International Journal of Risk & Safety in Medicine 25 (2013) 219–227 DOI 10.3233/JRS-130605 IOS Press
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Impact of training on Nigerian healthcare professionals’ knowledge and practice of pharmacovigilance Adeline Osakwea , Ibrahim Oreagbaa,b,∗ , Adebowale J. Adewunmic , Abisola Adekoyad and Iretiola Fajolue a
National Pharmacovigilance Centre, National Agency for Food and Drug Administration and Control, Abuja, Nigeria b Department of Pharmacology, College of Medicine, University of Lagos, Lagos, Nigeria c Accident and Emergency, Lagos University Teaching Hospital, Idiaraba, Lagos, Nigeria d Pharmacy Department, Lagos University Teaching Hospital, Idiaraba, Lagos, Nigeria e Department of Peadiatrics, Lagos University Teaching Hospital, Idiaraba, Lagos, Nigeria Received 12 May 2013 Accepted 31 July 2013 Abstract. BACKGROUND: Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug related problem.. The effectiveness of this system revolves on the active participation of the healthcare practitioners. Poor knowledge and practice of pharmacovigilance has necessitated training of healthcare professionals in different parts of Nigeria. OBJECTIVES: The objectives of this study are to determine the knowledge and practice of pharmacovigilance amongst health professionals in Nigeria and the impact of previous training in pharmacovigilance on their knowledge and practice. METHODS: In this descriptive cross sectional study, purposive and systematic random sampling method was used in selecting health facilities and health care practitioners respectively. Data were collected using a three-part peer-reviewed structured questionnaire administered through electronic mail (25) and self administration by healthcare professionals (316). RESULTS: Respondents who had received training on pharmacovigilance had better knowledge of correct definition of pharmacovigilance (P = 0.001) and better theoretical knowledge and practice scores of pharmacovigilance (P = 0.001). Receiving quarterly newsletters was not significantly associated (p = 0.220) with improved knowledge of pharmacovigilance. Overall, knowledge and practice of pharmacovigilance in Nigeria was still below average. The main challenges faced in the reporting and detecting of ADR were lack of awareness, poor communication, lack of continuity in training and poor funding. CONCLUSION: Although training was associated with improved knowledge and practice of pharmacovigilance amongst the health care providers studied, its overall impact was mild. Strengthened awareness creation and innovations in PV training methods are necessary to improve the efficiency of the program. Keywords: Pharmacovigilance, adverse drug reaction, knowledge and practice, spontaneous reporting, health care practitioner
1. Introduction Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug related problem [1]. ∗ Address for correspondence: Ibrahim Oreagba, Department of Pharmacology, College of Medicine, University of Lagos, Lagos, 12003 Idi-araba, Nigeria. Tel.: +234 8023519433; +234 07043335829; E-mail: [email protected].
0924-6479/13/$27.50 © 2013 – IOS Press and the authors. All rights reserved
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It has been estimated that adverse drug reactions (ADRs) are the 4th to 6th largest cause of mortality in the USA [2]. They result in the death of several thousands of patients each year, and many more suffer from ADRs. The percentage of hospital admissions due to adverse drug reactions in some countries is about or more than 10% – Norway 11.5%; France 13.0%; UK 16.0% [3]. In Nigeria, the situation is obviously worse due to wide spread irrational use of medicines and this situation is compounded by inadequate research and lack of data in this area. It is difficult to estimate the number of people that have died or been disabled in our hospitals from unsuspected adverse drug reactions. In Nigeria, the National Pharmacovigilance Centre (NPC) situated in the National Agency for Food and Drug Administration & Control (NAFDAC) has the mandate to ensure safety of all medicines through a PV system which relies on spontaneous reporting of ADRs by healthcare practitioners (HCPs), marketing authorization holders and the general public. A national PV policy document was launched recently in Abuja Nigeria to facilitate the practice of PV. The mainstay of the policy is awareness creation, capacity building and generating ADR reports, Obviously the effectiveness of this policy depends on the active participation of the healthcare practitioners. Awareness and capacity building for HCPs is facilitated through conferences, training workshops, seminars and electronic distribution of quarterly PV newsletters. The objectives of the newsletter are to disseminate information on pharmacovigilance activities nationally and globally, to educate stakeholders on drug safety issues and to promote spontaneous reporting and rational use of drugs [4]. The NPC has distributed over 80,000 individual case safety reports (ICSR) forms and 6,000 Guides for detecting and reporting ADRS to healthcare professionals nationwide. Over 12,000 healthcare practitioners have been trained through train the trainer (TOT) workshops while many more have received PV quarterly newsletters. The National pharmacovigilance center has also recently introduced a Pharmacovigilance Rapid Alert System for Consumer Reporting (PRASCOR) to stimulate enhanced consumer reporting. These credible inputs notwithstanding, the output and impact in terms of actual ADRs reported fall far short of WHO recommendation. Over 11,000 completed ICSR forms have so far been received at the NPC from inception till date. WHO indicates that adequate reporting translates to 200 reports/million inhabitants/year [5]. This means that in any given year, NPC expects 28,000 individual case reports but this is not the case. The obvious under detection/under reporting of ADRs and other medicines related problems amidst a dearth of operational research on PV requires elaborate study to determine the impact of PV training and challenges faced by health professionals in their practice of PV and to proffer possible solutions from the healthcare practitioners themselves. In Nigeria, some studies have explored knowledge, perceptions and practice of PV amongst different categories of HCPs [6–9] none to the best of our knowledge has actually looked into knowledge and practice of PV in the context of capacity building for HCPs. This study aims to examine the impact of previous PV training on knowledge and practice of PV amongst Nigerian health care professionals.
