Pharmacovigilance: What it is and why it matters
Introduction:
The importance of pharmacovigilance was first highlighted in 1848, when a girl named Hannah Greener from England died after being administered chloroform for anesthesia to remove an infected toenail. Due to concerns around the safety of using anesthetics, the Lancet set up a commission to solve this issue, encouraging doctors to report deaths. Thereafter, Pharmacovigilance was officially introduced in December 1961 with the publication of a case report in the Lancet by W. McBride, the Australian doctor who first suspected a casual link between Thalidomide, a drug used to treat morning sickness during pregnancy and Phocomelia (serious fetal deformities).
This led to the establishment of regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and the development of strict regulations for drug approval, labeling, and post-marketing surveillance.
Over the years, pharmacovigilance has become an integral part of drug development and post-marketing surveillance, aimed at ensuring the safety and efficacy of drugs. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has developed guidelines for pharmacovigilance that are followed by regulatory agencies and pharmaceutical companies around the world.
What is Pharmacovigilance?
Pharmacovigilance, is also know as drug safety surveillance, is the science and activities related to detection, assessment, understanding and prevention of adverse effects of drugs or other related problems.It plays an important role in ensuring the safety and efficacy of medicines and vaccines, both before and after they approved for use.
Why it matters?
Pharmacovigilance is particularly concerned with ADRs ( Adverse Drug Reaction), which are drug responses that are noxious and unintended, and which occur at does normally used for prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function.continuous monitoring of side effects, contraindications and outright harmful effects which could result in high degree of morbidity, and in some cases, even mortality, are essential to maximize benefited and minimize risks.
No degree of care and caution at the pre-clinical and clinical testing stages can guarantee absolute safety, when a drug is marketed and prescribed to large populations across country and outside. Because clinical trials involve several thousands of patients at most, less common side effects and ADRs are often unknown at the time a drug enters the market.
Here are some of the reasons why pharmacovigilance is important:
Patient Safety: Pharmacovigilance ensures that any adverse reactions or side effects associated with a drug are detected and evaluated promptly, allowing for the identification of potentially harmful drugs. This helps to protect the safety of patients who use these drugs.
Identifying Safety Signals: By analyzing the data from adverse event reports, pharmacovigilance can identify potential safety signals that may not have been detected during the clinical trials. This enables regulatory authorities to take appropriate actions to lessen potential risks to patients.
Promoting Rational Use of Medicines: Pharmacovigilance also helps to promote the rational use of medicines. By identifying drugs that are associated with high risk of adverse events, healthcare providers can make informed decisions about which drugs to prescribe and how to monitor their patients.
Enhancing Public Health: Pharmacovigilance plays a crucial role in enhancing public health by ensuring that only safe and effective medicines are available on market. This helps to built trust and confidence in the healthcare system, and ultimately contributes to improved patient outcomes.
Supporting Regulatory Decision Making: Pharmacovigilance also plays a crucial role in supporting regulatory decision making. By providing data on the safety of drugs, pharmacovigilance professionals can help regulatory authorities make informed decisions about the approval, withdrawal, or restriction of drugs.
Drug Development: The insights and data gathered through pharmacovigilance help to inform drug development and improve he design of clinical trials. This allows pharmaceutical companies to produce safer and more effective medicines that can be used to treat a wide range of diseases.
Overall, pharmacovigilance is essential for building public trust in the healthcare system. By ensuring the safety and effectiveness of drugs, pharmacovigilance helps to establish a culture of transparency and accountability, which is essential for maintaining the confidence of patients, healthcare professionals, and regulatory authorities.
References:
Suke SG, Kosta P, Negi H. Role of Pharmacovigilance in India: An overview. Online J Public Health Inform. 2015 Jul 1;7(2):e233. doi; 10.5210/ojphi.v7i2.5595. PMID: 26392851; PMCID: PMC4576445.
Hamid AAA, Rahim R, Teo SP. Pharmacovigilance and its Importance for Primary Health Care Professionals. Korean J Fam Med. 2022 Sep;43(5):290-295. doi: 10.4082/kjfm.21.0193. Epub 2022 Sep 20. PMID: 36168900; PMCID: PMC9532191.
Student Name: Rachana Vemula
Student ID: 067/042023
Qualification: Pharm. D
e-MailID: vemularachana17@gmail.com
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