CMS Interpretive Guidelines: Pharmacy Services and Unnecessary Drugs
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CMS Interpretive Guidelines: Pharmacy Services and Unnecessary Drugs Carla Saxton McSpadden, RPh, CGP Assistant Director of Policy and Advocacy American Society of Consultant Pharmacists. Copyright 2006 American Society of Consultant Pharmacists. Timeline for Pharmacy Tags.

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CMS Interpretive Guidelines: Pharmacy Services and Unnecessary DrugsCarla Saxton McSpadden, RPh, CGPAssistant Director of Policy and AdvocacyAmerican Society of Consultant Pharmacists

Copyright 2006 American Society of Consultant Pharmacists


Timeline for pharmacy tags l.jpg
Timeline for Pharmacy Tags Unnecessary Drugs

  • 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/implementation scheduled for DECEMBER 18, 2006

c 2006 ASCP


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Tags Combined Unnecessary Drugs

  • 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 Unnecessary Drugs

  • 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 2006 ASCP


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SOM Components Unnecessary Drugs

  • 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 2006 ASCP


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Training of surveyors Unnecessary Drugs

  • Representatives from each state survey agency will be attending 2-day train-the-trainer session in Baltimore this week (including association representatives); They will receive info/tools to bring back to their state for training of other surveyors

  • Satellite/webcast training sessions in December; registration/info available at:

    • http://cms.internetstreaming.com

c 2006 ASCP


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Key Points Unnecessary Drugs

  • 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 2006 ASCP


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F425 - Pharmaceutical Services Unnecessary DrugsRegulations

  • 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 - Unnecessary DrugsWhat 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 Unnecessary Drugs

  • 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

    • Acquiring - Administering

    • Receiving - Disposal

    • Dispensing - Labeling/Storage, incl. CSs

    • Authorized personnel

c 2006 ASCP


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F425 - Pharmaceutical Services Unnecessary DrugsProvision 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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Considerations Regarding Timeliness Unnecessary Drugs

  • 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 2006 ASCP


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Considerations Regarding Timeliness Unnecessary Drugs

  • 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 2006 ASCP


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Considerations Regarding Timeliness Unnecessary Drugs

  • 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 2006 ASCP


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F425 - Pharmaceutical Services Unnecessary DrugsPharmacist Services

  • 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.”

  • 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)

c 2006 ASCP


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F425 - Pharmaceutical Services Unnecessary DrugsProcedures

  • Pharmaceutical Services Procedures

    • Acquiring

    • Receiving

    • Dispensing

    • Administering

    • Labeling/Storage, including controlled substances

    • Disposal

    • Authorized personnel

c 2006 ASCP


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Policies and Procedures Unnecessary Drugs

  • First, you need them!

  • And, you need to educate and train staff about them - including PRN staff! Both PHARMACY and FACILITY STAFF!

  • And, you need to use them!

  • And, you need to revisit them occasionally!

  • If your 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 2006 ASCP


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Examples of P+Ps Unnecessary Drugs

  • E-Kits (from F425)

    • “Availability of an emergency supply of medications, if allowed by state law, including…

      • Types or categories of medications

      • Amounts, dosages/strengths to be provided

      • Location of the supply

      • Personnel authorized to access the supply

      • Record keeping

      • Monitoring for expiration dates

      • Steps for replacing the supply when medications are used”

c 2006 ASCP


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Examples of P+Ps Unnecessary Drugs

  • IVs (from F425)

    • “Intravenous (IV) therapy procedures if used within the facility (consistent with state requirements) may include…

      • Determining competency of staff

      • Facility-based IV admixture procedures that address…

        • Sterile compounding

        • Dosage calculations

        • IV pump use

        • Flushing procedures”

c 2006 ASCP


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Examples of P+Ps Unnecessary Drugs

  • IVs (from F431)

    • “Label contains…

      • Name and volume of the solution

      • Resident’s name

      • Infusion rate

      • Name and quantity of each additive

      • Date of preparation

      • Initials of compounder

      • Date and time of administration

      • Initials of person administering medication, if different than compounder

      • Ancillary precautions, as applicable

      • Date after which the mixture must not be used”

c 2006 ASCP


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Examples of P+Ps Unnecessary Drugs

  • Receipt of medications by facility (from F425)

    • “How the receipt of medications from dispensing pharmacies (and family members or others, where permitted by state requirements) will occur

    • How it will be reconciled with the prescriber’s order and the requisition for the medication

    • How staff will be identified and authorized in accordance with applicable laws and requirements to receive the medications

    • How access to the medications will be controlled until the medications are delivered to the secured storage area; and

    • Which staff will be responsible for assuring that medications are incorporated into the resident’s specific allocation/storage area”

c 2006 ASCP


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Examples of P+Ps Unnecessary Drugs

  • Disposal of medications (from F425)

    • “Timely identification and removal (from current medication supply) of medications for disposition

    • Identification of storage method for medications awaiting final disposition

    • Control and accountability of medications awaiting final disposition consistent with standards of practice

    • Documentation of actual disposition of medications to include:

      • resident name

      • medication name/strength/quantity

      • prescription number (as applicable)

      • date of disposition

      • involved facility staff, consultant(s) or other applicable individuals

    • Method of disposition consistent with applicable state and federal requirements, local ordinances, and standards of practice”

c 2006 ASCP


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F428 - MRR Unnecessary DrugsRegulations

  • 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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Are once monthly drug regimen reviews performed by a pharmacist still required?

