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Drug Safety In The New Millennium

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Metoprolol vs Toprol XL. Captopril TID vs Monopril QD? MS-Contin vs. immediate release/prn ... The contents presented do not necessarily reflect CMS policy. ... – PowerPoint PPT presentation

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Title: Drug Safety In The New Millennium


1
Drug Safety In The New Millennium
  • Darren M. Triller, PharmD
  • Quality Improvement, IPRO

2
Learning Objectives
  • Review functional processes necessary for safe
    ambulation
  • Discuss impact of medications on body systems
    needed for ambulation
  • Propose methods for reducing fall-related
    injuries in high risk seniors

3
Can You Say Overrated?
4
Miracles of Modern Medicine
5
What are some of the most overrated modern drugs?
6
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7
What do we know about Vioxx?
  • Increased heart attack risk
  • Never purported to be a superior pain reliever!
  • May reduce ulcers more than PLACEBO
  • NSAIDS still harm and kill tens of thousands a
    year through kidney damage, ulcers, HTN
  • Elderly are most at risk
  • All NSAIDS should be used at minimum effective
    dose, for shortest possible time period
  • Narcotics may be safer!

8
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9
Are you Runnin on Dunkin?
10
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11
CLEVELAND, May 21 A meta-analysis of data from
42 clinical trials found a 43 increase in
relative risk of myocardial infarction among type
2 diabetics treated with rosiglitazone (Avandia).
The odds ratio for MI was 1.43 (95 confidence
interval 1.03-1.98, P0.03), said Steven E.
Nissen, M.D., of the Cleveland Clinic, lead
author of the meta-analysis, which was released
online today by the New England Journal of
Medicine.
12

A panel of heart specialists issued a warning in
June 2005 about the drug Natrecor, which has been
associated with higher rates of kidney failure
and death. In addition, a leading cardiovascular
expert, the Cleveland Clinics Dr. Eric J. Topol,
said the congestive heart failure drug does not
meet minimal safety standards.
13
Once almost routinely prescribed, hormone therapy
(HT)in the form of estrogen plus progestinhad
been found by WHI researchers to increase women's
risk of breast cancer, heart attack, stroke, and
leg and lung clots. Those findings were given
high-profile coverage in the consumer press.
14
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15
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16
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17
Drugs as Cause of Harm
18
Re-align Our Thinking on Drugs
  • Drugs are to be used only when necessary
  • Drug use should be based on evidence of impact on
    real outcomes
  • Drugs are to be used for specific indications
  • Symptom control
  • Treatment of a real disease
  • Prevention of a likely event
  • Drugs are to be removed when ineffective or when
    risk outweighs benefits
  • Drug regimens should be periodically reconsidered

19
Risk vs. Benefit What are you trying to
accomplish?
20
Role of Home Care Practitioners
  • Pay close attention to medications
  • Reconciliation
  • Adherence
  • Responsiveness
  • Clinical/laboratory parameters
  • Always suspect medications as cause of new
    sign/symptoms in medicated elderly
  • Report anything suspicious

21
What is needed to stand?
  • Suitable environment
  • Voluntary nervous system
  • Muscle strength
  • Visual acuity
  • Vasoconstriction
  • Plasma volume
  • Oxygen carrying capacity
  • Blood glucose
  • Cardiac reserve
  • HR
  • Stroke volume

22
What is needed to avoid / limit injury?
  • Bone density
  • Intact coagulation cascade
  • Safe environment
  • Support system (family, EMS, etc…)

23
Medications Part of the solution, or part of the
problem?
  • Increased reliance upon medications
  • Increased access under Part D
  • Increased likelihood of interactions/adverse
    events
  • Increased complexity/difficulty in management

24
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25
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26
What do drugs affect?
  • Suitable environment
  • Voluntary nervous system
  • Muscle strength
  • Visual acuity
  • Vasoconstriction
  • Plasma volume
  • Oxygen carrying capacity
  • Blood glucose
  • Cardiac reserve
  • HR
  • Stroke volume

27
Voluntary Nervous System
  • Many drugs can impair ability to control
    voluntary movements
  • Alcohol
  • Benzodiazepines (e.g. lorazepam)
  • Sleep aides (e.g. Ambien)
  • Antipsychotics/antidepressants
  • Narcotics
  • Seizure/neuropathic pain medications (e.g.
    Neurontin)

28
Muscle Strength
  • Myopathy/myalgia/neuropathy
  • Drugs
  • Chronic corticosteroids
  • Cholesterol lowering agents
  • Zidovidine
  • Chemotherapeutic agents
  • Vitamin deficiencies

29
Visual Acuity
  • Anticholinergic agentsaccommodation
  • Antipsychotics retinal deposits
  • Digoxin halo
  • Antirheumatic drugs irreversible maculopathy
    (hydroxychloroquine)
  • Corticosteroids, allopurinol cataracts
  • Erectile dysfunction color changes

