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DEA Regulations: Controlled Substances Listed in Schedule II

Controlled Substance Prescriptions in the Long Term Care Setting Updated to include DEA Statement of Policy published in the Federal Register on October 6, 2010. DEA Regulations: Controlled Substances Listed in Schedule II. 21 CFR 1306.11 Requirement of Prescription Key Point:

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DEA Regulations: Controlled Substances Listed in Schedule II

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  1. Controlled Substance Prescriptionsin the Long Term Care SettingUpdated to include DEA Statement of Policypublished in theFederal Register on October 6, 2010

  2. DEA Regulations: Controlled Substances Listed in Schedule II 21 CFR 1306.11 Requirement of Prescription Key Point: A pharmacist may dispense directly a controlled substance listed in Schedule II, which is a prescription drug as determined under the Federal Food, Drug and Cosmetic Act, only pursuant to a written prescription signed by the practitioner, except as provided in paragraph (d) of this section.

  3. DEA Regulations: Controlled Substances Listed in Schedule II 21 CFR 1306.11 Requirement of Prescription-paragraph (d) In the case of an emergency situation, as defined by the Secretary in § 290.10 of this title, a pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral authorization of a prescribing individual practitioner…

  4. DEA Regulations: Controlled Substances Listed in Schedule II Provided that: • the quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period must be pursuant to a written prescription signed by the prescribing individual practitioner); and • within 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. (Some states may require a stricter guideline of 72 hours after authorizing an emergency oral prescription).

  5. LEVO-DROMORAN LEVORPHANOL MEPERIDINE METADATE METHADONE METHYLIN METHYLPHENIDATE MORPHINE MS CONTIN MSIR NEMBUTAL NUMORPHAN OPANA. ORAMORPH SR OXYCODONE OXYCONTIN OXYIR PALLADONE PERCOCET PERCODAN RITALIN ROXANOL ROXICET ROXICODONE ROXIPRIN SECONAL TYLOX VYVANSE ACTIQ ADDERALL AMPHETAMINE ASTRAMORPH-PF AVINZA B & O SUPPOSITORY CESAMET CODEINE CONCERTA D-AMPHETAMINE DAYTRANA DEMEROL DESOXYN DEXEDRINE DEXTROAMPHETAMINE DEXTROSTAT DILAUDID DURAGESIC DURAMORPH ENDOCET ENDODAN ETH-OXYDOSE FENTANYL FENTORA FOCALIN HYDROMORPHONE INFUMORPH KADIAN List of Common CII Medications

  6. Let’s Review!Schedule II Controlled Substance Medications • A Schedule II controlled substance medication requires a written prescription from the practitioner, except in the case of an emergency. • In an emergency, the pharmacist can dispense a Schedule II controlled substance medication upon receiving oral authorization from the practitioner. • Emergency dispensing of a Schedule II controlled substance must be limited to the amount adequate to treat the resident during the emergency period. • The practitioner must deliver a signed written prescription to the pharmacy within seven (7) days after orally authorizing an emergency prescription. Some states may require a stricter guideline of 72 hours after authorizing an emergency oral prescription.

  7. Let’s Review!Schedule II Controlled Substance Medications • Dispensing beyond the emergency period requires a written prescription signed by the individual practitioner. • There are no refills of Schedule II controlled substances. The pharmacy can partially fill a prescription for a LTCF or terminally ill patient, and dispense partial quantities of the total amount that was ordered by the practitioner, for up to 60 days from the date of issue. (For example: The practitioner orders Percocet 5/325mg tablets, with a prescribed quantity of 60 tablets. The pharmacist can send 20 tablets of Percocet 5/325mg in 3 “partial fills” to the LTCF or terminally ill patient, for up to 60 days from the date of issue).

  8. Let’s Review!Schedule II Controlled Substance Medications • According to the Drug Enforcement Administration (DEA): the practitioner may, in writing, authorize an “agent” to prepare a controlled substance prescription only based on the instructions of the prescribing practitioner as to the required elements of a valid prescription, and then provide the prescription to the practitioner to review and personally sign. • The agent of the practitioner may not orally communicate a Schedule II controlled substance order to the pharmacy under any circumstances.

