Almost all medicines have side effects. However, the balance between the active substances and the side effects must be such that it is justified to put a medicine on the market. When a medicine becomes available to patients, the possible side effects are known. However, new side effects can sometimes be experienced by the users of the medicines. It is then important to report these side effects to a special institution, the Lareb, which carries out further research.
Dutch Adverse Effects Center: Lareb
An organization that deals with this is the Netherlands Adverse Center called Lareb. This institution collects as many side effects as possible from medicines and vaccines that are reported by doctors and other care providers and by pharmacies, but also side effects that are reported by patients themselves. In this way it is discovered whether a certain side effect is striking and new side effects are known.
Discover side effects in practice
Although attempts are made to get to know as many side effects as possible during the extensive studies in the development of a medicine, it does happen that a new side effect only becomes known during frequent use by patients. For that reason, reports from practice are of great importance. Even if it is not entirely clear whether the side effect is caused by the vaccine or the drug, reporting is still important. Further investigations can then provide a definitive answer. By reporting side effects by patients, they can make a good contribution to the safety of medicines and vaccines.
Who reports side effects?
Reporting side effects by patients is especially important in the following cases:
If the side effect is not stated on the package leaflet.
Side effects of a new drug or vaccine.
Side effects in children.
Doctors and pharmacists are required to report cases where serious side effects lead to:
An (extension of) a hospitalization.
Permanent disability or invalidity.
Birth defect in a child.
Life threatening situation or death.
Procedure by Lareb with reports
Every report of an update at Lareb is analyzed in detail. The reports are initially checked for completeness, any uncertainties and quality. In the event of uncertainties and sometimes to get a better picture, the reporter will be contacted (if possible). The report is then compared with previous reports (even worldwide), after which the report is further studied to discover new side effects. Annually, there are approximately 2,000 serious reports out of a total of approximately 10,000. The number of reports is not an indication of the extent of the seriousness of the side effects, because some medicines are used much more often than others and therefore the number of reports can therefore be greater.
Action after notification to the MEB
Important reports are passed on anonymously to the MEB (Medicines Evaluation Board). This board is responsible for the marketing authorization that manufacturers receive for a new medicine and for pharmacovigilance. In the event of new signals, the MEB takes action if necessary by, for example, informing the supplier of the product that the update must be included in the package leaflet. In very serious cases, with the risk of dangerous side effects, the MEB can withdraw the medicine or vaccine from the market.
Share Lareb knowledge globally
The scientific knowledge that Lareb gains is shared worldwide through organizations such as the EMA (European Medicines Agency) and the WHO (World Health Organization). The EMA provides support to a number of scientific committees, each of which is responsible for a specific aspect of medicines. The WHO maps healthcare worldwide and coordinates healthcare activities with the aim of promoting the health of the world's population.
Video: What are the differences between an adverse drug reaction and a drug allergy? (April 2020).
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