Transcript New CMS Guidance to Surveyors: Pharmacy Services and

New CMS Guidance to
Surveyors: Pharmacy Services
and Unnecessary Medications
February 2007
Copyright 2007 American Society of Consultant Pharmacists
Timeline for Pharmacy Tags
• Reminder: Appendix N Deleted - Effective June 2004
• Pharmacy Services and Unnecessary Medications
–
–
–
–
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: DECEMBER 18, 2006
c 2007 ASCP
2
Tags 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
• DRR/MRR
– New Tag F431 = Old Tags F427 (b) (2) and (3), F431, F432
• Control, Labeling, and Storage
c 2007 ASCP
3
SOM Components
• Appendix P: Survey Protocol for LTC
– Task 5 – text added that describes the assessment of
pharmaceutical services
– Sub-Task 5A – text revised to state that each surveyor
completing a medication pass observation will review drug
storage on their assigned units
– Sub-Task 5C – text added to guide the surveyor to use the
investigative protocol for F329 for each Resident Review,
DELETED adverse drug reactions section of 5C, part G3
– Sub-Task 5E – complete revision of text and renaming of 5E
as Medication Pass and Pharmacy Services
c 2007 ASCP
4
SOM Components
• Appendix PP: Interpretive Guidelines for LTC
– Regulations (HAVEN’T CHANGED)
– Interpretive Guidelines, or Guidance to Surveyors
– Investigative Protocol
• New combined investigative protocol for
Unnecessary Medications (F329) and
Medication Regimen Review (F428)
– Deficiency Categorization/Severity Guidance
c 2007 ASCP
5
Training of surveyors
• Representatives from each state survey
agency attended a 2-day train-the-trainer
session in Baltimore; They received info/tools
on F329 to bring back to their state for
training of other surveyors
• Satellite/webcast training sessions on
December 15; archived program available at:
– http://cms.internetstreaming.com
c 2007 ASCP
6
Online SOM Resources
• CMS website with SOM:
http://www.cms.hhs.gov/manuals/downloads/som107
_Appendicestoc.pdf
• CMS website with transmittal regarding changes to
pharmacy sections:
http://www.cms.hhs.gov/transmittals/downloads/R22S
OMA.pdf
• Nursing Facility Survey and Regulations Briefing
Room on ASCP website:
www.ascp.com/public/pr/nfsurvey or
www.ascp.com/som
c 2007 ASCP
7
Key Points According to CMS
• Care Process - Looking at patient and medication
regimen holistically
• Importance of all aspects of medication management
• When taking multiple meds, risks and benefits of any
one must be viewed in relation to the entire regimen
• Broadening focus beyond psychoactive medications
• Additional guidance on:
– Monitoring for effectiveness
– Assessing possibility that med may paradoxically
cause/exacerbate symptoms it was intended to
treat/prevent
c 2007 ASCP
8
F425 - Pharmaceutical Services
Regulations
•
•
The facility must:
– Provide routine and emergency medications and biologicals to its
residents, or obtain them under an agreement
– Provide pharmaceutical services including procedures that assure
the accurate acquiring, receiving, dispensing, and administering of
all medications and biologicals to meet the needs of each resident
– Employ or obtain the services of a licensed pharmacist who
provides consultation on all aspects of the provision of pharmacy
services in the facility
The facility may:
– Permit unlicensed personnel to administer medications if state law
permits, but only under the general supervision of a licensed nurse.
c 2007 ASCP
9
Pharmacy Services What do the old guidelines say?
• Interpretive Guidelines
– The facility is responsible for the timeliness of the services
– A drug, whether prescribed on a routine, emergency, or as
needed basis, must be provided in a timely manner; If
failure to provide a prescribed drug in a timely manner
causes the resident discomfort or endangers his or her
health and safety, then this requirement is not met
• Survey Procedures
– During the surveyor’s observation of the drug pass, are all
ordered medications available?
c 2007 ASCP
10
New F425 - Overview
• Provision of Medications
– Timeliness/Availability to meets needs of each resident
• Services of a Pharmacist
– “The facility is responsible for employing or contracting for
the services of a pharmacist to provide consultation on all
aspects of pharmaceutical services.”
