Pennsylvania Academy of Family Physicians Foundation & UPMC 43rd Refresher Course in Family Medicine CME Conference March 10-13, 2016

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1 Pennsylvania Academy of Family Physicians Foundation & UPMC 43rd Refresher Course in Family Medicine CME Conference March 10-13, 2016 Disclosures: Drugs in Older Adults: Beers Criteria Heather Sakely, PharmD, BCPS Speaker has no disclosures and there are no conflicts of interest. The speaker has attested that their presentation will be free of all commercial bias toward a specific company and its products. The speaker indicated that the content of the presentation will not include discussion of unapproved or investigational uses of products or devices.

2 1 Drugs in Older Adults: AGS 2015 Beers Criteria Update Heather Sakely, PharmD, BCPS Director, Geriatric Pharmacotherapy Director, PGY2 Geriatric Pharmacy Residency Department of Medical Education UPMC St. Margaret Learning Objectives Describe the purpose and utility of the 2015 AGS Beers Criteria. Name appropriate prescribing limitations for nitrofurantoin, proton pump inhibitors and non-benzodiazepine, benzodiazepine receptor agonist hypnotics. Name differences between correctional dose insulin and insulin sliding scale. Name 3 medications with strong anticholinergic properties. 2 Disclosures The speaker has no conflict of interest, financial agreement, or working affiliation with any group or organization. Abbreviation PIM: Potentially Inappropriate Medication 3 1

3 Leader in Geriatric Medicine. 4 Dr. Mark Beers Learning Objectives Describe the purpose and utility of the 2015 AGS Beers Criteria. Name appropriate prescribing limitations for nitrofurantoin, proton pump inhibitors and non-benzodiazepine, benzodiazepine receptor agonist hypnotics. Name differences between correctional dose insulin and insulin sliding scale. Name 3 medications with strong anticholinergic properties AGS Beers Update Identify medication that have an unfavorable balance of benefits and harms in MANY older adults, particularly when compared with pharmacological and nonpharmacological alternatives Poor health outcomes Confusion Falls Mortality 6 2

4 Timeline and Applicable Populations * Original Beers List * Nursing Home patients ONLY ALL older adults * 1999 CMS adopted for SNF regs *Adoption of criteria into quality measures *AGS s first update *Quality measures 13-member interdisciplinary panel of experts in geriatric care and pharmacotherapy Update 2012 AGS Beers Criteria Modified Delphi method for systematic review & grade evidence Followed IOM standards for evidenced based approach Applicable to ALL older adults, except: Palliative and hospice care *Fewer changes * New tables (renal, drug intx) 7 Educational tool and Quality Measure 2015 Update Process and Documents Literature search August 2011-July 2014; updated December 2014 Published systematic review, meta-analyses, randomized controlled trials, and observational studies 20,748 1,188 unduplicated citations for full panel review 8 What is the PURPOSE of the Beers Criteria? To identify potentially inappropriate medications that should be avoided in many older adults To reduce adverse drug events and drug related problems, and to improve medication selection and medication use in older adults Designed for use in any clinical setting; also used as an educational, quality, and research tool 3

5 Benefits and Challenges The Beers Criteria have had many positive impacts Use of many medications included in the Beers Criteria has declined Increased appreciation of special considerations that should be applied when prescribing for older adults Benefits and Challenges However, implementation of the Beers Criteria has led to several unintended consequences Many clinicians misunderstand the purpose of the criteria, mistakenly believing that the criteria judge all uses of the listed drugs to be universally inappropriate Health systems have often reinforced this perception, implementing quality improvement and decision support systems that implicitly consider any use of these medications to be problematic Benefits and Challenges However, implementation of the Beers Criteria has led to several unintended consequences Some prior authorization programs build around the Beers Criteria have been misapplied by payors and/or misinterpreted by the prescribing clinician 4

6 Optimizing Use of the Beers Criteria: A Guide As part of 2015 update of the Beers Criteria, AGS created a workgroup to encourage optimal use of the criteria by patients, clinicians, health systems, and payors Included input from key stakeholders Workgroup developed: 7 key principles to guide optimal use of the criteria Guidance for how clinicians and others can apply these principles in everyday practice Ambassadors and Gatekeepers for proper interpretation of this TOOL 7 Key Principles Ambassadors and Gatekeepers for proper interpretation of this TOOL 14 Organization AGS 2015 Beers Criteria Table Table 1 Table 2 Table 3 Table 4 Table 5 Topic Definitions of Quality of Evidence and Strength of Recommendations Medications to AVOID for many or most older adults Medication for older adults with specific DISEASES or SYNDROMES to avoid Medication to be used with CAUTION Non anti infective DRUG DRUG interactions Table 6 Table 7 Tables 8 10 Table Table 1 Table 2 15 Non anti infective medications to avoid or the dosage of which should be adjusted based on the individual s KIDNEY FUNCTION Drugs with strong ANTICHOLINERGIC properties DIFFERENCES between 2012 and 2015 AGS Beers Criteria Alternative Paper Alternatives for Medications included in High Risk Medications in Elderly Measure Alternatives to Medications Included in the Potentially Harmful Drug Disease Interactions in the Elderly 5

