Transcript Adverse Drug Reactions & Older Adults with Dr. Patricia Keys

Patricia A. Keys, Pharm.D., C.G.P.
Clinical Associate Professor
Mylan School of Pharmacy
Duquesne University
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Adverse Drug Event (ADE)- untoward and
unintended events rising from the use or misuse
of medication 1.
Potentially Inappropriate Medication(PIM)-a
drug for which the risk of an adverse event
outweighs the clinical benefit, particularly when
there is evidence in favor of a safer or more
effective alternative therapy for the same
condition 2.
1.Morandi et al.2011
2. Laroche et al. 2009
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*Type A- Probable and predictable based on
the drugs pharmacologic profile. Includes
dose-related events. Ex. Insulin and
hypoglycemia
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Type B-unpredictable and unanticipated
(ideosyncratic). Ex. Vioxx and C-V events
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Allergic- immune-mediated reaction
3. Wooten 2010.
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The science of ADR’s
Incorporates detection, assessment,
understanding and prevention of adverse
effects, particularly long-term and short-term
side effects of medicines.
Prospective consideration and rapid
recognition are key to reducing serious
adverse events.
3. Wooten 2010.
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ADE’s are the most common cause of preventable
non-surgical adverse events in medicine.
ADE’s are the 4th -6th leading cause of death in the
U.S.
3-24% of hospital admissions are due to ADE’s
30% of inpatients experience an ADE as an
unexpected complication of treatment.5
More than 180,000 severe or fatal ADE’s occur in the
elderly in the outpatient setting each year; ½ are
preventable. 4
4. Avorn and Shrank 2008.
5. Hohl et. al 2011
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ADE’s on average increase length of hospital
stay an average of 1.9-2.2 days.
Attributable cost (2008) per event estimated
at $3034-$4352.
Extrapolated national inpatient costs
estimated at $2.2- 5.6 billion annually (2008)
based on 1.5 million hospital days.
5. Hohl et al 2011
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Absence of “frail elderly” in controlled trials=
“therapeutic orphans”.
Health care providers’ formal
education/training in geriatrics is often
limited
Stereotypes of aging– “missing the target”
Polypharmacy- multiple doctors, multiple
drugs= increased statistical probability.
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Altered pharmacokinetics/pharmacodynamics in
aging
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Altered cognition- adherence problems
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Sensory disabilities- vision, hearing, coordination
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Social isolation in the community- caregiver support
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Deliberate non-adherence- fears, finances, friends.
(half of all drugs prescribed are not taken!!!!!!)
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Interactions with OTC/herbal products
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One pharmacy, one pharmacist
Shared decision -making for optimal
adherence
Caregiver support/education
Avoid mail order
Assistive devices -cell phone alarms, apps
Pill containers/labeling
Reassess patient’s medication regimen at
least twice yearly
Individualized medication education-MTM
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Fragmented health care/record keeping
Transitions in care
Managed care- limited options for extended
care for poor without a skilled need.
Prospective reimbursement
Volume of patients/ orders/ drugs- nursing,
pharmacies, physicians
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1.Identify PIM’s and patient factors
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2.Communicate to effect change
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Criteria based- Beer’s List 6, STOPP-START
criteria7
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Data driven- Based on frequency of
significant problems seen, identify highest
risk offending drugs and target prevention
strategies there
6. Beers List Panel of Experts 2012
7. Gallagher et al 2011
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Explicit criteria- identify high-risk drugs
using a list of PIM’s identified and reviewed
by a panel of experts as having an
unfavorable risk: benefit profile considering
alternative treatments available
Implicit criteria- understood; identify high
risk drugs on the basis of a single trained
evaluator’s experience, on a per patient basis.
6. Beers List Expert Panel 2012
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Third revision
Partnership with the American Geriatrics Society.
Expert Consensus Panel- Geriatricians,
pharmacists, nurses.
Categorize PIMs into two categories- medications
to avoid in all individuals age 65 and older; and
medications considered inappropriate when used
by older adults with certain diseases or
syndromes.
