|Year : 2015 | Volume
| Issue : 4 | Page : 154-158
Perception of Nigerian medical students on adverse drug reaction reporting
Abdullahi Rabiu Abubakar1, Bashir A. Z. Chedi2, Khalid Garba Mohammed3, Mainul Haque1
1 Unit of Pharmacology, Faculty of Medicine (FP), Universiti Sultan Zainal Abidin (UniSZA), 20400 Kuala Terengganu, Terengganu, Malaysia
2 Department of Pharmacology, College of Medicine, Bayero University, Kano, Nigeria
3 Faculty of Pharmaceutical Sciences, Bayero University Kano, Nigeria
|Date of Web Publication||5-Oct-2015|
Unit of Pharmacology, Faculty of Medicine (FP), Universiti Sultan Zainal Abidin (UniSZA), 20400 Kuala Terengganu, Terengganu
Source of Support: None, Conflict of Interest: None
Spontaneous reporting (SPR) and intensive monitoring are the conventional systems used for detecting, recording, and reporting adverse drug reactions (ADRs). Using spontaneous reporting a lot of successes has been made as existing ADRs were identified and new ones prevented through this methods. The aim of this appraisal was to evaluate the knowledge, attitude, and the practice of medical students with regards to ADRs reporting and to see if differences exist between the level of study and genders. The questionnaire was adopted, modified, and validated from previous studies. It comprised of 25 questions. It was administered year-IV and V medical students of Bayero University Kano, Nigeria. The data collected were coded and analyzed using the Statistical Package for the Social Sciences (SPSS) version 20, currently known as IBM SPSS Statistics. The response rate was 74%. Among the 108 participants, 80% got the definition of ADRs correct; 63% of them knew the precise functions of pharmacovigilance (PV). In addition, 82% strongly agreed that ADR reporting is health care workers responsibility; 82% also said PV should be taught in detail. Meanwhile, 99% have noticed patient experiencing ADRs; 67% said even mild ADRs should be reported. The outcome of this study showed good knowledge and attitude with respect to ADRs and PV among the medical students surveyed. Unfortunately, the practice of medical students was found to be unsatisfactory. There is a need to upgrade the students teaching the curriculum with respect to ADRs monitoring.
Keywords: Adverse drug reaction, medical students, perception, pharmacovigilance, spontaneous reporting
|How to cite this article:|
Abubakar AR, Chedi BA, Mohammed KG, Haque M. Perception of Nigerian medical students on adverse drug reaction reporting. J Adv Pharm Technol Res 2015;6:154-8
|How to cite this URL:|
Abubakar AR, Chedi BA, Mohammed KG, Haque M. Perception of Nigerian medical students on adverse drug reaction reporting. J Adv Pharm Technol Res [serial online] 2015 [cited 2020 Oct 1];6:154-8. Available from: http://www.japtr.org/text.asp?2015/6/4/154/165021
| Introduction|| |
Pharmacovigilance (PV) is described by WHO as a process of detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. ,, The first endeavor made to resolve the problem of drug safety was announced in 1961 promptly after the disaster caused by thalidomide treatment in pregnant women. ,,,, The spontaneous reporting system, on many occasions, was applied to facilitate early detection and prevention of new drugs tragedy also to expand quality assurance and safety in labeling of pharmaceutical products. ,,,,, However, apart from the advantages of Spontaneous reporting (SPR) the major hitch is underreporting; in many hospitals only 10% of adverse drug reactions (ADRs) incidents were reported. ,,,,,, The primary focus of SPR is to report all the prevalence of ADRs even if not much data is available and the causal relationship is yet to be established. , Surveys carried out specified that SPR have continuously received reports from doctors, dentists, and pharmacists in all of the countries studied. ,,, Surprisingly, <25 reports obtained from countries such as Congo, Cyprus, and Uzbekistan. One of the advanced country on the African continent is South Africa, and the reported cases were only a few hundred; however, over 20,000 reports were generated from the USA annually. , PV as the program requires a multidisciplinary approach and can only be accomplished if all health care teams are committed to organizing and implementing proper ADRs reporting system. ,,,, As such doctors, nurses, and pharmacists are the backbone of PV program and are solemnly responsible for detecting, recording, and reporting ADRs. ,,,,,, It is the responsibility of doctors, as well as a pharmacist, to counsel their patients on the likelihood of ADRs that may occur during the treatment. ,,,,,
The WHO center for ADRs monitoring is known as Uppsala Monitoring Centre. ,,, It is an International establishment with the responsibility of coordinating PV program based on an agreement made in 1978, and reconsolidated in December 2001, between the WHO and Swedish Government. ,,, The current survey will be carried out to assess the knowledge, attitude, and the practice of medical students in Nigeria.
