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.
See Safety Alert 003/25 available on Safety Alert Broadcast System and below factsheet.
See Safety Notice 002/25 available on Safety Alert Broadcast System and associated factsheets.
- Frequently Asked Questions – Disruption to the supply of intravenous (IV) fluid bags, last updated Tuesday 10 September 2024
- Information for NSW Health clinicians - Conservation strategies for sodium chloride 0.9% 250 mL IV fluid bags, last updated Tuesday 24 December 2024
- Information for NSW Health clinicians – Clinical recommendations for managing intravenous (IV) fluids shortage, last updated Thursday 22 August 2024
- Information for NSW Health services – Intravenous Fluids Stewardship (IVFS), last updated Tuesday 13 August 2024
- Information for NSW Health clinicians – Intravenous (IV) fluid bags – International alternatives and associated safety considerations, last updated Wednesday 22 January 2025
- Information for NSW Health clinicians – Risk of air embolism when administering intravenous (IV) fluids without in-line air detection, last updated Thursday 22 August 2024
- Information for clinicians caring for maternity patients – Intravenous fluids and oxytocin infusions, last updated Tuesday 6 August 2024
- Poster; Sodium chloride 0.9% (Bioluz) solution for infusion bag - International alternative product
- Poster; Sodium chloride 0.9% (Lavoisier) solution for infusion bag - International alternative product
- Poster: Sodium chloride 0.9% (Baxter USA – VIAFLOW bag) solution for infusion bag - International alternative product
- Poster: Sodium chloride 0.9% (B. Braun Malaysia) intravenous infusion B.P. bottle - International alternative product
- Poster; Sodium chloride 0.9% (B. Braun, USA) intravenous injection bag - International alternative product
- ACI Sip Til Send factsheet
- ACSQHC factsheet for consumers - Intravenous (IV) fluids shortage
Date last updated:
| Medicine Affected | Issued | Updated | Update | Links | Status |
|---|---|---|---|---|---|
| Benzathine benzylpenicillin | 27 Oct 2023 | 23 Apr 2025 | There is an ongoing disruption to the supply of benzathine benzylpenicillin (Bicillin L-A) 600,000 units/1.17 mL suspension for injection and benzathine benzylpenicillin (Bicillin L-A) 1,200,000 units/2.3 mL suspension for injection until 30 September 2025 due to manufacturing issues. Orspec have received approval to import supply of an international alternative, benzathine benzylpenicillin (EXTENCILLINE) 1,200,000 units powder and solvent for suspension from France under Section 19A of the Therapeutic Goods Act 1989 until 30 September 2025. The S19A alternative is also listed on the Pharmaceutical Benefits Scheme (PBS). For further information regarding the disruption to supply, please refer to the Therapeutic Goods Administration (TGA) shortage information page and the factsheet developed by the Australian Commission on Safety and Quality in Health Care (ACSQHC). Clinicians should refer to the Australian Injectable Drug Handbook (AIDH) monograph for further information regarding the administration considerations for the S19A alternative. Facilities are encouraged to develop a local plan surrounding this disruption to supply including reviewing stock holdings, reserving supply of the Australian registered products for priority indications and considering the lead times for the S19A alternative. | Current | |
| Amiodarone 150 mg/3 mL solution for injection | 07 Feb 2025 | 16 Apr 2025 | There is a current disruption to the supply of amiodarone 150 mg/3 mL solution for injection ampoules (JUNO) due to manufacturing issues until 20 June 2025. Wholesalers have indicated that remaining supply of the alternative Australian registered amiodarone solution for injection will be constrained with limited release until at least April 2025.The Therapeutic Goods Administration (TGA) has approved number of international alternatives from the UK and US for use under Section 19A (S19A) of the Therapeutic Goods Act until 31 July 2025. International alternatives are also available via the TGA’s Special Access Scheme (SAS). Refer to the Medication Safety Communication for information and guidance on the use of the S19A and SAS alternatives. Clinicians should be aware that the international alternatives differ from the Australian registered products in terms of administration, concentration requirements and storage requirements. Importantly, the use of in-line filters may be necessary as an extra precaution during administration – refer to Safety Notice 007/22 for further advice. | Current | |
| Methylphenidate | 04 Dec 2024 | 16 Apr 2025 | There is a current disruption to the supply of multiple strengths of methylphenidate modified-release (Concerta and Methylphenidate-Teva) and immediate-release (Ritalin and Artige) tablet products due to manufacturing issues. Further shortages of methylphenidate modified-release products, including Ritalin LA capsules, are anticipated from 21 April 2025. The availability of all methylphenidate modified-release products is expected to be affected until 31 December 2025. NSW Health has introduced a temporary exemption which enables community pharmacists to release previously dispensed prescriptions and repeats for methylphenidate hydrochloride modified release tablets to patients to assist them with sourcing ongoing supply if their usual pharmacy is unable to obtain their medicine due to the shortage. The exemption will remain in place until 31 December 2025. Medsurge has received approval under Section 19A (S19A) of the Therapeutic Goods Act 1989 to import supply of methylphenidate hydrochloride (Concerta) 18 mg, 27 mg, 36 mg and 54 mg extended-release tablets from Switzerland until 30 June 2025. The S19A alternatives are identical in active ingredient and strength; however, differ in excipients and pack size, and are not labelled in English. Refer to the Dear Health Care Professional letter prepared by Medsurge for further information. Clinicians are encouraged to proactively review patients’ treatment plans and update to available products where appropriate. Refer to the TGA Shortage Information page and NSW Health factsheet for further information. | Current | |
| Midazolam 5 mg/1 mL injection ampoules | 15 Apr 2025 | 15 Apr 2025 | There are ongoing disruptions to the supply of all brands of Australian registered midazolam 5 mg/1 mL injection ampoules due to manufacturing issues and unexpected increases in consumer demand. The disruption to supply is expected to resolve in late May/early June 2025. Aborns Pharmaceuticals have received approval under Section 19A (S19A) of the Therapeutic Goods Act 1989 to import supply of midazolam (Aguettant) 5 mg/mL injection ampoules from France until 30 June 2025. Supply is expected to arrive in late April/early May 2025. In the absence of the Australian registered products or where the S19A alternative is unavailable, clinicians can utilise alternative concentrations of midazolam injection ampoules including 5 mg/5 mL and 15 mg/3 mL formulations. Refer to Safety Notice 008/25 for further information and recommendations for managing this disruption to supply. | Current | |
| Flecainide acetate 150 mg/15 mL (10 mg/1 mL) injection ampoule | 18 Nov 2024 | 07 Apr 2025 | There is a current disruption to the supply of flecainide acetate 150 mg/15 mL (10 mg/1 mL) injection ampoule (Tambocor) due to manufacturing issues until 30 June 2025. Medsurge have received approval under Section 19A (S19A) of the Therapeutic Goods Act to import supply of flecainide 150 mg/15 mL injection ampoule (Tambocor) from Germany until 31 July 2025. The S19A alternative is identical in active ingredient, excipients, strength, and storage requirements, however is not labelled in English. Please note the S19A alternative has a lead time of 15 business days. Refer to the Dear Health Care Professional letter prepared by Medsurge for further information. | Current | |
| Abrysvo vaccine | 07 Apr 2025 | 07 Apr 2025 | A shelf-life extension for selected batches of Abrysvo vaccine (respiratory syncytial virus pre-fusion F protein 120 μg/0.5 mL bivalent vaccine powder for injection vial + diluent syringe) has been approved in Australia by the Therapeutic Goods Administration (TGA). The shelf life has been extended from 24 months to 36 months. The storage conditions remain unchanged (refrigerate between 2 -8 degrees Celsius prior to reconstitution). A full list of batches and updated expiries can be accessed in the Dear Health Care Professional Letter prepared by Pfizer. Clinicians should ensure that products are over-labelled with the updated expiry accordingly. | Current | |
| Olanzapine injection | 28 Jan 2025 | 07 Apr 2025 | There is a current disruption to the supply of olanzapine (Zyprexa IM) 10 mg powder for injection vial due to an unexpected increase in consumer demand until 7 June 2025. Intermittent supply may be available during this time and facilities are encouraged to place backorders at wholesalers to ensure they receive stock as it becomes available. ORSPEC Pharma have received approval under Section 19A (S19A) of the Therapeutic Goods Act to import supply of olanzapine (Zyprexa Intramuscular) for injection 10 mg vial from the USA until 31 May 2025. The S19A alternative is identical in ingredient, strength, and storage requirements to the Australian registered product. Please note, the S19A alternative has a lead time of approximately 10 - 15 business days. For further information regarding the S19A alternative, refer to the Dear Health Care Professional letter prepared by ORSPEC Pharma. | Current | |
