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

2016 ◽  
Vol 51 (1) ◽  
pp. 39-43 ◽  
Author(s):  
Lieth H. Quffa ◽  
Mark Panna ◽  
Michael R. Kaufmann ◽  
Matthew McKillop ◽  
Nicole Maltese Dietrich ◽  
...  
Keyword(s):  
Risk Evaluation ◽  
Primary Outcome ◽  
Serum Magnesium ◽  
Intervention Group ◽  
Monitoring Program ◽  
Safety Monitoring ◽  
Mitigation Strategy ◽  
Collaborative Practice ◽  
Monitoring Methods ◽  
The Impact

Background: Limited studies have been published examining dofetilide’s postmarketing use and its recommended monitoring. Objective: To evaluate the impact of a collaborative pharmacy-cardiology antiarrhythmic drug (AAD) monitoring program on dofetilide monitoring. Methods: This retrospective cohort study was performed to assess if a novel monitoring program improved compliance with dofetilide-specific monitoring parameters based on the Food and Drug Administration’s Risk Evaluation and Mitigation Strategy. Results: A total of 30 patients were included in the analysis. The monitoring parameters evaluated included electrocardiogram, serum potassium, serum magnesium, and kidney function. The primary outcome evaluated was the composite of these dofetilide monitoring parameters obtained in each cohort. In the standard cohort, 245 of 352 (69.6%) monitoring parameters were completed versus 134 of 136 (98.5%) in the intervention group ( P < 0.05). Conclusion: A collaborative pharmacy-cardiology AAD monitoring program was associated with a significant improvement in dofetilide monitoring. This improvement could potentially translate into enhanced patient safety outcomes, such as prevention of adverse drug reactions and decreased hospitalizations.

Pharmacist-Led Transition of Care Pilot Targeting Older People After Emergency Department Discharge

2020 ◽  
Vol 35 (6) ◽  
pp. 273-282
Author(s):  
Scott M. Pearson ◽  
Anushka Tandon ◽  
Danielle R. Fixen ◽  
Sunny A. Linnebur ◽  
Gretchen M. Orosz ◽  
...  
Keyword(s):  
Emergency Department ◽  
Older People ◽  
Primary Outcome ◽  
Transitional Care ◽  
Intervention Group ◽  
Chronic Obstructive ◽  
P Value ◽  
Historical Cohort ◽  
Obstructive Pulmonary Disease ◽  
The Impact

OBJECTIVE: To evaluate the impact of a pharmacist-led transitional care intervention targeting high-risk older people after an emergency department (ED) visit.<br/> DESIGN: Retrospective cohort study of older people with ED visits prior to and during a pharmacist-led intervention.<br/> SETTING: Patients receiving primary care from the University of Colorado Health Seniors Clinic.<br/> PARTICIPANTS: The intervention cohort comprised 170 patients with an ED visit between August 18, 2018, and February 19, 2019, and the historical cohort included 166 patients with an ED visit between August 18, 2017, and February 19, 2018. All included patients either had a historical diagnosis of heart failure or chronic obstructive pulmonary disease, or they had an additional ED visit in the previous six months.<br/> INTERVENTIONS: The pilot intervention involved postED discharge telephonic outreach and assessment by a clinical pharmacist, with triaging to other staff if necessary.<br/> MAIN OUTCOME MEASURE: The primary outcome was the proportion of patients with at least one repeat ED visit, hospitalization, or death within 30 days of ED discharge. Outcome rates were also assessed at 90 days postdischarge.<br/> RESULTS: The primary outcome occurred in 21% of the historical cohort and 25% of the intervention cohort (adjusted P-value = 0.48). The incidence of the composite outcome within 90 days of ED discharge was 43% in the historical group compared with 38% in the intervention group (adjusted P-value = 0.29).<br/> CONCLUSION: A pharmacist-led telephonic intervention pilot targeting older people did not appear to have a significant effect on the composite of repeat ED visit, hospitalization, or death within 30 or 90 days of ED discharge. A limited sample size may hinder the ability to make definitive conclusions based on these findings.

