Knowledge Type: DrugAlert

Teva Pharma has advised that Androderm^® will be removed from the Pharmaceutical Benefits Scheme (PBS) from 1 April 2023, as follows:

Androderm^® Transdermal Patch
Testosterone 5mg/24 hours
ARTG 82398

Androderm^® will remain available to patients as a private 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 Teva Pharma on 1800 288 382 or your pharmacist at HPS Pharmacies.

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HPS Pharmacies wish to advise that AstraZeneca has discontinued Byetta^® as follows:

Byetta^® Injection
Exenatide 5 micrograms/20 microlitres
ARTG 123609 

Byetta^® Injection
Exenatide 10 micrograms/40 microlitres
ARTG 123610

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

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HPS Pharmacies wish to give notice that Viatris, in consultation with the Therapeutic Goods Administration (TGA), has issued a product defect alert for Vancomycin Viatris as follows:

Vancomycin Viatris 500mg Vials
Vancomycin 500mg
ARTG 373670

Vancomycin Viatris 1000mg Vials
Vancomycin 1000mg
ARTG 373671

This product defect alert has been issued due to a suspected packaging error. A small number of cartons labelled as Vancomycin Viatris 500mg have been found to contain vials of Vancomycin Viatris 1000mg.

Affected batches are:

• 500mg vials – batch number 7607760 (please inspect all stock as only a single batch of this strength has been distributed)
• 1000mg vials – batch number: 7607754

Stock from the above batches should be carefully examined before use to detect any discrepancies between the label on the carton and the label on the vial.

Please inspect your stock and quarantine any impacted 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 impacted 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 Viatris on 1800 274 276, or your pharmacist at HPS Pharmacies.

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HPS Pharmacies wish to advise that Perrigo is experiencing a supply interruption for Fentanyl Intranasal as follows:

Fentanyl Intranasal
Fentanyl 450mcg/1.5ml 

As stock is severely limited, Perrigo has instituted a supply restriction. Supply is currently restricted to ambulance and related emergency services customers only.

This supply interruption is due to machinery requiring repair by the overseas-based manufacturer. While an additional batch was manufactured to cover the expected machine downtime, this batch failed quality assurance and compliance review and is unable to be distributed.

An estimated return date for normal supply is not yet 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 Perrigo or your pharmacist at HPS Pharmacies.

Perrigo contacts for each state and territory are:

• Mark Thomas – [email protected] – 0490 304 888 (NSW, Qld, ACT)
• Susanne Coutts – [email protected] – 0403 866 079 (Vic, Tas).
• Fiona Romano – [email protected] – 0417 336 342 (WA, SA, NT)

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Further to DrugAlert volume 833, HPS Pharmacies wish to give notice that Janssen-Cilag, in consultation with the Therapeutic Goods Administration (TGA), has issued a product defect alert for CADD™ Infusion System Disposables as part of the Veletri^® Consumables kit:

Electric Infusion Pump Administration Set
ARTG 329620

This product defect alert has been initiated due to two potential issues with the CADD™ Infusion System Disposables, which are part of the Veletri^® Consumables kit.

Issue 1: Under-delivery due to tubing occlusion, despite the pump displaying that the infusion is running correctly.

Issue 2: False “No disposable attached (NDA)” alarms.

Affected batches: 200943, 201422, 210114, 210846, 220048, 220519 & 221293.

Janssen advises that affected products should not be used to deliver life sustaining medications. Janssen will coordinate the replacement of impacted stock as new unaffected stock becomes available.

Janssen provides the following workarounds to be used in the interim:

• Prime the set using the pump. If the fluid doesn’t flow properly or takes an abnormally long time to prime, or if the pump displays a higher than expected priming volume, replace the reservoir or set. The priming volume is listed on the packaging for each administration set.
• If a pump displays an NDA alarm, the user can attempt to resolve the alarm by repositioning the CADD Medication Cassette Reservoir while connected to the pump, repositioning the reservoir by disconnecting from the pump and reattaching it to the pump, or replacing the reservoir.

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 Janssen on 1800 226 334, or your pharmacist at HPS Pharmacies.

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The Therapeutic Goods Administration (TGA) has issued a statement regarding the current shortages of some antibiotics throughout Australia.

Affected products include:

• Amoxicillin (capsules and suspension);
• Amoxicillin + clavulanic acid (tablets and suspension)
• Cefalexin (suspension currently affected);
• Metronidazole (suspension currently affected);
• Flucloxacillin (capsules);
• Phenoxymethylpenicillin (tablets/capsules and suspension);
• Sulfamethoxazole/trimethoprim (injection and tablets); and
• Trimethoprim (tablets).

Actions to address supply issues:

1. Alternative brands of Australian-registered products will be supplied, where available. To avoid confusion, review product labels carefully as alternative brands may appear different;
2. HPS Pharmacies is also able to access internationally-registered alternatives approved for supply under Section 19A of the Therapeutic Goods Act 1989.

