Clinical Trial Management – enhancing patient safety.

Clinical trials are the backbone of the drug development process. These processes Generate vital data and insights that drive the discovery and approval of new therapies. A successful clinical trial hinges on efficient and effective management, ensuring that projects proceed smoothly and comply with regulatory requirements. This article will explore the best practices for managing clinical trials and how implementing these strategies can optimise your trial management process.

Thorough Planning and Design

Thorough planning and design are the cornerstones of a successful clinical trial. Developing a robust clinical trial protocol and a detailed study design is crucial. This ensures that all aspects of the trial are meticulously considered and potential issues are proactively addressed.

Critical elements of trial planning include:

• Setting clear, attainable objectives and primary endpoints
• Identifying the appropriate patient population and inclusion/exclusion criteria
• Determining the most effective and practical study design
• Defining data collection and management processes
• Outlining the statistical analysis plan and methodologies
• Establishing recruitment strategies and timelines
• Allocating sufficient resources to execute the trial

Assembling an Experienced Team

An experienced and dedicated clinical trial team is a linchpin of efficient project management. The team’s skills and expertise are vital for overseeing key aspects of trial execution, including regulatory compliance, patient recruitment, data management, and safety monitoring. To further enhance your trial management capabilities, consider collaborating with external partners or outsourcing to specialised service providers.

Early and Continuous Stakeholder Engagement

Engaging stakeholders, such as regulatory authorities, clinical investigators, and patients, is paramount. Early and continuous engagement ensures the consideration of various perspectives and the proactive addressing of potential concerns, fostering a collaborative and informed approach to trial management.

Key components of stakeholder engagement include:

• Establishing a Medical Advisory Board consisting of key opinion leaders and experts to advise on trial design and execution
• Consulting regulatory authorities during planning to ensure alignment with guidelines and prevent future submission issues
• Involving patients and advocacy groups to improve trial design, as well as understand and address barriers related to patient recruitment and retention

Embracing Technology and Innovation

Technology can significantly enhance trial management, improving efficiency and data quality. Consider incorporating innovative tools and platforms like Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), and patient engagement mobile apps into your trial management process.

The benefits of using technology in clinical trial management include:

• Streamlined and real-time data collection and monitoring
• Improved patient engagement, compliance, and retention
• Enhanced communication and collaboration among trial stakeholders
• Reduced data entry errors and accelerated data analysis

Managing Risks Proactively

Effective risk management is essential for efficient trial conduct and to avoid costly setbacks. Establish a risk management plan, conduct periodic risk assessments, and implement appropriate mitigation strategies. Adopt a risk-based monitoring (RBM) approach to optimise trial resources further and address potential issues more effectively.

Ensuring Data Integrity and Quality

The integrity and quality of the data generated during a clinical trial are critical to achieving valid and reliable results. Adhering to good clinical practice (GCP) guidelines, implementing rigorous data management processes, and utilising centralised monitoring and quality control measures can help maintain data integrity and reliability. Additionally, performing periodic quality audits to identify and address potential compliance or data quality issues.

Fostering Effective Communication and Collaboration

Effective communication among trial stakeholders is crucial for streamlined execution and project success. Maintain open lines of communication among trial teams, external service providers, and other stakeholders to ensure the timely and accurate sharing of information. Establish regular meetings and updates to discuss trial progress, address concerns, and make informed decisions on key aspects of trial management.

Implementing Adaptive Trial Design and Execution

Adaptive trial designs allow for increased flexibility during the trial, enabling adjustments in response to emerging trial data or other factors. Consider incorporating adaptive designs to optimise trial efficiency, reduce sample sizes, shorten the trial duration, or adapt the trial design based on interim analyses.

Prioritising Patient-centric Approaches

A patient-centric approach in trial design and execution can improve patient compliance, retention, and overall trial outcomes. Focus on minimising patient burden, addressing concerns or barriers related to trial participation, and engaging patients throughout the trial process. Implement remote monitoring, telemedicine, and patient engagement platforms to enhance patient experience.

Continuously Improving and Evolving

Clinical trial management should involve continuous improvement and learning, enabling organisations to adapt and evolve their practices based on lessons learned. Therefore, ensure regular trial performance reviews, identify improvement areas, and implement necessary adjustments to streamline processes, enhance efficiency, reduce costs, and improve overall trial outcomes.

