Medication Safety Updates

The CEC Medication Safety Updates table is a repository of information intended for use by NSW health clinicians in relation to current medication safety issues including disruptions to supply, recalls, discontinuations as well as current and emerging safety risks. Where there is a shortage of a medicine listed on the NSW Medicines Formulary, the substitute(s) specified on this page is considered to be Formulary-approved for use during the shortage period. The information may not be relevant to clinicians from other states or territories and is not the complete list of medicine shortages reported to the Therapeutic Goods Administration – refer to the TGA Medication Shortages Information Initiative and Medicines Safety Update.

Date last updated:
Medicine Affected Issued Updated Update Links Status
Nirsevimab 18 Apr 2024 18 Apr 2024 Sanofi has recently communicated an error on the packaging of the Australian registered Beyfortus (nirsevimab) 50 mg/0.5 mL product. The outer packaging incorrectly refers to the product as a 1 mL solution for injection. For further information, refer to Dear Health Care Professional letter prepared by Sanofi.

Dear Health Care Professional letter

Current
Malathion 18 Apr 2024 18 Apr 2024 There is a current disruption to the supply of malathion (KP24 Medicated Lotion) for the treatment of head lice until the end of April 2024. Alternatives including benzyl alcohol (Neutra Lice Advance) and dimeticone (Hedrin 15) remain available. For further information, refer to the Australian Medicines Handbook.

Australian Medicines Handbook – Head lice

Current
Mycophenolate mofetil 26 Mar 2024 18 Apr 2024 There is a current disruption to the supply of multiple brands of mycophenolate 250 mg capsules and 500 mg tablets due to manufacturing issues. The Australian registered products, mycophenolate mofetil (Cellcept) 250 mg capsules and 500 mg tablets will be discontinued from the market on 01 August 2024, with a reduction in supply until stock is exhausted. Refer to the NSW Medicines Formulary Information 01/24 released in April 2024 regarding the use of generic mycophenolate mofetil in NSW public hospitals. If there is an urgent requirement or issues obtaining stock, facilities should contact HealthShare NSW for assistance. It is recommended that facilities closely monitor their stock levels and consider the need to dispense smaller quantities for PBS patients (i.e. 1 month) until the supply returns to normal.

NSW Medicines Formulary Information 01/24

Current
Antiseptics - various 13 Mar 2023 18 Apr 2024 A number of antiseptic agents were discontinued from the Australian market or have been acquired by another sponsor. A factsheet has been prepared to outline the products affected, potential alternatives and associated safety considerations. The factsheet has been updated on 18 April 2024 with additional information regarding the Section 19A alternative of povidine iodine (Dukal) 10%.

CEC Factsheet

Current
Miostat (Carbachol) intraocular injections 12 Apr 2024 12 Apr 2024 There is a current disruption to the supply of Miostat (Carbachol) 0.15 mg/1.5 mL intraocular injection vials. The estimated return to supply date is variable throughout Q2, 2024. Supply of an internationally registered alternative from Switzerland is available via the Therapeutic Goods Administration Special Access Scheme (SAS) via Orspec and Medsurge. The product is identical in active ingredient, strength, form and contains the same excipients, however, is labelled in German. Please note, the SAS alternatives have a lead time of 7 -25 business days. Current
Urografin 04 Apr 2024 12 Apr 2024 There is a current disruption to the supply of Urografin 30% 250 mL bottle due to manufacturing issues until late July 2024. Supply of internationally registered alternatives are available under the Therapeutic Goods Administration Special Access Scheme (SAS) from Netherlands via Medsurge and Ireland via Orspec. The products are identical in active ingredient, strength, presentation and excipients. Please note, the alternative from the Netherlands is not labelled in English. Current
Miochol-E (acetylcholine intraocular solution) 12 Apr 2024 12 Apr 2024 There is a current disruption to the supply of Miochol-E (acetylcholine) intraocular solution 20 mg/2 mL until at least May 2024 due to manufacturing issues. Internationally registered alternatives are available for supply under the Therapeutic Goods Administration Special Access Scheme (SAS) from Italy (Miovisin 20 mg/2 mL) via Medsurge and Orpsec and USA (Miochol-E) via ProPharmaceutical Group. The products are identical in active ingredient, strength, and form. Please note, the alternative from Italy is not labelled in English and both SAS alternatives have a lead time ranging from 7 -15 business days. Current
Nirmatrelvir 150 mg/ritonavir 100 mg (Paxlovid) 01 Aug 2022 12 Apr 2024 A shelf-life extension for nirmatrelvir 150 mg/ritonavir 100 mg (Paxlovid) tablets has been approved in Australia by the Therapeutic Goods Administration (TGA). The shelf life has been extended from 18 months to 24 months and may be applied retrospectively to Paxlovid products manufactured prior to this approval being granted. The storage conditions of ‘Store below 25 degrees Celsius’ remain unchanged. As Paxlovid is a co-packaged product and the active ingredients may have had different production dates, the updated expiry date must be determined by identifying the specific batch number. A full list of batches and updated expiries can be accessed in the Dear Health Care Professional Letter prepared by Pfizer.

Dear Health Care Professional Letter

Resolved
Naloxone nasal spray and PFS 10 Aug 2022 12 Apr 2024 There is a current disruption to the supply of naloxone nasal spray (Nyxoid) with limited availability expected throughout the coming months. Pro Pharmaceuticals Group have received approval under Section 19A (S19A) of the Therapeutic Goods Act to import supply of an alternative naloxone nasal spray from the UK until 19 July 2024. The S19A alternative is identical in strength, pack size and storage. For further information, refer to the Dear Health Care Professional letter, prepared by Pro Pharmaceuticals Group. Please note 1.8 mg of naloxone is equivalent to 2.2 mg of naloxone hydrochloride dihydrate.

Dear Health Care Professional Letter

Current
Diltiazem 09 Mar 2023 12 Apr 2024 There is a current disruption to the supply of diltiazem 240 mg (Vasocardol CD and Cardizem CD) controlled release capsules due to manufacturing issues until 30 April May and 30 June 2024 respectively. Product sponsors are working to expedite the next shipment. Alternative brands and strengths remain available. Current
Dobutamine hydrochloride 250 mg/20 mL 13 Apr 2023 12 Apr 2024 There is a current disruption to the supply of dobutamine hydrochloride (DBL) 250 mg/20 mL solution for injection due to manufacturing issues until 26 April 2024. Orspec Pharma has received approval under section 19A (S19A) of the Therapeutic Goods Act to import supply of dobutamine (Slate Run) 12.5 mg/mL injection vials from the United States until 31 May 2024. The S19A alternative is identical in active ingredient and storage requirements. The US alternative differs to the Australian registered product with regard to excipients (contains ethanol) and packaging size (10 ampoules rather than 1 vial) but is identical in overall volume and final concentration (250 mg/20 mL). For further information, refer to the Dear Health Care Professional Letter prepared by Orspec.

Dear Health Care Professional letter

Resolved
Entecavir 21 Aug 2023 12 Apr 2024 There is a current disruption to the supply of multiple brands of entecavir 0.5 mg and 1 mg tablets due to manufacturing issues and unexpected increases in consumer demand. Limited stock remains available. NSW Health facilities can contact HealthShare NSW for further information on obtaining supply. It is recommended that facilities closely monitor their stock levels and consider the need to dispense smaller quantities for PBS patients (i.e. 1 month) until the supply returns to normal. Current
Salbutamol solution for inhalation 11 Sep 2023 12 Apr 2024 There is a current disruption to the supply of salbutamol 2.5 mg/2.5mL (Cipla) nebules until late July 2024 due to manufacturing issues. Alternative salbutamol products including salbutamol 5 mg/2.5 mL solution for inhalation and salbutamol MDI are unaffected and remain available. Refer to the Medication Safety Communication for further information on this disruption to supply, available alternatives, and associated safety considerations.

Medication Safety Communication

Resolved
Benzathine benzylpenicillin 27 Oct 2023 12 Apr 2024 There is an ongoing current disruption to the supply of benzathine benzylpenicillin (Bicillin L-A) 600,000 units/1.17 mL and 1,200,000 units/2.3 mL suspension for injection until 15 November 2024 and 28 June respectively due to manufacturing issues and unexpected increases in consumer demand. For further information, refer to the Safety Notice (005/24).

Safety Notice 005/24

Current
Heparin 5000 units/5 mL 27 Mar 2024 09 Apr 2024 There is a current disruption to the supply of heparin sodium (Pfizer) 5,000 units/5 mL injection ampoules due to manufacturing issues. Orspec have received approval under Section 19A (S19A) of the Therapeutic Goods Act to import supply of heparin sodium 5,000 units/5 mL solution for injection or concentrate for solution for infusion (Wockhardt) from the United Kingdom until 30 April 2024 (subject to change). The S19A alternative products differ in presentation and contain additional excipients. One of the S19A alternatives contains preservatives. In the absence of the Australian registered product or where the S19A alternative is unavailable/contraindicated, clinicians wishing to prepare a heparin 5,000 units/5 mL (1,000 units/1 mL) preparation can do so using alternative products. For further information regarding the disruption to supply and alternatives available, refer SN:004/24 for further information.

Dear Health Care Professional Letter
Safety Notice 004/24

Current
Xylocaine 2% with adrenaline 1:200,000 20 mL injection vial 08 Dec 2023 08 Apr 2024 There is a global disruption to the supply of Xylocaine (lidocaine) 2% with adrenaline 1:200,000 20 mL injection vial with limited stock available due to manufacturing issues until 1 June 2024. Reach have received approval under Section 19A (S19A) of the Therapeutic Goods Act to import supply of alternative products from the USA until 30 April 2024. Please note the Australian registered product and the S19A alternative contain sodium metabisulfite and should not be used in patients with hypersensitivity to sulfite-containing medications. For further information regarding the differences between the Australian registered product and the S19A alternative, refer to the Dear Health Care Professional letter prepared by Reach. Additionally, refer to the Medication Safety Communication for further information on this disruption to supply, other available alternatives, and associated safety considerations.

Medication Safety Communication
Reach – Dear Health Care Professional Letter

Current
Busulfan injection 08 Apr 2024 08 Apr 2024 There is a current disruption to the supply busulfan (Accord) 60 mg/10 mL concentrated injection vial due to manufacturing issues which is expected to resolve on 31 May 2024. Orspec have received approval under section 19A (S19A) of the Therapeutic Goods Act to import supply of busulfan (SteriMax) 60 mg/10 mL vial for injection from Canada until 30 August 2024. The S19A alternative is identical in active strength and ingredient to the Australian Registered product but differs with regard to recommended infusion time and stability once reconstituted. For further information regarding these differences, please refer to the Dear Health Care Professional letter prepared by Orspec.

Dear Health Care Professional Letter

Current
Dexamethasone, framycetin and gramicidin ear drops 02 Apr 2024 02 Apr 2024 There is a current disruption to the supply of dexamethasone, framycetin and gramicidin (Sofradex and Otodex) ear drops. The disruption is expected to last until 3 May 2024 for Sofradex ear drops and until 31 May 2024 for Otodex ear drops, due to manufacturing issues. Limited stock of Otodex ear drops remain available. Supply of an alternative product under the Special Access Scheme (SAS) of the Therapeutic Goods Act is currently being investigated. In the case of a complete disruption to supply, alternative therapy should be sought in consultation with local Infectious Diseases/Microbiology service. Alternatives may include flumetasone with clioquinol (Locacorten Vioform) or ciprofloxacin with hydrocortisone (Ciproxin HC) ear drops. The combination product triamcinolone, neomycin, gramicidin and nystatin (Kenacomb/Otocomb Otic) may be used if fungal infection is suspected. Current
Hydroxocobalamin solution for injection 14 Dec 2023 20 Mar 2024 There is a current disruption to the supply of multiple brands of hydroxocobalamin 1 mg/1 mL solution for injection due to manufacturing issues. The estimated return to supply date is variable throughout Q1, 2024. Pro Pharmaceuticals have received approval under Section 19A (S19A) of the Therapeutic Goods Act to import supply of international alternatives from Switzerland and the United Kingdom. The Australian registered products and S19A alternatives all contain hydroxocobalamin (either as acetate or chloride salt) and are identical in strength, formulation and storage requirements. However, there are differences in excipients and presentation. Refer to the Medication Safety Communication for further information on this disruption to supply, available alternatives, and associated safety considerations.

