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.
Olainfarm has established Pharmacovigilance Group with main task 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. Olainfarm has implemented and continues to improve a Pharmacovigilance System, which helps to ensure the safer use of drugs. As part of it 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.