David Parra, Pharm.D., FCCP, BCPS Clinical Pharmacy Program Manager in Cardiology/Anticoagulation VISN 8 Pharmacy Benefits Management Clinical Associate Professor Department of Experimental and Clinical Pharmacology College of Pharmacy, University of Minnesota Cardiovascular Guideline-Driven Pharmacotherapies: Optimizing Management
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David Parra, Pharm.D., FCCP, BCPS
Clinical Pharmacy Program Manager in Cardiology/Anticoagulation
VISN 8 Pharmacy Benefits Management
Clinical Associate Professor
Department of Experimental and Clinical Pharmacology
College of Pharmacy, University of Minnesota
Cardiovascular Guideline-Driven
Pharmacotherapies:
Optimizing Management
Presenter disclosure information
Financial Disclosure: I do not have a financial relationships with any commercial entity which may represent, in perception or reality, a conflict of interest in the context of this presentation
The views expressed in this presentation reflect those of the author, and not necessarily those of the Department of Veterans Affairs
Objectives
• Explain what optimizing management with guideline-driven
pharmacotherapy entails
• Optimize management of guideline-driven pharmacotherapy
in the treatment of heart failure with reduced ejection
fraction (HFrEF)
• List 3 general barriers to guideline adherence
• List 3 general strategies most likely to improve guideline
adherence
Cardiovascular Guideline-Driven Pharmacotherapy:
Optimizing Management
Right Drug
Right Time
Right Dose
Right Patient
Optimal Pharmacotherapy
Guideline-Driven Pharmacotherapy:
Optimizing Management
• Focus on
– Heart failure with reduced ejection fraction
• Complex pharmacotherapy
• Many opportunities for improvement
• We are at risk of “out with the old…in with the new”
Applying ACC/AHA Guideline Classification of Recommendations and
Levels of Evidence
A recommendation with Level of
Evidence B or C does not imply that
the recommendation is weak. Many
important clinical questions
addressed in the guidelines do not
lend themselves to clinical trials.
Although randomized trials are
unavailable, there may be a very
clear clinical consensus that a
particular test or therapy is useful or
effective.
*Data available from clinical trials or
registries about the usefulness/
efficacy in different subpopulations,
such as sex, age, history of diabetes,
history of prior myocardial infarction,
history of heart failure, and prior
aspirin use.
†For comparative effectiveness
recommendations (Class I and IIa;
Level of Evidence A and B only),
studies that support the use of
comparator verbs should involve
direct comparisons of the treatments
or strategies being evaluated.
HypertensionHypertensionHypertensionHypertension
Left VentricularLeft VentricularLeft VentricularLeft Ventricular
Symptomatic Heart Symptomatic Heart Symptomatic Heart Symptomatic Heart Failure: Tip of the IcebergFailure: Tip of the IcebergFailure: Tip of the IcebergFailure: Tip of the Iceberg
DiabetesDiabetesDiabetesDiabetes
AsymptomaticAsymptomaticAsymptomaticAsymptomatic
Left Ventricular Left Ventricular Left Ventricular Left Ventricular
Hydralazine/ISDN: A-HeFTTrial design: 1,050 black patients who had New York Heart Association class III or IV heartfailure with EF< 35% were randomly assigned to receive a fixed dose of isosorbide dinitrate plus hydralazine or placebo in addition to standard therapy for heart failure (target 225mg hydralazine; ISDN 120mg). Median follow-up 10 months.
43 percent reduction in the rate of death
from any cause [hazard ratio, 0.57; P=0.01]
33 percent relative reduction in the rate of
first hospitalization for heart failure [16.4
percent vs. 22.4 percent, P=0.001]
Utilization of Hydralazine/ISDN in HFrEF
• In the Get With The Guidelines– Heart Failure registry from April 2008 to
March 2012Among 11,185 African American patients eligible for H-ISDN
therapy, only 2,500 (22.4%) received H-ISDN
J Am Heart Assoc. 2013;2:e000214 doi: 10.1161/JAHA.113.000214
Titration to Optimal Doses:
“My Patient is on Everything”
Does it still matter?
Guideline-Driven Pharmacotherapy:
Optimizing Management
Knowledge that the guidelines exist is
insufficient but so is familiarity with the
guidelines
Cardiovascular Guideline-Driven Pharmacotherapy:
Optimizing Management
Right Drug
Right Time
Right Dose
Right Patient
Optimal Pharmacotherapy
Right Drug
Right Dose
Right Patient
Right Time
Guideline-Driven Pharmacotherapy: Barriers to Optimizing Management (Guideline Adherence)
Cabana et al. JAMA 1999;282:1458-1465.
Guideline-Driven Pharmacotherapy: Barriers to Optimizing Management (Guideline Adherence)
• Different guidelines can have different barriers
• Within a guideline, barriers can differ between
recommendations
• Barriers can change over time (e.g. cost, awareness)
Cabana et al. JAMA 1999;282:1458-1465.
Interventions to Improve Adherence to
Cardiovascular Disease Guidelines
• Dissemination of guidelines alone has little to no effect on practice
• Numerous studies conducted (mostly on physicians), but overall
impact on guideline adherence and impact is unclear
• Strategies that demonstrated the strongest benefit were (in order)
organizational change, patient education, provider education, and
provider reminder systems
• Audit and feedback as well as patient self-management showed
differing results or small advantages
Fam Pract. 2014;31(3):247–66.
BMC Fam Pract. 2015;16(147).
Organizational Change to Improve Adherence
to Cardiovascular Disease Guidelines
• Strategies for guideline implementation via organizational
change included
– IIIImproved mproved mproved mproved collaboration with pharmacists, medically supervised collaboration with pharmacists, medically supervised collaboration with pharmacists, medically supervised collaboration with pharmacists, medically supervised
nurses, prevention coordinators or hospital nurses, prevention coordinators or hospital nurses, prevention coordinators or hospital nurses, prevention coordinators or hospital specialistsspecialistsspecialistsspecialists
• Meta-analysis based on 14 trials with 32,465 patients had an
overall OR of 1.96 (95% CI 1.40 to 2.75) in favor of
organizational change over usual care
Fam Pract. 2014;31(3):247–66.
Cardiovascular Team-Based Care
Brush JE Jr, Handberg EM, Biga C, Birtcher KK, Bove AA, Casale PN, Clark MG, Garson A Jr, Hines JL, Linderbaum JA, Rodgers GP, Shor RA,
Thourani VH, Wyman JF. 2015 ACC health policy statement on cardiovascular team-based care and the role of advanced practice providers.
J Am Coll Cardiol 2015;65:2118–36.
Summary
• Optimizing management with guideline-driven pharmacotherapy
entails the right drug, right patient, right dose, and right time
• Underutilization and under dosing of proven pharmacotherapy is
problematic in HFrEF
• Barriers to guideline adherence are complex and multi-factorial
• Organizational change, patient education, and provider education
appear to have the greatest impact on guideline adherence