minnesotas call to action minnesotas call to action for unnecessary medications (f329) &...

Minnesota’s Minnesota’s

Call To ActionCall To Action

For Unnecessary Medications For Unnecessary Medications (F329)(F329)

&&

Pharmacy Services (F425, 428, Pharmacy Services (F425, 428, 431)431)

TJ/CMS2007 - 2

Overview of New Overview of New GuidanceGuidance• Not about medications, it’s about the resident. • We have complex elderly residents with

multiple medical disorders and multiple medications; medication-related issues are not uncommon.

• Do not manage medications; manage residents who take medications (holistic approach to medication management).

• Need a coordinated, systematic, facility-wide approach to the resident care process, not an individual discipline approach.

TJ/CMS2007 - 3

Overview of New Overview of New GuidanceGuidance

• Use an interdisciplinary approach with individualized care to monitor and manage all medications.

• Therefore an increased responsibility of facility, prescribers, consultant pharmacist, and dispensing pharmacy regarding medication management.

• Try not to be overwhelmed; it’s good resident care.• Remember, the regulations haven’t changed, the

descriptions or interpretive guidelines have.• Start learning about the guidance and begin

implementing changes.• Expect more changes, revisions in the future.

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Coordination & Coordination & CommunicationCommunication

• Now is the time to begin talking to one another…share ideas for implementation, develop a plan for transitioning to the new guidelines, collaboratively write/review/update policies and procedures

• Considered keeping a notebook in the facility so that they can write down questions or issues as they arise, then can review with pharmacist, medical director, physicians, QA Committee, others.

TJ/CMS2007 - 5

Coordination & Coordination & CommunicationCommunication

• Examples of where communication is mentioned in new guidelines…

F425: “Develop mechanisms for communicating, addressing, and resolving issues related to pharmaceutical services”

F425: “Interacting with the quality assessment and assurance committee to develop procedures and evaluate pharmaceutical services…”

TJ/CMS2007 - 6

Coordination & Coordination & CommunicationCommunication• Examples of where communication is mentioned in new

guidelines… F329: “It is important that the facility clearly identify who

is responsible for prescribing and identifying the indications for use of medication(s), for providing and administering the medication(s), and for monitoring the resident for the effects and potential adverse consequence of the medication regimen; This is also important when care is delivered or ordered by diverse sources such as consultants, providers, or suppliers (e.g., hospice or dialysis programs)”

F425: “Coordinate pharmaceutical services if and when multiple pharmaceutical service providers are utilized (e.g., pharmacy, infusion, hospice, prescription drug plans [PDP])”

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F329F329What’s Changed?What’s Changed?

•Only the Guidance has changed.

Increased information on indication,

monitoring, adverse consequences for

broader range of types of medications

Modification of Gradual Dose Reduction

Inclusion of tapering

TJ/CMS2007 - 8

F425, 428, 431F425, 428, 431What’s Changed?What’s Changed?


Increased information on what is

pharmaceutical services.

Increased information about Medication

Regimen Review.

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Development of the Development of the GuidanceGuidance• Pharmacy Services and Unnecessary Medications• Involved 2 separate expert panels for both the

pharmacy services tags and unnecessary medication tags

Released for 1st public comment period - October 2004

1st Comment period ended - January 2005 Expert panels reconvened - April 2005 Due to significant number of comments received

during 1st comment period and subsequent revisions, a 2nd draft was released September 2005

Expert panels reconvened again - December 2005/January 2006

Final documents released - September 15, 2006 Effective date/implementation scheduled for

DECEMBER 18, 2006

TJ/CMS2007 - 10

Tags CombinedTags Combined• Unnecessary Medications

New Tag F329 = Old Tags F329, F330, F331 Unnecessary Drugs

• Pharmaceutical Services New Tag F425 = Old Tags F425, F426, and F427 (b) (1)

Pharmaceutical Services, Procedures, Consultation New Tag F428 = Old Tags F428, F429, F430

Medication Regimen Review (DRR) New Tag F431 = Old Tags F427 (b) (2) and (3), F431,

F432 Control, Labeling, and Storage

F329F329Unnecessary MedicationsUnnecessary Medications

Interpretive Interpretive GuidelinesGuidelines

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Medications and Long-Term Medications and Long-Term CareCare • Medications are an integral part of long-term and

subacute care • Can improve function and quality of life• Can help attain various outcomes, for example

Curing acute illness Diagnosing disease or condition Arresting or slowing disease process Reducing or eliminating symptoms Preventing disease or symptoms

• “Medications are probably the single most important health care technology in preventing illness, disability, and deaths in the geriatric population” (Avorn 1995)

TJ/CMS2007 - 13

Scope of the ProblemScope of the Problem

•Medications are also a known public health problem

Described in the medical, nursing, and pharmacology literature for many decades

Discussed repeatedly in the mass media Relevant in every setting

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Source: Parade Magazine, March 12, 2006

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Drug-Related ProblemsDrug-Related Problems(Categories)(Categories)

1. A medical indication for the drug2. Too little of the correct drug3. Too much of the correct drug4. Incorrect drug5. Medical problem secondary to adverse drug

reaction6. Drug-drug, drug-food, drug-lab test interactions7. Medical problem due to patient not receiving

drug8. Medical problem resulting from a drug for which

there is no valid medical indication

TJ/CMS2007 - 16

Not a New ConcernNot a New Concern

• J Amer Bd of Family Practice, 95; 8:195-205, Ackerman et al.

“It is safe to assume that many of our nursing home patients are suffering from drug side effects, drug interactions, or both.”

“Careful review and pruning of the medication list could be the single most important service the clinician can provide to his or her nursing home patients”

• Ann Internal Medicine, (10/92), Vol. 43, No.4, Beers et al. Inappropriate medication prescribing common in

NHs

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Economic Impact of Diseases Economic Impact of Diseases Affecting Americans Age 65 and Affecting Americans Age 65 and OlderOlder

•If adverse reactions to medications were classified as a disease, it would rank as the 5th leading cause of death in the U.S.

CV Disease $171 Billion Cancer $104 Billion Alz. Disease $100 Billion DM $92 Billion Medication-Related Problems $66.2 Billion

JAMA April 1998

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ILLNESS

MEDICATION DRUG ADVERSE EFFECT

DRUGINTERACTION

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Overview of Drug-Related Overview of Drug-Related Problems Problems in the Elderlyin the Elderly

•25% of patients over 80 experience ADRs; 10% of patients <60.

•A 75 y.o. is 7 times more likely to experience an ADR than a 25 y.o.

•Frequency of ADRs in >60 y.o. is 2-7 times greater than <60 y.o.

•More likely to require hospital admission

6 X that of general population

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Medication Adverse Medication Adverse ConsequenceConsequence• Adverse drug reaction

-Side effect -Toxic effect -Hypersensitivity -Idiosyncratic -Adverse medication interaction

• Medication-Food interaction• Medication-Disease interaction

• 50-80% of adverse consequences are potentially avoidable without reducing therapeutic effects of medications. (Predictable)

TJ/CMS2007 - 21

““Allergic”/Adverse Drug Allergic”/Adverse Drug ReactionsReactions

•Drug•Brief description of reaction•Date of occurrence

Drug Reaction (date)Aspirin g.i. upsetAmoxicillin hives, itch (8/94)Erythromycin diarrhea

(9/89) Haldolstiff neck/jaw (3/92)

TJ/CMS2007 - 22

Study in 2 academic-based Study in 2 academic-based nursing homesnursing homes

•Most frequent causes for the preventable adverse consequences:

Inadequate monitoring Failure to act on monitoring Errors in ordering

Wrong dose Wrong medication

Medication-medication interactions

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Drug-Related Problems Drug-Related Problems

• Consequences Treatment Failure New medical

problem

• Subsequent Events Physician revisit Further Rx Urgent care visit ER visit Hospital admit LTCF admit Death No further attention

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•$80 billion/year spent on prescription drugs in U.S.

•$76.6 billion/year spent on drug-related problems.

- $47 billion related to hospital admissions

- 8.7 million hospital admissions- 17 million ER visits

•>200,000 deaths/year due to ADRs.

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•For every $1.00 spent on drugs for nursing home patients, $1.33 is spent on treating the problems these drugs cause. ($4 billion/yr)

• Gurwitz, JH, et al. The incidence of adverse drug events in two large academic long term care facilities. AmJMed 2005:118:251-8.

• The statutory criteria for Medication Therapy Management Services (i.e., multiple chronic disease, multiple drugs, drug expenditures > $4,000/yr) will probably result in similar acuity levels for ambulatory patients.

• Kidder, Samuel W. DUR by Pharmacists-Lessons Learned for MTMS. The Consultant Pharmacist 12/2005

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Hx:Hx: 81 yo female with mild HTN, OA, 81 yo female with mild HTN, OA, OP.OP. Total Hip Replacement scheduled Total Hip Replacement scheduled 7/23/04.7/23/04.7/16/04: Weakness, ataxia, cognitive

impairment.6pm E.R. visit & 11pm hospital

admit. (R/O CVA. Carotid ultrasound, CT head, MRI head, BP 184/110, mild ↓Na+).

Medications on admission:Lisinopril 5mg q.d. HCTZ 12.5mg q.d.Fosamax 70mg q. wk Calcium w Vit D b.i.d.

ASA E.C. 325 q.d. Vioxx 25mg q.d. Alprazolam 0.25mg t.i.d.prn Vicodin 1-2 q. 6 hr prn

TJ/CMS2007 - 27

7/17/04: 12noon CNS Sx improved.All tests negative.Lisinopril increased to 10mg

q.d.Atenolol 25mg q.d. added.Alprazolam, Vicodin, HCTZ

held.BP 130/82

TJ/CMS2007 - 28

7/17/04: 1:00pm T.J. call to vendor pharmacy to obtain Rx history.

-Alprazolam 0.25mg x 30 1/18/04, 3/11/04, 4/27/04, 6/3/04, 6/24/04, 7/14/04

-Vioxx 25mg x 28 6/25/04-Vicodin x 100 7/14/04

1:30pm Physician arrives

TJ/CMS2007 - 29

Etiology of Drug-Related Etiology of Drug-Related ProblemsProblems

1. 3 different prescribers2. Lack of pharmacist intervention3. Weakness, ataxia, impaired cognition

Alprazolam, Vicodin4. Elevated BP

Antagonism of ACE Inhibitor (lisinopril) antihypertensive effect by Vioxx as well as possible Vioxx-induced HTN.

5. HyponatremiaPossibly Vioxx and HCTZ

TJ/CMS2007 - 30

7/18/04: 10am Discharged after 40 hr hospitalization

1pm On dock at lake2pm Pontoon ride

Spends rest of day enjoying children and grandchildren.

