The Genuine Danger of Counterfeit Medicines

This European Federation of Pharmaceutical Industries and Associations (EFPIA) YouTube video from 2008 details the dangers and prevalence of fraudulent, adulterated and counterfeit medications in developed and non-developed countries around the globe.

The data and information in this story is still particularly relevant given that this dangerous criminal act has grown in size and scope since this piece was first produced.

Secure Pharma Chain Blog, endorses the use by all members of the global pharmaceutical supply chain to deploy technologies and solutions to protect their inventories and the health care consumer.

To learn more about pharmaceutical anti-counterfeiting solutions, visit: www.xstreamsystems.net

Mayo Clinic: The Do’s and Don’ts of Buying Prescriptions Online

The following pointers are from MayoClinic.com about the do’s and don’ts to buying prescription drugs online:

Things to do:

• Do consult your doctor. Only take medications prescribed for you by your doctor or another health care professional who knows you. He or she can determine if a particular drug is safe for you or if another treatment would be more appropriate.
  
• Do use a licensed pharmacy. The National Association of Boards of Pharmacy can tell you whether an online pharmacy is licensed and in good standing. Some sites carry a seal of approval from Verified Internet Pharmacy Practice Sites (or VIPPS). To gain this approval, sites must maintain state licenses and allow inspections by the National Association of Boards of Pharmacy.
  
• Do insist on access to a registered pharmacist. Reputable sites offer toll-free access to registered pharmacists to answer your questions. Some online pharmacies have traditional physical locations as well. If you have questions about a medication after you begin taking it or you're concerned about drug reactions, it may be valuable to speak with a pharmacist in person.


• Do read the privacy and security policies. Before placing an order, be confident that your credit card number, personal health information and other personally identifiable information will be protected.


• Do compare prices. You may find great deals online, but there aren't any guarantees. Check your local drugstore's price—it might beat the online price. If online prices are significantly lower than your local pharmacy, you should question whether the site is legitimate.


• Do be alert for counterfeits. In some cases, drugs ordered online turned out to contain no active ingredient or to contain the wrong medicine. Reduce your risk by only using legitimate online pharmacies. Don't use any medicine that arrives in altered or unsealed packaging.

Things not to do:

• Don't use a site that bypasses prescriptions. Online pharmacies that dispense medication without a valid prescription are violating U.S. law. Don't be lured in by sites that give you a prescription if you complete an online questionnaire. Only your doctor can safely prescribe medication for you.


• Don't order medication that's not approved by the Food and Drug Administration (FDA). It's illegal to import unapproved drugs into the United States. Taking an inappropriate or unsafe drug can have life-threatening consequences.


• Don't overlook the address and phone number. Steer clear of sites that don't provide a street address and phone number or that list only foreign contact information. Use only U.S. pharmacies. International pharmacies may sell drugs that do not have FDA approval or that are illegal in the United States.


• Don't succumb to false claims. Don't buy medication from sites that advertise "miracle cures" or those that use impressive terminology to disguise a lack of good science.


• Don't keep complaints quiet. If your order doesn't arrive, you find unauthorized charges on your credit card or you have another problem with an online pharmacy, report it to the FDA. Speaking up can help promote a safer marketplace for everyone.

As offered in this blog before, it is very important to be vigilant in buying any prescription medications online.

Remember, “if a deals sounds too good to be true, it probably is” is the best advice when dealing with online products. Counterfeit and fraudulent drugs permeate the web with some estimates as high as 60% of online medications as counterfeit product. Protect yourself and your family and follow these do’s and don’ts.

For more helpful tips visit: http://www.mayoclinic.com/.

To learn more about XStream Systems revolutionary anti-counterfeiting technology and solutions visit: http://www.xstreamsystems.net/.

Repeating the Dangerous Statistics of Counterfeit and Fraudulent Medications

In the past we have blogged on quite a few statistics and on these in particular. It seems reasonable and relevant to repeat some of these statistics as it relates to counterfeit, fraudulent and adulterated medications.

