REPORTING OF ADVERSE DRUG REACTIONS: EVALUATION OF KNOWLEDGE, ATTITUDE AND PRACTICE AMONG HOSPITAL PHARMACISTS IN ASHANTI REGION

ABSTRACT
Background: Spontaneous adverse drug reaction (ADR) reporting helps in the detection of serious, unexpected and unusual ADRs. Healthcare professionals play an integral part in the success of every pharmacovigilance programme. Even though the pharmacovigilance programme of Ghana was launched in 2001, under-reporting of ADRs by pharmacists and other health professionals has been the bane of the programme. Data on factors that contribute to the low reporting rate in Ghana is however limited.
Objective: The main objective of this study was to assess the knowledge, attitudes, and practice of pharmacovigilance among hospital pharmacists in Ashanti Region of Ghana.
Methods: The study was a cross-sectional survey of 120 hospital pharmacists across 38 hospitals; grouped as government (27), quasi-government (9) and private (2). The self-administered questionnaire was piloted and wordings rephrased to eliminate any ambiguity.
Information from the returned questionnaire was coded and entered into SPSS version 20 software. The results were presented as mean ± standard deviation, frequencies, and percentages. Charts were drawn with MS Excel, 2013.
The knowledge of the pharmacists in ADR reporting procedure was assessed by their answers to 12 specific knowledge questions. The score obtained by each respondent was graded as poor, average, good, very good or excellent.
The rate of ADR reporting was calculated by dividing the number of pharmacists that reported an ADR by the number that saw an ADR, and the result multiplied by 100.
Findings: The participant response rate in this study was 79.2%. Of the 95 pharmacists who completed the questionnaire, 43 (45.7%) had seen a patient with suspected ADR in the past one year prior to the study, however only 29 (69%) of them reported them by completing the ADR form. Reasons given for not reporting the ADRs included “reaction commonly reported for the suspected drug” (46.2%), “reporting form not available in the hospital” (38.5%), and “I do not know the reporting procedure” (38.5%). Over 80% of respondents have adequate knowledge of the reporting procedure, with tertiary hospital pharmacists having lesser knowledge than their counterparts in the primary and secondary hospitals in the reporting procedure [p = 0.026]. Overall, there was no statistically significant difference between age of respondents (p = 0.534), rank (p = 0.384), level of hospital (p = 0.524), or place of practice (p = 0.732) and ADR reporting. Refresher training on drug safety and ADR reporting, making available ADR forms, introducing electronic reporting of ADRs, and introducing pharmacovigilance as a major course into pharmacy education curriculum were some of the strategies suggested by respondents to improve ADR reporting.
Conclusion and Recommendation: The ADR reporting rate among the hospital pharmacists in Ashanti Region was 69%. Majority of pharmacists involved in this study had adequate knowledge in the reporting procedure. Lack of time or heavy workload, absence of ADR reporting form, and inability of some pharmacists to recognize and diagnose ADRs were some factors that contributed to under-reporting of ADRs in the Ashanti Region.

To further improve the reporting rate, refresher courses in drug safety and ADR reporting should be periodically conducted for hospital pharmacists. ADR reporting forms should also be made readily available in the wards, consulting rooms and pharmacies, and pharmacovigilance training in pharmacy schools should be intensified to equip the newly trained pharmacist to diagnose and report ADRs to align with FDA policy.


CHAPTER ONE
1.1       Introduction
Pharmacovigilance is the science and activities relating to detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Such drug-related problems include adverse drug reactions (ADRs), unintended injuries or complications that arise from iatrogenic drug related cause or prolong hospital admission and result in disability or death (WHO, 2006).

Adverse drug reaction is defined by World Health Organization (WHO) as any noxious, unintended, and undesirable effect of a drug, which occurs at doses used in humans for prophylaxis, diagnosis, or cure of a disease (WHO, 2002). The risk of ADR is associated with all drug therapy and it is determined by myriad of factors, including dose and frequency of administration, genotype, and pharmacokinetic properties of special populations, such as paediatric and geriatric patients, and those with liver and kidney impairment. Due to the high prevalence rate and potentially serious outcomes, ADRs may have dramatic consequences in clinical practice both from economic and clinical perspectives.

