Author : Krushangi Shah, Basant Sharma, Snehal Patel, Anupama Ramkumar, Bhoomika Patel

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Spontaneous reporting of adverse events (AEs) by the healthcare practitioners, the patient or caregiver is the most widely used and recommended tool to monitor the safety of a marketed medicines. Data form the USFDA lists Adverse drug reactions (ADRs) popularly known as side effects as the 4th leading cause of death in the developed world. Adverse drug reactions (ADRs) not only account for market withdrawals but also for changes in labels or introduction of new-labeled warnings for prescription drugs. (1)

While the drug may have undergone extensive clinical testing during development and its safety profile largely known, the very nature of it being done on a limited number of patients in controlled trial conditions precludes many of the rare AEs being detected. Once marketed,

medicines are not used under the same conditions as clinical trials. They are used by a larger number of patients across a range of age groups, who have varied lifestyles, comorbid conditions, or are taking several medicines simultaneously. Common and predictable side effects are characterized during the development phase of the drug, but idiosyncratic or rare side effects may only be known once the medicine is used by a large number of patients under actual conditions of use. In addition, some side effects might not get discovered until the medicine has been used over a long period of time or even after stopping treatment. It is therefore imperative that the safety of medicines is monitored even after they are marketed so as to identify any formerly unknown information on side effects and, if required, vital action can be taken to protect public health.

The process of reviewing the safety of medicines following their authorization is known as Pharmacovigilance [2]. India, which is also one of the members of the WHO Programme for International Drug Monitoring has a formal system of Pharmacovigilance run as the Pharmacovigilance programme of India (PvPI) under whose aegis ADR monitoring centres have been set up across the country to monitor medicinal safety [3]. One of the ways regulatory authorities monitor the safety of medicines is by collecting and analysing spontaneous reports of suspected side effects from health professionals, patients or consumers called ‘spontaneous adverse drug reaction reports’ (SADR) [2]. The success of this widely used and recommended method is totally dependent on the contribution of health professionals and consumers to ensure that the observed side effects are adequately reported and recorded for analysis. In reality the program is plagued by underreporting in most parts of the world were such initiatives are run. WHO recommends a reporting rate of 200 events per million people per year as being adequately representative; most developed countries have a reporting rate of 130 and India around 40. While the reporting rate of SADRs in India has significantly gone up in the last few years, it contributes to less than 2% of the reported events in VigiBase, the WHO global safety data base hosted by Uppsala Monitoring Centre, and is disproportionate to the country’s vast population and medicine consumption.

Underreporting of SADRs by physicians is considered one of the major obstacles in

the success of the Pharmacovigilance Programme of India; thus having a
negative impact on the public health [4]. Hence the present study was undertaken to evaluate the perception of physicians towards ADR reporting in India, and their awareness towards available resources.


A questionnaire-based cross-sectional survey was performed for this study. The study questionnaire was designed and prevalidated with clinical practitioners on the answerability and information value of the questions Knowledge and perception based questionnaire (containing 9 questions was designed to obtain the information about knowledge regarding ADR reporting system in India and perception of ADR reporting (Appendix-1). More than one answer was allowed in some questions.

In the first question, the participating physicians were inquired about the average number of patients they had examined in last 6 months and in the second about the number of side effects seen amongst these. The response to the first two questions was based of their day-to-day practice. The next question sought their response on the usual course of action if a drug related AE was encountered and this included the option of changing medication, reducing the dose, informing the patient or reporting possibilities. The succeeding two questions were perception based asking about physician’s choice on recipient of their ADR reporting information whether they would report to pharmacist, medical representative and senior medical

representative or nearest PV cell. The other question was asked to them on the ideal way according to them to manage these AEs by options like informing the patient and managing the event, informing the company and/or informing the regulatory authority. The practitioners were also
asked about the number of ADRs they have reported in last 6 months and if reported, to whom, Medical representative or the regulatory authority (PV cell). And the last three questions were knowledge based inquiring whether the physician knew about the location of the nearest PV cell, and reporting mode options (phone, fax, e-mail, in person, Not Applicable) if
they report to a PV cell and the minimum requirements to report an ADR.

The study population surveyed involved medical practitioners from varied
specialties from Ahmedabad. A total of 60 questionnaires were distributed to medical doctors, excluding the practitioners involved in the pre validation. Those who were not willing to participate or did not return the questionnaire within the given time were excluded from the study. The
completion of the questionnaire by respondents was taken as their consent to participate in the study. Hence, out of 60 questionnaires, only 53 were taken into consideration.

The information was recorded and analysed using simple descriptive statistics with use of graphs and figures to interpret and report the results of this survey. In order to preclude any potential bias, the disclosure of name of the responder was made optional.


