What is pharmacovigilance
Pharmacovigilance is an important tool for ensuring safe and effective drugs. The purpose is to gather information about safety in clinical use and shorten the time until the safety profile of a drug is well known.
- Adverse drug reactions
- Interactions with other medicinal products
- New effects of a medicinal product
- Lack of efficacy of medicinal product
- Dependence, abuse
Pharmacovigilance takes place both at national and international level. The Norwegian Medicines Agency is actively contributing to the European Medicines Agency's Committee for pharmacovigilance, Pharmacovigilance Risk Assessment Committee (PRAC). Close European cooperation and a shared knowledge base make it possible to act quickly when necessary. Risk minimisation measures may, for example, limit use or provide new information on safe use.
Pharmacovigilance Risk Assessment Committee (PRAC)
PRAC is the committee at the European Medicines Agency that is responsible for assessing and monitoring safety issues for human medicines..
The Committee consists of:
- nominated members from all EU countries, plus Norway and Iceland
- six independent scientific experts appointed by the European Commission
- representatives of health professionals and patient organizations
Report side effects
Reporting suspected side effects is an important tool for obtaining more information about medicinal products on the market and contributing to safe use. Patients and healthcare personnel are encouraged to report suspected adverse drug reactions. It is most important to report suspected adverse events that are serious and/or unknown. It is also important to report adverse reactions for medicines marked with a black triangle. This is medicinal products that is monitored more closely than other medicines, and is on a joint European monitoring list.
Spontaneous reporting and signal detection
Spontaneous reporting is the core data-generating system of international pharmacovigilance, relying on healthcare professionals and consumers to identify and report suspected adverse drug reaction.
The spontaneous reports are used for detection of signals of a possible causal relationship between an adverse event and a drug. Using epidemiological and statistical methods, these signals are further evaluated and tested.
Why are medicinal products monitored after they have been approved?
The pharmaceutical regulatory authorities approve a medicine after assessing the benefits and risks of the medicinal product on the basis of clinical studies. A product only comes on the market if the benefit is greater than the risk. It ensures that patients have access to the treatment they need, without them being exposed to unacceptable adverse reactions.
Clinical studies include a relatively small group of patients who take part for a limited period of time and under controlled conditions. In practice, the medicine will be used by a larger and more complex group of patients. They may have other illnesses and may take other medicines at the same time. Some rare adverse reactions only appear after long-term use in many people. It is therefore important that all medicines are monitored as long as they are in use.
The medicines regulatory authorities are constantly collecting information about practical experiences with the use of the medicine, and analyze the information carefully. This ensures that the medicine has greater benefit than risk.
The Marketing Authorization Holder (MAH) has the primary responsibility for monitoring
The Norwegian Medicines Agency is responsible for the detection and monitoring of adverse reactions of all medicinal products approved in Norway, but it is still the pharmaceutical company that markets the individual medicine in Norway (MAH) that has primary responsibility for the effect and safety of their medicinal products.
The MAH must ensure that it has an appropriate system of pharmacovigilance and risk management in place in order to assume responsibility and liability for their products on the Norwegian market and to ensure that appropriate action may be taken when necessary. In order to fulfil the requirements, the MAH must ensure that all information relevant to the risk- benefit balance of medicinal products is reported to the authorities periodically through Periodic Safety Update Reports (PSUR) and continuously through expedited reporting of Individual Case Safety Reports (ICSR).