30
Vasoconstriction
  • Beta-blockers metoprolol, carvedilol, etc
  • Oral, Ophthalmic
  • Alpha blockers Doxazocin (Cardura),
  • Tamsulosin (Flomax)
  • Calcium channel blockers (amlodipine)
  • Vasodilators nitrates, hydralazine
  • Sloppy Drugs Antipsychotics, antidepressants,
    anticholinergics

31
Plasma Volume
  • Direct Diuretics
  • Loops Lasix (especially acute use)
  • Thiazides HCTZ
  • Caffeine, theophylline
  • Indirect
  • Vomiting
  • Diarrhea
  • Hyperglycemia
  • Sedation, decreased ambulation

32
Oxygen Carrying Capacity
  • Anemia Chemotherapy, HIV, antibiotics
  • Pulmonary toxicity
  • Amiodarone
  • Chemotherapy
  • NSAIDS, aspirin
  • Beta blockers

33
Blood Glucose
  • Hypoglycemics
  • Insulin
  • Sulfonylureas (e.g. glyburide)
  • Meglitinides (e.g. Prandin)
  • Byetta, Symlin
  • Stopping glucocorticoids

34
Cardiac Reserve
  • Heart rate/Contractility
  • Beta blockers
  • Calcium channel blockers
  • Amiodarone/antiarrhythmics
  • Digoxin

35
What DONT drugs affect?
  • Suitable environment
  • Voluntary nervous system
  • Muscle strength
  • Visual acuity
  • Vasoconstriction
  • Plasma volume
  • Oxygen carrying capacity
  • Blood glucose
  • Cardiac reserve
  • HR
  • Stroke volume

36
How might drugs affect degree of injury?
  • Bone density
  • Intact coagulation cascade
  • Safe environment
  • Support system (family, EMS, etc…)

37
Injury Due to Falls
  • Fracture
  • Chronic corticosteroids
  • Chronic/frequent heparin
  • Hemorrhage
  • Anticoagulants (heparin, warfarin)
  • Antiplatelet drugs (Plavix, aspirin)
  • Cognition/impaired request for assistance

38
Summary
  • Ambulation is an incredibly complex activity
  • Drugs can affect practically all physiological
    functions
  • Drugs can increase severity of sustained injuries
    and delay access to medical attention

39
Typical Home Care Patient
  • Recent index event
  • Multiple comorbidities
  • Cardiovascular disease
  • COPD
  • Diabetes
  • Neuropsychiatric illnesses
  • Multiple drugs
  • Variable environments and support systems

40
What can be done?
  • General
  • Staff training and awareness
  • Assessing patients for risk
  • Direct resources towards highest risk pts
  • Improve responsiveness

41
Steps to Medication Simplification
42
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43
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44
Remove Old/Expired Drugs
  • OR
  • Prepare the work environment

45
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46
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47
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48
Prepare the Work Environment
  • Take inventory- everything present
  • Double-check against orders
  • Necessary drug not ordered?
  • Overlooked drug contributing to problem?
  • Patient taking duplicative therapy
  • Old/expired- remove/discard
  • Unused- sequester

49
Prepare the Work Environment
  • Help patient develop orderly system for adherence
  • Physical location and arrangement
  • List with administration times
  • Electronic reminders

50
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51
Single (Good) Pharmacy
  • Do you know your pharmacist(s) by name?
  • Does your pharmacy deliver?
  • Are you satisfied with the time spent with you?
  • Are pharmacists helpful to you when you have a
    question or problem with your medications?
  • Would you consider using a different pharmacy if
    they offered better service to you?
  • Collect and share the data

52
Non-Drug Alternatives
  • Overactive bladder
  • Diabetes
  • Diuretics
  • Antihypertensives
  • Cholesterol
  • Laxatives
  • Vitamins
  • Weight loss drugs

53
Coordinate Doses with Established Daily Routine
  • Schedule day around meds, or vice versa?
  • Trouble makers require special attention
  • Diabetic drugs
  • Diuretics
  • Warfarin
  • Ask directly about drugs interfering with
  • quality of life

54
Long-acting/Sustained Release Products
  • Bisphosphonates (e.g. Fosamax)
  • Darbepoetin (Aranesp)
  • Metoprolol vs Toprol XL
  • Captopril TID vs Monopril QD?
  • MS-Contin vs. immediate release/prn
  • Patches (e.g. estrogen, clonidine)

55
Decrease Multiple Meds for Single Condition
  • Combination products
  • HIV regimens
  • Caduet (Lipitor Norvasc)
  • Glucovance (glyburide metformin)
  • Duoneb (albuterol Atrovent)
  • Vasoretic (enalapril HCTZ)
  • Olmesartan and Norvasc?

