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Exclusive: Eli Lilly’s recalled emergency diabetes drug came from plant cited by FDA

Source: Reuters

Oct 4 (Reuters) – A recently recalled batch of Glucagon Emergency Kits, Eli Lilly and Co’s (LLY.N) therapy for diabetic patients in crisis, was manufactured at an Indiana factory cited by U.S. health regulators this year for quality-control violations, including several involving that product, according to the company and a Reuters review of federal inspection records.

The Indianapolis-based company on Sept. 24 issued a voluntary U.S. recall of one lot of the kits whose key ingredient is Glucagon, a drug used to treat dangerously low blood sugar in diabetes patients. The company issued a voluntary recall in Canada the following day.

Lilly’s recall notices said that the company had received a report of a patient who experienced seizures even after being injected with the drug, a sign that the treatment was not potent enough to work. The company said the product failure might be related to its manufacturing process, without elaborating.

In response to Reuters’ inquiries, Lilly told the news organization that the affected kits were produced at a company facility in Indianapolis, and that the kit that prompted the recall had been distributed in Canada. As Reuters reported in May, the Indianapolis plant had been cited by U.S. health regulators for substandard sanitation and quality control procedures.

Separately, Lilly is facing a federal criminal investigation into alleged manufacturing irregularities involving another of its U.S. factories in New Jersey, details of which were first reported by Reuters earlier this year. The recall of Glucagon kits made in Indianapolis is the first indication of potential patient harm due to recent manufacturing issues at the company’s plants.

“Lilly is deeply committed to manufacturing high-quality medicines for patients who need them—nothing is more important to us,” the company said in a statement. “We take our obligations seriously and have rigorous quality systems in place to ensure compliance with stringent regulatory requirements.”

In all, roughly 66,000 Glucagon Emergency Kits were affected by the recalls, Lilly spokeswoman Kathryn Beiser told Reuters. She said about 19,000 of those were distributed to U.S. customers and nearly all the rest in Canada. She said the kits were produced at the Indianapolis plant around May 2020. Beiser declined to say whether Lilly has received other reports of adverse events related to the Glucagon kits.

EMERGENCY KITS

The recalled Glucagon Emergency Kit was designed for diabetes patients whose blood sugar is plummeting, and who need to raise it quickly to avoid complications that can include seizures or death. The kit consists of a vial, which is supposed to contain freeze-dried Glucagon powder, and a separate syringe filled with liquid.

Normally, a caregiver inserts the liquid-filled syringe needle into the Glucagon vial in order to dilute the powder before administering it. Lilly’s recall announcement said the vial used by the stricken patient contained liquid, instead of powder.

The company’s Indianapolis plant performs what is known in the industry as “fill and finish” – receiving raw drugs made at other facilities, putting them into vials and syringes, and shipping them to customers.

U.S. Food and Drug Administration inspection records from March 2021 viewed by Reuters cited numerous quality-control violations at that plant, such as staff failing to properly monitor environmental conditions where the finished drugs are made and failing to establish appropriate procedures to prevent contamination.

The FDA inspectors said they observed lapses in the manufacturing of the Glucagon kits as well as in Lilly’s COVID-19 antibody therapy bamlanivimab and several other drugs, according to the inspection records, dated March 16. They concluded that Lilly must take steps to remedy the lapses but did not recommend regulatory action on the part of the FDA.

Lilly spokeswoman Beiser said U.S. distribution of Glucagon Emergency Kits from the lot that was later recalled had ceased by March 25, a little more than a week after the FDA inspection report. Beiser said the distribution of the lot followed its regular process via wholesaler channels and was not related to the FDA report, adding that “any suggestion” it ended for other reasons is false.

Meanwhile, emergency kits from that same batch continued to be distributed in Canada, Beiser said. Distribution of 44,000 kits in Canada began in February 2021 and continued through the middle of September, she said. The patient complaint that triggered the late September recall involved a kit that had been shipped to Canada, Beiser told Reuters.