Program for the use of antipsychotics with metabolic monitoring in North Carolina medicaid children

2017 ◽  
Vol 41 (S1) ◽  
pp. S343-S343
Author(s):  
S. Wegner ◽  
J. McKee ◽  
T. Trygstad ◽  
L. Wegner ◽  
A. Stiles
Keyword(s):  
Insurance Coverage ◽  
Safety Data ◽  
Monitoring Program ◽  
Safety Monitoring ◽  
Point Of Sale ◽  
Clinical Endpoints ◽  
Metabolic Monitoring ◽  
Before And After ◽  
Competing Interest ◽  
The Impact

IntroductionChildren are at greater risk than adults for weight gain and metabolic disorders including hyperlipidemia and diabetes with newer antipsychotics. A web-based safety-monitoring program using a prior documentation model required submission of patient safety data (prior documentation) for insurance coverage at the pharmacy point of sale. This program launched in April of 2011, covering all NC Medicaid and Health Choice recipients under age 18. Clinical monitoring parameters and interactive educational features were developed with pediatric psychiatric experts and key mental health stakeholder groups.ObjectivesUsing a four-year run in period and a full 9 months of post implementation claims data, evaluate the rates of antipsychotic prescribing and safety monitoring before and after the implementation of the A + KIDS program.ResultsImplementation of this program was associated with a consistent monthly decrease in overall antipsychotic use and increases in patient monitoring of glucose and lipid (Figure. 1, Table 1).ConclusionsThe prior documentation registry was effective in decreasing antipsychotic use and increasing safety monitoring. The impact of changing to more traditional prior authorization on the same clinical endpoints is currently under evaluation.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Effect of a High Value Care Curriculum on Standardized Patient Exam in the Core Clerkship in Internal Medicine

2020 ◽  
Author(s):  
Amit K Pahwa ◽  
Kevin Eaton ◽  
Ariella Apfel ◽  
Amanda Bertram ◽  
Rebecca Ridell ◽  
...  
Keyword(s):  
Internal Medicine ◽  
Medical Students ◽  
Primary Outcome ◽  
Intervention Group ◽  
Virtual Patients ◽  
The Core ◽  
Standard Curriculum ◽  
And Control ◽  
The Impact ◽  
Core Clerkship

Abstract Background: While there are increasing curricula on high value care, little is published on the effectiveness of curricula on medical students’ ability to practice high value care.Methods: In addition to the standard curriculum, the intervention group received two classroom sessions and three virtual patients focused on the concepts of high value care. The primary outcome was number of tests and charges for tests on standardized patients.Results: One hundred forty-one students enrolled in the Core Clerkship in Internal Medicine and 69 completed the high value care curriculum. There were no significant differences in ordering of appropriate tests (3.1 vs. 3.2 tests/students, p = 0.55) and inappropriate tests (1.8 vs. 2.2, p = 0.13) between the intervention and control. Students in the intervention group had significantly lower median Medicare charges ($287.59 vs. $500.86, p = 0.04) and felt their education in high value care was appropriate (81% vs. 56%, p = 0.02).Conclusions: This is the first study to describe the impact of a high value care curriculum on medical students’ ordering practices. While number of inappropriate tests were not significantly different, students in the intervention group refrained from ordering expensive tests.

A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs

Drug Safety ◽  
2021 ◽  
Author(s):  
Ameet Sarpatwari ◽  
Mayookha Mitra-Majumdar ◽  
Katsiaryna Bykov ◽  
Jerry Avorn ◽  
Steven Woloshin ◽  
...  
Keyword(s):  
Risk Evaluation ◽  
Mitigation Strategy ◽  
Modal Approach ◽  
The Impact

Clinical and Procedural Evaluation of a Pharmacy Pharmacokinetic Consult Service

2019 ◽  
Vol 33 (5) ◽  
pp. 618-627 ◽  
Author(s):  
Tyler Chanas ◽  
Rebecca Hockman ◽  
Terran Rice ◽  
Heather Cox-Hall ◽  
Stephanie Mallow-Corbett ◽  
...  
Keyword(s):  
Intervention Group ◽  
Monitoring Program ◽  
Medication Administration ◽  
Therapeutic Drug ◽  
Antibiotic Administration ◽  
Consult Service ◽  
Drug Concentrations ◽  
Medical Intensive Care ◽  
Procedural Evaluation ◽  
The Impact

