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CLINICAL &

REGULATORY

NEWS BY

PHARMERICA

NOV / DEC 2019

The Changing Regulatory Environment in Skilled NursingBy David Milstein, CPh and Janis Russell, Pharm.D., MBA

Many regulatory changes relating to long-term care go into effect in 2019. This article is intended to give a brief summary of the upcoming changes and is not meant to be a comprehensive guide. PharMerica has additional resources available with more detailed information about each of these regulations.

Hazardous Waste PharmaceuticalsThe EPA has updated its rule concerning hazardous waste pharmaceuticals (HWPs). The rule has three parts: the sewering ban, Subpart P, and the nicotine exception. Effective August 21, 2019, a ban on sewering (flushing) any hazardous waste for all healthcare facilities was instituted. Subpart P will have a staggered implementation so be aware of what is happening in your state. Non-authorized states (which include Alaska and Iowa) must

comply with the regulations as of August 21, 2019. Authorized states must adopt by July 1, 2021, while authorized states that require legislative action have until July 1, 2022. The following states have adopted as of August 21, 2019: Florida, Kentucky, New Jersey, Pennsylvania and New Mexico. The nicotine exception exempts over-the counter nicotine replacement therapies such as gums, lozenges, and patches, from being P-listed or defined as acute hazardous waste. Prescription nicotine products, e-cigs, and other liquid nicotine devices are still considered hazardous waste. This part does not have an adoption timeline because it’s more lenient than the

Continued on page 2

December 1, 2019• USP 800

August 21, 2019• EPA Rule

October 1, 2019• PDPM

InformRx PHARMACY NEWS

2 | www.pharmerica.com | NOV / DEC 2019

The Changing Regulatory Environment in Skilled Nursing, cont.

law currently in place and states can choose not to adopt it. More detailed information about the EPA rule can be found in the September/October edition of InformRx.

Patient Driven Patient ModelStarting October 1, 2019, the Patient Driven Payment Model (PDPM) immediately goes into effect. PDPM is a new case mix classification system which moves residents covered by Medicare Part A into a prospective payment system. PDPM changes the payment system from therapy based to payment groups based on specific, data-driven resident needs. The consultant pharmacist will be able to aid the facility in coding for the correct diagnoses/medication combination by reviewing admitting data and pointing out mismatch medication-diagnoses combinations or missing diagnoses. This classification must be done within seven days of the resident admission; an iMRR completed by a consultant pharmacist can help the nursing facility comply. PharMerica has published a PDPM guide and a series of articles to help facilities implement a process for transitioning to PDPM and has collaborated with McKnight’s and Skilled Nursing News to publish PDPM webinars presented by T.J. Griffin, Senior Vice President of LTC Pharmacy for PharMerica, and Leah Klusch, Executive Director of the Alliance Training Center. All of these resources are available at www.pharmerica.com/pdpm.

Phase IIIStarting November 28, 2019, Phase III CMS regulation updates will go into effect. As part of Phase III, CMS now says it may allow PRN (Pro re Nata) prescriptions for antipsychotics to run more than 14 days if an attending physician or prescriber documents the duration and rationale in a resident’s medical record. This decision would be a reversal, with standards adopted last year requiring a doctor’s evaluation to prescribe as-needed antipsychotic medications for more than two weeks. CMS also announced that it may delay implementation of certain Phase III QAPI and compliance and ethics-related requirements. Another feature of Phase III involves nursing facilities hiring an infection preventionist (IP), a person who is trained in infection prevention and

control. This person should have training in nursing, medical technology, microbiology, epidemiology or other related fields. CMS recently proposed to change the Infection Preventionist’s required time at a facility from “part time” to “sufficient time.”

USP 800Hazardous drugs are handled throughout a healthcare organization, posing risks to employees, patients and the environment. USP 800 goes into effect on December 1, 2019, and outlines best practices for handling these drugs through nearly every aspect of the medication process. It affects not just the pharmacy but a variety of personnel, such as the nursing unit staff, environmental services, and more. Regulatory bodies are expected to enforce the standards, and non-compliance could potentially result in citations. As such, facilities should have policies and procedures in place that outline how NIOSH-listed hazardous drugs are handled. Facilities may adopt the best practices outlined in USP 800 or perform their own analysis of risk/benefit to develop policies and procedures. PharMerica is working to assist our facilities with identifying hazardous medications.

