Update: Isentress® and Dificid® Added to Dispense in Original Container Chart
OptumRx continues to focus audits on prescriptions that must be dispensed in their original container per the manufacturer’s [FDA approved] labeling and package insert. If the prescription claim detail shows that a pharmacy dispensed a medication in a quantity different from the original package size (and not a multiple), the audit risk is significant and discrepancies can be difficult to appeal.
OptumRx’s latest targets are Isentress® and Dificid®.
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Section 16 How Supplied/Storage and Handling of the product labeling state the following:
| Product | Dosage Form | Guidance |
| Isentress® | Tablets | Store in the original package with the bottle tightly closed. Keep the desiccant in the bottle to protect from moisture. |
| Oral Suspension | Store in the original container. Do not open foil packet until ready for use. | |
| Dificid® | Tablets | Store DIFICID tablets at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F). See USP controlled room temperature. Store in the original bottle. |
| Granules for oral suspension | Store DIFICID granules for oral suspension at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F). Store in the original package. Do not open pouch until time of use. Once reconstituted, store DIFICID oral suspension refrigerated at 2°C-8°C (36°F-46°F) for up to 12 days. Store capped in the original bottle. |
PAAS National® continues to express frustration and disdain with OptumRx’s audit practices. OptumRx would rather develop audit algorithms to profit from this dispensing behavior than put in hard-stop rejections to stop claims at the Point-of-Sale (something they would do if they were really concerned with patient safety).
Unfortunately, the FDA has also been lackadaisical by allowing inconsistent and vague manufacturer labeling. Store in the original container does not necessarily mean Dispense in the original container – how is a pharmacist to know if the FDA has approved the product to be dispensed in a vial in these situations? It’s simply not clear. Consider Section 16 from Linzess®: “Keep LINZESS in the original container. Do not subdivide or repackage. Protect from moisture. Do not remove desiccant from the container. Keep bottles tightly closed in a dry place.” This direction is very clear to dispensing pharmacists. PAAS has made several requests [to the FDA] to standardize the manufacturer Storage and Labeling requirements for products that must be dispensed in the original container– from a patient safety, and pharmacist awareness, perspective. The FDA, unfortunately, defers to the manufacturer submission for labeling and package insert information language, but they have intervened on other labeling requirements when patient safety is involved (e.g., insulin pens).
PAAS continues to reach out to manufacturers as PBM audit issues arise, with mixed results. For example, Auvelity® has the same language “Store AUVELITY in original bottle”; however, the manufacturer indicated to PAAS that, “When a quantity less than the amount available in the manufacturer’s original bottle is prescribed, transferring the tablets to a pharmacy vial does not conflict with the AUVELITY labeling.” The manufacturers of Isentress® and Dificid® would only reiterate that the products must be “stored in the original container”.
Due to the difficulty of appealing these type of discrepancies, PAAS has added them to the Dispense in Original Container Chart to help protect our members and support conservative dispensing practices. Unfortunately, the burden falls on the pharmacy to ensure FDA dispensing requirements are met even if the PBM does not put a hard stop in place on these medications.
PAAS Tips:
- Post the Dispense in Original Container Chart for staff to utilize at data entry and filling stations.
- Pharmacies that utilize compliance packaging to serve LTC and assisted living facilities are not exempt from these FDA storage and handling requirements. These medications are exempt from Medicare Part D short-cycle dispensing requirements which apply to patients in skilled facilities.
- Communicate with facilities and patients who utilize special packaging on the requirements for dispensing full bottles with certain medications.
- If a prescription is written for a quantity different from the package size, contact the prescriber to inform them of the dispensing requirements and request authorization to change the quantity.
- Approval should be documented with a clinical note containing the date, name and title of who you spoke with, a summary of your discussion, and your initials.
- If a prescriber insists on a patient receiving less than a full bottle, document this along with the clinical reason given by the prescriber (e.g., patient received some doses in the hospital and the prescriber does not want to give the patient more due to waste – prescriber is aware of storage requirements and requests pharmacy to dispense as is). There is no guarantee this type of note will prevent a recoupment; however, it shows the pharmacy did their due diligence to attempt to dispense in the original container and that the authorization was denied by the prescriber (versus refusing to dispense altogether, which is an option).
- Contact your pharmacy’s software vendor to see if NDCs can be flagged with alerts at data entry to ensure the quantity billed matches the package size.
- Flag inventory shelves for medications with special packaging/dispensing requirements.
- Consider performing scheduled self-audits to ensure appropriate dispensing.
I have a Bachelor of Arts in Communications from the University of Wisconsin – Madison. Prior to joining PAAS in 2017, I worked for Walgreens for 19 years.
As an Analyst at PAAS, I really enjoy being able to help independent pharmacies succeed. I have always been a fan of the underdog and am excited to be able to give you the tools you need to take on the giants of the PBM industry.
