Description of the Risk Management of Medication Errors for Centrally Authorised Products in the European Union

Hoeve, Christina E.; Francisca, Reynold D. C.; Zomerdijk, Inge M.; Sturkenboom, Miriam; Straus, Sabine M. J. M.

doi:10.1007/s40264-019-00874-7

Cited by 13 publications

(10 citation statements)

References 15 publications

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“…Even though the patient safety is the first aim of every health professional and it should be in the center of every health system, despite intense advances in technology, the prevalence of APO is still very high [9,10,30]. However, there is a very little data in literature about perception from frontline nurses and doctors, who are working in health centers and hospitals, even though any possible success in error reduction depends on full support from these workers only [29].…”

Section: Discussionmentioning

confidence: 99%

“…Despite the rapid development of medicine, the sophistication of medical equipment, as well as the increasing adoption of modern and effective risk control techniques, there is a growing possibility of errors in health care. According to data from the most of European Union countries, about 8-12% of patients suffer some damage as a result of treatment errors [9,10]. One of the reports of the American Medical Institute says that every year over a million people suffer the consequences caused by mistakes in health care.…”

Section: Introductionmentioning

confidence: 99%

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Attitudes and factors associated with adverse patient outcomes as perceived by nurses and medical doctors

Vukotić¹,

Despotović²,

Joksimović³

et al. 2022

Biomedicinska istraž.

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Introduction.The patient and his safety should be at the center of quality health care, which is a challenge for every health system. Adverse patient outcomes (APO) are defined as damage caused by a drug or other intervention in a primary, secondary or tertiary health care facility, which results in a complication of the primary or the emergence of a new disease or injury. The aim of our study was to determine how frequent the APO are, and to determine the differences between nurses and doctors in the frequency, causes and attitudes towards APO.Methods. This cross-sectional study included 100 health professionals, nurses and medical doctors employed at the primary and secondary level of health care. The research was conducted in the period from May to October 2020. The questionnaire was partially taken from a general questionnaire offered on the website of the Agency for Healthcare Research and Quality and the standardized Perceived stress scale was used to measure the degree of subjective stress.Results. Forty-four health professionals (44%) experienced adverse patient outcomes in their career, doctors (52%) significantly more often than nurses (36%) (p = 0.039). More than a half of respondents (52.3%) declared that APO happens few times a month. Seventy percent of the respondents blame their own stress burden as the main factor associated with APO. Doctors more often than nurses (69.2%) blame problems in communication between health professionals as the main cause of APO (27.8%) (p = 0.046). Conclusion.For doctors, the main cause of APO is problem in communication, while nurses more often think that patient safety is priority when compared to doctors. Almost two thirds of respondents blame their own stress burden as a factor associated with APO.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Attitudes and factors associated with adverse patient outcomes as perceived by nurses and medical doctors

Vukotić¹,

Despotović²,

Joksimović³

et al. 2022

Biomedicinska istraž.

View full text Add to dashboard Cite

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“…The increased awareness of the topic of medication errors since 2005 is reflected by an increase of case reports of medication errors in EudraVigilance [ 6 ]. Medication error safety concerns were listed in the risk management plan for almost a quarter of centrally authorised products approved in the European Union in the years 2010–17 [ 7 ].…”

