Discontinuation of Depo-Provera® and Depo-Ralovera® Vials

HPS Pharmacies wishes to advise that Pfizer are discontinuing both medroxyprogesterone vials.
The products will be delisted from the PBS and discontinued on the following dates:

Depo-Provera®
Medroxyprogesterone 150 mg/mL vial
ARTG 12300
Discontinuation Date: 1st July 2024

Depo-Ralovera®
Medroxyprogesterone 150 mg/mL vial
ARTG 44464
Discontinuation Date: 1st November 2024

Pfizer has launched Depo-Provera® 150 mg/mL pre-filled syringe (ARTG 401610) on 1st June 2024 with PBS listing and is now available at wholesalers.

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 rearding this matter, please contact Pfizer on 1800 629 921
or your pharmacist at HPS Pharmacies.

Availability of Gentamicin Ampoules

To address the anticipated supply interruption of Pfizer Gentamicin ampoules from Nov 2024 to March 2025, HPS would move Gentamicin Injection 80mg/2mL to Gentamicin Noridem (supplied by Interpharma) effective from 17th June 2024:

Gentamicin Noridem
Gentamicin (as sulfate) 80mg/2mL
ARTG 391250

Gentamicin Noridem is an Australian registered product that also contains gentamicin (as sulfate) 80mg/2mL. This is a suitable alternative in most situations. However, this product contains sodium metabisulfite as a preservative. In susceptible people, this sulfite can cause allergic-type reactions, which may be severe.

In comparison, the Pfizer Gentamicin product does not contain any antimicrobial preservative.

The presence of the preservative in the Noridem product precludes other off-label routes of administration. Aminoglycosides can be administered via inhalation for the treatment of chronic pulmonary infections. However the Noridem product should not be used via this route due to the risk of airway irritation associated with the presence of sodium metabisulfite. Tobramycin, an alternate aminoglycoside is available and certain brands are approved for administration via inhalation. Supply of Tobramycin (Sun) 300 mg/5 mL solution for inhalation ampoule remains available. For more information, please refer to the safety notice produced by NSW Health.

If a sulfite-free gentamicin product is required, the possibility of supply via the Special Access Scheme (SAS) could be explored on a case-by-case basis. The lead time for accessing SAS stock is longer and ongoing availability is not certain.

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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Medicine Safety Alert for Andrographis – Anaphylaxis Risk

The Therapeutic Goods Administration (TGA), has published a safety alert for medicines containing the herb Andrographis paniculata (andrographis) on its risk of causing allergic reactions (which can include life-threatening anaphylaxis) in some people including those who had used the product previously without any reaction.

Patients presenting with any type of allergic reactions after taking a medicine containing andrographis should be advised to avoid products containing the ingredient in the future.

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.

The TGA safety alert can be found at the following link; https://www.tga.gov.au/news/safety-alerts/medicines-containing-andrographis-paniculata-safety-advisory.

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

Drug Recall for Aciclovir ACCORD 500 mg/ 20mL injection vials

HPS Pharmacies wish to give notice that Accord Healthcare, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for Aciclovir ACCORD 500 mg/ 20mL injection vials as follows:

Aciclovir ACCORD

Aciclovir 500 mg/ 20mL injection vials

ARTG 313549

The only batch affected by this drug recall are:

  • M2313158 (Exp: 03/2025)

This drug recall was initiated due to Batch No. M2313158 possibly containing a glass particle contaminant within the vial solution. This problem was reported by the manufacturer after inspection of retention samples.

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 Accord Healthcare on 1800 222 673 or your pharmacist at HPS Pharmacies.

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Availability of Morphine Oral Solution

Further to DrugAlert volume 917, 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 taken over sponsorship of the Ordine® range and anticipates a return to normal supply later this year.

The table below details the expected return dates for each strength of morphine oral liquid (currently branded as Ordine®, but may be rebranded).

