Awareness, Attitude And Practice Of Health Care Professionals To Adverse Drug Reaction Reporting In Jibia LGA, Katsina State
A study of patients on antiretroviral treatment attending the comprehensive care clinic at Katsina General Hospital (KGH) revealed high incidence (48.6%) of Adverse Drug Reactions (ADRs) with underreporting being a key problem among healthcare professionals involved. The objective of this study was to determine the awareness, attitude and practice of health care professionals to adverse drug reaction reporting in Jibia LGA, katsina State. This was a descriptive cross sectional study whose sample size comprised 308 health care professionals working at the KGH, who are key decision makers in the provision of health services. A probability sampling was utilized via a skip interval random technique, to ensure each respondent in the different clinical units in the population were considered. Self-administered semi structured questionnaires were used as data collection tools for the study that included demographic data. The study report highlights deficits in the practice of ADR reporting can be resolved only if all healthcare professionals are made aware of the importance of reporting, the reporting system, and their obligation to report ADRs.
1.1 Background of the Study
The World Health Organization (WHO) defines an Adverse Drug Reaction (ADR) as “a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.” (WHO, 1972). Several classification methods have been proposed to describe ADRs such as by their severity (mild, moderate or severe), source of reported data (reported by patient, observer or machine), by reaction time (acute or latent) and whether the reaction is localized or systemic.
The pharmacological classification which classifies ADRs into Types A-F is most commonly used. Type A (Augmented) is an exaggeration of the drug’s normal pharmacological actions, type B (Bizarre) is one due to unexpected reactions (Rawlins and Thompson, 1977), type C (Chronic) which occurs with long term use of a drug, type D (Delayed) which occurs after a period of time has elapsed from cessation of medication, type E (End of use) as a result from sudden stopping or immediate cessation of use (Aronson and White, 1996) and type F which is a failure of therapy (Edwards & Aronson, 2000). An ADR may result from both drug related factors (drug effects, drug use, synergistic effects between a drug and a disease or between two drugs) and also non-drug related factors (abnormal pharmacokinetics due to genetic factors, age or disease states).
The WHO defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. This has been broadened in recent years to include herbal products, traditional and complementary medicines, blood products, biological, medical devices and vaccines (WHO, 2002).
A study of almost 19000 admissions was able to show that 6.5% of patient admissions to two National Health Service hospitals in the United Kingdom (UK) were related to an ADR (Pirmohamed et al., 2004). A Swedish study had implicated ADRs as 7th most common cause of death (Wester, Jonnson, Sigset, Druid & Hagg, 2008). According to the WHO, costs of ADRs, including hospitalisations, surgery and lost productivity, exceed the cost of medicines in some countries (WHO, 2008).
In Europe it was estimated that 197,000 deaths are reported annually from ADRs (European Commission, 2008). The costs of drug-related morbidity and mortality exceeded United States Dollars (USD) 177 billion in 2000 in the United State of America (USA) (Ernst and Grizzle, 2001) while the total estimated annual cost to society due to ADRs in the European Union (EU) was 79 billion euros (European Commission, 2008).
A study done in South Africa concluded that ADRs are an important cause of admissions and contribute to inpatient morbidity in the public healthcare system of 14% (Mehta et al., 2008). The majority of reactions were dose related, with a high proportion of reactions being preventable, thus highlighting the importance of improving drug selection, use and monitoring, particularly in vulnerable patient groups. Further they noted that Human immunodeficiency virus (HIV)/ acquired immunodeficiency syndrome (AIDS) appeared to be an important determinant of the profile of patients, drugs implicated and nature of ADRs seen in hospitalized patients in a country with a high burden of this disease.