56
PolyPill!
New Zealand-India Collaboration for Super-Drug
Trial
In the next few months a New Zealand-led clinical
trial begins for a pill claimed by two British
researchers to have the potential for a greater
impact on the prevention of disease in the
Western world than any other known
intervention. All the medicines in the polypill
aspirin, a statin to lower cholesterol and two
blood pressure drugs are already widely used.
They are also no longer covered by patents, so
the polypill will be cheap to produce and at a
few dollars a month will be more affordable in
developing countries.
57
Discontinue/Substitute Cautionary Meds
  • Beers List
  • Propoxyphene (Darvocet)
  • Anticholinergic drugs
  • http//providers.ipro.org/index/presc-drug-plan
  • Cognitive impairment
  • Falls
  • Constipation
  • Inefficacy

58
Steps are important, but best not to walk alone….
59
Partner with…
  • Referring institutions
  • JCAHO and other accreditation standards focus
    heavily on medication reconciliation
  • Pay for performance rates affected by poor
    outcomes, complications, readmission rates
  • Administrators are encouraged to engage local
    institutions for collaboration

60
Partner with…
  • Community Pharmacies
  • Quality of clinical service vary widely
  • Competition is fierce
  • Expectations placed on them may be increasing
  • Medication measures
  • Automation
  • Recommend home care make concerted effort to
    engage them

61
Pharmacists Potential Impact for Polypharmacy
Patients in a Community Based Clinic
Pamela Foral, Pharm.D., BCPS Creighton
University School of Pharmacy Health
Professions and Alegent Health, Omaha, NE
N 110 patient 74 patients required
intervention 132 non-therapeutically altering
medication recommendations
62
Possible Approach to Community Pharmacy
  • Create list of specific needs for your patients
  • Delivery (CVS Delmar, e.g.)
  • Counseling/education
  • Check for duplicative therapies
  • Check for available combination products
  • Check for sustained release products
  • Check for non-drug alternatives
  • Check for potential problems/Beers meds
  • Assist with intervention as necessary

63
Plan for Monitoring Danger Drugs?
64
Possible Approach to Community Pharmacy
  • Consider the needs of the pharmacy
  • Clinical information (e.g. active med list,
    allergies, lab data, diagnoses)
  • Advanced warning/turnaround time for requests
  • Clinical intervention/evaluation
  • Inventory control/work flow
  • Reimbursement (MTM via Part D, e.g.)
  • OTC sales (medical supplies, e.g.)
  • Alerts to inpatient status

65
Possible Approach to Community Pharmacy
  • Organize formal dialogue
  • Pharmacy owners, district managers
  • VNA administration
  • Third parties
  • Insurers
  • Inpatient facilities
  • Academic institutions
  • IPRO
  • Start small, and expand upon successes

66
IPROs DADE Project
  • The DADE Project is being conducted by IPRO with
    approval and financial support from CMS
  • A large number of anticholinergic drugs are
    included in a list of medications considered
    potentially inappropriate for use in seniors
    (Beers List Medications)
  • Despite the designation, use of anticholinergics
    is still common
  • A growing body of evidence demonstrates harm
    associated with use of these agents

67
DADE Resources
  • Free CME for prescribers
  • Patient worksheet
  • Clinical tool for prescribers (pending)

http//providers.ipro.org/index/pres-drug-plan-pre
scribers
68
What can be done with medications?
  • Increase monitoring of necessary medications
  • Routinely as part of care plan
  • Upon initiation of any drug
  • Upon dose adjustment of any drugs
  • Upon withdrawal of any drugs

69
Increase monitoring of necessary medications
  • Assess Gait, cognition, vital signs including
    orthostatic blood pressures
  • Request (demand?) results of blood work
  • Barbituates, phenytoin
  • CBCs (anemia, thrombocytopenia)
  • Report any significant findings (e.g.
    hypoglycemia)

70
Reduce Risk of Harm
  • Bone strength
  • Bisphosphonates (e.g. Fosamax)
  • Calcium
  • Hemorrhage
  • Anticoagulation monitoring (INR)

71
Conclusion
  • Medications may contribute to falls and injury
  • Multiple steps needed
  • Screening/removal of inappropriate meds
  • Increased monitoring and reporting
  • Promote osteoporosis screening/treatment
  • Make use of all available MTM services (and ask
    for more!)

72
Points to Consider
  • What are some of the challenges (barriers)
    unique to YOUR agency?

73
Next Step
  • What are you going to do differently TOMORROW
    as a result of what you have learned today??

74
Contact Information
  • Darren Triller, PharmD
  • Director, Pharmacy Services
  • Phone 518-426-3300 ext. 125
  • Email dtriller_at_nyqio.sdps.org
  • Sara Butterfield , RN, BSN, CPHQ, CCM
  • Director
  • Phone 518-426-3300 ext. 104
  • Email sbutterfield_at_nyqio.sdps.org
  • This material was prepared by IPRO, the
    Medicare Quality Improvement Organization for New
    York State, under contract with the Centers for
    Medicare Medicaid Services, an agency of the
    U.S. Department of Health and Human Services.
    The contents do not necessarily reflect CMS
    policy. Publication Number 8SOW-NY-TSK1B-08-02.

75
This material was prepared by IPRO, the Medicare
Quality Improvement Organization for New York
State, under contract with the Centers for
Medicare Medicaid Services (CMS), an agency of
the U.S. Department of Health and Human Services.
The contents presented do not necessarily reflect
CMS policy. 8SOW-NY-TSK1D3-08-05
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