Exploring the Prescribing Process of Domperidone for Low Milk Supply:A Qualitative Study Among Mothers, IBCLCs, and Family Doctors

BACKGROUND: When mothers are confronted with milk supply problems, taking domperidone is regularly suggested. However, domperidone has been associated with sudden cardiac death and caution in prescribing is advised. In 2016, a multidisciplinary group of authors from a tertiary academic hospital (Erasmus MC) published a clinical protocol in a leading Dutch physicians’ journal to support Dutch family physicians in prescribing domperidone to stimulate lactation. RESEARCH AIM: To explore consumer and health care provider perspectives and experiences regarding the prescribing of domperidone for lactation insufficiency following publication of a national clinical protocol. METHODS: A cross-sectional qualitative study was performed using semi-structured interviews (N = 40) based on a topic list covering the prescribing process. Participants were mothers (n = 18) who had been advised to try domperidone to boost their milk supply between November 2016 and May 2018, their International Board Certified Lactation Consultants (n = 9), and their family physicians (n = 15). Another group of participants (mothers; n = 6) answered short questionnaires. All interviews were recorded, transcribed and analyzed using ATLAS.ti software. The resulting list of codes was organized according to the topics. RESULTS: In the process leading to domperidone use to stimulate lactation, participant family physicians relied on the IBCLC, pharmacist, or mother to guide the prescription of domperidone, often citing the published national clinical protocol as back up. The medical safeguards incorporated in the protocol (e.g., taking medical history, physical exam, performing electrocardiograms, limiting dosage) were usually not implemented. CONCLUSIONS: Though the availability of a national clinical protocol in which the prescribing of domperidone for lactation is supported appeared to increase the willingness of participant family physicians to prescribe, gaps were identified between clinical practice and this clinical protocol for prescribing domperidone

Development and validation of a tool to assess the risk of QT drug-drug interactions in clinical practice

Background The exact risk of developing QTc-prolongation when using a combination of QTc-prolonging drugs is still unknown, making it difficult to interpret these QT drug-drug interactions (QT-DDIs). A tool to identify high-risk patients is needed to support healthcare providers in handling automatically generated alerts in clinical practice. The main aim of this study was to develop and validate a tool to assess the risk of QT-DDIs in clinical practice. Methods A model was developed based on risk factors associated with QTc-prolongation determined in a prospective study on QT-DDIs in a university medical center inthe Netherlands. The main outcome measure was QTc-prolongation defined as a QTc interval > 450 ms for males and > 470 ms for females. Risk points were assigned to risk factors based on their odds ratios. Additional risk factors were added based on a literature review. The ability of the model to predict QTc-prolongation was validated in an independent dataset obtained from a general teaching hospital against QTc-prolongation as measured by an ECG as the gold standard. Sensitivities, specificities, false omission rates, accuracy and Youden's index were calculated. Results The model included age, gender, cardiac comorbidities, hypertension, diabetes mellitus, renal function, potassium levels, loop diuretics, and QTc-prolonging drugs as risk factors. Application of the model to the independent dataset resulted in an area under the ROC-curve of 0.54 (95% CI 0.51-0.56) when QTc-prolongation was defined as > 450/470 ms, and 0.59 (0.54-0.63) when QTc-prolongation was defined as > 500 ms. A cut-off value of 6 led to a sensitivity of 76.6 and 83.9% and a specificity of 28.5 and 27.5% respectively. Conclusions A clinical decision support tool with fair performance characteristics was developed. Optimization of this tool may aid in assessing the risk associated with QT-DDIs.Clinical Pharmacy and Toxicolog

Medication-Related Hospital Readmissions Within 30 Days of Discharge:Prevalence, Preventability, Type of Medication Errors and Risk Factors

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Prevalence and determinants of intravenous admixture preparation errors:A prospective observational study in a university hospital