A similar study on pharmacovigilance for antiretroviral (ARV) drugs in Abidjan, Cote d’Ivoire indicated that ADRs accounted for the most frequent reason (45.5%) for treatment modification and interruptions in patients on ARV treatment (Antoine et al., 2019). HIV infected patients receiving ARV treatment were more likely to be admitted with an ADR than those not on ARV treatment. An evaluation of African pharmacovigilance systems carried out by the Management Sciences for Health (MSH), Strengthening Pharmaceutical Systems (SPS) program, reported that insufficient and inadequate resources to monitor safety of medicines; the unreliable supply of quality, safe, and effective medicines; poor penetration of pharmacovigilance training among health care practitioners; and the weak state of the health systems in Africa are likely to contribute to significant medicines-related harm (SPS Program, 2019).
In Nigeria, the report further noted that the reporting rate of ADRs remains low despite the launch of the pharmacovigilance programme in 2007. The report indicated that the PPB in Nigeria the regulator in-charge of pharmaceuticals, had only received 15 reports per million of the population in 2010 against the WHO recommended reporting rate of greater than 200 reports per million population per year (SPS Program, 2019). The current reporting system involves the use of a Poor Quality Drug Reporting Form (“pink form”) to report poor quality medicines and the Suspected ADRs Notification Form (“yellow form”) to report suspected ADRs to medicines (Ministry of Medical Services [MoMS] & Ministry of Public Health and Sanitation [MoPHS], 2009). The present study was planned to investigate the Knowledge, Attitudes and Practices (KAP) related to ADR reporting among health care professionals in a tertiary care hospital.
1.2 Statement of the Problem
A study done at KGH revealed that there was a high incidence (48.6%) of ADRs among the sampled patients on ARV treatment attending the comprehensive care clinic (Mwangangi, Juma, Scott, Nyamu & Kuria, 2009). A more recent study in the same institution indicated health workers’ knowledge on ADRs reporting was a major determinant of reporting (Obonyo, Wang’ombe, Olewe & Ongore, 2014).
They noted that health workers who had been trained and had more knowledge on ADR reporting were more likely to report than those who had not been trained and had less knowledge about reporting. In the same study, key informants identified several health provider and health systems factors that affect reporting such as lack of knowledge on reporting schemes, poor attitudes, unavailability of reporting tools, high workloads and the costs incurred when sending a hard copy report to the PPB.
The PPB reported that ADRs are significantly under-reported in the country citing core teams from 12 ARV therapy ADR surveillance sites in Nigeria having identified lack of awareness at lower cadres, increased workload and limited time to report
ADRs as major challenges that were facing the reporting of ADRs (Pharmacy and Poisons Board [PPB], 2022). In Africa, there has been increased access to newly introduced essential medicines which call for a greater need to monitor and promote their safety and effectiveness. Studies have documented how ADRs contribute to patient morbidity and hospitalization in Africa indicating figures of 4.5 – 8.4% of all hospital admissions being related to ADRs, 1.5 – 6.3% of patients being admitted as a direct result of ADRs; and 6.3 – 49.5% of all hospitalized patients developed ADRs (SPS Program, 2019).
1.3 Purpose of the Study
The purpose of the study is awareness, attitude and practice of health care professionals to adverse drug reaction reporting in Jibia LGA, Katsina State
1.4 Objectives of the Study
1.4.1 General Objective
To determine the awareness, attitude and practice of health care professionals to adverse drug reaction reporting.
1.4.2 Specific Objectives
- To establish the level of knowledge on ADRs reporting among health care professionals at the KGH.
- To establish the attitudes towards reporting of ADRs among health care professionals at the KGH.
- To establish the practices of reporting of ADRs among health care professionals at the KGH.
1.5 Research Questions
- What is the level of knowledge on ADRs reporting among health care professionals at the KGH?
- What are the attitudes towards reporting of ADRs among health care professionals at the KGH?
- What are the practices of reporting of ADRs among health care professionals at the KGH?
1.6 Organization of the Study
This study contains five chapters.
- Chapter one contains the background information to the problem, statement of the problem, research objectives, and the research questions. Also, chapter one provides the significance and scope of the study.
