Preventable and non-preventable adverse drug events in hospitalized patients: a prospective chart review in the Netherlands.
Drug Saf. 2011 Nov 1;34(11):1089-100
Authors: Dequito AB, Mol PG, van Doormaal JE, Zaal RJ, van den B…

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The causes of and factors associated with prescribing errors in hospital inpatients: a systematic review.

Drug Saf. 2009;32(10):819-36

Authors: Tully MP, Ashcroft DM, Dornan T, Lewis PJ, Taylor D, Wass V

Prescribing errors are common, they result in adverse events and harm to patients and it is unclear how best to prevent them because recommendations are more often based on surmized rather than empirically collected data. The aim of this systematic review was to identify all informative published evidence concerning the causes of and factors associated with prescribing errors in specialist and non-specialist hospitals, collate it, analyse it qualitatively and synthesize conclusions from it. Seven electronic databases were searched for articles published between 1985-July 2008. The reference lists of all informative studies were searched for additional citations. To be included, a study had to be of handwritten prescriptions for adult or child inpatients that reported empirically collected data on the causes of or factors associated with errors. Publications in languages other than English and studies that evaluated errors for only one disease, one route of administration or one type of prescribing error were excluded. Seventeen papers reporting 16 studies, selected from 1268 papers identified by the search, were included in the review. Studies from the US and the UK in university-affiliated hospitals predominated (10/16 [62%]). The definition of a prescribing error varied widely and the included studies were highly heterogeneous. Causes were grouped according to Reason’s model of accident causation into active failures, error-provoking conditions and latent conditions. The active failure most frequently cited was a mistake due to inadequate knowledge of the drug or the patient. Skills-based slips and memory lapses were also common. Where error-provoking conditions were reported, there was at least one per error. These included lack of training or experience, fatigue, stress, high workload for the prescriber and inadequate communication between healthcare professionals. Latent conditions included reluctance to question senior colleagues and inadequate provision of training. Prescribing errors are often multifactorial, with several active failures and error-provoking conditions often acting together to cause them. In the face of such complexity, solutions addressing a single cause, such as lack of knowledge, are likely to have only limited benefit. Further rigorous study, seeking potential ways of reducing error, needs to be conducted. Multifactorial interventions across many parts of the system are likely to be required.

PMID: 19722726 [PubMed - indexed for MEDLINE]

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Treatment of chronic non-malignant pain in the elderly: safety considerations.

Drug Saf. 2009;32(6):457-74

Authors: Barber JB, Gibson SJ

Non-malignant pain in the elderly is frequently under-treated, with physicians appearing to be uncertain concerning how best to achieve optimum management of this common problem in individual cases. The aim of this review is to provide a brief overview and discuss the variety of interacting factors that contribute to the continuing under-treatment of chronic non-malignant pain in the older population. The central objective is to encourage safer and more effective pain management in a population that is highly vulnerable to painful conditions and to the consequences of poorly treated pain. Under-treatment of pain as experienced by the elderly is largely a consequence of uncertainties that arise within a complex environment that is underscored and exacerbated by the progressive and rapid aging of the global population. Uncertainties include the optimum management of pain in geriatric syndromes, frailty and dementia, and their impact on diagnosis, pain assessment and choices of treatment modalities. There is an inadequate evidence base for pharmacological interventions in older persons with respect to pharmacokinetic and pharmacodynamic changes that occur with aging. In this review, the prevalence of chronic pain and the incidence of adverse drug reactions are identified as factors that encourage conservatism in prescribing, as are major predictors of adverse drug reactions, i.e. aging, inappropriate combinations of medications and polypharmacy. The major classes of analgesic drugs are summarized with reference to their mechanisms of action, analgesic properties and known adverse effects. Although all medications have associated risks, the use of analgesics in managing persistent pain in elderly people is widely supported and guided on the basis of clinical experience and consensus among specialists in geriatrics and pain management. It is concluded that the absence of trial data, specific to the elderly, is substantially offset by information based on clinical experience and expert consensus statements. Used appropriately, analgesic and adjuvant treatments can and should be employed to relieve persistent pain in the expanding elderly population.

PMID: 19459714 [PubMed - indexed for MEDLINE]

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Safety profile of the respiratory fluoroquinolone moxifloxacin: comparison with other fluoroquinolones and other antibacterial classes.

