Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

Friday, March 23 - Legal Considerations for Prescribing Controlled Substances

30 views

Published on

Legal Considerations for Prescribing Controlled Substances
0006-0000-18-002-L03-P | .15 CEUs |
Tony J. Park, PharmD, JD

Published in: Law
  • Be the first to comment

  • Be the first to like this

Friday, March 23 - Legal Considerations for Prescribing Controlled Substances

  1. 1. Legal Considerations for Prescribing Controlled Substances TONY J. PARK, PHARM.D., J.D. 1
  2. 2. 2 Conflict of Interest Statement I have no conflicts of interests, whether they be real or apparent, nor do I have any financial interest in any company, product, or services that may be mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria.
  3. 3. The Goal of this presentation: Legal Considerations for Prescribing Controlled Substances is to inform and educate Pharmacists on how to furnish Naloxone, fulfill their corresponding responsibility, and more. 3
  4. 4. Learning Objectives  Evaluate the new regulations of controlled substances, like Naloxone and the dangers of erroneous prescribing.  Describe the importance of CURES and list how to register and utilize the program.  Outline the regulations for Naloxone furnishing in California.  Discuss the new pharmacist standard of practice to meet corresponding responsibility. 4
  5. 5. KEYS TO THIS LECTURE I. NALOXONE II. CORRESPONDING RESPONSIBILITY III. LEGITIMATE MEDICAL PURPOSE IV. RED FLAG INDICATORS V. NEW PROCEDURE FOR DISPENSING CONTROLLED SUBSTANCES i. CLEAR & CONVINCING EXISTENCE OF RED FLAG INDICATORS ii. DUTY OF INQUIRY / CONDUCT A REASONABLE INQUIRY 5
  6. 6. Naloxone - The Law  CA Business and Professions Code § 4052.01: a pharmacist may furnish naloxone in accordance with a protocol approved by the Board of Pharmacy and Medical Board of California.  Emergency regulation took effect 04/10/2015 - permanently adopted regulation took effect 01/28/2016.  Emergency regulation took effect April 10, 2015 – in effect until April 10, 2016.  Permanently adopted regulation took effect January 28, 2016, replacing the emergency version : California Code of Regulations (CCR) § 1746.3. 6
  7. 7. Naloxone – How to Be Trained to Furnish Pharmacist may furnish Naloxone HCl so long as: 1. Completed a minimum of one hour of an approved C.E. program specific to the use of naloxone in intramuscular, intranasal, and all other FDA approved formulations; OR 2. Completed an equivalent curriculum-based training program completed in a board recognized school of pharmacy (i.e. as a pharmacy student). 7
  8. 8. Naloxone – To Whom May Pharmacist Furnish Q: Who is the recipient? A: A recipient is the person to whom the naloxone is furnished. Q: Who is the patient? A: The patient is the person to whom the naloxone would be administered. (Note: The recipient may or may not also be the patient.) http://www.pharmacy.ca.gov/publications/naloxone_faq.pdf 8
  9. 9. Naloxone Mandatory Pre-Screening BEFORE furnishing, Pharmacist must screen recipient with Qs: A. Does recipient currently use or has history of using illicit or prescription opioids? (If recipient answers yes, pharmacist may skip screening question B.); B. Is recipient in contact with anyone who uses or has a history of using illicit or prescription opioids? (If recipient answers yes, pharmacist may continue.); C. Does the person to whom the naloxone would be administered have a known hypersensitivity to naloxone? (if recipient answers yes, pharmacist may not provide naloxone. If recipient responds no, pharmacist may continue. 9
  10. 10. Naloxone Mandatory Pre-Screening The screening questions shall be made available on the Board of Pharmacy’s website in alternate languages for patients whose primary language is not English.  Naloxone Screening Questions - English  Naloxone Screening Questions - Spanish  Naloxone Screening Questions - Traditional Chinese  Naloxone Screening Questions - Korean  Naloxone Screening Questions - Russian  Naloxone Screening Questions - Tagalog  Naloxone Screening Questions – Vietnamese // 10
  11. 11. Naloxone – What Product Exactly May Be Furnished CCR § 1746.3(c)(4) Pharmacist may supply naloxone hydrochloride as an  Intramuscular injection,  Intranasal spray,  Autoinjector,  or in another FDA- approved product form. Pharmacist may also recommend optional items when appropriate, including alcohol pads, rescue breathing masks, and rubber gloves. 11
  12. 12. Naloxone – How To Label - CCR § 1746.3(c)(5) Pharmacist shall label the naloxone hydrochloride consistent with law and regulations. Labels shall include:  an expiration date for the naloxone hydrochloride furnished. Examples of appropriate labeling is available on the Board of Pharmacy’s website.  http://www.pharmacy.ca.gov/licensees/naloxone_labels.shtml 12
  13. 13. Naloxone – How To Label - CCR § 1746.3(c)(5) 13 TEACHING TOOL
  14. 14. Naloxone – How To Label - CCR § 1746.3(c)(5) 14 TEACHING TOOL
