1. Getting Medications Right For Your Patients and Your Program Lorin Yolch, PharmD, CGP, FASCP Washington State Hospice & Palliative Care Organization

2. Cumulative Impact of CMS Reform The cumulative impact will almost certainly wreak havoc on hospice service models and will heavily influence quality of care unless funds are made up by reducing costs or increasing revenue with the latter being a tougher assignment in most cases…. 5/29/20162

3. Direct Costs “Anything associated with direct care” Medication Costs Supplies DME Salaries Nursing, Aides, SW, Chaplain…. 5/29/20163

4. Indirect Costs Supportive costs such as marketing, administrative salaries, information management supplies, utilities, rent, staff education, depreciation, etc… 5/29/20164

5. For example ADC 100, patient days = 37,000 Net patient revenue $6,000,000. Experiences remainder of the 2% per year scheduled CMS cuts through 2019: The hospice may experience an approximate $120,000 less in reimbursement per year totaling $480,000 K over the next 4 years (2019) The 2% sequester will continue indefinitely… 5/29/20165

6. There is Good News… Medication costs CAN be reduced! Let’s discuss how to do this through a comprehensive Pharmaceutical Care initiative for your hospice. 5/29/20166

7. Pharmaceutical Care The direct, responsible provision of medication- related care for the purpose of achieving definite outcomes that improve a patients quality of life. Medication related + Care related + Outcome related 5/29/20167

8. Medication related Includes decision to or not to use medications as well as judgements regarding medication selection, dose, route, frequency and method of administration plus patient education. 5/29/20168

9. Care related The pharmacist providing direct personal concern (i.e. care) for the well-being of another person just as nursing and medicine does. Integrated, collaborative and cooperative domains of care including medical care, nursing care and pharmaceutical care. 5/29/20169

10. Outcome related Identifying potential and actual medication- related problems Resolving actual medication-related problems Preventing potential medication-related problems 5/29/201610

11. Quality Use of Medicine Framework 1.Ascertain current medications 2.Identify patients at high risk of or experiencing ADE 3.Estimate life expextancy of high risk patients 4.Define overall care goals in context of life expectancy 5.Define and confirm current indications for ongoing treatment 6.Determine the time until benefit for disease modifying medications 7.Estimate the magnitude of benefit versus harm for each medication 8.Review the relative utility of each medication in use 9.Identify drugs which may be discontinued 10.Implement and monitor a drug utilization plan

12. Medication-related problems Untreated indication Improper medication selection Subtherapeutic dosage Failure to receive medication Overdosage Adverse drug reaction Drug–Drug and Drug-Food Interaction Medication use without an indication 5/29/201612

13. CMS F Tag 329 “ Unnecessary Medications” 1.Excessive Dose or Duplicate Therapy 2.Excessive Duration 3.Medication Given Without Adequate Indication For Use 4.Medication Given Without Adequate Monitoring 5.Presence of Adverse Consequences Which Indicate The Dose Should Be Reduced or Discontinued 6.Any Combination of the Reasons Above 5/29/201613

14. Hospice CoPs 2008 Defined the role of the pharmacist for Hospice. As an industry, have we met the CoPs ? Let’s take a look at select sections… 5/29/201614

15. Medicare Part D & Hospice Was reform necessary? Has continuity improved? Have outcomes improved? Medicare Part D reform affirmed the right of hospices to use a formulary and resulted in approximately 25% increase in the cost of medications for the hospice industry. 5/29/201615

16. Medication Cost What is cost? Cost is defined by the buyer! Pharmacy Hospice Cost is NOT average wholesale price ! 5/29/201616

17. Are Medication Costs Rising? Yes, at rates never seen before…. Brand name medications: Generic medications: 5/29/201617

18. Why Medication Prices Are Rising Industry consolidation Drug shortages Raw material shortages Unanticipated demand Manufacturing difficulties Regulation Business and economic issues 5/29/201618