Purpose: Though previous studies have shown benefit with pharmacist-managed dosing of antibiotics, many institutions still do not offer such services. Our objective was to determine and report novel outcomes associated with the implementation of a pharmacist-managed pharmacokinetic/pharmacodynamic consult service and to assess the impact of direct pharmacist involvement in therapeutic drug monitoring. Methods: Retrospective cohort study of patients who received vancomycin or an aminoglycoside in the medical intensive care unit from January 5, 2013, to January 6, 2015, divided into 2 groups: before/after implementation of the consult service on January 6, 2014. Results: Nine-hundred sixty-two patients were included. Groups were similar at baseline. There were fewer critical values after implementation of the consult service (40.8% vs 27.3%, P < .001). The intervention group had significantly more vancomycin troughs within therapeutic range (15.4% vs 32.8%, P = .019). Time from order entry to medication administration was shorter when pharmacists entered the medication order, although this difference was nonsignificant (103 minutes vs 77 minutes, P = .054). Conclusion: Implementation of a pharmacist-managed dosing and monitoring program led to significantly decreased rates of critical value drug concentrations and increased rates of therapeutic concentrations, with a 25% (NS) decreased time-to-antibiotic administration, therefore demonstrating the additive value of the pharmacist-managed over pharmacist-monitored approach.

scholarly journals Clozapine and hematologic adverse reactions: Impact of the Risk Evaluation and Mitigation Strategy program

2020 ◽  
Vol 10 (3) ◽  
pp. 70-75
Author(s):  
Eric P. Borrelli ◽  
Erica Y. Lee ◽  
Aisling R. Caffrey
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Risk Evaluation ◽  
Treatment Effectiveness ◽  
Adverse Event Reporting System ◽  
Fold Increase ◽  
Time Frame ◽  
Mitigation Strategy ◽  
Future Research ◽  
The Impact

Abstract Introduction In October 2015, the Food and Drug Administration (FDA) instituted an update to the mandatory Risk Evaluation and Mitigation Strategy (REMS) program for clozapine to improve safety monitoring of hematologic events. However, the impact of the clozapine REMS program on reporting of hematologic adverse events has not been quantified. Methods We assessed adverse event reports for agranulocytosis, granulocytopenia, leukopenia, and neutropenia from the FDA Adverse Event Reporting System (FAERS) for a 1-year time period before (October 2014 to September 2015, pre-REMS) and after (October 2015 to September 2016, post-REMS) the implementation of the clozapine REMS program. The AERSMine platform was used to capture historical effect estimates (October 2004 to September 2014). Reporting odds ratios (ROR), proportional reporting ratios (PRR), and corresponding Taylor series 95% confidence intervals (CIs) were calculated for hematologic events with clozapine compared with all other medications using OpenEpi. Results Reporting rates for agranulocytosis, granulocytopenia, leukopenia, and neutropenia with clozapine all increased from the pre-REMS to post-REMS time frames, ranging from a 2-fold increase with leukopenia to a 40-fold increase with neutropenia; the composite measure of all hematologic reports had a 12-fold increase. During the post-REMS time frame, the ROR increased by 1691% (111.4, 95% CI 100.6-123.4) compared with the pre-REMS time frame (7.1, 95% CI 5.2-9.6), and the PRR increased by 1280% (83.1, 95% CI 76.8-90.0 vs 6.9, 95% CI 5.1-9.4) for the composite outcome. Discussion We observed significant increases in reports of hematologic adverse events with clozapine after the introduction of the clozapine REMS program. Future research should explore the impact of the less stringent exclusionary and discontinuation criteria on utilization (eg, expanded access) and clinical outcomes (eg, treatment effectiveness and adverse events).

scholarly journals Pupillometry pain index decreases intraoperative sufentanyl administration in cardiac surgery: a prospective randomized study

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Vivien Berthoud ◽  
Maxime Nguyen ◽  
Anouck Appriou ◽  
Omar Ellouze ◽  
Mohamed Radhouani ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cardiac Surgery ◽  
Primary Outcome ◽  
Randomized Study ◽  
Intervention Group ◽  
Prospective Randomized Study ◽  
Control Group ◽  
Standard Group ◽  
Postoperative Course ◽  
The Impact

