The Return of Patient Safety Teams, Post Serialization

Change is afoot, we are entering a new phase of activity within the pharmaceutical sector. The next stage of patient protection is starting to take shape across the industry, and it is a case of going back to the future. Though, no DeLorean, TARDIS or even a hot tub time machine are needed to make this change, we are not going to have hover boards or give cousin Chuck Berry a new sound. Instead of fighting Daleks we are going to wage war on counterfeiters and grey marketeers.

So why back to the future?

Historically pharmaceutical companies had departments that either had the name or the goal of Patient Safety. Their task was to protect their patients and the supply chain from counterfeit products and grey market activities. They were supplied with generous budgets and were highly innovative in their approach and projects. Things were improving, technology was being adopted and solutions implemented.

However, this all changed about five years ago when a behemoth appeared on the horizon, demanding attention, action and budget. By demand I mean, no choice, a must do, just to keep in business. It came in the name of "patient safety” and devoured time, resources and budget. It was of course serialization.

Almost overnight Patient Safety teams morphed into Serialization teams, as companies across the globe prepared for, procured and implemented their serialization strategies.

Now don’t get me wrong, serialization has its benefits. It provides a basic level of protection, but it is not a good enough tool to fight the issues faced by the industry.

Now the winds are changing again, and it is time to go back to the future. The Serialization teams are slowly but surely receding as they move into production and maintenance mode, and we are starting to see a return to active Patient Safety teams.

These teams are looking to take up where they left off all those years ago, identifying what they need to do to help improve patient safety and product security.

In this new phase the focus will be back on protecting the patient and securing the supply chain, rather than meeting regulatory requirements that bring limited benefits to either the patient or the business.

In the passing years technologies and solutions have evolved, and businesses can now start to leverage the base given to them by serialization. We see this as the industry starts to move away from physical, additive technologies such as holograms, taggants, inks and labels towards truly data-rich digital solutions that bring so many benefits—not only to the patients but to the businesses themselves.

Utilizing what they already have in place post serialization, companies can now begin to add more protection against counterfeits and diversion with digital technologies such as blockchain. Next-generation solutions can deliver the business data that pharmaceutical companies have always wanted but were never able to access. Data that will help them better understand their logistics, what product is where and when some action is taken on a specific product. These innovations will drive forward not only patient safety but real efficiencies in the supply chain.

I am looking forward to seeing how this develops and what innovations will take place as some of the brightest minds in the supply chain and product protection industries start to focus back on patient safety and their real business needs.

After all, if you want to go back to the future you need a Dr. Brown!