| Atropine 1% eye drops | 31 Mar 2025 | 31 Mar 2025 | There is a current disruption to the supply of atropine (Atropt) 1% eye drops due to manufacturing issues until 19 May 2025. Internationally registered alternatives are available under the Therapeutic Goods Administration’s Special Access Scheme (SAS) from New Zealand via Pro Pharmaceuticals, and Canada from Orspec and Medsurge. The SAS alternatives are identical in active ingredient and strength, however differ in excipients (not clinically significant) and presentation (5 mL bottle for the Canadian products, as opposed to 15mL bottle for the New Zealand and ARTG product). The SAS alternative from Pro Pharmaceuticals has a short lead time of 1 to 2 business days whilst the SAS alternatives from Orspec and Medsurge have prolonged lead times from 7 to 15 business days. | Current | |
| Dexamethasone, framycetin and gramicidin ear drops | 26 Mar 2025 | 26 Mar 2025 | There is a current disruption to the supply of dexamethasone, framycetin and gramicidin (Otodex and Sofradex) ear drops. The disruption is expected to last until 23 May 2025 for Otodex ear drops and until 31 July 2025 for Sofradex ear drops, due to manufacturing issues. Supply of an internationally registered alternative from the United Kingdom is available under the Therapeutic Goods Administration Special Access Scheme (SAS) via Link. The SAS alternative is identical in active ingredients, strength, excipients, and storage requirements, however differ in presentation (labelled as ear/eye drops as opposed to ear drops). Please note that the SAS alternative has not been approved for use as eye drops in Australia. In the case of a complete disruption to supply, alternative therapy should be sought in consultation with local Infectious Diseases/Microbiology service. | Current | |
| Antacid suspensions | 21 Oct 2022 | 11 Mar 2025 | Mylanta oral liquid formulations and Gastrogel oral liquid were discontinued from the Australian Market in June 2020 (Mylanta) and October 2024 (Gastrogel). Gaviscon oral liquid formulations remain available, however, due to high consumer demand, supply disruptions may occur. Various antacid tablet formulations, including Mylanta double strength, as well as Gaviscon and Mylanta chewable tablets remain available as alternative options. For recommendations regarding the most suitable antacid for nasogastric administration, please refer to Do Not Rush to Crush, accessible via CIAP for further information. | Current | |
| Cyanokit (hydroxocobalamin) | 04 Feb 2025 | 10 Mar 2025 | There is a current disruption to the supply of hydroxocobalamin (Cyanokit) powder for solution for infusion due to a product recall involving batch 2404 which carries a potential risk of microbial contamination. Supply from Medsurge, ProPharmaceuticals , Clinect, and Sanax Medical and First Aid Supplies has been affected with return to supply not expected until September 2025. Refer to the Therapeutic Goods Administration (TGA) Database of Recalls, Product Alerts and Product Corrections (DRAC) for further information on managing the affected stock and alternative therapies. For further advice on alternatives for the treatment and management of cyanide poisoning refer to the Therapeutic Guidelines or contact NSW Poisons Centre (13 11 26). Contact the CEC Medication Safety team at CEC-MedicationSafety@health.nsw.gov.au for further information. | Current | |
| Permethrin cream | 18 Mar 2024 | 07 Mar 2025 | There is a current disruption to the supply of permethrin (Lyclear) 5% cream. Intermittent supply is expected with the date for return to full supply unclear. Facilities are encouraged to have backorders in place to ensure they receive supply when it becomes available. Additionally, Reach Pharmaceuticals has received approval under Section 19A (S19A) of the Therapeutic Goods Act to import supply of permethrin (Encube) 5% cream from the US until 30 September 2025. The S19A alternative is identical in active ingredient, strength and storage conditions to the Australian registered products but differs in tube size and excipients. For further information, please refer to the Dear Health Care Professional letter prepared by Reach Pharmaceuticals. | Current | |
| Acarbose | 11 Dec 2024 | 05 Mar 2025 | There is an ongoing disruption to supply of acarbose (Glybosay) 50 mg and 100 mg tablets until the end of March 2025 due to manufacturing issues. In addition, Viatris acarbose 50 mg and 100 mg tablets were discontinued from the Australian market on 24 February 2025. Medsurge have received approval to import acarbose (Morningside) 50 mg and 100 mg tablets from the United Kingdom under Section 19A (S19A) of the Therapeutic Goods Act 1989 until 31 May 2025. The S19A alternative is identical in active ingredient and excipients. Please refer to the Dear Health Care Professional letter prepared by Medsurge. Please note the S19A alternative has a lead time of up to 18 business days. | Current | |
| Betaxolol 0.5% eye drops | 16 Dec 2024 | 03 Mar 2025 | Betaxolol 0.5% eye drops (Betoptic) were discontinued from the Australian market on 11 December 2024, and betaxolol 0.5% eye drops (Betoquin) will be discontinued from 1 May 2025, due to commercial viability. Internationally registered alternatives are available under the Therapeutic Goods Administration’s Special Access Scheme (SAS) from the UK via Medsurge, Orspec, Pro Pharmaceuticals Group, and Link and USA via Medsurge. The SAS alternatives are identical in active ingredient, strength and excipients, however differ in regard to storage conditions (between 20°C and 25°C for the USA product, as opposed to below 25°C). The SAS alternatives from Pro Pharmaceuticals Group and Link have a short lead time of 1 to 2 business days whilst the SAS alternatives from Orspec and Medsurge have prolonged lead times from 7 to 18 business days. | Current | |
| Heparin 50 units in 5 mL | 08 Jan 2024 | 25 Feb 2025 | There is a current disruption to the supply of heparinised saline (Pfizer) 50 unit/5 mL injection ampoules due to manufacturing issues until 30 April 2026. 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 1989 until 31 May 2026. 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. | Current | |
| Naloxone nasal spray | 24 Feb 2025 | 24 Feb 2025 | There is a current disruption to the supply of naloxone nasal spray (Nyxoid) with limited availability until 31 December 2025 due to unexpected increases in consumer demand. LINK has received approval under Section 19A (S19A) of the Therapeutic Goods Act to import supply of an alternative naloxone (Nyxoid) 1.8 mg nasal spray from the UK until 31 January 2026. The S19A alternative is identical in strength, delivered dose, formulation, and device to the Australian registered product, however is only indicated for use in adults and adolescents aged 14 years and over. Clinicians are encouraged to reserve supply of the Australian registered stock for those patients who are unable to use the S19A alternative. For further information, refer to the Dear Health Care Professional letter, prepared by LINK. Please note 1.8 mg of naloxone is equivalent to 2.2 mg of naloxone hydrochloride dihydrate. | Current | |
| Gemeprost | 18 Feb 2025 | 18 Feb 2025 | The Australian registered product, gemeprost (Cervagem) 1 mg pessaries will be discontinued in Australia from 16 June 2025 with a reduction in supply until stock is depleted. Sites are encouraged to review protocols that include gemeprost and consider alternative agents. | Current | |
| Hydrocortisone 100 mg powder for injection | 18 Feb 2025 | 18 Feb 2025 | The Therapeutic Goods Administration (TGA) have released a recall notice for hydrocortisone 100 mg powder for injection (CIPLA). This recall relates to one batch of CIPLA hydrocortisone 100 mg powder for injection (batch: HY0082401A and expiry: 04/2026). Please refer to the TGA Recall Notice (RC-2025-RN-00025-1) for further information on this recall and the required actions. | Current | |
| Creon capsules | 03 Sep 2024 | 18 Feb 2025 | There are ongoing disruptions to the supply of all strengths of Creon capsules due to supply chain issues. Supply of all strengths is expected to be constrained until further notice. It is recommended that facilities closely monitor their stock levels, ensure back orders are placed based on historical usage and consider the need to dispense smaller quantities for outpatients (i.e. 1 month) until the supply returns to normal. | Current | |
| Clonazepam 0.5 mg tablets | 25 Oct 2024 | 17 Feb 2025 | There is a current disruption to supply of clonazepam (Paxam®) 0.5 mg tablets due to manufacturing issues until the end of December 2024. Emergency stock is available through Viatris for clonazepam (Paxam) 0.5 mg tablets during this disruption. Additionally, Link have received approval under Section 19A (S19A) of the Therapeutic Goods Act 1989 to import supply of clonazepam 0.5 mg tablets from the US until 31 March 2025. The S19A alternative is identical in active ingredient and strength however differs in pack size (bottle of 100 or 500 tablets) and storage requirement (between 20°C and 25°C as opposed to below 25°C). Note that the Australian registered product and the S19A alternative contains lactose. For further information, please refer to the Dear Health Care Professional letter prepared by Link. Facilities are encouraged to place backorders of clonazepam 0.5 mg tablets at wholesalers to ensure they receive stock as it becomes available. | Resolved | |