Effective clinical trial management relies on robust planning, assembling an experienced team, engaging stakeholders, embracing technology, managing risks, maintaining data integrity, fostering effective communication, implementing adaptive trial designs, prioritising patient-centric approaches, and continuously improving and adapting. By incorporating these best practices into your trial management process, you can optimise resource allocation, reduce clinical trial timelines, minimise setbacks, and enhance the likelihood of successful trial outcomes. Ultimately, adopting these strategies will enable your organisation to contribute to advancing medical knowledge, accelerate the approval of novel therapies, and improve patients’ lives worldwide.

Take a look at our testimonials here to learn more about how MMD has supported partners to ensure best practices for clinical trial management.

Interested in learning more? Schedule a free consultation with our clinical trial experts today!” by emailing Kwesi@mymedicaldepartment.com or contacting via LinkedIn here.

The pharmaceutical industry continually evolves, with companies facing increasing pressure to optimise resources while maintaining a competitive edge. As a result, outsourcing strategies have become prevalent among industry leaders, from CEOs and CMOs to Pharmacovigilance managers and COOs. This article will delve into the pros and cons of outsourcing strategies for pharma, allowing you to make informed decisions on the best approach for your pharmaceutical company.

The pros of outsourcing strategies for pharma.

Cost Reduction

Outsourcing non-core tasks can lead to significant cost savings for pharmaceutical companies. Outsourced partners often provide services at a lower price than maintaining an in-house team, primarily due to economies of scale, lower labour costs, and well-established infrastructures. This cost reduction allows organisations to focus their resources on their core competencies and enhance their R&D and innovation capabilities.

Our team of industry experts allows your organisation to save on costs associated with maintaining in-house personnel for non-core tasks. By leveraging our economies of scale, lower labour costs, and well-established infrastructures, we provide cost-effective solutions, helping you allocate more resources toward your core competencies, R&D, and innovation.

Access to Expertise

Outsourcing specialised functions, such as clinical development or regulatory affairs, enables pharmaceutical companies to access a pool of experts with deep industry knowledge and experience. These external partners often have a wealth of skills and resources that would otherwise take significant time and investment to develop in-house. Outsourcing leads to quicker turnaround times and improved service quality.

We offer specialised expertise in various functions, such as clinical development and regulatory affairs, to help your company access deep industry knowledge and experience. Our skilled professionals can deliver quicker turnaround times and improved service quality compared to the time and investment needed to develop such capabilities in-house.

Scalability

Outsourcing allows pharmaceutical companies to scale operations more quickly in response to market demands or shifts in strategic direction. Engaging external partners can also help you manage sudden fluctuations in workload without hiring additional employees or investing in new infrastructure, providing a more agile and responsive approach to business operations.

With our assistance, your organisation can quickly scale its operations in response to market demands or shifts in strategic direction. Our flexible outsourcing solutions enable you to manage sudden workload fluctuations without hiring additional staff or investing in new infrastructure, providing a more agile and responsive approach to your business operations.

Risk Mitigation

Outsourcing can help reduce risks associated with regulatory compliance and quality management. For example, external partners often have robust quality management systems, processes, and regulatory insights to strengthen your company’s compliance and minimise potential breaches related to document preparation, adverse event reporting, and safety monitoring.

Through our robust quality management systems, processes, and regulatory insights, we help mitigate risks associated with regulatory compliance and quality management. By partnering with us, your company can minimise potential breaches related to document preparation, adverse event reporting, and safety monitoring, ensuring compliance and protecting your organisation’s reputation.

Speed to Market

By leveraging external networks and expertise, pharmaceutical companies can speed up their product development and approval processes, significantly shortening their time to market. Additionally, outsourcing can reduce the risk of unexpected issues or delays during development by capitalising on the partner’s expertise in target markets.

MMD’s extensive external networks and expertise allow your company to accelerate product development and approval processes, significantly shortening your time to market. By capitalising on our in-depth knowledge of specific regulatory environments and markets, we can help reduce the risk of unexpected issues or delays during the development process, enabling your organisation to maintain its competitive edge.

While outsourcing can offer significant benefits, pharmaceutical companies must consider potential drawbacks. These may include losing control over outsourced processes, increased confidentiality and data security risks, communication challenges with external partners, potential reputational risks if the outsourcing partner fails to meet expectations or regulatory standards, and excessive dependency on external partners. Therefore, let’s explore the cons and how we mitigate those risks.

The pros of outsourcing strategies for pharma.

