Abstract

1. Abstract The Knowledge, Perceptions, and Practice of Pharmacovigilance among Community Pharmacists in Lagos State, Southwest Nigeria Oreagba, Ibrahim Adekunle (1,3); Ogunleye, Julius Olajide (2); Olayemi, Oluwafemi Sunday (1) oreagbai@yahoo.com 1: University of Lagos, Nigeria; 2: Faculty of Clinical Pharmacy, West African Postgraduate College of Pharmacists; 3: National Pharmacovigilance Centre. National Agency for Food and Drug Administration Problem statement: Adverse drug reactions (ADRs) are significant causes of morbidity and mortality. ADRs may cause many hospitalizations and lead to large economic burdens to patients and to society. Since pharmacovigilance plays an essential role in the outcome of therapy, its evolution and its importance as a science are critical for effective clinical practice and public health science. Spontaneous reporting of ADRs remains the cornerstone of pharmacovigilance and is important in maintaining patient safety. The success of this activity, however, is dependent on the frequency of reporting by the health care professionals, under-reporting being the main disadvantage. Community pharmacists both have an important responsibility in monitoring the ongoing safety of medicines and are widely accessible to do it. Objectives: To investigate the knowledge, perceptions and practice of pharmacovigilance among community pharmacists in Lagos State, southwest Nigeria Design: A descriptive, cross-sectional study Setting: The study was carried out in private community pharmacies in Lagos, one of the largest metropolitan cities in Nigeria, located in the southwest. Study population: A multistage random sampling technique was employed in the selection of 420 community pharmacists in Lagos Outcome measure(s): Knowledge of pharmacovigilance, practice of pharmacovigilance Results: About 55% of respondents had ever heard of the word pharmacovigilance out of which less than half (representing only 18% of all respondents) could define the term. 40% of the respondents stated that patients reported ADRs to them at least once a month, and 20% reported to the relevant authorities, but only 3% of respondents actually reported an ADR to the National Pharmacovigilance Centre. The most important reason for poor reporting was lack of knowledge about how to report ADRs (44.6%). Meanwhile, 90% of respondents believed that the role of the pharmacists in ADR reporting was important. Most community pharmacists were willing to practice pharmacovigilance if they were trained. Conclusions: Community pharmacists in Lagos had poor knowledge about pharmacovigilance. The reporting rate was also poor. There is an urgent need for educational programs to train pharmacists about pharmacovigilance and ADR reporting. The problem of underreporting can be considerably reduced by actively involving community pharmacists in the surveillance of drug safety within the context of the pharmaceutical care they provide. Pharmacovigilance and knowledge about risks of ADRs should be part of the undergraduate and postgraduate pharmacy education curriculum and ADR reporting, part of a pharmacist's basic tasks • Funding source(s): Self funded

2. Introduction The concept of Pharmacovigilance (PVG) i.e. drug safety monitoring is an old one but is just beginning to generate interest in many developing countries including Nigeria Adverse drug reactions (ADRs) are significant causes of morbidity and mortality. ADRs may cause many hospitalizations and lead to large economic burdens to patients and to society.2 Since pharmacovigilance plays an essential role in the outcome of therapy, its evolution and its importance as a science are critical for effective clinical practice and public health science. Spontaneous reporting of ADRs remains the cornerstone of pharmacovigilance and is important in maintaining patient safety. However, the success of this activity is dependent on the frequency of reporting by the health care professionals, underreporting being the main disadvantage.3

3. Introduction In order to boost the performance of the Nigerian Pharmacovigilance system, it is necessary to assess the practice of pharmacovigilance, and identify reasons for under-reporting amongst healthcare professionals Community Pharmacists both have an important responsibility in monitoring the ongoing safety of medicines and are widely accessible to do it

4. Objectives In Nigeria, there is very scarce information on the activities of pharmacists in pharmacovigilance. This study aims to investigate the knowledge, perceptions and practice of Pharmacovigilance amongst community pharmacists in Lagos State, South west Nigeria. Also, their attitude towards ADRs reporting was investigated.