A study from the United States of America projected that about 11.4-35.5% of all emergency department visits are due to drug-related causes (Budnitz, et al., 2007). It was similarly found that in Europe, up to 20% of ambulatory patients experience ADRs and approximately 10-20% of geriatric hospital admissions are due to drug-related issues. Another consequence of ADRs is the prolong hospital stay. A prospective study showed that the average number of days spent in hospitals due to ADRs was increased from 8 days for patients without ADRs, to 20 days if an ADR is involved (Davies, et al., 2009). Available data from the Food and Drug Authority show that 5%, 1% and 2.5% of 325 (2012), 260 (2013) and 436 (2014) ADR reports respectively submitted to the National Pharmacovigilance Centre of Ghana resulted in death.


Aside the human costs, such as morbidity and mortality, ADRs have an economic burden on the scarce health resources especially to poor countries (Ayani, et al., 1999). The United Kingdom’s data on incidence of hospitalizations and deaths resulting from ADRs exhibited an estimate of 6.5% and 0.15% respectively (Pirmohamed, et al., 2004). In 2007, the cost of emergency department visit due to ADR was estimated to be $333 per visit and $7,528 per hospitalization in Canada. (Wu, et al., 2012).

Efforts to document ADRs began internationally when the thalidomide tragedy was reported in 1961. Spontaneous ADR reporting became a safety tool in pharmacovigilance for monitoring ADRs (Waller, 2006). To this end, health professionals like pharmacists, doctors and nurses became the key players in spontaneous ADR reporting because they were directly involved in medicines use and well informed of the expected and unexpected effects of medicines.

In spite of being a cheap source of pharmacovigilance and the fact that it could be used throughout the lifespan of a drug to monitor its safety, the rate of spontaneous ADR reporting is still lower than expected, with only 6% of all ADRs being reported by healthcare professionals (Hazel & Shakir, 2006). This low rate of reporting of ADRs can delay signal detection and hence impact negatively on the health of the public.

A myriad of factors have been reported as the causes of underreporting of ADRs, among these are personal and professional characteristics of health carers, and their knowledge and attitudes to reporting (Lopez-Gonzalez, et al., 2009). Some studies carried out in Nigeria, India and United Arab Emirates, evaluating knowledge of doctors in adverse drug reaction reporting indicate among other factors, inadequate knowledge about reporting format, not knowing where reports should be sent to, busy schedule, unavailability of reporting forms, and lack of incentives as the reasons responsible for under-reporting (Kamtane 2012, Oshikoya 2009, Lisha 2012, and Fadare 2011).


A study conducted among community pharmacists in Malaysia (Elkami, et al., 2011) showed that most respondent pharmacists had very little knowledge about the procedure for reporting ADRs. Another study conducted among pharmacy students in South India (Reddy, et al., 2014) showed that an educational intervention was a positive factor in ADR reporting.

Ghana, officially, started pharmacovigilance and spontaneous adverse drug reaction monitoring activities in 2001 when she became the 65th nation to join the WHO Programme for International Drug Monitoring (Uppsala Report, 2001). The major challenge of the programme is under-reporting by healthcare professionals. Available data from WHO Ghana ADR Report (Nwokike & Eghan, 2010) showed that, using a standard of 100 reports per million population, expected reporting rate was 23 but only 1.55 was observed, despite wide spread availability of ADR forms in health facilities across the country. Studies on reasons for under-reporting of ADRs by health workers in Ghana are scarce. One such study (Sabblah, et al., 2014) conducted among doctors in the Greater Accra region in 2012 showed that even though 59.5% had seen a patient with an ADR in the past one year prior to that study, only 21% reported them by completing the ADR reporting form.

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Item Type: Ghanaian Project Material  |  Attribute: 51 pages  |  Chapters: 1-5
Format: MS Word  |  Price: GH50  |  Delivery: Within 30Mins.
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