Rita Shane, Pharm.D., FASHP, FCSHP Director, Pharmacy Services Cedars- Sinai Medical Center, Los Angeles Assistant Dean, Clinical Pharmacy UCSF

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1 Rita Shane, Pharm.D., FASHP, FCSHP Director, Pharmacy Services Cedars- Sinai Medical Center, Los Angeles Assistant Dean, Clinical Pharmacy UCSF School of Pharmacy

2 Objec&ves Determine the implications of the Affordable Care Act on medication management in health systems Describe the importance of having an accurate medication list to prevent adverse drug events and readmissions Describe the impact of specialty drugs on management of chronic diseases and health care costs

3 Health System Transforma&on Traditional Acute Care Focus Encounter- based Medical care Treatment of acute conditions Admissions Medication orders Outpatient revenue Oral medications mainstay for chronic diseases Health Care Focus Patient- centered care Team- based care Preventing readmissions Transitions of care Patient s medication list Outpatient costs Biologics infusions, injections and therapeutic advances for chronic diseases

4 Cedars- Sinai Medical Center 896 bed, acute, tertiary care, teaching hospital Medical delivery network Teaching programs Affiliated with UCLA School of Medicine USC and UCSF Schools of Pharmacy Nursing Institute Research Institute Electronic Medical Record

5 Clinical Care Medicine Surgery Pediatrics Obstetrics- Gynecology Neurosciences Oncology Cancer Institute Heart Institute Critical Care- adult, pediatrics, neonates Solid Organ Transplantation Rehabilitation Emergency Services Outpatient Surgery, Diagnostic and Clinical Services

6 Ensuring Safe Medication Use

7 Ensuring the Accuracy of the Medica&on List An accurate medication history is essential to prevent adverse drug events and harm A variety of individuals enter medication information into traditional and electronic health records across different settings: MD offices, hospitals, community pharmacies, home health agencies Errors introduced in any of these settings can become hardwired into the patient record Kwan, JL; Lo, L. Medication Reconciliation During Transitions of Care as a Patient Safety Strategy. Ann Intern Med. 2013;158:

8 Ensuring the Accuracy of the Medica&on List Clinicians rely on the information and prescribe medications that are listed even though the information may be inaccurate Up to 67% of patients admitted to the hospital have unintended medication discrepancies Review of 12 studies demonstrated that 45% of patients had at least 1 clinically significant discrepancy Kwan, JL; Lo, L. Medication Reconciliation During Transitions of Care as a Patient Safety Strategy. Ann Intern Med. 2013;158:

9 Ensuring the Accuracy of the Medica4on List

10 Hospital Pharmacist s Role in Evalua&ng Medica&ons Medica4ons Prior to Admit Medica&on List As well as new orders Drug Indica&on Dose Route Frequency Dosage form Pa4ent Characteris4cs Age (pediatrics/ geriatrics) Gender Height/Weight Allergies Kidney/Liver Func&on Current labs Previous admissions Current Medica4on List Drug- drug interac&ons Drug- disease interac&ons Drug- food interac&ons Duplicate therapy Contraindica&ons Medica&ons needed but not prescribed Monitoring requirements Special Considera4ons High risk pa&ents or therapies such as: Chemotherapy Pediatrics ICU Blood thinners An&bio&cs Dura&on

11 Transi&ons of Care Model Objective: Evaluation of Medication List, Adherence, and Literacy Identify High- Risk Patients Validate Medication History Assess Adherence and Literacy Educate Patient Notify MD Regarding Drug- Related Problems Identified along with Recommend- ations Post- Discharge Follow- Up within 72 Hr - Med Rec - Adherence & Literacy Reinforcement - Education Additional Calls up to 30 Days Based on Risk Assessment

12 Resolu&on of Drug- Related Problems (DRPs) in High- Risk Hospitalized Pa&ents 7.4 Drug- Related Problems Iden4fied Per Pa4ent Based on Medica4on History 21% of inpa4ent orders were changed due to DRPs iden4fied 40% of resolved DRPs were classified as life- threatening or serious/significant 12

13 Assessing Medica&on Adherence and Literacy - Low health literacy affects 9 out of 10 adults - 50% of pa9ents do not adhere to their medica9ons as prescribed resul9ng in avoidable hospitaliza9ons which cost > $100 billion/yr Adherence 1. Do you ever forget to take your medicine? 2. Are you careless at times about taking your medicine? 3. When you feel better do you sometimes stop taking your medicine? 4. Sometimes if you feel worse when you take the medicine, do you stop taking it? Literacy 1. Name of medicine? 2. Indication of medicine? 3. Strength of medicine? 4. Frequency/directions of medicine? Cutler, DM; Everett, W. Thinking Outside the Pillbox Medication Adherence as a Priority for Health Care Reform. N Engl J Med 2010; 362:

