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 Table of Contents  
Year : 2015  |  Volume : 1  |  Issue : 1  |  Page : 4-6

Pharmacovigilance: What dermatology physicians should know?

1 Director, Pragma Vigilance GmbH, Zurich, Switzerland
2 Department of Dermatology, NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital, Nagpur, Maharashtra, India

Date of Web Publication1-Dec-2015

Correspondence Address:
Sudhir Bansod
Hanggiwiesstrasse 6, 8862, Wilen Bei Wollerau, Zurich
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/WKMP-0110.170762

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How to cite this article:
Bansod S, Pande S. Pharmacovigilance: What dermatology physicians should know?. Indian J Drugs Dermatol 2015;1:4-6

How to cite this URL:
Bansod S, Pande S. Pharmacovigilance: What dermatology physicians should know?. Indian J Drugs Dermatol [serial online] 2015 [cited 2023 Jun 1];1:4-6. Available from: https://www.ijdd.in/text.asp?2015/1/1/4/170762

Life consists of apparent dualities which are, in fact, complementary. With health comes sickness, as the other side of the coin. Sickness and its treatment have been known since ancient times. In addition to using medicines in the treatment of sickness, Hippocrates (370 BC) was also aware of the concept of side effects of medicines, as is evidenced by his reports of adverse reactions to cow's milk. Thus, the medicines have two sides of a coin - efficacy and safety. The study of safety aspects of medicines termed as pharmacovigilance; gained prominent attention after disastrous side effect of sealed limbs (phocomelia) observed due to the use of thalidomide for nausea in pregnancy in 1961.

  Need for Pharmacovigilance Top

From an ethical point of view, a drug can only be administered to humans if the benefits/efficacy of the drug is greater or favorable as compared to the risk/safety of the drug. Thus, the benefit-risk profile of a drug must be in favor of the treated patient population. In order to assess the risk profile of the drug, a systematic study on safety aspects of the drug is warranted ranging from the phases of clinical development up to the postmarketing phase of the drug. The clinical development phases typically involve studies from benchside to bedside; i.e., chemical and biological in vitro laboratory studies, preclinical or nonclinical animal studies and clinical phase human studies.

The need for characterizing the safety profile of the drug from animal and human studies and communicating this comprehensive information to prescribers and health-care providers is of paramount importance to ensure the safe use of drugs in clinical medicine.

Rising up to this challenging task, the WHO established its Programme for International Drug Monitoring in 1963, particularly due to the 1961 thalidomide disaster. According to the WHO, "Pharmacovigilance" is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. The Collaborating Centre for International Drug Monitoring located at Uppsala, Sweden, coordinates the pharmacovigilance activities in more than 120 countries. The aims [1] of pharmacovigilance are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programs by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.

  Benefits of Pharmacovigilance Top

Pharmacovigilance is an activity that is aimed at continuous monitoring of safety profile of a drug in real life practice. Most of the safety data that is available to a physician/doctor prescribing a drug comes from clinical trials that are conducted in a controlled manner and with a limited number of patients. Through reporting of adverse events or reactions occurring in day-to-day practice, more information about the drug is generated globally at WHO-Uppsala Monitoring center. This information is analyzed by experts with proper statistical tools and data about attributable drug risk is generated. Through this method, authentic information is added to "package insert" or "label" of the drug which can be passed to a doctor or patient taking these drugs.

Another important benefit of pharmacovigilance is generation of safety alert or safety signals about drug usage that can be further explored by obtaining more information from manufacturers. If the safety signal is authenticated, appropriate management of risk of the drug usage is done. Information of drug side effects is conveyed to treating physicians. If there are serious safety issues about the drug, use of the same drug can be prohibited by regulatory authorities. Thus, process of pharmacovigilance works to improve the safety of human use of the drug. This is indeed necessary in dermatology practice when many of dermatological diseases are chronic and requires newer drugs to bring better therapeutic outcome. These newer drug formulations enter into the market after clinical trials were done in a controlled environment and its use in "Real World" scenario may bring unlabeled side effects. These side effects can be effectively reported through pharmacovigilance.

  Pharmacovigilance Processes Top

The various processes in pharmacovigilance can be broadly divided into (1) collection of safety data. (2) Processing and databasing of safety data. (3) Safety signal detection. (4) Retrieval and analysis of safety signal related data. (5) Communication of results of analysis to stakeholders. (6) Active risk management.

It is a myth that pharmacovigilance is the domain of pharmacologists only. In fact, the role of pharmacologists in the process of pharmacovigilance is limited to analysis of case reports submitted by physicians. The basic pillar of PhV is formed by a collection of adverse drug reaction (ADR) reports. Subsequent processing and analysis of ADR reports is dependent on quality and completeness of ADR reports only!

  Stakeholders in Pharmacovigilance Top

In addition to WHO, there are several other stakeholders in pharmacovigilance with varying interests and responsibilities.