Medication Safety Communication

Resolved
Plerixafor 20 Mar 2024 20 Mar 2024 There is a current disruption to the supply of plerixafor (ARX) 24 mg/1.2 mL solution for injection until 21 June 2024 due to manufacturing issues. The alternative brand, Mozobil, remains available. Facilities are encouraged to have backorders in place to ensure they receive supply when it becomes available. Current
Octreotide 28 Feb 2024 20 Mar 2024 There is a current disruption to the supply of octreotide (GH and Sandostatin) 50 microg/1mL, 100 microg/1 mL and 500 microg/1 mL injection ampoules due to manufacturing issues and unexpected increases in consumer demand. The return to stock date for products are variable throughout 2024/2025 and remaining supply is constrained. It is recommended that facilities closely monitor their stock levels and consider the need to dispense or distribute smaller quantities. Generic Health has received approval under Section 19A (S19A) of the therapeutic Goods Act to import supply of octreotide (Omega) 50 microg/1mL, 100 microg/1 mL and 500 microg/1 mL injection ampoules from Canada until 30 April 2025. The S19A alternatives are identical in active strength and ingredient to the Australian registered products but differ with regard to form (vial instead of ampoule), excipients and route of administration. For further information, please refer to the Dear Health Care Professional letter prepared by Generic Health.

Dear Health Care Professional letter

Current
Acetazolamide 500 mg injection 16 Mar 2023 20 Mar 2024 There is a current disruption to the supply of acetazolamide (Glaumox) 500 mg powder for injection until 28 February 2025 due to manufacturing issues. Phebra has received approval under Section 19A (S19A) of the Therapeutic Goods Act to import supply of an alternative product acetazolamide for injection (Mylan) 500 mg from the United States until 30 April September 2024. The product is identical in active ingredient, strength and formulation to the Australian registered product. Current
Dulaglutide 09 Oct 2022 20 Mar 2024 There is an ongoing disruption to the supply of dulaglutide (Trulicity) 1.5 mg/0.5 mL solution for injection prefilled pen until 31 December 2024. Medsurge has received approval under section 19A (S19A) of the Therapeutic Goods Act to import supply of dulaglutide (Trulicity) 1.5 mg/0.5 mL solution for injection prefilled pen (Eli Lilly) from the Netherlands and Switzerland until 31 January 2025. The S19A products are identical to the Australian registered product in terms of concentration, excipients and storage requirements. However, the product labelling and Product Information is in German (box clearly states brand name “Trulicity”). Clinicians should use this product according to the Australian Product Information. Please note - the S19A alternative is not currently listed on the Pharmaceutical Benefits Scheme.

TGA shortage statement

Current
Ciprofloxacin 400 mg/200 mL intravenous infusion bags 19 Mar 2024 19 Mar 2024 In October 2023, Pfizer announced that ciprofloxacin (DBL) 400 mg/200 mL intravenous infusion bags products would be discontinued in Australia. Remaining supply is now exhausted at a wholesaler level. Alternative strength products – ciprofloxacin (Aspen) 100 mg/50 mL and 200 mg/100 mL injection for intravenous infusion remain available. Current
Gliclazide 80 mg tablets 18 Jan 2024 19 Mar 2024 There is a current disruption to the supply of gliclazide 80 mg tablets due to manufacturing issues until March 2024. Supply of international alternatives are available from various suppliers via the Therapeutic Goods Administration Special Access Scheme (SAS). The SAS alternatives are identical in active ingredient and strength. Note that the SAS alternatives may come in pack sizes of 28 tablets, 60 tablets or 500 tablets. Resolved
Chloramphenicol eye drops 18 Jan 2024 19 Mar 2024 There is a current disruption to the supply of chloramphenicol 5 mg/mL eye drops until February 2024 due to manufacturing issues. Chloramphenicol 1% eye ointment remains available. Resolved
Aciclovir injections 16 Nov 2023 19 Mar 2024 There is an ongoing disruption to the supply of multiple brands and strengths of intravenous aciclovir due to manufacturing issues and unexpected increases in consumer demand. The return to normal supply dates vary and remaining stock is limited. For information regarding the use of aciclovir during the disruption to supply, refer to the fact sheet from the National Centre for Antimicrobial Stewardship. If there is an urgent requirement or issues obtaining stock, facilities should contact HealthShare NSW for assistance.

National Centre for Antimicrobial Stewardship Fact Sheet

Current
Molnupiravir 30 Sep 2022 19 Mar 2024 The TGA has recently approved the extension of shelf life of LAGEVRIO molnupiravir 200 mg capsule to 30 months when stored below 30 degrees Celsius. This extension retrospectively applies to all stock that has been imported to Australia noting that stock currently in the market is labelled with an expiry date of 18 months from the date of manufacture. Refer to the Dear Health Care Professional letter prepared by MSD for further information.

Dear Health Care Professional Letter

Resolved
Esmolol hydrochloride powder for injection 29 Sep 2023 19 Mar 2024 There is a current disruption to the supply of esmolol hydrochloride (Brevibloc) 2.5 g powder for injection until 30 December 2023 due to manufacturing issues, with limited supply available directly from Phebra. Facilities are also encouraged to have backorders in place to ensure they receive supply when it becomes available. Resolved
Fludarabine phosphate 01 Sep 2023 19 Mar 2024 There is an ongoing disruption to the supply of fludarabine (Ebewe) 50 mg/2 mL concentrated injection vial until 2 June 2024. Supply of Fludarabine (Juno) 50 mg powder for injection is now available. Link Healthcare have received approval under Section 19A of the Therapeutic Goods Act to import supply of fludarabine (Actavis) 25 mg/mL solution for injection from Sweden and fludarabine (Bendarabine) 50 mg powder for injection or infusion from Germany until 30 April 2024. Refer to the Medication Safety Communication released in September 2023 regarding the available alternatives, and associated safety considerations.

Medication Safety Communication

Current
Quinapril 15 Dec 2022 19 Mar 2024 There is a current disruption to the supply of quinapril and quinapril with hydrochlorothiazide products due to ongoing investigations by the Therapeutic Goods Administration (TGA) into potential contamination with low levels of N-nitroso-quinapril. The disruption to supply is expected to continue until at least 30 April 2024. On 13 December 2022, The Therapeutic Goods Administration (TGA) recalled multiple brands and strengths of quinapril tablets (APO, Generic Health, Acquin) due to identifying unacceptable levels of N-nitroso-quinapril. As a precautionary measure, sponsors of all marketed quinapril and quinapril with hydrochlorothiazide products have paused supply of quinapril products while the TGA continues to investigate. In cases of complete disruption to supply, advice should be sought regarding alternative treatment options. Further information regarding the shortage and TGA investigation is available on the TGA webpage

TGA Safety Alert

Current
Cefaclor oral liquid 04 May 2023 19 Mar 2024 There is an ongoing disruption to the supply of cefaclor (Ceclor) 125 mg/5 mL and 250 mg/5 mL powder for oral liquid until 30 October 2024 due to manufacturing issues. Supply of cefaclor (Keflor) 125 mg/5 mL remains unaffected. For patients admitted to hospital, consider reserving remaining oral liquid formulations for paediatric patients and for those patients with enteral feeding and swallowing difficulties (see Do Not Rush to Crush, accessible via CIAP for further information). Current
Lithium SR tablets 21 Sep 2023 19 Mar 2024 There is a current disruption to the supply of lithium 450mg (Quilonum SR) tablets until 27 October 2023 due to manufacturing issues. Link Healthcare have received approval under Section 19A of the Therapeutic Goods Act to import supply of lithium Carbonate extended release (Rising) 450 mg tablets from the United States until 31 January 2024. The product is identical in active ingredient but differs with regard to presentation, pack size and excipients (not clinically significant). For further information refer to the Dear Health Care Professional letter prepared by Link. In the event of a complete disruption to supply specialist advice should be sought before switching to an alternative strength and formulation (e.g. lithium 250 mg immediate release tablets). Facilities should consider removing supply from imprest in clinical areas, and individual dispensing of this medicine during the disruption to supply period.

Dear Health Care Professional letter

Resolved
Desmopressin acetate 17 Nov 2020 19 Mar 2024 There is an ongoing disruption to the supply of Desmopressin (Minirin) 10 microgram/actuation nasal spray with supply not anticipated until 30 September 2024. Alternate desmopressin formulations (tablets, sublingual wafers and injection ampoule) are unaffected. Medsurge have received approval under section 19A (S19A) of the Therapeutic Goods Act to import supply of an alternative desmopressin (Apotex) 10 microgram/0.1 mL nasal spray from the US until 30 October 2024. Please note this product must be stored in an upright position and any solution remaining after 50 sprays must be discarded as the amount delivered thereafter may be substantially less than 10 micrograms of drug (S19A alternative contains 5 mL compared to the 6 mL in the Australian registered product). Refer to the Dear Health Care Professional letter prepared by Medsurge for further information.

Dear Health Care Professional

Current
Permethrin cream 18 Mar 2024 18 Mar 2024 There is a current disruption to the supply of permethrin (Lyclear) 5% cream which is expected to resolve in June 2024. Supply of international alternatives are available from various suppliers via the Therapeutic Goods Administration Special Access Scheme (SAS). The SAS alternatives may differ to the Australian registered product in volume and excipients, including benzyl alcohol and formaldehyde solution which may cause dermal reactions. Please note that the SAS alternatives have a lead time of up to 18 business days. In case of complete disruption to supply, clinical alternatives, such as ivermectin, may be considered. Current
Lisdexamfetamine 23 Aug 2023 13 Mar 2024 There is an ongoing disruption to the supply of multiple strengths of lisdexamfetamine (Vyvanse) capsules due to manufacturing issues until April 2024. Lisdexamfetamine 50 mg (Vyvanse) is now available. Refer to the TGA Shortage Information webpage for further information. Use of patient's own supply (where available) may be required during the disruption to supply. Emergency stock of all affected strengths is available through Takeda Pharmaceuticals. Additionally, Medsurge have received approval under Section 19A (S19A) of the Therapeutic Goods Act to import supply of lisdexamfetamine 60 mg until 30 June 2024. The S19A alternative is identical in active ingredient however, differs in packaging size and capsule presentation. For further information, please refer to the Dear Health Care Professional letter prepared by Medsurge. In case of a complete disruption to supply, advice should be sought from the patient’s specialist about alternative treatment options.

Dear Health Care Professional Letters
TGA Shortage Information

Current
Methylprednisolone sodium succinate injection 11 Jul 2023 13 Mar 2024 There is an ongoing disruption to the supply of methylprednisolone sodium succinate (Solu-Medrol Act-O-Vial) 40 mg powder for injection due to manufacturing issues. Supply is expected to return from April 2024. The disruption to the supply of the 125 mg has now resolved. Link Healthcare have received approval under Section 19A of the Therapeutic Goods Act to import supply of methylprednisolone sodium succinate (Solu-Medrone) 40 mg for injection from the United Kingdom until 31 May 2024. The 40 mg S19A alternative has been listed on the Pharmaceutical Benefits Scheme (PBS) effective as of 1 November 2023. Refer to the Medication Safety Communication for further information on this disruption to supply, available alternatives, and associated safety considerations.

Medication Safety Communication

Resolved
Fluoxetine dispersible tablets 28 Nov 2023 12 Mar 2024 There is a current disruption to the supply of fluoxetine (Zactin) dispersible tablets due to manufacturing issues until 30 April 2024. Medsurge and LINK have received approval under Section 19A (S19A) of the Therapeutic Goods Act to import supply of alternative products from the UK until 31 May 2024. The S19A alternative products differ in strength and form (10 mg capsules) to the Australian registered product. The TGA has approved a Serious Scarcity Substitution Instrument (SSSI) which allows pharmacists to dispense the 20 mg or 10 mg capsules when the dispersible tablet is unavailable without prior approval to substitute from the prescriber. The instrument remains in force until 31 May 2024. The S19A alternative available from LINK is eligible for PBS subsidy, however patients will require a prescription from their regular prescriber dated on or after 1 February 2024. Further information about the substitution and the conditions required is available on the PBS Medicine Shortages page and the TGA webpage. Further information regarding the shortage is available via the Therapeutic Goods Administration webpage.

TGA Shortage Information
TGA SSSI Information

Current
Disulfiram 19 Dec 2023 08 Mar 2024 There is a current disruption to the supply of disulfiram (Antabuse) 200 mg effervescent tablets due to manufacturing issues until 26 July 2024. Supply of an international alternative from Italy disulfiram (Etiltox) 200 mg tablets is available from Link Pharmaceuticals via the Therapeutic Goods Administration Special Access Scheme (SAS). The product is identical in active ingredient, strength, and storage requirements but differs with regard to form ( tablet) and presentation (box and tablet blisters labelled in Italian). Other registered therapeutic alternatives to manage alcohol dependence remain unaffected.

TGA  shortage database

Current
Paracetamol solution for injection 31 Oct 2023 08 Mar 2024 There is a current global disruption to the supply of multiple brands of paracetamol 1000 mg/100 mL solution for injection products due to a raw material issue. The disruption to supply is not expected to resolve until at least 30 June 2024, with the potential to extend until December 2024. For further information, refer to the safety Alert (004/24). Oral and rectal paracetamol products remain unaffected.

