Proposed Opioid Blister Packaging Requirements May Adversely Affect Patients With Cancer-Related Pain

July 29, 2019

In a comment letter to Acting Food and Drug Administration (FDA) Commissioner Norman E. “Ned” Sharpless, MD, ASCO expressed concerns that a proposed modification to the existing Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) could adversely affect patients with cancer-related pain.

The modification would require certain forms of immediate-release (IR) opioid analgesics to be made available in fixed-quantity unit-of-use blister packaging for outpatient dispensing. Although ASCO appreciates FDA’s efforts to reduce the amount of unused opioid analgesics – consequently reducing opportunities for misuse, abuse, inappropriate access, and overdose – the society expressed concern that this proposal has the potential to limit access to appropriate medical opioid therapy for some patients with cancer who may require individualized dosing for effective management of their pain.

ASCO also raised concerns about FDA’s suggestion that it may be appropriate to first require that blister packages be made available for the most commonly prescribed IR opioid analgesics for treatment of acute pain, with the expectation that blister packages be made available for other, less commonly prescribed products after the initial rollout. ASCO strongly urges FDA to consider the needs of patients with cancer if this stepwise approach is taken, as well as continue to require that blister packaging not be the only packaging option available from manufacturers.

ASCO supports the Administration’s efforts to address the opioid crisis but continues to urge policymakers to ensure that policies aimed at addressing one crisis don’t inadvertently create another by limiting access to needed pain management for patients with cancer.

Read the full comment letter.

Read commentaries and see an infographic on the role of opioids in managing cancer-related pain.

Read ASCO’s policy brief on opioid therapy and access to treatment.

Follow the latest cancer policy updates through ASCO in Action.