Abstract
PurposeTo evaluate the clinical manifestations and causative drugs associated with adverse drug reactions (ADRs) spontaneously reported by community pharmacists and to compare the ADRs by age.MethodsADRs reported to the Regional Pharmacovigilance Center of the Korean Pharmaceutical Association by community pharmacists from January 2013 to June 2014 were included. Causality was assessed using the WHO-Uppsala Monitoring Centre system. The patient population was classified into three age groups. We analyzed 31,398 (74.9%) ADRs from 9,705 patients, identified as having a causal relationship, from a total pool of 41,930 ADRs from 9,873 patients. Median patient age was 58.0 years; 66.9% were female.ResultsGastrointestinal system (34.4%), nervous system (14.4%), and psychiatric (12.1%) disorders were the most frequent symptoms. Prevalent causative drugs were those for acid-related disorders (11.4%), anti-inflammatory products (10.5%), analgesics (7.2%), and antibacterials (7.1%). Comparisons by age revealed diarrhea and antibacterials to be most commonly associated with ADRs in children (p < 0.001), whereas dizziness was prevalent in the elderly (p < 0.001). Anaphylactic reaction was the most frequent serious event (19.7%), mainly associated with cephalosporins and non-steroidal anti-inflammatory drugs. Among 612 ADRs caused by nonprescription drugs, the leading symptoms and causative drugs were skin disorders (29.6%) and non-steroidal anti-inflammatory drugs (16.2%), respectively.ConclusionsAccording to the community pharmacist reports, the leading clinical manifestations and causative drugs associated with ADRs in outpatients differed among age groups.
Highlights
An adverse drug reaction (ADR), as defined by the World Health Organization (WHO), is “a noxious and unintended response of a drug, which occurs at a dose normally used in humans for prophylaxis, diagnosis, or therapy” [1]
Comparisons by age revealed diarrhea and antibacterials to be most commonly associated with ADRs in children (p < 0.001), whereas dizziness was prevalent in the elderly (p < 0.001)
Among 612 ADRs caused by nonprescription drugs, the leading symptoms and causative drugs were skin disorders (29.6%) and non-steroidal anti-inflammatory drugs (16.2%), respectively
Summary
An adverse drug reaction (ADR), as defined by the World Health Organization (WHO), is “a noxious and unintended response of a drug, which occurs at a dose normally used in humans for prophylaxis, diagnosis, or therapy” [1]. Previous reports have suggested that 7–11.2% of ADRs result in hospitalization [2,3] and that the mean cost of ADRs leading to admission was 2721 Euros per patient [4]. Previous studies on ADRs have focused on inpatient care settings. While hospitalized patients are under close medical monitoring, outpatients are not. Because the contact is intermittent and consultation hours are constrained, it is difficult for physicians to secure sufficient communication time to ascertain the presence of ADRs in ambulatory care settings. The risk and expense of treatment of ADRs in outpatients may increase because remedial action is often delayed [5]. Considering the large proportion of prescriptions issued in ambulatory care, knowledge of ADRs in this population is important to prevent medicationrelated harm
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