Dispensing Controlled Substances PDF

CHAPTER 5 Dispensing Controlled Substances Ryan A. Nelson, Pharm D., Esq. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com. Controlled Substance (CS) Prescriptions  Defined as an order for medication dispensed to or for an ultimate...

CHAPTER 5 Dispensing Controlled Substances Ryan A. Nelson, Pharm D., Esq. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com. Controlled Substance (CS) Prescriptions  Defined as an order for medication dispensed to or for an ultimate user  The Rx does not include orders for medication dispensed for immediate administration (i.e., hospital Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com chart orders).  Prohibition against prescriptions for office use Those Allowed to Prescribe CSs  Individual practitioners (IPs) authorized to prescribe (or issue medication orders) in their state and registered by DEA or exempt from registration  Employees or agents of IP may communicate prescriptions to Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com a pharmacist or prepare the Rx for signature of IP  Delegation of prescriptive authority not legal unless agent also has prescriptive authority  When suspicious, might check the validity of a DEA number by performing the calculations or searching national database Features of a DEA Number  First letter identifies the type of registrant  A>B>F>G= hospitals, individual practitioners  M= mid-level practitioner  P or R= manufacturer or distributer  Second letter is usually the first letter of the prescriber’s last name. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  Add the 1st, 3rd, and 5th digits  Add the 2nd, 4th, and 6th digits x 2  The last digit of this sum equals the last digit of the DEA number. Example: AN1257218  1+5+2=8 (2+7+1)x2=20 28(check digit) 4 Those Allowed to Dispense Controlled Substances  Only a pharmacist acting in usual course of professional practice and who is registered individually or employed by a registered pharmacy or institutional practitioner Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  Ancillary personnel may engage in CS dispensing activities if permitted by state law.  IPs may dispense if permitted by state law. Information Requirements of CS Prescriptions  Date of issuance required: no predating or postdating  Must contain full name and address of patient  Drug name, strength, dosage form, and quantity Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com prescribed; directions for use  Name, address, and registration number of practitioner  Before filing, must contain written or typed name or initials of dispensing pharmacist, the date dispensed, and the units or volume dispensed Other Requirements of Written CS Rxs  Must be signed on day of issuance  Written in ink, indelible pencil, or typed and manually signed Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  Corresponding responsibility of pharmacist and prescriber that a CS Rx complies with all requirements IPs Exempt from Registration  Must include registration number of institution and special internal code number  Must include name of prescriber stamped, typed, or hand printed, as well as signature of prescriber Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  IPs in armed services or public health must include on the Rx the service ID number in place of the registration number. Correcting Errors and Omissions  Waiting for DEA to pass Rule on topic  Past: for C-III, C-IV, and C-V Rxs: the pharmacist may add or change any information after consultation with practitioner and documentation, except for the patient’s name, name of CS (except generic substitution), or Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com prescriber’s signature.  Take new verbal Rx if needed where permitted  Past: for C-II Rxs: DEA used to allow additions/changes to be made the same as with other CS Rxs. That position has flip-flopped in recent years, but at this time, RPh can correct based on state law/policy until DEA Rule is proposed/passed. Purpose of CS Prescription  A CS Rx must be for a legitimate medical purpose in the usual course of professional practice.  Generally means acting in accordance with accepted standards of medical practice. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  Corresponding responsibility upon the pharmacist  Knowingly prescribing or dispensing a CS Rx not for a legitimate medical purpose violates the law.  “Knowingly” standard is one of a conscious disregard for the obvious.  When suspicions should exist, a pharmacist is expected to exercise professional judgment and investigate. Legitimate Medical Purpose and Usual Course of Professional Practice  Examples of invalid prescriptions include narcotic prescriptions written:  for the purpose of maintaining or detoxifying an addict  Physically dependent= legitimate Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  Psychologically dependent-underlying condition resolved= not valid  for fictitious patients  without a good-faith medical examination  when there is no medical reason  A facially valid Rx is not necessarily a valid Rx. Legitimate Medical Purpose and Usual Course of Professional Practice (cont.)  