Medication related litigation in Ireland: A 6-year review.

AIMS: The primary aims of the study were to identify those medications most frequently associated with clinical litigation in Ireland and to quantify the cost of such litigation. Secondary aims were to identify where in the medication-use process claims were most likely to arise, the medication incident types involved and the primary injury alleged. METHODS: The National Incident Management System (NIMS) for incident and claims management was searched to identify all medication-related claims finalised from 2011 to 2016 (inclusive). The physical case files were obtained and additional data not available on NIMS was extracted in order to build a detailed picture of the incident and subsequent claim. RESULTS: The search identified 79 relevant claims, of which 48 closed with a payment to the plaintiff. These 48 claims involved 54 medications. Medication groups identified included general anaesthetics (n = 7), opioids (n = 6), penicillins, antithrombotics and local anaesthetics (all n = 5). The errors alleged occurred exclusively at the administration (58%) and prescribing (42%) stages of the medication-use process. Medication incident types included wrong dose/strength (n = 17), wrong drug (n = 7) and adverse drug reaction (n = 6). The most commonly pleaded primary injuries were allergic reaction (n = 9), deterioration in clinical status (n = 9) and post-traumatic stress disorder (n = 8). The median total cost of these claims was €60 991, including median damages of €33 858. CONCLUSIONS: This study links data on medication incidents, actual harm to patients and litigation costs. Thus, it presents a comprehensive picture of the consequences of medication error.

[Oral drops: unsafe or unwieldy method of administration?] / Druppels: onveilige of onhandige toedieningsvorm?

The Netherlands Medicines Evaluation Board (MEB) was recently informed about a serious pipamperone overdose in a 6-year-old boy, which happened because the boy was given the medication in streams rather than in drops. This article describes the use of drops in pharmaceutical patient care and explains why the MEB has maintained marketing authorization for the product on the basis of currently available information. The MEB urgently requests the healthcare professional groups to report all problems concerning drug use to the Netherlands Pharmacovigilance Centre Lareb, and the Portal for Patient Safety; this is the only way in which it can be verified whether incidental medication errors are actually, and continue to be, incidental.

Thematic Analysis of Obstetric Anesthesia Cases From the AANA Foundation Closed Claims Database.

Maternal morbidity and mortality in the United States continues to be high. Understanding parturient complications and causes of death is critical to determine corrective actions. Analysis of closed malpractice claims evaluates patient care, identifies preventable morbidity and mortality, and offers recommendations for improvement. A review of obstetric anesthesia malpractice claims filed against nurse anesthetists (N = 21), extracted from the American Association of Nurse Anesthetists Foundation Closed Claims database, was completed. The malpractice claims included 18 maternal claims and 3 neonatal claims. The most common adverse maternal outcomes were maternal death (8/18) and nerve injury (4/18). Hemorrhage accounted for the greatest number of maternal deaths (3/8) followed by cardiovascular failure, emboli, and neuraxial opioid overdose. All neonatal claims (3/3) involved hypoxic encephalopathy resulting in 1 neonatal death and 2 cases of neonatal permanent brain injury. The majority of maternal cases were identified as nonemergent (15/18) and involved relatively healthy patients (15 identified as ASA physical status 2). Qualitative analysis of closed claims provides the opportunity to identify patterns of injuries, precipitating events, and interventions to improve care. Themes related to poor outcomes in this study include care delays, failed communication, incomplete documentation, maternal hemorrhage, and lack of provider vigilance.