| Azithromycin 600 mg tablets | 09 Sep 2024 | 17 Feb 2025 | There is a current disruption to the supply of azithromycin (Zithromax) 600 mg tablets due to manufacturing issues until 20 December 2024. Supply of an internationally registered alternative from the United States is available under the Therapeutic Goods Administration Special Access Scheme (SAS) via Medsurge. The SAS alternative is identical in active ingredient and strength, however, differs in presentation (pack of 30 tablets), storage requirements (between 20-25°C), and contains additional excipients (not clinically significant). Please note, the SAS alternative also has a lead time of 15 business days. | Resolved | |
| Anidulafungin | 30 Jul 2024 | 17 Feb 2025 | There is a current disruption to the supply of anidulafungin (Eraxis) 100 mg powder for injection until 28 February 2025 due to manufacturing issues. Supply of anidulafungin (Eraxis) 100 mg powder for injection from the United States is available under Section 14 (S14) of the Therapeutic Goods Act 1989 and available for order via regular wholesalers. The product is identical in formulation and quality however differs from the Australian product with regard to appearance and packaging. For further information, please refer to the Dear Health Care Professional letter prepared by Pfizer. Micafungin remains available and may be considered in consultation with advice provided by local Infectious Diseases/Microbiology services. | Resolved | |
| Amikacin 500 mg/2 mL | 02 Jul 2024 | 17 Feb 2025 | There is a current disruption to the supply of DBL amikacin 500 mg/2 mL (as sulfate) injection vial due to manufacturing issues. Pfizer has received approval under Section 14 and 14A of the Therapeutic Goods Act 1989 to import and supply amikacin 500 mg/2 mL from the UK until 31 December 2024. The alternative product is identical to the Australian registered product, however it does not comply with standards due to differences in the appearance of the packaging and the information contained in the package leaflet. There will be labels overstickered on the packaging to provide important information – please refer to the images of the overstickered UK product. For further information, refer to the TGA Section 14 consent database and the Dear Health Care Professional letter prepared by Pfizer. | Images of overstickered UK product |
Resolved |
| Azithromycin oral suspension | 13 May 2024 | 17 Feb 2025 | There is a current disruption to the supply of azithromycin (Zithromax) 200 mg/5 mL oral suspension due to unexpected increases in consumer demand until 31 January 2025. Alternative international products from South Korea and United States of America (USA) have been approved for supply under Section 19A (S19A) of the Therapeutic Goods Act 1989. For further information regarding the safety considerations for the alternatives, refer to SN:028/24 or contact the CEC Medication Safety team at CEC-MedicationSafety@health.nsw.gov.au. | Resolved | |
| Miostat (Carbachol) intraocular injections | 12 Apr 2024 | 17 Feb 2025 | There is a current disruption to the supply of Miochol-E (acetylcholine) intraocular solution 20 mg/2 mL until 30 June 2025 due to manufacturing issues. Limited supply remains available, however is short dated (expiry 30 June 2025). Internationally registered alternatives from the USA may be available via LINK and Medsurge under the Therapeutic Goods Administration Special Access Scheme (SAS). | Resolved | |
| Dosulepin (dothiepin) capsules | 06 Nov 2024 | 17 Feb 2025 | There is a current disruption to the supply of dosulepin (dothiepin) 25 mg capsules (Dothep and Dosulepin Viatris brands) due to manufacturing issues until 3 January 2025. The 75 mg capsules remain available. An internationally registered alternative dosulepin (dothiepin) 25 mg tablet is available under the Therapeutic Goods Administration’s Special Access Scheme (SAS) from Belgium via Medsurge. The SAS alternative is identical in active ingredient but is not labelled in English and differs in pack size (100 capsule pack). Please note, the SAS alternative has a lead time of approximately 20 business days. | Resolved | |
| Cefaclor oral liquid | 04 May 2023 | 17 Feb 2025 | There is an ongoing disruption to the supply of cefaclor (Ceclor) 250 mg/5 mL powder for oral liquid with limited availability until 15 February 2025 due to manufacturing issues. Supply of cefaclor 125 mg/5 mL (Keflor and Ceclor) and 250 mg/5 mL (Keflor) 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). | Resolved | |
| Fludarabine phosphate | 01 Sep 2023 | 17 Feb 2025 | There is an ongoing disruption to the supply of fludarabine (Ebewe) 50 mg/2 mL concentrated injection vial until 3 February 2025. Supply of the Juno brand remains available. It is recommended that facilities closely monitor their stock on hand and place back orders when required. | Resolved | |
| H2 antagonist oral tablets and capsules | 19 Nov 2024 | 14 Feb 2025 | There is a current disruption to supply of all strengths of famotidine tablets and nizatidine capsules due to manufacturing and increase in demand. Dates for return to supply are variable depending on brand throughout early to mid 2025. Intermittent supply of both medicines may be available during this time. Ranitidine 150 mg and 300 mg tablets have been re-registered for use in Australia and may be used as an alternative. Facilities are encouraged to place back orders for all three medicines at wholesalers to ensure they receive stock as it becomes available. In the event of a complete disruption to supply of the Australian registered products, international alternatives may be available via the Therapeutic Goods Administration Special Access Scheme | Current | |
| Tirzepatide | 04 Dec 2023 | 14 Feb 2025 | There is a current disruption to the supply of all strengths tirzepatide (Mounjaro) injection vials due to an increase in consumer demand with limited availability until 31 August 2025. Supply of Australian registered tirzepatide (Mounjaro) KwikPens remains unaffected. Eli Lilly have received approval under section 19A (S19A) of the Therapeutic Goods Act 1989 to import further supply of tirzepatide (Monjuaro) KwikPens from the UK until 31 March 2025 to assist with the management of the disruption to supply of the vials. The products are identical in active ingredient and strength, however, differ with regard to excipients and presentation (presented in a pre-filled pen). Clinicians are encouraged to follow the most up-to-date advice of the Therapeutic Goods Administration regarding this issue and information available Eli Lilly. | Current | |
| Acetylcysteine 2 g/10 mL (200 mg/1 mL) injection ampoules | 16 Dec 2024 | 14 Feb 2025 | There is a current disruption to the supply of acetylcysteine 2 g/10 mL (200 mg/1 mL) (DBL) injection ampoules due to manufacturing issues until 30 April 2025. There is an anticipated disruption to the supply of acetylcysteine (LINK) 2g/10 mL (200 mg/1 mL) injection ampoules from 12 March 2025 to 19 May 2025. LINK have approval under Section 19A (S19A) of the Therapeutic Goods Act 1989 to import the supply of acetylcysteine 200 mg/1 mL (2 g/10 mL) (Martindale) from the UK until 31 March 2025. This product is identical in active ingredient, strength and formulation to the LINK Australian registered product. Please note that the S19A alternative product must be ordered directly from LINK and there is a current lead time of 7-14 business days. Refer to the Dear Health Care Professional letter prepared by LINK for further information. | Current | |
| Heparin – multiple strengths | 16 Dec 2024 | 14 Feb 2025 | There is a current disruption to the supply of heparin 5000 units/1 mL and 5000 units/5 mL products due to manufacturing issues and unexpected increases in consumer demand. The return to supply dates are variable throughout early to mid 2025 depending on product strength. The disruption to supply of the 25,000 units/5 mL product has now resolved. For further information regarding the disruption to supply, please refer to Safety Notice: 036/24. Alternative internationally registered products are available under Section 19A (S19A) of the Therapeutic Goods Act 1989 or via the Therapeutic Goods Administration Special Access Scheme (SAS). Please refer to the factsheet for information surrounding the differences between the Australian Registered products and the available international alternatives and associated safety considerations. | Current | |
| Octreotide | 28 Feb 2024 | 14 Feb 2025 | There is a current disruption to the supply of octreotide (GH) 50 microg/1 mL, 100 microg/1 mL and 500 microg/1 mL injection ampoules due to manufacturing issues and unexpected increases in consumer demand until 31 May 2025. Generic Health has received approval under Section 19A (S19A) of the Therapeutic Goods Act to import supply of octreotide (Omega) 50 microg/1 mL, 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. Please note, the S19A alternative includes an overlabel “For Subcutaneous (SC) Use Only” which has been approved by the TGA. For further information, please refer to the Dear Health Care Professional letter prepared by Generic Health. | Current | |
| Ribavirin 200 mg tablets | 05 Dec 2024 | 14 Feb 2025 | Ribavirin 200 mg tablets were discontinued in Australia from 1 January 2025 due to manufacturing reasons. An internationally registered alternative is available under the Therapeutic Goods Administration’s Special Access Scheme (SAS) from the USA via LINK and Medsurge. The SAS alternative is identical in active ingredient and strength, however, differs with regard to excipients (not clinically significant), pack size (168 tablets instead of 100 tablets) and storage conditions (between 20°C and 25°C as opposed to below 25°C). Please note, the SAS alternative has a long lead time of approximately 15 business days | Current | |
