FTag 428 Medication Regimen Review Drug Use Problems in Long Term Care Residents and Key Elements to

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F-Tag 428 Medication Regimen ReviewDrug Use
Problems in Long Term Care Residents and Key
Elements to Performing a Drug Regimen Review

• Robert L. Maher Jr., Pharm.D, BCPS, CGP
• Assistant Professor of Clinical Pharmacy
• Duquesne University School of Pharmacy
• Vice-President of Clinical Services
• Mission Pharmacy Services
• October 26th , 2007

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Timeline for Pharmacy Tags

• Reminder Appendix N Deleted - Effective June
  2004
• Effective date/implementation scheduled for
  DECEMBER 18, 2006

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Tags Combined

• Pharmaceutical Services
• New Tag F428 Old Tags F428, F429, F430
• DRR/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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MRR -What does it say currently?

• More Frequent Reviews
• Weekly Reviews depending on the residents
  condition and the drugs they are taking
• High Risk Residents
• Drug Therapy With High Potential for Less Severe
  Adverse Outcomes In Persons Over 65 (AKA Beers
  list)
• Note
• Review by the surveyor is not necessary for drug
  therapy given the first seven consecutive days
  upon admission/readmission, unless there is an
  immediate threat to health and safety

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MRR -What does it say currently?

• The director of nursing and the attending
  physician are not required to agree with the
  pharmacists 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

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Prior to F-Tag 428

• The director of nursing and the attending
  physician are not required to agree with the
  pharmacists 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

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F428 - MRR

• Definition in glossary
• Goal of promoting positive outcomes and
  minimizing adverse consequences associated with
  medications
• The review includes the following with
  medication-related problems and med errors
• Identifying
• Reporting
• Resolving
• Done by collaborating with others members of the
  interdisciplinary team.

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F428 - MRR

• What are these So things were preventing,
  identifying, reporting, and resolvinghow are
  MRPs, med errors, and irregularities defined?

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F428 - MRRMRPs

• A Medication-Related Problem (MRP) is
• (NOTE HOW SIMILAR THESE ARE TO THE UNNECESSARY
  MED CATEGORIES IN F-TAG 329)
• Use of a medication without adequate indication
  for use
• Use of a medication without identifiable evidence
  that safer alternatives or more clinically
  appropriate medications have been considered

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F428 - MRRMRPs

• Use of an appropriate medication that is not
  reaching treatment goals for reasons such as
  timing or techniques of administration, dosing
  intervals, etc.
• Use of a medication in an excessive dose
  (including duplicate therapy) or for excessive
  duration
• Presence of an adverse consequence associated
  with medication(s)

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F428 - MRRMRPs

• Use of a medication without adequate monitoring
• Inadequate monitoring of response to med, or
• Inadequate response to findings/results
• Presence of or risk for medication errors
• Presence of a clinical condition that might
  warrant initiation of medication
• Medication interaction - TOP 10 DIs in LTC

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F428 - MRRMed Errors

• A medication error isnt actually defined in
  document, but NCCMERP definition is
• A medication error is any preventable event
  that may cause or lead to inappropriate
  medication use or patient harm while the
  medication is in the control of the health care
  professional, patient, or consumer. Such events
  may be related to professional practice, health
  care products, procedures, and systems, including
  prescribing order communication product
  labeling, packaging, and nomenclature
  compounding dispensing distribution
  administration education monitoring and use.

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F428 - MRRIrregularities

• An irregularity is
• Any event that is inconsistent with usual,
  proper, accepted, or right approaches to
  providing pharmaceutical services (as defined by
  F425), or that impedes or interferes with
  achieving the intended outcomes of those
  services.

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F428 - MRR

• Given those definitions, important to note that
  document also states
• This guidance is not intended to imply that all
  adverse consequences related to medications are
  preventable, but rather to specify that a SYSTEM
  exists to assure that medication usage is
  evaluated on an ongoing basis

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F428 - MRRFrequency of Review

• Monthly or more frequently, depending on
• the residents condition, and
• the risks for adverse consequences related to
  current medications
• This sounds alarming, but it is virtually the
  same as current survey guidelines

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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 - MRRSources of Information

• May include, but are not limited to
• MARs
• Prescribers orders
• Progress, nursing, consultants notes
• RAI/MDS
• Lab reports
• Forms/reports reflecting behavioral monitoring
  and/or changes in condition
• QM/QI reports
• Attending physician, facility staff
• Interviewing, assessing, and/or observing the
  resident
• Ask yourself, how many of these do I use and
  should I be using more sources or different types
  of sources than I am now?

