Drug Discontinuation
Further to DrugAlert Vol 492, HPS Pharmacies wish to give notice that Pfizer has discontinued the following morphine tartrate ampoules:
DBL™ Morphine Tartrate
Morphine tartrate 120mg/1.5mL
ARTG 16324
DBL™ Morphine Tartrate 400mg/5mL ampoules will continue to be available.
Morphine sulfate or morphine hydrochloride may be considered as alternatives. The following comparison table may be used to aid clinical decision making. The relevant product information should be reviewed for further information.
|
DBL™ Morphine Tartrate Injection |
DBL™ Morphine Sulfate Injection |
Juno Morphine Hydrochloride Injection |
| Approved indication |
Symptomatic relief of severe and intractable pains of various categories, in terminal cancer patients. |
Relief of moderate to severe pain not responsive to non-opioid analgesics. It may also be used as a pre-operative medication and as an analgesic adjunct in general anaesthesia. |
Relief of moderate to severe pain not responsive to non-opioid analgesics; symptomatic relief of severe and intractable pain; terminal cancer pain; and as a pre-operative medication and analgesic adjunct in general anaesthesia |
| Composition |
Morphine tartrate trihydrate, sodium metabisulphite 1mg/mL in water for injections. The pH of the solution is 4.0-5.0. |
Isotonic, morphine sulfate pentahydrate and sodium chloride in water for injections. Hydrochloric acid (1N) is used to adjust the pH to 3.2-4.0. |
Morphine hydrochloride in water for injections. The pH of the solution is 3.0-5.0. Hydrochloric acid (0.1N) is used to adjust the pH of the solution. |
| Dose equivalence |
Morphine tartrate contains almost an equivalent amount of morphine base per milligram as morphine sulfate and morphine hydrochloride.1 |
| Approved route of administration |
Subcutaneous, intramuscular and slow intravenous administration |
Subcutaneous, intramuscular and intravenous administration |
Subcutaneous, intramuscular or slow intravenous injection. |
| Strengths |
400mg/5mL |
5mg/1mL
10mg/1mL
15mg/1mL
30mg/1mL |
10mg/1mL
50mg/5mL
20mg/1mL
100mg/5mL |
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.
Drug Availability
HPS Pharmacies wish to give notice that the following brands of azithromycin vials are experiencing a supply interruption:
The Azith brand of azithromycin 500mg vials is currently available. Two internationally registered brands of azithromycin vials have also been approved for supply under Section 19A of the Therapeutic Goods Act 1989. These products can be sourced if the current supply of Azith is insufficient to meet demands. 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.
Drug Recall
Further to DrugAlert Vol 505, HPS Pharmacies wish to advise that the Therapeutic Goods Administration (TGA) has initiated drug recalls of additional ranitidine products.
All batches of the following products are currently affected by a recall:
| Product |
Strength |
ARTG |
| Zantac® Oral Liquid |
150mg/10mL |
35188 |
| Zantac® Tablets |
150mg |
53324 |
| Zantac® Tablets |
300mg |
53323 |
| Zantac® Effervescent Tablets |
150mg |
45993 |
| Zantac® Injection Ampoules |
50mg/2mL |
12536 |
| Zantac® Double Strength Tablets (OTC) |
300mg |
95076 |
| Zantac® Tablets (OTC) |
150mg |
71786 |
| APO-Ranitidine Tablets |
150mg |
122013 |
| APO-Ranitidine Tablets |
300mg |
122014 |
| Chemmart Ranitidine Tablets |
150mg |
121976 |
| Chemmart Ranitidine Tablets |
300mg |
121979 |
| Terry White Chemists Ranitidine Tablets |
150mg |
121975 |
| Terry White Chemists Ranitidine Tablets |
300mg |
121978 |
| ApoHealth Ranitidine Acid and Heartburn Tablets |
150mg |
254412 |
| ApoHealth Ranitidine Acid and Heartburn Tablets |
300mg |
254413 |
| Mylanta® Ranitidine 24 Hour Action Tablets |
300mg |
116268 |
| Ranitidine Sandoz Tablets |
150mg |
70325 |
| Ranitidine Sandoz Tablets |
300mg |
70356 |
| Ranitidine GH Tablets |
150mg |
219141 |
| Ranitidine GH Tablets |
300mg |
219142 |
| Ranital® Forte Tablets |
300mg |
117184 |
| Ranital® Tablets |
150mg |
75206 |
| Pharmacy Choice Acid & Heartburn Relief Tablets |
150mg |
192601 |
| Pharmacy Choice Acid & Heartburn Relief Extra Strength Tablets |
300mg |
194056 |
| Rani 2® Tablets |
150mg |
285696 |
| Rani 2® Tablets |
300mg |
285693 |
| Pharmacy Action Heartburn & Acid Indigestion Relief Tablets |
150mg |
191837 |
| Pharmacy Action Heartburn & Acid Indigestion Relief Forte Tablets |
300mg |
191838 |
| Pharmacy Care Heartburn Relief Tablets |
150mg |
219877 |
| Pharmacy Care Heartburn Relief Extra Strength Tablets |
300mg |
219926 |
| Amcal Heartburn Relief Tablets |
150mg |
219875 |
| Amcal Heartburn Relief Extra Strength Tablets |
300mg |
219924 |
This recall has been initiated following confirmation of, or in some cases the potential presence of, trace amounts of the impurity, N-nitrosodimethylamine (NDMA). The TGA advises that consumers are not at immediate risk with the use of ranitidine products as the risks are associated with long-term exposure to the NDMA contaminant. Further information can be found on the TGA website.