Loss of Control

Outsourcing can result in relinquishing some control over the outsourced processes or services. At MMD, we prioritise transparent communications and robust project management strategies to ensure you stay informed and involved throughout every step of the process. We work closely with your team to understand your goals and objectives and maintain a balance between delegating responsibilities and providing the oversight needed to guarantee that outsourced tasks meet the desired standard.

Confidentiality and Data Security

Outsourcing can expose your company to increased risks regarding handling sensitive information, as data is shared with external partners. At MMD, we treat your data as our own, adhering to stringent confidentiality and data security standards. We implement rigorous data protection policies and practices to safeguard your organisation’s proprietary information and intellectual property at all times.

Communication and Time Zone Challenges

Working with external partners, particularly those in different time zones, can present communication challenges. At MMD, we invest in the tools and resources required for efficient collaboration and provide dedicated account managers to ensure smooth information exchange and decision-making between your team and ours. We emphasise clear communication and well-defined workflows, enabling your team to work seamlessly with our experts, regardless of geographic boundaries.

Reputational Risks

Pharmaceutical companies may face reputational risks, fines, or sanctions if the outsourcing partner fails to deliver the desired quality or meet regulatory standards. MMD addresses this by combining our extensive industry experience with best-in-class quality control measures, ensuring deliverables meet and often exceed your expectations. Our reputation and proven track record serve as your guarantee that we will uphold your company’s highest standards.

Over-dependency on External Partners.

Relying excessively on external partners can lead to dependency, potentially hindering your company’s ability to independently make decisions, develop internal capabilities, or execute tasks without outsourcing support. MMD strives to strike a healthy balance, offering tailored services that complement and enhance your company’s internal capabilities rather than create excessive reliance. We aim to empower your organisation to maintain flexibility and adaptability, enabling you to respond effectively to evolving market conditions and business needs.

In conclusion, outsourcing strategies offer various benefits to pharmaceutical companies, such as cost reduction, access to expertise, scalability, risk mitigation, and speed to market. However, potential downsides include loss of control, confidentiality concerns, communication challenges, reputational risks, and dependency on external partners.

Effective outsourcing strategies require meticulous planning, diligent oversight, and selecting the right partner. Your pharmaceutical company can survive and thrive in the dynamic industry landscape by finding the right balance between outsourced and in-house services.

If you want to contact our team to discuss your needs, email enquiries@mymedicaldepartment.com.

About Medical Department Services

Welcome to our My Medical Department Services Spotlight. This resource unveils and discusses our exceptional services to support your pharmaceutical endeavours. Our trusted and experienced professionals support many doctors and pharmacists from across the globe. We provide top-notch services across various domains to ensure your organisation’s success in an ever-evolving industry landscape. By leveraging our diverse expertise, we cater to the unique needs of pharmaceutical companies, reinforcing their capabilities for innovation and continued growth. Our services meet industry standards and provide a competitive edge, ensuring your products’ success in the market.

Medical Affairs

Our Medical Affairs team, with extensive knowledge and experience, empowers your organisation by delivering valuable insights through Advisory Boards, Key Opinion Leader (KOL) engagement activities, and targeted scientific communication strategies. We also develop tailored evidence-generation plans to ensure your products are well-supported throughout their life cycle while maintaining solid relationships with stakeholders and regulatory authorities.

Medical Sign-off and Code Compliance

Navigating the complex world of compliance obligations can be challenging. Our meticulous and experienced team will guide you through the process, ensuring your promotional campaigns have maximum impact without breaching industry regulations. We work diligently to maintain brand integrity by balancing medical accuracy and regulatory compliance in every aspect of your campaigns.

Market Access

Our Market Access services strengthen your pharmaceutical products’ reach and competitiveness. We offer insightful formulary support materials and innovative approaches to budget impact modelling. Furthermore, we provide comprehensive health technology appraisals, all working towards optimum market penetration and sustained success. These innovative approaches can open up new possibilities for your products.

Medical Communication

Expert medical writing and communication are vital for effective data dissemination throughout a product’s life cycle. Our Medical Communication services provide a fully integrated approach. This service ensures consistency across your business and delivers key messages with clarity and impact to healthcare professionals, patients, and other stakeholders.

Pharmacovigilance

Our Pharmacovigilance services focus on patient safety throughout clinical development and after product launch. By providing comprehensive case processing, interim reporting, signal management, and QPPV activities, we help you to adhere to Good Pharmacovigilance Practice, safeguarding your organisation’s reputation and patient safety.

