Pharmacy Law Update: Opioids and Other Drugs

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1 Pharmacy Law Update: Opioids and Other Drugs Charlie Mollien, PharmD, JD Director of Pharmacy Compliance & Privacy Officer Meijer Pharmacy & Meijer Specialty Pharmacy

2 Disclosures I have no material conflicts of interest. 1

3 Objectives 1. Describe the current state of the opioid epidemic in the United States. 2. Discuss the pharmacist's corresponding responsibility and processes and best practices. 3. Discuss the recent changes to the Michigan Public Health code about controlled substances. 2

4 The opioid crisis 3

5 MME dispensed in the U.S. peaked in 2011 From 2011 to 2017, MME dispensed declined by 29% from 240B MME to 171B MME. 4

6 The opioid lawsuits

More than 320 lawsuits are consolidated into one multidistrict

7 The opioid crisis Hundreds of lawsuits and the judge tasked with overseeing the litigation. More than 320 lawsuits are consolidated into one multidistrict litigation case before Ohio District Court Judge Dan Polster [I]n my humble opinion, everyone shares some of the responsibility... 6

8 Opioid lawsuit targets Drug companies, wholesale distributors, and pharmacies are being sued across America. Allergan fka Actavis (Watson) Cephalon Endo Insys Janssen Mallinckrodt Teva The failure to effectively monitor and report suspicious orders aggressive misinformation campaigns Misbranding failure to implement measures to prevent the filling of suspicious orders patient advocacy groups to evade FDA regulations concerning consumer drug-marketing Amerisourcebergen Cardinal Health Masters Pharmaceuticals The failure to effectively monitor and report suspicious orders McKesson Omnicare Distribution Center The failure to prevent the filling of improper prescriptions Cnty. of Chippewa v. Purdue Pharma L.P., No. 2:17-cv (W.D. Mich. Filed Dec. 19, 2017), at *

9 Opioid lawsuit targets Drug companies, wholesale distributors, and pharmacies are being sued across America. Costco CVS Health The failure of all Retailer Defendants to effectively monitor and report suspicious orders of prescription drugs and to implement measures to prevent filling of improper prescriptions greatly contributed to the vast increase in opioid overuse and addiction. Distributing excessive opioids Dispensing CS s despite red flags Rite Aid Walgreens Additionally, Retailer Defendants foisted a perverse incentive system on their employees that prevented their pharmacists from meeting their obligations under federal and Michigan law. In doing so, Retailer Defendants greatly contributed to the vast increase in opioid overuse and addiction. Inadequate training to stop employee diversion and suspicious prescriptions Rewards for filling opioid prescriptions Cnty. of Chippewa v. Purdue Pharma L.P., No. 2:17-cv (W.D. Mich. Filed Dec. 19, 2017), at *17. 8

10 Retail pharmacies Pharmacists are the last line of defense and the gatekeeper of prescription drugs. Policies and procedures Directly at odds with [the pharmacist s] performance of due diligence obligations Financially disincentive pharmacists from exercising due diligence, creating an untenable situation ripe for diversion, especially for a higher duty of care for dispensing opioids Inadequate training Failed to adequately train pharmacists and pharmacy techs on how to properly and adequately handle prescriptions for opioid painkillers What constitutes a proper inquiry into whether a prescription is legitimate Whether a prescription is likely for a condition for which the FDA has approved treatments with opioids, Measures and/or actions to take when a prescription is identified as phony, false, forged, or otherwise illegal. Failed to instruct pharmacists and pharmacy techs on how to address situations when they are forced to decline filling a prescription for a customer who submitted a prescription the pharmacist identifies as suspicious Cnty. of Chippewa v. Purdue Pharma L.P., No. 2:17-cv (W.D. Mich. Filed Dec. 19, 2017), at *79. 9

11 Retail pharmacies Pharmacists are the last line of defense and the gatekeeper of prescription drugs. Pharmacists are the last line of defense in keeping drugs from entering the illicit market. They are meant to be the drug experts in the healthcare industry delivery system and as such have considerable duties and responsibility in the oversight of patient care. They cannot blindly fill prescriptions written by a doctor, even one registered under the CSA to dispense opioids, if the prescription is not for a legitimate medical purpose. Pharmacists are the gatekeeper of a closed system of prescription drug distribution to protect the health, safety and welfare of our citizens through limited access to drugs that can have serious and lethal adverse consequences. The law does not require a pharmacist to dispense a prescription of doubtful, questionable, or suspicious origin. To the contrary, the pharmacist who deliberately ignores a questionable prescription when there is reason to believe it was not issued for a legitimate medical purpose may be prosecuted. Cnty. of Chippewa v. Purdue Pharma L.P., No. 2:17-cv (W.D. Mich. Filed Dec. 19, 2017), at *

