Availability of morphine sulfate injection products: Information for health professionals
22 May 2013
- All strengths of DBL™ Morphine Sulfate Injection products are in limited supply due to manufacturing issues resulting in delays to packaging.
- To maintain supply, Hospira have arranged for an alternative 10mg/mL Morphine Sulphate Injection, WOCKHARDT Morphine Sulphate Injection 10mg/1mL. This product can now be ordered from nominated wholesalers.
- Unlike the DBL product, the preservative-containing WOCKHARDT product must only be administered by the intravenous, intramuscular and subcutaneous routes.
- Both products are now in circulation.
- Health professionals must follow the instructions on the packaging, poster and other morphine-related letters being distributed by the supplier, Hospira.
Morphine sulfate injection registered in Australia:
- is currently supplied by a single company, Hospira, under the name DBL™ Morphine Sulfate Injection and comes in 5 mg/1mL, 10 mg/1mL, 15 mg/1ml and 30 mg/1mL strengths.
- is packaged at a single manufacturing plant in Europe
- is in limited supply due to a recent upgrade of this manufacturing plant which has resulted in significant delays to the packaging and supply of product from this site.
The limited supply is being carefully managed by health authorities and Hospira.
To manage the limited supply, Hospira has worked with the TGA to make available an alternative supply of morphine sulfate injection10mg/1mL ampoules, which is the most widely used strength. The alternative product is WOCKHARDT Morphine Sulphate Injection 10mg/1mL, which has gone through a regulatory approval process in the United Kingdom.
Please note that there will not be alternative products for the 5 mg/1mL, 15 mg/1mL and 30mg/1mL products and their supply will be remain tight over the first half of 2013.
There are critical formulation differences between DBL™ Morphine Sulfate Injection and WOCKHARDT Morphine Sulphate Injection products which have potential patient safety implications.
The WOCKHARDT Morphine Sulphate Injection:
- contains preservative (unlike the DBL product),
- can be administered by the following routes ONLY,
- because of the preservative, is not safe to be used for the following routes:
Although the registered DBL product has not been approved for use by the intrathecal route, and references intravenous, intramuscular and subcutaneous routes only on its packaging, it is understood that there is a certain amount of off-label use by the epidural and intrathecal route. Unlike the DBL product, the preservative-containing WOCKHARDT product must only be administered by the intravenous, intramuscular and subcutaneous routes.
Health professionals who use the DBL Morphine 10mg/mL product for the epidural or intrathecal route are advised to reserve stock of the DBL product or the other strengths of DBL Morphine products so that they will be able to continue to administer Morphine by the epidural and intrathecal route whilst the shortage exists.
Health professionals are asked to:
- take note of all correspondence from Hospira Australia Pty Ltd (the sponsor) consisting of:
- May 2013
- April 2013
- November 2013
- January 2013
- Letter dated 14 December 2012 - Re: DBL Morphine Sulfate Injection BP 10mg/1mL (pdf,175kb)
- Poster (landscape) dated 13 December 2012 - Morphine - Wockhardt Sulphate Injection safety poster (pdf,248kb)
- Poster (portrait) dated 13 December 2012 - Morphine - Wockhardt Sulphate Injection safety poster (pdf,242kb)
- note that both the DBL and WOCKHARDT products are both now available in Australia and you must now put in place provisions to ensure that the WOCKHARDT product is not administered by epidural or intrathecal routes.
- display the posters (available above or from Hospira) prominently where Morphine ampoules are stocked or used to mitigate the risk in areas where these procedures are carried out, such as in operating theatres.
- follow the instructions on the packaging, poster and other morphine-related letters being distributed by the supplier, Hospira.
WOCKHARDT morphine sulfate injection which contains preservative should be accounted for on a separate page in the Schedule 8 drug register.
Morphine sulfate is used for the 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. It is widely used in hospitals, clinics and ambulance settings throughout Australia. The most commonly used strength of morphine sulfate for injection is 10 mg/1mL ampoules.
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Content last updated: Wednesday, 22 May 2013
Content last reviewed: Wednesday, 22 May 2013
Web page last updated: Wednesday, 22 May 2013