19. Medication Price Increases MedicationApproximate Hospice Cost 2013 Approximate Hospice Cost 2015 Amitriptyline 100mg Tablet$4.00$91.00 Atropine Opth. Soln 1%-5$9.00$21.00 Erythromycin Estolate Susp 400 mg/5ml; 240 ml $25.00$350.00 Morphine 60 mg ER; #100$75.00$125.00 Morphine 20 mg/ml; 30ml$9.00$18.00 Nystatin Susp 100,000 U 240 ml $25.00$42.00 Oxycodone 20 mg/ml;30ml$57.00$284.00 Tetracycline 250 mg cap #100 $3.50$236.00 5/29/201619

20. Necessary Hospice Infrastructure Pharmacotherapeutic Support System 3 Essential Components: a. Pharm D b. Preferred Drug List c. Pharmacy & Therapeutics Committee 5/29/201620

21. PharmD “My Hospice can’t afford to hire a pharmacist!” Really? “Your Hospice can’t afford not to hire a pharmacist!” 5/29/201621

22. Hospice PDL Composed by symptom and by medication. Must be a dynamic document! Update quarterly! Patient specific! 5/29/201622

23. P & T Committee Multidisciplinary hospice stakeholders meet on a scheduled basis to oversee all issues relative to hospice medication use. Adding or deleting medications from PDL Adverse drug reaction reporting e-Prescribing protocol Medication diversion and error review Medication cost per patient day Patient education tools Pharmacy QA Symptom management algorhythms Therapeutic interchange 5/29/2016 23

24. Hospice Preferred Drug List Please see sample provided 5/29/201624

25. Therapeutic Categories That Matter The Most Antiemetics – Olanzapine (Zyprexa®) – Select “older” medications are now $$$$ Prochlorperazine suppositories (Compazine®) Promethazine suppositories (Phenergan®) Anitipsychotics – Typical Chorpromazine (Thorazine®) – Atypical Opioids 5/29/2016 25

26. Target Drugs Benzonatate capsules Doxycycline Hyclate Dronabinol Fentanyl IR (not transdermal!) Hydrocodone SR Hydromorphone SR Inhalers - all Memantine Megestrol Acetate Mupirocin Oxycodone CR and concentrate 20 mg/ml Phenobarbital IV 5/29/201626

27. Benchmark Medication Costs National PPD goal = $8.00 – Post Medicare Part D reform = $10.00 ? 5/29/201627

28. Goal Opioid Utilization for Hospice Opioid % Utilization Buprenorphine Codeine Fentanyl Hydromorphone Morphine Methadone Oxycodone Oxymorphone Hydrocodone SR Tramadol 0 20 15 30 20 10 0 5 5/29/201628

29. Separating “Good From Great” Great management of PDL = medication cost PPD of $6.00 or less. Good = $8.00 or less. Ask what is different. 5/29/201629

30. Benchmarking Hospice Performance DrugHospice A PPD < $6 Hospice B PPD < $8 Hospice C PPD < $10 Hospice D PPD < $12 Target Drug Unique Drug Formulary Status “Inhalers”$265.00$350.00$2,350.00$3,300.00Yes No Methadon e $910.00$628.00$550.00$ 35.00Yes Fentanyl Transderm $401.00$650.00$1,935.00$6,200.00No Yes Morphine IR + CR $3,800.00$2600.00$3,018.00$1,700.00No Yes Memantine $152.00$711.00$1,425.00$1510.00Yes No Oxycodone 20 mg/ml + SR 1,000.00$1,900.00$1975.00$2825.00YesNoIR Tabs Only Hydromor- phone $225.00$0.00 $310.00YesNo 5/29/201630

31. Oral Morphine Equivalents Please see handout provided 5/29/201631

32. Adverse Drug Reaction Reporting Required by JCAHO! 5/29/201632

33. ADR Predictors Predictors of ADRs in the Elderly Taking more than four medications*Longer than 14-day hospital stay Having more than four active medical problems General medical unit admission instead of a geriatric ward Two to four new medications added during a hospitalization Lower Mini-Mental State Exam score Alcohol use historyUse of certain medications (diuretics, NSAIDs, antiplatelets, digoxin)* Older Age*Comorbidities* * Indicates predictors for severe ADRs Lee JK, Mendoza DM, Mohler, MJ, Morris, SJ. Geriatrics. In: DiPiro JT, Talbert RL, Yee GC, et al., eds. Pharmacotherapy: A Pathophysiologic Approach. 8 th ed. New York City: McGraw-Hill; 2011:7-21.

