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Improving Dementia Care: New Initiatives, New Opportunities The Centers for Medicare & Medicaid Services (CMS) has recently increased its focus on appropriate care for individuals with dementia who reside in nursing facilities. As part of its program, “Partnership to Improve Dementia Care in Nursing Homes,” CMS has updated portions of the State Operations Manual, the document that guides how care should be provided in nursing facilities. Pharmacists and other health care practitioners working in these facilities need to be aware of these changes, which may require adaptations to policies, procedures, and documentation for residents with dementia. In addition, it may affect the use of certain types of medications for these residents. Key Words: Antipsychotic, Centers for Medicare & Medicaid Services, Dementia, Elderly, Nursing facility, State Operations Manual. Abbreviations: CMS = Centers for Medicare & Medicaid Services, MRR = Medication regimen review, QAA = Quality Assessment and Assurance, SOM = State Operations Manual.

Caren McHenry Martin

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n March 2012, the Centers for Medicare & Medicaid Services (CMS) launched the “National Partnership to Improve Dementia Care and Reduce Unnecessary Antipsychotic Drug Use in Nursing Homes” (now referred to as the “Partnership to Improve Dementia Care in Nursing Homes”), with the goal of decreasing the off-label use of antipsychotics by 15%.

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According to CMS, the goal of this program is to “optimize the quality of life and function of residents in America’s nursing homes by improving approaches to meeting the health, psychosocial, and behavioral health needs of all residents, especially those with dementia.”1 As a result, CMS has updated the manual used by state and federal surveyors to uphold CMS standards for nursing facility quality, to meet this goal (Appendix P and

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Appendix PP of the State Operations Manual [SOM]). These changes—which specifically address appropriate use of psychopharmacologic medications for patients with dementia—are likely to affect the nursing facility survey process and the consultant pharmacist’s medication regimen review (MRR). It also presents the consultant pharmacists with new opportunities to educate and participate in the care of these residents.

What’s New, and Why? The updates to the SOM in Appendix P include changes in the resident sampling process for the traditional survey to ensure that surveyors review an adequate number of residents with dementia who are receiving an antipsychotic medication. Surveyors are instructed to: Request a list of the names of residents who have a diagnosis of dementia and who are receiving, have received, or presently have PRN [as needed] orders for antipsychotic medications over the past 30 days. and Ensure that, at a minimum, at least one of the residents on the list who is receiving an antipsychotic medication is in the Phase 1 sample for a comprehensive or focused record review…If the facility population includes residents with dementia, ask the administrator or director of nursing to describe how the facility provides individualized care and services for residents with dementia and to provide policies related to the use of antipsychotic medications in residents with dementia.1 In addition, Appendix PP of the SOM has been updated with: • A new section of interpretive guidance related to the review of care and services for a resident with dementia (F309) • Revisions to the antipsychotic medication section of F329 (Table 1) • A new severity example at the end of the interpretive guidance at F329 (Unnecessary Drugs) Throughout the changes to the SOM, CMS emphasizes the need for “Person-Centered Care,” in which the nursing facility provides a supportive environment that recognizes the individual needs and preferences of each resident. According to CMS, “Individualized, person-centered

approaches may help reduce potentially distressing or harmful behaviors and promote improved functional abilities and quality of life for residents.”1 The revised SOM sends a strong statement that psychopharmacologic medications (especially antipsychotics) should be used judiciously as part of this person-centered approach.

