Availability of IV Fluids Update

Further to DrugAlert vol 957, HPS Pharmacies wish to advise that multiple suppliers are continuing to experience a supply interruption for various IV fluids, including all volumes of the following products:

  • Glucose 5% bags (Baxter, B. Braun, Frensenius Kabi)
  • Hartmann’s solution bags (Baxter, B. Braun, Frensenius Kabi)
  • Sodium chloride 0.9% bags (Baxter, B. Braun, Frensenius Kabi)
  • Water for injection bags (Baxter, B. Braun, Frensenius Kabi)

As this supply interruption may continue until the end of the year, it is important to manage available supplies appropriately.

One area where IV fluids may be conserved is in the administration of antimicrobials. Where appropriate, administration via push injection (SC, IM, or IV) may be considered. Antimicrobials that may be considered for bolus IV administration are shown in Table 1.

Table 1. Antibiotics suitable for IV bolus injection (from NSW Health)

Antimicrobial Adult patients Paediatric patients*
Amoxicillin Bolus N/A
Amoxicillin + clavulanic acid Bolus N/A
Benzylpenicillin Bolus (up to 1.2g) N/A
Cefepime Bolus Bolus
Cefotaxime Bolus Bolus
Ceftazidime Bolus Bolus
Ceftriaxone Bolus (up to 2g) Bolus (up to 50mg/kg and max 1g/dose)
Cefazolin Bolus (up to 2g) Bolus
Flucloxacillin Bolus (up to 2g) N/A
Gentamicin Bolus Bolus
Tobramycin Bolus N/A

*Above recommendations for paediatric bolus apply to injections given over 5 minutes

Additional considerations:

  • The data provided in Table 1 identifies medications with data to support their safety and efficacy as a bolus IV injection. However, this administration method may not be appropriate in every case; specific information should be sought for individual patients.
  • Administering antimicrobials via IV push increases the risk of thrombophlebitis; monitor patients carefully.
  • Additional caution required for medications administered via central lines.
  • Antibiotics that exhibit time-dependent killing (i.e. beta-lactams) may not be appropriate for push administration in critically unwell patients.
  • Consider principles of antimicrobial stewardship to determine if a switch to oral therapy is appropriate. The Therapeutic Guidelines: Antibiotic provides further information (see Principles of antimicrobial use – Guidance for antimicrobial intravenous to oral switch).

References that should be consulted in each case include:

  • Australian Injectable Drugs Handbook – for adult patients;
  • Paediatric Injectable Guidelines (Royal Children’s Hospital, Melbourne) – for children; or
  • Paediatric Injectable Medicines Handbook (Westmead Children’s Hospital) – for children.

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 your local HPS Pharmacies, or email the HPS Pharmacy Standards team at [email protected].

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Packaging Update for Metoprolol IV Viatris 5mg/5mL

HPS Pharmacies wish to give notice that Viatris is updating the packaging of their metoprolol vials as follows:

Metoprolol IV Viatris Vials
Metoprolol tartrate 5mg/5mL
ARTG 204665

The new packaging for this product will contain a green cap on the vial (old packaging contained an orange vial cap). There has been no change to the product label or the formulation of this product.

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 Viatris on 1800 274 276 or your pharmacist at HPS Pharmacies.

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Availability of Intravenous Fluids

HPS Pharmacies wish to advise that multiple suppliers are experiencing supply interruptions for various IV fluids, including all volumes of the following products:

  • Glucose 5% bags (Baxter, B. Braun, Frensenius Kabi)
  • Hartmann’s solution bags (Baxter, B. Braun, Frensenius Kabi)
  • Sodium chloride 0.9% bags (Baxter, B. Braun, Frensenius Kabi)
  • Water for injection bags (Baxter, B. Braun, Frensenius Kabi)

Suppliers have implemented strategies to manage the supply interruption, including restricting quantities that may be ordered. This supply interruption is anticipated to continue over the next two to three weeks.

During this period, it is recommended that management strategies be implemented at a local level to conserve supplies. Affected IV fluids should only be used where clinically necessary. If an alternative IV fluid or administration practice is required, the Australian Injectable Drugs Handbook should be consulted for advice.

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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Discontinuation of Symbicort® Rapihaler™ 50/3

HPS Pharmacies wishes to advise that AstraZeneca is discontinuing Symbicort® Rapihaler™ 50/3 as follows:

Symbicort® Rapihaler™
Budesonide 50 µg + Formoterol fumarate dihydrate 3 µg
ARTG 158898

Symbicort® Rapihaler™ 50/3 is set to be discontinued by end-August 2024, although warehouse supplies are already exhausted.