• Pharmaceutical Services Procedures
–
–
–
–
Acquiring
Receiving
Dispensing
Authorized personnel
- Administering
- Disposal
- Labeling/Storage, including
controlled meds
c 2007 ASCP
11
F425 - Pharmaceutical Services
Provision of Meds
• 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
c 2007 ASCP
12
Considerations Regarding
Timeliness
• Do you have a mechanism/process to identify and
prioritize the communication of new medication
orders and new admits?
• Do facility staff know to tell and pharmacy staff know
to ask whether a re-admit needs a supply of their
medications re-sent?
• Do you have a way to identify and ‘fast-track”
antibiotics, pain medications, and other “acute
condition” treatments (e.g., N/V)?
c 2007 ASCP
13
Considerations Regarding
Timeliness
• Do you periodically look at E-Kit utilization and
medications dispensed after-hours to evaluate
whether medications need to be added to or deleted
from the E-Kit?
• Do nursing facility staff prompt or encourage MD/NPs
to utilize medications in the E-Kit when they are
prescribing medications after-hours? Do the MD/NPs
servicing residents in your facility have copies of or
off-site access to the list of E-Kit contents?
c 2007 ASCP
14
Considerations Regarding
Timeliness
• Do your state rules/regulations and/or the facility’s
policies and procedures and/or your pharmacy
contract mention specific medication delivery/
administration timeframes?
• Are your staff aware of any of the above
rules/policies? Are they aware of the timeliness
stipulation in the regulatory guidance?
c 2007 ASCP
15
F425 - Pharmaceutical Services
Pharmacist Services
• Consultant pharmacist’s responsibilities, in
collaboration with the facility, MAY include:
WE’LL START WITH A BIG ONE…..
– Coordinate pharmaceutical services if and when
multiple service providers are utilized, for
example:
• Multiple pharmacies
• Infusion provider
• Hospice
• Prescription Drug Plan (PDP)
c 2007 ASCP
16
F425 - Pharmaceutical Services
Pharmacist Services
– P+Ps - “Develop, implement, evaluate, and revise
(as necessary)”
– IV therapy procedures
– E-Kits
– Develop mechanisms for communicating,
addressing, resolving issues related to pharmacy
services
– “Strive to assure” meds requested, received and
administered in timely manner
– Med pass review/feedback
– ID team, QA+A Committee
c 2007 ASCP
17
F425 - Pharmaceutical Services
Pharmacist Services
– MRR procedures (more on MRR in F428, but this
is P+Ps)
• Conducting MRR for each resident
• Addressing expected time frames for
conducting and reporting
• Addressing irregularities
• Documenting and reporting results
• Addressing MRRs for residents:
– anticipated to stay less than 30 days
– who experience an acute change in condition as
identified by facility staff
c 2007 ASCP
18
F425 - Pharmaceutical Services
Pharmacist Services
• NOTE in F425 regarding interim MRRs:
“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.”
c 2007 ASCP
19
F425 - Pharmaceutical Services
Interim MRRs
•
EXAMPLES of how the facility may identify residents anticipated to be
short-stay or who experience an acute change in condition….
– CHANGE IN CONDITION
• Residents for which a “Change in Condition” MDS was
completed - Section AA and/or A of MDS, Question 8 (a) will be
answered with a “3” if the resident has experienced a significant
change in status.
• Residents have triggered Section J, Question 1 of MDS, as this
indicates new problems present in the last 7 days
• Residents have triggered Section P, Questions 5, 6, 7, 8, or 9
– (5) - Hospital Stays in last 90 days
–
–
–
–
(6) - ER Visits in last 90 days
(7) - MD Visits in last 14 days
(8) - MD Orders in last 14 days
(9) - Abnormal Lab Values in last 90 days
c 2007 ASCP
20
F425 - Pharmaceutical Services
Interim MRRs
• EXAMPLES of how the facility may identify residents anticipated
to be short-stay or who experience an acute change in
condition….
