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Q. What is the definition of a counterfeit drug?
A. U.S. law defines counterfeit drugs as those sold under a product name without
proper authorization. Counterfeiting can apply to both brand name and generic
products, where the identity of the source is mislabeled in a way that suggests
that it is the authentic approved product. Counterfeit products may include
products without the active ingredient, with an insufficient or excessive quantity
of the active ingredient, with the wrong active ingredient, or with fake packaging.
Q. What risks are involved with taking counterfeit drugs?
A. An individual who receives a counterfeit drug may be at risk for
a number of dangerous health consequences. Patients may experience
unexpected side effects, allergic reactions, or a worsening of their
medical condition. A number of counterfeit products do not contain
any active ingredients, and instead contain inert substances, which
do not provide the patient any treatment benefit. Counterfeit drugs
may also contain incorrect ingredients, improper dosages of the correct
ingredients, or they may contain hazardous ingredients.
Q. What is the worldwide prevalence of counterfeit drugs?
A. The extent of the problem of counterfeit drugs is unknown. Counterfeiting
is difficult to detect, investigate, and quantify. For these reasons, it is hard
to know or even estimate the true extent of the problem. What is known is that
counterfeit drugs can be found worldwide and are more prevalent in developing
countries. The World Health Organization (WHO) estimates that counterfeit drugs
range from less than 1% in developed countries to over 30% in some developing
countries.
Q. What is the prevalence of counterfeit drugs in the U.S.?
A. Drug counterfeiting occurs less frequently in the U.S. than in other
countries due to the strict regulatory framework that governs the production
of drug products and the distribution chain, and enforcement against
violators. However, the U.S. has recently experienced two highly publicized
examples of counterfeit drugs within the U.S. distribution system:
Lipitor tablets, a cholesterol-lowering medication, and Procrit, an
injectable drug used to stimulate red blood cell growth. FDA continues
to believe, and works to ensure, that the overall quality of drug products
that consumers purchase from U.S. pharmacies remains high. The American
public can be confident that these medications are safe and effective.
Q. Should consumers who currently purchase drugs over the Internet
or import medications from other countries be concerned about counterfeits?
A. Consumers can be confident in the quality, safety, and efficacy of drugs purchased
from a state-licensed pharmacy in the U.S. Websites that sell drugs over the
internet are not necessarily legitimate licensed pharmacies and may be located
anywhere around the world. Consumers need to be cautious when they buy drugs
over the internet, because they may not receive the FDA-approved drug, which
has been reviewed for safety and effectiveness. For those consumers who
purchase drugs over the Internet, look for websites that have the Verified Internet
Pharmacy Practice Sites (VIPPS) seal. These are licensed pharmacies where FDA-approved
medications can be purchased. These sites are identified by the VIPPS hyperlink
seal displayed on their Website. Unless medications have been purchased from
a state-licensed pharmacy website in the U.S., the safety and efficacy of these
medications cannot be guaranteed. For more information on VIPPS, go to www.vipps.info.
Q. Why is FDA focusing on counterfeit drugs?
A. Although FDA does not believe that the number of counterfeits entering
the U.S. drug supply has significantly escalated in recent years, the
agency believes that it needs to be proactive to prevent counterfeit
drugs from reaching consumers. Growth in counterfeiting may be spurred
by the economic incentives provided by an increasing volume of high
cost drugs, the development of technologies that make it easier to
counterfeit drugs, and the ability to sell drugs directly to consumers
without face-to-face contact through purchases over the internet.
Q. How can pharmacists, physicians, and other healthcare professionals
identify counterfeit medications?
A. Pharmacists, physicians, and other healthcare professionals should familiarize
themselves with those drugs most likely to be counterfeited and how to identify
these products. FDA periodically places updated information regarding counterfeiting
on its website at www.fda.gov/counterfeit. Healthcare professionals should suspect
that a patient may have received a counterfeit drug if the patient has experienced
an unexplained worsening of their medical condition or an unexpected side effect.
