|Year : 2017 | Volume
| Issue : 3 | Page : 146-151
Knowledge, Attitude, and Practice About Pharmacovigilance Among Healthcare Providers of a Tertiary Care Teaching Hospital in New Delhi (India)
Monika Agarwal, Jamshed Ahmed, Vandana Roy
Department of Pharmacology, Maulana Azad Medical College, New Delhi, India
|Date of Web Publication||24-Oct-2017|
Department of Pharmacology, Maulana Azad Medical College, New Delhi
Source of Support: None, Conflict of Interest: None
Introduction: Adverse drug reactions (ADRs) are among the leading causes of morbidity and mortality globally. The college has recently been recognized as an Adverse Drug reaction Monitoring Center under the National Pharmacovigilance Program. This study was conducted to assess the knowledge, attitude, and practice (KAP) about pharmacovigilance among healthcare providers and medical students of the college and associated hospital. Materials and Methods: A cross-sectional, questionnaire-based survey was conducted. A pretested, validated questionnaire for assessing the KAP of pharmacovigilance among the healthcare providers and medical students was used. Results: The knowledge and attitude of healthcare providers toward reporting of ADRs was satisfactory. Awareness about the pharmacovigilance activities in the institution was less as only 27.8% were aware. More than 90% participants agreed that reporting of ADRs is important, should be made mandatory, and believed that it would help patient safety in the long term. Less than 50% healthcare providers reported regular ADRs. The reasons for not reporting ADRs included difficulty in knowing whether an ADR has occurred or it is a symptom of disease, lack of time, ADR is already well known, managing the patient is more important, or ADR is mild. Training on how to report an ADR during their professional course was received by 60.4% of the healthcare providers. The pharmacists were less aware, whereas the medical students were well aware about the importance of pharmacovigilance. Conclusion: There is a need to improve the culture of reporting ADRs among the healthcare providers in the institute. The first step would be to increase awareness about facilities and processes in place for reporting ADRs. Incorporation of training about pharmacovigilance in the curriculum of all the healthcare providers may help in increasing awareness and practice of reporting ADRs.
Keywords: Attitude, healthcare providers, knowledge, pharmacovigilance, practice
|How to cite this article:|
Agarwal M, Ahmed J, Roy V. Knowledge, Attitude, and Practice About Pharmacovigilance Among Healthcare Providers of a Tertiary Care Teaching Hospital in New Delhi (India). MAMC J Med Sci 2017;3:146-51
|How to cite this URL:|
Agarwal M, Ahmed J, Roy V. Knowledge, Attitude, and Practice About Pharmacovigilance Among Healthcare Providers of a Tertiary Care Teaching Hospital in New Delhi (India). MAMC J Med Sci [serial online] 2017 [cited 2022 May 29];3:146-51. Available from: https://www.mamcjms.in/text.asp?2017/3/3/146/217118
| Introduction|| |
Adverse drug reactions (ADRs) represent a major burden on society, resulting in significant morbidity, mortality, and healthcare costs. A study from India revealed that around 6% of hospital admissions are estimated to be due to ADRs and about 6 to 15% of hospitalized patients experience serious ADRs. Furthermore, a Swedish study estimated that 3.1% of deaths in the general population were attributed to ADRs.
Pharmacovigilance has been defined as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem.” In 2010, the Pharmacovigilance Programme of India (PvPI) was initiated for monitoring ADRs in the country. The larger goal of the program is to safeguard public health by assuring the safety of medicinal products. Doctors, nurses, and pharmacists are key professionals involved in prescribing, dispensing, administering, storage, and disposal of medicines. Their role in strengthening the pharmacovigilance program by reporting ADRs that would help increase patient safety cannot be overemphasized. Underreporting of ADRs is a common problem in the pharmacovigilance program. Findings from various studies have revealed that ADR reporting by healthcare providers is linked to their knowledge, attitude, and practice (KAP) about pharmacovigilance.
