FDA authorizes CISplatin importation from China.
Due to the critical shortage of CISplatin, the FDA has authorized Qilu Pharmaceutical, in conjunction with its distributor Apotex, to temporarily import CISplatin manufactured and marketed in China and not FDA-approved in the US. As with other imported products, this medication has unique packaging and labeling characteristics that may contribute to confusion and errors. Qilu's CISplatin is available as a 50 mg/50 mL injection in a preservative-free, multidose amber vial, similar to the FDA-approved product. However, it comes as a slightly viscous, colorless-to-yellowish clear liquid, as opposed to a clear and colorless, solution.
The FDA posted a letter from Qilu which contains important prescribing information and explanation that bisulfite, metabisulfite, sodium bicarbonate, and fluorouracil can affect stability in relation to compatibility in solution. The imported product has similar storage recommendations to the US product, such as store at 15-25 [degrees]C, protect from light, and avoid refrigeration.
A sticker, applied to the carton and vial, contains the following information: translated name of CISplatin, the strength, the concentration, the US National Drug Code (NDC), a linear bar code that is readable by US systems, and these warning statements, "Stop! Verify Drug Name and Dose!" and "CISplatin doses greater than 100 mg/m2 once every 3 to 4 weeks are rarely used."
The imported product's carton and vial label state the lot number, production date, and expiration date in Chinese characters, but this information has not been added to the sticker. Since there is both a production and expiration date, pharmacy staff may confuse the two dates.
The manufacturer's letter provides a table with the lot number and expiration date, but it is unclear how organizations will be able to translate the information on the carton and vial unless this information is also added to the sticker or translated into the table. For now, organizations should consider creating a label that includes the translated lot number and expiration date and apply it to the carton and vial. Ensure master formulation records are updated to include product-specific instructions for compounding.
Because the product is slightly viscous, an accurate dosage should be ensured by injecting sodium chloride into the vial and shaking it to remove any drug on the inner wall after the initial drug removal. However, questions remain about this step, which, presumably, would take place if one is unable to remove at least 50 mL from the vial. It may be difficult for practitioners to operationalize the washing process described to withdraw the expected amount of medication. This may also impact the volume in the infusion bag, product compatibility with closed-system transfer devices, or sterile compounding technologies such as robotics and gravimetrics.
ISMP is in communication with the FDA and the manufacturer to better understand the amount of overfill in the vial and the need for this process.
Mix-ups between look-alike timolol eye drop formulations
Timolol maleate ophthalmic 0.5% solution is a beta-adrenergic blocker indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Organizations have reported mix-ups between generic once-daily and twice-daily formulations made by Bausch + Lomb due to the same generic name and similar-looking cartons and dropper bottles.
However, these products are not equivalent. While the product with the NDC number 68682-0045-50 is indicated for once-daily dosing, the other product with the NDC number 68682-0813-05 is indicated for twice-daily dosing, although it may be decreased to once daily if intraocular pressure is well controlled.
While the once-daily formulation outer carton states "Once Daily," this information is not displayed on the dropper bottle label.
The manufacturer reported that potassium sorbate was added to the once-daily formulation to enhance the ocular bioavailability. The concern is that if the once-daily formulation is used twice a day, this could lead to increased systemic absorption, with the potential risk of adverse cardiovascular events in vulnerable patients (although none have been reported so far). Also, if the twice-daily formulation is only used once a day, it may result in ineffective treatment of the patient's condition.
ISMP has been in contact with the FDA and the manufacturer to recommend differentiation of the generic names, cartons, and dropper bottles.