High risk medications in the elderly/ Beers criteria updates

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1 High risk medications in the elderly/ Beers criteria updates Date- 9/9/2016 Matt Just, Pharm.D., CGP and Jordan Wolf, Pharm.D., CGP Thrifty White Pharmacy Wi-fi Information: NETWORK: EC-CTR PASSWORD: westgate252 Disclosure Matt and Jordan report no actual or potential conflicts of interest associated with this presentation 1

2 Learning Objectives Upon successful completion of this activity, pharmacists should be able to: Discuss physiological changes associated with aging How they affect pharmacokinetics and pharmacodynamics of medications Identify specific medications considered to be high risk in the elderly and understand the implications of using those medications in elderly patients Discuss alternatives for High Risk Medications in elderly patients Outline Pharmacokinetic and pharmacodynamics changes in elderly High Risk Medications/Potentially Inappropriate Medications in the Elderly 2015 Beers Criteria Updates Alternative Approaches to High Risk Medications in the Elderly Summary: How to avoid adverse effects in elderly patients Resources Appendices Why is this important? The population is aging quickly Average US life expectancy is 77.5 years, vs 49.2 years at the beginning of the 20 th century Baby boomer generation is getting older >75 year old is the fastest growing patient population right now Elderly patients generally have more than one disease state Prescribed more medications than non-elderly people Polypharmacy is common Multiple prescribers complicate med regimen Many new medications are not studied in this population 2

3 Physiological Changes Affecting Pharmacokinetics and pharmacodynamics Decreased renal function Decreased hepatic function Lower muscle mass Decreased gastric motility Absorption Reduced gastric motility Results in increased drug absorption Reduced blood flow Reduced drug absorption Decreased gastric acid secretion Elevated gastric ph Additive effect from chronic PPI use seen in many geriatric patients Can cause reduced drug absorption Swallowing difficulties, poor nutrition, dependence on feeding tubes can also influence absorption Distribution Decreased muscle mass, increase in body fat, decreased total body water Fat soluble drugs will have greater volume of distribution (Vd) Ex: benzodiazepines Vd may be reduced for water-soluble drugs Ex: digoxin, atenolol, lithium, hydrochlorothiazide Less albumin production Reduced protein binding [see Appendix A for highly protein-bound drugs] Increased free drug concentration of drugs that are highly protein bound Phenytoin, warfarin, naproxen 3

4 Metabolism Decreased hepatic function Reduced blood flow Decreased liver mass Reduced intrinsic metabolic activity including CYP enzymes Results in decreased first pass metabolism Ex: beta blockers, CCB, opioids See Appendix B for drugs with impaired hepatic metabolism in elderly Excretion Decreased renal function (50% decrease from age 25 to 85) Reduced blood flow Decreased kidney mass Reduction in the size and number of functioning nephrons See Appendix C for drugs with age-related reductions in renal excretion Serum creatinine Not great by itself to measure kidney function Decreased muscle mass in elderly results in decreased SCr Better to use creatinine clearance Pharmacodynamic changes Elderly patients are more likely to experience significant adverse effects from medications Ex: orthostatic hypotension, drowsiness, confusion Receptors change as we age Number of receptors and sensitivity Homeostatic mechanisms are less stable See Appendix D for altered PD of drugs in elderly 4

5 Blood pressure management Concern for orthostatic hypotension and hypotension in general Low BP may be more dangerous than high BP. 150/90 mmhg may be a reasonable BP goal Why? The risk of orthostatic hypotension, bradycardia, and falls may outweigh the benefits of tight blood pressure control in elderly patients who are more susceptible to the effects of blood pressure medications. Always monitor blood pressure and adjust doses as needed Anticholinergic properties Side effect toxidrome Hot as a hare [increased body temperature] Blind as a bat [mydriasis] Dry as a bone [dry mouth, dry eyes, decreased sweat] Red as a beet [flushed face] Mad as a hatter [delirium] Anticholinergic properties Table 7 of 2015 Beers Criteria 5