  15. 15. Naloxone – How to Properly Furnish Pharmacist must provide the recipient: 1. Training in opioid overdose prevention, recognition, response, and administration of the antidote naloxone, with an appropriate consultation (patient MAY NOT waive); 2. A copy of the current naloxone fact sheet approved by the BOP: http://www.pharmacy.ca.gov/publications/naloxone_fact_sheet.pdf 3. If recipient gives written/verbal consent, pharmacist must notify patient’s PCP of any drug/device furnished; 4. If patient does not have a PCP or does not give consent, then pharmacist must provide patient a written record of the furnishing. 15
  16. 16. Naloxone – Recordkeeping  Each naloxone hydrochloride product furnished by pharmacist pursuant to this protocol shall be documented in a medication record for the naloxone recipient, and securely stored within the originating pharmacy or health care facility for a period of at least three years from the date of dispense.  The medication record shall be maintained in an automated data or manual record mode … readily retrievable during the pharmacy or facility’s normal operating hours. 16
  17. 17. Controlled substance Rxs shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of her professional practice. Responsibility for the proper prescribing and dispensing of controlled substances is upon the prescriber, but a corresponding responsibility rests with the pharmacist who fills the prescription. The following are NOT legal prescriptions: (1) a prescription issued not in the usual course of professional treatment or in legitimate and authorized research; or (2) an order for an addict which is NOT part of an authorized narcotic treatment program for the purpose of providing the user with controlled substances to keep him comfortable during treatment. Corresponding Responsibility on Pharmacists – CUCSA § 11153 17
  18. 18. Corresponding Responsibility - The Old Norm  Prescriber: Hello, Pharmacist. I’d like to call an order for my Patient: Vicodin ES #100, 1 PO Q 4-6 H PRN + 5 refills, AND Soma #100, 1 PO Q 8H PRN + 5 refills, AND Xanax 1mg #100, 1 PO TID PRN + 5 refills.  Pharmacist : Certainly, Doctor. It’s great hearing from you again, and thank you for your prescription order. 18
  19. 19. Current Norm  Prescriber: Hello, Pharmacist. I’d like to call an order for my Patient Soma #100, 1 PO Q 8H PRN + 5 refills, AND Xanax 1mg #100, 1 PO TID PRN + 5 refills.  Pharmacist: Doctor, may I please get the patient’s diagnosis?  Prescriber: Why do you need it?  Pharmacist: Because our pharmacy policy now requires it, and we do not want to get into trouble with the DEA.  Prescriber: It’s for Chronic Lower Back Pain. 19
  20. 20. Ideal Norm ASK THE PRESCRIBER:  Diagnosis +  Prescriber’s Qualifications +  Previously Failed Drug Treatments +  Copies of Lab Tests, X-Rays, Patient Charts +  Ask Prescriber if she checked CURES 20
  21. 21. Ideal Norm (cont.) AT THE PHARMACY:  Check prior pharmacy records Refill too soon? Therapeutic duplication?  Check CURES Therapeutic duplication? Doctor / Pharmacy shopping?  Briefly Assess the Patient Appear to be Physically in Pain? Nervous Demeanor?  Ask the Patient Why choose MY pharmacy? (if long distance from his home) Why choose THIS particular Smith? (if long distance from his home) Why pay cash? (when have a perfectly good insurance) Why taking these drugs? (if does not appear to be in pain/discomfort) 21
  22. 22. 2013 Policy D-35.981 (reaffirmed in 2018 Annual Mtg): “AMA Response to Pharmacy Intrusion Into Medical Practice” 1. Our AMA deems inappropriate inquiries from pharmacies to verify the medical rationale behind prescriptions, diagnoses and treatment plans to be an interference with the practice of medicine and unwarranted. 2. Our AMA will work with pharmacy associations such as the National Association of Chain Drug Stores to engage with the Drug Enforcement Administration, the federal Department of Justice, and other involved federal regulators and stakeholders, for the benefit of patients, to develop appropriate policy for pharmacists to work with physicians in order to reduce the incidence of drug diversion and inappropriate dispensing. 3. If the inappropriate pharmacist prescription verification requirements and inquiry issues are not resolved promptly, our AMA will advocate for legislative and regulatory solutions to prohibit pharmacies and pharmacists from denying medically necessary and legitimate therapeutic treatments to patients. 22
  23. 23. Legitimate Medical Purpose  CCR § 1761(b): Even after conferring with the prescriber, a pharmacist shall not compound or dispense a controlled substance prescription where the pharmacist knows or has objective reason to know that said prescription was not issued for a legitimate medical purpose. Q: How does a Pharmacist “know or have reason to know” ??? 23
