Download Overview of the Final Nursing Home Survey Guidelines

Overview of the Final Nursing Home
Survey Guidelines Pharmacy Services & Unnecessary
Medications
Copyright 2006 American Society of Consultant Pharmacists
Timeline for Pharmacy Tags
• Reminder: Appendix N Deleted - Effective June 2004
• Pharmacy Services and Unnecessary Medications
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–
–
–
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
c 2006 ASCP
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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 2006 ASCP
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SOM Components
• Appendix P: Survey Protocol for LTC
– Task 5E Revised - Now evaluates not only the Medication
Pass, but ALSO Pharmacy Services (F425), including
Storage/Labeling/Controlled Medications (F431)
• 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)
– Severity Guidance
c 2006 ASCP
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Online SOM Resources
• CMS website with SOM:
http://www.cms.hhs.gov/manuals/downloads/som107
_Appendicestoc.pdf
• CMS website with Survey and Certification (S&C)
Memos to States/Regions
http://www.cms.hhs.gov/SurveyCertificationGenI
nfo/PMSR/list.asp#TopOfPage
• Nursing Facility Survey and Regulations Briefing
Room on ASCP website:
www.ascp.com/public/pr/nfsurvey or
www.ascp.com/som
c 2006 ASCP
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Key Points
• Regulations themselves have not changed - same as
they are now
• These new guidelines take a holistic approach to
medication management, stressing the importance of
the care process as a whole
• Just because these Tags contain the majority of
pharmacy-related content within Appendix PP, do not
ignore other sections of Appendix PP that are
impacted by or mention medication use AND, above
all, do not forget to provide good pharmaceutical care
c 2006 ASCP
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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 2006 ASCP
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Pharmacy Services What does it say now?
• 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 2006 ASCP
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New F425 - Overview
• Provision of Medications
– Timeliness/Availability to meets 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
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–
–
–
Acquiring
Receiving
Dispensing
Authorized personnel
- Administering
- Disposal
- Labeling/Storage, incl. CSs
c 2006 ASCP
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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 2006 ASCP
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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 2006 ASCP
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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 2006 ASCP
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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 2006 ASCP
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F425 - Pharmaceutical Services
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.”
c 2006 ASCP
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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 2006 ASCP
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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 2006 ASCP
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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 2006 ASCP
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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 2006 ASCP
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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 2006 ASCP
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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 2006 ASCP
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F425 - Pharmaceutical Services
Labeling, Storage, CSs
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•
•
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 2006 ASCP
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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 2006 ASCP
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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 (HOAs on
medical records)
– Reporting of medication errors
c 2006 ASCP
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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 2006 ASCP
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MRR What does it say currently?
• It may be necessary to review more frequently (e.g.,
every week) depending on the resident’s condition
and the drugs they are taking
• Drug Therapy With High Potential for Less Severe
Adverse Outcomes In Persons Over 65 (AKA: Beers
list)
• Review by the surveyor is not necessary for drug
therapy given the first seven consecutive days upon
admission/readmission, unless there is an immediate
threat to health and safety
c 2006 ASCP
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MRR What does it say currently?
• 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 2006 ASCP
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F428 - MRR
• What is MRR?
– Definition in glossary:
Thorough evaluation of the medication regimen of a resident,
with the goal of promoting positive outcomes and minimizing
adverse consequences associated with medications; The
review includes preventing, identifying, reporting, and
resolving medication-related problems (MRPs), medication
errors, or other irregularities and collaborating with others
members of the interdisciplinary team.
– So, what are these “things” we’re preventing, identifying,
reporting, and resolving…how are MRPs, med errors, and
irregularities defined?
c 2006 ASCP
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F428 - MRR
MRPs
• A Medication-Related Problem (MRP) is:
(NOTE HOW SIMILAR THESE ARE TO THE
UNNECESSARY MED ‘CATEGORIES’ IN
F-TAG 329)
– Use of a medication without adequate indication
for use
– Use of a medication without identifiable evidence
that safer alternatives or more clinically
appropriate medications have been considered
c 2006 ASCP
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F428 - MRR
MRPs
– 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)
c 2006 ASCP
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F428 - MRR
MRPs
– 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”
c 2006 ASCP
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F428 - MRR
Med 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
c 2006 ASCP
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F428 - MRR
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.”
c 2006 ASCP
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F428 - MRR
• Given those definitions, important to note that
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…”
c 2006 ASCP
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F428 - MRR
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
c 2006 ASCP
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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 2006 ASCP
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F428 - MRR
Sources of Information
• May include, but are not limited to:
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–
–
MARs
Prescribers’ orders
Progress, nursing, consultants’ notes
RAI/MDS
Lab reports
Forms/reports reflecting behavioral monitoring and/or changes in
condition
– QM/QI reports
– Attending physician, facility staff
– Interviewing, assessing, and/or observing the resident
• Ask yourself, how many of these do I use and should
I be using more sources or different types of sources
than I am now?
c 2006 ASCP
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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/averse consequences?