  9. DEA Regulations: Controlled Substances Listed in Schedule III-V 21 CFR 1306.21 Requirement of Prescription Key point: A pharmacist may dispense directly a controlled substance listed in Schedule III, IV or V which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, only pursuant to either a written prescription signed by a practitioner or a facsimile of a written, signed prescription transmitted by the practitioner or the practitioner’s agent to the pharmacy or pursuant to an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required in §1306.05, except for the signature of the practitioner.

  10. Refilling of Schedule III-V Controlled Substances 21 CFR 1306.22 Refilling of Prescriptions • No prescription for a controlled substance in Schedule III or IV shall be filled or refilled for more than six months after the date on which such prescription was issued and no such prescription authorized to be refilled may be refilled more than five times. • The prescribing practitioner may authorize additional refills of Schedule III or IV controlled substances on the original prescription through an oral refill authorization transmitted to the pharmacist provided that…the total quantity authorized, including the amount of the original prescription, does not exceed five refills nor extend beyond six months from the date of issue of the original prescription.

  11. SCHEDULE III CONTROLLED SUBSTANCES ACETAMINOPHEN W/CODEINE #3 ACETAMINOPHEN W/CODEINE #4 ANABOLIC STEROIDS (ANADROL, ANDROID, HALOTESTIN, NANDROLONE, OXANDRIN ) ASPIRIN WITH CODEINE #2 ASPIRIN WITH CODEINE #3 ASPIRIN WITH CODEINE #4 BENZPHETAMINE (DIDREX) BUPRENORPHINE (BUPRENEX) BUTABARBITAL (BUTISOL) BUTALBITAL COMBINATIONS (FIORINAL) CODEINE CONTAINING ANALGESICS WITH LESS THAN 90 MG/ DOSE UNIT (TYLENOL with CODEINE, EMPRACET, NOVO-GESIC) DRONABINOL (MARINOL) FENFLURAMINE (PONDIMIN) HYDROCODONE CONTAINING ANALGESICS (VICODIN, LORCET, LORTAB, ANEXSIA, ZYDONE, VICOPROFEN) HYDROCODONE CONTAINING COUGH SYRUPS (HYCODAN, HYCOTUSS, TUSSAFIN, TUSSIONEX) KETAMINE (KETALAR) PHENDIMETRAZINE (PLEGINE) PHENTERMINE (FASTIN, IONAMIN) SCHEDULE IV CONTROLLED SUBSTANCES ALPRAZOLAM (XANAX) BENZODIAZEPINES BUTORPHANOL (STADOL) CHLORAL HYDRATE CHLORDIAZEPOXIDE (LIBRIUM) CHLORDIAZEPOXIDE & AMITRIPTYLINE CHLORPHENTERMINE CLONAZEPAM (KLONOPIN) CLORAZEPATE DIPOTASSIUM (TRANXENE) DIAZEPAM (VALIUM, VALRELEASE, DIASTAT) DIETHYLPROPION (TENUATE) ESTAZOLAM (PROSOM) ETHCHLORVYNOL (PLACIDYL) FLURAZEPAM (DALMANE) HALAZEPAM (PAXIPAM) LORAZEPAM (ATIVAN) MAZINDOL (SANOREX) MEPROBAMATE (EQUANIL) MIDAZOLAM (VERSED) OXAZEPAM (SERAX) PEMOLINE (CYLERT) PENTAZOCINE AND ALL COMBINATIONS (TALWIN-NX, TALACEN) List of Common Schedule III-V Controlled Substances

  12. SCHEDULE IV CONTROLLED SUBSTANCES (cont’d) PHENOBARBITAL PRAZEPAM (VERSTRAN) PROPOXYPHENE IN ALL COMBINATIONS (DARVON, DARVOCET-N, WYGESIC) QUAZEPAM (DORAL) SIBUTRAMINE (MERIDIA) TEMAZEPAM (RESTORIL) TRIAZOLAM (HALCION) ZALEPLON (SONATA) ZOLPIDEM (AMBIEN) SCHEDULE V CONTROLLED SUBSTANCES CODEINE CONTAINING COUGH SYRUPS (LESS THAN 180 MG/ 10 ML) ROBITUSSIN-AC, TUSSI-ORGANIDINNR DIPHENOXYLATE W/ATROPINE (LOMOTIL) PREGABALIN (LYRICA) List of Common Schedule III-V Controlled Substances

  13. Let’s Review!Schedule III-V Controlled Substance Medications • A Schedule III-V controlled substance medication requires either: (1) a written prescription signed by a practitioner, or (2) a fax of a written, signed prescription transmitted by the practitioner or the practitioner’s agent to the pharmacy, or (3) an oral prescription communicated by the practitioner or the practitioner’s agent to a pharmacist. • A Schedule III-V controlled substance medication can have five (5) refills in a six (6) month period. A Schedule III-V controlled substance cannot be filled or refilled more than six (6) months after the date on which the prescription was issued.

