Unlike Dick the Butcher



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Unlike Dick the Butcher

  • Unlike Dick the Butcher

    • ”The first thing we do, let's kill all the lawyers”
    • Not: medications are bad
    • Rather, suggesting need for judicious use and continuous re-litigation


Demographics

  • Demographics

    • Aging and Multimorbidities
    • Polypharmacy and ADR’s
  • Age-related changes

    • Pharmacodynamics (absorption, clearance)
    • Body Composition
  • What are we doing? Whose standard?

  • Bad Drugs: Beer’s List, HEDIS High Risk Meds

  • Semper Vigilentes – Med Review as a SOP



Population Explosion

  • Population Explosion

    • Where we are:
      • Over 65 years old: 12.9% of population
      • Over 75: 6.1% 18,766,000
    • Where we’re going






Compression of Morbidity

  • Compression of Morbidity



Large heterogeneity  difficult to find applicable studies

  • Large heterogeneity  difficult to find applicable studies

      • “No index…prospectively tested and found to be accurate in a large diverse sample…no study was completely free from potential sources of bias. Testing of transportability was limited, raising concerns about overfitting and underfitting. These factors limit a clinician's ability to assess the accuracy of these indices across patient groups that differ according to severity of illness, methodology of data collection, geographic location, and time.”
  • The Controversy

    • How far can we extrapolate data for this population?
    • To what extent can we base clinical practice on biologic plausibility in the absence of clinical trail data?


Over 50% of older adults have 3+ chronic conditions

  • Over 50% of older adults have 3+ chronic conditions

  • Increased risk of:

    • Death
    • Institutionalization
    • Increased utilization of healthcare resources
    • Decreased quality of life
    • Higher rates of adverse effects of treatment or interventions
  • Almost all existing “guidelines” have single disease focus

  • Best approaches to decision-making and clinical management of older adults with multimorbidity remain unclear





Difficult to define a uniform threshold for treatment complexity and feasibility

  • Difficult to define a uniform threshold for treatment complexity and feasibility

  • Influenced by

    • Treatment regimen
    • Older adult’s unique characteristics
  • Barriers to assessing complexity and feasibility



~100,000 emergency hospitalizations/year due to adverse drug events (ADEs)

  • ~100,000 emergency hospitalizations/year due to adverse drug events (ADEs)

  • 10.7% of hospital admissions in older adults

  • “If medication related problems were ranked as a disease, it would be the fifth leading cause of death in the US!”



Absorption

  • Absorption

    • Other drugs, nutrition, gastric emptying
  • Distribution

    • ↑adipose/↓lean, water
  • Binding/Localization

    • ↓albumin
  • Biotransformation

    • ↓Hepatic Clearance (some drugs), great variability
  • Elimination

    • ↓GFR












Less stringent control reasonable in those with a long history of diabetes, limited life expectancy, or comorbid conditions

  • Less stringent control reasonable in those with a long history of diabetes, limited life expectancy, or comorbid conditions



Hematologic

  • Hematologic

  • Endocrine agents

  • Cardiovascular agents

  • Central Nervous System Agents

  • Anti-infective









Influenced by the way risk information is presented to the patient

  • Influenced by the way risk information is presented to the patient

  • Multimorbidity patients face more preference-based and complex decisions

  • Eliciting preferences may make clinical management more time-consuming



Medication Management Capacity

  • Medication Management Capacity

    • Drug Regimen Unassisted Grading Scale (DRUGS)
      • Edelberg HK, Shallenberger E, Wei JY. Medication management capacity in highly functioning community-living older adults: detection of early deficits. J Am Geriatr Soc. 1999 May;47(5):592-6.
    • Hopkins Medication Schedule (HMS)
      • Carlson MC, Fried, LP, Xue QL, et al. Validation of the Hopkins Medication Schedule to Identify Difficulties in Taking Medications Journal of Gerontology: Feb 2005;60A,2: Health Module 217-223
    • Medication Management Instrument for Deficiencies in the Elderly (MedMaIDE)
      • Orwig D, Brandt N, Gruber-Baldini, A. Medication Management Assessment for Older Adults in the Community. The Gerontologist 2006;46:661-668




Methods to Look at Inappropriate Prescribing e.g.:

  • Methods to Look at Inappropriate Prescribing e.g.:

    • American Geriatrics Society 2012 Beer’s Criteria
    • STOPP (Screening Tool of Older Persons’ potentially inappropriate Prescriptions)
    • START (Screening Tool to Alert doctors to the Right Treatment)
    • Clinical Judgment






Original 1991 – Nursing home pts

  • Original 1991 – Nursing home pts

  • Updates

    • 1997: All elderly; adopted by CMS in 1999 for nursing home regulation
    • 2003: Era of generalization to Med D, then NCQA, HEDIS
    • 2012: Further adoption into quality measures


Specific aim – update 2003 Beers Criteria using a comprehensive, systematic review and grading of evidence

  • Specific aim – update 2003 Beers Criteria using a comprehensive, systematic review and grading of evidence

  • Strategy:

