TGA touts alternatives in diltiazem shortage

3 minute read

The commonly prescribed blood pressure medication is like hen’s teeth in regional areas, but there are other options.

The TGA has approved “multiple overseas diltiazem medicines” that can be used while locally registered brands are unavailable, but has refused to be drawn on whether supply to rural and regional Australia is lagging behind metropolitan centres.

TMR reported this week that diltiazem hydrochloride, a commonly prescribed medication for blood pressure, angina and atrial fibrillation, is in short supply in regional Australia. The TGA’s medicine shortage reports database currently lists nine formulations of diltiazem as either unavailable, limited availability or emergency supply only, with resupply dates varying from 17 February to 30 July depending on brand and formulation.

“There are three brands of diltiazem marketed in Australia: Cardizem, Vasocardol and Diltiazem Sandoz,” a TGA spokesperson told TMR.

“Sanofi-Aventis Australia, who is the sponsor of all three brands, notified the TGA of shortages of all diltiazem strengths due to manufacturing issues. Sanofi-Aventis advised they have emergency supply of diltiazem available.

“Pharmacists may contact Sanofi-Aventis’ Medical Information line on 1800 818 806 if they are unable to access diltiazem from their wholesaler.”

Information on the four overseas alternatives approved by the TGA can be found at Section 19A by searching for diltiazem. All are available from either Ingenus Pharmaceuticals or Oceanside until 31 May.

The ongoing shortage of antibiotics amoxicillin, cefalexin and metronidazole was “expected to improve within the next three months”, the TGA spokesperson said.

“To minimise the impact of the current antibiotic shortages, the TGA has implemented several management actions, including an Antibiotic Shortage webpage with advice for prescribers. Prescribers may also consider prescribing an alternative antibiotic with a similar spectrum of availability.

“[The TGA is] continuing to prioritise the approval of overseas-registered alternative antibiotics for temporary supply – some of the approved products are also listed on the PBS.

“[We are] making legal instruments which allow pharmacists to dispense another amoxicillin or cephalexin product to a patient when one is unavailable without prior approval from the prescriber, and [we are] working with wholesalers to facilitate equitable distribution and prevent stockpiling.”

When asked about the lag between supply to metropolitan areas and rural and regional areas, the TGA quoted information about the Community Service Obligation Funding Pool “ensuring that all of Australia’s 5800 community pharmacies can order any brand of PBS medicine, and receive delivery within 24 to 72 hours”.

There are currently 392 medications listed on the TGA’s active shortage list with a further 64 anticipated to be in short supply in the near future, including AstraZeneca’s covid vaccine Vaxzevria (from 20 March 2023 until 15 February 2025, due to “commercial viability”), schizophrenia medication apo-aripiprazole (from 14 April to 26 May), and antipsychotic olanzapine (until early March).

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