Pharmacovigilance Knowledge and Attitude of Health Professionals: A Preand Post-intervention Study
Objective: The objective of the current study was to evaluate healthcare professionals' knowledge and attitude towards pharmacovigilance in Ribat University Hospital, Sudan.
Methods: This was a pre and post-intervention study conducted at the National Ribat University Hospital in Khartoum, Sudan. The sample size was calculated as 98. The phases of the study were as follow: Pre- intervention phase: Knowledge and attitude of health professionals towards Pharmacovigilance were assessed by using a pre-tested questionnaire after obtaining ethics approval and a written informed consent.
Intervention phase: The health professionals were divided into four subgroups. Each group had the same number and categories of the sample. Each subgroup received structured information about Pharmacovigilance by either lecture sessions, pamphlets, mobile phones (SMS) or posters. The sessions were conducted by the researcher.
Post-intervention phase: Reassessment of knowledge and attitude of health professionals towards Pharmacovigilance took place by using a pre-tested questionnaire. Assessment of Knowledge and Attitude was based on Likert scale. Descriptive and inferential analysis was performed by SPSS version 21.
Results: The mean respondents’ pharmacovigilance knowledge was improved from 45% to 64% between pre and post-intervention phases (p=0.007). The mean respondents’ pharmacovigilance attitude was improved from 78% to 84.3% between pre and postintervention phases (p=0.254).
Conclusion: The study concluded that, pharmacovigilance knowledge of health professionals in Ribat University Hospital, Sudan is inadequate. Most health professionals have positive attitude towards pharmacovigilance. Health professionals’ knowledge of pharmacovigilance significantly improves after intervention. Pharmacists showed higher level of pharmacovigilance knowledge (92.9%) compared to physicians (66%) and nurses (25%). Healthcare professionals with less years of experience showed higher pharmacovigilance knowledge (69.6%) compared to the more experienced (42.6%).
Knowledge, Attitude, Health professionals, Pharmacovigilance
Pharmacovigilance is defined as “the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems” . The concern of Pharmacovigilance is extended recently to include herbs, complementary and alternative medicine practices, medical devices, blood products and vaccines [2-6].
Adverse drug reaction (ADR) is “anxious, undesirable and unintended effect occurs due to drug treatment at doses normally used in man for diagnosis, prophylaxis and treatment” .
ADRs are one of the leading causes of mortality and morbidity around the world [8-10]. In the UK, 6.5% of hospital admitted patients were due to an adverse drug reaction, and 15% of patients have experience ADRs during their hospital admission . Reporting of ADRs is inadequate, it has been estimated that only 6-10% of ADRs are reported . However, poor results of monitoring ADRs was found in many counties around the world .
In Sudan, the National Medicines and Poisons Board (NMPB) was formed in 2001, a law of drugs and poisons was introduced in 2009. A pharmacovigilance committee was introduced; the aim is to aware health professionals about pharmacovigilance and ADRs. The committee members visit the health facilities for this purpose, and they utilize the social media and others means of communication to achieve their objectives. In Sudan, Pharmacovigilance studies were scanty. ADRs awareness among health professionals is inadequate due to lack of knowledge on how to report ADRs .
Many studies conducted among health professionals elsewhere showed lack of knowledge about pharmacovigilance and ADRs reporting, so there is a need to study the knowledge of health professionals regarding PhV as they are responsible to report ADR during their practice. Attitude of health professionals towards pharmacovigilance will encourage them to report and follow ADRs. Hence this study was designed to evaluate health professionals' knowledge and attitude towards pharmacovigilance among health professionals in Ribat University Hospital, Sudan and to assess the impact of an intervention.
The design was a pre- and post-intervention to study knowledge and attitude of health professionals in Ribat University hospital, Sudan about Pharmacovigilance. The sample Size was calculated by the formula: n=Z2*P (1-P)/d2 (estimate proportion=0.10, error=0.05, CI= 0.90, Z=1.64). Sample size=98, included pharmacists, physicians, and nurses. One hundred and fifty questionnaires were distributed and 100 responded giving response rates as 77%.
Knowledge and attitude of health professionals towards Pharmacovigilance were assessed by using a pre-tested questionnaire after obtaining ethics approval and a written informed consent (Annex 1). The questionnaire was pre-tested in Khartoum Teaching Hospital. It included questions about pharmacovigilance and ADRs definitions, PhV purpose and components, ADRs treatment, what are the health professionals supposed to report ADRs etc.
The health professionals were divided into four subgroups. Each group had the same number and categories of the sample. Each subgroup received structured information about Pharmacovigilance by either lecture sessions, pamphlets, mobile phones (SMS) or posters (Annex 2). The information disseminated was about pharmacovigilance and ADRs definitions, components, objectives, importance, who is to report ADRs and reasons behind not reporting ADSs. Two sessions were given separated by seven days and conducted by the researcher. Pamphlets were given twice in the hospital separated by one-week time. Posters were in place for one week and SMS were sent twice separated by one week. All the materials given in the intervention were prepared by the researcher.
