Senior Care Pharmacy Coalition Provides Comments on the Food and Drug Administration’s Proposed Opioid Mail-Back Notice

DATE: June 24, 2022

The Proposed Modification Imposes Unnecessary Burden on Long-Term Care Pharmacies

The Senior Care Pharmacy Coalition (SCPC) has submitted a comment letter to the Food and Drug Administration (FDA) regarding the agency’s notice of a policy to require that pharmacies  include a “mail-back” envelope with every prescription dispensed in an outpatient setting. The notice, which is not a formal proposal to change existing policy, concerns a policy that would modify the current Opioid Analgesic Risk Evaluation and Mitigation Strategy. SCPC strongly supports the FDA’s efforts tor reduce opioid abuse and diversion but believes the use of mail-back envelopes for residents of LTC facilities would not significantly reduce the risk of diversion, while creating confusion for residents, LTC facilities, and LTC pharmacies that could undermine patient care.

SCPC represents long-term care (LTC) pharmacies, and its members serve one million patients in a variety of LTC settings, including skilled nursing, nursing, intermediate care, and assisted living facilities (collectively, LTC facilities) throughout the country. There are many reasons that use of mail-back envelopes for opioids makes no sense for residents in LTC facilities.

First, in most LTC facilities, opioids are not dispensed directly to patients. Rather, LTC pharmacies dispense the drugs in specialized packaging that is delivered to LTC facility staff, who in turn administer drugs to residents when needed and as prescribed throughout the day. Residents typically do not have access to multiple doses of opioids at one time so the risk of diversion from patient supplies is virtually non-existent. Residents themselves would not be able to use mail-back envelopes since they do not have access to unused or unneeded doses of medications.

Second, most LTC facility residents may lack the capacity to use mail-back envelopes effectively. Fifty-nine percent of LTC residents suffer from four or more chronic conditions and 75% suffer from cognitive impairments. On average, LTC residents take 12 prescriptions per month. Given the number of prescriptions each resident takes and the level of cognitive impairment among residents, providing them with mail-back envelopes is more likely to lead to confusion and undermine patient care than it is to reduce diversion of opioids.

Third, federal law already requires that LTC pharmacies and LTC facilities adopt extensive protocols to prevent diversion. Opioids are kept in locked compartments within locked medication carts, and opioid reconciliation occurs as frequently as once each nursing shift. During opioid reconciliation, facility and pharmacy staff must account for every pill or tablet, which substantially reduces the risk of diversion. The risk of diversion already is low in LTC facilities such that adding mail-back envelopes is unlikely to further reduce the risk.

Fourth, state laws already impose detailed disposal requirements on LTC pharmacies and LTC facilities. The risk of diversion rather than appropriate disposal is small.

Finally, while the FDA suggests that manufacturers would pay the cost of proving the mail-back envelopes, their use would add administrative costs for LTC pharmacies since LTC pharmacies must package and deliver medications to facilities and, in conjunction with LTC facility staff, must satisfy extensive federal and state administrative and reporting requirements concerning opioid utilization management. Nothing in the FDA’s notice addresses who will pay for additional – and potentially significant – LTC pharmacy costs.

The obvious solution would be to exempt residents in LTC facilities, and the LTC pharmacies that serve them from any policy that would require the use of mail-back envelopes. Unfortunately, the notice would tie the use of mail-back envelopes to all outpatient settings, and the agency does not define outpatient settings. The FDA itself employs varying definitions of outpatient settings, such that some types of LTC facilities may be outpatient for one regulatory purpose, but inpatient for other regulatory purposes. Other federal agencies similarly have differing definitions of outpatient settings for different purposes and categorize different types of LTC facilities variously.

This is not the first time that potential or proposed FDA policies did not fully consider whether policy changes should be applied to residents in LTC facilities either because residents in LTC facilities do not face the problems the policy change seeks to address or because the policy change would undermine patient care. 

Should the FDA decide to proceed from public comment to policy proposal, the agency must exclude LTC facilities from the definition of outpatient settings, or otherwise exempt residents in LTC facilities and the LTC pharmacies who serve them from any requirement that they receive mail-back envelopes with prescriptions for opioids. In doing so, the FDA would avoid confusion and better ensure the quality of care for residents in LTC facilities.