34. Preventing ADRs Strategies to Prevent ADRs in the Elderly Evaluate comorbidities, frailty, and cognitive function Identify caregivers to take responsibility for medication management Evaluate renal function and adjust dosesMonitor drug effects Recognize that clinical signs or symptoms can be an ADR Minimize the number of medications prescribed (combination products) Adapt treatment to patient’s life expectancy Realize that self-medication and nonadherence are common and can lead to ADRs Lee JK, Mendoza DM, Mohler, MJ, Morris, SJ. Geriatrics. In: DiPiro JT, Talbert RL, Yee GC, et al., eds. Pharmacotherapy: A Pathophysiologic Approach. 8 th ed. New York City: McGraw-Hill; 2011:7-21.

35. ADRs in the Elderly Be careful when drugs that alter cognition are prescribed (antipsychotics, benzodiazepines, antiarrhythmics, opioids, etc.) Falls can be one of the most damaging ADRs – Increase mortality – Strong association with benzodiazepines, antidepressants, and antipsychotics Lee JK, Mendoza DM, Mohler, MJ, Morris, SJ. Geriatrics. In: DiPiro JT, Talbert RL, Yee GC, et al., eds. Pharmacotherapy: A Pathophysiologic Approach. 8 th ed. New York City: McGraw-Hill; 2011:7-21.

36. e-Prescribing Protocol e-Prescribing of controlled substances, including CII’s is now legal in all 50 states. 2015: 4 million e-Rx’s for controlled substances thus far! Regulations may vary, state by state. 5/29/201636

37. Medication Diversion & Error Review Individual states are now imposing new regulations aimed at preventing diversion of opioids from the home of hospice patients. – Example: State of Virginia now requires hospice to report patient death to the distributing pharmacy of record. 5/29/201637

38. Nonadherence Elderly patients are at an increased risk for medication non-adherence Barriers to adherence – Lack of understanding/provider education – Inconvenience – Polypharmacy – Complex regimens – Treatment of asymptomatic conditions – Cost Lee JK, Mendoza DM, Mohler, MJ, Morris, SJ. Geriatrics. In: DiPiro JT, Talbert RL, Yee GC, et al., eds. Pharmacotherapy: A Pathophysiologic Approach. 8 th ed. New York City: McGraw-Hill; 2011:7-21.

39. Medication Nonadherence Factors 3+ chronic conditionsLiving alone 5+ chronic medicationsRecent hospital discharge Increased dosing frequency (TID or more than 12 doses/day) Reliance on a caregiver 4+ medication changes in the last yearLow literacy level 3+ prescribersMedication costs Significant cognitive or physical impairments History of medication nonadherence Lee JK, Mendoza DM, Mohler, MJ, Morris, SJ. Geriatrics. In: DiPiro JT, Talbert RL, Yee GC, et al., eds. Pharmacotherapy: A Pathophysiologic Approach. 8 th ed. New York City: McGraw-Hill; 2011:7-21.

40. Assessing Nonadherence 1.How do you take your medications? 2.How do you organize your medications? 3.How do you schedule your meal and medication times? 4. How do you pay for your medications 5. How do you think the medications are working for your condition? 6. How many times in the last week/month have you missed a dose? Lee JK, Mendoza DM, Mohler, MJ, Morris, SJ. Geriatrics. In: DiPiro JT, Talbert RL, Yee GC, et al., eds. Pharmacotherapy: A Pathophysiologic Approach. 8 th ed. New York City: McGraw-Hill; 2011:7-21.

41. Improving Adherence Patient education Making dosing regimens more convenient Serial follow-up with patients Must keep in mind specific belief-related variables for each patient – Personal – Cultural Lee JK, Mendoza DM, Mohler, MJ, Morris, SJ. Geriatrics. In: DiPiro JT, Talbert RL, Yee GC, et al., eds. Pharmacotherapy: A Pathophysiologic Approach. 8 th ed. New York City: McGraw-Hill; 2011:7-21.

