COVID therapies and the National Medication Stockpile (Victoria)

HPS Pharmacies wishes to advise that Victorian access to COVID therapies on the National Medication Stockpile (NMS) is coming to an end in April 2024.

COVID therapies held by the NMS have the following expiry dates:

  • Paxlovid® (nirmatrelvir + ritonavir) – expiry end of January 2024
  • Lagevrio® (molnupiravir) – expiry end of January 2024
  • Veklury® (remdesivir) – expiry end of April 2024

If a prescriber wishes to prescribe one of these therapies after this time, it must be supplied through the Pharmaceutical Benefits Scheme (PBS) or written as a private prescription. PBS criteria for Paxlovid® and Lagevrio® are available on the PBS website; Veklury® does not currently have a PBS indication.

Retain this notice in a prominent position, including in other related business units for at least one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies.

 

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Availability of BCG Bladder Instillation

HPS Pharmacies wishes to give notice that Merck Sharp & Dohme are continuing to experience a supply interruption for OncoTICE® as follows:

OncoTICE Bladder Instillation
Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain)
ARTG 59912

This is a long-term supply interruption that is expected to continue until at least the end of December 2024. The Therapeutic Goods Administration (TGA) has authorised the supply of an internationally registered alternative under Section 19A of the Therapeutic Goods Act 1989. The alternative product, VesiCulture BCG, is registered in Denmark. The package insert and product labelling is in English.

Some of the key differences between VesiCulture and OncoTICE® are summarised in the table below (adapted from Link Communication 2023).

  OncoTICE® VesiCulture
Strain Tice BCG BCG Danish strain 1331
Contents of one vial 500 million CFU
(2-8 × 108 CFU)
30mg per vial
(Approx. 2.5 x 108 CFU)
Pack size One or three glass vials Four glass vials
Dosage Each instillation comprises 2-8 × 108 CFU (the contents of one reconstituted and diluted vial of OncoTICE suspended in 0.9% sodium chloride up to a total volume of 50 mL) Normal dose (120 mg) = 4 reconstituted vials. The required dose is resuspended in 50 ml sterile preservative-free 0.9% sodium chloride.
Standard dose 1 vial 4 vials
Storage of reconstituted product 2 hours at 2-8 °C. Protect from light Up to 4 hours at 2-8 °C. Protect from light

Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Merck Sharp & Dohme on 1800 818 553, or your pharmacist at HPS Pharmacies. For further information on VesiCulture, please consult the Instructions for Use.

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Insulin Cartridge Defect Alert

HPS Pharmacies wish to give notice that Novo Nordisk, in consultation with the Therapeutic Goods Administration (TGA), has issued an urgent product defect alert for multiple batches of the following insulin products:

Product Presentation ARTG
Actrapid® Penfill 169623
NovoMix® 30 Flexpen 143166
Mixtard® 30/70 Penfill 169629
Novorapid® Flexpen 133445
Novorapid® Penfill 133444
Protaphane® Penfill 169635

The defect alert was initiated following the discovery of a circumferential crack below the “shoulder” of cartridges received from one supplier. These cracks are superficial and do not compromise the integrity of the cartridge. Therefore, they do not pose a risk of contamination or evaporation of the product. However, if the cartridge cracks while being handled, the product will leak and the pen will not work. To date, Novo Nordisk has not received any customer complaints regarding this issue.

Novo Nordisk advises healthcare professionals to inspect the cartridges prior to dispensing to the patient. If defect product is found, it may be returned to the wholesaler for replacement. Patients should not use any product with a crack in the glass cartridge.

Please inspect your stock and quarantine all affected products. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. All affected products will be quarantined for return to the supplier, and HPS Pharmacies will arrange for replacement stock as soon as possible. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Novo Nordisk on 1800 668 626 or your pharmacist at HPS Pharmacies.

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Drug Recall for Metformin Sandoz 1000mg

HPS Pharmacies wish to give notice that Sandoz, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for Metformin Sandoz tablets as follows:

Metformin Sandoz
Metformin 1000mg
ARTG 292865

The only batch affected by this drug recall is: E920021 (expiry Jan 2025)

This drug recall was initiated following the recovery of the N-Nitrosodimethylamine (NDMA) impurity.

Please inspect your stock and quarantine any defect stock. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. All affected products will be quarantined for return to the supplier, and HPS Pharmacies will arrange for replacement stock as soon as possible. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Sandoz on 1800 726 369 or your pharmacist at HPS Pharmacies.

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Service Update for ClopineCENTRAL®

HPS Pharmacies wishes to give notice that Pfizer is making some changes to the support provided by the Clopine® Services Team. The following changes will come into effect on 1 February 2024:

  • The role of the Clopine® Services Team will be limited to directing users to the haematologist and will no longer be a conduit of information between the haematologist and the user.
  • Additional blood or medical history files will not be handled by the Clopine® Services Team and must be discussed with the haematologist directly.
  • Any adjustments to monitoring (e.g. overrides) must be entered directly into ClopineCENTRAL® by the treating team.
  • Users are strongly encouraged to record and maintain all patient medical history (including information from the haematology consultations) in their own internal records.