Maulana Azad Medical College (MAMC) has been recognized as an ADR Monitoring Center (AMC) under the PvPI. It is associated with Lok Nayak hospital (LNH), a tertiary care hospital. The hospital caters to about one million patients in out-patients and 70,000 in-patients annually. Reporting of ADRs by healthcare providers is being encouraged by sensitizing programs. There is no availability of data on the KAP of pharmacovigilance among the healthcare providers and medical students within the institute. This data would help to improve the quality of the existing pharmacovigilance program within the institute. Hence, the current study was conducted to assess the KAP about pharmacovigilance and implementation of the program within the institute among the healthcare providers and medical students in MAMC and associated LNH.
| Materials and Methods|| |
A cross-sectional, observational study was conducted in the Department of Pharmacology in MAMC, New Delhi and associated LNH. The protocol was approved by the Institutional Ethics Committee. Written informed consent was taken from the survey participants.
Healthcare providers, including doctors, nurses, pharmacists, and medical students (third semester onward and interns) working in the hospital were included in the study.
A pretested, structured, and validated questionnaire was used in the study. The questionnaire was validated by face and content validation. The questionnaire was divided into the following parts: (i) demographic characteristics, (ii) KAP of pharmacovigilance, (iii) and suggestions on possible ways to improve pharmacovigilance. There were 13 questions relating to the basic knowledge and information about pharmacovigilance, 9 questions relating to attitude, and 7 questions relating to perception regarding identification of ADR and its reporting.
The healthcare providers were given the questionnaire after explaining to them the purpose of the study. They were requested to complete the questionnaire and give it back immediately to maximize the response rate.
Data analysis was carried out using MS Excel spreadsheet and percentage of observations was noted.
| Results|| |
The questionnaire was administered to 100 doctors and nurses each, 50 pharmacists, and 250 medical students. The sample size was of convenience. There are 50 pharmacists working in the hospital and all were included. Each year 250 medical students enter the college and the students of sixth semester were included. Of the total respondents, 52% were females and 66.4% were within the age group of 21 to 30 years [Table 1].
More than 70% of healthcare providers were aware of what is pharmacovigilance, the pharmacovigilance program being run by the Government of India, the method used by pharmaceutical companies to monitor ADRs, and the ADR reporting system in India as well as in the hospital [Table 2]. About 50 to 60% participants knew who all can report ADRs, the organization responsible for ADR reporting in India and the existence of the Committee for Pharmacovigilance in the institution. Awareness about the pharmacovigilance activities in the institution was less. Less than 50% participants were aware of the designated officer for it, training workshops, and sources of information available in the campus to increase awareness about ADRs, and only 27.8% knew about the facilities available to report ADRs in the institution [Table 2].
|Table 2: Knowledge and awareness of healthcare providers about pharmacovigilance|
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The majority (98.6%) of participants agreed that reporting of ADRs is important and more than 90% participants agreed that reporting of ADRs should be mandatory. Reporting of ADRs was believed to be the responsibility of a healthcare provider by 90%, and 89% agreed that ADR reporting is a professional obligation. They opined that teaching about pharmacovigilance activities during their education and training may improve the culture of reporting of ADRs. Over 90% healthcare providers believed that reporting of ADRs would help patient safety in the long term. The majority (70%) agreed that many ADRs are avoidable. About 59% were in agreement that all ADRs, even the less serious, need to be reported [Table 3].
Lesser than 50% healthcare providers reported having come across ADRs, keeping records of ADRs or reporting to the AMC in the college [Table 4]. Among the reasons for not reporting ADRs included the following: (i) difficulty in knowing whether an ADR has occurred or it is a symptom of disease (22.8%), (ii) lack of time(19.8%), (iii) ADR is already well known (17.8%), and (iv) managing the patient is more important (14.2%) or ADR is mild (12.4%) [Figure 1]. It was found that 59.6% respondents try to prevent ADRs and only 30.6% had come across drug alerts. Training on how to report an ADR during their professional course had been received by 60.4% of the healthcare providers.
| Discussion|| |
Safe use of medicines is an essential component of quality health care. Thus, use of medicines must be monitored continuously through an effective pharmacovigilance system. Reporting of ADRs by all involved in the use of medicines, which includes doctors, nurses, pharmacists, patients, and the people, is the first step in the process.
