Evaluation of the knowledge, attitude and practices on adverse drug reactions and pharmacovigilance among healthcare professionals in a Nepalese hospital: a preliminary study
P Subish, M Izham, P Mishra
adverse drug reactions, knowledge attitude and practice, nepal, pharmacovigilance
P Subish, M Izham, P Mishra. Evaluation of the knowledge, attitude and practices on adverse drug reactions and pharmacovigilance among healthcare professionals in a Nepalese hospital: a preliminary study. The Internet Journal of Pharmacology. 2007 Volume 6 Number 1.
Under reporting of Adverse Drug Reactions (ADRs) is a common problem in pharmacovigilance programs. Previous studies conducted out side Nepal acknowledged a poor Knowledge, Attitude and Practices (KAP) among the healthcare professionals regarding ADR monitoring and pharmacovigilance programs. Similar data is lacking in Manipal Teaching hospital (MTH) where pharmacovigilance program was started two years ago. Hence we studied the demographic details of the healthcare professionals and analyzed their knowledge, attitude and practices of healthcare professionals regarding adverse drug reactions and pharmacovigilance.
A survey was carryout among healthcare professionals. A KAP questionnaire was developed (Cronbach alpha value 0.72) and given to 24 healthcare professionals (10 doctors, 2 pharmacists and 12 nurses) working at MTH. The KAP questionnaire had a total of 25 questions. Each correct/positive answer was given a score of '1' whereas the negative/wrong answers were given a score of '0'. The total score is 25.
Nearly two third (66.7%) of the respondents were in the age group of 20-30 years old. The median duration of service of the respondents was 17 months. The mean ± SD total score was 11.3 ±4 .1 for nurses, 13.6 ± 3.7 for doctors and 13.0±7.1 for pharmacists. The study identified the KAP scores to be low and recommended educational and managerial intervention. It is expected that though these programs the KAP and awareness among the healthcare professionals will improve.
Adverse Drug Reactions (ADRs) are associated with a significant morbidity and mortality. 1,2,3,4 Recent estimates suggest ADRs to be the fourth major cause of death in the Unites States of America (USA). 3 In order to identify the culprit drugs causing ADRs, several countries have initiated pharmacovigilance programs in the recent past. Because of the variation in drug response among individuals, prescribing habits, drug regulatory system, availability of drugs etc, it has been recommended for every country to set up their own pharmacovigilance programs. 5
Although pharmacovigilance programs are successful in improving drug use patterns, under reporting of ADRs is felt as a major problem. 6 In order to improve the reporting rate, it is important to improve the Knowledge, Attitude and Practices (KAP) of the healthcare professionals regarding ADR reporting and Pharmacovigilance. Prior to carry out any intervention, it is necessary to evaluate the baseline KAP of the healthcare professionals regarding ADR monitoring and Pharmacovigilance. During our literature review, we could locate only few studies that evaluate the KAP of the healthcare professionals. 7,8,9
In Manipal Teaching Hospital (MTH), Pokhara, Nepal, the spontaneous reporting of ADRs was started more than three years ago (September 2004). MTH is recognized as the regional center for pharmacovigilance for the Western part of Nepal. The KAP of the healthcare professionals at MTH is not known. Hence, the present study was conducted with the following objectives:
to study the demographic details of the healthcare professionals under study
to analyze the knowledge, attitude and practices of healthcare professionals regarding adverse drug reactions and pharmacovigilance
to evaluate the knowledge, attitude and practices of healthcare professionals in terms of their demographic background
Study type: Survey method involving the doctors, nurses and pharmacists of MRH was carried out.
Study site: The study was carried out at MTH, a 700 bedded tertiary care hospital located in Western region of Nepal with average bed occupancy of about 200 patients and an average out patients of about 450 per day. On each day about 50 patients get admitted to the hospital. The hospital caters the healthcare needs of the patients of Western and Midwestern region of Nepal.
Inclusion and exclusion criteria: The healthcare professionals were randomized and included in the study. They were randomized in such a way that 10 percentage of the study population were included. Altogether a total of 24 healthcare professionals including 7 consultants/ doctors with a post graduate degree, 12 nurses, 2 pharmacists and 3 medical officers were included in the study. The healthcare professionals who were not willing to participate in the study and the ones who were on leave were excluded.
Sampling procedure: The list of all the healthcare professionals working in the hospital was obtained from the Human Resource Department (HRD) of the Hospital. The healthcare professionals were divided in four categories A, B, C and D. From each category approximately 10% of the subjects are selected by using the “Random Numbers Table.” Random sampling was carried out in the presence of the HRD personnel.
Study tools: For the purpose of the study, the KAP questionnaire was used. This KAP questionnaire is a newly developed questionnaire. It consists of a total of 25 questions. Among these questions 15 (1-5, 8-12, 17, 18, 21, 24, 25) were related to the Knowledge 5 (6, 7, 16, 22, 23) were related to Attitude and remaining 5 (13-15, 19-20) were related to the Practice aspects. (Appendix 1)
Designing of the questionnaire: The KAP questionnaire was designed by the researchers of the Pharmacovigilance center in MTH. The initial draft was made and circulated to the members of the research team and modifications were carried out as per the suggestions. Upon receiving the responses from healthcare professionals, its reliability was tested by finding the Cronbach alpha value (0.72).
