What would you think?

Would you administer a medication to a patient if you were warned by the FDA that by giving it you have increased this

resident’s risk of death?

Strategies in Psychoactive Medication Management of Residents

in Skilled Nursing Facilities

Lou Czechowski RPh FASCP

Senior Health First LLC

“A Consultant Pharmacist Service”

• FOR IMMEDIATE RELEASEJune 16, 2008

FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs

• The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia.

• In 2005, the FDA announced similar labeling changes for "atypical" antipsychotic drugs. At that time, Boxed Warnings, the FDA's strongest, were added. The Boxed Warning will now be added to an older class of drugs known as "conventional" antipsychotics. The warning for both classes of drugs will say that clinical studies indicate that antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis.

• "Thomas Laughren, M.D., director of the FDA's Division of Psychiatry Products in the Center for Drug Evaluation and Research. "The prescribing information for all antipsychotic drugs will be updated to describe the risk of death in elderly patients being treated for symptoms associated with dementia."

It’s problems such as these that has lead to regulation of psychoactive medications in

Long Term Care

CMS REGULATIONSAntidepressants, Sedative Hypnotics, Anxiolytics and

Antipsychotics

Antidepressants

“antidepressants” are prescribed for conditions other than depression, including:- Anxiety disorders- Post-traumatic stress disorder- Obsessive compulsive disorder- Insomnia- Neuropathic pain (ex. diabetic peripheral neuropathy)- Migraine headaches- Urinary incontinence

Gradual Dose Reduction (GDR) RequirementsDuration - in accordance with pertinent literature-clinical practice guidelines.

Antidepressants to manage behavior, stabilize mood, or treat a psychiatric disorder, during the first year in which a resident is admitted or after initiationGDR should be attempted during at least two separate quarters (with at least one month between the attempts), unless clinically contraindicated. After - first year, a GDR - attempted annually, unless clinically contraindicated. The GDR may be considered clinically contraindicated if:-The continued use is in accordance with relevant current standards of practice, and the physician has documented the clinical rationale for why any attempted dose GDR would be likely to impair the resident’s function or cause psychiatric instability by exacerbating an underlying medical or psychiatric disorder;

-OR- The resident’s target symptoms returned or worsened after the most recent GDR within the care center and physician has documented the clinical rationale for why any additional attempted GDR at that time would be likely to impair the resident’s function or cause psychiatric instability by exacerbating an underlying medical or psychiatric disorder.

AnxiolyticsIndications1. Use is for one of the following indications as defined in the Diagnostic and Statistical Manual of MentalDisorders, Fourth Edition, Training Revision (DSM-IV TR) or subsequent editions:o Generalized Anxiety Disordero Panic Disordero Symptomatic anxiety that occurs in residents with another diagnosed psychiatric disorder (ex.depression, adjustment disorder)o Sleep disorders (refer to Sedative/Hypnotic requirements)o Acute alcohol/benzodiazepine withdrawalo Significant anxiety in response to a situational triggero Delirium, dementia and other cognitive disorders with associated behaviors that:Are quantitatively and objectively documented Are persistentAre not due to preventable or correctable reasonsConstitute clinically significant distress

Anxiolytics should only be used when:2. Evidence exists that other possible reasons for the individual’s distress have been considered; AND3. Use of the anxiolytic results in maintenance or improvement in the resident's mental, physical or psychosocial well-being (ex. as reflected on the MDS or other assessment tools); OR4. There are clinical situations that warrant the use of anxiolytics such as:a. A long-acting benzodiazepine is being used to withdraw the resident from a short-acting benzodiazepine.b. Used for neuromuscular syndromes (ex. cerebral palsy, tardivedyskinesia, restless leg syndrome, orseizure disorders)c. Symptom relief in end-of-life situations5. These regulations pertain to short-acting and long-acting benzodiazepines, Buspar (Buspirone), and anyantidepressants (except Wellbutrin [Bupropion]) used as an anxiolytic.

