Urgent notice: Sandoz Morphine Sulfate Injection USP 2mg/ml (1ml ampoules) – DIN 02242484
The Ontario Pharmacists' Association, working in collaboration with the Ontario Ministry of Health and Long-Term Care and Health Canada’s Health Products and Food Branch, is advising all pharmacists and their team members to be aware of a safety warning related to Sandoz Morphine Sulfate Injection USP. Some boxes of Sandoz Morphine Sulfate Injection USP 2mg/ml (1ml ampoules), DIN 02242484, may contain ampoules labeled as Isoproterenol Hydrochloride Injection 0.2mg/ml (1ml ampoules), DIN 00897639, in addition to ampoules labeled as containing morphine.
Links to the English and French memos from Health Canada to pharmacies, medical clinics and hospitals can be found here:
- 2012-03-21 HPFB Notice_HCP_Sandoz_Morphine_English
- 2012-03-21 HPFB Notice_HCP_Sandoz_Morphine_French
- 2012-03-21 HPFB Notice_Hosp_Sandoz_Morphine_English
- 2012-03-21 HPFB Notice_Hosp_Sandoz_Morphine_French
- An image of the affected box can be found here.
While the lots of morphine (Lot CC2824 Exp. 2014-12) and isoproterenol (Lot CB8787 Exp. 2012-11) have been identified, it is unclear whether other similar packages exist and the depth of this problem. Pharmacists and other team members are urged to be vigilant in checking the exterior packaging and its contents for boxes of both Sandoz morphine and Sandoz isoproterenol prior to dispensing.
The Ontario Pharmacists’ Association remains committed to working with the Ministry of Health and Long-Term Care, the Ontario College of Pharmacists, and other healthcare associations to ensure as smooth a transition as possible for healthcare providers in their management of the challenges associated with drug shortages. We will continue to keep you updated as new information becomes available.
Ministry update on the drug shortage issue
To address the current shortage of certain injectable medications, the Ministry of Health and Long-Term Care has developed a five-point action plan that will guide the Ontario government’s response. The plan includes health care system strategies for inventory and impact assessment, inventory management, facilitated procurement, modification of services and communications. Pharmacists and other health care providers who work with injectable medications affected by the production slowdown are urged to review the Ministry’s March 20 update. A framework to help guide and support ethical decision-making in the allocation of resources is now available and can be found here.
To ensure patient safety, all health care providers are being encouraged to engage in dialogue on strategies to conserve supply, and to consider therapeutic options, including alternate dosage forms and modified dosing. The Drug Information and Research Centre at the Ontario Pharmacists’ Association (OPA) can provide information on drug availability and identification, therapeutic uses of drugs, method of drug administration, drugs in pregnancy and lactation, adverse effects of drugs, precautions and contraindications of drug use, drug interactions, pharmacokinetics, drug stability, formulary issues and other drug-related topics.
As indicated in our March 13 message to members, OPA is playing a critical role as a member of the Ministry’s Drug Shortage Technical Advisory Group (DSTAG), providing recognized leadership in areas such as drug information and guidance on issues such as resource allocation and inventory management. We are participating in daily conference calls with the Ministry’s Emergency Operations Centre (EOC); have provided the profession’s perspective on the ethical framework document; and have been asked to participate in several ad hoc working groups that support the technical advisory group.
At the Ministry’s request, your Association is currently working on a mechanism to collect and collate aggregated information from pharmacists that will then be forwarded to the EOC. This mechanism will also be help to identify any trends or changes in prescribing, and may help to identify future shortages or back orders of solid dosage forms resulting from these changes.
As indicated in the Ministry’s March 20 memo, Local Health Integration Networks (LHINs) will play a key role in managing the shortage issues locally, and in tracking inventories. The Ontario Pharmacists’ Association has emphasized that since community pharmacies are not yet integrated into the LHIN structure, OPA must be included in all information from the Ministry regarding inventory levels. The Ministry has been very receptive to this message and all stakeholders recognize the important role of pharmacists in managing the shortage challenges.