MS Drug Safety, Security & Validation
We all know about counterfeit Rolex watches or Gucci handbags – the stories of people paying big bucks for items that aren’t legitimate have been around for years. But here’s one I had not considered – what about counterfeit drugs? No, I’m not talking about passing off a bag of oregano as marijuana. I’m talking about people being duped into believing what they think are prescription drugs really being fakes. Or perhaps the drugs they are taking did not come through the standard prescription drug pipeline to reach our pharmacy.
No one here is foolish enough to order their drugs via mail order by way of India, right? Crossing over the border to Canada to get our drugs has enough hazards let alone having something shipped from a continent or two away. The discussion about getting drugs in a more affordable way through the mail comes up often, and besides pointing out the obvious that this is an illegal way to get prescription drugs in the U.S., there are also real dangers involved. If something shows up in a plain brown wrapper, we have no way of knowing if that drug we have received is legitimately what it claims to be or just another knockoff, like the cheap Gucci bag or affordable Rolex. Viagra is a good example – there are plenty of scams for that little blue pill.
There is a new law coming into effect in 2017 to help protect patients from this scenario and worse. It is drug package serialization, the assigning of 2-dimensional codes to pharmaceutical packages. These numbers will be traceable through the drug supply chain that flows from the Manufacturer to the Repackagers , then on to the Wholesalers who ultimately send our drugs to Pharmacies who dispense it to us.
Stop and think about all the cyber crimes committed these days and you can easily imagine the various ways this supply chain for our drugs might be corrupted. An article in the Pharmacy and Therapeutics Journal talks about the need for this process –
“Preventing inadvertent medication errors is only one perceived benefit of drug package serialization; the FDA has promoted the SNI (Serialized Numerical Indicators) primarily as a way of preventing drug counterfeiting. Thefts of high-value prescription medications continue to occur… thieves broke into an Eli Lilly warehouse in Enfield, Connecticut, and stole $75 million worth of prescription drugs. The criminals took pallets of the anti-cancer drugs gemcitabine (Gemzar) and pemetrexed (Alimta), the schizophrenia drug olan-zapine (Zyprexa), the antidepressant duloxetine (Cymbalta), and other prescription agents. Theoretically, those stolen drugs would not be able to re-renter the legal distribution chain if they had SNIs printed on 2D bar codes … on each package label. “
There is an excellent report from the Pew Charitable Trust on the Drug Quality and Security Act, and their slides explain more ways that our drug supply chain might be interrupted, comparising our health, and also monitored.
Think about the ways these drugs can be compromised. That is why this Drug Quality and Security Act has been passed and will be required from all pharmaceutical companies by 2017.
By now you are probably thinking ok, this is interesting, but what does it have to do with MS and our drugs? All of our drug manufacturers will have to comply with this law by 2017, and just recently EMD Serono, the maker of Rebif among many other drugs, released an app for this very purpose. If you don’t know apps, they are the programs that run on smart phones and computers that are tailored to very specific actions- it could be a game such as Angry Birds or a weight tracking app. In this case, their app is called Check My Meds™, and if you are a doctor, pharmacist or patient, you can enter the unique code on your drug made by EMD Serono to verify it is legitimate and the companies along the supply chain have properly handled our drugs.
According to a press release about Check My Meds™, which popped up on my Google alert I have set for MS drug stories, Allan Coukell, senior director for health programs at The Pew Charitable Trusts says “Counterfeit and compromised drugs have breached the U.S. drug supply numerous times over the past decade. By serializing medicines three years in advance of statutory requirements to do so, EMD Serono has taken steps to increase security of the drug supply chain and protect patients.”
I loaded Check My Meds™ on my iPad and am surprised at how straightforward it is to use. Even though I don’t take Rebif, I was able to take a closer look at this app. EMD Serono has put their major drug therapies on this app, and those include drugs for MS, infertility, and HIV disorders, among others. I would hope that the other pharmaceutical companies behind our MS drugs are just a step behind what has been done by this company. You simply scan the two dimensional code (often called a QR code), and the app tells you if what you have on hand is the real deal. Once a scan is entered, you get a screen that authenticates the drug, and the information includes a product description, serial number and the expiration date for the specific drug. You would be prompted to call the company if there is any question about the validity of the code.
Getting stuck with a knock-off handbag or wearing a fake name brand watch poses no danger other than a blow to our ego or wallets, but taking a counterfeit or mishandled drug could have a serious effect on our health. Kudos to EMD Serono for leading the way in watching out for our safety. I can only hope the other pharmas who make their money off Multiple Sclerosis won’t be far behind.
Wishing you well,