The Year DEA Prescriber Agent: New Interpretation What it means to you! Richard B Greene, PharmD, MBA, FASCP 1
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1 Disclaimer DEA: Prescriber Agent: New Policy, New Interpretation Richard B. Greene, PharmD, MBA, FASCP ARX Consulting I, Richard B. Greene, do not have any real or apparent commercial affiliations related to the content of this presentation. 2 Objectives Describe the current interpretations of Drug Enforcement Administration (DEA) rules regarding the prescribing and dispensing of controlled substances Define Agent of the Prescriber as it relates to prescribing of controlled substances. Distinguish the difference between the controlled substance regulations for longterm care residents, hospice patients and other patients Identify the documentation required to ensure pharmacy compliance with the DEA regulations. 3 The Year 1970 Gas was 36 a gallon The EPA was created The Beatles broke-up Child resistant caps required in retail pharmacy The World Trade Center was completed Lithium was approved for Manic Depression Bar Codes, Floppy Disks and were not available yet. Controlled Substance Act passed 4 Federal Controlled Substances Law Prescriptions for Controlled Dangerous Substances Purpose of issue Rx must be for legitimate medical purpose (21 CFR (a)) Practices which alert RPh to unauthorized or inappropriate prescribing Larger quantities prescribed by a prescriber as compared to other prescribers of the same specialty Dose, quantity, combination drugs outside of accepted medical practice Irrational combinations frequently prescribed Patients travel to pharmacy to have prescription filled Erasures, misspellings, hospital Rx s (esp. VA Medical Centers) alterations Nonexistent person 5 Required Elements of a Valid Written Prescription for a Controlled Substance (21CFR ) Full name of the patient Full address of the patient (not just the facility name) Pharmacist must fill in if missing Drug name strength & dosage form 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 & Manual prescriber signature 6 Richard B Greene, PharmD, MBA, FASCP 1
2 Changes a pharmacist CAN NOT make to a Schedule II prescription DEA states that "the essential elements of the [Schedule II] prescription written by the practitioner (such as the name of the controlled substance, strength, dosage form, and quantity prescribed) may not be modified orally. Instructions are in opposition to DEA's previous policy which permitted the same changes a pharmacist may make to schedules CIII-V prescriptions after oral consultation with the prescriber. 7 Who may Prescribe a Scheduled Substance? A prescription order for a controlled substance may be issued only by a physician, dentist, podiatrist, veterinarian, mid-level practitioner or other registered practitioner who is: 1. Authorized to prescribe controlled substances by the jurisdiction in which he/she is licensed to practice. 2. Registered with DEA or exempted from registration (i.e., Public Health Service and Bureau of Prison physicians). 8 Mid Level Practitioners Permitted by the United States or the jurisdiction in which he/she practices DEA Mid Level Practitioner Web Site reg/practioners/index.html Examples: nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists, physician assistants, and pharmacists. 9 Mid Level Practitioners AMB Ambulance Service AS Animal Shelters DOM Doctors of Oriental Medicine ET Euthanasia Technicians HMD Homeopathic Physician MP Medical Psychologists ND Naturopathic Physician NP Nurse Practitioners NH Nursing Homes OD Optometrists PA Physician Assistants RPH Registered Pharmacists 10 Use of Hospital s DEA A practitioner (e.g., intern, resident, staff physician, mid-level practitioner) who is an agent or employee of a hospital or other institution May administer, dispense or prescribe controlled substances under the registration of the hospital or other institution in which he or she is employed provided that: Criteria for the Use of Hospital s DEA The hospital or institution authorizes the practitioner to dispense or prescribe under its registration and assigns a specific internal code number for each practitioner so authorized Richard B Greene, PharmD, MBA, FASCP 2
3 C have Controlled Substance Schedules The drugs and drug products under the jurisdiction of the CSA are divided into five schedules. Controlled substances in Schedules II-V have an accepted medical use in the United States, and Schedule I substances do not. 13 Scheduling of C Schedule I Cannot be prescribed Schedule II High potential for abuse Schedule III Less abuse potential than Schedule II Schedule IV Low abuse potential relative to Schedule III Schedule V Low abuse potential relative to Schedule IV CI CII CIII CIV - CV CFR Requirement of Prescription (a) A pharmacist may dispense directly a controlled substance listed in Schedule II that is a prescription drug as determined under section 503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) only pursuant to a written prescription signed by the practitioner, except as provided in paragraph (d) of this