| Ezetimibe | 25 Oct 2024 | 14 Feb 2025 | There is a current disruption to the supply of multiple brands of ezetimibe 10 mg tablets due to manufacturing issues. The return to supply date is variable throughout early to mid 2025 depending on brand. Reach have received approval under Section 19A (S19A) of the Therapeutic Goods Act 1989 to import supply of ezetimibe 10 mg tablets from the US until 31 March 2025. The S19A alternative is identical in active ingredient and strength however differs in pack size (bottle of 90 tablets). Note that the Australian registered product and the S19A alternative contains lactose. For further information, please refer to the Dear Health Care Professional letter prepared by Reach. | Current | |
| Timolol 0.5% eye drops | 05 Nov 2024 | 14 Feb 2025 | There is a current disruption to the supply of timolol 0.5% eye drops (Timoptol) until 31 March 2025 due to manufacturing issues. LINK Pharmaceuticals has received approval under Section 19A (S19A) of the Therapeutic Goods Act 1989 to import the supply of timolol 0.5% eye drops from the UK until 30 June 2025. The S19A alternative is identical in active ingredient, strength and formulation, however, differs in storage (below 25°C after opening and kept in the outer carton). Refer to the Dear Health Care Professional letter prepared by LINK Pharmaceuticals for further information. Please note, the S19A alternative is available to order via regular wholesalers and available for supply on the PBS until the S19A approval lapses. | Current | |
| Midazolam 5 mg/5 mL injection ampoules | 08 Oct 2024 | 14 Feb 2025 | There is a current disruption to the supply of midazolam 5 mg/5 mL (Viatris and Accord) injection ampoules due to manufacturing issues until 28 February 2025 (Accord) and 15 March 2025 (Viatris). Facilities are encouraged to have backorders in place to ensure they receive supply when it becomes available. Supply of the Pfizer products (plastic ampoules) has now resolved and should be reserved for patients where alternative brands are unsuitable, such as those needing take-home packs for managing paediatric epilepsy. Midazolam 5 mg/5 mL (Viatris) injection ampoules (glass) from New Zealand are available under Section 14 and 14A of the Therapeutic Goods Act 1898 via regular wholesalers. The product is identical in formulation and quantity but differs in regard to extra routes of administration and appearance. This product should be used as per the Australian Product Information. For further information, please refer to the Dear Health Care Professional letter prepared by Viatris. | Current | |
| Salbutamol solution for inhalation | 12 Sep 2024 | 14 Feb 2025 | The disruption to the supply of salbutamol 2.5 mg/2.5 mL (Ventolin) nebules has now been resolved. Salbutamol 2.5 mg/2.5 mL nebules (Cipla) remain unavailable until 31 August 2025. It is recommended that facilities closely monitor their stock levels. | Current | |
| Miochol-E (acetylcholine intraocular solution) | 12 Apr 2024 | 14 Feb 2025 | There is a current disruption to the supply of Miochol-E (acetylcholine) intraocular solution 20 mg/2 mL until 30 June 2025 due to manufacturing issues. Limited supply remains available, however is short dated (expiry 30 June 2025). Internationally registered alternatives from the USA may be available via LINK and Medsurge under the Therapeutic Goods Administration Special Access Scheme (SAS). | Current | |
| Adrenaline 1:10,000 (1 mg/10 mL) | 04 Sep 2024 | 14 Feb 2025 | There is a current disruption to the supply of Link® adrenaline (epinephrine) 1:10,000 (1 mg/10 mL) prefilled syringes (PFS) until 24 January 2025 due to manufacturing issues. The disruption to supply of adrenaline (Aguettant/Juno) 1:10,000 (1 mg/10 mL) PFS is now resolved. Adrenaline 1:10,000 (1 mg/10 mL) ampoules remain available. The TGA have also released a product defect alert for the Link PFS product. Refer to Safety Notice (SN:030/24) and TGA Recall Alert for recommendations on the management of the disruption to supply, product defect information, and clinical and safety considerations regarding the use of these products. | Current | |
| Salbutamol metered dose inhaler – various adaptors | 29 Apr 2021 | 12 Feb 2025 | Clinicians are advised to ensure that a compatible adaptor is available to enable the administration of bronchodilators using metered-dose inhalers (MDIs) via ventilation circuits. Refer to the ‘Information for NSW Health clinicians’ factsheet for further information regarding available adaptors, their compatibility considerations, and recommendations surrounding their use. | Current | |
| Capecitabine 500 mg tablets | 11 Feb 2025 | 11 Feb 2025 | There is a current disruption to supply of capecitabine 500 mg tablets (Sandoz and Xelabine) due to manufacturing issues and increase in consumer demand until 28 February 2025 (Xelabine) and 2 May 2025 (Sandoz). An internationally registered alternative is available under the Therapeutic Goods Administration’s Special Access Scheme (SAS) from the USA via Link Healthcare. The SAS alternative is identical in active ingredient and strength, however, differs in terms of excipients (not clinically significant), storage conditions (between 20°C and 25°C as opposed to below 25°C) and indications – please refer to Australian product information for indications. Please note, the SAS alternative has a lead time of approximately 7 to 10 business days. Section 19A applications are currently under review. | Current | |
| Gentamicin 80 mg/2 mL ampoules | 01 Jul 2024 | 07 Feb 2025 | There is a current disruption to the supply of gentamicin (Pfizer) 80 mg/2 mL (as sulfate) injection BP ampoules until 6 June 2025 due to manufacturing issues. The alternative Australian registered product gentamicin (Noridem) 80 mg/2 mL (as sulfate) solution for injection ampoule is currently constrained due to unexpected increases in consumer demand. For further information regarding this disruption to supply and associated safety considerations regarding available Australian and international Section 19A alternatives, refer to the Safety Notice (003/25). | Current | |
| Thiamine hydrochloride (Thiamine Sterop) 100 mg/2 mL solution for injection | 28 Jan 2025 | 28 Jan 2025 | Thiamine hydrochloride (Thiamine Sterop) 100 mg/2 mL solution for injection was registered on the Australian Register of Therapeutic Goods (ARTG) in July 2024. There are important differences between Thiamine Sterop and thiamine hydrochloride (Biological Therapies) 100 mg/1 mL solution for injection, the previous sole product of parenteral thiamine used in NSW Health facilities. Differences include Thiamine Sterop being indicated only for administration via the intravenous (IV) route and available as a 2 mL formulation, whereas Biological Therapies thiamine is indicated for both IV and intramuscular (IM) routes and available as a 1 mL formulation. Refer to the Medication Safety Communication for further information on the differences between the two parenteral thiamine products, including associated precautions, safety issues, and impacts on clinical practice. | Current | |
| Budesonide 200 microg and formoterol 6 microg dry powder inhalation | 21 Jan 2025 | 21 Jan 2025 | Multiple generic products of budesonide 200 mcg and formoterol 6 mcg dry powder inhalation are now available. Clinicians are reminded that the generic products have differing administration devices, storage conditions, expiry periods after opening and age groups for administration. Further information can be found in the Product Information for each individual product and on the Asthma Australia website. | Asthma Australia – MART: Maintenance and Reliver Therapy Asthma Australia – Using DuoResp Spiromax 200/6 (budesonide-formoterol) inhaler for an asthma attack |
Current |
| Aciclovir injections | 16 Nov 2023 | 14 Jan 2025 | There is an ongoing disruption to the supply of aciclovir 250 mg/10 mL (DBL and Accord) and 500 mg/20 mL (Accord) injection vials due to manufacturing issues. Return to supply dates range between December 2024 and February 2025. The disruption to supply of the Viatris branded aciclovir has now resolved. An internationally registered alternative aciclovir (Wockhardt) 250 mg powder for solution for infusion from the UK is available under the Therapeutic Goods Administration’s Special Access Scheme (SAS) via ProPharmaceuticals Group. The SAS alternative is identical in active ingredient, strength, and storage requirements to the Australian registered products. Please note, the SAS alternative requires reconstitution, and each vial contains 26 mg of sodium. The product also has a lead time of 5–7 days. | Resolved | |
| Tenofovir disoproxil fumarate plus emtricitabine tablets | 02 Sep 2024 | 09 Jan 2025 | There is a current disruption to supply of tenofovir disoproxil fumarate 300 mg plus emtricitabine 200 mg tablets (multiple brands) due to manufacturing issues and increased demand with varying return to supply dates from 8 November 2024 to 1 July 2025. It is recommended that facilities closely monitor their stock levels and consider the need to dispense smaller quantities until the supply returns to normal. Phero Pharma have received approval under Section 19A (S19A) of the Therapeutic Goods Act 1989 to import supply of emtricitabine and tenofovir disoproxil fumarate 200 mg/300 mg (Laurus Labs) from the USA until 31 May 2025. The S19A alternative is identical in active ingredient and strength however, differs in storage conditions. The S19A alternative should be used within 6 weeks of first opening. Refer to the Dear Health Care Professional letter prepared by Phero Pharma for further information. Please note, the S19A alternative is available to order via regular wholesalers and will be listed and available for supply on the PBS from 1 October 2024 until the S19A approval lapses. | Current | |
