Setting
The study was carried out in three universities (out of five) in southwestern Nigeria that offer pharmacy as a course and their curricula are unified [27].
Design and study population
The study was a cross-sectional survey and was undertaken with due permission from the institutions and with written consents from respondents. The list of the respondents which was obtained from their Deans served as the sample frame. Due to time and cost, the three universities were purposively selected in spite of the fact that they are in the same geographical zone and close to the base of the researchers.
Inclusion criteria
Only final year (Part V) pharmacy undergraduate students who would have taken requisite courses in medication safety and clinical pharmacy took part in the study.
Exclusion criteria
Pharmacy students in lower classes (Parts 1, 11, 111 and IV) and those in the postgraduate (PG) level were excluded from the study because the former had no clinical exposure and have not taken courses in PV subjects. For the later, not all the PG students had their first degrees in Pharmacy or hold Pharm.D degrees. Some of them read allied pharmacy courses such as botany, zoology, chemistry, and microbiology in their first degrees and decided to pick higher degrees in pharmacology, pharmaceutical chemistry, pharmaceutical microbiology, phytochemistry among others. These categories of PG students are not regarded as core pharmacy students.
Questionnaire design and questionnaire administration
The study adapted the survey instruments used in similar studies to measure knowledge; attitude and perception about PV activities elsewhere [28,29,30,31,32]. However, some of the survey instruments (questionnaire, Additional file 1) were modified to suit the Nigerian environment. A total of 31-item survey instrument of three domains, namely demographics, knowledge and perceptions of final year pharmacy students on ADRs reporting and pharmacovigilance were designed.
The first part contained 6-item survey questions on demographics such as age, current university, gender, and questions on whether the students have ever heard of the terms adverse drug reaction, pharmacovigilance and if they have taken any course that was related to pharmacovigilance.
The second part contained questions on core issues which were designed to measure the students’ basic knowledge about pharmacovigilance and adverse drug reaction reporting. The questions had their answers in multiple choice format and students were asked to choose the correct answers to the questions. Knowledge on ADR reporting was measured using 10 true or false items. A weighted score of 1 was assigned to each correct answer and 0 for each wrong answer. The maximum score obtainable for the 10-item survey was 10 and the minimum score was 0. Each student’s knowledge about PV activities was assessed by adding all correct answers over the maximum obtainable score. Results obtained were in percentages. Since the pass mark for pharmacy courses in Nigerian universities is 50%, any respondent who got less than 5 questions correctly out of 10 the questions in the survey item (<5/10) was deemed to have performed poorly and therefore considered to have poor knowledge about PV activities. Meanwhile, undergraduate pharmacy students are graded in Nigeria as follows: scores <50% (poor), 50–60% (good), 60–69% (very good) and >70% (excellent).
The third section of the questionnaire contained 15 survey items which were designed to evaluate the perceptions of the pharmacy students toward adverse drug reporting. Students’ perceptions of ADR reporting were measured on a 5-point Likert scale. This showed their level of agreement or otherwise on statements about ADR monitoring and reporting and pharmacovigilance in Nigeria as 1 = strongly disagree, 2 = disagree, 3 = slightly agree, 4 = agree, and 5 = strongly agree. The questionnaires were structured and contained mostly closed-ended questions whose answers were not mutually exclusive.
In filling the questionnaire, the students were asked to work independently by avoiding any interaction amongst them and to refrain from consulting reference materials. This was done to ensure that actual individual students’ knowledge about PV activities was employed in filling the questionnaire. The questionnaire was hitherto pre-tested among 10 final year pharmacy students who did not take part in the study and the comments of the pharmacy students were used to make necessary corrections and modifications such as the reframing of some questions into multiple choice format and rewriting of some abbreviations such as ADRs and PV in full for clarity. The pilot testing of questionnaires was to ensure that the concepts being measured were understood and that the answers provided were germane to the concepts (face validity). Effort was also made to ascertain if the respondents to the piloted test understood what was asked for as contained in the questions and if the questions actually covered what was examined on PV activities (content validity). The Cronbach alpha test for each set of questionnaire was determined and the final Cronbach alpha value for the entire questionnaire was computed. The questionnaires were administered to the students by the researchers by face to face meeting in the presence of their course coordinators and about 15 min later, completed questionnaire were collected by the researchers. The questionnaire for the study is presented as additional file 1.
Statistical analysis
Data on demographics, knowledge and perceptions of pharmacy students’ toward ADRs about PV activities were analyzed with IBM SPSS Statistics 20 and presented in percentages, means, standard deviations and median at 50% percentile.
Knowledge score of the respondents about PV was computed and presented in percentages and means. The association between knowledge score and the demographic variables of gender and the presence of PV courses in the universities was determined using the independent Student t test. While the association between respondents’ knowledge of PV with their ages and respective universities were examined using the analysis of variance (ANOVA).
Perceptions of the final year pharmacy students about PV activities were presented with descriptive statistics such as frequency and median at 50% percentile. These were used in describing their opinion to specified statements in ordinal scale. The ranked variables were evaluated using Kruskal–Wallis and Mann–Whitney U tests as appropriate at P < 0.05.