RSS 1.0Pharmacy
Recent Submissions
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Safety and efficacy of ianalumab in patients with Sjögren's disease: 52-week results from a randomized, placebo-controlled, phase 2b dose-ranging study.Objective: The objective of this study was to report 52-week safety and efficacy of ianalumab from phase 2b dose-finding study in patients with Sjögren's disease (SjD). Methods: Patients randomly received (1:1:1:1) ianalumab (5, 50, or 300 mg) or placebo subcutaneously every 4 weeks until week 24 (treatment period [TP]1). At week 24, patients on 300 mg were rerandomized to continue 300 mg or receive placebo until week 52 (TP2), patients on placebo were switched to ianalumab 150 mg, and patients on 5 and 50 mg directly entered posttreatment safety follow-up. Patients who discontinued treatment early or completed treatment entered safety follow-up (≥20 weeks). Results: During TP1, 190 patients were randomized (placebo = 49, 5 mg = 47, 50 mg = 47, 300 mg = 47). Of these 190 patients, 90 (47.4 %; 43 continued 300 mg and 47 received placebo) entered TP2, and 81 of 90 (90.0%) completed the study treatment. By week 52, efficacy was sustained in patients who continued 300 mg in TP2 (EULAR Sjögren's Syndrome Disease Activity Index, EULAR Sjögren's Syndrome Patient Reported Index, patient global assessment, and physician global assessment change from week 24: -1.45, -0.46, -4.69, and -6.86, respectively). Stimulated salivary flow rates and autoantibody levels numerically improved in the 300 mg group. Treatment-emergent adverse events were not dose-dependent, except for injection-site reactions. Cases of decreased neutrophil counts (Common Terminology Criteria for Adverse Events v4.03 grade 3 according to laboratory listings) were observed in three patients during the posttreatment follow-up, occurring at 3.5, 5.5, and 3 months, after the last ianalumab administration. None were associated with infection except one incidental finding of asymptomatic cytomegalovirus infection (IgM-positive). Conclusion: In patients with SjD, ianalumab 300 mg demonstrated sustained efficacy through week 52 and a favorable safety profile up to two years of follow-up.
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Contemporary dental pharmacology: evidence-based considerations.No abstract available.
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Drug utilisation study in hospitalised chronic kidney disease patients, using World Health Organisation prescribing indicators: an observational studyBackground: Chronic kidney disease (CKD) is associated with comorbidities and altered pharmacokinetics, making appropriate prescribing, and monitoring necessary to minimise drug-related problems (DRPs). Therefore, this study aimed to describe the drug-utilisation pattern in hospitalised CKD patients. Methods: An observational study was conducted in hospitalised adult (≥18 years old) CKD patients in the UK using WHO prescribing indicators, from November 2021 to April 2022 in a large teaching hospital in England from admission until discharge. This study used STATA version 16 for analysis. Results: The mean number of drugs per prescription was 11.1(±5), the percentage of encounters resulting in the prescription of an antibiotic was 62%, the percentage of drugs prescribed by generic name was 90%, the percentage of encounters resulting in the prescription of an injection was 94%, and the percentage of drugs prescribed from essential drugs list or formulary was 89%. The most frequent drug group prescribed Alimentary Tract and Metabolism was 22%. Longer hospital stays, admission to a renal ward, and the number of comorbidities were independently associated with polypharmacy. Conclusion: Not all prescribing indicators evaluated in this study were in full compliance with WHO recommendations. Polypharmacy was found in most participants which might require interventions to avoid DRPs. Further research is needed to evaluate factors associated with prescribing in the CKD population and prescriber perspectives on decision-making in the context of available guidelines and patient factors.