Contact your consultant pharmacist for assistance or to receive additional information about these new regulations.

InformRx CLINICAL CORNER


Congestive Heart Failure Clinical Update By Daniel Kerr Rph, PharmD Candidate

Continued on page 4

IntroductionHeart failure (HF) is a condition in which there is a loss of cardiac function resulting from the heart having a decline in its pumping efficiency. Weakening or stiffening of the heart muscle leads to the decline in pumping efficiency and insufficient delivery of blood to the body. Heart failure (HF) is divided into two main types: HF with preserved left ventricular ejection fraction (HFpEF) or HF with reduced ejection fraction (HFrEF).1,2

Symptoms that suggest HF include dyspnea at rest or exertion, fatigue, loss of exercise tolerance, and edema. HFpEF patients have heart failure symptoms but with a close to normal ejection fraction of >50%. HFrEF, classified as when the left ventricular ejection fraction (LVEF) is <40%, can result in not enough oxygenated blood transported to the body’s organs.

HFpEF has an estimated prevalence of 50% of all heart failure patients and is increasing.1 It is seen more in older women with hypertension and also with conditions such as obesity, atrial fibrillation, coronary artery disease (CAD), and diabetes.3 Risk factors for HFpEF include older age, being overweight, and smoking.1 Hypertension is the most significant cause and risk for HFpEF. Hypertension prevalence is over 60% in patients with HFpEF.3 HFrEF is commonly seen from left ventricle (LV) dysfunction and often accompanied with LV enlargement. Hypertension is also the most significant risk factor for

HFrEF and for heart failure overall. Obesity, diabetes, metabolic syndrome, and atherosclerotic disease are additional risk factors for heart failure.

An estimated 2%-3% of adults >45 years old have heart failure.1 The prevalence increases with age. For ages 65-69, approximately 20 per 1,000 people have heart failure and for ages >85, there are 80 per 1,000 individuals with heart failure.3 Heart failure is the second most common diagnosis for hospital inpatient stays for individuals on Medicare and/or > ages 75 years.4 With 20% of the population expected to be >65 years old in 30 years, heart failure will affect a significant number of people.

There are two main methods of classifying heart failure: the ACC/AHA HF stages and the New York Heart Association (NYHA) classification method. The ACC/AHA puts a HF patient in stages of A,B,C,D and emphasizes the disease progression and cardiac structure changes. Patients only move forward and advance to higher, more severe stages with the ACC/AHA method. The NYHA method classifies patients by their functional status and limitations of physical activity. Patients can move between classes depending on their condition at the time.

HF

HFrEF

HFpEF

ACC/AHA

NYHA

ACE

ARB

ARNI

Heart Failure

Heart Failure Reduced Ejection Fraction

Heart Failure Preserved Ejection Fraction

American College of Cardiology/American Heart Association

New York Heart Association

Angiotensin-Converting Enzyme

Angiotensin Receptor Blockers

Angiotensin Receptor–Neprilysin Inhibitor

List of Abbreviations



Congestive Heart Failure, cont.

Continued on page 5

The ACC/AHA Stages of Heart Failure from the ACC/AHA Guidelines3

A At high risk for HF but without structural heart disease or symptoms of HF

B Structural heart disease but without signs or symptoms of HF

C Structural heart disease with prior or current symptoms of HF

D Refractory HF requiring specialized interventions

The NYHA Classification Summary from the Heart Failure Society of America2

No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea.

Slight l imitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitations, or dyspnea.

IIIA: Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.

IIIB: Marked limitation of physical activity. Comfortable at rest, but minimal exertion causes fatigue, palpitation, or dyspnea.

Unable to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency present at rest. If any physical activity is undertaken, discomfort is increased.