Antibiotics with a current S19A approval include:

• Amoxicillin (capsules and suspension);
• Amoxicillin + clavulanic acid (tablets and suspension);
• Cefalexin (capsules);
• Metronidazole (tablets and suspension);
• Flucloxacillin (oral solution);
• Phenoxymethylpenicillin (tablets/capsules);
• Sulfamethoxazole + trimethoprim (injection and tablets); and
• Trimethoprim (tablets).

3. The TGA has made two Serious Scarcity Substitution Instruments (SSSIs). One SSSI allows pharmacists to offer an alternative amoxicillin presentation if the prescribed strength or form is unavailable, the other allows an alternative cefalexin presentation to be dispensed when the prescribed one is unavailable.
4. The Special Access Scheme (SAS) may also be considered, if required.

The National Centre for Antimicrobial Stewardship also provides fact sheets with general advice about potential alternative therapies during interruptions in the supply of antimicrobials in Australia. These may be useful when reviewed in conjunction with the current Therapeutic Guidelines: Antibiotic or local guidelines.

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.

HPS Pharmacies recognises that these supply issues are challenging. Your pharmacist at HPS Pharmacies can provide further advice regarding current stock availability.

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HPS Pharmacies wish to give notice that Generic Health, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for Pharmacy Action Dry Cough Relief oral liquid as follows:

Pharmacy Action Dry Cough Relief
Pholcodine 1mg/mL
ARTG 189867 

This recall has been initiated in response to a safety concern with the active ingredient and affects all batches.

Safety concerns around pholcodine have been highlighted following the recent recommendation of the European Medicines Agency to revoke marketing authorisation for pholcodine-containing medicines in Europe. This is based on data indicating that use of pholcodine in the 12 months before general anaesthesia with neuromuscular blocking agents (NMBA) is a risk factor for developing an anaphylactic reaction to NMBAs.

It is worth noting that the evidence supporting the efficacy of pholcodine is limited and therapeutic alternatives are available for managing dry cough.

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 Generic Health on (03) 9809 7900 or your pharmacist at HPS Pharmacies.

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HPS Pharmacies wish to give notice that Medicianz Healthcare, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for Medsurge Mupirocin Nasal Ointment as follows:

Medsurge Mupirocin Nasal Ointment
Mupirocin (as calcium) 2% (5g tube)
ARTG 300228

The manufacturer is recalling one batch due to an out-of-specification result found during routine annual stability testing. The batch being recalled has subsequently been tested and passed specification. Therefore, there is no immediate impact on product quality.

Affected batch number: 072106.1

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 Medsurge Healthcare on 1300 788 261 or your pharmacist at HPS Pharmacies.

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HPS Pharmacies wish to give notice that Smiths Medical, in consultation with the Therapeutic Goods Administration (TGA), has issued a product defect alert for CADD™ Infusion System Disposables as follows:

CADD™ Infusion System Disposables

ARTG 145297 and 316997

This product defect alert has been initiated due to two potential issues.

Issue 1: Lack of delivery or under-delivery related to tubing occlusion.

This error may occur despite the pump displaying that the infusion is running properly.

This issue affects specified medication cassette reservoirs with flow stop and administration sets used with all CADD™ pumps (see Table 1 for details, pages 6-8).

Issue 2: False “No disposable attached (NDA)” alarms.

There is a potential that CADD-Legacy pumps may not detect a properly attached CADD Medication Cassette Reservoirs with Flow Stop. In these cases, the pump will issue an NDA alarm which the user must clear before using the pump.

This issue affects specified 50 mL and 100 mL medication cassette reservoirs with Flow Stop used with CADD™ Legacy Infusion Systems (see Table 2 for details, page 8). This issue does not impact 250 mL Flow-Stop and non-Flow Stop CADD Medication Cassette Reservoirs.

The above issues have the potential to cause serious patient harm. Smiths Medical advises that affected products should not be used to deliver life sustaining medications.

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.

Further information is available:

• Frequently asked questions
• Product defect alert (please review for further details of the alert as well as affected items and lot numbers).

Should you require further information regarding this matter, please contact Smiths Medical on 1800 654 949, or your pharmacist at HPS Pharmacies.

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Further to DrugAlert volume 737, HPS Pharmacies wish to give notice that Clinect is continuing to experience a supply interruption for Imdur^® and Monodur^® as follows:

Imdur^® Durules
Isosorbide mononitrate 120mg
ARTG 62795 

Monodur^® Durules
Isosorbide mononitrate 120mg
ARTG 64284

Normal supplies of Imdur^® and Monodur^® 120mg tablets are expected to resume by late March 2023.

The Therapeutic Goods Administration (TGA) made a Serious Scarcity Substitution Instrument (SSSI) to help manage this long-term out of stock situation. The SSSI allows pharmacists to substitute registered medicines containing 60mg of isosorbide mononitrate in a modified-release tablet while the 120mg tablets are unavailable.

This SSSI has been extended to 30 June 2023, unless revoked earlier by the TGA. Points to consider during this time include:

• The quantity supplied to a patient under the SSSI must match the total dose prescribed;
• The SSSI may not be used to substitute medicines if the prescriber has indicated on the prescription that substitution is not permitted; and
• The patient, or the person acting on their behalf, must consent to the substitution.

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 Clinect on (03) 9918 5555 or your pharmacist at HPS Pharmacies.

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