Minnesota’s
Call To Action
For Unnecessary Medications (F329)
&
Pharmacy Services (F425, 428, 431)
Overview of New Guidance
• 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
-2
Overview of New Guidance
• 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.
TJ/CMS2007
-3
Coordination & Communication
• 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
-4
Coordination & Communication
• Examples of where communication is mentioned in
new guidelines…


TJ/CMS2007
-5
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…”
Coordination & Communication
• Examples of where communication is mentioned in new
guidelines…


TJ/CMS2007
-6
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])”
F329
What’s Changed?
• Only the Guidance has changed.

Increased information on indication, monitoring,
adverse consequences for broader range of types
of medications
TJ/CMS2007
-7

Modification of Gradual Dose Reduction

Inclusion of tapering
F425, 428, 431
What’s Changed?
• Only the Guidance has changed.

Increased information on what is pharmaceutical
services.

Increased information about Medication Regimen
Review.
TJ/CMS2007
-8
Development of the Guidance
• Pharmacy Services and Unnecessary Medications
• Involved 2 separate expert panels for both the
pharmacy services tags and unnecessary medication
tags







TJ/CMS2007
-9
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
Tags Combined
• Unnecessary Medications

New Tag F329 = Old Tags F329, F330, F331
 Unnecessary Drugs
• Pharmaceutical Services



TJ/CMS2007
- 10
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
F329
Unnecessary Medications
Interpretive Guidelines
Medications and Long-Term Care
• 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
- 12
Scope of the Problem
• Medications are also a known public health
problem



TJ/CMS2007
- 13
Described in the medical, nursing, and
pharmacology literature for many decades
Discussed repeatedly in the mass media
Relevant in every setting

TJ/CMS2007
- 14
Source: Parade Magazine, March 12, 2006
Drug-Related Problems
(Categories)
1. A medical indication for the drug
2. Too little of the correct drug
3. Too much of the correct drug
4. Incorrect drug
5. Medical problem secondary to adverse drug reaction
6. Drug-drug, drug-food, drug-lab test interactions
7. Medical problem due to patient not receiving drug
8. Medical problem resulting from a drug for which
there is no valid medical indication
TJ/CMS2007
- 15
Not 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
TJ/CMS2007
- 16
Economic Impact of Diseases
Affecting Americans Age 65 and Older
• 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
Cancer
Alz. Disease
DM
Medication-Related Problems
JAMA April 1998
TJ/CMS2007
- 17
$171 Billion
$104 Billion
$100 Billion
$92 Billion
$66.2 Billion
ILLNESS
DRUG
ADVERSE
EFFECT
MEDICATION
DRUG
INTERACTION
TJ/CMS2007
- 18
Overview of Drug-Related Problems
in 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

TJ/CMS2007
- 19
6 X that of general population
Medication Adverse Consequence
• 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
- 20
“Allergic”/Adverse Drug Reactions
• Drug
• Brief description of reaction
• Date of occurrence
TJ/CMS2007
- 21
Drug
Reaction (date)
Aspirin
Amoxicillin
Erythromycin
Haldol
g.i. upset
hives, itch (8/94)
diarrhea (9/89)
stiff neck/jaw (3/92)
Study in 2 academic-based
nursing homes
• Most frequent causes for the preventable
adverse consequences:



Inadequate monitoring
Failure to act on monitoring
Errors in ordering



TJ/CMS2007
- 22
Wrong dose
Wrong medication
Medication-medication interactions
Drug-Related Problems
• Consequences


