Perception of Pharmacovigilance by Nurses and Midwives of the Cocody University Teaching Hospital in Abidjan

Objective: To assess the perception on pharmacovigilance by the nurses and midwives at the University Teaching Hospital (CHU) of Cocody in 2017. Methodology: Descriptive and analytic cross-sectional study conducted in 17 services of the University Teaching Hospital (CHU) of Cocody using an anonymized and standardized questionnaire. Results: The response rate was 39.33% for the 86 nurses and 21 midwives with at least 10 years of professional experience (50.6%). 57.94% of the respondents (n = 62) have already heard about pharmacovigilance during their basic training (40.18%, n = 43). However, only 19.63% (21/107) of the respondents knew about the existence of a pharmacovigilance unit which they wrongly located to the pharmacy (11/21) of the CHU of Cocody. 40.18% of respondents (n = 43) had previously experienced an adverse drug reaction that was reported (76.74%, n = 33) to a hierarchical supervisor (60.60%, n = 20). The causes of non-reporting were either the frequent occurence (4/10) or the benign nature (2/10) of the adverse drug reaction. Specific actions to be taken (37.38%, n = 40) and a feedback (28.97%, n = 31) were the respondents’ main expectations for the stimulation of the reporting system. They also wanted the pharmacovigilance monitors to regularly visit their services (34.57%, n = 37) and to provide them with the reporting forms (30.84%, n = 33). Conclusion: Our study has allowed us to highlight the lack of knowledge of the pharmacovigilance and to identify certain factors that could improve the perception of the pharmacovigilance by the nurses and the midwives in Ivory Coast.


Abstract
Objective: To assess the perception on pharmacovigilance by the nurses and midwives at the University Teaching Hospital (CHU) of Cocody in 2017. Methodology: Descriptive and analytic cross-sectional study conducted in 17 services of the University Teaching Hospital (CHU) of Cocody using an anonymized and standardized questionnaire. Results: The response rate was 39.33% for the 86 nurses and 21 midwives with at least 10 years of professional experience (50.6%). 57.94% of the respondents (n = 62) have already heard about pharmacovigilance during their basic training (40.18%, n = 43). However, only 19.63% (21/107) of the respondents knew about the existence of a pharmacovigilance unit which they wrongly located to the pharmacy (11/21) of the CHU of Cocody. 40.18% of respondents (n = 43) had previously experienced an adverse drug reaction that was reported (76.74%, n = 33) to a hierarchical supervisor (60.60%, n = 20). The causes of non-reporting were either the frequent occurence (4/10) or the benign nature (2/10) of the adverse drug reaction. Specific actions to be taken (37.38%, n = 40) and a feedback (28.97%, n = 31) were the respondents' main expectations for the stimulation of the reporting system. They also wanted the pharmacovigilance monitors to regularly visit their services (34.57%, n = 37) and to provide them with the reporting forms (30.84%, n = 33). Conclusion: Our study has allowed us to highlight the lack of knowledge of the pharmacovigilance and to identify certain factors that could improve the perception of the pharmacovigilance by the nurses and the midwives in Ivory Coast.

Introduction
According to WHO, pharmacovigilance is defined as the science and activities related to the detection, evaluation, understanding and prevention of the risk of adverse effects and any other problems related to the use of the drug [1]. Although it is a well-established activity in industrialized countries, it encounters difficulties in sub-Saharan Africa in its implementation. In Côte d'Ivoire, a West African country, the absence of a National Pharmacovigilance Center (NPVC) hampers the setting up of a national system of pharmacovigilance [2] [3]. In this context, the Clinical Pharmacology Department of the University Teaching Hospital (CHU) of Cocody records and evaluates the reports of the adverse drug reactions (ADRs).
However, these reportings are conducted exclusively by doctors at the CHU of Cocody. Hence, the need to understand the perception of the pharmacovigilance by the nurses and the midwives who are the paramedical personnel in Côte d'Ivoire.
Our study was the first to focus on the perception of the pharmacovigilance by the nurses and midwives practicing at the CHU of Cocody. It was justified, on one hand by the fact that nurses and midwives have regulatory obligation like any other healthcare professionals to report ADR in Côte d'Ivoire [2]. On the hand, by the fact that in 2017, nurses and midwives accounted for the majority of health care workers in the Ivorian health system [4]. The overall objective of our study was to assess the perception on pharmacovigilance by the nurses and midwives practicing at the University Teaching Hospital (CHU) of Cocody in 2017. The specific objectives were to describe the professional characteristics of the nurses and the midwives, to determine their general knowledge on pharmacovigilance, to determine their expectations (following an ADR report) and lastly, to identify the measures to stimulate their spontaneous notification.

Study Population
Our survey targeted the nurses and midwives practicing in 2017 in any of the included in the study. On the contrary, the nurses and the midwives employed in the selected services but absent (with the exception of those on night shifts) at the time of the survey or who did not give their consent or who did not complete the survey form were not included in the study.

Study Process
In a first step, we developed based on the literature reviews • The professional characteristics (profession, name of the specific hospital service, and seniority in the position). • General knowledge on pharmacovigilance (source of information, pharmacovigilance teaching hours in the basic training, existence and location of a pharmacovigilance unit at the CHU of Cocody, importance given to pharmacovigilance in practice).
• Reporting of adverse drug reactions (existence of ADRs in the service, types of adverse reactions reported, reporting methods, reasons for non-reporting).
• The expectations of nurses and midwives after reporting an ADR.
• Measures to improve the rate of reporting of ADR by the nurses and midwives.

Statistical Analysis
The data was analyzed using the EPI info7.

