|Year : 2021 | Volume
| Issue : 2 | Page : 248-255
Assessment of a pharmacovigilance module: An interventional study on knowledge, attitude, and practice of pharmacy students
Subish Palaian1, Mohamed Izham Mohamed Ibrahim2, Pranaya Mishra3, Pathiyil Ravi Shankar4
1 Department of Clinical Sciences, College of Pharmacy and Health Sciences, Ajman University, Ajman, UAE
2 Department of Clinical Pharmacy and Practice, College of Pharmacy, QU Health, Qatar University, Doha, Qatar
3 Ross University School of Medicine, Miramar, FL, USA
4 IMU Centre for Education, International Medical University, Kuala Lumpur, Malaysia
|Date of Submission||17-Sep-2020|
|Date of Decision||30-Sep-2020|
|Date of Acceptance||16-Dec-2020|
|Date of Web Publication||26-May-2021|
Dr. Subish Palaian
Department of Clinical Sciences, College of Pharmacy and Health Sciences, Ajman University, Ajman
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: The aim of the study was to assess the impact of a pharmacovigilance module on the knowledge, attitude, and practice (KAP) of pharmacy students and elucidate their feedback on the module. Methodology: Bachelor of pharmacy students at Pokhara University, Nepal, were assessed for their baseline KAP on drug safety and related issues using a KAP questionnaire (Cronbach alpha 0.70) consisting of 25 questions. Students' baseline KAP was assessed and after that, they were grouped into either control (2nd and 4th year) or test (1st and 3rd year) groups. The later received the pharmacovigilance training in three 1-h sessions spread over 6 months at 0, 90, and 180 days; the sessions covered introduction to pharmacovigilance, theoretical aspects of pharmacovigilance, and adverse drug reaction reporting procedures. KAP scores and student feedback were analyzed at 5% significance level. Results: A total of 124 students (control = 56 and test = 68) were studied. The median (interquartile ranges [IQRs]) of the baseline scores prior to grouping the students into control and test groups was 20 (18.25–21.00) for knowledge, 19.5 (18.00–21.00) for attitude/practice, and 39 (37.00–41.00) for the total score. Males (n = 81) had a slightly higher median score of 40 (37–42) than females (n = 43), who had a median score of 38 (36–41). The KAP score for the control group was 40 (38–42) at baseline, 42 (20–44) during first follow-up, 41.5 (40–44) during second follow-up, and 41 (39–44.5) during third follow-up. For the test group, upon intervention, the KAP scores improved from 39 (36.25–40.75) at baseline to 42 (39.50–44.00) at the 1st follow-up, 43 (41–45) at the 2nd follow-up, and 44 (42–45) at the 3rd follow-up (P < 0.001). The median feedback score (IQR) was 86 (81.5–90.0). Conclusions: Pharmacy students had good attitude/practice scores and relatively poor knowledge scores at baseline, which improved postintervention. Student feedback about the module was positive.
Keywords: Adverse drug reactions, education module, health-care professionals, Nepal, patient safety, pharmacovigilance, pharmacy
|How to cite this article:|
Palaian S, Ibrahim MI, Mishra P, Shankar PR. Assessment of a pharmacovigilance module: An interventional study on knowledge, attitude, and practice of pharmacy students. J Pharm Bioall Sci 2021;13:248-55
|How to cite this URL:|
Palaian S, Ibrahim MI, Mishra P, Shankar PR. Assessment of a pharmacovigilance module: An interventional study on knowledge, attitude, and practice of pharmacy students. J Pharm Bioall Sci [serial online] 2021 [cited 2022 May 20];13:248-55. Available from: https://www.jpbsonline.org/text.asp?2021/13/2/248/316935
| Introduction|| |
Future health-care professionals (HCPs) need to be competent in handling adverse drug reactions (ADRs) in health-care practice and reporting them to the relevant authority. Since only limited information is available on medicine safety prior to marketing and most of the adverse effects are noticed once the medicines are used in a wide variety of patients, safety monitoring of all available products is mandatory. Hence, immediate reporting of ADRs of medicines while they are in common use by the general public is essential which eventually helps in early prediction and prevention of larger negative consequences. It is well understood that many ADRs can be prevented with improvements in the prescription, dispensing, and utilization of medicines. To enhance the safe use of medicines, HCPs should possess adequate knowledge of ADRs and their early detection and prevention strategies. Upon the occurrence of an ADR, HCPs must report ADRs via the existing ADR reporting mechanism in the country and hence should be knowledgeable about the ADR reporting systems in their regions and countries. It is well known that attitudes toward ADRs influence actual reporting by HCPs.,, Studies have acknowledged poor knowledge and perception among health professionals on pharmacovigilance.,