6 Medications and Falls Over 30% of patients over 65 years old who live in the community fall each year Even higher percent in institutionalized patients Falling can lead to complications such as bone fracture, bleeding or brain injury Falls associated with medications can be caused by: orthostatic hypotension, dizziness, sedation, confusion/ delirium, impairment of motor function, slowed response rate Practitioners should be assessing for falls yearly High Risk Medications in the Elderly Potentially inappropriate Medications (PIMs) PIMS have found to be associated with poor health outcomes i.e. confusion, falls, mortality, etc. Recognizing and avoiding these medications can help to decrease the risk for Adverse Events Not an absolute contraindication for use in these patients, but they should be used with caution! High Risk Medications in the Elderly Multiple Resources Exist Which Identify High Risk Medications 2015 Updates to Beer s Criteria STOPP/START Criteria The Pharmacy Quality Alliance (PQA) and CMS Have Identified High Risk Medication Lists Many Third Party Payers have identified their own lists of High Risk Medications* 6

7 STOPP/START STOPP (Screening Tool of Older Persons Potentially Inappropriate Prescriptions) START (Screening Tool to Alert doctors to Right Treatments) Developed in Europe in 2008 Updated in 2015 to include drugs affecting or being affected by renal function Beers Criteria: 2015 Updates Updates Released October 8 th, 2016 Expert panel reviewed 6,700 clinical trials and research studies from a pool of 20,000 articles published since their 2012 revision Specific aim to update the 2012 AGS Beers Criteria using a comprehensive, systematic review and grading of evidence on drug-related problems and adverse drug events in older adults Beers criteria 2015: Disclaimers Target Audience: Practicing Clinicians Intended for use in all ambulatory, acute, and institutionalized care settings for populations aged 65 and older in the US Exception: Hospice and Palliative Care Patients See Document How to Use the American Geriatrics Society 2015 Beers Criteria A Guide for Patients, Clinicians, Health Systems, and Payors 7

8 Beers criteria 2015: What Changed? Added Separate Guidance on avoiding 13 combinations known to cause significant harmful drug-drug interactions Added a list of medications to avoid based on Renal Function Added Three new medications and two new medication classes Removed several medications Modified recommendations for several medications from the 2012 Beers Criteria Noteworthy Changes to Beers Criteria Previous recommendation to avoid anti-infective Nitrofurantoin in individuals with a CrCl <60mL/min changed Now states to avoid in CrCl <30mL/min NOTE: Long-term use of Nitrofurantoin for suppression should still be avoided due to concerns of irreversible pulmonary fibrosis, liver toxicities, and peripheral neuropathy Non-benzodiazepine, benzodiazepine receptor agonist hypnotics ( Z Drugs ) should be avoided without consideration of duration of use because of their association with harms balanced with minimal efficacy at treating insomnia Noteworthy Changes to Beers Criteria Removed Recommendation to avoid antiarrhythmic drugs as firstline treatment for atrial fibrillation evidence and guidelines suggest that rhythm control can have outcomes as good or better than rate control Exceptions: Amiodarone still to be avoided as first-line therapy for A-Fib unless individual has Heart Failure with substantial left Ventricular Hypertrophy Dronedarone to be avoided in individuals with permanent A-Fib or with severe or recently decompensated Heart Failure Disopyramide should be avoided because it is highly anticholinergic Digoxin should be avoided as first-line therapy for A-Fib or Heart Failure and should not be prescribed in daily doses greater than 0.125mg (125mcg)/day for any indication 8

