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In today’s day and age we’ve seen everything become a knock off from designer hand bags to shoes and even hundred dollar bills. Although wearing fake copies of Dolce & Gabbana boots never killed anyone imitation prescription drugs can cause tragic, preventable deaths. The most unscrupulously produced counterfeits that kill innocent people are what we want to make you aware of by reading this blog.
We have provided information for everyone; even if you don’t take prescription drugs someone you know and love does. Health professionals, parents, patients and everyone else should be aware and educated of this public health risk. Not being informed of counterfeit drugs may hurt you or a loved one.

What are Prescription Counterfeits?

It's scary to realize the multitude of factors that can be manipulated to produce fake drugs. It's even scarier to realize that people are increasingly vulnerable to falling for this illegal scheme. It's hard to differentiate fake drugs from the intended, safe drugs. There could be a change in the dosage of the active ingredient (higher or lower), no active ingredients at all, the fraudulent prescription may contain other harmful ingredients that aren't supposed to be included, or a con artist could possibly hand you a drug that is supposed to treat a heart attack and you wanted a drug to treat epilepsy. Then you have to think about the fact that the packaging just might be changed and the contents inside do not correlate. You can imagine the tragic consequences that result from taking unsecured prescription drugs.

(http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/default.htmesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/default.htm

History of Drug Counterfeiting

Counterfeit medications are not under the restraints of quality control. They are made to look exactly like the real medications they are imitating. It is estimated that five percent of the world's medications are counterfeits, costing manufacturers losses of approximately twenty billion dollars per year. Many times fake drugs contain the correct ingredients in incorrect quantities, but most contain a wrong active ingredient, or no active ingredient at all. History shows that substituting or omitting active ingredients can cause many health risks.

Years ago in Haiti, nearly one hundred cases of fatal kidney insufficiency in children was documented due to contaminated counterfeit cough syrup. Counterfeit vaccines have been found in Niger, and research shows that up to eighty thousand children were treated with the impostor drugs. Over one hundred children acquired fatal infections, possibly from the fake vaccines.

Counterfeit drugs have been ignored by the pharmaceutical industry and regulatory agencies. The Pharmaceutical Security Institute has been established to investigate and locate counterfeit medications. Reports from this institution have not been provided to authorities or made public though. A global conference on counterfeiting was organized in Switzerland in 2002. The conference concluded that this underestimated problem was not being taken seriously by governments.

The WHO was developed to react to concerns about counterfeit medications. In the mid-1980s it requested to initiate programs for the prevention and detection of counterfeit drugs, as well as the importation and smuggling of these substances. Lack of funds have prevented the WHO from being effective.

http://search.ebscohost.com/login.aspx?direct=true&db=cmedm&AN=14583061&site=ehost-live

Counterfeit Drugs: In the News or Not

There is very little information about counterfeit drugs in the news. You would think that with counterfeit drugs becoming more prevalent on the market that there would be more information available about them. However, Pharmaceutical companies and governments are reluctant to notify the problem to health staff and the public because of the notion that the publicity will harm the sales of these companies’ brand-name products in a fiercely competitive business. This was so shocking to us! Once again greed has played a major factor in how the phamaceutical companies go about their issues even when it can possibly interfere with the lives of others. We're guessing the pharmaceutical companies don’t really care how many people don’t know or die from these counterfeit drugs as long as they're still getting their money. Cockburn states, “that most of the literature on counterfeit drugs is from local investigative journalism.” For people who are rightfully concerned, you can go to the FDA website to obtain more information. On the other hand, there are really no reliable accessible databases whereby health workers or the public can access completely current details of which products are being faked (Cockburn, 2009).
Cockburn, R., Newton, P., Agyarko, E., Akunyili, D., White, N., (2005) The Global Threat of Counterfeit Drugs: Why Industry and Governments Must Communicate the Dangers. Volume 2 Issue 4 April 2005. Retrieved October 1, 2009.

