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Table of Contents
Year : 2014  |  Volume : 2  |  Issue : 2  |  Page : 33-35

Pharmacovigilance : Its clinical implications in health care management

1 Professor & Head, Department of Pharmacology, SBKS Medical Institute & Research Centre, Sumandeep Vidyapeeth, Piparia, Vadodara, Gujarat, India
2 Tutor, Department of Pharmacology, SBKS Medical Institute & Research Centre, Sumandeep Vidyapeeth, Piparia, Vadodara, Gujarat, India

Date of Web Publication24-Aug-2018

Correspondence Address:
B M Sattigeri
Professor & Head, Department of Pharmacology, SBKS Medical Institute & Research Centre, Sumandeep Vidyapeeth, Piparia, Vadodara, Gujarat
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2347-6486.239547

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How to cite this article:
Sattigeri B M, Moorthy V. Pharmacovigilance : Its clinical implications in health care management. J Integr Health Sci 2014;2:33-5

How to cite this URL:
Sattigeri B M, Moorthy V. Pharmacovigilance : Its clinical implications in health care management. J Integr Health Sci [serial online] 2014 [cited 2023 Jun 9];2:33-5. Available from: https://www.jihs.in/text.asp?2014/2/2/33/239547

  Introduction Top

Any noxious change which is suspected to be due to a drug that occurs at doses normally used in man, requires treatment or reduction in the dose and indicates caution for future use of the same drug is called as an adverse drug reaction (ADR) [1]. Pharmacovigilance is an inherent branch of pharmacology which is defined by WHO as “the science relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems” [2]. It plays a very important role in the rational use of the medications.

Patient safety in the use of medications has been a great concern since the adverse drug reactions were considered as 4’h-6’h leading cause of death in US and were also estimated 3-7 % to be the cause of hospital admissions, thus contributing to the economic burden in the health care management [3],[4],[5].

In 1998 Lazarou and colleagues showed that the incidence of serious adverse drug reactions was 6.7%, with 0.3% of them being fatal reactions which forced ADRs to be considered as a serious public health problem [6].Therefore, no drug is inherently safe, for example; commonly used drugs like non-steroidal anti-inflammatory drugs (NSAIDs) are known to cause gastric irritation, oral hypoglycaemic agents used in the treatment of diabetes are prone to cause hypoglycaemia etc. Most of these are preventable in nature. Daviesvet al had reported 19% ADR in a pilot study of which 59% were avoidable .

Evolution of pharmacovigilance:

In 1932, Sulphanilamide used in the treatment of streptococcal infections caused death in 105 individuals. This led to the enforcement of Food Drugs and Cosmetic Act in 1938. This Act compelled the manufacturers to show scientific evidence of drug safety prior to its release in the market and use in patients. However, the seriousness of the adverse effects caused by the drugs was more highlighted with the Thalidomide Tragedy that occurred in 1960s.Thalidomide was in those days frequently used to treat morning sickness in pregnant women. It was noticed that, as a consequence the (more than 10000) babies born to mothers on Thalidomide had Phocomelia (seal limbs) as birth defects [Figure 1] [8].
Figure 1: Phocomelia (seal limbs) caused by Thalidomide.

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This alarming adverse effect became a cause for the initiation of International Drug Monitoring Program by WHO in 1968. Initially 10 countries contributed to the program which then slowly got expanded and led to the establishment of the National Pharmacovigilance centres. Yet, as on today only few countries contribute to the pharmacovigilance program which is coordinated by WHO in collaboration with the Uppsala Monitoring Centre, Sweden.

Pharmacovigilance program in India:

In India the pharmacovigilance program was introduced in 1986 with initial establishment of 12 regional centres and it almost took a decade for the country to join WHO and the program became operational since January 2005 and was renamed in 2010 as Pharmacovigilance Program of India (PvPI). The operation of the program is through the Central Drugs Standard Control Organization (CDSCO), Ghaziabad, New Delhi. Since then a slow growth and expansion occurred with evolution of stringent laws in the country.