Beiser declined to comment specifically on why distribution of Glucagon Emergency Kits from the batch continued for another six months in Canada after distribution had ceased in the United States. She did not answer questions about whether the affected patient recovered.

Health Canada, a regulatory agency similar to the U.S. FDA, declined to comment about Lilly’s voluntary recall of the Glucagon Emergency Kits, or why kits from the batch continued to be distributed in Canada for months after they had ceased to be distributed in the United States.

The FDA declined to comment on distribution of the kits, whether it had received other reports of adverse events, had re-inspected Lilly’s Indianapolis facility or if it planned additional actions related to the recall.

“It is important to note that this recall was a voluntary action taken by the company,” FDA spokesman Jeremy Kahn said, without elaborating. “We have been closely evaluating this event and will continue to monitor the marketplace and manufacturing efforts to help ensure the availability of safe products for U.S. consumers.”

FEDERAL PROBE

The recall comes as Lilly faces a criminal investigation by the U.S. Department of Justice into alleged manufacturing irregularities and records-tampering at a separate factory in Branchburg, New Jersey, that produces bamlanivimab and other drugs.

The Justice Department has not accused Lilly of any wrongdoing, and the company said earlier this year that it is cooperating in the probe. Lilly did not respond to a question from Reuters about the status of that investigation. The Justice Department did not respond to a request for comment.

Bamlanivimab, the COVID-19 antibody, manufactured at the Branchburg facility has been sent to the Indianapolis fill-and-finish plant to be put into vials and shipped.

A group of FDA inspectors arrived at the Indianapolis plant in mid-February and stayed for more than two weeks, according to a redacted version of their report, which Reuters obtained via a Freedom of Information Act request.

In their report, the inspectors listed Glucagon as among the drugs where Lilly “failed to establish an adequate system for monitoring environmental conditions,” and noted that Lilly failed to establish and follow appropriate written procedures “to prevent microbiological contamination of drug products purporting to be sterile.”

In addition, the inspectors said Lilly did not properly conduct quality-control sampling of glass components like vials and pharmaceutical ingredients for drugs including Glucagon, bamlanivimab and the cancer drug Cyramza.

In Lilly’s April 6 response to the FDA obtained by Reuters through an open records request, the company said it takes the inspectors’ findings “very seriously” and is implementing actions to resolve concerns “on aggressive timelines.”

Lilly said it has established a comprehensive environmental monitoring program designed to assess microbiological control of manufacturing spaces, the redacted response said. The company did not respond to questions about the status of its efforts to rectify violations noted by the FDA at the Indianapolis plant.

Reporting by Dan Levine in San Francisco and Marisa Taylor in Washington, DC; Additional reporting by Allison Martell in Toronto; Editing by Michele Gershberg and Marla Dickerson

Our Standards: The Thomson Reuters Trust Principles.

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Business

How document management tools are transforming the healthcare sector

Grace Nam, Strategic Solutions Manager, Healthcare, at Laserfiche 

With much of the NHS still stuck in the analogue age, outdated systems and siloed patient data are causing headaches for healthcare professionals and patients alike. Reports of doctors having to enter seven passwords just to access the information they need whilst patient satisfaction hits a record low with less than 25% of people stating that they are satisfied with the NHS in Britain makes for a bleak picture. 

Healthcare institutions should be prioritising how their data is managed, stored, and shared across estates. The lack of unity and siloes puts sensitive patient data at risk, meaning that healthcare leaders may face hefty compliance fines, and patients may receive delayed support or a decrease in quality of care as a result. 

As we look to the future, digitisation will be crucial to bring healthcare operations up to par – especially for a sector that handles such sensitive data and where efficiency gains can mean lives saved. Digitising patient touchpoints will give healthcare professionals a detailed picture of every patient’s medical history and ensure compliance with rules on data transparency. 

But how do we ensure that digitised records are as safe and secure as the patients listed in them? And what role can AI and automation play in lessening the load on overstretched healthcare professionals? 