section. Schedule II A CII drug may only be dispensed pursuant to a valid Written prescription, signed by the practitioner and must list: The full name and address of the patient Drug name, strength, dosage form, quantity prescribed and directions for use Name, address and registration number of the practitioner Practitioner s signature Federal Controlled Substances Law Prescriptions for Controlled Dangerous Substances The Act and Drug Enforcement Administration regulations contain no specific limits on the number of days worth of a Schedule II controlled substance that a physician may authorize per prescription. Multiple Schedule II prescriptions (Interpretation of CFR ) DEA s regulations allow practitioners to provide individual patients with multiple prescriptions for a specific Schedule II CS, written on the same date, to be filled sequentially. The combined effect of such sequential multiple prescriptions is that it allows a patient to receive over time up to a 90-day supply of that CS Richard B Greene, PharmD, MBA, FASCP 3
4 Emergency prescription (d) In the case of an emergency situation, as defined by the Secretary in of this title, a pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral authorization of a prescribing individual practitioner, provided that: Federal Controlled Substances Law Prescriptions for Controlled Dangerous Substances Scheduled II dispensing requirements Emergency oral CII prescriptions All 3dee determinations must be made (21 CFR ) Emergency administration of CII is needed for patient care No proper alternative available Not readily possible for prescriber to present a written Rx prior to dispensing Federal Controlled Substances Law Prescriptions for Controlled Dangerous Substances Scheduled II dispensing requirements (continued) Emergency oral CII prescriptions (continued) When receiving emergency oral CII RPh must Reduce Rx to writing with all required information Make reasonable effort to determine prescriber s authority (if not known) (i.e., call back) Emergency CII prescription (21 CFR ) A pharmacist MUST receive the written prescription within 7 days from an oral authorization The prescription should include: A Notation: Authorization for Emergency Dispensing Date of oral authorization If the information is not received within 7 days, the pharmacist is required to report this missing information to the DEA Emergency CII prescription (21 CFR ) Dispensing beyond the emergency period requires a written prescription signed by the individual practitioner. Schedule II (continued) Emergency Kits Must have valid written Rx unless the Emergency Rule applies E-Kits should never be used routinely to dispense drugs that should have been reordered E-Kits are not starter doses E-Kits should only be used for unanticipated emergencies Richard B Greene, PharmD, MBA, FASCP 4
5 Federal Controlled Substances Law Prescriptions for Controlled Dangerous Substances Scheduled II dispensing requirements Except in emergency only pursuant to valid, written Rx Only valid for 30 days Do not fill in the date if it is missing Can be faxed if have original prescriptions before dispensing 25 DEA Regulations CFR (g) A prescription prepared in accordance with written for a Schedule II narcotic substance for a patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or a hospice program which is licensed by the state may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The practitioner or the practitioner's agent will note on the prescription that the patient is a hospice patient. The facsimile serves as the original written prescription for purposes of this paragraph (g) and it shall be maintained in accordance with (h). 26 Schedule II (continued) Facsimile Only for residents in long-term care or in a Medicare hospice program Fax must meet all of the requirements e e of a valid, written prescription order (including the signature of the practitioner). For hospice patients, prescription must state hospice patient. May be transmitted only by practitioner or the practitioner s agent Federal Controlled Substances Law Prescriptions for Controlled Dangerous Substances Scheduled II dispensing requirements (continued) Partial filling CII (21 CFR ) When full quantity not available Must note partial filling on Rx; date and quantity Must complete order with 72 hours but if not, must notify prescriber and receive new Rx Exceptions for long-term care facilities or hospice patients DEA Regulations CFR Section Partial filling of prescriptions. (b) A prescription for a Schedule II controlled substance written for a patient in a Long Term Care Facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities to include individual dosage units.. The pharmacist must record on the prescription whether the patient is "terminally ill" or an "LTCF patient.". The total quantity of Schedule II controlled substances dispensed in all partial fillings must not exceed the total quantity prescribed. 29 Emergency CII Prescription Review 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 patient 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.) 30 Richard B Greene, PharmD, MBA, FASCP 5