Pharmacists will more likely face enforcement action in situations where there is blatant or glaring misconduct as opposed to isolated prescriptions. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  DEA has published examples of situations that might be suspicious. Medical Arts Pharmacy v. State Board of Pharmacy (Cal. Ct. App. 1981)  Pharmacy filled Rx for the same person, multiple different addresses, many of the address were nonexistent.  Came from the same prescriber.  Patient names included Henry Ford, Fairlane Ford, and Pearl Harbor. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  Pharmacist claimed he did not know the Rx were not valid. Ruling- Whether a pharmacist knew that Rx’s were not for a legitimate medical purpose can be inferred from strong circumstantial evidence.  A pharmacist must recognize the possibility of wrongdoing and not consciously choose to disregard it. Corresponding Responsibility Doctrine  Both the prescriber AND the pharmacist are legally responsible for the proper prescribing and dispensing of controlled substances.  CS Rx must comply with all requirements.  If a prescribing doctor violates the rule, do NOT accept the Rx. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  Postdating  Office Use May be appropriate to correct Rx. Document everything you do. Corresponding Responsibility Doctrine Cases US v Hayes- Meaning/ vagueness of doctrine Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com Ryan v Dan’s Food- public policy defense Exercise of Clinical Judgment and Pain Treatment  Treatment of pain is a legitimate medical purpose.  Drug tolerance and physical dependence as a consequence of opioid use is normal and natural.  The quantity of drugs prescribed and frequency of Rxs Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com alone are not indicators of improper prescribing.  The pharmacists’ role under CSA is determining the legitimacy of Rx for pain rather than therapeutic appropriateness of using opioids. Differentiating Treatment of Pain from Treatment of Addiction  Important to determine whether the purpose of opioid treatment is legally for pain or illegally for addiction  Important to ascertain whether taper-down dosages are for detoxification of addiction or withdrawal due to Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com physical dependence  Exceptions allowing for treatment of addicts outside of licensed addiction programs or DATA Ascertaining the Legitimacy of Opioid Rxs in Pain Treatment  Alleged pain clinics create special concerns for pharmacists.  Pharmacists should familiarize themselves with the medical standards of practice for diagnosing and Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com treating pain.  Consider discussion with both the patient and prescriber regarding the pain and the treatment. Federal/State Efforts to Balance Pain Treatment with the Opioid Epidemic  Overdose deaths in the U.S. continue to rise.  Various federal and state efforts have been implemented to help address the epidemic, including prevention, treatment, and enforcement efforts. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  Examples of various efforts: prescribing guidances and laws, prescription drug monitoring programs (PDMPs), naloxone access, FDA REMS, medication disposal, expansion of partial fills, mandated electronic prescribing Dispensing C-II Drugs  General rule: C-II prescriptions must be written and signed by a prescriber.  CMS requires Electronic Rx for Medicare Part D Rxs.  Some states have stricter laws (e.g., quantity limits, Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com time limits, security Rx forms). Dispensing C-II Drugs (cont.)  Exceptions:  Emergency situations  Narcotic compounded drug for direct administration by infusion: faxed Rx serves as original Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  Long-term care facility (LTCF) patients: faxed Rx serves as original  Hospice patients for narcotic C-II drugs: faxed Rx serves as original  Electronic (pursuant to requirements discussed later) Partial Filling of C-II Drugs  The 2016 Comprehensive Addiction and Recovery Act (CARA) law allows pharmacies to provide partial fills of a C-II medication, if requested by patient or prescriber, up to 30 days from the date of the prescription if state law does not prohibit. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  CARA also allows partial fills of schedule II–controlled substances when a pharmacist receives a verbal emergency prescription, with any remainder being provided within 72 hours.  In LTCFs or for terminally ill patients, may partially fill for up to 60 days from date of issuance, provided recordkeeping requirements are met. Partial Filling of C-II Drugs  Long standing 72-hour partial fill still permitted if pharmacy is unable to supply  “unable to supply” also includes other situations (e.g., verifying information with the prescriber) Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  Remaining partial fill qty must be obtained within 72 hours or no more permitted and pharmacist to contact prescriber to inform  DEA clarified pharmacy must obtain w/in 72 hours, but patient can pick up after that time frame  Pharmacist to document details of partial fill Multiple C-II Rxs for Same Drug and Patient on Same Day  Permitted provided:  Each Rx must be on a separate blank.  