Centralising patient data to meet regulatory requirements

More sensitive data means more scrutiny of data management. The NHS highlights the importance of looking after patient data carefully to adhere with the Data Protection Act (DPA), Common Law Duty of Confidentiality (CLDC), and GDPR. The DPA for example outlines that consent has to meet certain guidelines to be valid such as being used for a clearly defined purpose and being withdrawable – as easy to withdraw the data as it is to give it. However, outdated systems and disparate data make it difficult for NHS bodies to fulfil these requirements. 

Creating a frictionless experience for busy healthcare professionals is crucial. Staff need to understand what data they can share, how they should share it, and what data should be deleted after a given time. A robust content services platform that centralises patient data improves this regulatory compliance by providing a complete oversight of record history and a single source of truth. Through this platform, medical professionals can share information securely and power automated retention policies that manage documentation throughout its lifecycle, ensuring compliance with regulations and retention laws. 

This effective recordkeeping should be scalable and flexible, allowing for changes in existing workflows and evolving regulatory requirements. 

Securing patient data as cyber-attacks soar

Regulatory compliance is just one piece of the cybersecurity puzzle. Ageing IT infrastructure and legacy systems leave patient data vulnerable to cyber attacks that have the potential to affect real lives. For instance, the recent Synnovis attack led to the leak of 400GB of sensitive data and sparked huge impacts for end-users with the cancellation of thousands of medical procedures. 

By streamlining patient data management, healthcare professionals can also streamline security efforts and reduce the risk of cyber-attacks. Healthcare institutions should manage all patient data and customer information with secure storage, encryption, and stringent access controls through a platform that can track user activities and provide detailed audit trails of document access and modifications.  

What’s more, this digitalised data management gives healthcare providers the opportunity to use AI. They can use this to integrate various data sources, including patient information and medical records, into the Electronic Health Record (EHR) system, creating a comprehensive view of a patient’s health history. Healthcare providers can also use AI to optimise medical records management, facilitating secure and centralised storage of medical records. This enables authorised staff to access information quickly and efficiently, while adhering to regulations. Automation can also streamline record lifecycles, minimising manual work and potential compliance fines. 

Reducing the administrative burden on healthcare professionals

In addition to data security benefits, AI and automation can automate many manual tasks to free up valuable time for clinicians, who can then focus on delivering improved patient care. A snapshot survey of NHS and social care managers found that 20% spent seven to eight hours a day on admin – valuable time that could be spent helping patients. 

In the NHS, technology and systems can be varied across a healthcare estate. With cloud-based integrations, healthcare leaders can synchronise their estate’s legacy processes and technologies with new solutions, allowing clinicians, physicians, staff, and patients to access their records anywhere, anytime. Weaving in powerful workflow automation can also immediately reduce admin headaches. Automation easily captures and populates information between departments, eliminating the need for manual data entry and wasted time looking through physical paperwork. 

In fact, AI could save clinicians four hours of admin time each week. This could be through automating patient communication such as appointment scheduling and sending post-operative reminders. It could mean the improvement of clinical decision-making, where AI can analyse large quantities of clinical data to identify patterns and trends that can inform better treatment decisions. It could also mean enhancing healthcare data exchange, where AI can easily capture and integrate various types of patient data, including demographics, insurance information, and medical records. This not only ensures accurate data processing, but also allows for quick retrieval of information. 

How healthcare providers manage their data is fast becoming a top priority. Whether healthcare providers are looking to remain compliant, protect data, or weave in time-saving technologies like AI and automation, effective document management will be vital to success. 

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Pharmaceuticals

Enhancing Energy Security in the Pharmaceutical Sector: Strategies and Challenges

By Stephen Grant, Managing Director, ENGIE Impact B2B Implementation Solutions

Energy security, referring to the uninterrupted availability of affordable energy sources, has become a paramount concern in recent years. Russia’s invasion of Ukraine and weaponisation of its energy highlighted the inherent vulnerabilities of energy supply chains. In the immediate aftermath of the war’s outbreak, Europe took measures to avoid supply disruptions, ease market pressures, and save energy.

