1. Daniel Wermeling, Pharm.D. Professor, College of Pharmacy

2. Is Pain a Symptom or a Disease or Both? Is There a Moral/Ethical Obligation to Treat Pain? Is Pain Treatment a Basic Human Right? Is There a Legal Obligation to Treat Pain?

3. An Unusual Legal Standard Dual duties Typically only to patient Given opioid problems, also duty to society Legal Principle of Balance Yet if pain management was optimized would harms be reduced?

4. 2009 Rx Opioid Poisoning Data 2012 - ~ 40,000 deaths from DAWN reports from prescription drug overdose 16,000 were opioid related Underestimate – why? In Ky – 2012 - about 1000 deaths 4

5. Drug Abuse and Overdose is Directly Tied to Access KY Opioid Mortality Rate 15.3/ 100K KY is about 70,000 gms/100K in Sales

6. Reactions to Overdose Epidemic New Laws and Regulations Creating Potential Professional Jeopardy Federal State Local Professional Licensing Boards Professional Societies Pseudo-government agencies Criminal Prosecution Administrative Action Civil Malpractice

7. Federal Initiatives FDA – Food Drug and Cosmetic Act Drug approval process – determine if product is safe and effective REMS – Risk Evaluation and Mitigation Strategies DEA- Controlled Substance Act Issue/rescind licenses to authorized prescribers, pharmacies and pharmacists With FDA assess drug abuse liability and schedule Issue national quota for industrial production or importation of each CS Control returns and destruction of CS

8. Federal Initiatives Center for Medicare Services – Insurability EPA – Environmental Protection Act Drugs as waste – water, air, and land

9. State Initiatives New laws and regulations KY HB 1 – see handout Facilities and ownership Prescribing and dispensing KASPER Medicaid – reimbursement pressures Pharmacists and dispensing Substance abuse treatment and harm reduction

10. Other Initiatives Licensing Boards – Professional Standard of Care Professional Societies – Guidelines, Best Practices Local government Ordinances to ban pain clinics Zoning restrictions on locations Law enforcement drug take-back days Public Health – Substance abuse treatment and harm reduction

11. Professional Duty Prescribe and Dispense Legally Authorized and Therapeutically Appropriate Analgesics Consistent with getting the right drug to the right patient Denial of opioid to a legitimate patient can be a liability Giving access to an inappropriate patient can be a liability

12. Controlled Substance Duty Grid Valid? YesNo Ther. App.? Yes Prescribe Dispense Error NoError Is Rx legally valid? Is Rx therapeutically appropriate? How do you decide? What is the balance of harms when you err?

13. Duty Expanded Knowledge-based standards apply You have the background to know the benefits and harms Professional standards apply Meaning that you have to exercise good judgment Patient and societal expectations apply

14. Biases that lead to under-treatment of pain Just “Say No” is not appropriate Play it safe, no harm if drug retained or “ not stocked” Prejudice/ bias against minorities and poor Fear of regulation or liability Reimbursement problems Off label use

15. Areas Where Care/Caution is Necessary Obvious Fraud – bulk Rx writing Ambiguous Rx Over-zealous screening – conservatism and alienating patients What else is required? Preserving patient care relationship Go beyond processing and make sure patient’s pain therapy goals are being met

16. Challenges to Duty Palliative Care Pain Relief Promotion Act Oregon law permitted physician assisted suicide, including use of Controlled Substances, “in violation of the Controlled Substance Act” It is/was illegal to use a drug to hasten death Tension between the spectrum of improved pain management (analgesia at what cost in SE) palliative care, and physician assisted suicide Recent Supreme Court Ruling Against U.S. DOJ

17. What Are Additional Resources & Requirements to Manage Pain Therapy and Abuse/Overdose Risks? Industry has developed abuse-resistant formulations Industry-based educational programs KASPER and similar databases to query Doctor shopping Pharmacy shopping Over-use Enhanced law-enforcement

18. Food and Drug Administration Responses Risk Evaluation and Mitigation Strategies (REMS) Required for New Drug Approval – long-acting or extended release products Also materials and practices are required for generic drugs of originally approved drugs Clinical trials to assess risk Post-marketing trials to assess signals of risks or new unexpected risks

19. Medication Guides and Patient Package Inserts Communication tools Medication Guides Follow FDA approved labeling Based on additional professional labeling Required to be dispensed with the drug Actiq example www.actiq.com/pdf/actiq_med_guide_4_5_07.pdf

20. Communication Plans Industry must inform key audiences Letters to providers Information about REMS and safety protocols Information through relevant professional societies

21. Elements to Assure Safe Use Prescriber training, certification and demonstrate that: Understand risk-benefit and read materials Can diagnose product for the condition Can diagnose and treat adverse events associate with the risks of the drug product Pharmacies, practitioners and healthcare settings must the certified Drugs dispensed only in certain settings Patients are in a registry, subject to monitoring and subject to testing

22. Dispenser Assurances for Safe Use Only certified pharmacists enrolled in the REMS Only certain providers and settings Enrollment requires forms, and, Systems and protocols for safe use Training for dispensers and drug administrators Provide information on program adverse events to FDA

23. Patient Assurances For Safe Use Document understanding and consent Pregnancy, drugs or abuse and LFTs Subject to monitoring at least every 6 months Must be enrolled in a registry

24. Implementation Systems and Assessment Programs Industry to work with healthcare providers to assess compliance, adverse events, etc. Develop and maintain databases Providers, patients, dispensers, etc. Provide reports and assessment of activity, adverse events, known risks and potentially new and unknown risks

25. Patient Risk Assessment and Safe Use Group I – no past or present personal or family substance abuse issues or addiction Group II – past or family history but no current active addiction Group III – Patients with active substance abuse disorder or significant psychopathology Screening tools are available

26. How to Avoid Professional Jeopardy Are you operating “inside the box”, or “outside the box”, which can be OK for some patients, in relation to the legal standard of care? What is in the box? Typical pain indication (cancer, surgery, etc.) Daily dose of < 180 mg morphine equivalent Older patient Limited contact with non medical users No active psychiatric or substance abuse disorders Documentation, monitoring as appropriate

27. Pharmacists are Being Sued for Dispensing Opioids Kentucky, Ohio, Nevada and others Remember your duties Ask questions Get help Board of Pharmacy Drug Control Board DEA

28. 5 Steps Pharmacists Must Take to Ensure Validity of CS Rx Ensure state authorized prescribers write/order Prescription is written in the usual course of treatment Verify DEA registration Access prescriber and patient within prescription monitoring program Review the entire prescription order Changes or alterations in Rx Description of or access to treatment plan Date of issuance State specific versus federal requirements Documentation of your actions

29. Options When There is a Concern Regarding Inappropriate Prescribing Examine state law options regarding retention, return with note on back, or simple return to patient Contact the pharmacy PIC and or management about concerns Or contact Board of Pharmacy, Board of Medicine, DEA to investigate A KY pharmacist may seize a prescription thought to be inappropriate. Must turn over to law enforcement within 24 hours.