Clinical Development and Operations

Leveraging our experience in clinical trial management, we help optimise planning and execution, incorporating medical monitor support, research scientist/physician collaboration, and DSMB participation. Moreover, this support ensures the safety of trial participants while adhering to Good Medical Practice and other regulatory guidelines.

Regulatory

Our Regulatory services aim to streamline your pathway through the complex and highly regulated pharmaceutical landscape. With expert guidance on gap analysis, regulatory due diligence, clinical overviews, and regulatory agency submission and negotiation, our team navigates you from product concept to market success.

Quality and Compliance

Ensuring your organisation’s quality framework is well-documented and implemented is critical for maintaining a solid reputation and adhering to industry requirements. From individual Standard Operating Procedure (SOP) writing to whole Quality Management System (QMS) implementation and audit preparedness services, our Quality and Compliance team has you covered.

Medical Information

We offer prompt, accurate, and reliable Medical Information services, including standard document creation, custom responses, and 24/7 availability. We train our team to manage and follow up on adverse events. In addition, we support product quality complaints, ensuring the highest level of science and compliance.

Strategic Consultancy

Our Strategic Consultancy services help you make well-informed decisions about portfolio management. They include competitive landscape analyses, TPP validation, and clinical development plan creation. Our integrated expertise across various functional domains ensures market access and promotional claim substantiation are kept at the forefront. This includes everything from TPP through commercialisation stages, allowing you to optimise the value of your assets and return on your investments.

Medical Writing

Our seasoned Medical Writing team is adept at presenting complex scientific concepts logically, concisely, and memorable. Our medical writers ensure your material consistently resonates with its target audience. Covering various content types, from protocol to publication and clinical overviews to promotional copy.

At My Medical Department, we aim to offer our pharmaceutical partners comprehensive services tailored to their unique needs. Our expert team collaborates with your organisation through a multidisciplinary approach to provide the highest level of support throughout your product’s journey.

Digitalisation for Pharma: An introduction.

Thanks to the power of digitalisation, the pharma industry is undergoing a significant transformation. This shift presents new opportunities with innovative technologies and underscores the crucial need for pharmaceutical CEOs and Directors to be well-versed in digitalisation best practices. The industry can significantly enhance efficiency and impact by implementing digital strategies across various functions, from R&D to sales and marketing, empowering leaders and giving them control over the industry’s future.

This blog is a guide for industry leaders, empowering them to optimise digital technologies and gain a competitive edge in the pharmaceutical industry. It explores cybersecurity, blockchain technology, cloud computing, and digital marketing themes, providing a comprehensive roadmap for digital transformation.

Artificial Intelligence and Machine Learning

In the pharmaceutical industry, AI and Machine Learning are increasingly pivotal. This is particularly emphasised in data analysis, drug discovery, and personalised medicine development. These technologies are crucial in identifying potential targets for novel drugs and creating tailored patient therapies. Thereby increasing the likelihood of success.

For example, investing in AI and machine learning platforms can provide faster access to data. This access can leverage algorithms to analyse large data sets, improving decision-making and insights. Consequently, AI tools to accelerate drug recovery can enhance development and reduce failure rates.

Big Data Analytics

The pharmaceutical industry generates immense data, which enables better decision-making and saves time and resources. Big data analytics can improve patient outcomes, optimise supply chains, and enhance research operations. Leaders can implement a data-driven culture throughout the organisation and consider partnering with data analytics providers. In addition, they can invest in in-house capabilities to maximise the data generated. Finally, leaders can identify trends s by applying big data analytics to areas like R&D, supply chain optimisation, and marketing. This, in turn, instils confidence in their strategies and helps them make more informed decisions.

Internet of Things (IoT) Devices

IoT devices like wearables and sensors collect real-time data to monitor biometrics, medication adherence, and human activities. Integrating IoT devices into clinical trials enables remote monitoring of patients and real-time data collection, significantly optimising treatment plans and enhancing patient outcomes. However, it is crucial to consider data privacy and security when implementing IoT devices. Collaborating with providers to adhere to regulatory requirements is paramount to protecting sensitive patient information.