• 7/23/04: Successful hip replacement surgery

TJ/CMS2007 - 31

COST ?$

TJ/CMS2007 - 32

Medication Related Problem Expenses:

•-Telemetry $1,770/d x 2 days•-ER Room $1,949.50•-CT head $1,074 •-MRI head $2,126•-Carotid Ultrasound $821•-Pelvis X-Ray $208•-EKG $177•-Labs/BMPs, CBC, UA, UC, TSH, B12,

troponin, lytes, medications, PT/OT evaluation, etc.

TJ/CMS2007 - 33

Hospitalization Bill for 40 hour admission

$13,198.50

TJ/CMS2007 - 34

F329 IntentF329 Intent• Select medications based on assessing relative

benefits and risks to individual

• Evaluate individual’s signs and symptoms to identify underlying causes, including adverse consequences

• Select and use of medications in doses and for duration appropriate to individual’s clinical conditions, age and underlying causes of symptoms

• Use of non-pharmacological interventions, when applicable, to minimize need for medications, permit use of lowest possible dose, or allow discontinuation of medications

• Monitor efficacy and clinically significant adverse consequences of medications

TJ/CMS2007 - 35

Preserve Quality of LifePreserve Quality of Life

TJ/CMS2007 - 36

Unnecessary MedicationsUnnecessary Medications(1) General. Each resident’s drug regimen must

be free from unnecessary drugs. An unnecessary drug is any drug when used:

(i) In excessive dose (including duplicate drug therapy); or

(ii) For excessive duration; or (iii) Without adequate monitoring; or(iv) Without adequate indications for its use;

or(v) In the presence of adverse

consequences which indicate the dose should be reduced or discontinued; or

(vi) Any combinations of the reasons above.

Unnecessary MedicationsUnnecessary Medications

(2) Antipsychotic Drugs. Based on a comprehensive assessment of a resident, the facility must ensure that—

(i) Residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record; and

(ii) Residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs.

TJ/CMS2007 - 38

DefinitionsDefinitionsAdverse consequenceAdverse consequence - is an unpleasant symptom or event

that is due to or associated with a medication, such as impairment or decline in an individual’s mental or physical condition or functional or psychosocial status. It may include various types of adverse drug reactions and interactions (e.g., medication-medication, medication-food, and medication-disease).

Behavioral interventionsBehavioral interventions -- individualized non-pharmacological approaches (including direct care and activities) that are provided as part of a supportive physical and psychosocial environment and are directed toward preventing, relieving, and/or accommodating a resident’s distressed behavior.

TJ/CMS2007 - 39

DefinitionsDefinitionsClinically significantClinically significant - refers to effects, results, or

consequences that materially affect or are likely to affect an individual’s mental, physical, or psychosocial well-being either positively by preventing, stabilizing, or improving a condition or reducing a risk, or negatively by exacerbating, causing, or contributing to a symptom, illness, or decline in status.

Distressed behavior - is behavior that reflects individual discomfort or emotional strain. It may present as crying, apathetic or withdrawn behavior, or as verbal or physical actions such as: pacing, cursing, hitting, kicking, pushing, scratching, tearing things, or grabbing others.

TJ/CMS2007 - 40

DefinitionsDefinitions

Indications for useIndications for use - is the identified, documented clinical rationale for administering a medication that is based upon an assessment of the resident’s condition and therapeutic goals and is consistent with manufacturer’s recommendations and/or clinical practice guidelines, clinical standards of practice, medication references, clinical studies or evidence-based review articles that are published in medical and/or pharmacy journals.

TJ/CMS2007 - 41

DefinitionsDefinitions

MonitoringMonitoring - is the ongoing collection and analysis of information (such as observations and diagnostic test results) and comparison to baseline data in order to:

Ascertain the individual’s response to treatment and care, including progress or lack of progress toward a therapeutic goal;

Detect any complications or adverse consequences of the condition or of the treatments; and

Support decisions about modifying, discontinuing, or continuing any interventions.

Psychopharmacologic medicationsPsychopharmacologic medications - any medication used for managing behavior, stabilizing mood, or treating psychiatric disorders.

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Non-pharmacological Non-pharmacological InterventionsInterventions• Increasing the amount of resident exercise, intake of liquids

and dietary fiber in conjunction with an individualized bowel regimen to prevent or reduce constipation and the use of medications (e.g. laxatives and stool softeners).

• Identifying, addressing, and eliminating or reducing underlying causes of distressed behavior such as boredom and pain. Utilizing music-aroma-pet therapy, etc.

• Using sleep hygiene techniques and individualized sleep routines; assess exercise, naps, caffeine, fluids, environment.

• Accommodating the resident’s behavior and needs by supporting and encouraging activities reminiscent of lifelong work or activity patterns, such as providing early morning activity for a farmer used to awakening early.

TJ/CMS2007 - 43

Overview Overview • Non-pharmacological approaches require

assessing and understanding causes for need of medication

• ABC’s: Antecedent…..Behavior….Consequence.

• Approaches involve reduction/elimination of impediments, triggers and causes

Examples of Non-Pharmacological Interventions:• Modification of environment• Modification/elimination of psychological stressors

Accommodation of previous lifelong activities or roles

Modification of staff/resident interactions Behavioral Interventions

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Medication ManagementMedication Management

•Resident Choice & Advance Directives•Indications for Use•Monitoring •Dose•Duration•Tapering/ Gradual Dose Reduction•Adverse Consequences

TJ/CMS2007 - 45


•Is based in the Care Process.•Attending physician plays a key leadership

role in developing, monitoring, and modifying the medication regimen in conjunction with the Interdisciplinary Team, comprised of:

The resident Their representatives Other professionals Direct care staff

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Promoting Care ProcessPromoting Care Process

• F329 notes that medication management is based in the care process

Recognition or identification of the problem/need/risk

Assessment (gathering details) Diagnosis/cause identification Management/treatment Monitoring Revising interventions, as warranted

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Strategies: Care ProcessStrategies: Care Process

•Advise prudent “disease management” Must be in context Needs a sound biological basis Hard to isolate targeted organs Often invokes the “law of unintended

consequences”

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The “Cascade Effect”The “Cascade Effect”

• Symptoms (including those related to medications often part of a cascade of problems

Medication lethargy decreased oral intake fluid/electrolyte imbalance further lethargy weight loss skin breakdown

Pneumonia confusion medication lethargy skin breakdown

TJ/CMS2007 - 49


•Members of the interdisciplinary team participate in the care process by:

identifying, addressing, advocating for, monitoring, and communicating the resident’s needs and changes in condition.

Selecting medications and non-pharmacological interventions

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ChallengesChallenges

• Nonpharmacologic interventions can be contrary to the instincts of some physicians, consultant pharmacists, and nurses

• Often require somewhat more time for staff to deliver, practitioners to identify

• Promoting a patient-centered approach The “easy way out” is often harder on the

patient Medications should not constitute “path of

least resistance”

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When treating the disease, treat the When treating the disease, treat the whole patient & consider therapeutic whole patient & consider therapeutic alternativesalternatives

Elderly patient with CHF, DM, HTN Medications: Lasix, KCl, Lanoxin,

Glucotrol, Calan SR

Alternative: ACE Inhibitor (lisinopril)

+/CHF, +/HTN, +HypoK, +/Diabetic nephropathy

TJ/CMS2007 - 52

Clinical Strategies: Clinical Strategies: Key PrinciplesKey Principles

•Respect for basic biology Good / Patient-Centered

Coordinated care of individuals with [A+B+C+D+etc]

Bad / Discipline (or Provider)-Centered [Care for patient with A] + [Care for patient with

B] + [Care for patient with C] + [Care for patient with D] + [etc.]

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Discipline-Centered CareDiscipline-Centered Care

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Resident/Patient-Centered Resident/Patient-Centered CareCare

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Strategies: Multiple Strategies: Multiple PrescribersPrescribers

• Next day or Monday review of medications prescribed during nights and weekends

Follow-up with attending physician of questionable orders, undefined symptoms, high-risk medications

• Emphasize attending physicians as being responsible for coordinating all medical orders, “prescribing gatekeepers”

• Clear identification of, and limits on, roles of consultants, providers, or suppliers (e.g., hospice, pain clinic, psychiatry, specialists, dialysis programs)

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Strategies: Strategies: Medications and Related Medications and Related RisksRisks

•Promote use of references about how to care for patients with various conditions that may require medications

Books, monographs, articles, PDR, etc Pertinent clinical protocols and guidelines Effective application of current standards

of practice Computer-based resources

•Provide FDA / manufacturer warnings

TJ/CMS2007 - 57

Compliance StrategiesCompliance Strategies

•Encourage relevant patient-specific documentation to explain decisions

•Not a good pharmacy consultation “Please provide a diagnosis to justify the

continued use of this medication.” “They have a diagnosis; you should start a

medication.”•Clearly distinguish economic-based

recommendations from clinical ones

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Strategies: Strategies: Promote Pertinent Promote Pertinent DocumentationDocumentation

•What should be documented? How did we identify the symptom How did we decide that the symptom

reflected a problem? How did we decide the problem or

symptoms required a treatment? How did we identify a cause (or decide

a cause could not be identified)?

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Documentation And Care Documentation And Care ProcessProcess

How did we decide the cause could (or could not) be treated?

How did we decide that the cause should (or should not) be treated?

Why did we decide that the treatment needed to include a medication?

Why did we decide that a high-risk medication was indicated?

How did we decide that an existing high-risk medication could not be discontinued or tapered?

How did we try to prevent an ADR? How did we show that we were monitoring for a

potentially significant ADR?

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Regarding Medications, Good Regarding Medications, Good Intentions Alone Are Not Intentions Alone Are Not EnoughEnough

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Where in the clinical record would you look to obtain information about a resident’s medication

regimen?

