An evaluation of the knowledge and perceptions of pharmacy students on pharmacovigilance activities in Nigeria

Post marketing surveillance of drugs is important because it is impossible to determine all adverse effects of drugs before they are put to use [1, 2]. Hence knowledge in pharmacovigilance (PV) activities and adverse drug reactions (ADRs) reporting become necessary in this regard. Such knowledge should be taught in the university at the undergraduate level while more knowledge should be acquired by health care professionals during practice [3]. However, the level of knowledge of undergraduate students in health-related discipline such as pharmacy, about ADR reporting and PV activities has not been fully studied in Nigeria. Since training and quality of knowledge are important for good professional practice, would-be health professionals such as student doctors, pharmacists among others are expected to be knowledgeable enough in their chosen career in order to render quality professional service that could guarantee favourable therapeutic outcomes by improving patients’ quality of life.

Arguably, health workers, especially pharmacists, are believed to be better placed to report ADRs because they are easily accessible, operate flexible and long working hours and easily come in contact with a lot of patients [4]. In addition, pharmacists are expected to play a leading role in the monitoring and reporting of ADRs. In this regard, the role of pharmacist in Nigeria about PV activities are to: monitor drug use, misuse, and abuse at all times in order to ensure proper medication use [5]. They are to direct ADR reports to the National Agency for Food Drug Administration and Control (the official organization that collates ADRs reports in Nigeria), conduct post-marketing surveillance, report medication errors and suspected counterfeit or substandard drugs; and monitor drug utilization [6]. However, the knowledge and perception of community pharmacists in Nigeria towards ADR reporting have poor [5]. This poor knowledge among community pharmacists in Nigeria may be due to lack of appropriate training in the undergraduate curriculum [5].

Meanwhile, it was documented that pharmacists’ involvement in the reporting of ADRs improved the volume and quality of reports in developed countries [7]. This appears not to be so in Nigeria [5].

Nevertheless, outcomes from similar studies conducted in developed countries revealed among other things, that pharmacy students had inadequate knowledge, poor awareness but positive attitude of PV activities [8–19]. However, only one of such studies showed that there was significant difference in perceptions of the students on ADR reporting [20]. In that study, pharmacy students’ inadequate knowledge on PV activities was attributed to inadequate PV courses in the Faculty of pharmacy curricula [21]. Furthermore, two independent studies assessed the knowledge and attitude of would-be healthcare professionals towards PV and ADR reporting and found that their knowledge of PV activities were low and average respectively [8, 20]. In all, none of the above-mentioned studies, evaluated the students’ PV knowledge across institutions. To the best of our knowledge, no known study in Nigeria assessed the relationship between the demographic characteristics of would-be healthcare professionals and knowledge of PV.

This study was therefore aimed at investigating the knowledge and perceptions of pharmacy students about pharmacovigilance with a view to providing information on their knowledge and perceptions about PV as well as the demographic factors that are related to PV activities. The study will contribute to the existing literature in light of the scarcity of relevant data on pharmacy students’ knowledge about PV activities in Nigeria.

Pharmacy was first established as a Department in the Nigerian College of Arts, Science and Technology, in 1957 and pharmacy curricula was dominated by compounding and dispensing. Later, courses like pharmacology, toxicology, and pharmaceutical microbiology were added to the curricula [22]. In 1962, the University of Ife (now Obafemi Awolowo University) was established and it took over the training in pharmacy in a Department in the Faculty of Science. It continued to award Diploma in Pharmacy till 1965 while concurrently running a programme for the Bachelor of Pharmacy which was started in 1963. As at now, candidates applying into the first year of the Bachelor of Pharmacy (B. Pharm) programme are required to have credit passes in five (5) subjects including english, mathematics, physics, chemistry and biology in the Senior Secondary Certificate Examination or its equivalent [23].

The B. Pharm. Degree is a 5 year program which was designed in such a way that the basic sciences are taught in parts 1 and 11; while in parts 111, IV and V, students are taking through clinical or professional training. Clerkship and externship programmes are conducted in their final year (part V), where they are expected to register for clinical pharmacy courses such as pharmacokinetics, therapeutics, clinical pharmacy clerkship, chemotherapy, drug information among others [24]. There is no stand-alone course in medication safety. In clinical pharmacy clerkship, for instance, the students are posted to hospitals to conduct ward rounds with other health care workers, review prescriptions (where necessary), monitor patients’ drug use, learn vital issues on medication safety and document therapeutic outcomes. Also, pharmacy students are exposed to pharmacy-supervised experiences (externship) in government approved community pharmacies as partial requirement for the award of the Bachelor of Pharmacy (B.Pharm) degree. The main goal of the entire exercise is to among other things, train the students in practical clinical pharmacy activities such as scrutinizing prescriptions for completeness, monitor drug–drug interactions, document actual and potential drug-related problems [25]. The mode of teaching is didactic in nature.