Electronic Health Records (EHRs)

EHRs are revolutionising clinical trials by consolidating patient information in one place, facilitating effective coordination and collaboration between trial personnel. A study published in Applied Clinical Trials revealed that using EHRs in clinical trials reduced data entry errors by 70-80% and decreased the time required for data collection by 30-40%. By adopting and investing in EHR systems, researchers can collect, store, and share vital patient data, leading to improved trial efficiency. Integrating EHR platforms and research databases ensures seamless access to real-world data, maintaining an ethical and secure landscape for clinical trials.

Telemedicine and Remote Monitoring

The rise of telemedicine and remote monitoring positively impacts the way clinical trials are conducted. A review in the journal Clinical Trials highlighted the advantages of telemedicine, such as providing patients with flexible and convenient care options, expanding trial access, and enhancing data collection. Implementing telemedicine services and remote patient monitoring in trials significantly reduces participant attrition, improves adherence to treatment plans, and aids in real-time data assessment. For example, a study by the Veterans Health Administration found a 25% reduction in hospital readmissions when using telehealth services. Collaborating with remote monitoring providers ensures the effectiveness of devices and upholds patient privacy standards.

Automation and Robotics

Automation and robotics play a significant role in streamlining routine processes within the pharmaceutical industry, consequently reducing human error and boosting overall efficiency. Therefore, it is essential to invest in technologies such as robotic process automation (RPA) for handling repetitive tasks, utilise robotics in laboratories and manufacturing for enhanced accuracy, consistency, and productivity, and actively collaborate with technology providers to stay up to date on the latest trends and developments in automation.

Cybersecurity

As the pharmaceutical industry continues its digitalisation journey, cybersecurity emerges as a critical factor in safeguarding sensitive patient data and intellectual property. Organisations must develop a robust cybersecurity framework, train employees on best practices, and regularly assess and monitor their security posture. Best practices include creating a robust cybersecurity framework within the organisation. Training employees on cybersecurity best practices, implementing strong access controls, and conducting risk assessments, penetration testing, and vulnerability scanning to assess and monitor the organisation’s security posture regularly.

Blockchain Technology

Blockchain technology brings secure, distributed data storage possibilities that greatly benefit various aspects of the pharmaceutical industry. These include supply chain management, clinical trial processes, and patient consent management. Organisations should explore and evaluate blockchain applications that align with their objectives to harness its potential. This can be achieved by firstly selecting the most suitable platforms for specific use cases. Then collaborating with blockchain technology providers or investing in developing in-house capabilities to build and implement this innovative technology effectively.

Cloud Computing

Embracing cloud computing in the pharmaceutical industry can result in significant cost savings, improved performance, and increased availability of resources and data. To capitalise, investing in cloud computing infrastructure is vital while considering essential factors like scalability, security, and cost. Organisations should use cloud-based platforms and tools for crucial tasks such as data storage, analytics, and collaboration. Additionally, ensuring data privacy and adhering to regulatory requirements are paramount when migrating workloads to the cloud.

Digital Marketing

Digital marketing is crucial for promoting products and services, engaging customers, and managing brand reputation. Leaders should invest in digital marketing alongside traditional marketing. This type of marketing includes developing a comprehensive digital marketing strategy that targets your audience and engages stakeholders and customers using a wide variety of channels, including social media, email, and content marketing. Finally, leaders should employ data-driven marketing to measure effectiveness and improve campaign performance.

Digitalisation is transforming the pharmaceutical industry. By incorporating the best practices identified in this article, pharma leaders can maximise efficiency, accelerate innovation, and embrace a culture of data-driven decision-making. My Medical Department has the expertise to help you navigate the digital realm and optimise your promotional campaigns, ensuring the most impactful presentation of your data. If you would like to discuss the digitalisation of pharma, feel free to reach out.

The curling wheeze and tight-lipped breathing of inflammatory lung conditions (1), the severe abdominal pain and gastrointestinal disruption of inflammatory bowel disease (IBD) (2), and the arduous stiffness associated with rheumatoid arthritis (RA) (3) are common inflammatory ailments that globally prevail. Though the aetiology of each disease is not well understood, each share a similar pathophysiology of unaccounted immune cell recruitment and inflammation (1, 2, 3). With this gap in knowledge, current therapies aim at managing symptoms and preventing further damage by targeting inflammatory pathways (1,2,3). However, the toxicity associated with immune modulators has created an urgency into finding alternative therapies.

