While most pharmaceutical companies are well on their way to being fully prepared for full compliance with the new Drug Quality& Security Act, there are still many companies that are not prepared or that may not understand the value.
In fact, many pharmaceutical companies assume that the pharmaceutical serialization process is simply costing them money with the additional software, the need to be more closely aligned with packaging service and third party logistics providers and the increased time for data management through the system.
The Reality
The reality is that the use of the pharmaceutical serialization process will provide a comprehensive way to track and trace all products. With this ability, it will be much harder for counterfeit drugs to enter the supply chain and compete with legitimate pharmaceutical companies.
The National Association of Boards of Pharmacy reports that approximately $75 billion dollars per year is spent on counterfeit drugs. This is money that is not paid to the pharmaceutical companies, but often customers at pharmacies, drug stores or department stores as well as buying online are unaware of the substitution of a counterfeit medication.
Finding Weak Links
With the ability to track and trace from the packaging company through the Third Party Logistics service to the repackaging facility, warehouses and through to the end user, it is possible to determine where in the system the counterfeit products enter.
It is also possible to determine just where specific batches of product are located, which is a critical factor should there be the need for a recall. With the ability to use track and trace pharmaceutical companies can contact the pharmacies or stores to have specific batches pulled from the shelves faster, easier and with less risk of incident.
When fully implemented, this ability will also allow notification of patients prescribed specific batches of medications about any potential risks or concerns. While these recalls will have an impact on the reputation of a company, it will be much smaller than if a tragic death occurs or serious illness are linked to contaminated medications.
