1/24/2016. Continued. Objectives: Typical referral: 74 year old male with nausea/vomiting/diarrhea/weight loss

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1 A typical day for the pharmacist without a pharmacy at the University of Utah Sugarhouse Clinic. Updates for Safe Medication Use in Older Adults Karen Gunning, Pharm.D, BCPS, BCACP, FCCP Professor and Chair (Interim) of Pharmacotherapy Adjunct Professor of Family & Preventive Medicine University of Utah College of Pharmacy & School of Medicine Consulting about drug dosing in family medicine pts Working with residents to develop drug therapy plans in complicated chronic disease management patients Managing drug therapy for Type 2 diabetes patients, hypertension, hyperlipidemia, smoking cessation, asthma via collaborative practice agreements Medication reconciliation of patients who experience a transition in care (inpt outpt, NH outpt, NH ALF etc) Previsit planning via medication refill protocol On the fly teaching of patients, residents, attending and clinic staff regarding medication issue. Typical referral: 74 year old male with nausea/vomiting/diarrhea/weight loss PMH: CKD on dialysis, Afib s/p ablation, anemia, GERD, hyperthyroidism, hyperlipidemia, hypertension, colon cancer. Meds: Amiodarone, warfarin, simvastatin, omeprazole, ranitidine, prochlorperazine, ondansetron, bumetanide, amlodipine, venofer, aranesp, calcium carbonate, vitamin d, zemplar, oxycodone/apap, MVI, glucosamine. Labs: TC 98, LDL 40, HDL 47, INR 2.5, creatinine 5.6, sodium 132 (BMP otherwise wnl), TSH < 0.003, T4 = Vitals: 118/64, HR 82, Wt 146 (down 9 lbs in 2 months) Care: PCP, Cardiology, Endocrine, Nephrology, GI, Oncology, and two different hospitals in two different systems. Issues: Methimazole stopped 6/2011 by endocrine, cardiology d/c amiodarone and suggested d/c of warfarin if nephrology agreed. Was admitted to the hospital and amiodarone was restarted becuause they thought pt was taking, and did not d/c warfarin. Continued. Review of all records by clinical pharmacist Pt d/c d simvastatin, amiodarone, and warfarin as per various specialists Pt s methimazole restarted Effect on patient symptoms positive. Objectives: Recognize important updates in potentially inappropriate medications for older adults since the most recent BEERS list was published. Assess medication use for prevention in older patients and understand time to benefit. Use shared decision making to help patients and caregivers weigh risks vs. benefits of medication therapy. Evaluate and apply evidence associated with medication discontinuation in older adults 1

2 Polypharmacy Not just many drugs - Hyperpharmacotherapy the prescription, administration, or use of more medications than are clinically indicated in a given patient Polypharmacy can occur in a patient on one drug Polypharmacy or Hyperpharmacotherapy? Use of several medications at the same time Use of medications in doses or for time periods longer than are known to be effective Using medications that are non-essential for treating a medical problem. Non-compliance or under/over compliance Patient/doctor miscommunication Use of over the counter, expired, or another person s medication How does this happen? More than one doctor, hospital, health system, EMR***** More than one pharmacy More than one chronic disease OTC s, dietary supplements Med sharing/trading Non-compliance or under/over compliance Patient/doctor/pharmacy/caregiver miscommunication Add aging to the mix Pharmacodynamic and pharmacokinetic changes occur with age Altered drug absorption, distribution, metabolism, elimination (ADME) = pharmacokinetics Altered relationship of drug at receptor = pharmacodynamics PLUS cognitive decline Another question. Is the medication intended to treat the side effect of another medication? Stimulants to treat drug induced sedation Sedatives to treat drug induced excitation Antiemetics to treat drug induced nausea Antitussives to treat drug induced cough Chronic acid suppression to treat GI issues caused by NSAIDs Overview Updates to BEERs Criteria Chronic Disease Management Therapy Goals for Older Adults Shared Decision Making Medication Discontinuation 2

