TGA shortages guidance

THE Therapeutic Goods Administration has released new resources on the upcoming medicines shortages reforms, which will see mandatory reporting of items in short supply starting from 01 Jan.

Effective from the start of next year, sponsors of prescription and some OTC medicines will be required to report all medicine shortages - including those arising from discontinuations or recalls within specified timeframes.

The TGA will automatically and prominently publish information about all current and anticipated shortages with critical patient impact through a special website.

Sponsors will also be “strongly encouraged” to publish information about shortages with low or medium patient impact.

A “Medicines Watch List” details items that have been predetermined as having critical patient impact, and includes antimicrobial agents, vaccines, anticoagulants, obstetric drugs, antivenoms, poisons treatments and emergency/critical medicines.

S3 products on the list include adrenaline autoinjectors, naloxone, salbutamol inhalers and sublingual glyceryl trinatrate.

The TGA has urged suppliers to engage closely with health bodies to assess the impact of shortages, such as Society of Hospital Pharmacists Specialty Practice Groups - see tga.gov.au.