Anxiolytic (Anti-Anxiety Medication) regulationsBrand Name Generic Name Daily Dose Thresholds (mg/day)Ativan Lorazepam 2 mgDalmane Flurazepam 15mgDoral Quazepam 7.5mgKlonopin Clonazepam 1.5 mgLibrium Chlordiazepoxide 20 mgProSom Estazolam 0.5 mgSerax Oxazepam 30 mgTranxene Clorazepate 15 mgValium Diazepam 5 mgXanax Alprazolam 0.75 mgThe following medications are not appropriate for use as an anxiolyticEquanil, - MeprobamateAtarax, Vistaril, -HydroxyzineBenadryl -Diphenhydramine

Anxiolytic Gradual Dose Reduction (GDR) RequirementsDuring the first year in which a resident is admitted or after initiationGradual Dose Reduction (GDR) should be attempted during at least two separate quarters (with at least one month between the attempts), unless clinically contraindicated. After the first year, a GDR should be attempted annually, unless clinically contraindicated. The GDR may be considered clinically contraindicated if:- The continued use is in accordance with relevant current standards of practice, and the physician has documented the clinical rationale for why any attempted dose reduction would be likely to impair the resident’ s function or cause psychiatric instability by exacerbating an underlying medical or psychiatric disorder;

OR- The resident’s target symptoms returned or worsened after the most recent GDR within the care center, and the physician has documented the clinical rationale for why any additional attempted dose reduction at that time would be likely to impair the resident’s function or cause psychiatric instability by exacerbating an underlying medical or psychiatric disorder.

Sedative HypnoticsBefore initiating medications to treat insomnia, other factors potentially causing insomnia should be evaluated,including, for example:- Environment, such as excessive heat, cold, or noise; lighting- Inadequate physical activity- Care center routines that may not accommodate residents’ individual needs (ex. time for sleep, awakening,toileting, medication treatments)- Provision of care in a manner that disrupts sleep- Caffeine or medications known to disrupt sleep- Pain and discomfort- Underlying conditions (secondary or co-morbid insomnia) such as psychiatric disorders (ex. depression), cardiopulmonary disorders (ex. COPD, CHF), urinary frequency, pain, obstructive sleep apnea, and restless leg syndromeIt is expected that interventions (such as sleep hygiene approaches, individualizing the sleep and wake times to accommodate the person’s wishes and prior customary routine, and maximizing treatment of any underlying conditions) are implemented to address the causative factor(s). The use of sedating medications for residents with diagnosed sleep apnea requires careful assessment, documented clinical rationale, and close monitoring.

Sedative HypnoticsThese guidelines apply to any medication that is being used to treat insomnia. Initiation of medications to induce or maintain sleep should be preceded or accompanied by other interventions to try to improve sleep.

All sleep medications should be used in accordance with approved product labeling (ex. timing and frequency of administration relative to anticipated waking time).The use of sedating medications for residents with diagnosed sleep apnea requires careful assessment, documented clinical rationale, and close monitoring.

Exceptions:- Use of a single dose sedative for dental/medical procedures- During initiation of treatment for depression, pain or other co-morbid conditions, short-term use of a sedative/hypnotic may be necessary until symptoms improve or the underlying aggravating factor can beidentified and/or effectively treated.

Ambien -Zolpidem 5mg Ambien CR- Zolpidem CR 6.25 mgAtivan - Lorazepam 1 mgLunesta - Eszopiclone 1 mgProSom - Estazolam 0.5 mgRestoril - Temazepam 15 mgRozerem -Ramelteon 8 mgAtarax, Vistaril, etc. -Hydroxyzine 50 mgDalmane Flurazepam- 15Benadryl Diphenhydramine- 25 mgDoral Quazepam - 7.5 mgHalcion Triazolam - 0.125 mgNoctec, etc. - Chloral hydrate 500 mg

Sedative Hypnotic Gradual Dose Reduction (GDR) RequirementsFor as long as a resident remains on a sedative/hypnotic that is used routinely and beyond the manufacturer’s recommendations for duration of use, required Gradual Dose Reduction (GDR) quarterly unless clinically contraindicated. Clinically contraindicated means:- The continued use is in accordance with relevant current standards of practice, and the physician has documented the clinical rationale for why any attempted dose reduction would be likely to impair the resident’s function or cause psychiatric instability by exacerbating an underlying medical or psychiatric disorder,

OR- The resident’s target symptoms returned or worsened after the most recent attempt at tapering the dose within the care center, and the physician has documented the clinical rationale for why any additional attempted dose reduction at that time would be likely to impair the resident’s function or cause psychiatric instability by exacerbating an underlying medical or psychiatric disorder.

