Scary Stuff

A sobering new report from the United Nations, "Counterfeiting: a global spread, a global threat," was released last Friday. It details the growing enterprise of counterfeiting and its allure to organized criminals.

Why? "Counterfeiting has become fertile ground for organized crime because the syndicates realize they can make great profit at little risk," said Sandro Calvani, the director of the U.N. Interregional Crime and Justice Research Institute (UNICRI), which wrote the report.

The extensive report addresses all varieties of counterfeiting, with counterfeit medicines, "products which may cause serious damage to the health and safety of consumers," as a prominent part. (To read the report and an executive summary, go to http://www.unicri.it/wwd/emerging_crimes/counterfeiting.php)

Of particular interest is the section on "The Scale of the Problem."

In this section¸ the report looks at the attraction and impact of counterfeit drugs in highly developed versus developing countries, and the strategies adopted by counterfeiters. In developed countries, the report notes, counterfeiters focus on drugs with the highest market share and profitability; whereas in developing countries, they focus on the constant demand for drugs that combat epidemics and serious diseases, such as malaria and HIV.

Seemingly out of a horror film plot - though sadly not - the report also raises a very scary point about the large presence of counterfeit drugs in developing countries (as high as 10-30% in Africa, Asia and parts of Latin America according to the WHO). According to the report, the long-term effects of patients unknowingly taking counterfeit medicines to combat serious diseases could actually "promote the development of new strains of viruses, parasites and bacteria ... for example in the case of malaria or HIV."

The UNICRI report calls for an improved global response to counterfeiting that goes beyond just punishing offenders on the basis of economic damages or a violation of public faith (the approach for prosecuting counterfeiting items such as luxury goods). It outlines a series of proposals based on the need to punish counterfeiters that takes into account the problem's complex nature and the severity of the offenses possible.

I hope our and other governments will take this report seriously and work together to combat this growing problem. If not, we can be certain that organized crime will continue counterfeiting, counterfeit drugs will make their way into legitimate supply chains and our health will be further jeopardized.

We must work together globally to address this scourge; otherwise we fate our children and their children to deal with a problem that will only grow worse and more difficult to solve.

As always, our job today is to stay vigilant and protect ourselves and our families. Remember, we are the last barrier to harm!

• SAFE DRUG (click here)checklist to learn how to avoid, deter, and report suspected counterfeit drugs.
  
• SAFEMEDS EMAIL ALERT SYSTEM (click here), which broadcasts FDA Counterfeit Alert Network notices as soon as they come out.
  
• Verified Internet Pharmacy Practice Sites (click here), that are accredited by The National Association of Boards of Pharmacy's (NABP) as legitimate pharmacies.
  

The Bahamas - Not Just a Vacation Spot Anymore

The ongoing New York Times series "A Toxic Pipeline" continues to shed light on the complex routes that counterfeit drugs take before being sold by Internet pharmacies, many of which purport legitimacy with Canadian, British or Australian websites.

Today, the series (http://www.nytimes.com/2007/12/17/world/middleeast...) focused on the "complex supply chain of fake drugs" that starts with China, goes through the United Arab Emirates, then the Bahamas and finally to Britain before making its way to U.S. buyers. This roundabout path is used to fool the customs officials and buyers into thinking that their drugs are coming from a "trusted" source.

This chilling expose shows this couldn't be further from the truth. These drugs are made in China. Unscrupulous sellers transfer them between "Free Trade Zones" in the Middle East that have little regulation or accountability so as to hide their origins. They are shipped to the UK en route to the Bahamas for Internet sales. Once ordered by US customers, they are shipped back to the UK for a British stamp to make them appear "legitimate."

Counterfeiters are willing to go these extra miles because the profits are worth it. And vulnerable patients are the prime targets for these creatures that sell through these questionable and dangerous sources.

Health officials worldwide are trying to better ensure the safety of our prescription drugs. The reality, however, is that coordinating worldwide regulatory bodies to effectively address this growing challenge that will not happen soon enough for those already injured by these products or those who will be.