Total of 53 responses were taken into consideration for this survey from
Ahmedabad, which is one of the larger cities in India. All the responders were practitioners from various medical specialties including family physicians, consultant physicians, paediatricians, dermatologists, gynaecologists, E.N.T specialists, ophthalmologists, neurologists, critical care and emergency medicine specialists, anaesthetists, cardiologists and

Over the past 6 months, 41.51% of the doctors had seen more than 500 patients 33.96% practitioners had consulted around200 – 500 patients; 15.10% doctors examined 100-200 patients and rest of the physicians had about 50-100 patients [Table 1].

For the surveyed physicians, 30% doctors observed more than 6 cases of suspected AE in the last six months, 26.42% doctors observed 2 to 5 cases of ADRs, while the rest of the group (43.40%) did not observe
more than 1 ADR [Table 2].

1 2

The action taken in response to the adverse effects for most of them was replacing or modifying treatment [Chart 1]; and doctors had different preferences for reporting ADRs [Chart 2]; less than 4% responded that they would report the event to the PV cell [Chart 3].

The awareness of the nearest PV cell or the available of modes of reporting as well knowledge on the minimum requirements

of reporting were lacking amongst the larger number of respondents.

Out of 53, 36 practitioners were totally unaware about the location of the nearby PV cell. 43% of the practitioners were ignorant about the means by which they can report an ADR; an additional 17% thought it is necessary to report the ADR in person [Chart 4].

3 4

5 6

Also the minimum requirements to report an ADR were unknown to 77.36% physicians. According to several of the physicians, observation of rash, itching, breathing difficulties, severe life threatening/anaphylactic ADR were the reporting requirements for an ADR.


Globally, drug regulators are placing increased thrust on robust safety
monitoring mechanisms for pharmacovigilance. The PvPI program of India has also taken great strides in this regard with the National Coordination

Centre in Ghaziabad and zonal offices as well as almost 150 ADR monitoring cells around the country.

A dedicated help line number, a web-based ADR reporting form and a mobile application form easily available modes of reporting suspected ADRs to the health authority. These ADRs once reported and assessed are further data based in the WHO repository Vigibase, thus not only adding
value on safe guarding national health but contributing to global efforts in PV.

However, the overall strength of any system lies in its weakest link. Multiple studies and repeatedly demonstrated the low reporting rates of ADR form the healthcare and patient communities. (5, 6, 7, 8)

Our survey with its limited regional population corroborated these findings
with majority of respondents, who were all practicing physicians being inadequately unaware of the need of watchful assessment and reporting.

Studies earlier than ours have cited various reasons for this phenomenon, which include complacency, insecurity and legal issues, case series publication, diffidence, professional responsibility, lethargy and financial incentives to report. The results in our survey point to lack of awareness and knowledge on pharmacovigilance amongst our respondents. (5, 6, 7, 8)

These include their own responsibility to detect and report, the minimum
requirements of reporting, and the

existence of the PVPI function. Training and awareness program amongst
the medical community on the needs of PV, their own reporting responsibilities, the structure and functioning of PVPI and information on  the minimum requirements of ADR reporting is the need of the hour to
ensure the PVPI mission of protecting national health form adverse effects of medicines can indeed be upheld.


We hereby take the opportunity to thank all the physicians who took part in the survey willingly and also the physicians who validated and advised us on designing the survey form.


1. Siramshetty VB, Nickel J, Omieczynski C, Gohlke BO, Drwal MN, Preissner R. WITHDRAWN–a resource for withdrawn and discontinued drugs.Nucleic Acids Res. 2016;44(D1):D1080-6.

2. New EU pharmacovigilance legislation- key concepts, European
Medicine Agency, 2013. [Last accessed on 1st July, 2013] Available from: docs/en_GB/documents_library/ Other/2012/07/ WC500129593.pdf

3. Pharmacovigilance program of India, 2010. CDSCO, Ministry of Health
and Family Welfare, Government of India. 2010. [Last accessed on 1st

July, 2013]: Available from: htm

4. Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of underreporting of adverse drug reactions: a systematic review. Drug Saf. 2009;32(1):19-31.

5. Kamtane R, Jayawardhani V. Knowledge, attitude and perception of
physicians towards adverse drug reaction (ADR) reporting: A pharmacoepidemiological study. Asian J Pharm Clin Res 2012;5(3):210–214

6. Khan SA, Goyal C, Chandel N, Rafi M. Knowledge, attitudes, and practice of doctors to adverse drug reaction reporting in a teaching hospital in India: An observational study. J Nat Sci Biol Med. 2013;4(1):191-6.

7. Lihite RJ, Lahkar M. An update on the Pharmacovigilance Programme of India. Front Pharmacol. 2015;6:194.

8. Sabblah G, Akweongo P, Darko D, Dodoo ANO, Sulley AM. Adverse
Drug Reaction Reporting by Doctors in a Developing Country: A Case
Study from Ghana. Ghana Med J. 2014 Dec; 48(4): 189–193.