9 Additions to 2015 beers criteria Proton Pump Inhibitors Avoid Scheduled use for > 8 weeks unless: Oral Corticosteroid or Chronic NSAID use Erosive Esophagitis Barrett s Esophagus Pathalogical Hypersecretory Condition Demonstrated need for maintenance treatment (i.e. Due to failure of drug discontinuation trial or H2 Blockers) Alternatives: H2-Blockers, PRN Antacids Antipsychotics 2015 Update: Antipsychotics should be avoided as first-line treatment of delirium because of conflicting evidence of efficacy and significant potential for adverse effects Falls, Sedation, psychomotor slowing, extrapyramidal effects, orthostasis 2015 Updates: Avoid taking 3 or more concomitant CNS medications due to fall risk May be indicated if nonpharmacological options have failed AND the older adult is threatening substantial harm to self or others When indicated, recommend lowest dose for shortest duration Special Considerations: With parkinsonism: low dose of clozapine or quetiapine With epilepsy: risperidone or haloperidol as alternatives 9

10 Benzodiazepines Long-acting: chlordiazepoxide, clorazepate, diazepam, flurazepam, nitrazepam Shorter-acting: alprazolam, lorazepam, oxazepam, temazepam Associated with Cognitive Impairment, Delirium, Falls, Fractures, Sedation, Confusion, Etc. Alternatives: If patient is on a long-acting agent, switch to short-acting benzo For anxiety: recommend SSRI, SNRI, buspirone as alternatives For sleep: recommend non-drug therapy or alternative med (i.e. Trazodone, Remeron) Tricyclic antidepressants Amitriptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline Highly Anticholinergic, Sedating, Cognitive Impairment, Causes Orthostatic Hypotension Alternatives For depression: Trazodone, SSRI, bupropion, mirtazapine For neuropathic pain: SNRI, gabapentin, topical products (lidocaine, capsaicin) First generation antihistamines Brompheniramine, chlorpheniramine, clemastine, diphenhydramine, doxylamine, hydroxyzine, meclizine, promethazine Highly anticholinergic, clearance decreases with age, tolerance develops when used as hypnotic Note: short-term use of diphenhydramine in allergic reactions may be appropriate in some patients Alternatives: Nasal sprays [normal saline or steroid], Second generation antihistamines Avoiding triggers 10

11 Blood pressure/cv meds Peripheral alpha-1 blockers (doxazosin, prazosin, terazosin ) Dilatory effects are non-specific and can affect the vasculature and cause orthostatic hypotension Avoid use as an antihypertensive Alternatives: Tamsulosin (Prostate-specific), 5-alpha reductase inhibitor (finasteride, dutasteride) Central Alpha Blockers (Clonidine, Guanfacine, Etc.) High Risk of Adverse CNS Effects, May cause Bradycardia and Orthostatic Hypotension Alternatives: Select alternative antihypertensive medication classes Analgesics NSAIDS (Including Aspirin >325mg/day) Increased risk for GI Bleeds, Peptic Ulcer Disease, Renal Impairment, Exacerbation of Heart Failure Avoid chronic use unless alternatives are not effective AND patient can take gastro protective agent Alternatives: APAP, Topical Analgesic Agents Keep aspirin dose low (81mg/day for primary prevention) to prevent increased risk of bleeding Skeletal Muscle Relaxants Most poorly tolerated by older adults due to anticholinergic properties, sedation, increased risk for fractures; Efficacy at doses tolerated by older adults questionable Analgesics 2015 Update: Opioids have been added to the list of drugs to avoid in individuals with a history of falls or fractures Can cause constipation and CNS Side Effects Alternatives: Topicals, APAP, Gabapentin or Cymbalta in Chronic Pain Avoid Meperidine Lack of Efficacy, Neurotoxicity risk, Safer Alternatives Available Avoid Pentazocin CNS Adverse Effects, Safer Alternatives Available 11

