The Lareb Foundation is a small organization in a big world. Its most important contacts are the professional organizations, the government and the pharmaceutical industry.
Because the Foundation is itself an organization of doctors and pharmacists, it has ready access to practitioners in the field. Current European legislation does not permit direct reporting by patients themselves, although the Lareb Foundation would not be opposed to its future introduction. Partly in view of the fact that doctors and pharmacists report suspected adverse drug reactions on a purely voluntary basis, it is important to inform them of the importance of reporting. In addition to the feedback it provides, both direct and in the form of publications, the Foundation offers targeted information to potential reporters in the form of mailings and presentations. The report form itself has a carefully designed layout and is distributed in various ways, such as inclusion with the regular Drug Bulletin and the annual Parmacotherapeutisch Kompas, the pharmacopoeia which forms a standard desk reference book for 90% of Dutch doctors. It is important that the reporter can rely on respect to privacy and confidentiality. Lareb does not receive any information about the identity of the patient and no information about the reporter will be given to third parties. The Dutch law is also strict on privacy.
An important means of communication with the reporting parties is the "feedback report''. Not only is receipt of each report acknowledged, but the assessment made by the Lareb and the conclusions drawn with regard to the reported adverse drug reaction are notified to the person making the report.
Besides wishing to encourage reporting, the Lareb Foundation believes that it is important to raise the level of awareness among doctors and pharmacists with regard to adverse drug reactions. This will not only lead to a better standard of reporting but will serve to reduce significantly the harmful effects of prescription medicines as well. Doctors will prescribe more critically and will be more inclined to consider adverse drug reactions as the cause of complaints at an earlier stage in their differential diagnosis, whereupon they will become able to discontinue use of the drug or to adapt the dosage to avoid both unnecessary costs and unnecessary impact in terms of patient health.
Because the Lareb Foundation is an independent organization working on behalf of the government, good communication with that government is very important. Reports are forwarded to the Medicines Evaluation Board Agency weekly. Every six weeks, a meeting is held between the Lareb Foundation, the Agency and the Health Inspectorate. Besides possible "signals", these meetings also discuss international developments.
Needless to say, the Lareb Foundation maintains close contact with the pharmaceutical industry, which also has a vested interest in effective pharmacovigilance. All serious ("15-day") reports are forwarded to the relevant Marketing Authorization Holder, as required by international legislation. These reports are anonymous, neither the patient nor the reporter can be traced. Similarly, all such reports made directly by the pharmaceutical industry to the government are entered into the Lareb Foundation's database. In the short term, the Foundation aims to achieve a free exchange of less serious reports as well. All articles concerning a specific preparation are submitted for comment to the relevant Marketing Authorization Holder prior to publication.
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