Controlled Substance and Drug Diversion

TrainingTracy Hendershot, MD

President-Elect -- WVAFP

Allopathic and Osteopathic Physicians and Physician Assistant Requirements- Requirement began May 2014

- Unless a PHYSICIAN has completed a wavier attesting that they have not prescribed, administed or dispense a CS during the entire previous reort period OR

- PHYSICIAN must complete a minimum of 3 credit hours of Drug Diversion and Best Practice Prescribing of CS Training, APPROVED by their respective licensing board prior to their 2 year renenwal

- PHYSICIAN ASSISTANT must be appropriate license under their supervision PHYSICIAN

Reference: WV Code 30- 1-7a and Legislative Rules 11CSR6 and 11CSR1B.

Pharamcist

• Q.  Do I still need to complete the "End of Life Care" CPE that was mandatory for all first time license renewals?  

A.  No, the end of life CPE requirement was deleted from the law.  The statute now requires the Drug Diversion CPE each reporting period.  So, you will have to get 3 hours of this CPE every 2 years going forward as part of your 30 hours, but end of life care is no longer required.

WV Prescription Drug Monitoring Program

Registering with BOP

WV PDMP When to Use It

– Authorized prescribers writing prescriptions for controlled substances are required to access and query the Board of Pharmacy Controlled Substance Monitoring Database for a specific client prior to writing a prescription for a controlled substance.

Code Chapter 60A-9-4Required Information(1) The name, address, pharmacy prescription number and Drug Enforcement Administration

controlled substance registration number of the dispensing pharmacy or the dispensing physician or dentist;

(2) The full legal name, address and birth date of the person for whom the prescription is written;

(3) The name, address and Drug Enforcement Administration controlled substances registration number of the practitioner writing the prescription;

(4) The name and national drug code number of the Schedule II, III, and IV controlled substance dispensed;

(5) The quantity and dosage of the Schedule II, III and IV controlled substance dispensed;(6) The date the prescription was written and the date filled;(7) The number of refills, if any, authorized by the prescription;(8) If the prescription being dispensed is being picked up by someone other than the patient

on behalf of the patient, the full legal name, address and birth date of the person picking up the prescription as set forth on the person’s government-issued photo identification card shall be retained in either print or electronic form until such time as otherwise directed by rule promulgated by the board of pharmacy; and

(9) The source of payment for the controlled substance dispensed.

Code Chapter 60A-9-4Required Information

(d) Reporting required by this section is not required for a drug administered directly to a patient by a practitioner. Reporting is, however, required by this section for a drug dispensed to a patient by a practitioner: Provided, That the quantity dispensed may not exceed an amount adequate to treat the patient for a maximum of seventy-two hours with no greater than two seventy-two-hour cycles dispensed in any fifteen-day period of time.

REQUIREMENTS PRIOR TO DISPENSING OR PRESCRIBING CONTROLLED SUBSTANCES• If less than 50% of your

patients are on controlled substances for chronic non-malignant pain, you are responsible for following the 7 national guidelines, developed by the Federation of State Medical Boards, that support rational and transparent opioid prescribing

1) Patient evaluation (H&P)2) Creating a Treatment Plan3) Informed Consent4) Periodic Review (file BOP

report in chart annually)5) Referral & Pain

Management6) Documentation7) Compliance with State

Laws

WV Code 16- 5H-1

• Defines and establishes operational guidance, training and ownership requirements for Pain Management Clinics

Pain Management Clinics

• If more than 50% of your practice patients are on controlled substances for chronic non-malignant pain, you will be required to becomes licensed as a Pain Management Clinic.

• Code Chapter 16-5H

Licensed by:

-DHHR

-Secretary of State

-State Tax Department

Inspection required prior to licensing and periodically thereafter

Pain Management ClinicsWV Code Chapter 16-5H-4-Must have a designated physician who shall:

(A)Have a full active license to practice medicine, surgery or osteopathic medicine or surgery in this state

(B)Meet one of the following training requirements:

(i) Complete a pain medicine fellowship accredited by the

ACGME or other similar program approved by the

Secretary of WVDHHR

(ii) Hold board certification by the American Board of Pain

Medicine or current board certification by the American

Board of Anesthesiology or such other board certification

as may be approved by the Secretary of WVDHHR

• EXEMPTIONS: - Facility affiliated with an accredited medical

school - Hospital licensed in WV or facility located on the

campus of a licensed hospital - Hospice program - Nursing home - Ambulatory Surgery Center - Clinical Research Facility

Pain Management Clinics

Hydrocodone Combo Products

Source: http://www.aafp.org/news/health-of-the-public/20140917hcps-sked2.html

WV 2015 Session

• Relates to opioid antagonists (SB 335, SB 231, HB 2009)

• Overdose Prevention Act (SB 18, SB 230, HB 2045)

• Permits certain optometrists, APRNs and PAs to prescribe Schedule II hydrocodone combination drugs for up to three days (SB 428, HB2776)

• Permits school nurses to possess and administer opioid antagonists (SB 497)

FDA APPROVED ER/LA

https://rems.community360.net/default.aspx