Thiamine Shortage — Plight of Low-Cost, Lifesaving Orphan Drugs
http://www.100md.com
《新英格兰医药杂志》
To the Editor: The recent three-month nationwide shortage of intravenous formulations of vitamin B1 (thiamine) highlights the fact that only one company, American Pharmaceutical Partners, is manufacturing this lifesaving drug.1 This shortage was the second in the past few years, and the company has not provided a reason for the shortages. The retail cost of parenteral thiamine can be as low as 89 cents for 100 mg with collective purchases, so it is no wonder there was a shortage of this medication when blockbuster drugs hold more commercial promise.
Parenteral thiamine is used to treat thiamine-deficiency disorders, such as Wernicke's encephalopathy, the Wernicke–Korsakoff syndrome, and high-output heart failure due to beriberi.2 Patients with malabsorption syndromes may also require parenteral thiamine. Thiamine supplementation is also commonly used in chronically malnourished patients and in patients with alcoholism. Oral administration is the preferred route for thiamine, although intravenous or intramuscular administration is required in medical emergencies.
The federal government and the Food and Drug Administration should step up and enforce mechanisms to ensure an uninterrupted supply of lifesaving and cheap orphan drugs. Incentives for the manufacturers or importation of the drugs from Canada or Europe are both viable options.
P. Dileep Kumar, M.D.
Port Huron Hospital
Port Huron, MI 48060
References
Thiamine hydrochloride for injection. Bethesda, Md.: American Society of Health-System Pharmacists, December 2005. (Accessed January 13, 2006, at http://www.ashp.org/shortage/thiamine.cfm?cfid=23522325&CFToken=51951252.)
Russell RM. Vitamin and trace mineral deficiency and excess. In: Kasper DL, Braunwald E, Fauci AS, Hauser SL, Longo DL, Jameson JL, eds. Harrison's principles of internal medicine. 16th ed. New York: McGraw-Hill, 2005:403-11.
Parenteral thiamine is used to treat thiamine-deficiency disorders, such as Wernicke's encephalopathy, the Wernicke–Korsakoff syndrome, and high-output heart failure due to beriberi.2 Patients with malabsorption syndromes may also require parenteral thiamine. Thiamine supplementation is also commonly used in chronically malnourished patients and in patients with alcoholism. Oral administration is the preferred route for thiamine, although intravenous or intramuscular administration is required in medical emergencies.
The federal government and the Food and Drug Administration should step up and enforce mechanisms to ensure an uninterrupted supply of lifesaving and cheap orphan drugs. Incentives for the manufacturers or importation of the drugs from Canada or Europe are both viable options.
P. Dileep Kumar, M.D.
Port Huron Hospital
Port Huron, MI 48060
References
Thiamine hydrochloride for injection. Bethesda, Md.: American Society of Health-System Pharmacists, December 2005. (Accessed January 13, 2006, at http://www.ashp.org/shortage/thiamine.cfm?cfid=23522325&CFToken=51951252.)
Russell RM. Vitamin and trace mineral deficiency and excess. In: Kasper DL, Braunwald E, Fauci AS, Hauser SL, Longo DL, Jameson JL, eds. Harrison's principles of internal medicine. 16th ed. New York: McGraw-Hill, 2005:403-11.