3 BEERs List Overview Written by the American Geriatrics Society (AGS) Broken down into 3 sections: Potentially inappropriate medications (PIMS) and classes to avoid in older adults Potentially inappropriate medications and classes to avoid in older adults with certain diseases and syndromes that the drugs listed can exacerbate the disease or syndrome Medications to be used with caution in older adults 2 components added in 2015: renal drug dosing, and drug/drug interactions. Not applicable to patients in palliative or hospice care igeriatrics available in the app store Beers 2015 Changes: Potentially Inappropriate Medications Avoid nitrofurantoin if creatinine clearance is < 30 ml/min (to be used acute use only) Avoid use of z sleeping drugs (eszopiclone, zaleplon and zolpidem) regardless of duration of use. Avoid sliding scale insulin Avoid use of proton pump inhibitors beyond 8 weeks. Cautious use of selected antiarrhythmic agents in patients with A Fib may be appropriate depending on comorbind conditions Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults JAGS; 2015: Beers List 2015: Commonly Encountered PIM s Diphenhydramine, meclizine, hydroxyzine Benztropine Nitrofurantoin Dronederone, digoxin, amiodarone TCA s, Benzodiazepines, butalbital, carisoprodol and all muscle relaxants, first and second generation antipsychotics Testosterone (except with confirmed hypogonadism with clinical symptoms) Desiccated thyroid Systemic estrogens/progestins Megestrol acetate Glyburide NSAIDs, especially ketorolac and indomethacin Commonly Encountered Drug/Disease PIM s Disease/Conditions Falls/Fractures Cognitive impairment Delirium Heart Failure CKD PIM Opioids, all sleepers Z sleepers Atypical antipsychotics, H2 Blockers, anticholinergics NSAIDs, Diltiazem/Verapamil, Glitazones NSAIDs Drugs to be used with caution in older adults: Commonly encountered agents Aspirin for primary prevention No data on benefit in those > 80 years old. Risk increases with age Dabigatran Bleeding risk increased if age > 75, and anyone with CRCL < 30 ml/min Prasugrel Bleeding risk increased if age > 75 Antipsychotics, diuretics, carbamazepine, mirtazapine, oxcarbazepine, SNRI, SSRI, TCA Significant risk of hyponatremia New for 2015: Significant Drug/Drug Interactions in Older Adults Drug Drug Interaction ACEI Triamterene Hyperkalemia Antipsychotics >2 other CNS active Increased risk of falls Antidepressants Anticholinergics Benzodiazepines Opioids Steroids NSAID GI bleeds Warfarin Amiodarone Risk of bleeding NSAIDS 3

4 New for 2015: Commonly encountered issues in medication use and kidney function Medication CRCL Recommendation Apixaban <25 Avoid Enoxaparin <30 Reduce dose Rivaroxaban <30 Avoid (reduce dose 30 50) Spironolactone <30 Avoid Duloxetine <30 Avoid Gabapentin <60 Reduce dose Pregabalin < 60 Reduce dose Tramadol <30 Reduce dose (IR), Avoid (ER) H2 blockers <50 Reduce dose Colchicine <30 Reduce dose OTC Medications to avoid You told me I couldn t take Benadryl so I bought this the name is long and starts with a D Diphenhydramine Many combination and similar products Risks: confusion, dry mouth, constipation, dizziness, falls, urinary retention clearance reduced in older adults NSAIDs (ibuprofen, naproxen) Risks: gastrointestinal bleeding, increased risk of kidney injury JAGS 2012: Beers Criteria Insurance Rejections: Case in point Citalopram (Celexa) FDA warning in 2011 Citalopram causes dose dependent QT interval prolongation. FDA Recommendation: No one should receive doses >40 mg daily Adults over 60 years should not receive doses >20 mg daily HEDIS Measures HEDIS is Healthcare Effectiveness Data and Information Set Tool used by more than 90% of health plans to measure performance on important dimensions of care and service Total of 81 measures to help compare the performance of health plans Medicare Medication Management Measure: Medicare Members 65 years and older who received at least one prescription for a drug with high risk of side effects in the elderly Recommendation: Review medication history for high risk medication in the elderly and consider alternative therapy choices FDA/safety Donohue JM, et al. Am J Manag Care 2013 Choosing Wisely Don t prescribe a medication without conducting a drug regimen review. Antipsychotics Choosing Wisely: Don t use antipsychotics as first choice to treat behavioral psychological symptoms of dementia BEERs Criteria: AVOID for behavioral problems of dementia unless non pharmacological options have failed Reasoning: increased risk of cerebrovascular accident (stroke) and mortality (DEATH) in persons with dementia AGS JAGS 2012: Beers Criteria AGS 4