– SHORT STAY RESIDENTS
• See Section Q of MDS, Question 1 (c):
– Stay projected to be of a short duration - discharge projected
within 90 days (do not expected discharge due to death):
» 0. No
» 1. Within 30 days
» 2. Within 31-90 days
» 3. Discharge status unknown
c 2007 ASCP
21
F425 - Pharmaceutical Services
Pharmacist Services
– Procedures/guidance regarding contacting
prescriber about medication issue (e.g., info to
gather)
– Process for receiving, transcribing, recapitulating
med orders
– Medication packaging
– Automated dispensing machines/delivery
devices/cabinets
– Medication references/resources
– Staff education
c 2007 ASCP
22
F425 - Pharmaceutical Services
Acquisition
• Acquisition
–
–
–
–
–
–
–
Emergency supply
Contacting pharmacy (When, How, Who)
Availability of needed meds/Timeliness
Meds dispensed by PHYSICIAN
Verification/clarification of orders
Procedure when delivery of med delayed or NA
Transport of meds from pharmacy to facility
c 2007 ASCP
23
F425 - Pharmaceutical Services
Receiving + Dispensing
• Receiving
– How receipt will occur and how it will be reconciled with
order/requisition
– How staff will be identified/authorized to receive and how
access will be controlled until stored
– Which staff will incorporate into resident-specific area
• Dispensing
– Delivery and receipt of medications from pharmacy
– Labeling
– Type of medication packaging
c 2007 ASCP
24
F425 - Pharmaceutical Services
Administering
• Administering
– Continuity of staff without unnecessary
interruptions
– Reporting of medication errors (How, To Whom)
– Staff authorized to administer
– 5+ “rights”
– Defining schedules for administration to:
• Maximize effectiveness
• Avoid potential interactions
• Recognize resident choices and activities
c 2007 ASCP
25
F425 - Pharmaceutical Services
Administering
– General guidelines for monitoring (What,
Frequency, Timing, Results)
– Techniques and precautions for alternate routes
– Documentation of administration
– Providing medication and medication device
information/references
– Clarifying orders prior to administration
– Reconciliation of orders - including who may
transcribe orders and enter orders onto MAR
c 2007 ASCP
26
F425 - Pharmaceutical Services
Disposing
• Disposing
– Timely identification and removal of meds from
current supply
– Storage method for meds awaiting disposal,
including control and accountability
– Method and documentation of disposition
c 2007 ASCP
27
F425 - Pharmaceutical Services
Labeling, Storage, CSs
•
•
•
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)
Storage
– Location, security and authorized access to med storage areas,
discontinued meds
– Environmental conditions of storage areas
Controlled Meds
– Location, security and authorized access - including refrigerated CSs
– Records of receipt and disposition for all controlled meds
– Periodic reconciliation (e.g., Frequency, How, By Whom, Documentation)
c 2007 ASCP
28
F425 - Pharmaceutical Services
Authorized Personnel
• Authorized Personnel
– Assure only persons authorized by state/federal
requirements are administering
– Provide current info on meds being used in facility
– Assure ongoing competency of all staff (inc. PRN)
– Training on med administration-related
devices/equipment (e.g, IV pumps, glucometers,
nebulizers, syringes, etc)
– Identifying pharmacy personnel authorized to
access medications
c 2007 ASCP
29
Policies and Procedures
• First, you need them!
• You need to actually use them - And educate and
train staff about them - including PRN staff!
• And, you need to revisit them occasionally!
