Knowledge Type: DrugAlert

HPS Pharmacies wish to advise that multiple suppliers are experiencing a supply interruption for gliclazide tablets, as follows.

Product	ARTG	Current Status
APX-Gliclazide 80mg	337479	Late March 2024
Nidem 80mg	79023	Early March 2024
Glyade 80mg	70433	Discontinued
Glayde MR 30mg	139728	Discontinued
APO-Gliclazide MR 30mg	151303	Late May 2024
Gliclazide MR Viatris 30mg	295541	End-March 2024
Pharmacor Gliclazide MR 30mg	316934	Mid-March 2024

Gliclazide 60mg modified-release tablets are not affected by this supply interruption and remain available.

The Therapeutic Goods Administration (TGA) has implemented a Serious Scarcity Substitution Instrument (SSSI) to help manage this situation. The SSSI allows pharmacists to supply gliclazide 60mg modified-release tablets while the 30mg tablets are unavailable, providing the conditions of the SSSI are met, including:

• The patient, or person acting on behalf of the patient, must be given suitable instructions regarding dose administration of the substituted medicine, i.e. 60mg tablets should be halved to obtain a 30mg dose; and
• When the 60mg tablets must be halved, instructions should be given to split the tablet along the score line to maintain the modified-release properties of the tablet. The halved tablet must then be swallowed whole and not crushed, chewed, or broken further.

This SSSI is in force until 31 July 2024, unless revoked earlier by the TGA. Information on PBS arrangements is available on the PBS Medicines Shortages page.

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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Further to DrugAlert volume 890, HPS Pharmacies wishes to provide an update on the availability of morphine oral solution. While Ordine^® Oral Solution was discontinued by Mundipharma in 2023, Arrotex Pharmaceuticals has now announced that it will be taking over the sponsorship of the Ordine^® range.

Arrotex anticipates that supplies of all strengths of Ordine^® Oral Solution will resume by late August 2024. In the meantime, several overseas registered morphine oral solution products remain approved for supply under Section 19A of the Therapeutic Goods Act 1989.

Products approved under Section 19A include:

• Morphine sulfate 2mg/mL oral solution (Hikma)
• Morphine sulfate 10mg/5mL oral solution (Martindale Pharma)
  • Warning – this product contains ethanol (0.4mL per 5mL) and sucrose (2.25g per 5mL).
• Morphini HCl Streuli (morphine hydrochloride) 10mg/mL oral drops (Switzerland)
  • Warning – this product is not labelled in English. Additional care is required when storing and dispensing this medicine. Appropriate auxiliary labels should be provided. Health professionals should refer to the Australian product information for dosing information.
  • Warning – this product contains alcohol (1.2% v/v).

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 Mundipharma on 1800 188 009 or your pharmacist at HPS Pharmacies.

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HPS Pharmacies wish to give notice that Seqirus, in consultation with the Therapeutic Goods Administration (TGA), has issued a product defect correction for ADT™ Booster as follows:

ADT™ Booster
Diphtheria and Tetanus Vaccine
ARTG 130919

The only batch affected by this notice is DT403A (expiry 31/01/2026)

This defect alert was initiated as a small number of syringes in batch DT403A are missing the batch number and expiry details on the syringe label. These details are still present on the box containing the syringe and the syringe is still identifiable as ADT™ Booster. Therefore, the health risk to patients is considered low.

Seqirus advises staff to inspect stock and identify any syringes with a labelling defect. If a defect is found, the product carton should be referred to for batch and expiry details. The vaccine may still be administered, but the syringes must not be removed from the carton until they are to 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 Seqirus on 1800 642 865 or your pharmacist at HPS Pharmacies.

 

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Further to DrugAlert vol 902, HPS Pharmacies wish to give notice that Aspen Pharmacare Australia is experiencing a supply interruption for the following local anaesthetic products:

Product	ARTG	Anticipated availability
Xylocaine 2% Adrenaline 1:200,000 5X20mL (theatre pack)	12021	Early June 2024
Xylocaine 0.5% Adrenaline 1:200,000 5X20mL (theatre pack)	12008	Long term out of stock
Marcain 0.25% with Adrenaline 1:400,000 5x20mL (sterile theatre pack)	125878	Late April-early May 2024
Marcain 0.5% with Adrenaline 1:200,000 5x20mL (sterile theatre pack)	48329	Late March-early April 2024

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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HPS Pharmacies wish to advise that Pfizer is experiencing a supply interruption for magnesium sulfate ampoules as follows:

DBL™ Magnesium Sulfate Injection
Magnesium Sulfate Heptahydrate 2.47g/5mL
ARTG 16311

Normal supplies are expected to resume by late February to early March 2024.

Supplies of Phebra Magnesium Sulfate Heptahydrate 50% Injection are currently available in most states and territories. This product contains 2.5g/5mL of magnesium sulfate.

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 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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