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Friday, March 23 - New Laws Review 2018


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New Laws Review 2018
0006-0000-18-001-L03-P | .15 CEUs |
Tony J. Park, PharmD, JD

Published in: Law
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Friday, March 23 - New Laws Review 2018

  1. 1. California Pharmacy Law Update 2018 1 Tony J Park, Pharm.D., J.D. California Pharmacy Lawyers
  2. 2. 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. 2 Conflict of Interest Statement
  3. 3. 3 The Goal of this CE is to ensure Pharmacists stay concurrent with the new regulations enforced by the California Board of Pharmacy.
  4. 4. Learning Objectives  Describe the changes in State and Federal laws for 2018.  Explain the overarching trends in the regulatory climate for California pharmacists.  Summarize new standards of practices regarding corresponding responsibility.  Identify resources for staying current on changing regulatory issues. 4
  5. 5. Where to Find New Laws Changes: The 2018 Law Book:  2015: 298 pg (letter)  2016: 285 pg (letter)  2017: 434 pg (legal)  2018: 465 pg (legal) 5
  6. 6. Statutory Mandate Protection of the public shall be the highest priority for the California State Board of Pharmacy in exercising its licensing, regulatory, and disciplinary functions. Whenever the protection of the public is inconsistent with other interests sought to be promoted, the protection of the public shall be paramount. CA Business and Professions Code 4001.1 6
  7. 7. Resources  Board Website: -- on the far right of the webpage: Quick Hits see 2018 legislation Laws and Regulations  Join the board’s subscriber alert 7
  8. 8. Email Addresses Must Be Reported to Board Effective July 1, 2017  Each pharmacist, intern pharmacist, pharmacy technician, designated representative-3PL shall join the board’s email list within 60 days of licensure or at the time of license renewal – beginning July 2017  Email addresses shall updated by licensee within 30 days of a change in the email address.  The email address shall not be posted on the board’s online license verification system.  Reminders placed on each renewal to report and keep current the email address with the board. B&P § 4013 8
  9. 9. Controlled Substances Inventory Reconciliation New CCR § 1715.65: Effective Date of Regulation: April 1, 2018 The challenge: combat drug loss and diversion from within pharmacies and prescription drug abuse within California. The solution: require pharmacies and clinics to perform a physical count inventory at least every 3 months of all C-II controlled substances to be better equipped to spot and stop employee drug diversion from the pharmacy earlier and prevent excessive drug losses from occurring. 9
  10. 10. Controlled Substances Inventory Reconciliation New CCR § 1715.65 (effective 04/01/2018): The code: (highlights)  Full C-II count AND reconciliation at least once every 3 months (ok to start with last biennial inventory, if w/n past 3 months);  Reviewed by the PIC or Clinic’s Consultant Pharmacist;  Written Policies & Procedures required on exactly how to fulfill this code;  No estimate counts allowed; 10
  11. 11. Controlled Substances Inventory Reconciliation (cont) How to reconcile (CCR § 1715.65(c): 1. Perform a physical count, not an estimate, of all quantities of federal C-II controlled substances. 2. Review all acquisitions and dispositions of federal C-II controlled substances since the last inventory reconciliation report; 3. Compare (1) and (2) to determine if there are any variances; 4. All records used to compile each inventory reconciliation report shall be maintained in the pharmacy or clinic for at least 3 years in a readily retrievable form; 5. Possible causes of overages shall be identified in writing and incorporated into the inventory reconciliation report. 11 TEACHING TOOL
  12. 12. Example: Norco 10/325  Last inventory (before the biz day) on 01/01/2018 = #50 in stock.  All acquisitions from 01/01/18 to before the biz day on 04/01/18 = #2,000  All dispensings = #1,500  All reverse distributions (expired) = #100  Q: What SHOULD be the physical count ? 12Controlled Substances Inventory Reconciliation (cont)
  13. 13. Mandatory Reporting (CCR § 1715.65 (d): A pharmacy or clinic shall report in writing identified losses and known causes to the board within 30 days of discovery unless the cause of the loss is theft, diversion, or self-use in which case the report shall be made within 14 days of discovery. If the pharmacy or clinic is unable to identify the cause of the loss, further investigation shall be undertaken to identify the cause and actions necessary to prevent additional losses of controlled substances. 13Controlled Substances Inventory Reconciliation (cont)
  14. 14. Theft & Impairment – B&P § 4104(c) Within 14 days of the receipt or development of the following information with regard to any licensed individual employed by or with the Pharmacy, the Pharmacy must report to BOP: (1) [ADMISSION] Any admission of: [A] Chemical, mental, or physical impairment affecting his ability to practice; OR [B] Theft, diversion, or self-use of dangerous drugs; (3) [TANGIBLE EVIDENCE] Any video or documentary evidence showing: [A] Chemical, mental, or physical impairment affecting his ability to practice; OR [B] Theft, diversion, or self‐use of dangerous drugs; (5) [FIRING] Any termination based on : [A] Chemical, mental, or physical impairment affecting his ability to practice; OR [B] Theft, diversion, or self‐use of dangerous drugs. 14Controlled Substances Inventory Reconciliation (cont)
