Discontinuation of Saizen® 3mg

Drug Discontinuation

HPS Pharmacies wish to give notice that Merck Serono Australia are discontinuing Saizen® 3mg powder for injection as follows:

Saizen® 3 Powder for Injection
Somatropin (rmc) 3mg
ARTG 42232

Saizen® 3 powder for injection vial with diluent vial will be discontinued and no longer available from the 16th of July 2019. Alternative preparations that may be considered include Saizen® 6mg/1.03mL solution for injection. This product is presented in glass cartridges for multidose use.

For medicines that are intended for self-administration by subcutaneous injection, patients should receive adequate education on the correct administration procedures specific to the injection device 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 Merck Serono on (02) 8977 4100 or your pharmacist at HPS Pharmacies.

Availability of Azithromycin

Drug Availability Update

Further to DrugAlert Vol 445, HPS Pharmacies wish to give notice that all suppliers are continuing to experience a supply interruption for azithromycin vials as follows:

Azithromycin Powder for Injection
Azithromycin 500mg

While wholesale stocks are limited, HPS Pharmacies are able to access a limited supply based on historic usage. Normal supplies of azithromycin powder for injection are expected to resume by early August 2019.

Some internationally registered brands of azithromycin vials have been approved for supply under Section 19A of the Therapeutic Goods Act 1989. Please note that Section 19A alternatives are subject to a longer lead time and different pricing as they must be sourced internationally.

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.

Baxter Potassium Chloride Intravenous Infusion Bag

Drug Quarantine

HPS Pharmacies wish to advise that Baxter Healthcare, in consultation with the Therapeutic Goods Administration (TGA), have given notice of a drug quarantine for Baxter Potassium Chloride 10mmol and 0.29% Sodium Chloride 100mL intravenous infusion bags as follows:

Baxter Potassium Chloride and Sodium Chloride Intravenous Infusion
Potassium chloride 10mmol and Sodium Chloride 0.29%
ARTG 159379

The only batch affected by this recall is BN: W66L5 with an expiry date of January 2020.

This drug quarantine request has been initiated as a precautionary measure pending further investigation into possible microbial contamination. One report of an adverse event occurring during the infusion of this product has been received. The bag in question was sent for microbiological testing where it returned a positive result. It is considered likely that this single positive result is due to the bag already having been opened. However, further testing is required.

Please inspect your stock and quarantine all affected products until further notice. 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. 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 your pharmacist at HPS Pharmacies, or Baxter on 1800 229 837.

Availability of Folinic Acid Vials

Drug Availability

HPS Pharmacies wish to give notice that Pfizer Australia is experiencing a supply interruption of folinic acid vials as follows:

Product Strength ARTG Expected Return Date
DBL™ Leucovorin Calcium 15mg/2mL 16351 Currently available
DBL™ Leucovorin Calcium 50mg/5mL 42148 Early September 2019
Pfizer Leucovorin Calcium 50mg/5mL 61885 Early November 2019
Pfizer Leucovorin Calcium 100mg/10mL 61887 Currently available
DBL™ Leucovorin Calcium 300mg/30mL 116688 Early December 2019

While wholesaler stocks of folinic acid vials are currently limited, HPS Pharmacies has managed to secure a limited supply for the benefit of our clients.

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 Pfizer Australia on 1800 629 921.

Discontinuation of Keytruda® 50mg

Drug Discontinuation

HPS Pharmacies wish to give notice that Merck Sharp & Dohme (Australia) are discontinuing Keytruda® 50mg powder for injection as follows:

Keytruda® Powder for Injection
Pembrolizumab (rch) 50mg
ARTG 226597

Keytruda® 50mg powder for injection will be discontinued in Australia this year. This product is still listed on the Pharmaceutical Benefits Scheme (PBS). However, supplies are currently limited.

Keytruda® 100mg/4mL concentrated injection vial will be the only presentation of Keytruda® available following discontinuation of the 50mg powder for injection.

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 Merck Sharp & Dohme (Australia) on (02) 8988 8000 or your pharmacist at HPS Pharmacies.

Availability of OncoTICE®

Drug Availability

HPS Pharmacies wish to give notice that Merck Sharp & Dohme (Australia) are experiencing a supply interruption for OncoTICE® vials as follows:

OncoTICE® Vials
Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain) 5 hundred million CFU
ARTG 59912

This supply interruption is due to an unexpected increase in demand. Normal supplies are expected to resume in late December 2019. While wholesale stocks are limited, HPS Pharmacies has been able to secure a limited supply based on our historical monthly usage.

BCG-medac, an internationally registered brand of BCG vials, has also been approved for supply under Section 19A of the Therapeutic Goods Act 1989. This product is derived from a different substrain of Mycobacterium bovis BCG. The following table provides a comparison of the two products. Please refer to the BCG-medac package insert provided with the product or the Summary of Product Characteristics for further details.