2. Methods 2.1. Design This is a descriptive cross sectional study.
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2.2. Setting The setting for this study is Nigerian health facilities where HCPs are found. The study population comprised 1427 healthcare practitioners. A significant proportion of these (about 30%) have been exposed to pharmacovigilance activities through email receipt of quarterly PV newsletters and/or formal face-toface training organized by the National Pharmacovigilance Center in Nigeria. 2.3. Sample size determination The sample size was determined using the formula for the comparison of two proportions [10]. Assuming a 50% prevalence of knowledge of HCPs already trained in PV and 33% for health care providers not trained on PV [6], a two-sided significance level at 0.05 and a critical value corresponding to the power of the study at 80%, a sample size of 254 would be required. However, to cater for losses or incomplete responses, a larger sample size of 341 was used in this study. 2.4. Sampling technique A systematic random sampling method was used in selecting health practitioners for this survey. This was achieved by selecting three hundred and forty one (341) email contacts from a list of 1427, using one in every three contacts on the HCPs mailing list of the National Pharmacovigilance Center. The exceedingly poor response from the sample population necessitated additional purposive sampling of three hundred and fifty healthcare practitioners from two tertiary institutions. For representativeness, one was selected from Northern Nigeria (National Hospital Abuja) and the other from Southern Nigeria (Lagos University Teaching Hospital, Lagos). The consideration here was the large pool of healthcare practitioners in these institutions. 2.5. Data collection instrument Data were collected using a 4-part peer-reviewed structured questionnaire administered through electronic mail and self administration. The first part was designed to capture the demographics; the second part comprised questions designed to test the general knowledge of the professionals on pharmacovigilance while the third section inquired on actual practice undertaken. The last part was structured to be open ended to elicit a list of challenges and recommendations for addressing them. 2.6. Instrument validation The questionnaire was adapted from the literature and peer reviewed by experts at the NPC before being pilot tested on different set of healthcare practitioners. The final instrument was then adjusted by rephrasing some of the questions for clarity and further reviewed by a biostatistician before distribution. 2.7. Data analysis Data were analyzed using Statistical Package for Social Sciences (SPSS) software version 15.0 for Windows. The data were subjected to frequency analysis and Pearson’s chi-square tests for association between variables. Values of p < 0.05 were considered as significant. Knowledge of pharmacovigilance was assessed by selecting five questions under the knowledge section and rating responses on a scale of
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1–5 where a score of 1 and 2 was rated as poor knowledge, 3 as fair knowledge while a score of 4 or 5 was interpreted as good knowledge. The same method was used to assess practice of pharmacovigilance. 2.8. Ethical considerations Permission for the study was obtained from the National Drug Safety Advisory Committee. The questionnaire was accompanied by a carefully worded letter which specified that completing it meant consent to participate in the survey of which all information will be treated with professional confidentiality and used only for research purposes. 3. Results Out of the 341 respondents to the questionnaire, pharmacists constituted the highest percentage of 35.2% (n = 120), followed by medical doctors 24.6% (n = 84), nurses 22.6% (n = 77), medical laboratory scientists 6.2% (n = 21) while other professionals (radiographers, physiotherapist, biomedical engineers and dietitians) constituted the remaining 11.4%. There were more female respondents (63%) than males. Majority of the respondents (188) had bachelors degree while doctorate degree (5) had the lowest frequency. 71 respondents (20.8%) had no University degrees but possessed diploma in nursing and science laboratory technology. A high percentage of the respondents (31.8%) had 0–5 years professional experience while 19.4% had more than 25 years professional experience. Others include 6–10 yrs (17.3%), 11–15 years (7%), 16–20years (10.3%) and 21–25 years (7.9%). Table 1 shows the socio-demographic characteristics of the healthcare practitioners that were surveyed. Medical laboratory scientists, 18(85.7%) had the highest proportion of good PV knowledge scores followed by pharmacists 75(62.5%), nurses 41(53.2%) and medical doctors 42(50%). Overall, 199(58%) respondents had correct knowledge of the definition of PV. The association between training and knowledge of pharmacovigilance definition was statistically significant (p = 0.001) implying that respondents who were trained were more likely to correctly define PV (Table 2). 3.1. Effect of training on knowledge scores of pharmacovigilance The knowledge base of the health care professionals was rated as good, fair, and poor based on responses to the questions posed to determine knowledge of pharmacovigilance practice. Overall, 25.8% (n = 88) of respondents had good knowledge scores, 16.1% (n = 55) had fair knowledge scores while 58.1% (n = 198) had poor knowledge scores. Of those that received training on pharmacovigilance, 48.9% (n = 46) had good knowledge scores of PV, 18.1% (n = 17) had fair knowledge scores and 33.0% (n = 31) had poor knowledge scores. Statistical analysis showed that training had a significant impact on the knowledge scores (p = 0.001) (Table 3). 3.2. Practice of pharmacovigilance Of the 94 professionals that had received training on PV, 26.6% (n = 25) had good practice scores, 24.5% (n = 23) had fair practice scores and 48.9% (n = 46) had poor practice scores on pharmacovigilance (Table 4).
