Documente Academic
Documente Profesional
Documente Cultură
Introduction
Use of drug for any indication always involves some patients are considered when therapeutic decisions are
benefit and possible risk. This risk can be minimized made. It ensures that health care providers and
using quality medicine in appropriate dose and consumers have the information they need to make
frequency as advised by prescribing physician. But their decision about treatment.3
possibility of risk is still there with drugs due to variable
patient factors. The issue of drug safety was initiated in 1961, following
the thalidomide disaster resulting in phocomelia in
Reporting of an adverse drug reaction (ADR) is an thousands of newborns. Lack of laws regulating drug
integral component of medical treatment. ADRs are one development and marketing led to many more tragedies
of the leading causes of morbidity and mortality, adding related to drugs. Thalidomide use by pregnant mothers
to overall healthcare cost. The estimated burden of resulted in birth of thousands of congenitally deformed
ADRs is approximately 2.9-5.6% of all hospital infants.4 After that incidence, some important
admissions.1 The overall incidence of serious ADRs is guidelines were framed to monitor safety of drugs,
6.7% and of fatal ADRs is 0.32% in hospitalized patients, foods and environmental contaminants for adverse
making these ADRs a leading cause of deaths. reactions and toxicity.
Pharmacovigilance can be defined as a discipline to The need of universal drug monitoring system was
identify, review and understand drug adverse effects recognized after world globalization to ensure safety of
and take required precautionary actions to curtail these medicinal products due to trading and communication
drug linked problems as per World Health Organization across borders. Such efforts led to emergence of
(WHO).2 Pharmacovigilance has emerged an art and practice and science of pharmacovigilance. Many
science to assess the safety and efficacy of drugs and countries have their established pharmacovigilance
other therapeutic products. It helps in reducing the risk systems, laws, regulatory bodies and framed guidelines
of harm by ensuring that good quality medicines are for health care providers as well as for consumers.5, 6
used appropriately and expectations and concerns of
*
Associate Professor, Department of Pharmacology, FOD, Jamia Millia Islamia, New Delhi-110025.
**
Additional Director, Directorate General of Health Services (DGHS), Govt. of NCT of Delhi, New Delhi-110032.
Correspondence to: Dr Deep Inder, Department of Pharmacology, FOD, Jamia Millia Islamia, New Delhi-110025.
E-mail Id: drdeep73@gmail.com
1. Collecting new drug information from The three layered structure report the serious,
pharmaceutical companies conducting clinical trials, unexpected adverse drug reactions (ADRs) to the
reliable scientific resources, healthcare providers, National Pharmacovigilance Centre (PVC) directly.
consumers, reputed journals, published literature Possible regulatory steps are taken by NPAC based on
etc. the data received from various centers. After causality
2. Causality risk assessment and analysis of the above assessment done at PVCs, all these reports are sent to
information. the WHO-ADR Monitoring Centre at Uppsala, Sweden,
3. Disseminating its outcome contents as well as any which helps to update the world pool of information on
action taken on specific drug to all health sectors. this topic.
An ADR form of Malaysia and Canada covers the highest Under this program, periodic safety update reports
number of data (43), while Brazil falls to the opposite (PSURs) need to be submitted every 6 months for the
end with a number of 17 data elements.10,11 first 2 years of marketing of drug in India, and annually
for the subsequent 2 years.
Causality Assessment
Training programs, CMEs, discussions, and interaction
One of the most important, and challenging, problems meetings need to be held every 6 months after the
in pharmacovigilance is that of the determination of initial training to sensitize health care providers. All data
causality. Based on causality assessment, signal is generated (including reporting forms) should be
determined. Usually more than one report is required to archived for a minimum period of 5 years at the Zonal
generate a signal, depending upon the event and quality pharmacovigilance centers (PVCs).
of the information available.12
ISSN: 2349-7181 8
J. Adv. Res. Med. 2015; 2(3) Inder D et al.
Figure 1.Adverse Drug Reaction reports collection and monitoring from peripheral centers to CDSCO
9 ISSN: 2349-7181
Inder D et al. J. Adv. Res. Med. 2015; 2(3)
easy working medicines to patients for quick action, 4. Health care providers should decide priorities for
to develop trust and faith in patients, irrespective of spontaneous reporting, e.g. type of drugs, severity
thinking any harmful effect of drugs. Even if any of ADR, unexpected ADR.
ADR occurs, they don’t report for the fear of losing 5. Hospital administration and management should
monetary benefits. facilitate easy contact and quick access to a hospital
10. Roles and responsibilities of human resource are pharmacovigilance system, e.g. use of Information
not clearly delegated which is a flaw in health Technology (toll free phone calls, fax, worldwide
management. Structural and policy changes are web, e-mail, use of reminders or circulating
required within the drug regulatory authorities.17 advertisements in newspapers and television).