Comparison OncoTICE®  BCG – medac
(S19A alternative)
Contents per vial 2-8×108 colony forming units BCG bacteria 2×108 to 3×109 viable units BCG bacteria
Substrain Tice substrain RIVM substrain
Accessories Closed system for reconstitution is not provided with the product Complete closed system with a connecting piece and a catheter adaptor for reconstitution and handling is provided with the product
Administration recommendations One vial per bladder instillation. Reconstitute with 50mL saline One vial per bladder instillation.
Reconstitute with 50mL saline

Please note that Section 19A alternatives are subject to a longer lead time and different pricing as they must be sourced internationally.

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 (Australia) on (02) 8988 8000or your pharmacist at HPS Pharmacies.

Availability of Miochol-E

Drug Availability

HPS Pharmacies wish to give notice that Bausch & Lomb (Australia) are experiencing a supply interruption for Miochol-E® ampoules as follows:

Miochol-E® Ampoules
Acetylcholine chloride 20mg/2mL
ARTG 118510 

There is currently a worldwide shortage of this product. Normal supplies are expected to resume in August 2019.

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 Bausch & Lomb (Australia) on 1800 251 150 or your pharmacist at HPS Pharmacies.

Availability of Pethidine

Drug Availability

HPS Pharmacies wish to give notice that Pfizer Australia is experiencing a supply interruption for DBL™ Pethidine Hydrochloride Injection BP as follows:

DBL™ Pethidine Hydrochloride Injection BP
Pethidine Hydrochloride 100mg/2mL
ARTG 107387

DBL™ Pethidine Hydrochloride Injection BP
Pethidine Hydrochloride 50mg/1mL
ARTG 107386

Normal supplies of DBL™ Pethidine Hydrochloride 100mg/2mL and 50mg/1mL are expected to resume by mid-August 2019.

An internationally registered brand of pethidine 50mg/1mL ampoules has been approved for supply under Section 19A of the Therapeutic Goods Act 1989. Please note that Section 19A alternatives are subject to a longer lead time and different pricing as they must be sourced internationally.

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 Australia on 1800 629 921 or your pharmacist at HPS Pharmacies.

Availability of Heparin

Drug Availability Update

Further to DrugAlert 464, HPS Pharmacies wish to give notice that Pfizer Australia is continuing to experience a supply interruption for heparin as follows:

DBL™ Heparin Sodium Injection BP
Heparin sodium 5,000 IU/0.2mL
ARTG 16349

Supplies are expected to return to normal in late July 2019. An internationally registered brand of heparin sodium has been approved for supply under Section 19A of the Therapeutic Goods Act 1989. However, supplies of this product are also currently unavailable and not expected to be in stock until late June 2019. The packaging for this product is in the German language. Please refer to the Australian product information for DBL™ Heparin Sodium for further information when using this product.

Supply of heparin sodium under Section 19A is associated with a longer lead time as the product must be sourced internationally. This product is also significantly more expensive than the Australian registered product it replaces. Consideration of therapeutic alternatives such as low molecular weight heparins, where appropriate, may be preferred.

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 Australia on 1800 629 921 or your pharmacist at HPS Pharmacies.

Availability of Local Anaesthetic Products

Drug Availability Update

Further to DrugAlert Vol 466, HPS Pharmacies wish to give notice that Aspen Pharmacare Australia Pty Ltd is continuing to experience a supply interruption for the following local anaesthetic products:

Product ARTG Current Status
Marcain 0.25% 5 x 20mL 48380 Currently available
Marcain 0.5% 5 x 10mL 11937 Currently available
Marcain 0.5% 5 x 20mL 48328 Currently available
Naropin 0.2% 5 x 10mL 52406 Currently available
Naropin 0.2% 5 x 20mL 52405 Currently available
Naropin 0.75% 5 x 10mL 52400 Currently available
Naropin 0.75% 5 x 20mL 52399 Currently available
Naropin 1% 5 x 10mL 52398 Currently available
Naropin 1% 5 x 20mL 52397 Currently available
Xylocaine® 1% 5 x 20mL 48361 Currently available
Xylocaine® 2% 5 x 20mL 48364 Currently available
Xylocard® 500 10% 10 x 5mL 12036 Currently available
Xylocaine® 2% with adrenaline 1:80,000 10 x 5mL 54520 Currently available
Xylocaine® 1% with adrenaline 1:200,000 5 x 20mL 12015 Expected return late August 2019
Xylocaine® 2% with adrenaline 1:200,000 5 x 20mL 12021 Expected return late July 2019
Xylocaine® 0.5% with adrenaline 1:200,000 5 x 20mL 12008 Currently available
Xylocaine® 1% with adrenaline 1:100,000 10 x 5mL 12017 Currently available
Marcain 0.25% with adrenaline 1:400,000 5 x 20mL 125878 Currently available
Marcain 0.5% with adrenaline 1:200,000 5 x 20mL 48329 Limited availability

The product information should be consulted for further information on the appropriate use of these agents. In order to avoid medication errors, it is also requested that all staff exercise additional diligence when prescribing, supplying, and administering these products during this supply interruption.

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.