Recently, Incannex Healthcare received approval for a phase I study investigating the safety profile of IHL-675A, a novel anti-inflammatory that is indicated for the treatment of inflammatory diseases including inflammatory lung conditions, IBD, and RA (4). IHL-675A is comprised of cannabidiol (CBD) and hydroxychloroquine (HCQ) (4). Currently, CBD has only been approved for the treatment of seizure disorders (Lennox-Gastaut syndrome and Dravet syndrome) (5).

Over the years, the importance of the endocannabinoid system in controlling homeostasis and mediating metabolic and inflammatory pathways has become a popular target for pharmacotherapy (6). CBD is one of the main active cannabinoids found in Cannabis sativa (5). Cannabinoids are an exogenous molecule that share structural and chemical similarities to cannabinoids (6). Though the mechanism of action remains elusive, pre-clinical studies have shown that CBD indirectly improves anti-inflammatory pathways by inhibiting T cell proliferation, inducing T cell apoptosis, and reducing the migration and adhesion of immune cells (6).

Conversely, HCQ is a well-tolerated anti-malarial and anti-inflammatory compound that has been traditionally indicated for the treatment of RA and malaria (7). Despite the anti-inflammatory mechanism remaining unclear, studies have shown that HCQ disrupts antigen-presentation and processing, preventing activation and differential of CD4+ T cells (7). Furthermore, studies have shown that HCQ induces apoptosis of autoreactive T cells, and interferes with the activation of the humoral immune response, thus reducing the presence and production of inflammatory cytokines (7).

Despite both compounds have individually shown anti-inflammatory properties, preclinical studies conducted by Incannex into IHL-675A has demonstrated that CBD and HCQ act synergistically to inhibit the production of inflammatory cytokines (IL-1, Il-6, TNFα, IL-12, and IFN-γ) in mouse models (7). Furthermore, IHL-675A demonstrated greater anti-inflammatory properties compared to CBD by 109% to 767% from 24 hours post-drug administration (7). These preclinical studies, though minimal, show promising results for the treatment of inflammatory conditions in humans.

Though the hurdle of a phase I trial is hard to surpass, the idea of a safe and effective treatment provides silver-lining to the treacherous battle of chronic inflammatory conditions. The competitiveness of the pharmaceutical industry is the foundation of innovative drug developments.  IHL-675A has shown to be a strong competitor within this battle, and hopefully within a few years, a solution to inflammatory conditions is approved.

References:

1. Agarwal A., et al., Chronic Obstructive Pulmonary Disease, 2022. StatPearls Publishing, Available at https://www.ncbi.nlm.nih.gov/books/NBK559281/
2. McDowell C., et al., Inflammatory Bowel Disease, 2022. StatPearls Publishing, Available at https://www.ncbi.nlm.nih.gov/books/NBK470312/
3. Chauhan K., et al,m Rheumatoid Arthritis, 2022. StatPearls Publishing, Available at https://www.ncbi.nlm.nih.gov/books/NBK441999/
4. SmallCaps, Incannex Healthcare to begin phase 1 clinical trial for IHL-675A following ethics approval, Nicholaos L., 2022, Available at https://smallcaps.com.au/incannex-healthcare-phase-1-clinical-trial-ihl-675a-following-ethics-approval/ [Accessed 11AUG2022]
5. Meissner H., et al., Cannabidiol (CBD), 2022. StatPearls Publishing, Available at https://www.ncbi.nlm.nih.gov/books/NBK556048/
6. Atalay S., et al., Antioxidative and Anti-Inflammatory Properties of Cannabidiol. Antioxidants, 2020; 9(1) 20
7. Bansal P., et al., Hydroxychloroquine: a comprehensive review and its controversial role in coronavirus disease 2019. Annals of Medicine, 2021; 53(1): p. 117-134
8. Incannex, Positive In vivo results confirm strong synergistic activity of IHL-675A to inhibit inflammation, Incannex, 2020, Available at https://company-announcements.afr.com/asx/ihl/cf6be2f2-2d2b-11eb-8f4b-aa3736f8de15.pdf [Accessed 11AUG2022]

Ecopharmacovigilance

The rate at which modern medicine is progressing is astonishing. Production and usage of medicines across the globe continue to grow substantially. The global pharmaceutical market is estimated to exceed USD 1.5 Trillion in the coming years. No doubt these new medicines have improved quality of life and saved lives for some of the most terrible diseases and conditions, however their unwanted presence in the environment is raising alarm bells. As a result, a concept combining pharmacovigilance and environmental pharmacology, was first introduced as Pharmaco Environmentology in 2006 by Syed Ziaur Rahman. 