Background Intravenous admixture preparation errors (IAPEs) may lead to patient harm. Insight into the prevalence as well as the determinants associated with these IAPEs is needed to elicit preventive measures. Aim The primary aim of this study was to assess the prevalence of IAPEs. Secondary aims were to identify the type, severity, and determinants of IAPEs. Method A prospective observational study was performed in a Dutch university hospital. IAPE data were collected by disguised observation. The primary outcome was the proportion of admixtures with one or more IAPEs. Descriptive statistics were used for the prevalence, type, and severity of IAPEs. Mixed-effects logistic regression analyses were used to estimate the determinants of IAPEs. Results A total of 533 IAPEs occurred in 367 of 614 admixtures (59.8%) prepared by nursing staff. The most prevalent errors were wrong preparation technique (n = 257) and wrong volume of infusion fluid (n = 107). Fifty-nine IAPEs (11.1%) were potentially harmful. The following variables were associated with IAPEs: multistep versus single-step preparations (adjusted odds ratio [OR(adj)] 4.08, 95% confidence interval [CI] 2.27–7.35); interruption versus no interruption (OR(adj) 2.32, CI 1.13–4.74); weekend versus weekdays (OR(adj) 2.12, CI 1.14–3.95); time window 2 p.m.-6 p.m. versus 7 a.m.-10 a.m. (OR(adj) 3.38, CI 1.60–7.15); and paediatric versus adult wards (OR(adj) 0.14, CI 0.06–0.37). Conclusion IAPEs, including harmful IAPEs, occurred frequently. The determinants associated with IAPEs point to factors associated with preparation complexity and working conditions. Strategies to reduce the occurrence of IAPEs and therefore patient harm should target the identified determinants

Guidelines for mono, double and triple antithrombotic therapy

Guidelines for antithrombotic therapy are complex, especially if a patient has several indications that require antithrombotic therapy. In general, no patient should receive lifelong double or triple antithrombotic therapy. In this overview, we outline the most common indications for mono, double and triple antithrombotic therapy; the preferred antithrombotic therapy and the recommended duration of therapy. Both antiplatelet therapy and therapeutic anticoagulation therapy with vitamin K antagonists or direct oral anticoagulants were included. European guidelines were used or, if no European guidelines were available, the Dutch guidelines were used

Comparison of two algorithms to support medication surveillance for drug-drug interactions between QTc-prolonging drugs

Background: QTc-prolongation is an independent risk factor for developing life-threatening arrhythmias. Risk management of drug-induced QTc-prolongation is complex and digital support tools could be of assistance. Bindraban et al. and Berger et al. developed two algorithms to identify patients at risk for QTc-prolongation. Objective: The main aim of this study was to compare the performances of these algorithms for managing QTcprolonging drug-drug interactions (QT-DDIs). Materials and Methods: A retrospective data analysis was performed. A dataset was created from QT-DDI alerts generated for inand outpatients at a general teaching hospital between November 2016 and March 2018. ECGs recorded within 7 days of the QT-DDI alert were collected. Main outcomes were the performance characteristics of both algorithms. QTc-intervals of > 500 ms on the first ECG after the alert were taken as outcome parameter, to which the performances were compared. Secondary outcome was the distribution of risk scores in the study cohort. Results: In total, 10,870 QT-DDI alerts of 4987 patients were included. ECGs were recorded in 26.2 % of the QT-DDI alerts. Application of the algorithms resulted in area under the ROC-curves of 0.81 (95 % CI 0.79-0.84) for Bindraban et al. and 0.73 (0.70-0.75) for Berger et al. Cut-off values of >= 3 and >= 6 led to sensitivities of 85.7 % and 89.1 %, and specificities of 60.8 % and 44.3 % respectively. Conclusions: Both algorithms showed good discriminative abilities to identify patients at risk for QTcprolongation when using >= 2 QTc-prolonging drugs. Implementation of digital algorithms in clinical decision support systems could support the risk management of QT-DDIs

Drug-drug interactions with metronidazole and itraconazole in patients using acenocoumarol

PURPOSE: Various population-based cohort studies have shown that antimicrobial agents increase the risk of overanticoagulation in patients using coumarins. In this study, we assessed this association in hospitalized patients. METHODS: We included all patients hospitalized in the Spaarne Gasthuis (Haarlem/Hoofddorp, the Netherlands), who started using an antimicrobial agent during acenocoumarol treatment or vice versa between 1 January 2015 and 1 July 2019. Patients were followed from start of concomitant therapy until 48 h after termination of the concomitant therapy or discharge, whichever came first. We analyzed the association between the antimicrobial agents and the risk of overanticoagulation, defined as an interpolated INR above 6, using Cox regression analysis. We corrected for multiple testing with the Bonferroni correction. Patients who started using acenocoumarol and amoxicillin/clavulanic acid were used as reference group. RESULTS: In the study population, sixteen antimicrobial agents were started frequently concomitantly with acenocoumarol treatment. We included 2157 interaction episodes in 1172 patients. Patients who started using the combination of co-trimoxazole (HR 3.76; 95% CI 1.47-9.62; p = 0.006), metronidazole (HR 2.55; 95% CI 1.37-4.76; p = 0.003), or itraconazole (HR 4.11; 95% CI 1.79-9.45; p = 0.001) concomitantly with acenocoumarol treatment had an increased risk of overanticoagulation compared with patients using acenocoumarol and amoxicillin/clavulanic acid concomitantly. The associations for metronidazole (p = 0.045) and itraconazole (p = 0.015) remained statistically significant after correction for multiple testing. CONCLUSION: Co-trimoxazole, metronidazole, and itraconazole increase the risk of overanticoagulation in patients using acenocoumarol. These combinations should be avoided if possible or otherwise acenocoumarol doses should be reduced and INR measured more frequently

