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Now, in the 21st century, there is a wide assortment of drugs available for the effective treatment of various conditions. However, there are no fully safe drugs. Each of them causes more or less pronounced side effects (adverse reactions. Earlier the adverse drug reactions were defined as caused by the appropriate (in accordance with the Summary of Product Characteristics) usage of drugs for the prevention, diagnosis, or treatment of a disease. Adverse drug reactions can also occur when drugs have been used in order to achieve a positive impact on bodily functions (physiology). Now the legislation amendments are in force and the definition of adverse reaction is amended to ensure that it covers noxious and unintended effects resulting not only from the authorised use of a medicinal product at normal doses, but also from medication errors and uses outside the terms of the marketing authorisation, including the misuse and abuse of the medicinal product. The suspicion of an adverse drug reaction, meaning that there is at least a reasonable possibility of there being a causal relationship between a medicinal product and an adverse event, now is the sufficient reason for reporting. The term „suspected adverse reaction” should be used when referring to reporting obligations.
In relation to adverse drug reactions, there is a globally used term “pharmacovigilance” (farmakon in Greek means drugs, but vigilantia in Latin – alertness, care, concern). As stated by the World Health Organisation (WHO), pharmacovigilance is a science and the activities related to the gathering, monitoring, researching, and assessing of drug safety data. The aim of the above-mentioned science and activities is to identify new information on adverse drug reactions and to prevent their potentially harmful effect on human health. Other factors affecting drug safety include a decrease in their efficacy, overdose, misuse, or abuse of drugs.
We have established a special unit – Pharmacovigilance Group. Its main task is to monitor the safety of use of the drugs manufactured and registered by JSC “Olainfarm”. We keep track of both marketed drugs and drugs in the research stage. The Company has implemented and continues to improve a Pharmacovigilance System, which helps to ensure the safer use of drugs. As part of this System, we:
- study new potential risks that may affect drug quality, safety, and efficacy and, consequently, the health of the patients (as result – we can obtain the new information to update the Patients leaflet and Summary of Product Characteristics);
- when assessing interrelation and risks, we also evaluate the potential benefits;
- provide the latest information to physicians, pharmacists, patients, our representative offices and contractual partners.
We receive information on adverse drug reactions from physicians, pharmacists, other health care specialists, our affiliates in other countries, contractual partners, and patients. We assess the information and, if needed, report it to the European Medicines Agency (EMA) through “Eudravigilance” database, to the State Agency of Medicines (SAM) of the Republic of Latvia, as well as to other countries’ competent authorities and to our representative offices.
With kind regards,
Pharmacovigilance Group of the JSC Olainfarm
Dr.Uldis Armanis; M.P.H.
Head of Pharmacovigilance Group, QPPV JSC Olainfarm