PrEP Shortages Hit Pharmacies in Sydney, Melbourne

A shortage of PrEP hit pharmacies in Sydney and Melbourne over the past couple of months, with some users reporting difficulties in securing their medication. 

Inquiries by Star Observer found that there was indeed some shortage, after the recall of batches of Tenofovir Disoproxil Emtricitabine Mylan 300/200 pills in December 2020.

Australia’s Therapeutic Goods Administration on its website has listed PrEP shortages as current and anticipated for all three generic versions available through the Pharmaceutical Benefits Scheme. The patient impact is “medium” according to the TGA.

There is a current shortage of Lupin PrEP that is listed as “unavailable”. The shortage started on January 11 and is estimated to last till May 31, 2021 with the reason given as “manufacturing”. 

The shortage for Apotex PrEP is anticipated from February 15, 2021 to July 26, 2021. The reason for the shortage is said to be due to “unexpected increase in demand”. 

 With regard to Mylan PrEP, TGA anticipates that supply will be impacted from February 26, 2021 to March 26, 2021.

According to TGA, “an unregistered product has been approved for supply under Section 19A. Link Medical Products Pty Ltd can be contacted on 1800 181 060 for further information on supply.”

The shortages and possibly increased demand for other generic versions could be linked to the recall of Mylan PrEP last year. 

“The shortage followed the recall of Mylan PrEP which is what most PrEP users were on,” a pharmacist, who did not wish to be named, told Star Observer. “To make supplies last we gave users one bottle instead of three to ride out the shortage, but by January and February, even these were not enough to meet the demand.” 

While two other generic versions of PrEP from Apotex and Lupin General Health were available in Australia through the Pharmaceutical Benefits Scheme, the supply was not consistent, according to the pharmacies. This led to shortages, with customer queries being directed to pharmacies which still had some stocks.

 Mylan PrEP supply lines have now resumed with many pharmacies reporting that stocks is now available. The TGA however anticipates that supply will be impacted for a month.

John Silverii’s Pharmacy in Fitzroy North posted on its website last week that customers who require their three month supply of Mylan PrEP could email their prescription to request pickup or delivery. 

In December 2020, Australia’s Therapeutic Goods Administration had issued a recall alert for all batches of the Tenofovir Disoproxil Emtricitabine Mylan 300/200 pills over apprehension of split tablets leading to ineffective dosage. 

Mylan PrEP is prescribed for the treatment of HIV in adults over the age of 18 in combination with other antiretroviral agents and as pre-exposure prophylaxis (PrEP). The combination of emtricitabine/tenofovir is shown to be up to 99 percent effective in reducing risk of HIV transmission.

Last year in April, Truvada manufactured by the American pharmaceutical company, Gilead was taken off from the PBS in favour of cheaper, but equally effective generic equivalents from Mylan, Apotex and Lupin. 

Anyone who is having trouble accessing PrEP because of any shortage, lockdowns, or distance for a dispensing pharmacy – you can contact PAN (PrEPaccessNOW) via pan.org.au or head to PrEP’D For Change prepdforchange.com