12 Endocrine System Sliding Scale Insulin Not recommended due to higher risk of hypoglycemia without improvement in hyperglycemia regardless of care setting Alternative: Basal-bolus insulin preferred Glyburide, Chlorpropamide Higher risk for sever prolonged hypoglycemia Alternatives: glimepiride or glipizide Endocrine system Estrogens can cause recurrent breast cancer, endometrial cancer, lack of demonstrated cardio protective effect Topical Low-Dose Intravaginal estrogen may be indicated for Dyspareunia, Lower Urinary Tract Symptoms, other vaginal symptoms For hot flashes: non-drug therapy, SSRIs, gabapentin, venlafaxine For bone density: calcium, vitamin D, bisphosphonates, raloxifene Androgens Potential for cardiac problems; Contraindicated in Prostate CA Avoid unless indicted for confirmed hypogonadism with clinical symptoms Endocrine system Megestrol Minimal Effect on Weight; Increased risk for thrombotic effects and possible death in older adults Alternatives: Remeron, Metoclopramide Can Cause Extrapyramidal symptoms Avoid, unless for gastroparesis Alternatives for nausea: Ondansetron, granisetron, dolasetron 12

13 Other Beers Criteria Features Table 3. Drug-Disease or Drug-Syndrome Interactions Table 5. Non-Anti-Infective Drug-Drug Interactions that should be Avoided in Older Adults Table 6. Non-Anti-Infective Medications that should be avoided or have their dosage reduced with varying levels of kidney function Table 7. Drugs with Strong Anticholinergic Properties Alternative Approaches to High Risk Meds in Elderly Patients 2015 AGS Document Alternative Medications for Medications in the Use of High-Risk Medications in the Elderly and Potentially Harmful Drug-Disease Interactions in the Elderly Quality Measures Non-pharmacological Interventions Patient Education Note: When High Risk medications are used in elderly patients, ensure proper monitoring for both efficacy and potential side effects Summary: how to help prevent adverse effects in the elderly Be aware of the PK/PD changes in elderly and which medications are most affected Suggest alternatives when appropriate Help prevent the prescribing cascade For example, many patients will have chronic constipation due to anticholinergic meds Prevent polypharmacy and Identify Potentially Inappropriate Medications Counsel patients on potential side effects of medications and educate them on alternative options that are available 13

14 Assessment 1 Which of the following does not represent a physiological change associated with aging, which can affect the pharmacokinetics and pharmacodynamics of medications? A. Decreased Renal Function B. Decreased Hepatic Function C. Decreased Total Body Fat D. Decreased Gastric Motility Assessment 2 Which of the following is not a compelling indication, which may warrant the use of a Proton Pump Inhibitor beyond 8 weeks? A. Oral Corticosteroid or Chronic NSAID use B. Barrett s Esophagus C. Previously failing discontinuation of Proton Pump Inhibitor D. All of the above ARE appropriate indications for long term PPI use Assessment 3 Which of the following is the best way to manage diabetes in an elderly patient with significant renal impairment? A. Sliding Scale Novolog TID with meals B. Glyburide 5mg BID C. Metformin 1000mg BID and Lantus 35 units qd D. Lantus 35 units qd and Novolog 10 units TID with meals 14

15 References 2015 Beers Criteria and Associated Documents: *2015 Beers Pocket Card Now Available Non-Pharmacological Intervention Toolkit (Behavioral and Psychological Symptoms of Dementia): References American Geriatrics Society 2015 updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc Nov; 63(11): Steinman MA, Beizer JL, Dubeau CE, et al. How to Use the American Geriatric Society 2015 Beers Criteria A Guide for Patients, Clinicians, Health Systems, and Payors. J Am Geriatr Soc Dec; 63 (12): e1-e7. PL Detail-Document, STARTing and STOPPing medications in the elderly. Pharmacist s Letter/ Prescriber s Letter Sept. Hanlon JT, Semla TP, Schmader KE. Alternative Medications for Medications in the Use of High-Risk Medications in the Elderly and Potentially Harmful Drug-Disease Interactions in the Elderly Quality Measures. J Am Geriatr Soc Dec; 63(12):e8-e18. Zeimer H. Medications and Falls in Older People. Journal of Pharmacy Practice and Research. 2008; 38(2): Hughes SG. Prescribing for the elderly patient: why do we need to exercise caution? J Clin Pharmacol. 1998; 46: Wooten, JM. Pharmacotherapy Considerations in Elderly Adults. South Med J. 2012; 105(8): Appendix A: Highly protein-bound drugs Amiodarone Amlodipine Antipsychotics Bupropion Calcium channel blockers Carbamazepine Cefazolin Ceftriaxone Cilostazol Citalopram Dipyridamole Midazolam Furosemide NSAIDs PPIs Phenytoin Prazosin Quinidine Raloxifene Rapaglinide Sertraline Sulfonylureas Tamsulosin Terazosin Tolcapone Tolterodine Warfarin 15

