Keeping counterfeit and tainted pharmaceutical products away from patients is a concern shared by all drug companies. In 2012, 64 people were killed as a result of receiving steroid injections that had been contaminated with fungal meningitis. The contaminated medications had come from compounding pharmacies. Compounded pharmaceuticals are individually formulated to meet a patient’s specific needs. In 2013, Congress began looking at ways to improve the e-pedigree serialisation procedures to make it easier to monitor and control the supply of medications that were made in compounding pharmacies to prevent another problem like the one from 2012.
On November 27, 2013, President Obama signed the Drug Quality and Security Act into law. This bill amended the Federal Food, Drug, and Cosmetic Act and applied new rules to how the drug supply chain is monitored and protected. According to the Centers for Disease Control and Prevention, people in at least 20 states were impacted by the contaminated injections.
Included in the Drug Quality and Security Act is the Federal Drug Supply Chain Security Act. This portion of the larger law deals specifically with preventing counterfeit medications from reaching patients in the United States and elsewhere. According to reporting by the Securing Industry website, new methods and technologies are being tried out to improve the e-pedigree serialisation to protect the pharmaceutical supply chain.
Many people do not realize how large the problems with counterfeit medications are. In one incident in 2015, law enforcement agents confiscated more than 20 million pills that were fake. The people who make, distribute and sell counterfeit drugs do it because they can make a lot of money. They exploit people’s need for certain medications. Some patients turn to counterfeit drugs, not knowing they are fake, because they can get them cheaper than through authentic channels or because they are hard to get other ways.
Pharmaceutical companies will need to be in compliance with the rules and regulations set forth by the Federal Drug Supply Chain Security Act by November 2017. These regulations on the pharmaceutical track and trace require pharmaceutical and medical packaging include the lot number, serial number, expiration data and a national drug code. To reach these goals, the pharmaceutical industry is working on implementing new e-pedigree serialisation procedures.
To help with this, Covectra has teamed up with AT Information Products to come up with a solution. Covectra is a company that works on e-pedigree serialisation solutions and AT Information products provides printing services for medical packaging materials. The two companies have developed a new technology to improve the track and trace pharmaceutical processes that are used by pharmaceutical companies. Their new technology does meet all of the requirements set down by the Federal Drug Supply Chain Security Act. It is flexible and easy to use.
The technology also has applications beyond the pharmaceutical industry. More and more industries are looking to serialisation processes. These include the automobile, tobacco, food and beverage and electronic industries.
The new solution put forth by AT Information Products and Convectra uses Hewlett Packard printing technologies and clean, “green” inks that are water based. They have been specifically developed to be used on a wide variety of pharmaceutical packaging options. It can print on blister packaging and be scaled to the correct size. It can be used on just about every kind of material that is used for pharmaceutical packaging such as foil, plastic, boxes that are glossy, paper and any other materials that may be used for this. Anytime e-pedigree serialisation is needed, this new technology can effectively manage it.
Pharmaceutical companies have a lot of options available to them when it comes to packaging. It is possible to develop very specific packaging to meet the needs of the patient and to protect the integrity of the product. One very popular packaging option is the carded blister package. It gives drug companies the ability to include things such as product information and coupons in the package. This is also a safe and secure way to package pharmaceutical products.
Keeping counterfeit and contaminated drugs off the shelves and away from patients is something that all drug companies takes very seriously and are working on.