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Investigation into the linearity of the Roche c 702 carbamazepine assay.Background: Carbamazepine is an anticonvulsant drug which is monitored in patients due to toxic side effects. At Manchester University NHS Foundation Trust (MFT), carbamazepine is measured using Roche's Kinetic Interaction of Microparticles in Solution (KIMS) method on the c 702 platform. The assay has an upper limit of linearity of 20 mg/L. Samples with concentrations above this limit should be identified and manually diluted. However, a poor EQA return from UK NEQAS for Tox and TDM Distribution 456 has highlighted an issue with the Roche KIMS assay. Sample A of the distribution had a carbamazepine concentration of 36 mg/L but was underreported by several Roche users. This indicated that the assay was not consistently identifying high concentration samples which required a dilution. Method: In this investigation, fresh frozen plasma was spiked with carbamazepine concentrations ranging from 15 to 40 mg/L. The spiked samples and EQA material were analysed at two clinical laboratories using the Roche KIMS assay. Results: Samples spiked with concentrations 20-30 mg/L were not consistently identified for dilution by the analyser. This was observed at both hospital sites. Spike samples and EQA with concentrations >30 mg/L were correctly identified at both sites. Conclusion: The manual dilution policy has been changed at MFT, so all samples with a carbamazepine level ≥15 mg/L will be manually diluted. The problem was reported to Roche who are investigating the issue further. We would suggest that other laboratories look at validating their dilution protocols.
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The value of patient-reported outcomes in early-phase clinical trialsNo abstract available
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Advances in pharmacotherapy for heart failure and reduced ejection fraction: what's new in 2024?Introduction: Updated guidelines for heart failure with reduced ejection fraction (HFrEF) and acute decompensation have improved outcomes, but ongoing efforts are focused on uncovering new evidence and developing novel therapies. This review examines the limitations of current treatments and the potential impact of emerging therapies. Areas covered: A literature search focused on studies investigating drugs for HFrEF. We review recent clinical trials and emerging therapies to assess evidence strength, explore guideline updates, and identify strategies to optimize patient outcomes. Expert opinion: The HFrEF treatment landscape is rapidly evolving, with advances in therapies like sodium/glucose cotransporter inhibitors and sacubitril-valsartan. Though managing acute decompensated heart failure remains challenging, recent trials suggest improvements in diuretic strategies and anti-inflammatory treatments. Ongoing research is essential for validating these therapies and incorporating them into standard practice.
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Prevalence, contributory factors and severity of medication errors associated with direct-acting oral anticoagulants in adult patients: a systematic review and meta-analysisPurpose: This study aimed to estimate the prevalence, contributory factors, and severity of medication errors associated with direct acting oral anticoagulants (DOACs). Methods: A systematic review and meta-analysis were undertaken by searching 11 databases including Medline, Embase, and CINHAL between January 2008 and September 2020. The pooled prevalence of errors and predictive intervals were estimated using random-effects models using Stata software. Data related to error causation were synthesised according to Reason's accident causation model. Results: From the 5205 titles screened, 32 studies were included which were mostly based in hospitals and included DOAC treatment for thromboembolism and atrial fibrillation. The proportion of study population who experienced either prescription, administration, or dispensing error ranged from 5.3 to 37.3%. The pooled percentage of patients experiencing prescribing error was 20% (95% CI 15-25%; I2 = 96%; 95% PrI 4-43%). Prescribing error constituted the majority of all error types with a pooled estimate of 78% (95%CI 73-82%; I2 = 0) of all errors. The common reported causes were active failures including wrong drug, and dose for the indication. Mistakes such as non-consideration of renal function, and error-provoking conditions such as lack of knowledge were common contributing factors. Adverse events such as potentially fatal intracranial haemorrhage or patient deaths were linked to the errors but causality assessments were often missing. Conclusions: Despite their favourable safety profile, DOAC medication errors are common. There is a need to promote multidisciplinary working, guideline-adherence, training, and education of healthcare professionals, and the use of theory-based and technology-facilitated interventions to minimise errors and maximise the benefits of DOACs usage in all settings. Protocol: A protocol developed as per PRISMA-P guideline is registered under PROSPERO ID = CRD42019122996.
