new cms guidance to surveyors: pharmacy services and unnecessary medications copyright 2007 american...

New CMS Guidance to Surveyors: Pharmacy Services and Unnecessary Medications

Copyright 2007 American Society of Consultant Pharmacists

February 2007

c 2007 ASCP 2

Timeline for Pharmacy Tags

• Reminder: Appendix N Deleted - Effective June 2004• Pharmacy Services and Unnecessary Medications

– Released for 1st public comment period - October 2004– 1st Comment period ended - January 2005– Expert panels reconvened - April 2005– Due to significant number of comments received during 1st

comment period and subsequent revisions, a 2nd draft was released September 2005

– Expert panels reconvened again - December 2005/January 2006

– Final documents released - September 15, 2006

– Effective date: DECEMBER 18, 2006

c 2007 ASCP 3

Tags Combined

• Unnecessary Medications – New Tag F329 = Old Tags F329, F330, F331

• Unnecessary Drugs

• Pharmaceutical Services– New Tag F425 = Old Tags F425, F426, and F427 (b) (1)

• Pharmaceutical Services, Procedures, Consultation – New Tag F428 = Old Tags F428, F429, F430

• DRR/MRR – New Tag F431 = Old Tags F427 (b) (2) and (3), F431, F432

• Control, Labeling, and Storage

c 2007 ASCP 4

SOM Components

• Appendix P: Survey Protocol for LTC– Task 5 – text added that describes the assessment of

pharmaceutical services– Sub-Task 5A – text revised to state that each surveyor

completing a medication pass observation will review drug storage on their assigned units

– Sub-Task 5C – text added to guide the surveyor to use the investigative protocol for F329 for each Resident Review, DELETED adverse drug reactions section of 5C, part G3

– Sub-Task 5E – complete revision of text and renaming of 5E as Medication Pass and Pharmacy Services

c 2007 ASCP 5

SOM Components• Appendix PP: Interpretive Guidelines for LTC

– Regulations (HAVEN’T CHANGED)– Interpretive Guidelines, or Guidance to Surveyors– Investigative Protocol

• New combined investigative protocol for Unnecessary Medications (F329) and Medication Regimen Review (F428)

– Deficiency Categorization/Severity Guidance

c 2007 ASCP 6

Training of surveyors

• Representatives from each state survey agency attended a 2-day train-the-trainer session in Baltimore; They received info/tools on F329 to bring back to their state for training of other surveyors

• Satellite/webcast training sessions on December 15; archived program available at:– http://cms.internetstreaming.com

c 2007 ASCP 7

Online SOM Resources

• CMS website with SOM: http://www.cms.hhs.gov/manuals/downloads/som107_Appendicestoc.pdf

• CMS website with transmittal regarding changes to pharmacy sections: http://www.cms.hhs.gov/transmittals/downloads/R22SOMA.pdf

• Nursing Facility Survey and Regulations Briefing Room on ASCP website: www.ascp.com/public/pr/nfsurvey or www.ascp.com/som

c 2007 ASCP 8

Key Points According to CMS

• Care Process - Looking at patient and medication regimen holistically

• Importance of all aspects of medication management• When taking multiple meds, risks and benefits of any

one must be viewed in relation to the entire regimen• Broadening focus beyond psychoactive medications• Additional guidance on:

– Monitoring for effectiveness– Assessing possibility that med may paradoxically

cause/exacerbate symptoms it was intended to treat/prevent

c 2007 ASCP 9

F425 - Pharmaceutical ServicesRegulations

• The facility must:– Provide routine and emergency medications and biologicals to its

residents, or obtain them under an agreement– Provide pharmaceutical services including procedures that assure

the accurate acquiring, receiving, dispensing, and administering of all medications and biologicals to meet the needs of each resident

– Employ or obtain the services of a licensed pharmacist who provides consultation on all aspects of the provision of pharmacy services in the facility

• The facility may:– Permit unlicensed personnel to administer medications if state law

permits, but only under the general supervision of a licensed nurse.

c 2007 ASCP 10

Pharmacy Services - What do the old guidelines say?