Thus, attitude changes among HCPs, a crucial factor can be partly achieved by exposing them to ADR reporting and pharmacovigilance when they are students. In developed nations, pharmacovigilance is addressed in medical and pharmacy curricula., Nepal is a developing country with limitations in establishing a strong pharmacovigilance mechanism, and hence, ADRs are often underreported. Since pharmacists are experts of medicines, they should play a vital role in medicine safety monitoring and reporting. Pharmacists are able to report ADRs occurring in the community through community pharmacy practice. To successfully contribute to pharmacovigilance activities, pharmacists should be knowledgeable and well versed with the existing systems and a most appropriate time to impart these knowledge and skills can be during their undergraduate studies. In Nepal, pharmacovigilance is underemphasized in the undergraduate pharmacy curriculum compared to other topics.,, Training pharmacy students on pharmacovigilance can produce future pharmacists well versed with drug safety monitoring and can thus contribute to the national pharmacovigilance program. The undergraduate pharmacy curriculum in Nepal largely prepares the candidates for jobs in pharmaceutical industries and provides less training for jobs in hospitals or community pharmacies and on the safe use of medications though the scenario is changing recently. This approach in pharmacy education can lead to a poor understanding among students about existing pharmacovigilance programs. It may limit their contribution to medicine safety programs, ultimately leading to the underreporting of ADRs, which is a common problem related to pharmacovigilance. At the student level, an individual is more open to adopting changes that can easily be comprehended, and thus, it is essential to make students aware of pharmacovigilance. Investment in the quality of education necessitates the development of educational research and the measurement of the impact of the investment on knowledge, attitude, and practice (KAP). The initiative mentioned in the current study may be helpful for members from other developing countries working on pharmacovigilance educational needs. This study aimed to evaluate the KAP of pharmacy students toward ADRs and pharmacovigilance, to study the impact of the educational intervention on their KAP, and to obtain students' feedback on the sessions.
| Methodology|| |
This was a prospective pre–post interventional study evaluating KAP scores of pharmacy students attending education sessions with control group students.
The research proposal was discussed and approved by the Dean of the School of Pharmaceutical and Biomedical Sciences at Pokhara University and the program coordinator of the pharmacy program. Verbal consent was obtained from the students prior to enrollment in the study. This research is an educational initiative involving knowledge sharing and quality improvement and hence did not require approval at the institute level.
Duration of the study and study location
The study was conducted over a period of 6 months during the year 2009. The study was carried out in the western region of Nepal. The study location was the School of Pharmaceutical and Biomedical Sciences at Pokhara University, Nepal.
Study population and sampling procedure
All pharmacy students (1–4-year BPharm students) from the School of Pharmaceutical and Biomedical Sciences, affiliated with Pokhara University, were included after obtaining verbal consent. The participation in the research was voluntary. The control group had 2nd and 4th year students and the test group had 1st and 3rd year students, chosen based on odd or even numbers of the year of study. Absentees of the first session were completely excluded from further analysis.
A modified version of a KAP questionnaire, previously used by researchers in Nepal, was used. This questionnaire had 25 questions (14 questions on knowledge, i.e., items 1, 2, 3, 8, 9, 12, 14, 15, 16, 17, 18, 21, 22, 24, and 11 questions on attitude/practice, i.e., items 4, 5, 6, 7, 10, 11, 13, 19, 20, 23, and 25). The questionnaire was pretested (Cronbach's alpha score = 0.70). Correct/positive responses were given a score of 2, and the wrong/negative responses a score of 1.
Students' feedback ábout the intervention was evaluated using 20 questions with a Likert-type scale (maximum score for individual questions 5 and maximum total score 100). This questionnaire was previously used in other studies in both Nepal and Malaysia. For the feedback questionnaires, the scoring was performed based on a response scale ranging from 1 to 5, with 1 meaning “strongly disagree” and 5 meaning “strongly agree.” Only whole numbers were to be used for indicating agreement.
The baseline KAP scores were calculated prior to the intervention in both the groups, though only the test groups were provided the intervention. KAP assessment was done at 0, 30, 90, and 180 days. Feedback responses from the test group students who receive the training were obtained after all three sessions were completed.
The intervention provided in this research included three training sessions: Session I (small group exercises), Session II (slide presentation), and Session III (visit to the regional pharmacovigilance center).
The main objective of Session I (small group exercises) was to introduce students to the existing national pharmacovigilance program and teach them to assess the causality and severity of ADRs using the Naranjo algorithm and the modified Hartwig and Siegel scale, respectively. The students also received copies of “Pharmacovigilance Nepal: a guide for HCPs,” and other published materials on the topic.
