Adverse Drug Reactions in a Tertiary Care Emergency Medicine Ward - Prevalence, Preventability and Reporting

Abstract

PurposeTo identify the prevalence and preventability of adverse drug reactions (ADRs) in an emergency ward setting in a tertiary hospital in Sweden and to what extent the detected ADRs were reported to the Medical Product Agency (MPA).MethodsIn this prospective cross sectional observational study, 706 patients admitted to one of the Emergency Wards, at the Karolinska University Hospital in Solna, Stockholm during September 2008 –September 2009, were included. The electronic patient records were reviewed for patients’ demographic parameters, prevalence of possible ADRs and assessment of their preventability. In addition, the extent of formal and required ADR reporting to national registers was studied.ResultsApproximately 40 percent of the patient population had at least one possible ADR (n = 284). In the multivariable regression model, age and number of drugs were significantly associated with risk of presenting with an ADR (p<0.01 and p<0.001, respectively). Sex was not identified as a significant predictor of ADRs (p = 0.27). The most common ADRs were cardiovascular, followed by electrolyte disturbances, and hemorrhage. In 18 percent of the patient population ADRs were the reason for admission or had contributed to admission and 24% of these ADRs were assessed as preventable. The under-reporting of ADRs to the MPA was 99%.ConclusionsADRs are common in Emergency Medicine in tertiary care in Sweden, but under-reporting of ADRs is substantial. The most frequent ADRs are caused by cardiovascular drugs, and significantly associated with age and number of drugs. However, only a minority of the detected serious ADRs contributing to admission could have been avoided by increased risk awareness.

Queixas técnicas e reações adversas a medicamentos notificadas em um hospital regional (Brasil): um estudo transversal

“…Outros pesquisadores também identificaram maior proporção de pacientes do sexo feminino que sofreram RAM 5,19 . Esta susceptibilidade das mulheres é explicada, possivelmente, devido às condições obstétricas, bem como alterações metabólicas pertinentes ao desequilíbrio hormonal 20 .…”

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Comparison of clinical value of dynamic contrast-enhanced MRI and SPECT renal dynamic imaging of GFR measurement in the evaluation of renal function in renal transplantation

“…The safety of contrast media was evaluated according to the modified Hartwing severity grading standards: [6] Grade 1: mild adverse drug reactions and diseases, which were no need to be treated; Grade 2: transient impairment to patients, which needed some interventions such as drug withdrawal of suspicious drugs, without other treatments or (prolonged) hospitalization; Grade 3: transient impairment to patients, which needed some interventions such as drug withdrawal of suspicious drugs or other treatments, without (prolonged) hospitalization; Grade 4: patients had to be hospitalized or had to prolong the hospital stay for no less than 1 d; Grade 5: patients needed intensive care; Grade 6: permanent impairment to patients; Grade 7: indirectly leading to a patient's death; Grade 8: directly leading to a patient's death.…”

Analysis of adverse drug reactions in a tertiary care emergency medicine department: prevalence, preventability and reporting

“…1 Drug-related problems (DRP), including adverse drug reactions (ADRs), constitute a significant health-and quality problem particularly affecting the elderly. 2 ADRs are the fourth leading cause of death. 3 In 2010, Central Drugs Standard Control Organization (CDSCO) under the aegis of Govt., of India, Ministry of Health and Family welfare and Pharmacovigilance Programme of India (PvPI) has established adverse drug monitoring centers in various tertiary care hospitals all over India with the objective to improve the reporting rate of ADRs in India.…”