Treatment Failure
New medical problem
• Subsequent Events








TJ/CMS2007
- 23
Physician revisit
Further Rx
Urgent care visit
ER visit
Hospital admit
LTCF admit
Death
No further attention
•$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.
TJ/CMS2007
- 24
• 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 > $4,000/yr) will
probably result in similar acuity levels for ambulatory
patients.
•
TJ/CMS2007
Kidder, Samuel W. DUR by Pharmacists-Lessons Learned for MTMS. The Consultant Pharmacist 12/2005
- 25
Hx: 81 yo female with mild HTN, OA, OP.
Total Hip Replacement scheduled 7/23/04.
7/16/04:
Weakness, ataxia, cognitive impairment.
6pm E.R. visit & 11pm hospital admit.
(R/O CVA. Carotid ultrasound, CT head,
MRI head, BP 184/110, mild ↓Na+).
Medications on admission:
Lisinopril 5mg q.d.
Fosamax 70mg q. wk
ASA E.C. 325 q.d.
Alprazolam 0.25mg t.i.d.prn
TJ/CMS2007
- 26
HCTZ 12.5mg q.d.
Calcium w Vit D b.i.d.
Vioxx 25mg q.d.
Vicodin 1-2 q. 6 hr prn
7/17/04:
TJ/CMS2007
- 27
12noon CNS Sx improved.
All tests negative.
Lisinopril increased to 10mg q.d.
Atenolol 25mg q.d. added.
Alprazolam, Vicodin, HCTZ held.
BP 130/82
7/17/04:
1:00pm T.J. call to vendor pharmacy
to obtain Rx history.
-Alprazolam 0.25mg x 30 1/18/04, 3/11/04,
4/27/04, 6/3/04, 6/24/04, 7/14/04
-Vioxx 25mg x 28
6/25/04
-Vicodin x 100
7/14/04
1:30pm Physician arrives
TJ/CMS2007
- 28
Etiology of Drug-Related Problems
1. 3 different prescribers
2. Lack of pharmacist intervention
3. Weakness, ataxia, impaired cognition
Alprazolam, Vicodin
4. Elevated BP
Antagonism of ACE Inhibitor (lisinopril)
antihypertensive effect by Vioxx as well
as possible Vioxx-induced HTN.
5. Hyponatremia
Possibly Vioxx and HCTZ
TJ/CMS2007
- 29
7/18/04:
10am Discharged after 40 hr
hospitalization
1pm
2pm
On dock at lake
Pontoon ride
Spends rest of day enjoying children
and grandchildren.
• 7/23/04:
TJ/CMS2007
- 30
Successful hip replacement surgery
COST ?$
TJ/CMS2007
- 31
Medication Related Problem Expenses:
•
•
•
•
•
•
•
•
TJ/CMS2007
-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.
- 32
Hospitalization Bill for 40 hour admission
$13,198.50
TJ/CMS2007
- 33
F329 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
- 34
Preserve Quality of Life
TJ/CMS2007
- 35
Unnecessary 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.
TJ/CMS2007
- 36
Unnecessary 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.
Definitions
Adverse 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 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
- 38
Definitions
Clinically 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
- 39
Definitions
Indications 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
- 40
Definitions
Monitoring - 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 medications - any medication used for
managing behavior, stabilizing mood, or treating psychiatric
disorders.
TJ/CMS2007
- 41
Non-pharmacological
Interventions
• 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
- 42
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
TJ/CMS2007
- 43
Medication Management
• Resident Choice & Advance Directives
• Indications for Use
• Monitoring
• Dose
• Duration
• Tapering/ Gradual Dose Reduction
• Adverse Consequences
TJ/CMS2007
- 44
Medication Management
• 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
TJ/CMS2007
- 45
Promoting 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
TJ/CMS2007
- 46
Strategies: Care Process
• Advise prudent “disease management”




TJ/CMS2007
- 47
Must be in context
Needs a sound biological basis
Hard to isolate targeted organs
Often invokes the “law of unintended
consequences”
The “Cascade Effect”
• Symptoms (including those related to medications
often part of a cascade of problems


TJ/CMS2007
- 48
Medication  lethargy  decreased oral intake
fluid/electrolyte imbalance  further lethargy
 weight loss skin breakdown
Pneumonia  confusion  medication 
lethargy skin breakdown
Medication Management
• Members of the interdisciplinary team
participate in the care process by:


TJ/CMS2007
- 49
identifying, addressing, advocating for,
monitoring, and communicating the resident’s
needs and changes in condition.
Selecting medications and non-pharmacological
interventions
Challenges
• 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”
TJ/CMS2007
- 50
When treating the disease, treat the whole
patient & consider therapeutic alternatives
Elderly patient with CHF, DM, HTN
Medications:
Lasix, KCl, Lanoxin,
Glucotrol, Calan SR
Alternative:
ACE Inhibitor (lisinopril)
+/CHF, +/HTN, +HypoK,
+/Diabetic nephropathy
TJ/CMS2007
- 51
Clinical Strategies:
Key Principles
• Respect for basic biology

Good / Patient-Centered


Bad / Discipline (or Provider)-Centered

TJ/CMS2007
- 52
Coordinated care of individuals with [A+B+C+D+etc]
[Care for patient with A] + [Care for patient with B] +
[Care for patient with C] + [Care for patient with D] +
[etc.]
Discipline-Centered Care
TJ/CMS2007
- 53
Resident/Patient-Centered Care
TJ/CMS2007
- 54
Strategies: Multiple Prescribers
• 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)
TJ/CMS2007
- 55
Strategies:
Medications and Related Risks
• 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
- 56
Compliance 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
TJ/CMS2007
- 57
Strategies:
Promote Pertinent Documentation
• What should be documented?