• Interpretive Guidelines– The facility is responsible for the timeliness of the services – A drug, whether prescribed on a routine, emergency, or as

needed basis, must be provided in a timely manner; If failure to provide a prescribed drug in a timely manner causes the resident discomfort or endangers his or her health and safety, then this requirement is not met

• Survey Procedures– During the surveyor’s observation of the drug pass, are all

ordered medications available?

c 2007 ASCP 11

New F425 - Overview

• Provision of Medications– Timeliness/Availability to meets needs of each resident

• Services of a Pharmacist– “The facility is responsible for employing or contracting for

the services of a pharmacist to provide consultation on all aspects of pharmaceutical services.”

• Pharmaceutical Services Procedures– Acquiring - Administering– Receiving - Disposal– Dispensing - Labeling/Storage, including – Authorized personnel controlled meds

c 2007 ASCP 12

F425 - Pharmaceutical ServicesProvision of Meds

• Factors that may help determine timeliness and guide procedures for acquisition include:– Availability of meds to enable continuity of care for

anticipated admission or transfer– Condition of resident (e.g., severity/instability of

condition, current S+S, potential impact of a delay)– Category of medication (e.g., antibiotic, pain)– Availability of medications in emergency supply– Ordered start time

c 2007 ASCP 13

Considerations Regarding Timeliness

• Do you have a mechanism/process to identify and prioritize the communication of new medication orders and new admits?

• Do facility staff know to tell and pharmacy staff know to ask whether a re-admit needs a supply of their medications re-sent?

• Do you have a way to identify and ‘fast-track” antibiotics, pain medications, and other “acute condition” treatments (e.g., N/V)?

c 2007 ASCP 14


• Do you periodically look at E-Kit utilization and medications dispensed after-hours to evaluate whether medications need to be added to or deleted from the E-Kit?

• Do nursing facility staff prompt or encourage MD/NPs to utilize medications in the E-Kit when they are prescribing medications after-hours? Do the MD/NPs servicing residents in your facility have copies of or off-site access to the list of E-Kit contents?

c 2007 ASCP 15


• Do your state rules/regulations and/or the facility’s policies and procedures and/or your pharmacy contract mention specific medication delivery/ administration timeframes?

• Are your staff aware of any of the above rules/policies? Are they aware of the timeliness stipulation in the regulatory guidance?

c 2007 ASCP 16

F425 - Pharmaceutical ServicesPharmacist Services

• Consultant pharmacist’s responsibilities, in collaboration with the facility, MAY include:

WE’LL START WITH A BIG ONE…..– Coordinate pharmaceutical services if and when

multiple service providers are utilized, for example:• Multiple pharmacies• Infusion provider• Hospice• Prescription Drug Plan (PDP)

c 2007 ASCP 17


– P+Ps - “Develop, implement, evaluate, and revise (as necessary)”

– IV therapy procedures– E-Kits– Develop mechanisms for communicating,

addressing, resolving issues related to pharmacy services

– “Strive to assure” meds requested, received and administered in timely manner

– Med pass review/feedback– ID team, QA+A Committee

c 2007 ASCP 18


– MRR procedures (more on MRR in F428, but this is P+Ps)

• Conducting MRR for each resident• Addressing expected time frames for

conducting and reporting• Addressing irregularities• Documenting and reporting results• Addressing MRRs for residents:

– anticipated to stay less than 30 days– who experience an acute change in condition as

identified by facility staff

c 2007 ASCP 19


• NOTE in F425 regarding interim MRRs:“Facility procedures should address…

• how and when the need for a consultation will be communicated,

• how the medication review will be handled in the pharmacist is off-site,

• how the results or report of their findings will be communicated to the physician

• expectations for the physician’s response and follow-up, and

• how and where this information will be documented.”

c 2007 ASCP 20

F425 - Pharmaceutical ServicesInterim MRRs

• EXAMPLES of how the facility may identify residents anticipated to be short-stay or who experience an acute change in condition….– CHANGE IN CONDITION

• Residents for which a “Change in Condition” MDS was completed - Section AA and/or A of MDS, Question 8 (a) will be answered with a “3” if the resident has experienced a significant change in status.