  • Incorporate new evidence

  • Grade the evidence

  • Use an interdisciplinary panel

  • Incorporate exceptions



Framework

  • Framework

  • Expert panel

    • 11 members
  • IOM 2011 report on guideline development

    • Includes a period for public comment
  • Literature search



Co-chairs

  • Co-chairs

    • Donna Fick, PhD
    • Todd Semla, MS, PharmD
  • Panelists (voting)

    • Judith Beizer, PharmD
    • Nicole Brandt, PharmD
    • Catherine DuBeau, MD
    • Nina Flanagan, CRNP,CS-BC
    • Joseph Hanlon, PharmD, MS
    • Peter Hollmann, MD
    • Sunny Linnebur, PharmD
    • Stinderpal Sandhu, MD
    • Michael Steinman, MD


Literature search: ADE, inappropriate drug use, med errors, polypharmacy x age/human/English

  • Literature search: ADE, inappropriate drug use, med errors, polypharmacy x age/human/English



Survey to panel to rate (strong agreestrong disagree)

  • Survey to panel to rate (strong agreestrong disagree)

    • 2003 Beers meds
    • New additions
  • Ratings tallied, shared with panel, 2 rounds of consensus

  • In-person: review survey draft and lit search

  • 4 groups reviewed lit, selected citations

  • Evidence tables prepared, rated quality of evidence and strength of recommendation

  • Final group consensus



Quality

  • Quality

  • High Evidence

    • Consistent results from well-designed, well-conducted studies that directly assess effects on health outcomes (2 consistent, higher-quality RCTs or multiple, consistent observational studies with no significant methodological flaws showing large effects)
  • Moderate Evidence

    • Sufficient to determine effects on health outcomes, but the number, quality, size, or consistency of included studies, generalizability, indirect nature of the evidence on health outcomes (1 higher-quality trial with > 100 participants; 2 higher-quality trials with some inconsistency, or 2 consistent, lower-quality trials; or multiple, consistent observational studies with no significant methodological flaws showing at least moderate effects) limits the strength of the evidence
  • Low Evidence

    • Insufficient to assess effects on health outcomes because of limited number or power of studies, large and unexplained inconsistency between higher-quality studies; important flaws in design or conduct, gaps in the chain of evidence
    • Or lack of information on important health outcomes


Strength of recommendation

  • Strength of recommendation

  • Strong:

    • Benefits clearly > risks and burden OR risks and burden clearly > benefits
  • Weak:

    • Benefits finely balanced with risks and burden
  • Insufficient:

    • Insufficient evidence to determine net benefits or risks




  • Continuous arrivals of new drugs on the market1

  • Older formulations unavailable in European formularies2

  • Only 12-21% of the medications identified are being used by older adults3

  • Tangible benefit to patients in terms of clinical outcomes2



Table 2: Medications or medication classes that should be avoided in persons 65 years or older

  • Table 2: Medications or medication classes that should be avoided in persons 65 years or older

  • Table 3: Medications that should not be used in older person known to have specific medical diseases or conditions.

  • Table 4: Medications that should be used with caution



A total of 53 medications or medication classes, which are divided into three tables.

  • A total of 53 medications or medication classes, which are divided into three tables.

  • Constructed and organized by:



34 potentially inappropriate medications/classes to avoid in older adults independent of diagnoses or conditions.

    • 34 potentially inappropriate medications/classes to avoid in older adults independent of diagnoses or conditions.
    • Notable mentions:
        • Sliding Scale Insulin
        • Antipsychotics for Behavioral Health issues associated with dementia
        • Non benzodiazepine Hypnotics
        • Megestrol
















Older adults often under-represented in drug trials potentially underestimating medication related problems/evidence grading.

  • Older adults often under-represented in drug trials potentially underestimating medication related problems/evidence grading.

  • Does not comprehensively address the needs of palliative and hospice care patients

  • Does not address other types of potential potentially inappropriate medications

    • e.g.:
      • dosing of primarily renally eliminated medications,
      • drug-drug- interactions


This is just one tool that can be utilized to optimize medication management in older adults.

  • This is just one tool that can be utilized to optimize medication management in older adults.

  • Need to make sure the Beers list is used in a patient centered manner



For the Health Professional

  • For the Health Professional

  • Downloadable pocket card

  • Evidence tables with links to supporting references

  • Beers app – AGS iGeriatrics

  • For the Layperson

  • Summary in lay language

  • Q & A on what to do if one of your drugs is on the Beers list

  • Medication diary & tips for safe use of meds









Quality prescribing includes:

  • Quality prescribing includes:

  • Correct drug for correct diagnosis

  • Appropriate dose (label; dose adjustments for co-morbidity, drug-drug interactions)

  • Avoiding underuse of potentially important medications (e.g., bisphosphonates for osteoporosis)

  • Avoiding overuse (e.g., antibiotics)

  • Avoiding potentially inappropriate drugs

  • Avoiding withdrawal effects with discontinuation

  • Consideration of cost





Quality Metrics

  • Quality Metrics

    • HEDIS: http://www.ncqa.org/HEDISQualityMeasurement/HEDISMeasures/HEDIS2013/HEDIS2013FinalNDCLists.aspx
  • Improved patient care

  • Decrease liability



Medication Management & Monitoring takes a team!

  • Medication Management & Monitoring takes a team!

  • It needs to be patient centered.

  • Most importantly, monitoring needs to be evaluated on an ongoing basis.




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