Critical shortages round up


medicine blister packs

Medicines currently under shortage with critical patient impact include naloxone solution, adrenaline, Fluarix Tetra, MMR vaccines and more

The TGA has published information about current medicines shortages that have a critical patient impact.

This information is based on details provided in the notifications submitted by sponsors.

“It is important to note that sometimes disruptions to supply cannot be avoided,” says the TGA.

“The problem of medicine shortages is not unique to Australia. Mandatory reporting of medicine shortages will not prevent these disruptions.”

Here is a summary of current shortages with critical patient impact:

Brand name

Product

Supply impact to

Reason

Naloxone Juno

Naloxone hydrochloride (as dihydrate) 400 micrograms/1 mL solution for injection, ampoule

15 Jul 2019

Manufacturing

Rimycin 300

Rifampicin 300 mg capsule bottle

30 Jun 2019

Manufacturing

Provera

Medroxyprogesterone acetate 100mg tablet blister pack

30 Sep 2019

Manufacturing

Fluarix Tetra

Inactivated split influenza vaccine suspension for injection 0.5mL pre-filled PRTC syringe without needle

 

Only available under NIP or government programs

31 Mar 2020

 

Unexpected Increase in Demand

Priorix-Tetra

(live varicella vaccine

Measles virus

Mumps virus

Rubella virus)

Priorix-Tetra Vaccine 0.5mL powder for injection vial with diluent syringe

31 Oct 2019

Manufacturing

Priorix Albumin Free Vaccine

(Measles virus

Mumps virus

Rubella virus)

Priorix Albumin Free Vaccine 0.5mL powder for injection vial and diluent syringe

 

Only available under NIP or government programs

01 Oct 2019

 

Manufacturing

M-M-R II

(Measles virus

Mumps virus

Rubella virus)

M-M-R II Powder for injection vial with pre-filled diluent syringe, single dose

 

Only available under NIP or government programs

30 Sep 2019

Unexpected Increase in Demand

 

TGA Management Actions:
16/5/19 Stock is under constrained supply for the private market and state/territory programs.

DBL Heparin Sodium

(Porcine mucous) 5000IU/0.2mL injection BP ampoule

30 Jul 2019

Manufacturing

Aspen fentanyl

Fentanyl (as citrate) 100 microgram/2 mL solution for injection

31 Jul 2019

 

Manufacturing

 

TGA Management Actions:

An unregistered product has been approved for supply under Section 19A. See the website: https://www.tga.gov.au/ws-s19a-index and search for the active ingredient.

Aspen fentanyl

Fentanyl 500 microgram/10 mL solution for injection

31 Jul 2019

 

Manufacturing

 

TGA Management Actions:

An unregistered product has been approved for supply under Section 19A. See the website: https://www.tga.gov.au/ws-s19a-index and search for the active ingredient.

DBL fentanyl

Fentanyl 100 microgram/2mL (as citrate) injection USP ampoule

30 Sep 2019

 

Unexpected Increase in Demand

 

TGA Management Actions:

An unregistered product has been approved for supply under Section 19A. See the website: https://www.tga.gov.au/ws-s19a-index and search for the active ingredient.

Neulactil

Periciazine 2.5mg tablet blister pack

01 Jul 2019

 

Manufacturing

 

TGA Management Actions:

An unregistered product has been approved for supply under Section 19A. See the website: https://www.tga.gov.au/ws-s19a-index and search for the active ingredient.

Neulactil

Periciazine 10mg tablet blister pack

01 Jul 2019

 

Manufacturing

 

TGA Management Actions:

An unregistered product has been approved for supply under Section 19A. See the website: https://www.tga.gov.au/ws-s19a-index and search for the active ingredient.

LPV Phenoxymethylpenicillin

Phenoxymethylpenicillin 500mg (as potassium) capsule blister pack

05 Jul 2019

 

Manufacturing

 

TGA Management Actions:

27/5/19 Other strengths are available.

DBL morphine sulfate

Morphine sulfate 15mg/1mL injection BP ampoule

30 Jul 2019

 

Manufacturing

Zyban sustained release

Bupropion hydrochloride 150mg tablet blister pack

31 Oct 2019

 

Manufacturing

Miochol-e

Acetylcholine chloride 20mg/2mL powder for solution for intraocular irrigation ampoule

31 Oct 2019

 

Manufacturing

Dibenyline

Phenoxybenzamine hydrochloride 10mg capsule jar

30 Jun 2020

 

Manufacturing

Adrenaline-Link 1:1,000

1mg/1mL adrenaline (epinephrine) acid tartrate injection BP ampoule

05 Jul 2019

 

Manufacturing

Adrenaline-Link 1:10,000

1mg/10mL adrenaline (epinephrine) acid tartrate injection BP ampoule

15 Jul 2019

 

Manufacturing

 

TGA Management Actions:
5/6/19 Other presentations are available.

Marcain 0.5% with adrenaline

1:200,000 20mL injection vial

16 Aug 2019

 

Manufacturing

 

TGA Management Actions:

12/06/2019 Sponsor is working to expedite the next shipment.

DBL Leucovorin Calcium

Folinic acid 300mg/30mL (as calcium folinate) Injection Vial

05 Sep 2019

 

Manufacturing

Atropine injection BP

Atropine sulfate monohydrate 1.2 mg/1 mL injection BP ampoule

25 Oct 2019

 

Manufacturing

 

TGA Management Actions:

4/06/2019 Supply of an alternative product is under consideration.

DBL Vancomycin

Vancomycin (as hydrochloride) 500mg powder for injection vial

28 Jun 2019

 

Manufacturing

 

TGA Management Actions:

4/06/2019 Alternative generic products are available.

Dantrium

Dantrolene sodium hemiheptahydrate 25mg capsule bottle

31 Jul 2020

 

Manufacturing

 

TGA Management Actions:

An unregistered product has been approved for supply under Section 19A. See the website: https://www.tga.gov.au/ws-s19a-index and search for the active ingredient.

Dantrium

Dantrolene sodium hemiheptahydrate 50mg capsule bottle

31 Jul 2020

 

Manufacturing

 

TGA Management Actions:

An unregistered product has been approved for supply under Section 19A. See the website: https://www.tga.gov.au/ws-s19a-index and search for the active ingredient.

 

For more information, see the Medicine Shortages Information Initiative

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