AMDA Long Term Care Medicine 2012: Page 2 of 3

April 13, 2012

Rational Polypharmacy is Key to Managing Pain in Long-Term Care Residents

Polypharmacy and pain are commonly encountered in long-term care (LTC) residents, with about 60% to 70% of individuals reporting the latter. Uncontrolled pain can significantly affect residents’ physical function and quality of life. A rational approach to polypharmacy includes management of pain to improve functional capacity while avoiding drug–drug interactions or adverse drug events. This approach is a key component of quality drug prescribing, said Todd Berner, MD, Health Outcomes and Pharmacoeconomics, Research and Development, and field scientist, Endo Pharmaceuticals, at an AMDA Long Term Care Medicine 2012 product theater.

Low-quality prescribing is costlier prescribing because it is associated with more adverse drug events that may require additional expense to treat, such as emergency department visits and hospital admissions, said Berner. Incentives by the Centers for Medicare & Medicaid Services (CMS) for accountable care organizations to achieve financial bonuses may be impacted by elements of pain management pathways and their clinical performance measures, especially within transitions of care, he said. One such measure may be the ability of LTC residents to participate in rehabilitative sessions.

“Patients’ ability to participate in their rehabilitation because their pain is well controlled, compared to not being able to participate in their rehabilitation, can affect their length of stay and the facility’s level of reimbursement,” he said. “It starts from the point of recognizing pain, and you end up being four square in the center of healthcare reform.”

Recognition, evaluation, and management of pain in LTC residents are components of F-Tag 309 quality of care requirements. In 2009, CMS released revised guidance and investigative protocols for F-Tag 309, stating that “each resident must receive and the facility must provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being in accordance with the comprehensive assessment and plan of care.” A facility is in compliance if each resident has his or her pain managed in alignment with these goals. The protocol determines whether the facility has provided and the resident has received care and services to address and manage pain. It applies to residents who state that they have pain, who display indicators of pain (that cannot be attributed to another cause), are found to have pain, and receive pain treatment.

In addition to evaluating residents with pain, each facility under F-Tag 309 must develop and implement interventions consistent with current standards of practice and recognize or provide measures to minimize or prevent pain when pain is anticipated. The goals of clinical assessment of pain are to identify and characterize the pain by type, quality, location, intensity, and etiology. “The single most reliable indicator of the existence and intensity of pain is the individual’s self report,” said Berner.

“We found that’s it’s very difficult to make correlations between pain scales from one observer to another, from one patient’s self report to another,” he said. “What we determined was functional capacity and quality of life were much more reliable measures of response to pain therapy. Functional end points—observing and speaking to a nursing home resident who says, ‘Today, I could take my meals in a chair, but yesterday I couldn’t get out of bed.’—enable one to correlate that level of function with response to the pain therapy.”

An analgesic should be selected and titrated on an individual basis.  Considering that most older patients use multiple drugs (about 60% use five or more medications weekly), polypharmacy should be rational. The incidence of adverse drug reactions increases significantly when patients take four or more drugs. The most common interactions involve the CYP450 metabolic enzyme system.

Topical treament is often overlooked in pain therapy, said Berner. “Topical therapy is not for everybody; a certain percentage can’t tolerate it but on the other hand, for those who do, it’s one less pill to take,” he said. “With topical therapy, therapy can be interrupted immediately by removing the patch. There are no gastrointestinal issues and there are fewer drug–drug interactions.”—Wayne Kuznar


Long-Term Care is a Challenge for Huntington’s Patients with Chorea

Chorea (abnormal involuntary movements) may be the first presenting symptom of Huntington’s Disease (HD). Although chorea may be minimal at the outset, affecting only the face or distal portions of the limbs, the degenerative nature of HD is such that chorea becomes generalized, interfering with voluntary movements, said Victor Sung, MD, assistant professor, Department of Neurology, University of Alabama-Birmingham (UAB), and clinical director, UAB/HDSA [Huntington Disease Society of America] Huntington’s Disease Center of Excellence, at an AMDA Long Term Care Medicine 2012 product theater.

Chorea affects 90% of patients with HD at some stage in their illness, said Sung. Identifying a long-term care (LTC) facility that meets the needs of patients with HD is an important hurdle for many families because the degenerative nature of HD can require 24-hour supervision of those affected.

Patients with HD differ from the average LTC resident in that they are younger, often lack serious comorbid medical diagnoses on admission, and can have severe movement, psychiatric, and behavioral disorders. The motor, psychiatric, and cognitive symptoms are referred to as the “HD triad,” said Sung.

Currently, the only FDA-approved treatment for chorea associated with HD is tetrabenazine. This agent is thought to work by reversibly depleting monoamines, such as dopamine, serotonin, norepinephrine, and histamine, from nerve terminals by inhibiting vesicular monoamine transporter subtype 2 (VMAT2), decreasing uptake of monoamines into synaptic vesicles and depleting monoamine stores.

The effects of tetrabenazine on monoamine depletion are due primarily to the actions of alpha-HTBZ and beta-HTBZ, two metabolites that are metabolized through the CYP2D6 enzyme. As such, tetrabenazine has significant interactions with some antidepressants, including paroxetine. CYP2D6 testing is offered through Lundbeck, the drug’s manufacturer, said Sung.