The total quantity prescribed does not exceed 90-day supply. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  The practitioner determines a legitimate medical purpose to do this.  The practitioner writes instructions on each Rx (other than first) as to earliest date each Rx may be dispensed.  Multiple Rxs do not create undue risk of diversion.  Permissible under state law Dispensing C-III, C-IV, and C-V Drugs  May be dispensed pursuant to written, faxed, electronic, or oral order  Oral orders must be promptly reduced to writing. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  IPs may administer or dispense without a prescription. Refilling C-III and C-IV Rxs  For C-III and C-IV drugs: limit of 6 months after date of issuance or five times, whichever comes first  The practitioner may orally authorize additional refills if original was written for less than five and authorization Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com is recorded on hard copy or in automated system.  The refill quantity cannot exceed quantity originally authorized. Recording Refills of C-III and C-IV Rxs  If nonautomated system, must record required information on back of Rx or other readily retrievable document  If automated system, must provide online retrieval either by display or hard copy printout of the original Rx Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com information and up-to-date refill history  Hard copy printout requirements  In lieu of printout, may maintain bound logbook or separate refill file  Records must be maintained for 2 years.  Pharmacies must have an auxiliary system for documenting refills, if computerized system suffers downtime. Partial Filling of C-III, C-IV, and C-V Rxs  Permitted provided:  Recorded in same manner as refill  The total quantity dispensed does not exceed total prescribed. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  No dispensing after 6 months from date of issuance  Important to differentiate partial fills from refills  Example: Lorazepam #30 i qd 5rf  Total qty= #180  If pt gets #15, they can get 11 more partial fills of #15 Labeling  The label must include date of filling if a C-II drug and date of initial filling if in another schedule.  Refills should be labeled with both date of initial filling and date of dispensing. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  Labels must include all required information plus a cautionary statement prohibiting the ultimate user from transferring the drug.  Labeling requirements are not applicable if prescribed for administration to an institutionalized patient, provided that restrictions and requirements are met. Electronic Transmission Rxs  Prescribers must:  Undergo identity proofing  Digitally sign using two of three possible factors for authentication Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  An agent can enter Rx information but cannot have access to authentication factors and sign. Transferring Prescription Information  CS Rx information (except C-II) may be transferred one time between pharmacies if state law allows and requirements are followed by both the transferring pharmacy and receiving pharmacy. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  Rx information sharing among pharmacies participating in common-electronic record systems is not subject to the transfer Rx requirements (CS Rxs may be transferred up to maximum refills allowed).  DEA permits a retail pharmacy, upon request, to electronically transfer a C II–V e-Rx to another pharmacy for initial dispensing on a one-time basis. Return of CSs to Pharmacy for Disposal  Historically, the DEA forbade that CSs be returned by a patient or LTCF to a pharmacy for disposal.  The Secure and Responsible Drug Disposal Act of 2010 allows an ultimate user to deliver to another Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com person for disposal.  DEA regulations in 2014 allow authorized entities, including pharmacies, to collect CSs from ultimate users, provided they register as a “collector.” Central Filling of Rxs  Pharmacies that fill Rxs for other retail pharmacies pursuant to contractual arrangement.  May fill both new and refill Rxs. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  Any Rx dispensed for another pharmacy must be transported to that pharmacy for furnishing to patient.  The label of the dispensed drug must indicate at which pharmacy the drug was dispensed. Central Filling of Rxs (cont.)  Cannot accept Rxs directly from patient or practitioner or deliver Rx directly to patient or practitioner. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  Corresponding responsibility doctrine applies to pharmacists at both facilities. Internet Prescriptions  Rogue internet pharmacy businesses are those that sell Rx medications to customers either without requiring Rxs or by issuing Rxs pursuant to online surveys. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  The Ryan Haight Act defines a valid Rx as one that has been issued for a legitimate medical purpose by a practitioner who has conducted at least one in-person medical evaluation of the patient.  DEA permits limited exceptions to telemedicine CS Rx without in-person evaluation State Electronic Drug Rx Monitoring Programs (PDMPs)  All states have a PDMP.  A state PDMP requires a pharmacy to electronically transmit to the state a record of the CS Rx dispensed. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  Enables states to determine possible diversion and abuse situations.  Most PMPs allow or mandate practitioners to request patient-specific information.  Many states share data between PDMPs. Long-Term Care (LTC) Pharmacy  LTC facilities (LTCFs) not registered with DEA.  DEA concerned about excess supplies of CSs and thus permits automated dispensing systems, partial filling, and voluntary collection receptacles by Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com registered “collectors.” Automated Dispensing Systems (ADS) in LTCFs  ADS is a mechanical system that stores, packages, counts, labels, and dispenses medications and maintains transaction information.  The purpose is to reduce stocks of excess CSs in Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com LTCFs.  A pharmacy that installs ADS must maintain separate DEA registration at LTCF location.  Distributions that a pharmacy makes to ADSs do not count toward the pharmacy’s 5% limit that would require a separate registration as a distributor. LTCF Nurses as Agents of the Prescriber  The DEA has changed positions as to whether LTCF nurses can be an agent of the prescriber.  The latest Federal Register notice permits an agency relationship, provided there is a formal written, Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com witnessed agreement.  An agent may only perform certain acts.  Prepare written Rx for signature  Call in Rx to pharmacy (C-III, IV, & V)  Cannot call in a C-II  Fax a Rx, including C-II Dispensing from LTCF Emergency Kits  LTCF emergency kits permitted  The pharmacy is responsible for the kits.  The DEA does not consider a nurse as an agent of the Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com prescriber for this purpose.  The prescriber must issue the prescription to the pharmacy and the pharmacist must authorize nurse to dispense from the kit. Recordkeeping  Every registrant must keep a complete and accurate record of all CSs.  Three types of records involved:  Inventory Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  Drugs received  Drugs dispersed  Negligent recordkeeping is a violation of the CSA. General Recordkeeping Requirements  Records generally must be kept for 2 years.  Certain records may be kept at a central location with notification to the DEA. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  Centralized records require that the DEA be notified.  Records must be able to be delivered to a registered location within two business days per DEA request.  C-I and C-II records must be maintained separately unless readily retrievable. Inventory Records  Prior to beginning business and subsequently every 2 years, an inventory must be conducted containing a complete and accurate record of all CSs “on hand.”  “On hand” means in possession of or under the control Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com of the registrant.  Inventory may be taken at the beginning or end of the business day; records must be written, typed, or printed. Inventory Records (cont.)  Newly scheduled drugs must be inventoried on date of scheduling.  The exact count must be made of C-I or C-II drugs. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  The estimated count is permissible for other schedules unless container holds more than 1,000 units.  Inventory Records Exact Count Estimated count  Substance is listed in  Generally, if schedule I or schedule schedule III, IV, or V II Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  Holds 1,000 units  If the container holds (cap/tabs) or less. more than 1,000 tablets or capsules. Records of Receipt  Acceptable records of receipt include invoices and Form 222.  A pharmacy must record the date of receipt on the invoice or Form 222. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  If the invoice contains both CSs and nonCSs, the CSs must be identified in a manner so as to be readily retrievable.  Records of receipt must contain all required information. Records of Dispersal  Acceptable records of dispersal include Rxs, record books, Form 222, invoices, records of disposal, theft or loss, etc.  Prescriptions may be filed in one of two ways and each Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com Rx must contain all required information. 1. In 3 separate files: C-II; C-III, IV, & V; noncontrolled Rx 2. In 2 separate files: C-II; C-III, IV, & V with noncontrolled Rx Nonprescription Schedule V Sales  In some states, C-V products may be sold without Rx, provided:  Dispensing done only by a pharmacist  No more than 8 oz of an opium-containing product or 4 oz Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com of any other CS may be dispensed to the same purchaser within a 48-hour period (some states have stricter requirements).  