Issue link: http://www.e-digitaleditions.com/i/883179
Counterfeiting There are many routes and schemes for falsifying and adulterating medicines and then (re-)introducing them into the supply chain. On-dose identification programs may never halt these crimes, but clearly identifying tablets and capsules independent of their packaging is a big help. According to a March 2013 report from The ThomsenGroup, "The average U.S. retail pharmacy dis- penses 78% to 82% of its daily prescription volume from bulk tablets and capsules." Once the dosage leaves its package and lands on a pharmacist's counting tray, any traceable link to its lot number, expiration date and, pos- sibly, the name of the manufacturer is severed. Furthermore, some distributors accept returns of drug products that were dispensed from bulk. That raises the risk of expired, substituted, or counterfeit medications entering the supply chain. Anti-counterfeiting strategies can now go well beyond what debossing and basic printing can provide. Advances in covert identifiers, such as microtags, and the introduc- tion of thermal inkjet printing technologies are helping drug makers improve how they secure their brands and enhance patient safety. Ink manufacturers are developing edible color-shifting inks and UV-visible pigments that require a "black light" to see (photo). Other inks become visible only after exposure to an inert gas. There are also cartridge-based thermal inkjet printers that print not only on the faces of tablets, but also into bisects and detailed debossing. This more complex marking makes counter- feiting more difficult, and legitimacy be can be verified optically at the point of use. Branding: Dress for success! Pharmaceutical companies strive to differentiate their products from competing products. Innovator brands must also differentiate themselves from the expanding field of generic rivals. A product's "trade dress"—its phys- ical characteristics, such as shape, size, color, bisects, engraving, debossing, and printing—is a unique combi- printing with ink." The Agency also offers some guidance on what the imprint should include: "Inclusion of a letter or number in the imprint, while not required, is encour- aged as a more effective means of identification than a symbol or logo by itself." Business drivers Apart from the regulatory requirements, which identi- fication scheme manufacturers select depends on their goals for branding, marketing, artwork, and even the dos- ing strategy. In a recent Freund-Vector survey, respon- dents were equally divided in designating where deci- sions about on-dose identification are made: Half said the staff in the corporate marketing and half said the staff in formulation development. Certainly, marketing would create the most appealing designs, but every proposal must account for the formulation's characteristics and manufacturability, including debossing on a tablet press. The primary reason identifiers are added to SODFs is to prevent people from taking the wrong medication, which can cause injury or death. With the stakes that high, best practice is to consider identification schemes when you start developing the product and that you con- tinue doing so until the product is finalized and the NDA or ANDA is filed. SODF markings should include text and numerals that are legible and easy to recognize and describe. Keep in mind that patients and others may separate tablets and capsules from their original packaging, perhaps for stor- age in a daily-reminder pillbox. In such cases, the only means to identify the product is on the dose. While brand identifiers (logos, symbols, unusual char- acters, etc.) may be unique and deter counterfeiting, they may also be ambiguous. Imagine a patient, caregiver, or first-responder in an emergency trying to describe the # symbol over the phone, perhaps to someone at a hospital or poison control center. Is it a pound sign, hashtag, number sign, or crosshatch? How about a company logo that "kind of looks like" something different to different people? Ambiguity hampers communication and endan- gers people's health. 34 October 2017 Tablets & Capsules Removing tablets and capsules from their original packaging— which is common—severs any link to the label and inserts. Only the marking on the dosage form itself enables you or others to identify it. Digital thermal inkjet printing enables manufacturers to apply machine-readable QR codes onto tablets and capsules. Covert inks activated by UV light are in development and could provide another means to deter counterfeiting.