E-DRUG: Stability of drugs beyond labeled expiration dates
[As a follow-on to postings on recycling of drugs in the US, Riaz has (below)
commented on a study done by the US Army on stability of medicines beyond
labeled expiration dates (SLEP). Reference to the published study is given. The
same study was commented on in an article in Wall Street Journal some years ago
and you will find the articcle in the E-drug archive on 30 March 2000. Here the
moderator have copied Mark Raijmakers comment to the article as it appears in
'Forwarded to me from the US, the Wall Street Journal (WSJ)on drug
donations and expired drugs. The contribution in the WSJ on pharmaceuticals is
split into two sections: 'major business news' on donations of expired drugs
and a 'page one feature' analysis of the reasons behind expiry-date setting of
The 'major business news' is a very business minded article paying no
attention to the complexity of drug donations' practice suggesting developing
countries should accept expired drugs because the US military has done tests
that prove them usable. The article is not providing any
arguments why expired drug donations are or should not be accepted in many
donations' cases. It also doesn't pay attention to the context of drug
donations to developing countries where in the majority of cases expired drugs
cannot be tested like the US military has done.
The 'page one feature' analysis will certainly provoke a lot of discussion
about the real reasons of expiry-date setting. The WSJ article merely suggests
that marketing or economical reasons are the reasons of expiry-date setting
although some quality arguments are also incorporated into the article.
For you that remember ... on the e-drug mailing list there has been an
extensive discussion on expired drug donations between May 8 and May 23, 1997.
More than 10 e-druggers participated in this discussion which provides some
interesting viewpoints on the issue of donating expired drugs.'
Does anyone know and have access to the US Department of Defense study
on drug expiry and drug stability?
I recall it reached some stunning conclusions on the stability of
many drugs necessary in conflict situations, including many drugs on the
EDL's of developing countries. The empirical evidence this provides may
usefully inform the debate. It may also tell us much about the need to
keeping sales high.
Lyon RC (1), Taylor JS (1), Porter DA (2), Prasanna HR (1), Hussain AS (3).
Stability profiles of drug products extended beyond labeled expiration dates.
Journal of pharmaceutical sciences 2006; 95(7): 1549-1560.
Affiliation(s): (1) Division of Product Quality Research, Center for Drug
Evaluation and Research, Food and Drug Administration, HFD-941, White Oak, Life
Sciences Building 64, 10903 New Hampshire Avenue, Silver Spring,
Maryland 20993-0002, USA (2) Division of Field Science, Office of Regional
Operations, Office of Regulatory Affairs, Food and Drug Administration,
Rockville, Maryland 20857, USA (3) Vice President & Global Head of
Biopharmaceutical Development, Sandoz, 506 Carnegie Center, Princeton, New
Jersey 08540, USA
The American Medical Association has questioned whether expiration
dating markedly underestimates the actual shelf life of drug products.
Results from the shelf life extension program (SLEP) have been evaluated
to provide extensive data to address this issue. The SLEP has been
administered by the Food and Drug Administration for the United States
Department of Defense (DOD) for 20 years. This program probably contains
the most extensive source of pharmaceutical stability data extant. This
report summarizes extended stability profiles for 122 different drug
products (3005 different lots). The drug products were categorized into
five groups based on incidence of initial extension failures and
termination failures (extended lot eventually failed upon re-testing).
Based on testing and stability assessment, 88% of the lots were extended
at least 1 year beyond their original expiration date for an average
extension of 66 months, but the additional stability period was highly
variable. The SLEP data supports the assertion that many drug products,
if properly stored, can be extended past the expiration date. Due to the
lot-to-lot variability, the stability and quality of extended drug
products can only be assured by periodic testing and systematic
evaluation of each lot.
Third World Network