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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, residents allergies,
  potential interactions/averse consequences?
• Is dose, frequency, route, duration consistent
  with residents condition, manufacturers
  recommendations, and applicable standards of
  practice?

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F428 - MRRMRR 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?

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F428 - MRRMRR Considerations

• Has MD/staff noted and acted upon possible
  medication-related causes of recent or persistent
  changes in the residents 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

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F428 - MRRMRR 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

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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
• 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

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F428 - MRRNotification 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

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F428 - MRRNotification of Findings

• Pharmacists 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

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F428 - MRRResponse 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

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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
• 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 its 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.

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How to sort through all the MRPs in Long Term care
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Types of Suboptimal Drug Use

• 1. Overutilization (polypharmacy)
• 2. Underutilization
• 3. Inappropriate utilization
• Hanlon JT, et al. J Am Geriatr Soc
  200149200-9.

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Total Drug Therapy Cost Control

• Total Drug Cost (Product Cost Distribution
  Cost) x Utilization Medication Related Problems
  (Therapeutic Failures ADRS)

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Performing MRR

• Familiarize with Medicare and Medicaid
  requirements
• Familiarize with recent facility surveys
• Familiarize with documentation procedures
• Familiarize with lines of communication
• Familiarize with Medical and Nursing Staff
• Set dates and times for doing MRR

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Performing MRR

• Get to know the following people
• ADON, DON, Medical Director, Medical Records
• What reports
• Infection control
• Restraints
• Behavioral
• QI Meeting to attend
• Committee to involve

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Performing MRR

• The Chart
• Admission Records
• History and Physical Examination
• Physician or Prescriber Orders
• MARS
• Omissions (reasons)
• Prn use frequency documented effect
• Nursing Progress Notes
• Hospital Discharge Note - ?? Fax to the pharmacy

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Performing MRR

• The Chart
• Nursing Progress Notes
• Nursing Staff Communication
• Resident Condition
• Daily Progress
• Treatment Plans
• Vital Signs
• Monthly Summaries
• Monitoring of Outcomes of Therapy
• Documentation of Adverse Effects
• Functional Ability of Resident
• Resident Complaints

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Performing DRR

• The Chart
• Physician or Prescriber Progress Notes
• Diagnosis, Rationale, Therapeutic Outcomes
• Consultant Notes
• Psych, Dietary, Social Services, etc..
• DRR Documentation, Justification of Med use
• Clinical Lab Data
• Urinalysis, Serum Drug Concentration, CBC, Renal
  Function test, Thyroid Test
• Timing of labs

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Performing MRR

• Timing of MRR
• Prospective DRR
• Upon Admission
• Target high risk medications
• Concurrent MRR
• Retrospective MRR
• Discontinued medications question of why??

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Performing MRR

• DRR Time Requirements
• No more than 100 reviews in one day
• Industry standard according to open surveys 9
  minutes/chart
• Factors to consider
• The complexity of MRR
• Number of Chronic Conditions
• Medical Acuity Level of the Resident
• Duration of residency in the facility
• Chronic Care or postacute care
• The pharmacist familiarity with a particular
  resident

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Targeting the High Risk Elderly Patient

• Specific Medications
• NTD Renally Cleared Medications
• Phase I metabolized medications
• Class of Medications
• anticonvulants narcotic analgesics
• antipsychotics sedative/hypnotics
• anticholinergics

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Targeting the High Risk Elderly Patient

• Patients on Beers Criteria Drugs
• CrCl lt50ml/min
• Low BMI lt22kg/m2
• gt6 chronic active medical conditions
• Polypharmacy gt 9 or more chronic meds

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Targeting the High Risk Elderly Patient

• Prior history of an adverse drug reaction
• Advanced age (gt85)
• Those with a history of non-compliance
• Those recently discharged from the hospital
• Those with certain illness (e.g. dementia)

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Preventing ADRs in the Elderly