42. Patient Education Tools Hospice patient population medication specific written material left in the home for patient and care giver education. 5/29/201642

43. Pharmacy QA Pharmacy dispensing error reporting Patient satisfaction Nurse satisfaction 5/29/201643

44. Therapeutic Interchange Defined as the dispensing of a drug that is therapeutically equivalent to but chemically different from the drug originally prescribed by a physician or other authorized prescriber. Example: Substitution of ipratropium bromide inhalation solution(Atrovent)® for Spiriva® or Tudorza® Example: Substitution of oral prednisone 10 mg per day for Pulmicort® nebulization solution. 5/29/201644

45. Therapeutic Interchange Although usually of the same pharmacologic class, drugs appropriate for therapeutic interchange may differ in chemistry or pharmacokinetic properties, and may possess different mechanism of action, adverse- reaction, toxicity, and drug interaction profiles. In most cases, the interchanged drugs have close similarity in efficacy and safety profiles. 5/29/201645

46. Symptom Management Algorhythms Please see sample provided 5/29/201646

47. Pharmacology in End-of-Life Care

48. Olanzapine (Zyprexa®) The replacement for haloperidol? Why? Olanzapine = Ondansetron(Zofran®) + haloperidol ! 5/29/201648

49. Pathophysiology of nausea / vomiting Neurotransmitters l Serotonin l Dopamine l Acetylcholine l Histamine Neurotransmitters l Serotonin l Dopamine l Acetylcholine l Histamine EPEC Project 1999 Vomiting Center Cortex Chemoreceptor Trigger Zone (CTZ) VestibularApparatus GI Tract 5/29/201649

50. Vomiting Center ACh m H1 H1 Μu-opioid5HT 2 Gut Wall Chemoreceptor Trigger Zone Cerebral Cortex Vestibular nuclei ? 5HT 3 ά2ά2 D2D2 5HTGABA H1H1 AChm 5HT 3 Gastric irritants Abdominal Radiotherapy Intestinal distension Cytotoxic Chemotherapy Opioids, Digoxin Hypercalcemia/ Uremia Clonidine Fear/ Anxiety Movement/ Vertigo Raised Intracranial pressure Gastric atony Retroperistalsis Thoracic & abdominal muscle contractions ACh m =anticholinergics 5HT=serotonin type 2,3,& undefined D 2 =dopamine type 2 H 1 =histamine type 1 GABA=gamma- aminobutyric acid ά2 = alpha adrenergic type 2 Palliative Care Pocket Consultant 2001 Modified from Twycross et al., 1997 5/29/201650

51. The Top 3 EOL Care Comorbidities Metabolic Syndrome (Diabetes et al) COPD Heart Failure

52. Metabolic Syndrome Any 3 criteria from the list below: Hyperglycemia Hypertension Hypertriglyceridemia  HDL-C(Men < 40 mg/dL; Women < 50 mg/dL) Waist circumference > 40” (men) & > 35” (women)

53. EOL Care of Diabetes Guidelines: ADA Does diabetes contribute to terminal prognosis? EOL Care Goal

55. Glycemic Control in Palliative Care Less stringent goals may be necessary – A1C <8% Remaining life-expectancy and extent of comorbid conditions must be evaluated in order to set realistic goals for glycemic control Standards of medical care in diabetes--2013. Diabetes Care. 2013;36 Suppl 1(Supplement 1):S11-66.

56. Standards of Medical Care in DM Standards of medical care in diabetes--2013. Diabetes Care. 2013;36 Suppl 1(Supplement 1):S11-66.

57. From the Palliative Care Literature HBA1C goal of < 7.5% in the terminal phase of cancer may be beneficial for survival. Kondo S, Kondo M, Kondo A. Glycemia control using A1C level in terminal cancer patients with preexisting type 2 diabetes. J Palliat Med. 2013;16(7):790-3.