TJ/CMS2007
- 58
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)?
Documentation And Care Process







TJ/CMS2007
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?
- 59
Regarding Medications, Good
Intentions Alone Are Not Enough
TJ/CMS2007
- 60
Where in the clinical record
would you look to obtain
information about a
resident’s medication
regimen?
TJ/CMS2007
- 61
Location of Information
• Hospital discharge
summaries & transfer
notes
• Progress notes &
interdisciplinary notes
• History & physical
examinations
• Resident Assessment
Instrument (RAI)
• Plan of care
TJ/CMS2007
- 62
• Lab reports
• Professional consults
• Medication orders
• Medical Regimen Review
(MRR) reports
• Medication
Administration Records
(MAR)
Six Medication Management
Considerations
I. Indications for use of medication
II. Monitoring for efficacy & adverse
consequences
III. Dose
IV. Duration
V. Tapering/gradual dose reduction (GDR)
VI. Prevention, identification & response to
adverse consequences
TJ/CMS2007
- 63
I.
TJ/CMS2007
- 64
Indications for Use of
Medication
Indications for Use of Medication
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
- 65
Indications for Use of Medication
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
TJ/CMS2007
- 66
Unnecessary Meds
General
• 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
TJ/CMS2007
- 67
Indications for Use of Medication
What do these 5 circumstances have in common?
•
•
•
•
•
TJ/CMS2007
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
- 68
What information would you
consider when evaluating
indication for use?
TJ/CMS2007
- 69
Information
• Mental, physical, psychosocial & functional status
• Goals & preferences of the resident/designated
representative
• Allergies
• History of prior & current medications and nonpharmacological interventions
• Recognition of need for end-of-life or palliative care
• Refusal of care & treatment
• RAPS
TJ/CMS2007
- 70
Case 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
•
TJ/CMS2007
- 71
Care plan for mood and behavior, bowel & bladder
incontinence, and weight loss.
Case Scenario
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.
TJ/CMS2007
- 72
Case Scenario
Labs
•
K+ = 3.6 (on admission)
•
TSH = 2.5 (on admission)
Weight
TJ/CMS2007
•
110 lbs (on admission)
•
97 lbs (6 months later)
- 73
Case 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
TJ/CMS2007
- 74
• 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
Clinical “Triggers”
• Admission or readmission • Unexplained decline in
function or cognition
• Clinically significant
change in
• New medication order or
condition/status
renewal order
TJ/CMS2007
• New, persistent or
recurrent clinically
significant symptom or
problem
• Irregularity in
pharmacist’s monthly
medication regimen
review
• Worsening of existing
problem/condition
• Multiple prescribers
- 75
Physician 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
TJ/CMS2007
- 76
Faxing 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
TJ/CMS2007
- 77
• [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?
TJ/CMS2007
- 78
• 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.
TJ/CMS2007
- 79
• 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?
TJ/CMS2007
- 80
• 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)
TJ/CMS2007
- 81
• [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° prn
15 mg qd
TJ/CMS2007
- 82
• [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)
TJ/CMS2007
- 83
• [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?
TJ/CMS2007
- 84
• 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)
TJ/CMS2007
- 85
Indication
• 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
TJ/CMS2007
- 86
Indication
• 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
TJ/CMS2007
- 87
Indication
• Resident started on risperidone for being
resistive to cares.




TJ/CMS2007
- 88
Did facility rule out other causes?
Is resistance harmful?
Is this behavior persistent?
Were other interventions considered, tried?
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
TJ/CMS2007
- 89
Summary
Indication for Use:


TJ/CMS2007
- 90
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
II. Monitoring for Efficacy &
Adverse Consequences
TJ/CMS2007
- 91
Monitoring for Efficacy
& 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
TJ/CMS2007
- 92
Monitoring for Efficacy
& Adverse Consequences
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
TJ/CMS2007
- 93
Monitoring for Efficacy
& Adverse Consequences
•
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
TJ/CMS2007
- 94
Importance of Monitoring
• Tracks progress towards therapeutic goals
• Detects emergence or presence of any
adverse consequences
BENEFIT
RISK
TJ/CMS2007
- 95
Monitoring Parameters
• Resident’s condition
• Pharmacological properties of medication
& its risks
• Individualized therapeutic goals
• Potential for clinically significant adverse
consequences
TJ/CMS2007
- 96
Monitoring
What is the purpose of monitoring?

To incorporate medication-related goals and monitoring
parameters into the resident’s comprehensive care plan




TJ/CMS2007
- 97
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
Monitoring
• 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
TJ/CMS2007
- 98
Examples of tools used for determining
baseline status as well as for monitoring
may include, but are not limited to:
• Physiological, Cognitive,
& Functional Status:






TJ/CMS2007
- 99
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)
Examples of tools used for determining
baseline status as well as for monitoring
may include, but are not limited to:
• Mood/Affect:



Geriatric Depression
Scale (GDS)
Cornell Depression in
Dementia Scale
Mania Rating Scale
• Behavior



TJ/CMS2007
- 100
Behavioral Pathology in
Alzheimer’s Disease
Rating Scale
(Behave AD)
Cohen-Mansfield Agitation
Inventory (CMAI)
Neuro-psychiatric
Inventory-Nursing Home
Version (NPI-NH)
Case Scenario
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.
TJ/CMS2007
- 101
Case Scenario
Medications
TJ/CMS2007
•
Aspirin 325mg daily for prevention
•
Naproxen 500mg twice daily for pain
•
Lisinopril 30mg daily for hypertension
•
Alendronate 70mg weekly for Osteoporosis
- 102
Summary
Monitoring Efficacy & Adverse Consequences:

Track progress towards therapeutic goals

Detect adverse consequences


TJ/CMS2007
- 103
Parameters – resident’s condition,
pharmacological properties & risks,
individualized therapeutic goals, clinically
significant adverse consequences
Monitoring Tools and Methods job aid
III. Dose
(Including Duplicate Therapy)
TJ/CMS2007
- 104
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

TJ/CMS2007
- 105
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, …………….…………………………………..
TJ/CMS2007
- 106
The same dose of a medication given
two different people may cure one
and harm the other. (2-edged sword)
TJ/CMS2007
- 107
Drugs Don’t Have Doses,
People Do!
TJ/CMS2007
- 108
Duplicate 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
TJ/CMS2007
- 109
Duplicate 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
TJ/CMS2007
- 110
Dose/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.
TJ/CMS2007
- 111
Summary
Dose:

TJ/CMS2007
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
- 112
IV. Duration
TJ/CMS2007
- 113
Duration
• Looking at resident conditions are medications
being used for the appropriate time frames?
• Is condition still present?
• Acute vs. Chronic
TJ/CMS2007
- 114
Importance 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
TJ/CMS2007
- 115
Duration
• 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
TJ/CMS2007
- 116
Summary
Duration:



TJ/CMS2007
- 117
Periodic re-evaluation necessary
Clinical rationale for continued use may be
demonstrated in clinical record
Staff or prescriber may present pertinent clinical
reasons
V. Tapering of Medication
Dose/Gradual Dose Reduction
(GDR) for Antipsychotic
Medications
TJ/CMS2007
- 118
Tapering/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
TJ/CMS2007
- 119
Tapering/GDR
Indicated when:



TJ/CMS2007
- 120
Clinical condition improves or stabilizes
Underlying causes of original target symptoms
have resolved
Non-pharmacological interventions have been
effective in reducing symptoms
Non-Pharmacologic
Behavioral Intervention
TJ/CMS2007
- 121
Factors to Consider
• Coexisting medication regimen
• Underlying causes of symptoms
• Individual risk factors
• Pharmacological characteristics
TJ/CMS2007
- 122
Tapering/GDR: “Real Impact”
• New classes of medications added to those
needing tapering
• Categories of GDR: Antipsychotics
• Categories of Tapering: Sedative Hypnotic,
Other “Psychopharmacologic medications”.
TJ/CMS2007
- 123
Behavior 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
TJ/CMS2007
- 124
Pharmacologic
Behavior Management
• Often over-rated, over-utilized, and lacking
adequate documentation.
TJ/CMS2007
- 125
GDR/Tapering for Antipsychotics
• Old:



TJ/CMS2007
- 126
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
GDR/Tapering for Antipsychotics
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
TJ/CMS2007
- 127
GDR/Tapering for Antipsychotics
• 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:
TJ/CMS2007
- 128
Antipsychotic indication &
GDR Contraindications
• Behavioral symptoms related to
dementia


TJ/CMS2007
- 129
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.
Antipsychotic indication &
GDR Contraindications
• Other psychiatric disorders
(e.g., schizophrenia, bipolar mania,
depression with psychotic features)

TJ/CMS2007
- 130
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
Antipsychotic indication &
GDR Contraindications
• Other psychiatric disorders
(e.g., schizophrenia, bipolar mania,
depression with psychotic features)

TJ/CMS2007
- 131
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.
Antipsychotics
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.
TJ/CMS2007
- 132
Tapering for Sedatives/Hypnotics
• Old:



TJ/CMS2007
- 133
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
Tapering for Sedatives/Hypnotics
• New:


TJ/CMS2007
- 134
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)
Sedatives/Hypnotics
MH is an 82 yr WF who has been at the
facility for the last 3 months. She is
taking temazepam at bedtime.
TJ/CMS2007
- 135
Tapering for
“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
TJ/CMS2007
- 136
Psychopharmacological
Medications
• “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…)
TJ/CMS2007
- 137
Tapering for Psychopharmacological
Meds
• New:


TJ/CMS2007
- 138
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
Psychopharmacological
Medications
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.
TJ/CMS2007
- 139
Tapering
Clinically Contraindicated
• Hypnotics

TJ/CMS2007
- 140
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
Tapering
Clinically Contraindicated
• Hypnotics

TJ/CMS2007
- 141
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.
Psychopharmacological
Medications
• Tapering Other Psychopharmacologic
Meds

TJ/CMS2007
- 142
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
Tapering
Clinically Contraindicated
• Psychopharmacological Medications

TJ/CMS2007
- 143
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
Tapering
Clinically Contraindicated
• Psychopharmacological Medications

TJ/CMS2007
- 144
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.
Tapering and GDR
When would the interdisciplinary team
evaluate the resident’s response to
medications and consider reduction or
discontinuation of medications?
TJ/CMS2007
- 145
Tapering/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:



TJ/CMS2007
- 146
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
The “Art of 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

TJ/CMS2007
- 147
Educate nursing staff re: PRN use
Summary
Tapering/GDR:



TJ/CMS2007
- 148
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
VI. Prevention, Identification
& Response to Adverse
Consequences
TJ/CMS2007
- 149
Adverse Consequences
• Increased Adverse Consequence Risk




TJ/CMS2007
- 150
Advanced age
Multiple co-morbid conditions
Number of medications
Certain pharmacologic classes
ADRs Increase With Number
of Medications
TJ/CMS2007
- 151
Strategies:
Adverse 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
TJ/CMS2007
- 152
Adverse Consequences
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
TJ/CMS2007
- 153
Importance
• Adverse consequences related to medications
are common!
• In a 2005 study, 42% of adverse drug events
were judged preventable
• Most common omissions included:


TJ/CMS2007
- 154
Inadequate monitoring
Lack of/delayed response to signs, symptoms, or
laboratory evidence of medication toxicity
Adverse Consequences
• 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, lifethreatening, or serious were preventable
 34% (105/308) of significant events were
considered preventable
TJ/CMS2007
- 155
Question
According to the investigative protocol guidance,
which of the following signs or symptoms may be
associated with medications:
TJ/CMS2007
A.
Dehydration
B.
Constipation
C.
Bruising
D.
All of the above
- 156
Adverse Consequences
• Any medication can cause adverse consequences
• Considerations include…



TJ/CMS2007
- 157
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
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
TJ/CMS2007
- 158
Summary
Prevention, Identification & Responses to
Adverse Consequences:
TJ/CMS2007

Statistics demonstrate need & importance

Tables I & II job aids

Drug Information Resources job aid
- 159
Table I:
Medication Issues of Particular Relevance
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
TJ/CMS2007
- 160
Table II:
Medications with Significant
Anticholinergic Properties
TJ/CMS2007

Anticholinergic side effects are common

Medications in many categories have
anticholinergic properties

Use of multiple medications with
anticholinergic properties may be particularly
problematic
- 161
TABLE I:
Medication Issues of Particular Relevance
• 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
TJ/CMS2007
- 162
TABLE I:
Medication Issues of Particular Relevance
• 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
TJ/CMS2007
- 163
Analgesics
• Acetaminophen
• NSAIDs
• Opioids
• Pentazocine
• Propoxyphene
TJ/CMS2007
- 164
Avoid >4 Gm/day, LFTs.
Trial APAP alternative;
interactions with ASA,
anticoagulants, anti-platelet
agents; risks for GI bleed,
renal insuff, CHF; CNS effects
with some NSAIDs.
Shorter-acting agent trial
before long-acting; avoid
meperidine; ADRs.
Limited efficacy; >ADRs.
Risks > Benefits.
Antibiotics
• All
Confirmed/suspected
infection. (e.g., not for
asymptomatic bacteruria)
TJ/CMS2007
• Aminoglycosides,
IV Vanco
Renal Fn, serum levels
to minimize ADRs.
• Nitrofurantoin
Renal insuff (CrCl<60);
- 165
ADRs (pulmonary,
neuropathy).
Anticoagulants, Anticonvulsants,
Antidepressants
• Warfarin
• Anticonvulsants
INRs; interactions
Duration based on indication;
possible serum levels; ADRs
on liver, bone marrow, derm.,
CNS, falls.
• Antidepressants
• MAOIs; TCAs
TJ/CMS2007
- 166
Indication; 2 or >; duration;
GDR/tapering; worsening Sx;
interactions; ADRs (CNS, GI,
falls, seizures, serotonin
syndrome).
BP-tyramine; antichol., etc.
Antidiabetic 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
TJ/CMS2007
- 167
95 y.o. female in nursing home with
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.
TJ/CMS2007
- 168
Important History
• Hospitalized 7/04 with discharge
diagnosis of Actos-induced exacerbation
of CHF.
TJ/CMS2007
- 169
Antifungals (systemic imidazoles)
• Significant interactions with warfarin,
phenytoin, theophylline, sulfonylureas;
also rifampin, cimetidine.
• Liver impairment
TJ/CMS2007
- 170
Antimanic medications
• Lithium



TJ/CMS2007
- 171
Caution with renal impairment, CV disease,
severe debilitation, dehydration, sodium
depletion.
Serum level monitoring.
Interactions : thiazides, ACEIs, NSAIDs
Antiparkinson medications
• Confusion, restlessness, delirium, dyskinesia,
dizziness, hallucinations, agitation, nausea.
• Postural hypotension, falls.
• Adverse effect dilemma
TJ/CMS2007
- 172
Antipsychotics
• Analysis of antipsychotic use by 693,000
Medicare nursing home residents


TJ/CMS2007
- 173
28.5% received excessive doses
32.2% lacked appropriate indications for
use
Antipsychotic medications
• Diagnoses





