|Year : 2020 | Volume
| Issue : 1 | Page : 17-21
Knowledge, attitude, and practice of adverse drug reaction, and adverse drug reaction reporting among practising dermatologists in Maharashtra: A questionnaire-based survey
Sushil Pande, Manasi Shirolikar
Department of Dermatology, NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital, Nagpur, Maharashtra, India
|Date of Submission||06-Feb-2019|
|Date of Decision||23-May-2019|
|Date of Acceptance||18-Feb-2020|
|Date of Web Publication||23-Jun-2020|
Dr. Manasi Shirolikar
Department of Dermatology, NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital, Digdoh Hills, Hingna, Nagpur - 440 019, Maharashtra
Source of Support: None, Conflict of Interest: None
Introduction: Adverse drug reactions (ADRs) are common in a dermatological practice. Underreporting of ADR is a concern for dermatologists across the world. Aim: This survey aims to assess the attitudes and current reporting practices of ADRs and to understand possible causes for underreporting of ADRs amongst practising dermatologists of Maharashtra This will help to better understand, which steps will be effective to increase the reporting of ADRs. Study Design: Descriptive cross sectional questionnaire based study. Materials and Methods: The descriptive cross sectional questionnaire based study was conducted in Department of Dermatology of tertiary care hospital in central India from a period of April 2017 to September 2018.The target population was all practising dermatologists across Maharashtra. All practising dermatologists willing to participate in the survey were included while postgraduate students in dermatology and other fields, those not willing to participate in the study, doctors of non-allopathic disciplines practicing dermatology were excluded. Results: A total of 49% of the surveyed dermatologists see cases of ADRs often in their practice. Of these, the most common cutaneous adverse reaction is to topical corticosteroids. 30% of surveyed dermatologists had heard of the ADR reporting system but did not know how it is done while 27% had reported ADRs. Conclusion: The current trend of underreporting of ADRs is alarming as many dermatologists are not even aware that ADR in their practice needs to be reported.
Keywords: Adverse drug reaction reporting, practising dermatologists, questionnaire
|How to cite this article:|
Pande S, Shirolikar M. Knowledge, attitude, and practice of adverse drug reaction, and adverse drug reaction reporting among practising dermatologists in Maharashtra: A questionnaire-based survey. Indian J Drugs Dermatol 2020;6:17-21
|How to cite this URL:|
Pande S, Shirolikar M. Knowledge, attitude, and practice of adverse drug reaction, and adverse drug reaction reporting among practising dermatologists in Maharashtra: A questionnaire-based survey. Indian J Drugs Dermatol [serial online] 2020 [cited 2020 Jul 4];6:17-21. Available from: http://www.ijdd.in/text.asp?2020/6/1/17/287442
| Introduction|| |
The World Health Organization (WHO) defines adverse drug reactions (ADRs) as “a response to a drug which is noxious and unintended, and which occurs at doses normally used in men for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.” Pharmacovigilance is defined as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.”
The current knowledge about ADRs stems almost entirely from physicians who observed these reactions in their patients and reported them to the authorities (the hospital committee, drug manufacturers, medical journals, etc.). Even obscure ADRs have been highlighted due to the attention of their physicians.
Underreporting of ADR is a cause for concern in today's evidence-based medical world. This survey aims to assess the attitudes and current reporting practices of ADRs among dermatologists in Maharashtra. This will help to better understand, which steps will be effective to increase the reporting of ADRs.
Several studies conducted across the UK and the Netherlands have revealed that the principal causes for underreporting of ADRs are the absence of an easier method, and of reporting forms (UK) and the ADR already being well-known (Netherlands). India is a member country of the WHO program in global monitoring of ADRs, and as such it is necessary for us to recognize the factors that go into the nonreporting of ADRs.
The current study was intended to determine the pattern of reporting ADR in dermatology practice and to understand the possible causes for underreporting of ADRs among practising dermatologists of Maharashtra.
| Materials and Methods|| |
The descriptive cross-sectional questionnaire-based study was conducted in the department of dermatology of tertiary care hospital in Central India from a period of April 2017 to September 2018.
The target population was all practising dermatologists across Maharashtra. The survey instrument was prepared and validated by circulating it among peers and experts. After getting approval from the ethics committee, the survey was sent through e-mail, or link provided through other communication methods such as WhatsApp to the questionnaire on www.surveymonkey.com. The participants were provided with information about the survey before answering the questions. If they wished to continue, it was regarded as implied consent.
