Federal Regulation of Controlled Substances 4 PDF

Federal Regulation of Controlled Substances 4 February 26, 2024 Learning Objectives Describe regulations for refilling controlled substances Describe how to record refills for controlled substance prescriptions Describe partial filling requirements for schedule II drugs Describe partial filling requ...

Federal Regulation of Controlled Substances 4 February 26, 2024 Learning Objectives Describe regulations for refilling controlled substances Describe how to record refills for controlled substance prescriptions Describe partial filling requirements for schedule II drugs Describe partial filling requirements for schedule II drugs for LTCF or terminally ill patients Describe partial filling requirements for schedule III, IV and V prescriptions List the items required on a prescription label for a controlled substance Describe legal transfer of controlled substance prescription information for refills (III-V) Describe regulations for the sale of controlled substances without a prescription Describe requirements for mailing controlled substances 2 Review C2 drugs can NEVER be CALLED IN for non-emergency circumstances! 3 Describe regulations refilling controlled substances PRESCRIPTIONS FOR SCHEDULE II DRUGS ARE NOT REFILLABLE CIII and CIVs may be refilled up to 5 TIMES WITHIN 6 MONTHS of the date on which the prescription is issued, if so authorized by the prescribing physician. After 5 authorized refills, or after the expiration date of 6 months from the issue date, whichever comes first, the prescription is not refillable. A new and separate prescription, written or oral, is required. Mississippi Board of Medical Licensure has stricter requirements 4 Describe regulations refilling controlled substances If less than 5 refills are originally authorized, additional refills of an original prescription may be authorized by the prescribing practitioner and be added to the original prescription through an oral refill authorization transmitted to the pharmacist provided the following conditions are met:  The total quantity authorized, including the amount of the original prescription, does not exceed 5 refills within a 6-month period from the date of issue of the original prescription.  The pharmacist obtaining the oral authorization must record on the reverse of the prescription the: 1. 2. 3. 4. Date of authorization Quantity of medication per refill Number of additional refills authorized Initials of the pharmacist who received the authorization original 5 Describe regulations refilling controlled substances  The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription.  The prescriber must issue a new and separate prescription for any additional quantities beyond the 5 refill, 6 month limitation. 6 Describe regulations refilling controlled substances CV prescriptions may be refilled in accordance with the prescriber’s instructions Many states limit refills of CV prescriptions to the same maximum of 5 refills within a 6 month period 7 Describe how to record refills for controlled substance prescriptions Records of controlled substance refills may be kept in one of three ways:  On the back of a paper prescription   On a paper patient medication record   On the computer  8 Describe how to record refills for controlled substance prescriptions  ON THE BACK OF A PAPER PRESCRIPTION  The refill should be noted  The note should be initialed and dated by the pharmacist  Indicate the quantity dispensed (if not indicated, it is assumed that the full amount of the refill was dispensed) 9 Describe how to record refills for controlled substance prescriptions  ON A PAPER PATIENT MEDICATION RECORD The record should be readily retrievable. The record should contain the following:  Prescription number  Name and dosage form of the controlled substance  Date of each refilling  Quantity dispensed  Initials of the dispensing pharmacist for each refill  The total number of refills for that prescription 10 Describe how to record refills for controlled substance prescriptions  ON THE COMPUTER As an alternative to recording refill information on the back of a prescription or other document, a pharmacy may use a computer for the storage and retrieval of refill information for schedule III and IV prescriptions. Such a system MUST provide online retrieval, either by means of a CRT display or hard copy printout, of the original prescription order information for those prescription orders currently authorized for refilling which must include but is not limited to:  Prescription number  The date of issuance of the original prescription  The full name and address of the patient  The name, address, and DEA number of the prescriber  Name, strength, dosage form and quantity of the controlled substance  The quantity dispensed if different from the quantity prescribed  The total number of refills authorized by the prescriber 11 Describe how to record refills for controlled substance prescriptions  ON THE COMPUTER The system must provide immediate retrieval of the current refill history for controlled substance prescriptions that have been authorized for refills in the last 6 months and certain backup documentation to show that the refill information is correct. The backup documentation can consist of a hard copy printout of each day’s controlled substances prescription refill data, which must be verified, dated, and signed by the pharmacist who refilled the prescription. This document must be maintained in a separate file at the pharmacy for a period of 2 years from the dispensing date. If the pharmacy data processing is linked to an off-premises computer center, the printout must be provided to the pharmacy within 72 hours of the dispensing date. 12 Describe how to record refills for controlled substance prescriptions  ON THE COMPUTER In lieu of the printout, the pharmacy may maintain a bound logbook or separate file for refills in which each individual pharmacist involved in dispensing medications verifies the prescriptions that the pharmacist refilled and that each pharmacist signs. This log book must also be maintained for a period of 2 years. A data processing refill recordkeeping system must be able to provide the DEA with a refill-by-refill audit trail for any specific dosage form of a controlled substance by brand name, generic name, or both. This audit trail must be on a printout that includes the information described in the method for manual refill recordkeeping and the name or identification code of the dispensing pharmacist. This information must be in such a form that it can be retrieved and available to the DEA in 48 hours. The system must include a backup procedure for refilling prescriptions during computer downtime. The procedure must ensure that only those prescriptions with refill authorizations are refilled by the pharmacy and that the data on refills for input into the system is collected and retained for entry as soon as the computerized system is back in operation. 