This product is a low-strength option that is mainly prescribed for children, although the discontinuation may also affect some adults. Patients should be encouraged to discuss alternative therapies with their prescriber as soon as possible. This may require changing to a different delivery device. The Asthma Australia website is a useful resource for instructional videos on how to use asthma devices correctly.

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 AstraZeneca on 1800 805 342 or your pharmacist at HPS Pharmacies.

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Availability of Ozempic®

HPS Pharmacies wish to advise that Novo Nordisk is continuing to experience a supply interruption for Ozempic® as follows:

Ozempic® 0.25/0.5mg Pen
Semaglutide 1.34mg/mL
ARTG 308324

Ozempic® 1mg Pen
Semaglutide 1.34mg/mL
ARTG 315107

Novo Nordisk has advised the Therapeutic Goods Administration (TGA) that Ozempic® supplies will remain limited for the rest of 2024. Internationally registered alternatives have been approved for supply under Section 19A of the Therapeutic Goods Act 1989. These alternative products are currently not subsidised on the Pharmaceutical Benefits Scheme (PBS).

As it is not known when sufficient quantities of Ozempic® will be available to meet demand, the TGA provides the following advice for prescribers:

  • Do not initiate new patients on semaglutide unless there are no suitable alternatives or there is a compelling clinical reason to do so;
  • Consider if patients already prescribed semaglutide could be changed to an alternative; and
  • Conserve supplies for patients who are stabilised on semaglutide who have no other treatment options.

For more information, please go to the Ozempic (semaglutide) shortage page available on the TGA website.

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 Novo Nordisk on 1800 668 626 or your pharmacist at HPS Pharmacies.

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Discontinuation of Timoptol® and Timoptol®-XE Eye Drops

HPS Pharmacies wishes to advise that Mundipharma is discontinuing Timoptol® and Timoptol®-XE eye drops as follows:

Timoptol® Eye Drops
Timolol maleate 0.5%
ARTG 28775

 Timoptol®-XE Eye Drops
Timolol maleate 0.5%
ARTG 50306

Timoptol® 0.5% eye drops are to be discontinued in late November 2024 and Timoptol®-XE 0.5% are to be discontinued in late July 2024.

The following internationally registered alternatives have been approved for supply under Section 19A of the Therapeutic Goods Act 1989:

  • Alternatives to Timoptol®-XE 0.5%
    • Timoptol®-XE 0.5% (South Africa)
    • Timoptol®-LA 0.5% (UK)
  • Alternative to Timoptol® 0.5%
    • Timolol 0.5% w/v eye drops solution Brown and Burk (UK) – S19A approval begins 1/11/2024.

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

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Safety Notice – Adrenaline Aguettant 1:10,000 (1 mg / 10 mL) PFS

There is a supply disruption of the Adrenaline Aguettant 1:10,000 (1 mg / 10 mL) pre-filled syringe that is expected to last until 15th August 2024. There is an alternate TGA registered pre-filled syringe available, Adrenaline Link 1:10,000 (1 mg / 10 mL), however there are a few differences between the products (see table below). Supply of Adrenaline Aspen 1:10,000 (1 mg / 10 mL) ampoules remain available.

Connector Compatibility
Adrenaline pre-filled syringes may be administered through a connector valve which are used to connect peripheral and central vascular access devices to IV lines. Not all connectors are compatible with Link’s glass syringe and reports of blocked syringes have been reported. To ensure patient safety, ensure that a compatible connector is used. Listed below are the compatible valve connectors for the two products (as per information provided by Juno Pharmaceuticals and Link Healthcare):

Recommendations
Please discuss with your clinical coordinators to ensure that hospital staff are informed of the differences and determine which compatible connectors are available and stored with the pre-filled syringe. Ensure that a safety notice is kept with the adrenaline pre-filled syringes until supply disruption is resolved.

Where the adrenaline ampoules are used users need to be aware of the risk of injury due to their presentation in a glass ampoule and the requirements for drawing up doses in a timely manner for emergency situations. If utilising smaller quantities for resuscitation trays or emergency trolleys, clinicians should consider the need to protect individual ampoules 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 Juno Pharmaceuticals on (03) 8888 1288, or your pharmacist at HPS Pharmacies.

List of differences between Adrenaline pre-filled syringes and compatible connectors

Adrenaline Aguettant Adrenaline Link
Polypropylene syringe Glass syringe
Notable excipients:
None
Notable Excipients:
Sodium metabisulfite

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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.