Background/Objectives: Pharmacovigilance aims to identify, assess, and minimize drug risks, with spontaneous reporting playing a central role. However, the high level of underreporting and the varying data quality are limitations that should be minimized through prospective cohort studies. Methods: Spontaneous reports reported to the Drug Commission of the German Medical Association (AkdÄ) over one year were compared with the adverse drug reaction (ADR) cases systematically recorded in hospital emergency departments. The frequencies of the demographic patient characteristics and the odds ratios, as the relationship between suspected and concomitant medication, were calculated. Results: In the spontaneous reports, cases were reported by patients a median of 12 years younger, and the group of older patients was less represented (10.8% versus 27.3% in the prospective cohort study). Within the study, cases with polypharmacy were documented significantly more often (a median of seven drugs [IQR 3;10] versus a median of two drugs [IQR 1;5] in the spontaneous reports). New drugs and drugs discussed in the media were frequently reported as causing ADRs, whereas drugs with an effect on the central nervous system were more often suspected in the emergency department setting. Conclusions: Both sources for ADRs provide complementary information that improves the detection of risk signals. The aim for the future is to further increase the awareness of spontaneous reports and to answer specific questions with the help of structured investigations. It is important to compare and validate the findings of spontaneous reports and investigations in regular intervals to improve drug safety.

Background/Objectives: The pharmacovigilance aims to identify, assess and minimize drug risks. Therefore, spontaneous reports play a central role. However, the high level of underreporting and the varying data quality are limitations that should be minimized by prospective cohort studies. Methods: The spontaneous reports reported to the Drug Commission of the German Medical Association (AkdÄ) within one year were compared with the adverse drug reaction (ADR) cases systematically recorded in the hospital emergency departments. The frequencies of the demographic patient characteristics and the odds ratios as the relationship between suspected and concomitant medication were calculated. Results: In the spontaneous reports, the reported cases were a median of 12 years younger, and the group of very old people was less strongly represented (10.8% versus 27.3% in the prospective cohort study). Within the study, cases with polypharmacy were documented significantly more often (median 7 drugs [IQR 3;10] versus median 2 drugs [IQR 1;5] in the spontaneous reports). New drugs and drugs discussed in the media were frequently reported as causing ADRs, whereas drugs with an effect on the central nervous system were more often suspected in the emergency department setting. Conclusions: Both sources of ADRs provide complementary information that can improve risk signal detection. The aim for the future is to further increase awareness of spontaneous reports and to identify specific issues using structured investigations.

Background: Medication errors (MEs) are an important cause of preventable harm but remain insufficiently quantified in emergency care. This study assessed the frequency, characteristics, and clinical impact of MEs among adverse drug reaction (ADR)–related emergency department (ED) admissions in Germany. Methods: We conducted a prospective multicenter study across six EDs between 2015 and 2021 (n = 7967). ADRs and MEs were classified using standard causality (World Health Organization-Uppsala Monitoring Centre (WHO-UMC)) and preventability criteria (Schumock). Patient, medicine, symptom, and outcome characteristics were compared between ADRs caused by MEs and ADRs without documented MEs. Regression models assessed factors associated with ME involvement among ADR cases and length of hospital stay. Results: 20.1% of ADR-related cases involved an ME. Clinical presentation, symptom burden, triage severity, and discharge outcomes were similar between groups. MEs clustered around commonly used chronic medications, including pantoprazole, torasemide, metoprolol, ramipril, phenprocoumon, and ibuprofen. Schumock analysis showed preventability as primarily linked to dosing errors (30%), non-adherence (28%), contraindications (26%), and monitoring (20%). Medicine-specific symptom clusters mirrored expected pharmacological effects but were not specific to ME involvement. Multimorbidity was associated with slightly lower odds of ME attribution, although the estimate was borderline (OR 0.84, 95% CI 0.71–1.00); no robust associations were identified for the other patient-level characteristics examined. Adjusted length of hospital stay was slightly longer in cases involving MEs (+4.8%; p = 0.025), corresponding to an adjusted difference of 0.33 days. Conclusions: MEs were identified in a substantial proportion of ADR-related ED admissions. Most MEs arose from routine prescribing and monitoring processes involving commonly used medicines, suggesting that preventive efforts should focus on upstream safeguards, including medication reviews, electronic prescribing support, pharmacist involvement, and adherence support, rather than detection at emergency presentation.

Background: Medication errors (MEs) are a frequent cause of preventable harm but remain insufficiently quantified in emergency care. This study assessed the frequency, characteristics, and clinical impact of MEs among adverse drug reaction (ADR)–related emergency department (ED) admissions in Germany. Methods: We conducted a prospective multicenter study across six EDs over six years (n=7,967). ADRs and MEs were classified using standard causality (World Health Organization-Uppsala Monitoring Centre (WHO-UMC)) and preventability criteria (Schumock). Patient, drug, symptom, and outcome characteristics were compared between ADRs with and without MEs. Regression models assessed predictors of MEs and length of stay in hospital. Results: 20.1% of ADR-related cases, involved a preventable ME. Clinical presentation between groups; symptom burden, triage severity, and discharge outcomes, were similar. MEs clustered around chronic medications (pantoprazole, torasemide, metoprolol, ramipril, phenprocoumon, ibuprofen). Schumock analysis showed preventability as primarily linked to dosing errors (30%), non-adherence (28%), contraindications (26%), and monitoring (20%). Drug-specific symptom clusters mirrored expected pharmacology but were not error-specific. Multimorbidity was modestly protective (OR 0.84, 95%CI 0.71–1.00), while age, sex, polypharmacy, and number of diagnoses were not. Length of hospital stay was slightly longer in ME cases (+0.37 days; p = 0.037). Conclusion: MEs were identified in a substantial proportion of ADR-related ED admissions. Most MEs arose from routine prescribing and monitoring processes involving commonly used drugs suggesting that preventive efforts should focus on upstream safeguards, including medication reviews, electronic prescribing support, pharmacist involvement, and adherence monitoring, rather than detection at emergency presentation.