• If your pharmacy contract is fairly specific, make sure
policies and procedures are consistent with it
• Look at F425 (+other tags) for examples of what to
address in your policies and procedures, as it
specifically outlines topics that can serve as a
guideline for reviewing/writing your P+Ps
c 2007 ASCP
30
F431- Storage, Labeling, Controlled Meds
Regulations
• 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 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
c 2007 ASCP
31
F431- Storage, Labeling, Controlled Meds
Regulations
• Labeling…
– Medications and biologicals used in the facility must be
labeled in accordance with currently accepted professional
principles, and include the appropriate accessory and
cautionary instructions and expiration date when applicable
• Storage…
– In accordance with state and federal laws/requirements, the
facility must store all medications and biologicals in locked
compartments under proper temperature controls and permit
only authorized personnel to have access (to the keys)
c 2007 ASCP
32
F431- Storage, Labeling, Controlled Meds
Regulations
• Controlled Meds…
– The facility must provide separately locked, permanently
affixed compartments for storage of controlled medications
listed in Schedule II…and other medications subject to
abuse, except when the facility uses single unit package
medication distribution systems in which the quantity stored
is minimal and a missing dose can be readily detected
c 2007 ASCP
33
F431 - Labeling
New Key Points
• 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
c 2007 ASCP
34
F431 - Labeling
New Key Points
•
For compounded IV preparations, label contains:
– Name and volume of solution
– Resident’s name
– Infusion rate
– Name and quantity of ach 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)
c 2007 ASCP
35
F431 - 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
c 2007 ASCP
36
F431 - Access and Storage
New Key Points
• 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
c 2007 ASCP
37
F431 - Access and Storage
New Key Points
• Temperature, light, humidity…
– Important that facility implement procedures that
address and monitor the safe storage and
handling of medications in accordance with
manufacturer specifications, state requirements,
and standards of practice (e.g., USP)
c 2007 ASCP
38
F428 - MRR
Regulations
• The drug regimen of each resident must be
reviewed at least once a month by a licensed
pharmacist
• The pharmacist must report any irregularities
to the attending physician and the director of
nursing
• And, these reports must be acted upon
c 2007 ASCP
39
F428 - MRR
What is MRR?
• Definition in glossary:
“Thorough evaluation of the medication regimen of a
resident by a pharmacist, 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.”
c 2007 ASCP
40
F428 - MRR
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
c 2007 ASCP
41
F428 - MRR
MRR Considerations
• MRR considers factors, such as:
– Has MD/staff documented objective findings,
diagnoses, symptoms to support indication?
– Has MD/staff identified and acted upon, or should
they be notified about, resident’s allergies,
potential interactions/adverse consequences?
– Is dose, frequency, route, duration consistent with
resident’s condition, manufacturer’s
recommendations, and applicable standards of
practice?
c 2007 ASCP
42
F428 - MRR
MRR Considerations
– Has MD/staff documented progress towards or
maintenance of the goal(s) for medications
therapy?
– Has MD/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?
c 2007 ASCP
43
F428 - MRR
MRR Considerations
– Has MD/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
Dysphagia, swallowing difficulty
Excessive sedation, insomnia, or sleep disturbance
c 2007 ASCP
44
F428 - MRR
MRR Considerations
•
•
•
•
•
•
•
•
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
c 2007 ASCP
45
F428 - MRR
Notification of Findings
• Pharmacist is expected to document either
that no irregularity was identified or the nature
of the irregularity(ies), if any were identified
– If none, pharmacist would include a signed and
dated statement to that effect
• Format and process of report can be
determined by facility and CP
c 2007 ASCP
46
F428 - MRR
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
• Collaboration should occur between CP and facility to
identify the most effective means of notification/
documentation
c 2007 ASCP
47
F428 - MRR
Notification 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
• Guidelines strive to find balance between:
– Encouraging/facilitating other HC professionals to utilize
– Allowing facilities flexibility in determining a consistent
location that suits their needs
c 2007 ASCP
48
F428 - MRR: Response to Findings
Old Guidelines
• The director of nursing and the attending physician
are not required to agree with the pharmacist’s
report, nor are they required to provide a rationale
for their acceptance or rejection of the report;
They must, however, act upon the report
• This may be accomplished by indicating acceptance
or rejection of the report and signing their names
• The facility is encouraged to provide the medical
director with a copy of drug regimen review reports
and to involve the medical director in reports that
have not been acted upon
c 2007 ASCP
49
F428 - MRR: Response to Findings
New Guidelines
• 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
• Encourage sharing of report with entire ID team
c 2007 ASCP
50
F428 - MRR
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 MD are same, follow established facility
procedure to resolve the situation (also see new F-501)
• No specific timeframe provided for when a report that
is not acted upon officially becomes delinquent or
“not acted upon”
c 2007 ASCP
51
F428 - MRR
Lack of Action or Rejection
• What about continuing to document an issue
that the physician has disregarded or rejected
that is considered less clinically significant or
where evidence of a valid clinical reason for
rejection has been documented?