Session II (slide presentation) aimed to address the theoretical aspects of pharmacovigilance and
Session III (visit to the Regional Pharmacovigilance Center) covered the operational aspects of a pharmacovigilance program. Students were divided into small groups of 10–15 students.
Data normality was verified using the one-sample Kolmogorov–Smirnov test. The scores were not normally distributed and the median (interquartile range [IQR]) total score of the students was compared among the subgroups using Mann–Whitney U-test and Kruskal–Wallis test and the pre–post median KAP scores using Wilcoxon signed-rank test at P = 0.05.
Prior to conducting the study, a pilot study was conducted to test the study methods in terms of their feasibility and validity.
| Results|| |
In total, 124 pharmacy students (56 in the control and 68 in the test group) participated [Table 1].
Among the 124 pharmacy students, the majority (65.3%) were males, and a high percentage of the students were self-financed (84.7%) [Table 1].
Baseline knowledge, attitude, and practice scores
The median (IQRs) overall baseline scores were 20.0 (18.2–21.0) for knowledge, 19.5 (18.0–21.0) for attitude/practice, and 39.0 (37.0–41.0) for the total score. The maximum possible knowledge, attitude/practice and total scores were 28, 22, and 50.
Students' responses to the knowledge questions
A high percentage of the students (n = 104; 83.9%) knew how to reach the regional pharmacovigilance center in case of a suspected ADR. Only a small number of respondents (n = 9; 7.3%) were knowledgeable about the scales used for the causality assessment of ADRs [Table 2].
|Table 2: Pharmacy students’ responses to knowledge-related questions (n=124)|
Click here to view
Students' responses to the attitude/practice questions: the responses to the attitude/practice questions are listed in [Table 3].
|Table 3: Students’ responses to attitude/practice-related questions (n=124)|
Click here to view
Respondents' knowledge, attitude, and practice scores at the time of enrollment
The scores differed significantly according to age and year of study. The details are listed in [Table 4].
|Table 4: Baseline knowledge, attitude, and practice scores among student subgroups (n=124)|
Click here to view
Knowledge, attitude, and practice outcomes before and after the intervention
In the test group, upon intervention, the knowledge scores improved between the baseline and the first follow-up (P = 0.000) and between the first and the second follow-up (P = 0.001). Similarly, the attitude/practice scores also improved between the first and the second follow-up (P = 0.000). There was also an overall improvement in the total scores between the baseline and first follow-up (P = 0.000) and between the first and second follow-up (P = 0.000).
The control group which did not receive any intervention also showed an improvement in the knowledge scores between the baseline and first follow-up (P = 0.000) and an improvement was noticed in the attitude/practice scores between the baseline and first follow-up (P = 0.020). The total score in this group also improved significantly between the baseline and first follow-up (P = 0.000) and between the second and third follow-up (0.040). Further details are in [Table 5].
|Table 5: Knowledge, attitude, and practice outcomes among pharmacy students before the intervention and at different time points after the educational intervention|
Click here to view
Feedback on the educational intervention
The feedback was obtained from 65 students since three of them submitted incomplete feedback forms. The median feedback score (IQR) was 86 (81.5–90.0). Overall, the students had positive perceptions of the training, except a question on the success of the national ADR monitoring program in the country, which had a poor score. In this case, the median score (IQR) was 3 (2–3). The median score (IQR) for each item is presented in [Table 6].
|Table 6: Pharmacy students’ feedback about the pharmacovigilance sessions|
Click here to view
| Discussion|| |
This study was carried out in Nepal to evaluate the KAP of pharmacy students towards ADR and pharmacovigilance, to study the impact of the educational intervention on their KAP, and to obtain students' feedback on the sessions. In brief, the findings indicated that the future HCPs had good attitude and practice scores but poor knowledge scores. The assessment also showed improvement after the intervention, and the students' feedback on the sessions was positive.
Pharmacovigilance is a key to the rational use of medicines and helps to create awareness of medicine safety among the public. Pharmacists are key players in the health-care system. Data worldwide showed low pharmacovigilance-related knowledge among HCPs., Similarly, there is also inadequate teaching of pharmacovigilance to students, who are future HCPs. Increasing students' awareness in the area of drug safety and familiarizing them with the existing pharmacovigilance programs can help them in reporting ADRs.