  24. 24. Legitimate Medical Purpose - Drug Wholesalers’ Obligation to Report Suspicious Orders to Board B&P § 4169.1:  A wholesaler, upon discovery, shall notify the board in writing of any suspicious orders of controlled substances placed by California licensed pharmacy or wholesaler by providing the board a copy of the information that the wholesaler provides to the United States Drug Enforcement Administration.  Suspicious orders include, but are not limited to, orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency. 24
  25. 25. HSC § 11153.5(c) : Factors to be considered in determining whether a wholesaler . . . furnished controlled substances knowing or having a conscious disregard for the fact that the controlled substances are for other than legitimate medical purposes shall include, but not be limited to,  whether the use of controlled substances was for purposes of increasing athletic ability or performance,  the amount of controlled substances furnished,  the previous ordering pattern of the customer (including size and frequency of orders),  the type and size of the customer, and  where and to whom the customer distributes the product. 25Legitimate Medical Purpose - Drug Wholesalers’ Obligation
  26. 26. Drug Enforcement Agency DEA Pharmacists Manual – 2010 (Pg. 30)  A 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 along with the issuing practitioner, for knowingly and intentionally distributing controlled substances.  Such action is a felony offense, which may result in the loss of one’s business or professional license . . . . 26
  27. 27. In the Matter of Accusation Against Pacifica Pharmacy; Thang Tran… “Precedential Decision”  On August 9, 2013 the BOP made this case a “precedential decision.”  Which allows the BOP to rely on this case in all future accusations as legal precedence.  Copy of the case available as public record: http://www.pharmacy.ca.gov/meetings/agendas/2013/13_jul_bd_pres_mat.pdf CA Gov.Code §11425.60  An agency may designate as a precedent decision a decision or part of a decision that contains a significant legal or policy determination of general application that is likely to recur. 27
  28. 28. In the Matter of Accusation Against Pacifica Pharmacy… RPh Thang Tran – What he did Right:  Checked DLs of individuals who dropped off Rxs  Sometimes checked MD licenses & NPI #s  Sometimes contacted prescribers to verify the Rx  Evaluated pain patients by observing the Dx written on some Rxs  Documented early refills in patient profiles  No prior record (neither he nor the PHY) 28
  29. 29. In the Matter of Accusation Against Pacifica Pharmacy… RPh Thang Tran – What he did Wrong:  Did not routinely verify Rxs with Dr. “T”  Considered his RPh role in verifying the legitimacy of the Rxs as merely verifying the Rx with the prescriber – with no need to further evaluate the patient & Rx to determine legitimacy  Did not ask patients about their Rx nor other medical information  Instances where patient received 80mg Oxycontin as initial therapy (10, 15, 20, 30, 40, and 60 mg also available).  Did not know about accessing CURES  Saw nothing wrong with filling Rxs for prescribers or patients located far away from the PHY  35+ miles between Patient & Prescriber  20+ miles between Patient & PHY 29
  30. 30. In the Matter of Accusation Against Pacifica Pharmacy… BOP Revocation based on:  “Dispens[ing] numerous prescriptions for controlled substances without determining whether any prescription was written for a legitimate medical purpose.” 30
  31. 31. In the Matter of Accusation Against Pacifica Pharmacy… Defensive arguments:  The pharmacist did not knowingly violate the rule of corresponding responsibility.  Gvmt’ failed to prove that the Rxs in question were dispensed for any reason other than for a legitimate medical purpose. 31
  32. 32. BOP Red Flags of Corresponding Responsibility 1. Irregularities on the face of the Rx 2. Nervous Patient demeanor 3. Age or presentation of Patient (e.g., young with chronic pain meds) 4. Multiple Patients @ same address 5. Cash payments 6. Early refill requests 7. Rxs for unusually high quantities 8. Rxs for duplicative drugs 9. Same prescribing patterns for multiple patients 10. Initial Rxs written for high-dose opiates (e.g., Oxycontin 80mg for 1st- time user) 11. Long distances travelled from Patient home to MD and/or PHY 12. Inconsistent prescriber qualifications in relation to Rxs prescribed 13. Rxs with no logical connection to Dx or Treatment 32
  33. 33. More Red Flags of Corresponding Responsibility - DEA 1. Patients coming to the pharmacy in groups, especially if their home addresses are outside of the pharmacy’s local trade area, each with the same prescriptions issued by the same prescriber; 2. The same diagnosis codes for many patients; 3. Prescriptions written for potentially duplicative drug therapy; 4. The same combinations of drugs prescribed for multiple patients; 5. Excessively celebratory patient demeanor. 33
  34. 34. Red Flags of Corresponding Responsibility BOP Guidance:  https://www.youtube.com/watch?v=jdeQ0GeJjAM&feature=youtu.be  http://www.pharmacy.ca.gov/publications/corresponding_responsibility.pdf 34
