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

Transcription

1 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 of interest. 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. 1

2 the opioid lawsuits Cnty. Of Chippewa v. Purdue Pharma L.P. Manufacturers Allergan fka Actavis (Watson) Cephalon Endo Insys Janssen Mallinckrodt Teva Pharmacies Costco CVS Health Rite Aid Walgreens Wholesalers Amerisourcebergen Cardinal Health Masters Pharmaceuticals McKesson Omnicare Distribution Center Manufacturers The failure of all Manufacturer Defendants to effectively monitor and report suspicious orders of prescription opioids, their aggressive misinformation campaigns aimed at increasing public consumption of highly addictive opioids, their failure to forthrightly provide accurate information to FDA, their failure to adhere to FDA regulations regarding misbranding, their failure to implement measures to prevent the filling of suspicious orders, and their perverse utilization of so-called patient advocacy groups to evade FDA regulations concerning consumer drugmarketing greatly contributed to a vast increase in opioid overuse and addiction. Manufacturer Defendants conduct thus directly caused a public-health and law-enforcement crisis across this country, including in the County of Chippewa, Michigan. Cnty. of Chippewa v. Purdue Pharma L.P., No. 2:17-cv (W.D. Mich. Filed Dec. 19, 2017), at *16. 2

3 Wholesale Distributors The failure of all Distributor Defendants to effectively monitor and report suspicious orders of prescription opioids and to implement measures to prevent the filling of improper prescriptions greatly contributed to the vast increase in opioid overuse and addiction. Distributor Defendants conduct thus directly caused a public-health and law-enforcement crisis across this country, including in the County of Chippewa, Michigan. Cnty. of Chippewa v. Purdue Pharma L.P., No. 2:17-cv (W.D. Mich. Filed Dec. 19, 2017), at * Retail Pharmacies 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. 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. Cnty. of Chippewa v. Purdue Pharma L.P., No. 2:17-cv (W.D. Mich. Filed Dec. 19, 2017), at *17. Retail Pharmacies Last line of defense and gatekeeper 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. Cnty. of Chippewa v. Purdue Pharma L.P., No. 2:17-cv (W.D. Mich. Filed Dec. 19, 2017), at *73. 3

4 Retail Pharmacies The DEA s 2010 Practitioner s Manual section on Valid Prescription Requirements 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 *74. Retail Pharmacies (allegations) The Metrics System Pharmacists are directed to meet unattainable goals; if the goals were met, they would violate the law about professional responsibilities and governing practice rules No measurement for pharmacy accuracy or customer safety Pharmacist bonuses are calculated on how many prescriptions that pharmacist is able to fill within a year Pharmacists required to fill more than 600 prescriptions per work shift Increased demand for productivity with cuts in pharmacy technician hours, leaving pharmacists severely understaffed and unable to to provide all services required by the MAPS system Cnty. of Chippewa v. Purdue Pharma L.P., No. 2:17-cv (W.D. Mich. Filed Dec. 19, 2017), at *77. Retail Pharmacies (allegations) Pharmacy policies 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 Cnty. of Chippewa v. Purdue Pharma L.P., No. 2:17-cv (W.D. Mich. Filed Dec. 19, 2017), at *79. 4

5 Retail Pharmacies (allegations) 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. More than 320 lawsuits are consolidated into one multidistrict litigation case before Ohio District Court Judge Dan Polster Photo source: National Prescription Opiate Litigation Judge s comments with attorneys in MDL [I]n my humble opinion, everyone shares some of the responsibility, and no one has done enough to abate it. That includes the manufacturers, the distributors, the pharmacies, the doctors, the federal government and state government, local governments, hospitals, third-party payors, and individuals. Just about everyone we ve go on both sides of the equation in this case.... I m confident we can do something to dramatically reduce the number of opioids that are being disseminated, manufacturer, and distributed. Just dramatically reduce the quantity, and make sure that the pills that are manufactured and distributed go to the right people and no one else, and that there be an effective system in place to monitor the delivery and distribution, and if there s a problem, to immediately address it and to make sure that those pills are prescribed only when there s an appropriate diagnosis, and that we get some amount of money to the government agencies for treatment. Because sadly, every day more and more people are being addicted, and they need treatment. Transcript of Proceedings at 412, In re: Nat l Prescription Opiate Litig., No. 1:17-md DAP (N.D. Ohio Filed Jan. 9, 2018). 5

