2011 PPE Disclosure Statement

1. 2011 PPEDisclosure Statement It is the policy of the Oregon Hospice Association's (OHA) Continuing Medical Education Program to insure balance, independence, objectivity, and scientific rigor in all its educational programs. All faculty participating in any OHA-sponsored programs are expected to disclose to the program audience any real or apparent affiliation(s) that may have a direct bearing on the subject matter of the continuing education program. This pertains to relationships with pharmaceutical companies, biomedical device manufacturers, or other corporations whose products or services are related to the subject matter of the presentation topic. The intent of this policy is not to prevent a speaker from making a presentation. It is merely intended that any relationships should be identified openly so that the listeners may form their own judgments about the presentation with the full disclosure of the facts. Dr. Lewarne is a contractor for ProCare Hospice Care.

2. DEA Interpretation of the Controlled Substances Law and Federal REMS Program: Impacts for End-of-Life Care Dr. Raeanna Lewarne, R.Ph., PharmD, BCPS Oregon Hospice Association Sept 2011

3. Presenter & Disclosure Presenter: Dr. Raeanna Lewarne, RPh, PharmD, BCPS • Clinical Sales & Marketing Consultant for ProCareHospiceCare LLC; Duluth, GA • Owner and President of Vital Healthcare Solutions LLC; Minneapolis, MN • Clinical Writing Instructor for University of Colorado Health Sciences Center; Aurora, CO Disclosure: The presenter has been a consultant/advisor to Bristol-Myers Squibb Co, Plainsboro, NJ, Otsuka America Pharmaceutical Inc, Rockville, MD and ProCare HospiceCare LLC, Duluth, GA.

4. Learning Objectives • Provide a history of pain management risk versus benefit evaluation and its relation to DEA interpretation of C-II law, the new opioid REMS program, and impact for hospice. • Explain the new DEA ruling of “Agent of the Physician” and how it impacts the hospice industry. • List DEA requirements for written, faxed and e-prescribing of C-II through C-IV medications. • Describe the role and intent of the new federal Risk Evaluation and Mitigation Strategy (REMS) program for opioids.

5. History of Pain Management • Opiophobia Era (1990 and prior) • Routine under treatment of pain supported by “Do No Harm” • Enlightened Era (1990-2002) • Clinical practice guidelines emerged • Increase in prescribing opioids. Increase in addiction. • Pharmacovigilant Era (2002 – present) • Increased regulations in light of increased prescribing

6. The Pharmacovigilant Era • Need to ensure appropriate pain relief balanced by an equally important need to protect public against drug addiction, diversion and trafficking. • Contrary to Oath of Hippocrates and the physicians allegiance to the well being of the patient. Of Ethical Concern! • due to competition between the patient and societal obligations on the part of the physician • threat of serious sanctions if patients are given the benefit of the doubt.

7. How Have These Progressive Changes Impacted our Current State of Action?

8. Recent Pharmacovigilance • DEA fines nursing home pharmacies in Ohio, Michigan, Virginia and Wisconsin in 2009 for violation of Controlled Substance Act • Nursing home RN may not call in orders to the NH pharmacy • Nursing home pharmacy may not dispense controlled substances without original prescriber’s order

9. DEA Actions • DEA agents have conducted inspections in several LTC pharmacies • Chart order faxed to Rx is not a valid script [42 CFR 1306.21] • Nursing home RN not able to phone in order to Rx • This includes medications dispensed from ebox

10. DEA Regulations Long term care environment and practices are different but not exempt from compliance with CSA regulations. Nursing homes are not prescribers or dispensers or registrants under the regulation. DEA has indicated nurses are not agents of the practitioner under the regulation.

11. DEA RegulationsREVIEW

12. DEA Regulations – Review:Requirement of a CS Script • All prescriptions for controlled substances shall be dated as of, and signed on, the day when the issued and shall bear: • the full name and address of the patient, • the drug name, strength, dosage form, • quantity prescribed (written & number), • directions for use, • refill information (none for CII) and • the name, address and DEA registration number of the practitioner. http://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_05.htm

13. DEA Regulations – Review:Dispensing of CII Medication (a) A pharmacist may dispense directly a controlled substance listed in Schedule II, which is a prescription drug as determined under the Federal Food, Drug and Cosmetic Act, only pursuant to a written prescription signed by the practitioner, except as provided in paragraph (d) of this section. A prescription for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner’s agent to a pharmacy via facsimile equipment, provided that the original written, signed prescription is presented to the pharmacist for review prior to actual dispensing of the controlled substance, except as noted in paragraph (e), (f) or (g) of this section http://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_11.htm

