Practices and awareness of pharmacovigilance in ALERT hospital, Addis Ababa, Ethiopia, a pilot study

¹Armauer Hansen Research Institute (AHRI), Addis Ababa, Ethiopia

^&Corresponding author
Daniel Legese Achalu, Armauer Hansen Research Institute (AHRI), Addis Ababa, Ethiopia

Introduction    

Pharmacovigilance is defined by World Health Organization (WHO), as “Science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems” [1]. The main purpose of pharmacovigilance (PV) is to ensure the safe, rational, and effective use of medicines through continuous monitoring and reporting of drug-related problems or ADR [2].

According to WHO, adverse drug events (ADE) are “any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment” [3,4]. Adverse drug reaction is “a response which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function” [3,5]. Adverse drug events are a global health problem with significant morbidity and mortality and represent a significant patient safety concern [3]. Adverse drug reactions may cause many hospitalizations and lead to large economic burdens to patients, and society as well [6]. Out of hospital admissions in worldwide about 4.2-6.0 % of admissions were due to serious ADRs [7]. It was estimated that ADEs are the fourth to sixth leading cause of death in the USA [8]. Studies have shown that hospitalized patients are at significant risk for experiencing ADEs. As a meta-analysis of 39 prospective studies from US hospitals estimated, ADEs accounted for 4.6% of all fatalities from hospitalized cases [9]. In Ethiopia estimated burden of ADRs was high; about 10.3% of hospital admissions were due to ADR [10].

Pharmacovigilance plays a vital role in protecting patients while on treatment [2]. Early detection and strict monitoring of ADEs reduce hospital admissions; thus, saving a significant number of resources that could be spent on patient care [11] and decreasing drug-associated morbidity and death [2]. Unfortunately, underreporting of ADRs is observed globally. Approximately, only 5-10% of all adverse reactions are truly reported worldwide [12,13]. In Ethiopia ADR reported is less than 1%; on estimation, about 0.5 ADR cases per million populations were reported annually [14].

Ethiopia launched PV in 2002 and became member of WHO drug safety monitoring in 2009. To ensure safe drug use, all health professionals at health facilities and all other stakeholders are expected to report ADR, ADE, medication error, product defects, and any drug-related problems to the national PV center at the Ethiopian Food and Drug Authority (EFDA) as soon as possible. Patients are also expected to report any drug-related problem encountered with to health professional and then to EFDA [15].

Despite practicing PV activities, Ethiopia is known by ADR underreport [14], poor awareness and knowledge of PV [16,17]. The knowledge, awareness, and practices of health professionals at health facilities are critical in achieving the aim of PV. However, many studies showed poor awareness and practices of PV at health facilities lead to underreporting. In Ethiopia, little effort was made to assess the level of PV practices and internal and external factors hindering the health facilities from practicing PV. Thus, this study was focused on the assessment of practice and awareness of PV at selected health facility settings, particularly aimed to answer research questions: how is the awareness of health professionals on PV? Is the PV practiced in the hospital and how its system works? What were the strengths and weaknesses of, and opportunities and threats to the hospital in practicing PV activities?

Methods     

Study setting and period: this study was conducted from September to February 2020 in ALERT hospital, which is located 7km southwest of Addis Ababa, Kolfe Sub-city, on Jimma Road, around Zenebework. ALERT was established in 1934. ALERT hospital provides both general and specialized healthcare services which generally structured under departments like; emergency, outpatient, inpatient, rehabilitation-physiotherapy, pharmacy and laboratory services. In ALERT hospital, there is established system by which ADRs are assessed and reported. Pharmacovigilance activities are undertaken by multi-disciplinary team which is comprised of clinical pharmacists and other clinicians. This team detects the occurrence of ADR and assesses ADR if occurred. The team performs causality assessment, identifies whether ADR preventable or not, and takes appropriate measures as per guidelines. Then this team reports suspected ADR to Drug Information Services (DIS). Drug Information Services coordinates the overall activities of PV and the DIS focal person overtakes the responsibility and receives reports from all HCWs, compiles, and reports to the National PV Center (NPC), EFDA.

Study design: concurrent mixed research design was employed, using both quantitative and qualitative data collection techniques. Descriptive study design was used for quantitative part and in addition, a qualitative study was undertaken through in-depth interviews to assess healthcare workers´ awareness and factors affecting practicing PV in the hospital.

Study participants: all health professionals working in clinical care: physicians, nurses, pharmacists, DIS focal persons, and the head of the hospital pharmacy were participants in this study.

Inclusion and exclusion criteria: all professionals working at PV relevant units, who have at least 6 months of work experience, were present at the time of data collection, and volunteers were included. However, non-volunteers and other health workers without direct involvement in PV activities were excluded.

Sample size and sampling techniques: a convenient sampling technique was used. Study participants who were supposed to be potential sources of PV information and have fulfilled the eligibility criteria were included. Accordingly, forty-six healthcare workers were selected for the quantitative survey while two key informants were purposively selected to participate in the qualitative interview.