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Multi-disciplinary implementation of sapropterin for treatment of phenylketonuria patients in a Regional Metabolic CentrePhenylketonuria (PKU) is a rare, autosomal recessive metabolic disorder caused by deficiency of phenylalanine hydroxylase affecting about 1/10,000 babies born in the UK, requiring lifelong treatment with an ultra-low protein diet to restrict phenylalanine intake. Sapropterin is an analogue of tetrahydrobiopterin, a PAH co-factor, indicated for the treatment of responsive patients of all ages with PKU, defined as a reduction of 30% or more in phenylalanine blood concentration. A pharmacist-dietitian multidisciplinary team led the Implementation of high-cost drug Sapropterin for PKU patients at Queen Elizabeth Hospital Birmingham. Sapropterin was recommended by NICE TA729, NHSE commissioning position and BIMDG consensus pathway for commencing sapropterin. From December 2021 to November 2023, 21 out of 35 patients with at least one PAH amenable variant responded after testing, with an average phenylalanine blood concentration reduction of 49% and a mean increase in natural protein intake of 126%. Multi-disciplinary management optimise Sapropterin prescription and increase natural protein intake. The service has expanded its capacity by developing the role of specialist dietitian supplementary prescriber. Use of pharmacogenomic data allowed personalised care for patients with Sapropterin amenable variants, improving their lives by allowing some a normal diet for the first time in their lives.
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Antifungal prophylaxis against invasive Candida and Aspergillus infection in adult heart transplant recipients: protocol for a systematic review and meta-analysis.Introduction: Invasive fungal infections (IFI) can contribute to increased mortality and morbidity rates after heart transplant in adults. The most common causes are Aspergillus and Candida species. There is uncertainty on how effective antifungal prophylaxis is against Candida spp infections and limited guidance on the prevention of Aspergillus spp infections. This systematic review and meta-analysis will assess the literature to see if antifungal prophylaxis reduces the incidence of IFI after heart transplant in adults. Methods and analysis: This systematic review protocol follows the Preferred Reporting Items for Systematic reviews and Meta Analysis guidelines. A systematic search of the Cochrane Library, Web of Science, Scopus, Embase, MEDLINE, and Proquest databases will be undertaken. Reference lists of retrieved publications and conference abstracts will also be searched. Title, abstract and full-text screening will be undertaken by two reviewers. Discrepancies will be resolved by a third reviewer. Studies with paediatric patients, multi-organ transplants, or patients with a second heart transplant will be excluded, along with those who do not have clear definitions and diagnostic criteria for IFI. Risk of bias will be assessed using the Cochrane Risk of Bias 2 tool and the Risk of Bias in Non-randomised Studies of Interventions tool. A meta-analysis will be carried out, but if studies are not deemed to be sufficiently similar, only a narrative synthesis will be undertaken. Ethics and dissemination: Ethical approval is not required for this systematic review as primary data will not be collected. The results of the review will be disseminated through publication in an academic journal and scientific conferences.
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Factors influencing implementation and adoption of direct oral penicillin challenge for allergy delabelling: a qualitative evaluationBackground: Over 95% of penicillin allergy labels are inaccurate and may be addressed in low-risk patients using direct oral penicillin challenge (DPC). This study explored the behaviour, attitudes and acceptability of patients, healthcare professionals (HCPs) and managers of using DPC in low-risk patients. Methods: Mixed-method, investigation involving patient interviews and staff focus groups at three NHS acute hospitals. Transcripts were coded using inductive and deductive thematic analysis informed by the Theoretical Domains Framework. Findings: Analysis of 43 patient interviews and three focus groups (28 HCPs: clinicians and managers) highlighted themes of 'knowledge', 'beliefs about capabilities and consequences', 'environmental context', 'resources', 'social influences', 'professional role and identity', 'behavioural regulation and reinforcement' and a cross-cutting theme of digital systems. Overall, study participants supported the DPC intervention. Patients expressed reassurance about being in a monitored, hospital setting. HCPs acknowledged the need for robust governance structures for ensuring clarity of roles and responsibilities and confidence. Conclusion: There were high levels of acceptability among patients and HCPs. HCPs recognised the importance of DPC. Complexities of penicillin allergy (de)labelling were highlighted, and issues of knowledge, risk, governance and workforce were identified as key determinants. These should be considered in future planning and adoption strategies for DPC.
