Medication Risk in the Older Adult: A Hidden and Costly Epidemic

1
Medication Risk in the Older Adult A Hidden and
Costly Epidemic

• Penny Shelton, Pharm.D., CGP, FASCP
• Director of Experiential Programs
• Associate Professor, Dept of Pharmacy Practice
• Campbell University
• Claudia Schlosberg, J.D.
• Director of Policy and Advocacy
• American Society of Consultant Pharmacists

2
Agenda

• Medication Use in Older Adults
• Medication Related Problems (MRPS)
• Costs of MRPs
• Preventability
• Inappropriate Prescribing and Non-Adherence
• MTM and the Role of Pharmacists
• Policy Implications and Recommendations
• Case Studies

3
Medication Use in the Elderly

• Seniors make-up approx. 12 of U.S. population
  but account for 37.2 of total Rx spend
• Medicare Part D increased prescription
  utilization by almost 5 in 2006
• 40 OTC medications

Kaufman DW, et al. JAMA 2002287337-44 IMS
1997 Ketcham JK, Simon KI. Am J Managed Care
200814SP14-21 U.S. Census Bureau
4
MRPs are Common among Older Adults

• Older adults (65 ) are
• 2.5 txs more likely to visit ERS due to an MRPs
  than younger individuals.
• 7 txs more likely to be hospitalized for an MRPs
  than younger individuals.
• Budnitz DS, Pollock, DA, Weidenbach KN, et al,
  National Surveillance of ER Visits for Outpatient
  ADEs, JAMA, 2006 2961858-1866.

5
Outcomes of Medication Related Problems

• 10 of all hospital admissions
• 28 of hospitalizations of the elderly
• ADRs (17)
• Non-adherence (11)
• 23 of all nursing home admissions
• Vermiere E, Hearnshaw H, Van Royen P, Denekens
  J.  Patient adherence to treatment  three
  decades of research  a comprehensive review.  J
  Clin Pharm Ther 200126331-342 Col N, Fanale
  JE, Kronholm P. The role of medication
  noncompliance and adverse drug reactions in
  hospitalizations of the elderly. Arch Intern Med
  19901508415 Lazarou J, Pomeranz BH, Corey PN.
  Incidence of adverse drug reactions in
  hospitalized patients.  JAMA 1998279(15)12005.
  Strandberg LR.  Drugs as a reasons for nursing
  home admissions.  J Am Health Care Assoc
  19841020-3

6
Example Falls

• Falls- No risk factor for falls is as
  potentially preventable or reversible as
  medication use.
• Leipzig, Gumming and Tinetti, 1999)
• 1 in 3 seniors fall each year, 30 of falls
  result in injury
• Average non-fatal injury costs 7,300
• 48 million the annual cost of falls from a
  populationof 100,000 seniors

7
Costs of MRPs in 2000

• 13.8 billion physician visits
• 121.5 billion hospitalizations
• 5.8 billion emergency room visits
• 32.8 billion nursing home care
• 3.5 billion new prescriptions
• 177.4 billion direct medical costs of
• DRPs

Prescription drug costs in 2006 217 billion
Ernst FR, Grizzle AJ. J Am Pharm Assoc
200141192-9
8
Annual Cost of Diseases Affecting People 65 in
the US
9
Older Adults at Highest Risk

• Older adults are at the highest risk for
• medication related problems (MRPS) due to
• age-related physiological changes
• high-prevalence of multiple chronic diseases
• large numbers of prescription and OTC
  medications
• visual and cognitive impairments that interfere
  with
• proper use and adherence to medications
• poverty
• language, literacy, and cultural barriers

10
Potential Medication-Related Problems (MRPs)

• Untreated indications
• Improper drug selection
• Subtherapeutic dose
• Failure to receive drugs
• Overdosage
• Adverse drug reactions
• Drug interactions
• Drugs without an indication

Strand, et al. Drug Intell Clin Pharm
1990241093-97
11
The Domino Effect
KCL
HCTZ
ZYLOPRIM
DIABETA
MECLIZINE
12
Common Symptoms of the Elderly Drug or Disease?

• Fatigue
• Altered mental status
• Falling
• Constipation
• Blurred vision
• Depression
• Dizziness

13
Medication Problem or Aging?

• Any symptom in an elderly patient should be
  considered a drug side effect until proven
  otherwise.

