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ORIGINAL ARTICLE
Year : 2020  |  Volume : 13  |  Issue : 4  |  Page : 356-361  

Assessment of knowledge, attitude, and practice of health-care professionals in adverse drug reaction reporting in a tertiary care hospital


Department of Pharmacy Practice, N.E.T. Pharmacy College, Raichur, Karnataka, India

Date of Submission02-Mar-2019
Date of Decision15-Oct-2019
Date of Acceptance15-Oct-2019
Date of Web Publication20-Jul-2020

Correspondence Address:
Shiv Kumar
Department of Pharmacy Practice, N.E.T. Pharmacy College, Raichur - 584 103, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/mjdrdypu.mjdrdypu_75_19

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  Abstract 


Aims: A cross-sectional questionnaire survey was carried out with an aim to assess the knowledge, attitude, and practice (KAP) of health-care professionals in adverse drug reaction (ADR) reporting. Materials and Methods: The study involved health-care professionals (doctors, pharmacists, and nurses) from Navodaya Medical College Hospital and Research Centre, Raichur, during the period from September 2018 to November 2018. Data were collected using especially designed questionnaire form consisting of questions regarding KAP of ADR reporting. Results: Of 100 study population, doctors were more in number (52%) followed by pharmacists (28%) and nurses (20%). Spontaneous reporting system was not much familiar to health-care professionals as a common method used in ADR reporting (53%). Majority of the health-care professionals admitted their responsibility to report ADR (58%). Awareness about nearby ADR monitoring center, Pharmacovigilance Program of India (PvPI) of the Central Drugs Standard Control Organization, ADR PvPI app, and ADR reporting form, among health-care professionals were 48%, 12%, 40%, and 47%, respectively, which can be correlated with unsatisfactory awareness among the study population. About 52% of the study population had a neutral response to the question whether ADR reporting is a professional obligation to them. About 38% of the population think that ADR reporting is time-consuming with no outcome, and 31% of the study population expressed a neutral response to the same question. Most of the study population believed that all serious ADRs are known before a drug is marketed (56%). The practice of ADR reporting was low among health-care professionals (61%) though majority of them came across through patients experiencing ADRs (67%). Difficulty in decision-making was the main factor causing ADR underreporting (32%), followed by lack of time (25%). Conclusions: This study revealed that majority of health-care professionals have insufficient knowledge and less positive attitude which resulted in low ADR reporting.

Keywords: Adverse drug reaction reporting, health-care professionals, knowledge, attitude, and practice


How to cite this article:
Kumar S, Sooraj Babu S J, Wilson A. Assessment of knowledge, attitude, and practice of health-care professionals in adverse drug reaction reporting in a tertiary care hospital. Med J DY Patil Vidyapeeth 2020;13:356-61

How to cite this URL:
Kumar S, Sooraj Babu S J, Wilson A. Assessment of knowledge, attitude, and practice of health-care professionals in adverse drug reaction reporting in a tertiary care hospital. Med J DY Patil Vidyapeeth [serial online] 2020 [cited 2020 Dec 5];13:356-61. Available from: https://www.mjdrdypv.org/text.asp?2020/13/4/356/290181




  Introduction Top


Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse drug reaction (ADR) or any other medicine-related problem to improve the safety of medicines. According to the World Health Organization (WHO) definition, an ADR is any noxious, unintended, and undesired effect of a drug, which occurs at doses used in humans for prophylaxis, diagnosis, or therapy.[1]

The WHO initiated an international drug monitoring program in 1968 to coordinate activities worldwide. The Pharmacovigilance Program of India (PvPI) was launched with a broad objective to safeguard the health of 1.27 billion people of India. ADRs are reported from all over the country to NCC-PvPI, which also works in collaboration with the WHO Program for International Drug Monitoring and also contributes to the global ADRs database. NCC-PvPI monitors the ADRs among the Indian population and helps the regulatory authority of India (Central Drugs Standard Control Organization [CDSCO]) in taking decision for safe use of medicines.[2] The CDSCO under Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India is the National Regulatory Authority of India. Its headquarter is located at Food and Drug Administration Bhawan, Kotla Road, New Delhi - 110 002.[3] A number of studies conducted worldwide indicated spontaneous reporting of ADRs as a cornerstone for successful pharmacovigilance and highlighted the significance of the contribution of health professionals in this regard.[1]

Out of the several methods of detecting ADRs, spontaneous reporting is one that has contributed significantly to improved levels of pharmacovigilance in many countries. The importance of health-care workers in the area of spontaneous reporting of ADRs, and the development of ADR databases worldwide has been established. Spontaneous reporting of ADRs remains the cornerstone of pharmacovigilance, and it is important in maintaining patient safety. However, the success of this activity is dependent on the frequency of reporting by the health-care professionals.[4]

ADRs are underreported and undisclosed in developing countries due to a lack of medication monitoring and prioritization of medication safety or even lack of an ADR reporting system. The nurses and pharmacists have very important roles to play in ADR monitoring and reporting. Despite the better ADR reporting culture of the developed nations, underreporting is a major issue with spontaneous reporting. The predictors of underreporting have been described severally by many workers, but these differ from study to study.[5],[6],[7]

Hence, the present study was planned with an objective to determine the knowledge, attitude, and practice of ADR reporting among health-care workers (medical doctors, nurses, and pharmacists) in a tertiary care teaching hospital.