The present study was a questionnaire-based study, which included healthcare providers of a tertiary care teaching hospital in North India. The need for such a study was felt as the college was recently recognized as an AMC. The center is working toward increasing awareness and training programs among the healthcare providers, medical students, and patients. It is also trying to create a culture of reporting ADRs. It was felt that the results of the study would help the AMC in identifying areas that need to be addressed.
The study showed that the healthcare providers, namely, doctors, nurses, pharmacists, and medical students had knowledge and a supportive attitude toward pharmacovigilance. However, the actual practice of reporting was low among the participants. Similar observations have been reported by other studies from India that the prescribers have knowledge, but poor practice for reporting ADRs.,
A section of the healthcare providers was not aware about pharmacovigilance and some thought that pharmacovigilance includes drug-related problems in only the allopathic system of medicine. Although this is lesser than other studies, but it is an area that needs to be addressed.,, There are other systems of medicines in existence in India that use medicines from other sources such as herbs, animal products, and minerals. These are perceived as being natural products and, hence, safe. The doctors often do not take history from patients about use of medicines from other systems. The program involves monitoring of ADRs of all medicines (from all systems of medicines), vaccines, blood products, and even medical devices. It is essential to make the healthcare providers aware about the fact that any system of medicine, even medical devices and vaccines can cause ADRs and thus should be reported. The study revealed that although many (75.4%) professionals know about the pharmacovigilance program run by the Government of India, less knew about the organization responsible for this and the international organization (World Health Organization − Uppsala Monitoring Centre) monitoring the same. Lack of awareness about this is not a problem as it will not influence reporting of ADRs by healthcare providers or the quality of the pharmacovigilance program in the institution.
An important finding of the study was that, although a majority of healthcare providers knew about the existence of ADR reporting system in the institution, very few knew about the modalities available for doing it. This requires rectification, and there is a need to generate awareness regarding the facilities available for reporting ADRs, the designated officer for pharmacovigilance activities and various sources of information available in the campus to facilitate ADR reporting.
This study also revealed that the basic knowledge of pharmacists regarding pharmacovigilance was lesser than the other healthcare providers in all areas. This is similar to observation in another study from South India. Pharmacists are key stakeholders involved in procurement, storage, dispensing, and disposal of medicines. They have a crucial role in the safe use of medicines. Thus, the concept of pharmacovigilance for patient safety needs to be emphasized during their professional training, and continued medical education programs should be organized regularly to update their knowledge.
An encouraging finding of this study was that the majority of participants (>90%) considered that ADR reporting is important and should be made mandatory. It should be taught during their training. Moreover, about 80% participants thought that ADR reporting is their professional obligation, which is more in the studies done in Nagpur and Tamil Nadu., A study from India showed that 64% healthcare providers are reporting ADRs. In this study, despite having a good attitude toward reporting of ADRs, only 45% healthcare providers had ever reported ADRs. Also, 32% participants want to report only serious ADRs which is lesser than the percentage observed in another study. There is a need to emphasize to the healthcare providers that all adverse reactions must be reported whether mild or serious.
Among the reasons given for not reporting ADRs in this study, was difficulty in deciding if an ADR had occurred or it was a disease symptom, lack of time, the ADR is well known and mild, and legal issues. Similar reasons have also been pointed out in other studies.,, Lack of knowledge of where and how ADRs should be reported would automatically affect reporting, which could also be a reason for less reporting of ADRs stated in this study, in which only 27% participants have knowledge about the facilities available to report ADRs in the institution. Another issue could be that only 16% to 47% pharmacist, nurses, and doctors stated that they had received training on how to report an ADR. These findings suggest that there is a need for more interventions, continuous medical education, and workshops to improve awareness about the pharmacovigilance program and the various facilities available for ADR monitoring in the institution.