6 Schedule III, IV and V Can be dispensed only pursuant to: A valid written prescription signed by the practitioner, A facsimile of a written, signed prescription transmitted to the pharmacy by the practitioner or the practitioner s agent, or Pursuant to an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required for a valid prescription, such as authorized refills, except for the signature of the practitioner 31 Section Requirement of prescription. (a) A pharmacist may dispense directly a controlled substance listed in Schedule III, IV, or V that is a prescription drug as determined under section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) only pursuant to either a paper p prescription p signed by a practitioner, a facsimile of a signed paper prescription transmitted by the practitioner or the practitioner's agent to the pharmacy, an electronic prescription that meets the requirements of this part and part 1311 of this chapter, or an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required in Sec , except for the signature of the practitioner. 32 Section Refilling of prescriptions. (a) No prescription for a controlled substance listed in Schedule III or IV shall be filled or refilled more than six months after the date on which such prescription was issued. No prescription p for a controlled substance listed in Schedule III or IV authorized to be refilled may be refilled more than five times. Section Refilling of prescriptions. 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 Review Schedule III-V Schedule CIII-V prescription requirements: 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. 35 Review Schedule III-V A partial fill of a Schedule III-V prescription 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. 36 Richard B Greene, PharmD, MBA, FASCP 6
7 Transfer Schedule III, IV and V Prescriptions Refills One time basis only Transfer is communicated directly between two licensed pharmacists Void on Rx Record on reverse side invalidated Rx Name, address and DEA registration of the pharmacy transferred Name of pharmacist receiving Date of the transfer and the name of the pharmacists transferring 37 Transfer Schedule III, IV and V Prescriptions (Continued) Pharmacist receiving Transfer on the face of the Rx Provide all Rx information, date of issuance of original, original number of refills, date of original dispensing, number of refills remaining, and dates and locations of previous refills Name, address, DEA registration, and Rx number from which transferred Name of pharmacist who transferred Name, address, DEA registration, and Rx number from which originally filled Maintain for 3 years from date of last fill Electronically accessing the same Rx record must satisfy all requirements of a manual transfer 38 Communicating Prescriptions Only an individual practitioner can issue But once prepared, a valid prescription may be communicated to a pharmacist by: An employee, or An agent of the individual employee. Agent means: an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser; except that such term does not include a common or contract carrier, public warehouseman, or employee or the carrier or warehouseman, when acting in the usual and lawful course of the carrier s or warehouseman s business Interpretation of Agent Practitioner s nurse Practitioner s secretary An employee of LTCF is not an agent of the practitioner Legacy Order Process Prescriber communicates order to facility staff (written, phone, fax, electronic) Facility transmit the order to the pharmacy Pharmacy fills the order and delivers. Pharmacy then starts t trying to contact t the physician for the prescription Pharmacy continued to reach out until the issue was resolved Richard B Greene, PharmD, MBA, FASCP 7
8 Leading Events 1. In April 2009 the Drug Enforcement Administration (DEA) conducted audits in the Cleveland area, 2. DEA Interpretation: The DEA does NOT recognize the Nursing Facility nurse as an agent of the physician and does NOT see the chart order as a legitimate order for a controlled substance in a Nursing Facility, 3. If the pharmacy does not have a faxed complete Controlled Substance prescription, OR does not have a direct verbal authorization from the prescriber to a pharmacist, Nurses can NOT administer the Controlled Substance from the facility CS EDK and the pharmacy can NOT fill the order. 43 Multi-Million dollar fines and penalties being levied 2008 and 2009 $58,000,000 in fines and numerous registration actions Several large pending cases Pharmacy Manufacturer Distributor 44 Federal Register / Vol. 75, No. 193 / Wednesday, October 6, 2010 / Rules and Regulations (page ) Penalties and Fines Administrative sanctions; Letter of Admonition Administrative Hearing Loss of Registration DOJ Civil Prosecution. Consent Decree. Fines DOJ Criminal Prosecution. Fine. Jail. Forfeiture Board of Pharmacy Action. Licensure DEA Policy Clarification October 6 Federal Register DEA defines agent and expands interpretation beyond employees of a physician Policy applies to CIII-CV C controlled o medications LTCF nurse designated agent OR other designee may telephone orders to pharmacy on behalf of prescribing physician Written agreement between physician and designee establishing agency Must have separate documentation allowing agency to be rescinded 47 Agent of Prescriber Schedule II Prescriptions 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. 48 Richard B Greene, PharmD, MBA, FASCP 8
