Patterns of Adverse Drug Reactions in Different Age Groups: Analysis of Spontaneous Reports by Community Pharmacists

• Published in: PloS one 2015-07, Vol.10 (7), p.e0132916-e0132916
• Main Authors: Yu, Yun Mi, Shin, Wan Gyoon, Lee, Ju-Yeun, Choi, Soo An, Jo, Yun Hee, Youn, So Jung, Lee, Mo Se, Choi, Kwang Hoon
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Adverse Drug Reaction Reporting Systems; Age; Aged; Aged, 80 and over; Ambulatory care; Analgesics; Anaphylaxis; Anti-inflammatory agents; Antibiotics; Causality; Cephalosporins; Child; Child, Preschool; Children; Communities; Diarrhea; Disorders; Drug dosages; Drug stores; Drug-Related Side Effects and Adverse Reactions - epidemiology; Drug-Related Side Effects and Adverse Reactions - etiology; Drugs; Female; Gastrointestinal system; Geriatrics; Humans; Infant; Infant, Newborn; Inflammation; Male; Middle Aged; Nervous system; Nonsteroidal anti-inflammatory drugs; Older people; Patient safety; Patients; Pharmaceutical sciences; Pharmacies; Pharmacists; Pharmacology; Pharmacovigilance; Prescription drugs; Side effects; Skin; Studies; Systematic review; Young Adult
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0132916

To 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. ADRs 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. Gastrointestinal 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. According to the community pharmacist reports, the leading clinical manifestations and causative drugs associated with ADRs in outpatients differed among age groups.