AntipsychoticsIndicationsAn antipsychotic should only be used for the following conditions/diagnoses as documented in the resident’s clinicalrecord and meets the definition(s) in the Diagnostic & Statistical Manual of Mental Disorders, Fourth Edition, Training Revision (DSM-IV TR) or subsequent editions:- Schizophrenia- Schizo-affective disorder- Delusional Disorder- Mood Disorders (mania, bipolar disorder, depression with psychotic features, and treatment-refractorymajor depression)- Schizophreniform disorder- Psychosis NOS- Atypical psychosis- Brief psychotic disorder- Dementing illnesses with associated behavioral symptoms- Medical illnesses or delirium with manic or psychotic symptoms and/or treatment-related psychosis or mania(ex. Thyrotoxicosis, neoplasms, high dose steroids)

AntipsychoticsCriteriaSince diagnoses alone do not warrant the use of antipsychotics, the clinical condition must also meet at least one of the following criteria:1. The symptoms due to mania or psychosis (such as: auditory, visual or otherhallucinations; delusions [such as paranoia or grandiosity])2. The behavioral symptoms present a danger to the resident or others3. The symptoms are significant enough that the resident is experiencing one or more of the following:a. inconsolable or persistent distress (ex. fear, continuous yelling, screaming, distress associated withend-of-life, or crying)b. a significant decline in functionc. substantial difficulty receiving needed care (ex. not eating resulting in weight loss, fear and not bathing leading to skin breakdown or infection)

AntipsychoticsAdditional requirementsAcute Psychiatric Situations- When an antipsychotic is initiated or used to treat an acute psychiatric emergency (i.e. recent or abrupt onset or exacerbation of symptoms) related to one or more of the allowable conditions/diagnoses listed above, that use must meet all of the following additional requirements:o The acute treatment is limited to 7 days or lesso A clinical in conjunction with the interdisciplinary team must evaluate and document the situation within 7 days, to identify/address any contributing/underlying causes of the condition and verify the continued need of the antipsychotico Pertinent non-pharmacological interventions must be attempted, unless contraindicated, and documented following the resolution of the acute psychiatric situation

AntipsychoticsEnduring Psychiatric Situations- When an antipsychotic is used to treat an enduring (i.e. non-acute, chronic or prolonged) condition, the target behavior must be clearly and specifically identified, and monitored objectively and qualitatively, in order to ensure the behavioral symptoms are:o Not due to a medical condition or problem (ex. headache or joint pain, fluid or electrolyte imbalance, pneumonia, hypoxia, unrecognized hearing/visual impairment) that can be expected to improve or resolve as the underlying condition is treated; ANDo Persistent or likely to reoccur without continued treatment; ANDo Not sufficiently relieved by non-pharmacological interventions; ANDo Not due to environmental stressors (ex. alteration in the resident’s customary location or daily routine, unfamiliar care provider, hunger/thirst, excessive noise for that individual, inadequate orinappropriate staff response, physical barriers) that can be addressed to improve the psychoticsymptoms or maintain safety; ANDo Not due to psychological stressors (ex. loneliness, taunting, abuse), or anxiety/fear stemming from misunderstanding related to cognitive impairment (ex. the mistaken belief that this is not where he/she lives or inability to find his/her clothes/glasses) that can be expected to improve or resolve as the situation is addressed

Antipsychotics

Exception: When an antipsychotic is used for behavioral disturbances related to Tourette’s disorder, of for non-psychiatric indications such as movement disorders associated with Huntington’s disease, hiccups, nausea/vomiting associated with cancer or cancer chemotherapy, or adjunctive therapy at end-of-life.

AntipsychoticsInadequate IndicationsAntipsychotics should not be used if the only indication is any of the following:

1. Wandering2. Poor self-care3. Restlessness4. Impaired memory5. Mild anxiety6. Insomnia7. Unsociability8. Inattention or indifference to surroundings9. Fidgeting10. Nervousness11. Uncooperativeness12. Verbal expressions or behavior that are not due to the conditions listed under Indications and do not represent a danger to the resident or others.