  35. 35. In the Matter of Accusation Against Pacifica Pharmacy… Red Flags that should give the pharmacy/pharmacist an inkling of a potential problem, and thus invoke the Duty of Inquiry:  Same prescribing patterns for multiple patients  Initial Rxs written for high-dose opiates (e.g., Oxycontin 80mg for 1st-time user)  Long distances travelled from Patient home to MD and/or PHY  Inconsistent prescriber qualifications in relation to Rxs prescribed  Rxs with no logical connection to Dx or Treatment 35
  36. 36. In the Matter of Accusation Against Pacifica Pharmacy… THE [NEW] RULES: [1] If, to a clear and convincing degree, red flags exist, then the RPh MUST: Inquire about the legitimacy of the Rx by conducting a reasonable inquiry. [2] Then, if the results of a reasonable inquiry do NOT overcome the RPh’s concern about whether the Rx is written for a legitimate medical purpose, Then the RPh must NOT fill that Rx. [3] If not, then the RPh has violated his duty of inquiry, thus failed his corresponding responsibility to dispense controlled substances only for legitimate medical purposes. 36
  37. 37. How to Incorporate CURES into a Reasonable Inquiry Suggested procedure: 1. Identify and Document the Existence of at least every Red Flag; 2. Conduct (& document) a Reasonable Inquiry to resolve each Red Flag; • Incorporate a CURES lookup as part of the Reasonable Inquiry; 3. ALWAYS print a hardcopy of the CURES report; • Why in the case of dispensing the controlled substance? • Why in the case of NOT dispensing the controlled substance? 4. Document to a detailed degree, every resolution (AND non) of the red flag; • Also create a dedicated “Denied CS” file. Why? 5. If resolve every red flag, then MUST dispense. 6. If cannot resolve even one red flag, then MUST NOT dispense. 37
  38. 38. CA SB-482 (2016) Controlled substances: CURES database  An act to amend §§ 11165 and 11165.1, and to add § 11165.4 of the Health and Safety Code, relating to controlled substances. 38
  39. 39. CA SB-482 Controlled substances: CURES database Highlights (MANDATORY CURES LOOKUP):  This law requires a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance,  to consult the CURES database to review a patient’s controlled substance history,  no earlier than 24 hours, or the previous business day,  before prescribing a Schedule II, Schedule III, or Schedule IV [not C-V] controlled substance to the patient for the first time,  and at least once every 4 months thereafter if the substance remains part of the treatment of the patient. 39
  40. 40. 40CA SB-482 Controlled substances: CURES database (e) This section is not operative until six months after the Department of Justice certifies that the CURES database is ready for statewide use and that the department has adequate staff, which, at a minimum, shall be consistent with the appropriation authorized in Schedule (6) of Item 0820-001-0001 of the Budget Act of 2016 (Chapter 23 of the Statutes of 2016), user support, and education. The department shall notify the Secretary of State and the office of the Legislative Counsel of the date of that certification.
  41. 41. 41CA SB-482 Controlled substances: CURES database To date, there has NOT YET been indication by the DOJ about the system’s readiness.
  42. 42. CA SB-482 – Dentists’ Exemption Highlights (EXCEPTION TO MANDATORY CURES LOOKUP):  But this duty to consult CURES does NOT apply to one . . .  Who prescribes . . . a controlled substance to a patient, as part of the patient’s treatment for a surgical procedure, and the quantity of the controlled substance does not exceed a nonrefillable five- day supply of the controlled substance to be used in accordance with the directions for use, in any of the following facilities: A “place of practice”, as defined in B&P § 1658 . . . "Place of practice" means any dental office where any act of dentistry is practiced as defined by § 1625 . . . 42
  43. 43. CA SB-482 Controlled substances: CURES database Highlights (PENALTY):  This law would provide that a health care practitioner who fails to consult the CURES database is required to be referred to the appropriate state professional licensing board solely for administrative sanctions, as deemed appropriate by that board. 43
  44. 44. CA SB-482 Controlled substances: CURES database Highlights (IMMUNITY):  HSC § 11165.1(f): “A health care practitioner, pharmacist, and any person acting on behalf of [the same],  when acting with reasonable care and in good faith,  is not subject to civil or administrative liability arising from any  false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database  or for any resulting failure of the CURES database to accurately or timely report that information.” 44
  45. 45. CA SB-482 Controlled substances: CURES database Highlights (PATIENT COPY):  HSC § 11165(c)(3):  “In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patient’s CURES patient activity report  as long as no additional CURES data is provided and keep a copy of the report in the patient’s medical record . . .” 45
  46. 46. Thank you ! Tony J. Park, Pharm.D., J.D. California Pharmacy Lawyers TPark@CAPharmacyLaw.com 46

×