Transcript Basic Training - Best Care Practices

Basic
Training
Update on Most Recent
Pharmacy-Specific LTC Regulations
Presented By:
Martha M. Little, PharmD, Certified Geriatric Pharmacist
Region IV Board of Directors, ASCP
Director of Quality Improvement, Omnicare, Inc.
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Training
Major medication-related FTags:
F-329: Unnecessary Medications
F-332/333: Medication Errors
F-425: Pharmaceutical Services
F-428: Medication Regimen
Review
F-431: Storage, Labeling,
Controlled substances
Most of these were revised and
implemented in December 2006 (all
but F-332/333)
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»F-Tag 425:
Pharmaceutical Services
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F-Tag 425:
•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
- Administering
– Receiving
- Disposal
– Dispensing
- Labeling/Storage, incl. CSs
– Authorized personnel
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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
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F425 - Pharmaceutical Services
Pharmacist Services
•Consultant pharmacist’s responsibilities, in collaboration with the facility,
MAY include:
– Coordinating pharmaceutical services if and when multiple service
providers are utilized, for example:
• Multiple pharmacies
• Infusion provider
• Hospice
• Prescription Drug Plan (PDP)
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F425 - Pharmaceutical Services
Pharmacist Services
–
–
–
–
–
–
-Develop, implement, evaluate, and revise P&P’s
Developing IV therapy procedures
E-Kits
Develop mechanisms for communicating, addressing, resolving issues
related to pharmacy services (AKA, acting as liaison between facility
and pharmacy)
Helping facility “strive to assure” meds are requested, received and
administered in timely manner
Med pass review/feedback
ID team, QA+A Committee
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F425 - Pharmaceutical Services
Pharmacist Services
• MRR procedures (more on MRR in F428, but this is
P+Ps) - so P&Ps should address:
– Conducting MRR for each resident
– Addressing expected time frames for conducting
and reporting
– Addressing irregularities
– Documenting and reporting results
– Addressing MRRs (AKA - Interim MRRs) for
residents:
» anticipated to stay less than 30 days
» who experience an acute change in condition as
identified by facility staff
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F425 - Pharmaceutical Services
Pharmacist Services
•NOTE in F-Tag 425 about Interim MRRs:
“Facility procedures should address…
• how and when the need for a consultation will be communicated,
– how the medication review will be handled if the pharmacist is offsite,
• 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.”
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F-Tag 428: Medication Regimen Review (MRR)
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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”
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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
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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
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F428 - MRR
Notification of Findings
•Pharmacist’s findings are part of the clinical record
– If not maintained within active clinical record, it must still
be maintained within facility and readily available
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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
•Encourage sharing of report with entire ID team
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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 (also see new F501)
•No specific timeframe provided for when a report that is not
acted upon officially becomes delinquent or “not acted upon”
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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 recommendations.
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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 and…
– Potassium supplements
– Spironolactone
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F428 - MRR
Top 10 Drug Interactions in LTC
•Digoxin and…
– Amiodarone (Cordarone)
– Verapamil (Calan, Verelan)
•Theophylline and…
– Fluoroquinolones (Cipro, Levaquin)
•Can access Top 10 DIs in LTC online at: www.scoup.net
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Example of Citation at F-428
•2 of 15 sampled residents did not have physician follow-up to
CP’s recommendations
– One was regarding GDR for antipsychotic
– One was regarding duplicative therapy with 2 long-acting
narcotics and resident wishing to discontinue one
•Pharmacist interviewed; She had in-serviced staff about new
CMS guidelines and had discussed lack of responses with DON 2
months prior
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F-Tag 329: Unnecessary Medications
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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”
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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”
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F329 - Medication Management Considerations
•Monitoring and Prevention of Adverse Consequences
– Are relevant clinical guidelines and/or manufacturer’s specifications
for use, dose, duration, monitoring being followed?
• AMDA CPGs are widely used by surveyors
• Black Box Warnings
– http://formularyproductions.com/blackbox/
•Dose
– 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
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F329 - Medication Management Considerations
•Duplicate Therapy
• Acetaminophen-containing products
• Multiple laxatives
• Multiple benzodiazepines
• Anticholinergic effects
•Duration
– Acute conditions where short-term meds often used:
• Cough/Cold
• Nausea/Vomiting
• Acute Pain
• Psychiatric/Behavioral Symptoms
– PPIs/H2 blockers used for prophylaxis during acute phase of medical
illness
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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 is to answer these questions:
– Is the medication still needed?
– Is the resident being maintained on the lowest effective dose?