Ethical Considerations
When collecting the data, we respected the anonymity of the nurses and midwives and ensured that their activities were not disrupted during working hours.
Moreover, we obtained the oral agreement of the Head of the services and the Unit Care Supervisors (UCS) of the selected services. In addition, a written authorization from the Director of the Medical and Scientific Department of the University Teaching Hospital of Cocody was obtained before the beginning of the study. Finally, no healthcare provider completed the questionnaire under coercion.

Professional Characteristics of Nurses and Midwives
Of the 272 paramedics (196 nurses and 76 midwives) surveyed, only 39.33% (86 nurses and 21 midwives) voluntarily answered the questions (Table 1). They mainly worked in the service of internal Medicine (58.46%) and Surgery (52.11%) and had in the majority of cases (50.6%) a professional experience of less than 10 years ( Table 2). The other primary information such as age, sex, specialty and place of residence were incorrectly entered on the questionnaire and could not be showed in a table.

General Knowledge on Pharmacovigilance by Nurses and Midwives
In our study, 57.94% (62/107) of paramedics (52 nurses and 10 midwives) had already heard of pharmacovigilance (

Reporting of Adverse Events by Nurses and Midwives
In our survey, 40.18% (43/107) of the paramedics had already come across an adverse event (Table 3), mainly an adverse drug reactions (32/43). They reported these events in 76.74% (33/43) of the cases to a hierarchical supervisor  (Table 3) were related to their frequent occurence (4/10) or their benign nature (2/10).

Expectations and Measures to Stimulate Spontaneous Notification
Specific instructions such a code of conduct (37.38%) and a feedback after reporting (28.97%) were the main expectations of our respondents (Table 4). They also wanted a regular visit of the pharmacovigilance monitors in their services (34.57%) and the provision of the reporting forms to stimulate a spontaneous reporting of adverse drug reactions (Table 4).

Discussion
The spontaneous notification is based solely on the will of the healthcare professionals, despite its mandatory nature in many countries, particularly in Côte d'Ivoire [1] [2]. It is, therefore, associated with the perception on pharmacovigilance by the same professionals. Our study had some limitations mainly related to how the data were collected (self-administered questionnaire or administered by the registrar of pharmacology) and the availability of paramedical personnel. However, it allowed us to collect 107 responses (39.33%) out of 272 total administered questionnaires. This response rate, lower than what is reported in the literature [5]- [10] highlights the difficulties encountered during the data collection.

Socio-Professional Characteristics of the Nurses and Midwives
In our study, the response rate of the paramedics varied significantly according to the profession (nursing or midwifery) (Chi 2 = 6.058, ddl = 1, P < 0.02) and the service in which they are working (Chi 2 = 18.634, ddl = 4, P < 0.001). This could explain the various level of their knowledge on pharmacovigilance. In addition, most of our paramedics (54/107) had a professional seniority of less than 10 years. This was not reported in several studies [5] [6] [7] [8] [9] in which the majority of nurses interviewed had more than 11 years of working experience.

Knowledge of the Pharmacovigilance by the Nurses and Midwives
In our survey, 57.94% (62/107) of paramedics had already heard of the term pharmacovigilance mainly during their basic training ( Apart from that, 80.37% (86/107) of the paramedics in our study were unaware of the existence of the pharmacovigilance unit and wrongly located it at the pharmacy (11/21). This could be a barrier to reporting of the adverse drug reactions at the CHU of Cocody. Our results were comparable to those of a Saudi study [10] in which 62.5% of healthcare professionals said they did not know the term "pharmacovigilance". Furthermore, in two (2) Italian and Portuguese studies [6] [7], the nurses did not know the existence of the national pharmacovigilance system in 50% and 58.1% of cases respectively.

Declaration of the Nurses and Midwives
In our work, the ignorance of the reporting procedures was another factor that could negatively influence the perception on pharmacovigilance. In fact, the majority of the 33 respondent paramedics (n = 20, 60.60%) had reported the adverse drug reactions to their hierarchical supervisor and none of these events were reported to the pharmacovigilance unit. This did not comply with the Regulatory Act that creates the national pharmacovigilance system in Côte d'Ivoire [2]. Under these conditions, a special emphasis should be made on the procedural aspects of the Act if the desire is to increase the number of adverse drug reactions reporting at the CHU of Cocody. Furthermore, in our survey, 4 out of 10 respondent paramedics did not report the adverse drug reactions because of their frequent occurrence (  [2]. In an Italian study [6], the poor knowledge of the pharmacovigilance system, the fear of conflicts with doctors and the fear of legal reprisals were the main reasons for the under-reporting of the adverse drug reactions by nurses.

Expectations of the Nurses and Midwives and Actions to Be Taken
In our study, paramedics mainly expected a precise code of conduct and a feedback on a reported event (Table 4). In addition, to stimulate a spontaneous notification, most of the respondent paramedics had suggested a regular visit of the pharmacovigilance monitors in their different services (34.57%, n = 37) and the provision of the reporting forms (30.84%; n = 33) as shown in Table 4. These

Conclusion
Our study allowed us to identify factors that may influence the perception of the pharmacovigilance by the nurses and midwives. The main barrier to reporting of the adverse drug reactions at the CHU of Cocody were an insufficient hourly volume in pharmacovigilance at initial training, the ignorance of the existence of the pharmacovigilance unit and the lack of knowledge of reporting procedures.
This could be improved with a continuous training of these paramedical personnel, regular contact with the pharmacovigilance monitors and a specific code of conduct to be followed in case of any occurrence of adverse drug reactions.