Safety Alert 004/24

Current
Suxamethonium chloride 100 mg/2 mL 08 Mar 2023 08 Mar 2024 There is a current disruption to the supply of suxamethonium (Juno) 100 mg/2 mL solution for injection until 1 May 2024 due to manufacturing issues. Juno have received approval under Section 19A (S19A) of the Therapeutic Goods Act to import supply of an alternative product registered in the UK until 30 June 2024. The UK alternative is identical in active ingredient strength and storage requirements, but differs in packaging presentation and excipients. Current
Hydralazine 05 Mar 2024 05 Mar 2024 There is a current disruption to the supply of hydralazine (Alphapress) 25 mg and 50 mg tablets until late April 2024 due to manufacturing issues. Medsurge have received approval under Section 19A (S19A) of the Therapeutic Good Act to import supply of hydralazine 25 mg and 50 mg tablets from the United States until 30 June 2024. The S19A alternatives are identical in active strength and ingredient to the Australian registered product, however, contain additional excipients, including lactose (not present in the Australian registered product). For further information, refer to the Dear Health Care Professional Letter prepared by Medsurge.

Dear Health Care Professional letter

Current
Gliclazide 30 mg MR tablets 04 Mar 2024 04 Mar 2024 There is a current disruption to the supply of gliclazide 30 mg modified release tablets due to manufacturing issues until the end of June 2024. Gliclazide 60 mg modified release tablets remain unaffected and can be halved to attain a 30 mg dose. Additionally, the Therapeutics Goods Administration (TGA) has made a Serious Scarcity Substitution Instrument (SSSI) which allows community pharmacists to dispense gliclazide 60 mg tablets to patients with a prescription for gliclazide 30 mg tablets. The instrument will be in effect until 31 July 2024. Further information regarding the shortage and SSSI is available on the TGA webpage.

TGA Shortage Information

Current
Rifampicin 01 Nov 2023 04 Mar 2024 There is a current disruption to the supply of rifampicin (Rifadin) 300 mg capsules until 30 April 2024 due to manufacturing issues. Supply of rifampicin (Rimycin) 150 mg and 300 mg is also impacted until April 2024. Sites are encouraged to place back orders with their preferred wholesalers and consider additional local strategies to ensure equity of access to supply, e.g., adjusting dispensed quantities. Alternatively, Sanofi have received approval under Section 19A (S19A) of the Therapeutic Good Act to import supply of rifampicin (Rifadin) 300 mg capsules from the UK and rifampicin (Rifadine) 150 mg and 300 mg capsules from Belgium until 30 April 2024. The S19A alternative is identical in active ingredient and excipients to the Australian registered product. Current
Valganciclovir 27 Nov 2023 04 Mar 2024 There is a current disruption to the supply of multiple brands of valganciclovir 450 mg tablets. The Viatris brand is impacted until at least 30 April 2024 and the Hetero brand is not expected to be available until 31 December 2024. Viatris have received approval to supply alternative stock that is available under Section 14 (S14) of the Therapeutic Goods Act until 30 June 2024. Refer to the Thearpeutic Goods Administration S14 Consent database for further information.

TGA S14 Consent database

Current
Barium sulfate oral suspension products 08 Jun 2022 04 Mar 2024 There is an ongoing disruption to the supply of barium sulfate oral suspension products. An international alternative from the USA is approved for use under Section 19A (S19A) of the Therapeutic Goods Act. In addition, several suppliers have international alternatives available via the Therapeutic Goods Administration Special Access Scheme (SAS). Please refer to the Medication Safety Communication which has been updated to reflect the evolving situation and to assist sites and NSW Health clinicians with management of this disruption to supply.

Medication Safety Communication

Current
Amoxicillin 12 Oct 2022 04 Mar 2024 There is a current disruption to the supply of amoxicillin 500 mg/5 mL oral liquid due to manufacturing issues until 29 April 2024. Other strengths of amoxicillin oral liquid are available. Current
Sotalol 28 Feb 2024 28 Feb 2024 There is a current disruption to the supply of sotalol (Carino) 40 mg/4 mL infusion concentrate which has been available for use in Australia under the Therapeutic Goods Administration Special Access Scheme (SAS). A return to supply is not anticipated until 31 May 2024. A number of suitable alternative antiarrhythmic agents registered for use in Australia remain available and may be considered for use in consultation with local clinicians. Current
Betamethasone (as acetate and sodium phosphate) injection 21 Feb 2023 26 Feb 2024 There is an ongoing disruption to the supply of betamethasone (as acetate and sodium phosphate) (Celestone Chronodose) 5.7 mg/1 mL injection due to a global recall which occurred in 2023. Supply is continually improving and the product is expected to return to normal supply on 31 March 2024. For further information on accessing supply, please refer to the Customer letter prepared by Organon.

Organon Customer letter

Current
Itraconazole 16 Nov 2022 26 Feb 2024 In February 2023, itraconazole (Sporanox) tablets were discontinued. Itraconazole (Sporanox) 10 mg/mL oral solution will also be discontinued, with supply expected to be exhausted around 31 May 2024. Sites are encouraged to review current protocols and consider treating patients with suitable alternative antifungal agents. An international alternative itraconazole (JAMP) 10 mg/mL oral solution from Canada is available via Medsurge under the Therapeutic Goods Administration Special Access Scheme. The product is identical in active strength and ingredient but differs with regard to stability (must be discarded one month after opening). Current
Imipenem plus cilastatin injections 21 Feb 2024 21 Feb 2024 The Australian registered product, imipenem plus cilastatin 500 mg/500 mg powder for injection (Primaxin) will be discontinued in Australia from 29 February 2024, with a reduction in supply until exhausted. Supply of internationally registered alternatives of imipenem plus cilastatin 500 mg/500 mg powder for injection from Canada and the UK are available via ProPharmaceuticals Group under the Therapeutic Goods Administration Special Access Scheme (SAS). The SAS alternatives are identical in active strength and ingredient, however differ in pack sizes (packs of 10). Current
Heparin 50 units in 5 mL 08 Jan 2024 20 Feb 2024 There is a current disruption to the supply of heparinised saline (Pfizer) 50 unit/5 mL injection ampoules due to manufacturing issues until 31 January 2024. Orspec have received approval to import supply of Heparin sodium 10 IU/mL (50IU/5mL) (Wockhardt) flushing solution from the United Kingdom under Section 19A (19A) of the Therapeutic Goods Act until 29 February 2024. The S19A alternative is identical in active ingredient and excipients but differs in presentation (pack of 10 glass ampoules). For further information regarding the S19A alternative, refer to the Dear Health Care Professional letter prepared by Orspec.

Dear Health Care Professional letter

Resolved
Pralidoxime iodide 24 Jan 2024 20 Feb 2024 Current stock on hand of pralidoxime iodide 500 mg/20 mL (5A) at multiple NSW Health facilities is due to expire on 31 January 2024. The product sponsor, Phebra, has advised that they will be releasing a new batch for supply in the coming days. Facilities are encouraged to have backorders in place to ensure they receive supply when it becomes available. Please note that due to logistical reasons, orders may not be received by facilities until early next week. Resolved
Buprenorphine (Temgesic) sublingual tablets 13 Feb 2023 20 Feb 2024 There is a current disruption to the supply of buprenorphine (Temgesic) 200 microgram sublingual tablets until at least mid March 2023. Limited emergency supply may be available – please contact Noman.Masood@health.nsw.gov.au to determine availability. Resolved
Trimethoprim plus sulfamethoxazole oral liquid 19 May 2023 20 Feb 2024 There is a current disruption to the supply of trimethoprim 40 mg plus sulfamethoxazole 200 mg per 5 mL (Septrin) oral liquid due to manufacturing issues. Supply may return from late November 2023, however there is potential for further delay. Orspec and Reach Pharmaceuticals have received approval under Section 19A (S19A) of the Therapeutic Goods Act to import supply of an alternative products from Switzerland and the United Kingdom respectively until 30 November 2023. Refer to the Medication Safety Communication for further information on this disruption to supply, available alternatives and associated safety considerations.

Medication Safety Communication

Resolved
Phenoxymethylpenicillin 11 Oct 2022 20 Feb 2024 There is a current disruption to the supply of multiple phenoxymethylpenicillin oral formulations due to an unexpected increase in demand and manufacturing issues which is expected to extend into quarter 3 of 2023. The TGA has made a Serious Scarcity Substitution Instrument (SSSI) which allows community pharmacists to dispense an alternative phenoxymethylpenicillin oral liquid or suspension product when the prescribed one is unavailable, or an alternative 250 mg capsule/tablet if the prescribed dose is divisible by 250 mg without prior approval to substitute from the prescriber. Further information about the substitution and the conditions required is available on the PBS Medicine Shortages page. For patients admitted to hospital, consider reserving remaining oral liquid formulations for paediatric patients and utilise the capsule formulation for patients with enteral feeding and swallowing difficulties (see Do Not Rush to Crush, accessible via CIAP for further information). Resolved
Vigabatrin 11 Jul 2023 20 Feb 2024 There is a current disruption to the supply of vigabatrin (Sabril) 500mg tablets due to manufacturing issues until at least 30 October 2023. The Therapeutics Goods Administration (TGA) has made a Serious Scarcity Substitution Instrument (SSSI) which allows community pharmacists to dispense a vigabatrin oral sachets when the prescribed tablets are unavailable without prior approval from the prescriber. The instrument will be in effect until 31 January 2024, unless ended earlier if the scarcity is resolved. Further information regarding the shortage and SSSI is available on the TGA webpage. Additionally, Sanofi have received approval under Section 19A (S19A) of the Therapeutics Goods Act to import supply of alternative 500 mg tablets from the UK until 31 January 2024, however supply of the stock is limited. The alternative is identical in active ingredient and strength. It should be noted that the blister packaging of the S19A alternative is blue (compared to the Australian registered stock which is clear).

TGA Shortage Information

Resolved
Amoxicillin plus clavulanic acid tablets 05 Sep 2022 20 Feb 2024 There is a current disruption to the supply of multiple brands of amoxicillin plus clavulanic acid 875 mg/125 mg tablets. Refer to Medication Safety Communication (updated 19 October 2022) for further information on this disruption to supply, available alternatives and associated safety considerations.

Medication Safety Communication

Resolved
Lidocaine (lignocaine) 50 mg/5 mL and 100 mg/5 mL solution for injection 03 Aug 2023 20 Feb 2024 There is a current disruption to the supply of lidocaine (lignocaine) 1% 50 mg/5 mL and lidocaine (lignocaine) 2% 100 mg/5 mL (Baxter and Pfizer brands) solution for injection due to changes in commercial viability until 30 November 2023, with limited supply available. Alternative brands remain available. Refer to the Safety Notice (SN023/23) released on 23 August 2023 for further information regarding this disruption to supply and potential risk mitigation strategies.

Safety Notice 023/23

Resolved
Atracurium 22 Jun 2022 20 Feb 2024 There is a disruption to the supply of multiple brands of atracurium injection and DBL has discontinued production of atracurium 25 mg/2.5 mL injection. Supply of an alternative product registered in Europe, Atracurium Hameln 25 mg/2.5 mL solution for injection, is available via Medsurge under the Special Access Scheme (SAS) of the Therapeutic Goods Act. Resolved
Mesna tablets 20 Oct 2023 20 Feb 2024 There is current disruption to the supply of mesna (Uromitexan) 400 mg tablets until 11 December 2023 due to logistical issues. The 600 mg tablets and IV formulations remain unaffected. The IV injection may be used to give an oral dose. The oral dose does not need to be changed if the IV injection is given orally or into a feeding tube (see Do Not Rush to Crush, accessible via CIAP for further information). Resolved
Pentamidine 17 Nov 2023 20 Feb 2024 There is a current disruption to the supply of pentamidine (DBL) 300 mg powder for injection due to manufacturing issues until 8 December 2023. Supply of internationally registered product from the UK is available via Orspec under the Special Access Scheme (SAS) of the Therapeutic Goods Act. The SAS alternative is identical in active ingredient, however, differs in storage requirements once reconstituted and presentation (packs of 10 vials). Please note that the SAS alternative has a lead time of 7-10 business days. Resolved
Mianserin 05 Sep 2023 20 Feb 2024 There is a current disruption to the supply of mianserin (Lumin) 10 mg and 20 mg tablets until 22 September and 30 September 2023 respectively, due to manufacturing issues. LINK has received approval under Section 19A (S19A) of the Therapeutic Goods Act to import supply of mianserin (Mylan) 10 mg tablets from the UK until 31 October 2023. The S19A alternative is identical in active ingredient, however differs with regard to strength, pack size, storage requirements and excipients (not significant). For further information, refer to the Dear Health Care Professional Letter prepared by LINK.