7 Noteworthy Changes to PIMs and Older Adults PIM Nitrofurantoin Antiarrhythmics Nonbenzodiazepine, benzodiazepine receptor agonist hyponotics Insulin Sliding Scale Proton Pump Inhibitors Desmopressin Drug-Disease and Drug-Syndrome PIM Dementia/cognitive impairment: Nonbenzodiazepine, benzodiazepine receptor agonist hypnotics Falls/fractures: opioids Delirium: antipsychotics 16 Constipation removed Drug to be used with CAUTION Unchanged Drug-Drug Intx NEW! Drugs to avoid/adjust w/ Kidney Function NEW! Strong Anticholinergics New scale used to assess level of anticholinergic activity Loratadine removed from list Learning Objectives Describe the purpose and utility of the 2015 AGS Beers Criteria. Name appropriate prescribing limitations for: nitrofurantoin, proton pump inhibitors and non-benzodiazepine, benzodiazepine receptor agonist hypnotics. Name differences between correctional dose insulin and insulin sliding scale. Name 3 medications with strong anticholinergic properties. Organ System, Therapeutic Category, Drugs Nitrofurantoin Rationale Recommendation Quality of Evidence Potential for pulmonary toxicity, hepatoxicity, and peripheral neuropathy, especially with long term use; safer alternatives available Avoid in individuals with CrCl < 30mL/min or for long term suppression of bacteria Low Strength of Recommendation Strong Old recommendation: avoid nitrofurantoin in individuals with CrCl < 60mL/min. 2 retrospective studies: Safety and efficacy in patients with CrCl 30 ml/min New! Long term use of nitrofurantoin for suppression should still be avoided 18 New! *Irreversible pulmonary fibrosis *Liver toxicity *Peripheral neuropathy 6

8 Organ System, Therapeutic Category, Drugs Rationale Recommendation Quality of Evidence Strength of Recommendation Proton pump inhibitors Risk of Clostridium difficile infection and bone loss fractures Avoid scheduled use for > 8 weeks unless for highrisk patients (e.g., oral NSAID use), erosive esophagitis, Barrett s esophagitis, pathological hypersecretory condition, or demonstrated need for maintenance treatment (e.g., due to failure of drug discontinuation trial or H2 blockers) High Strong Multiple studies and 5 systematic reviews and meta-analyses support an association between PPI exposure and 19 Avoid PPI > 8 weeks without justification clostridium difficile infection, bone loss, and fractures Organ System, Therapeutic Category, Drugs Nonbenzodiazepine, benzodiazepine receptor agonists hypnotics Eszopiclone Zolpidem Zaleplon Rationale Recommendation Quality of Evidence Benzodiazepine receptor agonists have adverse events similar to those of benzodiazepines in older adults (e.g., delirium, falls, fractures); increased emergency department visits and hospitalizations; motor vehicle crashes; minimal improvement in sleep latency and duration) Avoid Moderate Strong Nonbenzodiazepine, benzodiazepine receptor agonist hyponotics (eszopiclone, zaleplon, zolpidem) AVOID WITHOUT consideration of duration of use Association with harms balanced with minimal efficacy for insomnia Strength of Recommendation 20 Learning Objectives Describe the purpose and utility of the 2015 AGS Beers Criteria. Name appropriate prescribing limitations for nitrofurantoin, proton pump inhibitors and non-benzodiazepine, benzodiazepine receptor agonist hypnotics. Name differences between correctional dose insulin and insulin sliding scale. Name 3 medications with strong anticholinergic properties. 7