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A novel cell model of the proteinase/antiproteinase balance observed in alpha-1 antitrypsin deficiency.Background: Alpha-1 antitrypsin deficiency (AATD) is a genetic condition resulting from mutations in the alpha-1 antitrypsin (AAT) protein, a major systemic antiproteinase, resulting in reduced/no release of AAT, disrupting the proteinase/antiproteinase balance. A sustained imbalance can cause structural changes to the lung parenchyma, leading to emphysema. Predicting and assessing human responses to potential therapeutic candidates from preclinical animal studies have been challenging. Our aims were to develop a more physiologically relevant in vitro model of the proteinase/antiproteinase balance and assess whether the data generated could better predict the efficacy of pharmacological candidates to inform decisions on clinical trials, together with expected biomarker responses. Methods: We developed an in vitro model assessing the proteinase/antiproteinase balance by the changes in the fibrinogen cleavage products of neutrophil elastase (NE) and proteinase 3 (PR3). This allowed the assessment of physiological and pharmaceutical neutrophil serine proteinase (NSP) inhibitors to determine the putative threshold at which the maximal effect is achieved. Results: AAT significantly reduced NE and PR3 activity footprints, with the maximal reduction achieved at concentrations above 10 μM. The inhibitor MPH966 alone also significantly reduced NE footprint generation in a concentration-dependent manner, leveling out above 100 nM but had no effect on the PR3 footprint. At levels of AAT consistent with AATD, MPH966 had an additive effect, reducing the NE activity footprint more than either inhibitor alone. Conclusion: Our results support an inhibitor threshold above which the activity footprint generation appears resistant to increasing dosage. Our model can support the testing of inhibitors, confirming activity biomarkers as indicators of likely pharmaceutical efficacy, the assessment of NSP activity in the pathophysiology of emphysema, and the likely function of biological or pharmacological inhibitors in disease management.
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Nurses' attitudes, behaviours, and enablers of intravenous to oral switching (IVOS) of antibiotics: A mixed-methods survey of nursing staff in secondary care hospitals across the Midlands region of England.Background: Intravenous (IV) antibiotic use in secondary care in England is widespread. Timely appropriate intravenous to oral switch (IVOS) has the potential to deliver significant clinical and operational benefits. To date, antimicrobial stewardship (AMS) efforts around IVOS have not focused on the nursing staff who administer antibiotics, which represents a significant gap in AMS programmes. Aims: To determine the involvement of bedside nurses in acute trusts in the Midlands region of England in IVOS in their organisations and describe their views regarding how to improve IVOS. Methods: An anonymous self-administered mixed-methods online survey was developed and distributed to nursing staff in acute trusts via antimicrobial stewardship networks between March and May 2023. Quantitative data was analysed to describe participant demographics and behaviours, whereas barriers and enablers to IVOS were explored through thematic content analysis of responses to open-ended questions. Findings: 545 nursing staff responded to the survey. The majority (65.3%) routinely suggested IVOS to clinicians, despite only 50.6% being aware of local IVOS policies. One third (34.7%) did not suggest IVOS, relying on doctors, believing their patients needed IV treatment, or lacked knowledge and skills to request IVOS. Content analysis of suggestions for improving the rate of IVOS proposed three major themes (People, Process, System) and identified that education and training, improved confidence and interprofessional relationships, and prompts were important drivers. Conclusions: Nursing staff suggest IVOS to other clinicians, but more education and resources are needed to enable and empower them in this role.