• Residents have triggered Section J, Question 1 of MDS, as this indicates new problems present in the last 7 days

• Residents have triggered Section P, Questions 5, 6, 7, 8, or 9– (5) - Hospital Stays in last 90 days– (6) - ER Visits in last 90 days– (7) - MD Visits in last 14 days– (8) - MD Orders in last 14 days– (9) - Abnormal Lab Values in last 90 days

c 2007 ASCP 21

F425 - Pharmaceutical ServicesInterim MRRs

• EXAMPLES of how the facility may identify residents anticipated to be short-stay or who experience an acute change in condition….

– SHORT STAY RESIDENTS• See Section Q of MDS, Question 1 (c):

– Stay projected to be of a short duration - discharge projected within 90 days (do not expected discharge due to death):

» 0. No» 1. Within 30 days» 2. Within 31-90 days» 3. Discharge status unknown

c 2007 ASCP 22


– Procedures/guidance regarding contacting prescriber about medication issue (e.g., info to gather)

– Process for receiving, transcribing, recapitulating med orders

– Medication packaging– Automated dispensing machines/delivery

devices/cabinets– Medication references/resources– Staff education

c 2007 ASCP 23

F425 - Pharmaceutical ServicesAcquisition

• Acquisition– Emergency supply– Contacting pharmacy (When, How, Who)– Availability of needed meds/Timeliness – Meds dispensed by PHYSICIAN – Verification/clarification of orders– Procedure when delivery of med delayed or NA– Transport of meds from pharmacy to facility

c 2007 ASCP 24

F425 - Pharmaceutical ServicesReceiving + Dispensing

• Receiving– How receipt will occur and how it will be reconciled with

order/requisition– How staff will be identified/authorized to receive and how

access will be controlled until stored– Which staff will incorporate into resident-specific area

• Dispensing– Delivery and receipt of medications from pharmacy– Labeling– Type of medication packaging

c 2007 ASCP 25

F425 - Pharmaceutical ServicesAdministering

• Administering– Continuity of staff without unnecessary

interruptions– Reporting of medication errors (How, To Whom)– Staff authorized to administer– 5+ “rights”– Defining schedules for administration to:

• Maximize effectiveness• Avoid potential interactions• Recognize resident choices and activities

c 2007 ASCP 26

F425 - Pharmaceutical ServicesAdministering

– General guidelines for monitoring (What, Frequency, Timing, Results)

– Techniques and precautions for alternate routes– Documentation of administration– Providing medication and medication device

information/references– Clarifying orders prior to administration– Reconciliation of orders - including who may

transcribe orders and enter orders onto MAR

c 2007 ASCP 27

F425 - Pharmaceutical ServicesDisposing

• Disposing– Timely identification and removal of meds from

current supply– Storage method for meds awaiting disposal,

including control and accountability – Method and documentation of disposition

c 2007 ASCP 28

F425 - Pharmaceutical ServicesLabeling, Storage, CSs

• Labeling– Labeling of meds prepared by facility staff (e.g., IVs)– Requirements for non-pharmacy labels (e.g., OTC)– Label changes due to change in order/directions– Labeling of multi-dose vials (e.g., expiration dates)

• Storage– Location, security and authorized access to med storage areas,

discontinued meds– Environmental conditions of storage areas

• Controlled Meds– Location, security and authorized access - including refrigerated CSs– Records of receipt and disposition for all controlled meds– Periodic reconciliation (e.g., Frequency, How, By Whom, Documentation)

c 2007 ASCP 29

F425 - Pharmaceutical ServicesAuthorized Personnel

• Authorized Personnel– Assure only persons authorized by state/federal

requirements are administering– Provide current info on meds being used in facility– Assure ongoing competency of all staff (inc. PRN)– Training on med administration-related

devices/equipment (e.g, IV pumps, glucometers, nebulizers, syringes, etc)