• 28 - 56 or ADEs are preventable
• Most ADEs result from errors in order writing
• 78 are due to systems failure
• Improve information systems when ordering meds
• Increase patient education
• Systematic review of medications
• DUE and DUR

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Principles for Optimizing Drug Use in the Elderly

• Consider whether drug therapy is necessary
• Promote the use of a small number of drugs to
  treat common problems
• Adjust doses and or/dosage intervals for
  medications
• Establish reasonable therapeutic endpoints and
  monitor for desired outcome
• Monitor for adverse drug reactions
• Regularly review the need for chronic medications

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Chronic Medication Review Steps

• Assess whether ADRs are the cause of any symptoms
• Match problem list with drug list
• If on drug but no match with problem list
  consider whether drug is necessary
• If has a chronic condition and not on a
  medication consider whether there is an evidence
  based drug to tx the condition
• Assess the monitoring for efficacy/safety/appropri
  ateness of the remaining medications

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Assessing Prescribing Appropriateness Using the
Medication Appropriateness Index

• Is there an indication for the drug?
• Is the medication effective for this condition?
• Is the dosage correct?
• Are the directions correct?
• Are the directions practical?
• Are there clinically significant drug-drug
  interactions?
• Are there clinically significant drug-disease
  interactions?
• Is there unnecessary duplications of drugs?
• Is the duration of therapy acceptable?
• Is this drug on the formulary or the least
  expensive alternative compared to others of equal
  utility?
• (Hanlon, et al)

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CMS Guidelines for Monitoring Medication Use

• Drug Monitoring
• ACE-I K
• AEDS (older) levels
• Aminoglycosides Scr, levels
• Antidiabetics Blood sugar
• Antipsychotics EPS, TD
• APAP (gt4gm/d) LFTS
• Appetite stimulants weight, appetite
• Digoxin Scr, level
• Diuretic K
• Erythropoiesis stimulants BP, iron, ferritn,
  CBC
• Fibrates LFTS, CBC
• Iron iron, ferritin, CBC
• Lithium level
• Niacin blood sugar, LFTs
• Statins LFTs
• Theophylline levels
• Thyroid replacement TFTs
• Warfarin INR

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CMS Drug-Drug Interactions

• Drug Effected Precipitant Drug (s)
• ASA NSAIDs
• ACE-I K supplements, K sparing diuretics
• Anticholinergic Anticholinergic
• Antihypertensives levodopa, nitrates
• Antiplatelet NSAID
• CNS med CNS med
• Digoxin amiodarone, verapamil
• Lithium ACEI, thiazide diuretics, NSAIDs
• Meperidine MAOI
• Phenytoin imidazoles
• Quinolones Type IA,C, II antiarrhythmics
• SSRI tramadol, st john wort
• Sulfonylureas imidazoles
• Theophylline imidazoles, quinolones,
  barbiturates
• Warfarin amiodarone, NSAIDs, sulfonamides,
  macrolides, quinolones, phenytoin, imidazoles

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Clinically Important Drug-Disease Interactions
Determined by Expert Panel Consensus

• Drug Disease
• Alpha blockers Syncope
• Anticholinergics BPH, constipation, dementia,
  glaucoma (narrow angle)
• Aspirin PUD
• Barbiturates Dementia
• Benzodiazepines Dementia, falls
• Bupropion Seizures
• CCB 1st generation CHF (systolic dysfunction)
• Corticosteroids DM
• Digoxin Heart block
• Lindblad C, Hanlon J et al. Clin Ther 2006 (in
  press)

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Clinically Important Drug-Disease Interactions
Determined by Expert Panel Consensus

• Drug Disease
• Metoclopramide Parkinsons disease
• Non-aspirin NSAIDs CRF, PUD
• Opioid analgesics Constipation
• Sedative/hypnotics Falls
• Thioridazine Postural hypotension
• Tricyclic antidepressants BPH, constipation
• dementia, falls, heart block
• postural hypotension
• Typical antipsychotics Falls
• Lindblad C, Hanlon J et al. Clin Ther 2006 (in
  press)

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Overutilization (Polypharmacy) in the Elderly

• Polypharmacy defined as
• 1. Concomitant use of multiple drugs
• 2. Use of more medications than are
• clinically indicated