And so our job is to stay vigilant and protect ourselves and our families. Remember, we are the last barrier to harm!

To help you, check out the tools on this website including the:

• SAFE DRUG checklist to learn how to avoid, deter, and report suspected counterfeit drugs.
  
• SAFEMEDS EMAIL ALERT SYSTEM, which broadcasts FDA Counterfeit Alert Network notices as soon as they come out.
  
• Verified Internet Pharmacy Practice Sites (click here), that are accredited by The National Association of Boards of Pharmacy's (NABP) as legitimate pharmacies.
  

IMPACT-ing Prescription Drug Safety

In February 2006, the World Health Organization launched the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) to build coordinated efforts between countries to address the great deal of harm from fake medicines around the globe.

This is no minimal bureaucratic effort. IMPACT is a partnership of all the major stakeholders: international organizations, non-governmental advocacy and patient groups, law enforcement, pharmaceutical manufacturers and their trade associations, as well as government drug regulatory authorities.

This week, IMPACT members are meeting in Lisbon to review findings and recommendations for how to turn the tide on the growing dangers of counterfeit drugs. These are available in a draft background paper for discussion and finalization of principles that could serve legislation for all WHO member states. The draft paper, "Draft Principles and Elements for National Legislation against Counterfeit Medical Products" can be found at:
http://www.who.int/impact/events/Principles_ElementsforNationalLegisl...

An important recommendation of the draft report is a call for governments around the world to adopt a tougher stand against the perpetrators of counterfeit medicines that reflects the "gravity" of their offenses. This includes introducing severe criminal sanctions against its perpetrators regardless of evidence of specific harm caused to others-something I've called for in the past, given the potentially dire consequences - including death - of consumers unknowingly using counterfeit drugs.

I will be keeping a close eye on the outcome of this week's meeting and hope that members of IMPACT adopt these and other patient safety oriented recommendations.

In the meantime, my old call: remember to protect yourself and your family! You are the last barrier to harm!

Tools on this website can help you:

• Download the SAFE DRUG checklist to learn how to avoid, deter, and report suspected counterfeit drugs.
  
• Sign up for the SAFEMEDS EMAIL ALERT SYSTEM, which broadcasts FDA Counterfeit Alert Network notices as soon as they come out.
  
• If you do buy drugs online, only use Verified Internet Pharmacy Practice Sites (click here), that are accredited by The National Association of Boards of Pharmacy's (NABP) as legitimate pharmacies.
  

An Easy Prescription to Follow

If you're looking to purchase drugs online, here are a couple of simple ways to increase the possibility the website you're considering buying drugs from is a legitimate website, and to protect yourself from receiving counterfeit or contraband drugs.

1. Make sure the website carries a VIPPS® Seal, which signals that the online pharmacy has the seal of approval by The National Association of Boards of Pharmacy.

2. Check that the site requires a valid prescription by a licensed healthcare provider.

3. Check to see if there's a licensed pharmacist available to answer questions about your medicine or your order, and valid contact information.
   

If any of the above isn't true for the website, be suspicious! There's a strong chance that the website is not legitimate, nor are the drugs that come from it. This is even the case for websites that appear to be American or Canadian.

Unfortunately, an FDA study released last month concluded that many purchasers of drugs online are people specifically trying to avoid needing a valid prescription. Others were trying to find drugs at cheaper prices. Here, too, the FDA found that people were misguided, since more than half of the prescription drugs the FDA looked at for its study had FDA-approved generic versions, likely sold at lower prices.

Taking medicines without a valid prescription presents inherent risks, which are then compounded when the drugs are bought from illegitimate websites. While the need to save money is understandable, no amount of cost savings is worth risking your family's health and possibly their lives.

This website offers tools to help you make sure the prescription drugs you're buying come from a legitimate, safe source. Click here. It also has a guide for ways to find safe drugs at cheaper prices. Click here.

Remember protect yourself and your family! You are the last barrier to harm!