14. DEA RegulationsExceptions to a written CII (d) Emergency (e) Compounded for direct administration (f) For a Long Term Care Facility resident **The prescriber or agent must note that patient is enrolled in a LTCF on the script** (g) For a patient enrolled in a hospice care program certified and/or paid for my Medicare under Title XVIII or a hospice program which is licensed by the state. **The prescriber or agent must note the patient is enrolled in hospice on the script** http://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_11.htm

15. DEA RegulationsNEW Electronic Guidelines (e) Electronic prescription for Controlled Substances recently approved An approved electronic prescription and verification system can take the place of the written signature requirement 1311.135 (a) Only the registrant or his agent can enter data for a controlled substance prescription, provided that only the registrant may sign the prescription in accordance with 1311.120(b)(11) and 1311.140. http://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_05.htm http://www.deadiversion.usdoj.gov/21cfr/cfr/1311/subpart_c100.htm#135

16. DEA Regulations - Review: Refilling & Issuing Multiple Scripts (a) The refilling of a prescription for a controlled substance listed in Schedule II is prohibited (b)(1) An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance provided: (i) for a legitimate medical purpose (ii) written instructions indicating the earliest date on which a pharmacy may fill each subsequent prescription (iii) the practitioner determines that providing the patient with multiple prescriptions does not create an undue risk of diversion or abuse (iv) state law must allow it http://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_12.htm

17. DEA Regulations – Review:Partial Filling of CII Scripts (b) A patient in a Long Term Care Facility (LTCF) or documenting a terminal illness may be filled in partial quantities to include individual dosage units. The pharmacist must record on the prescription whether the patient is "terminally ill" or an "LTCF patient." A prescription that is partially filled and does not contain the notation "terminally ill" or "LTCF patient" shall be deemed to have been filled in violation of the Act. Schedule II prescriptions for patients in a LTCF or patients with a terminal illness shall be valid for a period not to exceed 60 days from the issue date unless sooner terminated by the discontinuance of medication. http://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_13.htm

18. Agent of the Physician

19. Controlled Substance Act • CSA’s purpose is to prevent illegal trafficking & abuse of potentially harmful or addictive substances • Requires specific criteria for a prescription • States a script may be prepared by the agent for the signature of the practitioner, but the prescribing practitioner is responsible for all aspects of the prescription and for the medical determination • Again, nothing can be delegated to the agent • The prescriber MUST decide when, if, and what the patient needs 21 USC Sec 801a. http://uscode.house.gov/download/pls/21C13.txt http://www.federalregister.gov/articles/2010/10/06/2010-25136/role-of-authorized-agents-in-communicating-controlled-substance-prescriptions-to-pharmacies

20. Definition of “Agent” per Controlled Substance Act • An authorized person who acts on behalf of or at the direction of a manufacturer, distributor or dispenser • Note dispenser includes prescriber • An agent can communicate the information to the pharmacy via hand delivery, facsimile, phone call or an electronic transmission • CANNOT make the determination for medical need • CANNOT sign or call in an order on behalf of the prescriber without the official order FIRST Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies. Drug Enforcement Agency, 21 CFR 1306. The Federal Register, Rules and Regulations. Oct 6, 2010; 75(193): 61613-7. http://www.federalregister.gov/articles/2010/10/06/2010-25136/role-of-authorized-agents-in-communicating-controlled-substance-prescriptions-to-pharmacies

21. The issue… • The DEA does not consider a nurse in LTC facility to automatically be an authorized agent of the physician (i.e. CANNOT call or fax an order for the physician) • Pharmacy can’t release a physician’s order for a controlled substance from the nurse until it is received from the physician • Enforcement of the lack of “explicit and transparent agent authorization” is what prompted the citations by the DEA of LTCFs & pharmacies in 2009 • This is now being enforced to include patients outside of the LTC setting

22. Compliance with CSA requirements To be consistent with the purpose of the CSA to implement a “closed system” of distribution and for DEA to enforce this framework, an agency relationship between a registered individual practitioner and an identified agent for the purposes of communicating controlled substance prescriptions must be explicit and transparent. DEA believes its existing regulations are adequate in addressing the role of an authorized agent but will analyze whether additional federal rulemaking or guidance is needed beyond this statement to establish the necessary explicit and transparent nature of an authorized agency relationship, particularly when outside an employer-employee relationship.