TJ/CMS2007 - 62

Location of InformationLocation of Information

• Hospital discharge summaries & transfer notes

• Progress notes & interdisciplinary notes

• History & physical examinations

• Resident Assessment Instrument (RAI)

• Plan of care

• Lab reports

• Professional consults

• Medication orders

• Medical Regimen Review (MRR) reports

• Medication Administration Records (MAR)

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Six Medication Management Six Medication Management ConsiderationsConsiderations

I. Indications for use of medicationII. Monitoring for efficacy & adverse

consequencesIII. Dose IV. DurationV. Tapering/gradual dose reduction

(GDR)VI. Prevention, identification & response

to adverse consequences

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I.I. Indications for Use of Indications for Use of MedicationMedication

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Indications for Use of Indications for Use of MedicationMedication

Indications require evaluation of information such as:

Co-morbid conditions, signs, and symptoms Goals and preferences Allergies, potential interactions Past and current medications and interventions Recognition of need for end-of-life or palliative

care Refusal of care and treatment Assessment instruments and diagnostic tools

TJ/CMS2007 - 66


Analysis is used to:•Rule out other causes of symptoms•Identify whether signs/symptoms are

significant/persistent to warrant medication

•Determine if the medication addresses symptom/condition

•Identify whether the benefits outweigh risks

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Unnecessary MedsUnnecessary MedsGeneralGeneral • Diagnosis alone may not warrant treatment with

medication• PRN meds - important to evaluate and document:

Indication(s) Specific circumstances for use Frequency of administration

• Orders from multiple prescribers can increase resident’s chances of receiving unnecessary meds

• Although the guidelines generally emphasize the older adult resident, adverse consequences can occur at any age; therefore, these requirements apply to residents of all ages

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What do these 5 circumstances have in common?

• A clinically significant change in condition/status

• A new or recurrent clinically significant symptom

• A worsening of an existing problem or condition• An unexplained decline in function or cognition• Psychiatric disorders or distressed behavior

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What information would What information would you consider when you consider when

evaluating indication for evaluating indication for use? use?

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InformationInformation

• Mental, physical, psychosocial & functional status

• Goals & preferences of the resident/designated representative

• Allergies

• History of prior & current medications and non-pharmacological interventions

• Recognition of need for end-of-life or palliative care

• Refusal of care & treatment

• RAPS

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Case ScenarioCase Scenario

Ms. D. is an 80-year-old female admitted 6 months ago to the nursing home. Her current clinical record describes her as follows:

• With “general symptoms” of cardiovascular disease

• Suspected s/s ischemic MI

• Dementia, history of seizures

• Care plan for mood and behavior, bowel & bladder incontinence, and weight loss.

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During the most recent certification survey, the pharmacy MRR notes were reviewed and a request to clarify indications for use of all medications was recommended in the last two monthly MRRs.

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Labs• K+ = 3.6 (on admission)

• TSH = 2.5 (on admission)

Weight• 110 lbs (on admission)

• 97 lbs (6 months later)

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Case ScenarioCase Scenario • Olanzapine (Zyprexa) 5mg

at bedtime for behaviors (yelling, and refusing care)

• Lorazepam (Ativan) 2mg vial IM for seizure activity

• Lorazepam (Ativan) 0.5mg for anxiety manifested by restless movement

• Temazepam (Restoril) 7.5mg at bedtime as needed for sleep

• Phenytoin (Dilantin) 100mg at 8am, and 200mg at 5pm

• KCL elixir 20mEq at 8am

• Levothyroxine (Synthroid) 100mcg daily

• Rantidine (Zantac) 150mg daily for GI distress

• Donepezil (Aricept) 5mg daily

• Isosorbide Dinitrate 20mg one tablet three times daily for angina

• Megesterol acetate (Megace) 800mg daily to increase appetite

• Atenolol (Tenormin) 50mg daily

• ASA 25mg/dipyridamole 200mg)(Aggrenox) one cap daily

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Clinical “Triggers”Clinical “Triggers”

• Admission or readmission

• Clinically significant change in condition/status

• New, persistent or recurrent clinically significant symptom or problem

• Worsening of existing problem/condition

• Unexplained decline in function or cognition

• New medication order or renewal order

• Irregularity in pharmacist’s monthly medication regimen review

• Multiple prescribers

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Physician OrdersPhysician Orders

• CLARIFY CONFUSING ORDERS• CLEARLY MARK STOP DATES• AVOID OPEN ENDED ORDERS• AVOID DOSAGE RANGES• CAREFULLY TRANSCRIBE HOSPITAL DISCHARGE ORDERS• MAKE SURE ORDERS WITH PARAMETERS ARE FOLLOWED• MAKE SURE LABS ARE DONE AS ORDERED• CHECK FOR DRUG ALLERGIES PRIOR TO ORDERING FROM

PHARMACY OR TAKING A MED FROM EMERGENCY KIT• INFORM PRESCRIBER OF FREQUENTLY REFUSED DOSES

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Faxing to PhysiciansFaxing to Physicians

• INCLUDE PERTINENT AND CURRENT MEDICATIONS• INFORM OF PRN MEDICATION USE *FREQUENCY

*EFFECTIVENESS• CLEARLY LIST SYMPTOMS, VITAL SIGNS • HOW LONG SYMPTOMS PRESENT• BE SPECIFIC ON YOUR DESIRED OUTCOME

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•[FAX] Concern: Loretta in ER last night for epistaxis. Still c/o dizziness and headache today. Now states behind eye “throbbing.” BP now 160/92. BP this am 192/90 (with meds given). Physician lisinopril to 20 mg BID yesterday. Has only Tylenol 650 mg per standing orders. Any changes?

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•Response by Physician: T#3. i – ii po q 4 to 6° prn pain if not allergic. BP should improve if ↓ pain. Toprol XL 25 mg i po daily - start today if BP remains high.

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•Response by Pharmacist: Did Dr. know Loretta already on atenolol for BP? Might want to that or DC it & Δ to Toprol. Already receiving in addition to Zestril 20 mg BID, Norvasc 10 mg qd, HCTZ 25 mg qd, Atenolol 50 mg qd. Do you want to change above orders?

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•2nd Repsonse by Physician: D/C Toprol. *Would be nice to see med sheets when asking the [question] “Any changes?”My memory can’t keep track of everyone’s meds (How is BP today? Better? ?HA better with pain meds)

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•[FAX] Regarding: Resident has anxiety, should we Paxil (currently 10 mg qd) or add Ativan? Also, how often should we draw CEA?

•Physician Response: No more CEA’s Ativan 0.5 mg po q 6° prn15 mg qd

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•[FAX] Regarding: Resident has been having trouble sleeping & would really like a “gentle” sleeping pill. Tylenol PM?

•Physician Response: Tylenol PM 1 tablet at bedtime

(650/25 mg)

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•[FAX] For Your Information: Resident is receiving Ativan 0.5 mg tab po 30 mins. before bath prn. We are wondering if she could benefit from Zyprexa to help her with her behaviors.

•Physician Response: What behaviors?

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•Discussion (last slide): Resident was already on Depakote 125 TID since 1/06, and it was increased 2/06 to 250 TID. This was never mentioned in fax.

•F/U fax to MD: Frequently combative & resistant with cares, refuses to change soiled clothes for days and does not like to bathe. She slaps out & yells.

= Rx Zyprexa 1.25 qd (3/06)

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IndicationIndication

• Considerations include whether…. An appropriately detailed

evaluation/assessment has occurred Other causes of symptoms have been ruled out Signs, symptoms are persistent or clinically

significant enough to warrant medication use Non-pharmacological interventions were

considered Particular medication is indicated to manage

that symptom/condition

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• Considerations include whether…. Intended or actual benefit justifies

potential risks Resident’s goals and preferences (inc. end-

of-life needs) have been considered Resident has allergies to the medication or

the potential for interactions Effectiveness and adverse consequences

from previous and current therapy have been considered

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•Resident started on risperidone for being resistive to cares.

Did facility rule out other causes? Is resistance harmful? Is this behavior persistent? Were other interventions considered, tried?

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Question Question

Which of the following is NOT an appropriate indication for an antipsychotic?

A. Delirium

B. Depression with psychotic features

C. Schizoaffective disorder

D. Wandering

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SummarySummary

Indication for Use: Evaluation of resident helps to identify

needs, comorbid conditions & prognosis to determine factors that are affecting signs, symptoms and test results

Clinical “triggers” warranting evaluation

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II.II. Monitoring for Efficacy Monitoring for Efficacy & Adverse & Adverse

ConsequencesConsequences

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Monitoring for Efficacy Monitoring for Efficacy & Adverse Consequences& Adverse Consequences

Steps in Monitoring• Identify information and how it will be

obtained and reported• Determine frequency• Define method to communicate,

analyze and act• Re-evaluate and updating approaches

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Sources may help to define monitoring criteria:

•Manufacturers’ package inserts, black-box warnings

•Facility policies and procedures•Pharmacists•Clinical guidelines or standards of practice•Medication references•Published clinical studies or articles

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• Review Psychopharmacological and Sedative/Hypnotic medications quarterly

• Documentation must include: Resident’s target symptoms and

effect of medication Changes in resident’s function Medication-related side effects or

adverse consequences

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Importance of MonitoringImportance of Monitoring

• Tracks progress towards therapeutic goals

• Detects emergence or presence of any adverse consequences

BENEFIT RISK

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Monitoring ParametersMonitoring Parameters

• Resident’s condition

• Pharmacological properties of medication & its risks

• Individualized therapeutic goals

• Potential for clinically significant adverse consequences

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Monitoring Monitoring What is the purpose of monitoring?

To incorporate medication-related goals and monitoring parameters into the resident’s comprehensive care plan

In some cases, can refer to facility’s established protocols or P+Ps

To optimize med therapy (BENEFITS) while minimizing adverse consequences (RISKS)

To establish parameters for evaluating the ongoing need for the medications

To verify or differentiate the underlying diagnoses/causes of signs and symptoms

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MonitoringMonitoring• What are the steps or components of monitoring?

Identify the essential information and how it will be obtained and reported

Determine the frequency and duration of monitoring Define the methods for communicating, analyzing, and

acting upon relevant information Re-evaluate and update monitoring approaches

• Using QUANTITATIVE and QUALITATIVE monitoring parameters facilitates consistent and objective collection of info by facility

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ExamplesExamples of tools used for determining of tools used for determining baseline status as well as for baseline status as well as for

monitoring monitoring may include, but are may include, but are not limited to:not limited to:

• Physiological, Cognitive, & Functional Status:

Vital signs, ECG, lab studies, blood sugars, HgbA1C

Resident Assessment Instrument (RAI)

Minimum Data Set (MDS)

Pain scales

Physical Self Maintenance Scale (PSMS)

Functional Alzheimer’s Screening Test (FAST) scale

Mini-Mental Status Exam (MMSE)

Confusion Assessment Method (CAM)

Instrumental Activities of Daily Living Scale (IADL)

Abnormal Involuntary Movement Scale (AIMS)

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ExamplesExamples of tools used for determining of tools used for determining baseline status as well as for baseline status as well as for

monitoring monitoring may include, but are may include, but are not limited to:not limited to:

• Mood/Affect:

Geriatric Depression Scale (GDS)

Cornell Depression in Dementia Scale

Mania Rating Scale

• Behavior

Behavioral Pathology in Alzheimer’s Disease Rating Scale (Behave AD)

Cohen-Mansfield Agitation Inventory (CMAI)

Neuro-psychiatric Inventory-Nursing Home Version (NPI-NH)

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Ms. A is a 78 yr old woman recently admitted to the facility within the month after sustaining a fall at home and fracturing her ankle. She has a history of hypertension, stroke 2 yrs ago and heart attack in her 60s. She is being seen in physical therapy for rehab.Blood Pressure and pulse are checked daily in the morning.