Countries and regions around the world are now accelerating their clean energy transition through structural reforms of the energy system. This involves diversifying import routes and sources, filling gas storage tanks, and investing in infrastructure to reduce dependency on single suppliers. Additionally, they are promoting the import of renewable and low-carbon energy carriers as part of the broader goal to decarbonise the energy system while enhancing energy efficiency to reduce overall demand.

Energy supply security is not only a national issue but is also a critical concern for industries that depend on gas as their main energy source, such as the pharmaceutical sector. Given its specialised nature, stringent regulatory requirements, and reliance on continuous operation for the manufacture of critical products, this industry faces heightened risks. For pharmaceutical companies, maintaining a stable and secure energy supply is essential to ensuring the quality and safety of life-saving medications.

Strategies for Enhancing Energy Security

To enhance the energy security of an organisation, efforts should be directed towards minimising reliance on external energy sources like gas while maximising the utilisation of local, renewable energy and electrifying operations. The main strategies include:

  • Reducing energy consumption: Introducing energy efficiency measures is the first step to lowering dependence on fossil fuels. From behavioral changes to technologies that minimise energy use, such as LED lighting or heat pumps that recover and reuse waste heat, reducing demand is a ‘no-regret’ option. Energy management systems that take an end-to-end approach can have a substantial impact on demand, integrating advanced monitoring, control, and optimisation technologies to manage and reduce energy consumption across the entire production process, from energy and material sourcing to product delivery.
  • Electrification: When paired with a reliable renewable or low-carbon energy supply, electrification is synonymous with decarbonisation, as it significantly reduces the need for fossil fuels to power equipment and transport vehicles. As technologies advance, an increasing number of industrial processes can be powered by electricity.
  • On-site renewable energy solutions: This may involve installing solar panels on facility rooftops, utilising biomass boilers, and exploring geothermal energy options. Solutions must consider the geographic (availability of underground heat sources) and operational conditions of the relevant sites. On-site biogas and biomass are less common in the pharma sector as companies don’t have sufficient waste products to valorise.

These measures have the dual impact of not only promoting energy security but also enhancing energy efficiency and carbon emissions reduction. An additional driver of security is replacing aging assets, such as gas boilers, with efficient electrical boilers that can be powered by green energy.

Challenges and Financial Considerations

While the urgency and benefits of undertaking measures to improve energy security are clear, the journey is not without its challenges.

  • The cost of implementing decarbonisation solutions is one of the main reasons companies delay their efforts, as it typically involves substantial upfront capital.
  • Physical space constraints could make it impractical to implement on-site solutions like solar panels or biomass boilers. An on-site biomass solution, for instance, needs space to store the biomass.
  • Integrating new technologies into existing production processes is another big hurdle. Suppose the decision has been made to use a heat exchanger for heat recovery. This means interfering with the existing production system and potentially modifying it. Some clients view this as a risk to ongoing operations.
  • Cultural resistance from on-site engineering teams is another common obstacle. These teams are accustomed to operating their existing reliable systems. They might resist the introduction of innovative technologies, or even resent external teams interfering with methods that have been successful for many years.

The question is how to overcome these obstacles. Looking at the financial aspect, there are two approaches to consider when analysing how to make energy security projects feasible: internal carbon pricing (ICP) and as-a-service models.

Companies that prioritise reducing their carbon footprint and are willing to accept the cost can usher carbon projects through their internal commitment process by setting up an ICP mechanism, paving the way to implement reduction projects. They can assign a cost to carbon, such as $100 per ton, which is then factored into their long-term financial analysis. This approach often improves the business case for investing in low-carbon technologies by quantifying the economic benefits of reducing emissions.

Companies more concerned about reducing cost can use an as-a-service model, which eases the financial burden by shifting the upfront cost to the service provider. In this case, the energy solutions provider finances the initial capital investment for new technologies and then charges the client a service fee. This approach not only reduces the upfront cost for clients but also aligns the incentives of both parties towards achieving energy savings, carbon reductions, and energy security.