The TGA has analysed sample batches of Ranitidine Sandoz® 50mg/5mL concentrated injection. No NDMA was detected in these samples, therefore, there is no recall required for Ranitidine Sandoz® ampoules. However, the TGA has suspended the supply of all ranitidine products to Australian warehouses pending further investigation.
Patients who have been prescribed ranitidine are advised to continue taking their medication until they have spoken with their doctor about appropriate alternatives. Healthcare professionals can consult the National Prescribing Service for advice regarding the management of gastro-oesophageal reflux disease and acid reflux during pregnancy.
Possible alternatives to ranitidine include:
- An alternate H2 receptor antagonist;
- A proton pump inhibitor; and/or
- Diet and lifestyle modification.
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.
This notice replaces previous alerts regarding ranitidine recalls. 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.
Drug Availability Update
Further to DrugAlert 490, 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
DBL™ Heparin Sodium Injection BP
Heparin sodium 5,000 IU/1mL
ARTG 12881
This supply interruption is due to a delay in internal processes which has now been resolved by Pfizer. There are no safety concerns with the above products. Supplies of each product are expected to return to normal in mid-November 2019.
The following heparin sodium presentations are currently unaffected by this supply interruption:
- Heparin sodium 5,000 IU/5mL
- Heparin sodium 25,000 IU/5mL
- Heparin sodium 35,000 IU/35mL
Therapeutic alternatives such as low molecular weight heparins may be considered, where appropriate.
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.
Drug Recall
Further to DrugAlert Vol 501, HPS Pharmacies wish to advise that Aspen Australia, in consultation with the Therapeutic Goods Administration (TGA), has initiated a drug recall for all batches of the following Zantac® products.
| Product |
Strength |
ARTG |
| Zantac® Oral Liquid |
150mg/10mL |
35188 |
| Zantac® Tablets |
150mg |
53324 |
| Zantac® Tablets |
300mg |
53323 |
| Zantac® Effervescent Tablets |
150mg |
45993 |
| Zantac® Injection Ampoules |
50mg/2mL |
12536 |
| Zantac® Double Strength Tablets (OTC) |
300mg |
95076 |
| Zantac® Tablets (OTC) |
150mg |
71786 |
This recall has been initiated following confirmation of the presence of trace amounts of the impurity, N-nitrosodimethylamine (NDMA) in these products. NDMA is classified as a probable human carcinogen and can be found in low levels in a variety of foods, some drinking water, and air pollution.
The TGA advises that consumers are not at immediate risk with the use of ranitidine products as the risks are associated with long-term exposure to the NDMA contaminant. Patients who have been prescribed ranitidine are advised to continue taking their medication until they have consulted their doctor about possible alternatives. Further information can be found on the TGA website.
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 Aspen Australia on 1300 659 646 or your pharmacist at HPS Pharmacies.
Drug Recall
Further to DrugAlert Vol 504, HPS Pharmacies wish to advise that Apotex, in consultation with the Therapeutic Goods Administration (TGA), has also initiated a drug recall of ranitidine products.
All batches of the following products are currently affected by a recall:
| Product |
Strength |
ARTG |
|
Zantac® Oral Liquid
|
150mg/10mL |
35188 |
|
Zantac® Tablets
|
150mg |
53324 |
|
Zantac® Tablets
|
300mg |
53323 |
|
Zantac® Effervescent Tablets
|
150mg |
45993 |
|
Zantac® Injection Ampoules
|
50mg/2mL |
12536 |
|
Zantac® Double Strength Tablets (OTC)
|
300mg |
95076 |
|
Zantac® Tablets (OTC)
|
150mg |
71786 |
|
APO-Ranitidine
|
150mg |
122013 |
|
APO-Ranitidine
|
300mg |
122014 |
|
Chemmart Ranitidine
|
150mg |
121976 |
|
Chemmart Ranitidine
|
300mg |
121979 |
|
Terry White Chemists Ranitidine
|
150mg |
121975 |
|
Terry White Chemists Ranitidine
|
300mg |
121978 |
|
ApoHealth Ranitidine Acid and Heartburn
|
150mg |
254412 |
|
ApoHealth Ranitidine Acid and Heartburn
|
300mg |
254413 |
|
Mylanta® Ranitidine 24 Hour Action
|
300mg |
116268 |
|
Ranitidine Sandoz
|
150mg |
70325 |
|
Ranitidine Sandoz
|
300mg |
70356 |
|
Ranitidine GH
|
150mg |
219141 |
|
Ranitidine GH
|
300mg |
219142 |
|
Ranital® Forte
|
300mg |
117184 |
|
Ranital®
|
150mg |
75206 |
The TGA has suspended the supply of all other ranitidine products to Australian warehouses pending further investigation.