23. Who is an Authorized Agent? • As of October 6, 2010, to be an agent of the physician the DEA “believes it in the best interests of the practitioner, the agent, and the dispensing pharmacist that the designation of those persons authorized to act on behalf of the practitioner and the scope of any such authority reduced to writing.” • The DEA has not given specific guidance as to an agreement that is not individually signed (i.e. an all-encompassing agreement between the physician and a nursing facility) • Pharmacists will likely require proof of “agency status” prior to dispensing • Agency agreement example provided by DEA http://www.amda.com/advocacy/dea.cfm?printPage=1&. July 8, 2011.

24. NHPCO & OHA Stance • Estimated that 90% of hospices have not implemented contractural agreements between physicians and hospice nurses • There is lack of clarity as to if and/how this regulation impacts hospices • NHPCO working group does not wish to risk asking the DEA thereby putting hospices at risk for further scrutiny and/or legal action • Hospices should weigh the risks versus benefits of implementing contract agreements Jacques D. Personal Communication – NHPCO Working Group. Sept 7, 2011.

25. Up to date information Great resources • American Medical Directors Association • http://www.amda.com/advocacy/dea.cfm?printPage=1& • Federal Register • http://www.federalregister.gov/articles/2010/10/06/2010-25136/role-of-authorized-agents-in-communicating-controlled-substance-prescriptions-to-pharmacies • Specific questions: • Mark W. Caverly, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration • 8701 Morrissette Drive, Springfield, VA 22152 • (202) 307-7297

26. Review • A LTCF nurse is NOT automatically considered an agent of the physician by the DEA – especially when no direct employer-employee relationship explicit and transparent • No double agents (an agent cannot delegate to another person) • All controlled substances must contain the valid elements of a prescription • Remember: it is the DUTY of the pharmacist to verify all prescriptions, patient information and agency relationships

27. Review • CIIs: • Must have an INK signature unless electronically sent • Can only be sent via fax if for a LTCF or pt with a terminal diagnosis AND this information is written on the script by the prescriber or agent • An agent may NOT call in an emergency CII prescription • Pharmacist must receive written or electronic prescription within 7 days or they are required to report it • No refills ever allowed • Partial dispensing is routinely allowed for LTCF & terminal diagnosis patients

28. Review • CIII, CIV & CV • Can be verbal, written, faxed or electronically sent (with prescribers signature) by prescriber or agent • CIII & CIV may only have a maximum of 5 refills in a 6 month period

29. What Hospice Can Do • Petition for change! Allow LTC facilities the same privileges as hospitals • Educate local pharmacies regarding the federal law • Be familiar with your state’s laws • Obtain an organizational agent of the physician contract when needed

30. What YOU can do • Be proactive! Anticipate the needs of the patient to obtain meds before a symptom crisis occurs • Form relationships with your local physicians and pharmacists • Be familiar with your state and federal laws • Obtain an organizational agent of the physician contract when needed

31. Risk Evaluation Mitigation Strategies

32. REMS • REMS = Risk Evaluation Mitigation Strategies • Released in April 2011 as part of a comprehensive action plan to address the national prescription drug abuse epidemic • A risk management plan that FDA can require a drug company to manage risks of a drug or biological product • Safety & educational program designed to ensure benefits outweigh the risks & risks of harm are minimized

33. Opioids With REMS • Thus far: • Abstral (fentanyl sublingual tablets) • Embeda (morphine sulfate and naltrexone) ER capsules • *No longer marketed but still approved • Morphine sulfate oral solution • Onsolis (fentanyl buccal soluble film) • Oxycodone oral solution • Oxycontin (oxycodone) CR tablets

34. FDA Goal • All long-acting and extended-release opioids will have a REMS program as there is a disproportionate safety problem associated with long-acting medications • Butrans (transdermal buprenorphine) • Dolophine (methadone) • Duragesic (transdermal fentanyl) • Exalgo (hydromorphone SR) • MS Contin, Kadian, Avinza, Oramorph (all morphines) • Opana ER (oxymorphone)

35. REMS Plan Must Contain • Product and contact information (provided by manufacturer) • Timetable for submission of assessments • May include Additional Elements • Medication guide and/or patient package insert • Communication plan • Elements to assure safe use • Implementation system • Education program for healthcare professionals • Patient education