Heart failure is a chronic condition that often has episodes of worsening signs and symptoms referred to as decompensation. Decompensated HF is also called acute HF. Renal function decline, neurohormonal activation, and cardiac function deterioration are major reasons for acute HF. Most acute HF patients present severe enough to be hospitalized, often due to severe volume overload.2 Noncompliance and inadequate medication management are also common reasons for acute HF hospitalizations.

Decreased cardiac output from HF results in compensatory responses from the body to attempt

to maintain adequate cardiac output.5 These responses include the activation of the renin-angiotensin-aldosterone system (RAAS) and the sympathetic nervous system, which further results in vasoconstriction, sodium and water retention, and ventricular remodeling. Endogenous neurohormones are activated, including norepinephrine, angiotensin II, aldosterone, vasopressin, and proinflammatory cytokines. Much of pharmacotherapy is aimed at antagonizing this neurohormonal activation at various spots in the pathway.

Biomarker Measuring

B-type natriuretic peptide (BNP) or its amino-terminalcleavage equivalent (NT-proBNP) are peptides that aregenerated from cardiomyocytes from various triggers.3

Both are generally elevated in HF and are increasinglyused to diagnose and monitor HF.6 However, natriureticpeptide biomarkers should be used in combination withother diagnostic tools since elevated plasma levelsof natriuretic peptides are also associated with othercardiac and noncardiac causes (e.g. atrial fibrillation,renal failure, and advancing age).

Nonpharmacological Treatment Nonpharmacological treatment of HF is an important part of a patient’s treatment plan. Patient education has been shown to decrease days of hospitalizations.3 Knowledge of how to monitor their symptoms, monitor weight changes, take medications correctly, limit sodium intake, and stay active are necessary to

Class I

Class II

Class III

Class IV




Continued on page 6

help patients improve outcomes. Studies regarding restriction of sodium intake for patients with HF have had mixed results, which has made it difficult to make precise recommendations about daily sodium intake. Sodium homeostasis is altered in HF and some studies have indicated a worsening neurohormonal profile with sodium restriction. ACC/AHA recommends <1500mg/day for stage A and B patients. However, for stage C and D patients, the data is insufficient to recommend specific levels, but ACC/AHA considers <3g/day a reasonable restriction level. Continuous positive airway pressure can also be used to help HF status and sleep apnea associated with HF. Exercise training and cardiac rehabilitation are also helpful for those patients able to participate.

Pharmacological TreatmentThe ACC/AHA treatment guidelines are organized around the four stages of HF (A,B,C,D) and are in general agreement with other guidelines (Heart Failure Society of America and the European Society of Cardiology).

• Stage A: Stage A begins with controlling risk factorssuch as hypertension and hyperlipidemia withcurrent guidelines to decrease the risk of HF.3

• Stage B: Stage B presents with structural heartdisease and patients with HFrEF should be onACE inhibitors (or angiotensin II receptor blockers(ARBs)) and beta blockers to prevent symptomaticHF since they have been shown to slow down leftventricular remodeling and improve mortality.

• Stage C: In stage C heart failure, guidelines becomemore patient symptom specific and incorporate morenumerous pharmacological therapies. ACE inhibitortherapy (ARB if cannot tolerate ACE inhibitor) shouldbe used in combination with beta blockers unlesscontraindicated. ACE inhibitor treatment shouldbegin at low doses and increase to target doses fromclinical trials or to the maximum tolerated dose. Betablocker treatment should not be delayed, and patientsdo not need to be on high doses of ACE inhibitorsbefore initiating beta blocker treatment. Beta blockersmay initially cause a slight worsening of symptomsbefore improvements are seen. Beta blockers shouldbe initiated at very low doses followed by gradualincrements to target doses or maximum tolerateddoses. For volume overload, loop diuretics can improve symptoms by decreasing clinical fluid retention. Initiatewith low doses and titrate to increase urine outputuntil weight decreases (approximately 0.5-1.0kgdaily). Diuretics can cause depletion of potassiumand magnesium and often require supplementation.Aldosterone receptor antagonists are also used asadd on therapy for patients. Estimated creatinineclearance of > 30ml/min and potassium levels of <5.0 mEq/dl are required and should be continuouslymonitored. Spironolactone at 12.5-25mg daily canbe used and has been shown to improve mortalitywhen added to an existing ACE inhibitor/beta-blockercombination. The combination of hydralazine andisosorbide dinitrate is recommended as add ontherapy in African Americans that remain symptomaticdespite ACE inhibitor/beta blocker combinationtreatment or patients that cannot tolerate an ACEinhibitor or ARB. Digoxin can be added to a patient’streatment plan if they have persistent symptomsdespite optimal therapy management. Lower digoxindoses are recommended for use in the elderly, whoare at increased risk of digoxin toxicity.

