Impact of a Pharmacy-Cardiology Collaborative Practice on Dofetilide Safety Monitoring

Quffa, Lieth H.; Panna, Mark; Kaufmann, Michael; McKillop, Matthew; Dietrich, Nicole Maltese; Franck, Andrew J.

doi:10.1177/1060028016669962

Cited by 6 publications

(4 citation statements)

References 10 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…For example, the RMMs developed in the US by the Veterans Administration for dofetilide, an anti-arrhythmic agent, featured a multi-disciplinary collaboration that resulted in a deep understanding of the clinical context of use. The results of this consultation yielded a programme that integrated successfully into the health care system, was accepted by the end users and led to improved patient outcomes [47].…”

Section: Designing Rmms That Promote Desired Behavioural Changes and mentioning

confidence: 99%

Risk Management for the 21st Century: Current Status and Future Needs

Mouchantaf

Auth²,

Moride

et al. 2021

Drug Saf

View full text Add to dashboard Cite

Global adoption of risk management principles outlined in the International Conference on Harmonisation (ICH) E2E guideline and the Council for International Organizations of Medical Sciences (CIOMS) Working Group VI guidance introduced greater proactivity and consistency into the practice of pharmacovigilance and benefit-risk management throughout the lifecycle of a drug. However, following the release of these guidelines there have been important advances in the science and practice of risk minimisation itself, especially in terms of how risk minimisation measures (RMMs) are designed, implemented, disseminated and evaluated for effectiveness in real-world healthcare settings. In this article, we describe how the field of design, implementation, dissemination and evaluation of RMMs has advanced in recent years while highlighting current areas of challenge and possible solutions. Where possible we cite global examples to demonstrate how evidencebased approaches have informed the development of RMMs. In this context, while taking into consideration local healthcare system policies and national legislations, we conclude with a call for a global effort to harmonise certain areas that focus on, but are not limited to, standardising certain terms and definitions, consistent application of robust methodologies, and outline of best practices for risk minimisation design, implementation, and dissemination.

show abstract

Section: Designing Rmms That Promote Desired Behavioural Changes and mentioning

confidence: 99%

Risk Management for the 21st Century: Current Status and Future Needs

Mouchantaf

Auth²,

Moride

et al. 2021

Drug Saf

View full text Add to dashboard Cite

show abstract

“…In addition, although this study addressed compliance to a dofetilide program, the primary focus was on longitudinal monitoring of any patient on dofetilide and not specifically on the patients being initiated as an inpatient. 19…”

Section: Discussionmentioning

confidence: 99%

“…To our knowledge, there are only 4 reports of pharmacist-managed dofetilide initiation programs in the literature. 6,12,17,19 Two reports described dofetilide protocols that were created before the removal of the FDA REMS program, which had governed the use of dofetilide until 2016, and none of the studies evaluated adherence to their inpatient protocols or difference in adherence rates after a modification. 6,12,17, 19…”

Section: Introductionmentioning

confidence: 99%

Pharmacist-Managed Inpatient Dofetilide Initiation Program: Description and Adherence Rate Post-Root Cause Analysis

Carpenter

Gagnon

et al. 2019

Journal of Pharmacy Practice

View full text Add to dashboard Cite

The aim of this article is to describe the pharmacist-managed dofetilide initiation program at Maine Medical Center (MMC), assess the adherence rate to 8 core clinical metrics, and review adverse effects before and after a root cause analysis (RCA). Core clinical metrics included pharmacist note entered within 4 hours of dose administration, dose chosen correctly per renal function, QTc measurements obtained and reviewed 2 hours after each dose, appropriate dose adjustment per the most recent QTc measurement, documentation of patient education, and assessment of conduction abnormality, drug–drug interactions, and serum potassium and magnesium concentrations. The primary outcome was adherence rate to all 8 core clinical metrics before and after the RCA. The safety outcome was the total number of adverse events. One hundred patients undergoing elective dofetilide initiation were evaluated: 50 pre-RCA and 50 post-RCA. Adherence rate to all core metrics was 14% in the pre-RCA group and 44% in the post-RCA group ( P < .001). Torsade de pointes occurred 3 times in the pre-RCA group and never in the post-RCA group. After the RCA, adherence to MMC’s pharmacist-managed inpatient dofetilide initiation program significantly improved.

show abstract

“…This program was originally created to increase compliance with the United States Food and Drug Administration's risk evaluation and mitigation strategy (REMS) program for dofetilide . Results from our health‐system's pharmacist‐directed ambulatory care dofetilide monitoring have been previously reported, and the REMS program for dofetilide has since been eliminated . However, our success with dofetilide led to the expansion of the pharmacy‐cardiology AAD management program to include sotalol and amiodarone.…”

Section: Introductionmentioning

confidence: 99%

Impact of a pharmacy‐cardiology collaborative management program during initiation of antiarrhythmic drugs

Kibert

Franck

Dietrich

et al. 2019

J Am Coll Clin Pharm

Self Cite

View full text Add to dashboard Cite

Objective Antiarrhythmic drugs (AADs) are commonly used for management of atrial fibrillation and other cardiac arrhythmias. However, the use of AADs in clinical practice is challenging due to the risk of serious adverse drug events associated with these medications. Adherence to recommended monitoring parameters may improve safety in these agents. The primary objective of this study was to determine the effectiveness of a pharmacy‐cardiology collaborative approach to AAD management. Methods This retrospective cohort study was conducted to assess AAD management with a pharmacy‐cardiology collaborative program compared with usual care in a United States Department of Veterans Affairs (VA) medical center. Results Ninety patients were included for evaluation; 40 in the preintervention group and 50 in the postintervention group. Complete recommended baseline monitoring parameters were obtained for 29 patients (72.5%) in the preintervention group and 47 patients (94%) in the postintervention group (P < .01). There were significantly more clinical interventions (P < .01) in the postintervention group, including AAD dose adjustment or discontinuation, interacting medication dose adjustment or discontinuation, electrolyte supplementation, monitoring ordered, and total interventions. Conclusion The study results demonstrate a statistically significant improvement in adherence to recommended baseline monitoring parameters with a greater number of clinical interventions when a pharmacy‐cardiology collaborative AAD management program was involved compared with usual care. The increased interventions and improved adherence to monitoring parameters may allow for safer use of these agents.

show abstract

Impact of a Pharmacy-Cardiology Collaborative Practice on Dofetilide Safety Monitoring

Cited by 6 publications

References 10 publications

Risk Management for the 21st Century: Current Status and Future Needs

Risk Management for the 21st Century: Current Status and Future Needs

Pharmacist-Managed Inpatient Dofetilide Initiation Program: Description and Adherence Rate Post-Root Cause Analysis

Impact of a pharmacy‐cardiology collaborative management program during initiation of antiarrhythmic drugs

Contact Info

Product

Resources

About