The guidelines clearly state that antipsychotics can only be used after all other causes of behavior— medical, emotional, environmental, etc.—have been ruled out. In a May 2013 memo to state survey directors, who evaluate nursing facilities each year, CMS states: It has been a common practice to use various types of psychopharmacological medications in nursing homes to try to address behaviors without first determining whether there is a medical, physical, functional, psychological, emotional, psychiatric, social or environmental cause of the behaviors…All interventions, including medications, need to be monitored for efficacy, risks, benefits and harm… When antipsychotic medications are used without an adequate rationale, or for the purpose of limiting or controlling behavior of an unidentified cause, there is little chance that they will be effective. In addition, they commonly cause complications such as movement disorders, falls, hip fractures, cerebrovascular adverse events (cerebrovascular accidents and transient ischemic events) and increased risk of death.1

Research Backs the Revisions CMS’s position on antipsychotics is backed by some solid research, suggests Lisa O’Hara, PharmD, CGP, owner, Comprehensive Therapy Specialists, LLC, and corporate clinical director, Granview Pharmacy, Indianapolis, Indiana. “It was quite an eye-opener for me when I really started looking at the adverse event data with these (antipsychotic) medications,” says O’Hara. Data from the Agency for Healthcare Research & Quality reveals

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Improving Dementia Care: New Initiatives, New Opportunities

these startling statistics, based on 180 studies reporting adverse effects2: • Extrapyramidal side effects (EPS) occur in 1 out of every 10 patients receiving olanzapine and 1 out of 20 receiving risperidone. • Cerebrovascular accidents are associated with risperidone use in 1 out of 34 patients. • Cardiovascular (CV) adverse events are associated with risperidone in 1 out of 53 patients and 1 out of 48 patients on olanzapine. • One out of every 100 patients treated with an atypical antipsychotic died as a result of treatment with the antipsychotic during the 10-12 week trials. O’Hara said the reaction she received as she began sharing this information with nurses, prescribers, and nursing facility administrators was also a revelation. “Time and time again, I heard them say the same thing: ‘I had no idea these medications were this dangerous,’” says O’Hara. That’s why O’Hara thinks consultant pharmacists in nursing facilities can play an instrumental role in beginning a paradigm shift in dementia care. “When the facility staff and prescribers get educated, it changes things,” says O’Hara. “They have a new interest and incentive in changing how they go about managing these patients.” And when the education comes from the pharmacist, who is recognized as an authority on medication management, it has a big impact. “I hadn’t been able to get some of my facilities to change their antipsychotic use for six years. Then, suddenly, after I talked with them about this data, I had everyone on board and our antipsychotic number went from 18 patients to 5, and even included some patients with psychiatric diagnoses.”

Consultant pharmacists in nursing facilities can play an instrumental role in beginning a paradigm shift in dementia care.

Facility-Wide Changes It’s also important for the consultant pharmacist to encourage facilities to take a critical look at their internal

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processes of care management for dementia patients, says Wendy Stearns, RPh, director of clinical services for Pharmerica, Tampa, Florida. “Most facilities need to update their current policies and procedures regarding antipsychotics and dementia care,” says Stearns, who suggests this also may require the facility to play a more active role in the medication management of these residents. “We need to help them understand that they can’t just rely on a monthly psychoactive medication report from their pharmacy or consultant pharmacist,” says Stearns. Instead, facility staff at all levels need to be able to identify and document how they have assessed the resident’s behaviors, involved residents and their families in discussions about potential approaches to address dementia-related behaviors, and implemented and monitored individualized, person-centered care plans. Facilities also need to be sure the care of residents with dementia is addressed during their Quality Assessment and Assurance (QAA) meetings, suggests Stearns. “Surveyors will be looking for evidence that the QAA committee discusses strategies for coordinating care of residents with dementia,” she says, including strategies recommended as part of the pharmacists’ monthly medication review. “Surveyors will want to see how the QAA committee facilitates monitoring responses to the pharmacist’s medication review recommendations and how the facility is overseeing and monitoring residents receiving antipsychotics for appropriate diagnosis, behavior monitoring, and dose-reduction attempts.” Stearns also sees opportunities for consultant pharmacists to assist facilities with the new staff training requirements for dementia care, that require all staff be trained upon hire, then annually, to ensure they can identify, communicate, and address behaviors in residents with dementia.