• Stage D: Stage D patients with HF will have persistentlysevere symptoms despite maximum therapymanagement. These patients should be evaluatedfor advanced treatment strategies, such as implanted cardiac devices, transplants, and investigationalstudies, or considered for palliative care.




Recent UpdatesThe 2017 ACC/AHA update to the 2013 guidelines have some noteworthy changes for stage C patients, including the addition of an angiotensin receptor–neprilysin inhibitor (ARNI) (valsartan/sacubitril) and a sinoatrial node modulator (ivabradine).6 An ARNI, ACE

inhibitors, or ARBs may be used with evidenced-based beta-blockers in stage C HFrEF to reduce morbidity and mortality. Aldosterone antagonists may be additionally used in select patients.

The evidenced-based beta blockers recommended have not changed from the 2013 guidelines: bisoprolol,

Figure 1. The algorithm of care recommended from the 2017 ACC/AHA guideline update6

Figure 1: ACEI indicates angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor-blocker; ARNI, angiotensin receptor-neprilysin inhibitor; BP, blood pressure; bpm, beats per minute; C/I, contraindication; COR, Class of Recommendation; CrCl, creatinine clearance; CRT-D, cardiac resynchronization therapy–device; Dx, diagnosis; GDMT, guideline-directed management and therapy; HF, heart failure; HFrEF, heart failure with reduced ejection fraction; ICD, implantable cardioverter-defibrillator; ISDN/HYD, isosorbide dinitrate hydral-nitrates; K+, potassium; LBBB, left bundle-branch block; LVAD, left ventricular assist device; LVEF, left ventricular ejection fraction; MI, myocardial infarction; NSR, normal sinus rhythm; and NYHA, New York Heart Association. Continued on page 7

Step 1 Establish Dx of HFrEF;

assess volume; initiate GDMT

Step 2 Consider the following

patient scenerios

Step 3 Implement indicated GDMT.

Choices are not mutually exclusive, and no order is

inferred

Step 4 Reassess symptoms

Step 5 Consider additional therapy

HFrEFNYHA class I –IV

(Stage C)

ACEI or ARB ANDGDMT beta blocker; diuretics as needed

(COR I)

NYHA class II–IVprovided est. CrCI>30

mL/min & K+<5.0 mEq/L

NYHA class III–III HFAdequate BP on ACEI or ARB*; No C/I to ARB or

sacubitril

NYHA class III–IV,in black patients

NYHA class II–III LVEF≤35%; (caveat: > 1 y

survival, >40 d post MI)

NYHA class III–IV, LVEF≤35%, NSR & QRS ≥150 ms with LBBB

pattern

NYHA class III–III, NSR, heart rate ≥70 bpm on

maximally tolerated dose beta blocker

Aldosterone antagonist (COR I)

Discontinue ACEI or ARB; initiate ARNI*

(COR I)

Hydral-Nitrates†‡ (COR I)

ICD‡ (COR I)

CRT or CRT-D‡ (COR I)

Ivabradine (COR IIa)

Refractory NYNA class III-IV

(Stage D)

Symptoms improved

Palliative Care‡ (COR I)

Transplant‡(COR I)

LVAD‡ (COR IIa)

Investigational studies§

Continue GDMT with serial reassessment & optimized dosing/adherence


References1. DynaMed Plus (database online).Ipswich (MA): EBSCO Information Services; 2016. Https://www.dynamed.com.

Accessed July 22, 2019.