TJ/CMS2007
- 174
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
Antipsychotics:
Additional 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:



TJ/CMS2007
- 175
Inconsolable or persistent distress
Significant decline in function
Substantial difficulty receiving needed care
Antipsychotics:
Inadequate indications
•
•
•
•
•
•
•
•
TJ/CMS2007
Wandering
Poor self-care
Restlessness
Impaired memory
Mild anxiety
Insomnia
Unsociability
Inattention or
indifference to
surroundings
- 176
•
•
•
•
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
Antipsychotic Dose Thresholds
in Dementing Illnesses
•
•
•
•
•
•
•
•
•
TJ/CMS2007
Chlorpromazine
Fluphenazine
Haloperidol
Loxapine
Molindone
Perphenazine
Thioridazine
Thiothixene
Trifluoperazine
- 177
75mg
4mg
2mg
10mg
10mg
8mg
75mg
7mg
8mg
•
•
•
•
•
Aripiprazole
Clozapine
Olanzapine
Quetiapine
Risperidone
10mg
50mg
7.5mg
150mg
2mg
Antipsychotics:
Monitoring/Adverse Consequences
•
•
•
•
Anticholinergic
Akathisia
NMS
Arrhythmias;
heartrelated events
• Falls
• Lethargy/Sedation
TJ/CMS2007
- 178
•
•
•
•
•
•
Pseudoparkinsonism
Blood sugar elevation
Increased lipids
Orthostatic hypotension
TIA/CVA in dementia
Tardive dyskinesia
Tardive Dyskinesia
• Risk factors





TJ/CMS2007
- 179
Increased age
Brain damage, CVAs, seizures, etc.
Total cumulative antipsychotic dose
Antipsychotic dosage
Antipsychotic agent
Anxiolytics
• Indications
 BZDPs, Buspirone, antidepressants
• Dosage
• Duration (Tapering/GDR)
• Adverse Consequences
• Diphenhydramine, hydroxyzine:
 Not appropriate
• Meprobamate:
 addictive, sedating, not indicated
TJ/CMS2007
- 180
Anxiolytics: Dosage Thresholds
•
•
•
•
•
•
•
•
•
•
TJ/CMS2007
Flurazepam
Chlodiazepoxide
Clorazepate
Diazepam
Cloazepam
Quazepam
Esazolam
Alprazolam
Oxazepam
Lorazepam
- 181
15mg
20mg
15mg
5mg
1.5mg
7.5mg
0.5mg
0.75mg
30mg
2mg
Cardiovascular 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
TJ/CMS2007
- 182
Cardiovascular medications
• 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
TJ/CMS2007
- 183
Cardiovascular medications
• 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
TJ/CMS2007
- 184
Cholesterol lowering medications
• 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
TJ/CMS2007
- 185
Cognitive 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
TJ/CMS2007
- 186
Case Scenario
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
TJ/CMS2007
- 187
Case Scenario
Medications
• Donepezil 10mg in the evening
• Loperamide 2mg as needed for loose
stools
• Calcium 500mg and Vit D 400 IU twice
daily
TJ/CMS2007
- 188
Cough-Cold-Allergy Medications
• 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.
TJ/CMS2007
- 189
Gastrointestinal 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
TJ/CMS2007
- 190
Gastrointestinal 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
- 191
Glucocorticoids
• Document necessity for continued use
• Hyperglycemia, psychosis, edema, insomnia, HTN,
osteoporosis, mood lability, depression
TJ/CMS2007
- 192
Hematinics
• EPO



Assess anemia etiology before use
Monitor BP, serum Fe/ferritin, CBC
Excess dose/duration

Polycythemia, MI, stroke
• Iron



TJ/CMS2007
- 193
Not indicated for anemia of chronic disease
Justify use >2months; >q.d.
Baseline serum Fe or ferritin, periodic CBC
Laxatives
• Flatulence, bloating, abdominal pain
• Bulk formers & stool softeners
 Adequate fluids to avoid bowel obstruction
TJ/CMS2007
- 194
Muscle 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)
TJ/CMS2007
- 195
Orexigenics
(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
- 196
Osteoporosis medications
• Bisphosphonates



TJ/CMS2007
- 197
Specific administration guideline adherence
Esophageal or gastric erosion
Potential GI symptoms with corticosteroids, ASA,
NSAIDs
Platelet inhibitors
• ASA, Dipyridamole, Clopidogrel
 Thrombocytopenia, bleeding
 HA, dizziness, vomiting

