The Therapeutic Goods Administration (TGA) has confirmed a shortage of Prednefrin Forte 10mL eye drops in Australia, which isn’t expected to be available until January next year, but its supplier has confirmed it is working towards providing an alternative product.
The Allergan Australia-distributed eye drop – with the active ingredients phenylephrine hydrochloride and prednisolone acetate – has not been available since February. Authorities have stated the impact on patients is “medium”.
The therapy is approved for severe inflammation (non-infectious) of the eye, such as acute iritis, iridocyclitis, scleritis, episcleritis, uveitis, resistant ocular allergy and inflammation following eye surgery.
A spokesperson for Allergan, an AbbVie company, confirmed the Prednefrin Forte eye drops bottle (ARTG 23235) is currently unavailable with supply expected to resume in early 2022.
“This is related to a supply disruption due to manufacturing reasons,” the spokesperson said.
“Our main priority is minimising any impact to patients and we are working towards arranging supply of an alternative product.”
If a medicine appears in the medicine shortages reports database, the TGA stated that an alternative medicine registered in another country can be included in the Section 19A database, or a suitable alternative unregistered medicine may be accessible through the Special Access Scheme (SAS).
Alternative options
The NSW Government’s Clinical Excellence Commission – the lead agency supporting safety improvement in the NSW health system – also issued an alert to the state’s health professionals in public health organisations on 3 March.
The communication provides a list of potential alternative agents, as well as precautions and safety issues associated with alternative products.
“Equivalent alternatives to the Australian registered prednisolone acetate 1%/phenylephrine 0.12% eye drops (Prednefrin Forte) are unavailable and at this time, [and] there is no provisionally registered product available through Section 19A of the Therapeutic Goods Act,” it stated.
“Existing Prednefrin Forte stock should be reserved for use in patients where alternative agents may be inappropriate e.g. allergy or clinical indication.”
In the absence of Prednefrin Forte, the NSW commission advised dexamethasone 0.1% eye drops (Maxidex) are the preferred alternative (as per ACI Ophthalmology Network).
“For indications where [Prednefrin Forte] eye drops are essential, sites may wish to consider local aseptic compounding options,” the commission said.
It pointed to Medsurge Healthcare, which may be able to supply prednisolone acetate 1% via the Therapeutic Goods Administration’s Special Access Scheme (SAS). The product is registered in New Zealand, with product information and labelling in English. Lead time is five to seven business days.
LINK Healthcare may also be able to provide prednisolone acetate 1%/phenylephrine hydrochloride 0.12% eye drops via the SAS, however, this product doesn’t have English packaging or labelling. Lead time is three to four weeks.
“Alternative ophthalmic corticosteroids that continue to be available include fluorometholone 0.1% eye drops (FML), fluorometholone acetate 0.1% eye drops (Flarex) and prednisolone sodium phosphate 0.5% eye drops (Minims),” the NSW Clinical Excellence Commission stated.
According to Optometry Australia, many compound pharmacies were still refining their formulations for the equivalent medicine. It’s also likely the cost of the formulation will be significantly higher than the unavailable commercial product.
The TGA’s alert can be found here.
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