Gurwitz J, Monane M, Monane S, Avorn J. Brown
University Long-term Care Quarterly Letter 1995
14
Risk Factors for MRPs in Elderly Outpatients

• PATIENT CHARACTERISTCS
• Polypharmacy
• Dementia
• Multiple chronic diseases
• Impaired kidney function
• Recent hospitalization
• Age ? 85 years
• Multiple prescribers
• Regular use of alcohol ( 1 fl oz/d)
• Prior ADR

Hajjar ER, et al. Am J Geriatr Pharmacother
2003182-9)
15
MRPs in Older Ambulatory Patients

• 1523 ADE identified from records and MD reports
• 27.6 preventable
• Prescribing stage
• wrong drug/wrong therapeutic choice (27.1)
• wrong dose (24)
• inadequate patient education (18)
• drug-drug interactions (13.3)
• Monitoring stage
• Failure to respond to lab values or drug
  toxicity(36.6)
• Inadequate lab monitoring (36.1)

Gurwitz JH, et al. JAMA 20032891107-16.
16
Preventability of MRPs
Of fatal, life-threatening serious events
Of significant events
Preventable 42
Preventable 19
17
Event Rate Issues

• Rate found may be underestimate
• Based on chart review - limitations
• Classifiers required strong evidence
• Extrapolation to total US Medicare population
  (n38,000,000)
• 1,900,000 MRPs per year in ambulatory setting
• 180,000 life threatening or fatal MRPs (50
  preventable)
• To Err is Human, IOM

18
Estimated Annual Incidence of MRPs Treated in US
Emergency Departments
Red line - general population rate of ADEs
beginning at age 60, ADE rate begins to exceed
general population
Budnitz, D. S. et al. JAMA 20062961858-1866.
19
Factors Associated with Medication Errors

• The most common groups of factors associated with
  errors were those related to
• Knowledge and the application of knowledge
  regarding drug therapy (30 percent)
• Knowledge and use of knowledge regarding patient
  factors that affect drug therapy (29.2)
• Use of calculations, decimal points, or unit and
  rate of expression factors (17.5 percent) and
• Nomenclature (13.4 percent).

• Lesar et al., Factors related to errors in
  medication prescribing, JAMA. 277(4)312-317,
  1997, from To Err is Human, IOM 2000.

20
Inappropriate Prescribing

• 25 percent of prescriptions written for older
  people living the community are for potentially
  inappropriate medications
• Failure to routinely screen for potential drug
  interactions, even when medication history
  information is readily available.
• Computerized alerts and clinical decision support
  tools while helpful, are limited
• Alert burden
• Non-geriatric focus
• Need to fully integrate clinical and lab
  information
• Not a substitute for clinical judgment

21
Inappropriate Prescribing in Various Ambulatory
Settings
22
Noncompliance

• Lack of understanding
• Barriers to communications
• Complex regimen
• Differing doses
• Inconvenient scheduling
• Lack of perceived need
• Adverse events
• Cost
• Social isolation

23
Rx During 1 Year Following Fracture in Previously
Untreated Women
Andrade SE, et al. Arch Intern Med
20031632052-7
24
State Example A Utilization and Cost Summary for
Uncoordinated Care Patients
Uncoordinated Care Utilization and Cost
Percentages
45
\\46
36
32
1.8 B
10
Percent Patients
Percent Prescription Costs
Percent Prescriptions
Percent MedicalCosts
Percent All Costs (drug medical)
25
State Example B Utilization and Cost Summary for
Uncoordinated Care Patients
Coordinated Care Patients
Uncoordinated Care Patients
366M
4.3M rxs
539M
40,000 pts
39
41
27
32
905M
7
Percent Patients
Percent Prescription Costs
Percent Prescriptions
Percent Medical Costs
Percent All Costs (drug medical)
26
State Example C Utilization and Cost Summary for
Uncoordinated Care Patients
Coordinated Care Patients
Uncoordinated Care Patients
75 M
45
48
160.7 M
235.6 M
34
30
8
Percent of Prescription Costs
Percent ofTotal Prescriptions
Percent of Medical Costs plus Prescription Costs
Percent of Patients
Percent of Medical Costs
27
State Example Percent Total Dollars By Cost
Groups
Comparison of Uncoordinated Care vs. Coordinated
Care Patients by Cost Groups (Percentage and
Amount of Total Costs)
130 M
123 M
97 M
82 M
87 M
58
74 M
90
58
61 M
47
69
59
57
19 M
42
53
42
41
31
43
97
3
10

