A pharmacist may dispense a schedule III, IV, or V prescription drug pursuant to either a written, faxed, electronic, or oral order from the individual practitioner or practitioner's agent, providing that all required information is contained on the prescription and that electronic prescriptions conform to DEA requirements. Oral orders must be promptly reduced to writing; written and faxed prescriptions must contain the signature of the prescriber (21 C.F.R. § 1306.21(a)). Individual practitioners may administer or dispense a schedule III, IV, or V controlled substance in the course of professional practice without a prescription (21 C.F.R. § 1306.21(b)). Institutional practitioners may administer or dispense (but not prescribe) a schedule III, IV, or V controlled substance pursuant to a written, faxed, or oral prescription promptly reduced to writing by the pharmacist as well as administer or dispense an order for medication by an individual practitioner that is to be dispensed for immediate administration to the ultimate user (21 C.F.R. § 1306.21 (c)).
No schedule III or IV prescription may be filled or refilled more than 6 months after the date of issuance of the prescription or more than five times, whichever comes first (21 C.F.R. § 1306.22(a)). These restrictions do not apply to schedule V prescription drugs. After the expiration of the 6-month period or the fifth refill, the prescriber must authorize a new prescription. The pharmacist may telephone the prescriber for authorization and create a new prescription.
If the prescriber who issued the original prescription initially authorized fewer than five refills, the prescriber can authorize additional refills without having to issue a new prescription. In any event, the total quantity of refills authorized, including the number on the original prescription, cannot exceed five refills. A pharmacist who obtains oral authorization for additional refills must record the refill either in hard copy form or in an automated data system. The quantity of each additional refill authorized cannot exceed the quantity originally authorized on the prescription.
If an automated system is not used, every refill must be recorded either on the back of the prescription or on another document in a way that makes the information readily retrievable. The recorded information must be retrievable by prescription number and must include:
The name and dosage form of the drug
The date refilled
The quantity dispensed
The initials of the dispensing pharmacist for each refill
The initials of the pharmacist receiving the refill authorization
The total number of refills for that prescription
If the pharmacist merely initials and dates the back of the prescription, it is deemed that the full face amount of the prescription was dispensed.
It is not advisable that pharmacists refill controlled substance prescriptions when the prescriber is not available for authorization on the expectation that the prescriber will subsequently approve the refill. This practice is illegal, unless authorized by state law, and even in states that so authorize, refills are generally confined to emergency situations where the patient's health would be jeopardized if the prescription was not refilled. In the case of Daniel Family Pharmacy, 64 Fed. Reg. 5314 (February 3, 1999), reported in the case studies section of this chapter, a pharmacist refilled a narcotic drug prescription for an employee believing the refill would be approved by the prescriber. The prescriber, however, refused authorization, leading the pharmacist down a path of escalating illegal activities.
As an alternative to the method of recording refill information (discussed earlier), a pharmacy may use an electronic system for the storage and retrieval of refill information for schedule III and IV prescriptions (21 C.F.R. § 1306.22(f)). Such a system must provide online retrieval of the original prescription order information and the up-to-date refill history of the prescription. The pharmacist must verify and document that the refill data entered into the system are correct.
If the system provides a hardcopy printout of each day's refill data, it must be provided to the pharmacy within 72 hours of the date on which the refill was dispensed. It must be verified, dated, and signed by each pharmacist who refilled the prescriptions listed on the printout. This document must be maintained in a separate file at the pharmacy for a period of 2 years from the dispensing date. 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 signs a statement verifying the prescriptions that the pharmacist refilled. The logbook also must be maintained for a period of 2 years.
All computerized systems must be able to print out any refill data that the pharmacy is responsible for maintaining. This includes, for example, a refill-by-refill audit trail of any schedule III or IV prescription. The printout must include:
The name of the prescriber
The name and address of the patient
The quantity dispensed on each refill
The date of dispensing for each refill
The name or identification code of the dispensing pharmacist
The number of the original prescription order
If records are kept at a central location, the printout must be capable of being sent to the pharmacy within 48 hours.
Pharmacies with an automated system must have an auxiliary system for documenting refills in the event that the computerized system suffers downtime. The auxiliary system must maintain the same information as the automated system. A pharmacy must use either a manual or electronic system, but not both, to store and retrieve refill information.
It is permissible for pharmacists to partially fill a prescription for a schedule III, IV, or V drug, provided that:
The 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 6 months after the date of issuance.
Pharmacy providers should not confuse a refill with a partial fill and ensure that patients have access to their medication when appropriate. For example, consider a prescriber who orders a patient a schedule IV medication, #30 lorazepam 1 mg tablets with five refills, and instructs the patient to take one tablet daily as needed. The patient could obtain a total of 180 pills in 6 months from the issuance date of the prescription, if he or she obtained the medication each month (30 initial pills the first month, 30 additional pills each month for the next 5 months). However, if the patient desires to obtain only 15 tablets at one time, the patient could return for an additional 11 partial fills of 15 tablets (the total quantity dispensed in all partial fillings [180] does not exceed the total quantity prescribed [180]). Often, pharmacy computer programs identify a partial fill as a refill and warn the pharmacist after five partial fills that the prescription has no valid refills, when actually the patient is still permitted to receive the medication.
A pharmacist dispensing a controlled substance must affix to the container a label that shows the date of filling if it is a schedule II drug (21 C.F.R. § 1306.14(a)). The label must show the date of the initial filling if it is for a schedule III, IV, or V drug (21 C.F.R. § 1306.24(a)). The date of initial filling should be used when dispensing refills of schedule III or IV prescriptions. Technically, because the Food, Drug and Cosmetic Act specifies that the label must contain the date of filling, both dates should be on the label of a refill to comply with both laws. In addition, the regulation requires the label to include:
Pharmacy name and address
Serial number of the prescription
Name of the patient
Name of the prescriber
Directions for use and cautionary statements, if any
For schedule II, III, and IV drugs, the label should also include a cautionary statement: "Caution: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed" (21 C.F.R. § 290.5).
These labeling requirements do not apply if the drug is prescribed for administration to an institutionalized ultimate user (medication order; 21 C.F.R. § 1306.14(c) and 21 C.F.R. § 1306.24(c)) provided that:
If the drug is in schedule II, no more than a 7-day supply is dispensed at one time. If the drug is in schedule III, IV, or V, no more than a 34-day supply or 100 dosage units, whichever is less, is dispensed at one time.
The drug is not in the possession of the ultimate user before the administration.
The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the drug.
The system used by the pharmacist in filling the prescription is adequate to identify the supplier, the product, and the patient, and to state the directions for use and cautionary statements.