AntipsychoticsDoses for acute indications (ex. delirium) may differ from those used for long-term treatment, but should be the lowest possible to achieve the desired therapeutic effects.Brand name Generic name Daily Dose Thresholds (mg/day) used to managebehavioral symptoms related to dementing illnessesClozaril- Clozapine 50 mgCompazine Prochlorperazine Not customarily used for the treatment of behavioral symptomsHaldol Haloperidol 2 mgLoxitane Loxapine 10 mgMellaril Thioridazine 75 mgMoban Molindone 10 mgNavane Thiothixene 7 mgProlixin Fluphenazine 4 mgGeodon Ziprasidone Not customarily used for the treatment of behavioral symptomsRisperdal Risperidone 2 mgSeroquel Quetiapine 150 mgStelazine Trifluoperazine 8 mgThorazine Chlorpromazine 75 mgTrilafon Perphenazine 8 mgZyprexa Olanzapine 7.5 mgAbilify Aripiprazole 10 mg

Antipsychotic Gradual Dose Reduction (GDR) Requirements

Within the first year in which a resident is admitted on an antipsychotic or after initiation Gradual Dose Reduction (GDR) must be attempted in two separate quarters (with at least one month between attempts), unless clinically contraindicated. After the first year, a GDR must be attempted annually, unless clinically contraindicated.For any resident receiving an antipsychotic to treat dementia-related behavioral symptoms, the GDR may be considered clinically contraindicated if:-The resident’s target symptoms returned or worsened after the most recent attempt at a GDR within the care center;

AND- The physician as documented the clinical rationale for why any additional attempted dose reduction at that time would be likely to impair the resident’s function or increase distressed behavior.

AntipsychoticsFor any resident receiving an antipsychotic to treat a psychiatric disorder other than dementia-related behavioral symptoms, the GDR may be considered clinically contraindicated if:-The continued use is in accordance with relevant current standards of practice, and the physician has documented the clinical rationale for why any attempted dose reduction would be likely to impair the resident’s function or cause psychiatric instability by exacerbating an underlying psychiatric disorder;

OR- The resident’s target symptoms returned or worsened after the most recent GDR attempt within the care center, and the physician has documented the clinical rationale for why any attempted dose reduction would be likely to impair theresident’s function or cause psychiatric instability by exacerbating an underlying psychiatric disorder

Antipsychotics Monitoring/Adverse ConsequencesResidents are to be adequately monitored for antipsychotic adverse consequences, such as:- Anticholinergic effects- Akathisia- Neuroleptic Malignant Syndrome (NMS)- Cardiac arrhythmias- Death secondary to heart-related events (ex. heart failure, sudden death)- Falls- Lethargy- Increase in total cholesterol and triglycerides- Parkinsonism- Blood sugar elevation (including diabetes mellitus)- Orthostatic hypotension- Cerebrovascular event (ex. stroke, transient ischemic attack) in older residents with dementia- Tardive dyskinesia- Excessive sedationWhen antipsychotics are used without monitoring, they may be considered unnecessary medications because of inadequate monitoring.

AntipsychoticsMonitoring

AntipsychoticsMonitoring

Antipsychotics Monitoring

• Behavior Form Problems

– Often not seriously taken

– Lack of proper behaviors for monitoring suggested by CMS regulation of clinician

– Problem area often found by surveyors

AntipsychoticsMonitoring

• Behavior forms “benefits”

– Quanitative assessment

– Identify trends (positive or negative)

– Comply with CMS regs

AntipsychoticsMonitoring

• To improve “compliance”– Have physician specify targeted behaviors (from

regulations)• 1. The symptoms due to mania or psychosis (such as: auditory, visual or

other• hallucinations; delusions [such as paranoia or grandiosity])• 2. The behavioral symptoms present a danger to the resident or others• 3. The symptoms are significant enough that the resident is experiencing

one or more of the following:• a. inconsolable or persistent distress (ex. fear, continuous yelling,

screaming, distress associated with• end-of-life, or crying)• b. a significant decline in function• c. substantial difficulty receiving needed care (ex. not eating resulting in

weight loss, fear and not bathing leading to skin breakdown or infection)