Also, if a patient reports that the drug tastes or looks different, if tablets
are chipped or cracked, or if the patient experiences burning at the injection
site for an injectable drug, they might have a counterfeit. Healthcare professionals
who believe that a patient has received a counterfeit drug should contact the
FDA immediately. In addition, any irregularity in packaging or labeling of a
drug product should be reported to the FDA and to the manufacturer immediately.
Healthcare professionals can contact the FDA at http://www.fda.gov/medwatch or
1-800-FDA-1088.
Q. What can consumers do to protect themselves from counterfeit drugs?
A. Consumers can protect themselves from the risks associated with
counterfeit drugs by purchasing prescription medications from state-licensed
pharmacies in the U.S. Consumers must be vigilant when examining their
personal medications, paying attention to the presence of altered or
unsealed containers or changes in the packaging of the product. Differences
in the physical appearance of the product, taste, and unexpected side
effects experienced should alert the patient to contact their physician,
pharmacist, or other healthcare professional who is providing treatment.
Q. What should consumers do if they suspect that they have
a counterfeit drug?
A, If a consumer believes that they may have received a counterfeit drug, they
should check with their pharmacist first. The pharmacist will know if the
manufacturer recently changed the appearance, flavor, or packaging of a drug
product. Also, if a pharmacy changes from one generic manufacturer to another
generic manufacturer for dispensing the same drug, the color or shape of the
drug product may be different. In this event, your pharmacist can verify that
it is not a counterfeit and can explain the change.
Q. How does FDA work with domestic and foreign government agencies
to combat counterfeits?
A. FDA is currently working with various U.S. government agencies, such as the
Department of Homeland Security (Customs and Border Protection) and the Department
of Justice, to combat counterfeit drugs. FDA is also very active in WHO’s
International Medical Products Anti-counterfeiting Task Force (IMPACT) which
is a public/private effort to develop regulatory, legislative, enforcement, communication,
and technological tools to combat counterfeit drugs around the world. FDA also
works bilaterally and multilaterally with individual countries and regions.
Q. How does FDA work with the public and industry to combat counterfeits?
A. FDA works with pharmaceutical manufacturers, wholesale distributors,
retailers, and other dispensers to identify and prevent counterfeit
drugs. FDA’s Action
Plan outlined in the 2004 Counterfeit Drug Task Force Report is based on the
efforts of the public and private sector to implement solutions to further secure
our nation’s drug supply. FDA continues to work with these entities on
the solutions and measures outlined in this Report. (http://www.fda.gov/oc/initiatives/counterfeit/report02_04.pdf)
Q. Are there any promising technologies that have the capability
of preventing counterfeiting?
A. There are several technologies that may prove helpful, including
radio frequency identification (RFID) chips and taggants. For example, radio
waves are used to automatically read RFID tags that are contained on items,
such as pharmaceutical products. These tags could have individual serial
numbers on each product, thus allowing the product to be tracked and traced
through the supply chain. Appropriate implementation and use of this technology
can help decrease the opportunities for diversion and counterfeiting by allowing
wholesale distributors and pharmacies to authenticate that the product was
handled by legitimate, licensed entities in the drug supply chain.
Q. Is expressing a concern for counterfeit drugs an excuse to crack
down on cheap drugs that Americans import from Canada?
A. No, the FDA is concerned about unsafe counterfeit drugs from any
country. Counterfeits are not equivalent in quality, safety, and efficacy
to the authentic drug. Counterfeits may enter the U.S. distribution
system from within the U.S. or from other countries, including Canada. FDA
is not attempting to single out any individual country in its efforts to
protect Americans from counterfeit drugs. FDA can only ensure that FDA-approved
products that have undergone the extensive review process are safe and effective;
many products from other countries have not undergone this process
and therefore present potential safety risks.
Q. How do counterfeits relate to current bioterrorism issues?
A. Although counterfeit drugs and bioterrorism may potentially be related,
FDA has no reason to believe that counterfeit drugs are being manufactured
or introduced for any reason other than making a profit. The FDA is
not currently aware of activity where use of counterfeit drugs is connected
with terrorism. However, FDA is working with appropriate agencies within
the Department of Health and Human Services and the Department of Homeland
Security to ensure that if any such threat appears, it will be immediately
identified and addressed.