The B. Pharm degree is unclassified with a pass mark of 50% in all courses except in Dispensing, and Forensic Pharmacy and Pharmacy Ethics, where the pass mark is 60%. Upon successful completion of the part V Bachelor of Pharmacy examinations, students are inducted into the pharmacy profession and are required to proceed for a 1-year compulsory internship program in approved or designated centres/institutions [25, 26]. The prospect of getting a job after graduation as a pharmacist is very high in Nigeria.

A total of 342 final year pharmacy students properly filled the questionnaire. Data obtained were used for analysis. Response rate was 98.3%. The Cronbach alpha values for the first, second and third set of questionnaire were 0.73, 0.72, and 0.71 respectively. Test of reliability of the final copy of the questionnaire gave a Cronbach alpha value of 0.72. Majority of the final year pharmacy students were males (65.2%). Most respondents were between 21 and 30 years of age with a mean age of 25.5 ± 4.3 years. Only 2.6% of them were above 30 years of age. The mean knowledge score in pharmacovigilance and adverse drug reporting by the final year students was 4.25 ± 0.18. There were significant differences in the mean scores in the knowledge domain by gender (P < 0.001) as well as the current universities attended (P < 0.001). Also, there was a significant difference in the mean scores of pharmacovigilance knowledge between the respondents who had taken some courses in pharmacovigilance and those who did not (P < 0.001). Furthermore, there was a significant association between those respondents who had taken courses related to pharmacovigilance, with their current universities (P < 0.001).

The computed Kruskal–Wallis and Mann–Whitney U values for all the survey statements in Table 3 were significant at P < 0.05.

The knowledge of Nigerian pharmacy students on the reporting of ADRs and pharmacovigilance activities is inadequate. This result agrees with the findings of previous studies conducted elsewhere [8–13, 20]. Low knowledge of PV could trigger the need to review curriculum in terms of expanding or increasing the course content of PV courses vis-a-vis clinical courses relating to PV. The significant differences in the mean knowledge score on PV activities by gender (P < 0.001) could be attributed to the differences in their level of interest in PV subjects (11). The study revealed that female students had better knowledge of ADR reporting than their male counterparts. This finding is at variance with the result of a similar study [33]. Furthermore, most pharmacy students’ inability to correctly answer Survey Statement 9 in Table 2 (all ADRs are known before a drug is marketed) is a flaw in their knowledge of PV activities, in spite that they claimed to have acquired enough knowledge to indeed monitor and report ADRs (Survey Statement 1 in Table 3). The misconceptions on whether it is possible to detect all side effects caused by drugs in the pre-marketing phase of clinical trial could have been addressed by pharmacy educators or instructors. However, reasons for pharmacy students’ poor knowledge of ADR monitoring could be due to absence of enough PV courses in their universities’ curricula [10], and lack of adequate hands-on training during clerkship [34] on how ADRs reporting forms should be used. Variations in knowledge of PV activities amongst students in the three universities which was significant at P < 0.001 constitute notable findings of this study. These variations could be attributed to differences in the content of PV-related courses of each university in spite of the fact that the curricula of the faculties of pharmacy are unified [27]. Bridging this knowledge gap could be achieved by deliberate increase in the course content in PV subjects which could be achieved during curriculum review. Curriculum review is done whenever it is necessary. To review the curriculum, a committee is set up by the Faculty Board of Examiners (FBE) which is made of members from various departments in the faculty. The outcome of the review exercise is deliberated upon by FBE and recommended to the Business Committee of Senate (BCS) for further processing. The BCS vets it and passes it on to Senate for final approval.

