Assessment of a Pharmacovigilance Module: An Interventional Study on Knowledge, Attitude, and Practice of Pharmacy Students.

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. Copyright:

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,[1] 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.[2] 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.[345] Studies have acknowledged poor knowledge and perception among health professionals on pharmacovigilance.[67]

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.[89] 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.[101112] 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

Study type

This was a prospective pre–post interventional study evaluating KAP scores of pharmacy students attending education sessions with control group students.

Study approval

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.

Questionnaires

A modified version of a KAP questionnaire, previously used by researchers in Nepal,[13] 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[14] and Malaysia.[15] 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.

Data collection

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.

Educational intervention

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[16] and the modified Hartwig and Siegel scale,[17] respectively. The students also received copies of “Pharmacovigilance Nepal: a guide for HCPs,”[18] 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 analysis

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.

Pilot study

Prior to conducting the study, a pilot study was conducted to test the study methods in terms of their feasibility and validity.[19]

RESULTS

In total, 124 pharmacy students (56 in the control and 68 in the test group) participated [Table 1].

Table 1

Respondents’ demography (n=124)

Demographic parameters	Frequency (%)
Gender
Male	81 (65.3)
Female	43 (34.7)
Age (years)
15-20	57 (46.0)
21-25	64 (51.6)
Not available	3 (2.4)
Method of financing
Self-financing	105 (84.7)
Scholarship	14 (11.3)
Not available	5 (4.0)
Place of origin
Urban	91 (73.4)
Rural	31 (25.0)
Not available	2 (1.6)
Year of study
1st*	37 (29.8)
2nd	26 (21.0)
3rd*	31 (25.0)
4th	30 (24.2)

*Test group

Respondent details

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)

Question	Number of students with the correct answer, n (%)
Which one of the following drugs is known to cause fatal anaphylactic reactions?	90 (72.6)
The system reported to be commonly affected by adverse drug reactions is	46 (37.1)
‘Type I hypersensitivity’ reactions can be prevented by which one of the following methods?	58 (46.8)
The regional pharmacovigilance center in western Nepal is located at	104 (83.9)
Upon occurrence of an adverse drug reaction, what needs to be done with the suspected drug?	85 (68.5)
Which one of the following is a drug that was withdrawn from the market due to potent cardiovascular toxicity?	30 (24.2)
In Nepal, the pharmacovigilance activities started in the year	40 (32.3)
Which of the following methods is commonly employed by the pharmaceutical companies to monitor adverse drug reactions to new drugs once they are launched in the market?	95 (76.6)
The national pharmacovigilance center in Nepal is located at	64 (51.6)
The international center for adverse drug reaction monitoring is located in	27 (21.8)
Which one of the following is the agency in United States of America involved in drug safety issues?	54 (43.5)
Which one of the following scales is used to establish the causality of an adverse drug reaction?	9 (7.3)
Which one of the following scales is used to establish the severity of an adverse drug reaction?	20 (16.1)
Which one of the following is the WHO online database for reporting adverse drug reactions by the member countries?	6 (4.8)

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)

Question	Number of students with a yes/positive response (%)
Do you think knowing more about adverse drug reactions is relevant to you?	119 (96.0)
In the future, will you be interested in carrying out research activities related to pharmacovigilance?	112 (90.3)
Have you ever come across someone experiencing an adverse drug reaction?	47 (37.9)
The important factor necessary to report an adverse drug reaction is	89 (71.8)
Do you think Nepal should be actively involved in pharmacovigilance activities?	120 (96.8)
Are you interested in learning more about adverse drug reactions?	118 (95.2)
The healthcare professional responsible for reporting adverse drug reaction in a hospital is	49 (39.5)
Do you think reporting adverse drug reaction is necessary?	119 (96.0)
Do you think reporting adverse drug reaction should be made mandatory?	94 (75.8)
Do you think that herbal drugs are free from adverse drug reactions?*	96 (77.4)
Who has the responsibility to ensure drug safety?	83 (66.9)

*Answering “yes” to this question was considered negative

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)

Demographic parameters	Median (IQR)	P
Gender
Male (n=81)	40 (37-42)	0.101
Female (n=43)	38 (36-41)
Age (years)
15-20 (n=57)	38 (37-40)	<0.001**
21-25 (n=64)	40 (38-42)
Method of financing
Self-financing (n=105)	40 (37-41)	0.855
Scholarship (n=14)	39.5 (37.75-41.00)
Place of origin
Urban (n=91)	40 (37-41)	0.288
Rural (n=31)	38 (37-41)
Year of study
1st (n=37) *	38 (36.5-40.0)	<0.001***
2nd (n=26)	38 (37-40)
3rd (n=31) *	39 (36-41)
4th (n=30)	41.5 (39.75-44.00)