11. Self medicine by people based on the claims 6. There should be a separate column provided for
produced by different pharmaceutical companies as ADR reporting in patient’s prescription slip/ file.
advertisements on media and social sites is another 7. Information and support for reporting ADRs should
factor leading to ADRs. ADRs arising due to self be facilitated by means of therapeutic consultation
medication are rarely reported. among clinicians about evidence of suspected ADRs
12. Lack of safety data on drug interaction between the and causality assessment of suspected ADRs.
existing/ established allopathic medicines and 8. Feedback information on hospital
traditional drugs and vaccines.18 pharmacovigilance activities should be made
13. Lack of safety data on adverse drug reaction due to available to health care providers’ e.g. periodic
any interaction of allopathic medicines with Unani, summary of reported ADRs in hospital, periodic
herbal or other traditional systems of medicine. summary of specific type of ADR and information
ADR reporting for traditional and herbal medicines, about ADR warnings.
especially the multicomponent and adulterated 9. Consolidating ADR monitoring and
ones is not done seriously and reports present are pharmacovigilance reports at specified centers to
negligible. be sent to National Pharmacovigilance center
14. Problems related to competition within clinicians to (AIIMS, New Delhi).
publish rare adverse effects in medical journals 10. There should be an involvement of all categories of
without sharing information among Health care healthcare professionals in ADR reporting and
providers for job promotions. pharmacovigilance planning to incorporate the
15. Most of drug manufacturers do not care to invest in sense of ownership.
ADR monitoring for economic reasons. Moreover, a 11. ADR reporting forms should always be available. An
lot of sensitization and setting up of new systems acknowledgment receipt should always be issued
will consume resources such as good labs, along with a code number to each department for
recruitment of human resource, patient′s ability to further follow up to avoid fake reporting.
pay for tests, infrastructure for proper causality 12. Periodic meetings of experts from National
assessment, funding agency etc. Even government’s Pharmacovigilance Program with physicians,
participation to sensitize community regarding pharmacists and nurses should be arranged to
ADRs reporting is not adequate.19 create awareness regarding objectives and to boost
reporting. Moreover National Pharmacovigilance
How to Overcome these Obstacles/ Hurdles to Unit should periodically collect ADR forms from
Promote Reporting of Adverse Drug Reactions hospitals by sending their representatives.
(ADRs)? 13. All ADRs (common and unidentified) should be
published in newspapers and reputed journals and
Following steps may be taken to foster culture of should be projected by media to spread information
reporting ADRs: about ADR among masses. Each hospital should
have a database on ADRs, which can be easily
1. Each hospital (primary, district level, tertiary care) accessible to all.
should establish its local “Pharmacovigilance 14. ADR reporting awareness should be introduced in
center” for reporting, collecting ADRs. the curriculum in all types of academic institutions,
2. Identity of ADR reporter (doctor, dentist, e.g. schools, colleges, universities etc. ADR drop
physiotherapist, nurse, and pharmacist) should be boxes/ suggestion boxes should be introduced at
kept confidential to promote pharmacovigilance. strategic sites in and around hospitals for public
3. To spread awareness among physicians, convenience.
pharmacists and nurse, pharmacovigilance 15. ADR monitoring should be made mandatory in all
workshops/ CMEs should be conducted periodically. government sponsored public health programs, e.g.
ISSN: 2349-7181 10
J. Adv. Res. Med. 2015; 2(3) Inder D et al.
RCH program, Cancer awareness program, vector make pharmacovigilance an integral part of all
born disease control program, National AIDS government run national programs. All this is possible
control program etc. by positively changing the mindset of all stake holders in
16. Certain new medicines are approved on urgent government and hospitals, so that ADR reporting
basis during epidemics, e.g. Ebola, H1N1, H1N5 etc becomes an accepted and understood routine in health
based on phase III/IV studies or without any care system, thus boosting Indian economy.
evidence of preliminary studies. Data regarding
such drugs should be procured from the population Source(s) of Support: Nil
which was prescribed such medicines. National
drug regulatory authorities should collaborate on Conflict of Interest: Nil
harmonizing the terms of conditional approval, and
develop systems to allow sharing of information on References
medicines in this category irrespective of drug
patent status. 1. Singh A, Bhatt P. Comparative evaluation of adverse
17. Sponsors should take responsibility to conduct Post drug reaction reporting forms for introduction of a
Marketing Surveillance (PMS) as a public health spontaneous generic ADR form. J Pharmacol
protection measure. International agencies and aid Pharmacother Jul-Sep 2012; 3(3): 228-32.
programs should make every effort to comply with 2. Van den Bemt PMLA, Egberts TCG, de Jong-van den
these requirements and provide the necessary data. Berg LTW et al. Drug-related problems in
18. Regulatory authorities should be encouraged to hospitalized patients. Drug Safety 2000; 22(4): 321-
establish databases of clinical information on ADRs 33.
for scientific studies to examine and quantify signals 3. Pal S, Dodoo A, Mantel A et al. Pharmacovigilance
of possible emerging risk. The regulatory and safety of medicines. In: The world medicines
authorities, on request should provide technical situation 2011. Geneva: WHO, 2011.
