Knowledge Type: DrugAlert

HPS Pharmacies wishes to advise that Sanofi-Aventis is discontinuing Vivaxim^® as follows:

Vivaxim^® Injection Syringe
Hepatitis a virus antigen + Salmonella typhi Vi polysaccharide
ARTG 82745

This product will no longer be supplied in Australia once the current stocks have been depleted. The last batches manufactured have an expiry date of 30 November 2024.

Single antigen vaccines that may be considered as alternatives include:

• Avaxim^® (inactivated hepatitis A vaccine);
• Havrix^® 1440 (inactivated hepatitis A vaccine);
• Havrix^® Junior (inactivated hepatitis A vaccine);
• Vaqta^® (inactivated hepatitis A vaccine);
• Typhim Vi^® (salmonella typhi vi polysaccharide vaccine); and
• Vivotif^® Oral (oral typhoid vaccine).

Individual product information documents should be consulted for information on indications and administration instructions.

Sanofi-Aventis also anticipates that Avaxim^® may experience a supply shortage during April and May 2024.

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 Sanofi-Aventis on 1800 829 468 or your pharmacist at HPS Pharmacies.

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HPS Pharmacies wish to advise that there is currently a limited supply of paracetamol for parenteral use. The following products are affected.

Product	ARTG	Estimated Return Date
B. Braun Paracetamol 1g/100mL Bottle	275359	Early March 2024
Paracetamol BNM 1g/100mL Bag	201870	Limited stock – supplier managed
Paracetamol KABI 1g/100mL Bag	218687	Mid-March 2024
Paracetamol KABI 1g/100mL Vial	203624	Mid-late February 2024

HPS Pharmacies is currently sourcing various brands via staged supply from the manufacturer, where possible.

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.

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HPS Pharmacies wish to advise that Pfizer has discontinued Hyoscine Hydrobromide ampoules as follows:

DBL™ Hyoscine Hydrobromide Ampoules
Hyoscine Hydrobromide 400 mcg/1mL
ARTG 16347

There is currently not an Australian-registered product that is a direct substitute for this product. Hyoscine butylbromide ampoules remain available. However, as the butylbromide salt does not readily cross the blood-brain barrier, it lacks the central effects of hyoscine hydrobromide.

An internationally registered hyoscine hydrobromide 400mcg/mL product may be available via the Special Access Scheme (SAS). Please note that this product is subject to a longer lead-time and different pricing as it must be sourced internationally.

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 Pfizer on 1800 675 229 or your pharmacist at HPS Pharmacies.

 

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HPS Pharmacies wish to advise that Pfizer is experiencing a supply interruption for Bicillin^® L-A as follows:

Bicillin L-A
Benzathine benzylpenicillin tetrahydrate 1,200,000 Units / 2.3 mL
ARTG 147169 

Bicillin L-A
Benzathine benzylpenicillin tetrahydrate 600,000 units/1.17 mL
ARTG 293456

This global shortage is due to an unexpected increase in demand as well as manufacturing constraints. Pfizer advises that normal supplies of the higher strength will return by end-June 2024, while normal supplies of the lower strength are expected to return by mid-November 2024.

The Therapeutic Goods Administration (TGA) has authorised the supply of an internationally registered alternative of the 1.2 million IU strength under Section 19A of the Therapeutic Goods Act 1989. This product differs from the Australian version in presentation, storage, final volume, and excipients. Some of the key differences are shown in the table below.

	Bicillin® L-A	S19A alternative
Expression of active ingredient	Benzathine benzylpenicillin tetrahydrate	Benzylpenicillin benzathine
Appearance	White fluid suspension Pre-filled syringe	Vial of powder + ampoule of solvent for suspension
Volume required for 1.2 million IU dose	2.3 mL	3.5 mL diluent + powder = 4.5 mL (approx.)
Preparation	Pre-filled single use syringe	Reconstitute immediately before use
Consumer information	Australian CMI	UK leaflet
Product information	Australian PI	UK Summary of Product Characteristics
Storage conditions	2-8°C (storage at 30°C allowed for single period of 2 months)	Below 25°C

During this supply interruption, Pfizer will be closely controlling the supply of very limited quantities of Bicillin^® L-A. Bicillin^® L-A pre-filled syringes should be conserved for use in neonatal and paediatric patients and in healthcare settings where the S19A product is not appropriate. Advice should be sought from an infectious disease expert, local guidelines, and/or the Australian Therapeutic Guidelines.

For further information, including important safety considerations, please refer to the fact sheet produced by the Australian Commission on Safety and Quality in Health Care.

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 Pfizer on 1800 675 229, or your pharmacist at HPS Pharmacies.

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HPS Pharmacies wish to give notice that Boehringer Ingelheim, in consultation with the Therapeutic Goods Administration (TGA), has issued a product defect correction for Spiriva^® Respimat^®, as follows:

Spiriva Respimat Solution for Inhalation
Tiotropium (as bromide monohydrate) 2.5mcg/dose
ARTG 325662

The following batches are affected by this notice:

• E96634 – expiry October 2025
• E63130 – expiry December 2025
• E61076 (samples) – expiry November 2025

This defect alert was initiated following reports of the dose counter stopping after the tenth dose and not locking after the 60^th dose. Boehringer Ingelheim advises that the dose counter is still functional, and the device will continue to deliver doses after the tenth dose. However, the counter will not move any further and will still show that only ten doses have been delivered.

Confusion caused by this issue could lead to an overdose (due to the dose counter not changing) or underdose (due to the ‘lock out’ function not working).

Spiriva^® Respimat^® is not being recalled as this may lead to a supply interruption. Patients should continue to use their medication as prescribed but should be made aware of this issue. If a patient finds that the counter on their device stops after the tenth dose, they should return it to the dispensing pharmacy or contact Boehringer Ingelheim’s Medical Information line on 1800 226 315 to arrange a replacement.

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 Boehringer Ingelheim on 1800 226 315 or your pharmacist at HPS Pharmacies.

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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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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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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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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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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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