2. Heart Failure Society of America. Executive Summary: HFSA 2010 Comprehensive Heart Failure Practice Guideline. JCard Fail. 2010;16(6):475-539. doi:10.1016/j.cardfail.2010.04.005

3. Yancy CW, Bozkurt B, Butler J, et al. 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report ofthe American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines.Circulation. 2013;128(16):e240-e327. doi:10.1161/CIR.0b013e31829e8776

4. HCUP Fast Stats. https://www.hcup-us.ahrq.gov/faststats/landing.jsp. Accessed August 3, 2019.

5. Parker RB, Nappi JM, Cavallari LH. Chronic Heart Failure. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, WellsBG, Posey L. eds. Pharmacotherapy: A Pathophysiologic Approach, 10e New York, NY: McGraw-Hill;. Http://accesspharmacy.mhmedical.com.ezproxymcp.flo.org/content.aspx?bookid=1861&sectionid=146056207. AccessedAugust 03, 2019.

6. Yancy CW, Jessup M, Bozkurt B, et al. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline forthe Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association TaskForce on Clinical Practice Guidelines and the Heart Failure Society of America. J Card Fail. 2017;23(8):628-651.doi:10.1016/j.cardfail.2017.04.014

Contact your consultant pharmacist for assistance or to receive additional information about congestive heart failure.



carvedilol, and sustained release metoprolol. For patients with chronic symptomatic HFrEF class II or III who tolerate an ACE inhibitor or ARB, replacement with an ARNI is recommended due to new data showing a further reduction in morbidity and mortality. An ARNI should not be used with ACE inhibitors within 36 hours of the last dose of an ACE inhibitor or in patients with a history of angioedema. Ivabradine is recommended as an addition to treatment in patients with HFrEF (class II-III, LVEF < 35%) who are at maximum tolerated

doses of beta blockers and in sinus rhythm with a heart rate of >70bpm.

ConclusionHeart failure will continue to be a significant disease to manage in the elderly and in long-term care. Recent guideline updates include the addition of an angiotensin receptor–neprilysin inhibitor (ARNI) (valsartan/sacubitril) and a sinoatrial node modulator (ivabradine). ARNI use is a first-line option and is a recommended substitution for ACE inhibitors or ARBs in chronic symptomatic HFrEF class II or III patients. Proper disease management through guideline-directed management and therapy (GDMT) should be followed to help improve patients’ quality of life and decrease healthcare costs. Following GMDT may further assist long-term care facilities in improving quality measures and reducing facility costs by decreasing hospital admission/readmission rates.


InformRx SENIOR LIVING SPOTLIGHT

Updated Aspirin Use Guidelines ReleasedWith aspirin use in the elderly controversial because of their higher bleeding risk, the 2015 Beers Criteria by the American Geriatrics Society previously advised using caution in administering aspirin for primary prevention of cardiovascular disease for adults over the age of 80 and the 2002 ACC/AHA guidelines recommended that the decision to start low-dose aspirin in adults 60-69 with a 10 percent or greater 10-year cardiovascular disease risk should be an individual one.

Now, the guidelines for use of low-dose aspirin in healthy elderly for the primary prevention of cardiovascular events has changed following trials and a review of clinical studies.

The 2019 updated recommendations for facilities are as follows:

• ACC/AHA Guidelines: The 2019 updatedACC/AHA guidelines strongly recommendagainst the use of low-dose aspirin (70-100mg orally daily) on a routine basis for theprimary prevention of atherosclerotic vasculardisease (ASCVD) among adults >70 years ofage due to risk of harm.

• Beers Criteria: The 2019 updated Beers Criteriarecommends exercising extra caution with the use ofaspirin for primary prevention of ASCVD in patients 70years or older due to the risk of major bleeding.

As a result of this updated guidance, facilities should reevaluate their policies and practices regarding aspirin use. Since low-dose aspirin is not recommended for use in adults 70 and over for primary prevention of cardiovascular disease because of the increased chance of bleeding, which holds a greater risk of harm than benefit, organizations should individualize care to determine if use of aspirin is appropriate.

To learn more about optimal medication therapy for your residents for improved outcomes, compliance and savings, contact PharMerica at [email protected].

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