Dear Health Care Professional letter

Resolved
Lignocaine (Xylocaine®) with adrenaline sterile theatre packs 15 Dec 2021 20 Feb 2024 Disruption to the supply of lignocaine (Xylocaine®) with adrenaline sterile theatre packs, anticipated to last until 15 September 2022. Reach Pharmaceuticals has an unregistered product from Austria, Xylanaest 1% with Epinephrine 1:200,000 5 mL ampoule (Gebro Pharma), that has been approved for supply under section 19A of the Therapeutic Goods Act 1989 until 30 November 2022. Reach has confirmed that this product can be used according to the Australian Product Information. The S19A product contains sodium metabisulfite (as does the Australian registered product), a sulfite that may cause allergic-type reactions including anaphylactic symptoms in susceptible people. Use of Xylanaest 1% with Epinephrine 1:200,000 5 mL ampoule (Gebro Pharma) is contraindicated in patients with hypersensitivity to sulfite-containing medications. The S19A product must be stored below 25oC and in its original packaging to protect from light. The attached Medication Safety Communication provides further information and guidance on alternatives as well as potential safety issues for local mitigation.

Medication Safety Communication

Resolved
Multiple nuclear medicine therapies 19 Feb 2024 19 Feb 2024 OPAL, Australia’s only multi-purpose nuclear reactor, will be undergoing essential maintenance and upgrades from Monday 18 March to Friday 5 July 2024. ANSTO has been working productively with alternative suppliers to source supply of multiple nuclear medicine therapies for the domestic market during this period. See customer update from ANSTO for the most up-to-date information.

Customer update – ANSTO
Subscribe to receive updates from ANSTO

Current
Mixtard insulin 27 Nov 2023 07 Feb 2024 In 2023, Novo Nordisk discontinued Mixtard 50/50 penfill human insulin (rys) 100 units/mL due to changes in commercial viability. Novo Nordisk have announced that further discontinuations will occur throughout 2024/2025 for Mixtard products. Mixtard 30/70 InnoLet human insulin (rys) 100 units/mL will be discontinued as of July 2024, and Mixtard 30/70 penfill human insulin (rys) 100 units/mL will be discontinued on 1 February 2025. For further information, please contact Novo Nordisk. Specialist advice should be sought about alternative insulin options based on individual patient considerations. Current
Gastrografin 09 Nov 2023 01 Feb 2024 There is a current disruption to the supply of Gastrografin oral liquid until 31 January 2024 due to manufacturing issues. Omnipaque, an alternative non-ionic contrast agent remains available. Orspec and Reach Pharmaceuticals have received approval under section 19A (S19A) of the Therapeutic Goods Act to import supply of Gastrografin gastrointestinal solution from the United Kingdom and Switzerland until 31 March and 30 April 2024, respectively. The S19A alternative available from Orspec is identical in active ingredients, strength and storage requirements but differs with regard to excipients and presentation (pack of 10 x 100 mL bottles). The S19A alternative from Reach is identical to the Australian registered product but is labelled in German (please note, minimum order quantity of 20 x 100 mL bottles). In addition, an alternative agent from Switzerland is also available from Orspec via the Therapeutic Goods Administration Special Access Scheme (SAS), which is identical to the Australian registered product but is labelled in German. Facilities are advised to reserve Gastrografin for clinical indications where alternative imaging solutions such as Omnipaque are not suitable. For further information regarding the differences between the Australian registered product and S19A alternative, refer to the Dear Health Care Professional letter prepared by Orspec and Reach.

Orspec – Dear Health Care Professional Letter
Reach – Dear Health Care Professional Letter

Resolved
Prochlorperazine 5 mg tablets 15 Jan 2024 18 Jan 2024 There is a current disruption to the supply of multiple brands and pack sizes of prochlorperazine 5 mg tablets due to manufacturing issues until April 2024. Orspec have received approval under Section 19A (S19A) of the Therapeutic Goods Act to import supply of prochlorperazine 5 mg tablets from Ireland until 30 June 2024. Additionally, supply of international alternatives are available from various suppliers via the Therapeutic Goods Administration Special Access Scheme (SAS). The S19A and SAS alternatives are identical in active ingredient and strength. Note that the S19A and various SAS alternatives come in a pack size of 250 tablets and 100 tablets respectively, and contain lactose which should not be used in patients with lactose allergies. For more information on the differences between the Australian registered product and the S19A alternative, refer to the Dear Health Care Professional letter prepared by Orspec.

Orspec – Dear Health Care Professional Letter

Current
Dexamethasone 01 Jun 2022 18 Jan 2024 The disruption to the supply of dexamethasone injection products has now resolved. Please be aware that the sponsors of some of the Australian registered dexamethasone injectable products have received consent under Section 14 and 14A of the Therapeutic Goods Act 1989 to import and supply therapeutic goods that do not comply with standards (out of specification for pH). Refer to TGA Section 14 consent dataset for further information.

TGA Section 14A consent database

Resolved
Estradiol transdermal patches 15 Jan 2024 15 Jan 2024 There is a current disruption to the supply of multiple strengths and brands of estradiol transdermal patches due to manufacturing issues. The return to normal supply dates vary between March to May 2024. Reach have received approval under Section 19A (S19A) of the Therapeutic Goods Act to import supply of alternatives for estradiol 25 microg/24 hours transdermal patches from Germany until 31 March 2024. Additionally, Medsurge have received S19A approval for all other strengths of estradiol transdermal patches from Germany until 31 July 2024. The S19A alternatives are identical in active ingredient and strength however contains soybean oil and should not be used in patients with soy/peanut allergies. For more information on the differences between the Australian registered and the S19A alternatives, refer to the Dear Health Care Professional letters prepared by Reach and Medsurge.

Reach – Dear Health Care Professional Letter
Medsurge - Dear Health Care Professional Letter

Current
Ampicillin 07 Sep 2023 09 Jan 2024 There is a current disruption to the supply of ampicillin (Austrapen) 1 g powder for injection due to manufacturing issues until mid-December 2023. Alternative brands have also been impacted due to the increase in demand. ProPharmaceuticals Group has received approval under Section 19A (S19A) of the Therapeutic Goods Act to import supply of ampicillin (Eugia) 1 g injection vials from the US until 31 January 2024. The S19A alternative is labelled in English and is identical to the Australian registered product in active strength and ingredient. In the case of a complete disruption to supply, amoxicillin may be considered, or further alternative treatment options in consultation with local Infectious Diseases/Microbiology service. Resolved
Olanzapine depot injections 24 Oct 2023 09 Jan 2024 There is a current disruption to the supply of all strengths of olanzapine depot injections (Zyprexa Relprevv) due to logistical issues until 15 April 2024. Limited supply may be available directly from Pharmaco. Facilities are also encouraged to have backorders in place at their preferred wholesaler to ensure they receive supply when it becomes available. Alternatively, supply of internationally registered depot injections from Europe, the UK and India are available via Link and Medsurge under the Special Access Scheme (SAS). The SAS alternatives are identical in active ingredient and excipients. Please note the European alternatives from Medsurge are not labelled in English and the Indian alternative from Medsurge is to be protected from light. Facilities placing orders on these SAS products should contact Link/Medsurge to obtain a copy of the Product Information which contains the depot’s administration instructions. Link have received approval under Section 19A (S19A) of the Therapeutics Goods Act to import supply of international alternatives of olanzapine depot injections. Facilities are encouraged to place a backorder to ensure they receive stock as it becomes available. Refer to the Safety Notice (SN: 034/23) released on 24 November 2023 for further information on the disruption to supply, available alternatives, and associated safety considerations.

Safety Notice 034/23

Current
Multivitamin liquid for infants (Pentavite) 05 Sep 2023 08 Dec 2023 There is a current disruption to the supply of multivitamin liquid for infants (Pentavite) until late September 2023. Refer to the Medication Safety Communication for further information on this disruption to supply, available alternatives, and associated safety considerations.

Medication Safety Communication

Resolved
Heparin 5000 units/0.2 mL 19 Jun 2023 06 Dec 2023 There is a current disruption to the supply of the 50 pack of heparin 5000 units/0.2 mL injection ampoules until October 2023. Pfizer have indicated the 5 pack of heparin 5000 units/0.2 mL injection ampoules will continue to be available and cover usual demand. Resolved
Tirzepatide 04 Dec 2023 04 Dec 2023 There is a current disruption to the supply of all strengths tirzepatide (Mounjaro) injection due to an increase in consumer demand with limited availability until 31 August 2024. Clinicians are encouraged to follow the most up-to-date advice of the Therapeutic Goods Administration regarding this issue

TGA Shortage Information

Current
Minoxidil 16 Nov 2022 16 Nov 2023 There is a disruption to supply of minoxidil (Loniten) 10 mg tablets until 31 July 2023 due to manufacturing issues. Orspec Pharma has received approval under section 19A (S19A) of the Therapeutic Goods Act to import supply of minoxidil (Roma Pharmaceuticals) from the UK until 30 August 2023. Stock is expected to be available from 27 December 2022, and sites are encouraged to place orders as soon as possible to ensure continuous supply during the shortage period. The s19A alternative is identical in active ingredient and strength to the Australian registered product. Information regarding differences in pack sizes is available in the Dear Health Care Professional letter prepared by Orpsec.

Dear Health Care Professional letter

Resolved
Glucagon (GlucaGen) hypokit 25 Jul 2023 16 Nov 2023 There is a current disruption to the supply of glucagon (GlucaGen) hypokit due to manufacturing issues until 31 October 2023, with limited supply available. Facilities should reserve remaining stock for the treatment of life threating hypoglycaemia (and not for diagnostic purposes). Refer to the Safety Notice (SN020/23) released on 10 August 2023 for further information on this disruption to supply, available alternatives and associated safety considerations.

Safety Notice 020/23

Resolved
Quinine dihydrochloride 6% solution for injection 06 Jul 2021 16 Nov 2023 The drug sponsor has advised that this medication will now be supplied in packs of 5 (previously 10). Please see attached letter for further information including new ordering code. Facilities that stock this medication for emergency use may need to increase the number of packs held on-hand.

Phebra memo

Resolved
Funnel web spider antivenom 07 Nov 2022 16 Nov 2023 There is a current disruption to the supply of funnel web spider antivenom vials until 31 January 2023 due to manufacturing issues. The drug sponsor, Seqirus has advised that emergency stock is available and that supply can be delivered within 12 hours in most cases. If emergency supply is required, sites are advised to escalate requests via the Seqirus customer service line – (03) 9389 2000. Resolved
Labetalol 19 Jul 2021 16 Nov 2023 There is a current disruption to the supply of labetalol (Presolol) 100 mg and 200 mg tablets until 15 September 2023 due to manufacturing issues. Supply of internationally registered products from the UK and USA are available via Link, Medsurge and Orspec under the Special Access Scheme (SAS) of the Therapeutic Goods Act. Please note the SAS alternatives contain additional excipients, including lactose (not present in the Australian registered product). Resolved
Eprosartan 07 Nov 2022 16 Nov 2023 There is a current disruption to the supply of eprosartan 400 mg tablets until 31 May 2024 due to manufacturing issues. In the event that supply is completely exhausted, clinicians will need to switch patients to the equivalent dose of another angiotensin receptor blocker or an alternative antihypertensive medicine. Current
Dexamethasone, framycetin and gramicidin ear dops 19 May 2023 16 Nov 2023 There is a current disruption to the supply of dexamethasone, framycetin and gramicidin (Otodex and Sofradex) ear drops due to manufacturing issues until 15 June 2023. Supply of a UK registered product is available via Link under the Special Access Scheme (SAS) of the Therapeutic Goods Act. The SAS product is identical in active ingredient, strength, excipients, storage and shelf-life to the Australian registered product. Resolved
Glyceryl trinitrate tablets 08 Dec 2020 16 Nov 2023 There is a current disruption to the supply of glyceryl trinitrate (Nitrostat 19A) 300 microg sublingual tablets until 1 March 2023. Limited emergency supply may be available – please contact Noman.Masood@health.nsw.gov.au to determine availability. Supply of a registered product from the USA is available via Link under the Special Access Scheme (SAS) of the Therapeutic Goods Act. Glyceryl trinitrate (Nitrolingual) 400 microg oral spray remains available as an alternative treatment option. Ensure patients being switched between formulations receive adequate education including appropriate administration and need for priming. Resolved
Filgrastim 10 Nov 2023 10 Nov 2023 The Therapeutic Goods Administration announced the deletion of all strengths of Neupogen brand filgrastim injection products from late 2023 to early 2024 with a reduction in supply until remaining stock is exhausted. Refer to the Medication Safety Communication for further information on this discontinuation, available alternatives, and associated safety considerations.

Medication Safety Communication

Current
Cefalexin oral liquid 22 Dec 2022 01 Nov 2023 There is a current disruption to the supply of multiple cefalexin oral liquid formulations due to an unexpected increase in demand and manufacturing issues which is expected to extend into quarter 2 of 2024. The TGA has updated the Serious Scarcity Substitution Instrument (SSSI) which allows community pharmacists to dispense another cefalexin oral liquid product of a different strength to a patient when one is available without prior approval to substitute from the prescriber. The instrument remains in force until 30 April 2024. Further information about the substitution and the conditions required is available on the PBS Medicine Shortages page and the TGA webpage. For patients admitted to hospital, consider reserving remaining oral liquid formulations for paediatric patients and utilise the capsule formulation for patients with enteral feeding and swallowing difficulties (see Do Not Rush to Crush, accessible via CIAP for further information).