58. EOL Care Symptom Management Prevention of hyperglycemia – Diabetic Keto-Acidosis – Confusion – Blurred vision Prevention of hypoglycemia – Agitation – Confusion – Diaphoresis Prevention of polyuria – Decrease risk of urinary tract infections in the immobile patient

59. Diabetes Remember: The HBA1C goal is no longer 7% ! Autonomic dysfunction? Neuropathic Pain? Renal Function? Vision?

61. Initiate insulin therapy with daily glargine or detemir or bedtime NPH Beginning dosage: 10 units or 0.1-0.25 units/kg Oral agent failure: A1C above target If A1C remains > A1C goal over 3 months, discontinue oral secretagogue, continue oral insulin sensitizer(s), and initiate multidose insulin or intensive insulin therapy or consult an endocrinologist Suggested titration schedule—Adjust every 2-3 days If FPG: >180 mg/dL Add 6 units If 141-180 mg/dL Add 4 units or Add 1 unit insulin each day until If 121-140 mg/dL Add 2 units fasting SMBG is at goal If 100-120 mg/dL Add 1 unit If 80-99 mg/dL No change If < 80 mg/dL Subtract 2 units FPG: Fasting plasma glucose SMBG: self-monitored blood glucose Treatment naïve: A1C ≥ 10% or < 10% when considering early insulin initiation Adapted from: Triplitt CL, Repas T, Alvarez CA. Diabetes Mellitus. Figure 57-9, Insulin algorithm for type 2 DM in children and adults (reprinted with permission from Texas Diabetes Council). In: DiPiro JT, Talbert RL, Yee GC, et. al. Pharmacotherapy: A Pathophysiologic Approach. 9 th ed. New York, NY: McGraw-Hill; 2014: 1178. Initiation of once-daily insulin therapy for type 2 diabetes mellitus in children and adults

62. Oral Agents for the Treatment of Type 2 Diabetes Mellitus Drug ClassSpecial Precautions Sulfonylureas (1 st and 2 nd generations) Severe hypoglycemia, weight gain; dose adjustment in renal impairment Short-acting insulin secretagogues CYP 2C8/9 and 3A4 metabolism Biguanides CHF(lactic acidosis), GI side effects; dose adjustment in renal and hepatic impairment Thiazolidinediones Caution in hepatic impairment, bladder cancer; contraindicated in CHF (causes edema) α-Glucosidase inhibitors Caution in renal impairment, elevated LFTs; contraindicated in chronic intestinal diseases Dipeptidyl peptidase-4 (DPP-4) inhibitors Pancreatitis; dose adjustment in renal impairment (except linagliptin) Bile acid sequestrants Constipation, drug-drug absorption interaction issues, increased in triglycerides Dopamine agonists Cardiac valvular fibrosis, hypotension, significant nausea, impulse control disorders

63. Injectable Agents for the Treatment of Type 2 Diabetes Mellitus Drug ClassSpecial Precautions Rapid acting insulin Hypoglycemia, hypokalemia Short acting insulin Hypoglycemia, hypokalemia Intermediate acting insulin Hypoglycemia, hypokalemia Long acting insulin Hypoglycemia, hypokalemia Glucagon-like peptide-1 (GLP-1) agonists GI side effects, thyroid tumors (Bydureon), pancreatitis; avoid use in impaired gastric motility; use not recommended in severe renal impairment Amylinomimetics Avoid use in impaired gastric motility

64. Principles of Geriatric Palliative Medicine 5/29/201664

65. Factors Affecting Pharmacokinetics of Drugs in the Elderly 5/29/201665

66. Medications Considered to have a High Potential for Severe Adverse Outcomes in Older Patients 5/29/201666

67. Pain Assessment Questions 5/29/201667

68. Types of Pain and Treatment 5/29/201668

69. Stepladder Approach to Pain Management 5/29/201669

70. Opioid Side Effects and Treatment Options 5/29/201670

71. Geriatric Dosing and Adverse Effects for Commonly Used Drugs in End-of-Life Care 5/29/201671

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75. Remember: “It is neither immoral nor unethical to think about the cost of therapy!” Methadone Mary 1998 5/29/201675

76. Questions ? Lorin.Yolch@deltacarerx.com www.deltacarerx.com 5/29/201676