Key Success Factors

The financial side of implementation is only one aspect of a broader strategy to achieve the means to energy security. We can identify three additional factors that are instrumental to the successful implementation of energy security and decarbonisation projects:

  • Stakeholder engagement: This may be the linchpin to rolling out energy security measures. On-site engineering teams, for instance, often hold the budget of the local site. So, even if the corporate team is onboard with the solutions, the local teams must pay for them. Ensuring all stakeholders, from leadership to on-site engineering teams, are engaged and aligned with the project’s goals and understand its benefits, is paramount. Otherwise, the project could become difficult, if it’s not derailed altogether.
  • Centralised project management: A strategic approach with central control and governance helps standardise processes and technologies across different sites. Centralisation that industrialises the procurement, installation, and commissioning of technology accelerates the overall program.
  • Comprehensive agreements: Establishing master service agreements at the corporate level facilitates smoother implementation across multiple locations. These agreements provide a strategic framework that supports consistent and cohesive project execution, avoiding the complexities of negotiating individual contracts in different countries.

Building Resilience to Energy Risks

The pharmaceutical supply chain is complex and global. A breakdown of energy security at any point of this chain can have cascading effects, potentially disrupting the production and availability of essential products. The dependence on energy imports due to limited domestic energy resources, viewed in the light of potential disruptions to energy supply routes due to ongoing geopolitical complexities, has thus raised concerns about energy security in Europe, Asia, and beyond.

An appropriate response to this potential threat is within our grasp, as it dovetails with measures to accelerate the energy transition. Building energy resilience entails diversifying energy sources to reduce dependency on any single supply, improving energy efficiency to reduce overall energy needs, and enhancing local energy production to bolster self-sufficiency. Pharma companies can achieve these measures by forging strategic partnerships with service providers that merge consulting capabilities with the capability to implement the required solutions, thereby facilitating their transition to a more secure and sustainable future.

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Business

How 5G and AI are shaping the future of eHealth

Global Director for AI/ML Solutions, Mona Nia Tecnotree

The digital transformation of the healthcare industry continues to gain momentum. This shift can be attributed to the rapid advancement of widely applied technologies such as 5G networks, cloud computing, artificial intelligence (AI), and big data.

Moreover, integrating 5G networks with cloud-based healthcare platforms and AI is driving the emergence of intelligent eHealth technology, projected to reach $208 billion by 2030, according to recent reports. Recent research by Grand View Research emphasises that the synergy between 5G and AI is pivotal in transforming healthcare by enabling faster data exchange, reducing latency, and improving the reliability of health solutions. This collaboration aims to revolutionise the healthcare sector by facilitating hyper-personalisation, optimised care, enhanced sales and services, and streamlined operations. Leading venture firms actively invest in healthcare start-ups using AI, fostering a rapidly growing ecosystem of innovative advancements.

As AI and 5G continue to make waves through all industries, healthcare needs to adapt to changes quickly. However, with operational, security, and data privacy concerns, healthcare organisations remain wary. As such, they must analyse their current and future needs to understand how AI and 5G technologies can help fulfil them and establish a comprehensive plan to guarantee its efficient and secure implementation in their practices.

Recent research by the International Data Corporation (IDC) emphasises that the synergy between 5G and AI could potentially reduce operational costs by up to 20% and improve patient outcomes by enabling more accurate diagnostics and personalised treatments.

5G Integration in eHealth

5G technology stands at the forefront of healthcare reform with its superior data speed and dramatically reduced latency. Tailored to concurrently accommodate multiple connected devices such as sensors, wearables and medical equipment, 5G is truly indispensable in healthcare, allowing IoT devices to seamlessly transmit accurate data for healthcare providers.

It empowers healthcare professionals to handle large, high-definition files like clinical visuals, videos, and real-time patient insights. 5G’s capability for network slicing—dedicating specific network segments for certain uses—simplifies the management of such files. In addition, it optimises the performance of each application, thereby removing the strain on medical staff.