This concept has slowly evolved into Ecopharmacovigilance which is defined as “the science and activities concerning detection, assessment, understanding and prevention of adverse effects or other problems related to the presence of pharmaceuticals in the environment, which affect both human and the other animal species”.

Ecopharmacovigilance aims to ensure that significant environmental issues associated with pharmaceuticals in the environment are identified in a timely way and addressed appropriately. Ecopharmacovigilance is of significant concern these days since the unwanted presence of even trace amounts of active pharmacological ingredients in the environment may pose a risk.

There are various ways by which pharmacological pollutants may end up in the environment, such as in the patients’ excreta in the sewerage system and via release into the waste waters by manufacturers or hospitals and the terrestrial depositions. The largest release of medicines into the environment comes from the humans or animals taking them. Medicines are excreted from the body either in their unchanged form or as metabolites in faeces and urine and find their way into sewers or sewage treatment plants.

Several studies have documented the effects of pharmaceutical pollution on various animal species, such as vultures and fish. Ecopharmacovigilance is emerging as a promising approach to prevent the environmental risks posed by unwanted pharmaceutical agents ending up in the environment. However, it is impractical to implement rigorous EPV processes for all the pharmaceutical substances with complex and diversified chemical, biological or toxicological properties. Consequently, the concept of “targeted EPV” has evolved and is aimed at targeted detection, evaluation, understanding, and prevention of adverse effects of high-priority hazardous pharmaceuticals in the environment.

“Targeted EPV” implementation focusses on targeted monitoring of the presence of high-risk agents in the environment, targeted reporting of over-standard discharge, targeted management of main emission sources, targeted legislation and conduct of research on high-priority pharmaceutical pollutants, as well as targeted educational strategies for specific areas and key populations.

Although the detected concentrations of pharmaceuticals in the environment are generally low, (ng/L to μg/L) potential direct and indirect risks for human and animal populations do exist and hence should be carefully monitored. This is of further importance in the case of special populations including pregnant women, children and older patients, who may be vulnerable to even very low concentrations of medicines.

Addressing issues related to pharmaceutical pollution is one of the key current aims of Ecopharmacovigilance in managing the environmental safety of medicines. Environmental safety of medicines will be another challenge that regulators and researchers will need to face and work on collaboratively to address this vital issue and develop new strategies to minimise environmental risks.

The US, EU and Canada is already regulating in this area and undertaking Environmental Risk Assessment (ERA) in pharmaceuticals. At present there are no specific guidelines for ERA of pharmaceuticals in Japan, Australia and many other countries.

It will be important to watch this space and stay abreast of developments in this area and see what challenges and opportunities present themselves.

References:

1. Silva LJG, Lino CM, Meisel L, Barceló D, Pena A. Ecopharmacovigilance. In: Barcelo D, editor.

The Handbook of Environmental Chemistry. Germany: Springer-Verlag Berlin and Heidelberg

GmbH & Co. KG; 2012. pp. 213–42.

2. Holm, G., Snape, J. R., Murray-Smith, R., Talbot, J., Taylor, D., and Sörme, P. (2013). Implementing Ecopharmacovigilance in Practice: Challenges and Potential Opportunities. Drug Saf. 36 (7), 533–546. doi:10.1007/s40264-013-0049-3

3. Wang, J., He, B., Yan, D., and Hu, X. (2017). Implementing Ecopharmacovigilance (EPV) from a Pharmacy Perspective: A Focus on Non-steroidal Anti-inflammatory Drugs. Sci. Total Environ. 603-604, 772–784. doi:10.1016/j.scitotenv.2017.02.209

Amongst many things, the COVID-19 pandemic questioned our traditional, separated work-home lifestyle divide ingrained over generations. The paradigm shift, to working from home (WFH) promised individuals the return of and flexibility with time – no more commutes, distractions, nor concrete set hours. Initially, this “gift” from COVID provided nuclear families and co-habitants with more time together, gave flexibility and some freedoms back to the individual, and overall was beneficial to many. However, underneath the rose petals of WFH, the thorns of raised risks of cardiovascular diseases (CVDs) present a menacing and longer-term health threat.