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Table 1 Sociodemographic characteristics of the healthcare practitioners surveyed (n = 341) Description
Frequency
(%)
215 126
63 37
84 21 77 39 120
24.6 6.2 22.6 11.4 35.2
188 77 71 5
55.1 22.6 20.8 1.5
130 59 24 35 27 66
38.1 17.3 7.0 10.3 7.9 19.4
Gender Women Men Profession Medical doctor Medical lab. scientist Nurse Others∗ Pharmacist Educational qualification Bachelors degree Master degree Others∧ PhD Degree Years of experience in practice 0–5 6–10 11–15 16–20 21–25 25 and above ∗
these included radiographers, physiotherapist, biomedical engineers and dietitians. ∧ these had diploma in nursing and science laboratory technology. Table 2 Effect of training on Knowledge of correct definition of pharmacovigilance Knowledge of correct definition of pharmacovigilance Received training on PV No Yes Total
Yes (%)
No (%)
Total (%)
126 (51.0) 73 (77.7) 199 (58.4)
121 (49.0) 21 (22.3) 142 (41.6)
247 (100.0) 94 (100.0) 341 (100.0)
Chi sq −19.895a , df = 1, p = 0.001, n = 341. Table 3 Effect of training on knowledge scores of pharmacovigilance Knowledge score Received training on PV
Good (%)
Fair (%)
Poor (%)
Total (%)
No Yes Total
42 (17.0) 46 (48.9) 88 (25.8)
38 (15.4) 17 (18.1) 55 (16.1)
167 (67.6) 31 (33.0) 198 (58.1)
247 (100.0) 94 (100.0) 341 (100.0)
Chi sq −41.275a , df = 2, p = 0.001, n = 341.
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A. Osakwe et al. / Impact of pharmacovigilance training on knowledge and practice Table 4 Effect of training on practice of pharmacovigilance Practice score
Received training on PV
Fair (%)
Good (%)
Poor (%)
Total (%)
No Yes Total
28 (11.3) 23 (24.5) 51 (15.0)
38 (15.4) 25 (26.6) 63 (18.5)
181 (73.3) 46 (48.9) 227 (66.6)
247 (100.0) 94 (100.0) 341 (100.0)
Chi sq −18.544a , df = 2, p = 0.001, n = 341.
Table 5 Effect of PV quarterly newsletters on knowledge of pharmacovigilance Knowledge Score Received only quarterly newsletter
Good (%)
Fair (%)
Poor (%)
Total (%)
No Yes Total
78 (24.7) 10 (40.0) 88 (25.8)
51 (16.1) 4 (16.0) 55 (16.1)
187 (59.2) 11 (44.0) 198 (58.1)
316 (100.0) 25 (100.0) 341 (100.0)
Chi sq −3.025a , df = 2, p = 0.220, n = 341.
3.3. Effect of pharmacovigilance training on filling ADR forms Of the 94 professionals that had received training on PV, only 38.3% (n = 36) had filled an ADR form in the last 6 months while 61.7% (n = 58) had not, and only 21.9% (n = 54) of those without PV training had filled the ADR form in the last six months. Training was significantly associated with reporting of ADRs. 3.4. Effect of newsletters on knowledge of pharmacovigilance In whole, 25 out of the 341 respondents received only quarterly newsletter. 40.0% (n = 10) of these had good knowledge score of PV, 16.0% (n = 4) had fair knowledge score and 44.0% (n = 11) had poor knowledge score on PV. Receiving quarterly newsletters was not significantly associated (p = 0.220) with improved knowledge of PV (Table 5). 4. Discussion The most recent training organized by the NPC took place throughout the country in 2011 involving 2700 HCPs. Some of the respondents took part in these workshops which was followed up with quarterly electronic mail newsletters, some others received only electronic mail newsletters. Our findings, revealed that overall, respondent’s knowledge and practice of pharmacovigilance was generally inadequate despite the fact that about a third were trained on pharmacovigilance. Several studies [10–12] have shown poor knowledge and practice of pharmacovigilance amongst health professionals
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suggesting the need for more training perhaps with different strategies. A Nepalese study for example examined HCPs specifically doctors, pharmacists and nurses and showed below average knowledge scores for each professional group [12]. We also observed that more medical doctors had low PV scores compared to the other groups, implying that many of them had poor knowledge of PV. Studies [13–15] have shown low knowledge scores of PV amongst doctors. This, it is believed, will lead to poor reporting of adverse drug reactions. A systematic review [16] established an association between knowledge of health professionals on PV and reporting rate. This review also revealed that the medical specialty was the professional characteristic most closely associated with under-reporting in 76% of studies involving physicians. Interventions aimed at improving reporting rate must therefore focus more on the doctors, indeed pharmacists can effectively play this role as suggested by studies [17, 18]. The quality of the reports also plays an important role [19] although it was not measured in this study. Strangely, more medical laboratory scientists had good knowledge scores of PV. This may be adduced to curiosity which may motivate learning about PV. Despite their overall poor knowledge of pharmacovigilance, about three quarters of respondents could correctly define PV, a recent study amongst private doctors in Lagos Nigeria showed similar proportion being able to correctly define PV [9]. This is a good improvement on previous studies which had shown inaccurate definitions of PV amongst