Warisara Srisuriyachanchai

Adverse drug reactions (ADRs) represent a major public health concern, occurring in about 6–10% of patients and contributing significantly to morbidity and mortality (Geer et al., 2016; Lazarou et ...

Purpose: The aim of the study was to describe Adverse Drug Reactions (ADRs) characteristics, compare ADR severity and outcomes as rated by patients and pharmacist, and identify factors associated with ADR severity. Methods: A cross-sectional study was conducted among patients from a secondary care hospital in northeastern Thailand who had experienced an ADR within the previous year. A self-administered questionnaire was mailed to eligible patients. Patients assessed ADR severity their most severe ADR using visual analog scale. These rating were compared with pharmacist assessment based on the Hartwig and Siegel scale. Additional data on ADR severity and outcomes were collected by a research pharmacist from both electronic and paper medical records database. Causality assessment was performed by researcher pharmacist using the Naranjo’s algorithm. Results: Of 745 invited patients, 381 completed the questionnaire. The mean patient-rated ADR severity score was 6.4 ± 2.94. According to patient ratings, ADRs were classified as mild (25.5%), moderate (32.0%), and severe (42.5%), whereas pharmacist assessments classified ADRs as mild (63.2%), moderate (33.9%), and severe (2.9%). The most commonly reported ADRs, classified by systemic organ class, were skin and subcutaneous tissue disorders (30.7%). Agreement between patient and pharmacist assessments was slight for ADR severity (κ = 0.043), and fair for ADR outcomes (κ = 0.212). Positive agreement between patient and pharmacist assessments was 31.2% for severity and 85.0% for outcomes. Higher patient-reported severity was associated with greater number of comorbidities, higher levels of anxiousness and bothersomeness, acute onset of ADRs, and greater confidence in identifying ADRs. Conclusion: Patients tended to rate ADR severity higher than pharmacists, particularly when symptoms affected daily activities. Incorporating patient-reported assessments may support the timely recognition and communication of suspected ADRs while complementing, rather than replacing, professional clinical assessment.

Background: Serious adverse drug reactions (ADRs) can lead to hospital admission and can be fatal, but some of them are preventable. This study aimed to determine the types and frequencies of serious cutaneous ADRs and the methods employed to manage and prevent them, as well as to assess the factors related to their seriousness. Methods: A cross-sectional study was conducted retrospectively on inpatients and outpatients at a tertiary care hospital. All data were collected from the medical records database over a period of 3 years. Serious cutaneous ADRs were identified in the hospital database using the International Classification of Disease and Related Health Problems, 10th Revision (ICD-10). Results: A total of 2151 cases were retrieved using the ICD-10, and 436 patients were randomly selected for this study. Of these, 218 patients experienced ADRs (50.0%). The major clinical symptoms of the eight serious ADRs included anaphylaxis (38.5%) and urticaria (30.2%). The most commonly suspected drug group was antibiotics (45.0%). The main methods of ADR management were drug treatment (84.4%) and drug withdrawal (81.2%). The primary method of ADR prevention was patient drug allergy cards (52.3%). Factors affecting the severity of ADRs were having an underlying condition (p = 0.031) and the concomitant use of drugs (p = 0.044). Conclusions: Anaphylaxis was the most common serious ADR. Patients with underlying diseases and those taking concomitant drugs are more likely to present with serious ADRs. The prevention of serious ADRs should be promoted at all levels in hospitals to reduce harm and prevent their reoccurrence.

Background: Few studies have been conducted on how patients identify, manage, and prevent severe adverse drug reactions (ADRs). This study aimed to explore the reasoning that patients use to identify symptoms of severe ADRs and the methods they employ to manage and prevent them. Methods: A cross-sectional survey using structured telephone interviews was administered to patients with a self-assessed severe ADR and to patients with serious skin ADRs from a hospital medical record database (in-patient and out-patient) from 1 September 2016 to 1 September 2019. Patients identified via the medical records were asked to assess their ADR for severity, and only patients that rated their ADR as severe were followed up with a telephone interview. Structured telephone interviews were conducted with respondents by a research pharmacist and audio-recorded. Results: A total of 722 patients with a severe ADR were identified, with 300 completing the interview (41.6%). The most frequently cited reasons for classifying ADRs as severe was worsening ADR symptoms (58.3%), severe ADR symptoms (44.4%), and ADR symptoms interfering with their life (36.4%). Only severe ADR symptoms were significantly different between the questionnaire and the medical records database groups (p = 0.007). The most frequent method of ADR management was discontinuation of drug by physicians (88.3%). About 79.0% of patients stated that they increased their carefulness when using other drugs after experiencing ADRs. The main method patients used to prevent ADRs was informing healthcare professionals (HCPs) about their drug allergy history (65.7%). Conclusions: Worsening ADR symptoms were often used to identify severe ADRs. However, HCPs were mainly responsible for the management and prevention of severe ADRs. Increasing awareness of ADRs by HCPs, and providing additional drug information, may improve patient safety.

Adverse drug reaction (ADR) severity levels are mainly rated by healthcare professionals (HCPs), but patient ratings are limited. This study aimed to compare patient-rated and pharmacist-rated ADR severity levels and determined methods employed for ADR management and prevention by patients and HCPs. A cross-sectional survey was conducted in outpatients visiting two hospitals. Patients were asked about ADR experiences using a self-administered questionnaire, and additional information was retrieved from the medical records. In total, 617 out of 5594 patients had experienced ADRs (11.0%), but 419 patients were valid (68.0%). Patients commonly reported that their ADR severity level was moderate (39.4%), whereas pharmacists rated the ADRs as mild (52.5%). There was little agreement between patient-rated and pharmacist-rated ADR severity levels (κ = 0.144; p < 0.001). The major method of ADR management by physicians was drug withdrawal (84.7%), while for patients, it was physician consultation (67.5%). The main methods for ADR prevention by patients and HCPs were carrying an allergy card (37.2%) and recording drug allergy history (51.1%), respectively. A higher level of ADR bothersomeness was associated with higher ADR severity levels (p < 0.001). Patients and HCPs rated ADR severity and used ADR management and prevention methods differently. However, patient rating of ADR severity is a potential signal for severe ADR detection of HCPs.

Healthcare professionals (HCPs) play a key role in the monitoring of severe adverse drug reactions (ADRs). The present study aims to explore practices and barriers of HCPs in severe ADR monitoring and reporting, to evaluate their attitudes towards the monitoring and to assess the related factors. Self-administered questionnaires produced in hard copy and Google form were sent to 510 HCPs by stratified random sampling. Of the 350 HCPs that responded (68.6%), 44.9% had ever monitored ADRs. The most common practices were the observation of abnormal symptoms for ADR identification (88.5%), discontinuation of the suspected drug for ADR management (88.5%) and advice on recurrent drug allergy for ADR prevention (88.5%). Most HCPs (93.0%) obtained further patient history to identify severe ADRs. The uncertainty of the causal relationship was a major barrier to ADR reporting (60.0%). Pharmacists were more involved with practices in ADR monitoring and reporting (OR 20.405; p < 0.001), whereas longer work experience (>20 years) was negatively related to the practices (OR 0.271; p = 0.024). Over one-third (37.6%) of HCPs had a positive attitude towards severe ADR monitoring. In conclusion, the practices in severe ADR monitoring varied among different professions. However, the barriers to the reporting of ADRs still exist; hence, improving knowledge and cooperation among HCPs should be promoted.