For more than 15 years, shortages of critical and non-critical drugs — from oncology treatments, emergency room and surgical suite essentials to antibiotics and flu medicines — have burdened healthcare systems and compromised patient care and outcomes.
“The issue became uncomfortably real for me as I recently searched for a pharmacy that could fill my daughter’s amoxicillin prescription,” comments Vicki Cookson, Strategy Director, Vault RIM, Enterprise at Veeva.
She adds: “How would I feel, I wondered, if I needed immediate access to a treatment for a life-threatening illness as opposed to a common antibiotic?”
Despite ongoing analysis and guidance, supply gaps continue; this is especially true for generic drugs, which account for most of the medications prescribed in Europe and the United States.
“For some generics manufacturers, margins in the low single digits can make consistent quality and compliance a challenge,” said Sofia Lange, Strategy Director, Quality & Manufacturing at Veeva. “The costs of not addressing quality can drive a small supplier out of business, further shrinking supplies.”
Lack of data transparency on the macro and micro level
Lack of data transparency throughout the supply chain is a core challenge for regulators and suppliers of all sizes. It prevents insights into supply fluctuations and their root causes.
Decreased access to global compliance and quality data for the active pharmaceutical ingredients (APIs) and finished drugs manufactured offshore has only compounded supply risks.
Between 2020 and 2022, the US FDA’s 5-year backlogs for offshore API facility inspections have increased from 30% to 80% … and the agency is pivoting to remote and other inspection formats.
“Regulators, governments, patient advocates and industry groups are actively working to solve today’s supply problems. By listing the generics most vulnerable to shortages, the European Medicines Agency (EMA) has taken an essential first step, which should help to guide future efforts,” said Cookson.
So far, these discussions have emphasised the need for economic incentives to help generics manufacturers update their manufacturing processes and improve supply chain data collection, monitoring and analytics.
Meanwhile, at the “micro” level — at the individual facility and company — there is a new focus on establishing information transparency and connecting data across functions. Data-driven approaches are helping more companies to reduce the risk of shortages by improving the efficiency of compliance and quality operations.
Connecting cross-functional data for more agile change control
One area of focus is improving post-approval process change control; this is a time and labour intensive behind-the-scenes process that often leads to supply delays.
Using traditional approaches, with disconnected data, separate IT systems and manual processes, a single change control process can take from 6 months to 2 years to complete.
Depending on the regulatory agencies and regional requirements involved, the work required can delay a drug’s availability by up to 5 years. Today, a typical large biopharma company manages 40,000 of these applications each year, with up to 200 for a single product.
Imagine if the EMA approved one manufacturer’s new therapy 2 years ago. Since then, the company has developed a safer manufacturing process that reduces product costs.
Its leaders also plan to use more sustainable packaging to reduce its carbon footprint and to shift from laboratory based quality control to real-time batch release. Each of these continuous improvements may require separate regulatory agency approval.
Gathering the data required for each change takes months. First, regulatory teams must determine the impact of each change and which countries and internal documents will be affected. Supply chain teams must then do the same for individual product lots.
According to Lange, the quality department must then ensure that all change impact assessments are completed; they must also identify and make sure that affected documents and processes are up-to-date, incorporate changes into new training programmes and even qualify potential new suppliers.
The team will also have to manage and keep track of these actions and estimate the potential risks of making each change.
Currently, at many companies, regulatory and quality teams use different electronic systems for each of these steps and communicate by email and phone. Delayed communication and errors can result in non-compliance and regulatory warning letters.
But that’s only the beginning. After compiling, publishing and submitting the applications, regulatory teams must optimise ongoing communication with regulatory agencies.
In the end, regulators from each affected country can still decide that they need to reinspect the facility to reapprove the new and improved product, triggering additional delays in product availability.
Connecting manual/disconnected processes to gain speed and cut costs
Unified approaches to quality and regulatory data management bring different software together onto a single platform, which can help to streamline and simplify change control. They make it easier for users to meet regulatory requirements … and to spot and address problems faster.
Integrating quality, regulatory and supply chain data, documents and processes can enable even greater agility. It is now possible, for example, to connect regulatory and quality data and content, particularly product documentation, with a corporate enterprise resource planning (ERP) system.
A growing number of companies of all sizes and types are unifying quality and/or regulatory data management.
Some are connecting regulatory and quality operations to facilitate cross-functional collaboration, whereas others are connecting regulatory and quality data with their ERPs, which can potentially reduce batch-release timelines by up to 30%.
Functional and cross-functional teams expect greater data transparency to make compliance and real-time information exchange easier, which would mitigate the risk of drug supply gaps.
Assessing the costs of disconnected systems
Every day that a drug isn't available costs a manufacturer hundreds of thousands to millions of dollars, whether for highly specialised drugs or everyday over-the-counter medicines.
Unified approaches that improve data visibility, centralise access to real-time information and automate workflows are already proving that they can speed patient access to the treatments they need.
Tracking the time and cost of using traditional approaches and technologies can reveal surprising insights into the total cost of ownership and operation. Consider the savings and improvements from the following:
- reorienting highly trained and qualified people away from manual/administrative tasks to focus on priority efforts, such as interaction with regulators
- reducing the time spent on disconnected, one-off email and telephone communications, measured by the number of hours each employee spends on these efforts each day, within teams and across functions
- minimising the risk of errors and duplication of tasks resulting from disconnected manual information exchange
- strengthening patient and healthcare providers’ trust in access to critical treatments; although this cannot be measured, quantifying missed product release deadlines could offer insights into performance gaps and trends
- avoiding the intangible but significant reputational costs of having a drug supply problem.
Disconnected data that’s not visible within systems can affect name-brand, generic and biopharma manufacturers alike. Change control is only one of several behind-the-scenes operations that drain time and resources and delay patient access to treatments.
CMC submissions and submissions publishing are two other examples, both of which are undergoing significant change.
As the current drug supply situation has reminded us, we are all patients and the industry’s supply chain issues affect us all. Solutions already exist to help automate more behind-the-scenes processes and maximise access to connected real-time information.
However, they can only work from a foundation of connected and transparent data at the individual plant level and beyond.