Cuidados na administração de medicamentos: as responsabilidades dos profissionais de enfermagem / Care in the administration of medicines: the responsibilities of nursing professionals

Objetivo: avaliar o conhecimento de profissionais de enfermagem atuantes em uma instituição hospitalar pública quanto às responsabilidades jurídicas e éticas envolvidas na administração de medicamentos. Método: estudo avaliativo, exploratório, com abordagem quantitativa e qualitativa. Foram aplicados questionários a162 profissionais de enfermagem. Os dados quantitativos formaram um banco de dados, digitados no software Statistical Package for the Social Sciences – SPSS. As informações qualitativas foram submetidas à análise de conteúdo. Resultados: constatou-se que os profissionais de enfermagem necessitam de maior aprofundamento científico acerca do Código de Ética da Profissão e que o conhecimento dos enfermeiros acerca das responsabilidades perante os erros de medicação foi superior ao dos técnicos e auxiliares de enfermagem. A advertência verbal foi a principal conduta adotada para responsabilizar os profissionais envolvidos após a ocorrência dos erros. Conclusão: constata-se que o conhecimento acerca do direito e da deontologia propiciam um fazer com resultados efetivos.

National Rules for Drug-Drug Interactions: Are They Appropriate for Tertiary Hospitals?

The application of appropriate rules for drug-drug interactions (DDIs) could substantially reduce the number of adverse drug events. However, current implementations of such rules in tertiary hospitals are problematic as physicians are receiving too many alerts, causing high override rates and alert fatigue. We investigated the potential impact of Korean national DDI rules in a drug utilization review program in terms of their severity coverage and the clinical efficiency of how physicians respond to them. Using lists of high-priority DDIs developed with the support of the U.S. government, we evaluated 706 contraindicated DDI pairs released in May 2015. We evaluated clinical log data from one tertiary hospital and prescription data from two other tertiary hospitals. The measured parameters were national DDI rule coverage for high-priority DDIs, alert override rate, and number of prescription pairs. The coverage rates of national DDI rules were 80% and 3.0% at the class and drug levels, respectively. The analysis of the system log data showed an overall override rate of 79.6%. Only 0.3% of all of the alerts (n = 66) were high-priority DDI rules. These showed a lower override rate of 51.5%, which was much lower than for the overall DDI rules. We also found 342 and 80 unmatched high-priority DDI pairs which were absent in national rules in inpatient orders from the other two hospitals. The national DDI rules are not complete in terms of their coverage of severe DDIs. They also lack clinical efficiency in tertiary settings, suggesting improved systematic approaches are needed.

Medication errors as malpractice-a qualitative content analysis of 585 medication errors by nurses in Sweden.

BACKGROUND: Many studies address the prevalence of medication errors but few address medication errors serious enough to be regarded as malpractice. Other studies have analyzed the individual and system contributory factor leading to a medication error. Nurses have a key role in medication administration, and there are contradictory reports on the nurses' work experience in relation to the risk and type for medication errors. METHODS: All medication errors where a nurse was held responsible for malpractice (n = 585) during 11 years in Sweden were included. A qualitative content analysis and classification according to the type and the individual and system contributory factors was made. In order to test for possible differences between nurses' work experience and associations within and between the errors and contributory factors, Fisher's exact test was used, and Cohen's kappa (k) was performed to estimate the magnitude and direction of the associations. RESULTS: There were a total of 613 medication errors in the 585 cases, the most common being "Wrong dose" (41 %), "Wrong patient" (13 %) and "Omission of drug" (12 %). In 95 % of the cases, an average of 1.4 individual contributory factors was found; the most common being "Negligence, forgetfulness or lack of attentiveness" (68 %), "Proper protocol not followed" (25 %), "Lack of knowledge" (13 %) and "Practice beyond scope" (12 %). In 78 % of the cases, an average of 1.7 system contributory factors was found; the most common being "Role overload" (36 %), "Unclear communication or orders" (30 %) and "Lack of adequate access to guidelines or unclear organisational routines" (30 %). The errors "Wrong patient due to mix-up of patients" and "Wrong route" and the contributory factors "Lack of knowledge" and "Negligence, forgetfulness or lack of attentiveness" were more common in less experienced nurses. The experienced nurses were more prone to "Practice beyond scope of practice" and to make errors in spite of "Lack of adequate access to guidelines or unclear organisational routines". CONCLUSIONS: Medication errors regarded as malpractice in Sweden were of the same character as medication errors worldwide. A complex interplay between individual and system factors often contributed to the errors.