– Identifying pharmacy personnel authorized to access medications

c 2007 ASCP 30

Policies and Procedures• First, you need them!• You need to actually use them - And educate and

train staff about them - including PRN staff! • And, you need to revisit them occasionally!• If your pharmacy contract is fairly specific, make sure

policies and procedures are consistent with it • Look at F425 (+other tags) for examples of what to

address in your policies and procedures, as it specifically outlines topics that can serve as a guideline for reviewing/writing your P+Ps

c 2007 ASCP 31

F431- Storage, Labeling, Controlled MedsRegulations

• The facility must employ or obtain the services of a licensed pharmacist who:– Establishes a system of records of receipt and

disposition of all controlled medications in sufficient detail to enable an accurate reconciliation

– Determines that medication records are in order and that an account of all controlled medications is maintained and periodically reconciled

c 2007 ASCP 32


• Labeling…– Medications and biologicals used in the facility must be

labeled in accordance with currently accepted professional principles, and include the appropriate accessory and cautionary instructions and expiration date when applicable

• Storage…– In accordance with state and federal laws/requirements, the

facility must store all medications and biologicals in locked compartments under proper temperature controls and permit only authorized personnel to have access (to the keys)

c 2007 ASCP 33


• Controlled Meds…– The facility must provide separately locked, permanently

affixed compartments for storage of controlled medications listed in Schedule II…and other medications subject to abuse, except when the facility uses single unit package medication distribution systems in which the quantity stored is minimal and a missing dose can be readily detected

c 2007 ASCP 34

F431 - LabelingNew Key Points

• Facility ensures labeling in response to order changes is accurate and consistent with state requirements (I.e., nurse cannot re-label or alter label)

• For meds designed for multiple administrations - “Multi-Dose” (e.g., inhalers, eye drops, etc), label is affixed in manner to promote administration to resident for whom it was prescribed– In other words, if there isn’t space for an entire label, still

better have - at least - resident’s name on actual product container

c 2007 ASCP 35


• For compounded IV preparations, label contains:

– Name and volume of solution

– Resident’s name

– Infusion rate

– Name and quantity of ach additive

– Date of preparation

– Initials of compounder

– Date and time of administration

– Initials of person administering medication if different than compounder

– Ancillary precautions, as applicable

– Date after which mixture must not be used (i.e., expiration date)

c 2007 ASCP 36


• For OTCs in bulk containers (in states that permit), label contains:– Original manufacturer’s OR pharmacy-applied label

indicating:• Medication name• Strength• Quantity• Accessory instructions• Lot number• Expiration date, when applicable

– If resident-specific supply of OTC, label contains above plus resident’s name

c 2007 ASCP 37

F431 - Access and StorageNew Key Points

• Med pass…– During a med pass, medications must be under

the direct observation (vs. control) of the person administering the medications or locked in the med storage area/cart

• Self-administration…– Important that the facility have procedures for the

control and safe storage of medications for those residents who can self-administer

c 2007 ASCP 38

F431 - Access and StorageNew Key Points

• Temperature, light, humidity…– Important that facility implement procedures that

address and monitor the safe storage and handling of medications in accordance with manufacturer specifications, state requirements, and standards of practice (e.g., USP)

c 2007 ASCP 39

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

c 2007 ASCP 40

F428 - MRRWhat is MRR?

• Definition in glossary:

“Thorough evaluation of the medication regimen of a resident by a pharmacist, with the goal of promoting positive outcomes and minimizing adverse consequences associated with medications; The review includes preventing, identifying, reporting, and resolving medication-related problems (MRPs), medication errors, or other irregularities and collaborating with others members of the interdisciplinary team.”

c 2007 ASCP 41

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

c 2007 ASCP 42

F428 - MRRMRR Considerations

• MRR considers factors, such as:– Has MD/staff documented objective findings,

diagnoses, symptoms to support indication?– Has MD/staff identified and acted upon, or should

they be notified about, resident’s allergies, potential interactions/adverse consequences?