| Materials and methods|| |
The appraisal was carried out among the population of medical students of Bayero University Kano (BUK), Nigeria, which is located in the Kano state of Nigeria, with a population of 9.4 million people.  This research was designed as a cross-sectional questionnaire-based study to assess the medical students' knowledge, attitude, and the practice on ADRs and PV. A universal sample of 146 medical students of year-IV and V from BUK, Nigeria were selected out of the total of 519 medical students in the department of medicine. Only students studying medicine that reached year-IV and V and who were willing to take part in the study were selected. All other year medical students were excluded. The survey tool was adopted, modified, and validated. , It comprises of four parts: Section A is demographic information. Section B comprises of knowledge questions designed with yes/no options; a score of 1 was allocated to the yes answer and 0 to the no answer. Section C comprise of attitude questions framed into three points Likert's scale (3 = strongly agree, 2 = neutral, 1 = strongly disagree). Finally, section D comprises of practice questions with yes/no options. A score of 1 was assigned to the yes answer and 0 to the no answer. It was first pilot-tested in 20 medical students who were not involved in the main survey. Their response was then tested for validity and reliability and the overall Cronbach's alpha was calculated as 0.69.
The questionnaires were shared among 146 respondents to answer. One-hundred and eight medical students from year-IV and V completed and returned the questionnaires giving the response rate of 74%. Descriptive statistics were carried out to evaluate the knowledge, attitude, and practice score of the participants. Independent t-test was performed to determine if there was the difference in mean knowledge score on ADRs and PV between year-IV and V; and between genders. The study was conducted from June 2014 to February 2015. This research was approved by the ethical committee of UniSZA; Memo No: UniSZA.N/1/628-1 (70), July 21, 2014.
| Results|| |
One-hundred and eight medical students responded giving the response rate of 74%. The summary of the demographic information is shown in [Table 1].
Of the 108 participants, 86 (80%) and 71 (66%) got the right definition of ADR and PV; 68 (63%) identified the correct functions of PV. Similarly, 77 (71%) knew the right people to report ADRs, 77 (71%) learned how to treat ADRs. Ninety-two (85%) heard about drugs banned due to ADRs; 101 (94%) said not all drugs on the market are safe. In addition, 92 (85%) felt that it is mandatory to have PV center in all medical schools. In contrast, only 11 (10%) located any PV center; and 42 (39%) recognized the method commonly applied in ADR reporting. The results are shown in [Table 2].
Eighty-nine (82%) strongly agreed that ADR reporting is health care workers responsibility; 88 (82%) said PV should be taught in detail. Similarly, 103 (95%) strongly agreed that ADRs monitoring will help patients. In addition, 56 (52%) worried about a legal aspect of PV. In contrast, 91 (84%) strongly agreed that ADR reporting is a waste of time; 80 (74%) strongly disagreed that they were adequately trained on PV; also, 52 (48%) stated that all serious ADRs were recognized before the drugs are marketed. The results are shown in [Table 3].
Of the total respondents, 107 (99%) have noticed patient experiencing ADRs; 72 (67%) said mild ADRs such as a headache, fever, and vomiting should be reported. Similarly, 90 (83%) acknowledged that patient can report his symptoms to nearby PV center; 105 (97%) expected feedback from PV center. In contrast, only 4 (4%) have ever reported ADRs; only 9 (8%) had access to the ADRs reporting form. Furthermore, only 15 (14%) had training on PV; only 20 (19%) read any article on ADRs monitoring. The results are shown in [Table 4].
