Though we’re fewer than six months away from the Drug Supply Chain Security Act (DSCSA) enforcement date in November 2018, companies still fall into an array of buckets in terms of readiness. Some are prepared and even have aggregation capabilities, some are working out efficiency, connectivity or training issues in their packaging lines or level 4 systems. Others are perhaps a bit later to the party.
Unsurprisingly, last week’s Serialization Innovation Summit hosted by Adents in Philadelphia brought a range of responses from attendees in terms of readiness and familiarity with concepts and new technologies.
The following is a breakdown of the trends from the summit based on what they brought to mind:
Blockchain… it’s everywhere. The much-hyped technology will not solve any problems on its own but offers promise for the pharma supply chain in its ability to store and share one ledger of transactions with all partners. Tianna Umann, Cross Domain Solution Architect at Microsoft, explained that there are multiple types of blockchain (and trust levels), and that the kinds that benefit enterprise are private or consortium, as opposed to public.
Smart contracts are essentially the programmed version of the terms of the real-world contract. They provide the ability to integrate the business processes into the blockchain.
Umann offered an example that a smart contract was created for 1000 units of medication A. That shipment moves through the supply chain, with each carrier scanning the datamatrix to ensure all 1000 units are transferred. Each step is logged along with additional variables such as temperature and humidity. When the retail store only receives 900 units, the transaction is flagged and trading partners are alerted that the smart contract for 1000 units has been violated, causing the carrier immediately upstream to incur a penalty.
David Aguero, Manager Systems and Informatics, St. Jude Children’s Research Hospital pointed out that the DSCSA regulations don’t mandate a centralized ledger—it may ultimately be businesses needs that drive the adoption of the technology.
What is going to happen in Europe with the Falsified Medicines Directive (FMD) in February 2019???
Only around 45 of the approximately 2,200 companies are fully onboarded to the European Medicines Verification System (EMVS) with several hundred more having reached out.
Maarten Van Baelen, Market Access Director at Medicines for Europe,provided an update, explaining the good news that more partners are added each day. He feels that Europe can be ready by February with strong industry and governmental involvement, but that awareness among end users and manufacturers/market authorization holders (MAHs) still presents a challenge.
There are fees charged by the National Medicines Verification Organization (NMVO) to establish the system, and MAHs will have to pay operational fees in each of the countries they market products in.
There is also limited support of awareness in most hospitals regarding integration. Van Baelennotes that some hospitals only found out about the requirements six months ago and some are looking at ways to be exempted.
Sorin Haias, President and Founder of Lives International, discussed the integration of cold chain and serialization data. Haias, whose company provides data loggers and thermal validation systems to the pharmaceutical industry, explained that a customer can use Adents Prodigi to create unique serial numbers and then place a tracker in the final package with aggregated temperature-sensitive products. The serial numbers are associated with the unique temperature tracking hardware in that package.
Real-time information on temperature, light, shock and more can be displayed via API from Prodigi and their XperTrack platform. The user will be notified in case of alarms, and the raw data from shipment is stored in the Prodigi cloud, with a status report emailed when the shipment arrives at its final destination.This seems like an interesting way of combining multiple forms of data—that are collected anyway for temperature-controlled products—into one location, so companies could track what happened to a given unit during risky handoffs and shipment.
Pharmacists talked about the need for serialization at the unit of issue. At this point, meeting DSCSA requirements typically only tracks medicines to the hospital door. Often, pharmacists are splitting units of sale up into many doses, and what happens to doses within the hospital walls (from pharmacies to preparation to cabinets and more) isn’t tracked.
Dennis A. Tribble, Director of Healthcare Industry Operations at Becton Dickinson, noted that other tools will be needed to meet the spirit of the DSCSA regulations regarding location, sequestering and managing lots of suspected counterfeit drugs.
It may not be exactly related to packaging, but AI, mixed reality and machine learning are bringing some really interesting possibilities to healthcare.
Desmond Creary, Health Business Leader of the Americas at Microsoft, explained that in one Louisiana health system, HIPAA-compliant data analysis is being used to help predict which patients with heart disease are likely to code, allowing providers to make interventions before some serious complications arise. They are reducing the time for physicians to discuss, send tests and get opinions by reviewing data from similar patients—identifying what worked and what didn’t—to more quickly narrow down treatment options. This can reduce treatment plan decisions by days or weeks, when in the past, the patient would continue to become sicker while waiting.
On the packaging side, Solutions Architect Luc Vo Van demonstrated use of the HoloLens mixed-reality headset, which he used to scan packages in a box, check for commissioned status and decommission one of the packs. The headset is designed to allow the wearer to perform job duties where the task is best suited, without having to move to an HMI or other screen.
A lab-use example was also presented, in which lab procedures appeared in the employee’s field of view on the headset. They were able to continue with the hands-on work without interacting with a screen or needing to remove gloves.
Blame serialization! Supply Chain Wizard’s Evren Ozkaya brought up a fun fact: When a line stops, people are fairly quick to blame serialization for the downtime, even when the actual cause turns out to be completely unrelated (ahem, unplugged cord).