Multiple anti-counterfeit technologies with distinct advantages and drawbacks exist today. Primarily, these can be used in three different ways:
Tamper-evident/tamper-resistant packing
Packaging having an indicator or barrier to entry which, if breached or missing, should provide visible or audible evidence to consumers that tampering has occurred. Eg. film wrappers, shrinkable seals and bands, breakable caps, tape seals, blister packs, etc.
Product authentication
Authentication features can be embedded either on the dose or on packaging of the medicines.
Comparison of Authentication Characteristics
Holograms for Anti-counterfeiting
Holograms can combine three layered security features and become a most powerful weapon against counterfeiting. In such solutions, holograms can provide overt first line authentication while covert features such as scrambled images, microtext, UV-sensitive or other specialised inks provide second line authentication for trained examiners and appropriate decoding equipment. Serialization of holograms is another trend that combines authentication with traceability. Some of these developed technologies are binary encrypted holograms, light diffraction hologram elements in a product label, or a combination of a hologram, 2D datamatrix, and thermal monitoring.
Track and trace technology
This is the process of assigning a unique identity to each stock unit during manufacture which then remains with it through the supply chain until its consumption, and is called the track and trace system. Information is attached in the form of a unique pack coding, enabling access to the same information on a secure database.
Pedigree
This is a type of track and trace system of the drugs in a location. In the US, the final pedigree regulations were drafted in 1999 for PDMA. A drug pedigree is a paper document or electronic file that records the details of distribution of a prescription drug from its manufacture through wholesale transactions, until it is received by the dispenser, which is usually a pharmacy or physician. The person who receives a pedigree along with the drug shipment must verify that each recorded distribution took place and that the drug-specific information (such as lot number and manufacture date) is correct. This system of pedigree passage and authentication is intended to ensure that prescription drugs cannot easily be diverted or replaced with counterfeit products. The electronic system has largely replaced the paper system because of disadvantages like incompatibility with the bulk of pharmaceuticals, record keeping failures and fraud, and higher probability of counterfeit with paper pedigree.
Several other advantages are offered by the track and trace system like a reduction in the number of medication errors, automated pharmacy billing, effective inventory control, facilitation of product recalls, and identification of theft and product diversion.
Mass Serialization
Serialization includes the processes of generating, encoding, and verifying the unique identity of individual physical items. Without mass serialization, the authenticity and validity of the pedigree relates only to the lot number consisting of thousands of bottles. However, a specific bottle of a particular drug cannot be authenticated. When combined with track and trace technology, serialization facilitates the tracking of a product through the supply chain and allows for targeted identification of products for recall. Global Standards one (GS1) is a not-for-profit organization that develops global standards for the identification of goods and services. GS1 standards are used for the identification of pharmaceutical products in 60 countries around the world. The GS1 identifiers related to the pharmacy supply chain are:
Global Trade Item Number (GTIN)
A 14/13/12/8 digitally unique identification number is assigned by the manufacturer in accordance with GS1 allocation rules for trade items or products and services. It is constructed from a company prefix assigned by GS1, an item reference number designated by the company, and a check digit. Prior to market requirements for item-level serialization and verification, Astrazeneca made it as an internal initiative.
Serialized Global Trade Item Number (sGTIN)
A unique number that identifies a particular trade item, created by appending a serial number to the GTIN of the product. In their draft guidance for serialized identifier prescription drugs, the FDA proposed the use of the NDC (which forms part of the GTIN in the US realm) combined with an eight-digit serial number. In March 2010, the FDA issued guidance addressing the package level SNI (Serialized Numerical Identifier) to be “applied to a prescription drug at the manufacture and repackaging of the product to facilitate its track and trace”.
The main challenges of implementing serialization are the complexity of data that is to be tracked, and the need for potentially huge, multi-access databases.
Data Carriers
Data carriers are graphical systems used to convey the product identifiers and associated information in computer and/or human readable format. A mark, tag, or label applied at the source represents them. Computer readable formats include linear and two dimensional (2D) bar codes and radio frequency identifier (RFID) tags.
Multi-level approach
Anti-counterfeiting technological approaches are interdependent for their effectiveness, and integrating them yields a more robust system. In this respect, a combination of overt and covert measures may provide optimal security because they help prevent counterfeiting and reassure end-users. For example, using drug product serialization in combination with electronic pedigree greatly increased the level of security by the ability to verify both the product and the transaction integrity. For example, the serialization of holographic labels. Some organizations such as Authentix and Nosco have made initiatives to combine the respective limitations and the potential of both Data Matrix and RFID, such that cases and pallets can be tracked with RFID tags, while medicines can be tracked with Data Matrix. However, a multi-level approach may also result in additional costs as the technologies become more sophisticated and should be implemented based on the risk analysis of the drug to be counterfeited.
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