doctors (38%) [6] pharmacists (18%) [8] and nurses (23%) [20]. Our experience during training sessions showed that health care providers tended to retain definitions of key PV concepts than other parts of the lecture. Furthermore, their knowledge scores was significantly increased immediately after training as recorded in post test documents but this was not sustained and therefore was not reflected in our findings. Studies have shown that training has its highest impact when measured immediately after training exercise [21, 22]. Thereafter knowledge scores may gradually decrease or disappear with time. This calls to question the effectiveness of the method employed in training HCPs. During training sessions, emphasis should be placed more on case scenarios and role plays rather than didactic sessions. This will enhance learning and skill development and therefore make it long lasting. In a recent study in the Netherlands [23] a practice-based, skill-oriented method in pharmacovigilance training during GP traineeship was associated with an increase in the number of reported ADRs after completion of this traineeship, compared with a lecture-based method. An important observation in our study was a significant association between PV training received by respondents and their improved knowledge and practice of pharmacovigilance (p < 0.05). The implication of this is that more training, covering more health professionals will be required to gradually build up a highly efficient and well informed group of HCPs (Pharmacovigilantes). While training had a significant impact on PV knowledge and practice scores, newsletters did not have any significant impact, this may be due to poor reading culture amongst HCPs. Furthermore, the very low email response observed during data collection could be due to the fact that many of the HCPs hardly respond to their emails and were not likely to read the PV newsletters. A good percentage of the respondents indicated that pharmacovigilance was very relevant to effective healthcare delivery service whereas many of them do not seem to practice it as shown in this study. Reasons for not practicing it in the workplace includes lack of awareness, poor communication, lack of continuity, ignorance and inadequate manpower as documented by previous studies [24] and these need to be addressed. One limitation of the study is the mode of assessing impact which depended on the respondents ability to recall if they had been exposed to PV, which may be subject to recall bias. Furthermore, a truly
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representative sample may not have been achieved since HCPs were not selected from each of the six geopolitical zones in Nigeria. The improved knowledge and practice recorded could have been due to some other interventions other than the training attended by respondents. Finally selection bias may occur as respondents who are more interested in PV may, over the months, have attended other PV trainings, and even listened to television and radio programs on PV. All these may affect their current knowledge and practice of PV, hence a prospective study could have been employed to establish a true association. 5. Conclusion Although training was associated with improved knowledge and practice of pharmacovigilance amongst the health care providers studied, its overall impact was mild. Strengthening awareness creation and innovations in PV training methods are necessary to improve the efficiency of the program. Acknowledgments We appreciate the contributions of staff of the National Pharmacovigilance Centre. Authors’ contributions AO and IO were involved in the conception and design of the work that led to the manuscript. They also contributed to drafting and critical revision of the manuscript. AA, JA and IF were involved in the acquisition of data and contributed to critical revision of the manuscript. AO performed data entry, data analysis and interpretation and drafted the manuscript. All authors have read and approved the final manuscript. Conflict of interest The authors declare that they have no conflict of interest. References [1] World Health Organization (WHO). Guide to Detecting and Reporting Adverse Drug Reaction 2002 WHO/EDM/QSM/2002.2. [2] Lazarou J, Pomeranz BH, Corey PN. Incidence of ADRs in hospitalized patients: A meta-analysis of prospective studies. Journal of the American Medical Association 1998;279:1200-5. [3] Kongkaew C, Noyce PR, Ashcroft DM. Hospital admissions associated with adverse drug reactions: A systematic review of prospective observational studies. Ann Pharmacother 2008;42(7):1017-25. [4] Pharmacovigilance Food and Drug Information Centre newsletter 2012: Vol. 5 No 1. [5] The Importance of Pharmacovigilance: Safety monitoring of medicinal products. WHO-UMC 2002. [6] Ohaju-Obodo JO, Iribhogbe OI. Extent of pharmacovigilance among resident doctors in edo and lagos states of Nigeria. Pharmacoepidemiol Drug Saf 2010;19(2):191-5. [7] Oreagba A, Ogunleye OJ, Olayemi SO. The knowledge, perceptions and practice of PVG amongst community pharmacists in lagos state, South West Nigeria. Pharmacoepidermiology and Safety 2010;20(1):30-5.