Reassessment of knowledge and attitude of health professionals towards Pharmacovigilance took place by using the same pre-tested questionnaire. Assessment of Knowledge and Attitude was based on Likert scale. Ten questions of knowledge were asked. If the respondent scored from five to ten correct answers was considered as having good knowledge and if scored less than five correct answers was considered as having poor knowledge. Six questions of Attitude were asked to the respondents. If the respondent scored more than three correct answers was considered as having positive attitude and if scored less than four correct answers was considered as having a negative attitude. The data were analyzed by Statistical Package of Social Sciences (SPSS) software, version 20. Descriptive and inferential statistics were used. Comparison between qualitative variables was made by using the person’s chi-square to test significance; p<0.05 was considered significant.
One hundred and fifty questionnaires were distributed among the health professionals and 100 responded (response rate was 66.7%). Table (1) shows the socio-demographic characteristics of the respondents. Males and females were 16% and 84% respectively. Physicians, nurses and pharmacists were 50%, 36% and 14% respectively. Less than two years of working experience was reported by 44% of the respondents, whereas 22% had experience 2-5 years and 34% had working experience more than five years.
|Years of experience|
|Less than two||44||44|
|2 to 5||22||22|
|More than 5||34||34|
Table 1: Socio-demographic factors (n=100).
This research was conducted to study the Table (2) shows the comparison of the respondents’ knowledge about Pharmacovigilance in the pre and post-intervention phases. The mean pharmacovigilance knowledge in the pre-intervention phase was 45% and in the post-intervention phase was 64% (p=0.007).
|number (%)||number (%)|
|PV definition||40 (40%)||77 (77%)||0.007|
|PV purpose||55 (55%)||75 (75%)|
|PV contents||71 (71%)||80 (80%)|
|PV benefits||48 (48%)||68 (68%)|
|ADR definition||47 (47%)||76 (76%)|
|Treatment of independent ADR||53 (53%)||58 (58%)|
|Important information in reporting||69 (69%)||84 (84%)|
|Location of ADR reporting center||9 (9%)||48 (48%)|
|US agency for drug safety||37(37%)||48 (48%)|
|Responsibility for reporting ADR||21 (21%)||29 (29%)|
|Mean pharmacovigilance knowledge in pre-intervention=45%, in post intervention=64%.|
Table 2: Comparison of Pharmacovigilance Knowledge in pre and post interventions
Table (3) shows the comparison of the respondents’ attitude towards Pharmacovigilance between pre and post-intervention phases. The mean healthcare professionals’ attitude towards pharmacovigilance in the pre-intervention phase was 78.0%, and in the post-intervention phase was 84.3% (p=0.254).
|number (%)||number (%)|
|Discourage from reporting||50 (50%)||63 (63%)||0.254|
|Reporting obligation||81 (81%)||90 (90%)|
|Presence of monitoring for ADR center||82 (82%)||80 (80%)|
|Reporting necessary||91(91%)||97 (97%)|
|PV teaching in detail||97(97%)||98 (98%)|
|Reporting by non-medical personnel||67(67%)||78 (78%)|
|Mean attitude in the pre-intervention phase= 78.0%, and in the post-intervention phase= 84.3%.|
Table 3: Comparison of respondents’ attitude towards pharmacovigilance in the pre and post-intervention phases
Table (4) shows the relation between pharmacovigilance knowledge before intervention and social factors. Nurses, physicians and pharmacists with good knowledge were 25%, 66% and 92.9% respectively, p<0.0001. Healthcare professionals with less than 2 years of experience and had good knowledge were 69.6% and those with experience of two years and more and had good knowledge were 23 (42.6%), p=0.0001.
|Social characteristics||Level of knowledge||Total||P|
|Nurse||9 (25%)||27 (75%)||36||<0.001|
|Physician||33 (66%)||17 (34%)||50|
|Pharmacist||13 (92.9%)||1 (7.1%)||14|
|Less than 2||32 (69.6%)||14 (30.4%)||46||0.0001|
|2 and more||23(42.6%)||31(57.4%)||54|
Table 4: Relation between pharmacovigilance knowledge and social characteristics.