| Carboplatin 450 mg/45 mL injection vials | 09 Jan 2025 | 09 Jan 2025 | There is a current disruption to supply of carboplatin 450 mg/45 mL solution for injection vial (Accord) due to manufacturing issues until the end of February 2025. DBL carboplatin 150 mg/15 mL and 450 mg/45 mL injection vials (Pfizer) remain available. Facilities are encouraged to place backorders at wholesalers to ensure they receive stock as it becomes available. Pfizer should be contacted directly if supply of DBL carboplatin is not available at wholesalers. | Current | |
| Insulin – multiple products | 17 Dec 2024 | 17 Dec 2024 | Novo Nordisk is discontinuing multiple insulin products globally, impacting availability in Australia. Stock of the affected products will be depleted over the next 2 years. For further information regarding the discontinuations and information regarding safety considerations for alternative products, refer to Safety Notice 035/24. The Therapeutic Goods Administration (TGA) has issued a Serious Scarcity Substitution Instrument (SSSI) for Protaphane Innolet and Ryzodeg FlexTouch, allowing pharmacists to dispense a penfill of the same insulin to patients with a valid prescription. The SSSI for Ryzodeg FlexTouch is valid until 31 March 2025, and for Protophane Innolet until 28 February 2026. More information is available on the TGA website. |
TGA medicine shortage information |
Current |
| Estradiol transdermal patches | 15 Jan 2024 | 05 Dec 2024 | There is a current disruption to the supply of multiple brands and strengths of estradiol transdermal patches due to manufacturing issues, with normal supply expected to resume from late 2024 throughout 2025. A number of internationally registered alternatives from Germany and the USA have been approved for use under Section 19A (S19A) of the Therapeutic Goods Act 1989 and are available via Sandoz and Medsurge. Please note that these international alternatives differ from the Australian registered products in terms of excipients (for example, some products contain soybean oil), which should be considered before prescribing. The Therapeutic Goods Administration (TGA) has made a Serious Scarcity Substitution Instrument (SSSI) which allows community pharmacists to dispense an alternative brand of estradiol transdermal patch or 2 packs of half the prescribed strength to make the same equivalent daily dose. The instrument will be in effect until 31 January 2026. Further information regarding the shortage and SSSI is available on the TGA webpage. | Current | |
| BCG (Bacillus Calmette-Guerin) vaccine powder for injection | 04 Jun 2021 | 20 Nov 2024 | 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 from New Zealand via LINK under Section 19A (S19A) of the Therapeutic Goods Act 1989 until 30 June 2025. 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, please refer to the Dear Health Care Professional letter prepared by LINK. | Current | |
| OncoTICE BCG (Bacillus Calmette-Guerin) injection vial (antineoplastic) | 11 Feb 2021 | 20 Nov 2024 | 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 2026. 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 until 31 January 2026. 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. For further information, refer to the Dear Health Care Professional letter provided by LINK. | Current | |
| Desmopressin acetate | 17 Nov 2020 | 20 Nov 2024 | There is an ongoing disruption to the supply of Desmopressin (Minirin) 10 microgram/actuation nasal spray with supply not anticipated until 30 September 2025. 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 2025. 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. | Current | |
| Dulaglutide | 09 Oct 2022 | 20 Nov 2024 | There is an ongoing disruption to the supply of dulaglutide (Trulicity) 1.5 mg/0.5 mL solution for injection prefilled pen until 30 June 2025. 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. | Current | |
| Malathion | 18 Apr 2024 | 19 Nov 2024 | Malathion (KP24 Medicated Lotion) for the treatment of head lice has been discontinued. Alternatives including benzyl alcohol (Neutra Lice Advance) and dimeticone (Hedrin 15) remain available. For further information, refer to the Australian Medicines Handbook. | Discontinued | |
| Acetazolamide 500 mg injection | 16 Mar 2023 | 15 Nov 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 (XGen) 500 mg from the United States until 30 April 2025. The product is identical in active ingredient, strength and formulation to the Australian registered product. | Current | |
| Paracetamol solution for injection | 31 Oct 2023 | 14 Nov 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 late 2024. | Resolved | |
| Mo-99 Gentech Generators | 19 Feb 2024 | 13 Nov 2024 | OPAL, Australia’s only multi-purpose nuclear reactor, will be undergoing essential maintenance and upgrades from Monday 18 March to mid-October 2024. Due to this maintenance, there is an anticipated supply constraint of Mo-99 for Gentech Generators from 6 to 15 September. ANSTO has been working with alternative international suppliers to source supply of multiple nuclear medicine therapies for the domestic market during this period. Refer to the customer update from ANSTO for the most up-to-date information. | Customer update – ANSTO |
Resolved |
| Oxytocin 10 units/1 mL | 26 Aug 2024 | 13 Nov 2024 | There is a current disruption to the supply of oxytocin (Generic Health) 10 units/1 mL ampoules due to logistical issues until at least mid-September 2024. Other Australian registered brands remain available (including Syntocinon and Viatocinon) however, differ in storage requirements – particularly the length of time that they can be stored outside of refrigerated storage. Refer to the oxytocin monograph in the Australian Injectable Drug Handbook (AIDH) or the individual Product Information for further information on the storage requirements for each brand. | Resolved | |
| Oseltamivir (Tamiflu) suspension | 24 Jul 2024 | 13 Nov 2024 | There is a current disruption to the supply of oseltamivir (Tamiflu) 6 mg/mL powder for oral suspension until early August 2024 due to unexpected increases in consumer demand. All strengths of oseltamivir capsules continue to be available. In the case of a complete disruption to the supply of the powder for oral suspension, individual doses and suspensions of oseltamivir may be prepared using capsule contents. For further information, please refer to the CEC Factsheet. | Resolved | |
| Atropine | 19 Sep 2024 | 13 Nov 2024 | There is a current disruption to supply of atropine 600 microg/1 mL and 1200 microg/1 mL until at least early October 2024. Internationally registered alternatives are available under the Therapeutic Goods Administration’s Special Access Scheme (SAS) from the United Kingdom (via Medsurge and ORSPEC Pharmaceuticals) and Canada (via Medsurge). The SAS alternatives are identical in active ingredient, however differ with regard to excipients (not clinically significant), presentation, storage requirements (between 15 and 30°C and may require protection from light) and pack size (only available in packs of 10). Please note that the lead time for order of the SAS alternatives is between 15 – 18 days. | Resolved | |
| Tenecteplase | 22 Jun 2022 | 29 Oct 2024 | 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. | Resolved | |
| Isoniazid 100 mg tablets | 26 Jun 2024 | 15 Oct 2024 | There is a current disruption to the supply of isoniazid (Arrotex) 100 mg tablets due to manufacturing issues until 27 September 2024. Link have received approval under Section 19A (S19A) of the Therapeutic Goods Act to import supply of the isoniazid (Teva) 100 mg tablets from the USA until 31 October 2024. The S19A alternative differs in pregnancy category, storage conditions, excipients, and presentation to the Australian registered product. Further alternatives may be available under the Therapeutic Goods Administration Special Access Scheme (SAS). Refer to the Medication Safety Communication for further information on this disruption to supply, available alternatives and associated safety considerations. | Resolved | |
| Olanzapine depot injections | 24 Oct 2023 | 14 Oct 2024 | There is a current disruption to the supply of all strengths of olanzapine depot injections (Zyprexa Relprevv) due to logistical issues until 30 November 2024. Limited supply may be available directly from Pharmaco. Link has approval under Section 19A (S19A) of the Therapeutics Goods Act to import supply of international alternatives of olanzapine depot injections however supply is limited. Facilities are encouraged to place backorders at wholesalers to ensure they receive stock as 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. Refer to the TGA webpage for further information on the disruption to supply and the Safety Notice (SN: 034/23) released on 24 November 2023 for additional information on the available alternatives and associated safety considerations. | Current | |