Pfizer advises that these changes are being made with the intention of streamlining their services. They are not related to any safety, efficacy or quality issues with the service.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact the Clopine® Services Team on 1800 656 403, or your pharmacist at HPS Pharmacies.

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Discontinuation of Imigran® Nasal Spray and Injection®

HPS Pharmacies wish to advise that Aspen is discontinuing the following sumatriptan products:

  • Imigran® (sumatriptan) 10mg Nasal Spray;
  • Imigran® (sumatriptan) 20mg Nasal Spray;
  • Imigran® (sumatriptan) MKII 6mg/0.5mL Autoinjector; and
  • Imigran® (sumatriptan) MKII 6mg/0.5mL Injection.

An alternative brand of sumatriptan 6mg/0.5mL injection is available in the autoinjector presentation. However, there is currently no alternative brand of sumatriptan nasal spray. Wholesalers may still have stock available of the 20mg nasal spray, but supplies of the 10mg nasal spray have been depleted.

Retain this notice in a prominent position, including in other related business units for at least one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact Aspen on 1300 659 646 or your pharmacist at HPS Pharmacies.

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Availability of Xylocaine with Adrenaline

HPS Pharmacies wish to give notice that Aspen Pharmacare Australia is experiencing a supply interruption for the sterile theatre pack presentations of Xylocaine with Adrenaline vials, as follows:

Product ARTG Anticipated availability
Xylocaine 2% Adrenaline 1:200,000 5X20mL (theatre pack) 12021 February 2024
Xylocaine 0.5% Adrenaline 1:200,000 5X20mL (theatre pack) 12008 Long term out of stock

All other Aspen local anaesthetic products are available.

Retain this notice in a prominent position, including in other related business units until supplies return to normal. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact your pharmacist at HPS Pharmacies, or Aspen Pharmacare Australia on 1300 659 646.

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Update on InterPharma Sodium Chloride 0.9% ampoules

Further to DrugAlert volume 900, HPS Pharmacies wish to give notice that InterPharma, in consultation with the Therapeutic Goods Administration (TGA), has provided an update on Sodium Chloride 0.9% 10mL irrigation Solution.

A causal link between the reported Ralstonia cases and use of the 10mL ampoules has not been established. The TGA advises that the 10mL ampoules may be immediately removed from quarantine and used as normal.

Please note that all batches of InterPharma Sodium Chloride 0.9% 30mL ampoules remain subject to a recall notice and must not be used.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact InterPharma on 1300 308 213 or your pharmacist at HPS Pharmacies.

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Drug Recall for InterPharma Sodium Chloride 0.9% 30mL

Further to DrugAlert volume 899, HPS Pharmacies wish to give notice that InterPharma, in consultation with the Therapeutic Goods Administration (TGA), has initiated an urgent recall of all batches of Sodium Chloride 0.9% 30mL irrigation Solution.

This recall has been initiated due to possible contamination with Ralstonia pickettii, a bacteria that can cause infection in people with a weakened immune system.

The products currently affected by this issue are shown below.

InterPharma Sodium Chloride 0.9% 30mL ampoules: (Recall)

  • ALL batches

InterPharma Sodium Chloride 0.9% 10mL ampoules: (Quarantine)

  • 2304400
  • 2301530
  • 2301531
  • 2207874

Please inspect your stock and quarantine all affected products. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. All affected products will be quarantined, and HPS Pharmacies will arrange for replacement stock as soon as possible. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact InterPharma on 1300 308 213 or your pharmacist at HPS Pharmacies.

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Drug Quarantine Update for InterPharma Sodium Chloride 0.9%

Further to DrugAlert volume 898, HPS Pharmacies wish to give notice that InterPharma has extended the quarantine to include all batches of Sodium Chloride 0.9% 30mL irrigation Solution. The batches currently affected by this quarantine are shown below.

InterPharma Sodium Chloride 0.9% 10mL ampoules:

  • 2304400
  • 2301530
  • 2301531
  • 2207874

InterPharma Sodium Chloride 0.9% 30mL ampoules:

  • ALL batches

InterPharma advise that alternative options for the 30mL irrigation solution include unaffected batches of Sodium Chloride 0.9% for Injection ampoules (10mL or 20mL) or Sodium Chloride 0.9% Irrigation sachets (30mL).

This urgent product quarantine has been initiated owing to possible contamination with Ralstonia pickettii. Whilst this has not yet been confirmed, as a precaution, products from the affected batches should be removed from use immediately and quarantined until further notice.

Please inspect your stock and quarantine all affected products. If HPS Pharmacies provide imprest management services to your facility, an HPS representative will inspect all stock stored in the designated imprest areas at the earliest opportunity. All affected products will be quarantined, and HPS Pharmacies will arrange for replacement stock as soon as possible. An HPS Pharmacies staff member will contact senior medical and nursing staff if there is an immediate impact to your facility.

Retain this notice in a prominent position, including in other related business units for one month. Report any problems identified with medicines, vaccines or medical devices to the TGA.

Should you require further information regarding this matter, please contact InterPharma on 1300 308 213 or your pharmacist at HPS Pharmacies.

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