12 Corresponding responsibility

13 With controlled substances, You can t, unless you can. Corresponding responsibility A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. Remember, state laws may further restrict how you handle dispensing of CS s. 21 CFR

14 Corresponding responsibility With controlled substances, You can t, unless you can. Fulfilling your corresponding responsibility is a process that requires professional judgement. It is not a checklist. 13

15 Corresponding responsibility With controlled substances, You can t, unless you can. Verify prescriber s license and DEA registration Ensure the prescription has all required information Avoid dispensing certain drug combinations Document and resolve all red flags before dispensing Know and follow REMS program requirements Use Prescription Drug Monitoring Programs (MAPS) Provide access to naloxone Know guidelines and educate prescribers and patients on proper use and disposal of opioids 14

16 Top reasons for DEA action against pharmacies DEA inspections of pharmacies expected to increase in 2018 and beyond. In 2017, the top 3 DEA enforcement areas resulted in $24 million in settlements against pharmacies. Filling prescriptions with invalid DEA numbers Store level diversion Recordkeeping violations 15

17 Other comments Accurate recordkeeping and inventory Be able to produce required records, such as prescriptions, invoices, 222 Forms, POA s, destruction records (DEA 41 Forms) Be able to reconcile your inventory for a DEA inspection Never allow a CS drug to be returned to the pharmacy, unless A dispensing error occurred, or The drug is recalled.

18 Opioid Treatment Guidelines

19 Know pain treatment guidelines Pain treatment is not intended to eliminate pain. Set realistic expectations To improve function; opioids will not eliminate pain No good evidence opioids improve pain or function with long-term use Use immediate-release opioids For acute pain, do not use Methadone, transdermal fentanyl, and extended-release versions of opioids such as oxycodone, oxymorphone, hydrocodone, and morphine Limit days supply to expected pain duration using the lowest-effective dose 3 days or less often sufficient for acute pain More than 7 days is rarely needed 18

20 Know pain treatment guidelines Pain treatment is not intended to eliminate pain. Dosing triggers A treatment plan should be in place with any patient taking 50 MME or more daily Using 90 MME or more daily should be the exception Offer naloxone to at-risk patients Patients must be aware of overdose risk Risk is greatest with history of overdose, history of substance use disorder, taking 50 MME Question unusual doses/combinations Acute treatment should usually be 3-7 days Opioid + BZD should be an exception 19

21 Characteristics of Initial Prescription Episodes and Likelihood of Long-Term Opioid Use The largest increments in probability of continued use were observed after the: Highest probability (predictors) of long-term use associated with treatments initiated with: Fifth and thirty-first days on therapy Second prescription 700 morphine milligram equivalents cumulative dose First prescriptions with 10- and 30-day supplies Long-acting opioids Tramadol Shah A, Hayes CJ, Martin BC. Characteristics of Initial Prescription Episodes and Likelihood of Long-Term Opioid Use United States, MMWR Morb Mortal Wkly Rep 2017; 66: DOI: 20

22 Focus Areas for the Government

23 Buprenorphine, one of the DEA s focus areas Both the DEA number and DEA Waiver ID are required for treating opioid dependence 22

24 Final comments on controlled substances Focused on Medicare data to identify misuse, abuse, and diversion. FDA oversight focused on using REMS to address opioid crisis OIG Workplan includes evaluating use of PDMP s EPS integrates with PMP Aware (INSPECT, MAPS, and OARRS) Evaluating proper billing Are claims adequately supported by proper documentation? Additional reviews of pharmacies with questionable billing will occur Invalid prescriber identifiers Payments made to entities after the patient s death 23

25 Recent DEA guidance

26 Transferring controlled substance prescriptions DEA issued new guidance in 2017 that changes its prior stance. Rx format Refill* Unfilled CII CIII-V CII CIII-V Paper, fax, or oral N/A Yes No Electronic N/A Yes Yes, electronically *Subject to the one-time transfer rule and its sharing of real-time, online database exception. 25

27 Recent Michigan law changes

28 Annual inventory

29 Annual controlled substance inventory Applies to manufacturers, distributors, prescribers, and dispensers Must conduct an inventory of all controlled substance (CII-V) drugs each year Between April 1 and June 30 each year Keep inventory record for 2 years Include name, address, DEA number, and indication of when inventory to was taken (e.g. opening or closing of business) No longer required to submit the inventory to LARA $25,000 fine for failure to conduct inventory removed from law Must make inventory available to LARA upon request 28

30 Controlled substances scheduling

31 Controlled substance scheduling Tianeptine sodium classified as a schedule II controlled substance effective July 4, Not available in the U.S. Used for depression and depression-associated anxiety in other countries There is evidence to suggest that the drug also is used recreationally for anxiolytic (anxiety-reducing) effects, and, in sufficiently high doses, affects the body like a narcotic. Available for online purchase as an unregulated 30