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F329 - Unnecessary Meds
Tapering/GDR
•Opportunities for evaluation of medication, in regards to duration/dose:
– CP’s MRR (pharmacist)
– MD’s visit or signing of orders (physician)
– During quarterly MDS review (facility)
•What to evaluate:
– Have the resident’s target symptoms improved? (i.e., less severe, less
frequency)
– Has the resident’s function improved? (e.g., could look at MDS)
– Has the resident experienced any medication-related adverse
consequences?
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OLD
NEW
For dementiarelated behaviors
NEW
For psychiatric
conditions
Frequency
Twice a year, but
only for organic
mental syndrome
Twice in first year,
annually thereafter
“
CC
Two failed GDRs or
Documentation of clinical
rationale or Psychiatric Dx
Failed GDR +
documentation
Failed GDR +
documentation OR
Documentation of clinical
rationale
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F329 - Unnecessary Meds
Tapering for Sedatives/Hypnotics
•Sedatives/Hypnotics now include…
• New agents (non-benzodiazepine)
• Sedating antidepressants (e.g., trazodone)
• Sedating antihistamines (e.g, hydroxyzine)
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GDR/Tapering Sedatives/Hypnotics
OLD
NEW
Frequency
Taper 3 times within 6
months after 10 days of
continuous daily use
Quarterly for those meds
used beyond manufacturer
recom. for duration
Failed 3 taper
attempts
Failed taper +
documentation
OR
Documentation of clinical
rationale
CC
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F329 - Unnecessary Meds
Tapering for Psychopharmacological Meds
•Psychopharmacological meds now grouped together, so it’s more than just
benzodiazepines…it’s:
“any med used for managing behavior, stabilizing mood, or treating
psychiatric disorders”
– What classes might this include or impact? According to Table 1 of F329….
• Anticonvulsants
• Antidepressants
• Anxiolytics - including buspirone, antidepressants
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GDR/Tapering Psychopharmacological
Meds
OLD
NEW
Includes what?
BZDs + misc anxiolytics
Any med used to
manage behaviors,
stabilize mood, treat
psychiatric
conditions
Frequency
Twice a year
Twice in first year,
annually thereafter
Two failed taper attempts
Failed taper +
documentation
OR
Documentation of
clinical rationale
CC
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QUESTION
•Which of the following is a psychopharmacological medication?
– A. Carbamazepine (Tegretol) for bipolar disorder
– B. Zolpidem (Ambien) for insomnia
– C. Propranolol (Inderal) for migraine headaches
– D. Valproic acid (Depakote, Depakene) for seizure disorder
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F329 - Unnecessary Meds
Behavior Monitoring
•So, which med classes mention behavior monitoring? According to Table 1 of
F-329…
– Antipsychotics
• “Before initiating or increasing for enduring condition, target
behaviors must be clearly and specifically identified and monitored
objectively and qualitatively”
• “After initiating or increasing the dose, the behavioral symptoms
must be reevaluated periodically to determine the effectiveness of
the antipsychotic and the potential for reducing or discontinuing
the dose”
– Anxiolytics
• “When used for delirium, dementia, and other cognitive disorders
with associated behaviors, behaviors to be quantitatively and
objectively documented”
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OSCAR Data
•OSCAR is a CMS database: Online Survey Certification and
Reporting (OSCAR)
•Data is collected by state surveyors at the time of the annual
survey on CMS form 672, Resident Census and Conditions of
Residents
– http://www.cms.hhs.gov/cmsforms/downloads/CMS672.p
df
•Pharmacies/pharmacists often provide reports to facilities
comparing their psychotropic medication utilization rates to
state and national averages - these averages come from OSCAR
data
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OSCAR Data
•Form 672 asks surveyors to document the number of residents
receiving the various classes of psychotropic medications
•Examples of medications in each class are provided on the form
- but basically they’re counting medications based on its
pharmacological class
•Frequently asked question:
Q: Now that the SOM defines psychotropic medications
differently, based on how a medication is used rather than
its pharmacological class, should medications be counted
based on the new definition?
