1 INTRODUCTION
Adverse drug reactions (ADRs) are a critical health matter [1]. The
ADR definition
according to the WHO is “any response to a drug that is noxious and
unintended and that occurs at doses used in humans for prophylaxis,
diagnosis, or therapy, excluding failure to accomplish the intended
purpose” [2].
Various publications have documented the issue of ADRs. Approximately
3.2-7% of acute hospital admissions are due to ADRs [3, 4]. ADRs
result in extended hospitalization and increased morbidity, mortality
[5] and hospital costs [6]. Every year, more than 770,000 people
suffer or die from ADRs [7]. According to a meta-analysis carried
out in the United States, ADRs accounted for the fourth and sixth most
common causes of death [8]. A study from Iran indicated that
approximately 11.8% of patients had suffered at least one ADR [9].
In another report from Iran, approximately 16.8% of the patients had
experienced at least one ADR, and 2.9% of ADRs were fatal [10]. A
study from South India reported an incidence of ADRs of 9.8%;
approximately 3.4% was the reason for hospital admission, and 3.7%
appeared during hospitalization [11]. A retrospective study in Saudi
Arabia revealed that 54% of ADRs could be prevented. The annual
incidence ranged from 0.07% in 1993 to 0.003% in 1999 [12]. In
Nepal, the occurrence of ADRs was 0.9%. Severe ADRs were reported in
0.9% of males and 10.8% of females [13].
No health setting is immune from ADRs, hence pharmacovigilance (PV)
becomes a very important aspect to ensure safe use of medicines in any
healthcare setting. The definition of PV according to the WHO is “the
science and activities relating to the detection, assessment,
understanding, and prevention of adverse effects or any other possible
drug-related problems” [14]. The current monitoring system for ADRs
was established after the tragedy of thalidomide ADRs in 1950s [15].
Therefore, the reporting of common ADRs postmarketing is of great
advantage. The incidence of ADRs and other drug-associated problems
varies between different countries. This might be attributed to the
differences in diseases, prescribing practices, heredities, diet, and
culture. Drug manufacturing procedures that have an impact on drug
quality, content, distribution, usage, indications, and dosing, as well
as the use of other or medicines (herbal or traditional) are considered
related factors that might cause specific toxicological problems for a
drug when used alone and/or in combination with other drugs [15].
Continuous monitoring and reporting of ADRs are considered the backbone
for their early detection. ADR detection is the building block of PV and
inclusive systems for maintaining patient safety. In poor-resource
setting like Yemen, the reporting was expected to reach up to 4100
reports per 25 million individuals per year. The countries with the best
reporting rates should report on at least 200 cases per 1,000,000
individuals annually, as stated by the WHO. Nevertheless, only 10% of
serious ADRs are reported [16]. The reporting system in Yemen is not
working properly due to insufficient coverage and knowledge about the
role of ADRs and PV in the improvement of health services among several
health-care professionals as well as a lack of information on how, where
and to whom to report ADRs. All these obstacles have resulted in a poor
situation regarding patient safety; thus, many patients could die from
an ADR every year. We are not certain regarding the level of knowledge,
attitude and practice of CPs towards ADR reporting and PV in Yemen.
Thus, this study was carried out in Aden city to assess the Yemeni CPs’
knowledge, attitudes, and practices towards medication safety. It was
intended to identify the knowledge gaps, beliefs and behavioral patterns
that may indicate needs, problems and barriers to assist plan and
implement interventions such education and training activities.