AbstractPupillometry has proven effective for the monitoring of intraoperative analgesia in non-cardiac surgery. We performed a prospective randomized study to evaluate the impact of an analgesia-guided pupillometry algorithm on the consumption of sufentanyl during cardiac surgery. Fifty patients were included prior to surgery. General anesthesia was standardized with propofol and target-controlled infusions of sufentanyl. The standard group consisted of sufentanyl target infusion left to the discretion of the anesthesiologist. The intervention group consisted of sufentanyl target infusion based on the pupillary pain index. The primary outcome was the total intraoperative sufentanyl dose. The total dose of sufentanyl was lower in the intervention group than in the control group and (55.8 µg [39.7–95.2] vs 83.9 µg [64.1–107.0], p = 0.04). During the postoperative course, the cumulative doses of morphine (mg) were not significantly different between groups (23 mg [15–53] vs 24 mg [17–46]; p = 0.95). We found no significant differences in chronic pain at 3 months between the 2 groups (0 (0%) vs 2 (9.5%) p = 0.49). Overall, the algorithm based on the pupillometry pain index decreased the dose of sufentanyl infused during cardiac surgery.Clinical trial number: NCT03864016.

scholarly journals Extended-Release and Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS):

2017 ◽  
Vol 103 (4) ◽  
pp. 7-16
Author(s):  
Daniel U. Rabin ◽  
Heather K. Tarbox ◽  
Lois Colburn ◽  
Kelly C. Alfred
Keyword(s):  
Health Care Providers ◽  
Risk Evaluation ◽  
Extended Release ◽  
Clinical Decision Making ◽  
Opioid Analgesics ◽  
The United States ◽  
Mitigation Strategy ◽  
Care Providers ◽  
Long Acting ◽  
The Impact

In response to the proliferation and abuse of opioids in the United States, the U.S. Food and Drug Administration (FDA) recently required manufacturers of extended-release and long-acting (ER/LA) opioid analgesics to provide education for prescribers of these medications through an FDA-approved risk management program. As a part of its Risk Evaluation and Mitigation Strategy (REMS), the FDA provided a blueprint for content to help accredited continuing medical education (CME) providers develop educational modules for prescribers. The University of Nebraska Medical Center (UNMC), the Federation of State Medical Boards (FSMB), the FSMB Foundation, The France Foundation, and CECity worked collaboratively to create “Extended-Release and Long-Acting Opioid Analgesics,” a prescriber education program aligned with the FDA blueprint, comprised of live meetings and web-based enduring activities that spanned April 2014 to February 2016. A total of 4,535 health care providers participated in the live and enduring REMS CME activities and completed evaluations of these activities. The evaluations were analyzed to learn more about the impact of the content on prescribers' knowledge and clinical decision-making. Results were similar for live and enduring activities. Participant-knowledge increased by 22 percentage points. Several competence measures suggest that learners returned to practice with more confidence, and 83% declared specific practice changes they planned to make to improve patient assessment and care. More than one-third of the evaluation respondents felt there were no barriers to making intended practice changes. More than 95% of the respondents said the activity increased their ability to apply knowledge, skills, and judgment in practice. Analysis suggests that live and enduring educational activities, following the FDA REMS blueprint, can impact prescriber attitudes and future care-decisions related to ER/LA opioid analgesics. These results justify additional efforts to involve more participants in these REM activities.

scholarly journals Effects of a Mobile and Web App (Thought Spot) on Mental Health Help-Seeking Among College and University Students: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
David Wiljer ◽  
Jenny Shi ◽  
Brian Lo ◽  
Marcos Sanches ◽  
Elisa Hollenberg ◽  
...  
Keyword(s):  
Mental Health ◽  
Usual Care ◽  
Help Seeking ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Postsecondary Students ◽  
Health And Wellness ◽  
Web App ◽  
The Impact