  Materials and Methods Top


The cross-sectional questionnaire survey was done using 100 health-care professionals (doctors, pharmacists, and nurses) during the period from September 2018 to November 2018. Data were collected by using specially designed questionnaire form. The study was conducted in Navodaya Medical College Hospital and Research Centre (NMCH and RC), Raichur. The sample size was calculated with respect to interest of participation of the study population. Inclusion criteria satisfy all the health-care professionals, that is, doctors, nurses, and pharmacists working in NMCH and RC, Raichur, during the study and all the trainees and internship students. Exclusion criteria include inadequately filled questionnaires and the health-care professionals who are not willing to participate in the study.

Ethical consideration

The ethical approval to conduct the study was obtained from the Institutional Ethics Committee of N.E.T Pharmacy College, Raichur. The ethical approval number of this study was NETPC/IAEC/2018/14.

Data analysis

The collected data were expressed in percentage.


  Results Top


The cross-sectional questionnaire survey was done among 100 health-care professionals (doctors, pharmacists, and nurses) on ADR reporting. Female participants (54%) exceeded male participants. Of 100 study population, doctors were more in number (52%) followed by pharmacists (28%) and nurses (20%) [Table 1].
Table 1: Distribution of study population according to profession (n=100)

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Knowledge on adverse drug reaction reporting among health professionals

Majority of the health-care professionals were aware of the actual purpose of pharmacovigilance (to enhance patient safety in relation to the use of drugs: 67%). The WHO definition of ADR was known to most of the health-care professionals (64%). Awareness about CDSCO as a regulatory body responsible for ADR monitoring was satisfactory among professionals (60%). Half percentage of the respondents believed that all serious ADRs, ADRs to vaccines, ADRs to new drugs, and unknown ADRs need to be reported indicating satisfactory knowledge. Spontaneous reporting system was not much familiar to health-care professionals as a common method used in ADR reporting (53%). Majority of the health-care professionals admitted their responsibility to report ADR (58%). Awareness about nearby ADR monitoring center, PvPI of CDSCO, ADR PvPI app, and ADR reporting form, among health-care professionals were 48%, 12%, 40%, and 47%, respectively, which can be correlated with unsatisfactory awareness among the study population. However, 63% of the respondents had no blind belief about safety of drugs available in market, and the same percentage of the study population was aware of at least one drug banned due to ADR [Table 2].
Table 2: Knowledge on adverse drug reaction and adverse drug reaction reporting among health-care professionals

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Attitude toward adverse drug reaction reporting among health professionals

The study revealed 88% of health-care professionals agreeing that ADR monitoring and reporting are beneficial to patients. About 52% of the study population had a neutral response to the question, whether ADR reporting is a professional obligation to them. About 38% of the population think that ADR reporting is time-consuming with no outcome, and 31% of the study population expressed a neutral response to the same question. Most of the health-care professionals had a neutral response to question enquiring their worry about legal problems involved in reporting ADR (53%). Most of the study population believed that all serious ADRs are known before a drug is marketed (56%). Neutral response was expressed by most of the population to the question whether ADR reporting affects patient confidentiality (42%). Positive attitude was found among majority of the health-care professionals to have a detailed syllabus on pharmacovigilance (84%) [Table 3].
Table 3: Attitude toward adverse drug reaction reporting among health professionals

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Practice of adverse drug reaction reporting

The practice of ADR reporting was low among health-care professionals (61%) though majority of them came across through patients experiencing ADRs (67%) and trained to report ADR (55%), and most of the study population accepted free access to ADR reporting forms (65%). Difficulty in decision-making was the main factor causing ADR underreporting (32%), followed by the lack of time (25%) [Table 4].
Table 4: Practice of adverse drug reaction reporting

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  Discussion Top


The cross-sectional questionnaire survey was done using health-care professionals (doctors, pharmacists, and nurses) on ADR reporting. Female participants (54%) exceeded male participants. Of the 100 study population, doctors were more in number (52%) followed by pharmacists (28%) and nurses (20%). Majority of the health-care professionals were aware about the actual purpose of pharmacovigilance (to enhance patient safety in relation to the use of drugs: 67%). The WHO definition of ADR was known to most of the health-care professionals (64%). Awareness about CDSCO as a regulatory body responsible for ADR monitoring was better among professionals (60%). Half percentage of the respondents believed that all serious ADRs, ADRs to vaccines, ADRs to new drugs, and unknown ADRs need to be reported indicating satisfactory knowledge. Spontaneous reporting system was not much familiar to health-care professionals as a common method used in ADR reporting (53%). Majority of the health-care professionals admitted their responsibility to report ADR (58%). Awareness about nearby ADR monitoring center, PvPI of CDSCO, ADR PvPI app, and ADR reporting form, among health-care professionals were 48%, 12%, 40%, and 47%, respectively, which can be correlated with unsatisfactory awareness among the study population. However, 63% of the respondents had no blind belief about the safety of drugs available in market, and the same percentage of the study population was aware about at least one drug banned due to ADR. The study pointed out the need of improvisation in knowledge level of health-care professionals, so that practice of ADR reporting can be increased. This result has some similarity to the results of the study conducted by Mohamed et al. in Saudi Arabia where lack of knowledge of health-care team resulted in low practice of ADR reporting.[8]

