In Part I of
this series, I explained the definition of pharmaceutical expiration
dates and ‘do not use beyond’ dates, and how both are
determined.

Additionally,
I reviewed information from the Shelf Life Extension Program (SLEP)
database, which led to a temporary Emergency Use Authorization in
2009, permitting the use of certain Tamiflu products (to treat H1N1
influenza) for up to an additional five years beyond the imprinted
expiration date. (See
Part I of this series for more information. )

Part II will
examine the data regarding use of common antibiotics beyond their
expiration dates.

The following
is excerpted from my upcoming book, Armageddon Medicine.

Does a can
of tuna go bad overnight? What about a bottle of medicine? Common
sense suggests the answer is no, but is there any evidence?

The primary
source of information regarding the prolonged stability of medications
comes from the Shelf Life Extension Program database. Rather than
discard millions of dollars worth of expired drugs stockpiled for
emergency use, the U.S. federal government tested representative
lots of selected medications for extended stability. These stockpiled
drugs are aimed at emergency use for injuries and infections rather
than chronic diseases such as diabetes, heart disease, and asthma.
The most useful data for the layman is related to drugs to combat
bacterial and viral infections.

Of the antibiotics
tested, all passed assays for stability, potency, and appearance
for at least a year beyond the original expiration date.

Of the lots
tested, the following had their expiration date extended by the
number of months indicated.

Medication
Name
Dosage
Form
Average
extension in months (range)

Amoxicillin
sodium
Tablets

23 (22–23)

Ampicillin

Capsules

49 (22–64)

Cephalexin

Capsules

57 (28–135)

Ciprofloxacin

Tablets
55 (12–142)

Doxycycline
Hyclate
Capsules

50 (37–66)

Erythromycin
lactobionate
Powder

60 (38–83)

Sulfisoxasole

Tablets

56 (45–68)

Tetracycline
HCl
Capsules

50 (17–133)

Silver
sulfadiazine
Cream
57 (28–104)

A
summary of the Shelf Life Extension Prorgarm (SLEP) data is available
in The Journal of Pharmaceutical Sciences, Vol. 95, No. 7,
July 2006.

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the rest of the article

October
29, 2010