On November 15, 2019, FDA published updated product labeling for all insulin pens available in the United States market that advises the product should only be sold in full, unopened boxes. As you know, this is a significant deviation from what pharmacies – particularly in the long-term care space – have performed in the past. In order to minimize waste and reduce costs to the entire system, it is customary for pharmacies to dispense single pens upon demand. Pharmacy Network Services has taken the position to delay on implementation of this change until absolutely necessary in order to minimize changes that impact its client facilities. Pharmacy Network Services has recently been in contact with a number of industry associations and other similar pharmacy providers that service other markets, and the overwhelming consensus is that we must now implement the changes in accordance with FDA and CMS guidance.
Going forward, the pharmacy has been made aware that CMS and the PBMs that administer Medicare Part D benefits (as well as commercial insurance plans and state Medicaid programs) intend to strictly follow the guidance set forth by the FDA. Therefore, pharmacies are not able to provide less than a full box of insulin pens to these patients at this time. You will begin to see full boxes of insulin pens being dispensed in order to comply with CMS and PBM guidelines in order to avoid future audits.
This change presents two important considerations for patients that are discharged from long-term care facilities:
- If the patient is discharging to their home, consider sending any remaining supply of the patient’s insulin pens home with the patient. Retail pharmacies may have difficulty obtaining authorization to fill an additional quantity of pens upon discharge. Please ensure your Policy and Procedure documents reflect this consideration.
- If the patient is potentially returning to the facility (e.g. a short-term discharge to the hospital with a likely readmission), it is recommended to store the patient’s remaining insulin pens appropriately. Do not discard remaining pens until it is clear that the patient will not be returning to the facility. It will likely be impossible to obtain authorization for readmission fills from the PBMs, resulting in potentially avoidable charges to the facility in the event pens are discarded and a patient readmits to the facility before the supply should be entirely used.
Pharmacy Network Services definitely understands that this change goes against what we all consider to be prudent goals of minimizing waste and cost to the system, and is potentially disruptive to customary practices. Pharmacy leadership will continue to monitor this situation and keep you aware of any future changes. Please reach out to the pharmacy if you have any questions.