ADVERSE DRUG REACTIONS; MEDICATION SIDE EFFECT REACTIONS

Adverse drug reaction is any noxious and unintended response to a medicinal product which arises from the use of a medicinal product within or outside the terms of the marketing authorization, due to medication error, misuse (including overdose), abuse or occupational exposure and causal relationship cannot be excluded.

Physicians, nurses and midwives have to inform the State Agency of Medicines or the marketing authorisation holder of the suspected serious adverse drug reactions to medicinal products (including vaccines), they may also report non-serious adverse reactions. In addition patients are encouraged to report of suspected adverse drug reactions or use the help of pharmacists in sending the report. One report may contain information about more than one adverse drug reaction.

Collection of adverse drug reactions enables to merge experience of many physicians in the use of a medicine in a large amount and in different patients and gives an opportunity to detect reactions which occur rarely but are serious. Such information is important in the benefit-risk assessment of a medicinal product and in this way helps to choose the best treatment for a patient. In case of a negative change in the benefit-riskbalance the product information will be updated, additional risk minimisation measures will be introduced or the marketing authorisation will be suspended or revoked (depending on the severity of the risk).

Adverse drug reaction is serious if it results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, causes long-term incapacity for work,a severe or profound disability or causes a congenital anomaly or a birth defect.

Causality assessment means assessment of a relationship between a medicinal product and the reaction. There are six standard categories of relationship between a drug and the event: certain, probable, possible, unlikely, unclassified and unclassifiable (unassessable).
338 spontaneous reports of suspected adverse drug reactions were sent to the State Agency of Medicines in the year 2017. 1003 reactions were described in the reports.
230 reports were sent by Health Care Professionals: 125 directly to State Agency of Medicines, 98 to Marketing Authorisation Holder (10 reports were solicited reports from post-authorisation studies or programmes).

Marketing authorisation holders sent 7 reports from medical literature which described adverse reactions from the use of medicines in Estonia.

108 reports were sent by patients: 72 directly to State Agency of Medicines (of those 4 reports with the assistance of pharmacist), 36 to Marketing Authorisation Holder (of those 2 reports with the assistance of pharmacist).

Of 338 reports 246 described adverse reactions in association with medicines and 92 with vaccines.

Adverse reactions described in 286 reports were assessed to be at least possibly related to the medicine or vaccine. In 1 case the association was certain in 107 cases probable and 178 possible. In 201 cases the patients recovered, 13 were recovering at the time of reporting, 4 recovered with sequelae, 4 recovered partially, in 56 cases there was no data and 8 patients died.

Adverse reactions described in 52 reports were assessed to be unlikely related to the medicine or vaccine. In 19 cases the patients recovered, 4 recovered partially, 5 were not recovered at the time of reporting /follow-up, in 22 cases there was no data and 2 patients died.

Source: http://www.ravimiamet.ee/sites/default/files/ravimiamet_aastaraamat_2018.pdf
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