Data collection procedures and instruments: semi-structured questionnaires and interview guiding questions were prepared and used as instruments to collect information about awareness of healthcare workers (HCWs) about PV and factors affecting practicing PV at the hospital. The contents of the tool of survey include the socio-demographic variable of HCWs, awareness of health professionals about PV, practices level of pharmacovigilance in hospitals, and attitude and perception of health professionals on reporting ADR/ADE. In addition, an unstructured open-ended question was used to capture responses of participants through probing. Questionnaires were self-administered to 46 participants for quantitative data collection. The two selected key informants were asked the questions in-depth and the answers were recorded during data collection. Relevant documents at the hospital were reviewed to obtain secondary data.

Data quality managements: to ensure the quality, the data was collected by the principal investigator. Both qualitative and quantitative methods of data collection were employed to enrich the data and the study used primary data. Data were checked for correctness and completeness.

Data analysis and interpretation: SPSS version 21 was used for data entry and analysis. After the data were cleaned and organized, descriptive statistics were computed and the results were presented under respective study objectives. Frequency distribution was used to describe quantitative data to address the research question. In the case of interview data, the audio records and field notes were transcribed into words and then coded. Codes were categorized into themes, and the analysis and interpretation were done thematically under corresponding objectives. Finally, the analyzed themes were translated from Amharic to English by bilingual translators. The accuracy of the translation was checked to ensure data validity and the absence of discrepancies.

Ethical consideration: before the study began, an official letter from AHRI was written to the ALERT hospital, and permission was obtained. Consent was obtained from each participant before the actual data collection and the information provided by the respondents was also kept secret. All potential identifiers (names and mobile number) were removed from questionnaires to ensure confidentiality.

Results     

Personal information of participants: forty-six health professionals working at ALERT hospital completed the questionnaires. Out of 46, physicians (26.1%), pharmacists (28.3%) and nurses (45.6%) participated. About 89.1% of the participants were first-degree holders. More than three-fourths (77%) of participants had more than two years of work experience (Table 1).

Awareness of healthcare workers on pharmacovigilance: the awareness of healthcare workers (HCWs) on PV activities was assessed. From 46, only 39.1% knew the term PV and 17.4% were aware existence of NPC in Ethiopia. Only 41.3% of participants responded that they were aware of the system for drug safety monitoring the in hospital. Even though the most of participants (91.3%) knew the importance of reporting ADR, they were less aware of how to report it (Table 2).

Practice of pharmacovigilance in ALERT Hospital: throughout their work experiences, out of the total participants, 25 (54.3%) had encountered with ADR. Out of 25, only 14 (56%) reported the identified ADRs to the concerned body (Table 3). As a key informant said, “PV activities were practiced in the hospital. Identification, processing, assessing, and reporting ADR were conducted by the hospital´s HCWs. After assessing ADR, different management actions have been taken; discontinuing, withholding, and switching medication and close observation/follow-up were among common actions undertaken in managing ADR based on its severity,” [DIS focal]. Secondary data, from kept copies of reported ADR in the hospital was assessed. As reviewed from DIS data, poor documentation of PV was observed. Copy of ADRs reported to NPC was not kept at the site, but a total of 7 reports starting from September 2018 were documented at the time of observation for the study. Delay of action taken in response to ADRs and reporting them to NPC in some cases was observed.

Reasons for not reporting adverse events: the reasons why healthcare workers didn´t report the ADRs they suspected were also assessed. Accordingly, majority of them (81.8%) didn´t report due to a lack of awareness about pharmacovigilance. Other identified barriers to reporting of ADRs by HCWs were lack of information on how and to whom to report (72.7%), lack of reporting form (45.5%), and work overload (27.3%) (Table 4). As the result obtained from the interview showed, the awareness of health professionals on PV was poor. As pointed out by respondents, the main reason for less awareness is lack of training. “There was no single person who has received PV training. However some individuals, especially clinical pharmacists well understood PV by their effort, throughout Google search, they updated themselves,” [head of pharmacy].

Attitude and perception of healthcare workers on reporting adverse drug reaction: participants were asked their views on reporting the identified ADRs to the concerned body. As observed from responses of HCWs, negative attitudes and wrong perceptions of the HCW towards ADR reporting were identified (Table 5). Key respondents pointed out that: “negative attitude toward ADR reporting was also observed among HCWs. They think that reporting doesn´t make a difference, and assume that it is just for the sake of bureaucracy,” [head of the pharmacy]; “HCW had a perception of reporting serious ADR and usually ignored the mild one. In some cases, they even assumed the case was not related to the drug just before a further investigation was done,” [DIS focal].

Strength, weakness, opportunities, and threats analysis of ALERT hospital in practicing pharmacovigilance: SWOT analysis of PV activities was done based of data obtained from interviews with the two key informants and observation in order to identify strengths, weaknesses, challenges and opportunities of the hospital in practicing PV in accordance with the national guidelines. Through assessment, weaknesses, strengths, opportunities, and threats of the hospital in practicing PV were identified (Table 6).