  • Yes - this is a regulatory requirement; therefore, it has not changed

  • As stated in both the new guidelines and the current guidelines, there is mention of more frequent reviews when necessary, depending on:

    • Resident’s condition

    • Risks for adverse consequences related to medications

c 2006 ASCP


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F428 - MRR pharmacist still required?

  • 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.”

c 2006 ASCP


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F428 - MRR pharmacist still required?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 pharmacist still required?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 pharmacist still required?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 pharmacist still required?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 pharmacist still required?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 pharmacist still required?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 pharmacist still required?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 pharmacist still required?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 pharmacist still required?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: Response to Findings Current (‘old’) Interpretive 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 2006 ASCP


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F428 - MRR Interpretive GuidelinesLack 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 Interpretive GuidelinesLack 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 Interpretive GuidelinesRegulations

  • 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 Interpretive GuidelinesRegulations

  • 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 Interpretive GuidelinesRegulations

  • 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 Interpretive GuidelinesNew 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 2006 ASCP


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F431 - Labeling Interpretive GuidelinesNew 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 2006 ASCP


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F431 - Labeling Interpretive GuidelinesNew 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 Interpretive GuidelinesNew 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 self-administer

c 2006 ASCP


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F431 - Access and Storage Interpretive GuidelinesNew 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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F329 - Unnecessary Meds Regulations Interpretive Guidelines

  • 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


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F329 - Unnecessary Meds Interpretive GuidelinesRegulations

  • 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


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F329 - Medication Management as part of the Care Process Interpretive Guidelines

  • 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 2006 ASCP


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F329 - Unnecessary Meds Interpretive GuidelinesGeneral

  • 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 Interpretive GuidelinesGeneral

  • 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 2006 ASCP


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F329 - Unnecessary Meds Interpretive GuidelinesGeneral

  • 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


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F329 - Unnecessary Meds Interpretive GuidelinesTapering/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


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F329 - Unnecessary Meds Interpretive GuidelinesTapering/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


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F329 - Unnecessary Meds Interpretive GuidelinesGDR/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


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F329 - Unnecessary Meds Interpretive GuidelinesGDR/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


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F329 - Unnecessary Meds Interpretive GuidelinesGDR/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


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F329 - Unnecessary Meds Tapering for Sedatives/Hypnotics Interpretive Guidelines

  • 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


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F329 - Unnecessary Meds Interpretive GuidelinesTapering 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


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F329 - Unnecessary Meds Interpretive GuidelinesTapering 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


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F329 - Unnecessary Meds Interpretive GuidelinesTapering 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


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F329 - Unnecessary Meds Interpretive GuidelinesTapering 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


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When should we implement the new gradual dose reduction/tapering guidelines?

  • Probably not wise to initiate dose reduction attempts on every psychopharmacological medication for every resident in December, just to comply with guidelines

  • Might be more prudent, on an individual basis, to evaluate past gradual dose reduction/tapering attempts when considering future attempts…don’t necessarily want the burden of managing dose reductions on a multitude of residents at one time

c 2006 ASCP


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F329 - Unnecessary Meds reduction/tapering guidelines?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


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Role of Beers Criteria reduction/tapering guidelines?

  • 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


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F329 - TABLE 1: Medication Issues of Particular Relevance reduction/tapering guidelines?

  • 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


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F329 - TABLE 1: Medication Issues of Particular Relevance reduction/tapering guidelines?

  • Current (“old”) guidelines include 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 2006 ASCP


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F329 - TABLE 2: Anticholinergic Meds reduction/tapering guidelines?

  • 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


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F329 - TABLE 2: Anticholinergic Meds reduction/tapering guidelines?

  • 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


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F329 - TABLE 2: Anticholinergic Meds reduction/tapering guidelines?

  • 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


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Examples of ways to prepare… reduction/tapering guidelines?

  • Based on these….

    • F425: “Developing procedures and guidance regarding when to contact a prescriber about a medication issue and/or adverse effects, including what information to gather before contacting the prescriber”

    • F329: “An evaluation of the resident helps to identify his/her needs, comorbid conditions, and prognosis to determine factors (including medications and new or worsening medical conditions) that are affecting signs, symptoms, and test results. This evaluation process is important when making initial medication/intervention selections and when deciding whether to modify or discontinue a current medication intervention”

  • You might want to help your facility prepare by….

c 2006 ASCP


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Examples of ways to prepare… reduction/tapering guidelines?

  • When a problem is being reported to MD/NP…among the general assessment info they collect and pass along, you might suggest obtaining and communicating the following info:

    • Non-pharmacological interventions tried

    • Previously attempted medications to treat same or similar problem and response

    • Current medications and diagnoses/conditions

    • Allergies/Sensitivities

      • What was the reaction?

c 2006 ASCP


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Examples of ways to prepare… reduction/tapering guidelines?