Total Cost Groups (Medical and Drug Costs)
Unpublished data, Southeastern Consultants Mary
Kay Owen, R.Ph., C.Ph., 2008
28
Improving the Quality of Medication Use in
Elderly Patients

• Putting the pieces of the puzzle together to
  create a solution remains a formidable, but not
  insurmountable task.All the pieces of the puzzle
  lie before us it remains for us to find a way to
  fit them together
• Jerry H. Gurwitz, M.D.

Gurwitz JH, Arch Intern Med 2002 1621670-3
29
Role of the Pharmacist
Because of the immense variety and complexity of
medications now available, it is impossible for
nurses and doctors to keep up with all of the
information required for safe medication use.
The pharmacist has become an essential resource .
. . And thus access to his/her expertise must be
possible at all times. Institute of
Medicine To Err is Human Building a
Safer Health System - 2000
30
What is MTM?

• Defined by the American Medical Associations
  2008 Current Procedural Terminology (CPT) as
• Medication Therapy Management service(s) (MTMS)
  describe face-to-face patient assessment and
  intervention as appropriate, by a pharmacist. 
  MTMS is provided to optimize the response to
  medications or to manage treatment-related
  medication interactions or complications.

31
What is MTM?

• Distinct from dispensing and related activities,
  e.g., counseling
• Patient-centered, not product-centered
• Focus on the whole patient, not a drug product
• Requires collaboration with treatment team

32
MTM Goals

• Promote appropriate, safe and effective
  medication use.
• Improve quality of life and quality of care
• Empower patients/caregivers to be active
  participants in medication and health care
  management
• Be cost effective
• Decrease overall health care costs
• Others

33
Examples of MTM Services

• Patient assessment for MRPs
• Formulating a medication treatment plan
• Selecting, initiating, modifying, administering
  medication within the scope of license
• Monitoring drug therapy outcomes safety and
  effectiveness
• Comprehensive medication review to identify and
  resolve drug-related problems
• Providing patient education to enhance adherence
• Documenting and communicating recommendations to
  other providers

34
Settings for Delivering MTM Services

• All settings of patient care
• Community pharmacies
• Hospitals
• Nursing facilities
• Office practices
• Home visits
• Anywhere that involves patients and/or caregivers
  and managing the patients medications
• Empowerment model
• Work collaboratively with other providers

35
Self-insured Employer The Diabetes 10 City
Challenge

• Outcomes
• Decrease in A1C (5.2), LDL (32), SBP (15.7),
  DBP (9.2)
• Increase in nutrition, exercise, and weight loss
  goals
• Employer savings of 918 per employee in total
  health care costs
• ROI of at least 41 beginning in the second year
• 50 reduction in absenteeism and fewer workers
  compensation claims
• 97.5 of patients reported being satisfied or
  very satisfied with their diabetes care

36
Private Sector Minnesota Collaborative

• BlueCross BlueShield of Minnesota, Fairview
  Health Services of Minneapolis, and the
  University of Minnesota one year prospective
  study
• 637 drug therapy problems resolved (285 patients)
• 78 without direct involvement with physician
• 22 through collaboration with a physician
• Patients receiving MTM services demonstrated
  significant improvement in
• Drug problems resolved
• Drug therapy goals achieved
• Improved HEDIS measures

37
Private Sector Minnesota Collaborative

• Drug expenditures increased by 19.7
• Total health expenditures decreased from 11,965
  to 8,197 per person
• Expenditures decreased by 57.9 for facilities
  and 11 for professional claims
• Return on Investment (ROI) was 121 (dollars
  saved for each dollar invested)
• Now a benefit option to employer health plans
  across the U.S. as ClearScript

38
Medicaid MTM Programs

• Missouri - Pharmacists and primary care providers
  working collaboratively have reduced per capita
  annual program expenditures by 6,804 - total
  savings 2.4 million annually.
• Minnesota - Pharmacists identified 3.1 drug
  therapy problems per recipient. Inadequate
  therapy represented 73 of resolved problems.
• Other states with Medicaid MTM programs Florida,
  Maryland, Mississippi, Ohio, Virginia, Vermont .
  . . .

