The pharmaceutical supply chain that delivers needed medicines to patients around the world is complex and critical. It also appears to be outdated.
Consider this: We buy salmon at our local Whole Foods grocery store and are informed of the origin of the fish. We buy coffee beans at the same store and are informed in great detail that it was sourced from farms around the world under sustainable conditions that have been certified by a third party.
After the grocery store, we may wish to order a pizza for the kids, so we order one online through the Domino’s Pizza app. After placing the order, we are shown a “Pizza Tracker,” which gives us a clear view of where our pizza is in the process—from being made in the kitchen to being whisked away in the delivery vehicle—all of which can be tracked online.
And yet, when it comes to medication, consumers never receive this level of detail regarding origin.
In fact, when you ask where your medicine was manufactured, you may get a puzzled look from your local pharmacists. Ask if the medicine you received contains gluten or some egg component (to check for allergens) and again you may receive a puzzled look.
Not only may pharmacists not have access to the information, but also it is likely that customer service representatives at the call center for the pharmaceutical manufacturer may not know the exact origin either.
This is because the pharmaceutical supply chain is highly complex and opaque. Active pharmaceutical ingredients (APIs) originate in one country and then go through the various stages of manufacturing all the way to packaging and shipping through one or more other countries.
So what’s the big deal? Why is knowing the origin or having traceability so important for medicines today? There are two important reasons, as described below.
The first reason is that patients, consumers, and the public want and expect greater transparency for the products they buy today, especially for what they put into or onto their bodies.
From our food to our clothing to our cosmetics, consumers are more conscious of provenance than ever before. This is because doing business with the right kind of company matters as much as, if not more than, the quality and price of the product. This is especially true for many millennials.
Greater transparency is not only important for consumers, it also is becoming increasingly important for regulatory bodies, including the U.S. Food and Drug Administration (FDA), which is advancing new laws such as the Drug Supply Chain Security Act (DSCSA) outlining ways that pharmaceutical companies and their supply chain partners must operate to bring about greater security for consumers.
We know more about products and companies today than we did in the past. Those who commit to providing transparency are starting to win more share. From stores such as Costco, which has made sustainability a cornerstone of its sourcing strategy, to Whole Foods, which relies on it as a core unique selling point, consumers like to do business with companies that can tell them “where the product comes from.”
The second reason is that there is increased risk with respect to counterfeiters who wish to take advantage of the high profit margins in the pharmaceutical industry.
From counterfeits of pain medicines to high-priced oncology products, the illicit trade in pharmaceuticals is not stopping—and, in fact, could get worse in the years ahead. Thus, confirmed traceability—not only of the packaging, but also of the dosage—is going to become increasingly more important.
Having traceability attached to the product allows manufacturers to confirm the product’s authenticity—and also to determine whether there is leakage or diversion in the supply chain.
Imagine the typical scenario that occurs today. A pharmaceutical company’s general manager is alerted by the authorities that boxes of the firm’s product were found in a garage or warehouse run by alleged criminals whom they have busted. The authorities want to know if this product is indeed the company’s product—or if it is counterfeit.
Today, the company often is able to determine the authenticity of the product in a lab using commonly used instruments. However, the bigger question is not authenticity, but traceability, which allows manufacturers to potentially prevent future diversion of their products because it empowers them to determine which distributors might be engaged in such illicit activity.
This is really the key point: Manufacturers need to be proactive at preventing problems from occurring in the first place. Currently, however, most are reactive to counterfeits and suspect products that get intercepted by law enforcement.
So how can we reimagine the pharmaceutical supply chain?
We believe that, given advances in new technology, there is an opportunity to use molecular taggants to integrate directly onto tablets or capsules—directly on dose so that origin, authenticity, and integrity can be elevated. While putting serialized bar codes on boxes is a crucial first step, it’s not going to be sufficient when tablets and capsules can be taken out of packaging very easily.
By integrating traceability through the use of molecular taggants into, for example, film coatings or other excipients, pharmaceutical companies can provide the much-needed transparency, traceability, and trust for patients, consumers, and regulators.
So instead of simply reacting to alerts from legal authorities, one can envision pharmaceutical companies proactively testing medical tablets and capsules originating from “hot spots” within a specific geographic area. This testing of tablets and capsules can demonstrate not only authenticity, but also traceability.
Similar to the pizza tracker, coupling serialization with molecular taggants on dose—and the proactive testing of products—can provide a treasure-trove of data: in effect, a “meds tracker” for companies and potentially patients as well.
When a future patient walks into a drugstore and asks, “Where do my pills come from?” they will get a clear answer.
The value is not just in knowing where medications come from, but also in providing consumers with the confidence they need in the industry that has the ability to do more good than any other.
About the Author
Bob Miglani is Business Development Advisor at Applied DNA Sciences, a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft measures, product genotyping, and DNA mass production for diagnostics and therapeutics.
This story can also be found in the September/October 2018 issue of Pharmaceutical Processing.