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[8] Oshikoya KA, Awobusuyi J. Perception of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria. BMC Clin Pharmacol 2009;9:14. [9] Awodele O, Akinyede A, Adeyemi OA, Awodele DF. Pharmacovigilance amongst doctors in private hospitals in Lagos West Senatorial District, Nigeria Int J Risk Saf Med 2011;23(4):217-26. [10] Wang H, Chow S. Sample size calculation for comparing proportions. Wiley Encyclopedia of Clinical Trials 2007. [11] Li Q, Zhang SM, Chen HT, Fanq SP, Yu X, Liu D, et al. Awareness and attitudes of healthcare professionals in Wuhan, China to the reporting of adverse drug reactions. Chin Med J 2004;117:856-61. [12] Palaian S, Ibrahim MI, Mishra P. Health professionals’ knowledge, attitude and practices toward pharmacovigilance in Nepal. Pharmacy Practice (Internet) 2011;9(4):228-35. [13] Chopra D, Wardhan N, Rehan HS. Knowledge attitude and practice associated with adverse drug reaction reporting amongst doctors in a teaching hospital. The International Journal of Risk and Safety in Medicines 2011;23(4):227-32. [14] Rehan HS, Vasudev K, Tripathi CD. Adverse drug reaction monitoring: Knowledge, attitude and practices of medical students and prescribers. Natl Med J India 2002;15:24-6. [15] Cosentino M, Leoni O, Banfi F, Leechini S, Frigo G. Attitudes to adverse drug reaction reporting by medical practitioners in a Northern Italian district. Pharmacol Res 1997;35:85-8. [16] Lopez Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: A systemic review. Drug Saf 2009;32:19-31. [17] Van Grootheest Ac, de Jong-van den Berg LT. The role of hospital and community pharmacists in pharmacovigilance. Res Social Adm Pharm 2005;1(1):126-33. [18] Oreagba IA. Pharmacovigilance and the role of hospital and community pharmacists. Nigerian Journal of Pharmacy 2009;42(2):24-8. [19] Tabali M, Jeschke E, bockelbrink A, Witt CM, Willich SN, Ostermann T, Matthes H. Educational intervention to improve physician reporting of adverse drug reactions in a primary care setting in complementary and alternative medicine. BMC Public Health 2009;9:274. [20] Rehan HS,Kumar Sah R, Chopra D. Comparison of knowledge, attitude and practices of resident doctors and nurses on adverse drug reaction monitoring and reporting in a tertiary care hospital. Indian J Pharmacol 2012;44(6):699-703. [21] Odili V, Oparah A. Immediate impact of a diabetes mellitus education programme on the knowledge of pharmacists. West African Journal of Pharmacy 2013;24(1):58-63. [22] Rajesh R, Vidyasagar S, Varma DM. An educational intervention to assess knowledge attitude practice of pharmacovigilance among health care professionals in an Indian tertiary care teaching hospital. International Journal of PharmTech Research 2011;3(2):678-92. [23] Gerritsen R, Faddegon H, Dijkers F, van Grootheest K, van puijenbroek E Effectiveness of Pharmacovigilance Training of General Practitioners Drug safety 2011;34(9):755-62. [24] Inman WH: Attitudes to adverse drug-reaction reporting. Br J Clin Pharmacol 1996;41:433-5.
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Impact of training on Nigerian healthcare professionals’ knowledge and practice of pharmacovigilance Adeline Osakwea , Ibrahim Oreagbaa,b,∗ , Adebowale J. Adewunmic , Abisola Adekoyad and Iretiola Fajolue a
National Pharmacovigilance Centre, National Agency for Food and Drug Administration and Control, Abuja, Nigeria b Department of Pharmacology, College of Medicine, University of Lagos, Lagos, Nigeria c Accident and Emergency, Lagos University Teaching Hospital, Idiaraba, Lagos, Nigeria d Pharmacy Department, Lagos University Teaching Hospital, Idiaraba, Lagos, Nigeria e Department of Peadiatrics, Lagos University Teaching Hospital, Idiaraba, Lagos, Nigeria Received 12 May 2013 Accepted 31 July 2013 Abstract. BACKGROUND: Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug related problem.. The effectiveness of this system revolves on the active participation of the healthcare practitioners. Poor knowledge and practice of pharmacovigilance has necessitated training of healthcare professionals in different parts of Nigeria. OBJECTIVES: The objectives of this study are to determine the knowledge and practice of pharmacovigilance amongst health professionals in Nigeria and the impact of previous training in pharmacovigilance on their knowledge and practice. METHODS: In this descriptive cross sectional study, purposive and systematic random sampling method was used in selecting health facilities and health care practitioners respectively. Data were collected using a three-part peer-reviewed structured questionnaire administered through electronic mail (25) and self administration by healthcare professionals (316). RESULTS: Respondents who had received training on pharmacovigilance had better knowledge of correct definition of pharmacovigilance (P = 0.001) and better theoretical knowledge and practice scores of pharmacovigilance (P = 0.001). Receiving quarterly newsletters was not significantly associated (p = 0.220) with improved knowledge of pharmacovigilance. Overall, knowledge and practice of pharmacovigilance in Nigeria was still below average. The main challenges faced in the reporting and detecting of ADR were lack of awareness, poor communication, lack of continuity in training and poor funding. CONCLUSION: Although training was associated with improved knowledge and practice of pharmacovigilance amongst the health care providers studied, its overall impact was mild. Strengthened awareness creation and innovations in PV training methods are necessary to improve the efficiency of the program. Keywords: Pharmacovigilance, adverse drug reaction, knowledge and practice, spontaneous reporting, health care practitioner
1. Introduction Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug related problem [1]. ∗ Address for correspondence: Ibrahim Oreagba, Department of Pharmacology, College of Medicine, University of Lagos, Lagos, 12003 Idi-araba, Nigeria. Tel.: +234 8023519433; +234 07043335829; E-mail: [email protected].