– Is dose, frequency, route, duration consistent with resident’s condition, manufacturer’s recommendations, and applicable standards of practice?

c 2007 ASCP 43


– Has MD/staff documented progress towards or maintenance of the goal(s) for medications therapy?

– Has MD/staff obtained and acted upon lab results, diagnostic studies, or other measurements?

– Do med errors exist or do circumstances exist that make errors likely to occur?

c 2007 ASCP 44


– Has MD/staff noted and acted upon possible medication-related causes of recent or persistent changes in the resident’s condition?…think “Geriatric Syndromes”

• Anorexia and/or unplanned weight loss, or weight gain• Behavioral changes, unusual behavior patterns• Bowel function changes• Confusion, cognitive decline, worsening of dementia• Dehydration, fluid/electrolyte imbalance• Depression, mood disturbance• Dysphagia, swallowing difficulty• Excessive sedation, insomnia, or sleep disturbance

c 2007 ASCP 45


• Falls, dizziness, impaired coordination• GI bleeding• Headaches, muscle pain, generalized aching/pain• Rash, pruritis• Seizure activity• Spontaneous or unexplained bleeding, bruising• Unexplained decline in functional status• Urinary retention or incontinence

c 2007 ASCP 46

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

• Format and process of report can be determined by facility and CP

c 2007 ASCP 47


• Timeliness of notification depends on potential for or presence of serious adverse consequences– Examples include:

• Bleeding resident on anticoagulants• Possible allergic reactions to antibiotic

• Collaboration should occur between CP and facility to identify the most effective means of notification/ documentation

c 2007 ASCP 48


• Pharmacist’s findings are part of clinical record– If not maintained within active clinical record, it must still be

maintained within facility and readily available

• Guidelines strive to find balance between:– Encouraging/facilitating other HC professionals to utilize– Allowing facilities flexibility in determining a consistent

location that suits their needs

c 2007 ASCP 49

F428 - MRR: Response to Findings Old Guidelines

• The director of nursing and the attending physician are not required to agree with the pharmacist’s report, nor are they required to provide a rationale for their acceptance or rejection of the report; They must, however, act upon the report

• This may be accomplished by indicating acceptance or rejection of the report and signing their names

• The facility is encouraged to provide the medical director with a copy of drug regimen review reports and to involve the medical director in reports that have not been acted upon

c 2007 ASCP 50

F428 - MRR: Response to FindingsNew Guidelines

• Physician either:– Accepts recommendation and acts, OR– Rejects the recommendation and provides a brief

explanation, such as in a dated progress note • “It is not acceptable for a physician to document only

that he/she disagrees with the report without providing some basis for disagreeing.”

• For those direct care issues that do not require physician intervention, DON or designated nurse can address and document action taken

• Encourage sharing of report with entire ID team

c 2007 ASCP 51

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”

c 2007 ASCP 52

F428 - MRRLack of Action or Rejection

• What about continuing to document an issue that the physician has disregarded or rejected that is considered less clinically significant or where evidence of a valid clinical reason for rejection has been documented?– “In these situations, pharmacist need only

reconsider annually whether to report again or make new recommendation.”

c 2007 ASCP 53

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 (ending in ‘pril’) and…– Potassium supplements– Spironolactone

c 2007 ASCP 54

F428 - MRRTop 10 Drug Interactions in LTC

• Digoxin and…– Amiodarone (Cordarone)– Verapamil (Calan, Verelan)