Implementation of a pharmacist-led transitional pharmaceutical care programme:Process evaluation of Medication Actions to Reduce hospital admissions through a collaboration between Community and Hospital pharmacists (MARCH)

What is known and objective: The recently conducted Medication Actions to Reduce hospital admissions through a collaboration between Community and Hospital pharmacists (MARCH) transitional care programme, which aimed to test the effectiveness of a transitional care programme on the occurrence of ADEs post-discharge, did not show a significant effect. To clarify whether this non-significant effect was due to poor implementation or due to ineffectiveness of the intervention as such, a process evaluation was conducted. The aim of the study was to gain more insight into the implementation fidelity of MARCH. Methods: A mixed methods design and the modified Conceptual Framework for Implementation Fidelity was used. For evaluation, the implementation fidelity and moderating factors of four key MARCH intervention components (teach-back, the pharmaceutical discharge letter, the post-discharge home-visit and the transitional medication review) were assessed. Quantitative data were collected during and after the intervention. Qualitative data were collected using semi-structured interviews with MARCH healthcare professionals (community pharmacists, clinical pharmacists, pharmacy assistants and pharmaceutical consultants) and analysed using thematic analysis. Results and Discussion: Not all key intervention components were implemented as intended. Teach-back was not always performed. Moreover, 63% of the pharmaceutical discharge letters, 35% of the post-discharge home-visits and 44% of the transitional medication reviews were not conducted within their planned time frames. Training sessions, structured manuals and protocols with detailed descriptions facilitated implementation. Intervention complexity, time constraints and the multidisciplinary coordination were identified as barriers for the implementation. What is new and Conclusion: Overall, the implementation fidelity was considered to be moderate. Not all key intervention components were carried out as planned. Therefore, the non-significant results of the MARCH programme on ADEs may at least partly be explained by poor implementation of the programme. To successfully implement transitional care programmes, healthcare professionals require full integration of these programmes in the standard work-flow including IT improvements as well as compensation for the time investment

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

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

Physicians' acceptance of pharmacists' interventions in daily hospital practice

Background The physicians' acceptance rate of pharmacists' interventions to improve pharmacotherapy can vary depending on the setting. The acceptance rate of interventions proposed by pharmacists located in the hospital pharmacy over the telephone and factors associated with acceptance are largely unknown. Objective To determine the physicians' acceptance rate of pharmacists' interventions proposed over the telephone in daily hospital practice and to identify factors associated with acceptance. Setting A retrospective case-control study was performed concerning adult patients admitted to a university hospital in the Netherlands. Method Pharmacists' interventions, based on alerts for drug-drug interactions and drug dosing in patients with renal impairment, recorded between January 2012 and June 2013 that were communicated over the telephone were included. Factors associated with physicians' acceptance were identified with the use of a mixed-effects logistic model. Main outcome measure The primary outcome was the proportion of accepted interventions. Results A total of 841 interventions were included. Physicians accepted 599 interventions, resulting in an acceptance rate of 71.2%. The mixed-effects logistic model showed that acceptance was significantly associated with the number of prescribed drugs (16 to ≤ 20 drugs ORadj 1.88; 95% CI 1.05-3.35, > 20 drugs ORadj 2.90; 95% CI 1.41-5.96, compared to ≤ 10 drugs) and the severity of the drug-related problem (problem without potential harm ORadj 6.36; 95% CI 1.89-21.38; problem with potential harm OR 6.78; 95% CI 2.09-21.99, compared to clinically irrelevant problems), and inversely associated with continuation of pre-admission treatment (ORadj 0.55; 95% CI 0.35-0.87). Conclusion Over the study period, the majority of pharmacists' interventions proposed over the telephone were accepted by physicians. The probability for acceptance increased for patients with an increasing number of medication orders, for clinically relevant problems and for problems related to treatment initiated during admission