Antipsychotic Medications History

• Antipsychotics are a group of psychoactive drugs commonly but not exclusively used to treat psychosis which is typified by schizophrenia. A first generation of antipsychotics, known as typical antipsychotics, was discovered in the 1950s. Most of the drugs in the second generation, known as atypical antipsychotics, have more recently been developed, although the first atypical anti-psychotic, clozapine, was discovered in the 1950s, and introduced clinically in the 1970s. Both classes of medication tend to block receptors in the brain's dopamine pathways but antipsychotic drugs encompass a wide range of receptor targets. A number of side effects have been observed in relation to specific medications, including weight gain, agranulocytosis,, tardive dyskinesia, tardive akathisias, tardive psychoses and tardive dysphrenias. The development of new antipsychotics, and the relative efficacy of different ones, is an important ongoing field of research. Antipsychotic medication is not generally regarded as a good treatment, just the best available. The most appropriate drug for an individual patient requires careful consideration.

The Term

• Antipsychotics are also referred to as neuroleptic drugs.]

The word neuroleptic is derived from Greek: "νεύρον" (originally meaning sinew but today referring to the nerves) and "λαμβάνω" (meaning take hold of). Thus, the word means taking hold of one's nerves. This term reflects the drugs' ability to make movement more difficult and sluggish, which clinicians previously believed indicated that a dose was high enough]

• Antipsychotics are broadly divided into two groups, the typical or first-generation antipsychotics and the atypical or second-generation antipsychotics.

• There are also dopamine partial agonists, which are often categorized as atypicals.

Antipsychotic History

• The first antipsychotic was chlorpromazine, which was developed as a surgical anesthetic.

• It was first used on psychiatric patients because of its powerful calming effect; at the time it was regarded as a "chemical lobotomy".

• Lobotomy was used to treat many behavioral disorders, including psychosis, although its "effectiveness" was (from a modern viewpoint) due to its tendency to markedly reduce behavior of all types. However, chlorpromazine quickly proved to reduce the effects of psychosis in a more effective and specific manner than the extreme lobotomy-like sedation it was known for.

All antipsychotic drugs tend to block D2 receptors in the dopamine pathways of the brain. This means that dopamine released in these pathways has less effect. Excess release of dopamine in

the mesolimbic pathway has been linked to psychotic experiences. It is the blockade of dopamine receptors in this pathway that is thought to control psychotic experiences.

The nigrostriatal pathway is a neural pathway that connects the substantia nigra with the striatum. It is one of the four major dopamine pathways in the brain, and is particularly involved in the production of movement, as part of a system called the basalganglia motor loop.Loss of dopamine neurons in the substantia nigra is one of the main pathological features of Parkinson's disease , leading to a marked reduction in dopamine function in this pathway. The symptoms of the disease typically do not show themselves until 80-90% of dopamine function has been lost.This pathway is also implicated in producing tardive dyskinesia, one of the side-effects of antipsychotic drugs. These medications (particularly the older typical antipsychotics) block D2 dopamine receptors in multiple pathways in the brain.The desired clinical effect of reducing psychotic symptoms is thought to be associated with blocking dopamine function in the mesolimbic pathway only. However, as many of these drugs are not selective, they block dopamine in all pathways. When this happens in the nigrostriatal pathway, similar movement problems to those found in Parkinson's disease can occur.

Geriatric Considerations • Many elderly patients receive antipsychotic medications for inappropriate

nonpsychotic behavior. Before initiating antipsychotic medication, the clinician should investigate any possible reversible cause; any stress or stress from any disease can cause acute “confusion” or worsening of baseline nonpsychotic behavior. Most commonly acute changes in behavior are due to increases in drug dose or addition of new drug to regimen; fluid electrolyte loss; infections; and changes in environment.

GERIATRIC CONSIDERATIONS In the treatment of agitated, demented, elderly patients, authors of meta-analysis of controlled trials of the response to the traditional antipsychotics (phenothiazines, butyrophenones) in controlling agitation have concluded that the use of neuroleptics results in a response rate of 18%.

Clearly neuroleptic therapy for behavior control should be limited with frequent attempts to withdraw the agent given for behavior control.

In light of significant risks and adverse effects in elderly population compared with limited data demonstrating efficacy in the treatment of dementia related psychosis, aggression, and agitation,

An extensive risk:benefit analysis should be performed prior to use.

