Pharmacovigilance – Its need for patient safety

Dr. Tejaswini Ashok, MBBS

The origins of pharmacovigilance may be traced back to January 29, 1848, 173 years ago, when a little girl from the north of England (Hannah Greener) died after getting chloroform anesthesia prior to the excision of an infected toenail. Sir James Simpson had discovered that chloroform was a safer and more potent anesthetic, and he had put it into clinical use. Hannah’s death was researched in order to figure out what happened to her, but it was difficult to figure out what killed her. It was later assumed that she most likely died as a result of a fatal arrhythmia or pulmonary aspiration. As a consequence of further deaths and public and physician concerns about the safety of anesthesia, committees were formed to address the issue [1]. The 1961 thalidomide disaster, in which congenital deformities were discovered in babies delivered to women who had taken thalidomide during pregnancy, changed the course of European pharmacovigilance [2]. The catastrophe exposed various difficulties and key concerns, including the reliability of animal studies, the industrial company’s actions, and the need of monitoring pharmaceuticals after they are marketed.

       A century of terrible occurrences has played a key part in defining today’s drug development structures and procedures, none more so than those involved with pharmacovigilance. The World Health Organization defines pharmacovigilance as the “science and activities relating to the detection, assessment, understanding, prevention of adverse effects or any other possible drug-related problems” [3]. Pharmacovigilance was first implemented in India in 1986, and the Pharmacovigilance Program of India has been in operation since 2010 [4]. Protecting human subjects during clinical trials, selecting the first safe dose, establishing the safety profile, communicating information to stakeholders, attending to surveillance activities, monitoring safety-related issues involving the quality of the manufactured product, understanding benefit-risk across patient populations, assuring consistency with important safety information are just a few of the activities of pharmacovigilance [5]. The need for pharmacovigilance should be emphasized by highlighting that a drug’s life truly begins when it is launched. According to studies, pharmaceutical errors most commonly occur in prescribing (29-56%), with a lack of understanding about the drug being the most common cause (29%) [6]. This necessitates the establishment of a competent pharmacovigilance control center capable of providing prescribers with timely and accurate information.

In this day and age, patients, like physicians, nurses, and pharmacists, are equally responsible for performing pharmacovigilance. Before starting any medication, doctors should educate patients on the importance of pharmacovigilance and the need for reporting any adverse drug reactions (ADR). Often, the concept of pharmacovigilance crosses patients’ minds when they are first prescribed a medicine but rapidly forget about it as they continue to take their medications without hesitation [7]. Patients with chronic diseases and various comorbidities who are on long-term pharmaceutical therapy must be extra cautious for potential ADRs or drug interactions. Doctors should ensure that patients do not just accept ADRs as an unavoidable side effect of the disease or medicine and neglect to notify them [7]. Tandon et al. demonstrated in a retrospective observational, cross-sectional study that given the population and number of pharmaceuticals prescribed and consumed by patients in India, ADRs are heavily underreported, owing to a lack of information and awareness of the Indian Pharmacovigilance Program [8]. It is to be understood that the submission of an ADR report has no legal ramifications for the reporter, and all reporter information is kept anonymous. This change allows for easy, consistent, and transparent reporting, allowing clinicians to report ADRs in a systematic fashion with minimal trouble [4].

However, pharmacovigilance does not end with reporting. It is a continuous process that extends beyond the documenting of adverse events. Monitoring generic and biosimilar drugs, disease-specific ADRs of antidiabetic, cardiovascular, and antipsychotic drugs, establishing a temporal relationship between an event and any of the drugs used in a fixed dose combination, and raising awareness are some of the challenges faced by pharmacovigilance in India [4]. Nevertheless, the implementation of a robust pharmacovigilance system is the need of the hour as ADRs are a major public health issue that lead to avoidable patient burden and hospitalizations. In addition to detecting substandard prescription, drug dispensing, and administration problems, well-functioning pharmacovigilance is essential to create trust between the physician and the patient, therefore boosting patient safety and public confidence in the country’s health system.

References:

  1. Routledge P. 150 years of pharmacovigilance. Lancet. 1998 Apr 18;351(9110):1200-1. doi: 10.1016/S0140-6736(98)03148-1. PMID: 9643710.
  2. Fornasier G, Francescon S, Leone R, Baldo P. An historical overview over Pharmacovigilance. Int J Clin Pharm. 2018 Aug;40(4):744-747. doi: 10.1007/s11096-018-0657-1. Epub 2018 Jun 15. PMID: 29948743; PMCID: PMC6132952.
  3. WHO. Pharmacovigilance: Ensuring the Safe Use of Medicines. Geneva, WHO, October 2004     https://www.who.int/teams/regulation-prequalification/pharmacovigilance
  4. Kalaiselvan V, Srivastava S, Singh A, Gupta SK. Pharmacovigilance in India: Present Scenario and Future Challenges. Drug Saf. 2019 Mar;42(3):339-346. doi: 10.1007/s40264-018-0730-7. PMID: 30269244.
  5. Beninger P. Pharmacovigilance: An Overview. Clin Ther. 2018 Dec;40(12):1991-2004. doi: 10.1016/j.clinthera.2018.07.012. Epub 2018 Aug 17. PMID: 30126707.
  6. Das BP, Rauniar GP, Bhattacharya SK. Medical errors challenges for the health professionals: need of Pharmacovigilance to prevent. JNMA J Nepal Med Assoc. 2006 Apr-Jun;45(162):273-8. PMID: 18365356.
  7. Lafond J. Pharmacovigilance implemented by patients: A necessity in the 21st century. Therapie. 2016 Apr;71(2):245-7. English, French. doi: 10.1016/j.therap.2016.02.007. Epub 2016 Mar 15. PMID: 27080846.
  8. Tandon VR, Mahajan V, Khajuria V, Gillani Z. Under-reporting of adverse drug reactions: a challenge for pharmacovigilance in India. Indian J Pharmacol. 2015 Jan-Feb;47(1):65-71. doi: 10.4103/0253-7613.150344. PMID: 25821314; PMCID: PMC4375822.

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