The Pitfalls and Opportunities With Posaconazole DR Oral Suspension

Challenges.

• Inpatient: The product is available as a medication box/kit and these are essentially patient-specific, complicating medication preparation and dispensing from an inpatient setting. Questions considered by our institution’s pharmacy team include:

  • How should packets be prepared when there is 1 primary diluent bottle for each of 8 packets? Would this look different if there were multiple patients needing the medication at once?

  • Where should doses be dispensed from (and are the packets all dispensed at once or individually)?

  • What to do with extra packets?

  • How to allow for appropriate barcode medication administration scanning of the doses?

• Ambulatory: The 8-day supply/counts are challenging for families who are accustomed to receiving medications every 30 days, particularly if an insurance company will not allow a 32-day supply. This requires families to come to the pharmacy more frequently (particularly if receiving other maintenance medications), and both family and pharmacy must identify the need to refill the medication (usually patient-specific ordering by the pharmacy given the cost) in advance. Additionally, this may subject families to a greater number of copayments, adding an additional financial burden.

Solutions.

• Inpatient: The full box is dispensed with the same barcode being used for the multiple packets. An educational handout (see Supplement S1) was created in conjunction with medication safety, pharmacy, and nursing leadership to provide clear instructions on how to prepare individual doses on the floor, and to ensure each dose was appropriately scanned prior to administration. In addition to the educational handout, administration instructions were added to the medication administration report in the electronic medical record (EMR). The inpatient pharmacist was in close contact with the pharmacy inventory team regarding discharge plans to ensure adequate supply of drug without over-purchasing. Use of the product is strictly limited, and there have not been multiple cases of patients needing treatment simultaneously because of the complexities of the medication and medication safety concerns.⁷ If the need were to arise, continuing with an individual supply (1 box per patient) at this time is anticipated.

• Ambulatory: When able and appropriate, change prescription of maintenance medications to a 90-day supply and an 88-day supply for posaconazole DR oral suspension (assuming ongoing clinical need). Have families call for a refill when opening the final box of posaconazole DR suspension (essentially 8 days before the supply is exhausted) to allow adequate time for refill, and as an easy way for families to remember to call.

Challenges.

• Inpatient: The short stability of the medication makes it nearly impossible for the medication to be prepared in the inpatient pharmacy, delivered to the floor, and given to the nurse to administer without any delays, which would elapse the beyond-use time.

• Ambulatory: A parent/guardian could not make premeasured doses if the patient were to be cared for by another family member or friend. This means the trained family member would not be able to miss any dosing time for the patient, education would need to extend to multiple family members/friends, or the patient would be at risk of missing a dose.

Solutions.

• Inpatient: Education sheets were created for nursing (Supplement S1), and the inpatient clinical pharmacist checked in daily to ensure there was no confusion or questions about the preparation or administration process (facilitated by nursing in this unique situation only). Comments were also placed in the EMR and dose labels about reviewing these instructions (completed by the verifying inpatient pharmacist).

• Ambulatory: The manufacturer provides a detailed education sheet for families, but it is multiple pages and includes 15 steps, which can be quite overwhelming. A simplified, patient-specific education sheet for families was created and the education process started with the first dose, to ensure families felt confident preparing and administering the correct dose (Supplement S2). Families were observed by nursing and the inpatient pharmacist prior to discharge to “self-lead” the preparation and administration and were asked about the need for additional family member education. How many family members were taught was left up to the family, but all were counseled on the importance of adherence and not missing doses.

Challenges.

• Inpatient: For patients requiring feeding tube administration, the posaconazole DR suspension is not an option at this time because only the manufacturer-provided notched tip syringes should be used when administering the product. Additionally, incompatibility with ENFit syringes/feeding tubes poses a safety risk for route of administration. Color vision–deficient staff need to differentiate syringes by size and cannot rely on the manufacturer’s directions, which uses colors specifically.

• Ambulatory: If families are color vision–deficient, manufacturer directions may be confusing, and alternative education would be needed to ensure proper preparation. Patients with NG tubes need alternative formulations.

Solutions.

Education sheets (see Supplements S1 and S2) that are not reliant on colors alone, but also clearly relate colors to syringe size, were created for nursing and families. For patients with feeding tubes, the use of crushed posaconazole DR tablets is preferred owing to incompatibility of manufacturer syringes and ENFit system; institutional directions (see Supplement S2) have been created for families and caregivers on how to do this. Therapeutic drug monitoring is used to ensure adequate dosing.

Challenges.

When patients are transitioning between products (IV to oral or oral to NG tube), special attention to detail is required. Both suspension formulations are now hidden in the EMR so that only pharmacists are able to place orders—to prevent confusion for providers during switching. Patient safety events may occur during feeding tube placement and the formulation is switched 1:1 to liquid IR suspension from DR tablets.

Solutions.

In conjunction with this, alerts were added to the EMR when ordering posaconazole, and pharmacist education (in the form of a clinical pearl presentation and internal guidance document for further reference) was provided to assist in ordering the right dose/conversion.

Challenges.

Because the DR suspension is now preferred for pediatric patients, there have been instances where insurance companies specifically prefer the DR suspension product. There have also been instances where insurance-preferred pharmacies are not able to order the product, and on 1 occasion the insurance strictly preferred the DR suspension but would only allow the family to fill the prescription at a pharmacy that was unable to order the product.

Solutions.

Early ambulatory prescribing of any posaconazole prescription is recommended (e.g., sending prescriptions as soon as it is known that a patient may require therapy) to allow for prior authorizations and peer to peer, time to order the product, and adequate education for all involved. Historically, most patients requiring any formulation of posaconazole require a minimum of a prior authorization. Several have required significant advocacy in order to receive the medication, with more than a week to receive approval for the medication, and potentially longer to get the product in stock and dispensed. It is an important reminder for all pharmacists, because most (if not all) patients starting to take posaconazole as an inpatient will require continuation in the outpatient setting, and thus early preparation is best.