The problem of counterfeit drugs, falsified drugs & drug adulteration has significantly impacted pharmaceutical industry over a last decade. Fuelled by internet sales, counterfeit prescription drugs have become an exploding industry.
In times of globalization, the supply chain for genuine pharmaceutical companies have become longer & complex which offers immense opportunities for counterfeiters. There are numerous challenges & issues around supply chain security as broadly listed:
- Counterfeiting – Manufacturing inferior drugs labelled with branded products
- Product Mix-up – Incorrect product put into distribution
- Gray Marketing- Fabricated shortages of drugs
Counterfeit drugs impacts pharmaceutical industry, poses risks to public health safety even causing deaths, impacts brand reputation & overall loss of patient confidence.
Legislation requires pharmaceutical companies to implement ‘Serialization’ as one of the best tools to combat & possibly control the counterfeit drug industry.
Typically drug supply chain consists of entities such as, manufacturers, wholesalers, distributors, pharmacies & end consumer. Ensuring secure track & trace capabilities throughout supply chain through product ‘Serialization’ can support addressing the challenges faced by pharmaceutical industry.
Serialization as simply put, is a unique serialized number (NDC + unique number) to each saleable unit(strip/vial/case/carton/shipper/pallet) of prescription product which is linked to information about the product’s origin, batch, expiry & certain other details. The serialization labels/codes can be created by client/manufacturer, generated either randomly or sequentially & printed as a 2D barcodes on each saleable unit & case.
Legislation will soon require the collection of serialization data & its verification as to which serial numbers were in each bundle, case & pallet & eventually what units were sent to each retailer through each touch point of supply chain. In order to have this information available without having the need to re-open each shipping case, it is required that manufacturers aggregate the data throughout the process. This information must be sent via ASN (Advance Shipment Notice) within each supply chain route. All parties within the route must retain the information, history & data for each inbound & outbound drug movements for audit purpose. Manufacturers soon to be complied to have electronic systems capable of tracing all packages of prescription drugs throughout the entire distribution chain to prevent & possibly early detect the entry point of a counterfeit drug & safeguard eventually public health.
Considerations to be made while implementing Serialization across your pharmaceutical supply chain:
- Budget allocation to upgrade systems (hardware/equipment & software): generating & applying unique serial numbers to products & managing this data for its traceability
- Depending on the products you manufacture & the markets you serve, you will need to ensure proper resource allocation for successful implementation
- Incorporating serial numbers will surely impact the speeds of your packing lines. To meet the current demands, automation in packing lines could be a good option
- Choosing right partners to with a complete know-how of pharmaceutical supply chain & IT industry is vital to success of the project. Note, numbers are to be generated, maintained, easily & securely available across supply chain for exchange
Whilst there is cost, production & issues, Serialization definitely brings in a lot of benefits:
- Monitoring & controlling a complex & global distribution n/w from manufacturer to consumer
- Authentication of the product at various touch points in supply chain through collaborative support of partners
- By leveraging those unique identifiers and interoperable data exchange networks, organizations can identify impacted parties, notify them, and withdraw the impacted product in a shorter amount of time
- Keeps brand reputation in tact
- Helps maintain consumer confidence
Enterprises should take the opportunity now to build sustainability into their business operations, collaborate in interoperable data exchange networks, and consider financial benefits with recalls and financial reconciliation processes.
For evaluating, implementing or addressing your serialization needs, call one of our expert consultants to help you be sorted!