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.