Caution with NSAIDs, warfarin
• Ticlodipine
 Risk > benefit (neutropenia)
 N, V, D
TJ/CMS2007
- 198
Respiratory medications
• Theophylline
 Drug interaction potential
 Monitor serum levels, toxicity
• Inhalant medications
 Anticholinergics: dry mouth
 Beta agonists: restlessness, tachycardia, anxiety
 Steroids: throat irritation and candidiasis
TJ/CMS2007
- 199
Sedatives/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)
TJ/CMS2007
- 200
Daily Dose Thresholds
for Sedative/Hypnotics
•
•
•
•
•
•
•
•
TJ/CMS2007
Chloral hydrate 500mg
Diphenhydramine 25mg
Estazolam
0.5mg
Eszopiclone
1mg
Flurazepam
15mg
Hydroxyzine
50mg
Lorazepam
1mg
Oxazepam
15mg
- 201
•
•
•
•
•
•
•
Quazepam
Ramelteon
Temazepam
Triazolam
Zaleplon
Zolpidem IR
Zolpidem CR
7.5mg
8mg
15mg
0.125mg
5mg
5mg
6.25mg
Thyroid medications
• Potential drug interactions affecting dosage
• Initiate at low dose, increase gradually
• Assess thyroid function studies periodically
TJ/CMS2007
- 202
Urinary incontinence medications
• Assess underlying cause and identify type of
incontinence: select medications accordingly
• Assess urinary symptoms periodically
• Monitor side effects
TJ/CMS2007
- 203
Table II:
Medications with
Significant Anticholinergic Properties
TJ/CMS2007

Anticholinergic side effects are common

Medications in many categories have
anticholinergic properties

Use of multiple medications with
anticholinergic properties may be particularly
problematic
- 204
Anticholinergic Side Effects
• Peripheral




Blurred vision
Dry mouth
Constipation
Urinary retention
• Central












TJ/CMS2007
- 205
Labile mood
Restlessness
Wandering
Ataxia
Confusion
Disorientation
Agitation
Psychosis
Insomnia
Delusions
Decreased attention
Span
Memory impairment
Table II:
Anticholinergic Meds
• Examples of anticholinergic effects:











TJ/CMS2007
- 206
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
Table II:
Anticholinergic 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



TJ/CMS2007
- 207
Antidiarrheals (diphenoxylate/atropine)
Antispasmodics (dicyclomine, hyoscyamine, etc.)
Anti-ulcer agents (cimetidine, ranitidine)
Table II:
Anticholinergic 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)
TJ/CMS2007
- 208
78 y.o. F. nursing home resident
Meds: Furosemide 20mg b.i.d.
Calcium 500mg t.i.d.
Risperdal 0.5mg b.i.d.
Hydroxyzine 25mg p.r.n.
Cogentin 1mg b.i.d.
Medical Problems:
Dementia
Dermatitis
Edema
Reflux esophagitis
TJ/CMS2007
- 209
Reglan 10mg b.i.d.
Senna-S b.i.d.
Metamucil 1 tsp b.i.d.
MOM 15 ml q.d.
Naproxen 375mg b.i.d.
Constipation
Osteoporosis
Parkinsonism
DJD
Summary
Six medication management considerations

Indication for Use

Monitoring Efficacy & Adverse Consequences

Dose

Duration

Tapering/GDR

TJ/CMS2007
- 210
Prevention, Identification & Responses to
Adverse Consequences
F425,428, 431-What’s Changed?
• Only the Guidance has changed.

Increased information on what is pharmaceutical
services.

TJ/CMS2007
- 211
Increased information about MRR.
F428
Medication Regimen Review
Interpretive Guidelines
Intent
• 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
TJ/CMS2007
- 213

Identification and reporting of irregularities

Action taken in response to irregularities
Overview
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)
TJ/CMS2007
- 214
Common Manifestations of Adverse Drug
Reactions in the Elderly That May Be
Incorrectly Interpreted as Signs of Aging
• Confusion
• Depression
• Lack of appetite
• Weakness
• Lethargy
• Ataxia
TJ/CMS2007
- 215
• Forgetfulness
• Tremor
• Constipation
• Dizziness
• Diarrhea
• Urinary retention
Disorders Precipitated or Exacerbated
by Drugs
•
•
•
•
•
•
•
•
•
•
•
•
TJ/CMS2007
Asthma:
CHF:
Depression:
Dizziness, ↓BP:
Essential Tremor:
Edema:
Gout:
Hypertension:
OBS:
Parkinsonism:
PUD:
Urinary Retention:
- 216
Beta Blockers (systemic, ocular)
NSAIDs, glitazones
Propranolol, Methyldopa, Clonidine
Numerous
Beta Agonists, Lithium
NSAIDs, glitazones, gabapentin, …
Loop & Thiazide Diuretics
NSAIDs, venlafaxine
Anticholinergics, Benzodiazepines, …
Antipsychotics, Asendin, Reglan
NSAIDs
Anticholinergics
Cheney Hospitalized
1/9/2006, 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.
TJ/CMS2007
- 217
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
TJ/CMS2007
- 218
Sources 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
of sources than I am now?
TJ/CMS2007
- 219
types
MRR 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?
TJ/CMS2007
- 220
MRR Considerations



TJ/CMS2007
- 221
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?
MRR Considerations

TJ/CMS2007
- 222
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
MRR Considerations










TJ/CMS2007
- 223
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
Location and Notification
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
TJ/CMS2007
- 224
Response to Irregularities Identified
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:


TJ/CMS2007
- 225
Physician accepts and acts upon suggestion
OR
Physician rejects and provides explanation for
disagreeing
Response 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
TJ/CMS2007
- 226
Lack 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”
TJ/CMS2007
- 227
Lack of Action or Rejection
• What about continuing to document an issue
that the physician has disregarded or
rejected?


