DEA’s Expected Guidance: It Should Reduce Current “Pain” at the (Intrathecal Pain) Pump Dispensing Process and Improve Therapeutic Outcomes

For more than 50 years, the Drug Enforcement Administration (DEA) has enforced the central mandate of the Controlled Substances Act (CSA) to maintain a closed chain of distribution for drugs with a potential for abuse and diversion.  The CSA and regulations promulgated by DEA are intended to reduce the potential for diversion and abuse and ensure that controlled substances are dispensed and delivered to patients for a legitimate medical purpose.  However, the well-intentioned statutory language enacted in 1970 did not anticipate important changes in clinical therapies and advances in medical technology, and in some cases has created obstacles both to ensuring needed patient access and successful medical outcomes.

One such requirement which has been a controversial issue for many years is the requirement that a controlled substance can only be dispensed and delivered to the “ultimate user.”[1]  Under the relevant definitions in the CSA, the dispensing/delivery of controlled substances is limited to the “ultimate user” (i.e., the patient or a member of the patient’s household).[2]  Why is this an issue?  Because a strict interpretation of the law and regulations (other than a recent and limited amendment to the CSA) prohibits any alternative dispensing or delivery of critically needed medicines, e.g., directly to the practitioner’s office, even where such alternatives inarguably provide a safer and more effective treatment, and inarguably remove the risk of diversion.

For example, intrathecal infusion therapy, via an implanted infusion pump, or Targeted Drug Delivery (TDD), is a last-line therapy for patients who have failed all other conventional pain therapies.  This lifesaving and life-sustaining option is reserved for a small but highly vulnerable population of approximately 130,000 patients suffering from severe chronic pain due to, for example, spinal cord injuries, amputation, cancer, or spasticity caused by multiple sclerosis. The therapy involves an FDA-cleared surgically implanted pump that typically involves the delivery of compounded liquid pain medication directly into the patient’s spinal column and requires medication refills every 60-90 days.  However, TDD medications are highly concentrated opioids and cannot be self-administered.  Highly concentrated opioid formulations (e.g., fentanyl, morphine, hydromorphone, etc.) used in intrathecal pain therapy have strict sterility and stability requirements and are life-threatening if mishandled.  A qualified medical professional must perform the refill; it cannot be done by the patient.  This procedure is usually performed in a practitioner’s office, and rarely done in the home setting.

At 1/100 to 1/300 the typical oral dose of opioid and other controlled substance medications, intrathecal pain pumps substantially reduce use of and reliance upon oral opioids, which, in turn, significantly reduces abuse and diversion.  Further, the therapy reduces or eliminates the side effects of opioids and leads to better health outcomes and patients’ return to activities of daily living.  But requiring that the medicine be dispensed or delivered to the patient or at the patient’s home rather than directly to the practitioner’s office creates a significant safety issue, a greater potential for diversion, and could compromise the efficacy of the medication.

In 2016, DEA issued a guidance letter stating that delivery or dispensing to a practitioner’s office for administration to the patient was not addressed in the CSA or DEA regulations and therefore not specifically prohibited.  This information was widely publicized, and we are aware that industry practice evolved whereby pharmacies would deliver or dispense to practitioner’s office in certain cases including those discussed above.  However, two events conspired to undermine this prior guidance.  First, in 2018 Congress passed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act, which created a narrow statutory exemption to the CSA’s “ultimate user” definition that authorizes the dispensing of injectable buprenorphine to a practitioner’s office for treatment of opioid use disorder.[3]   Second, the Trump Administration issued Executive Order 13891, requiring that all industry guidance be promulgated pursuant to specific criteria set forth in the Executive Order, including publication on an Agency’s website.  Then, President Biden revoked that Executive Order on his first day in office, January 20, 2021.  In either event, the 2016 DEA guidance letter is not currently published or otherwise available on DEA’s guidance portal.[4]

As a result, we are aware that DEA recently issued a letter stating that DEA’s current interpretation of the law and regulations require that, other than the specific SUPPORT Act statutory exception, all controlled substances must be dispensed or delivered to the patient or a member of the patient’s household (i.e., the “ultimate user”).  This interpretation would prohibit delivery to any other location such as a DEA-registered practitioner’s office or a nurse working as an agent of the practitioner in the field who would then deliver the medication specifically to the patient’s home for administration to the patient.

However, to DEA’s credit, we understand that the Agency has indicated that it intends to issue new guidance which would authorize dispensing or delivery to a practitioner’s office if the patient and practitioner execute a power of attorney (POA) wherein the patient specially authorizes the practitioner to receive the medicine on their behalf for the sole purpose of administration in the practitioner’s office.  We also understand that DEA has indicated this would be the only scenario in which the Agency believes the law and regulations would authorize an alternative dispensing or delivery of a prescription (other than the SUPPORT Act exception), excluding other dispensing models such as delivering the controlled substance medication to nurses for delivery and administration to patients at their residence.

With this much needed and anticipated new DEA guidance, a significant barrier to access will be removed, and patients will achieve better, safer access to life-sustaining medications, and the DEA will establish clear guidelines on how pharmacies may dispense these needed medications.  The proposed guidance furthers DEA’s goal of expanding access to alternative pain therapies while protecting the controlled system of drug delivery from diversion and abuse.

We do not know the timing of when DEA will issue such guidance, but we look forward to the guidance, and applaud DEA’s effort to expand access while maintaining the integrity of the controlled substance drug supply.  We also hope this is the first step towards the DEA and industry working together on additional CSA amendments to reduce obstacles to important patient care.

[1] 21 U.S.C.  § 802 (27) (The CSA’s “ultimate user” definition).

[2] See, e.g., id. § 802 (10) (defining “dispense”); § 802 (27) (defining “ultimate user”) and § 802(8) (defining “deliver or delivery”).

[3] 21 U.S.C. § 829a(a).

[4] See https://apps.deadiversion.usdoj.gov/guidance/#no-back-button.