advice and support to WHO member countries on 4. Kim JH, Scialli AR. Thalidomide: the tragedy of birth
the appropriateness of PMS plans submitted by defects and the effective treatment of disease.
sponsors when a drug is being introduced to Toxicol Sci 2011; 122: 1-6.
manage a specific public health campaign in a 5. Collins TF. History and evolution of reproductive
particular country. and developmental toxicology guidelines. Curr
19. The regulatory authorities should create database Pharm Res 2006; 12: 1449-65.
of “Suggestions/ recommendations for action” 6. Edwards IR. The WHO World Alliance for Patient
based on evaluations of periodic safety update Safety: a new challenge or an old one neglected?
reports (PSURs) by national authorities to improve Drug Saf 2005; 28: 379-86.
the implementation of such information. 7. Labadie J. Forensic pharmacovigilance and
20. Overall ADR reporting promotion needs change in substandard or counterfeit drugs. Int J Risk Saf Med
the mindset of health care providers and consumers 2012; 24: 37-39.
to make it an acceptable and understandable norm 8. Graham JE, Borda-Rodriguez A, Huzair F et al.
to improve healthcare.20,21,22,23,24 Capacity for a global vaccine safety system: the
perspective of national regulatory authorities.
Conclusion Vaccine 2012; 30: 4953-59.
9. Shaw D, Graeme L, Pierre D et al.
The effectiveness of national pharmacovigilance Pharmacovigilance of herbal medicine. J
activities is directly dependent on the active Ethnopharmacol 2012; 140: 513-18.
participation of Government and health care 10. WHO. WHO: Pharmacovigilance: ensuring the safe
professionals at all levels (doctors, dentists, use of medicines, 2004.
physiotherapists, pharmacists, nurses) which makes the 11. Coulter D, Hill G, Pal SN et al. Global Fund and
program a success. More genuine information collected minimum requirements for national
about ADRs will definitely be helpful for creating a Pharmacovigilance centre. In: A practical handbook
national database, which can be easily accessible to on pharmacovigilance of medicines used in
heath care professionals. Efforts are required to treatment of tuberculosis. WHO publishers, Geneva,
encourage health care professionals to report all ADRs, 2012.
even suspected ones, with the aim of promoting 12. Harmark L, van Grootheest AC. Pharmacovigilance:
rational use of medication minimizing the harmful methods, recent developments and future
effects of drugs. Changes at policy levels are required to
11 ISSN: 2349-7181
Inder D et al. J. Adv. Res. Med. 2015; 2(3)
perspectives. Eur J Clin Pharmacol 2008; 64(8): 743- drug reactions in developing countries-A case study
52. of Yemen, Nepal and Malaysia. Indian J Pharm Biol
13. Pharmacovigilance program of India 2010. CDSCO, Res 2014; 2(3): 37-43.
Ministry of Health and Family Welfare, Government 18. Thatte U, Bhalerao S. Pharmacovigilance of
of India, Nov 2010. Available from: http:// ayurvedic medicines in India. Indian J Pharmacol
www.cdsco.nic.in/pharmacovigilance_intro.htm. 2008; 40(7): 10-12.
Accessed on: Jul 7, 2012. 19. Moore N. The role of the clinical pharmacologist in
14. Bhati N, Khosla PP, Gupta S. Assessment of the management of ADRs. Drug Saf 2001; 24: 1-7.
Knowledge, Attitude and Practices (KAP) of Health 20. Biswas P. Pharmacovigilance in Asia. J Pharmacol
Professionals Towards Adverse Drug Reactions Pharmacother 2013; 4(1): S7-19.
(ADRs) and Pharmacovigilance in a Tertiary Hospital 21. Biswas P, Biswas A. Setting standards for proactive
of North India. Journal of Advances in Medical pharmacovigilance in India: The way forward.
Research (JAMR) 2014; 1(1): 95-98. Indian J Pharmacol 2007; 39: 124-28.
15. Amrita P, Kharbanda B. Knowledge, attitude and 22. Twenty-second pandemic pharmacovigilance
skills of nurses of Delhi towards adverse drug update. Pharmacovigilance update EMA/527985/
reaction reporting. Indian J Pharm Pract 2012; 5: 2010.
45-51. 23. Almenoff JS. Innovations for the future of
16. Ahmad A, Parimalakrishnan S, Mohanta GP et al. pharmacovigilance. Drug Saf 2007; 30: 631-33.
Incidence of adverse drug reactions with commonly 24. Lopez-Gonzalez E, Herdeiro MT, Figueiras A.
prescribed drugs in tertiary care teaching hospital in Determinants of under reporting of adverse drug
India. Int J Pharm Sci 2011; 3: 79-83. reactions: A systematic review. Drug Saf 2009; 32:
17. Alshakka M, Jha N, Algefri S et al. Problems and 19-31.
challenges faced in consumer reporting of adverse
ISSN: 2349-7181 12