Perspective of Saudi undergraduate pharmacy students on pharmacovigilance and adverse drug reaction reporting: A National Survey

Abstract

Objective: To evaluate Saudi undergraduate pharmacy students' knowledge, attitude and readiness towards pharmacovigilance and reporting of adverse drug reactions (ADRs). Methods:A cross-sectional survey was conducted between January 15, 2016 and February 18, 2016 using a structured, validated and pilot-tested questionnaire among senior (year 4, 5 and 6) undergraduate pharmacy students enrolled at a governmental or private university/college. Students completed an online 27-item questionnaire developed using Google Forms™. The questionnaire consisted of four sections:demographics; knowledge about pharmacovigilance and ADR reporting; attitudes towards ADR reporting;and pharmacy students' readiness towards ADR reporting. Results:Two hundred and fifty-nine students completed the questionnaire. Most of the participants were females (n = 174, 67.2%) and were year 4 (n = 128, 49.4%) students. Out of a total possible score of seven, the mean knowledge score (SD) was 4.15 (1.1). Multiple linear regression showed that after adjusting for gender and program of study (BPharm/PharmD), year of the study was found to be an independent predictor (P =0.03) of the total knowledge score. More than half of the respondents (n = 166, 64.1%) acknowledged that they do not know how to report ADRs to the relevant authorities in Saudi Arabia. The majority (n = 213, 82.2%) of respondents believed that information on how to report ADRs should be taught to senior pharmacy students. Conclusion:This study highlighted wide knowledge gaps about pharmacovigilance and ADR reporting among senior pharmacy students. There is a clear need to put more emphasis on theoretical and experiential aspects of ADR reporting in pharmacy curriculum. Keywords:Pharmacovigilance; Adverse drug reaction, Saudi Arabia; Pharmacy; Curriculum; Pharmacist Conflict of interest: None declaredFinancial disclosure: No funding was obtained from any governmental or private agency for this study. 2 Specific Contribution to Literature:This study further builds on existing evidence highlighting the issue of deficiencies in pharmacy undergraduate curriculum pertaining to pharmacovigilance and ADR reporting, especially in countries where patient-centered pharmacist role has not yet fully evolved. This is the first study that has assessed pharmacy students' knowledge, attitudes and readiness towards ADR reporting in Saudi Arabia. Our findings can partly explain poor ADR reporting practices by pharmacists reported by previously conducted studies in Saudi Arabia. In addition, this study has tested the feasibility of using web-based social media applications in recruiting participants for academic research. We have shown that recruitment through social media is possible, efficient and economical. We hope that future researchers will use this approach for recruitment especially in instances where participants are widely distributed geographically.

Pharmacovigilance in healthcare education: students’ knowledge, attitude and perception: a cross-sectional study in Saudi Arabia

“…This is an important concept that needs to be acknowledged by healthcare students in order to know how and where to report an ADR. The study findings showed that only one-third of pharmacy students knew that SFDA is the governmental monitoring agency for adverse drug reactions in Saudi Arabia which is lower than the rate reported by Alkayyal N et al [18]. The present study revealed that about onethird of pharmacy students reported that the topic of PV is well covered in their curriculum, which is lower (55.6%) than the study done by Rajiah et al, among pharmacy students in Kuala Lumpur [19].…”

Healthcare students' knowledge, attitude and perception of pharmacovigilance: A systematic review

“…Studies that evaluated pharmacovigilance knowledge, attitude or perception of healthcare students started to appear since 2011. The majority of the included studies involved pharmacy students [11][12][13][14][15][16][17][18][19], while few studies specifically focused on healthcare students [20][21][22], nursing students [23], and dental students [24,25]. The total number of included studies was twenty-nine, with sample sizes ranging from 30 to 874.…”

“…Attitude towards pharmacovigilance and ADR reporting was measured using multiple-choice response options ranging from 2 to 5 questions [20,30], and using a 5-point Likert scale [16,24]. Although only a few studies evaluated attitude; it should be noted that some questions used were related to measuring the perception rather than attitude [16,22,26,31]. The most commonly asked question was about the willingness of students to report any ADR in their future practice (S3 Appendix).…”

“…The most commonly asked question was about the willingness of students to report any ADR in their future practice (S3 Appendix). The attitude towards PV and ADRs from the included studies ranged from 25% to 97% [16,20,24].…”

Analysis of spontaneous reporting of suspected adverse drug reactions for non-analgesic over-the-counter drugs from 2008 to 2017

“…In order to improve health care professionals’ awareness of the importance of pharmacovigilance and encourage them to report ADRs, several educational interventions have been proposed. At the student level, the majority of interventions were lectures [34–36]. However, in the study by Schutte et al the students had an opportunity to assess real ADR reports and this kind of education offered students a valuable pharmacovigilance experience, which resulted in increased awareness of ADR reporting [37].…”