Individual Case Safety Reports and Useful Clinical Information

Abstract

Objectives: Individual case safety reports (ICSRs) could be an important source in giving further information to characterize the risk situation and aid in the prevention, diagnosis, management and treatment of adverse drug reactions (ADRs). The aim was to determine whether and where on the ICSRs clinically useful information was specified for rare ADRs in the paediatric population. Methods: ICSR concerning rhabdomyolysis occurring during use of antipsychotic medicines for patients up to 17 years of age were retrieved from the WHO Global ICSR database, VigiBase. The original case reports were requested and received from the national pharmacovigilance centres. We focused on five areas of information specified in a recent guideline for publishing ADRs.[1] Results: Eighteen original cases with an age span from 5 to 17 years were reviewed with the following outcomes. Circumstances preceding the reaction: 9 reports included this information, consisting primarily of abdominal, muscle and back pain. In eight of these reports, the full account of the symptoms and sequence of events were only found in the narratives. Underlying risk factors for rhabdomyolysis: Recorded for four of five patients in the narrative: seizures (n = 1), strenuous physical activity (n = 2), diabetic ketoacidosis (n = 1), alcohol use (n = 1). Four patients had Neuroleptic Malignant Syndrome (NMS) co-reported. Physical examination and laboratory tests: All values for patient temperature and laboratory values were given in free text. Elevated creatine phosphokinase (CPK) or myoglobin values were recorded in 14 reports ranging from 1200 to 95 000 IU/L (CPK). Patient temperature was specified for 5 patients, of whom 3 patients were also reported to experience NMS. Drug-reaction time-to-onset: 13 reports included information on the duration from drug start to reaction onset, which ranged from 4 days to 1.5 years. 9 reports included dates in the structured data, so that time to onset could be calculated and in 4 reports the information was specified in the narratives. Treatment of the reaction: Apart from stopping the drug (n = 18) and hospitalization (n = 16), other actions of treatment, such as forced intravenous fluids or resolving spontaneously, was given for 5 cases in the narrative. Conclusions: This study showed that useful clinical information was available to characterize the risk situation for these patients in this subset of reports. This should be regarded in the context that ICSRs are generally considered to be of poor quality. However, access to the free text fields recorded by the reporter was crucial to capture this information. Reference 1. Kelly WN, Arellano FM, Barnes J, et al. Guidelines for submitting adverse event reports for publication. Drug Saf 2007; 30 (5): 367-73