These statistics are taken from both the World Health Organization (WHO) and Peter Pitts who is the Director for Medicine in the Public Interest and are often quoted in presentations as it relates to this very dangerous subject. No industry thought leaders challenge these statistics:

• Globally 10% of Pharmaceuticals are Counterfeit or Adulterated
• $35 Billion in Sales of Counterfeit Drugs in 2006
• $75 Billion in Sales of Counterfeit Drugs Projected by 2010
• 12-16% Growth Expected Globally
• 1-2% Pharmaceuticals in the United States are Counterfeit or Adulterated
• With 3.4 Billion prescriptions (filled in 2008) in the United States
• 34 Million of these prescriptions were estimated to be filled with counterfeit medications

Given these startling statistics, we at XStream encourage all within the global pharmaceutical supply chain to deploy and variety of solutions and technologies to protect the worldwide consumer. Specifically XStream believes that by screening the contents of the medications inside its sealed container and authenticating the product protects the manufacturer, distributor, provider and consumer. XStream’s XT250 utilizes EDXRD which allows the user to verify the contents of the medication without opening the container, destroying the product or degrading the material inside.

FDA Issues Guidance on Anti-Counterfeiting Techniques: Physical-Chemical Identifiers for Drugs

The Food and Drug Administration continues in its efforts to regulate and provide guidance on anti-counterfeiting solutions. This press release from July 13, describes their latest efforts on providing guidance on physical-chemical identifiers (PCIDs) which are added to medications by the manufacturers to make drugs more difficult to counterfeit and adulterate.

XStream supports and believes that a variety of solutions and techniques are vital in protecting the pharmaceutical supply chain and healthcare consumer from fraudulent, adulterated and counterfeit medications. PCIDs are one component of a secure pharmaceutical supply chain.

Currently the FDA is seeking comments on this guidance:

The FDA July 13 issued a draft guidance on PCIDs used by manufacturers to make drugs more difficult to counterfeit and to make genuine versions of drugs easier to identify.

The draft “Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anti-Counterfeiting” is intended to provide guidance on the use of PCIDs in pills and capsules.

According to the agency, PCIDs have unique physical or chemical properties used to identify and authenticate a drug product or dosage. The substances include inks, pigments and flavors, as well as various chemicals that can be used as molecular tags to form a PCID. The FDA anticipates that many of the potential ingredients for PCIDs already are used as food additives, colorants or other “inactive ingredients with established safety profiles.”

The draft guidance recommends using the lowest level of PCID possible to ensure identification of the product. The PCID also should be a substance with no medicinal effect and no potential to interact with the drug’s active ingredient, according to the FDA.

Comments on the draft guidance may be submitted electronically at http://www.regulations.gov. The comments, due by Oct. 12, should be identified with docket number FDA-2009-D-0212.

Pirated Pills

The Sunday Leader reported that: Leading medical professionals claim that 30% of the medical drugs currently circulating in the country of Sir Lanka are fakes…

Several doctors at leading universities have voiced their concern over the validity of the drugs administered to patients and the difficulty in discerning the real version from the fake. “They (the counterfeiters) have all the packaging equipment — they look and feel exactly the same as genuine tablets even I, as a doctor, wouldn’t be able to tell them apart — but they are fake and sometimes harmful.”

The fake prescription can contain a variety of ingredients from sugar to borax, cement, toxic dyes, or other harmful chemicals. The scope of the counterfeits in Sir Lanka is enormous. At a current rate of $300 million in imports a year and a 30% counterfeit rate, the fake drug market would be valued at $90 million a year.

While counterfeit medicines are seen worldwide, two reasons cited for their prevalence in Sir Lanka is the lack of testing facilities locally and the lack of proper regulation. Regulatory authorities often rely on the importing pharmaceutical company testing and certification to document the medicines validity. (This in some cases is rather like putting the fox in charge of guarding the hen house.)


Disheartened, these doctors feel there is no valid way for them to check for substandard drugs in their county. We at XStream understand first hand the importance of pharmaceutical screening. There are options for checking the authenticity and quality of your medicines beyond packaging and traditional security measures. If you would like more information on this quick easy method of pharmaceutical authentication, please visit www.xstreamsystems.net.