Level of study
Independent t-test conducted showed that there was no statistically significance difference in the mean knowledge score on ADRs and PV between year-IV and V medical students at P = 0.956, upper and lower confidence interval (CI) (−0.0654 and 0.0619).
Independent t-test performed indicated that there was no statistically significance difference in the mean knowledge score on ADRs and PV between male and female medical students at P = 0.080, upper and lower CI (−0.1266 and 0.0072).
| Discussion|| |
According to our findings, 80% and 66% of the participants got the definition of ADRs and PV correctly. These findings are similar to the outcome of another survey among pharmacy students  but higher than the previous researches conducted. ,, Meanwhile, 63% knew the functions of PV, which is similar to the outcome of another study among pharmacy students.  In addition, 71% knew the people responsible for ADRs reporting which is higher than the finding of another survey.  Eighty-five percent heard about drugs banned due to ADRs, which is higher than the result of another survey among medical and dental students.  In contrast, only 10% located any PV center which coincides with the outcome of another study among pharmacy students  and among medicine students. , Finally, 39% recognized the method commonly applied in ADR reporting. This finding is comparable to the result of a survey conducted among pharmacy and medicine students. ,
Eighty-two percent strongly agreed that ADR reporting is health care workers responsibility, which is much higher than the outcome of other surveys among pharmacy students  among medical and dental students;  82% said PV should be taught in detail, which is similar to the result of another appraisal among pharmacy students.  Similarly, 95% strongly agreed that ADRs monitoring will help patients, which is much higher than the outcome of a study carried out among pharmacy students.  In contrast, only 15% strongly agreed that they were adequately trained on PV which similar to the findings of another study  but lower than the outcome of a study carried out among medical students. 
Of the total respondents, 99% have noticed patient experiencing ADRs, which is higher than the outcome of another appraisal conducted among medical and dental students  and among pharmacy students.  About 67% said mild ADRs such as a headache, fever, and vomiting should be reported; similar result was obtained in another research involving medicine and pharmacy student.  Similarly, 83% acknowledged that patient can report his symptoms to nearby PV center; this is higher than what was obtained in another study involving pharmacy students.  In contrast, only 4% have ever reported ADRs which is comparable to another survey among pharmacy students.  Furthermore, only 8% had access to ADRs reporting form; the similar outcome was obtained in another study. 
| Conclusion|| |
The outcome of this study showed good knowledge and attitude with respect to ADRs and PV among the medical students studied. Unfortunately, the practice of medical students was found to be unsatisfactory. ADR monitoring should be included in detail in medical students' curriculum. Furthermore, to implement the use of information and communication technology in prescription, dispensing, and drug administration, as well as the use of the automated system, in ADRs monitoring.
Limitation of the study
The outcome of this survey cannot be generalized to all Nigerian medical schools; more schools need to be studied to enable generalization of these findings.
The authors are much grateful to those medical students who participated in the study. The authors would like sincere thanks to the Faculty of Medicine, Universiti Sultan Zainal Abidin.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Abubakar AR, Simbak NB, Haque M. A systematic review of knowledge, attitude and practice on adverse drug reactions and pharmacovigilance among doctors. J Appl Pharm Sci 2014;4:117-27. Available from: . [Last accessed on 2015 Jan 10].
Abubakar AR, Simbak NB, Haque M. Drug safety surveillance: Modern trends and industrial action. J Young Pharm 2015;7:69-75. Available from: . [Last accessed on 2015 Feb 10].
Bisht M, Singh S, Dhasmana DC. Effect of educational intervention on adverse drug reporting by physicians: A cross-sectional study. ISRN Pharmacol 2014;2014:259476.
Iffat W, Shakeel S, Rahim N, Anjum F, Neesar S, Ghayas S. Pakistani physicians′ knowledge and attitude towards reporting adverse drug reactions. Afr J Pharm Pharmacol 2014;8:379-85. Available from: . [Last accessed on 2015 Jan 10].
Adedeji WA, Ibraheem WA, Fehintola FA. Attitude and practice of doctors toward adverse drug reactions (ADRs) reporting in a Nigerian tertiary health facility. Ann Ib Postgrad Med 2013;11:77-80.
