Management on detection and evaluation of medications adverse reactions

Abstract

Introduction: The adverse reaction represents an unintentional and harmful response to a medication that normally occurs during administration of different doses to a patient for prophylaxis, diagnose, or disease treatment, as well as in case of a physiological function modification, being at the same time a damaging and unintentional response determined by a medication. Pharmacovigilance is a scientific discipline which studies the safety of medications through detecting, evaluating, monitoring and preventing the adverse reactions, as well as other problems related to drugs. It has as a goal to monitor the frequency of such known reactions, so as it can evaluate and provide the risk-benefit report for the most used medical remedies. Purpose and objectives: The study of incidence and importance of detection, evaluation, treatment and prevention of adverse reactions. Establishment of adverse reaction role in regard with the clinical evolution of various diseases. Appreciation of adverse reactions incidence. Elucidation and presentation of the side effects impact on the body. Establishment of various methods/mechanisms for fighting against and preventing adverse reaction. Materials and methods: For running the research and achieving the abovementioned objectives, the communication files of the adverse reactions received by the Section of Pharmacovigilance and Rational Use of Drugs within the Agency of Drugs and Medical Devices were deeply researched and evaluated. Such materials refer to the period between 2012 and 2013, comprising 180 and 115 reporting files. All such files were received, analyzed, registered in the adverse reactions data base of medications and other suspected pharmaceutical products. Adversary reactions evaluated cases were communicated to the Uppsala Monitoring Center, with the purpose of evaluating adverse reactions, as well as determining their impact on the life quality of patients. Results: In the studied reporting files the predominance of adverse reactions in the third and fifth life decades can be noticed; a greater incidence of the oral administration of drugs and the predominance of solid pharmaceutical formulas can be distinguished (tablets, powder, capsules). The most frequent reports were the adverse reactions related to the following pharmaceutical groups of medications: anti-tuberculosis, antibiotics, uterotonics, antihypertetensives. Among the countries which caused adverse effects prevail India, followed by the USA, Germany, Turkey, Moldova, Romania, Norway and Argentina. The clinical picture of the allergic reactions is prevailed by the cutaneous syndrome (pruritus, hyperemia, eruptions, rash wounds), dyspeptic syndrome (nausea, vomiting, diarrhea,constipations), astheno-vegetative syndrome (headache, fatigue). Conclusion: Adverse reactions produce negative effects on the further patients’ life quality, with a medical-economic impact. The incidence of adverse reactions varies and is specified for each medication group. Undesirable medications effects can cause allergy in the human body, can decrease the effect of other medical remedies that are being administrated at the same time, can generate into a depressive state or fear to further administration of drugs. The methods to be used in fighting against adversary reactions and their prevention consist in identifying them as soon as possible, detailed analysis of the causes that could favor their occurrence and, of course reporting them to the Agency of Drug and Medical Devices.