36. Goals • Definition of Goal: desired safety-related health outcome or the understanding by patients and/or health care providers of the serious risk targeted • Must include one or more goals to reduce a serious risk • Opioid REMS goal: • Manufacturers describe & submit percentage of prescribers who complete the program at specified times • FDA expects the manufacturers of all LA & ER opioids to work together to reduce the burden on the REMS system

37. Medication Guide &Patient Package Insert • Based on professional & FDA-approved patient labeling • Required with dispensing if: • Patient labeling could help prevent serious adverse effects • Drug has risks the patient should be aware of and may effect their decision to use or continue use of the product • Drug is important for health and patient adherence to directions is critical to the drug’s effectiveness

38. Communication Plan • To inform key audiences about the risks of the drug • Manufacturers letters to healthcare providers • Promoting information about REMS programs • Explain safety protocols • Using professional societies to inform of risks and safety issues • Opioids REMS will require: • Manufacturer to develop an educational program for prescribers and patients • Information will be provided directly or through accredited CME

39. Elements to Ensure Safe Use Established to reduce a specific, serious risk listed with the drug Example Requirements: • HCPs have particular training, experience, or certification • Pharmacies, practitioners, or healthcare settings specially certified • Only dispensed in certain settings (i.e. infusion centers, hospitals) or to patients with evidence of safe-use (i.e. appropriate lab values) • Each patient using the medication may be subject to monitoring or enrolled in a registry

40. Prescriber Safe Use Example Requirements • Certification • Required to demonstrate: • Knowledge of risks and benefits • Ability to diagnose the condition for which the product is indicated • Ability to diagnose and treat potential adverse reactions

41. Prescribers & Opioid REMS • Opioids REMS • Manufacturer mandated prescriber education material for Opioids • Information on weighing risks versus benefits • Choosing patients • Managing and monitoring patients • Counseling patients • Recognize evidence & potential for misuse, abuse & addiction • At this time there will be no cost to participants & participation is voluntary

42. Safe Use: Pharmacists Example requirements • Only certified pharmacies (or certified physicians offices & healthcare settings) may dispense a particular REMS medication • Complete and sign enrollment forms • Develop order sets and protocols to ensure safe administration & dispensing • Train and provide education materials to selves & other HCPs • Provide info on ADE reporting

43. Safe Use: Patients Example requirements • Documentation of patient consent or understanding of risks • Pregnancy, LFT or other safe use tests • May be subject to monitoring (i.e. followed by physician q6months) • Enrolled in registry • Patient Education Opioid REMS • How to use and store products safely • Prescriber must counsel the patient on safe use • Will receive a Medication Guide with prescription

44. Timetable for Assessments • Timetable every 18 months, 3 years and 7 years after REMS is approved • FDA may choose shorter or longer frequencies • FDA can eliminate assessments if deemed unnecessary

45. Primary Concern: Patient Access to Medications Restricted? • Recent enforcement of DEA regulations • Agent of the physician • Opioid REMS • Central component to date will be education program for prescribers and patients • FDA very concerned about not interfering with access to pain treatment – diligent plan to continue without direct restrictions at this time

46. Opioid Certification Mandatory for Prescribers? • Originally thought the FDA was going to develop a plan linked to a HCPs ability to prescribe or dispense opioids • At this time deemed to be overly burdensome, HOWEVER… • As part of the comprehensive plan, • If the legislation will end up deciding to link prescriber education to DEA registration • Then it will require mandatory education without creating a duplicative system with manufacturers • Goal is still for FDA to eventually tie opioid education to DEA registration criteria

47. Update on Implementation of Opioids REMS May 16, 2011 FDA met to discuss next steps in implementing a REMS for opioids through a single shared system. Discussed: • Prescriber training • Medication Guides • REMS assessment plan • Administrative requirements FDA expects to provide Medication Guide documents on Opioid REMS by June 24, 2011 All manufacturers with an ER/LA opioid identified were required to submit plan to FDA by Aug 17, 2011 http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm259649.htm

48. Resources • FDA REMS and Opioid Analgesics Webinar • http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163655.htm • FDA Q&A on Long-Acting and Extended-Release Opioid REMS • http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm251752.htm • FDA-approved REMS list • http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

49. Entire safety system revolves around the individual

50. Pain Management is All About Body Composition Renal Function Hepatic Function Environment of care Ambulation status Etiology of Pain