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Medications• Aspirin 325mg daily for prevention

• Naproxen 500mg twice daily for pain

• Lisinopril 30mg daily for hypertension

• Alendronate 70mg weekly for Osteoporosis

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SummarySummary

Monitoring Efficacy & Adverse Consequences: Track progress towards therapeutic goals Detect adverse consequences Parameters – resident’s condition,

pharmacological properties & risks, individualized therapeutic goals, clinically significant adverse consequences

Monitoring Tools and Methods job aid

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III.III. Dose Dose

(Including Duplicate (Including Duplicate Therapy)Therapy)

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Dose influenced by:Dose influenced by:

Tables/Drug References provide general guidance on doses

Resident parameters (renal, hepatic, weight)

Current condition, signs and symptoms Co-morbid conditions Type of medication Therapeutic goals Clinical response Concurrent medications Possible adverse consequences Route of administration Inputs from interdisciplinary team

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Dose influenced by:Dose influenced by:

•Lab tests (i.e., serum medication concentrations) are only rough guide

Significant adverse consequences can occur even with lab results are within therapeutic range

Lab results alone warrant evaluation, but do not necessarily warrant dose adjustment

•Other test results

•Therefore, …………….…………………………………..

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The same dose of a medication The same dose of a medication given given two different people may cure one two different people may cure one and harm the other. and harm the other. (2-edged sword)(2-edged sword)

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Drugs Don’t Have Drugs Don’t Have Doses,Doses,People Do!People Do!

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Duplicate TherapyDuplicate Therapy

• Use of 2 or more medications from the same therapeutic class or the use of medications with similar effects from several classes

• Generally not indicated• Clinical rationale (because of different

mechanisms, synergism, standards of practice) may result in justification to reach therapeutic goals, but needs to be monitored

• Potentially can increase the risk of adverse consequences

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Duplicate TherapyDuplicate Therapy

•Duplicate therapy examples… Acetaminophen-containing products Multiple laxatives Multiple benzodiazepines Anticholinergic effects

•Documentation is necessary to clarify rationale for, benefits of, and monitoring of duplicate therapy

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Dose/Duplicative TherapyDose/Duplicative Therapy

•Is there justification for low or high doses?

•Are there medications in the same class? If yes is there any justification?

•Must Document.

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SummarySummary

Dose: Influencing factors - clinical response, possible

adverse consequences, diagnosis, signs & symptoms, current condition, age, coexisting medication regimen, lab & other test results, therapeutic goals, type of medication

Route of administration Duplicate therapy generally NOT indicated Dosage Tables & Drug Interaction Table job

aids

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IV.IV. DurationDuration

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DurationDuration

•Looking at resident conditions are medications being used for the appropriate time frames?

•Is condition still present?•Acute vs. Chronic

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Importance of DurationImportance of Duration

• Many conditions require treatment for extended periods, while others may resolve and no longer require medication

• Excessive Duration may lead to Increased risk of adverse consequences

Increased risk of medication interactions

Antibiotic resistance

• Inadequate Duration of Treatment may also lead to treatment failure

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DurationDuration• Some meds needed for extended periods, others

shorter-term Acute conditions

Cough/Cold Nausea/Vomiting Acute Pain Psychiatric/Behavioral Symptoms

• If stop date according to facility P+P, discontinuation should occur - otherwise document clinical rationale

• Clinical rationale for continued use of a medication may have been demonstrated in clinical record, or staff/prescriber may present clinical rationale

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SummarySummary

Duration: Periodic re-evaluation necessary

Clinical rationale for continued use may be demonstrated in clinical record

Staff or prescriber may present pertinent clinical reasons

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V.V. Tapering of Medication Tapering of Medication Dose/Gradual Dose Dose/Gradual Dose Reduction (GDR) for Reduction (GDR) for

Antipsychotic MedicationsAntipsychotic Medications

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Tapering/GDRTapering/GDR

Goals of Tapering or Gradual Dose Reduction (GDR):

• Determine lowest effective dose• Discontinue medication that is no

longer needed or of benefit to the resident

• Minimize exposure to increased risk of adverse consequences

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Tapering/GDRTapering/GDR

Indicated when: Clinical condition improves or stabilizes Underlying causes of original target

symptoms have resolved Non-pharmacological interventions have

been effective in reducing symptoms

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Non-Pharmacologic Non-Pharmacologic Behavioral InterventionBehavioral Intervention

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Factors to ConsiderFactors to Consider

• Coexisting medication regimen

• Underlying causes of symptoms

• Individual risk factors

• Pharmacological characteristics

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Tapering/GDR: “Real Tapering/GDR: “Real Impact”Impact”

•New classes of medications added to those needing tapering

•Categories of GDR: Antipsychotics•Categories of Tapering: Sedative

Hypnotic, Other “Psychopharmacologic medications”.

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Behavior MonitoringBehavior Monitoring• So, which med classes mention behavior

monitoring? According to Table 1… Antipsychotics

Before initiating or increasing for enduring condition, target behaviors must be clearly and specifically identified and monitored objectively and qualitatively

Anxiolytics When used for delirium, dementia, and

other cognitive disorders with associated behaviors, behaviors to be quantitatively and objectively documented

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Pharmacologic Pharmacologic Behavior ManagementBehavior Management

•Often over-rated, over-utilized, and lacking adequate documentation.

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GDR/Tapering for GDR/Tapering for AntipsychoticsAntipsychotics•Old:

The length of time before an antipsychotic dose reduction is attempted should be consistent with the condition being treated

Frequency of GDR: twice a year (for residents with organic mental syndrome)

GDR is clinically contraindicated if two previous attempts within the last year led to a return of symptoms or return to the previous dose was necessary OR physician provides clinical rationale OR the patient has a specific DX and meets criteria listed in guidelines

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GDR/Tapering for GDR/Tapering for AntipsychoticsAntipsychotics

GDR and behavior monitoring now applies to antipsychotics no matter what the

indication - behavioral symptoms related to dementia OR psychiatric disorder!

•No more exemption for psychiatric “special conditions” as mentioned in current guidelines

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GDR/Tapering for GDR/Tapering for AntipsychoticsAntipsychotics

•New: Within 1st year after admission on

antipsychotic or after initiation: GDR in 2 separate quarters, with at

least one month between attempts After 1st year,

GDR annually GDR is clinically contraindicated if:

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Antipsychotic indication &Antipsychotic indication &GDR ContraindicationsGDR Contraindications

•Behavioral symptoms related to dementia

The resident’s target symptoms returned or worsened after the most recent attempt at a GDR within the facility; 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 increase distressed behavior.

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•Other psychiatric disorders (e.g., schizophrenia, bipolar mania, depression with psychotic features)

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

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•Other psychiatric disorders (e.g., schizophrenia, bipolar mania, depression with psychotic features)

The resident’s target symptoms returned or worsened after the most recent attempt at a GDR within the facility 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.

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AntipsychoticsAntipsychotics

BW has been at the facility for the last 6 months. According to the physician order sheet (POS) the dose of the patient’s haloperidol was reduced approximately 3 months ago without any worsening of behavioral symptoms of dementia namely the hallucinations.

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Tapering for Tapering for Sedatives/HypnoticsSedatives/Hypnotics

•Old: Begin tapering after 10 days of continuous

daily use Frequency: three times within 6 months Tapering is clinically contraindicated if

three attempts within the last 6 months led to a decline

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Tapering for Tapering for Sedatives/HypnoticsSedatives/Hypnotics

•New: For as long as a resident remains on a

sedative/hypnotic that is used ROUTINELY and beyond the manufacturer’s recommendations for duration of use, the facility should attempt to taper the medication quarterly unless clinically contraindicated.

Sedatives/Hypnotics now include… New agents (non-benzodiazepine) Sedating antidepressants (e.g., trazodone) Sedating antihistamines (e.g, hydroxyzine)

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Sedatives/HypnoticsSedatives/Hypnotics

MH is an 82 yr WF who has been at the facility for the last 3 months. She is taking temazepam at bedtime.

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Tapering for Tapering for “Psychopharmacological Meds”“Psychopharmacological Meds”

•Old - ONLY APPLIES TO BENZODIAZEPINES:

Begin taper after 4 months of continuous daily use

Frequency: twice a year Tapering is clinically contraindicated if two

previous attempts within the last year led to a decline

•No mention of tapering of other pharmaceutical classes mentioned in old guidelines

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Psychopharmacological Psychopharmacological MedicationsMedications

• “Any medication used for managing behaviors, stabilizing mood, or treating psychiatric disorders”

• Important to understand the indication for use because many psychopharmacological medications may be used for multiple indications (examples…)

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Tapering for Tapering for Psychopharmacological MedsPsychopharmacological Meds

•New: Psychopharmacological meds now grouped

together, so more than just benzodiazepines

What classes might this include or impact? According to Table 1…. Anticonvulsants Antidepressants Anxiolytics - including buspirone,

antidepressants

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GF is an 84 yr old resident who has been at the facility for 2 years. Since being admitted to the facility, he has been on the same dose of sertraline for h/o depression.

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Tapering Tapering Clinically ContraindicatedClinically Contraindicated

•Hypnotics 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

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TaperingTaperingClinically ContraindicatedClinically Contraindicated

•Hypnotics The resident’s target symptoms returned

or worsened after the most recent attempt at tapering the dose within the facility 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.

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•Tapering Other Psychopharmacologic Meds

The facility should attempt to taper the medication during at least two separate quarters (with at least one month between the attempts), unless clinically contraindicated. After the first year, a tapering should be attempted annually, unless clinically contraindicated

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Tapering Tapering Clinically ContraindicatedClinically Contraindicated

•Psychopharmacological Medications 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

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TaperingTaperingClinically ContraindicatedClinically Contraindicated

•Psychopharmacological Medications The resident’s target symptoms returned or

worsened after the most recent attempt at tapering the dose within the facility 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.

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Tapering and GDRTapering and GDR

When would the interdisciplinary When would the interdisciplinary team evaluate the resident’s team evaluate the resident’s response to medications and response to medications and

consider reduction or consider reduction or discontinuation of medications?discontinuation of medications?