TGA Shortage Information

Current
Morphine hydrochloride (Ordine) oral solution 21 Jul 2023 20 Oct 2023 All strengths of immediate release morphine hydrochloride (Ordine) oral solution are being discontinued from the Australian market. Stock is expected to run out by April 2024. Refer to the Safety Notice (SN028/23) released on 17 October 2023 for further information on this discontinuation, available alternatives and associated safety considerations.

Safety Notice 028/23

Current
Semaglutide 03 Nov 2022 25 Sep 2023 There is an ongoing national disruption to the supply of semaglutide (Ozempic) solution for injection due to an increase in global demand. Distribution of limited supplies of semaglutide has commenced in Australia and will remain limited for the rest of 2023 and throughout 2024. Clinicians are encouraged to follow the most up-to-date advice of the Therapeutic Goods Administration regarding this issue. A number of Section 19A alternatives are available through multiple suppliers. Please note – while all the alternatives approved under S19A are the Ozempic brand, some are not labelled in English.

TGA Medicine Shortage Alert

Current
Misoprostol 16 Jun 2023 25 Sep 2023 There is a current disruption to the supply of misoprostol 200 microg tablets due to manufacturing issues until 17 November 2023. Orspec Pharma have received approval under Section 19A (S19A) of the Therapeutic Goods Act to import supply of an alternative product from the US until 31 January 2024. The S19A alternative is identical in strength and form but differs in presentation, excipients and storage. For further information, refer to the Dear Health Care Professional letter prepared by Orspec.

Dear Health Care Professional letter

Resolved
Tenecteplase 22 Jun 2022 13 Sep 2023 There is a current disruption to the supply of tenecteplase (Metalyse®) 40 mg and 50 mg powder for injection vials, which is expected to continue until the end of 2024. An updated Safety Notice (SN 027/23) was released on 13 September 2023 to reflect the updated duration of disruption to supply and outlines the process for obtaining supply through the NSW Health Pharmaceutical stockpile. Additionally, the Therapeutic Goods Administration (TGA) has approved a shelf-life extension for tenecteplase (Metalyse®) 40 mg and 50 mg powder for injection vials plus prefilled syringes. The shelf-life has been extended for an additional 12 months for all batches with an original expiry date from January 2022 to March 2025 inclusive.

Safety Notice 027/23

Current
Metronidazole (Fresenius Kabi) 500 mg/100 mL bottles 11 Sep 2023 11 Sep 2023 Concerns have been raised about the potential exposure of Metronidazole (Fresenius Kabi) 500 mg/100 mL infusion solution (Kabipac bottles) to light when removed from the bulk packaging box. Fresenius Kabi have stated that the Kabipac bottles are not light-sensitive and that they are in the process of reviewing the Product Information to reflect this information. For more details regarding the light stability, refer to the correspondence from Fresenius Kabi.

Fresenius Kabi Product Stability Notice

Current
Antacid suspensions 21 Oct 2022 11 Aug 2023 There is a current disruption to the supply of multiple brands and volumes of antacid suspension products with variable return to normal supply dates. Limited stock of Gastrogel 150 mL may be available from wholesalers. Supply of antacid chewable tablets (Gaviscon Dual Action) and granules (Gaviscon Infant) remains available, however may be limited due to the ongoing shortage of liquid formulations. Granules can be used for nasogastric administration (see Do Not Rush to Crush, accessible via CIAP for further information). Current
Prochlorperazine mesilate 12.5 mg/1 mL injection ampoules 13 Apr 2023 09 Aug 2023 There is a current disruption to the supply of prochlorperazine mesilate (Stemetil) 12.5 mg/1 mL injection ampoules due to manufacturing issues until 15 September 2023. Reach Pharmaceuticals has received approval under section 19A (S19A) of the Therapeutic Goods Act to import supply of prochlorperazine mesilate 12.5 mg/1 mL (Stemetil) from Ireland. The S19A alternative is identical in active ingredient and strength, however differs in excipients (not clinically significant). For further information, refer to the Dear Health Care Professional letter prepared by Reach Pharmaceuticals. Sites are encouraged to place back orders of the S19A alternative based on average usage and expected clinical need.

Dear Health Care Professional letter

Resolved
Trimethoprim-sulfamethoxazole 80 mg/400 mg injection 06 May 2020 02 Aug 2023 The disruption to supply of trimethoprim-sulfamethoxazole 80 mg/400 mg injection has been extended until 10 March 2023. Supply of an alternative product, registered in the UK, is available via Link under Section 19A (S19A) of the Therapeutic Goods Act until 31 March 2023; stock is available for direct order. Resolved
Digoxin 500 microg/2 mL ampoules 03 May 2023 02 Aug 2023 There is a current disruption to the supply of digoxin (Lanoxin Adult) 500 microg/2 mL injection ampoules until 20 August 2023 due to commercial changes. Propharma has received approval under section 19A (S19A) of the Therapeutic Goods Act to import supply of digoxin (Lanoxin) 500 microg/2 mL registered in the United Kingdom.The S19A alternative is identical in active ingredient, strength and excipients. For further information, refer to the Dear Health Care Professional Letter prepared by Propharma.

Dear Health Care Professional Letter

Resolved
Hyoscine butylbromide 21 Dec 2022 02 Aug 2023 There is an anticipated disruption to the supply of hyoscine butylbromide (Buscopan) 20 mg/1 mL ampoules from 1 January 2023 to 13 March 2023 due to manufacturing issues. Facilities are encouraged to place orders for Buscopan prior to the anticipated disruption date. Alternative products listed on the Australian Register of Therapeutic Goods (ARTG) include hyoscine butylbromide (Medsurge and SXP) 20 mg/1 mL. The alternative products are identical in active ingredient and strength, however differ in regard to storage requirements. The alternative products must be protected from light. For further information regarding the differences between the products, please refer to the Product Information available via the ARTG website.

ARTG Hyoscine Butylbromide

Resolved
Trimethoprim-sulfamethoxazole tablets 21 Dec 2022 02 Aug 2023 There is a current disruption to the supply of trimethoprim-sulfamethoxazole (Resprim Forte and Septrin Forte) 160 mg/800 mg tablets until February 2023 due to manufacturing issues. ProPharma has received approval under section 19A (S19A) of the Therapeutic Goods Act to import supply of sulfamethoxazole/trimethoprim USP (Aurobindo and Rising Health) 800 mg/160 mg tablets from the USA until 28 February 2023. The products are identical in active ingredient to the Australian registered products but differ in storage requirements and pack sizes. The USA alternatives also contains sodium benzoate as an additional excipient. For further information regarding the differences between the products, please refer to the Dear Health Care Professional letters prepared by Pro Pharma. Clinicians are encouraged to reserve trimethoprim-sulfamethoxazole tablets for priority indications such as treatment of pneumocystis jirovecii infection and prophylaxis in immunocompromised patients, treatment of stenotrophomonas maltophilia and nocardia infections.

Dear Health Care Professional letter

Resolved
Levodopa plus carbidopa 100 mg/25 mg tablets 14 Feb 2023 02 Aug 2023 There is a current disruption to the supply of multiple brands of levodopa plus carbidopa (APO, Kinson, Sinemet and Sinadopa) 100 mg/25 mg until 28 February 2023 due to manufacturing issues and unexpected increases in consumer demand. Limited supply of the APO brand is still available at wholesalers. Supply of an alternative product, registered in the USA, is available via Link under Section 19A (S19A) of the Therapeutic Goods Act until 28 May 2023. The US alternative is identical in active ingredient and strength but differs in presentation, excipients and storage requirements. For further information refer to the Dear Health Care Professional Letter prepared by Link.

Dear Health Care Professional letter

Resolved
Pyridostigmine 26 Oct 2022 02 Aug 2023 There is a current disruption to the supply of pyridostigmine (Mestinon Timespan) 180 mg tablets until 24 March 2023 due to manufacturing issues. Medsurge have received approval under section 19A (S19A) of the Therapeutic Goods Act to import supply of pyridostigmine bromide (Rising Pharmaceuticals) from the USA until 30 November 2022. Information regarding differences in pack size and storage requirements are available in the Dear Health Care Professional letter, prepared by Medsurge.

Dear Health Care Professional Letter

Resolved
Ephedrine sulfate 30 Sep 2022 02 Aug 2023 There is a current disruption to the supply of ephedrine sulfate (DBL) 30 mg/mL ampoule for injection. A product substitution has been arranged by the drug sponsor with the ephedrine hydrochloride SXP (Generic Health) 30 mg/mL ampoules. Refer to Medication Safety Communication for further information on this disruption to supply and safety considerations associated with the alternative product.

Medication Safety Communication

Resolved
Ryzodeg 70/30 FlexTouch 02 Jun 2023 02 Aug 2023 There is a long-term disruption to the supply of insulin degludec 70 aspart 30 (Ryzodeg 70/30 FlexTouch) until 5 June 2024 due to unprecedented global demand. Ryzodeg 70/30 Penfills (cartridge) are not affected. NovoPen delivery devices are available for the administration of Ryzodeg 70/30 Penfills (cartridge). Supply of alternative products also available via Orspec and Link under the Special Access Scheme (SAS) of the Therapeutics Goods Act. Refer to the Medication Safety Communication for further information on this disruption to supply, available alternatives and associated safety considerations.

Medication Safety Communication

Current
Olanzapine 09 Sep 2022 02 Aug 2023 There is a current disruption to the supply of olanzapine (Zyprexa) 10 mg/mL injection vials until 31 March 2023. Link Pharmaceuticals have received approval under section 19A (S19A) of the Therapeutic Goods Act to import supply of olanzapine for intramuscular injection 10 mg single dose vials (AuroMedics) from the USA until 30 April 2023. The S19A approved USA product is identical in active ingredient, strength and excipient ingredients to the Australian registered product. For more information, please refer to the Dear Health Care professional letter, prepared by Link Pharmaceuticals.

Dear Health Care Professional letter

Resolved
Oxybutynin tablets 10 May 2022 02 Aug 2023 There is a disruption to the supply of oxybutynin 5 mg tablets (Ditropan) until 15 December 2022. There are alternative oxybutynin tablet products accessible via an exemption granted by the Therapeutic Goods Administration (TGA) under section 19A. The Niche Generics S19A alternative from the UK (accessible via Orspec Pharma) will be PBS listed from 1 December 2022 for detrusor overactivity. An updated Medication Safety Communication was released on 17 August 2022 which provides further information on the shortage, potential alternatives and associated safety considerations.

Medication Safety Communication

Resolved
Metronidazole tablets 22 Aug 2022 02 Aug 2023 There is a current disruption to the supply of multiple brands of metronidazole 200 mg and 400 mg tablets. Refer to Medication Safety Communication (updated 19 October 2022) for further information on this disruption to supply, available alternatives and associated safety considerations. The alternative metronidazole (Crescent Pharma) 400 mg tablets available via LINK are now approved for use under section 19A of the Therapeutic Goods Act until 30 June 2023.

Medication Safety Communication

Resolved
Warfarin tablets 24 Feb 2023 02 Aug 2023 There is a current national disruption to the supply of warfarin (Coumadin) 2 mg and 5 mg tablets 20 March 2023 and 31 July 2023 respectively (subject to change). HealthShare NSW is working closely with the supplier to manage the disruption to supply. Emergency stock is available however supply is being constrained – facilities with a requirement for stock should contact Noman.Masood@health.nsw.gov.au. Supply of 1 mg Coumadin tablets remain available at wholesalers. A memo regarding this issue was sent to CEs and DCGs on 7 March 2023. A factsheet has been developed for patients, family and carers regarding the disruption to supply, and should be provided to all patients being discharged from a NSW Health facility on warfarin.