| Cinacalcet | 07 May 2024 | 08 Oct 2024 | There is an ongoing current disruption to the supply of cinacalcet 30 mg (Pharmacor) due to manufacturing issues. The estimated return to stock date is early October 2024. The disruption to supply of all strengths of Viatris brand and Pharmacor 60 mg and 90 mg tablets has now resolved. It is recommended that facilities closely monitor their stock levels until supply returns to normal. | Resolved | |
| Antiseptics - various | 13 Mar 2023 | 08 Oct 2024 | Several antiseptic agents were discontinued or acquired by another sponsor in Australia in 2023. For more information on the affected products, alternatives, and safety considerations, please refer to the CEC Factsheet. Additionally, there is currently a disruption to the supply of chlorhexidine gluconate (Bridgewest) 0.1% 30 mL and chlorhexidine acetate (Baxter) 0.1% 100 mL bottles. The Baxter 0.1% 100 mL bottle is expected to be available for existing customers by mid-October 2024. Alternative concentrations of chlorhexidine, such as 0.02% and 0.05% in 100 mL and 500 mL sizes, remain available from Baxter. Please note, if utilising lower concentrations, the dosage and duration of administration will require review on a on a case-by-case basis. | Current | |
| Alteplase 2 mg injection | 02 Sep 2024 | 27 Sep 2024 | There is a current disruption to the supply of alteplase (Cathflo) 2 mg injection approved for use under Section 19A of the Therapeutic Goods Act 1989. Supply of an internationally registered alternative from Canada is available under the Therapeutic Goods Administration Special Access Scheme (SAS) from Canada (via Pro Pharmaceuticals and Reach Pharmaceuticals) and Germany (via LINK Pharmaceuticals). Please note, the German alternative is not labelled in English (official English translation of the Product Information is available via LINK) and comes in a pack size of 5. Additionally, 5A compounded alteplase 2 mg/2 mL or 2.5 mg/2.5 mL syringes may be available from Baxter. Please note, the 5A product requires storage at -20 degrees Celsius and a 5A agreement with Baxter. Contact CEC-MedicationSafety@health.nsw.gov.au for further information. | Current | |
| Cefuroxime 125 mg/5 mL | 29 Jun 2023 | 19 Sep 2024 | 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 2025. 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. | Discontinued | |
| Captopril oral liquid | 09 May 2023 | 19 Sep 2024 | The Australian registered product, captopril (Capoten) 5 mg/mL oral liquid has been discontinued. An international alternative from the UK is available under the Therapeutic Goods Special Access Scheme via Reach Pharmaceuticals. The product is identical in active ingredient and strength to the Australian registered product. The SAS alternative differs in storage requirements (store below 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. | Discontinued | |
| Busulfan injection | 08 Apr 2024 | 18 Sep 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 19 August 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. | Resolved | |
| Phenelzine 15 mg tablet | 17 Feb 2021 | 18 Sep 2024 | The Australian registered medicine, phenelzine (Nardil) 15 mg (as sulfate) tablet was discontinued on 2 April 2020. Supply of an international alternative, Phenelzine Sulfate USP 15 mg Tablets from Canada is available via Medsurge under Section 19A (S19A) of the Therapeutic Goods Act until 30 September 2025. The S19A product differs from the Australian registered product with regard to excipients (not clinically significant), storage conditions (it does not require refrigeration) and its reduced pack size (60 tablets). For further information, refer to the Dear Health Care Professional letter prepared by Medsurge. Additionally, 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. | Discontinued | |
| Gliclazide 30 mg MR tablets | 04 Mar 2024 | 16 Sep 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. | Resolved | |
| Iodine-131 capsules | 15 May 2024 | 16 Sep 2024 | There is a current disruption to the supply of iodine-131 capsules from ANSTO until at least 27 May 2024 (refer to delivery schedule for updates). Supply of the oral liquid from ANSTO remains unaffected. Supply of capsules may be available from GMS. | Resolved | |
| Rifampicin | 01 Nov 2023 | 16 Sep 2024 | There is a current disruption to the supply of rifampicin (Rimycin) 150 mg until 23 August 2024. The disruption to supply of the Rifadin brand (both strengths) and Rimycin 300 mg has now resolved and supply is available. | Resolved | |
| Entecavir | 21 Aug 2023 | 16 Sep 2024 | There is a current disruption to the supply of multiple brands of entecavir 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. The disruption to the supply of 0.5 mg entecavir tablets has now resolved. | Resolved | |
| Betamethasone (as acetate and sodium phosphate) injection | 21 Feb 2023 | 16 Sep 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 30 June 2024. | Resolved | |
| Valganciclovir | 27 Nov 2023 | 16 Sep 2024 | In March 2024, Hetero announced the discontinuation of valganciclovir 450 mg tablets. In addition, there is an ongoing disruption to the supply of valganciclovir (Viatris) 450 mg tablets due to manufacturing issues until at least 24 May 2024. Limited supply of the Viatris product remains available under Section 14 (S14) of the Therapeutic Goods Act until 30 June 2024. Refer to the TGA S14 Consent database for further information. The Sandoz brand remains available; however, supply may be limited due to unexpected increases in consumer demand. | Resolved | |
| Urografin | 04 Apr 2024 | 13 Sep 2024 | There is a current disruption to the supply of Urografin 30% 250 mL bottle due to manufacturing issues until 31December 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 | |
| Dorzolamide 2% plus timolol 0.5% eye drops | 09 Sep 2024 | 09 Sep 2024 | There is a current disruption to supply of dorzolamide 2% / timolol 0.5% eye drops (multiple brands) with varying return to supply dates from early September 2024 to March 2025. Internationally registered alternatives are available under the Therapeutic Goods Administration Special Access Scheme (SAS) from the United Kingdom, Germany (via Orspec Pharma) and Belgium (via Medsurge). The SAS alternatives are identical in active ingredient, strength but differ in excipients (not clinically significant). Please note, the SAS alternatives from Belgium and Germany are not labelled in English. | Current | |
| Timolol XE 0.5% eye drops | 09 Sep 2024 | 09 Sep 2024 | There is a current disruption to supply of timolol XE 0.5% eye drops (Timoptol XE) until March 2025 due to manufacturing issues. LINK Pharmaceuticals have received approval under Section 19A (S19A) of the Therapeutic Goods Act 1989 to import the supply of timolol LA 0.5% gel forming eye drops from the UK until 30 June 2025. The S19A alternative is identical in active ingredient, strength, and excipients. Refer to the Dear Health Care Professional letter prepared by LINK Pharmaceuticals for further information. | Current | |
| Hyoscine hydrobromide | 26 Oct 2022 | 09 Sep 2024 | Hyoscine hydrobromide (DBL) 400 microg/1mL has been discontinued. An internationally registered alternative is available under the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS) from Germany via LINK. The SAS alternative is identical in active ingredient and strength however, differs in pack size (10 ampoules) and is not labelled in English. Please note, the SAS alternative contains 3.54 mg/mL of sodium, which should be taken into consideration for patients on a low sodium diet | Discontinued | |
| Filgrastim | 04 Sep 2024 | 04 Sep 2024 | In 2023, the Therapeutic Goods Administration announced the discontinuation of all strengths of Neupogen branded filgrastim injection products and supply is now exhausted. Refer to the Medication Safety Communication for further information on the available alternatives and associated safety considerations | Discontinued | |
| Abatacept 125 mg/mL injections | 14 Jun 2024 | 03 Sep 2024 | There is a current disruption to the supply of abatacept (Orencia) 125 mg/mL ClickJect prefilled autoinjector until 30 August 2024 and prefilled syringe until 30 September 2024. Refer to clinical guidance prepared by the Australian Rheumatology Association (ARA) to ensure supply is conserved for patients with no or limited alternatives. Bristol Myers Squibb (BMS) have received approval under Section 19A (S19A) of the Therapeutic Goods Act 1989 to import supply of an alternative product from China until 15 December 2024. BMS has confirmed that abatacept is made from a single manufacturing site and all products from Asia/Europe/US/Australia are identical. BMS have limited stock of the ARTG products and have developed a process to facilitate ordering of abatacept to ensure equitable access (refer to the Dear Pharmacist Letter prepared by BMS). Additionally, the Therapeutics Goods Administration (TGA) has made a Serious Scarcity Substitution Instrument (SSSI) which allows community pharmacists to substitute one product for the other, if appropriate. The instrument will be in effect until 31 October 2024. Further information regarding the shortage and SSSI is available on the TGA website. | Resolved | |
| Prochlorperazine 5 mg tablets | 15 Jan 2024 | 22 Aug 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 3 August 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. | Resolved | |
