Award presented for reporting of adverse drug reactions

Award presented for reporting of adverse drug reactions

In the ceremony of the Annual Award in Medicine 2013 organized by the Latvian Physicians Association on January 31st, 2014, the Director of the State Agency of Medicines (hereinafter also - SAM) Inguna Adovica presented an award for ethical behavior and significant contribution in reporting of adverse drug reactions to the Talsi Hospital and its Head Physician Brigita Aispure.

In October 2013 the State Agency of Medicines received several adverse reaction reports regarding one drug from the Talsi Branch of the Northern Kurzeme Regional Hospital. The reports were submitted by the Head Physician Brigita Aispure, whose specialty is anaesthesiology - reanimatology. After receiving the prompt reports, as well as due to the cooperation with other organizations involved, the evaluation of the adverse drug reaction cases was operatively conducted by SAM. Based on this evaluation SAM requested professional associations of doctors to provide additional information to their members regarding safe and correct use of medicines.

The Ethics in Pharmacovigilance of the World Health Organization states that to know of something that is harmful to another person, who does not know, and not telling or reporting, is unethical.

The State Agency of Medicines pays more and more attention to issues of adverse drug reaction monitoring or pharmacovigilance. Already in 2001 the monitoring of adverse drug reactions was defined in Latvia on a legal act level, thus, ensuring a joint approach to monitoring of adverse drug reactions in the European Union, but on January 22nd, 2013, a new Cabinet of Ministers Regulation No 47 “Procedure for Pharmacovigilance” was approved and for the first time it defined the term pharmacovigilance on a legal act level. Regulations provide certain procedures and the rights and responsibilities of involved parties - doctors, pharmacists, patients, marketing authorization holders of medicines, as well as regulatory authorities.

In 2013 SAM took several measures to ensure the implementation of the CM Regulation, but still holding ethical principles in higher esteem than legislative norms. It is no secret that medicines have a dual nature; they can not only treat patients, but also be harmful to their health. The effect of medicines can be most thoroughly evaluated when the medicine is used by a large number of people, therefore, in Europe and consequently also in Latvia adverse drug reaction reports are assembled regarding all types of medicines (medicines recently placed on the market, as well as medicines that have been used for many years) to make sure that the benefits provided by these medicines are still much greater than their potential risks. In the spring of 2013 SAM conducted an informative campaign “Reveal the dark side of medicines” inviting doctors, pharmacists and patients to report adverse drug reactions. These reports can still be submitted also electronically on SAM website.