A: Still count based on pharmacological class if you want
an accurate comparison to OSCAR data
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Role of Beers Criteria
•Beers Criteria is not listed and titled as such like they were in
the old guidelines, but Beers medications are incorporated into
pieces of the document (e.g., TABLES 1+2 of F-329)
•Reminder: New Beers criteria, as of 2003
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F329 - TABLES 1 and 2
•TABLE 1: Approximately 36 pages long
•Alphabetically lists examples of some classes 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
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F329 - TABLES 1 and 2
•Medications mentioned are not meant to be absolutely
contraindicated for every resident, but that the medication has
the potential to be unnecessary or inappropriate
•Daily Dose Thresholds listed for:
– Antipsychotics
– Anxiolytics
– Sedatives/Hypnotics
•TABLE 2: Lists medications with anticholinergic properties and
typical anticholinergic side effects
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Interim MRRs
•Checkbox on admission form for MDs to request medication
review
•Off-site review of new admits by either the CP or the dispensing
or in-house pharmacist
– Communication to facility (and primary CP) for
incorporation into reports and applicable follow-up
– Some using same form/documentation method as CP,
others using new form/documentation
– Some are using email/internet or electronic fax
•Interim MRR reports discussed at daily ID meetings
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Psychotropic Meds
•Behavior monitoring by exception, in an attempt to prevent all
zeroes or blanks on behavior monitoring sheets
•Lots of different psychotropic medication protocols being
developed and used
•No PRN orders for psychotropic meds…if there is an issue, staff
call MD for one-time dose or non-pharm intervention
•Non-Pharmacological Intervention “box” on order sheets
suggesting heat packs, dolls, music, etc. and facility policy states
“X” number (e.g., 2) have to be tried before using psychotropic
med
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F-Tag 332/333:
Medication Errors
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F-332-333: Medication Errors
Regulations
•“
The facility must ensure that:
– It is free of medication error rates of 5% or greater; and
– Residents are free from significant medication errors”
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F-332-333: Medication Errors
Definitions
•CMS defines “medication error” as:
“The observed preparation or administration of drugs or biologicals
which is not in accordance with:
• Physician’s orders;
• Manufacturer’s specifications (not recommendations) regarding
the preparation and administration of the drug or biological;
• Accepted professional standards and principles which apply to
professionals providing services. Accepted professional standards
and principles include the various practice regulations in each
State, and current commonly accepted health standards
established by national organizations, boards, and councils.”
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F-332-333: Medication Errors
Determining Significance
•“The relative significance of medication errors is a matter of professional
judgment.”
•Guidelines outlined by CMS for determining significance:
– Resident condition (e.g., diuretic administered to dehydrated resident)
– Drug category [e.g., Narrow Therapeutic Index (NTI) medications]
• Anticonvulsants
• Anticoagulants
• Antiarrhythmics
• Antiasthmatics
• Antimanics
– Frequency of error (e.g., several times versus one time)
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S&C Clarification Memo Sep. 2007
Medication administration errors associated with vitamins and minerals
should be COUNTED
•However, administration errors associated with nutritional and dietary
supplements should NOT be counted
•But, interactions between meds and nutritional/dietary supplements must
be monitored
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Online SOM Resources
•CMS website with SOM, Appendix PP:
www.cms.hhs.gov/manuals/Downloads/som107ap_pp_guidelin
es_ltcf.pdf
•CMS website with 2006 memo regarding changes to pharmacy
sections:
www.cms.hhs.gov/transmittals/downloads/R22SOMA.pdf
•Nursing Facility Survey and Regulations Briefing Room on ASCP
website: www.ascp.com/public/pr/nfsurvey or
www.ascp.com/som
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Various Clinical Resources
•Psychiatric info, including lab monitoring for psychotropic
medications:
– www.thecarlatreport.com/
•Beers List/Criteria
– Fink DM, Cooper JW, Wade WE. Updating the beers criteria
for potentially inappropriate medication use in older
adults. Arch Intern Med 2003;163:2716-24.
– Article in May 2004 edition of The Consultant Pharmacist
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Various Clinical Resources
•Drug Information References
– Geriatric Dosage Handbook by Lexi-Comp
•ASCP’s Clinical Reference Cards
– www.ascp.com/store/Medical-References.cfm
•General geriatric medical information
– Geriatrics At Your Fingertips
• www.GeriatricsAtYourFingertips.org
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Minimum Data Set (MDS)
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New MDS coming in 2009 Implementation date
for MDS, Version 3.0:
October 1, 2009
•New QI/QM reports to reflect MDS 3.0:
Much later, possibly 2011
•Meds no longer part of Section O; Instead, will be in new Section N; Of
course, still a few med-related questions in other sections
•There no longer 4 medication-related questions - only 2!!
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Medication Questions on new MDS, 3.0
•N1. Injections: Record the number of days that injectable medications were
received during the last 5 days or since admission if less than 5 days.
•N2. Medications Received: Check all medications the resident received at
any time during the last 5 days or since admission if less than 5 days:
– a. Antipsychotic
– b. Antianxiety
– c. Antidepressant
– d. Hypnotic
– e. Anticoagulant (warfarin, heparin, or low-molecular weight heparin)
– f. None of the above were received
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Thank You!
Questions/Discussion