Drug Safety Responsibility– For whom does the finger point?

The recent heparin recalls have left consumers fuming and pointing fingers at those who were supposedly protecting them from harm. With a difficult past year in both tainted food and medical products – this was the last straw.

But in reality, most in the industry knew the FDA was woefully understaffed and unequipped to cope with the expansion of global inspections required to guarantee the safety of our food and drug supply. Finally this week in answer to Pennsylvania Senator Arlen Spector’s request, FDA commission Andrew C. von Eschenbach asked congress for $275 million as an immediate budget submission. Increased funds will be use to increase inspections, modernize their science and staff, and upgrade their laboratory facilities.

Julie Zawisza, an F.D.A. spokeswoman said “These resources will accelerate the changes required for F.D.A. to protect and promote the health of all Americans in a rapidly changing world that poses new, emerging threats to the safety of food and medical product.”

One might asked, how could we let it get to this point? How indeed! The pharmaceutical industry has a history of relying of reactive testing, specific to the particular contaminant or variance they are guarding against. However, modern day protection requires a more proactive approach – a verification of the whole and an assurance against those criminal minds that can fool testing with traces of authentic material mixed in with the altered substance.

To further this point, we must have testing down the chain as well. As the saying goes, “Test Often, and Test Late!” The closer to consumer that authenticity testing is done, the more you are sure the consumer is receiving the “True Goods”. Too often each company points to the other on whose responsibility it is too safeguard the product.

Now it is the consumer who is doing the pointing and he or she is pointing at us all!

Healthcare Magazine Covers "Unique" Pharmaceutical Safety Solution

XStream Systems' answer to pharmaceutical authentication concerns in the industry are summarized in the April/May issue of Healthcare Distributor Magazine. The company's coverage is part of an article written by Bruce Kneeland on the future and safety of the supply chain.

The piece focused on the presentations, attendees and outcomes of a recent event in Pennsylvania on Feb. 26-27, 2008:

At the Secure Pharma 2008 conference in Philadelphia, Alan Clock and John Lundquist of XStream Systems discussed their new technology and the benefits it offers. The company's EDXRD systems are able to "scan" the contents of sealed bottles of pharmaceuticals. This breakthrough technique allows medicines to stay inside the manufacturer's or repackager's bottles, if if they are opaque.

Mr. Kneeland refers to the solution as "approaching the problem from a completely unique direction," which is absolutely true.

More information on Bruce Kneeland can be found at pharmacyconnections.com, and XStream Systems' website is xstreamsystems.net.

Is Your Medicine Filled with Empty Promises?

Your doctor prescribed a medicine to cure what ails you, and at first the prescription seems to really do the trick, but lately it’s just not living up to its billing. What went wrong? Until recently few of us, would even utter the thought: Could it be counterfeit?

Counterfeit drugs are on the rise, and what’s worse they are infiltrating our legitimate supply chain. So what can you as a consumer do to minimize your exposure to counterfeit drugs?

The FDA has a very informative website to keep consumers abreast of developments. Listed on the site are the latest recalls and issues. Also listed on the site are steps consumers can take to minimize their risks:

1. Only buy from authorized sources such as your local pharmacist.
2. Avoid buying from internet pharmacies (unless VIPP approved). Over 50% of medicines bought over the internet are found to be counterfeit.
3. Avoid buying prescriptions from outside the US.
4. Be vigilant in examining your personal medication: Does it look the same? Taste the same? Are the seals and tamper proof packaging in tact?
5. After taking your medication, be sure to report any new and usual side effects to your physician.

To further combat counterfeit drugs, the FDA has developed a website reporting system to track consumer’s adverse reactions to prescriptions. Often consumers do not associate adverse reactions to the possibility that their medication could be counterfeit and some of these reactions (as seen in the recent heparin cases) can be fatal.

In this day and age, it really is “let the buyer beware!” A savvy consumer will be vigilant in their inspection of medication, cautious in their purchase, and insistent on the highest quality of standards from their pharmacist and his suppliers.

In the United States, you should report incidents to the Medwatch program by clicking the logo on the right. You can also call by phone: 1-800-322-1088.