In the pivotal trial of tetrabenazine, the mean reduction in the total chorea score on the Unified HD Rating Scale (UHDRS) from baseline exceeded five unit in patients assigned to tetrabenazine, whereas those randomly assigned to received the placebo had a mean reduction of only one unit (P<.0001). On the UHDRS, chorea for each body part (face, bucco-oral-lingual, trunk, right upper extremity, left upper extremity, right lower extremity, left lower extremity) is scored on a 0 to 4 scale; the total score ranges from 0 to 28.  A reduction of three or more units was defined as clinically meaningful in the pivotal trial. By week 3 of treatment, significant efficacy was observed with tetrabenazine, and after the washout period, the total chorea score returned to baseline levels.

Dosing of tetrabenazine should be individualized, said Sung, who advised “start low and go slow.” The starting dosage in the pivotal trial was 12.5 mg on day 1 and 12.5 mg twice daily on days 2 to 7. The dosage was then increased weekly by 12.5 mg. Of the patients, 56% required more than 50 mg per day. The maximum daily dosage is 100 mg. Lundbeck recommends genotyping for CYP2D6 in patients who require dosages of more than 50 mg per day.

Tetrabenazine is not stocked in retail pharmacies. It is distributed directly to LTC facilities through an LTC specialized pharmacy. Patient assistance programs and refills are available through the LTC specialty pharmacy. —Wayne Kuznar


Treating Inappropriate Laughing and Crying Can Prevent Isolation of Long-Term Care Residents

Pseudobulbar affect (PBA), a disorder characterized by involuntary and inappropriate outbursts of laughing or crying, occurs secondary to other unrelated neurologic conditions, and can lead to social isolation when it occurs in long-term care (LTC) residents. In a typical 120-bed facility, the number of PBA cases can range from 6 to 27 in the population with Alzheimer’s disease or dementia, 1 to 13 in those with stroke, and 1 to 3 in those with Parkinson’s disease.

First described in the literature 130 years ago, PBA has had multiple terms applied to it throughout the literature, including affective instability, emotional dyscontrol, emotional/affective lability, said Manuel A. Suarez-Barcelo, MD, CMD, internist, Partners in Internal Medicine, North Miami Beach, FL, at an AMDA Long Term Care Medicine 2012 product theater.

The criteria for a PBA diagnosis require the presence of episodic (sudden and intense), brief (lasting seconds to minutes), frequent, stereotypical outbursts of crying, laughing, or both. The disorder is differentiated from depression by the episodes being incongruent or exaggerated relative to the patient’s mood and the patient’s inability to control his or her emotions. “Depressed patients can sometimes mask their depression, whereas the behavior is involuntary in PBA,” said Suarez-Barcelo. “There may be coexisting depression, but [with PBA] the patients usually can’t tell you why they’re doing what they’re doing,” he noted. Identification of PBA requires a team approach between the front-line observers, who should document the inappropriate crying or laughing episodes, and the prescribers (physician, nurse practitioner, physician assistant).

Social phobia, withdrawal, and isolation can result from PBA, and those affected often cannot participate in their prescribed rehabilitative therapy as a result of the episodes. “PBA can lead to social isolation because you’re disruptive to others,” said Suarez-Barcelo.

Disruption of the neural network controlling emotional motor expression is thought to be responsible for PBA. “It’s believed to result from a loss of frontal voluntary control or lesions in the cortico-ponto-cerebellar pathways,” said Suarez-Barcelo.

Dextromorphan HBr and quinidine sulfate (Nuedexta) is FDA-approved as a therapy for PBA; the dextromorphan is the active ingredient that acts on the central nervous system and the quinidine is a metabolic inhibitor that enables achievement of therapeutic dextromorphan concentration. The drug is covered under Medicare Part D.

Studies supporting the efficacy of dextromorphan HBr/quinidine sulfate in PBA were conducted in patients with amyotrophic lateral sclerosis and multiple sclerosis. A decrease in manifestations of PBA occured at week 1 of therapy and were sustained. Half of all patients treated with dextromorphan HBr/quinidine sulfate achieved remission (episode-free) over the final 14 days of the study.

The amount of quinidine (10 mg) in the tablet is .05% of the lowest commercially available dosage, contributing to the cardiovascular safety profile of dextromorphan HBr/quinidine sulfate, including a lack of reported torsades de pointes, said Suarez-Barcelo. Nevertheless, he noted that a baseline electrocardiogram “might be a good idea in some patients,” such as those taking drugs that prolong the QT interval or inhibit CYP3A4, and those with left ventricular hypertrophy or dysfunction.

Although the pharmacokinetics of dextromorphan HBr/quinidine sulfate are similar in adult and geriatric patients, there were too few patients 65 years and older enrolled in clinical trials to determine whether this age group responds differently than younger patients. However, the drug should be used with caution in patients prone to falls.

Dextromorphan HBr/quinidine sulfate should be started at one capsule daily for 7 days, followed by one capsule every 12 hours thereafter. The maximum dosage is two capsules in a 24-hour period. “You can periodically reassess the need for the medication after the patient goes into remission,” said Suarez-Barcelo.—Wayne Kuznar