”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
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
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 agreestrong disagree)
Survey to panel to rate (strong agreestrong 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.