Impact on Consultant Pharmacists For consultant pharmacists assessing the patient’s medication regimen during their monthly drug review, the changes to F329 may impact the MRR process. Several diagnoses have been added to the “Indications for Use” section of F329, with specific instructions about how antipsychotic medications can be employed. The

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guidelines clearly state that antipsychotics can only be used after all other causes of behavior—medical, emotional, environmental, etc.—have been ruled out and that they have to be used at the lowest possible doses for the shortest period of time (Figure 1). Physicians should only prescribe antipsychotic drugs after seeing the patient at the bedside, suggests Todd King, PharmD, CGP, senior director, clinical services, Omnicare, Inc., Raleigh, North Carolina. “The new CMS survey requirements mean that consultant pharmacists are going to need to be proactive in their assessment of recently started antipsychotic medications and communicate effectively with the prescriber when the guidelines suggest medication should be changed, discontinued, or altered,” says King. Equally important to the facility is the new listing of “Inadequate Indications” for antipsychotic medications (Figure 2). The revised guidelines clearly state that antipsychotics should be used for these indications only when the behavioral symptoms

present a danger to the resident or others, and are the result of mania or psychosis or are refractory to behavioral interventions listed in the plan of care. “CMS’s narrowing focus of appropriate indications for the use of the antipsychotics will require the consultant pharmacist to have a continued active role with the facility in ensuring that the facility is in compliance with all survey guidance,” says King.

“Most facilities need to update their current policies and procedures regarding antipsychotics and dementia care.” The new guidelines regarding emergency use of antipsychotic medications also are important to the pharmacist’s MRR process. “Emergency use” is defined as use during an acute treatment period of seven days or

Figure 1. Potential Behavior Triggers • Coexisting medical or psychiatric conditions, including acute/chronic pain, constipation, delirium, and others; or worsening of mental function • Adverse consequences related to the resident’s current medication • Boredom; lack of meaningful activity or stimulation during customary routines and activities • Anxiety related to changes in routines such as shift changes, unfamiliar or different caregivers, change of (or relationship with) roommate, inability to communicate • Care routines (such as bathing) that are inconsistent with a person’s preferences • Personal needs not being met appropriately or sufficiently, such as hunger, thirst, constipation • Fatigue, lack of sleep, or change in sleep patterns, which may make the person more likely to misinterpret environmental cues, resulting in anxiety, aggression, or confusion • Environmental factors; for example, noise levels that could be causing or contributing to discomfort or misinterpretation of noises such as overhead pages, alarms, etc. causing delusions and/or hallucinations. • Mismatch between the activities or routines selected and the resident’s cognitive and other abilities to participate in those activities/routines. For example, a resident who has progressed from mid to later stages of dementia may become frustrated and upset if he/she is trying but unable to do things that she previously enjoyed, or unable to perform tasks such as dressing or grooming.



Source: Reference 1.

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Something to Talk About: Improving Dementia Care: New Initiatives, New Opportunities Assessing and Addressing Elders’ Health Literacy

Figure 2. Inadequate Indications for Use of Antipsychotic Medications

Antipsychotic medications in persons with dementia should not be used if the only indication is one or more of the following: • Fidgeting • Impaired memory • Inattention or indifference to surroundings • Insomnia • Mild anxiety • Nervousness • Poor self-care • Restlessness • Sadness or crying alone that is not related to depression or other conditions • Uncooperativeness (e.g., refusal of or difficulty receiving care) • Wandering Source: Reference 1.

fewer, with a new requirement for follow-up evaluation by a clinician within those seven days. King suggests that the consultant pharmacist will need to work with facility leadership to design a process to make sure that emergency medication use is re-evaluated in a timely manner. This also applies to residents who are receiving antipsychotic medications at the time of admission. The new guidelines require the facility to re-evaluate the use of antipsychotic medications at the time of admission and determine, within two weeks of admission, if a dose reduction or discontinuation is warranted. “The new admission review is a great opportunity for the consultant pharmacist to impact positively the outcome for these residents,” says King, adding that the consultant pharmacist should play an important role in helping the facility develop processes to meet the intent of this rule. Now, more than ever, consultant pharmacists need to be sure they have clear documentation in place so that they are ready to discuss these patients with prescribers. The revised guidelines strongly encourage surveyors to speak with the practitioner/prescriber and/or consultant pharmacist in cases where an antipsychotic medication is prescribed for an elderly patient with dementia. Surveyors