6 the pharmacist s corresponding responsibility You can t, unless you can. The Controlled Substances Act is unique among criminal laws in that it stipulates acts pertaining to controlled substances that are permissible. That is, if the CSA does not explicitly permit an action pertaining to a controlled substance, then by its lack of explicit permissibility the act is prohibited. Electronic Prescriptions for Controlled Substances Final Rule, 75 FR 16236, (Mar. 31, 2010) (revising 21 CFR 1300, 1304, 1306 and 1311). 21 CFR Purpose of issue of prescription. (a) 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. (b) A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients. (c) A prescription may not be issued for "detoxification treatment" or "maintenance treatment," unless the prescription is for a Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment and the practitioner is in compliance with requirements in of this chapter. 6

7 Fulfilling your corresponding responsibility is a process that requires professional judgement. It is not a checklist. Verify prescriber s license and registration Ensure the prescription has all required information Avoid dispensing certain drug combinations Resolve and document red flags before dispensing Know and follow REMS program requirements Prescription Drug Monitoring Program (MAPS) Naloxone access Drug take back programs The VIGIL system 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. 7

8 opioid treatment guidelines Characteristics of Initial Prescription Episodes and Likelihood of Long-Term Opioid Use The largest increments in probability of continued use were observed after the: fifth and thirty-first days on therapy second prescription 700 morphine milligram equivalents cumulative dose first prescriptions with 10- and 30-day supplies Highest probability (predictors) of long-term use associated with treatments initiated with 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: Characteristics of Initial Prescription Episodes and Likelihood of Long-Term Opioid Use Days supply No. of prescriptions 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: 8

9 Acute pain treatment guidelines Use nonopioid therapies first Nociceptive pain APAP and NSAID s (arthritis & low back pain) Neuropathic pain Select antidepressants or anticonvulsants Exercise, weight loss, cognitive behavioral treatment (CBT), interventional treatments with injections, etc. Acute pain treatment guidelines Educate patient before starting opioids Realistic expected benefits Opioids can reduce pain during short- term use, but there is no good evidence that opioids improve pain or function with long-term use Complete pain relief is unlikely Common and serious harms Constipation, dry mouth, nausea, vomiting, drowsiness, confusion, tolerance, physical dependence, and withdrawal symptoms when stopping Serious risks include fatal respiratory depression and lifelong opioid use disorder Expectations for clinician and patient responsibilities to mitigate risks of opioid therapy Primary goal is improved function, which may occur while pain still present 9

10 Acute pain treatment guidelines Take the lowest effective dose and set treatment goals (expectations) Goals are an exit strategy Pain relief Functional goals (e.g. walk the dog, walk around the block, return to part-time work, attend a family sporting event or other recreational activity) Pain average, interference with Enjoyment of life, and interference with General activity (PEG) Assessment (clinically meaningful improvement means 30% improvement in scores) Use other validated instruments for comorbidities to ensure other conditions are optimized Use immediate-release opioids Extended-release and long-acting formulations are not appropriate for acute pain treatment Methadone, transdermal fentanyl, and extended-release versions of opioids such as oxycodone, oxymorphone, hydrocodone, and morphine Acute pain treatment guidelines Limit days supply to expected pain duration Acute pain Three days or less often sufficient More than seven days is rarely needed Chronic pain Pain lasting longer than 3 months or past the time of normal tissue healing (which could be substantially shorter than 3 months, depending on the condition) is generally no longer considered acute. Cancer treatment, palliative care, or end-of-life care have different treatment guidelines The pharmacist s role Know the treatment guidelines Acute pain treatment should be 3-7 days and only treated with immediate-release opioids, if an opioid is necessary. Combinations of opioids and benzodiazepines are the exception Patients receiving 50 MME or more daily should have a treatment plan Use of 90 MME or more daily should be the exception Educate patients Opioids will not eliminate pain; the goal is improved quality of life Make patients aware of naloxone with risk for opioid overdose (i.e. history of overdose, history of substance use disorder, or 50 MME/day or more) Review your state s Prescription Drug Monitoring Program MAPS 10

11 2018 Michigan law changes annual controlled substance inventory requirement Controlled substance inventory Licensed manufacturers, distributors, prescribers, and dispensers must conduct an inventory of all controlled substance (CII-V) drugs each year Must occur between April 1 and June 30 each year Keep inventory record for 2 years Don t forget to 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 Removed (up to) $25,000 fine for failure to conduct inventory Must make inventory available to LARA upon request 11