32 Naloxone

33 Making naloxone more accessible Prescriptions for naloxone may be issued to school boards. Naloxone may be prescribed and dispensed to individuals, school boards, or any other entity. Individuals at risk of opioid-related overdose Family members, friends, or other individuals who can assist someone experiencing an opioid-related overdose School board Any other person who acts at the direction of a prescriber, properly stores the drug, dispenses or administers the drug under a prescription for an individual, and does so free of charge. The patient name is the individual or entity the naloxone prescription is issued to (e.g. the name of the school board is the patient s name). MCL b 32

34 Making naloxone more accessible School board responsibilities and civil liability protections School boards may require at least two employees in each school to be trained to use and administer naloxone School RN s (or other trained employee) may possess and administer naloxone Must follow the Michigan Department of Education s medication administration guidelines Voluntary, but if required the school board must require one package of naloxone at each school Authorize the RN or trained employee to administer naloxone Notify the parent/legal guardian of an individual administered naloxone and encourage treatment Require school personnel to call 911 if a student may be experiencing an opioid-related overdose Annually report all instances of naloxone administration to the MDE Immunity from civil lawsuits for school employees Civil liability protections Prescribers and pharmacists for prescribing or dispensing naloxone Good Samaritans Does not apply if: Administered in a hospital by a MD, DO, PA, RN (NP), LPN Acting with willful and wanton misconduct (i.e. purposely cause harm or should have known your actions would cause harm) Stored or dispensed improperly by a prescriber or pharmacist Criminal and license disciplinary action protections Applies to anyone who administers naloxone in good faith 33

35 MAPS

36 New prescriber requirements with MAPS Michigan requires prescribers to be more informed and to education patients Prescribers must register with MAPS Prescribers must review MAPS June 1, 2018 Register w/maps Before prescribing or dispensing a CS Sanctions Compliant, or Notification letter DSC s options: denial, fine, reprimand, probation, limitation, suspension, revocation, or permanent revocation (may also require CE, training program, treatment program, examination, or any combination) June 1, 2018 Review MAPS Before prescribing or dispensing a CS when more than 3 days supply Exceptions: Administered to patient in a hospital or freestanding surgical outpatient facility Administered to an animal in a veterinary hospital or clinic Prescribed by DVM/VMD to be dispensed by RPh MCL A, , B,

37 MAPS reporting exceptions updated Law is effective March 27, In the following circumstances, CS do not need to be reported to MAPS: Administered in hospital while inpatient Dispensing prescribers for quantities less than a 48-hour supply from a freestanding outpatient surgical center, hospice, hospital, or mobile dental facility The administration of a controlled substance directly to a patient. Methadone and buprenorphine dispensed to a patient at a substance use disorder program, if the patient consents (if required), must be reported. Maintain consent from and provide to LARA upon request. Dispensing of controlled substances for inpatient animals at a veterinary hospital or clinic MCL a(1) 36

38 Prescribing

39 Ask and document before prescribing Law effective March 27, 2018 Before prescribing or dispensing a controlled substance to a patient, a licensed prescriber must: Ask the patient about other controlled substances the patient may be using Document the patient's response in the patient's medical or clinical record MCL a(3) 38

40 Prescriber-patient relationship Law is effective March 31, 2019 (or earlier if LARA promulgates rules) Controlled substances must not be prescribed unless there is a bona fide prescriber patient relationship with the patient the CS is prescribed for. Bona fide prescriber patient relationship means all of the following occurred by the prescriber: Reviewed the patient s medical records Completed a full patient assessment conducted in person or by telehealth Medical records created and maintained following medically accepted standards Pharmacists dispense in good faith, but have a corresponding responsibility (red flags must be resolved) MCL a, PA 101 of

41 Telehealth Understanding what it means. Telehealth The use of electronic information and telecommunication technologies to support or promote long-distance clinical health care, patient and professional health-related education, public health, or health administration. Telehealth may include, but is not limited to, telemedicine. Telemedicine The use of an electronic media to link patients with health care professionals in different locations. To be considered telemedicine under this section, the health care professional must be able to examine the patient via a real-time, interactive audio or video, or both, telecommunications system and the patient must be able to interact with the off-site health care professional at the time the services are provided. MCL (c), MCL

42 Telehealth Follow-up care must be available, but is required for controlled substances. Starting March 31, 2108, for telehealth services: The provider must be available to provide followup care or make a referral to another provider for treatment Starting April 2, 2018, When a controlled substance is prescribed, a prescriber must provide follow-up care to monitor the efficacy of the drug If follow-up cannot be provided, the prescriber must refer the patient to his or her PCP If the patient does not have a PCP, refer the patient to another prescriber geographically accessible to the patient for follow-up care MCL a,