• Theophylline and…– Fluoroquinolones (Cipro, Levaquin)

c 2007 ASCP 55

F329 - Unnecessary Meds Regulations

• Each resident’s medication regimen must be free from unnecessary medications. An unnecessary medication is any medication when used:– In excessive doses (including duplicate therapy); or– For excessive duration; or– Without adequate monitoring; or– Without adequate indications for its use; or– In the presence of adverse consequences which indicate the

dose should be reduced or discontinued; or– Any combinations of the reasons above

c 2007 ASCP 56

F329 - Unnecessary Meds Regulations

• Antipsychotics - Based on a comprehensive assessment of a resident, the facility must ensure that:– Residents who have not used antipsychotic drugs are not

given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record; and

– Residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs

c 2007 ASCP 57

F329 - Medication Management is Part of the Care Process

SIX MEDICATION MANAGEMENT CONSIDERATIONS

• Indications for use of the medication• Monitoring for efficacy and adverse consequences• Dose and duplicate therapy• Duration• Reevaluation and Tapering of a medication • Prevention, identification, and response to adverse

consequences

c 2007 ASCP 58

F329 - Unnecessary MedsIndication

• Opportunities for or circumstances that warrant evaluation of medication’s indication:– Admission or re-admission– Multiple prescribers– New medication order, especially if used as

emergency measure– Psychiatric disorder or distressed behavior– Change in condition, decline in function, new

symptom/condition

c 2007 ASCP 59

F329 - Unnecessary MedsMonitoring

• F329 contains sample monitoring tools and sources/references • What is the purpose of monitoring?

– To incorporate medication-related goals and monitoring parameters into the resident’s comprehensive care plan

• In some cases, can refer to facility’s established protocols or P+Ps

– To optimize med therapy (BENEFITS) while minimizing adverse consequences (RISKS)

– To establish parameters for evaluating the ongoing need for the medications

– To verify or differentiate the underlying diagnoses/causes of signs and symptoms

c 2007 ASCP 60

F329 - Unnecessary MedsMonitoring

• What are the steps or components of monitoring?– Identify the essential information and how it will be obtained and

reported

– Determine the frequency and duration of monitoring

– Define the methods for communicating, analyzing, and acting upon relevant information

– Re-evaluate and update monitoring approaches

• Using QUANTITATIVE and QUALITATIVE monitoring parameters facilitates consistent and objective collection of info by facility

c 2007 ASCP 61

F329 - Unnecessary MedsAdverse Consequences

• Any medication can cause adverse consequences• Considerations include…

– Following relevant clinical guidelines and/or manufacturer’s specifications for use, dose, duration, monitoring

• Black Box Warnings: http://formularyproductions.com/blackbox/

– Defining appropriate indications for use– Determining that the resident

• Has NKA to the medication• Is not taking other medications, products, food that would

be incompatible• Has no condition, history, or sensitivities that would

preclude use of that medication

c 2007 ASCP 62

F329 - Unnecessary MedsDose/Duplicate Therapy

• Dosing in older adults: Start LOW, Go SLOW• Lab tests (i.e., serum medication

concentrations) are only rough guide– Significant adverse consequences can occur even

with lab results are within therapeutic range– Lab results alone warrant evaluation, but do not

necessarily warrant dose adjustment

c 2007 ASCP 63

F329 - Unnecessary MedsDose/Duplicate Therapy

• Duplicate therapy…– Use of 2 or more medications from same class OR

Use of medications from different therapeutic categories that have similar effects or properties

• Acetaminophen-containing products• Multiple laxatives• Multiple benzodiazepines• Anticholinergic effects

– Documentation is necessary to clarify rationale for, benefits of, and monitoring of duplicate therapy

c 2007 ASCP 64

F329 - Unnecessary MedsDuration

• Some meds needed for extended periods, others shorter-term– Acute conditions

• Cough/Cold• Nausea/Vomiting• Acute Pain• Psychiatric/Behavioral Symptoms

– PPIs/H2 blockers (ulcer/GERD meds) used for prophylaxis during acute phase of medical illness

• If stop date according to facility P+P, discontinuation should occur - otherwise document clinical rationale

• Clinical rationale for continued use of a medication may have been demonstrated in clinical record, or staff/prescriber may present clinical rationale

c 2007 ASCP 65

F329 - Unnecessary MedsTapering/GDR

• Tapering of any medication may be indicated • Goal of GDR:

– Evaluate the continued need for the medication, AND

– Determine whether the resident is being maintained on the lowest effective dose

c 2007 ASCP 66

F329 - Unnecessary MedsTapering/GDR

• Opportunities for evaluation of medication, in regards to duration/dose:– CP’s MRR– MD’s visit or signing of orders– During quarterly MDS review

• What to evaluate:– Resident’s target symptoms and the effect of the medication

on symptoms (e.g., severity, frequency)– Changes in resident’s function during previous quarter

(e.g., MDS)– Whether resident experienced any medication-related

adverse consequences during previous quarter

c 2007 ASCP 67

Summary of Changes Between Advance Copy (Sep) and Final (Dec)

• Failed GDR/tapering isn’t the only way clinical contraindication can be determined for:– Antipsychotics used to treat psychiatric conditions– Sedatives/hypnotics– Psychopharmacological medications

• “So long as the medication is used in accordance with relevant current standards of practice, tapering/GDR may be considered clinically contraindicated if the physician has documented clinical rationale for why any attempted dose reduction would be likely to impair the resident's function or cause psychiatric instability by exacerbating an underlying medical or psychiatric disorder”

c 2007 ASCP 68

Summary of Changes Between Advance Copy (Sep) and Final (Dec)• Sedative/Hypnotics

– If tapering is utilized for sedatives/hypnotics, the most recent failed attempt - rather than three previous failed attempts - determines clinical contraindication

– Additional direction was added to consider tapering of a sedative/hypnotic if it is used beyond the manufacturer’s recommendations for duration of use

– Reference to clinical contraindication being valid for the remainder of the year has been deleted

• Under the cognitive enhancers section of Table 1, the reference to tapering of psychopharmacological medications has been deleted

c 2007 ASCP 69

F329 - Unnecessary MedsGDR/Tapering for Antipsychotics

• OLD:– The length of time before an antipsychotic dose reduction is

attempted should be consistent with the condition being treated

– Frequency of GDR: Twice a year (for residents with organic mental syndrome)

– GDR is clinically contraindicated if:• Two previous attempts within the last year led to a return of

symptoms or return to the previous dose was necessary OR • MD provides clinical rationale OR• Resident has a specific DX and meets criteria listed in

guidelines

c 2007 ASCP 70


• NEW:– For antipsychotics used to treat behavioral

symptoms related to dementia, GDR is clinically contraindicated if:

• Resident’s target symptoms returned or worsened after MOST RECENT GDR attempt WITHIN facility, AND

• MD has documented clinical rationale

c 2007 ASCP 71


• NEW:– For antipsychotics used to treat a psychiatric disorder,

GDR is clinically contraindicated if:• The continued use is in accordance with relevant current

standards of practice AND • MD has documented clinical rationale

OR• Resident’s target symptoms returned or worsened after

MOST RECENT GDR attempt WITHIN facility, AND• MD has documented clinical rationale

c 2007 ASCP 72


• NEW:– Within 1st year after admission on antipsychotic or

after initiation:• GDR in 2 separate quarters, with at least one

month between attempts– After 1st year,

• GDR annually

c 2007 ASCP 73

F329 - Unnecessary Meds Tapering for Sedatives/Hypnotics• OLD:

– Begin tapering after 10 days of continuous daily use

– Frequency: 3 times within 6 months– Tapering is clinically contraindicated if:

• 3 attempts within the last 6 months led to a decline

c 2007 ASCP 74

F329 - Unnecessary MedsTapering for Sedatives/Hypnotics• NEW:

– As long as resident is on sedative/hypnotic that is used ROUTINELY beyond the manufacturer’s recommendations for duration of use, taper at least QUARTERLY

– Tapering is clinically contraindicated if:• The continued use is in accordance with relevant current




c 2007 ASCP 75

F329 - Unnecessary MedsTapering for Sedatives/Hypnotics• NEW:

– Sedatives/Hypnotics now include…• New agents (non-benzodiazepine)• Sedating antidepressants (e.g., trazodone)• Sedating antihistamines (e.g, hydroxyzine)

c 2007 ASCP 76

F329 - Unnecessary MedsTapering for Psychopharmacological

Meds• OLD:

