Once viewed as a mundane part of the business — or in the case of child-resistant closures, a necessary fix — primary packaging of pharmaceuticals suddenly has morphed into a hotbed of creativity. From measured doses of biologic drugs self-administered by syringe, to electronic wearable injectors, to calendarized, unit-dosed blister packs containing multiple pages of patient instructions inside the label, the once-staid business of packaging drugs is evolving into a platform for innovation.
This vastly expanded variety of drug delivery formats has come about largely as the industry has sought to navigate its way through a veritable Scylla and Charybdis of regulatory requirements on the one hand, and security challenges on the other.
Admittedly, some of the latest pharmaceutical packaging trends can be traced to new kinds of drugs — biologics and the new class of biosimilars, for example — that require fresh approaches to the way drugs are administered to the patient, and new technologies that enable them. No one expects the basic plastic pill bottle to go the way the pair of pliers did in dentistry anytime soon, but chances are that most people have already encountered some of these new packaging methods when filling a recent prescription or purchasing an over-the-counter medicine.
This article will examine some of the key challenges having an impact on primary packaging, and how pharmaceutical manufacturers, contract firms and packaging vendors are responding.
Perhaps the biggest single challenge confronting the pharmaceutical industry from a packaging standpoint continues to be the need to combat the onslaught of counterfeiting that has swamped global pharmaceutical markets. The call for serialization has come about largely in response to this problem.
“The main challenge facing the industry in the United States as well as the EU will be the implementation of the requirement for serialization of all pharmaceutical product down to the smallest unit of sale,” points out Rick Seibert, senior vice president for Global Innovation and Technology Services at Sharp Packaging Solutions. “This regulatory-driven change will fundamentally change the way product is packaged, and possibly more importantly, labeled and safeguarded in the future.”
Jerry Martin, Pharmaceutical and Life Sciences consultant for the Association for Packaging and Processing Technologies (PMMI), recalls how several years ago he was contacted by a company that had developed a unique 2D barcode system designed to help eliminate drug counterfeiting. But when he approached some pharmaceutical companies with the idea, they weren’t interested. “We ran up against a complete denial that there was any problem,” he says. “And the FDA said it was not capable of policing the markets for counterfeiting of drugs.”
Finally, the problem got so bad that regulators in Europe and the FDA in the United States issued regulations requiring the serialization of packaging for tamper-proof medications, as well as the establishment of a track and trace system. In the U.S., these regulations go into effect over the next couple of years.
But having the technology to achieve track and trace and manufacture tamper-proof packaging is one thing, and ensuring that the entire global industry adopts the same technologies is another. “Companies are working together to come up with a compatible system for drugs moving through the supply chain,” Martin says. “The challenge is to come up with an internationally harmonized system — not unlike the UPC system for consumer products that we have now.”
In effect, that means everyone will have to use the same hardware and software to connect seamlessly across the various global supply networks throughout the industry — a tall order, to say the least. But Martin, for one, believes it can be done. “Serialization will eliminate the ability of counterfeiters to put product on the market,” he says. “This way, labeling will enable the distribution system to detect counterfeiting before products even get to a pharmacy.”
“Serialization will come to different parts of the world at different times,” says Carlo Domeneghetti, corporate procurement packaging COE Lead at Patheon in Monza, Italy. “But once in place, serialization, combined with tamper-evident packaging, will be the best way to guard against counterfeiting.”
Packagers are likely to take a layered approach to guarantee security and product integrity. “Ideally, there will be additional security features — some covert, some overt — deployed by brand owners as well, offering a tiered/layered program to assure security and product integrity,” says Seibert of Sharp.