Pharmacists play a vital role in ADR reporting programs., Hence, it is important to include adequate information about pharmacovigilance in pharmacy curricula. This study evaluated undergraduate pharmacy students' KAP related to ADRs and pharmacovigilance. The results showed high attitude scores at baseline but poor knowledge scores among the students, highlighting the need for education. Surprisingly, only 4.8% of the students knew the name of the WHO online database for member countries to report ADRs. All these findings suggest a lack of awareness and poor knowledge regarding national and international pharmacovigilance programs. A few studies have reported similar findings. Authors from Malaysia evaluated the perceptions and knowledge of pharmacy students in Malaysia and found respondents pharmacovigilance and ADR reporting related knowledge insufficient. One Saudi Arabian study assessed pharmacy students' knowledge, attitudes, and readiness concerning ADR reporting and pharmacovigilance. The authors found the students to be lacking in all three domains and believed that topics related to ADR reporting should be taught in pharmacy curricula. Another study in Saudi Arabia illustrated that the awareness and knowledge levels of HCPs in a hospital setting were insufficient. A study in Nigeria among pharmacy students evaluated their knowledge and perceptions of pharmacovigilance. They found that respondents lacked knowledge of pharmacovigilance activities.
The undergraduate pharmacy curriculum in Nepal is focused on the pharmaceutical industry and does not adequately cover areas related to the rational use of medicines; hence, greater awareness of these areas is necessary. The training program addressed these vital areas for familiarizing students with pharmacovigilance programs. Causality and severity assessments are very important in pharmacovigilance programs. Less than one-tenth of the students knew the name of the causality assessment scale, and less than one-fifth of them knew the name of the severity scale. Pharmacovigilance competencies for students, as future HCPs, are vital for the safe utilization of medicines. Pharmacovigilance topics can be included in existing courses, such as pharmacology and pharmacotherapy, or a unique course that focuses on pharmacovigilance and patient safety could be created.
Although the knowledge scores were low, almost all (96%) students believed that knowing more about ADRs was relevant. Similarly, nearly all (95.2%) of them wanted to learn more on ADRs. A high percentage (77.4%) of the students thought that herbal drugs carry equal potential for harm as allopathic medicines. However, a few students believed that because herbal medicines are derived from natural sources, they are free from ADRs. The sale of herbal drugs is very common in countries such as Nepal, and thus, there is also a need to make students aware of the possible harmful effects of herbal drugs.
The analysis of the feedback questionnaires revealed that the students liked the sessions. They indicated that the sessions improved their understanding of pharmacovigilance and its importance in the country. Upon training, students perceived the National Pharmacovigilance program as not being successful. More number of students felt the importance of incorporating pharmacovigilance into the curricula of health professionals. It was noticed that a good number of respondents, even after training, felt herbal medicines to be safe from ADRs, although herbal drugs are also known to cause ADRs. Most of the students, as mentioned in the feedback, would attend similar sessions in future. In a similar study in Malaysia, researchers conducted a pharmacovigilance education session and reported that students had positive opinions about the sessions.
According to Comoglio, there are three important aspects in educating HCPs. Awareness, knowledge, and reporting are pivotal to help prevent and mitigate both ADRs and medication errors. Undergraduate education is expected to provide sufficient skills and knowledge to the future HCPs regarding patient safety. Reumerman et al. stressed that there is a pressing need to improve and innovate existing pharmacovigilance education for undergraduate health-care students.
This study had a few limitations. The main limitation was the sample of the study, which involved students from only one institution and hence limited the generalizability of the results. Moreover, there was a possibility that resources were shared among the intervention and control groups, which may have led to an improvement in the scores of the control group who did not receive the training. Furthermore, the study was conducted in 2009 though information obtained by the authors leads to believe that the situation today is not much different from that described in the study.
| Conclusions|| |
In summary, the findings of the study showed that the pharmacy students' KAP on pharmacovigilance improved after intervention. Similarly, the students' feedback on the training was also positive. In countries such as Nepal, pharmacists could be a valuable resource for improving pharmacovigilance mechanisms. Regional pharmacovigilance centers and pharmacy colleges should take responsibility for teaching pharmacovigilance to students.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Stricker BH, Psaty BM. Detection, verification, and quantification of adverse drug reactions. BMJ 2004;329:44-7.
McDonnell PJ, Jacobs MR. Hospital admissions resulting from preventable adverse drug reactions. Ann Pharmacother 2002;36:1331-6.
Herdeiro MT, Figueiras A, Polónia J, Gestal-Otero JJ. Physicians' attitudes and adverse drug reaction reporting: A case-control study in Portugal. Drug Saf 2005;28:825-33.
Figueiras A, Tato F, Fontaiñas J, Gestal-Otero JJ. Influence of physicians' attitudes on reporting adverse drug events: A case-control study. Med Care 1999;37:809-14.