– “In these situations, pharmacist need only
reconsider annually whether to report again or
make new recommendation.”
c 2007 ASCP
52
F428 - MRR
Top 10 Drug Interactions in LTC
• Warfarin and…
– NSAIDs and COX-II inhibitors
– Phenytoin (Dilantin)
– Antibiotics
• Sulfonamides (Bactrim, Septra)
• Macrolides (Biaxin, Erythromycin, Zithromax)
• Fluoroquinolones (Cipro, Levaquin)
• ACE Inhibitors (ending in ‘pril’) and…
– Potassium supplements
– Spironolactone
c 2007 ASCP
53
F428 - MRR
Top 10 Drug Interactions in LTC
• Digoxin and…
– Amiodarone (Cordarone)
– Verapamil (Calan, Verelan)
• Theophylline and…
– Fluoroquinolones (Cipro, Levaquin)
c 2007 ASCP
54
F329 - Unnecessary Meds
Regulations
• Each resident’s medication regimen must be
free from unnecessary medications. An
unnecessary medication is any medication
when used:
–
–
–
–
–
In excessive doses (including duplicate therapy); or
For excessive duration; or
Without adequate monitoring; or
Without adequate indications for its use; or
In the presence of adverse consequences which indicate the
dose should be reduced or discontinued; or
– Any combinations of the reasons above
c 2007 ASCP
55
F329 - Unnecessary Meds
Regulations
• Antipsychotics - Based on a comprehensive
assessment of a resident, the facility must ensure
that:
– 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
– Residents who use antipsychotic drugs receive gradual dose
reductions, and behavioral interventions, unless clinically
contraindicated, in an effort to discontinue these drugs
c 2007 ASCP
56
F329 - Medication Management
is Part of the Care Process
SIX MEDICATION MANAGEMENT CONSIDERATIONS
•
•
•
•
•
•
Indications for use of the medication
Monitoring for efficacy and adverse consequences
Dose and duplicate therapy
Duration
Reevaluation and Tapering of a medication
Prevention, identification, and response to adverse
consequences
c 2007 ASCP
57
F329 - Unnecessary Meds
Indication
• Opportunities for or circumstances that
warrant evaluation of medication’s indication:
– Admission or re-admission
– Multiple prescribers
– New medication order, especially if used as
emergency measure
– Psychiatric disorder or distressed behavior
– Change in condition, decline in function, new
symptom/condition
c 2007 ASCP
58
F329 - Unnecessary Meds
Monitoring
• F329 contains sample monitoring tools and sources/references
• 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
c 2007 ASCP
59
F329 - Unnecessary Meds
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
c 2007 ASCP
60
F329 - Unnecessary Meds
Adverse Consequences
• Any medication can cause adverse consequences
• Considerations include…
– Following relevant clinical guidelines and/or manufacturer’s
specifications for use, dose, duration, monitoring
• Black Box Warnings:
http://formularyproductions.com/blackbox/
– 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
c 2007 ASCP
61
F329 - Unnecessary Meds
Dose/Duplicate Therapy
• Dosing in older adults: Start LOW, Go SLOW
• 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
c 2007 ASCP
62
F329 - Unnecessary Meds
Dose/Duplicate Therapy
• Duplicate therapy…
– Use of 2 or more medications from same class OR
Use of medications from different therapeutic
categories that have similar effects or properties
• Acetaminophen-containing products
• Multiple laxatives
• Multiple benzodiazepines
• Anticholinergic effects
– Documentation is necessary to clarify rationale for,
benefits of, and monitoring of duplicate therapy
c 2007 ASCP
63
F329 - Unnecessary Meds
Duration
•
•
•
Some meds needed for extended periods, others shorter-term
– Acute conditions
• Cough/Cold
• Nausea/Vomiting
• Acute Pain
