Patricia A. Keys, Pharm.D., C.G.P. Clinical Associate Professor Mylan School of Pharmacy Duquesne 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 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 reaction 3. 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 4 th -6 th 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 Avorn and Shrank Hohl et. al 2011

 ADE’s on average increase length of hospital stay an average of days.  Attributable cost (2008) per event estimated at $3034-$4352.  Extrapolated national inpatient costs estimated at $ 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 care  Managed care- limited options for extended care for poor without a skilled need.  Prospective reimbursement  Volume 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 criteria 7  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 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  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

 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 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): Laroche ML, Charmes JP, Bouthier F, Merle L. Inappropriate medications in the elderly. Clin Pharmacol Ther. 2009;85(1): Wooten JM. Adverse drug reactions: Part I. South Med J. 2010;103(10):1025-8; quiz Avorn J, Shrank WH. Adverse drug reactions in elderly people: A substantial cause of preventable illness. BMJ. 2008;336(7650): Hohl CM, Nosyk B, Kuramoto L, et al. Outcomes of emergency department patients presenting with adverse drug events. Ann Emerg Med. 2011;58(3): 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; 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); Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older americans. N Engl J Med. 2011;365(21):