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Tapering/GDRTapering/GDR• Opportunities for evaluation of medication, in

regards to duration/dose: Consultant Pharmacist’s MRR Physician’s visit or signing of orders During quarterly MDS review

• What to evaluate: Resident’s target symptoms and the effect of the

medication on symptoms (e.g., severity, frequency) Changes in resident’s function during previous

quarter (e.g., MDS) Whether resident experienced any medication-related

adverse consequences during previous quarter

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The “Art of The “Art of Tapering/GDR”Tapering/GDR”•Gradual (When in doubt, go slow)•Try not to reduce by >1/4 to 1/3 dose every

1-3 months, or longer (Hypnotics possible quicker)

Less likely to precipitate withdrawal dyskinesia Less likely to induce withdrawal anxiety,

insomnia, exacerbation of symptoms More likely to result in achieving minimal

effective dose

•PRN dosing can be part of tapering Educate nursing staff re: PRN use

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SummarySummary

Tapering/GDR: Tapering applies to ALL medications

Regulations require attempted GDR only for antipsychotic medications

Factors – coexisting medication regimen, underlying causes of symptoms, individual risk factors, pharmacological characteristics

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VI.VI. Prevention, Prevention, Identification & Identification &

Response to Adverse Response to Adverse ConsequencesConsequences

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Adverse ConsequencesAdverse Consequences

•Increased Adverse Consequence Risk Advanced age Multiple co-morbid conditions Number of medications Certain pharmacologic classes

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ADRs Increase With ADRs Increase With Number of MedicationsNumber of Medications

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Strategies: Strategies: Adverse ConsequencesAdverse Consequences • Promote system to anticipate, monitor for,

recognize, act upon adverse consequences Unanticipated decline, falls, confusion,

anorexia, dizziness, lethargy, incontinence, etc

• Medication regimen gets discussed for every change of condition, new symptom, worsening of symptoms despite treatment, etc

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Delirium Common medication-related adverse

consequence Individuals who have dementia may

be at greater risk for delirium Delirium is associated with higher

morbidity and mortality

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ImportanceImportance

• Adverse consequences related to medications are common!

• In a 2005 study, 42% of adverse drug events were judged preventable

• Most common omissions included: Inadequate monitoring Lack of/delayed response to signs,

symptoms, or laboratory evidence of medication toxicity

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• Another study of 18 nursing homes reported that:

51% (276/546) of the adverse consequences were considered preventable

72% (171/238) of those considered as fatal, life-threatening, or serious were preventable

34% (105/308) of significant events were considered preventable

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QuestionQuestion According to the investigative protocol guidance, which of the following signs or symptoms may be associated with medications:

A. Dehydration

B. Constipation

C. Bruising

D. All of the above

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Adverse ConsequencesAdverse Consequences• Any medication can cause adverse consequences• Considerations include…

Following relevant clinical guidelines and/or manufacturer’s specifications for use, dose, duration, monitoring

Defining appropriate indications for use Determining that the resident

Has NKA to the medication Is not taking other medications, products, food that

would be incompatible Has no condition, history, or sensitivities that

would preclude use of that medication

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Role of “Beers Criteria”Role of “Beers Criteria”

• Beers Criteria is not listed and titled as such (like they are in current guidelines)- But, Beers criteria medications are incorporated into pieces of the document (e.g., TABLES 1+2)

• New Beers criteria, as of 2003: Fink DM, Cooper JW, Wade WE. Updating

the beers criteria for potentially inappropriate medication use in older adults. Arch Intern Med 2003;163:2716-24.

Article in May 2004 edition of The Consultant Pharmacist

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SummarySummary

Prevention, Identification & Responses to Adverse Consequences:

Statistics demonstrate need & importance

Tables I & II job aids

Drug Information Resources job aid

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Table I:Table I: Medication Issues of Particular Medication Issues of Particular RelevanceRelevance

Examples of categories of medications that:

• Have potential to cause clinically significant adverse consequences

• Have limited indications for use• Require precautions in selection or

use• Require specific monitoring

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Table II:Table II: Medications with Significant Medications with Significant Anticholinergic PropertiesAnticholinergic Properties

Anticholinergic side effects are common

Medications in many categories have anticholinergic properties

Use of multiple medications with anticholinergic properties may be particularly problematic

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TABLE I: TABLE I: Medication Issues of Particular Medication Issues of Particular RelevanceRelevance

• Alphabetically lists examples of some categories of and/or specific medications that have the potential to cause clinically significant adverse consequences, have limited indications for use, require specific monitoring. or warrant consideration of risks vs. benefits

• Medications mentioned are not meant to be absolutely contraindicated for every resident, but that the medication has the potential to be unnecessary

• While Table 1 is 36 pages long, it does not include all categories nor all medications within a category

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TABLE I: TABLE I: Medication Issues of Particular Medication Issues of Particular RelevanceRelevance

• Current (“old”) guidelines include daily dose recommendations for psychotropic medications

• Previous drafts of revised guidance did NOT include dose examples

• But, final document includes Daily Dose Thresholds for:

Antipsychotics Anxiolytics Sedatives/Hypnotics

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AnalgesicsAnalgesics• Acetaminophen Avoid >4 Gm/day, LFTs.• NSAIDs Trial APAP alternative;

interactions with ASA, anticoagulants, anti-platelet agents; risks for GI bleed, renal insuff, CHF; CNS effects with some NSAIDs.

• Opioids Shorter-acting agent trial before long-acting;

avoid meperidine; ADRs.

• Pentazocine Limited efficacy; >ADRs.• Propoxyphene Risks > Benefits.

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AntibioticsAntibiotics

• All Confirmed/suspected infection. (e.g., not for asymptomatic bacteruria)

• Aminoglycosides, Renal Fn, serum levels IV Vanco to minimize ADRs.

• Nitrofurantoin Renal insuff (CrCl<60); ADRs (pulmonary, neuropathy).

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Anticoagulants, Anticoagulants, Anticonvulsants, Anticonvulsants, AntidepressantsAntidepressants

• Warfarin INRs; interactions• Anticonvulsants Duration based on

indication; possible serum levels; ADRs on liver, bone marrow, derm., CNS, falls.

• Antidepressants Indication; 2 or >; duration; GDR/tapering; worsening Sx; interactions; ADRs (CNS, GI, falls, seizures, serotonin syndrome).

• MAOIs; TCAs BP-tyramine; antichol., etc.

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Antidiabetic medicationsAntidiabetic medications

• All : Blood sugar monitoring, HbA1c. ?Long-term sliding scale insulin use

• Avandia : visual/macular monitoring• Actos, Avandia : Edema/CHF• Metformin : renal function; contrast dyes; CHF• Sulfonylureas : SIADH• Chlorpropamide, Glyburide : >t½ =

>hypoglycemia

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95 y.o. female in nursing home 95 y.o. female in nursing home with CHF, DMwith CHF, DM

• 5/25/05: Hospitalized with ↑SOB, fatigue, ↑edema. Chest x-ray shows significant CHF/cardiomegaly.

• Dx: CHF exacerbation, severe peripheral edema, renal insufficiency.

• Hx: 5/12/05 Glucotrol XL 10mg q.d. decreased to 5mg q.d. and Actos 30mg q.d. started.

• Tx: Increase Lasix. • Discontinue Actos. Start Lantus.

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Important HistoryImportant History

•Hospitalized 7/04 with discharge diagnosis of Actos-induced exacerbation of CHF.

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Antifungals Antifungals (systemic (systemic imidazoles)imidazoles)

•Significant interactions with warfarin, phenytoin, theophylline, sulfonylureas; also rifampin, cimetidine.

•Liver impairment

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Antimanic medicationsAntimanic medications

•Lithium Caution with renal impairment, CV disease,

severe debilitation, dehydration, sodium depletion.

Serum level monitoring. Interactions : thiazides, ACEIs, NSAIDs

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Antiparkinson medicationsAntiparkinson medications

•Confusion, restlessness, delirium, dyskinesia, dizziness, hallucinations, agitation, nausea.

•Postural hypotension, falls.

•Adverse effect dilemma

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AntipsychoticsAntipsychotics

•Analysis of antipsychotic use by 693,000 Medicare nursing home residents

28.5% received excessive doses

32.2% lacked appropriate indications for use

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Antipsychotic medicationsAntipsychotic medications•Diagnoses

Schizophrenia Schizo-affective

disorder Delusional

disorder Mood disorder

(Bipolar, depression with psychosis, etc.)

Schizophreniform disorder

Psychosis NOS Atypical psychosis Brief psychotic

disorder Dementing illness

with associated behavioral symptoms

Medical illness or delirium with manic or psychotic symptoms

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Antipsychotics: Antipsychotics: Additional criteriaAdditional criteria

•Symptoms are due to mania or psychosis; OR

•Behavioral symptoms present danger to self or others; OR

•Symptoms are significant enough that the resident experiences:

Inconsolable or persistent distress Significant decline in function Substantial difficulty receiving needed care

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Antipsychotics: Antipsychotics: Inadequate indicationsInadequate indications

• Wandering• Poor self-care• Restlessness• Impaired memory• Mild anxiety• Insomnia• Unsociability• Inattention or

indifference to surroundings

• Fidgeting• Nervousness• Uncooperativeness• Verbal expressions or

behavior not due to conditions listed under appropriate indications and that do not represent a danger to the resident or others

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Antipsychotic Antipsychotic Dose Dose ThresholdsThresholds in Dementing in Dementing IllnessesIllnesses• Chlorpromazine 75mg• Fluphenazine 4mg• Haloperidol 2mg• Loxapine 10mg• Molindone 10mg• Perphenazine 8mg• Thioridazine 75mg• Thiothixene 7mg• Trifluoperazine 8mg

• Aripiprazole 10mg

• Clozapine 50mg

• Olanzapine 7.5mg

• Quetiapine150mg

• Risperidone 2mg

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Antipsychotics:Antipsychotics:Monitoring/Adverse Monitoring/Adverse ConsequencesConsequences

• Anticholinergic• Akathisia• NMS• Arrhythmias;

heart-related events• Falls• Lethargy/Sedation

• Pseudoparkinsonism• Blood sugar elevation• Increased lipids• Orthostatic

hypotension• TIA/CVA in dementia• Tardive dyskinesia

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Tardive DyskinesiaTardive Dyskinesia

•Risk factors Increased age Brain damage, CVAs, seizures, etc. Total cumulative antipsychotic dose Antipsychotic dosage Antipsychotic agent