Applicable to patients in any setting
6. Beers List Expert Panel 2012
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STOPP= Screening Tool of Older Persons
Potentially Inappropriate Prescriptions (drugdrug, drug –disease interactions resulting in
potential toxicity)
START= Screening Tool to Alert to Right
Treatment (common prescribing omissions).
7. Beers List Expert Panel
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National Electronic Injury Surveillance SystemCooperative ADE Surveillance Project 2007-2009
2/3 of ADR’s presenting in elderly ER patients
that resulted in hospital admission were due to
four drug classes, alone or in combination:
Warfarin 33.3%,Insulins 13.9%,oral antiplatelet
agents 13.3%,oral hypoglycemics 10.7%.
Other “high risk” drugs ave. 1.2%
Advocates targeted intervention
8. Budnitz et al. 2007.
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Anticoagulants- bleeding/thrombosis
Antibiotics- c diff diarrhea, antimicrobial
resistance, toxicity
Antiarrhythmics (esp. digoxin)- toxicity
Anticonvulsants- toxicity
Premise: Close monitoring reduces ADE’s and
contains unnecessary costs
ADVANTAGES
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Greatest “bang for the
buck”- screen LARGE #’s of
patients
Provides potentially
immediate feedback to
prescribers either when the
order is written, or
Allows orders to be
changed by pharmacists
per protocol upon review
or prior to dispensing.
DISADVANTAGES/
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Expense of
purchasing/developing
software
Software options require
EMR/ CPOE
“Alert fatigue”
Only as good as the people
who write the program
Continuous quality
improvement- time and
$$$ (educate and train)
QUESTION: WHO SHOULD DO IT AND HOW
SHOULD IT BE DONE
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? Clinically trained Pharmacists- targeted
evaluation, multidisciplinary teams
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?Physicians- consults by geriatricians, peer
review prescribing
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?****Systems
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Electronic Medical Record (EMR)- access to
full chart (labs, physical assessment)
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Electronic Prescribing (CPOE)- computerized
gero-focused informatics/decision support
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Protocols (approved by Pharmacy and
Therapeutics Committees) for changing
orders to prevent problems.
“Once recognized, a side effect of a drug is
probably the single most reversible affliction
in all of geriatric medicine”.3
“Any new symptom in an older patient must be
considered to be a possible drug side effect
until proven otherwise.” 4
“Statistics are only true if it happens to the
other guy; if it happens to me- it’s 100%”3
4Avorn and Shrank 2008.
3 Wooten. 2010
1. Morandi A, Vasilevskis EE, Pandharipande PP, et al. Inappropriate medications in elderly
ICU survivors: Where to intervene? Arch Intern Med. 2011;171(11):1032-1034.
2. Laroche ML, Charmes JP, Bouthier F, Merle L. Inappropriate medications in the elderly.
Clin Pharmacol Ther. 2009;85(1):94-97..
3. Wooten JM. Adverse drug reactions: Part I. South Med J. 2010;103(10):1025-8; quiz
1029.
4. Avorn J, Shrank WH. Adverse drug reactions in elderly people: A substantial cause of
preventable illness. BMJ. 2008;336(7650):956-957.
5. Hohl CM, Nosyk B, Kuramoto L, et al. Outcomes of emergency department patients
presenting with adverse drug events. Ann Emerg Med. 2011;58(3):270-279.e4.
6. American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American
Geriatrics Society Updated Beer’s Criteria for Potentially Inappropriate Medication Use in
Older Adults. J AmerGerSoc 2012;1-16.
7. Gallagher PF, O’Connor MN, O’Mahoney D. Prevention of potentially inappropriate
prescribing for elderly patients: A randomized controlled trial using STOPP/START criteria.
Clin Pharmacol Ther 2011;89(6); 845-854.
8. Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for
adverse drug events in older americans. N Engl J Med. 2011;365(21):2002-2012.