13 Describe partial filling requirements for schedule II drugs The Comprehensive Addiction and Recovery Act of 2016 Section 702 amends section 309 of the Controlled Substances Act by adding that a prescription for a controlled substance in schedule II may be partially filled if: 1. It is not prohibited by State law; 2. The prescription is written and filled in accordance with this title, regulations prescribed by the Attorney General, and State law; 3. The partial fill is requested by the patient or the practitioner that wrote the prescription; AND.. 4. The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed. Remaining portions of a partially filled prescription may be filled within 30 days after the date on which the prescription is written. 14 Describe partial filling requirements for schedule II drugs Case study: A Medicaid patient comes into your pharmacy with a prescription for 90 Norco tablets. Medicaid only pays for 60 a month. What do you do? 15 Describe partial filling requirements for schedule II drugs for LTCF and terminally ill The CSA extends the 30 day limit to a period of 60 days for patients in a LTCF or with a documented terminal illness. For each partial filling, the dispensing pharmacist must record on the BACK of the prescription (or on another appropriate record, uniformly maintained and readily retrievable) the:  Date of the partial filling  Quantity dispensed  Remaining quantity authorized to be dispensed  Identification of the dispensing pharmacist 16 Describe partial filling requirements for schedule II drugs for LTCF and terminally ill Prescriptions are not valid after 60 days. CSA regulations permit individual doses as part of the partial filling. The total quantity dispensed on all such partial fillings cannot exceed the total quantity prescribed 17 Describe partial filling requirements for schedule III, IV and V prescription The partial filling of a prescription for a controlled substance listed in schedule III, IV or V is permissible, provided that:  Each partial filling is recorded in the same manner as a refill  The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed  No dispensing occurs beyond six months after the date on which the prescription was issued (CIII & CIV) 18 List the items required on a prescription label for a controlled substance The following items are required to be on the prescription label of all controlled substances (II-V):  Name and address of the pharmacy  Patient name  Prescription number  Date dispensed  Name of the prescriber  Directions for use  Cautionary statements (if any) 19 List the items required on a prescription label for a controlled substance All controlled substance prescription labels must contain the statement, “Caution; Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed” with two exceptions:  Schedule V prescriptions  Any controlled substance being dispensed in a blinded clinical study 20 List the items required on a prescription label for a controlled substance All of the above labeling requirements do not apply when a controlled substance (II-V) is prescribed for administration to a patient in an institution, provided that: at  Not more than a 7-day supply of a CII is dispensed at one time  Not more than a 34-day (or 100 doses, whichever is less) of a CIII-CV is dispensed one time  The controlled substance (CII-CV) is not in the possession of the ultimate user prior to administration  The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of CIIs-CVs.  The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product, and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription/order or required by law. 21 Describe legal transfer of controlled substance prescription information for refills (III-V) Original prescription information for a controlled substance (III-V) may be transferred on a ONE-TIME BASIS only for the purpose of refill dispensing. Pharmacies electronically sharing a real-time online database may transfer up to the maximum refills permitted by law and the prescriber’s authorization. The transfer must be communicated directly between two licensed pharmacists. The original and transferred prescription(s) must be maintained for a period of two years from the date of last refill. Pharmacies electronically accessing the same prescription record must satisfy all information requirements as for the transfer of manual prescriptions. The procedure allowing the transfer of prescription information for refill purposes is permissible only if allowable under existing state or other applicable law. 22 Describe legal transfer of controlled substance prescription information for refills (III-V) THE TRANSFERRING PHARMACIST COMPLETES THE FOLLOWING  Writes the word “VOID” on the face of the invalidated prescription.  Writes on the reverse side of the invalidated prescription the name, address and DEA registration number of the pharmacy to which it was transferred and the name of the pharmacist receiving the prescription information.  Records the date of transfer and the name of the pharmacist transferring the information. 23 Describe legal transfer of controlled substance prescription information for refills (III-V) THE PHARMACIST RECEIVING THE TRANSFERRED PRESCRIPTION INFORMATION COMPLETES THE FOLLOWING  Writes the word “TRANSFER” on the face of the transferred prescription  Enters all information required on the prescription by the CSA including the: Date of issuance of the original prescription Original number of refills authorized on the original prescription Date of original dispensing Number of valid refills remaining Date(s) and locations of the previous refill(s) Pharmacy’s name, address, DEA number and prescription number from which the prescription information was transferred Name of the pharmacist who transferred the prescription Pharmacy’s name, address, DEA number and prescription number from which the prescription was originally filled 24 Describe regulations for the sale of controlled substances without a prescription A controlled drug in Schedule V that is not a prescription drug under federal or state law may be sold over the counter provided that each of the following occurs:  The sale is made only by a pharmacist; although after the pharmacist has completed the professional and legal responsibilities of the sale, the actual cash transfer and delivery of the drug may be done by a non-pharmacist employee  No more than 240 mL or 48 dosage units of an opium-containing controlled substance or 120 mL or 24 dosage units of any other controlled substance may be sold or dispensed to the same buyer in any 48-hour period  The purchaser must be at least 18 years of age and any purchaser not known to the pharmacist must furnish ID and proof of age (when appropriate) 25 Describe regulations for the sale of controlled substances without a prescription  OTC sales for schedule V drugs must be recorded in a bound record book or registry containing:  Name and quantity of the item sold  Name and address of the purchaser  Date of purchase  Name and initials of the pharmacist seller  This bound record book or registry must be maintained for at least 2 years 26 Describe requirements for mailing controlled substances Controlled substances may be mailed by USPS, UPS, or FedEx 27