• Psychiatric/Behavioral Symptoms
– PPIs/H2 blockers (ulcer/GERD meds) used for prophylaxis during
acute phase of medical illness
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
c 2007 ASCP
64
F329 - Unnecessary Meds
Tapering/GDR
• Tapering of any medication may be indicated
• Goal of GDR:
– Evaluate the continued need for the medication,
AND
– Determine whether the resident is being
maintained on the lowest effective dose
c 2007 ASCP
65
F329 - Unnecessary Meds
Tapering/GDR
• Opportunities for evaluation of medication, in regards
to duration/dose:
– CP’s MRR
– MD’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
c 2007 ASCP
66
Summary of Changes Between
Advance Copy (Sep) and Final (Dec)
• Failed GDR/tapering isn’t the only way clinical
contraindication can be determined for:
– Antipsychotics used to treat psychiatric conditions
– Sedatives/hypnotics
– Psychopharmacological medications
• “So long as the medication is used in accordance with
relevant current standards of practice, tapering/GDR may
be considered clinically contraindicated if the physician
has documented 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”
c 2007 ASCP
67
Summary of Changes Between
Advance Copy (Sep) and Final (Dec)
• Sedative/Hypnotics
– If tapering is utilized for sedatives/hypnotics, the most recent failed
attempt - rather than three previous failed attempts - determines
clinical contraindication
– Additional direction was added to consider tapering of a
sedative/hypnotic if it is used beyond the manufacturer’s
recommendations for duration of use
– Reference to clinical contraindication being valid for the remainder
of the year has been deleted
• Under the cognitive enhancers section of Table 1, the reference
to tapering of psychopharmacological medications has been
deleted
c 2007 ASCP
68
F329 - Unnecessary Meds
GDR/Tapering for Antipsychotics
• 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
• MD provides clinical rationale OR
• Resident has a specific DX and meets criteria listed in
guidelines
c 2007 ASCP
69
F329 - Unnecessary Meds
GDR/Tapering for Antipsychotics
• NEW:
– For antipsychotics used to treat behavioral
symptoms related to dementia, GDR is clinically
contraindicated if:
• Resident’s target symptoms returned or
worsened after MOST RECENT GDR attempt
WITHIN facility, AND
• MD has documented clinical rationale
c 2007 ASCP
70
F329 - Unnecessary Meds
GDR/Tapering for Antipsychotics
• NEW:
– For antipsychotics used to treat a psychiatric disorder,
GDR is clinically contraindicated if:
• The continued use is in accordance with relevant current
standards of practice AND
• MD has documented clinical rationale
OR
• Resident’s target symptoms returned or worsened after
MOST RECENT GDR attempt WITHIN facility, AND
• MD has documented clinical rationale
c 2007 ASCP
71
F329 - Unnecessary Meds
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
c 2007 ASCP
72
F329 - Unnecessary Meds
Tapering for Sedatives/Hypnotics
• OLD:
– Begin tapering after 10 days of continuous daily
use
– Frequency: 3 times within 6 months
– Tapering is clinically contraindicated if:
• 3 attempts within the last 6 months led to a
decline
c 2007 ASCP
73
F329 - Unnecessary Meds
Tapering for Sedatives/Hypnotics
• NEW:
– As long as resident is on sedative/hypnotic that is used
ROUTINELY beyond the manufacturer’s recommendations
for duration of use, taper at least QUARTERLY
– Tapering is clinically contraindicated if:
• The continued use is in accordance with relevant current
standards of practice AND
• MD has documented clinical rationale
OR
• Resident’s target symptoms returned or worsened after
MOST RECENT GDR attempt WITHIN facility, AND
