Media attention regarding sudden cardiac death associated with domperidone use does not affect in hospital <scp>ECG</scp> recording

Berger, F.; Saâïd, Selma; Gelder, Teun van; Stricker, Bruno H.; Becker, Matthijs L.; Bemt, Patricia M. L. A. van den

doi:10.1002/pds.4321

Cited by 8 publications

(6 citation statements)

References 22 publications

(38 reference statements)

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“…Since July 2014, based on further evidence, dispensing domperidone in the Netherlands has required a prescription by a physician (College ter Beoordeling van Geneesmiddelen [Medicines Evaluation Board], 2014; Pharmacovigilance Risk Assessment Committee, 2014). As a result of both changing regulations and news coverage concerning domperidone, Dutch physicians, since, have been prescribing domperidone less often (Berger et al, 2017).…”

Section: Key Messagesmentioning

confidence: 99%

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

2020

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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.

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Section: Key Messagesmentioning

confidence: 99%

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

2020

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“…As a result, first-line treatments are frequently not adhered to when one of the interacting agents is substituted, especially in primary care where ECG monitoring is often not feasible. In tertiary care, low adherence to guidelines result in many overridden DDI alerts by physicians [18]; and ECG monitoring is rarely performed when QT-DDI alerts are overridden [19,20]. With the increasing number of QTc-prolonging drugs, QT-DDI alerts will reduce the physician responsiveness to this particular type of alert, also known as alert fatigue.…”

Section: Introductionmentioning

confidence: 99%

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

Berger

Sijs

Becker

et al. 2020

BMC Med Inform Decis Mak

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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 cutoff 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.

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“…Despite this, ECG QT interval measurements are not routinely performed in the clinic. One European study suggested that despite the media attention regarding domperidone-induced deaths, the rate of ECG measurements has not significantly changed and only 10% of patients prescribed domperidone receive ECG tests [34]. However, in our study, the rate of ECG monitoring in patients prescribed domperidone increased from 2011 to 2016.…”

Section: Discussionmentioning

confidence: 54%

Impact of Safety Warning on Domperidone Prescribing for Geriatric Patients in South Korea: Analysis of National Insurance Claim Data

Rhew

Han

2019

IJERPH

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Domperidone is a dopamine antagonist used for the symptomatic management of nausea and vomiting. Many countries banned or add a black box warning due to an increased risk of serious adverse cardiac effects. In 2014, the Korea Ministry of Food and Drug Safety also released a safety warning to carefully consider adverse cardiac effects when prescribing domperidone. Therefore, we conducted this study to analyze the impact of the safety warning on domperidone prescribing. This study included patients 65 years or older who used national health insurance services in the years 2011 and 2016, using the national patient sample dataset in South Korea. We analyzed the characteristics of domperidone prescribing and compared on pre- and post-safety warning. Prescribing frequency of domperidone was significantly reduced from 603,962 cases in 2011 to 24,623 cases in 2016. In 2011, 53,272 (8.8%) prescriptions were for greater than 30 mg/day, whereas only 200 (0.8%) prescriptions were in 2016. The number of patients with one or more comorbidities and electrocardiogram monitoring showed positive changes after the safety warning. In conclusion, after the 2014 safety letter was issued, domperidone was more safely prescribed in various aspects in elderly patients, including frequency of prescribing, maximum daily dose, and duration of continuous prescription.

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Media attention regarding sudden cardiac death associated with domperidone use does not affect in hospital ECG recording

Abstract: No effect of the media hype was found on the intensity of ECG monitoring in domperidone users. In the university medical centre, domperidone prescriptions were reduced.

Cited by 8 publications

References 22 publications

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

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

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

Impact of Safety Warning on Domperidone Prescribing for Geriatric Patients in South Korea: Analysis of National Insurance Claim Data

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