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Hospital pharmacy response to COVID-19 at two UK teaching hospitals: a departmental review of actions implemented to inform future strategy.Objectives: To determine the views of pharmacy staff on a departmental response to wave 1 of the UK COVID-19 pandemic in order to inform a strategy for a second wave at two large UK National Health Service (NHS) hospitals. Methods: This study was undertaken at two large teaching hospitals in the UK. Pharmacy staff attended local departmental focus groups. Staff attendance included pharmacists, pharmacy technicians and pharmacy assistants representing all pharmacy services including aseptics, ward-based services, dispensary/distribution and procurement. Responses were transcribed and analysed using thematic analysis. Results: A total of 138 pharmacy staff attended the departmental focus groups. This study identified which pharmacy-related changes implemented in the first wave will be beneficial to take forward into a second wave. These included extending the hours of the pharmacy service to critical care, retaining the competence of pharmacists and pharmacy technicians redeployed to critical care during wave 1, development of standard operating procedures for changes in practice, delivering/posting of dispensed outpatient medication to patients' place of residence, maintenance of ward-based pharmacy services, use of the healthcare app PANDO to aid team communication, utilisation of remote-controlled drug ordering, deployment of a COVID-19 ward stocklist, procurement of ready-made bags/prefilled syringes of critical care medications, aligning the central intravenous additive service with critical care demand to reduce waste and establishment of a pharmacy response in line with the hospital's implementation plan. Conclusions: This study has provided a number of recommendations for how hospital pharmacy departments may respond to a global pandemic. These experiences derived from the pharmacy departments at two large UK NHS Trusts may be used by other healthcare providers to help inform the pharmacy response to a global pandemic.
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Direct oral anticoagulant-related medication incidents and pharmacists' interventions in hospital in-patients: evaluation using reason's accident causation theory.Background Direct oral anticoagulants (DOACs) have revolutionised anticoagulant pharmacotherapy. However, DOAC-related medication incidents are known to be common. Objective To assess medication incidents associated with DOACs using an error theory and to analyse pharmacists' contributions in minimising medication incidents in hospital in-patients. Setting A large University academic hospital in the West Midlands of England. Methods Medication incident data from the incident reporting system (48-months period) and pharmacists' interventions data from the prescribing system (26-month period) relating to hospital in-patients were extracted. Reason's Accident Causation Model was used to identify potential causality of the incidents. Pharmacists' intervention data were thematically analysed. Main outcome measure (a) Frequency, type and potential causality of DOAC-related incidents; (b) nature of pharmacists' interventions. Results A total of 812 reports were included in the study (124 medication incidents and 688 intervention reports). Missing drug/omission was the most common incident type (26.6%, n = 33) followed by wrong drug (16.1%, n = 20) and wrong dose/strength (11.3%, n = 14). A high majority (89.5%, n = 111) of medication incidents were caused by active failures. Patient discharge without anticoagulation supply and failure to restart DOACs post procedure/scan were commonly recurring themes. Pharmacists' interventions most frequently related to changes in pharmacological strategy, including drug or dose changes (38.1%, n = 262). Impaired renal function was the most common reason for dose adjustments. Conclusion Prescribers' active failure rather than system errors (i.e. latent failures) contributed to the majority of DOAC-related incidents. Reinforcement of guideline adherence, prescriber education, harnessing pharmacists' roles and mandating renal function information in prescriptions are likely to improve patient safety.