Granas AG, Buajordet M, Stenberg-Nilsen H, Harg P, Horn AM. Pharmacists' attitudes towards the reporting of suspected adverse drug reactions in Norway. Pharmacoepidemiol Drug Saf 2007;16:429-34.
Abu Hammour K, El-Dahiyat F, Abu Farha R. Health care professionals knowledge and perception of pharmacovigilance in a tertiary care teaching hospital in Amman, Jordan. J Eval Clin Pract 2017;23:608-13.
Alslubi H, El-Dahiyat F. Patient safety practices among community pharmacists in Abu Dhabi, United Arab Emirates. J Pharm Health Serv Res 2019;10:203-10.
Cox AR, Marriott JF, Wilson KA, Ferner RE. Adverse drug reaction teaching in UK undergraduate medical and pharmacy programmes. J Clin Pharm Ther 2004;29:31-5.
Zenut M, Fialip J, Lavarenne J. Educational interest of systematic collection of adverse drug reactions (with regard to an experience of nearly 20 years), Pharmacoepidemiol Drug Saf 1998; 7 Suppl 1:S51-3.
Kathmandu University. Bachelor of Pharmaceutical Sciences (B.Pharm.) Curriculum (revised). Dhulikhel, Kavre, Nepal: Kathmandu University; 2004.
Pokhara University. Bachelor of Pharmaceutical Sciences (B.Pharm.) Curriculum. Pokhara, Nepal; Kathmandu University; 2004.
Council of Technical Education and Vocational Training. Available from: www.ctevt.org.np. [Last accessed on 2016 Jun 20].
Palaian S, Ibrahim MI, Mishra P. Health professionals' knowledge, attitude and practices towards pharmacovigilance in Nepal. Pharm Pract (Granada) 2011;9:228-35.
Subish P, Khanal S, Alam K, Paudel A. Introducing pharmacovigilance to postgraduate pharmacy students in Nepal. Am J Pharm Educ 2009;73:114.
Subish P, Poudel A, Izham MI. Pharmacovigilance sessions for undergraduate pharmacy students in Malaysia. J Pharm Pract Res 2009;39:329-30.
Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al.
A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30:239-45.
Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 1992;49:2229-32.
Subish P, Izham M, Mishra P. Pharmacovigilance in Nepal. A Guide for Healthcare Professionals. Pokhara, Nepal: Regional Pharmacovigilance Centre; 2007.
Subish P, Mohamed Izham MI, Mishra P, Shankar PR, Alam K. Education sessions for the pharmacy students on Pharmacovigilance: A preliminary study. J Clin Diagn Res 2010;4:2427-32.
Cosentino M, Leoni O, Banfi F, Lecchini S, Frigo G. Attitudes to adverse drug reaction reporting by medical practitioners in a northern Italian district. Pharmacol Res 1997;35:85-8.
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.
van Grootheest AC, de Jong-van den Berg LT. The role of hospital and community pharmacists in pharmacovigilance. Res Social Adm Pharm 2005;1:126-33.
van Grootheest K, Olsson S, Couper M, de Jong-van den Berg L. Pharmacists' role in reporting adverse drug reactions in an international perspective. Pharmacoepidemiol Drug Saf 2004;13:457-64.
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.
Alkayyal N, Cheema E, Hadi MA. Perspective of Saudi undergraduate pharmacy students on pharmacovigilance and adverse drug reaction reporting: A national survey. Curr Pharm Teach Learn 2017;9:779-85.
Almandil NB. Healthcare professionals' awareness and knowledge of adverse drug reactions and pharmacovigilance. Saudi Med J 2016;37:1359.
Osemene KP, Afolabi MO. An evaluation of the knowledge and perceptions of pharmacy students on pharmacovigilance activities in Nigeria. BMC Res Notes 2017;10:273.
van Eekeren R, Rolfes L, Koster AS, Magro L, Parthasarathi G, Al Ramimmy H, et al.
What future healthcare professionals need to know about pharmacovigilance: Introduction of the WHO PV core curriculum for university teaching with focus on clinical aspects. Drug Saf 2018;41:1003-11.
Simaan JA. Herbal medicine, what physicians need to know. J Med Liban 2009;57:215-7.
Comoglio RH. Undergraduate and postgraduate pharmacovigilance education: a proposal for appropriate curriculum content. Br Pharmacol Soc J 2019;86:779-90.
Reumerman M, Tichelaar J, Piersma B, Richir MC, van Agtmael MA. Urgent need to modernize pharmacovigilance education in healthcare curricula: Review of the literature. Eur J Clin Pharmacol 2018;74:1235-48.
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]