All practising dermatologists willing to participate in the survey were included in the study; while postgraduate students in dermatology and other fields; those not willing to participate in the study; and doctors of Homeopathy, Ayurveda, cosmetology, dentists, etc.; practising dermatology were excluded from the study.
| Results|| |
A total of 100 dermatologists from Maharashtra participated in the survey. Of the dermatologists surveyed, 38% had been practising for <5 years, 11% for 6–10 years, 37% for 11–20 years, and 14% for 21–30 years. The majority of dermatologists were private practitioners (65.66%), while 32.32% were faculty in a medical college, and only 2.02% were consultants in a private hospital. About 27% of those surveyed said that they had come across 1–5 cases of ADRs in the past 6 months, while 2% of responders said they had come across none. Dermatologists were also asked how often they saw patients of ADRs. The most common response with 49% was 'often', while 0% answered 'not seen' [Table 1].
There were four questions related to knowledge. The most common cutaneous side effects were found to be “local side effects due to topical corticosteroids, topical retinoids, tacrolimus, etc.,” and “fixed drug reactions,” while the least common was found to be “hair/nail-related side effects” [Table 2]. The most likely causes of cutaneous ADR (CADR) were found to be “corticosteroids (oral or topical)” and “antibiotics,” while the least likely cause was “antidiabetics [Table 3].” The most common systemic ADRs as revealed by the survey were “metabolic side effects (e.g., diabetes mellitus, hypertension, etc.)” and “hepatotoxicity,” while the least common was musculoskeletal side effects and “bone marrow suppression (e.g., due to Methotrexate, cyclophosphamide, azathioprine, etc.)” [Table 4]. The most likely cause of systemic ADR was found to be “antibiotics (including Anti-Koch's therapy, anti-leprosy drugs, etc.)” and “corticosteroids (oral or parenteral),” and the least likely cause was “antiepileptics” [Table 5].
|Table 2: Order of the most common to the least common cutaneous adverse drug reaction in dermatology practice (with one being the most common and nine being the least common)|
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|Table 3: Drugs causing cutaneous adverse drug reaction in dermatology practice (with one being the most common and six being the least common)|
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|Table 4: The pattern of systemic adverse drug reaction in dermatology practice (One being the most common to the six being the least common (with one being the most common and six being the least common)|
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|Table 5: Drugs causing systemic adverse drug reaction as observed in dermatology practice (with one being the most common and four being the least common)|
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There were two questions related to attitude. When faced with a difficult-to-diagnose or unknown drug reaction or reaction to the unknown drug in their practice; 69.47% of responders were most likely to do literature search on their own about drug reaction. About 86.02% of dermatologists confirmed a causal association of suspected drug/drugs with the given drug reaction based on clinical judgment, while only 22.58% used causality assessment tools, that is, WHO-UMC scale, Naranjo's algorithm, etc., and 12.9% advocated or performed diagnostic tests.
There were five practice-related questions. Of the responders, 30.93% had heard of ADR reporting system but did not know how it was done, while 20.62% did not know either or had heard of the system but did not know how it was done [Table 6]. Responders were most likely to report a case of ADR to the pharmacology department of a medical college (61.02%) and least likely to report it to the Indian Association of Dermatologists, Venereologists and Leprologists website (0%) and Indian Medical Association (1.69%). The most likely cause of not reporting ADR was “lack of know-how” (63.16%) while the least likely cause was fear of medicolegal consequences (7.89%). Only 37.89% of responders knew where ADR reporting forms were available, while 62.11% did not know [Table 7]. About 63.83% of dermatologists considered ADR reporting as essential since it will “increase our knowledge about ADR due to drugs used in dermatologic practice” while 4.26% considered it essential “as it is mandatory.”
|Table 6: Knowledge and practice of adverse drug reaction reporting system in India|
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|Table 7: Knowledge of availability of adverse drug reaction reporting forms|
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Finally, 100% of those surveyed thought that there is need for more educational activities such as continued medical education (CME), conferences, workshops, lectures, etc., in the field of CADR or its reporting; and 98.96% were willing to report ADR in their practice given proper know how information or a format of its reporting.
| Discussion|| |
The purpose of the questionnaire was to attempt to identify factors which hinder the reporting of adverse reactions by practising dermatologists. We undertook this pilot study in the region of Maharashtra. ADR is frequently not reported due to multiple reasons by many doctors including dermatologists.
The responses suggest that the lack of know-how (63%. 16), and available information (47.37%) may be a significant determinant of ADR underreporting. This is in accordance with the findings of studies from Zolezzi and Parsotam conducted in New Zealand, Li et al. conducted in China and Kelly et al. conducted in Australia. This is in contrast to Khan et al., in which “lack of clarity of information on ADR form about reporting” and “lack of awareness about the existence of pharmacovigilance program” were the fourth and seventh factors, respectively, for underreporting.
