Improving European cooperation on medication errors

Cheung, Ka-Chun; Rhijn, Arianne van; Cousins, David; Smet, Peter De

doi:10.1016/s0140-6736(14)60603-6

Cited by 4 publications

(4 citation statements)

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“…Accepting real‐world experience by involving healthcare professionals and patients in drug development and exploring the added value of knowledge from other domains such as human factors should become reality for every medication. Medication incident registries provide important opportunities to evaluate the use of medications in real world practice, 19 yet potential underreporting should be considered. International conferences by scientific organizations such as the German APV, the Drug Information Association, the European Geriatric Medicine Society or the European Association of Hospital Pharmacists may provide valuable opportunities to disseminate existing knowledge among different disciplines.…”

Section: Discussionmentioning

confidence: 99%

“…In the Netherlands, pharmacists, medical doctors, general practitioners, nurses, midwifes and other workers in healthcare can report MRPs to the Portal for Patient Safety (PPS; earlier named Central Medication Incidents Registration) 18,19 . PPS is a national medication incident registry that screens, analyses and evaluates MRPs and subsequently decides whether an alert should be disseminated to healthcare professionals.…”

Section: Introductionmentioning

confidence: 99%

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Opportunities for changes in the drug product design to enhance medication safety in older people: Evaluation of a national public portal for medication incidents

Karapinar-Çarkıt

Bemt

Sadik

et al. 2020

Brit J Clinical Pharma

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Aims Medication safety requires urgent attention in hospital pharmacy. This study evaluated the medication‐related problems/errors as reported to the Dutch medication incident registry and disseminated for information to pharmacists. Through analysis by an expert panel we aimed to better understand which problems could have been mitigated by the drug product design. Additionally, the (wider) implications of the problems for current hospital/clinical practice were discussed. Methods Items were extracted from the public Portal for Patient Safety. Items were included if relevant for older people and connected with the drug product design and excluded if they should reasonably have been intercepted by compliance to routine controls or well‐known professional standards in pharmaceutical care. To explore any underreporting of well‐known incidents, it was investigated if different medication‐related problems could be observed in a regional hospital practise over a 1‐month period. For 6 included items (cases), the implications for hospital/clinical practise were discussed in an expert panel. Results In total, 307 items were identified in the Portal for Patient Safety; all but 14 were excluded. Six cases were added from daily hospital practice. These 20 cases commonly related to confusing product characteristics, packaging issues such as the lack of a single unit package for an oncolytic product, or incorrect or incomplete user instructions. Conclusion Medication registries provide important opportunities to evaluate real‐world medication‐related problems. However, underreporting of well‐known problems should be considered. The product design can be used as an (additional) risk mitigation measure to support medication safety in hospital practice.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Opportunities for changes in the drug product design to enhance medication safety in older people: Evaluation of a national public portal for medication incidents

Karapinar-Çarkıt

Bemt

Sadik

et al. 2020

Brit J Clinical Pharma

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“…Initially, these reactions were not thought to be related to quality defects. Similarly, cases of abuse or misuse have led to increases in frequency of reports such as with ephedra, and medication errors have also manifested in the same way, such as with cabazitaxel …”

Section: Introductionmentioning

confidence: 99%

“…Similarly, cases of abuse or misuse have led to increases in frequency of reports such as with ephedra, 10 and medication errors have also manifested in the same way, such as with cabazitaxel. 11 This analysis was aimed at validating a novel algorithm to detect unexpected increases in frequency (UIF) of reports to be used as an indicator of potential quality defects, medication errors, and abuse or misuse.…”

mentioning

confidence: 99%

An algorithm to detect unexpected increases in frequency of reports of adverse events in EudraVigilance

Candore¹,

Zaccaria²,

Slattery³

et al. 2017

Pharmacoepidemiology and Drug

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PurposeThe European Medicines Agency developed an algorithm to detect unexpected increases in frequency of reports, to enhance the ability to detect adverse events that manifest as increases in frequency, in particular quality defects, medication errors, and cases of abuse or misuse.MethodsAn algorithm based on a negative binomial time‐series regression model run on 6 sequential observations prior to the monitored period was developed to forecast monthly counts of reports. A heuristic model to capture increases in counts when the previous 4 observations were null supplemented the regression. Count data were determined at drug‐event combination. Sensitivity analyses were run to determine the effect of different methods of pooling or stratifying count data. Positive retrospective detections and positive predictive values (PPVs) were determined.ResultsThe algorithm detected 8 of the 13 historical concerns, including all concerns of quality defects. The highest PPV (1.29%) resulted from increasing the lower count threshold from 3 to 5 and including literature reports in the counts. Both the regression model and the heuristic model components to the algorithm contributed to the detection of concerns. Sensitivity analysis indicates that stratification by commercial product reduces the PPV but suggests that pooling counts of related events may improve it.ConclusionThe results are encouraging and suggest that the algorithm could be useful for the detection of concerns that manifest as changes in frequency of reporting; however, further testing, including in prospective use, is warranted.

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Relevance of Foreign Alerts and Newsletters for the Medication Errors Reporting Programme in The Netherlands: An Explorative Retrospective Study

et al. 2014

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Improving European cooperation on medication errors

Cited by 4 publications

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Opportunities for changes in the drug product design to enhance medication safety in older people: Evaluation of a national public portal for medication incidents

Opportunities for changes in the drug product design to enhance medication safety in older people: Evaluation of a national public portal for medication incidents

An algorithm to detect unexpected increases in frequency of reports of adverse events in EudraVigilance

Relevance of Foreign Alerts and Newsletters for the Medication Errors Reporting Programme in The Netherlands: An Explorative Retrospective Study

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