyses the logical relations between the described reaction and medicinal product that could cause it. All the reports regarding the cases in which the relations between the product and reaction is possible, are collected in the data base of Department and after coding sent to a central data base of WHO in Sweden in Uppsala. By the process Poland takes part in the Program for International Drug Monitoring.