NCHR Public Comment on Fixed-Quantity Blister Packs for IR Opioid Analgesics

National Center for Health Research, July 20, 2019

National Center for Health Research’s Public Comments on Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain
[FDA-2019-N-1845]

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.

NCHR welcomes the FDA’s efforts to address the opioid crisis by requiring changes in packaging and disposal that reduce the availability of excess opioids.  Including fixed-quantity unit-of-use blister packaging options for solid, oral dosage forms of immediate-release (IR) opioids may reduce “misuse, overdose, and possibly reduc[e] the development of new opioid addiction,” but only if there are also changes in prescribing practices.

It is important to study the possible unintended consequences of blister packaging. Many U.S. patients have previous experiences with blister packaging for antibiotics and birth control, for example.  That could make blister packaging seem benign rather than a warning against misuse. In addition, meta-analysis findings indicate that packaging interventions increase medication adherence to a schedule.1  However, that study included weekly pill boxes and since opioids are not necessarily intended to be used on a schedule, it is unclear how blister packaging would affect use. Thus, blister packs could encourage patients could take more opioids than they otherwise would. In addition, blister packs can difficult for older patients with substantial dexterity problems to use, inappropriately limiting access.

To ensure that requiring the availability of blister packaging does not have unintended consequences that outweigh any benefits, we encourage the FDA to study blister packaging for outpatient IR-opioid dispensing to assess how such packaging influences prescribing and usage, and thus affects the misuse or abuse of opioids.  In particular, we would like to see evidence that

  1. the proposed new packaging is effective in increasing more appropriate prescribing and reducing the quantity of opioid analgesics dispensed per prescription
  2. blister packaging for opioids has a measurable effect on reducing the incidence of accidental childhood poisoning and makes the packaging more child resistant
  3. additional information provided with blister packaging has a measurable effect on patient understanding and compliance
  4. blister packaging reduces the number of unused tablets stored by patients
  5. blister packaging can serve as a partial deterrent to inappropriate access in an outpatient setting, regardless of whether or not patients feel comfortable being able to monitor inappropriate access
  6. patients take opioids only as needed and do not increase usage.

Thank you for the opportunity to comment on this important issue.

For questions or more information, please contact the National Center for Health Research at info@center4research.org or at (202) 223-4000.

Reference

  1. Conn VS, Ruppar TM, Chan KC, et al. Packaging interventions to increase medication adherence: Systematic review and meta-analysis. Current Medical Research and Opinion. 2015;31(1):145–160. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4562676/