How to Protect Yourself

Although there have been multiple attempts to secure the distribution of prescription drugs in the US, there continues to be challenges to our safety due to counterfeit drugs. Too many people have scarce funds and are unable to meet the cost that is required for the purchase of safe, effective FDA approved drugs. The purchase of prescription drugs over the internet is convenient, has the capability to compare prices of products with ease, provides almost total privacy when consulting a pharmacist, and it also has the possibility of taking your life or a loved one’s. This is why it is a matter of life or death to armor yourself with knowledge when considering purchasing prescriptions online.
Guidelines for buying online:
· Check for the VIPPS seal (Verified Internet Pharmacy Practice Site)—this program makes sure online drug stores are legal and honest.
· Look into websites with the National Association of Boards of Pharmacy before purchasing to ensure that the seller is properly licensed.
http://www.nabp.net/
· Beware of sites that sell prescription drugs without a prescription and/or products that are not approved by the FDA (this is illegal and unsafe).
· Make sure the site provides a pharmacist to answer questions online that are based in the U.S.
· Always talk to your primary healthcare provider before taking any medicine for the first time.
· Don’t try to self-diagnose or rely on questionnaires to decide on which medication to take; prescription drugs require a physical exam. Plus, there are many adverse drug interactions that may occur if you take a drug without knowing the proper associated precautions.
· All reputable online pharmacies should provide an address or toll-free phone number to contact in case of a problem.

Many choices exist for buying prescription drugs today. You might be gambling with your health and life when you throw your money away on ineffective drugs or even worse, harmful drugs that are just pretending to help you.

Guidelines for avoiding counterfeit drugs:
· Know your medications—color, size, taste, and side effects
· Pay close attention to the packaging—check altered or unsealed containers, or changes in packaging or labels
· Only buy prescription drugs from reputable sellers—check National Association of Boards of Pharmacy
· Make sure seller is properly licensed

http://www.fda.gov/ForConsumers/ProtectYourSelf/default.htm
http://dangerouspill.com/about_the_issue/event_video.html
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108904.htm

What Pharmaceutical Companies, Government and Health Agencies are Doing to Protect Consumers

The FDA (Food and Drug Administration) is our safeguard against drugs; they have the task of approving all new drugs that are intended to be sold to the public. We rely on the FDA and FTC (Federal Trade Commission) to force pharmacy companies to be honest and abide by laws when dealing with their products. The FDA also works with the NABP (National Association of Boards of Pharmacy) to impose U.S. and state laws within the pharmacy companies. The relationships among these federal groups is necessary to aid in protecting the U.S. from counterfeit drugs…not “unapproved new drugs,” which are defined as drugs that claim to be comparable to or a foreign version of a FDA- approved drug. These “unapproved new drugs” have an obvious risk-taking concern when consuming them but what about the FDA-approved drugs? We must still be cautious because of the increasingly intelligent counterfeiters and their technology which may have the capability of dispensing fake drugs that can go undetected despite our government’s current efforts. The WHO (World Health Organization) is an important organization for keeping the public and other organizations informed of drug related stats. There is a shocking and dramatic trend that outlines the increase in counterfeit drugs making their way into consumer hands! The WHO estimated that up to 50% of drugs in some countries are counterfeit!!! The government’s answer to our problem comes in a list of provisions suggested by the FDA Counterfeit Drug Task Force. This Agency will join forces with secret service, U.S. Customs and Border Protection, the Bureau of Engraving and Printing, and the Department of Justice, along with a range of private sector stakeholders to help curtail the dangers to the public when consuming counterfeit drugs that have entered the U.S. drug distribution channels. These are the provisions:
1) Ensuring safety concerning the actual drug product and its packaging—use of color-shifting inks, holograms, taggants, or chemical markers imbedded in a drug or its label and tamper-proof packaging
2) Providing a safe method for movement of the product as it travels through the U.S. drug distribution chain—require “pedigree papers” with electronic track and trace identification using radio-frequency identification (RFID)
3) Improving regulatory carelessness and enforcement—National Association of Boards of Pharmacy (NABP) with its Model Rules for Licensure of Wholesale Distributors and the creation of the Verified-Accredited Wholesale Distributors (VAWD) program
4) Increasing punishment for counterfeiters—collaboration with Sentencing Commission
5) Boosting concern and awareness of counterfeit drugs—report to Medwatch and the creation of a Counterfeit Alert Network (CAN) that will notify its members of a verified counterfeit event
6) Increasing collaboration internationally

http://www.cbp.gov/xp/cgov/travel/clearing/restricted/medication_drugs.xml
http://www.ftc.gov/bcp/
http://www.fda.gov/NewsEvents/Speeches/ucm052354.htm