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are also specifically instructed to look at other types of psychopharmacologic medications—such as mood stabilizers, anxiolytics, and antidepressants—to make sure the facility isn’t just switching from an antipsychotic to another category of psychopharmacologic agents. According to the federal guidance, “Surveyors should investigate further in cases where …an antipsychotic has been discontinued and a medication such as a mood stabilizer has been added.”1 That’s why King says his company is working with its consultant pharmacists to provide guidance on how best to communicate with surveyors. “We also work closely with our nursing facility clients to best coordinate the joint response to surveyor questions,” says King. Ongoing vigilance for patients using antipsychotic medications is also required, with the revised guidance specifically noting the need for re-evaluation of antipsychotic dosing and behavioral symptoms “at least during quarterly care plan review, but often more frequently, depending on the resident’s response to the medication.”1 Specific adverse consequences including cardiovascular, metabolic, anticholinergic, and neurologic effects are listed. “The patient-centered care approach is an opportunity for the consultant pharmacist to help the facility with

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Want to Know More?

The following organizations offer educational materials, sample policies, and clinical tools directed at improving dementia care in nursing facilities: American Geriatrics Society (AGS) http://www.americangeriatrics.org/press/id:4412 American Healthcare Association (AHCA) http://www.ahcancal.org/quality_improvement/qualityinitiative/Pages/Antipsychotics.aspx American Medical Directors Association (AMDA) http://www.amda.com/advocacy/dementiacare.cfm American Society of Consultant Pharmacists (ASCP) https://www.ascp.com Centers for Medicare & Medicaid Services (Surveyor training videos) http://surveyortraining.cms.hhs.gov/pubs/AntiPsychoticMedHome.aspx National Council of Certified Dementia Practitioners (NCCDP) http://www.nccdp.org/

their assessment of these medications,” says King. “The consultant pharmacist is a tremendous resource for assessment of adverse consequences that are often confused with comorbid conditions and other medications.” And it’s this sort of knowledge that can help secure consultant pharmacists as vital members of the interdisciplinary team, concludes King. “We should see these changes to the SOM as an opportunity for us to further showcase our skills.” n

For General Information About the Survey Process

Martin CM. QIS: The New Nursing Facility Survey Consult Pharm 2009;24:591-600. Martin CM, McSpadden, C. Implementing Changes to the State Operations Manual Consult Pharm 2007;22:105-17.

Caren McHenry Martin, PharmD, CGP, is a consultant pharmacist in Greensboro, North Carolina. Disclosure: No funding was received for the development of this manuscript. The author has no potential conflicts of interest. Consult Pharm 2014;29:16-23. © 2014 American Society of Consultant Pharmacists, Inc. All rights reserved. Doi:10.4140/TCP.n.2014.16.

References 1. Centers for Medicare & Medicaid Services. Advanced copy: dementia care in nursing homes: clarification to Appendix P State Operations Manual (SOM) and Appendix PP in the SOM for F309— quality of care and F329—unnecessary drugs. Memorandum of May 24, 2013. 2. Off-Label Use of Atypical Antipsychotics: An Update, Comparative Effectiveness Review No. 43, prepared by the Southern California Evidence-based Practice Center under Contract No. HHSA 2902007-10062-I for the Agency for Healthcare Research and Quality, September 2011. Available at www.effectivehealthcare.ahrq.gov/ offlabelantipsych.cfm.

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Improving dementia care: new initiatives, new opportunities.

The Centers for Medicare & Medicaid Services (CMS) has recently increased its focus on appropriate care for individuals with dementia who reside in nu...
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