"Drug counterfeiting underestimated for too long..." states the Chairman of Sanofi-Aventis

As reported by the Dow Jones News Service, "Drug counterfeiting has been underestimated for too long, Sanofi-Aventis Chairman said Thursday, also calling for more action from the European Union."

At the annual meeting of the European Federation of Pharmaceutical Industries and Associations, Jean-Francois Dehecq said that "drug counterfeiting 'used to be marginal, it is now totally industrialized.'" Counterfeit pharmaceuticals "represented approximately EUR45 billion in sales in 2006, making up for almost 10 percent of the world pharmaceutical market the World Health Organization estimates.

Link to the full story at Dow Jones.

What the True Pharmaceutical Security Focus Should Be: Authentication

As many of those who have spent many years within the Pharmaceutical Supply Chain, I watch the major players within the pharmaceutical industry jockey and debate the current initiatives that are intended to secure the safety and efficacy of the medications that we in the United States take daily.

In this era of globalization we in the United States find ourselves increasingly consuming medications that use foreign produced raw materials, outsourced manufacturing and are packaged overseas. Although most of these efforts are managed and regulated according to tight corporate and FDA scrutiny, serious issues have arisen recently which demonstrate nefarious intent to circumvent the safety and security of these globally produced products.

Additionally we find international and domestic criminal organizations, realizing the potential of high profits and low risk, using sophisticated operations to adulteration, dilute or counterfeit medications that make their way into our drug stores and healthcare providers.

The threats to our safety as a nation are real. The danger that contaminated, adulterated, diluted or counterfeit medications that our population currently faces is increasing every day.

Unfortunately we find that there are few deterrents or regulatory processes in place to adequately protect our population from these sophisticated threats to our collective health.

Currently the Congress, Federal and State regulatory agencies are grappling with the most effective way to deal with this clear and present danger. To date most if not all of their efforts have been focused on track and trace technologies and protocols. Track and trace encompass RFID, advance bar codes; hologram labels technology and pedigree protocols.

Although these efforts are part of the solution, they fall short of truly and efficiently solving the problem. The obstacles to quickly adapting them as an effective solution are many. They are costly, time consuming to adopt, have numerous technical challenges, are not standardized and most importantly require each member of the supply chain to be synchronized and monitored for them to be an effective deterrent.

However the biggest drawback is that the only thing that track and trace technologies and protocols adequately track and trace is the packaging that the medication is packaged. Despite all of the cost, technical challenges and time consuming efforts that they entail, these efforts do not authenticate or verify the actual contents which may have been adulterated, counterfeited, diluted or contaminated at one of various points within the supply chain.

Currently XStream Systems, XT250 technology has the ability to quickly, efficiently and effectively authenticate and verify the contents of the medication within the sealed container. This process can happen in a very cost effective manner anywhere within the Pharmaceutical Supply Chain with little or no change in processes or protocols. It can complement existing Track and Trace initiatives by actually providing authentication documentation or operate as a standalone system.

The cost of implementing and operating authentication technology such as the XT250 is a fraction of the initial start up costs of an RFID system and it could be operational in a fraction of the time that it would take for one segment of the Pharmaceutical Supply Chain to implement universally.

Maybe it is just too obvious but I hope that those in a position to make a difference take time to look at filling in the gaps in the current mindset and direction of protecting our Pharmaceutical Supply Chain. Hopefully they discover that the ultimate solution is to authenticate and verify what is in the bottle.

Alan Clock, Senior Vice President, Sales and Marketing, XStream Systems, Inc.

Tip of the Iceberg

When giving presentations across the country, there is one slide in particular that seems to stand out and really hit hard on the counterfeit pharma issue and what is really out there. This image contains a quote which says it all. It states, “Most of the counterfeits are detected largely by accident. It means that we are just seeing the tip of the iceberg...We presume there is an iceberg to be found somewhere under the tip, but no one has been able to put their head under the water.” By Valerio Reggi, World Health Organization (WHO) 2007.