• MD has documented clinical rationale
c 2007 ASCP
74
F329 - Unnecessary Meds
Tapering for Sedatives/Hypnotics
• NEW:
– Sedatives/Hypnotics now include…
• New agents (non-benzodiazepine)
• Sedating antidepressants (e.g., trazodone)
• Sedating antihistamines (e.g, hydroxyzine)
c 2007 ASCP
75
F329 - Unnecessary Meds
Tapering for Psychopharmacological
Meds
• OLD:
ONLY APPLIED 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
c 2007 ASCP
76
F329 - Unnecessary Meds
Tapering for Psychopharmacological
Meds
• NEW:
– Psychopharmacological meds now grouped together, so
more than just benzodiazepines…any med used for
managing behavior, stabilizing mood, or treating psychiatric
disorders
– According to Table 1, the following classes might be
considered psychopharmacological depending on how
they’re used:
• Anticonvulsants
• Antidepressants
• Anxiolytics - including buspirone, antidepressants
c 2007 ASCP
77
F329 - Unnecessary Meds
Tapering for Psychopharmacological
Meds
• NEW:
– Tapering is clinically contraindicated if:
• The continued use is in accordance with relevant current
standards of practice AND
• MD has documented clinical rationale
OR
• Resident’s target symptoms returned or worsened after
MOST RECENT GDR attempt WITHIN facility, AND
• MD has documented clinical rationale
c 2007 ASCP
78
F329 - Unnecessary Meds
Tapering for Psychopharmacological
Meds
• NEW: (SAME AS ANTIPSYCHOTICS)
– Within 1st year after admission on psychopharm
med or after initiation:
• Taper in 2 separate quarters, with at least one
month between attempts
– After 1st year,
• Taper annually
c 2007 ASCP
79
F329 - Unnecessary Meds
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
c 2007 ASCP
80
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.
c 2007 ASCP
81
F329 - TABLE 1: Medication
Issues of Particular Relevance
• While Table 1 is 36 pages long, it does not include all
categories nor all medications within a category
• 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, just that
the medication has the potential to be unnecessary
c 2007 ASCP
82
F329 - TABLE 1: Medication
Issues of Particular Relevance
• Old guidelines included daily dose recommendations
for psychotropic medications
• Previous drafts of revised guidance did NOT include
dose examples
• But, final document added Daily Dose Thresholds
back in for:
– Antipsychotics
– Anxiolytics
– Sedatives/Hypnotics
c 2007 ASCP
83
F329 - TABLE 2:
Anticholinergic Meds
• Examples of medications with anticholinergic properties…
– Antihistamines (diphenhydramine, chlorpheniramine)
– Antivertigo meds (e.g., meclizine, scopolamine)
– Respiratory meds (ipratropium, tiotropium)
– GI meds
• Antispasmodics (dicyclomine, hyoscyamine, etc)
• Antidiarrheals (e.g., diphenoxylate/atropine)
• Anti-ulcer agents (e.g., cimetidine, ranitidine)
• Phenothiazine antiemetics (e.g., promethazine,
prochlorperazine)
c 2007 ASCP
84
F329 - TABLE 2:
Anticholinergic Meds
• Examples of medications with anticholinergic properties…
– Antidepressants (tricyclics - e.g., amitriptyline, imipramine)
– Muscle relaxants (e.g., cyclobenzaprine, etc)
– Urinary antispasmodics (oxybutynin, tolterodine, etc)
– Antiparkinson meds (benztropine, etc)
– Antipsychotic meds (conventional - e.g., thioridazine,
chlorpromazine)
– Cardiovascular (e.g., furosemide, digoxin, nifedipine)
c 2007 ASCP
85
F329 - TABLE 2:
Anticholinergic Meds
• Examples of anticholinergic effects:
–
–
–
–
–
–
–
–
–
–
–
Slowed digestive motility
Constipation
Decreased sweating
Dry mouth, skin
Elevated BP
Blurred vision
Delirium
Confusion/disorientation
Difficult urination
Drowsiness
Dizziness
c 2007 ASCP
86
Thank you!!
--------------------------------Questions?