5 Antipsychotics JAMA Maust, et al. March 2015 Aim to determine absolute mortality risk Medication Mortality Risk Compared to NON USERS Number needed to Harm Haloperidol 3.8% (95% CI %) P< Risperidone 3.7% (95% CI %) P< Olanzapine 2.5% (95% CI 0.3% P= %) Quetiapine 2.0% (95% CI %) P< Antipsychotics JAMA Maust, et al. March 2015 Aim to determine absolute mortality risk Medication Mortality Risk Compared to ANTIDEPRESSANT USERS Number needed to Harm Haloperidol 12.3% (95% CI %) P< Quetiapine 3.2% (95% CI %) P< Does dose matter? YES High dose haloperidol equivalent group had significantly increased mortality over low dose haloperidol equivalent group 3.5% (95% CI %, p=0.02, NNH 29) Maust. D et al. JAMA Psychiatry 2015 Maust. D et al. JAMA Psychiatry 2015 Antipsychotics JAMA Maust, et al. March 2015 Conclusion: Atypical antipsychotics (group) have 3.5% greater mortality ( %, p=0.02) Absolute effect on mortality in elderly patients with dementia may be HIGHER than previously reported and INCREASES with DOSE. Benzodiazepines Choosing Wisely: Don t use benzodiazepines or other sedative hypnotics in older adults as first choice for insomnia, agitation or delirium. BEERs Criteria: Older adults have increased sensitivity to benzodiazepines AVOID for treatment of insomnia, agitation, delirium Increased risk of cognitive impairment, delirium, falls, fractures, and motor vehicle accidents Appropriate for seizure disorders, REM sleep disorders, ethanol/benzodiazepine withdrawal, severe generalized anxiety disorder, peri procedural anesthesia, and end oflife care Maust. D et al. JAMA Psychiatry 2015 JAGS 2012: Beers Criteria AGS Changing Goals Pharmacist Objective #2 & #3 Diabetes Choosing Wisely: Avoid using medications to achieve hemoglobin A1c <7.5% in most adults age 65 and older; moderate control is generally better. BEERs Criteria: avoid sliding scale insulin and glyburide JAGS 2012: Beers Criteria AGS ADA: Diabetes Care 2015 Reasonable A1c Life expectation target goal 7 7.5% Healthy older adults with long life expectancy 7.5 8% Older adults with moderate comorbidity and a life expectancy < 10 years 8 9% Older adults with multiple morbidities and shorter life expectancy 5

6 American Diabetes Association (ADA) 2015 Hyperlipidemia AHA/ACC 2013 Guideline focus ages years >70 years Recommendations: Clinical ASCVD: > 70 years it is reasonable to evaluate the potential for ASCVD risk reduction benefits and for adverse effects, drug drug interactions, and to consider patient preferences. [Expert Opinion] Moderate high intensity statin Diabetes: If > 75 years of age, it is reasonable to evaluate [Expert Opinion] Evidence supports to continue statin therapy over the age of 75 years if the patient was previously taking and is tolerating the medication ADA: Diabetes Care 2015 Stone NJ, et al. ACC/AHA 2013 Blood Cholesterol Guideline American Diabetes Association (ADA) 2015 ADA: Diabetes Care 2015 Dementia Choosing Wisely: Don t prescribe cholinesterase inhibitors for dementia without periodic assessment for perceived cognitive benefits and adverse gastrointestinal effects. Cholinesterase inhibitors modest benefits in delaying cognitive and functional decline and decreasing neuropsychiatric symptoms Impact on institutionalization, quality of life, and caregiver burden are less well established Recommendation: If goals of treatment are not attained after a reasonable trial (12 weeks) then consider discontinuing the medication. Benefits > 1 year have not been investigated AGS Evaluating Medications in the Older Adult AGS Approach to Multimorbidity What is the patient s (and/or family member s) primary concern? Conduct a complete review of care plan OR focus on specific aspect of care Identify current medical conditions and interventions. Is there adherence/comfort with the care plan? Consider patient preferences. Is relevant evidence available regarding outcomes? Consider prognosis. AGS Expert Panel Multimorbidity JAGS

7 AGS Approach to Multimorbidity Consider interactions among treatment and conditions. Weigh benefits and harms of treatment plan Communicate and decide for or against implementation or continuation of intervention/treatment Guidelines Guidelines combine research studies and put them into systematic review what is the estimated treatment effect? Globalize the evidence but localize the recommendation Use guidelines but individualize to your patient Reassess at selected intervals for benefit, feasibility, adherence, and alignment with preferences AGS Expert Panel Multimorbidity JAGS Medication Discontinuation When to say when DEprescribing Consider 4 questions: What is the patient s life expectancy? What is the known or estimated time to benefit of the medication? What are the goals of care? (patient/family goals) What is the treatment target? (outcomes) Holmes HM et al. Arch Int Med 2006;166: Four Steps of Medication Decision Making Looking at polypharmacy from the other side.. Less Time More Time Appropriate Medications Palliative Curative Arch Int Med 2006:166:606 Consider discontinuation as being as important as appropriate prescribing. Indicators for discontinuation: Diminished benefit Is medication still needed? Increased risk Does a new diagnosis make medication risky? Patient/family goals JAGS 2008;56:

8 The Deprescribing Process 5 steps 1. Medication list indications for each medication 2. Overall risk of drug induced harm 3. Assessment of each drug regarding current/future harm/benefit potential 4. Prioritize drugs for discontinuation those with the lowest benefit/greatest harm, or those with the lowest likelihood of harm with discontinuation. 5. Implement discontinuation and monitor patient closely Evidence into practice: Study of a systematic approach for medication discontinuation in older adults Evaluated 75 patients in a comprehensive geriatric assessment clinic for medication discontinuation using the Good Palliative Geriatric Practice algorithm (GP GP) 5 pts had life expectancy < 3 months excluded 6 did not meet criteria for d/c 64 patients had at least 1 med d/c d Mean age: 82.8 years Followed up for outcomes for a mean of 19.2 months Scott IA et al. JAMA Internal Med published online Arch Int Med 2010;170: GP GP Process Stop drug: Indication not valid/relevant at pt s age/disability level Known possible adverse reactions outweigh benefits Shift to another drug: Pt has adverse effects that might be related to drug & there is another drug that may be superior to the one in question Reduce dose: If the dosing can be reduced with no significant risk or loss of benefit Keep drug: If an evidence based consensus exists for using the drug for the indication at the current dose in the age group and disability level of the patient and the benefit outweighs all the possible known side effects. Arch Int Med 2010;170: Discontinuation: results 4.9 drugs recommended to be discontinued per pt Only 6 of 64 patients did not want to d/c meds 42 discontinued all meds suggested only 6/256 drugs were restarted in all of these pts Top 5 drug d/c: antihypertensives, nitrates, aspirin, statins, benzodiazepines Only 1 event thought to be contributed to by the drug d/c (DVT in a pt with warfarin for afib discontinued. Prescriber Barriers & Enablers to Deprescribing A Systematic Review Barriers Awareness Lack of agreement between beliefs/practice Inertia Fear change, perceive stopping is difficult other md is responsible Self Efficacy Skill/knowledge gaps Feasibility Time/effort Regulatory issues Patient issues Enablers Awareness Process of review/feedback Inertia Fear of adverse effects/harm Stopping = beneficial Self Efficacy Confident communication with patient/specialists Feasibility Time/effort Regulatory issues Patient issues Patient Barriers & Enablers to Deprescribing A Systematic Review Barriers: Disagreeing with the appropriateness of medication cessation, hope for future benefits, and psychological benefits process (PCP time). influences of physician/family/friends. fear non specific fears about stopping, fear of condition recurring, fear of withdrawal Enablers Agreeing with the appropriateness of medication cessation side effects, feeling that the medication is no longer necessary and lack of efficacy. process including md follow up, and knowing restart is possible. dislike not wanting to be on meds, being more in control, inconvenience, cost. Anderson K et al BMJ Open Dec 8;4(12):e Reeve Eet al Drugs Aging 2013; 30(10):

9 Keys to Deprescribing Ways to Simplify Understanding why. Having a clear process for cessation with support, monitoring and follow up Alignment with patient goals for medication therapy Prioritize a set of universal health outcomes Living as long as possible Maintaining function Alleviated pain and other symptoms Consider individual treatments in the patients likelihood of achieving the patient s most desired outcome or avoiding the least desired outcome Reeve E et al Drugs Aging 2013; 30(10): Reeve E et al JAGS 2013; 61: AGS Expert Panel Multimorbidity JAGS 2012 Shared Decision Making a fancy word to describe a CONVERSATION. Victor Montori, MD, MSc Professor at Mayo Clinic Shared Decision Making the process of interacting with patients who wish to be involved in arriving at an informed, values based choice among two or more medically reasonable alternatives The Clinician The Patient Shared Decision Making Information O Connor, et al. IHI 2004 Shared Decision Making 1. Invite patient to participate 2. Present options 3. Provide information on benefits/risks 4. Assist patient in evaluating options based on THEIR goals and concerns 5. Facilitate decision making 6. Assist with implementation Osteoporosis Bisphosphonate therapy what is the benefit? Reduced risk of osteoporotic fractures, including devastating hip and spine fractures Ott, CC J Med 2011 Erviti JAMA

10 Osteoporosis Bisphosphonate therapy what is the risk? Atypical fractures, rate increases > 5 years of therapy Renal dysfunction increases risk contraindicated CrCl<35 ml/min Complicated administration (once weekly, empty stomach, 8 oz of water, upright, 30 min before food) Osteonecrosis of jaw Abdominal problems (heartburn, nausea, pain) Cost $4 month up to $90 per month Osteoporosis Example Ott, CC J Med 2011 Erviti JAMA 2006 Mayo Clinic AFib/Anticoagulation Example Diabetes Example NICE 2009 Mayo Clinic One Size does NOT fit all Constipation vs anticoagulation Resources AGS Expert Panel Multimorbidity JAGS

11 Resources Choosing Wisely ( IHI clinic shareddecisions.mayoclinic.org 64 health care provider organizations have developed lists of Things Physicians and Providers Should Question Top 5 list of specific, evidence based recommendations provider and patients should discuss together in order to make wise decisions about the most appropriate care based on their individual situation AHRQ 11