43 Prescriber-patient relationship Prescribers are subject to disciplinary action for failure to comply with relationship requirement. If an investigation by LARA reveals the lack of a bona fide prescriber-patient relationship or the failure to provide required follow-up care, the complaint must be taken to the disciplinary subcommittee. The DSC s options are: Probation, limitation, denial, fine, suspension, revocation, or permanent revocation May also require CE; training program; treatment program; mental, physical, or professional competence examination; or any combination MCL ,

44 Compliance with federal law Ryan Haight Online Pharmacy Consumer Protection Act of 2008 Intended to regulate rogue internet pharmacies and the selling of controlled substances online Practice of telemedicine definition became effective January 15, 2010 that requires prescribers of controlled substances to Conduct at least one in-person medical evaluation of the patient before prescribing a controlled substance, or Meet an exception to the in-person medical evaluation before prescribing a controlled substance The term in-person medical evaluation means a medical evaluation that is conducted with the patient in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other health professionals. 21 USC 829(e) 43

45 Compliance with federal law Ryan Haight Online Pharmacy Consumer Protection Act of 2008 Exceptions Covering practitioner for another prescriber who has seen the patient in the last 2 years, whether in-person or by telemedicine and who does not conduct an in-person medical evaluation because he or she is temporarily unable to Treatment of a patient while in a hospital or research clinic Treatment of patients in the Indian Health Service or tribal units Treatment of patient in the physician presence of another practitioner registered with the DEA for prescribing controlled substances Special registration with the DEA (not available) Medical emergencies in the VA system Public health emergency declared by the U.S. Secretary of HHS Other exceptions created by regulation (none exist) 21 USC 829(e) 44

46 Prescribing opioids for acute pain Law is effective July 1, During a 7-day period of time, a prescriber may not prescribe more than a 7-day supply of an opioid for acute pain. Acute pain means pain that is the normal, predicted physiological response to a noxious chemical or a thermal or mechanical stimulus and is typically associated with invasive procedures, trauma, and disease and usually lasts for a limited amount of time. Pharmacists generally fill in good faith, unless they have reason to believe the prescribing is inappropriate. MCL b 45

47 Prescribing opioids to minors Law is effective June 1, Before an opioid may be prescribed the first time during a single course of treatment to a minor: Discuss with the minor and the minor s parent/guardian (or adult authorized to consent to treatment; if consent is other adult, may not prescribe more than a 72-hour supply); Risks of addiction and overdose Increase risk of addition with mental and substance abuse disorders Dangers of taking the opioid with a benzodiazepine, alcohol, or other CNS depressant Information required under 21 CFR (c)(18) Have the parent/guardian (or other adult) sign Start Talking Consent Form and place in the medical record (must be it s own document) Consent and required discussion not required for: Medical emergencies Treatment because of a surgery Situations where fulfilling requirements would be detrimental to the minor s health or safety, in the prescriber s professional judgment Treatment in hospice or a hospital oncology department or upon discharge Emancipated minors (legally not required) MCL b MCL b 46

48 msms.org michigan.gov/stopoverdoses

49 Dispensing

50 Dispensing more than the prescribed quantity Law is effective February 11, Additional quantities of a select prescription drugs may be dispensed at one time. Must consult the patient Allowed if in the pharmacist s professional judgment the additional quantity is appropriate Must have quantity remaining on prescription from total dosage units prescribed (never dispense more than total dosage units prescribed) Only applies to non-controlled substances and non-opioid schedule 5 drugs MCL (8) 49

51 Partial dispensing rules for CII s Effective March 27, 2018, Michigan law consistent with federal law Supply Rule LTCF/Terminally Ill Rule Patient/Prescriber Request Rule If the pharmacist is unable to supply the full quantity: Remaining portion may be dispensed within 72 hours of the first partial dispensing If remaining portion is not dispensed, the prescriber must be notified Prescriptions for patients in a LTCF or who are terminally ill: May partially dispense for 60 days from the issue date, or less if drug is discontinued. Record on the prescription LTCF patient or terminally ill. If the patient or the prescriber requests the prescription to be partially filled: The remaining portion may be dispensed within 30 days from the issue date. 21 USC 829(f), 21 CFR , MCL (3) 50

52 Questions.

Pharmacy Law Update: Opioids and Other Drugs. Disclosures. Objectives. I have no material conflicts of interest.

Pharmacy Law Update: Opioids and Other Drugs Charlie Mollien, PharmD, JD Director of Pharmacy Compliance & Privacy Officer Meijer Pharmacy & Meijer Specialty Pharmacy Disclosures I have no material conflicts