Patricia A. Keys, Pharm.D., C.G.P.Clinical Associate ProfessorMylan School of PharmacyDuquesne University

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.20112. Laroche et al. 2009

*Type A- Probable and predictable based on the drugs pharmacologic profile. Includes dose-related events. Ex. Insulin and hypoglycemia

Type B-unpredictable and unanticipated (ideosyncratic). Ex. Vioxx and C-V events

Allergic- immune-mediated reaction3. Wooten 2010.

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.

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

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

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.

Altered pharmacokinetics/pharmacodynamics in aging

Altered cognition- adherence problems

Sensory disabilities- vision, hearing, coordination

Social isolation in the community- caregiver support

Deliberate non-adherence- fears, finances, friends. (half of all drugs prescribed are not taken!!!!!!)

Interactions with OTC/herbal products

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

Fragmented health care/record keeping

Transitions in careManaged care- limited options for

extended care for poor without a skilled need.

Prospective reimbursementVolume of patients/ orders/ drugs-

nursing, pharmacies, physicians

1.Identify PIM’s and patient factors

2.Communicate to effect change

Criteria based- Beer’s List 6, STOPP-START criteria7

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 20127. Gallagher et al 2011

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

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

STOPP= Screening Tool of Older Persons Potentially Inappropriate Prescriptions (drug-drug, drug –disease interactions resulting in potential toxicity)

START= Screening Tool to Alert to Right Treatment (common prescribing omissions).

7. Beers List Expert Panel

National Electronic Injury Surveillance System-Cooperative 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 intervention8. Budnitz et al. 2007.

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

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/

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

? Clinically trained Pharmacists- targeted evaluation, multidisciplinary teams

?Physicians- consults by geriatricians, peer review prescribing

?****Systems

Electronic Medical Record (EMR)- access to full chart (labs, physical assessment)

Electronic Prescribing (CPOE)- computerized gero-focused informatics/decision support

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.