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Who Will Benefit from MTM?

• All patients, but most benefit will be realized
  by patients who are at highest risk
• Uses prescription or non-prescription medication
• Uses herbal products or dietary supplements
• Has an actual or potential drug-related problem
• Physicians and other prescribers
• Health care system

40
What the Research Shows

• Pharmacists can
• Help patients manage and monitor their drug
  therapy
• Improve overall medication use
• Improve clinical outcomes
• Decrease adverse drug events
• Improve quality of life
• Reduce overall health care costs

41
Return on Investment

• Ashville Project - Pharmacist MTM program for
  diabetics saved 1200/pt/yr with improved
  outcomes
• Minnesota MTM program resolved 3.1 drug therapy
  problems per recipient generating average cost
  savings of approx. 403/pt/yr
• Bussey, On average, 16.70 saved for every 1
  invested in clinical pharmacy services (review of
  104 studies)
• Schumock, benefit cost ratio ranged from 1.71 -
  17.01 (literature review).

42
Medicare Part D MTM- A misplaced opportunity

• Inconsistent and overly restrictive inclusion
  criteria - focus on total drug spend, not risk
  factors
• Poorly defined service criteria resulting in
  great variability and intensity of services
• In PDPs,
• Poor integration with health care providers
• Antithetical business model
• No outcomes criteria or monitoring
• Lack of adequate payment mechanism for
  provider/pharmacists

43
Improving Drug Therapy Outcomes

• Patients must be educated about the medication,
  including potential ADRs
• Records must contain all current medications,
  including OTC and herbals (HIT wil help!)
• Therapeutic end points and ADEs must be monitored
• Medication therapy should be systematically
  review at least annually (or whenever there is a
  significant change)
• Improve care coordination between primary care
  and others treating the patient including
  pharmacists
• Increase access to pharmacist-provided MTM for
  patients at highest risk

Knight EL, Avorn J. Ann Intern Med
2001135703-10.
44
How?

• Create new payment models to enhance
  collaborations between physicians and pharmacists
  (i.e. patient-centered medical home separate
  payment for clinical services from payment for
  product
• Establish Part B benefit for high risk
  beneficiaries
• Revamp physician incentives and performance
  measures to promote effective medication
  assessment and management
• Increase number of pharmacists with training and
  expertise in geriatrics

45
Why is MTM a Policy Imperative?

• The aging of the Baby Boom population, combined
  with an increase in life expectancy and a
  decrease in the relative number of younger
  persons, will create a surge in the elderly
  population that will severely strain the
  healthcare system.

46
Strain on the System

• As the baby boomers come of age, more money will
  be spent on pharmaceutical care.

47
Controlling Drug Spending

• Drug Re-importation
• Promotion of restrictive formularies and
  formulary management tools
• Promoting generic and therapeutic substitution
• Mandating comparative effectiveness research
• Limiting DTC
• Registration of drug reps
• Academic detailing

• The rapid growth of prescription drug
  expenditures is prompting consumers, policymakers
  and public and private payors to look for new
  ways to control drug spending.

48
Product Cost v. Appropriateness

• Sound medication therapy management principles
• Focus on more than the cost of the pill
• Require collaboration between prescriber and
  pharmacist
• Benefit from data exchange

• Appropriate prescribing
• Safety and effectiveness
• Persistence and adherence

49

• CASE STUDIES

50
QUESTIONS?
51
CONTACT INFORMATION

• Penny Shelton, Pharm.D., CGP, FASCP
• Director of Experiential Programs
• Associate Professor, Department of Pharmacy
  Practice
• Campbell University
• PO Box 1090
• Buies Creek, NC 27506
• 800-760-9697 ext. 1716
• sheltonp_at_campbell.edu

• Claudia Schlosberg, J.D.
• American Society of Consultant Pharmacists
• 1321 Duke Street
• Alexandria, VA 22314
• 703-739-1316, ext 128
• Cschlosberg_at_ascp.com