Discussion     

This descriptive study assessed the practice and awareness of PV in ALERT hospitals. The hospital had a system for drug safety monitoring. Multi-disciplinary teams were involved in the detection, assessment and management of suspected ADR. Since there was no PV focal person, DIS coordinated PV activities, and the DIS focal person was responsible for reporting ADR to NPC. This is different from what national PV guidelines suggests, “PV activities should be coordinated by DTC and PV focal person will be the link between EFDA and facilities” [15]. Drug information services is conducting PV activities in addition to drug information services, this may undermine the PV program. Since DTC is representative of different health service departments, it would be better for awareness creation than DIS. The coordination of PV under DIS may makes other professionals to perceive that it is the responsibility of pharmacists only. This study showed that only 41.3% of respondents knew the existence of a drug safety monitoring system in the hospital. So, the system of PV followed by ALERT hospitals may be the reason for low PV awareness among professionals and thereby underreporting.

As this study showed, generally the awareness of HCW on PV in this hospital was poor. Only 39.1% and 17% of the respondents were aware of PV and its existence at the national level respectively. This result is comparable to a previous study in Boru Meda Hospital, which identified that only 21 (36.8%) respondents knew the term pharmacovigilance [17]. A study in India reported similar results; doctors (54%) and pharmacists (60%) did not know the existence of a PV program, and doctors (74%) and pharmacists (60%) did not know the nearest PV center [18]. However, higher number of respondents (55%) had awareness on PV in Nigeria [19]. The main reason for this was absence of awareness awareness-creation mechanism in the hospital. There was no training given by the regulatory body and the hospital itself to the workers. The role of health professionals in ADR reporting is crucial for the success of PV program. So, the unawareness of HCW on PV, will negatively affect the goal of the program. Poor awareness leads to underreporting. Thus, an aggressive awareness-creation mechanism is needed.

Healthcare workers' involvement in PV practice was assessed and founded that around half of the participants (54.3%) encountered ADR through their experiences, of this only 56% had reported it. In contrast, a study at Boru Meda Hospital showed, that of 21.1% of HCWs who encountered ADR, 83.3% reported it to the concerned body [17]. Although the guidelines recommends timely reporting of ADR to NPC within 48 hours for serious, and 7 days for non-serious cases [15], delayed report of some ADRs to NPC was identified. So, this should be given attention as delay in ADR reporting reduces the opportunity to minimize drug-related morbidity and mortality.

This study also assessed factors affecting PV activities. Lack of awareness, negative attitude, wrong perception, and lack of training were identified as reasons for underreporting. A previous study in Ethiopia also identified poor knowledge and negative attitudes of health practitioners in practicing PV [18]. Other studies also found out similar reasons for not reporting; the lack of awareness and knowledge on how to report ADRs, attitude of professionals toward their activities are associated with poor ADR reporting [20]. In India, a lack of trained staff and a lack of awareness regarding the detection and communication of ADRs were reasons for underreporting [21]. In this study, even though some participants also pointed out unavailability of reporting forms hindered them from reporting, the availability of the forms at the site was identified through interviews and observation. So, this shows that there was a communication gap and unawareness of HCW where the yellow card was kept.

This study has several strengths as well as limitations. As strength, both quantitative and qualitative methods were employed to obtain reliable result. The researcher used primary data to assess awareness and practice of PV at a hospital, thus the originality of the data provides quality and meaningful results. The results of this study were compared to evidences from literature and national PV guidelines. Regarding limitations, the study was conducted only in ALERT hospitals and may not be generalizable for all health facilities. This was a pilot study in which only 46 individuals participated and only physicians, Pharmacists, and nurses were included in the survey. So, the results of this study may not exactly represent the views of the all-health professionals working in the hospital.

Conclusion     

This study's findings showed that health professionals' awareness of pharmacovigilance was poor. There was a gap in awareness of HCW in how and to whom to report, due to lack of training and mechanism awareness creation in the hospital. Generally, PV practices in the hospital were not well developed. Poor documentation and underreporting were identified. Many external and internal factors contributed to the under practice of PV activities in the hospital. This delays ADR reporting and reduces the opportunity to minimize drug-related morbidity and mortality. Thus, more aggressive training or educational intervention is required.

Competing interests     

The authors declare no competing interests.

Authors' contributions     

Daniel Legese Achalu: Identified the problems, conceptualized and designed the study; analyzed the data, and drafted the article. Gemechis Mikael Mamo: collected, cleaned, and organized the data. reviewed the article critically for important intellectual content. All the authors read, commented, and approved the final version of this manuscript.

Acknowledgments     

We are interested to forward our gratitude to AHRI for providing us all needed materials in conducting this study. We would like also to acknowledge ALERT hospital Management, DIS and health professional at this hospital for their voluntary participation and providing a valuable data for this study.

Tables     

Table 1: personal information of participants, ALERT hospital, 2020

Table 2: awareness of health workers on pharmacovigilance activities, ALERT hospital, 2020

Table 3. practice of Pharmacovigilance at ALERT Hospital by health professionals, 2020

Table 4: reasons why HCWs don´t report ADRs when they identified/encountered, ALERT Hospital, 2020

Table 5: attitude and perception of health workers on reporting ADR, ALERT hospital, 2020

Table 6: SWOT analysis: weakness, strength, opportunities, and threats of ALERT hospital in practicing PV, 2020

References