TJ/CMS2007
- 228
“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.”
F428 - 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.

TJ/CMS2007
- 229
So, what are these “things” we’re preventing,
identifying, reporting, and resolving…how are
MRPs, med errors, and irregularities defined?
Medication-Related Problems
• A Medication-Related Problem (MRP) is:
(NOTE HOW SIMILAR THESE ARE TO THE
UNNECESSARY MED ‘CATEGORIES’ IN F-TAG 329)


TJ/CMS2007
- 230
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
Medication-Related Problems (cont.)



TJ/CMS2007
- 231
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)
Medication-Related Problems (cont.)




TJ/CMS2007
- 232
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”
Common
Medication Interactions in LTC
TJ/CMS2007
• Warfarin - NSAIDs
• ACEI - Potassium suppl.
• Warfarin - Sulfonamides
• ACEI - Spironolactone
• Warfarin - Macrolides
• Digoxin - Amiodarone
• Warfarin - Quinolones
• Digoxin – Verapamil
• Warfarin - Phenytoin
• Theophylline - Quinolones
- 233
Medication 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)
TJ/CMS2007
- 234
Irregularities
• 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.”
TJ/CMS2007
- 235
F428 - 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
- 236
Frequency 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
- 237
Where 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
TJ/CMS2007
- 238
Notification 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
TJ/CMS2007
- 239
Location 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:


TJ/CMS2007
- 240
Encouraging/facilitating other healthcare
professionals to utilize
Allowing facilities flexibility in determining a
consistent location that suits their needs
Considerations for Medication
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
- 241
Considerations for Medication
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…

TJ/CMS2007
- 242
The pharmacist reviewing the prescriptions prior to
dispensing”
F425
Pharmaceutical Services
Interpretive Guidelines
Definitions
Pharmaceutical 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 medicationrelated issues including the prevention and reporting of
medication errors; and
• The provision, monitoring and/or the use of medication-related
devices.
TJ/CMS2007
- 244
Intent
• 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
TJ/CMS2007
- 245
Overview
• 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




TJ/CMS2007
- 246
Acquiring
Receiving
Dispensing
Authorized personnel
- Administering
- Disposal
- Labeling/Storage, incl.
controlled substances
Provision of Medications
• Factors that may help determine timeliness
and guide procedures for acquisition include:





TJ/CMS2007
- 247
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
Pharmacist 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:




TJ/CMS2007
- 248
Multiple pharmacies
Infusion provider
Hospice
Prescription Drug Plan (PDP)
Pharmacist Services
-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
- 249
Pharmacist Services
-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
- 250
Pharmacist 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
- 251
Pharmacist Services
-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
- 252
Pharmaceutical Services
• Acquisition
• Receiving & Dispensing
• Administering
• Disposition
• Labeling
• Storage
• Controlled Drugs
TJ/CMS2007
- 253
Labeling
• 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)
TJ/CMS2007
- 254
Controlled 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
- 255
F425 - Pharmaceutical Services
• 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
- 256
F425 - Pharmaceutical Services

TJ/CMS2007
- 257
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”
F431
Storage, Labeling,
Controlled Medications
Interpretive Guidelines
Intent
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
- 259
Labeling
New 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

TJ/CMS2007
- 260
In other words, if there isn’t space for an entire label, still
better have - at least - resident’s name on actual product
container
Labeling
New Key Points
• For compounded IV preparations, label contains:










TJ/CMS2007
- 261
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)
Labeling
New Key Points
• 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
- 262
Access and Storage
New 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…

TJ/CMS2007
- 263
Important that the facility have procedures for the control
and safe storage of medications for those residents who
can self-administer
Storage, Labeling, Controlled Meds
• The facility must employ or obtain the services
of a licensed pharmacist who:


TJ/CMS2007
- 264
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.
Controlled Medications
Old 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
- 265
Controlled Medications
Old vs. New
• New:



TJ/CMS2007
- 266
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
Controlled Medications
Old vs. New
• Old: Periodic reconciliations should be
monthly
• New: Periodic reconciliation of receipt,
disposition, and inventory for ALL controlled
medications (monthly or more frequently)

TJ/CMS2007
- 267
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
Controlled Medications
Old vs. New
• 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:


TJ/CMS2007
- 268
Consultant Pharmacist and facility develop and
implement recommendations for resolution
Review and revise monitoring procedures, as necessary
(e.g., increasing the frequency of reconciliation)