CEC Factsheet – Information for patients, family and carers

Resolved
Adrenaline 1:10,000 (1 mg/10 mL) 19 Mar 2020 02 Aug 2023 There is an ongoing disruption to the supply of adrenaline 1:10,000 (1 mg/10 mL) ampoules for injection due to commercial changes. HealthShare NSW have indicated that limited supply of the Aspen product is available from Symbion. The disruption to supply of the Link product is expected to continue until late April 2023. Facilities can also consider switching to the prefilled syringe formulation which is unaffected by the disruption to supply, ensuring that a local risk assessment is undertaken given connector incompatibility issues outlined in SN015/22. Resolved
Codeine linctus 07 Dec 2022 02 Aug 2023 There is a current disruption to the supply of codeine 5 mg/mL (Gold Cross) linctus until end of February 2023 due to a product recall. Supply of the alternative product codeine 5 mg/mL (Actacode) is available via wholesalers. Resolved
Japanese encephalitis vaccine 16 Mar 2022 02 Aug 2023 Pharmacy departments should contact Noman.Masood@health.nsw.gov.au if they are having difficulty securing stock of Japanese encephalitis vaccines. Vaccines are available through wholesalers, but supply may be constrained due to recent increased demand. Resolved
Dipyridamole (Persantin) 10 mg/2 mL 25 May 2023 07 Jul 2023 There is an ongoing disruption to the supply of dipyridamole (Persantin) 10 mg/2 mL injection ampoules which is expected to last until at least April 2024. Medsurge have received approval under Section 19A (S19A) of the Therapeutics Goods Act to import supply of an alternative product from Taiwan until 30 April 2024. The S19A alternative is identical in strength, form and storage but differs in presentation and excipients. The outer packaging and ampoule packaging is dual labelled in Taiwanese and English with the active ingredient and strength clearly identified in English. For further information, refer to the Dear Health Care Professional letter prepared by Medsurge. In the case of a complete disruption to supply, adenosine may be considered as an alternative agent for diagnostic imaging.

Dear Health Care Professional letter

Current
Cefuroxime 125 mg/5 mL 29 Jun 2023 29 Jun 2023 The Australian registered product, cefuroxime (Zinnat) 125 mg/5 mL granules for oral suspension has been discontinued due to changes in commercial viability. Reach Pharmaceuticals has received approval under section 19A (S19A) of the Therapeutic Goods Act to import supply of cefuroxime (Zinnat) 125 mg /5 mL oral solution from the UK until 30 June 2024. The product is identical in active ingredient, strength and storage requirements to the Australian registered product. The S19A alternative contains additional excipients including benzyl alcohol and propylene glycol, which precludes use in neonates. For further information, refer to the Dear Health Care Professional letter prepared by Reach Pharmaceuticals.

Dear Health Care Professional letter

Current
Hydrocortisone tablets 21 Feb 2023 16 Jun 2023 There is a current disruption to the supply of hydrocortisone (Hysone and Viatris) 4 mg and 20 mg tablets due to manufacturing issues until 31 March 2023, although further delays may occur. Refer to the Medication Safety Communication for further information on this disruption to supply, available alternatives and associated safety considerations.

Medication Safety Communication

Resolved
OncoTICE BCG (Bacillus Calmette-Guerin) injection vial (antineoplastic) 11 Feb 2021 14 Jun 2023 The Australian registered product, OncoTICE BCG 5 hundred million CFU powder for injection vial is subject to a disruption to supply with limited availability until 31 December 2024. Supply of an alternative product, BCG Culture SSI BCG 30 mg/vial (AJ Vaccines), is available via LINK under Section 19A (S19A) of the Therapeutic Goods Act 1989. The S19A product differs from the Australian registered product as they are derived from different substrains of Mycobacterium bovis BCG. Therefore, the recommended therapeutic dose and potency are NOT equivalent. Current
Sodium chloride 0.9% intravenous solutions 05 Apr 2023 13 Jun 2023 There is a current disruption to the supply of sodium chloride (Baxter and Freeflex) 0.9% 100 mL intravenous solutions due to manufacturing issues. The estimated date of return of supply is unclear. Baxter has received approval under Section 19A (S19A) of the Therapeutic Goods Act to import supply of an alternative product from the United States until 30 April 2024. Refer to the Medication Safety Communication for further information on this disruption to supply, available alternatives and associated safety considerations.

Medication Safety Communication

Current
Gentamicin 10 mg/1 mL 28 Apr 2020 07 Jun 2023 DBL gentamicin 10 mg/1 mL ampoules have been discontinued. The attached Medication Safety Communication provides further information and guidance on alternatives as well as potential safety issues for local mitigation.

Medication Safety Communication

Resolved
Potassium chloride 14 Sep 2021 07 Jun 2023 Pfizer has changed the labelling of the outer carton packaging of ‘Sterile Potassium Chloride Concentrate 10 mmol (0.75 g) in 10 mL’ ampoules to ‘Sterile Potassium Chloride Concentrate 75 mg in 1 mL’ ampoules. The new label does not specify the millimole (mmol) concentration of potassium chloride prominently which is a potential safety risk. A Safety Notice was issued on 10 September 2021.

Safety Notice 021/21

Resolved
Morphine Sulfate - MS Contin (granules for) suspension 24 Feb 2021 07 Jun 2023 Production of all strengths of MS Contin (granules for) suspension, have been discontinued. Some strengths will be unavailable from March 2021, with a total run-out of stock anticipated by end of 2021. See Medication Safety Communication for further information.

Medication Safety Communication

Resolved
Calcium gluconate 16 Dec 2021 07 Jun 2023 Phebra has changed the labelling of ‘Calcium Gluconate Injection 2.2 mmol of calcium in 10 mL’ to ‘Calcium Gluconate Injection - calcium gluconate monohydrate 931 mg in 10 mL solution for injection’. The new label does not specify the millimole (mmol) concentration of calcium gluconate prominently which is a potential safety risk. A Safety Notice was issued on 15 December 2021.

Safety Notice 026/21

Resolved
Salbutamol metered dose inhaler 29 Apr 2021 07 Jun 2023 There has been a recent change in the presentation of salbutamol metered dose inhalers which impacts its off-label use via the endotracheal tube for bronchospasm during anaesthesia. The cannister now has a counter attached, making the adaptor previously used incompatible. Refer to the CEC memo regarding this issue recently sent out to CEs and DCGs.

CEC Memo

Resolved
Posaconazole 17 Nov 2020 07 Jun 2023 Noxafil® MR tablets and suspension will be delisted from the PBS on 1 December 2020. Whilst a generic alternative to the MR tablet formulation will be available on the PBS from this date (Juno brand), there is currently no sponsor that will be listing a suspension formulation. Facilities should consider the need to supply the suspension to outpatients from the hospital pharmacy following local DTC processes. Juno MR tablets are considered bioequivalent to the Noxafil® MR tablets. Resolved
Flucytosine 07 Oct 2020 07 Jun 2023 The Australian registered product, flucytosine (Ancotil®) 2.5 g/250 mL injection will be discontinued and deleted from market on 31 October 2021. iNova Pharmaceuticals have access to a limited supply of flucytosine injection for hospitals who have patients in immediate need of the product. It is anticipated that stock depletion is likely to occur between July and September 2021 (timing is dependent on product demand). After depletion, no further stock will be available. The final batch has an expiry date of 31 October 2021. Supply of an alternative product Ancotil® 1% 2.5 g/250 mL injection (Austria) is available via Medsurge under the Special Access Scheme (SAS) of the Therapeutic Goods Act. Resolved
Dipyridamole/Aspirin 200 mg/25 mg modified release capsules 17 Feb 2021 07 Jun 2023 The Australian registered medicine ASASANTIN SR dipyridamole 200 mg/aspirin 25 mg sustained release capsules has been discontinued. The Australian registered medicine DIASP SR Dipyridamole/Aspirin 200 mg/25 mg modified release capsules is unavailable due to unexpected increase in demand. Supply of an alternative product, Aspirin and Extended-release Dipyridamole Capsules 25 mg/200 mg (USA), is available via Medsurge under Section 19A (S19A) of the Therapeutic Goods Act. Resolved
Etacrynic acid 29 Jul 2021 07 Jun 2023 The Australian registered product, etacrynic acid 25 mg tablets (Edecrin®) will be discontinued and deleted from market on 15 August 2021. Supply of an alternative product Edecrin® (Canada) 25 mg tablets are available via Medsurge under the Special Access Scheme (SAS) of the Therapeutic Goods Act. Resolved
Nitrofurantoin 29 Jul 2021 07 Jun 2023 The Macrodantin® brand of nitrofurantoin 50 mg and 100 mg capsules has/will be discontinued on 1 July 2021 and 4 November 2021 respectively. Consequently there is a shortage of APO-Nitrofurantoin 50 mg and 100 mg capsules due to an increase in demand until 15 October 2021 and 3 September 2021 respectively. Supply of alternative products; nitrofurantoin 50 mg capsules (Sun Pharma, USA) and nitrofurantoin 100 mg capsules (Morningside Healthcare, UK) are available via Medsurge under Section 19A (S19A) of the Therapeutic Goods Act. The S19A 100 mg capsules must be protected from light (not a requirement of the registered product). Resolved
Papaverine hydrochloride 27 Feb 2023 24 May 2023 There is a current disruption to the supply of papaverine hydrochloride (DBL) 120 mg/10 mL due to manufacturing issues until 30 April 2023. Supply of an alternative product from the USA is available via Medsurge under the Special Access Scheme (SAS) of the Therapeutic Goods Act. The alternative is identical in active ingredient but differs from the Australian registered product in strength and concentration (papaverine hydrochloride 60 mg/2 mL), and is presented in a vial rather than an ampoule. Other SAS alternatives may also be available. Resolved
Potassium chloride injection ampoule 19 May 2023 19 May 2023 There is a current disruption to the supply of potassium chloride (Pfizer) concentrate 10 mmol (750 mg) in 10 mL injection ampoule due to manufacturing issues. Supply may return from December 2023. An alternative Australian registered product (Juno) is currently available from wholesalers. Refer to the Safety Notice (SN:012/23) released on 18 May 2023 for further information on this disruption to supply, available alternative and associated safety considerations.

Safety Notice 012/23

Current
Captopril oral liquid 09 May 2023 09 May 2023 The Australian registered product, captopril (Capoten) 5 mg/mL oral liquid has been discontinued with a reduction in supply until stock is exhausted. Reach Pharmaceuticals has received approval under section 19A (S19A) of the Therapeutic Goods Act to import supply of captopril 25 mg /5 mL oral solution from the UK until 30 April 2024. The product is identical in active ingredient and strength to the Australian registered product. The S19A alternative differs in storage requirements (storebelow 30 degrees Celsius rather than 2 to 8 degrees Celsius), administration instructions (can be taken before or after meals rather than 1 hour before meals) and expiry (to be discarded 21 days after opening rather than 28 days). The alternative is labelled as 25 mg /5 mL but is identical in concentration. For further information, refer to the Dear Health Care Professional letter prepared by Reach Pharmaceuticals.

Dear Health Care Professional letter

Current
Folic acid 5 mg/mL injection 08 May 2023 08 May 2023 Folic acid (Phebra) 5 mg/mL injection will be discontinued from the market on 31 May 2023 due to commercial changes making it unviable to continue manufacturing. Refer to the Medication Safety Communication for further information on the discontinuation, an available alternative and associated safety considerations.

Medication Safety Communication

Current
Pristinamycin 13 Jan 2023 28 Mar 2023 There is a current disruption to the supply and availability of pristinamycin (SAS) tablets due to an ongoing international export ban. The length of the export ban has not been provided and Australian suppliers remain unable to obtain stock. Patients already established on pristnamycin will require urgent review by infectious diseases, microbiology and sexual health to have their therapy modified on a case-by-case basis. Further patients should not be initiated on pristinamycin until normal supply resumes. For further information and advice regarding the disruption to supply, refer to the attached Medication Safety Communication.

Medication Safety Communication

Current
Adenosine 6 mg/2 mL 07 Feb 2023 16 Mar 2023 There is a current disruption to the supply of adenosine (Adenocor) 6 mg/2 mL solution for injection due to unexpected increases in consumer demand until 27 February 2023. The product sponsor has advised that emergency supply stock has been depleted. Alternative brands are available for order via wholesalers. Resolved
Phenobarbital (phenobarbitone) elixir 22 Nov 2022 09 Mar 2023 There is a current disruption to the supply of phenobarbital (phenobarbitone) (Orion) 15 mg/5 mL elixir 100 mL bottles due to logistical issues until 28 February 2023. While there are no alternative phenobarbital (phenobarbitone) liquid products listed on the ARTG, phenobarbital tablets remain available and may be utilised for patients with enteral feeding and swallowing difficulties (see Do Not Rush to Crush, accessible via CIAP for further information). Facilities are encouraged to consider reserving remaining supply of phenobarbital elixir for paediatric patients. Resolved
Urokinase 16 Dec 2021 07 Mar 2023 Urokinase is a thrombolytic agent accessible via the Special Access Scheme (SAS) – some facilities have reported difficulties accessing supply through their normal channels. Reach Pharmaceuticals have stock of Urokinase injection available. Resolved
Tocilizumab injection vials 09 Jul 2021 07 Mar 2023 There is a critical disruption to the supply of all strengths and formulations of tocilizumab. Orders for intravenous tocilizumab for all indications are to be placed via the NSW Health stockpile. Supply will no longer be accessible via regular wholesalers and the drug sponsor. Please see factsheet available in ‘General information relating to COVID-19 treatments' tab at the top of the page for further information. A Safety Alert was issued on 31 August 2021. Patients should only receive a SINGLE DOSE of tocilizumab for the treatment of COVID-19, with use limited to those who meet the criteria outlined in the Safety Alert.

