In an ideal world, an anti-counterfeit solution would provide protection throughout the supply chain, allow for easy product identification by physicians, pharmacists, and patients, be easily implemented without ongoing costs—and improve brand image and marketability while it's at it. Yet most current anti-counterfeiting measures involve packaging technologies such as holograms, inks, bar codes and radio frequency ID (RFID) that, although useful, cannot ensure the integrity of the pharmaceutical supply chain, because drugs do not remain in their original packaging. Legitimate repackaging regularly occurs in the pharmacy and elsewhere, and authentic packaging—recycled or stolen—can contain adulterated, counterfeited drugs.
No single anti-counterfeiting technology can provide adequate protection. Pharma's objective must be to design products and packaging with features that are so hard to duplicate that counterfeiters will turn their sights elsewhere.
It is, after all, the counterfeit medications, not the containers, that are harmful to patients and costly to manufacturers. For tablet manufacturers, the solution is to modify the medication itself with on-tablet technologies that make pills difficult to fake but easy to identify. These technologies are also cost-efficient and stay with the medication from the factory to the patient.
A great number of counterfeits have been uncovered by patients and pharmacists who noticed that the tablet's color, shape, size, or taste was different from what they had experienced before. Several pharma companies have reported that a majority of the calls they receive from consumers questioning whether they have a counterfeit product are triggered by some type of sensory response related to the dosage form itself. A patient's personal detection system consists of eyes, nose, mouth, and hands, so a tablet's unique visual appearance, aroma, taste, or texture is important.
Many patients, especially the elderly who tend to take the most oral medications, often have trouble identifying drugs by reading labels, so this type of sensory identification helps protect patients at the point just before they consume the medication. Each individual sensory identifier on a tablet significantly enhances the likelihood of a patient calling the manufacturer, or their pharmacist or physician to question the authenticity of a medication.
With pearlescent coatings, a rainbow of colors is possible. These colors can only be duplicated by knowing the specific pigment grade combination and the processing procedures used in the drug's manufacture. They cannot be reverse engineered.
Simple visual and sensory means of identifying drugs can aid patients with compliance and safety. When patients can readily identify the right drug, they are more likely to take the right drug. A standardized tablet imprint system, for example, that identifies the dosage strength and name of a drug, combined with readily available information resources for patients and pharmacists, would help prevent many medication errors.
A United States Pharmacopeia (USP) survey on standard imprint codes drew the following comments from pharmacists:
- "We should be inventing a system where a patient would be able to identify a tablet."
- "The difficulties come in identifying tablets or capsules without any markings. They may be OTC or one of the many generics that are white, typically round, biconvex shaped."
- "The lack of a standardized and easily identifiable code on many medications makes the identification process too cumbersome. A national standard should be adopted. In addition, a manufacturer's unique identifier should also be employed to distinguish particular brands or products."