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Pharmaceuticals

Management of Idiopathic Pulmonary Fibrosis

Source: pharmacypracticenews

Idiopathic pulmonary fibrosis (IPF) is a progressive, debilitating, and often fatal interstitial lung disease characterized by scarring of the lungs with unknown etiology.1 This scarring causes the alveolar walls to become stiff and thick, preventing inflation, which reduces lung capacity and makes the exchange of oxygen and carbon dioxide more difficult. The decreased lung capacity and oxygen exchange increases breathlessness and decreases mobility and independence.2

Epidemiology

Although the precise cause of IPF is unknown, there is evidence that risk factors including age and environmental exposures play a role. The disease tends to affect adults in their sixth or seventh decade of life.3 In addition, there is a strong correlation between smoking and IPF, as well as evidence of a detrimental effect of smoking on survival.4 Environmental exposures to certain types of manufacturing-related dust and genetic factors also are contributors.5

Prognosis and Disease Course

Common symptoms of IPF include dry cough, shortness of breath, fatigue, chest pain, and unintentional weight loss.2 Because these symptoms are nonspecific and are associated with other diseases, such as asthma, chronic obstructive pulmonary disease, emphysema, and heart disease, the diagnosis of IPF often is delayed.1 Thus, significant declines in lung function can occur by the time a patient is correctly diagnosed. It is imperative to start patients on FDA-approved therapies as soon as possible to preserve lung function, reduce the risk for acute exacerbations, and improve outcomes.1

The prognosis of patients with IPF is poor; median survival duration is less than 4 years.1 The clinical course of IPF can vary by patient, with some patients experiencing a slowly progressive course and others rapidly progressing. At diagnosis, there are no distinguishing clinical characteristics to indicate the clinical course a patient is likely to experience. Acute exacerbations with clinically significant worsening of lung function and/or dyspnea can occur at any time during the course of the disease and are associated with a high risk for mortality.1

Treatment

Historically, the only treatment options available to patients with IPF were focused on symptom relief and not slowing the disease course. In 2014, the FDA approved 2 oral antifibrotic therapies for IPF: nintedanib (Ofev, Boehringer Ingelheim) and pirfenidone (Esbriet, Genentech) (Table).3 Current guidelines from respiratory societies recommend antifibrotic agents as first-line therapy for patients with IPF.6

In addition, patients can benefit from a holistic approach to care that includes pulmonary rehabilitation, education and support, vaccinations, and supplemental oxygen.2,7 Although there is no cure for IPF, medications combined with lifestyle changes can help to slow the decline in lung function, decrease respiratory symptoms, and reduce acute exacerbations.1

Table. Antifibrotic Agents Approved to Treat Idiopathic Pulmonary Fibrosis
MedicationDoseCommon AEsWarnings/
Precautions
Counseling Notes
Nintedanib (Ofev, Boehringer Ingelheim)Recommended dose: 150 mg twice daily every 12 h with food Mild hepatic impairment (Child-Pugh A): 100 mg twice daily every 12 h with foodDiarrhea Nausea Stomach pain Decreased appetite Headache Weight loss High blood pressureHepatic impairment Elevated liver enzymes GI disorders Embryo-fetal toxicity Arterial thromboembolic events Bleeding events GI perforationIf AEs occur, consider a temporary dose reduction to 100 mg twice daily Pregnancy category D
Pirfenidone (Esbriet, Genentech)Titration dose: Days 1-7: 267 mg 3 times daily (801 mg/d) Days 8-14: 534 mg 3 times daily (1,602 mg/d) Days 15 and beyond: 801 mg 3 times daily (2,403 mg/d)Nausea Rash Abdominal pain Upper RTI Diarrhea FatigueElevated liver enzymes Photosensitivity reaction or rash GI disordersPatients who miss =14 d should restart with 2-wk titration regimen Take with food Pregnancy category C
AEs, adverse events; GI, gastrointestinal; RTI, respiratory tract infectionBased on references 8 and 9.

Antifibrotic Agents

Nintedanib

Nintedanib is a tyrosine kinase inhibitor that targets multiple growth receptors involved in the pathogenesis of fibrotic tissue remodeling in interstitial lung disease. The recommended dose is 150 mg orally twice daily with food.8 A dose reduction to 100 mg orally twice daily should be considered for patients with mild hepatic impairment or for the management of adverse events (AEs).8 The most common AEs are diarrhea, nausea, and vomiting. The nintedanib labeling includes warnings and precautions related to hepatic impairment, elevated liver enzymes, gastrointestinal disorders, embryo-fetal toxicity, arterial thromboembolic events, and bleeding events.8

In clinical trials, nintedanib resulted in statistically significant reductions in the annual rate of lung function decline, as measured by forced vital capacity (FVC), preserving lung function, and reduced the risk for acute exacerbations in the first year of therapy.8

Pirfenidone

Pirfenidone is an antifibrotic medication that is thought to have multiple effects. It has been shown to regulate important profibrotic and pro-inflammatory cytokine cascades in vitro and to reduce fibroblast proliferation and collagen synthesis in animal models.9 The recommended maintenance dose of pirfenidone is 801 mg 3 times daily taken with food, but patients will titrate to the full dosage over a 14-day period.9 The most common AEs are nausea, rash, and abdominal pain. The labeling for pirfenidone includes warnings and precautions about elevated liver enzymes, photosensitivity, rash, and gastrointestinal disorders.9

In clinical trials, pirfenidone was shown to significantly reduce the risk for lung function decline as measured by FVC and to preserve lung function.9

Role of the Specialty Pharmacist

At AllianceRx Walgreens Prime, due to the complex nature of IPF, specialty pharmacists play a critical role educating, counseling and monitoring patients. Educating patients about the disease and the importance of receiving all recommended vaccinations is essential.1 Specialty pharmacists can provide counseling and support related to healthy lifestyle changes, such as smoking cessation, improved nutrition, and increased exercise.1,59 Because the diagnosis of IPF often is delayed due to misdiagnosis, patients likely will have had declining lung function for quite some time. Thus, it is crucial for pharmacists to educate patients about the importance of starting antifibrotic therapy as soon as possible to preserve lung function, slow disease progression, and improve outcomes.1 In addition, specialty pharmacists can educate patients and monitor for AEs associated with antifibrotic therapies. Both medications approved for IPF have warnings and precautions associated with their use. Pharmacists can counsel patients about signs and symptoms to be aware of and when to seek medical attention. Pharmacists also can help ensure patients keep their appointments for laboratory monitoring. By supporting IPF patients in these ways, specialty pharmacists can help optimize outcomes for this population.

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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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