  • National health authorities or regulatory authorities have a legal and moral responsibility to ensure that the medicines licensed by them for use in their people have an acceptable risk compared to the benefits, i.e., the benefit-risk profile is favorable. Some of the major health authorities are Food and Drug Administration in the USA, European Medicines Agency for the European Union, Medicines and Health Regulatory Agency in the UK and Central Drugs Standard Control Organization (CDSCO) in India
  • Pharmaceutical companies which own the license to market the drug have legal responsibility to ensure appropriate collection, processing and analysis of the safety data and timely communication of newly emerging risks to health authorities, healthcare professionals and to the patients at large
  • Health-care providers directly prescribe or advise the patients to use the medicines for various disease indications. However, they need to ensure that these are appropriately prescribed according to the labeling instructions and to look out for any safety issue
  • Patients are the end consumers of medicines. While anticipating positive/beneficial/efficacy results, the patients have to be made aware that negative/harmful/unsafe effects can occur. They need to report these unwanted effects to the health-care providers in their own interest and for the safe use of medicines for future patients. Sometimes, patients can report adverse effects of the drugs to helpline centers of various companies or share information on social media. This is commonly done by educated and "drug-conscious" patients, and thus the practice is more common in Western countries. However, completeness and quality of medical information as obtained from social media has some remaining gaps is the field of pharmacovigilance.[2]

  Pharmacovigilance Programme of India Top

In India, CDSCO initiated a nationwide pharmacovigilance program [3] in July, 2010 with the All India Institute of Medical Sciences (AIIMS), New Delhi as the National Coordinating Centre (NCC) for monitoring ADRs in India so as to safe-guard Public Health. The NCC was then shifted to the Indian Pharmacopoeia Commission, Ghaziabad, (U. P) in April 2011.

  • The mission of pharmacovigilance programme of India (PvPI) is to safe-guard the health of the Indian population by ensuring that the benefit of the use of medicine outweighs the risks associated with its use
  • The purpose of the PvPI is to collect data, analyze it and use these inferences to recommend informed regulatory interventions, besides communicating risks to health-care professionals and the public.
  • The vision of PvPI is to improve patient safety and welfare in Indian population by monitoring drug safety and thereby reducing the risk associated with the use of medicines.

The program has been implemented in various phases; initiation phase (2010–2011), expansion and consolidation phase (2011–2012), Expansion and maintenance phase (2012–2013), expansion an optimization phase (2013–2014) and is currently in excellence phase (2014–2015).

The program functions through ADR Monitoring Centres (AMCs) which collaborate with CDSCO zonal centers (North, South, East and West). As of end 2014, there were 90 AMCs including 70 governmental and 20 nongovernmental institutions, which reported more than 74 thousand individual case safety reports. An additional number of 140 institutions have been proposed as AMCs, which include 51 governmental and 89 nongovernmental institutions.

ADR reporting form for submission of ADR report is available [4] on http://www.ipc.gov.in/PvPI/ADRReportingForm.pdf.

  Role of Medical Colleges as Adverse Drug Reaction Monitoring Centers in India Top

The expansion of AMCs provides an excellent opportunity for newer medical colleges and hospitals to get involved into the PvPI and contribute to the overall safety of patients by monitoring and reporting adverse effects of drugs in clinical practice. The medical colleges can play a crucial role in increasing the number and quality of adverse event reports. Not only, they can help in correcting the current under-reporting of adverse effects of drugs with their privileged position as huge numbers of patients get treated in the various clinical specialties, but also there is an availability of clinical pharmacology and pharmacovigilance experts in these colleges.

  Role of Private Dermatology Practitioners Top

It is a common myth and misunderstanding that pharmacovigilance is the domain of pharmacologists only. In fact, every physician and health-care provider including nurses and paramedical staff could contribute to effective reporting of side effects of drugs. Side effects of drugs could be systemic or cutaneous. Cutaneous adverse reactions are easy to detect as they can be actually "seen." Hence, the dermatology practitioners have possibly a greater role and responsibility of reporting these cutaneous adverse reactions, which may be due to the drug or drug-drug interactions.

  Summary and Future Outlook Top

Pharmacovigilance has been in existence as long as 370 BC since the times of Hippocrates, although in its rudimentary form and concept. The 1961 thalidomide disaster was a real shock to the science of drug use, which stimulated thinking on a systematic way for the study of side effects to ensure the safe use of drugs in patients. It has been more than 50 years now, and the science of pharmacovigilance has evolved into a well-conceptualized and a formal science, with regulatory and legal aspects. Pharmacovigilance is here to stay and grow, offering possibilities of new jobs and further research into even more efficient ways of safe use of drugs in the ultimate interest of patients.

  References Top

Pharmacovigilance. Available from: http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/. [Last accessed on 2015 Oct 25].  Back to cited text no. 1
Lardon J, Abdellaoui R, Bellet F, Asfari H, Souvignet J, Texier N, et al. Adverse drug reaction identification and extraction in social media: A scoping review. J Med Internet Res 2015;17:e171.  Back to cited text no. 2
Central Drug standard control organization. Available from: http://www.cdsco.nic.in/forms/list.aspx?lid=1578&Id=1. [Last updated on 2015 Sep 18, Last accessed on 2015 Oct 25].  Back to cited text no. 3
National Coordination Centre, Indian Pharmacopoeia Commission, Ghaziabad. Available from: http://www.ipc.gov.in/PvPI/pv_adr.html. [Last accessed on 2015 Sep 09; Last updated on 2014 Jun 13].  Back to cited text no. 4


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