posted on 1:33 PM, June 25, 2014
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The American College of Medical Toxicology has released a position statement, Antidote
Shortages: Impact and Response, with recommendations for policy change and creation of
uniform guidelines to improve access to life-saving antidotes and anti-venoms.
Phoenix, AZ (PRWEB) March 12, 2013 -- The American College of Medical Toxicologyhas released a position
statement warning against dwindling supplies of antidotes and medications that healthcare providers use to treat
a wide variety of poisoningsand medical conditions. Antidotes are often used to treat toxic exposures such as
lead poisoning, drug overdoses, and bites by venomous snakes. Although this is a long standing problem
already recognized by the medical toxicology and emergency medicine communities, recent national trends
reveal that the situation is worsening.
According to the College, one of the reasons for the low supplies of antidotes is the infrequent use of these
important medications leading to limited financial incentives for pharmaceutical companies to produce them.
The FDA’s Orphan Drug program provides resources to support production of these medications, but this often
means that only a single company will assume responsibility for manufacturing a specific antidote. This single
producer may have difficulty meeting national demands.
Another issue contributing to antidote shortages is that medications may not be used past their expiration date.
Expiration dates are issued in accordance with federal regulations, but these dates may not represent a time at
which the drug has truly “expired.” Many medications are stable over time and remain safe to use far past their
labeled expiration dates, although they may not be as strong as they were at the time of production. It is
considered illegal in many states to administer expired medications. In the case of potentially life-saving
antidotes where the existing supply has expired, as is the case with some snake anti-venoms, discarding
“expired” stock may lead to a dangerous situation for the snakebite victim.
ACMT points out that Poison Centers have collaborated to address the antidote shortage in several ways. An
Anti-venom Index has been established to help locate scarce anti-venoms. For some other agents - particularly
medical countermeasures for chemical, biological, radiological, nuclear, and public health emergencies -
cooperation between the Department of Defense, the Food and Drug Administration, and pharmaceutical
companies has resulted in programs to extend the shelf-life of existing supplies.
In the conclusion of the position statement, the ACMT experts encourage pharmaceutical manufacturers and
governmental agencies such as Health and Human Services and the FDA to immediately evaluate and address
access to critical antidotes and anti-venoms. The experts hope that the newly granted authority and mandates of
the Food and Drug Administration Safety and Innovation Act of 2012 will facilitate a fresh approach to the
ongoing, worsening problem of drug shortages.
ACMT is a professional, nonprofit association of physicians with recognized expertise in medical toxicology.
The College is dedicated to advancing the science and practice of medical toxicology through a variety of