9 Organ System, Therapeutic Category, Drugs Insulin, sliding scale Rationale Recommendation Quality of Evidence Higher risk of hypoglycemia without improvement in hyperglycemia management regardless of care setting; refers to sole use of short or rapid acting insulins to manage or avoid hyperglycemia in absence of basal or long acting insulin; dose not apply to titration of basal insulin or use of additional short or rapid acting insulin in conjunction with scheduled insulin (e.g. correction insulin). Clarification of what constitutes an ISS ISS still on list!! Sole use of short- or rapid-acting insulins to manage or avoid hyperglycemia Absence of basal or long-acting insulin Avoid Moderate Strong Strength of Recommendation 22 Does NOT apply to correctional insulin (Titration of basal insulin or use of additional short- or rapid- acting insulin in conjunction with scheduled insulin) Learning Objectives Describe the purpose and utility of the 2015 AGS Beers Criteria. Name appropriate prescribing limitations for nitrofurantoin, proton pump inhibitors and non-benzodiazepine, benzodiazepine receptor agonist hypnotics. Name differences between correctional dose insulin and insulin sliding scale. Name 3 medications with strong anticholinergic properties. Strong Anticholinergics New scale used to assess level of anticholinergic activity Loratadine removed from list Measurement of anticholinergic burned is continually evolving. Drugs with Strong Anticholinergic Properties Antihistamines Antiparkinsonian Skeletal muscle Brompheniramine agents relaxants Cabinoxamine Benzotropine Cyclobenzaprine Chlorpheniramine Trihexylphenidyl Orphenadrine Clemastine Cyproheptadine Dexbrompheniramine Dexchlorpheniramine Dimenhydrinate Diphenhydramine (oral) Doxylamine Hydroxyzine Meclizine Triprolidine Risk: impaired cognitive and physical function and risk of dementia Anticholinergic = ANTI-SLUD Antidepressants Amitriptyline Amoxapine Clomipramine Desipramine Doxepine (> 6mg) Imipramine Nortriptyline Paroxetine Protriptyline Trimipramine Antipsychotics Chlorpromazine Clozapine Loxapine Olanzapine Perphenazine Thioridazine Trifluoperazine Antiarrhythmic Disopyramide 24 Antimuscarinics (UI) Darifenacine Fesoterodine Ravoxate Oxybutynin Solifenacin Tolterodine Trospium Antispasmodics Atropine (excludes ophth) Belladonna alkaloids Clidniumchlordiazepoxidine Dicyclomine Homatropine (excludes ophth) Hyoscyamine Propantheline Scopolamine (excludes ophth) Antiemetic Prochlorperazine Promethazine 8

10 Drugs with Strong Anticholinergic Properties Antihistamine: Diphenhydramine (oral) Muscle relaxant: cyclobenzaprine Antihistamines Brompheniramine Cabinoxamine Chlorpheniramine Clemastine Cyproheptadine Dexbrompheniramine Dexchlorpheniramine Dimenhydrinate Diphenhydramine (oral) Doxylamine Hydroxyzine Meclizine Triprolidine Antiparkinsonian agents Benzotropine Trihexylphenidyl Skeletal muscle relaxants Cyclobenzaprine Orphenadrine Antidepressants: paroxetine Antipsychotics: olanzapine Antimuscarinics: ALL! Antiemetic: prochlorperazine; promethazine 25 Antidepressants Amitriptyline Amoxapine Clomipramine Desipramine Doxepine (> 6mg) Imipramine Nortriptyline Paroxetine Protriptyline Trimipramine Antimuscarinics (UI) Darifenacine Fesoterodine Ravoxate Oxybutynin Solifenacin Tolterodine Trospium Antipsychotics Chlorpromazine Clozapine Loxapine Olanzapine Perphenazine Thioridazine Trifluoperazine Antispasmodics Atropine (excludes ophth) Belladonna alkaloids Clidniumchlordiazepoxidine Dicyclomine Homatropine (excludes ophth) Hyoscyamine Propantheline Scopolamine (excludes ophth) Antiarrhythmic Disopyramide Antiemetic Prochlorperazine Promethazine Alternative Medications list. 2 Quality Measures Use of High-Risk Medication in the Elderly (HRM) National Committee for Quality Assurance (NCQA) and Pharmacy Quality Alliance (PQA) Potentially Harmful Drug-Disease Interactions in the Elderly National Committee for Quality Assurance (NCQA) Negatively affect a healthcare plan s quality ratings. Goal of Alternative List: develop a list of alternative medications to those included in these two measures 26 Active Engagement in Pharmacotherapy should extend beyond Beers Criteria medications. Patients/caregivers learning about their medications Reason for taking Adverse effects Efficacy/lack thereof Problems with adherence or cost Review annually AND any time a new medication is prescribed Active patient and caregiver AND willingness and ability of clinicians to engage patients in shared decision-making and incorporate patient preferences and values into treatments 27 9

11 Drugs in Older Adults: AGS 2015 Beers Criteria Update Heather Sakely, PharmD, BCPS Director, Geriatric Pharmacotherapy Director, PGY2 Geriatric Pharmacy Residency Department of Medical Education UPMC St. Margaret 10

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