Drug Safety In The New Millennium

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Drug Safety In The New Millennium

• Darren M. Triller, PharmD
• Quality Improvement, IPRO

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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

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Can You Say Overrated?
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Miracles of Modern Medicine
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What are some of the most overrated modern drugs?
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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!

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Are you Runnin on Dunkin?
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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.
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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.
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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.
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Drugs as Cause of Harm
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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

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Risk vs. Benefit What are you trying to
accomplish?
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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

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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

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What is needed to avoid / limit injury?

• Bone density
• Intact coagulation cascade
• Safe environment
• Support system (family, EMS, etc)

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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

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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

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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)

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Muscle Strength

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

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Visual Acuity

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

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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

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Plasma Volume

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

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Oxygen Carrying Capacity

• Anemia Chemotherapy, HIV, antibiotics
• Pulmonary toxicity
• Amiodarone
• Chemotherapy
• NSAIDS, aspirin
• Beta blockers

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Blood Glucose

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

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Cardiac Reserve

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

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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

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How might drugs affect degree of injury?

• Bone density
• Intact coagulation cascade
• Safe environment
• Support system (family, EMS, etc)

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Injury Due to Falls

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

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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

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Typical Home Care Patient

• Recent index event
• Multiple comorbidities
• Cardiovascular disease
• COPD
• Diabetes
• Neuropsychiatric illnesses
• Multiple drugs
• Variable environments and support systems

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What can be done?

• General
• Staff training and awareness
• Assessing patients for risk
• Direct resources towards highest risk pts
• Improve responsiveness

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Steps to Medication Simplification
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Remove Old/Expired Drugs

• OR
• Prepare the work environment

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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

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Prepare the Work Environment

• Help patient develop orderly system for adherence
• Physical location and arrangement
• List with administration times
• Electronic reminders

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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

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Non-Drug Alternatives

• Overactive bladder
• Diabetes
• Diuretics
• Antihypertensives
• Cholesterol
• Laxatives
• Vitamins
• Weight loss drugs

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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

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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)

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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?

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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.
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Discontinue/Substitute Cautionary Meds

• Beers List
• Propoxyphene (Darvocet)
• Anticholinergic drugs
• http//providers.ipro.org/index/presc-drug-plan
• Cognitive impairment
• Falls
• Constipation
• Inefficacy

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Steps are important, but best not to walk alone.
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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

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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

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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
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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

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Plan for Monitoring Danger Drugs?
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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

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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

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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

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DADE Resources

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

http//providers.ipro.org/index/pres-drug-plan-pre
scribers
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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

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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)

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Reduce Risk of Harm

• Bone strength
• Bisphosphonates (e.g. Fosamax)
• Calcium
• Hemorrhage
• Anticoagulation monitoring (INR)

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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!)

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Points to Consider

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

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Next Step

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

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Contact Information

• Darren Triller, PharmD
• Director, Pharmacy Services
• Phone [phone] ext. 125
• Email dtriller_at_nyqio.sdps.org
• Sara Butterfield , RN, BSN, CPHQ, CCM
• Director
• Phone [phone] 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.

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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