With the start of 2013 we take a moment to anticipate what changes lie ahead for our industry and what impact they will have in the new year and beyond. Have you considered the impact that Serialization will play?
Serialization is to play a huge role in reducing the global proliferation of substandard, spurious, falsely-labeled, falsified, and counterfeit (SSFFC) drugs. SSFFC drugs can lack active ingredients, include incorrect ingredients, not have enough active ingredients, or even have too much of an active ingredient. Due to the clandestine and illegal nature of the manufacture and distribution of SSFFC drugs, the global breadth and scope the SSFFC problem is hard to quantify and harder still to contain and stop. What “IS” known is the public health risks of using SSFFC drugs. Here are a few:
- Illness or injury treatment failure
- Increased resistance to disease or virus infection
- Sickness and death
What is Serialization?
Typically, an individual drug carton has a label with the drug name, company’s name (or logo), lot number, and expiration date. In order to prevent SSFFC drugs from being manufactured, distributed, and used there must be a way to determine that a drug ‘unit’ (an example would be a small carton containing a bottle of eye drops) was made by the drug manufacturer listed on the label and that the contents match the label. Other than looking at the label (which could be a counterfeit), how can anyone really know that the drug is what the carton and label say it is? An electronic pedigree (e-pedigree) is one way to really know.
An e-pedigree is a verifiable file that tracks the ownership of a drug from initial manufacture through the supply and distribution chain all the way to a pharmacy, hospital, or doctor’s office. This e-pedigree also includes returns, recalls, and the proper disposal of drugs that have passed the expiration date. In order for the e-pedigree to be effective, it must track and trace the drug down to the smallest package or saleable unit/carton. In this manner regulating agencies can determine not only where a unit/carton originated, who had it and when, but can also identify if a counterfeit unit/carton was inserted in the supply and distribution chain.
What is the mechanism to differentiate each individual package or saleable unit/carton from each other? One mechanism is Radio Frequency Identification (RFID) tags. RFID tags can certainly provide the ability to track and trace an individual unit, and RFID information on unit/carton whereabouts can be added to an e-pedigree; however, an RFID solution requires special equipment to make and program the RFID tag, affix the RFID tag to the unit/carton, and read and track the RFID tag at points in the packaging line. The orientation of the tag placement – as well as the tag reader with respect to the tag placement as it traverses the line – is also critical. In order to make a determination of the validity of the unit/carton later in the distribution chain, an RFID tag reader would be required.
Serialization is the generation of a unique identification number that is added to the unit/carton, case, and pallet labels in the packaging line. The inspection stations keep track of the individual serial numbers on the unit/cartons and provide that information to the track and trace e-pedigree system. Although a serialization e-pedigree solution will be costly to implement, the cost impact is mitigated by the fact that packaging line printers and inspection stations already exist; labels are already being affixed to cartons, cases, and pallets.
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