0924-6479/13/$27.50 © 2013 – IOS Press and the authors. All rights reserved
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It has been estimated that adverse drug reactions (ADRs) are the 4th to 6th largest cause of mortality in the USA [2]. They result in the death of several thousands of patients each year, and many more suffer from ADRs. The percentage of hospital admissions due to adverse drug reactions in some countries is about or more than 10% – Norway 11.5%; France 13.0%; UK 16.0% [3]. In Nigeria, the situation is obviously worse due to wide spread irrational use of medicines and this situation is compounded by inadequate research and lack of data in this area. It is difficult to estimate the number of people that have died or been disabled in our hospitals from unsuspected adverse drug reactions. In Nigeria, the National Pharmacovigilance Centre (NPC) situated in the National Agency for Food and Drug Administration & Control (NAFDAC) has the mandate to ensure safety of all medicines through a PV system which relies on spontaneous reporting of ADRs by healthcare practitioners (HCPs), marketing authorization holders and the general public. A national PV policy document was launched recently in Abuja Nigeria to facilitate the practice of PV. The mainstay of the policy is awareness creation, capacity building and generating ADR reports, Obviously the effectiveness of this policy depends on the active participation of the healthcare practitioners. Awareness and capacity building for HCPs is facilitated through conferences, training workshops, seminars and electronic distribution of quarterly PV newsletters. The objectives of the newsletter are to disseminate information on pharmacovigilance activities nationally and globally, to educate stakeholders on drug safety issues and to promote spontaneous reporting and rational use of drugs [4]. The NPC has distributed over 80,000 individual case safety reports (ICSR) forms and 6,000 Guides for detecting and reporting ADRS to healthcare professionals nationwide. Over 12,000 healthcare practitioners have been trained through train the trainer (TOT) workshops while many more have received PV quarterly newsletters. The National pharmacovigilance center has also recently introduced a Pharmacovigilance Rapid Alert System for Consumer Reporting (PRASCOR) to stimulate enhanced consumer reporting. These credible inputs notwithstanding, the output and impact in terms of actual ADRs reported fall far short of WHO recommendation. Over 11,000 completed ICSR forms have so far been received at the NPC from inception till date. WHO indicates that adequate reporting translates to 200 reports/million inhabitants/year [5]. This means that in any given year, NPC expects 28,000 individual case reports but this is not the case. The obvious under detection/under reporting of ADRs and other medicines related problems amidst a dearth of operational research on PV requires elaborate study to determine the impact of PV training and challenges faced by health professionals in their practice of PV and to proffer possible solutions from the healthcare practitioners themselves. In Nigeria, some studies have explored knowledge, perceptions and practice of PV amongst different categories of HCPs [6–9] none to the best of our knowledge has actually looked into knowledge and practice of PV in the context of capacity building for HCPs. This study aims to examine the impact of previous PV training on knowledge and practice of PV amongst Nigerian health care professionals.
2. Methods 2.1. Design This is a descriptive cross sectional study.
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2.2. Setting The setting for this study is Nigerian health facilities where HCPs are found. The study population comprised 1427 healthcare practitioners. A significant proportion of these (about 30%) have been exposed to pharmacovigilance activities through email receipt of quarterly PV newsletters and/or formal face-toface training organized by the National Pharmacovigilance Center in Nigeria. 2.3. Sample size determination The sample size was determined using the formula for the comparison of two proportions [10]. Assuming a 50% prevalence of knowledge of HCPs already trained in PV and 33% for health care providers not trained on PV [6], a two-sided significance level at 0.05 and a critical value corresponding to the power of the study at 80%, a sample size of 254 would be required. However, to cater for losses or incomplete responses, a larger sample size of 341 was used in this study. 2.4. Sampling technique A systematic random sampling method was used in selecting health practitioners for this survey. This was achieved by selecting three hundred and forty one (341) email contacts from a list of 1427, using one in every three contacts on the HCPs mailing list of the National Pharmacovigilance Center. The exceedingly poor response from the sample population necessitated additional purposive sampling of three hundred and fifty healthcare practitioners from two tertiary institutions. For representativeness, one was selected from Northern Nigeria (National Hospital Abuja) and the other from Southern Nigeria (Lagos University Teaching Hospital, Lagos). The consideration here was the large pool of healthcare practitioners in these institutions. 2.5. Data collection instrument Data were collected using a 4-part peer-reviewed structured questionnaire administered through electronic mail and self administration. The first part was designed to capture the demographics; the second part comprised questions designed to test the general knowledge of the professionals on pharmacovigilance while the third section inquired on actual practice undertaken. The last part was structured to be open ended to elicit a list of challenges and recommendations for addressing them. 2.6. Instrument validation The questionnaire was adapted from the literature and peer reviewed by experts at the NPC before being pilot tested on different set of healthcare practitioners. The final instrument was then adjusted by rephrasing some of the questions for clarity and further reviewed by a biostatistician before distribution. 2.7. Data analysis Data were analyzed using Statistical Package for Social Sciences (SPSS) software version 15.0 for Windows. The data were subjected to frequency analysis and Pearson’s chi-square tests for association between variables. Values of p < 0.05 were considered as significant. Knowledge of pharmacovigilance was assessed by selecting five questions under the knowledge section and rating responses on a scale of
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1–5 where a score of 1 and 2 was rated as poor knowledge, 3 as fair knowledge while a score of 4 or 5 was interpreted as good knowledge. The same method was used to assess practice of pharmacovigilance. 2.8. Ethical considerations Permission for the study was obtained from the National Drug Safety Advisory Committee. The questionnaire was accompanied by a carefully worded letter which specified that completing it meant consent to participate in the survey of which all information will be treated with professional confidentiality and used only for research purposes. 3. Results Out of the 341 respondents to the questionnaire, pharmacists constituted the highest percentage of 35.2% (n = 120), followed by medical doctors 24.6% (n = 84), nurses 22.6% (n = 77), medical laboratory scientists 6.2% (n = 21) while other professionals (radiographers, physiotherapist, biomedical engineers and dietitians) constituted the remaining 11.4%. There were more female respondents (63%) than males. Majority of the respondents (188) had bachelors degree while doctorate degree (5) had the lowest frequency. 71 respondents (20.8%) had no University degrees but possessed diploma in nursing and science laboratory technology. A high percentage of the respondents (31.8%) had 0–5 years professional experience while 19.4% had more than 25 years professional experience. Others include 6–10 yrs (17.3%), 11–15 years (7%), 16–20years (10.3%) and 21–25 years (7.9%). Table 1 shows the socio-demographic characteristics of the healthcare practitioners that were surveyed. Medical laboratory scientists, 18(85.7%) had the highest proportion of good PV knowledge scores followed by pharmacists 75(62.5%), nurses 41(53.2%) and medical doctors 42(50%). Overall, 199(58%) respondents had correct knowledge of the definition of PV. The association between training and knowledge of pharmacovigilance definition was statistically significant (p = 0.001) implying that respondents who were trained were more likely to correctly define PV (Table 2). 3.1. Effect of training on knowledge scores of pharmacovigilance The knowledge base of the health care professionals was rated as good, fair, and poor based on responses to the questions posed to determine knowledge of pharmacovigilance practice. Overall, 25.8% (n = 88) of respondents had good knowledge scores, 16.1% (n = 55) had fair knowledge scores while 58.1% (n = 198) had poor knowledge scores. Of those that received training on pharmacovigilance, 48.9% (n = 46) had good knowledge scores of PV, 18.1% (n = 17) had fair knowledge scores and 33.0% (n = 31) had poor knowledge scores. Statistical analysis showed that training had a significant impact on the knowledge scores (p = 0.001) (Table 3). 3.2. Practice of pharmacovigilance Of the 94 professionals that had received training on PV, 26.6% (n = 25) had good practice scores, 24.5% (n = 23) had fair practice scores and 48.9% (n = 46) had poor practice scores on pharmacovigilance (Table 4).