Safety Alert 002/21

Resolved
Non-ionic iodinated media agents 10 May 2022 07 Mar 2023 There is an ongoing global disruption to the supply of non-ionic iodinated media agents. The disruption is due to the recent COVID-19 lockdown in Shanghai which impacted on the operational capacity of the production facility and the shutdown of normal shipping/airfreight routes out of the city. The estimated resolution date is October 2022. Refer to SN008/22 disruption to supply – non-ionic iodinated contrast media agents for further information, guidance on stock conservation and potential alternatives.

Safety Notice 008/22

Resolved
Tuberculosis medicines – multiple products 02 Mar 2022 07 Mar 2023 Pharmacy departments or TB programs should contact Noman.Masood@health.nsw.gov.au for assistance, if they are having difficulty sourcing the following agents from wholesalers: cycloserine 250 mg capsules, levofloxacin 500 mg tablets, pyrazinamide 500 mg tablets, prothionamide 250 mg tablets, aminosalicyclic sachets, clofazimine 100 mg tablets, rifampicin/isoniazid 75 mg/50 mg dispersible tablets OR rifampicin/isoniazid/pyrazinamide 75 mg/50 mg/150 mg dispersible tablets. Resolved
Paracetamol 48 mg/mL liquid formulations 22 Aug 2022 07 Mar 2023 There is a current disruption to the supply of multiple brands of paracetamol 48 mg/mL liquid formulations. The exact resolution date is currently unclear. HealthShare NSW have advised that supply of a 50 mg/mL suspension (Dymadon for Kids Strawberry 200 mL) will be available through regular wholesalers early this week – facilities are encouraged to place backorders to secure supply. If urgent requirement or problems obtaining supply, contact Noman.Masood@health.nsw.gov.au. Resolved
Cernevit injection 01 Jun 2021 07 Mar 2023 Disruption to the supply of Cernevit injection vials until 30 September 2021. Supply of compounded products available from Baxter containing Cernevit (including TPN) remain unaffected at this time. Alternate parenteral multivitamin preparations (e.g. combination of Soluvit N and Vitalipid N) may be required during this time. Consider differences in presentation, reconstitution steps and formulation – treating clinicians should assess suitability of available alternatives for patients on a case-by-case basis. Resources such as the Australian Society for parenteral and enteral nutrition (AuSPEN) adult vitamin guidelines for parenteral nutrition may aid clinicians in decision-making. Resolved
Cidofovir 30 May 2022 07 Mar 2023 The disruption to supply of cidofovir (Empovir) 375 mg/5 mL concentrated injection for infusion vials has been extended, an expected date of return has not been confirmed. CH2 have stock of cidofovir 375 mg/5 mL concentrated injection for infusion vials, available to access under the Special Access Scheme (SAS) of the Therapeutic Goods Act. This product is the same as the ARTG product. Resolved
Leucovorin calcium folinic acid (as calcium folinate) 01 Jun 2022 07 Mar 2023 There is a current shortage of DBL leucovorin calcium folinic acid 50 mg/5 mL (as calcium folinate) injection and an anticipated shortage of Pfizer leucovorin calcium folinic acid (as calcium folinate) 50 mg/5 mL injection. The 100 mg/10 mL injection continues to be available, as are the 15 mg tablets. Resolved
Atropine 22 Jun 2022 07 Mar 2023 There is a temporary disruption to the supply of atropine 600 microgram injection until 16 September 2022. Stock of atropine 1.2 mg injection (expiring 30 September 2022) is available. Resolved
Flucloxacillin 07 Dec 2022 20 Jan 2023 There is a current disruption to the supply of flucloxacillin (Flucil) 250 mg/5 mL and 125 mg/5 mL oral liquid due to manufacturing issues until 6 January 2023. Medsurge have received approval under section 19A (S19A) of the Therapeutic Goods Act to import supply of flucloxacillin (Athlone) 125 mg/5 mL 250 mg/5 mL Oral solution from the UK until 28 February 2023. The S19A alternatives are identical in active ingredient and strength to the Australian registered product, however, differ with regard to storage requirements once reconstituted. For further information regarding the differences between the 250 mg/5 mL products, please refer to the Dear Health Care professional letter, prepared by Medsurge.

Dear Health Care Professional Letter

Resolved
Mesalazine (Mesasal) 26 Oct 2022 20 Jan 2023 There is a current disruption to the supply of mesalazine 250mg (Mesasal) tablets until 30 November 2022 due to unexpected increases in consumer demand. Brands of mesalazine are not interchangeable due to differences in formulation and release characteristics. In cases of complete disruption to supply, specialist advice should be sought about alternative treatment options. Resolved
Flebogamma 10% DIF – all vial sizes 01 Apr 2021 14 Dec 2022 All vial sizes of Flebogamma 10% DIF immunoglobulin are temporarily unavailable and cannot be ordered in BloodNET. Click on the medicine name for more information regarding the reallocation process and information for clinic staff. Refer to the Medication Safety Communication for more information regarding the reallocation process and information for clinic staff.

Medication Safety Communication

Resolved
Prednisolone acetate 1%/phenylephrine 0.12% suspension (Prednefrin Forte) eye drops 03 Mar 2021 14 Dec 2022 There is a disruption to supply of Prednefrin Forte eye drops, anticipated to resolve on 1 Jan 2022. See Medication Safety Communication for further information

Medication Safety Communication

Resolved
Primidone 250 mg tablets 18 Nov 2021 14 Dec 2022 There is a disruption to the supply of primidone (Mysoline) 250 mg tablets. Supply of an alternative product is available from Link under Section 19A (S19A) of the Therapeutic Goods Act 1989 (Lannett brand from USA). Note that the S19A alternative comes in a pack size of 100 tablets (compared to the ARTG pack size of 200 tablets) and contains lactose which is not present in the ARTG product. Resolved
Gadobutrol 01 Feb 2022 14 Dec 2022 There is a temporary disruption to the supply of Gadobutrol 9.0708 g/15 mL injection (GADOVIST 1.0) until 18 March 2022. Resolved
Ceftolozane/tazobactam 12 Jan 2021 14 Dec 2022 The recall on all batches of ceftolozane/ tazobactam (Zerbaxa®) in December 2020 (due to sterility results of numerous batches being out of specification) continues to impact the supply of Zerbaxa® worldwide. The published expected supply date for Zerbaxa® has been revised to 1 March 2022. Alternative therapy should be sought in consultation with local Infectious Diseases/Microbiology service. Resolved
Atenolol 50 mg/10 mL oral solution 08 Jun 2021 14 Dec 2022 Disruption to the supply of Atenolol-AFT 50 mg/10 mL oral solution due to manufacturing delays. Supply of an alternative product, Atenolol 25 mg/5 mL Sugar Free Oral Solution (Essential Generics) is available via LINK under Section 19A (S19A) of the Therapeutic Goods Act 1989. Resolved
Azathioprine injection 29 Jul 2021 07 Dec 2022 The Australian registered product, azathioprine 50 mg powder for injection (Imuran®) has been discontinued. The product sponsor anticipates that their stock will be exhausted by the end of 2022, with minimal stock available at regular wholesalers. Supply of a USA registered alternative 100 mg Azathioprine powder for injection is available under the Therapeutic Goods Administration Special Access Scheme via Link Pharmaceuticals. Current
Bupivacaine with fentanyl (Marcain 0.125%) 25 Nov 2022 25 Nov 2022 Bupivacaine with fentanyl 100 mcg/20 mL (Marcain 0.125%) injection ampoules will be discontinued from 1 May 2023, with a reduction in supply until stock is exhausted. Sites are encouraged to review current protocols containing this medicine and consider alternative agents in consultation with anaesthetic teams. Current
Ertapenem 18 Oct 2022 22 Nov 2022 There is a current disruption to the supply of ertapenem 1 g injection vials (Juno and Fresenius Kabi brands) due to unexpected increases in demand. The shortage is expected to resolve in November 2022. Facilities are encouraged to place orders for an alternative product manufactured by MSD available through regular wholesalers. If urgent requirements or problems obtaining supply, please contact Damien.Dowling@Health.nsw.gov.au Resolved
Exenatide 09 Nov 2022 09 Nov 2022 The drug sponsor, AstraZeneca have advised that exenatide (Byetta) 5 mcg and 10 mcg pre-filled pens will be discontinued from the Australian market from 1 December 2022. The 5 mcg product is currently out of stock with most wholesalers across Australia and will not be replenished. The 10 mcg stock is expected to be exhausted in December 2022. Clinicians will need to consider alternative therapies for their patients, prior to a complete exhaustion of supply. Due to the current disruptions to the supply of alternative glucagon-like peptide-1 analogues (including semaglutide and dulaglutide), specialist advice may be required. Current
Hyoscine hydrobromide 26 Oct 2022 26 Oct 2022 There is a current disruption to the supply of hyoscine hydrobromide (DBL) 400 microg/1 mL ampoules until mid-November 2022 due to manufacturing issues. Pfizer, the product sponsor, have advised that short dated stock (November 2022) is available via direct purchase order if stock is required. Current
Cefotaxime 11 Oct 2022 26 Oct 2022 There is a current disruption to the supply of cefotaxime 1 g and 2 g powder for injection. Supply is expected to be available through regular wholesalers by early next week. If urgent requirement, facilities may place a direct purchase order through the product sponsor, Pfizer. Resolved
Benzylpenicillin 14 Jun 2022 16 Aug 2022 Supply of benzylpenicillin 1.2 g powder for injection (Benpen) will be available to order this week. Sequirius anticipate demand to be high and based on availability, the initial order volumes may be limited until a second batch is released later in August 2022. After that point, Sequirius expect continuous and sustained supply of benzylpenicillin 1.2 g powder for injection. Supply of the 600 mg and 3 g strengths continue to be available through regular wholesalers. Resolved
Healon GV OVD (sodium hyaluronate) 22 Jun 2022 19 Jul 2022 Johnson & Johnson Vision (J&J Vision) has advised that they will be discontinuing the production of Healon GV OVD (sodium hyaluronate). Facilities are advised to speak to their J&J vision representative about other alternatives to Healon GV OVD. Healon Endocoat and Healon 5 remain available. Link have identified alternative options to hyaluronic acid eye injections accessible via the Special Access Scheme (SAS) of the Therapeutic Goods Act. Zeiss also has a product which may be used as an alternative to Healon GV OVD. Please contact Link or Zeiss directly for more information. Local assessment of these products is required to determine suitability. Current
Cisatracurium 21 Apr 2020 23 Jun 2022 There is a disruption to the supply of cisatracurium 150 mg/30 mL injection until 17 May 2022. Stock of cisatracurium 10 mg/5 mL injection strength is available and there is also supply of an alternative product of cisatracurium 10 mg/5 mL (Kalcex) under Section 19A (S19A) of the Therapeutic Goods Act, accessible from the NSW Health pharmaceutical stockpile. A Medication Safety Communication was produced in September 2021 to provide guidance on alternatives to cisatracurium.

Medication Safety Communication

Resolved
Sodium valproate 16 Dec 2021 23 Jun 2022 There is a temporary disruption to the supply of multiple brands of sodium valproate 400 mg injection. Juno Pharmaceuticals has an unregistered product from France, Valproate de Sodium Aguettant 400 mg/4 mL, that has been approved for supply under section 19A of the Therapeutic Goods Act 1989 until 30 March 2022. Juno has confirmed that this product can be used according to the Australian Product Information. Resolved
Gallium injection 10 May 2022 09 Jun 2022 There is a current disruption to the supply of gallium citrate 74 MBq/mL injection. The supplier, GMS, is communicating directly to facilities on a weekly basis to inform them of the availability of Gallium injection for the coming week. Please escalate concerns to CEC-MedicationSafety@health.nsw.gov.au. Current
Thiopental (thiopentone) 01 Jun 2022 01 Jun 2022 There is a disruption to supply of thiopental sodium (Pentothal) 500 powder for injection until the end of July 2022. An alternative thiopental sodium (Omegapharm) 470mg powder for injection is available from wholesalers. Clinicians should note the lower strength of the Omegapharm product and that a smaller dilution volume is required to achieve the desired concentration. Refer to the Omegapharm Product Information for further information.

Omegapharm Thiopental Product Information

Resolved
Isoprenaline 09 Oct 2020 01 Jun 2022 Several new isoprenaline products have recently been registered in Australia and can now be ordered via wholesalers. S19A isoprenaline alternatives may still be in available in NSW Health facilities. Refer to the Medication Safety Communication for important safety information regarding these alternatives.

Medication Safety Communication

Resolved
Phebra electrolyte products 22 Mar 2022 22 Mar 2022 Phebra will be updating all packaging and labelling of electrolyte products to make the millimole (mmol) concentration more prominent. To ensure uninterrupted supply while Phebra enacts these changes, some products will continue to be supplied in their current labelling which does not have the mmol concentration displayed prominently. A memo was released by Phebra on 21 March 2022.