Need of Pharmacovigilance in Medical practice:

The principles of practicing medicine evolved by the pioneers like Osler and Semelweiss included “do no harm the patient”. Hence, medications were used in the patients with a purpose to save the lives but not cause harm to them. An insufficient evidence regarding the safety concerns of a newly an introduced drug, has made pharmacovigilance an integral part of clinical trial. Thus, Post Marketing Surveillance (PMS), a part of clinical trial is conducted to ensure safety aspects with regard to the newly introduced drug as no drug is inherently safe. Based on the observations during the PMS, the regulatory authority of India have banned or recalled certain drugs from the market for the serious unexpected adverse events caused by them.

For example; Thalidomide - Phocomelia (1965), Practolol - Sclerosing peritonitis (1975), Terfenadine - Torsade de pointes (1997), Rofecoxib - Cardiovascular effects (2004), Veralipride - Anxiety, depression, movement disorders (2007)[9].

  • It provides patient safety and ensures the rational use of medicines which in turns ensures the public confidence in the use of medicines.
  • It reduces the economic burden in health care management by preventing and reducing the occurrence of the adverse drug reactions.
  • It meets ethical concerns pertaining to the use of drugs in the treatment of disease conditions. It is considered as unethical if a noted ADR is not reported by the health care providers, patients or manufacturers.

India being the largest producer of pharmaceuticals in the world, there is an overabundance of drugs licenced and marketed (> 60000 branded formulations) in India. Hence, our country is considered to be a hub for clinical trials. The large number of drugs approved for marketing without long term safety studies and the use of Over the Counter (OTC) medications, more than the prescription only medications increase the risk of ADRs 10. This indicates for the immense need to understand the importance of pharmacovigilance and its implication in medical practice.

  Conclusion: Top

In view of supporting the PVPI many steps have been taken up by the Government of India. Establishment of Pharmacovigilance Committees in every medical college has been mandated by the Medical Council of India, under which, reporting of adverse drug reaction has been considered as the main motto, apart from identifying them.

A detailed history taking, listening to patient carefully, observing him, paying attention to every complaint of the patient and detailed examination of patient will act as a good practice in identifying the adverse drug reactions. Further, it is important to realise that reporting of an identified drug reaction is very essential to support the National Program for reducing the economic burden in health care management and add for better living of the patients.[10]

Sincere efforts made in reporting the adverse drug reactions by every doctor, nurse, pharmacist, medical student, patient/ patient's attendant, ward boys or any other support staff who come across will help in serving the mankind.

  References Top

KD Tripathi. In: Essentials of Medical Pharmacology, seventh edition, chapter six; Publisher; Jaypee Brothers Medical Publishers (P) LTD, p. 82.  Back to cited text no. 1
The importance of Pharmacovigilance. Geneva; World Health Organization: 2002.  Back to cited text no. 2
Karch FE, Lasagna L. Adverse drug reactions: A critical review. JAMA 1975; 234:1236-41.  Back to cited text no. 3
Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalised patients: A meta-analysis of prospective studies. JAMA 1998;279:1200-5.  Back to cited text no. 4
Moore N, Lecointre D, Noblet C, Mabille M. Frequency and cost of serious adverse drug reactions in a department of general medicine. Br J Clin Pharmacol 1998, 45(3), 301-308.  Back to cited text no. 5
Wiffen P, Gill M, Edwards J, Moore A. Adverse drug reactions in hospitalised patients. A systematic review of the prospective and retrospective studies. Bandolier Extra; June 2002; p 1-15.  Back to cited text no. 6
E C Davies, DR Mottram, Adverse Drug Reactions in hospital in-patients: a pilot Study. Journal of Clinical Pharmacy and Therapeutics (2006)31,p;335-341.  Back to cited text no. 7
Sharma HL, Sharma KK; In Principles of Pharmacology, second edition, Chapter eight, P-91., Publisher Paras Medical Publishers , Hyderabad, New Delhi.  Back to cited text no. 8
Imbs JL Pouyanne P and Haramburu F. Iatrogenic medication: estimation of its prevalence in French public hospitals. Thèrapie, 1999, 54(1) 21-27.  Back to cited text no. 9
Devang Parikh, B M Sattigeri Ashok Kumar, Shruti Brahambatt, “A survey study on use of over the counter (OTC) drugs among medical students, nursing and clerical staff of a tertiary care teaching rural hospital, Int J Res Med Sci. 2013 May;1 (2): 83-86.  Back to cited text no. 10


  [Figure 1]

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