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AnxiolyticsAnxiolytics

• Indications BZDPs, Buspirone, antidepressants

• Dosage• Duration (Tapering/GDR)• Adverse Consequences• Diphenhydramine, hydroxyzine:

Not appropriate• Meprobamate:

addictive, sedating, not indicated

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Anxiolytics: Anxiolytics: Dosage Dosage ThresholdsThresholds

• Flurazepam 15mg• Chlodiazepoxide 20mg• Clorazepate 15mg• Diazepam 5mg• Cloazepam 1.5mg• Quazepam 7.5mg• Esazolam 0.5mg• Alprazolam 0.75mg• Oxazepam 30mg• Lorazepam 2mg

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Cardiovascular medicationsCardiovascular medications

• Antiarrhythmics: mental function, falls, appetite, behavior, heart function

• Amiodarone: limited indications, pulmonary toxicity, hepatic, thyroid, heart failure, interactions with digoxin & warfarin

• Disopyramide: decrease contractility, heart failure, anticholinergic

• Antihypertensives: dose modification, gradually taper some, dizziness, postural hypotension, fatigue, risk for falls

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• Alpha blockers: significant hypotension and syncope with initial doses (slow titration); prazocin more CNS effects

• ACEIs: monitor K+, cough, renal failure, interactions that increase K+, angioedema

• Beta blockers: bradycardia, dizziness, fatigue, bronchospasm, depression, acute heart failure decompensation, mask tachycardia of hypoglycemia, increased effects in hepatic dysfunction

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• Ca+Channel blockers: constipation, edema, avoid short-acting

• Methyldopa: risk > benefit, bradycardia, sedation, depression

• Digoxin: Dx only includes CHF, AF, PSVT, Atrial flutter

• Diuretics: fluid-electrolyte imbalance, hypotension, urinary incontinence, falls

• Nitrates: HA, dizziness, lightheadedness, faintness, orthostatic hypotension

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Cholesterol lowering Cholesterol lowering medicationsmedications

• Statins: LFT monitoring, muscle pain, myopathy, rhabdomyolysis to kidney failure

• Cholestyramine: absorption interactions with other co-administered medications, constipation, dyspepsia, nausea, vomiting, abdominal pain

• Fibrates: LFT and CBC monitoring• Niacin: glucose and LFT monitoring, gallbladder

disease, gout, flushing

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Cognitive enhancersCognitive enhancers

• Cholinesterase inhibitors: evaluate continued use in advanced stages, cardiac conduction, insomnia, dizziness, N/V/D, anorexia, weight loss, caution in asthma-COPD

• Memantine: evaluate continued use in advanced disease, restlessness, distress, dizziness, somnolence, hypertension, HA, hallucinations, increased confusion

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AD is a 77 yr old female who has been recently admitted to the facility after the family was unable to care for her at home. Per the family, she is having continual episodes of urinary incontinence and her memory is getting worse.

PMH: Alzheimer’s disease for 2 years, new onset diarrhea over last 1 -2 months, osteoporosis

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Case ScenarioCase Scenario Medications

• Donepezil 10mg in the evening

• Loperamide 2mg as needed for loose stools

• Calcium 500mg and Vit D 400 IU twice daily

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Cough-Cold-Allergy Cough-Cold-Allergy MedicationsMedications

• Limited duration (<14 days), unless documentation otherwise

• Antihistamines: anticholinergic effects, prefer topical, lowest dose-shortest duration, sedation, confusion, cognitive impairment, distress, dry mouth, constipation, urinary retention, falls.

• Decongestants: dizziness, nervousness, insomnia, palpitations, urinary retention, HTN.

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Gastrointestinal medicationsGastrointestinal medications

• Prochlorperazine, promethazine Caution in Parkinson’s, narrow-angle

glaucoma, BPH, seizure disorder. Sedation, dizziness, postural hypotension,

NMS Anticholinergic effects Extrapyramidal symptoms and T.D. Arrhythmias

• Trimethobenzamide Relatively ineffective; EPSE, lethargy,

sedation, confusion

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Gastrointestinal medicationsGastrointestinal medications• Metoclopramide

Risk > benefit Restlessness, drowsiness, insomnia,

depression, distress, anorexia, EPSE, seizures

• PPIs, H-2 Antagonists Indications based on clinical symptoms

&/or endoscopy Trial alternate analgesics before use for

NSAID gastropathy H-2’s: dosed per renal function; confusion Cimetidine drug interactions PPI’s: risk of Clostridium difficile colitis

TJ/CMS2007 - 192

GlucocorticoidsGlucocorticoids

• Document necessity for continued use• Hyperglycemia, psychosis, edema, insomnia,

HTN, osteoporosis, mood lability, depression

TJ/CMS2007 - 193

HematinicsHematinics

• EPO Assess anemia etiology before use Monitor BP, serum Fe/ferritin, CBC Excess dose/duration

Polycythemia, MI, stroke• Iron

Not indicated for anemia of chronic disease Justify use >2months; >q.d. Baseline serum Fe or ferritin, periodic CBC

TJ/CMS2007 - 194

LaxativesLaxatives

• Flatulence, bloating, abdominal pain• Bulk formers & stool softeners

Adequate fluids to avoid bowel obstruction

TJ/CMS2007 - 195

Muscle relaxantsMuscle relaxants

• Poorly tolerated in elderly due to anticholinergic side effects, sedation, weakness

• Avoid abrupt cessation because of possible seizures or hallucinations

• Usage exception: Periodic use (1 x q. 3 months) for short duration (<=7days)

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Orexigenics Orexigenics (appetite stimulants)(appetite stimulants)

• Assess and manage underlying cause of anorexia/weight loss first

• Monitor efficacy at least monthly• Megesterol: fluid retention, adrenal insufficiency• Oxandrolone: sexual side effects, fluid retention• Dronabinol: tachycardia, orthostatic

hypotension, dizziness, dysphoria, impaired cognition, falls

TJ/CMS2007 - 197

Osteoporosis medicationsOsteoporosis medications

•Bisphosphonates Specific administration guideline

adherence Esophageal or gastric erosion Potential GI symptoms with corticosteroids,

ASA, NSAIDs

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Platelet inhibitorsPlatelet inhibitors

• ASA, Dipyridamole, Clopidogrel Thrombocytopenia, bleeding HA, dizziness, vomiting Caution with NSAIDs, warfarin

• Ticlodipine Risk > benefit (neutropenia) N, V, D

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Respiratory medicationsRespiratory medications

• Theophylline Drug interaction potential Monitor serum levels, toxicity

• Inhalant medications Anticholinergics: dry mouth Beta agonists: restlessness, tachycardia,

anxiety Steroids: throat irritation and candidiasis

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Sedatives/HypnoticsSedatives/Hypnotics

• Rule out underlying causes of insomnia Environment Inadequate physical activity Facility routine issues Caffeine, stimulating mediations Pain, discomfort Co-morbid conditions (psychiatric, medical)

• Caution in sleep apnea• Tapering/Gradual Dose Reduction guidelines• Barbiturates: Avoid (risks > benefits)

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Daily Daily Dose ThresholdsDose Thresholds for Sedative/Hypnotics for Sedative/Hypnotics

• Chloral hydrate 500mg

• Diphenhydramine 25mg• Estazolam 0.5mg• Eszopiclone 1mg• Flurazepam 15mg• Hydroxyzine 50mg• Lorazepam 1mg• Oxazepam 15mg

• Quazepam 7.5mg• Ramelteon 8mg• Temazepam 15mg• Triazolam 0.125mg• Zaleplon 5mg• Zolpidem IR 5mg• Zolpidem CR 6.25mg

TJ/CMS2007 - 202

Thyroid medicationsThyroid medications

• Potential drug interactions affecting dosage• Initiate at low dose, increase gradually• Assess thyroid function studies periodically

TJ/CMS2007 - 203

Urinary incontinence Urinary incontinence medicationsmedications

• Assess underlying cause and identify type of incontinence: select medications accordingly

• Assess urinary symptoms periodically• Monitor side effects

TJ/CMS2007 - 204

Table II:Table II: Medications with Medications with Significant Anticholinergic Significant Anticholinergic PropertiesProperties

Anticholinergic side effects are common

Medications in many categories have anticholinergic properties

Use of multiple medications with anticholinergic properties may be particularly problematic

TJ/CMS2007 - 205

Anticholinergic Side EffectsAnticholinergic Side Effects• Peripheral

Blurred vision Dry mouth Constipation Urinary retention

• Central Labile mood Restlessness Wandering Ataxia Confusion Disorientation Agitation Psychosis Insomnia Delusions Decreased attention

Span Memory impairment

TJ/CMS2007 - 206

Table II: Table II: Anticholinergic MedsAnticholinergic Meds• Examples of anticholinergic effects:

Slowed digestive motility Constipation Decreased sweating Dry mouth, skin Elevated BP or HR Visual impairment Delirium Mental status changes (cognitive decline, restless, etc.) Urinary retention or difficulty Drowsiness, lethargy, weakness Dizziness

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Table II: Table II: Anticholinergic MedsAnticholinergic Meds

• Examples of medications with anticholinergic properties

Antihistamines (H-1 blockers) Antidepressants (TCAs, paroxetine) Antivertigo (meclizine, scopolamine) Cardiovascular medications (furosemide,

digoxin, nifedipine, disopyramide) GI meds

Antidiarrheals (diphenoxylate/atropine) Antispasmodics (dicyclomine, hyoscyamine, etc.) Anti-ulcer agents (cimetidine, ranitidine)

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Table II: Table II: Anticholinergic MedsAnticholinergic Meds

• Examples of medications with anticholinergic properties

Antiparkinson (amantadine, benztropine, biperiden, trihexyphenidyl)

Muscle Relaxants (cyclobenzaprine, dantrolene, orphenadrine)

Antipsychotic (chlorpromazine, clozapine, olanzapine, thioridazine)

Phenothiazine (prochlorperazine, promethazine) Urinary Incontinence (oxybutynin, probanthaline,

solifenacin, tolterodine, trospium)

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78 y.o. F. nursing home resident78 y.o. F. nursing home resident

Meds: Furosemide 20mg b.i.d. Reglan 10mg b.i.d.

Calcium 500mg t.i.d. Senna-S b.i.d. Risperdal 0.5mg b.i.d. Metamucil 1 tsp b.i.d.

Hydroxyzine 25mg p.r.n. MOM 15 ml q.d. Cogentin 1mg b.i.d. Naproxen 375mg

b.i.d.