Drug Saf. 2009;32(5):359-78

Authors: Van Bambeke F, Tulkens PM

Moxifloxacin, a fluoroquinolone with potent activity against respiratory pathogens, is approved and considered as an alternative to beta-lactams and macrolides for the treatment of acute bacterial sinusitis and lower respiratory tract infections. In this review, we critically examine its safety profile in comparison with other fluoroquinolones and other antibacterial classes sharing similar indications. Data were extracted from published clinical trials, meta-analyses, postmarketing studies, spontaneous report systems and case reports for rare effects. Global analysis did not reveal significantly higher incidences of drug-related adverse effects than for comparators. Tendon rupture was infrequent with moxifloxacin, including when used in elderly patients with chronic obstructive pulmonary disease. Severe toxic cutaneous reactions and allergies were very rare. Phototoxicity and CNS adverse effects were less common than with other fluoroquinolones. Although causing a 4-7 msec corrected QT interval prolongation, severe cardiac toxicity was neither seen in large cohorts or clinical trials nor reported to pharmacovigilance systems. Hepatotoxicity was not different from what was observed for other fluoroquinolones (excluding trovafloxacin) and less frequent than reported for amoxicillin-clavulanic acid or telithromycin. The data show that using moxifloxacin, in its accepted indications and following the corresponding guidelines, should not be associated with an excessive incidence of drug-related adverse reactions, provided the clinician takes care in identifying patients with known risk factors and pays due attention to the contraindications and warnings mentioned in the labelling.

PMID: 19419232 [PubMed - indexed for MEDLINE]

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Prevalence, incidence and nature of prescribing errors in hospital inpatients: a systematic review.

Drug Saf. 2009;32(5):379-89

Authors: Lewis PJ, Dornan T, Taylor D, Tully MP, Wass V, Ashcroft DM

Prescribing errors affect patient safety throughout hospital practice. Previous reviews of studies have often targeted specific populations or settings, or did not adopt a systematic approach to reviewing the literature. Therefore, we set out to systematically review the prevalence, incidence and nature of prescribing errors in hospital inpatients. MEDLINE, EMBASE, CINAHL and International Pharmaceutical Abstracts (all from 1985 to October 2007) were searched for studies of prescriptions for adult or child hospital inpatients giving enough data to calculate an error rate. Electronic prescriptions and errors for single diseases, routes of administration or types of prescribing error were excluded, as were non-English language publications. Median error rate (interquartile range [IQR]) was 7% (2-14%) of medication orders, 52 (8-227) errors per 100 admissions and 24 (6-212) errors per 1000 patient days. Most studies (84%) were conducted in single hospitals and originated from the US or UK (72%). Most errors were intercepted and reported before they caused harm, although two studies reported adverse drug events. Errors were most common with antimicrobials and more common in adults (median 18% of orders [ten studies, IQR 7-25%]) than children (median 4% [six studies, IQR 2-17%]). Incorrect dosage was the most common error. Overall, it is clear that prescribing errors are a common occurrence, affecting 7% of medication orders, 2% of patient days and 50% of hospital admissions. However, the reported rates of prescribing errors varied greatly and this could be partly explained by variations in the definition of a prescribing error, the methods used to collect error data and the setting of the study. Furthermore, a lack of standardization between severity scales prevented any comparison of error severity across studies. Future research should address the wide disparity of data-collection methods and definitions that bedevils comparison of error rates or meta-analysis of different studies.

PMID: 19419233 [PubMed - indexed for MEDLINE]

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Reducing harm associated with anticoagulation: practical considerations of argatroban therapy in heparin-induced thrombocytopenia.

Drug Saf. 2009;32(3):203-18

Authors: Hursting MJ, Soffer J

Argatroban is a hepatically metabolized, direct thrombin inhibitor used for prophylaxis or treatment of thrombosis in heparin-induced thrombocytopenia (HIT) and for patients with or at risk of HIT undergoing percutaneous coronary intervention (PCI). The objective of this review is to summarize practical considerations of argatroban therapy in HIT. The US FDA-recommended argatroban dose in HIT is 2 microg/kg/min (reduced in patients with hepatic impairment and in paediatric patients), adjusted to achieve activated partial thromboplastin times (aPTTs) 1.5-3 times baseline (not >100 seconds). Contemporary experiences indicate that reduced doses are also needed in patients with conditions associated with hepatic hypoperfusion, e.g. heart failure, yet are unnecessary for renal dysfunction, adult age, sex, race/ethnicity or obesity. Argatroban 0.5-1.2 microg/kg/min typically supports therapeutic aPTTs. The FDA-recommended dose during PCI is 25 microg/kg/min (350 microg/kg initial bolus), adjusted to achieve activated clotting times (ACTs) of 300-450 sec. For PCI, argatroban has not been investigated in hepatically impaired patients; dose adjustment is unnecessary for adult age, sex, race/ethnicity or obesity, and lesser doses may be adequate with concurrent glycoprotein IIb/IIIa inhibition. Argatroban prolongs the International Normalized Ratio, and published approaches for monitoring the argatroban-to-warfarin transition should be followed. Major bleeding with argatroban is 0-10% in the non-interventional setting and 0-5.8% periprocedurally. Argatroban has no specific antidote, and if excessive anticoagulation occurs, argatroban infusion should be stopped or reduced. Improved familiarity of healthcare professionals with argatroban therapy in HIT, including in special populations and during PCI, may facilitate reduction of harm associated with HIT (e.g. fewer thromboses) or its treatment (e.g. fewer argatroban medication errors).

PMID: 19338378 [PubMed - indexed for MEDLINE]

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