The Healthcare Compliance
Packaging Council

 

In late March the HCPC co-hosted RxAdherence 2012 with UBM Canon. It was one of our best conferences in the 20 year history of the event. The quality of speakers we were able to assemble was a testament to the growing importance of medication adherence in the broader market. To have representatives from the Center for Medicare and Medicaid Services, the National Consumers League, the Veterans Administration and the Pharmacy Quality Alliance all gathered and focusing on medication adherence as a critical issue to their individual organizations was inspiring.

And yet, as we move slightly away from this discussion I am deeply concerned about another area of the supply chain which could undermine all these efforts at improving medication adherence. I'm talking about the security of the pharmaceutical supply chain. If you've been involved in this industry you are more than aware of the impact counterfeit medications have, most recently with counterfeit Avastin coming in through the legitimate supply chain and reaching patients. Yes, the patients may have been adherent but the drug wasn't real! And, yes, patients were harmed.

Now, going back almost 10 years when this problem received the most notoriety (Katherine Eban's book, Dangerous Doses) we all learned how poorly controlled and monitored our supply chain was. There has been work underway for quite some time to correct this and some progress has been made. Florida instituted a pedigree model that primarily cut out the unscrupulous distributors but did nothing to track units in the supply chain. California has put together the best requirements with planned implementation beginning in 2015 but , amazingly, there is an industry group, Pharmaceutical Distribution Security Alliance (PDSA), promoting a plan called RxTec that pulls the teeth on California's plan and all but eliminates any chance of stopping counterfeits before they reach a consumer.

So, why should an organization focused on medication adherence care about this action taking place two steps up the supply chain? One obvious reason is that adhering to counterfeit drugs doesn't do much good but, more importantly, is that a secure supply chain doesn't end until the patient takes the medication properly. When one segment fails the whole supply chain fails. We can't be almost safe.

In the California Track and Trace model there is also an opportunity for compliance prompting packaging. Since CPP is manufactured prior to pharmacy and needs to stay intact through pharmacy to the patient it offers a great vehicle to carry the serial ID required for T&T to the patient. Why should we care? Well, as a patient, if I hold in my hand an original manufacturer's package with a serial ID I have the ability to authenticate that package myself via smart phone (peace of mind) and I can also link to adherence programs or informational programs to learn about the drug or the condition being treated. Once again, who cares? Well, on the list of reasons for non-compliance right along with forgetfulness is patient health literacy. Patients all too often do not understand why they are taking a drug or what the implications of non-compliance are. Anything and everything we can do to alleviate this are dollars well spent.

Another important point is that CPP by nature is unique and requires special machinery to manufacture. This raises the bar on counterfeiters. Combine this unique package with item level serialization, carrying it through to the patient and we've got a pretty robust security system that goes well beyond 1,000 count bottles going in the back door of the pharmacy and getting broken down into amber vials where the tablets totally lose their identity and patients lose the benefit of all the supply chain security work.

Some in industry (seemingly those with the most money) claim that this whole process will cost too much. The prevalence of counterfeits is small (true) and even the frequency of fraud, diversion, etc. . is on a small scale compared with the legitimate supply chain, also true. I guess the simple answer to those folks is that these few incidences have the ability to cause great harm or even death and they have done exactly this in recent years. What is the value of a life?

Maybe the better way to look at this is a reference to the automotive industry. Seatbelts. As recently as the 1950's, coincidentally when the little amber vial was developed, cars generally did not have seatbelts. A few manufacturers offered them as options. Then the government decided to make them mandatory. Why? Because every time you got in your car you needed seatbelts? No, because 1 in 10,000 times you get in your car you might get into an accident.

Today in the US we deliver 3.4 billion prescriptions a year and estimates are that as much as 1% of our supply chain could be counterfeit. We don't really know of course because we lack visibility and adequate controls. That would mean in rough terms 34 million prescriptions. What if this estimate is off by tenfold and only 1/10 of 1% is counterfeit. Well, then only 3.4 million prescriptions might contain counterfeit drugs. Personally, I think 3.4 million is a big enough number to justify industry action.

Patients (WE) deserve better than the pharmaceutical market is offering. We deserve a secure supply chain where we can be confident that the drugs are real and we deserve all the tools available to help us take the medication properly so we gain the benefit from all that research and development.

Congress is currently debating which way they will direct industry, toward the secure California model or toward the toothless PDSA RxTec version. If you get the chance, put in your two cents, tell your congressman and senators that you want a secure supply chain for pharmaceuticals. Your life or that of a loved one may depend on it.