Coroners' reports to prevent future deaths provide some information on medication errors and adverse reactions. They rarely identify new hazards. At present they are often addressed to local bodies, but this could mean that wider lessons are lost.
Patients having a severe adverse drug reaction following an acute illness felt negative emotions towards their health care provider. Those with a chronic condition rationalized the event and coped better with its impact. Neither group felt that reporting the adverse reaction was their responsibility. Encouraging patients to report remains important but expecting patients to report solely for altruistic purposes may be unrealistic.
Aims We studied the international classi®cation of disease (ICD) hospital discharge codes to ®nd unreported adverse drug reactions (ADRs), and asked doctors about their attitudes to reporting some of these cases. Methods We examined the ICD codes assigned on discharge to identify ADRs and compared these with spontaneous reports made to the Committee on Safety of Medicines (CSM). Doctors involved were sent brief re Âsume Âs of cases and asked if they would report them. Results 49 of 21 365 patient episodes were coded on discharge as ADRs, of which 33 were`reportable'. Fourteen spontaneous reports were received by the CSM during the same period. The two groups did not overlap. 25 of 60 doctors responded to our questionnaire, and would have reported only 8 of 75 cases outlined. Conclusions The ICD coding allowed us to identify important ADRs which most doctors would not report spontaneously.
It was found that in both medicine and pharmacy, courses differed substantially in teaching about the Yellow Card Scheme and adverse drug reactions (ADRs). There is scope for increased involvement of the Medicines and Healthcare products Regulatory Agency in undergraduate education, in line with recommendations from the National Audit Office.
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Formal 'enhanced observations' involving allocating one or two nurses to place an patient under continuous observation when acutely ill and at risk of self-harm are ineffective, contribute to impersonal care, are stressful to practitioners and reinforce the perception of a custodial environment. The aim of this literature review was to systematically bring together published studies and research that identified alternative approaches to 'enhanced observations' from those proposed in the Standing Nursing and Midwifery Advisory Committee guidelines on individuals receiving care on open acute inpatient settings. The literature search strategy resulted in the retrieval of five empirical studies, with further analysis revealing six potential interventions relating to the development of an alternative approach to observations. These are: (1) assessment; (2) nurse autonomy; (3) ward management initiatives (4) engagement and collaboration; (5) a team approach; and (6) intermittent observations. The review emphasized how enhanced observations and the development of alternative approaches are a complex activity requiring planning and consideration to facilitate appropriate implementation. The review also highlights a dearth in empirical evidence for alternatives, and a need to revise current practices because of the dissatisfaction from clients and practitioners involved in this intervention.
The aim of this study was to determine the differences and potential mechanistic rationale for observed adverse drug reactions (ADRs) between four approved PARP inhibitors (PARPi).
Methods:The Medicines and Healthcare products Regulatory Authority (MHRA) Yellow Card drug analysis profiles and NHS secondary care medicines database enabled the identification of suspected ADRs associated with the PARPi in the UK from launch to 2020. The polypharmacology of the PARPi were data-mined from several public data sources.
Results:The overall ADRs per 100 000 R x identified across the four PARPi are statistically significant (χ 2 test, P < .001). Rucaparib has the greatest relative suspected ADRs, which can be explained by its least clean kinome and physicochemical properties. The suspected gastrointestinal ADRs of rucaparib and niraparib can be ascribed to their kinase polypharmacology. Suspected blood and lymphatic system ADRs of PARPi can be linked to their high volume of distribution (V d ). The thrombocytopenia rate of niraparib > rucaparib > olaparib tracked with the V d trend.Hypertension is only associated with niraparib and could be explained by the therapeutically achievable inhibition of DYRK1A and/or transporters. Arrhythmia cases are potentially linked to the structural features of hERG ion-channel inhibition found in rucaparib and niraparib. Enhanced psychiatric/nervous disorders associated with niraparib can be interpreted from the diverse neurotransporter off-targets reported.Conclusions: Despite their similar mode of action, the differential polypharmacology of PARP inhibitors influences their ADR profile.
Life-threatening ADRs continued to affect patients' lives long after the event. Patients' beliefs regarding the cause of the ADR differed, and may have influenced their trust in healthcare professionals and medicines. We propose that clear communication during the acute phase of a serious ADR may therefore be important.
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