– Is dose, frequency, route, duration consistent with
resident’s condition, manufacturer’s
recommendations, and applicable standards of
practice?
c 2006 ASCP
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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 2006 ASCP
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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 2006 ASCP
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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 2006 ASCP
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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
• Different iterations of this requirement
throughout the various drafts, but final focus
is on the use of the word “report” as a verb
rather than a noun
c 2006 ASCP
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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
• Collaborate with facility to identify the most effective
means of notification/documentation
• Notification/documentation may be done
electronically
c 2006 ASCP
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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
• Find balance between:
– Encouraging/facilitating other HC professionals to utilize
– Allowing facilities flexibility in determining a consistent
location that suits their needs
c 2006 ASCP
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F428 - MRR
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
c 2006 ASCP
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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
• No specific timeframe provided for when a report that
is not acted upon officially becomes delinquent or
“not acted upon”
c 2006 ASCP
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F428 - MRR
Lack of Action or Rejection
• What about continuing to document an issue
that the physician has disregarded or
rejected?
– “Pharmacist does not need to document a
continuing irregularity each month if it’s deemed to
be clinically insignificant or there is evidence of
valid clinical reason for rejection”
– “In these situations, pharmacist need only
reconsider annually whether to report again or
make new recommendation.”
c 2006 ASCP
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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 2006 ASCP
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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 2006 ASCP
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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 2006 ASCP
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F431 - Labeling
Now vs. New
• Now: This section imposes currently accepted
labeling requirements on facilities, even
though the pharmacies will be immediately
responsible for accomplishing the task
• New: Same
c 2006 ASCP
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F431 - Labeling
Now vs. New
• Now:
– Critical elements of the drug label in a long-term care facility
are:
• Name of the drug
• Strength
– The names of the resident and the physician do not have to
be on the label of the package, but they must be identified
with the package in such a manner as to assure that the
drug is administered to the right patient
– All drugs approved by the Food and Drug Administration
must have expiration dates on the manufacturer’s container
– Expiration dates must be on the labels of drugs used in long
term care facilities unless State law stipulates otherwise
c 2006 ASCP
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F431 - Labeling
Now vs. New
• New:
– Although medication packaging may vary, medication label
at a minimum includes:
• Names of the drug (generic and/or brand)
• Strength
• Expiration date, when applicable
• And typically includes:
– Resident’s name
– Route of administration
– Appropriate instructions/precautions
c 2006 ASCP
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F431 - 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
– 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 2006 ASCP
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F431 - Labeling
New Key Points
• For compounded IV preparations, label contains:
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–
–
–
–
–
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 2006 ASCP
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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 2006 ASCP
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F431 - Access and Storage
Now vs. New
• Now: Compartments, in the context of these
regulations, include but are not limited to drawers,
cabinets, rooms, refrigerators, carts, and boxes
• New: Basically the same
• Now: The provisions for authorized personnel to
have access to keys must be determined by the
facility management in accordance with Federal,
State, and local laws and facility practices
• New: Basically the same, except it also mentions
access in accordance with “standards of practice”
c 2006 ASCP
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F431 - Access and Storage
Now vs. New
• Now: Separately locked means that the key
to the separately locked Schedule II drugs is
not the same key that is used to gain access
to the non-Schedule II drugs
• New: Basically the same
c 2006 ASCP
57
F431 - Access and Storage
New Key Points
• What about pharmacy technicians doing
medication cart exchange or medication cart
inspections?
– As mentioned in F425, it does specifically address
technicians who may be delegated access to
medications by the facility’s pharmacist as a
function of their jobs
c 2006 ASCP
58
F431 - 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…
– Important that the facility have procedures for the control and
safe storage of medications for those residents who can selfadminister
c 2006 ASCP
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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 2006 ASCP
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F431 - Controlled Medications
Now vs. New
• Now: 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
c 2006 ASCP
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F431 - Controlled Medications
Now vs. New
•
New:
– Record of RECEIPT of ALL controlled medications with sufficient to allow
reconciliation, specifying:
• Name and strength of medication
• Quantity
• Date received
• Resident’s name (unless using automated dispensing machine, etc)
– Records of USAGE And DISPOSITION (destruction, waste, return, other
disposal) of ALL controlled medications with sufficient detail to allow
reconciliation, e.g.,
• MAR
• Proof-of-use sheets
• Declining inventory sheets
– Emergency Kits….