- Chapter two is about review of literatures, both theoretical and empirical. It begins with definition of key terms used in the study, the theoretical basis of the study as well as review of empirical literatures on HSB.
- Chapter two ends up with analysis of the research gap and the conceptual framework.
- Chapter three provides a discussion on how the research was accomplished. The chapter shows the research design used, the methods of data collection, presentation and analysis as well as techniques to ensure data credibility.
- Chapter four is all about presentation and discussion of findings; while
- Chapter five provides summary, conclusion, recommendations and areas for further study.
1.7 The Scope of the Study
The study covered health professionals in direct patient care in a teaching hospital in Katsina State, Nigeria. The study was limited to doctors and pharmacist of the hospital and did not cover nonclinical staff or staff from other hospitals. Therefore, generalization should be done with caution.
1.8 Limitations of the Study
As a result of the quantitative approach that was adopted, the underlying causes and reasons for the findings in this study were not revealed. Also, the generalisability of the findings to other Hospitals may be limited since the study concentrated on a single hospital with a sample that is not representative of the entire health sector of Nigeria. These notwithstanding, the findings of this study are credible and the information provided is very useful.
Conclusions and Recommendations
5.1.1 Level of knowledge on ADR reporting
- The knowledge score for all respondents using a pre-decided assignment as per their responses to the questions was 60.5% with pharmacists reporting a higher knowledge score than medical doctors, indicating 39.5% had less knowledge.
- All healthcare professionals were identified as qualified to report ADRs.
5.1.2 Attitude towards ADR reporting
- Respondents were inclined to report all ADRs and would be encouraged to report ADRs if reaction was serious and unusual; while on the other hand they would be discouraged to report because of not knowing where to report.
- ADR reporting was identified as a professional obligation with majority of the respondents indicating that ADR reporting should be compulsory.
5.1.3 Practices of ADR reporting
- Majority of the respondents reported that to have encountered ADRs in their practice and further, indicating that over 50% of the ADRs encountered were serious.
- Over 50.0% of the respondents indicated to have reported the ADRs they had encountered in their practice with the pharmacists showing a higher percentage than medical doctors.
- Only 32.3% of respondents indicated they had used PPB and its related structure for reporting ADRs, with the pharmacists showing a higher percentage than medical doctors. Majority of the medical doctors indicated they had reported to consultants.
- Respondents who were aware of the existence of an ADRs Reporting Centre in KGH was only 35.1% with pharmacists showing a higher percentage compared to medical doctors. Those who were aware of a Pharmacovigilance Department in PPB in Nigeria were 54.5% again with pharmacists showing a higher percentage compared to medical doctors.
- The KGH study also reported that majority of respondents would prefer to report
ADRs to the reporting center via email or a website.
- It was also noted that majority of the respondents had not been trained on how to report ADRs with pharmacists showing a higher percentage compared to medical doctors.
- All respondents showed interest in education and training with continuous medical education, training and refresher courses being cited the most preferred means.
- The respondents with less knowledge on ADRs should be taken through the training program. The training should include all health care professionals as the study concluded.
- The deficits in the practice of ADR reporting can be resolved only if all healthcare professionals are made aware of the importance of reporting, the reporting system, and their obligation to report ADRs.
- It would be highly recommended that focus group discussions be held with all healthcare professionals in KGH to highlight the importance of ADR reporting.
- Continuous medical education, reminders and awareness on the yellow forms by PPB in KGH and on their website reporting schemes should be instituted and implemented at the hospital. This will make the doctors fully accept ADR reporting as their role.
- Attitudinal and cultural changes are very necessary for a long term improvement of ADR reporting where it is to be viewed as an integral part of the clinical activities of health care professionals and to a large extent all healthcare professionals who come into contact with patients.
- The gaps between KAP and ADRs reporting among health care professionals working in KGH will be filled by improved training in ADR reporting and risk perceptions of drugs.
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