  15. 15. DEA Form 106 (Review) The registrant shall notify within the DEA within one business day of discovery of the theft or loss. The registrant shall complete and submit a DEA Form 106. 15Controlled Substances Inventory Reconciliation (cont)
  16. 16. DEA Form 106 (Review) What constitutes a “significant loss.” a. The actual quantity of controlled substance lost in relation to the type of business. b. The specific controlled substances lost. c. A pattern of losses over a specific time period. d. Whether the specific controlled substances are likely candidates for diversion. e. Local trends. 16Controlled Substances Inventory Reconciliation (cont)
  17. 17. Model Disciplinary Guidelines Amend 16 CCR §1760 (Effective 04/01/2018)  SB 1441 (Chapter 548, Statutes of 2008, Senator Ridley-Thomas) created the “Substance Abuse Coordination Committee” (SACC) which required the committee to formulate uniform and specific standards in specified areas that each healing arts board in dealing with substance-abusing licensees.  CCR § 1760 merely accommodated for the Substance Abuse Coordination Committee’s (SACC) uniform standards.  But during this change, the Board took the opportunity to increase the minimum probation term for a Category I violation from 1 year to 2 years. (“… because one year of probation monitoring is not sufficient to properly demonstrate that complete rehabilitation has occurred.”)  17
  18. 18. The so-called “Compounding Emergency Regulation”  Same as Before - CCR § 1735.2(i): (D)180-days non-aqueous, (E)14-days water-based oral, (F) 30 days topical/dermal and mucosal liquid and semi- solids. 18
  19. 19. The so-called “Compounding Emergency Regulation” CCR § 1735.2(i) New Stuff: (G) A pharmacist, using his or her professional judgment may establish an extended date as provided in (D), (E), and (F), if the pharmacist researches by consulting and applying drug-specific and general stability documentation and literature; analyzes such documentation and literature as well as the other factors set forth in this subdivision, and maintains documentation of the research, analysis and conclusion.  The factors must include: (i) the nature of the drug and its degradation mechanism, (ii) the dosage form and its components, (iii) the potential for microbial proliferation in the preparation, (iv) the container in which it is packaged, (v) the expected storage conditions, and (vi) the intended duration of therapy.  Documentation of the pharmacist’s research and analysis supporting an extension must be maintained in a readily retrievable format as part of the master formula. 19
  20. 20.  Gone: For Non-sterile compounds, (A) Method Suitability Test, (B) Container Closure Integrity Test, and (C) Stability Studies are NO LONGER mandatory.  Effective Date: 12/19/2017 20 The so-called “Compounding Emergency Regulation” CCR § 1735.2(i)
  21. 21. New Licensure Renewal Requirements. (Effective 01/01/2018) CCR § 1702(b):  Traffic infractions under $500 not involving alcohol, dangerous drugs, or controlled substances do not need to be disclosed. CCR § 1702(c):  As a condition of renewal, a pharmacist applicant shall disclose on the renewal form any disciplinary action against any license issued to the applicant by a government agency. For the purposes of this section, “disciplinary action” means an adverse licensure or certification action that resulted in a restriction or penalty being placed on the license, such as revocation, suspension, probation or public reprimand or reproval. 21
  22. 22. CCR § 1702.1(a) A pharmacy technician applicant for renewal who has not previously submitted fingerprints as a condition of licensure or for whom an electronic record of the licensee’s fingerprints does not exist in the Department of Justice’s criminal offender record identification database shall successfully complete a state and federal level criminal offender record information search conducted through the Department of Justice by the licensee’s or registrant’s renewal date that occurs on or after January 1, 2018 … 22 New Licensure Renewal Requirements. (Effective 01/01/2018)
  23. 23. CCR § 1702.1(a) (1) A pharmacy technician shall retain for at least three years as evidence of having complied with subdivision (a) either a receipt showing that he or she has electronically transmitted his or her fingerprint images to the Department of Justice or, for those who did not use an electronic fingerprinting system, a receipt evidencing that his or her fingerprints were recorded and submitted to the board. 23 New Licensure Renewal Requirements. (Effective 01/01/2018)
  24. 24. Board-Accredited CEs (Eff. 07/01/2017) NEW Section 16 CCR 1732.5(b):  At least two (2) of the thirty (30) hours required for pharmacist license renewal shall be completed by participation in a Board-provided CE course in Law and Ethics.  Pharmacists renewing their licenses which expire on or after July 1, 2019, shall be subject to the requirements of this subdivision. 24