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Table 1 Sociodemographic characteristics of the healthcare practitioners surveyed (n = 341) Description
Frequency
(%)
215 126
63 37
84 21 77 39 120
24.6 6.2 22.6 11.4 35.2
188 77 71 5
55.1 22.6 20.8 1.5
130 59 24 35 27 66
38.1 17.3 7.0 10.3 7.9 19.4
Gender Women Men Profession Medical doctor Medical lab. scientist Nurse Others∗ Pharmacist Educational qualification Bachelors degree Master degree Others∧ PhD Degree Years of experience in practice 0–5 6–10 11–15 16–20 21–25 25 and above ∗
these included radiographers, physiotherapist, biomedical engineers and dietitians. ∧ these had diploma in nursing and science laboratory technology. Table 2 Effect of training on Knowledge of correct definition of pharmacovigilance Knowledge of correct definition of pharmacovigilance Received training on PV No Yes Total
Yes (%)
No (%)
Total (%)
126 (51.0) 73 (77.7) 199 (58.4)
121 (49.0) 21 (22.3) 142 (41.6)
247 (100.0) 94 (100.0) 341 (100.0)
Chi sq −19.895a , df = 1, p = 0.001, n = 341. Table 3 Effect of training on knowledge scores of pharmacovigilance Knowledge score Received training on PV
Good (%)
Fair (%)
Poor (%)
Total (%)
No Yes Total
42 (17.0) 46 (48.9) 88 (25.8)
38 (15.4) 17 (18.1) 55 (16.1)
167 (67.6) 31 (33.0) 198 (58.1)
247 (100.0) 94 (100.0) 341 (100.0)
Chi sq −41.275a , df = 2, p = 0.001, n = 341.
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A. Osakwe et al. / Impact of pharmacovigilance training on knowledge and practice Table 4 Effect of training on practice of pharmacovigilance Practice score
Received training on PV
Fair (%)
Good (%)
Poor (%)
Total (%)
No Yes Total
28 (11.3) 23 (24.5) 51 (15.0)
38 (15.4) 25 (26.6) 63 (18.5)
181 (73.3) 46 (48.9) 227 (66.6)
247 (100.0) 94 (100.0) 341 (100.0)
Chi sq −18.544a , df = 2, p = 0.001, n = 341.
Table 5 Effect of PV quarterly newsletters on knowledge of pharmacovigilance Knowledge Score Received only quarterly newsletter
Good (%)
Fair (%)
Poor (%)
Total (%)
No Yes Total
78 (24.7) 10 (40.0) 88 (25.8)
51 (16.1) 4 (16.0) 55 (16.1)
187 (59.2) 11 (44.0) 198 (58.1)
316 (100.0) 25 (100.0) 341 (100.0)
Chi sq −3.025a , df = 2, p = 0.220, n = 341.