  14. Let’s Review!Schedule III-V Controlled Substance Medications • A partial fill of a prescription for a Schedule III-V controlled substance medication is allowed, provided that: (1) each partial filling is recorded in the same manner as a refilling, (2) the total quantity dispensed in all partial fills does not exceed the total quantity prescribed, and (3) no dispensing occurs after six (6) months from the date on which the prescription was issued. • According to the Drug Enforcement Administration (DEA): the practitioner may, in writing, authorize an “agent” to prepare a controlled substance prescription only based on the instructions of the prescribing practitioner as to the required elements of a valid prescription, and then provide the prescription to the practitioner to review and personally sign.

  15. Required Elements of a Valid Written Prescription for a Controlled Substance Full name of the resident Full address of the resident (not just the facility name) Drug name, strength, & dosage form Directions for use Quantity prescribed (some states may require alpha & numeric notation of quantity) Full name, full address, & DEA number of the practitioner Date issued & signature of the practitioner

  16. “Authorized Agent” of the Practitioner • The agent of the practitioner is a person authorized in a written, practitioner-signed agent agreement, to perform certain ministerial acts in connection with communicating prescription information to a pharmacy. • The most common means to communicate a prescription to the pharmacy include: • hand delivery • facsimile (FAX) • phone call • The role of the authorized agent of the practitioner depends upon: • the schedule of the controlled substance prescribed • the circumstances of the ultimate user • the method of communication

  17. Agent of the Practitioner’s Role: Schedule II Controlled Substances • An authorized agent of the practitioner may transmit a practitioner-prepared and practitioner-signed Schedule II controlled substance paper prescription via facsimile to the pharmacy on behalf of the practitioner. • An authorized agent of the practitioner may prepare a Schedule II controlled substance prescription based on the instructions of the prescribing practitioner as to the required elements of a valid prescription, provide the prescription to the practitioner to review and personally sign, then transmit the prescription via facsimile to the pharmacy on behalf of the practitioner .

  18. Agent of the Practitioner’s Role: Schedule II Controlled Substances • An authorized agent of the practitioner may transmit a practitioner-signed valid Schedule II controlled substance prescription, on behalf of the practitioner, to a pharmacy via facsimile for: • patients enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII. • patients enrolled in a hospice program which is licensed by the State. • residents of Long Term Care Facilities (LTCFs). • An authorized agent of the practitioner may not orally communicate a Schedule II controlled substance to a pharmacist under any circumstances.

  19. Agent of the Practitioner’s Role: Schedule III-V Controlled Substances • An authorized agent of the practitioner may transmit a practitioner-prepared and practitioner-signed Schedule III-V controlled substance paper prescription to the pharmacy on behalf of the practitioner. • An authorized agent of the practitioner may prepare a Schedule III-V controlled substance prescription only based on the instructions of the prescribing practitioner as to the required elements of a valid prescription, and then provide the prescription to the practitioner to review and personally sign. • An authorized agent of the practitioner may orally communicate a Schedule III-V controlled substance prescription, made by an individual practitioner, to a pharmacist.

  20. Agent of the Practitioner Agreement • A regulatory clarification, issued by the DEA as a statement of policy in the Federal Register on October 6, 2010, publicly articulates that an agent agreement must be established between the LTCF nurse and the prescribing practitioner in order for the nurse to act as an authorized agent of the prescribing practitioner. • Once this agreement has been executed, the authorized agent of the prescribing practitioner can perform all of the agent functions described in the previous slides. • It is important that the authorized agent of the prescribing practitioner be clearly identified as a designated individual person, and that his or her activities be subject to evaluation to ensure that they do not exceed the bounds of an agent’s role under the Controlled Substances Act.

