Counterfeit and adulterated drugs are an increasing problem, particularly in the United States. Not only do these activities strip profits from legitimate drug manufacturers, but they can also pose a health risk to the consumer. As a result, the US Food and Drug Administration (FDA) has issued guidelines covering "cradle-to-grave" tracking requirements that pharmaceutical companies must comply with for the drugs they produce. We'll look at a brief description of the pedigree guidelines, compliance options, and outstanding issues.
What Are Pedigree Guidelines?
Simply stated, the FDA's pedigree guidelines require data to be captured at each stage of the production and distribution process, until the drugs reach the customer or end user. The players principally affected by the guidelines are pharmaceutical manufacturers, drug distribution companies, drug wholesalers, and drug retailers.
From the manufacturer's perspective, the guidelines essentially require pharmaceutical companies to maintain data on each case of drugs leaving the shipping dock. This data starts with the drug manufacturer and includes, but is not limited to, such information clusters as the brand name and product identification (ID); manufacturing, shipping, and expiration dates; corporate and manufacturing addresses; quantity, weight, and lot number of the case; and the item description. The data collection gets considerably more complex if parts of the manufacturing process are contracted to third parties. Data must then be transmitted from the subcontractors, and consolidated into the primary manufacturer's pedigree database. As we will see later, there can be a heavy reliance on data residing in the existing enterprise resource planning (ERP) solution.
Once cases arrive at a distributor's warehouse, the pedigree is updated by adding warehousing data such as the address of the distribution center, the date of receipt, the warehouse location, and any additional product and lot information added to the case. Once cases leave the distribution center, the destination address is captured. The process can be continued up to the point where the consumers purchase drugs from their local pharmacy.
It would be wrong to think that there is a standard format by which the data is captured and transmitted to a drug manufacturer's customer. If it didn't work for electronic data interchange (EDI), why would it work for drug pedigrees? Major drug retailers can typically dictate the format and content of the pedigree data, so long as they comply with the local state's requirements.
The key to the pedigree data is twofold: (1) the eighteen-digit pedigree ID, and (2) knowing what you are receiving before you receive it. The first five digits designate the manufacturer, and are assigned by EPCGlobal, an industry-entrusted organization created to establish the global standard for real-time, automatic identification. The next twelve digits make up a sequential number, and the eighteenth digit is typically a check digit. In situations where both parties are using EDI, the ID can be included with the advance ship notice (ASN). Otherwise, an external file containing the same ID must be used to transmit the information. As the cases are received by the distributor, the label is scanned, and the unique pedigree ID is compared with the ID contained in the ASN. Mismatches may signify a counterfeit situation, or possible alteration. Included in the ASN or external file is the pedigree data collected to the point of receipt by the distribution center.
While some might like to include radio frequency identification (RFID) under the pedigree guideline umbrella, this would overcomplicate the process. Whether barcode labels or RFID tickets are used is a function of the technology and equipment used by the manufacturer (or required by the customer). From a software perspective, writing labels or tickets requires the same level of effort. In any case, few pharmaceutical companies have RFID technology fully deployed in their warehouses. Other manufacturers only have one or two customers demanding RFID compliance. Accordingly, manufacturers are using a "slap'n'ship" technique to implement RFID whereby RFID tickets are generated based on the ship-to customer, and at the end of the process. Hence the term "slap'n'ship," where the ticket is printed and slapped on the case just before being placed on the truck, is most appropriate.
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