10 minute read
COMPLIANCE
from EPM May 2022
by EPM Magazine
Author: Andre Caprio – director of business development, Covectra.
The Drug Supply Chain Security Act (DSCSA) has been an active topic of discussion amongst companies in the pharmaceutical supply chain for the past eight years. Enacted by Congress in November 2013, Title II of DQSA outlines the steps to achieve interoperability, electronic tracing of products at the package level, to identify and trace prescription drugs as they are distributed in the US territory. Since its inception, key industry associations, including the Healthcare Distribution Alliance (HDA), Pharmaceutical Development Group (PDG), and GS1 have dedicated exclusive panels to debate the impacts of DSCSA and to provide valuable resources in eff orts to collaborate for this industry wide objective. Although considerable progress has been achieved during the previous years, much work is still required until the pharmaceutical industry can fi nally “fl ip the switch” for DSCSA. Supply chain disruptions caused by the Covid-19 pandemic, coupled with a shift in focus towards vaccine development and distribution, have contributed to creating delays in DSCSA compliance eff orts. Nonetheless, per interoperable with approximately 1-5% of their trading partners. Furthermore, a major distributor, member of the Big Three family (the three largest distributors in the US), indicated concerns around data quality and failures caused by EPCIS/DSCSA syntax or semantics issues when receiving fi les from trading partners. These issues were present amongst third-party logistics providers (9% failure rate) and manufacturers (37% failure rate). Part of the challenge around data interoperability is because several serialisation solutions providers exist, each with their own proprietary software products, with thousands of trading partners in the pharmaceutical supply chain hosting their own data. Although some progress has been achieved in connecting these systems, the process has proven to be lengthy and labour intensive.
DATA QUALITY CONCERNS AT THE MANUFACTURER LEVEL
Throughout 2018 and 2019, the FDA ran a series of pilot studies that aimed to assess the impacts of having stakeholders verify the authenticity of a pharmaceutical product by scanning its unique data matrix barcode and authenticating it against the manufacturer hosted serialisation database. Simply put, once a product was scanned, the manufacturer’s system would provide a positive or negative result based on the unique information embedded on the product’s data matrix. Although the enforcement of this specifi c DSCSA milestone was later delayed in 2020, the results of the pilot studies were peculiar, with a high percentage of authentic products (upwards of 25%) returning a negative confi rmation. Many manufacturers were puzzled as to the cause of these “false negative” results. Upon further investigation on the embedded data contained in the faulty barcodes, the most common issues included the wrong placement of comma separators, use of double zeroes for lot and expiry dates, amongst other technical issues. Furthermore, it was concluded that most of the data errors were because of the FDA’s recent guidance during its public meeting in October of 2021, further enforcement discretions are highly unlikely to be granted. Therefore, the target date for full compliance and interoperability has been set for November 27th, 2023.
INTEROPERABILITY REMAINS THE BIGGEST HURDLE
As DSCSA legislation states, trading partners in the pharmaceutical supply chain must have systems in place which enable the capture, storage (up to six years), and transmission of data in EPCIS format amongst stakeholders. EPCIS is a GS1 standard that enables trading partners to share information about the physical movement and status of products as they travel throughout the supply chain – from business to business and ultimately to consumers. During the annual Traceability Seminar in November 2021, the HDA disclosed results of its recent supplier survey around data interoperability progress, which were far from encouraging considering the legislation was two years away from the ultimate deadline at that time. In this study, 54% of respondents were manufacturers and 46% were distributors. Amongst all participants, only 37% indicated they were actively
What next for DSCSA?
brand owners using CMO’s and contract packagers which were utilising serialisation solutions yielding poor results. The same scenario was raised by another distributor during the HDA’s annual Traceability Seminar in 2021. Here, the distributor indicated that at that time, less than 50% of manufacturers had the means to correct errors on their EPCIS fi les and data matrix barcodes. Additionally, low supplier onboarding activity and steady decrease in the engagement between manufacturers and distributors for data interoperability was a cause of grave concern.
ONGOING CHALLENGES IN THE DISPENSER COMMUNITY
As mentioned, the Covid-19 pandemic forced the supply chain to temporarily shift its eff orts from compliance towards vaccination. Dispensers were placed at the forefront of this battle and were naturally induced to focus on this matter as highest priority. This change in focus was clearly visible as only 9% of the participants during the HDA’s 2021 Traceability Seminar were organisations from the dispenser community. As well as diminished engagement around DSCSA compliance, budget constraints are an important factor which dispensers must consider, especially amongst independent pharmacies. It is anticipated that once dispensers are obligated to acquire their own serialisation solution, expenditures could amount to over $20,000 yearly. Assuming there are over 67,000 dispensers nationwide, the average cost of this requirement would be over $1 billion annually for this sector of the pharmaceutical industry. With cost as a primary determinant, the industry is likely to see the continuing trend in which distributors act as the data repository for their respective dispenser clients. During the fi rst phase of DSCSA compliance, which required trading partners to exchange lot level data in the form of EDI Advanced Shipping Notifi cations (ASNs), this was an easier task to achieve. However, when dealing with serialised data and the ability for a dispenser to reconcile received products against EPCIS fi les, additional challenges are likely to arise. The burden will be placed on the distributor to host the serialisation data and facilitate how their dispenser customers can access and utilise this data as part of a daily workfl ow.
