Three Reasons Pharmaceutical Serialisation is Here to Stay

Pharmaceutical serialisation

If you work in any part of the medical industry, you are probably familiar with e-pedigree serialisation. Also referred to as “track and trace pharmaceuticals,” epedigree solutions are put in place to increase accountability in the pharmaceutical supply chain to improve public safety. Issues such as counterfeit medications and pharmaceutical theft create a substantial threat to everyone involved: drug manufacturers, contract packaging providers, distributors, pharmacists, and — worst of all — the patients who take the medications.

The point of e-pedigree serialisation is to track every step of the pharmaceutical process, so that each step and anyone who has any hand in getting to the patient can be traced if any inconsistency arises. The level of effort required to comply with these e-pedigree serialisation regulations involves a much higher degree of documentation and effort. However, most pharma companies have far more hands involved in creating their product than ever in the past, leaving far greater potential for errors or mismanagement. A few reasons that e-pedigree serialisation is more important now than ever in the past include:

  1. Outsourcing is more common than in the past.

    The United States used to be a central figure in industrial production, but now most products are created in other countries and imported. Pharmaceuticals are no exception to this trend. More than 40% of drugs manufacturers depend on off-shore production to create their medications. While this keeps costs low for both manufacturers and the end user, other countries may have different manufacturing standards that expose the patient to an added risk. By using pharmaceutical serialisation, any inconsistency in the production of the medication can be tracked down the individual pill, adding an layer of protection to the patient.
  2. Packaging regulations make contract packaging the only way to go.
    Packaging safety has also become a hot button issue in the pharma industry. The medication industry is constantly looking for new ways to package drugs that makes tampering and contamination impossible, and is difficult for the wrong hands to open while still being feasible for the right hands to open. While the heightened safety is only beneficial to the public, the more complicated technology involved in medication packaging make it necessary for manufacturers to utilize contract packaging providers instead of handling it in-house.

    Contract packaging companies are third-parties that provide packaging solutions like plastic blister packs, pre filled syringes, and medication bottles on behalf of the manufacturing company. The trend in outsourcing the packaging piece of the medication manufacturing process increases safety, but adds another set of hands to the pot. Incorporating track and trace programs protects everyone involved.

  3. Abuse of prescription medication is a bigger issue than ever.

    Unfortunately, abuse of prescription medication is one of the most common reasons that Americans check in to rehab. Prescription meds serve a powerful role in the health and wellness of the American population, but in the wrong hands, it can be incredibly dangerous and even deadly. Sometimes people who are addicted to prescription meds use loopholes in the medical industry to fulfill their addiction, such as seeing multiple doctors for a single issue and receiving multiple prescriptions. Sometimes, these medications are acquired through nefarious processes like theft. Whatever the means, the track and trace program is designed to add an extra layer of protection to addictive drugs.

    Each step of the pharma supply chain process names a person who is accountable for the medications, and so mishandling and theft of them is more difficult than it was prior to serialisation. Meanwhile, serialisation also includes a database of which patients are receiving which drugs, so getting multiple prescriptions from more than one medical provider triggers alarm bells. The added layers of protection that prevent prescription medications from getting into the hands of people who abuse it is an important step in fighting the war on prescription drug abuse. This also helps connect prescription med abusers with the help they need to overcome the subject of their addiction.

It might be impossible to eliminate pharmaceutical errors and mismanagement altogether, however with track and trace programs, the room for error is sharply reduced.

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