The study revealed 88% of health-care professionals agreeing that ADR monitoring and reporting is beneficial to patients. About 52% of the study population had a neutral response to the question that ADR reporting is a professional obligation to them. About 38% of the population think that ADR reporting is time-consuming with no outcome, and 31% of the study population expressed a neutral response to the same question. Most of the health-care professionals were having a neutral response to question enquiring their worry about legal problems involved in reporting ADR (53%). Most of the study population believed that all serious ADRs are known before a drug is marketed (56%). Neutral response was expressed by most of the population to the question whether ADR reporting affects patient confidentiality (42%). Positive attitude was found among majority of the health-care professionals to have a detailed syllabus on pharmacovigilance (84%). The results were pointing to unsatisfactory attitude of health-care professionals in ADR reporting.

The practice of ADR reporting was low among health-care professionals (61%) though majority of them came across patients experiencing ADRs (67%) and trained to report ADR (55%) and most of the study population accepted free access to ADR reporting forms (65%). This result was similar to findings of the study conducted by Mulatu et al. in Ethiopia.[1]

Practice of ADR reporting can be increased with improvement in knowledge level and positive attitude among health-care professionals. The statement could seek support from the result of the study conducted by Alsaleh et al.[5] in Kuwait where knowledge and positive attitude of pharmacists proved beneficial to increase ADR reporting. Educational interventions and formal tailored and frequent training to health-care professionals can increase the ADR understanding and reporting processes significantly [Table 5].
Table 5: Possible factors responsible for underreporting of adverse drug reaction

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  Conclusions Top


This study showed a general lack of knowledge among medical practitioners which contributed to the failure of recognition of the type of ADRs which has to be reported. This study also revealed majority of health professionals having less positive attitude toward ADR reporting resulting in low ADR reporting. This could be due to low level of knowledge and awareness among health professionals toward ADR reporting. Educational intervention strategies either by introducing details of pharmacovigilance in undergraduate curriculum or health-care education or National Drug Control Authority awareness programs can help in improving ADR reporting. Better attitude can be achieved with better awareness programs given to health-care professionals.

Acknowledgment

We express our sincere thanks to Dr. H. Doddayya, Principal, N.E.T Pharmacy College, Raichur, for his valuable help and providing necessary facilities to carry out this project.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Mulatu WN, Alemayehu W. Assessment of Knowledge, Attitude and Practice of Health Professionals towards Adverse Drug Reaction Reporting and Factors Associated with Reporting. J Pharmacovigilance. 2014;2(4):1-7.   Back to cited text no. 1
    
2.
Available from: https://www.who.int/medicines/regulation/medicines-safety/about/collab-centres-india/en/. Last accessed on 2019 January 26   Back to cited text no. 2
    
3.
Available from: https://cdsco.gov.in/opencms/opencms/en/Clinical-Trial/SAE/. Last accessed on 2019 January 26.   Back to cited text no. 3
    
4.
Fadare JO, Enwere OO, Afolabi AO, Chedi BAZ, Musa A. Knowledge, Attitude and Practice of Adverse Drug Reaction Reporting among Health Workers in a Tertiary Centre in Northern Nigeria. Trop J Pharm Res 2011;10(3):235-42.   Back to cited text no. 4
    
5.
Alsaleh FM, Alzaid SW, Abahussain EA, Bayoud T, Lemay J. Knowledge, attitude and practices of pharmacovigilance and adverse drug reaction reporting among pharmacists working in secondary and tertiary governmental hospitals in Kuwait. Saudi Pharm J 2017;25:830-7.   Back to cited text no. 5
    
6.
Divya G. Impact of educational intervention knowledge, attitude and practice pharmacovigilance among nurses. AM&HS. 2018;6:32-5.   Back to cited text no. 6
    
7.
Green CF, Mottram DR, Rowe PH, Pirmohamed M. Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting. PubMed 2001;51:81-6.   Back to cited text no. 7
    
8.
Mohamed MM, Abdel L, Basel A, Abdel W. Knowledge and awareness of adverse drug reactions and pharmacovigilance practices among healthcare professionals in Al-Madinah Al-Munawwarah, Kingdom of Saudi Arabia. Saudi Pharm J 2015;23:154-61.  Back to cited text no. 8
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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