DEA Proposes Rule to Govern Partial Fills of Schedule II Drugs

More than four years after enactment of the Comprehensive Addiction and Recovery Act of 2016 (CARA), the Drug Enforcement Administration, on December 4, 2020, issued a proposed rule (the “Proposed Rule”) to address partial fills of prescriptions for Schedule II drugs.  Section 702 of CARA amended the Controlled Substances Act (CSA) to permit partial fills requested by either the practitioner that wrote the prescription for the medication or the patient for whom it was written.

Background

CARA was enacted in April, 2016 to address the burgeoning opioid crisis.  Section 702, which represents only a small portion of CARA, aims to reduce the threat of diversion, accidental overdose, and other problems posed by the presence of unused Schedule II controlled substances in households.  It amended Section 829 of the CSA by adding subsection (f), which permits a pharmacist to partially fill a prescription for a schedule II controlled substance where requested by the prescribing practitioner or the patient if all of the following conditions are satisfied: (1) the partial filling must not be prohibited by State law; (2) the prescription must be written and filled in accordance with the CSA, DEA regulations, and State law; and (3) the total quantity dispensed in all partial fillings must not exceed the total quantity prescribed. It also provides that the remaining portions of a partially filled prescription, if filled, must be filled no later than 30 days after the date on which the prescription is written, unless the prescription is issued as an emergency oral prescription, in which case the remaining portion, if filled, must be filled no later than 72 hours after it was issued.

The Proposed Rule

The Proposed Rule mostly addresses procedural and documentation aspects of the law, though it also provides that a prescription written for a quantity that exceeds State law limits (if any) does not constitute a valid prescription and thus may not be partially filled.

• Partial Fill Request by a Practitioner – In addition to fulfilling existing regulatory requirements for issuing a prescription, a practitioner who requests a partial fill of a Schedule II controlled substance must specify the quantity to be dispensed in the partial fill on the face of the written prescription, in the written record of an emergency oral prescription, or in the electronic prescription record, as the case may be. DEA proposes that the dispensing pharmacist must make a notation of the quantity dispensed on the face of the written prescription, in the written record of an emergency oral prescription, or in the electronic prescription record, as applicable.  In the case of an electronic prescription, there must be an electronic record that is permanently attached to the electronic prescription.  Also, the pharmacy must maintain a record with the date of each dispensing, the name or initials of the individual who dispensed the medication and all other existing regulatory requirements for Schedule III and IV prescription refills.

• Partial Fill Request by a Patient – Although DEA states in its cost analysis that it does not expect patients to request a partial fill very often, Section 702 of CARA expressly permits them to do so. While the Proposed Rule would not require an in-person request by the patient in all instances, it makes clear that the request must come from the patient and not from a member of the patient’s household.  The Proposed Rule suggests that a telephone call from the patient to the pharmacist or a signed, written note from the patient delivered by a family member to the pharmacy would satisfy this requirement.  The pharmacist, in turn, must document the partial fill as outlined above with respect to a partial fill request by a practitioner and indicate that the patient requested the partial fill by including the following statement on the prescription:  “Patient requested partial fill on [date such request was made].”  The pharmacist must also note the quantity dispensed.

In its regulatory analysis, DEA estimates that the Proposed Rule will achieve a net economic savings of $647 million per year and lead to intangible benefits such as reducing prescription drug abuse and improper disposal of unused medications.

Questions for Stakeholders

DEA is soliciting comments—due on or before February 2, 2021—on the following questions, most of which would inform the agency on its estimation of economic impact:

1. Why do so many prescriptions for schedule II controlled substances result in unused dosages?
2. Would prescribers start using this proposed regulatory provision and start giving instructions for partial filling of schedule II controlled substances, or are there other factors that are likely not to result in prescribers giving partial filling instructions?
3. How often would a prescriber instruct partial filling of a prescription for a schedule II controlled substance?
4. Is it reasonable to anticipate a prescriber will exercise professional judgment and foresight in determining when partial fill would most appropriate, resulting in minimal number of patients returning for the remainder of the partially filled prescription or experiencing pain because they run out of medication? Would prescribers be likely to use consistent criteria for determining when to give partial refills? Given that the majority of schedule II prescriptions are not fully utilized, should prescribers request partial fills in most cases?
5. How likely are patients to request partial filling at the pharmacy when the prescriber has not given instructions for a partial fill on the prescription?
6. Is it reasonable to assume that a patient interested in a partial filling of a schedule
   II controlled substance would request the prescriber to provide instructions on the prescription?
7. Is it reasonable to assume that when prescribers do not request a partial fill patients will generally not request a partial fill?
8. (Questions for industry including private and public plans and entitlements):
   • What are likely requirements for copay in a partial filling?
   • Would the copay be reduced?
   • Would there be a copay when a patient returns for filling the remainder of a partially filled prescription (full amount or reduced amount)?
   • Would a patient likely spend less on a partial fill than on a full prescription?
   • If so, would requesting two or more partial fills likely cost the patient more than filling the full prescription initially?