Full insight: Serialization done the right way can reduce drug prices
The rising prices of drugs is the second largest concern of the end-users after the disease itself. A short-term prescription course can charge you anywhere between $100 to $1200 per year. Long term and terminal diseases like Cancer may need medicines of up to $10,000 every month. Even the prices of old drugs have also spiked, as companies and insurers are bringing in medicines that have no competition in the market, thus spiking the prices.
However, drug makers and manufacturers have another story tell- that the drug-making process is becoming extremely complicated and expensive. Post the DSCSA regulations, stakeholders are building upon their infrastructure to be able to create an interoperable framework so that communicating between two different stakeholders, a key to DSCSA compliance.
While the complete process of compliance at every stage is intertwined and interdependent on the performance of each other, this essay will deal with only the serialization process because it constitutes almost all the pre-requisites for running a drug supply chain- scanning, verification and data preservation. Certainly, a lot of capital resources are required to set individual assets at work, which can add to the capital investment of a pharmaceutical firm. This article will explore:
· How serialization is influencing drug manufacturing
· The cost required to implement serialization processes
· And how can technology help in mitigating the cost
To begin with:
Serialization and its impact on drug manufacturing
It is not left to our imagination how important serialization has turned out to be to improve the efficiency and the safety of the drug supply chain. From managing bulk consignments to warehouse inventory management, Serialization has been there and done that. Serialization, thus, has become an unavoidable part of drug track and trace for improved visibility in a supply chain.
[Get the full explanation in this article]
The next subject in line is how eager are the stakeholders to implement in their supply chain? Do they realize its importance of serialization in fortifying the drug visibility in a supply chain? Surprisingly, as per Healthcare Packaging, in a survey, more than 50% of the participants were compliant-ready to meet advancing serialization and aggregation deadlines. Of the companies who had been interviewed, more than 52% have already adopted aggregation.
The same website talks about the costs involved with implementing the serialization processes, which can account for a sum anywhere between $1million to $4 million. Such a huge sum is actually driving out the smaller companies out of the business. And for the ones that are existing, the cost of medicines would merely increase by notches.
Some of the other challenges, and ensuing costs involved in resolving them, include:
Purchasing equipment: There is immense difficulty in procuring a piece of serialization equipment as there are very few suppliers. In fact, a few pieces of equipment purchased have an ROI of 30 years, but the machine delivery time is merely 2 years.
The time taken for implementation: More time means more money; Which is why circumventing issues arising out of serialization for full-scale production takes more time, which means investing more money.
Establishing a T3 format for communication: An important part of the process, it is mandatory to communicate with machines to retrieve data in a particular format. How to establish that format? How will it communicate with the other existing machines? Resolving all of these would mean investing in a third-party service provider who could help with the process.
Integration with the existing system: Serialization needs an interoperable setup. In other words, it has to communicate with the data repository to store important data. Not every machine or equipment might not have the capacity to connect with other systems, which make serialization difficult and complicated, demanding more capital investment.
Some of the other issues that involve costs and time include defining system architecture, finding qualified employees and training them when necessary.
It is important to note here that the DSCSA has merely outlined what serialization processes should have- verification of products to check their authenticity to eliminate everything that’s counterfeit. Whether or not this should be done with technology is something that stakeholders have to choose. And, most of them choose the ‘less-expensive’ path that involves an increase in manpower.
However, they fail to realize that increasing the manpower to perform serialization would only act adversely to the Return-on-Investment. This is because additional help would mean investing in their salaries plus the money wasted in delayed deliveries as a result of prolonged serialization timelines. So, does that really save any money? No.
Reduced cost and the role that technology has to play
The logic is simple. A one-time investment in getting the right systems and software in place can reduce up to 70% of your costs required for serialization. The perks include no additional manpower and faster delivery lines. How’s that possible?
VR-enabled multiscanners: AR-enabled multiscanners are fast gaining popularity among pharma companies. These not only empower supply chains while handling bulk consignments but also ensure seamless data capturing and storage, which can be used later.
Traceability suite for T3 communication: Imagine if you could track your product on a mobile-edge platform? Well, the TrackTraceRX suite makes that possible; Especially during the VRS process when a ‘suspect’ needs to be authenticated with the manufacturer and the results produced in the VRS audit, this platform is the best way to ensure that you stay up-to-date about the location of the product and your next steps.
API-first design: Data-sharing between stakeholders is possible only when software can communicate with each other. This is possible only when the software they use are interoperable and are built on the foundations of API-first design, which does not require any external IT support. Serialization depends a lot on how the API-first technology is utilized. TrackTraceRX’s traceability solutions just need to be plugged in. The instructions that follow are fluid and simple, which makes them easy to follow without the involvement of an IT team, thus saving additional costs of hiring one for this purpose. This way, training skilled labourers is easier and cost-effective too.
Affordability: The technology that’s used for serialization are advanced and affordable. Even the one-time investment is well within the budget of any small pharma manufacturer. All you need is a good vendor to get the right systems installed. How to find a reliable vendor?
[Things you should look for in your VRS provider]
Technical inclusion in a dynamic pharma ecology is extremely important, given the increased production cycle of medicines and their faster delivery deadlines. Shortening drug supply chain can reduce the cost of manufacturing drugs exponentially; However, usage of the right technology optimizes the benefits that serialization promises of, something that loses its purpose in the fight to affordability. The benefits being transparency of supply chain, higher inventory optimization, improved product recalls, and most of all safety from the counterfeit drug market.
It must be remembered that serialization must be upheld at any cost because it was, is and will continue to be the backbone of the pharma industry. And, saving money while implementing an effective serialization process should be the only thing in a stakeholder’s mind.