Another finding of concern in the study was that doctors did not agree that doctors and paramedics need to report. This is contradictory to the opinion of the majority of doctors that the reporting of ADR is a professional obligation. Thus, efforts to increase awareness about the role of all involved in the use of medicines for reporting ADRs has to be done.
Medical students were more aware about pharmacovigilance and their attitude indicates their understanding about its importance. This is because the Department of Pharmacology is sensitizing medical students about pharmacovigilance, its importance, and how to report ADRs. It is hoped that early training will help in laying a foundation for concepts about pharmacovigilance, the fact that medicines can cause adverse effects which can affect patient safety. As they graduate and start practicing medicine, they will be able to use medicines judiciously with more awareness about patient safety. The culture of reporting ADRs has to be inculcated from the beginning of their clinical training, so that it becomes a part of their practice later on.
| Conclusion|| |
A positive attitude toward pharmacovigilance exists among the healthcare providers and students of the institution. More continuous medical education programs need to be conducted to educate all healthcare providers about the importance of a pharmacovigilance program, the role of all healthcare providers in ensuring its success and the various facilities available in the institution for reporting ADRs. The need for an efficient pharmacovigilance program has been realized to ensure safe use of medicines. Its success will depend upon the involvement of all stakeholders in the use of medicines.
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Conflicts of interest
There are no conflicts of interest.
| References|| |
Onder G, van der Cammen TJ, Petrovic M, Somers A, Rajkumar C. Strategies to reduce the risk of iatrogenic illness in complex older adults. Age Ageing 2013;42:284-91.
Kumar VR, Ram VR, Prasad BG, Mohanta GP, Manna PK. A study of adverse drug reactions due to antihypertensive drugs in a tertiary care teaching hospital. Int J Pharm Life Sci 2011;2:767-72.
Wester K, Jönsson AK, Spigset O, Druid H, Hägg S. Incidence of fatal adverse drug reactions: a population based study. Br J Clin Pharmacol 2008;65:573-9.
World Health Organization. Safety of Medicine: A Guide to Detecting and Reporting Adverse Drug Reactions. Geneva: WHO/EDM/QSM/2002.2; 2002.
Isfahani ME, Mousavi S, Rakhshan A, Assarian M, Kuti L, Eslami K. Adverse drug reactions: attitude and practice of pharmacy students. J Pharm Care 2013;1:145-8.
Rishi RK, Patel RK, Bhandari A. Opinion of physicians towards adverse drug reactions reporting results of pilot study. J Community Nutr Health 2012;1:25-9.
Ghosh S, Ali S, Chhabra L, Prasad C, Gupta A. Investigation of attitudes and perception of medical practitioners on adverse drug reaction reporting—a pilot study. Pharma Res 2010;3:1-9.
Gupta P, Udupa A. Adverse drug reaction reporting and pharmacovigilance: knowledge, attitude and perceptions among resident doctors. J Pharma Sci Res 2011;3:1064-9.
Pimpalkhute SA, Jaiswal KM, Sontakke SD, Bajait CS, Gaikwad A. Evaluation of awareness about pharmacovigilance and adverse drug reaction monitoring in resident doctors of a tertiary care teaching hospital. Indian J Med Sci 2012;66:55-61. [Full text]
Modi PK, Kohli SK, Advani U, Singh H. Evaluation of knowledge, attitude and practice of pharmacovigilance among health care professionals in tertiary care teaching medical college in North India. World J Pharma Res 2014;3:2691-7.
Prakasam A, Nidamanuri A, Kumar S. Knowledge, perception and practice of pharmacovigilance among community pharmacists in South India. Pharm Pract 2012;10:222-6.
Gupta SK, Nayak RP, Shivaranjani R, Vidyarthi SK. A questionnaire study on the knowledge, attitude, and the practice of pharmacovigilance among the healthcare professionals in a teaching hospital in South India. Perspect Clin Res 2015;6:45-52.
] [Full text]
Ramesh M, Parthasarathi G. Adverse drug reaction reporting: attitudes and perceptions of medical practitioners. Asian J Pharm Clin Res 2009;2:10-4.
[Table 1], [Table 2], [Table 3], [Table 4]