  25. 25. Suspicious Orders of Controlled Drugs  Wholesalers must report to the board all suspicious orders of controlled drugs made by other wholesalers or pharmacies.  Suspicious orders include: orders deviating substantially from a normal pattern, and orders of unusual frequency Origin: AB 401 (Aguiar-Curry) This provision was board sponsored 25
  26. 26. Sales of Non-Prescription Diabetes Test Strips and Meters  Requires the board to post a list of authorized distributors of nonprescription diabetes test strips  Requires a pharmacy to retain records of acquisition and disposition for nonprescription diabetes test devices for at least 3 years  Makes purchasing from an unauthorized distributor unprofessional conduct for a pharmacy  Allows the board to embargo product for cause Origin: AB 602 (Bonta) 26
  27. 27. Partial Filling of C-IIs  Authorizes partial filling of C-II controlled drugs if requested by the patient or prescriber  Allows multiple fills, provided each partial filling is recorded on the prescription  The full prescription may be filled up to 30 days from the initial partial fill.  The prescription is no longer valid on the 31st day  Pharmacist may charge a dispensing fee for each partial fill 27
  28. 28. Partial Filling of C-IIs  Note each partial filling in CURES  Allow prorated dispensing fees for a health care service plan  Effective 7/1/18 Origin: AB 1048 Arambula 28
  29. 29. Telepharmacy New B&P § 4044.3, et.seq.  Defined as a system that is used by a supervising pharmacy to monitor the dispensing of prescription drugs by a remote site and provides related pharmacy services including consultation by an electronic method, using audio, visual, still image capture and store and forward technology. 29
  30. 30. Telepharmacy A telepharmacy system :  Shall be located in a medically underserved area -- “a location that does not have a pharmacy that serves the general public within 10 road miles of the remote site”  If a pharmacy is later established within 10 miles, the remote pharmacy can continue to operate  Remote pharmacy shall be staffed ONLY by pharmacists or pharmacy technicians  Cannot be operated by the state or in a state facility 30
  31. 31. Telepharmacy  If a remote site dispenses more than 225 prescriptions a day, over one year, it shall cease to be a remote dispensing site pharmacy and may become a pharmacy.  A supervising pharmacy may provide services to only one remote pharmacy 31
  32. 32. Telepharmacy  A supervising pharmacy may provide services to only one remote pharmacy  A supervising pharmacy must be within 150 road miles of the remote dispensing site pharmacy  The supervising pharmacy and remote pharmacy must be under common ownership  A pharmacy technician must be under direct supervision of a pharmacist whenever the remote pharmacy is open, audio and visual technology may be used to achieve supervision. 32
  33. 33. Telepharmacy  The PIC and the pharmacist on duty in the supervising pharmacy are responsible for sufficient staffing in both pharmacies 33
  34. 34. Telepharmacy  Drugs and devices may be ordered by a remote dispensing pharmacy:  Received and signed for by a pharmacy technician  Controlled substances accepted and signed for by a pharmacy technician in a remote site must be stored separately until reviewed and countersigned by a pharmacist.  Receipt and storage of controlled substances by a technician must be captured on video and kept for 120 days 34
  35. 35. Pharmacy Technicians in Remote Dispensing Pharmacies  Board to develop regulations for remote dispensing pharmacy technicians  A remote pharmacy technician may not:  Receive a prescription order from a prescriber  Consult with a patient about a prescription  Identify, evaluate or interpret a prescription  Interpret clinical data in a patient’s chart  Consult with a prescriber, nurse or other provider 35
  36. 36. Telepharmacy Requires Video and Audio Systems  Video and audio systems are required to ensure communication between the supervising pharmacy and remote pharmacy  To ensure supervision  To provide patient consultation, which must be provided on ALL prescriptions dispensed by the remote pharmacy. 36
  37. 37. Telepharmacy Audio and Video Systems The systems must be able to identify:  The pharmacy technician preparing each prescription and the supervising pharmacist  The pharmacist who reviewed the prescription with the data entry record The remote pharmacy must:  Perform barcode reading before dispensing of the stock bottle and prescription container,  Ensure pharmacist review before dispensing 37
  38. 38. Telepharmacy  A pharmacist must perform a monthly inspection of the remote pharmacy using a board-designed form.  Controlled substances  Locked separately  Perpetual inventory required  Supervising pharmacy must inventory and reconcile 38
  39. 39. Access to CURES data  Allows access to the CURES systems through a health information technology system in addition to the current CURES online portal.  The DOJ is developing the system connection and will require a memorandum of understanding  Urgency provision -- in effect now, but DOJ is not yet Origin: AB 40 (Santiago) 39
  40. 40. 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 40
  41. 41. Questions? Thank you Speaker Contact Information: Tony J. Park, Pharm.D., J.D. CPL-California Pharmacy Lawyers Email: 41