Medical Problems:Dementia ConstipationDermatitis OsteoporosisEdema ParkinsonismReflux esophagitis DJD

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SummarySummary

Six medication management considerations

Indication for Use Monitoring Efficacy & Adverse

Consequences Dose Duration Tapering/GDR Prevention, Identification & Responses to

Adverse Consequences

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F425,428, 431-What’s F425,428, 431-What’s Changed?Changed?


Increased information on what is

pharmaceutical services.

Increased information about MRR.

F428F428Medication Regimen ReviewMedication Regimen Review

Interpretive GuidelinesInterpretive Guidelines

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IntentIntent• The facility maintains resident’s highest practical

level of functioning and prevents or minimizes adverse consequences related to medication therapy to the extent possible, by providing:

Licensed pharmacist’s review of each resident’s medication regimen at least monthly

- More frequent based on resident condition & risks or adverse consequences related to current medications

Identification and reporting of irregularities Action taken in response to irregularities

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OverviewOverview

Factors increasing the risk of medication related issues

• Multiple medications are often required to address conditions, leading to complex medication regimens

• Transitions, such as a move from hospital to nursing home – Medications may be added, discontinued or changed

• Adverse consequences can mimic symptoms of chronic conditions (aging process, new conditions)

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Common Manifestations of Adverse Drug Common Manifestations of Adverse Drug Reactions in the Elderly That May Be Reactions in the Elderly That May Be Incorrectly Interpreted as Signs of AgingIncorrectly Interpreted as Signs of Aging

•Confusion•Depression•Lack of appetite•Weakness•Lethargy•Ataxia

•Forgetfulness•Tremor•Constipation•Dizziness•Diarrhea•Urinary retention

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Disorders Precipitated or Disorders Precipitated or Exacerbated by DrugsExacerbated by Drugs

• Asthma: Beta Blockers (systemic, ocular)• CHF: NSAIDs, glitazones• Depression: Propranolol, Methyldopa, Clonidine• Dizziness, ↓BP: Numerous• Essential Tremor: Beta Agonists, Lithium• Edema: NSAIDs, glitazones, gabapentin, …• Gout: Loop & Thiazide Diuretics• Hypertension: NSAIDs, venlafaxine• OBS: Anticholinergics, Benzodiazepines,

…• Parkinsonism: Antipsychotics, Asendin, Reglan• PUD: NSAIDs• Urinary Retention: Anticholinergics

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Cheney HospitalizedCheney Hospitalized1/9/2006, 06:37 AM1/9/2006, 06:37 AM

• Vice President Dick Cheney, 64, was taken to George Washington Hospital at 3 a.m. Monday experiencing shortness of breath, spokesman Steve Schmidt said.

• Doctors found his EKG unchanged and determined he was retaining fluid because of anti-inflammatory medication he was taking for a foot problem, Schmidt said without giving the name of the drug.

• Cheney, who has a history of heart problems and has a pacemaker in his chest, was placed on a diuretic.

• Schmidt said the Vice President was expected to be released from the hospital later Monday.

• A foot ailment forced the Cheney to use a cane Friday.

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Overview (continued)Overview (continued)

Reviews to help identify issues:

• Physician reviews orders and total program of care on admission and prescriber reviews at each visit

• Nurse reviews medications when sending orders to pharmacy and/or prior to administering medications

• Interdisciplinary team reviews as part of the comprehensive assessment for the RAI and/or care plan

• Pharmacist reviews the prescriptions prior to dispensing

• Pharmacist performs medication regimen review at least monthly

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Sources of InformationSources of Information• May include, but are not limited to:

MARs Prescribers’ orders Progress, nursing, consultants’ notes, H&P, discharge

summaries RAI/MDS Lab reports Forms/reports reflecting behavioral monitoring and/or

changes in condition QM/QI reports Attending physician, facility staff Interviewing, assessing, and/or observing the resident

• Ask yourself, how many of these do I use and should I be using more sources or different types of sources than I am now?

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MRR ConsiderationsMRR Considerations

• MRR considers factors, such as: Has physician/staff documented

objective findings, diagnoses, symptoms to support indication?

Has physician/staff identified and acted upon, or should they be notified about, resident’s allergies, potential interactions/averse consequences?

Is dose, frequency, route, duration consistent with resident’s condition, manufacturer’s recommendations, and applicable standards of practice?

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MRR ConsiderationsMRR Considerations

Has physician/staff documented progress towards or maintenance of the goal(s) for medications therapy?

Has physician/staff obtained and acted upon lab results, diagnostic studies, or other measurements?

Do med errors exist or do circumstances exist that make errors likely to occur?

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MRR ConsiderationsMRR Considerations Has physician/staff noted and acted upon

possible medication-related causes of recent or persistent changes in the resident’s condition?………………… ……think “Geriatric Syndromes” Anorexia and/or unplanned weight loss, or

weight gain Behavioral changes, unusual behavior

patterns Bowel function changes Confusion, cognitive decline, worsening of

dementia Dehydration, fluid/electrolyte imbalance Depression, mood disturbance

TJ/CMS2007 - 223

MRR ConsiderationsMRR Considerations Dysphagia, swallowing difficulty Excessive sedation, insomnia, or sleep

disturbance Falls, dizziness, impaired coordination GI bleeding Headaches, muscle pain, generalized

aching/pain Rash, pruritis Seizure activity Spontaneous or unexplained bleeding,

bruising Unexplained decline in functional status Urinary retention or incontinence

TJ/CMS2007 - 224

Location and Notification Location and Notification of MRR Findings of MRR Findings

•The Pharmacist must Document identification of irregularity Report irregularity to attending physician

or director of nursing

•Timeliness of notification depends on severity

•If no irregularities found, pharmacist signs statement indicating such

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Response to Irregularities Response to Irregularities Identified in the MRRIdentified in the MRR•Physician is not required to order

recommended treatments unless he/she determines they are medically valid/indicated

• If recommendation requires physician intervention, then:

Physician accepts and acts upon suggestionOR

Physician rejects and provides explanation for disagreeing

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Response to FindingsResponse to Findings

• Physician either: Accepts recommendation and acts, OR Rejects the recommendation and provides a brief

explanation, such as in a dated progress note • “It is not acceptable for a physician to document

only that he/she disagrees with the report without providing some basis for disagreeing.”

• For those direct care issues that do not require physician intervention, DON or designated nurse can address and document action taken

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Lack of Action or RejectionLack of Action or Rejection

• What about when MD does not act upon or rejects MRR report/recommendations and there is the potential for serious harm?

Facility and CP should contact Medical Director, OR

When attending and Medical Director are same, follow established facility procedure to resolve the situation

• No specific timeframe provided for when a report that is not acted upon officially becomes delinquent or “not acted upon”

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Lack of Action or RejectionLack of Action or Rejection

•What about continuing to document an issue that the physician has disregarded or rejected?

“Pharmacist does not need to document a continuing irregularity each month if it’s deemed to be clinically insignificant or there is evidence of valid clinical reason for rejection”

“In these situations, pharmacist need only reconsider annually whether to report again or make new recommendation.”

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F428 - MRRF428 - MRR• Definition of Medication Regimen Review:

Thorough evaluation of the medication regimen of a resident, with the goal of promoting positive outcomes and minimizing adverse consequences associated with medications; the review includes preventing, identifying, reporting, and resolving medication-related problems (MRPs), medication errors, or other irregularities and collaborating with others members of the interdisciplinary team.

So, what are these “things” we’re preventing, identifying, reporting, and resolving…how are MRPs, med errors, and irregularities defined?

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Medication-Related ProblemsMedication-Related Problems

• A Medication-Related Problem (MRP) is:(NOTE HOW SIMILAR THESE ARE TO THE UNNECESSARY MED ‘CATEGORIES’ IN F-TAG 329)

Use of a medication without adequate indication for use

Use of a medication without identifiable evidence that safer alternatives or more clinically appropriate medications have been considered

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Medication-Related Problems Medication-Related Problems (cont.)(cont.)

Use of an appropriate medication that is not reaching treatment goals for reasons such as timing or techniques of administration, dosing intervals, etc.

Use of a medication in an excessive dose (including duplicate therapy) or for excessive duration

Presence of an adverse consequence associated with medication(s)

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Medication-Related Problems Medication-Related Problems (cont.)(cont.)

Use of a medication without adequate monitoring

- inadequate monitoring of response to med, or

- inadequate response to findings/results Presence of or risk for medication errors Presence of a clinical condition that might

warrant initiation of medication Medication interaction - “TOP 10 DIs in LTC”

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Common Common Medication Interactions in LTCMedication Interactions in LTC

• Warfarin - NSAIDs

• Warfarin - Sulfonamides

• Warfarin - Macrolides

• Warfarin - Quinolones

• Warfarin - Phenytoin

• ACEI - Potassium suppl.

• ACEI - Spironolactone

• Digoxin - Amiodarone

• Digoxin – Verapamil

• Theophylline - Quinolones

TJ/CMS2007 - 234

Medication ErrorsMedication Errors

•A medication error isn’t actually defined in document, but NCCMERP definition is:

“A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.”

(Source: www.nccmerp.org)

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IrregularitiesIrregularities

•An irregularity is:“Any event that is inconsistent with usual, proper, accepted, or right approaches to providing pharmaceutical services (as defined by F425), or that impedes or interferes with achieving the intended outcomes of those services.”

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F428 - MRRF428 - MRR

• Given those definitions, it is important to note that the document also states:

“This guidance is not intended to imply that all adverse consequences related to medications are preventable, but rather to specify that a SYSTEM exists to assure that medication usage is evaluated on an ongoing basis…”

TJ/CMS2007 - 237

Frequency of ReviewFrequency of Review

•Monthly or more frequently, depending on:

the resident’s condition, and the risks for adverse consequences related

to current medications

•This sounds alarming, but it is virtually the same as current survey guidelines

•Remember, there was additional guidance related to this in F425

TJ/CMS2007 - 238

Where to Conduct the ReviewWhere to Conduct the Review

•Generally within facility because important info may be attainable only by talking to staff, reviewing “paper” chart, observing/speaking with resident

•BUT new technology (electronic health records) may permit the pharmacist to conduct some components of the review outside of the facility

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Notification of FindingsNotification of Findings

• Timeliness of notification depends on potential for or presence of serious adverse consequences

Examples include:

- Bleeding resident on anticoagulants- Possible allergic reactions to antibiotic

• Collaborate with facility to identify the most effective means of notification/documentation

• Notification/documentation may be done electronically

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Location of FindingsLocation of Findings

•Pharmacist’s findings are part of clinical record

If not maintained within active clinical record, it must still be maintained within facility and readily available

•Find balance between: Encouraging/facilitating other healthcare

professionals to utilize Allowing facilities flexibility in determining

a consistent location that suits their needs

TJ/CMS2007 - 241

Considerations for Medication Considerations for Medication Regimen Review (MRR)Regimen Review (MRR)

• When should I implement the new gradual dose reduction/tapering guidelines?