FDA• FOR IMMEDIATE RELEASE

June 16, 2008

FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs• The U.S. Food and Drug Administration today exercised its new authority under

the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia.

• In 2005, the FDA announced similar labeling changes for "atypical" antipsychotic drugs. At that time, Boxed Warnings, the FDA's strongest, were added. The Boxed Warning will now be added to an older class of drugs known as "conventional" antipsychotics. The warning for both classes of drugs will say that clinical studies indicate that antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis.

• "Thomas Laughren, M.D., director of the FDA's Division of Psychiatry Products in the Center for Drug Evaluation and Research. "The prescribing information for all antipsychotic drugs will be updated to describe the risk of death in elderly patients being treated for symptoms associated with dementia."

The medications involved in this action are:

• Conventional Antipsychotic Drugs• Atypical Antipsychotics• Compazine (prochlorperazine) • Abilify (aripiprazole)• Haldol (haloperidol) • Clozaril (clozapine)• Loxitane (loxapine) • FazaClo (clozapine)• Mellaril (thioridazine) • Geodon (ziprasidone)• Moban (molindrone) • Invega (paliperidone)• Navane (thithixene) • Risperdal (risperidone)• Orap (pimozide) • Seroquel (quetiapine)• Prolixin (fluphenazine) • Zyprexa (olanzapine)• Stelazine (trifluoperazine) • Symbyax (olanzapine and fluoxetine)• Thorazine (chlorpromazine) • Trilafon (perphenazine)

FDA

• Recently, two observational epidemiological studies were published that examined the risk of death in elderly patients with dementia who were treated with conventional antipsychotic drugs. The investigators compared the risk for death with use of an atypical antipsychotic versus either no antipsychotic or the use of a conventional antipsychotic. These studies have limitations that preclude reaching a definitive conclusion about comparative death rates for atypical and conventional antipsychotic drugs. Nevertheless, the FDA has concluded that these studies, along with the earlier evidence for atypical antipsychotic drugs, suggest that both classes of drugs should be considered to have an increased risk of death when used in elderly patients treated for dementia-related psychosis.

Concerns Related to Antipsychotics

• Dementia: [U.S. Boxed Warning]: Elderly patients with dementia-related psychosis treated with antipsychotics dare at an increased risk of death compared to placebo. Most deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Antipsychotics are not approved for the treatment of dementia-related psychosis.

• Seizures: Use with caution in patients at risk of seizures, including those with a history of seizures, head trauma, brain damage, alcoholism, or concurrent therapy with medications which may lower seizure threshold. Elderly patients may be at increased risk of seizures due to an increased prevalence of predisposing factors.

Implications of Black Box Warnings

• Thomas Laughren MD – director of the FDA divisison of psychiatry products noted– Not telling physicians to avoid use in dementia

– Meant to help families balance the risk of the medications against the benefit

• Evidence is poor supporting off label use of antipsychotics in treating dementia– None of the medications have an dementia as an

indication• Lack of indication indicates lack of data

Implications of Black Box Warnings

• Yon Chen MD (University of Mass) published a study in Archives of Internal Medicine found more than 1/3 of nursing home residents who were prescribed an antipsychotic and no clinical indications for the drug (Journal of Archives of Internal Medicine 1-11-10)

Implications of Black Box warnings

• Increased risk of Citations during survey

• Increased risk of lawsuits

Decreasing Risk

• Extensive Risk/Benefit documentation regarding black box warnings by physician

– Risk of diabetes, Cardiovascular disease

– Benefits pharmacological benefit of medication provides significant improvement in behaviors that posed harm to resident or others.

• Risk/Benefit waiver for families

– Include black box warnings

• ANTIPSYCHOTIC RISK / BENEFIT ACKNOWLEDGEMENT FORM• Date: ______• Resident / Room: _______________________Physician:_____________________

• Prescribed Antipsychotic__________________Diagnosis:__________________

• Because of the “black-box” warning in the prescribing information for antipsychotics when used in patients with dementia, a risk / benefit analysis is essential.