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Risks Associated with Polypharmacy

• Functional status decline
• ADRs
• Inappropriate drug use
• Increased medication administration errors
• Increased risk of geriatric syndromes

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Underutilization of Medication

• Undiagnosed and untreated condition (e.g.,
  depression)
• Diagnosed condition but omitted treatment (e.g.,
  post-MI)
• Underuse of preventive treatment (e.g.,
  vaccinations)
• One study found that 50 of 372 vulnerable
  adults not prescribed an indicated medication
  Biggest problems with no gastroprotective agent
  for high risk NSAID users, no ACE-I in diabetics
  with proteinuria, no calcium\Vit. D for those
  with osteoporosis
• (Higashi T et al. Ann Intern Med
  2004140714-20)
• Another study found that between 38-76 of
  assisted living residents had medication
  undertreatment Biggest problems with no ASA or
  beta blocker post MI non ACE-I in CHF patients
  and no calcium\Vit. D for those with osteoporosis
• (Sloane PD et al. Arch Int Med 20041642031-37)

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Inappropriate Prescribing

• Prescribing of medications that does not agree
  with accepted medical standards

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The Is of Geriatrics and MRPs

• Immobility
• Isolation
• Incontinence
• Infection
• Inanition
• Impaction
• Impaired senses

• Instability
• Intellectual Impairment
• Impotence
• Immunodeficiency
• Insomnia
• Iatrogenesis

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Medications with Anticholinergic Activity

• Anti-emetics/anti-vertigo and - (e.g. meclizine)
• Antiparkinsonians - (e.g. trihexyphenidyl)
• Antispasmodics- (e.g. belladonna, oxybutynin)
• Cold and allergy drugs- (e.g hydroxyzine)
• Sleep aids- (e.g. diphenhydramine)
• Skeletal muscle relaxants - (e.g. cyclobenzaprine)

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Psychotropic Drug Use in LTC
Reflects of residents with any use of drug
type within 7 days prior to MDS assessment. CMS
data, 1st quarter, 2006, http//www4.cms.hhs.gov
/states/mdsreports/res3.asp?varO1date8,
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Risk of Medications for In-Hospital Delirium in
the Elderly

• Drug Class Adj. OR CI Final Model
• Neuroleptics 2.50 1.15-5.43 4.48
  (1.82-10.45)
• Narcotics 1.71 0.97-2.99 2.54
  (1.24-5.18)
• H2 Blocker 1.42 0.81-2.47
• Digoxin 0.52 0.30-0.90
• Anticholin. 0.76 0.41-1.43
• Benzodiaz. 0.43 0.23-0.81
• Steroid 0.51 0.16-1.67
• NSAID 0.39 0.10-1.49
• plt0.05
• Schor JD et al. JAMA 1992267827-31.

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Communication

• Consultant Pharmacist Communication Techniques
• Meet your physicians
• What is the best type of communication?
• When do the physicians make rounds?
• Type written vs hand written recommendations

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Communication

• What physicians say they want from pharmacists
• Recommendations designed to achieve improved
  efficacy and decreased risk of adverse drug
  reactions
• Help in reducing unnecessary drug use
• Information about drug side effects and
  interactions

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Communication

• What physicians say they want from pharmacists
• Medication-related information and in-services
  for facility staff
• Monitoring and dosing of Narrow therapeutic drugs
• Help in developing processes for detecting and
  reporting adverse drug reactions
• Performance of drug regimen review as close as
  possible to point of prescribing

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Communication

• Many physicians feel it is the content that is
  lacking in recommendations from pharmacists
• Physician Pet Peeves
• Recommending changes from computer generated
  pharmacy profiles
• Closing the sale
• Communicate the solving of the problem not the
  perception of the problem.
• Communicating the regulatory issues and
  addressing the true patient concerns.

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Communication

• To Cite or Not to Cite
• Refer to guidelines and the medical literature,
  make sure it is relative to the elderly resident.
• What if the physician does not respond?
• Follow the paper trail
• Are they being sent back in a timely manner
• Meet with the medical director and create a good
  professional relationship
• Maintain a presence in the facility.
• Choice of words is always a plus

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Communication

• Consultant Software
• Communication examples
• In-house pharmacy reporting examples

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Questions ?