  21. Agent of the Practitioner Agreement • A practitioner, acting in the usual course of his or her professional practice, must determine that there is legitimate medical purpose for a controlled substance prescription. • The authorized agent of the prescribing practitioner may not make the determination that there is a legitimate medical purpose for a controlled substance prescription. • Where the pharmacist has reason to believe that a prescription has been communicated by an agent, the pharmacist, in accordance with his or her responsibility for proper dispensing of controlled substances, may have a duty to inquire into the legitimacy of the prescription. The particular circumstances will dictate the appropriate level of inquiry by the pharmacist.

  22. Agent of the Practitioner Agreement • DEA recommends that the original agency agreement be kept by the practitioner during the term of the agency relationship, and for a reasonable time after termination or revocation. • DEA requires that inventory and other records be kept for at least two years; this is a suggested time period for retention of agency agreements, but is not required by DEA. • A signed copy should also be provided to the prescribing practitioner’s authorized agent, the agent’s employer, and any pharmacies that receive regular communications from the agent pursuant to the agreement.

  23. Agent of the Practitioner Agreement Role of the Pharmacist • A pharmacist always has a corresponding responsibility to ensure that a controlled substance prescription conforms with the law and regulations. • The pharmacist also has a corresponding responsibility to ensure that the prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice, and a corresponding liability if a prescription is not prepared or dispensed in a manner consistent with CSA or DEA regulations. • Even when the pharmacist has a copy of the agency agreement, the pharmacist may also have a duty to inquire further depending on the circumstances.

  24. Revocation of the Agency Agreement • Because the agency agreement may be revoked at any time by either the practitioner or by the agent, the party terminating the agreement should notify the other party immediately upon termination. • The practitioner should notify those pharmacies that were originally made aware of the agency agreement of the termination of that agreement. • In most circumstances where the agent changes employment, the agreement should be revoked.

  25. Revocation of the Agency Agreement • The agency agreement shall be terminated immediately if and when any of the following occur: • The prescribing practitioner no longer possesses the active DEA registration specified in the agreement. • The agent of the practitioner is no longer employed in the manner described in the agreement. • The prescribing practitioner or the authorized agent revokes the agency agreement by completing the revocation section of the agency agreement, or by executing a written document that is substantially similar to the revocation section at the end of the agency agreement.

  26. Agency Agreement • Omnicare has created a sample agent agreement that is available for use by practitioners and nurses. This document is formatted as outlined in the DEA statement of policy articulated in the Federal Register, and is provided as a template for the practitioner-agent agreement. • Omnicare does not require that this specific template is used; but a similar agreement, containing the elements outlined in the Federal Register, must be signed by the prescribing practitioner and the authorized agent for the purposes of recognizing the facility nurse as an agent of the prescribing practitioner for the purposes of communicating controlled substance prescriptions to pharmacies.

  27. “Authorized Agent” of the Practitioner

  28. “Authorized Agent” of the Practitioner

  29. “Authorized Agent” of the Practitioner

  30. What Can We Do to Help Our Residents Get Their Medication? • Consult with your practitioners about executing agent agreements for your nurses. A separate agreement must be executed and signed for each practitioner and each agent . • Request signed, written prescriptions from practitioners for all controlled substance medications that are ordered for your residents, especially new Schedule II controlled substance medications and Schedule III-V controlled substance medications that are new or have no refills. • Remind practitioners to authorize a sufficient quantity of Schedule II controlled substance medication for your residents, especially for “prn” orders. • Remind practitioners to authorize refills on Schedule III-V controlled substance medications for your residents.

  31. What Can We Do to Help Our Residents Get Their Medication? • Remind hospital Discharge Planners to encourage practitioners to transfer new residents to your facility with signed, written prescriptions for all controlled substance medications. • Remember that, when the pharmacy owns the e-kit inventory, the use of contingency supply/emergency box/starter kit/automated dispensing machine (Pyxis, Suremed, Omnicell) controlled substance medications requires prior authorization by the pharmacist. You must contact the pharmacist prior to removing a controlled substance medication from the contingency supply, and you must have authorization from the pharmacist prior to removing a controlled substance medication from the contingency supply. • Consult the Omnicare staff pharmacist, consultant pharmacist, or your practitioner regarding the possible use of non-controlled pain medications for your residents.

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