| Duloxetine capsules | 17 Jul 2024 | 22 Aug 2024 | There is a current disruption to the supply of multiple brands of duloxetine 30 mg and 60 mg capsules due to manufacturing issues and unexpected increases in consumer demand. The estimated return to stock date is variable depending on the brand, ranging from late July 2024 to May 2025. Internationally registered alternatives for both strengths are available under the Therapeutic Goods Administration’s Special Access Scheme (SAS) from the United Kingdom (via Pro Pharmaceuticals), USA (via Medsurge and Orspec) and Italy (via Medsurge). The SAS alternatives are identical in active ingredient, however, the 30 mg SAS alternatives from Medsurge and ProPharma contain sucrose. Sucrose is an excipient with known effect, and this should be taken into consideration for patients with intolerance. | Current | |
| Disulfiram | 19 Dec 2023 | 22 Aug 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. | Resolved | |
| Uridine triacetate (Vistogard) oral granules | 22 Aug 2024 | 22 Aug 2024 | Effective immediately, supply of uridine triacetate oral granules (Vistogard) will be available via 24-hour antidote supply service through The Peter MacCallum Cancer Centre, Melbourne. This product is not registered for use in Australia and is available under the Therapeutic Goods Administration Special Access Scheme (SAS). Refer to the Dear Health Care Professional letter prepared by Phebra for information on accessing Vistogard oral granules. | Current | |
| Cefalexin oral liquid | 22 Dec 2022 | 22 Aug 2024 | There is a current disruption to the supply of cefalexin (Ibilex) 125 mg/5 mL powder for oral liquid due to manufacturing issues until 30 September 2024. The disruption to the supply of Keflex and Sandoz branded cefalexin has now resolved and supply is available via wholesalers. | Resolved | |
| Semaglutide | 03 Nov 2022 | 08 Aug 2024 | There is an ongoing national disruption in the supply of semaglutide (Ozempic) solution for injection due to an increase in global demand. Distribution of the limited supplies of Ozempic will remain restricted throughout 2024 and should be prioritized for patients with Type 2 diabetes. Several Section 19A alternatives are available through multiple suppliers; however, please note that while these alternatives are Ozempic brand, some are not labelled in English. Additionally, semaglutide (Wegovy) has been approved for use in Australia and may be available for chronic weight management. Patients seeking semaglutide for weight management should be prescribed Wegovy-branded semaglutide. Clinicians should follow the most current advice from the Therapeutic Goods Administration regarding this issue. | Current | |
| Melphalan | 13 Jun 2024 | 06 Aug 2024 | There is a current disruption to the supply of melphalan 50 mg (Melpha) powder for injection vials due to manufacturing issues until August 2024. The disruption to supply of the Alkeran brand has now resolved and supply is available. | Resolved | |
| Bupivacaine and adrenaline | 11 Jan 2022 | 06 Aug 2024 | 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. | Resolved | |
| Epoprostenol | 21 May 2024 | 06 Aug 2024 | Epoprostenol (Flolan) 500 microgram and 1.5 mg powder for injection has been discontinued in Australia from June 2024 with a reduction in supply until stock is depleted. Please see the discontinuation notification prepared by GSK for further information. Continue to refer to the Medication Safety Communication for information on available alternatives and associated safety considerations. | GSK - discontinuation notification |
Discontinued |
| Flucytosine | 07 Oct 2020 | 31 Jul 2024 | The Australian registered product, flucytosine (Ancotil®) 2.5 g/250 mL injection was discontinued and deleted from market on 31 October 2021. The product has since been discontinued globally, and no further stock is available via the Special Access Scheme. | Resolved | |
| Sterile talc | 30 Jul 2024 | 30 Jul 2024 | The Australian registered product, sterile talc (Perrigo) 5 g was discontinued in Australia in July 2024. Alternative Australian registered sterile talc (Steritalc) products are available to order via Novatech. Please note, the Steritalc product comes in multiple strengths and as a poudrage kit. Please contact Novatech for further information regarding available products. | Discontinued | |
| Methotrexate (Methoblastin) tablets | 17 Jul 2024 | 17 Jul 2024 | In July 2024, Pfizer announced a transition of methotrexate (Methoblastin) 10 mg tablets to a blister presentation and a discontinuation of their bottle presentations. The ingredients will remain the same, however the pack sizes will change to 10 or 50 tablets (previously 15 or 50) and the tablets will have different markings. Pfizer have advised that the product should be protected from light. They have also advised that during the transition it is possible that stock of both presentations (bottle and blisters) may be in circulation concurrently. For further information, please refer to the Dear Health Care Professional Letter prepared by Pfizer. A similar transition will occur for the Methoblastin 2.5 mg tablets in mid-2025. Refer to the CEC High Risk Medicine Standard: Methotrexate (oral) for further information on the safe management of methotrexate tablets. | Current | |
| Colestyramine | 22 Apr 2024 | 17 Jul 2024 | There is a current disruption to the supply of colestyramine (Questran Lite) powder sachet due to manufacturing issues until 30 August 2024. Pharmacor have received approval under Section 19A (S19A) of the Therapeutic Goods Act to import supply of an alternative cholestyramine oral suspension powder pouch from the US until 30 September 2024. The S19A alternative is identical in active ingredient and strength however, contains mannitol, fructose, sorbitol and aspartame. Clinicians should determine if the presence of these excipients is suitable for their patient. For further information, refer to the Direct Patient letter, Dear Health Care Professional letter and Product Information, prepared by Pharmacor. Additionally, refer to the mandatory dispensing letter prepared by Pharmacor for information on the TGA’s regulatory requirements when dispensing the S19A product. | Direct Patient letter, Dear Health Care Professional letter and Product Information |
Resolved |
| Enoxaparin | 12 Jun 2024 | 17 Jul 2024 | There is a short-term disruption to the supply of enoxaparin (Clexane) 40 mg/0.4 mL injection syringe (with safety lock system) with limited supply available until early next week. Other strengths of enoxaparin (Clexane) remain available. Facilities are encouraged to review stock holdings in clinical areas to assist with the management of the disruption to supply and ensure back orders are placed. | Resolved | |
| Amoxicillin | 12 Oct 2022 | 17 Jul 2024 | There is a current disruption to the supply of amoxicillin 500 mg/5 mL oral liquid due to manufacturing issues until 3 June 2024. Alternative strengths of amoxicillin oral liquid remain available. | Resolved | |
| Fluoxetine dispersible tablets | 28 Nov 2023 | 12 Jul 2024 | There is an ongoing disruption to the supply of fluoxetine (Zactin) dispersible tablets due to manufacturing issues. 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 30 September 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 30 September 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. | Resolved | |
| Eprosartan | 07 Nov 2022 | 24 Jun 2024 | The Therapeutic Goods Administration (TGA) announced that eprosartan 400 mg tablets have been discontinued in Australia. The 600 mg tablets will also be discontinued from 30 December 2024. Specialist advice should be sought regarding alternative treatment options. | Discontinued | |
| HYDROmorphone (Dilaudid®) Oral Liquid 1 mg/mL | 14 Apr 2021 | 20 Jun 2024 | Following the discontinuation of the Australian registered medicine medicine HYDROmorphone hydrochloride (Dilaudid®) oral liquid 1 mg/mL in 2021, supply of international alternatives has been intermittently available via the Therapeutic Goods Administration Special Access Scheme (SAS) and via Section 19A (S19A) of Therapeutic Goods Regulations. Most recently, there has been a global disruption to the supply of hydromorphone oral liquid, and SAS/S19A suppliers are unable to import international alternatives. Clinicians should review all patients currently being treated with hydromorphone oral liquid as soon as possible and begin discussions with patients/carers about the need to switch to alternate medicines for ongoing management of pain. Clinicians should utilise this opportunity to review their patient’s ongoing requirements for opioids. | Discontinued | |
| Morphine hydrochloride (Ordine) oral solution | 21 Jul 2023 | 17 Jun 2024 | In 2023, Mundipharma announced the discontinuation of all strengths of immediate-release morphine hydrochloride trihydrate (Ordine) oral solution from the Australian market. Sponsorship of all strengths of Ordine has been transferred to Arrotex Pharmaceuticals, with supply expected to resume from August 2024. The brand name and outer packaging will remain identical except for the logo which will change from Mundipharma to Arrotex Pharmaceuticals. In the interim, several S19A alternatives are available and can be used after consideration of their differences to Ordine oral solution. Refer to the Safety Notice (SN007/24) released on 21 May 2024 for further information on this discontinuation, available alternatives and associated safety considerations. | Current | |
| Xylocaine 2% with adrenaline 1:200,000 20 mL injection vial | 08 Dec 2023 | 13 Jun 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 September 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 |
Resolved |
| Lisdexamfetamine | 23 Aug 2023 | 13 Jun 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 |
Resolved |