12 Scheduling Tianeptine sodium Not available in the U.S. Schedule 2 drug in Michigan effective July 4, 2018 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 Naloxone 12

13 Increased naloxone accessibility 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 Increased naloxone accessibility 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 Increased naloxone accessibility 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 MCL c 13

14 Increased naloxone accessibility Statewide naloxone standing order Definition of prescription includes the chief medical executive s standing order for naloxone Allows a pharmacist to dispense from the standing order Receipt may include a reference to the standing order instead of a serial number (Rx number) MCL e MAPS MAPS registration Prescribers must register with MAPS before prescribing or dispensing a controlled substance to a patient Effective June 1, 2018 New sanctions available for failure to register If an investigation by LARA reveals a prescriber did not register with MAPS before prescribing a controlled substance, the complaint may be taken to the disciplinary subcommittee OR it may issue a notification letter about possible PHC violation (the letter is not discipline). The DSC s options include: denial, fine, reprimand, probation, limitation, suspension, revocation, or permanent revocation (may also require CE, training program, treatment program, examination, or any combination) MCL a, , 16221, 16221b,

15 MAPS reporting Beginning March 27, 2018, prescribers and dispensers must report to MAPS any controlled substances that are dispensed Does not apply to: The administration of a controlled substance directly to a patient. Dispensing prescribers from a health facility or agency (e.g. freestanding outpatient surgical center, hospice, hospitals, mobile dental facilities) if quantity is not more than a 48 hour supply Inpatient hospital administration Veterinary hospitals/clinics administering CS while animal is inpatient Methadone and buprenorphine dispensed to a patient at a substance use disorder program, if the patient consents (if required), must be reported. Maintain consent form and provide to LARA upon request. MCL a MAPS reporting New sanctions for failure to report (disciplinary subcommittee action) Mandatory sanctions for violations by the disciplinary subcommittee (DSC) First violation: Remedial CE program on prescription drug and opioid addiction Second or subsequent violation (or failure to complete CE program): DSC may impose denial, fine, reprimand, probation, limitation, Suspension, revocation, or permanent revocation of license if purposeful violation MAPS reporting Prescribers must obtain and review MAPS report before prescribing or dispensing a controlled substance that exceeds a 3- day supply Effective June 1, 2018 Does not apply to controlled substances: Administered to a patient in a hospital or freestanding surgical outpatient facility Administered to an animal in a veterinary hospital or clinic Prescribed by a veterinarian to be dispensed by a pharmacist MCL a 15

16 MAPS reporting New sanctions available for failure to obtain and review MAPS If an investigation by LARA reveals a prescriber did not register with MAPS before prescribing a controlled substance, the complaint may be taken to the disciplinary subcommittee OR it may issue a notification letter about possible PHC violation Notification letters are non-disciplinary The DSC s options include: denial, fine, reprimand, probation, limitation, suspension, revocation, or permanent revocation (may also require CE, training program, treatment program, examination, or any combination) MCL , 16221b, Prescribing Ask and document before prescribing 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) 16

17 Prescriber-patient relationship Controlled substances must not be prescribed unless there is a bona fide prescriber patient relationship with the patient the CS is prescribed for. Effective March 31, 2019, or sooner if CS rules promulgated by BoP 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 2018 Telehealth 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 Follow-up care required Starting March 31, 2108, for telehealth services: The provider must be available to provide follow-up 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,

18 Prescriber-patient relationship 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 , 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) 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 inperson 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) 18

19 Prescribing opioids for acute pain Effective July 1, 2018 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 Prescribing opioids to minors Effective June 1, 2018 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*); 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) *If consent is an other adult, may not prescribe more than a 72-hour supply MCL b 19

20 Prescribing opioids to minors Parent/guardian/adult 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) Dispensing Additional quantities 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), effective February 11,

21 partial dispensing rules CII s Consistent with federal law Supply 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. LTCF/Terminally Ill Rule 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. 21 USC 829(f), 21 CFR , MCL (3), eff. 3/27/2018 Patient/Prescriber Request Rule 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. partial dispensing rules CIII-V s CIII-V controlled substance prescriptions may be partially filled if: Each partial filling is recorded in the same manner as a refill. The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and No dispensing occurs after 6 months after the date on which the prescription was issued. 21 USC 829(f), 21 CFR , MCL (3), eff. 3/27/2018 Questions. 21