3.3. Effect of pharmacovigilance training on filling ADR forms Of the 94 professionals that had received training on PV, only 38.3% (n = 36) had filled an ADR form in the last 6 months while 61.7% (n = 58) had not, and only 21.9% (n = 54) of those without PV training had filled the ADR form in the last six months. Training was significantly associated with reporting of ADRs. 3.4. Effect of newsletters on knowledge of pharmacovigilance In whole, 25 out of the 341 respondents received only quarterly newsletter. 40.0% (n = 10) of these had good knowledge score of PV, 16.0% (n = 4) had fair knowledge score and 44.0% (n = 11) had poor knowledge score on PV. Receiving quarterly newsletters was not significantly associated (p = 0.220) with improved knowledge of PV (Table 5). 4. Discussion The most recent training organized by the NPC took place throughout the country in 2011 involving 2700 HCPs. Some of the respondents took part in these workshops which was followed up with quarterly electronic mail newsletters, some others received only electronic mail newsletters. Our findings, revealed that overall, respondent’s knowledge and practice of pharmacovigilance was generally inadequate despite the fact that about a third were trained on pharmacovigilance. Several studies [10–12] have shown poor knowledge and practice of pharmacovigilance amongst health professionals
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suggesting the need for more training perhaps with different strategies. A Nepalese study for example examined HCPs specifically doctors, pharmacists and nurses and showed below average knowledge scores for each professional group [12]. We also observed that more medical doctors had low PV scores compared to the other groups, implying that many of them had poor knowledge of PV. Studies [13–15] have shown low knowledge scores of PV amongst doctors. This, it is believed, will lead to poor reporting of adverse drug reactions. A systematic review [16] established an association between knowledge of health professionals on PV and reporting rate. This review also revealed that the medical specialty was the professional characteristic most closely associated with under-reporting in 76% of studies involving physicians. Interventions aimed at improving reporting rate must therefore focus more on the doctors, indeed pharmacists can effectively play this role as suggested by studies [17, 18]. The quality of the reports also plays an important role [19] although it was not measured in this study. Strangely, more medical laboratory scientists had good knowledge scores of PV. This may be adduced to curiosity which may motivate learning about PV. Despite their overall poor knowledge of pharmacovigilance, about three quarters of respondents could correctly define PV, a recent study amongst private doctors in Lagos Nigeria showed similar proportion being able to correctly define PV [9]. This is a good improvement on previous studies which had shown inaccurate definitions of PV amongst doctors (38%) [6] pharmacists (18%) [8] and nurses (23%) [20]. Our experience during training sessions showed that health care providers tended to retain definitions of key PV concepts than other parts of the lecture. Furthermore, their knowledge scores was significantly increased immediately after training as recorded in post test documents but this was not sustained and therefore was not reflected in our findings. Studies have shown that training has its highest impact when measured immediately after training exercise [21, 22]. Thereafter knowledge scores may gradually decrease or disappear with time. This calls to question the effectiveness of the method employed in training HCPs. During training sessions, emphasis should be placed more on case scenarios and role plays rather than didactic sessions. This will enhance learning and skill development and therefore make it long lasting. In a recent study in the Netherlands [23] a practice-based, skill-oriented method in pharmacovigilance training during GP traineeship was associated with an increase in the number of reported ADRs after completion of this traineeship, compared with a lecture-based method. An important observation in our study was a significant association between PV training received by respondents and their improved knowledge and practice of pharmacovigilance (p < 0.05). The implication of this is that more training, covering more health professionals will be required to gradually build up a highly efficient and well informed group of HCPs (Pharmacovigilantes). While training had a significant impact on PV knowledge and practice scores, newsletters did not have any significant impact, this may be due to poor reading culture amongst HCPs. Furthermore, the very low email response observed during data collection could be due to the fact that many of the HCPs hardly respond to their emails and were not likely to read the PV newsletters. A good percentage of the respondents indicated that pharmacovigilance was very relevant to effective healthcare delivery service whereas many of them do not seem to practice it as shown in this study. Reasons for not practicing it in the workplace includes lack of awareness, poor communication, lack of continuity, ignorance and inadequate manpower as documented by previous studies [24] and these need to be addressed. One limitation of the study is the mode of assessing impact which depended on the respondents ability to recall if they had been exposed to PV, which may be subject to recall bias. Furthermore, a truly
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representative sample may not have been achieved since HCPs were not selected from each of the six geopolitical zones in Nigeria. The improved knowledge and practice recorded could have been due to some other interventions other than the training attended by respondents. Finally selection bias may occur as respondents who are more interested in PV may, over the months, have attended other PV trainings, and even listened to television and radio programs on PV. All these may affect their current knowledge and practice of PV, hence a prospective study could have been employed to establish a true association. 5. Conclusion Although training was associated with improved knowledge and practice of pharmacovigilance amongst the health care providers studied, its overall impact was mild. Strengthening awareness creation and innovations in PV training methods are necessary to improve the efficiency of the program. Acknowledgments We appreciate the contributions of staff of the National Pharmacovigilance Centre. Authors’ contributions AO and IO were involved in the conception and design of the work that led to the manuscript. They also contributed to drafting and critical revision of the manuscript. AA, JA and IF were involved in the acquisition of data and contributed to critical revision of the manuscript. AO performed data entry, data analysis and interpretation and drafted the manuscript. All authors have read and approved the final manuscript. Conflict of interest The authors declare that they have no conflict of interest. References [1] World Health Organization (WHO). Guide to Detecting and Reporting Adverse Drug Reaction 2002 WHO/EDM/QSM/2002.2. [2] Lazarou J, Pomeranz BH, Corey PN. Incidence of ADRs in hospitalized patients: A meta-analysis of prospective studies. Journal of the American Medical Association 1998;279:1200-5. [3] Kongkaew C, Noyce PR, Ashcroft DM. Hospital admissions associated with adverse drug reactions: A systematic review of prospective observational studies. Ann Pharmacother 2008;42(7):1017-25. [4] Pharmacovigilance Food and Drug Information Centre newsletter 2012: Vol. 5 No 1. [5] The Importance of Pharmacovigilance: Safety monitoring of medicinal products. WHO-UMC 2002. [6] Ohaju-Obodo JO, Iribhogbe OI. Extent of pharmacovigilance among resident doctors in edo and lagos states of Nigeria. Pharmacoepidemiol Drug Saf 2010;19(2):191-5. [7] Oreagba A, Ogunleye OJ, Olayemi SO. The knowledge, perceptions and practice of PVG amongst community pharmacists in lagos state, South West Nigeria. Pharmacoepidermiology and Safety 2010;20(1):30-5.
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