[Submitted via U.S. Mail]
Robert W. Patterson
Drug Enforcement Administration
700 Army Navy Drive
Arlington, VA 22202
[Submitted electronically to ODLP@usdoj.gov]
DEA Diversion Control Division
Attn: Liaison and Policy Section
8701 Morrissette Drive
Springfield, VA 22152
RE: Temporary Changes to Aggregate Production Quotas for IV Opioid Products to Address Shortages
The undersigned groups respectfully request that the Drug Enforcement Administration (DEA) adjust aggregate production quotas (APQ) for certain opioids in order to mitigate ongoing drug shortages. As DEA may be aware, hospitals and other providers are currently facing critical shortages of a number of injectable opioid medications, including morphine, hydromorphone, and fentanyl. Intravenous (IV) opioids are used in a variety of practice settings within hospitals and ambulatory surgical centers for the treatment of acute, acute on chronic, or chronic pain that cannot be managed because the patient has a contraindication for oral opioid medications. Some opioids, such as fentanyl, also are used for sedation. Injectable opioids are critical to treating the pain needs of patients undergoing interventional procedures (e.g., cardiac catheterization or colonoscopy) and surgeries. These medications are also frequently used in intensive care units for surgical, trauma, burn, or oncology patients, when it is not clinically appropriate to use oral opioids. Having diminished supply of these critical drugs, or no supply at all, can cause suboptimal pain control or sedation for patients in addition to creating burdensome workarounds for healthcare staff.
Shortages of these injectable medications are largely attributable to manufacturing delays affecting Pfizer, the primary maker of these products, following its acquisition of Hospira. In a letter to customers, Pfizer indicated that the “anticipated full recovery dates for prioritized prefilled syringes have moved to 1Q19 and deprioritized syringes have moved to 2Q19.”1 On January 31, 2018, Pfizer sent customers a further update informing them that, due to a third-party supplier issue, none of these prefilled syringes of injectable opioids are currently being produced or released.2
Because these are vital medications, hospitals have been focused on locating alternative sources. We have been informed, however, that other manufacturers have been unable to step in and produce additional product because the DEA is approving only a small number of requests for the requisite pharmaceutical compounds due to current APQ limits. At present, supply options are dwindling.
Severe shortages of injectable opioids may threaten patient care in hospitals and surgical centers. We understand and share the DEA’s concern that these medications need to be well-managed and used judiciously to help stem the nation’s opioid epidemic. We fully support and use advances in pain management, such as multimodal analgesia, that enable patients to undergo procedures with fewer opioids and less reliance on opioids after surgery. Nonetheless, injectable opioids remain a crucial component of patient management during and immediately after many operations. With no appropriate opioids available, operations would have to be postponed or cancelled. In some cases, this could prove life-threatening to the patient.
Shortages also increase the risk of medication errors. Rather than selecting a product that might be most clinically efficacious for patients, during shortages prescribers are forced to order whichever IV opioid is available. Furthermore, dosing equivalency between the IV opioids differs significantly, which can lead to dosing errors. Moreover, using a more potent opioid based on supply alone defeats the national efforts to use hydromorphone and fentanyl only when absolutely necessary.
Given the ongoing shortages for these injectable medications, we urge DEA to use its discretionary authority to temporarily reallocate or revise APQ to allow other manufacturers to supply product until the shortages resolve. Our request is specific to these injectable medications and does not extend to other dosage forms or opioid products.
We thank DEA for its ongoing efforts to combat the opioid crisis, and we stand ready to assist the agency in any way possible. If you have questions, the appropriate contact person for each of the signatories can be found below.
American Hospital Association
Contact: Ashley Thompson
Senior Vice President, Public Policy
Analysis & Development
American Society of Anesthesiologists
Contact: Ashley Walton
Pain Medicine and Federal Affairs
American Society of Clinical Oncology
Contact: Karen Hagerty
Director, Reimbursement Policy
____________1 See Attachment A, Pfizer Customer Letters, dated July 20, 2017, and Nov. 27, 2017.
2 See Attachment B, Pfizer Customer Letter, dated Jan. 31, 2018.