Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign...
Transcript of Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign...
![Page 1: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/1.jpg)
Prescriptions: (Transfers of, Changes to, EPCS)
23rd National Conference on Pharmaceutical and Chemical Diversion
Dallas, Texas December 12, 2017
Loren T. Miller Associate Chief, Liaison and Policy Diversion Control Division
![Page 2: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/2.jpg)
2
LEGAL DISCLAIMER The following presentation was accompanied by an oral presentation on December 12, 2017, and does not purport to establish legal standards that are not contained in statutes, regulations, or other competent law. Statements contained in this presentation that are not embodied in the law are not binding on DEA. Summaries of statutory and regulatory provisions that are summarized in this presentation do not purport to state the full extent of the statutory and regulatory requirements of the cited statutes and regulations. I have no financial relationships to disclose.
![Page 3: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/3.jpg)
Prescriptions • §1300.01(b) A Prescription means, “an order for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user (e.g., an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription).”
U.S. Drug Enforcement Administration Diversion Control Division
4
![Page 4: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/4.jpg)
Prescriptions • §1306.03 Persons entitled to issue
prescriptions. • (a) A prescription for a controlled
substance may be issued only by an individual practitioner who is:
• (1) authorized to prescribe controlled substances by the jurisdiction in which he is licensed to practice his profession and . . .
U.S. Drug Enforcement Administration Diversion Control Division
5
![Page 5: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/5.jpg)
Prescriptions • (2) either registered or exempted from
registration pursuant to Secs. 1301.22 (c) and 1301.23 of this chapter.
U.S. Drug Enforcement Administration Diversion Control Division
5
![Page 6: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/6.jpg)
21 C.F.R. § 1306.04 (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.
6 U.S. Drug Enforcement Administration Diversion Control Division
![Page 7: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/7.jpg)
21 C.F.R. § 1306.04(a)
An order purporting to be a prescription issued not in the usual course of professional treatment … is not a prescription…
U.S. Drug Enforcement Administration Diversion Control Division
7
![Page 8: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/8.jpg)
21 C.F.R. § 1306.04(a)
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 .
U.S. Drug Enforcement Administration
Diversion Control Division
8
![Page 9: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/9.jpg)
Prescriptions • §1306.05 Manner of issuance of
prescriptions. • (a) All prescriptions for controlled
substances shall be dated as of, and signed on, the day when issued and shall bear the . . .
9
![Page 10: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/10.jpg)
Prescriptions full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner.
10
![Page 11: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/11.jpg)
Prescriptions • (b) A prescription issued by an
individual practitioner may be communicated to a pharmacist by an employee or agent of the individual practitioner.
U.S. Drug Enforcement Administration Diversion Control Division
11
![Page 12: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/12.jpg)
Prescriptions • (d) A practitioner may sign a paper
prescription in the same manner as he would sign a check or legal document (e.g., J.H. Smith or John H. Smith). Where an oral order is not permitted, paper prescriptions shall be written with ink or indelible pencil, typewriter, or printed on a computer printer and shall be manually signed by the practitioner. 12
![Page 13: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/13.jpg)
Prescriptions • (f) A prescription may be prepared by
the secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations.
U.S. Drug Enforcement Administration Diversion Control Division
13
![Page 14: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/14.jpg)
Prescription Transfers • Forms of a Prescription • The DEA’s regulations on Transfers: • The DEA’s policy on Transferring
Original Unfilled Prescriptions • What can be Transferred • What cannot be Transferred
U.S. Drug Enforcement Administration Diversion Control Division 14
![Page 15: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/15.jpg)
Changes to a Prescription? The CSA and current DEA regulations do not provide for a pharmacy to make changes to a written prescription for a schedule II controlled substance.
15
![Page 16: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/16.jpg)
Electronic Prescriptions for Controlled Substances (EPCS)
• Benefits of EPCS • Problems with EPCS • What is not an EPCS
U.S. Drug Enforcement Administration Diversion Control Division 16
![Page 17: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/17.jpg)
Unique Identification Number (UIN)
• When is it required • When is it not required • The practitioner with Multiple
DEA registrations • Impact on Prescription Drug
Monitoring Programs U.S. Drug Enforcement Administration
Diversion Control Division 17
![Page 18: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/18.jpg)
Multiple Prescriptions CII
Individual practitioner may issue multiple prescriptions which authorizes patient to receive a 90-day supply of a C-II 21 CFR § 1306.12(b)
![Page 19: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/19.jpg)
Multiple Prescriptions CII Each separate prescription is for legitimate medical purpose issued by practitioner acting in usual court of professional practice
Written instructions on each prescription indicating earliest date it can be filled
![Page 20: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/20.jpg)
Addresses on a Prescription • The Practitioner Address • The Patient Address
U.S. Drug Enforcement Administration Diversion Control Division
20
![Page 21: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/21.jpg)
Pre-Populated Prescriptions
An agent may not legally perform duties that must be personally performed by the individual practitioner.
![Page 22: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/22.jpg)
Pre-Populated Prescriptions The practitioner must first determine that a prescription for a controlled substance is for a legitimate medical purpose; then, the practitioner may authorize an agent to prepare the prescription
![Page 23: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/23.jpg)
Pre-Populated Prescriptions A pharmacy cannot provide in whole, or in part, pre-populated information on a document and have that document then become the prescription.
![Page 24: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/24.jpg)
Emergency Oral Schedule II Prescriptions
• What is an emergency • Who decides if it is an emergency • What are the prescribing limits • What is the responsibility of
prescriber & pharmacist
U.S. Drug Enforcement Administration Diversion Control Division 24
![Page 25: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/25.jpg)
Retail versus Central Fill Pharmacies
• Final Rule • Who can do central fill • Limitation on Central Fill dispensing • Common problems at both the retail
and central fill pharmacies
U.S. Drug Enforcement Administration Diversion Control Division 25
![Page 26: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/26.jpg)
Some Final Notes Dispelling misconceptions on what the DEA requires regarding prescriptions
U.S. Drug Enforcement Administration Diversion Control Division 26
![Page 27: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/27.jpg)
www.DEAdiversion.usdoj.gov
www.dea.gov
www.operationprevention.com
Handy Resources
U.S. Drug Enforcement Administration Diversion Control Division
27
![Page 28: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/28.jpg)
“Guideline for Prescribing Opioids for Chronic Pain” “Checklist for Prescribing Opioids for Chronic Pain” https://www.cdc.gov/drugoverdose/ prescribing/trainings.html
www.cdc.gov
28
![Page 29: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/29.jpg)
29
Contact Information
Loren T. Miller, Associate Chief Liaison and Policy Section/DRL Drug Enforcement Administration 8701 Morrissette Drive Springfield, Virginia 22317 [email protected] 202-307-8250 (Office)
![Page 30: Prescriptions (Transfer of, Changes to, EPCS)€¦ · Prescriptions • (d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document](https://reader031.fdocuments.in/reader031/viewer/2022011820/5eabcff85cf3035aad70abac/html5/thumbnails/30.jpg)
Thank You
30