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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