Modality of obtaining response: Every healthcare professional is given 30 minutes of time to fill the questionnaire. Any clarification needed in understanding the questionnaire was provided.
Data analysis: The filled KAP questionnaires were analyzed using descriptive statistics using the Microsoft excel spread sheet. The SPSS (version 9) package was used to calculate the Cronbach alpha value.
Altogether 24 healthcare professionals gave their responses. Among these healthcare professionals 11 (45.8%) were males and 13 (54.1%) were females.
Age distribution of the respondents: A higher number [(16 (66.7%)] of respondents were within the age group of20-30 years old followed by 31-40 years old [7 (29.17%)] and 40-50 years old [1 (4.17%)]. The mean SD age of the patients was 28.4 6.9 years old.
Educational qualification of the respondents: The details regarding the educational qualification of the respondents are listed in Table 1.
Worksite of the healthcare professionals: The worksite distribution of the healthcare professionals is listed in Table 2.
Duration of service of the healthcare professionals: The duration of the service of the healthcare professionals varied from 2 months to 94 months with a median (interquartile range) of 17 (11.3 – 35.0) months.
Specialty of the healthcare professionals: The specialty of the healthcare professionals is listed in Table 3.
Mean KAP scores of the respondents: The mean KAP scores of the respondents were classified based on their profession and the details are in Table 4.
Discussion: The present study evaluated the KAP of the healthcare professionals working in MTH regarding ADR reporting and pharmacovigilance. Overall, the KAP scores were low. Doctors and pharmacists had a slightly higher score than the nurses.
The World Health Organization (WHO) defines pharmacovigilance as “science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems.” The ultimate aim of pharmacovigilance is to ensure safe and rational use of medicines, once they are released for general use in the society. The most important outcome of pharmacovigilance is the prevention of patients being affected unnecessarily by negative consequences of pharmacotherapy. 10
Pharmacovigilance programs have played a major role in detection of ADRs and banning of several drugs from the market. 5 However, under reporting of ADRs is one of the major problems associated with pharmacovigilance programs. 6 It is known that spontaneous reporting programs (one of the most widely used methods of Pharmacovigilance) are associated with relatively low levels of reporting. It is likely that less than 10% of serious reactions are notified. Problems of motivating reporters, commitment, and fear of recrimination for errors may be some of the factors responsible. The scheme operates on the basis of reporting all ADRs despite uncertainty about a causal relationship. 6 Even in countries like the United Kingdom where Pharmacovigilance programs are well established, a high level of under reporting is documented. 6
One of the better means of overcoming under reporting is to increase the KAP of the healthcare professional regarding ADR monitoring and pharmacovigilance programs. A study from Northern India reported that the KAP regarding ADR monitoring was low and the scores needed an improvement. 7 A survey among medical residents in France showed that the majority of them had a lower knowledge regarding pharmacovigilance. 8 A study from Italy reported that doctors had little information concerning ADRs and ADR reporting systems. 9 A recent study from India also identified that the awareness about pharmacovigilance program and the knowledge of ADR reporting were very low among the doctors. 11 These findings suggest the need for interventions to improve the KAP of the healthcare professionals. The intervention can be of presentation regarding ADR monitoring and pharmacovigilance in clinical meetings, supply of leaflets to the healthcare professionals regarding drug safety issues etc. It is also recommended that pharmacists play a great role in educating other healthcare professionals regarding prevention, detection and reporting of ADRs. 6 A lower KAP score identified by our study further necessitates the need for pharmacist mediated intervention in order to improve the KAP of the healthcare professionals in this regard.
Conclusion: The study identified the KAP of the healthcare professionals in MTH regarding ADR monitoring and pharmacovigilance. Overall the KAP scores were low. Our findings suggest the need for educational and managerial interventions.
Acknowledgements: We acknowledge all the healthcare professionals who spend their valuable time in filling the questionnaire. We thank Mr. VS. Binu, the Statistician, Department of Community Medicine for helping us to find out the Cronbach alpha value for finding out the reliability of the questionnaire. We also thank Ms. Sudershan Devi, the Chief Matron of Manipal Teaching Hospital for helping us in getting the responses from the nurses. And our special thanks to Mr Sathish Pai, Human Resource Department for providing us the list of the healthcare professionals working in Manipal Teaching Hospital.
P. Subish M.Pharm Assistant Professor Department of Hospital and Clinical Pharmacy/ Pharmacology Manipal Teaching Hospital/ Manipal College of Medical Sciences Pokhara, Nepal. Phone: +977 61 526416 Extn: 130/221 E-mail: firstname.lastname@example.org, email@example.com