Probably not wise to initiate dose reduction attempts on every psychopharmacological medication for every resident right away, just to comply with guidelines

Might be more prudent, on an individual basis, to evaluate past gradual dose reduction/tapering attempts when considering future attempts…don’t necessarily want the burden of managing dose reductions on a multitude of residents at one time

TJ/CMS2007 - 242

Considerations for Medication Considerations for Medication Regimen Review (MRR)Regimen Review (MRR)

• Chances are… dispensing pharmacists are most likely already providing proactive “MRR,” but it may not be identified or labeled as such

F425: “Providing pharmaceutical consultation is an ongoing, interactive process with prospective, concurrent, and retrospective components. To accomplish some of these consultative responsibilities, pharmacists can use various methods and resources, such as technology, additional personnel (e.g., dispensing pharmacists, pharmacy technicians), and related policies and procedures”

F428: “Transitions in care such as a move from home or hospital to the nursing home, or vice versa, increases the risk of medication-related issues. It is important, therefore, to review the medications. Currently, safeguards to help identify medication issues include…

The pharmacist reviewing the prescriptions prior to dispensing”

F425 F425 Pharmaceutical ServicesPharmaceutical Services


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DefinitionsDefinitionsPharmaceutical ServicesPharmaceutical Services • The process of receiving and interpreting prescriber’s

orders; acquiring, receiving, storing, controlling, reconciling, compounding (e.g., intravenous antibiotics), dispensing, packaging, labeling, distributing, administering, monitoring responses to, using and/or disposing of all medications, biologicals, chemicals;

• The provision of medication-related information to health care professionals and residents;

• The process of identifying, evaluating and addressing medication-related issues including the prevention and reporting of medication errors; and

• The provision, monitoring and/or the use of medication-related devices.

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IntentIntent• Facility provides pharmaceutical services to

meet the needs to residents Medications and biologicals Services of licensed pharmacist

• Pharmaceutical services are coordinated within the facility

Procedures developed and implementation evaluated

• Pharmaceutical concerns and issues affecting residents and care are identified and evaluated

• Only persons authorized under state requirements administer medications

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OverviewOverview• Provision of Medications

Timeliness/Availability to meet needs of each resident• Services of a Pharmacist

“The pharmacist is responsible for helping the facility obtain and maintain timely and appropriate pharmaceutical services that support residents’ healthcare needs, that are consistent with current standards of practice, and that meet state and federal requirements.”

• Pharmaceutical Services Procedures Acquiring - Administering Receiving - Disposal Dispensing - Labeling/Storage, incl. Authorized personnel controlled substances

TJ/CMS2007 - 247

Provision of MedicationsProvision of Medications

•Factors that may help determine timeliness and guide procedures for acquisition include:

Availability of meds to enable continuity of care for anticipated admission or transfer

Condition of resident (e.g., severity/instability of condition, current S+S, potential impact of a delay)

Category of medication (e.g., antibiotic, pain) Availability of medications in emergency supply Ordered start time

TJ/CMS2007 - 248

Pharmacist ServicesPharmacist Services

• Consultant pharmacist’s responsibilities, in collaboration with the facility and medical director, may include:

-Develop, implement, evaluate, and revise (as necessary) procedures relating to pharmaceutical services

-Coordinate pharmaceutical services if and when multiple service providers are utilized, for example:

Multiple pharmacies Infusion provider Hospice Prescription Drug Plan (PDP)

TJ/CMS2007 - 249


-IV therapy procedures-Determine contents & monitor use of E-Kits-Develop mechanisms for communicating,

addressing, resolving issues related to pharmacy services

-Strive to assure medications requested, received and administered in timely manner

-Provide medication administration & medication error review and feedback

-Participate on interdisciplinary team to address and resolve medication-related needs or problems

TJ/CMS2007 - 250


-Establish procedures for Monthly Medication Regimen Review (MRR) (more on MRR in F428) Conducting monthly MRR for each resident Addressing expected time frames for conducting

the review and reporting findings Addressing the irregularities Documenting and reporting results of the MMR Addressing MRRs for residents:

anticipated to stay less than 30 days who experience an acute change in

condition as identified by facility staff

TJ/CMS2007 - 251

Pharmacist ServicesPharmacist Services• NOTE (in document):

“Facility procedures should address… how and when the need for a consultation will

be communicated, how the medication review will be handled in

the pharmacist is off-site, how the results or report of their findings will

be communicated to the physician expectations for the physician’s response and

follow-up, and how and where this information will be

documented.”

TJ/CMS2007 - 252


-Procedures/guidance regarding when to contact prescriber about medication issue &/or adverse effects, incl. info to gather before contact

-Process for receiving, transcribing, and recapitulating med orders

-Medication delivery system, packaging-Automated dispensing machines/delivery

devices/cabinets-Medication references/resources-Facility educational/informational needs

about medications

TJ/CMS2007 - 253

Pharmaceutical ServicesPharmaceutical Services

•Acquisition•Receiving & Dispensing•Administering•Disposition•Labeling•Storage•Controlled Drugs

TJ/CMS2007 - 254

LabelingLabeling

•Labeling of meds prepared by facility staff (e.g., IVs)

•Requirements for non-pharmacy labels (e.g., OTC)

•Label changes due to change in order/directions

•Labeling of multi-dose vials (e.g., expiration dates)

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Controlled SubstancesControlled Substances

•Controlled Meds-Location, security and authorized access of

Class II vs. III-V, including refrigerated CSs-Records of receipt and disposition for all

controlled meds-Periodic reconciliation (e.g., frequency,

method, by whom, documentation)

TJ/CMS2007 - 256

F425 - Pharmaceutical F425 - Pharmaceutical ServicesServices

•This impacts dispensing pharmacies too -Emergency supply (E-Kits) and 24/7

availability - ensuring timeliness -Procedures for clarifying orders -Procedures for contacting prescriber -Procedures when medication is not

available or delivery is delayed -Procedures for transporting meds between

pharmacy and facility -Defining schedules for administering

medications -Reporting of medication errors

TJ/CMS2007 - 257

F425 - Pharmaceutical F425 - Pharmaceutical ServicesServices

F425: “Providing pharmaceutical consultation is an ongoing, interactive process with prospective, concurrent, and retrospective components. To accomplish some of these consultative responsibilities, pharmacists can use various methods and resources, such as technology, additional personnel (e.g., dispensing pharmacists, pharmacy technicians), and related policies and procedures”

F431F431Storage, Labeling, Storage, Labeling,

Controlled MedicationsControlled Medications


TJ/CMS2007 - 259

IntentIntent

The facility, in coordination with the pharmacist, provides:

• Safe and secure storage and handling of all medication

• Accurate labeling to facilitate safe administration

• A system of records enabling reconciliation and accounting of controlled medications

• Identification of loss or diversion of controlled medications minimizing the time between actual loss and the detection of the extent of loss

TJ/CMS2007 - 260

LabelingLabelingNew Key PointsNew Key Points

• As mentioned in F425, facility ensures labeling in response to order changes is accurate and consistent with state requirements (I.e., nurse cannot re-label or alter label)

• For meds designed for multiple administrations - “Multi-Dose” (e.g., inhalers, eye drops, etc), label is affixed in manner to promote administration to resident for whom it was prescribed

In other words, if there isn’t space for an entire label, still better have - at least - resident’s name on actual product container

TJ/CMS2007 - 261


• For compounded IV preparations, label contains: Name and volume of solution Resident’s name Infusion rate Name and quantity of each additive Date of preparation Initials of compounder Date and time of administration Initials of person administering medication if different than

compounder Ancillary precautions, as applicable Date after which mixture must not be used

(i.e., expiration date)

TJ/CMS2007 - 262


• For OTCs in bulk containers (in states that permit), label contains:

Original manufacturer’s OR pharmacy-applied label indicating:

Medication name Strength Quantity Accessory instructions Lot number Expiration date, when applicable

• If resident-specific supply of OTC, label contains above plus resident’s name

TJ/CMS2007 - 263

Access and StorageAccess and StorageNew Key PointsNew Key Points

• Access can be controlled by keys, security codes or cards, or other technology (e.g., fingerprints)

• Med pass… During a med pass, medications must be under the

direct observation (vs. control ) of the person administering the medications or locked in the med storage area/cart

• Self-administration… Important that the facility have procedures for the

control and safe storage of medications for those residents who can self-administer

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Storage, Labeling, Controlled Storage, Labeling, Controlled MedsMeds

•The facility must employ or obtain the services of a licensed pharmacist who:

Establishes a system of records of receipt and disposition of all controlled medications (Class II-V) in sufficient detail to enable an accurate reconciliation.

Determines that medication records are in order and that an account of all controlled medications is maintained and periodically reconciled.

TJ/CMS2007 - 265

Controlled MedicationsControlled MedicationsOld vs. NewOld vs. New

•Old: A record of receipt and disposition of controlled drugs does not need to be proof of use sheets; The facility can use existing documentation such as the Medication Administration Record (MAR) to accomplish this record

TJ/CMS2007 - 266


• New: Record of RECEIPT of ALL controlled medications with

sufficient to allow reconciliation, specifying: Name and strength of medication Quantity Date received Resident’s name (unless using automated dispensing

machine, etc) Records of USAGE and DISPOSITION (destruction, waste,

return, other disposal) of ALL controlled medications with sufficient detail to allow reconciliation, e.g.,

MAR Proof-of-use sheets Declining inventory sheets

Emergency Kits…. Don’t forget about controlled medications located in

the emergency supply

TJ/CMS2007 - 267


•Old: Periodic reconciliations should be monthly

•New: Periodic reconciliation of receipt, disposition, and inventory for ALL controlled medications (monthly or more frequently)

Consultant Pharmacist is not required to perform reconciliation, but rather to evaluate and determine that the facility maintains an account of all controlled medications and completes reconciliation

TJ/CMS2007 - 268


• Old: If they reveal shortages: Pharmacist and the director of nursing may need to

initiate more frequent reconciliations Facility may have to utilize proof of use sheets on all

controlled drugs for all shifts When the source of shortage is located and remedied,

the facility may go back to periodic reconciliation by the pharmacist

• New: If discrepancies in records are identified or loss has occurred:

Consultant Pharmacist and facility develop and implement recommendations for resolution

Review and revise monitoring procedures, as necessary (e.g., increasing the frequency of reconciliation)

minnesotas call to action minnesotas call to action for unnecessary medications (f329) &...

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