CHALLENGES AND OPPORTUNITIES BEYOND 2023
Once DSCSA is in full eff ect, the pharmaceutical industry will be well equipped with a wealth of data pertaining to pharmaceutical products fl owing through the supply chain. This complex data network will provide many added benefi ts extending beyond the obvious compliance requirements. Improvements in internal processes will occur organically, including enhancements around product verifi cation and visibility within the supply chain - and eventually down to the patient level. Natural enhancements are likely to occur in the drug recall process, including more accurate chargeback and rebate processes. Also, pharmaceutical suppliers will benefi t from a granular view of inventory movement through the supply chain, thus having access to data to better direct sales and manufacturing operations. The outlined benefi ts are not immune to potential challenges imposed by the pharmaceutical industry and its governing federal regulators. As an example, the FDA’s Enhanced Drug Distribution Security at the Package Level draft, a concept introduced by the FDA in June of 2021. This guidance provided insights pertaining to aspirations of implementing a semi-centralised data repository, managed by the FDA, in which all trading partners would have to report to - an eff ort not well received by key stakeholders in the pharmaceutical industry and is highly improbable to take place soon. Further improvements in DSCSA compliance are only likely to happen if it adheres to the legislation’s original draft.
For pharmaceutical manufacturers, progressing digitalisation and moving to the cloud has been notoriously slow, and misperceptions of what moving to the cloud entails have been a signifi cant factor in this lack of adoption. Manufacturers with established legacy systems are often unduly concerned about the security aspects of moving to cloud. They have also been hesitant to invest in new infrastructure, even though the long-term savings off ered by cloud platforms outweigh its short-term costs. Despite this lag, the move from on-premise, local software installation, to cloud has become more commonplace. Many manufacturers have taken an intermediate hybrid cloud approach, which refers to a mixed computing, storage, and services environment made up of on-premises infrastructure, private cloud services and a public cloud. The trends of digital transformation and the International Society for Pharmaceutical Engineering (ISPE) Pharma 4.0 initiative have laid the foundations for the move to hybrid cloud. The ongoing need to drive speed-
KELLY DOERING
- senior director, Industry Marketing, Pharma, AspenTech
PERSPECTIVE ON PHARMA
How pharmaceutical manufacturers can benefi t fr om moving to cloud today
to-market and to be ready for demand spikes has been put into focus by Covid-19. In line with this, pharmaceutical manufacturers are adopting hybrid cloud infrastructure to enhance operational effi ciencies, reduce IT burden, drive costs down and improve data accessibility and analysis. This migration is gathering pace. Thanks to the Internet of Things (IoT), the breadth of connected equipment and systems available to pharmaceutical companies has been growing. Along with the goal of delivering medicines to market faster and minimising supply chain disruptions, another reason for embracing cloud solutions is the growing amount of data that accompanies a drug manufacturing project. The complexity of modalities being developed for therapeutics has resulted in more variables to measure, meaning larger data fi les and greater data volume. There is a real need for pharmaceutical companies to aggregate data from multiple sources, including manufacturing, lab systems and enterprise resource planning (ERP) solutions. By aggregating those data, businesses have greater opportunity to mine it, creating an integrated overview of how the whole business is performing. Cloud solutions can augment validated onpremise solutions and data can be extracted to feed machine learning. Cloud can also support the implementation of advanced digital solutions in remote locations with limited IT support. Many pharmaceutical companies are starting to think through applications and use cases around cloud, but questions remain. What sort of data from manufacturing, labs or fi nancial systems should be in the cloud, for instance and what should reside at plant level? What kind of cloud-based applications should they use? What is the data strategy pharmaceutical companies should follow, in the pursuit of greater accessibility to data for sharing, analysis and reducing the IT burden? The biggest question, however, is how can companies take advantage of the cloud now? Simply, the fi rst step is identifying the pain points; building strategy, aligning with the company’s business initiatives, and securing buy-in. The second is to determine key performance indicators (KPIs), plan and implement pilots, then assess and scale. New cloud-based approaches using AI and predictive capabilities are already delivering gains in the effi ciency and time-to-market of batch releases, for example, resolving the bottlenecks around reviewing of data. Electronic record-keeping and the reduction of human error mean organisations benefi t from fewer lost and increased data integrity.
STEP-BY-STEP
Process predictions is one area pharmaceutical companies often focus on, especially if quality or reliability may be at risk. Implementing predictive technologies is often the fi rst step pharmaceutical companies take on their move to cloud because it is lower risk. The results raised by predictive technologies around likely equipment failures further down the line are early fl ags that, if acted upon, will prevent problems occurring later, and minimise unplanned downtime. With relevant data collected and integrated seamlessly, the workfl ow can be made more effi cient with data in one place, and checks and controls can be handled electronically by automated systems, both on-premise and ultimately in the cloud where there is even greater accessibility to data.
REAPING THE REWARDS
Most pharmaceutical companies can benefi t from cost savings. The cost of building and scaling an on-premise IT set-up can be exorbitant. By moving to the cloud, pharmaceutical companies can offl oad much of this. Having data available in the cloud drives effi ciencies. In the development process, fi rms can start to circumvent the process of having to churn through reports and spreadsheets. Starting out on the journey to the cloud is becoming an imperative for pharmaceutical companies. They don’t have to do everything in one go but by getting underway they can use data to drive business advantage and competitive edge.