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Stewardship: it's going viral.Introduction: Historically, antimicrobial stewardship (AMS) has considered the judicious use of antibiotics. AMS is widely adopted across Europe and the US; recently antifungal AMS is gaining momentum but antiviral AMS has been little described. Here we describe the introduction of AMS virology reviews at University Hospitals Birmingham (UHBFT); a novel concept and an opportunity to broaden the beneficial aspects of AMS to virology, termed anti-viral stewardship (AVS). Method: In June 2022, a UK supply issue with aciclovir injection (ACV IV) was announced. In order to review and preserve parenteral ACV for those in greatest need, UHBFT pharmacist and virologists implemented a specialist review for patients prescribed more than 48 hours of treatment. This review initially lasted 10 weeks and data was collected on the advice offered, whether it was accepted, and time required completing the review. Results: AVS rounds halved IV ACV consumption, compared to pre or post intervention levels, with more than half of patients advised to stop or switch to oral therapy. Diagnostics and sampling guidance was offered in one quarter of reviews, whilst the remaining interventions were more stewardship focused. In almost all cases stewardship advice was readily accepted by clinical teams. Due to positive feedback from clinicians and its effective management of supply, the anti-viral stewardship (AVS) programme was re-introduced in June 2023. Conclusions: Antiviral AMS rounds provide an opportunity to optimise sampling, diagnosis and improve patient management. Introduction of regular AVS at UHBFT are now well established and plan to be implemented in other hospitals. Keywords: Aciclovir; Antimicrobial; Antiviral; Stewardship.
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What is the evidence that a pharmacy team working in an acute or emergency medicine department improves outcomes for patients: A systematic review.Pharmacy services within hospitals are changing, with more taking on medication reconciliation activities. This systematic review was conducted to determine the measured impacts of Pharmacy teams working in an acute or emergency medicine department. The protocol followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and was prospectively registered on PROSPERO, National Institute for Health and Care Research, UK registration number: CRD42020187487. The systematic review had two co-primary aims: a reduction in the number of incorrect prescriptions on admission by comparing the medication list from primary care to secondary care, and a reduction in the severity of harm caused by these incorrect prescriptions; chosen to determine the impact of pharmacy-led medication reconciliation services in the emergency and acute medicine setting. Seventeen articles were included. Fifteen were non-randomized controlled trials and two were randomized controlled trials. The number of patients combined for all studies was 7630. No studies included were based within the UK. All studies showed benefits in terms of a reduction in medicine errors and patient harm, compared to control arms. Nine articles were included in a statistical analysis comparing the pharmacy intervention arm with the non-pharmacy control arm, with a Chi2 of 101.10 and I2 value = 92%. However, studies were heterogenous with different outcome measures and many showed evidence of bias. The included studies consistently indicated that pharmacy services based within acute or emergency medicine departments in hospitals were associated with fewer medication errors. Further studies are needed to understand the health and economic impact of deploying a pharmacy service in acute medical settings including out-of-hours working.
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Sustainable medicines use in clinical practice: a clinical pharmacological view on eco-pharmaco-stewardship.Climate change continues to pose a dangerous threat to human health. However, not only is health impacted by this crisis, healthcare itself adds to the problem, through significant contributions to greenhouse gas emissions. In the UK, the National Health Service (NHS) is responsible for an estimated 4% of the overall national carbon footprint. Medicines account for a quarter of this and whilst they are vital for health now, through sustainable use they can also positively influence the environmental health of the future. In this review, we explore how clinical pharmacologists and other health care professionals can practice sustainable medicines use or eco-pharmaco-stewardship. We will discuss current and near future environmental practices within the NHS, which we suspect will resonate with other health systems. We will suggest approaches for championing eco-pharmaco-stewardship in drug manufacturing, clinical practice and patient use, to achieve a more a sustainable healthcare system.