BACKGROUND Mental health disorders are the most prevalent health issues among postsecondary students, yet few solutions to this emerging crisis exist. While mobile health technologies are touted as promising solutions for the unmet mental health needs of these students, the efficacy of these tools remains unclear. In response to these gaps, this study evaluates Thought Spot, a mobile and web app created through participatory design research. OBJECTIVE The goal of the research is to examine the impact of Thought Spot on mental health and wellness help-seeking intentions, behaviors, attitudes, self-stigma, and self-efficacy among postsecondary students in Canada. METHODS A 2-armed randomized controlled trial involving students from three postsecondary institutions was conducted. Students were eligible if they were aged 17 to 29 years, enrolled in full-time or part-time studies, functionally competent in English, and had access to a compatible digital device. The usual care group received a mental health services information pamphlet. The intervention group received the Thought Spot app on their digital device. Thought Spot is a standalone app that allows users to add, review, and search crowdsourced information about nearby mental health and wellness services. Users can also track their mood on the app. Outcomes were self-assessed through questionnaires collected at baseline and 3 and 6 months. The primary outcome was change in formal help-seeking intentions from baseline to 6 months, measured by the General Help-Seeking Questionnaire. A mixed-effects model was used to compare the impact of usual care and intervention on the primary outcome (formal help-seeking intentions). Secondary outcomes included changes in informal help-seeking intentions and help-seeking behaviors, help-seeking attitudes, self-stigma, and self-efficacy. RESULTS A total of 481 students were randomized into two groups: 240 to usual care, and 241 to the intervention group. There were no significant differences in help-seeking intentions between the usual care and intervention groups over 6 months (<i>F</i><sub>2,877</sub>=0.85; <i>P</i>=.43, <i>f</i>=0.04). Both groups demonstrated similar increases in formal help-seeking intentions at 3 and 6 months (<i>F</i><sub>2,877</sub>=23.52; <i>P</i>&lt;.001, <i>f</i>=0.21). Compared with males, females sought more help from formal resources (OR 1.86; 95% CI 1.22 to 2.83, <i>P</i>=.001). Females were less likely to seek help from informal sources than males (OR 0.80; 95% CI 0.22 to 0.73, <i>P</i>&lt;.001). CONCLUSIONS Prompting postsecondary students about mental health and help-seeking appears to increase help-seeking intentions. mHealth interventions may be as effective as information pamphlets in increasing formal help-seeking but may confer a small advantage in driving help-seeking from informal sources. Although there is enthusiasm, developers and health policy experts should exercise caution and thoroughly evaluate these types of digital tools. Future studies should explore the cost-effectiveness of digital interventions and develop strategies for improving their efficacy. CLINICALTRIAL ClinicalTrials.gov NCT03412461; https://clinicaltrials.gov/ct2/show/NCT03412461 INTERNATIONAL REGISTERED REPORT RR2-10.2196/resprot.6446

scholarly journals Effect of a high value care curriculum on standardized patient exam in the Core Clerkship in Internal Medicine

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Amit K. Pahwa ◽  
Kevin Eaton ◽  
Ariella Apfel ◽  
Amanda Bertram ◽  
Rebecca Ridell ◽  
...  
Keyword(s):  
Internal Medicine ◽  
Medical Students ◽  
Primary Outcome ◽  
Intervention Group ◽  
Cost Effective ◽  
The Core ◽  
The Right ◽  
And Control ◽  
The Impact ◽  
Core Clerkship

Abstract Background With almost 20% unnecessary spending on healthcare, there has been increasing interest in high value care defined as the best care for the patient, with the optimal result for the circumstances, delivered at the right price. The American Association of Medical Colleges recommend that medical students are proficient in concepts of cost-effective clinical practice by graduation, thus leading to curricula on high value care. However little is published on the effectiveness of these curricula on medical students’ ability to practice high value care. Methods In addition to the standard curriculum, the intervention group received two classroom sessions and three virtual patients focused on the concepts of high value care. The primary outcome was number of tests and charges for tests on standardized patients. Results 136 students enrolled in the Core Clerkship in Internal Medicine and 70 completed the high value care curriculum. There were no significant differences in ordering of appropriate tests (3.1 vs. 3.2 tests/students, p = 0.55) and inappropriate tests (1.8 vs. 2.2, p = 0.13) between the intervention and control. Students in the intervention group had significantly lower median Medicare charges ($287.59 vs. $500.86, p = 0.04) and felt their education in high value care was appropriate (81% vs. 56%, p = 0.02). Conclusions This is the first study to describe the impact of a high value care curriculum on medical students’ ordering practices. While number of inappropriate tests was not significantly different, students in the intervention group refrained from ordering expensive tests.

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