Morphine Oral Liquid Strength Estimated return date Overseas alternative (S19A)
1 mg/mL 27 September 2024 Yes
2 mg/mL 23 August 2024 Yes (also PBS listed)
5 mg/mL 27 September 2024 Yes – available mid-July 2024
10 mg/mL 29 November 2024 Yes – available mid-July 2024 (also PBS listed)

Information to note when considering one of the S19A alternatives includes:

  • 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 Arrotex on 1800 195 055 or your pharmacist at HPS Pharmacies.

 

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Availability of OxyNorm®

Further to DrugAlert volume 896, HPS Pharmacies wish to advise that Mundipharma has reversed its decision to discontinue OxyNorm® (oxycodone) capsules. While Mundipharma will continue to supply OxyNorm® capsules, OxyNorm® 10mg capsules are experiencing a supply interruption.

OxyNorm® Capsules
Oxycodone 10mg
ARTG 74143

Normal supplies of OxyNorm® 10mg capsules are expected to return by the end of 2024. OxyNorm® 5mg and 20mg capsules are currently 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 Mundipharma on 1800 188 009 or your pharmacist at HPS Pharmacies.

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Availability of Wafermine™ Update

Dear Valued Client,

Further to DrugAlert volume 945, HPS Pharmacies wish to advise that iX Syrinx is continuing to experience a supply interruption for Wafermine™ as follows:

Wafermine™ Wafers
Ketamine 25mg

Wafermine™ Wafers
Ketamine 50mg

Normal supplies of Wafermine™ 25mg and 50mg wafers are now expected to return by 20 July 2024.

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 iX Syrinx on (03) 9737 4333, or your pharmacist at HPS Pharmacies.

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Availability of Wafermine™

HPS Pharmacies wish to advise that iX Syrinx is experiencing a supply interruption for Wafermine™ as follows:

Wafermine™ Wafers
Ketamine 25mg

Wafermine™ Wafers
Ketamine 50mg

Normal supplies of Wafermine™ 25mg and 50mg wafers are expected to return by early July 2024.

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 iX Syrinx on (03) 9737 4333, or your pharmacist at HPS Pharmacies.

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Availability of Clexane® 40mg

HPS Pharmacies wish to advise that Sanofi-Aventis Australia is experiencing a short-term supply interruption for Clexane® as follows:

Clexane® Syringe
Enoxaparin sodium 40 mg/0.4 mL
ARTG 221718

Normal supplies of Clexane® 40mg are expected to return by 24 June 2024. Exarane® 40mg is an alternative product that also contains enoxaparin 40mg/0.4mL in a ready-to-use pre-filled syringe. Exarane® 40mg is currently available in some states, but it is also experiencing a temporary supply interruption in some states.

Unlike Clexane® syringes, Exarane® does not have a safety lock system. If Exarane® is used, additional care is required to avoid needlestick injury. Patients or carers supplied Exarane® for self-injection should be educated on how to use the syringes safely. Patient counselling can be complemented with the provision of the consumer medicines information (CMI) document, which contains administration instructions.

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 Sanofi-Aventis Australia on 1800 818 806, or your pharmacist at HPS Pharmacies.

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Defect Correction for Sublimaze® Injection

HPS Pharmacies wish to give notice that Piramal Critical Care, in consultation with the Therapeutic Goods Administration (TGA), has initiated a product defect correction for Sublimaze® ampoules as follows:

Sublimaze® Ampoules
Fentanyl (as citrate) 100 microgram/2mL
ARTG 48263

 This notice affects the following batches:

  • 2307459 (expiry May 2026)
  • 2307460 (expiry June 2026)

This product defect correction was initiated due to some cases of damaged or broken ampoules in unopened blister packs. The issue is readily identifiable prior to use.

Piramal Critical Care advises healthcare professionals to:

  • Ensure sufficient stock prior to surgeries;
  • Inspect stock and do not open blister packaging on ampoules that appear to be damaged or broken;
  • If an ampoule is damaged, closely inspect the remaining ampoules in the blister pack before use; and
  • Non-defective ampoules from the affected batches may be safely used as normal.

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 Piramal Critical Care at [email protected], or your pharmacist at HPS Pharmacies.

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