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Systematic review of room temperature stability of key beta-lactam antibiotics for extended infusions in inpatient settings.Background: Extended infusion (EI) of beta-lactam antibiotics may offer clinical benefits aligned with improved probability of target attainment for critical pharmacokinetic/pharmacodynamic parameters that correlate with efficacy. There is much research interest in prolonged and continuous infusions (collectively, extended infusions) of beta-lactams to improve patient outcomes, particularly in critically ill patients in intensive care. While definitive clinical trial data demonstrating beneficial outcomes is awaited, there has been limited focus on the stability of the agents given by EI, which may be an equally critical parameter. EI may allow for savings in nursing time due to reduced need for drug reconstitution. We set out to examine the data for stability for EI at room temperature, consistent with the requirements of 'A Standard Protocol for Deriving and Assessment of Stability- Part 1 Aseptic Preparation (Small Molecules)', which allows a 5% loss of active pharmaceutical ingredient (API) applicable for those territories that use the British Pharmacopoeia also for a 10% loss applicable in much of rest of the world. Methods: Searches using preferred reporting items for systematic reviews and meta-analyses (PRISMA) principles for stability data on freshly prepared beta-lactam antimicrobials for extended administration at room temperature (at or above 23°C) were conducted in November 2021 and updated in December 2022. Results: We found data to support the extension of the shelf life of 12 key beta-lactam antibiotics once reconstituted (aztreonam, amoxicillin, benzylpenicillin, flucloxacillin, piperacillin/tazobactam, cefazolin, cefmetazole, ceftaroline, ceftazidime, ceftriaxone, imipenem and meropenem) compliant with the NHS protocol, and data for five other agents (ticarcillin, cefepime, cefiderocol, cefoxitin and doripenem) which would be acceptable in regions outside the UK beyond that listed in the Summary of Product Characteristics. This review has not been registered under PROSPERO.
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Recommendations for setting a criterion and assessing commutability of sample materials used in external quality assessment/proficiency testing schemes.It is important for external quality assessment materials (EQAMs) to be commutable with clinical samples; i.e., they should behave like clinical samples when measured using end-user clinical laboratory in vitro diagnostic medical devices (IVD-MDs). Using commutable EQAMs makes it possible to evaluate metrological traceability and/or equivalence of results between IVD-MDs. The criterion for assessing commutability of an EQAM between 2 IVD-MDs is that its result should be within the prediction interval limits based on the statistical distribution of the clinical sample results from the 2 IVD-MDs being compared. The width of the prediction interval is, among other things, dependent on the analytical performance characteristics of the IVD-MDs. A presupposition for using this criterion is that the differences in nonselectivity between the 2 IVD-MDs being compared are acceptable. An acceptable difference in nonselectivity should be small relative to the analytical performance specifications used in the external quality assessment scheme. The acceptable difference in nonselectivity is used to modify the prediction interval criterion for commutability assessment. The present report provides recommendations on how to establish a criterion for acceptable commutability for EQAMS, establish the difference in nonselectivity that can be accepted between IVD-MDs, and perform a commutability assessment. The report also contains examples for performing a commutability assessment of EQAMs.
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Prevalence, contributing factors, and interventions to reduce medication errors in outpatient and ambulatory settings: a systematic reviewBackground: Medication errors are common events that compromise patient safety. Outpatient and ambulatory settings enhance access to healthcare which has been linked to favorable outcomes. While medication errors have been extensively researched in inpatient settings, there is dearth of literature from outpatient settings. Aim: To synthesize the peer-reviewed literature on the prevalence, nature, contributory factors, and interventions to minimize medication errors in outpatient and ambulatory settings. Method: A systematic review was conducted using Medline, Embase, CINAHL, and Google Scholar which were searched from 2011 to November 2021. Quality assessment was conducted using the quality assessment checklist for prevalence studies tool. Data related to contributory factors were synthesized according to Reason's accident causation model. Results: Twenty-four articles were included in the review. Medication errors were common in outpatient and ambulatory settings (23-92% of prescribed drugs). Prescribing errors were the most common type of errors reported (up to 91% of the prescribed drugs, high variations in the data), with dosing errors being most prevalent (up to 41% of the prescribed drugs). Latent conditions, largely due to inadequate knowledge, were common contributory factors followed by active failures. The seven studies that discussed interventions were of poor quality and none used a randomized design. Conclusion: Medication errors (particularly prescribing errors and dosing errors) in outpatient settings are prevalent, although reported prevalence range is wide. Future research should be informed by behavioral theories and should use high quality designs. These interventions should encompass system-level strategies, multidisciplinary collaborations, effective integration of pharmacists, health information technology, and educational programs.