• Benefits Potential Risks• Improved functional status Diabetes• Control of distressing symptoms Myocardial

Infarction• Improved quality of life Stroke

Death• While the resident is prescribed an antipsychotic, members of the interdisciplinary

care team will:• Ensure lowest possible doses are utilized• Review ongoing risk / benefit of continued use during interdisciplinary team

meetings• Attempt gradual dose reductions• Monitor for side effects of the medication • Please acknowledge that you have reviewed the risks vs. benefits of antipsychotic

use in this resident.

Strategies Decreasing antipsychotic use

• Ensure that Consultant Pharmacist Notes include review of antipsychotic medications

• Ensure that Physicians review CRPh notes thoroughly

• Psychoactive Committees

– Need to have a understanding of medications as well as regulation

Decreasing Antipsychotic Use

• Education

– Often staff is the most common reason that medications are initiated

– Need to rule out physical condition as underlying cause/contribution to exacerbation to behaviors

• CMS regs require this

Decreasing Antipsychotic Use

CMS Regulations• Not due to a medical condition or problem (ex. headache or joint pain, fluid or

electrolyte imbalance, pneumonia, hypoxia, unrecognized hearing/visual impairment) that can be expected to improve or resolve as the underlying condition is treated; AND

• o Persistent or likely to reoccur without continued treatment; AND• o Not sufficiently relieved by non-pharmacological interventions; AND• o Not due to environmental stressors (ex. alteration in the resident’s customary

location or daily routine, unfamiliar care provider, hunger/thirst, excessive noise for that individual, inadequate or

• inappropriate staff response, physical barriers) that can be addressed to improve the psychotic

• symptoms or maintain safety; AND• o Not due to psychological stressors (ex. loneliness, taunting, abuse), or

anxiety/fear stemming from misunderstanding related to cognitive impairment (ex. the mistaken belief that this is not where he/she lives or inability to find his/her clothes/glasses) that can be expected to improve or resolve as the situation is addressed

Decreasing Antipsychotic Use• Suggest new orders be written with a review (e.g. Quetiapine50mg q hs x 2 weeks then review)

• To observe for change in “physical condition”

• UTI, URI, pain related to physical condition

• Resolve in behaviors may be related to physical condition and interpreted as positive medication response

Decreasing Antipsychotic Use

• Have Consultant Pharmacist perform medication review to see if new onset behaviors related to medication(s)

– Oxybutynin, Phenytoin dosage etc..

• Rule out Hypo/Hyperthyroidism, anemia, change in renal function (affect medication clearance, e.g. Digoxin etc)

Psychoactive Rounds

• Medical Director , Consultant Pharmacist, Nursing other members of interdisciplinary team.

• Began in 2006 as an interdisciplinary meeting lasting 3-4 hours a month reviewing all residents

• Rounding began in 2008 with Medical Director, Consultant Pharmacist and representive member from the unit

Psychoactive Rounds

• Rounding last 1-2 hours monthly

• Improved psychoactive monitoring

– Use of behavioral forms was taken seriously by staff

– Point person (usually RN) was established to carry out recommendations from the rounding team

• Included, contacting psychiatry, updating behavior forms and any pertinent issues

Outcomes

• Decreased psychoactive medication use

• Established relationship between CRPh, physicians as well as staff

• Increased compliance with behavioral monitoring forms

Consultant Pharmacy Service

• The Office of the Inspector General (OIG) published an annual notice soliciting proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts. Public comments must be delivered by no later than 5 p.m. on March 1, 2010.

NEWS!

• The Office of the Inspector General (OIG) published an annual notice soliciting proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts. Public comments must be delivered by no later than 5 p.m. on March 1, 2010.

NEWS!

• At the same time, the United States

announced the unsealing of its Complaint

against two large nursing home chains,

Mariner Health Care, Inc.

SavaSeniorCare Administrative Services,

LLC , both of Atlanta, Georgia, and their

principals, Leonard Grunstein, Murray

Forman and Rubin Schron.

NEWS!

• The Government contends that Omnicare

offered its consultant pharmacist services

to nursing homes at below cost and below

fair market value in order to induce the

homes to refer their patients to Omnicare

for dispensing pharmacy services.

American Society of Consultant Pharmacists

• “Because of the potential for conflicts of interest, or the appearance of conflicts of interest, the American Society of Consultant Pharmacists recommends that consultant pharmacists who serve long-term care facilities should be independent of the long-term care pharmacy that provides medications to residents of the facility”- Feb 2010