Nevertheless, most of the students disagreed that adverse reactions caused by cosmetics should be reported (Survey Statement 15). Cosmetics, arguably represent the commonest and most widely used product all over the world. Most times they are regarded as daily needs. However, more often than not, a lot of people do not really have a clear understanding of what cosmetics are. The main issue is whether a product is a cosmetic or a drug or both. Sometimes, a product can be a cosmetic and a drug. This happens when the product has two or more intended uses. For instance, antidandruff shampoo is used for dual purposes. The shampoo cleanses the hair as a cosmetic agent while antidandruff is used to treat dandruff and therefore is a drug. Among other cosmetics/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims [35]. Anyway, this notable misconception associated with ADRs reporting arising from the use of cosmetics could be as a result of the students’ lack of experience in ADR reporting guidelines. Hence, they did not know what and what not to be reported.

Most of the students were of the opinion that monetary incentives to health workers could improve ADR reporting. This result is similar to the findings of Inman [36] who reported that lack of monetary incentives to ADRs reporters was one of the prominent “seven deadly sins’’ that caused ADR under-reporting. Monetary incentives for reporting ADRs have influenced the attitudes of some health workers toward ADRs reporting [36]. However, commercializing such a mandatory and fundamental health activity could be prone to abuse and froth with immense danger because the quest to make money could override the desire to render quality service. Therefore, other strategic approaches to incentivize pharmacists to report ADRs include but not limited to giving healthcare promoters access to ADRs data, making ADR reporting forms and data easy to obtain, interpret, and use. Also, improvement in infrastructural facilities such as internet connectivity, epileptic power supply could help especially in developing countries [37]. In addition, other non-monetary incentives could come in form of flexible work hours, training, the creation of a pleasant work environment, and granting sabbaticals to ADR reporters [38].

A remarkably high number of the students believed that pharmacist participation in ADRs reporting would have positive impact on PV activities. This finding is comparable with the result obtained by various researchers [34, 39]. In literature, it was revealed that ADR monitoring and reports emanated from community and hospital pharmacists [39–41]. Pharmacists in these settings come in contact with patients easily who either come to fill prescriptions or for consultations. In the course of this pharmacist-patient interactions, pharmacist could evaluate the patients’ medication profile and give professional advice that could ensure better medication outcome even at reduced cost.

Pharmacy students who responded to survey item 9 in the perception domain rightly noted that PV activities could be regarded as an integral part of pharmaceutical care. Pharmaceutical care which was an American concept has added a new dimension to the teaching and to the practice of pharmacy profession world-wide [25]. In addition, a comprehensive knowledge in clinical pharmacy courses and practical exposure to cases in the hospitals which the clerkship programme is meant to offer remains a unique opportunity that pharmacy students must utilize in order to understand and acquire the skills required for quality ADR reporting. The clinical exposure of the students would enhance their willingness to report ADRs because they would be familiar with PV cases in the hospitals and learn from their tutors how to deal with such cases in terms of reporting it to the appropriate PV centres.

Nevertheless, this study provided information on the knowledge and perception of pharmacy students about PV and the demographic factors that are related to PV activities in Nigeria. The study also added to the body of knowledge by proffering ways of enhancing the understanding of PV activities by university students. The major strength of this survey is that international readers could use the results as a basis for comparison with similar studies carried out abroad. In addition, the study focused on an issue that has not been adequately studied in Nigeria.

However, some prominent limitations of the study were that the universities examined were too few compared to the number of universities in Nigeria. The purposive selection of the three universities would have created some element of bias. A random sampling could have reduced such bias. The study did not include post graduate pharmacy students; and limitations associated with questionnaire-based studies such as subjective responses cannot be completely ruled out. Hence, this study may not generalizable. In spite of all this, results obtained from this study would provide information for further studies in Pharmacovigilance as well as provide clear intervention targets for pharmacy student educators.

The study revealed that Nigerian pharmacy students have inadequate knowledge of pharmacovigilance activities; but have positive perceptions towards ADR reporting. The mean score on students’ knowledge of PV activities was significant according to gender, students’ university and previous exposure to PV subjects. Periodic curriculum review with the motive of increasing the content of PV courses could enhance the students’ knowledge about PV. Also emphases should be laid on hands-on training and more focus should be paid to the clerkship and externship programmes because they afford the students the opportunity to have real life experiences with patients.

Further studies could focus on the evaluation of curricula to determine areas of differences that must be addressed in order to enhance pharmacy students’ knowledge about PV. In order to generalize the results of this study, it is strongly suggested that studies with larger samples and including students from more universities should be undertaken in the future. In addition, PV knowledge of post-graduate students who have the first degrees in pharmacy could be assessed too.