World Health Organization (WHO). Safety of Medicines. A Guide to Detecting and Reporting Adverse Drug Reactions. Why Health Professionals Need to Take Action. Geneva: World Health Organization; 2002. Available from: . [Last accessed on 2015 Jan 10].
The Uppsala Monitoring Centre (UMC). Report from the World Health Organisation Collaborating Centre for International Drug Monitoring; 2013. Available from: http://www.who-umc.org/graphics/28368.pdf
. [Last accessed on 2015 Jan 10].
Palaian S, Ibrahim MI, Mishra P. Health professionals′ knowledge, attitude and practices towards pharmacovigilance in Nepal. Pharm Pract (Granada) 2011;9:228-35.
Kiran LJ, Shivashankaramurthy KG, Bhooma S, Dinakar KR. Adverse drug reaction reporting among clinicians in a teaching hospital in South Karnataka. Sch J Appl Med Sci 2014;2:399-403. Available from: . [Last accessed on 2015 Jan 10].
Hanafi S, Torkamandi H, Hayatshahi A, Gholami K, Javadi M. Knowledge, attitudes and practice of nurse regarding adverse drug reaction reporting. Iran J Nurs Midwifery Res 2012;17:21-5.
Kamtane RA, Jayawardhani V. Knowledge, attitude and perception of physicians towards adverse drug reaction (ADR) reporting: A pharmacoepidemiological study. Asian J Pharm Clin Res 2012;5:210-4. Available from: http://www.ajpcr.com/Vol5
Suppl 3/1231.pdf. [Last accessed on 2015 Jan 10].
Elkalmi RM, Hassali MA, Ibrahim MI, Widodo RT, Efan QM, Hadi MA. Pharmacy students′ knowledge and perceptions about pharmacovigilance in Malaysian public universities. Am J Pharm Educ 2011;75:96.
Sanghavi DR, Dhande PP, Pandit VA. Perception of pharmacovigilance among doctors in a tertiary care hospital: Influence of an interventional lecture. Int J Risk Saf Med 2013;25:197-204.
Vora MB, Paliwal NP, Doshi VG, Barvaliya MJ, Tripathi CB. Knowledge of adverse drug reactions and pharmacovigilance activity among the undergraduate medical students of Gujarat. Int J Pharm Sci Res 2012;3:1511-5. Available from: . [Last accessed on 2015 Jan 10].
Reddy VL, Pasha SK, Rathinavelu M, Reddy YP. Assessment of knowledge, attitude and perception of pharmacovigilance and adverse drug reaction (ADR) reporting among the pharmacy students in South India. IOSR J Pharm Biol Sci 2014;9:34-43. Available from: . [Last accessed on 2015 Jan 10].
Iffat W, Shakeel S, Naseem S, Imam S, Khan M. Attitudinal survey to assess medical and dental students′ belief of ADR reporting in Pakistan. Int J Pharm Pharm Sci 2014b; 6:279-83. Available from: . [Last accessed on 2015 Jan 10].
Rehan HS, Vasudev K, Tripathi CD. Adverse drug reaction monitoring: Knowledge, attitude and practices of medical students and prescribers. Natl Med J India 2002;15:24-6.
Hema NG, Bhuvana KB, Sangeetha. Pharmacovigilance: The extent of awareness among the final year students, interns and postgraduates in a government teaching hospital. J Clin Diagn Res 2012;6:1248-53. Available from:http://www.jcdr.net/articles/PDF/2474/33%20-%204216_U%28P%29.pdf. [Last accessed on 2015 Jan 10].
Isfahani ME, Mousavi S, Rakhshan A, Assarian M, Kuti L, Eslami K. Adverse drug reactions: Knowledge, attitude and practice of pharmacy students. J Pharm Care 2013;1:145-8. Available from: . [Last accessed on 2015 Jan 10].
Durrieu G, Hurault C, Bongard V, Damase-Michel C, Montastruc JL. Perception of risk of adverse drug reactions by medical students: Influence of a 1 year pharmacological course. Br J Clin Pharmacol 2007;64:233-6.
[Table 1], [Table 2], [Table 3], [Table 4]
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