16 Appendix B: drugs with Impaired Hepatic Metabolism in the Elderly Alprazolam Amiodarone Amitriptyline Chlordiazepoxide Codeine Diazepam Imipramine Levodopa Lidocaine Meperidine Morphine Piroxicam Propranolol Quinidine Statins Theophylline Verapamil Warfarin Appendix C: Drugs with Age-related reductions in renal excretion ACE inhibitors Allopurinol Amantadine Aminoglycosides Atenolol Cephalosporins Digoxin Gabapentin Lithium Metformin Reglan Nitrofurantoin Penicillins Quinolones Ranitidine Vancomycin Appendix D: Drugs with Altered PD in Elderly Increased PD sensitivity [more profound effect]: Benzos Narcotic analgesics Anticoagulants CCBs [dihydropyridine] Anticholinergics Antihistamines Psychotropics QT prolonging meds Decreased PD sensitivity [decreased effect]: Beta blockers Beta agonists CCBs [non-dihydropyridine] Reflex tachycardia with vasodilators 16

17 Case Study: Jane Doe Medication Dose/route Frequency Indication Glyburide 5mg PO BID DM Diphenhydramine 25mg PRN Isosorbide 30mg PO BID CAD Diazepam (Valium) 5mg PO BID PRN Anxiety Lantus 15u SQ QHS DM Xalatan Ophthalmic 1 gt QHS Glaucoma Celexa 30mg PO QD Depression Norvasc 10mg PO QD HTN SimvastaWn (Zocor) 40mg PO QD Hyperlipidemia Metoprolol 100mg PO QD HTN Hydrocodone/APAP 1-2 tabs PO Q4-6hrs PRN Pain Oxycodone 5-10mg PO Q4-6hrs PRN Pain Zantac 150mg PO BID GERD Jane Doe (BD: 5/33; Weight: 125lbs) Medication Dose/route Frequency Indication Glyburide 5mg PO BID DM Diphenhydramine 25mg PRN Isosorbide 30mg PO BID CAD Diazepam (Valium) 5mg PO BID PRN Anxiety Lantus 15u SQ QHS DM Xalatan Ophthalmic 1 gt QHS Glaucoma Celexa 30mg PO QD Depression Norvasc 10mg PO QD HTN SimvastaWn (Zocor) 40mg PO QD Hyperlipidemia Metoprolol 100mg PO QD HTN Hydrocodone/APAP 1-2 tabs PO Q4-6hrs PRN Pain Oxycodone 5-10mg PO Q4-6hrs PRN Pain Zantac 150mg PO BID GERD Jane Doe (BD: 5/33; Weight: 125lbs) [BP: 100/50; Serum Creat: 2.1; HX falls, confusion] Medication Dose/route Frequency Indication Glyburide 5mg PO BID DM Diphenhydramine 25mg PRN Isosorbide 30mg PO BID CAD Diazepam (Valium) 5mg PO BID PRN Anxiety Lantus 15u SQ QHS DM Xalatan Ophthalmic 1 gt QHS Glaucoma Celexa 30mg PO QD Depression Norvasc 10mg PO QD HTN SimvastaWn (Zocor) 40mg PO QD Hyperlipidemia Metoprolol 100mg PO QD HTN Hydrocodone/APAP 1-2 tabs PO Q4-6hrs PRN Pain Oxycodone 5-10mg PO Q4-6hrs PRN Pain Zantac 150mg PO BID GERD 17

18 Questions? Matt Just Jordan Wolf 18