Why is Lot Tracking so important for Pharmaceutical Manufacturers?
Around seven percent of all medicines worldwide are counterfeit, which is a frightening number considering how many people depend on medications to live normal lives. Counterfeit medicines are illegal and extremely dangerous for patients. Due to the growth of counterfeit medications flooding the market, regulations and restrictions around drug manufacturing have been growing as well.
Restrictions and Regulations
The United States FDA Safety and Innovation Act (FDASIA), signed into law July, 2012, allows the FDA the authority to gather user fees from the industry to finance reviews of medical devices, innovator drugs, biosimilar biologics, and generic drugs. These include, but are not limited to:
ARCOS Reporting –
ARCOS Reporting is an automated drug reporting system that keeps an eye on controlled substances as they pass from the manufacturer all the way to the point of sale, including pharmacies, hospitals, teaching institutions, and practitioners.
Pedigree and ePedigree –
A process that provides serialization for all units of sale, regardless of size. Any drug distributed by wholesalers, repackagers, or distributers must have a pedigree. ePedigrees are nothing more than electronic records of pedigrees.
National Drug Code (NDC)
– These are numbers identifying human drugs listed in the FDA’s Drug Registration and Listing System (DRLS).
What is Lot Tracking?
Lot tracking is an effective method through which pharmaceutical manufacturers can track and trace their medication. This allows healthcare companies to remove both counterfeit medications and recalled medications. Lot tracking is essential for inventory management and supply chain integrity.
Lot tracking records data on a specific quantity of product – gallons, pounds, etc. – and makes it easy for manufacturers to trace the raw materials within a specific batch of medications.
Lot tracking simplifies the process in determining:
- which batches of medications are ready for purchase
- which batches expired and, if necessary,
- which batches of medication need to be recalled.
- (In the event of a recall, lot tracking allows the manufacturer to easily identify and target the specific problematic batch.)
To make this possible, each batch created is assigned a lot code, which is a unique series of numbers specific to that batch. In the event of a recall, manufacturers can use lot codes to see when the problem happened and what products were affected. The lot codes can also be used to answer patient, government, or processing questions and create the Pedigrees and ePedigrees required by law. These Pedigrees are identifying statements provided by certain wholesale distributors “prior to each wholesale distribution of prescription drugs.”
Supply Chain Integrity
These drug Pedigrees are not only required by law, but are also vital to creating supply chain transparency. A manufacturer’s reputation is directly linked to the integrity of its supply chain. Lot tracking increases supply chain integrity by tracing the Pedigree of each batch of drugs manufactured. Pharmaceutical manufacturers are held strictly accountable through these new rules and regulations regarding the manufacturing and distribution of prescription drugs. Through lot tracking, the ingredients and dosage of each batch of medication will be traced throughout all stages of production, processing and distribution.
Save money, Avoid Poor PR, and Maintain Reputation
Lot tracking aids manufacturers in the following of government rules and regulations regarding the manufacturing of pharmaceuticals. However, the bottom line is that lot tracking will help manufacturers save time and money, avoid poor public relations issues, and maintain a solid reputation. Most importantly, lot tracking will put counterfeiters out of business and keep patients healthy and safe from the dangers of counterfeit and recalled medications.