5. Method A cross-sectional observational survey was used in this study. A multistage random sampling technique was employed in the selection of the pharmacies. Following the Lagos state association of community pharmacists zonal coordination list, community pharmacies in Lagos state fall into 12 zones. 35 pharmacies per zone were randomly selected from each zone given a total of 420. The duly registered superintendent pharmacists who are in direct supervision of the selected pharmacies were included in the study.

6. Method The face-to-face questionnaire method was conducted with the pharmacists after obtaining their consent to participate in the study. The data were subjected to frequency analysis and Pearson’s chi-square tests using Statistical Package for Social Sciences (SPSS) software version 15.0 for Windows. Values of p<0.05 were considered as significant

7. RESULTS Table 1. Socio-demographic characteristics of community pharmacists in Lagos (n=332) Age Frequency (%) 25–34 50 (15.1) 35–44 60 (18.1) 45–54 106 (31.9) 55–64 76 (22.9) 65þ 40 (12.0) Gender Men 103 (31.0) Women 229 (69.0) Years of experience as Community Pharmacist 1–5 92 (27.6) 6–10 196 (59.1) 10 and above 44 (13.3) Post graduate qualifications M Pharm 4 (1.2) MBA 92 (27.7) MSc 56 (16.9) No response 180 (54.2) Ownership Self owned 120 (36.1) Employed 212 (63.9) The mean age of the respondents was 49.30 years. SEM¼3.13 (median 48.90). The mean years of practice as a community pharmacist was 6.19 years SEM¼0.335, (median 6.00).

8. RESULTS Table 2. Relationship between years of experience as Community Pharmacist and knowledge of Pharmacovigilance Years of experience Yes* (%) No (%) Total 1–5 29 (32) 63 (68) 92 (100) 6–10 111 (57) 85 (43) 196 (100) >10 44 (100) 0 (0) 44 (100) Total 184 (55) 148 (45) 332 (100) Chi sq - 10.3690 df=2 p<0.005 n=332. *Knowledge of pharmacovigilance.

9. RESULTS Table 3. Knowledge and Practice of Community Pharmacists towards Adverse Drug Reaction reporting in Lagos (n=332) Question Yes (%) No (%) Have you ever heard about Pharmacovigilance 184 (55) 148 (45) Correct definition of Pharmacovigilance 57 (19) 275 (81) Have you reported ADRs in the last 1 month ? 65 (22) 267 (78) Have you received reports of ADRs from patients in the last 1 month? 266(80) 66 (20) Do you report ADRs to the National Pharmacovigilance Centre? 10 (3) 322 (97) Do you know how to report ADRs? 40 (12) 292 (88) Do you know where to obtain the ADR forms? 40 (12) 292 (88)

11. POLICY IMPLICATION The main findings from this study were the fact that the knowledge and practice of pharmacovigilance amongst Nigerian community pharmacists was poor. In Nigeria, poor knowledge of pharmacovigilance is not peculiar to pharmacists alone, a study to determine the extent of pharmacovigilance among resident doctors in Nigeria9 showed a significant level of deficiency in their knowledge of pharmacovigilance. The study revealed that 78.1% of a total of 350 resident doctors in Nigeria had inadequate knowledge about pharmacovigilance.

12. POLICY IMPLICATION Reasons for poor reporting according to respondents in this study include lack of awareness about pharmacovigilance and lack of incentives for ADR reporting. One important reason for poor reporting as implied from this study is inaccessibility to the ADR forms, as 88% of respondents claimed that they did not have access to the forms

13. POLICY IMPLICATION Majority of respondents believed that community pharmacists were willing to practice pharmacovigilance if they are trained just as they agreed that they needed to update their knowledge of pharmacovigilance. As a follow up to this study, we plan to carry out an educational intervention which will consist of a training program for the community pharmacists who participated in this study, so that we will be able to evaluate the influence of the education on all the measured parameters. Posters and printed educational leaflets will be distributed to the pharmacies

14. CONCLUSION Community pharmacists in Lagos had poor knowledge about pharmacovigilance. If trained community pharmacists in Lagos were willing to practice pharmacovigilance. Pharmacovigilance and Knowledge about risks of ADRs should be part of the undergraduate and postgraduate pharmacy curriculum and ADR reporting part of a pharmacist’s basic tasks.