| Diltiazem | 09 Mar 2023 | 13 Jun 2024 | There is a current disruption to the supply of diltiazem (Cardizem CD) 240 mg controlled release capsules due to manufacturing issues until 30 June 2024. The product sponsor is working to expedite the next shipment. Supply of alternative controlled release diltiazem brands and strengths are available. | Resolved | |
| Ropivacaine 0.2% with fentanyl | 07 Jun 2024 | 07 Jun 2024 | All ropivacaine (Naropin) 0.2% with fentanyl products will be discontinued from the Australian market by the end of 2024. Supply of compounded alternatives are available from Slade and Baxter. The alternatives are identical in active ingredient, presentation, strength, storage, and final volume, however differs in shelf life. The Slade and Baxter alternatives have a shelf life of 51 days and 182 days respectively, from the date of compounding (compared to 2 years shelf life of the Australian registered products). | Current | |
| Plerixafor | 20 Mar 2024 | 22 May 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. | Resolved | |
| Sotalol | 28 Feb 2024 | 22 May 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. | Resolved | |
| Hydralazine | 05 Mar 2024 | 22 May 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. | Resolved | |
| Dipyridamole (Persantin) 10 mg/2 mL | 25 May 2023 | 22 May 2024 | 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. | Resolved | |
| Dobutamine hydrochloride 250 mg/20 mL | 13 Apr 2023 | 17 May 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 (not clinically significant) 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. | Resolved | |
| Diclofenac eye drops | 08 May 2024 | 08 May 2024 | In December 2023, Novartis announced the discontinuation of diclofenac sodium 1 mg/mL eye drops due to changes in commercial viability. In consultation with the relevant specialists, alternatives such as ketorolac trometamol 0.5% eye drops can be considered. | Discontinued | |
| Furosemide 40 mg/4 mL injection | 08 May 2024 | 08 May 2024 | The Australian registered product, furosemide (Lasix) 40 mg/4 mL injection was discontinued on the 15 May 2024 due to changes in commercial availability. The alternative strengths – furosemide 20 mg/2 mL and 250 mg/25 mL remain available. | Discontinued | |
| Quinapril | 15 Dec 2022 | 08 May 2024 | All strengths of quinapril have been discontinued from the Australian market following a product recall which occurred in December 2022. Specialist advice should be sought regarding alternative treatment options. | Discontinued | |
| Sevredol | 02 May 2024 | 02 May 2024 | The Australian registered product, morphine sulfate pentahydrate (Sevredol) 20 mg will be discontinued in Australia from April 2024 with a reduction in supply until stock is depleted. The 10 mg tablets will also be discontinued from July 2024. Supply of an internationally registered alternative Sevredol 10 mg and 20mg from the United Kingdom are available under the Therapeutic Goods Administration Special Access Scheme (SAS) via multiple suppliers. The SAS alternatives are identical in active ingredient, strength, and excipients to the Australian registered products, however, differ in pack size (56 tablets). Clinicians should review all patients currently being treated with Sevredol as soon as possible and begin discussions with patients/carers about the need to switch to alternate medicines for ongoing management of pain. Clinicians should utilise this opportunity to review their patient’s ongoing requirements for opioids. | Current | |
| Suxamethonium chloride 100 mg/2 mL | 08 Mar 2023 | 02 May 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. | Resolved | |
| 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. | Current | |
| 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. | 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. | Resolved | |
| 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. | Resolved | |
| 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. | Discontinued | |
| 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 | |
| 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. | Resolved | |
| 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. | 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 | |
| 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. | Resolved | |
| 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. | 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). | Discontinued | |
| 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 | |
| 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 | |
| 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 | |
| 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. | 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. | 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. | 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). | 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 | |
| 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. | 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. | 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 | |
| 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 | |
| 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 | |
| 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 |
Resolved |
| 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. | Resolved | |
| 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 | |
| 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. | 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 | |
| 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. | 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. | Resolved | |
| 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. | 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 | |
| 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 | |
| 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 | |
| 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. | Resolved | |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | |
| 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. | Resolved | |
| 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. | 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. | 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. | 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. | 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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. | Current | |
| Folic acid 5 mg/mL injection | 08 May 2023 | 08 May 2023 | Folic acid (Phebra) 5 mg/mL injection was discontinued in Australia 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. | Discontinued | |
| 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. | 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 | |
| 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. | 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. | 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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. | 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. | 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 | 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 | |
| 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 | |
| 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. 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. | Discontinued | |
| Bupivacaine with fentanyl (Marcain 0.125%) | 25 Nov 2022 | 25 Nov 2022 | Bupivacaine with fentanyl 100 mcg/20 mL (Marcain 0.125%) injection ampoules were discontinued in Australia from 1 May 2023. Sites are encouraged to review current protocols containing this medicine and consider alternative agents in consultation with anaesthetic teams. | Discontinued | |
| 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 | In December 2022, AstraZeneca advised that exenatide (Byetta) 5 mcg and 10 mcg pre-filled pens were discontinued from the Australian market. Supply is now exhausted. 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. | Discontinued | |
| 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. | Discontinued | |
| 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. | 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 | |
| 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. | Resolved | |
| 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. | 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. | Resolved | |
| 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 | |
| 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. | 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. | 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 | |
| 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 | |
| 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. | 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 | |
| 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. | Discontinued | |
| 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. | 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. | 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 | |
| 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. | 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). | 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 | |
| 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. | Resolved | |
| Methotrexate injection | 16 Jul 2020 | 18 Sep 2020 | Shortage of all affected strengths now resolved. | Resolved | |
| Amoxicillin/clavulanic acid IV injection | 04 Jun 2020 | 26 Aug 2020 | Shortage of Curam brand now resolved. | 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.