Update on Drug Shortages of Clinical Significance

From the Department of Pharmacy Services

March 3, 2008

Drug

Reason

Available supply

Anticipated Resolution of Shortage

Comments

Colchicine Injection / FDA is requesting that manufacturers of injectable colchicine cease production and distribution / Pharmacy has pulled colchicine injection from inventory in response to FDA’s action and the decision from P&T Committee to remove it from formulary. / Unknown / The action the FDA has taken does not affect oral colchicine products as they feel the risks with the medication are less acute, so it is still available as an alternative.
FDA has also released a MedWatch alert stating that colchicine is a highly toxic drug and it can easily be administered in excessive doses, especially when given intravenously. There is a narrow margin between an effective dose of the drug and a toxic dose that can result in serious health risks, including death. Side effects are generally not experienced until the patient has already received toxic levels of colchicine.The FDA is aware of 50 reports of adverse events associated with the use of intravenous colchicine, including 23 deaths. Potentially fatal effects include low blood cell counts, cardiac events, and organ failure.
Haemophilis Influenzae Type b Conjugate Vaccine (PedVax Hib); Comvax, a Hib/Hepatitis B vaccine; ActHIB and TriHIBit / Unavailable due to a recall resulting from manufacturer production problems. / Our supply of Hib vaccine, including that which is state-supplied, will be intermittent for the duration of this shortage. / Merck, the manufacturer, will not be able to resume production until late in 2008. / There is unlikely to be enough available to vaccinate all children for whom it is recommended. MHS does not currently have any of these Hib vaccines available.
Interim recommendationsfrom the Centers for Disease Control and Prevention (CDC) is to defer booster vaccination of most young children, who would ordinarily be administered a dose at 12–15 months of age, except for children in specific high risk groups.
Providers should register and track children for whom the booster dose is deferred to facilitate recalling them for vaccination when the supply improves.
Children at increased risk for Hib include: children with sickle cell disease, leukemia and malignant neoplasms, HIV and certain other immunocompromising conditions, asplenia, as well as American Indian (AI) and Alaska Native (AN) children. CDC recommends vaccinating these children according to the routinely recommended schedule. PedVax Hib and Comvax are preferred in AI/AN children due to more rapid seroconversion to protective antibody concentrations in the first 6 months of life.
More detailed information from CDC is available at
Please contact Pharmacy Services if you have questions about the shortages or current vaccine availability.
Heparin / Recall of multi-dose vials, single-dose vials and flushes from Baxter / APP has heparin products available and is increasing production. / Unknown / Pharmacy will be purchasing heparin while available from a manufacturer other than Baxter for the foreseeable future.However, it is anticipated that a shortage of heparin products due to this situation is likely and that at some point, Baxter heparin products may need to be used when there is no other alternative. When Pharmacy has no other manufacturer’s product available besides Baxter, we will provide an update and let providers know. Please contact Pharmacy Services with any questions about this situation and available heparin products.