*Test group, **Mann-Whitney U-test at α=0.05, ***Kruskal- Wallis test at α=0.05. The total number of respondents may not reach 124 or the percentage may not equal 100% due to missing values. IQR: Interquartile range

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

Groups	Variables	Scores, median (IQR)				P*
		Baseline	1st follow-up	2nd follow-up	3rd follow-up
Control (n=56)	Knowledge	20 (19-22)	22 (21-23)	21.5 (20-23.75)	21 (20-23)	0.000; B-IF
						0.730; I-IIF
						0.114; II-IIIF
	Attitude/practice	19 (18-21)	29 (19-21)	20 (19-21)	20 (19-21)	0.020; B-IF
						0.065; I-IIF
						0.148; II-IIIF
	Total	40 (38-42)	42 (20-44)	41.5 (40-44)	41 (39-44.5)	0.000; B-IF
						0.634; I-IIF
						0.040; II-IIIF
Test (n=68)	Knowledge	19 (18-21)	22 (20-23)	23 (21-24)	23 (22-25)	0.000; B-IF
						0.001; I-IIF
						0.080; II-IIIF
	Attitude/practice	20 (18.25-21.00)	20 (19-21)	20.5 (20-21)	21 (20-21)	0.082; B-IF
						0.000; I-IIF
						0.957; II-IIIF
	Total	39 (36.25-40.75)	42 (39.50-44.00)	43 (41-45)	44 (42-45)	0.000; B-IF
						0.000; I-IIF
						0.156; II-IIIF

*Wilcoxon signed-rank test at α=0.05. B: Baseline, IF: 1st follow-up, IIF: 2nd follow-up, IIIF: 3rd follow-up. IQR: Interquartile range

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

Statements	Pharmacy students (n=65)
1. The sessions made me aware of the concept of pharmacovigilance	5 (4-5)
2. Pharmacovigilance is essential to developing countries such as Nepal	5 (5-5)
3. Adverse drug reactions are one of the major causes of death in the world	4 (4-5)
4. Herbal drugs carry an equal risk of causing ADRs as modern medicines	4 (3-4)
5. The pharmacovigilance program in Nepal is successful	3 (2-3)
6. The ADR reporting form should be a single page	4 (3-5)
7. Pharmacovigilance should be made mandatory in Nepal	5 (4-5)
8. Pharmacovigilance should be incorporated in the curricula of doctors, pharmacists and nurses	5 (4-5)
9. The pharmaceutical industry should report adverse drug reactions	4 (3-5)
10. This session may be useful for me in my job	4 (4-5)
11. Hospital drug and therapeutics committees should be a part of the pharmacovigilance program	5 (4-5)
12. Causality assessment is an important step in pharmacovigilance	5 (4-5)
13. Severity assessment is not an important step in pharmacovigilance*	5 (3-5)
14. A substantial number of adverse drug reactions could be prevented if appropriate measures were taken	5 (4-5)
15. Patients should not be allowed to report adverse drug reactions*	5 (5-5)
16. Dosage adjustment is an important strategy to prevent the occurrence of ADRs	4 (4-4)
17. The session was informative and interesting	5 (4-5)
18. The facilitators performed their roles effectively	5 (4-5)
19. I would like to pursue a career in pharmacovigilance	4 (3-4)
20. I would welcome similar sessions in the future	5 (5-5)

The maximum possible score was 5, and the minimum was 1. *Questions 13 and 15 were reversed (negative questions) and hence were reverse scored. ADRs: Adverse drug reactions

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.[2021] Similarly, there is also inadequate teaching of pharmacovigilance to students,[8] 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.[2223] 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.[24] 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.[25] Another study in Saudi Arabia illustrated that the awareness and knowledge levels of HCPs in a hospital setting were insufficient.[26] A study in Nigeria among pharmacy students evaluated their knowledge and perceptions of pharmacovigilance. They found that respondents lacked knowledge of pharmacovigilance activities.[27]

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.[28]

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.[29] 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.[13]

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.[30] 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.[31]

Limitations

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

Nil.

Conflicts of interest

There are no conflicts of interest.