The World Health Organization (WHO) defines pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
Thalidomide is a sedative introduced in 1957 by a giant European pharmaceutical company and was sold under about 40 different names around the world, principally in Western countries and in Japan. This drug was believed to be safe for use in pregnancy and also indicated to alleviate morning sickness.
Therefore, it became popular among pregnant women within a short period of time. However, in 1962, its teratogenicity (the ability to cause defects in a developing fetus) was proved. As per Thalidomide Monograph for Professionals, the total number of infants affected by use during pregnancy is estimated at 10,000 of whom about 40% died around the time of birth. Those who survived had limb, eye, urinary tract, and heart problems. Consequently, new stringent regulations were evolved regarding drug safety, which we know today as pharmacovigilance.
Earlier pharmacovigilance or drug safety concept was mostly concentrated in regulated countries as their drug policies are very strong; a greater proportion of people are aware of drug safety. Nevertheless, recently, pharmacovigilance has emerged more profoundly in the developing countries as people are becoming concerned about safe medication, though it is still far away from reaching a minimum reasonable level. It is to be noted that the main objective of pharmacovigilance is to promote drug safety and effective drug use.
During the Covid-19 pandemic, medicines and vaccines especially drew the attention of the general population as they became a part of our life. In this scenario, pharmacovigilance is becoming an important area of interest.
Though medicines are tested adequately before introduction to the marketplace, individual response to any drug may be the subject of attention. Also, limited results from clinical trials, small numbers and controlled participants, limited span of trials, or the presence of co-morbidities are very crucial factors to be considered. Therefore, it becomes very important to be sure about potential drug interactions, long-term risks, or overdose effects of any new drug.
Pharmacovigilance is deeply focused on reporting adverse drug reactions to the concerned stakeholders. Adverse drug reactions usually refer to unintended or noxious effects of medicines. Lack of efficacy and unnecessary physiological alteration are also important parts in adverse drug information.
According to a study published in 2020, serious adverse drug reactions were found to be among the major causes of death in hospitalized patients in the United States, leading to extended hospitalization and doubling of the cost of treating these patients
Post-market safety monitoring is the only way to get an accurate picture of a drug’s safety. Regulators depend on reporting of adverse drug reactions to make sure medicines on the market are adequately safe. Unfortunately, all reporting systems suffer from under-reporting.
A study published in The Archives of Public Health on January 20, 2022 revealed that overall, 77.6% of the 268 respondents had observed adverse drug reactions; however, only 17.3% of the respondents had ever reported an adverse drug reaction to the concerned points.
Healthcare professionals are an important part of the pharmacovigilance system. They need substantial knowledge and expertise in the field of drug safety which will eventually contribute to this area through initial recognition, management, and reporting of the safety issues. Also, the healthcare professionals should be well educated about the requirement and technique of adverse drug event reporting.
The impulsive reporting system has been the backbone of pharmacovigilance. Therefore, the patient should be aware that if any unnecessary reaction is noticed while taking any medicine it must be informed to the concerned pharmacovigilance points (pharmaceutical company, hospital, healthcare provider etc).
This adverse drug reaction information is not only beneficial for individual patients; rather it may be a clue for the safety of that particular drug. It is a fact that the majority of our people are unaware about the adverse drug reaction points. Even the necessity of reporting is unclear to them.
In addition to unawareness, few other challenges are hindering the ongoing activities of pharmacovigilance. Among these issues is the absence of skilled manpower, very minimum information about drugs on web-based services or package inserts, and the lack of proper and easy healthcare regulations. Moreover, a lack of technological advancements in pharmacovigilance processes is also a concern.
In the above connection, both regular media and social media can be two important channels that will enable companies to move away from traditional pharmacovigilance systems to a more patient-centric system of the current age. There is scope of swift and open communication among patients, pharmaceutical companies, healthcare providers, and even regulators.
Dr Md Abu Zafor Sadek is a pharmacist, currently serving as Assistant General Manager of UniMed UniHealth Pharmaceuticals. He has been a Consultant of The World Bank.