  • Resident goals/preferences, for example - are they in a hospice program, near end-of-life, or does their Advance Directive state anything about medications?

    • See Minimum Data Set (MDS), Section J (Health Conditions), Question 5 - If checked, they have end-stage disease with 6 or fewer months to live

    • See MDS, Section P (Special Treatments and Procedures) - if (O) is checked under Question 1a, they are in a hospice program

    • See MDS, Section A, Question 10 - if (G) is checked, they have medication restrictions mentioned in their Advance Directive

c 2006 ASCP


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Examples of ways to prepare… reduction/tapering guidelines?

  • When taking a new medication order…you may suggest they use a standard form/process for documenting crucial info:

    • Medication?

    • Strength?

    • Dosage form?

    • Dose?

    • Frequency?

      • Specific times?

      • With or without food?

    • Routine/Scheduled or PRN?

    • Indication?

      • Should a new diagnosis be added to resident’s record?

      • If PRN, what are the specific circumstances for use?

    • Are there any exceptions to administration (e.g., BP or pulse less than X)?

c 2006 ASCP


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Examples of ways to prepare… reduction/tapering guidelines?

  • Duration?

  • Monitoring

    • ‘We’ll know it’s working if _____.’

    • ‘Something might be wrong if _____.’

      • What to monitor?

      • When to monitor?

      • How/By Whom should monitoring occur?

      • When to follow-up with or contact MD/NP?

  • This will help to:

    • Prompt the MD/NP to address “Unnecessary Med” issues upfront

    • Provide more documentation/evidence about the clinical rationale and expectations associated with the medication - protects the facility if a surveyor were to walk in

    • Reduce the need for future clarification by the pharmacy

  • c 2006 ASCP


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    Examples of educational in-services reduction/tapering guidelines?that might be of benefit …

    • Policies and procedures regarding pharmacy services:

      • Where to find the P+P manual

      • What’s in the manual

      • Other pharmacy-related “How-To’s” that aren’t mentioned in the manual - such as:

        • How to request a reorder

        • To whom to ask billing questions

        • How to contact pharmacy after-hours

      • Maybe also include an overview of what the consultant pharmacist does within the facility

    c 2006 ASCP


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    Examples of educational in-services reduction/tapering guidelines?that might be of benefit …

    • Medications and Falls

      • Falls are mentioned 15 times in F329, 14 of those incidences are regarding specific medications or classes with the potential to cause or contribute to falls

      • Plus, falls are mentioned in F428 as a geriatric syndrome that should be evaluated for its potential connection to medication use

      • And, falls are documented on MDS and trigger Quality Indicators (QIs)

    c 2006 ASCP


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    Examples of educational in-services reduction/tapering guidelines?that might be of benefit …

    • IV Medications

    • Disposal of medications

    • Labeling

      • Labeling preparations compounded or prepared in facility

      • Labeling OTC bulk/stock items

      • Properly dealing with label changes when medication order changes

      • Indicating “Date Opened” on multi-dose products

    c 2006 ASCP


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    Examples of educational in-services reduction/tapering guidelines?that might be of benefit …

    • Medication error reporting

      • Mentioned 5 times in F425 guidelines

      • Included in definition of “pharmaceutical services” and “medication regimen review (MRR)”

      • Mentioned in 3 examples of F425 deficiencies

    c 2006 ASCP


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    COORDINATION & COMMUNICATION! reduction/tapering guidelines?

    • Examples of where communication is mentioned in new guidelines…

      • F425: “Develop mechanisms for communicating, addressing, and resolving issues related to pharmaceutical services”

      • F425: “Interacting with the quality assessment and assurance committee to develop procedures and evaluate pharmaceutical services…”

    c 2006 ASCP


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    COORDINATION & COMMUNICATION! reduction/tapering guidelines?

    • Examples of where communication is mentioned in new guidelines…

      • F329: “It is important that the facility clearly identify who is responsible for prescribing and identifying the indications for use of medication(s), for providing and administering the medication(s), and for monitoring the resident for the effects and potential adverse consequence of the medication regimen; This is also important when care is delivered or ordered by diverse sources such as consultants, providers, or suppliers (e.g., hospice or dialysis programs)”

      • F425: “Coordinate pharmaceutical services if and when multiple pharmaceutical service providers are utilized (e.g., pharmacy, infusion, hospice, prescription drug plans [PDP])”

    c 2006 ASCP


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    COORDINATION & COMMUNICATION! reduction/tapering guidelines?

    • Now is the time to begin talking to one another…share ideas for implementation, develop a plan for transitioning to the new guidelines, collaboratively write/review/update policies and procedures

    • Have you considered keeping a notebook in the facility so that they can write down pharmacy questions or issues as they arise, then CP can review during his/her visit?

    c 2006 ASCP


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    Online SOM Resources reduction/tapering guidelines?

    • 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/SurveyCertificationGenInfo/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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    Thank you!! reduction/tapering guidelines?---------------------------------Questions?


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