ONLY APPLIED TO BENZODIAZEPINES– Begin taper after 4 months of continuous daily use– Frequency: Twice a year– Tapering is clinically contraindicated if:

• Two previous attempts within the last year led to a decline

c 2007 ASCP 77


Meds• NEW:

– Psychopharmacological meds now grouped together, so more than just benzodiazepines…any med used for managing behavior, stabilizing mood, or treating psychiatric disorders

– According to Table 1, the following classes might be considered psychopharmacological depending on how they’re used:

• Anticonvulsants• Antidepressants• Anxiolytics - including buspirone, antidepressants

c 2007 ASCP 78


Meds• NEW:

– Tapering is clinically contraindicated if:• The continued use is in accordance with relevant current




c 2007 ASCP 79


Meds• NEW: (SAME AS ANTIPSYCHOTICS)

– Within 1st year after admission on psychopharm med or after initiation:

• Taper in 2 separate quarters, with at least one month between attempts

– After 1st year, • Taper annually

c 2007 ASCP 80

F329 - Unnecessary MedsBehavior Monitoring

• So, which med classes mention behavior monitoring? According to Table 1…– Antipsychotics

• Before initiating or increasing for enduring condition, target behaviors must be clearly and specifically identified and monitored objectively and qualitatively

– Anxiolytics• When used for delirium, dementia, and other cognitive

disorders with associated behaviors, behaviors to be quantitatively and objectively documented

c 2007 ASCP 81

Role of Beers Criteria

• Beers Criteria is not listed and titled as such (like they are in current guidelines)- But, Beers criteria medications are incorporated into pieces of the document (e.g., TABLES 1+2)

• New Beers criteria, as of 2003:– Fink DM, Cooper JW, Wade WE. Updating the

beers criteria for potentially inappropriate medication use in older adults. Arch Intern Med 2003;163:2716-24.

c 2007 ASCP 82

F329 - TABLE 1: Medication Issues of Particular Relevance

• While Table 1 is 36 pages long, it does not include all categories nor all medications within a category

• Alphabetically lists examples of some categories of and/or specific medications that– Have the potential to cause clinically significant adverse

consequences– Have limited indications for use– Require specific monitoring, or – Warrant consideration of risks vs. benefits

• Medications mentioned are not meant to be absolutely contraindicated for every resident, just that the medication has the potential to be unnecessary

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F329 - TABLE 1: Medication Issues of Particular Relevance

• Old guidelines included daily dose recommendations for psychotropic medications

• Previous drafts of revised guidance did NOT include dose examples

• But, final document added Daily Dose Thresholds back in for:– Antipsychotics– Anxiolytics– Sedatives/Hypnotics

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F329 - TABLE 2: Anticholinergic Meds

• Examples of medications with anticholinergic properties…– Antihistamines (diphenhydramine, chlorpheniramine)– Antivertigo meds (e.g., meclizine, scopolamine)– Respiratory meds (ipratropium, tiotropium)– GI meds

• Antispasmodics (dicyclomine, hyoscyamine, etc)• Antidiarrheals (e.g., diphenoxylate/atropine)• Anti-ulcer agents (e.g., cimetidine, ranitidine)• Phenothiazine antiemetics (e.g., promethazine,

prochlorperazine)

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• Examples of medications with anticholinergic properties…– Antidepressants (tricyclics - e.g., amitriptyline, imipramine)– Muscle relaxants (e.g., cyclobenzaprine, etc)– Urinary antispasmodics (oxybutynin, tolterodine, etc)– Antiparkinson meds (benztropine, etc)– Antipsychotic meds (conventional - e.g., thioridazine,

chlorpromazine)– Cardiovascular (e.g., furosemide, digoxin, nifedipine)

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• Examples of anticholinergic effects:– Slowed digestive motility– Constipation– Decreased sweating– Dry mouth, skin– Elevated BP– Blurred vision– Delirium– Confusion/disorientation– Difficult urination– Drowsiness– Dizziness

Thank you!!---------------------------------

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