Table (5) shows relation between pharmacovigilance attitude before intervention and social factors. Pharmacists who had more positive attitude towards pharmacovigilance (92.9%) compared to nurses (77.8%) and physicians (62.0%), p<0.001. Health professionals with less than 2 years of experience and had positive attitude towards pharmacovigilance were 65.2% and those with experience more than two years and had negative attitude were 42 (77.8%), p=0.048.
|Social characteristics||Level of knowledge||Total||p|
|Nurse||28 (77.8%)||08 (22.2%)||36|
|Physician||31 (62.0%)||19 (38.8%)||50|
|Less than 2||30 (65.2%)||16 (34.8%)||46||<0.048|
|2 and more||42(77.8%)||12 (22.2%)||54|
Table 5: Relation between pharmacovigilance attitude and social characteristics
knowledge and attitude of Pharmacovigilance among health professionals in Ribat University Hospital, Sudan. The sample size was calculated as 98 and 100 responded giving response rates as 77%. The baseline healthcare professionals’ pharmacovigilance mean knowledge was low (47%). This finding is consistent with studies conducted in Egypt, Sudan, Ethiopia, Turkey, Nepal and China [17-22]. However, our findings are not in line with studies conducted in India, Kuwait, Lebanon, Yemen and Jordan where adequate knowledge of pharmacovigilance was observed [23-27]. According to our findings, pharmacists had better PhV knowledge followed by the physicians, the nurses acquired the least level of knowledge. This may be explained by the fact that pharmacist main goals and work experience is about drugs followed by the physicians .
In the current study, Pharmacovigilance mean knowledge showed significant improvement after interventions from 45% to 64% (p<0.001). These findings are consistent with studies conducted in Iran and China [29,30]. The significant improvement in Pharmacovigilance knowledge may reflect the readiness of respondents and their interest to improve their knowledge. The directions of knowledge may be different. Fang, et al. reported that both physicians and nurses had good knowledge regarding PhV: However, Physicians had better understand of what to report regarding ADRs while nurses know where to report . In a study conducted in India, Rehan, et al. reported that nurses acquired better knowledge compared to physicians and pharmacists in methods of drug disposal . The subjects with short experience (less than two years) had better knowledge than those with long experience (two years and more). This may be explained that the knowledge of respondents with short experience is still fresh due to short time of leaving classes, those with long experience were far from formal education and hence may forget much of their knowledge. This fact is also aggravated by the economic crises of the country which forces health professionals to work double shifts daily to be enabled to live in a good economic standard.
Our study showed that the attitude of health professionals towards pharmacovigilance was positive (78%). Health professionals with positive attitude in our study is consistent with findings from Pakistan and India [33,34]. Negative attitude towards pharmacovigilance was found among health professionals in Ethiopia and Saudi Arabia [18,35].
Insignificant improvement of attitude towards pharmacovigilance was seen after intervention, this may be due to the need for long time to change attitude not like knowledge which can be acquired in short duration. Our results reported more positive attitude of pharmacists towards pharmacovigilance compared to nurses and physicians (p<0.001) [36,37].
Positive attitude towards Pharmacovigilance was more among pharmacists (92.9%) compared to physician and nurses, 62.0% and 77.8%, p ≤ 0.001. It is also more among senior compared to junior health professionals (77.8%), 65.2%, p<0.048) . Studies of knowledge and attitudes towards pharmacovigilance studies in Sudan are very few, these findings may help to establish strategies to strengthen PhV and ADRs in the country and in the other similar settings. The author observed that after collection of data the policy makers in the hospital started to hold meetings in order to strengthen PV and ADRs .
The study concluded that pharmacovigilance knowledge of health professionals is inadequate. Health professionals’ knowledge of pharmacovigilance significantly improves after intervention. Most health professionals have positive attitude towards pharmacovigilance. The pharmacists have better knowledge and more positive attitude towards pharmacovigilance compared to physicians and nurses. Pharmacovigilance knowledge is higher among junior health professionals: however, positive attitude towards Pharmacovigilance was more among senior health professionals. The study pointed towards an urgent need for enforcement of pharmacovigilance policies in Sudan National Health System. The authors encouraged hospitals managements and colleagues at other hospitals to implement PhV which is not difficult but needs commitment.
The limitation is that, the study was conducted in one setting, so the findings can’t be generalized.
The authors would like to thank the Deanship of Scientific Research, Majmaah University, Saudi Arabia for supporting this research. The authors would like to acknowledge the administration of Ribat University Hospital for their support and cooperation.
Proposal development, data collection and writing the draft- Tayseer Elsadig Albadawi. Proofreading the manuscript and supervising the work-Tarig Mohamed Hassan, Nahid Osman Ahmed Eisa and Sawsan Mustafa Abdalla, Data analysis- Elsadig Yousif Mohamed. All authors contributed and approved the final manuscript.
Conflicts of Interest
All authors have none to declare.
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2Department of Community Medicine, Saudi Arabia
3Department of Biostatistics, Saudi Arabia
Citation: Tayseer Elsadig Albadawi, Tarig Mohamed Hassan, Nahid Osman Ahmed Eisa, Elsadig Yousif Mohamed, Sawsan Mustafa Abdalla, Waqas Sami, Pharmacovigilance Knowledge and Attitude of Health Professionals: A Pre-and Post-intervention Study, J Res Med Dent Sci, 2019, 7(5): 137-147.
Received Date: Oct 09, 2019 / Accepted Date: Oct 24, 2019 /