Basic Training

Update on Most Recent Pharmacy-Specific LTC Regulations

Presented By:

Martha M. Little, PharmD, Certified Geriatric PharmacistRegion IV Board of Directors, ASCP

Director of Quality Improvement, Omnicare, Inc.

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Major medication-related F-Tags:

F-329: Unnecessary MedicationsF-332/333: Medication ErrorsF-425: Pharmaceutical ServicesF-428: Medication Regimen ReviewF-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 ServicesPharmacist 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 ServicesPharmacist 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 ServicesPharmacist 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 ServicesPharmacist 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 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.”

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F-Tag 428: Medication Regimen Review (MRR)

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F428 - MRRRegulations

•“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 - MRRWhere 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 - MRRNotification 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 - MRRNotification 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 - MRRLack 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”

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F428 - MRRLack 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 - MRRTop 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 - MRRTop 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 MedsTapering/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 MedsTapering/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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OLDNEW

For dementia-related behaviors

NEWFor psychiatric

conditions

FrequencyTwice a year, but only for organic

mental syndrome

Twice in first year, annually thereafter

“

CCTwo 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 MedsTapering 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

FrequencyTaper 3 times within 6

months after 10 days of continuous daily use

Quarterly for those meds used beyond manufacturer

recom. for duration

CC Failed 3 taper attempts

Failed taper + documentation

OR Documentation of clinical

rationale

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F329 - Unnecessary MedsTapering 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 F-329….

• Anticonvulsants• Antidepressants• Anxiolytics - including buspirone, antidepressants

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GDR/Tapering -Psychopharmacological

MedsOLD 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

CC Two failed taper attempts

Failed taper + documentation

OR Documentation of

clinical rationale

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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 MedsBehavior 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.pdf

•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 ErrorsRegulations

•“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 ErrorsDefinitions

•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 ErrorsDetermining 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_guidelines_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