Phebra Memo

Current
Hydromorphone 2 mg and 4 mg (Dilaudid) tablets 22 Mar 2022 22 Mar 2022 There is a disruption to supply of hydromorphone 2 mg and 4 mg (Dilaudid) tablets which is expected to resolve by the first week of April. SAS stock may be accessible if urgently required, Noman.Masood@health.nsw.gov.au can be contacted for more details. Resolved
Epoprostenol (Flolan®) 02 Mar 2022 02 Mar 2022 There is an anticipated disruption to the supply of epoprostenol (Flolan®) 0.5 mg injections until 25 April 2022. Stock is still available from wholesalers. Staff should use alternative brands (e.g. Veletri®) or alternative strengths of Flolan® to manage this disruption to supply. Resolved
Fleet Ready-to-Use Enema 15 Feb 2022 15 Feb 2022 There is a disruption to supply of Fleet Ready-to-Use Enema with supply expected to resume in mid-late March, subject to updates from the supplier. A Medication Safety Communication has been issued.

Medication Safety Communication

Resolved
Bivalirudin 27 Aug 2021 09 Feb 2022 There is an anticipated disruption to the supply of bivalirudin 250 mg injection vials. A Medication Safety Communication was issued on 27 August 2021.

Medication Safety Communication

Resolved
HYDROmorphone (Dilaudid®) Oral Liquid 1 mg/mL 14 Apr 2021 09 Feb 2022 The Australian registered medicine HYDROmorphone hydrochloride (Dilaudid®) oral liquid 1 mg/mL has been discontinued. Supply of two alternative HYDROmorphone hydrochloride oral solution 1mg /mL, USP 473 mL products are available; Rhodes brand is available via Medsurge under Section 19A (S19A) of the Therapeutic Goods Act until 31 January 2023; Hikma brand (previously branded as West-Ward) is available via Link under S19A until 31 August 2022. Both S19A products differ from Dilaudid® oral liquid in that they contain sodium metabisulfite, a sulfite that may cause allergic type reactions. Use of this product is contraindicated in patients with hypersensitivity to sulfite containing medications. Current
Oxycodone and naloxone (Targin®) 09 Feb 2022 09 Feb 2022 There is an anticipated disruption to supply of oxycodone and naloxone (Targin®) 2.5/1.25 mg, 5/2.5 mg. 10/5 mg and 20/10 mg tablets. Supply return dates vary between the strengths and range from 1 – 2 weeks, with a potential further delay for the 20/10 mg tablet. Resolved
DRAXIMAGE MACROSALB® Kit 07 Dec 2021 09 Feb 2022 There is a temporary disruption to supply of DRAXIMAGE MACROSALB® Kit until 31 March 2022. ANSTO has arranged supply of a substitute medicine DRAXIMAGE MAA (Canada). This product is due to arrive in Australia on 15 December and will be available for supply to customers from the week commencing 20 December. Supply is authorised under an exemption granted by Therapeutic Goods Administration (TGA) under section 19A of the Therapeutic Goods Act 1989. Resolved
Bupivacaine and adrenaline 11 Jan 2022 11 Jan 2022 There is a disruption to the supply of bupivacaine 0.25% and adrenaline 1:400,000 (Marcain 0.25% with adrenaline 1:400,000) in 20 mL until September 2022. Supply of bupivacaine 0.5% and adrenaline 1:200,000 (Marcain 0.5% with adrenaline 1:200,000) in 20 mL is also low. There is limited short-dated stock (expiring May 2022) of both strengths still available – facilities have been advised to submit backorders with Symbion, allocations of this stock will occur from this week. Aspen are investigating alternatives to minimise the disruption during this long-term shortage. Information will be updated here as it becomes available. Current
Ketorolac 10 mg/1 mL injection 18 May 2021 15 Dec 2021 Ketorolac-Baxter 10 mg/1 mL ampoules are being discontinued effective 1 September 2022, however remaining stock is anticipated to be exhausted before this date. Refer to the Medication Safety Communication for further information and guidance on alternatives as well as potential safety issues for local mitigation.

Medication Safety Communication

Resolved
Artemether with lumefantrine 07 Dec 2021 07 Dec 2021 Artemether and Lumefantrine (20 mg/120 mg) (Riamet) tablets are available to order as a direct shipment through the wholesaler. Wholesalers may be reducing stock kept on hand of artemether and lumefantrine due to low usage, however supply is still available. Resolved
Ipratropium 250 microgram nebules 30 Nov 2021 30 Nov 2021 Disruption to the supply of ipratropium (Aeron) 250 microgram/mL nebules until 31 March 2022. Ipratropium (Aeron) 500 microgram/mL continues to be available – clinicians should be informed that 0.5 mL of the 500 microgram/mL is required for a 250 microgram dose. Resolved
Promethazine 29 Jul 2021 19 Oct 2021 DBL promethazine hydrochloride 50 mg/2 mL injection is out of stock until 30 August 2021. Link and Medsurge have alternative promethazine injection products available via the Therapeutic Goods Administration’s Special Access Scheme. Both companies have also applied to supply under Section 19A (S19A) of the Therapeutic Goods Act 1989 – currently awaiting outcome of application. Details will be updated when available. Resolved
Tocilizumab subcutaneous pre-filled syringes and pens 01 Oct 2021 01 Oct 2021 There is a critical disruption to the supply of tocilizumab pre-filled syringes and pens. During the period of supply disruption Medsurge may be able to supply alternatives, RoActemra tocilizumab 162 mg/0.9 mL solution for injection in pre-filled syringe and RoActemra tocilizumab 162 mg/0.9 mL solution for injection in pre-filled pen, under section 19A of the Therapeutic Goods Act 1989. Resolved
Furosemide (frusemide) 500 mg tablet 03 Mar 2021 22 Sep 2021 The Australian registered medicine, UREX FORTE furosemide (frusemide) 500 mg tablet is unavailable. Supply of an alternative product, Furosemid-ratiopharm 500 mg, is available via Medsurge under Section 19A (S19A) of the Therapeutic Goods Act. The S19A product differs from Urex Forte® tablets in terms of administration, Furosemid-ratiopharm must be taken on an empty stomach and unchewed with sufficient liquid (e.g. 1 glass of water). Resolved
Lignocaine (lidocaine) oral gel 07 May 2021 26 Jul 2021 Disruption to the supply of Mucosoothe oral gel 2% lignocaine 200 mL bottles has been resolved. Stock available through regular wholesalers. Resolved
Enoxaparin 29 Apr 2021 29 Jun 2021 Disruption to the supply of enoxaparin 20 mg and 40 mg strengths of enoxaparin has been resolved. Supply restrictions will remain in place to ensure equitable access – facilities should continue placing orders through regular wholesalers based on historical usage.

CEC Memo

Resolved
Testosterone undecanoate 40 mg capsule 29 Jun 2021 29 Jun 2021 The Australian registered product, Andriol Testocaps (testosterone undecanoate 40 mg capsule) has been discontinued. Link Pharmaceuticals may have alternative products available via the Therapeutic Goods Administration’s Special Access Scheme. Local assessments of suitability should be undertaken by the Drug and Therapeutics Committee with particular attention to product labelling. Current
BCG (Bacillus Calmette-Guerin) vaccine powder for injection 04 Jun 2021 04 Jun 2021 The Australian registered product, BCG Vaccine powder for injection with diluent has been discontinued. Supply of an alternative product, BCG Vaccine SSI – Mycobacterium bovis BCG, Danish strain 1331 (AJ Vaccines), is available via LINK under Section 19A (S19A) of the Therapeutic Goods Act 1989. The S19A product differs from the discontinued Australian product as they derived from different substrains of Mycobacterium bovis BCG. Therefore, the recommended therapeutic dose and potency are not equivalent. There are also differences in the contraindications to use and preparation for the S19A (contact LINK for detailed letter to Healthcare Professionals containing this information). Current
Adrenaline 1:1,000 (1 mg/mL) 21 May 2020 29 Apr 2021 Disruption to the supply of LINK adrenaline 1:1,000 1 mg/1 mL ampoules (both pack sizes) until September 2021. Other brands unaffected at this stage. Resolved
Glyceryl trinitrate injection 08 Dec 2020 29 Apr 2021 Supply disruption has been resolved. Stock is being distributed to regular wholesalers and should be available for ordering this week.

Medication Safety Communication

Resolved
Ergometrine maleate 12 Jan 2021 27 Apr 2021 Supply disruption has been resolved. Stock is being distributed to regular wholesalers and should be available for ordering this week.

Medication Safety Communication

Resolved
Furosemide (frusemide) 20 mg/2 mL injection 14 Jan 2021 14 Apr 2021 Disruption to the supply of Lasix® 20 mg/2 mL injection ampoules until late March 2021. Access to NSW HealthShare stock is open for this strength – follow order process as distributed by HealthShare. If urgent requirement or problems submitting request, contact Noman.Masood@health.nsw.gov.au. Resolved
Tenofovir/Emtricitabine 12 Jan 2021 24 Mar 2021 Recall on all batches of Tenofovir Disoproxil Emtricitabine Mylan 300/200 tablets on 23 December 2020 due to potential for split tablets to lead to ineffective dose. Supply of the Apotex brand should be available at wholesalers. S19A alternative also available through Link Pharmaceuticals until 28 February 2021 – Teva brand imported from the UK. Please note, the S19A product displays the dose of emtricitabine first (200 mg) followed by the dose of tenofovir disoproxil (245 mg). Tenofovir disoproxil is the active ingredient name – all brands ultimately have 245 mg of tenofovir disoproxil but are presented in different salt forms. Shortage resolved. Resolved
Tranylcypromine 21 Oct 2020 24 Feb 2021 Supply disruption of Parnate® has been extended until 31 January 2021. Emergency stock is available through Amdipharma. Both Amdipharma and Medsurge also have S19A products available (Packs of 100 tablets in a bottle compared to Australian registered product, 50 tablets in a blister).

TGA Alert

Resolved
Olmesartan 27 Jul 2020 24 Feb 2021 Olmesartan MYL, Alphapharm and Sandoz brands 20 mg and 40 mg tablets are now available. Accord brand (UK) 40 mg olmesartan tablets available as S19A from Link Pharmaceuticals.

Medication Safety Communication

Resolved
Prazosin 24 Feb 2021 24 Feb 2021 Disruption to the supply of all brands and strengths of prazosin tablets. Estimated resolution dates between late November to late December 2020. Serious Shortage Substitution Notice was issue by the TGA in October. S19A alternative for all strengths (1 mg, 2 mg and 5 mg) available through Medsurge (Canadian brand with English packaging). Please note – S19A product must be protected from light. Shortage resolved Resolved
Phenelzine 15 mg tablet 17 Feb 2021 17 Feb 2021 The Australian registered medicine, NARDIL phenelzine 15 mg (as sulfate) tablet was discontinued on 2 April 2020. Supply of an alternative product, Phenelzine Sulfate USP 15 mg Tablets (Lupin Pharmaceuticals) is now available via LINK under Section 19A (S19A) of the Therapeutic Goods Act until 30 September 2021. The S19A product differs from NARDIL with respect to storage conditions (it does not require refrigeration) and its reduced pack size (60 tablets). The TGA previously issued a joint statement with the Royal Australian and New Zealand College of Psychiatrists and the Society of Hospital Pharmacists of Australia to provide advice for health professionals about accessing alternative products and patient management.

TGA, SHPA and RANZCP Joint Statement

Current
Verapamil 5 mg/2 mL injection 23 Nov 2020 18 Dec 2020 Disruption to the supply of verapamil 5 mg/2 mL injection ampoules has been resolved. Resolved
Triamcinolone acetonide injection 29 Jun 2020 17 Nov 2020 Supply disruption resolved.

Medication Safety Communication

Resolved
Gentamicin 80 mg/2 mL 13 Mar 2020 04 Nov 2020 Supply disruption to Australian registered product resolved. NOTE – S19A Hospira product contains the preservative, sodium metabisulphite, which is an irritant and may cause bronchoconstriction.

Medication Shortage Communication

Resolved
Methotrexate injection 16 Jul 2020 18 Sep 2020 Shortage of all affected strengths now resolved.

Medication Safety Communication

Resolved
Amoxicillin/clavulanic acid IV injection 04 Jun 2020 26 Aug 2020 Shortage of Curam brand now resolved.

Medication Safety Communication

Resolved

The information is intended as a guide only and does not necessarily equate to expert opinion. The CEC does not endorse or recommend the use of any particular medication. Interpretation of recommendations should always be taken in context with the patient’s current condition and formal clinical assessment. Whilst the information is considered to be true and correct at the date of publication, changes in circumstances after the time of publication may impact on the accuracy of the information. The State of New South Wales is not in any way liable for the accuracy of any information printed and stored or in any way interpreted and used by a user.