9 Agent of Prescriber Schedule III, IV, V Prescriptions DEA issued a clarification to allow nurses in LTC or other prescriber designees to act as the prescriber s agent for C-III, IV, and CV and communicate the prescription to the pharmacy Must designate everyone individually not a facility No help for emergency prescriptions No help with chart orders 49 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. 50 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. 51 Agency Agreement Federal Register (sample) Federal Register provides 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 practitioneragent agreement. Agreement must contain 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 Richard B Greene, PharmD, MBA, FASCP 9
10 Agent of the Practitioner s Role 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 Agent Activities 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 gprescription p information to a pharmacy. The most common means to communicate a prescription to the pharmacy include: Hand delivery Facsimile (FAX) Telephone call Agent of the Practitioner s Role: Schedule II An authorized agent of the practitioner may transmit a practitioner-prepared and practitionersigned 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. 57 Agent of the Practitioner s Role: Schedule II 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. 58 Agent of the Practitioner s Role: Schedule III-V 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. 59 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 agent and the prescribing practitioner in order for the agent 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 60 the Act. Richard B Greene, PharmD, MBA, FASCP 10
11 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 61 inquiry by the pharmacist. 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. 62 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. 63 DEA Policy Statement Review Role of Authorized Agents in Communicating Controlled Substance prescriptions to pharmacies Policy statement published in Federal Register: October 6, s/rules/2010/fr1006.htm Provides guidance to establish valid agency to communicate prescriptions 64 What Can You Do to Help Your Patients Get Their Medication? Consult with your practitioners about executing agent agreements for designees. 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 facility 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 patients, especially for prn orders. Remind practitioners to authorize refills on Schedule III-V controlled substance medications for your patients. 65 What Can You Do to Help Your 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. Remind facility staff: The pharmacy owns the e-kit inventory The use of contingency supply/emergency box/starter kit/automated dispensing machine controlled substance medications requires prior authorization by the pharmacist. Facility must contact the pharmacist prior to removing a controlled substance medication from the contingency supply, and must have authorization from the pharmacist prior to removing a controlled substance medication from the contingency supply. Consult the staff pharmacist, consultant pharmacist, or your practitioner regarding the possible use of noncontrolled pain medications for your 66 residents. Richard B Greene, PharmD, MBA, FASCP 11
12 Agency Policy Applicable to: Oral schedules III-V prescriptions Faxing of manually signed schedules III-V Preparing a schedule II prescription for prescriber signature Faxing of schedule II prescription for a person in a hospice or long term care facility Agency policy Includes sample written agency agreement to confirm authority Practitioner may designate one or more persons Agent may not further delegate authority Includes revocation language Recommendations for Change Allow nurses in LTCF and hospice to act as agents of prescribers to transmit Schedule II-V CS orders Expand the definition of a valid prescription drug order to include chart orders for patients in LTCFs and hospice Design a new category of DEA registration that allows facilities to be custodians of controlled substances. 69 References USA Department of Justice Drug Enforcement Administration Office of Diversion Control DEA Pharmacist Manual Code of Federal Regulations Title 21 CFR, Part American Society of Addiction Medicine's (ASAM) American Academy of Pain Medicine (AAPM) University of Wisconsin Pain & Policy Studies Group: 70 Thank you for your participation! DEA: Prescriber Agent: New Policy, New Interpretation Richard B. Greene, PharmD, MBA, FASCP ARX Consulting rbgreene7@gmail.com Richard B Greene, PharmD, MBA, FASCP 12
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