The purchaser is at least 18 years of age.  The purchaser furnishes suitable identification.  The sale is recorded in a bound record book with all required information. Distributions from a Pharmacy to Another Practitioner  Invoice required for C-III, C-IV, and C-V products containing all required information  Form 222 required for C-II products Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  The total number of dosage units distributed to another registrant must not exceed 5% of total units of CSs distributed and dispensed in 1 year. Institutional Medication Records  Medication or chart orders are distinguished from prescriptions and need only contain the minimum information necessary to provide an acceptable dispersal record. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  Must be readily retrievable.  Discharge medication orders may only be dispensed pursuant to Rx. Disposal or Destruction  Must request/document via a DEA Form 41 (available online) and completed with required information.  The DEA allows destruction pursuant to various options. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  “Blanket authorization” may be allowed for hospitals.  A registrant may also transfer CSs to a reverse distributor.  Reverse distributor to use DEA Form 41 Records of Theft or Loss  A registrant must notify the DEA within 1 day of discovery of any “theft or significant loss” of any CS (should also notify police and most likely required to notify state board of pharmacy). Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  The DEA has listed several factors to be considered in determining whether a loss is significant.  A registrant must complete Form 106, which is available online. Records Required of Individual Practitioners  Must keep records of CSs they dispense, but not of those they prescribe.  Need not keep records of CSs they administer unless the IP regularly engages in dispensing or administering Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com and charges patients.  A record must be kept of CSs administered in the course of maintenance or detoxification of treatment of addiction.  May administer or dispense CS without Rx. DEA Form 222  Required for any distribution of C-I or C-II drugs.  Forms obtained by requesting in writing from nearest DEA office.  Triplicate forms phased out; single-sheet now used. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  Forms are serially numbered and issued with name, address, and registration number of registrant, authorized activity, and schedules registrant is authorized to handle.  A registrant may not correct or change any information or errors on the forms. Execution of Form 222  Number of last line completed must be noted on each form  The form must contain required information. The NDC number is optional (supplier must enter it).  Must be signed and dated by authorized person. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  The purchaser, upon receipt of order, must record number of containers received of each item and date received.  Partial order fills by supplier must be completed within 60 days. Single-Sheet DEA Form 222  The purchaser sends the original completed form to the supplier after making and retaining a copy.  The supplier would then keep the original form and inform DEA of the purchase via ARCOS or by sending Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com a copy of Form 222. Electronic Order System (CSOS)  May be used instead of Form 222  The purchaser can order any drug.  The registrant must obtain a digital certificate for each Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com DEA-registered location. Power of Attorney (POA)  Required to allow person other than one who signed registration to execute Form 222 Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com Distributions of C-I and C-II Drugs Between Registrants  Whenever registrants distribute C-I or C-II drugs among themselves, they must execute a Form 222 following proper procedure. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com Lost or Stolen Forms  If an unfilled order form is lost, the purchaser must execute another together with a statement noting the serial number of the lost form, date of lost form, and that the CSs were not received. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  Must maintain copy of second order form and lost order form with statement  The copy of the statement must be sent with original form to the supplier.  If forms stolen or lost other than in transmission, must notify DEA and provide serial numbers of missing forms; if found, DEA must be notified immediately. Preservation of Forms  Executed Form 222s must be maintained separately from all other records and retained for 2 years.  A copy of the single-sheet DEA Form 222 must be kept at the registered location. Copyright © 2025 by Jones & Bartlett Learning, LLC. www.jblearning.com  The supplier always keeps the original DEA Form 222.