However, the implementation of 5G technology shouldn’t be oversimplified. It’s essential to analyse the potential risks and challenges thoroughly. A principal component to consider is regulatory cybersecurity and data privacy. Given that 5G networks are susceptible to cyber attacks, it falls upon healthcare providers to protect data such as patient information.

Organisations should also consider the financial implications of implementing 5G technology, as it involves a considerable investment in infrastructure and equipment. Therefore, they must balance the potential gains against the costs to ensure the viability of the investment.

Recent discussions at Mobile World Congress 2024 highlighted the critical role of regulatory frameworks in ensuring the secure deployment of 5G in healthcare. Experts advocated for robust cybersecurity measures and collaborative efforts between technology providers and healthcare institutions to mitigate potential risks.

Marrying 5G and AI for Improved eHealth Solutions

Despite the challenges, integrating 5G and AI will pave the way for unprecedented growth within the internal medical ecosystem, enhancing healthcare quality and patient results. For example, deploying data to carry out descriptive-predictive-prescriptive analytics and transmitting the acquired insights using 5G can drastically improve the user experience while helping make informed decisions. Such an approach can assist healthcare organisations in identifying promising healthcare use cases like remote patient monitoring, surgical robotics, and telemedicine.

Moreover, AI-facilitated hyper-personalisation, driven by the profusion of data accessible through 5G networks, can evaluate patient histories, genetic profiles, and lifestyle elements alongside real-time vitals to prescribe tailored advice and treatments. AI can also automate scheduling appointments, streamline supply chain management, and enhance transactions such as claims and prior authorisations. AI-powered chatbots and virtual assistants can deliver real-life support, while patient and customer service applications can provide an enriched experience through increased data accessibility.

AI can also streamline healthcare services by predicting and managing disease outbreaks. Supported by 5G’s capacity for real-time operability, AI systems can instantly analyse patient data, oversee bed availability, and notify medical personnel of potential complications—promoting efficient, effective care delivery.

Finally, AI-empowered fraud detection algorithms operating on 5G networks can analyse copious amounts of data in real time to detect suspicious activities and alert responsible security teams. This can also be applied to security cameras that can detect anomalies in patients’ and visitors’ behaviour and notify appropriate staff members.

A study published in the Journal of Medical Internet Research (JMIR) in 2023 demonstrated that combining AI and 5G in telemedicine significantly improved patient satisfaction and reduced consultation times by 30%.

Shaping an AI Blueprint for 5G eHealth

Integrating AI and 5G technologies can revolutionise disease assessment and surveillance, facilitating more precise diagnostics and tailored treatments. In return, it will drastically improve the standard of care, curbing expenses and boosting efficiency.

Over the next few years, healthcare providers should focus on specific areas where 5G and AI can deliver the most impact. For example, developing telehealth platforms that excel in security, accessibility, and user-friendly interfaces will be paramount. This design aspect is set to thrive, particularly with 5G paving the way for high-definition video consultations, remote patient monitoring, and instant data sharing between patients and healthcare

providers.

The precision and availability of diagnostic applications powered by AI and tele diagnostic services will notably increase in tandem with the widespread adoption of 5G. The strategic emphasis should be on enriching its capabilities, ensuring compatibility with existing systems, and seamlessly integrating the tech into existing healthcare processes.

AI-guided care management systems will also play an integral role in eHealth. There is a need to structure these systems to constantly monitor patient progress, suggest highly personalised treatments, and coordinate care across multiple providers while prioritising patient privacy and data protection.

Finally, when it comes to home health monitoring, emphasis should be placed on creating IoT devices that can integrate seamlessly with AI-driven health platforms and securely transmit data; this will be a critical development within the field.

The synergy between 5G technology and AI will continue revolutionising the healthcare industry, offering more customised, efficient, and cost-friendly solutions. By developing a precise AI blueprint for critical eHealth applications and capitalising on the capabilities of 5G, the benefits will drastically outweigh the challenges.

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