This recall has been initiated following confirmation of the presence of trace amounts of the impurity, N-nitrosodimethylamine (NDMA) in these products. The TGA advises that consumers are not at immediate risk with the use of ranitidine products as the risks are associated with long-term exposure to the NDMA contaminant. Further information can be found on the TGA website.
Patients who have been prescribed ranitidine are advised to continue taking their medication until they have spoken with their doctor about appropriate alternatives. Healthcare professionals can consult the National Prescribing Service for advice regarding the management of gastro-oesophageal reflux disease and acid reflux during pregnancy.
Possible alternatives to ranitidine include:
- An alternate H2 receptor antagonist;
- A proton pump inhibitor; and/or
- Diet and lifestyle modification.
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 your pharmacist at HPS Pharmacies.
Drug Availability Update
Further to DrugAlert Vol 491, 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:
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.
Product Notice
Further to DrugAlert Vol 500, HPS Pharmacies wish to advise that Juno Pharmaceuticals has issued a medical safety alert for metaraminol syringes as follows:
Metaraminol Juno Syringe
Metaraminol (as tartrate) 5mg/10mL
ARTG 298219
Juno Pharmaceuticals has been made aware of leakage concerns relating to Metaraminol Juno 5mg/10mL pre-filled syringes when used with certain brands or types of IV extension sets.
Following local studies to determine IV set compatibility, Juno advises that the following needle-free connectors are compatible with the pre-filled syringes without the need for additional adaptors:
- ICU Medical – Nanoclave IV bungs;
- ICU Medical – Microclave Clear Connector;
- ICU Medical – Neutron;
- Carefusion™ SmartSite valve®; and
- BMDi TUTA Healthcare – Pulse needle-free injection site.
If narrow-bore tubing is to be used, it is recommended that a compatible Luer lock needle-free connector is connected to the extension set prior to connection of the syringe. Metaraminol Juno pre-filled syringes have been designed for manual bolus dosing. Alternative presentations (i.e. ampoules) should be used for IV infusions.
Juno Pharmaceuticals will continue to identify additional IV connectors that are compatible with these syringes. If you use a connector not listed above, Juno asks that you contact them so they can perform the relevant studies to determine compatibility.
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.
Instructions for use of Juno pre-filled syringes can be found here. Should you require further information, please contact your pharmacist at HPS Pharmacies, or Juno on (03) 8888 1288.
Drug Recall and Product Hold
Further to DrugAlert Vol 499, HPS Pharmacies wish to advise that the Therapeutic Goods Administration (TGA) has initiated a drug recall for the following ranitidine products.
| Brand |
Formulation |
ARTG |
| Mylanta® Ranitidine 24 Hour Action |
300mg tablets |
116268 |
| Ranitidine Sandoz |
300mg tablets |
70356 |
| Ranitidine Sandoz |
150mg tablets |
70325 |
| Ranitidine GH |
300mg tablets |
219142 |
| Ranitidine GH |
150mg tablets |
219141 |
| Ranital® Forte |
300mg tablets |
117184 |
| Ranital® |
150mg tablets |
75206 |
This recall has been initiated following the identification of the impurity, N-nitrosodimethylamine (NDMA) in some Australian supplied products. NDMA is classified as a probable human carcinogen and can be found in low levels in a variety of foods, some drinking water, and air pollution. The recall is a precautionary measure while Sandoz Australia conducts a full investigation.
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.
In addition to the above recall, the TGA has announced that all sponsors of ranitidine are to suspend supply to pharmacy wholesalers and retailers. The TGA is allowing the continued supply and sale of existing stock at the wholesale and retail levels until current supplies are exhausted. The TGA will provide further information as it becomes available.
The TGA advises that consumers are not at immediate risk with the use of ranitidine products as the risks are associated with long-term exposure to the NDMA contaminant. Further information can be found on the TGA website.
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 Sandoz Australia on (02) 8874 2345 or your pharmacist at HPS Pharmacies.
Product Notice
Further to DrugAlert Vol 487, HPS Pharmacies wish to advise that Juno Pharmaceuticals has updated the packaging and labelling for metaraminol syringes as follows:
Metaraminol Juno Syringe
Metaraminol (as tartrate) 5mg/10mL
ARTG 298220 + 298219
This change has occurred in response to concerns of look-alike packaging with adrenaline syringes and saline flush syringes. The labelling on the syringe barrel and the external plastic wrap are now purple (as shown below) in accordance with the anaesthetic labelling standard for vasopressors.
In addition, the new batch has been manufactured using a new barrel mould. Juno Pharmaceuticals is confident that this has rectified any concerns related to leakage. Testing found no issues when used with the following adaptors/IV sets:
- BD SmartSite™;
- BBraun Safesite®;
- BBraun extension line; and
- Tuta connector.
It is expected that the new packaging for Metaraminol Juno Syringes will begin to arrive from wholesalers shortly. It is recommended that additional diligence be exercised to prevent selection errors during this changeover period when products with old and new packaging may be present in clinical areas. There has been no change to 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 your pharmacist at HPS Pharmacies, or Juno on (03) 8888 1288.