• Don’t forget about controlled medications located in the emergency
supply, if your state allows
c 2006 ASCP
62
F431 - Controlled Medications
Now vs. New
• Now: Periodic reconciliations should be
monthly
• New: Periodic reconciliation of receipt,
disposition, and inventory for ALL controlled
medications (monthly or more frequently)
– CP not required to perform reconciliation, but
rather to evaluate and determine that the facility
maintains an account of all controlled medications
and completes reconciliation
c 2006 ASCP
63
F431 - Controlled Medications
Now vs. New
• Now: 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:
– CP and facility develop and implement recommendations for
resolution
– Review and revise monitoring procedures, as necessary
(e.g., increasing the frequency of reconciliation)
c 2006 ASCP
64
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 2006 ASCP
65
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 2006 ASCP
66
F329 - 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
c 2006 ASCP
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F329 - Unnecessary Meds
Indication
• Lots of 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 2006 ASCP
68
F329 - Unnecessary Meds
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
c 2006 ASCP
69
F329 - Unnecessary Meds
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
c 2006 ASCP
70
F329 - Unnecessary Meds
Monitoring
• TABLE of 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 2006 ASCP
71
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 2006 ASCP
72
F329 - Unnecessary Meds
Dose/Duplicate Therapy
• 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
• Route of administration influences absorption
and ultimately the dose
c 2006 ASCP
73
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 2006 ASCP
74
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 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 2006 ASCP
75
F329 - Unnecessary Meds
Tapering/GDR
• Tapering of any medication may be indicated when,
for example:
– the resident’s clinical condition has improved/stabilized
– the underlying causes have resolved
– non-pharmacological interventions have been effective
• Goal of GDR:
– Evaluate the continued need for the medication, and
– Determine whether the resident is being maintained on the
lowest effective dose
c 2006 ASCP
76
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 2006 ASCP
77
F329 - Unnecessary Meds
GDR/Tapering for Antipsychotics
• Now:
– 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 the patient has a specific DX and meets criteria
listed in guidelines
c 2006 ASCP
78
F329 - Unnecessary Meds
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
c 2006 ASCP
79
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
– 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 2006 ASCP
80
F329 - Unnecessary Meds
Tapering for Sedatives/Hypnotics
• Now:
– 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
c 2006 ASCP
81
F329 - Unnecessary Meds
Tapering for Sedatives/Hypnotics
• New:
– As long as resident is on sedative/hypnotic that is used
ROUTINELY during the previous quarter, taper at least
QUARTERLY
– Tapering is clinically contraindicated FOR REMAINDER OF
THAT YEAR if:
• Failed tapering attempts during previous 3 quarters, AND
• MD has documented clinical rationale
– Sedatives/Hypnotics now include…
• New agents (non-benzodiazepine)
• Sedating antidepressants (e.g., trazodone)
• Sedatig antihistamines (e.g, hydroxyzine)
c 2006 ASCP
82
F329 - Unnecessary Meds
Tapering for Psychopharmacological
Meds
• Now 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 new
guidelines
c 2006 ASCP
83
F329 - Unnecessary Meds
Tapering for Psychopharmacological
Meds
• New:
– Psychopharmacological meds now grouped together, so
more than just benzodiazepines
– Psychopharm defined as “any medication used for
managing behavior, stabilizing mood, or treating
psychiatric disorders”
– What classes might this include or impact? According to
Table 1….
• Anticonvulsants
• Antidepressants
• Anxiolytics - including buspirone, antidepressants
• Cognitive Enhancers
c 2006 ASCP
84
F329 - Unnecessary Meds
Tapering for Psychopharmacological
Meds
• New: (SAME AS ANTIPSYCHOTICS)
– Within 1st year after admission on psychopharm or after
initiation:
• Taper in 2 separate quarters, with at least one month
between attempts
– After 1st year,
• Taper annually
– Tapering is clinically contraindicated if:
• Resident’s target symptoms returned or worsened after
MOST RECENT tapering attempt WITHIN facility, AND
• MD has documented clinical rationale
c 2006 ASCP
85
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 2006 ASCP
86
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
– 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 2006 ASCP
87
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
c 2006 ASCP
88
F329 - TABLE 1: 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
c 2006 ASCP
89
F329 - TABLE 1: 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
c 2006 ASCP
90
F329 - TABLE 2:
Anticholinergic Meds
• Examples of medications with anticholinergic
properties…
– Antihistamines (H-1 blockers)
– 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 2006 ASCP
91
F329 - TABLE 2:
Anticholinergic Meds
• Examples of medications with anticholinergic
properties…
– Antidepressants (TCAs)
– Muscle relaxants (e.g., cyclobenzaprine, etc)
– Urinary antispasmodics (oxybutynin, tolterodine,
etc)
– Antiparkinson meds (benztropine, etc)
– Antipsychotic meds (conventional)
– Cardiovascular (e.g., furosemide, digoxin,
nifedipine)
c 2006 ASCP
92
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 2006 ASCP
93
SOM - Key Messages
• Increased responsibility of facility, prescribers, consultant
pharmacist, and dispensing pharmacy regarding
medication management, including between monthly
pharmacist visits
• Policies and Procedures will be the key, and actually use
them!
• CP as coordinator/evaluator of pharmaceutical services
• Tapering/GDRs have changed significantly - it’s more
about how the medication is being used rather than in
which class it is categorized
• Check your state regs/rules too!
• Care Process…looking at patient and medication
regimen holistically
c 2006 ASCP
94