Only 3% of doctors in the UK and 38% in the European Union (EU) who considered “lack of knowledge” to be an issue.
Other details which emerged from the survey were the kind of reactions, which were considered to be CADRS as well as systemic ADRs [Table 2] and [Table 4]. Drugs which are most often seen as the culprit in dermatological practice, according to those surveyed, were also identified [Table 3] and [Table 5].
All who were surveyed believed that there is need for more educational activities such as CME, conferences, workshops, and lectures in the field of CADR or its reporting; and 98.96% were willing to report ADR in their practice given proper know-how, information or a format of its reporting. In the EU, a set of measures called “good pharmacovigilance practices” (GVP) have been drawn up to facilitate the performance of pharmacovigilance. GVP applies to marketing-authorization holders, the European Medical Association, and medicines regulatory authorities in EU member states. There are complementary systems for spontaneous reporting in New Zealand and the United Kingdom, where they are known as prescription event monitoring. Data collection varies among countries. In France, for example, there are regional centers for collecting spontaneous reports, while Iran has a single national pharmacovigilance center to collect the data. Pharmacovigilance is much more than a regulatory activity; it also has a major role in clinical practice and the development of public health policy. There are national and regional centers that are located in hospitals, medical schools, or poison and medicine information centers that collaborate with a medicines regulatory authority.
Of those surveyed, 27.84% claimed to have reported an ADR in their practice, while the others had not reported any ADRs [Table 6].
A total of 62.11% of dermatologists responded that they do not know as to where the ADR forms are available [Table 7]. This observation is important because as most of the pharmacovigilance activities are limited to medical colleges and practising dermatologists are unaware of ADR reporting system prevalent in their region.
| Conclusion|| |
The current trend of underreporting of ADRs is alarming as many dermatologists are not even aware that ADR in their practice needs to be reported. We suggest that dermatologists need to be trained or educated about reporting of ADR through various educational activities or training programs. This should help them to know the importance of reporting ADR and its implications for the safety of patients.
Drug safety cannot be guaranteed at the time a drug is marketed because the extent and nature of exposure are limited, but after marketing, the timely definition of drug risk is certainly achievable. Adverse drug event reporting plays a large role in achieving this objective.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
World Health Organization. Definitions by World Health Organization; 1972. p. 1-16.
Bateman DN, Sanders GL, Rawlins MD. Attitudes to adverse drug reaction reporting in the Northern Region. Br J Clin Pharmacol 1992;34:421-6.
Belton KJ, Lewis SC, Payne S, Rawlins MD, Wood SM. Attitudinal survey of adverse drug reaction reporting by medical practitioners in the United Kingdom. Br J Clin Pharmacol 1995;39:223-6.
Eland IA, Belton KJ, van Grootheest AC, Meiners AP, Rawlins MD, Stricker BH. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 1999;48:623-7.
Edwards IR, Olsson S. WHO programme – Global monitoring. In: Mann R, Andrews A, editors. Pharmacovigilance. Chichester: Wiley Sons; 2002. p. 169-82.
Zolezzi M, Parsotam N. Adverse drug reaction reporting in New Zealand: Implications for pharmacists. Ther Clin Risk Manag 2005;1:181-8.
Li Q, Zhang SM, Chen HT, Fang SP, Yu X, Liu D, et al
. Awareness and attitudes of healthcare professionals in Wuhan, China to the reporting of adverse drug reactions. Chin Med J (Engl) 2004;117:856-61.
Kelly M, Kaye KI, Davis SR, Shenfield GM. Factors influencing adverse drug reaction reporting in New South Wales teaching hospitals. J Pharm Pract Res 2004;34:32-5.
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;4:191-6.
Belton KJ. Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. The European Pharmacovigilance Research Group. Eur J Clin Pharmacol 1997;52:423-7.
Medicines Agency E. Guideline on Good Pharmacovigilance Practices (GVP) – Module VI – Collection, Management and Reporting Submission of Reports of Suspected Adverse Reactions to Medicinal Products (Rev 2); 2017.
World Health Organization. The Safety of Medicines in Public Health Programmes: Pharmacovigilance an Essential Tool. WHO Libr Cat Data; 2006. p. 61.
Rogers AS, Israel E, Smith CR, Levine D, McBean AM, Valente C, et al
. Physician knowledge, attitudes, and behavior related to reporting adverse drug events. Arch Intern Med 1988;148:1596-600.
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]