FDA Guidance on Insulin Pens Puzzling

On October 13, 2020, the U.S. Food and Drug Administration issued a statement looking to clarify the intent of the November 2019 label revisions for insulin pens. The updated labeling contained “Dispense in this sealed carton” on insulin pen boxes and Section 16.2 of the package inserts state: “Dispense in the original sealed carton with the enclosed Instructions for Use.” PAAS National® Members should be familiar with our February Urgent Email Alert and subsequent Newsline articles in March and April.

Looking to get further clarity into the rationale for the labeling change, PAAS had submitted a Freedom of Information Act request to the FDA. In response, PAAS learned

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that a Tracked Safety Issue was opened for insulin pens back in June of 2018. Congruently, the clarification from this October recognizes the following concerns when breaking insulin pen boxes: medication errors (including wrong drug/dose resulting in hyper/hypoglycemia), missed doses, complaints of possible tampering, and dispensing without the Instructions for Use.

The October letter goes on to the following:

  1. Insulin pens are approved to be dispensed in their original sealed cartons
  2. Insulin pens are not labeled for dispensing as individual units
  3. Sealed cartons of insulin pens are intended to be dispensed to a single patient
  4. Each carton is sealed, with the intent to alert health care professionals and patients when it has been opened, individual insulin pens within the cartons do not have their own sealed package. The carton labeling and sealed packaging are important for both health care professionals and patients.
  5. The cartons help health care professional and patients differentiate between the insulin pens

However, to the bewilderment of many, the FDA also stated the following:

  1. The FDA claims the November 2019 revisions stated that health care professionals should dispense the pens to a single patient in the original sealed carton (note should, not must)
  2. The FDA understands there are situations where health care professionals may choose to dispense individual pens (outside of the carton), not in accordance with FDA-approved labeling, based on their own professional judgement
  3. Health care professionals should consider the known risks of dispensing individual pens, and incorporate additional safety measures (e.g. adding tamper-indicator tape, providing the Instructions for Use, and labeling individual pens for individual patient use)

So, what does this all mean for community pharmacies? More of the status quo – don’t break the box. While the FDA may “understand” and permit dispensing of individual pens on an exception basis, payers (and PBMs) may not. PAAS often sees PBMs hold pharmacies accountable for FDA labeling requirements (e.g. dispense in the original container medications). Moreover, pharmacists could incur additional liability by choosing to go against FDA labeling requirements despite warnings from the FDA.

PAAS Tips:

  • Pharmacies should always try to first bill an accurate days’ supply based on the prescribed quantity– many insurers have accommodated days’ supply limits well in excess of 90 days
  • If plan limits are exceeded follow the guidance below:
    • Multiple cartons – reduce the # of cartons and corresponding days’ supply until the claim will adjudicate. Document Insurance Limits Quantity (e.g. ILQ = 30 days) on the hard copy.
    • Single carton (in order of preference):
      • Call the PBM help desk and request an override
      • If no override is available, adjust the days’ supply to the Plan Limit

Members can view our eNewsline in the member portal for additional PAAS Tips.

Trent Thiede, PharmD, MBA