14 Criteria for Post- Discharge Follow- Up Adherence Literacy High literacy Intermediate literacy Low literacy High adherence No post-dc f/u needed Educate pt. No post-dc f/u needed Post-DC f/u needed Intermediate adherence Educate pt. No post-dc f/u needed Educate pt. No post- DC f/u needed? vs. Post-DC f/u needed? Post-DC f/u needed Use clinical judgment Low adherence Post-DC f/u needed Post-DC f/u needed Post-DC f/u needed

15 Post- Discharge Follow Up, Medica&on Literacy and Adherence Clinically significant discrepancies can result in adverse drug events and readmissions when patients go home or to a skilled nursing facility Post- Discharge Findings 58% of pts had discrepancies between their discharge medication list and what they were taking 33% of pts were taking more medications than were prescribed (excludes vitamins, herbals, etc) 35% of pts discharged to skilled nursing facilities had a drug related- problem 16% would have been readmitted based upon independent MD evaluation

16 High Cost Drugs for Complex, Chronic Diseases

17 Specialty Drugs Used to treat complex, chronic diseases such as multiple sclerosis, cancer, Crohn s disease, rheumatoid arthritis and orphan diseases Expensive: $20,000 to >$200,000/yr Generally injectable medications which need to be infused but can also include oral medications Require ongoing monitoring and patient follow up to ensure adherence and prevent adverse events Many are biologics which require special shipping, handling and storage

18 Specialty Drugs Represent 1/3 of national total drug costs $75.8 billion in 2010 >20% growth/year 2012 FDA approvals include 25 specialty drugs of which 13 are for cancer 907 drugs in biotech pipeline Anticipate that by 2018 will account for 50% of a health plan s pharmaceutical expenses. Represents 1-5% of population. Owens GM. New FDA approvals for 2013: a 15 year high. American Health and Drug Benefits.2013; 6(3): White Paper. Excelera Specialty Pharmacy Network ExceleraRX, LL. releases/specialty- drugs- will- account- for- 50- percent- of- all- drug- costs- by html. 18

19 Disease Complex, Chronic Diseases Cost/Patient/Year Cystic Fibrosis $300,000 Familial Hypercholesterolemia $176,000- injectable $295,000- oral Hereditary Angioedema Prophylaxis Hemoglobulinuria and Solid Organ Transplants Hunter Disease Cancer- oral drugs $350,000 $409,500 $375,000- $657,000 $60,000- $96,000

20 Complex, Chronic Diseases Medication Diseases Avg Cost Per Dose Infliximab Crohn s Disease, Rheumatoid Arthritis $2,000- $9,000 Immune Immune Disorders, $4,600 Globulin Transplant Ipilimumab Melanoma $30,000 Ziv- Aflibercept Colorectal Cancer $11,000 Brentumixab Large Cell and Hodgkin s $13,500 Vedotin Lymphomas Natalizumab Multiple sclerosis, Crohn s $3,600 Agalsidase Beta Fabry Disease $6,900

21 Complex Medica&ons Require Comprehensive Evalua&on of Each Prescrip&on Medication Ordered Patient with rheumatoid arthritis prescribed medication at 12.7 mg/kg; however dose should have been 8mg/kg Patient with multiple sclerosis prescribed medication and medical record review revealed previous anaphylactic (life threatening allergy) reaction Patient with Crohn s Disease had order for a herpes zoster (live shingles) vaccine Patient with Crohn s Disease with potential tuberculosis based on PPD Outcome Avoided Continuation of dose at 60% above manufacturer s maximum dose recommendations; risk of severe, life- threatening infections Potentially life- threatening allergic reaction Potential development of active shingle infection Potential exacerbation of infection and employee exposure

22 Pa&ent Considera&ons Many patients on specialty drugs have other diseases and conditions 30-40% of patients are not adherent Co- insurance and co- pays impact adherence and disease management Complex channels for how these medications are provided (restricted drug distribution systems) can create fragmentation of care Some medications are given in infusion centers Some are only available through specialty pharmacies Some are obtained through traditional community pharmacies

23 Managing Specialty Drug Complexity and Costs Multiple medications with risk for adverse events Multiple pharmacies and locations to obtain/administer medications Patient medication literacy, adherence and financial burden Essential patient care components: Complete and accurate medication lists Comprehensive patient and medication evaluation Determining optimal location for medication administration Patient education, ongoing follow- up and coordination of medications

24 Health Care Policy, Plan and System Considera&ons With the advent of multiple medications for treatment of the same disease, development of evidence- based guidelines will support rationale use Clinical pre- authorization by pharmacists can ensure compliance with guidelines and patient safety Biosimilars will provide some savings, however, these will require monitoring to ensure effectiveness and safety Efforts to de- fragment specialty drug channels are essential to achieve treatments goals and reduce costs

25 Pa&ent Safety Impera&ves Accurate medication handoffs at each transition of care are essential Medication lists are problem- prone and should be validated whenever patients access health care services Specialty drugs are complex, costly and require comprehensive evaluation and patient follow- up Pharmacists in collaboration with the health care team can play a key role in transitions of care and medication case management especially for high risk patients 25