Section: Introductionmentioning

confidence: 99%

Quality of MedDRA® Coding in a Sample of COVID-19 Vaccine Medication Error Data

Kralova

Wilson²,

Richebourg

et al. 2023

Drug Saf

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Introduction In recent years, there has been increasing interest from regulatory agencies and scientific organisations into the recording, coding and reporting of medication errors. Accuracy and consistency in the handling of medication error reports ensure the safety and effectiveness of medicines and provide reliable information to both healthcare professionals and patients. Objective The authors have examined a sample of Medical Dictionary for Regulatory Activities (MedDRA ® ) coded reports that describe medication errors to assess the accuracy and consistency of MedDRA ® coding, and to identify the main types of coding errors for the newly introduced COVID-19 vaccines. Methods The sample of coded terms was assessed by two MedDRA ® experts applying the Four Eyes Principle. It included 1500 reported terms drawn from the Uppsala Monitoring Centre database reported up to 25 August, 2021, describing medication errors for COVID-19 vaccines with their assigned MedDRA ® terms. Results One third of the records could not be assessed because of incomplete or unclear verbatims. In one third, MedDRA ® term assignments were correct, but another third of the sample was not adequately coded. The most frequent coding errors corresponded to vague MedDRA ® Preferred Term assignments despite more detailed information being available in the verbatim for a more precise coding. This observation is similar to findings in the EudraVigilance database, where some of the most frequently assigned MedDRA ® terms for medication errors also represent vague concepts. Conclusions The findings indicate that understanding of medication error documentation and of the importance of accurate extraction of information from case narratives, as well as knowledge of MedDRA ® content and coding guidelines need to be reinforced. The authors provide useful references to training opportunities and to the applicable International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use-Endorsed Guides for MedDRA ® users.

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“…To prevent medication errors in clinical practice, safety concerns may be included in the risk management plan and subsequently be addressed with routine and/or additional risk minimisation measures 7 8. Risk management is defined as a systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk 9.…”

Section: Introductionmentioning

confidence: 99%

Failure mode and effect analysis applied to improve the medication management process in a pharmacy of a teaching hospital and a proposal for a simplified rating system

2022

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BackgroundHealthcare is not as safe as it should be and medication error remains a significant source of preventable morbidity and mortality among patients.ObjectivesTo present a failure mode and effect analysis (FMEA) of the medication management process in the pharmacy of the largest teaching hospital in Tunisia. Secondly, to examine the validity of a proposed simplified risk rating method by comparing the degree of concordance with the FMEA rating system in classifying failure modes related to the studied process.MethodsThe FMEA method was applied to the medication management process in the pharmacy for 5 months from January 2020. For the traditional FMEA rating system, failure modes were prioritised according to the risk priority number, which considers severity, occurrence and non-detectability. Failure modes were classified for the traditional method considering three categories: accepted, requiring control and critical. The proposed rating system was based on two indices: the number of parts, which reflected severity, and the number of causes according to the 5M method (manpower, machines, material, methods and medium), which reflected occurrence. Failure modes were classified for the proposed method considering three categories: low, medium and high. Failure modes were independently analysed to determine the degree of agreement in ranking of risk between the two studied methods. Prioritised failure modes were targeted by decisions and solutions aiming to reduce risk and enhance safety.ResultsTwenty-four failure modes were identified for the six-step process of medication management in a pharmacy (overall criticality=2607). The most critical failure modes were: data error in drugs reception (risk priority number (RPN)=432), break in the cold chain (RPN=320) and non-optimal pharmaceutical analysis (RPN=280). A good agreement was found between the classic FMEA and the proposed rating methods (κ=0.795). A high correlation was shown between the two scorings (r=0.785). Three failure modes were underestimated by the proposed rating method.ConclusionsAn FMEA study on the medication management process in a teaching pharmacy showed that FMEA is an effective, proactive risk assessment that enables a better understanding of the studied process. The proposed risk scoring permits a good concordance with the classic method, with the advantage of being fast. Targeting the identified risks will allow integration into a continuous process of improvement and increase patient safety.

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Description of the Risk Management of Medication Errors for Centrally Authorised Products in the European Union

Cited by 13 publications

References 15 publications

Attitudes and factors associated with adverse patient outcomes as perceived by nurses and medical doctors

Attitudes and factors associated with adverse patient outcomes as perceived by nurses and medical doctors

Quality of MedDRA® Coding in a Sample of COVID-19 Vaccine Medication Error Data

Failure mode and effect analysis applied to improve the medication management process in a pharmacy of a teaching hospital and a proposal for a simplified rating system

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