Drug Counterfeiting Cases

People from all walks of life are potential drug counterfeiters, from CEO’s to measly con-artists that are out to make a few bucks. The one thing all these criminals have in common is that they do not care who they hurt to make money.
The president and CEO of NuCare Pharmaceuticals, Christopher Wayne Lamoreaux, knowingly purchased counterfeit prescription drugs from another pharmaceutical company to then repack and sell them as originals. The conterfiet drugs inculded Lipitor and Bextra (FDA 2005). Lamoreaux was sentenced to a federal prison for 21 months, 3 years of supervised probation and a fine of over $115,000.
http://libproxy.uta.edu:2066/login.aspx?direct=true&db=rzh&AN=2005102027&site=ehost-live

Babies bring the most peaceful loving thoughts to mind, but not for two California criminals. Shane Thompson and Margaret Thompson counterfeited baby formula that was meant for babies suffering from milk allergies. They didn’t do this by making their own formula up or adding fake ingredients, they simply peeled a label. The Thompsons scanned the label of the expensive specialized baby formal and made copies. They then purchased the cheapest milk-based formula and replaced the label with the copied ones. The counterfeited ‘specialized’ milk was then returned to a major grocery store, hence, making them a profit.
These counterfeit cans were then put back on the shelf and purchased by unknowing parents. The babies that were fed this formula suffered from a fever, vomiting, skin rash, and diarrhea due to a reaction to the cow proteins. Parents had to rush their babies to the hospital for treatment. The maker of the specialized formula, Mead Johnson, contacted authorities about the counterfeit infant formula.
The FDA stepped in and asked the grocery stores to take additional security measures and ID anyone returning the specialized milk. This lead to the arrest of Margaret Thompson who was finally convicted by matching her fingerprints on several of the counterfeit cans. Her husband’s fingerprints were also matched, and he was convicted as well. Shane Thompson was convicted to only seven months of prison, and his wife was placed on five year probation. The couple had to pay over $200,000 in fines.
Nordenburg, T. (2000). Counterfeiting couple pays high price for baby formula fraud. FDA Consumer, Nov-Dec; Vol. 34 (6), pp39

How to Report Unlawful Sales

While manufacturers, wholesalers, re-packagers, and pharmacists are in the best position to detect counterfeit drugs, healthcare professionals and consumers can be helpful informers. If you notice any inconsistencies with your medication or suspect a pharmacy of selling illegitimate drugs you should report the suspected counterfeit drugs to the pharmacist who sold you the medication (there may have been a genuine change in the manufacturing of the drug altogether). You can also report to the FDA by calling Medwatch at 1-800-332-1088 or go online to fill out a form:
www.fda.gov/oc/buyonline/buyonlineform.htm
www.fda.gov/medwatch

In Summary...

It is important to realize that the active ingredients in most counterfeit medications have been altered in some way. The use of counterfeit drugs causes many deaths that can be prevented. Everyone needs to become educated about this public health risk.

Counterfeit medications have been largely ignored by the pharmaceutical industry and regulatory agencies. The public has been kept in the dark about how prevalent the problem is because large drug companies do not want to scare the public and hurt their own sales. The WHO was developed to react to concerns about counterfeit medications, but a lack of funds has prevented it from being effective.

As consumers, we must protect ourselves from unknowingly purchasing counterfeit drugs. Making sure that your pharmacy is properly licensed is a great way to ensure that you will be purchasing genuine medications. Report any inconsistencies with your medications to your pharmacist, and if you suspect a pharmacy of selling counterfeits, you should report directly to the FDA.

Further Reading:

Counterfeit and Substandard Medicines
http://search.ebscohost.com/login.aspx?direct=true&db=a9h&AN=37325883&site=ehost-live

Dangerous Web Domains
http://search.ebscohost.com/login.aspx?direct=true&db=a9h&AN=33662969&site=ehost-live

The Menace of Counterfeit Drugs
http://search.ebscohost.com/login.aspx?direct=true&db=a9h&AN=36085080&site=ehost-live

The Deadly World of Fake Drugs
http://search.ebscohost.com/login.aspx?direct=true&db=a9h&AN=34046869&site=ehost-live