[Preventing interruptions during the administration of medicines]. / Administration du médicament, prévenir les interruptions de tâches.

The medication use pathway is a complex process with a high risk of error, all the more so if it is interspersed with interruptions. Interruptions during care procedures are a real problem which can result in serious adverse events. A legal frame obliges the health institutions to secure the administration of medicines. This priority objective is translated by risks assessments, tools of self-assessment, audits, corrective actions, which allow a raising awareness of the professionals to the risks associated to medicines.

Regulatory incentives to ensure better medicines for older people: From ICH E7 to the EMA reflection paper on quality aspects.

Ageing comes with an increased propensity in the alteration of human organ and body functions, which can e.g. result in multi-morbidity, frailty, polypharmacy, altered medication safety and/or efficacy, and problems with the practical use of medicines in a real world setting. Such problems may e.g. involve difficulties opening containers, swallowing large tablets, breaking tablets by hand, or correctly understanding the user instruction. This review aims to summarize the European regulatory activities towards better medicines for older people, with a main focus on formulation development and the overall drug product design. It addresses the ICH E7 guideline "Studies in support of special populations, geriatrics", the ICH Q8 guideline "Pharmaceutical development", the EMA good practice guide on "Risk minimisation and prevention of medication errors" and the forthcoming EMA CHMP QWP reflection paper on the "Quality aspects (pharmaceutical development) of medicines for older people". In addition, three key aspects to the practical use of medicines by older people are discussed in a wider context: multi-particulates including small tablets (also referred to as mini-tablets), ease of opening and storage conditions. Furthermore, attention is paid to work in progress e.g. incentives by the European national drug regulatory authorities, and patient centric drug product development.

Medication Errors: New EU Good Practice Guide on Risk Minimisation and Error Prevention.

A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient. Reducing the risk of medication errors is a shared responsibility between patients, healthcare professionals, regulators and the pharmaceutical industry at all levels of healthcare delivery. In 2015, the EU regulatory network released a two-part good practice guide on medication errors to support both the pharmaceutical industry and regulators in the implementation of the changes introduced with the EU pharmacovigilance legislation. These changes included a modification of the 'adverse reaction' definition to include events associated with medication errors, and the requirement for national competent authorities responsible for pharmacovigilance in EU Member States to collaborate and exchange information on medication errors resulting in harm with national patient safety organisations. To facilitate reporting and learning from medication errors, a clear distinction has been made in the guidance between medication errors resulting in adverse reactions, medication errors without harm, intercepted medication errors and potential errors. This distinction is supported by an enhanced MedDRA(®) terminology that allows for coding all stages of the medication use process where the error occurred in addition to any clinical consequences. To better understand the causes and contributing factors, individual case safety reports involving an error should be followed-up with the primary reporter to gather information relevant for the conduct of root cause analysis where this may be appropriate. Such reports should also be summarised in periodic safety update reports and addressed in risk management plans. Any risk minimisation and prevention strategy for medication errors should consider all stages of a medicinal product's life-cycle, particularly the main sources and types of medication errors during product development. This article describes the key concepts of the EU good practice guidance for defining, classifying, coding, reporting, evaluating and preventing medication errors. This guidance should contribute to the safe and effective use of medicines for the benefit of patients and public health.

[Adverse drug reaction - Definitions, risk factors and pharmacovigilance]. / Unerwünschte Arzneimittelwirkungen - Definitionen, Einteilung, Risikofaktoren und Pharmakovigilance.

Adverse drug reactions (ADR} are the downside of active pharmacotherapies and can only partially be avoided. Risk factors have been identified for certain ADR which should be taken into account for the choice and dosing of critical drugs. Medical staff have a legal obligation to report severe ADR and ADR caused by newly licensed drugs. Such reports are important for monitoring the safety of drugs that are on the market.