Pharmacovigilance: Overview

Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Before a medicine is authorized for use, evidence of its safety and efficacy is limited to the results from clinical trials, where patients are selected carefully and followed up very closely under controlled conditions. This means that at the time of a medicine's authorization, it has been tested in a relatively small number of selected patients for a limited length of time. After authorization, the medicine may be used in a large number of patients, for a long period of time and with other medicines. Certain side effects may emerge in such circumstances. It is therefore essential that the safety of all medicines is monitored throughout their use in healthcare practice. Pharmacovigilance is a process which includes: The monitoring of use of medicinal products in everyday clinical practice, so as to be able to identify previously unidentified adverse reactions or a change in the nature of adverse reactions. Risk-benefit assessment of medicinal products, which helps to decide what action, if necessary, is essential for safer use of medicinal products. Provision of information to healthcare professionals as well as to patients in order to improve the safe and effective use of medicinal products. There areas of Pharmacovigilance include: Product quality Adverse drug reactions Medications errors Serious Adverse Events (SAEs) As the names implies, these are “any untoward medical occurrence” that: Is fatal Is a threat to life Results in inpatient hospitalization Prolongs an existing hospital stay Results in persistent or significant disability or incapacity Results in a congenital anomaly or birth defect Regulatory measures Information from all of the above-mentioned sources is evaluated and may help to identify facts which have not been recognized in the course of clinical trials conducted prior to the placement of the product on the market. Adverse reactions not described to date may be identified, as well as a higher than anticipated frequency of incidence of known adverse reactions (i.e. that they occur more often than originally expected) or a more severe course than currently known. It may also turn out that some patient groups which have not been included in clinical trials are more sensitive to adverse reactions. Any new information is carefully analyzed and if necessary, regulatory action is taken to reduce the risk presented by the use of the medicinal product. Regulatory measures result in the change of conditions under which the medicinal product is marketed. It may involve the following: Changes to the texts accompanying the medicinal products (SPC and PIL) – amended warnings concerning adverse reactions and, if applicable, their possible prevention Restriction of indications for use of the medicinal product Change in dosage Change in dispensing (e.g. an OTC product may be switched to a prescription-only product) In rare cases, where the risks outweigh the benefits, the product may be withdrawn from the market The goal of pharmacovigilance is to protect patients and the public wherever possible and to disseminate knowledge among the relevant professional communities and to patients in order to minimize risk. The information here is provided as a general introduction to the topics and in no way constitutes legal, safety or any other form of professional advice. References: http://www.sukl.eu/medicines/what-is-pharmacovigilance http://apps.who.int/medicinedocs/documents/s19612en/s19612en.pdf https://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/ https://www.primevigilance.com/resources/what-is-pharmacovigilance/ By Babayeva N.