CVDs are characterised as a group of diseases (not exhaustive) including myocardial infarction, congestive heart failure, and myocardial ischemia, which affect the heart and blood vessels¹. Currently, CVDs are the leading cause of death globally². Though pharmaceutical intervention has helped reduce CVD prevalence and mitigate the risk of mortality over the years, its pathogenesis from multifactorial causes emphasises the importance of managing behavioural risk factors². More specifically, tabacco use, alcohol, physical inactivity, hypertension, obesity, and inadequate dietary intakes are proportional to CVD risk².

The impact of predisposing CVDs on COVID infection risks and outcomes has been extensively researched. However, the relationship of COVID infection and changed behaviours on the emergence of CVDs remains a novel topic. When SARS-Cov-2 spread and lockdowns commenced, communities and people were forced to stay in their homes, the subsequent lifestyle changes posed a physiological threat. As established, physical activity has a prophylactic effect on CVD². The decrease in activity to just basal metabolic rate from removing daily activities such as commuting to work, and the consequence of increased sedentary time due to longer work hours, increases the risk of cardiovascular disease by promoting weight gain³.

Weight gain leads to increased obesity rates. Studies have suggested that 1/3 Australians gained weight during the pandemic, as well as 42% of Americans stating weight gain, with more than 16 United States of America states now having obesity rates of 35% or higher⁷. The accepted hypothesis linking obesity to CVD is centred on the ability of adipose tissue to produce pro-inflammatory cytokines, which directly impair myocardial function and contribute to the formation of atherosclerotic plaques⁸. This weight gain and consequential increased CVD risk is compounded further by irregular eating behaviours such as snacking and increased consumption of highly processed foods, which also promote atherosclerosis of blood vessels and hypertensive characteristics¹.

The complex impacts of WFH also exacerbate other pre-disposing CVD risk factors through behavioural changes¹. During lockdown, alcohol sales increased by 29% with tobacco expenditure increasing by 13%^4,5, being used by some to mitigate the psychosocial pressure of lockdown. Increased tobacco and alcohol intakes indirectly increase CVD risk through blood pressure elevation, increases in cholesterol, and increases in triglyceride levels⁶.

COVID-19 presented WFH as a lifestyle delicacy on a silver platter. However, masked by the initial charade of increased work flexibility and freedom, the menacing wave of CVD health risks threatens the community in the longer term. CVD risks are multifactorial, whereby control of the modifiable risk factors can help mitigate the risk and severity. With WFH becoming the normalised practice, community programs should be initiated to emphasise the importance of staying active, eating healthy, and reducing alcohol and tobacco intake. As a community, we were able to slow but not stop COVID-19 from taking our breath away, but individually we can stop behavioural and lifestyle changes from contributing to our community’s longer-term CVD and mortality. 

References

1. Ruan Y., et al., Cardiovascular disease (CVD) and associated risk factors among older adults in six low-and middle-income countries: results from SAGE Wave 1. Biomed Central, 2018, 18(1): p. 778
2. Muhammad D.G. et al, COVID-19 lockdown may increase cardiovascular disease risk factors. The Egyptian Heart Journal, 2021, 73(1): p. 2
3. Powell-Wiley T.M., et al, Obesity and Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation, 2021, 143(21): e984–e1010
4. Huge increase in Australian alcohol sales during the COVID-19 pandemic, Meacham S., 9NEWS, 2022, Accessed 14JUL2022, Available at https://www.9news.com.au/national/covid19-pandemic-blamed-for-huge-increase-in-alcohol-sales-across-australia/b8da58fa-b7b8-4d81-87ef-2baee80148ca
5. Lee B.P., et al., Retail Alcohol and Tobacco Sales During COVID-19. Annals of Internal Medicine, 2021
6. Larsson S.C., et al., Alcohol Consumption and Cardiovascular Disease. Circulation, 2020, 13(3): e002814
7. Has the Pandemic Affected Obesity Rates?, Beaumont, [Unknown Author], 2022, Accessed 14JUL2022, Available at https://www.beaumont.org/health-wellness/blogs/has-the-pandemic-affected-obesity-rates
8. Carbone S., et al., Obesity paradox in cardiovascular disease: where do we stand?. Vascular Health and Management Risk, 2019, 15(1): p. 89-100

In a rapidly changing world where technological developments happen on a daily basis, it is only logical that advanced telecommunications and computer technologies are used to improve health care and expand access to health services. The necessity to provide high quality and accessible medical attention was highlighted with the COVID-19 pandemic where interpersonal interactions were minimised to reduce contagion. Governments needed to provide a quick response to the high-volume demand and rapidly expanded telemedicine services^4,5. Telecommunications posed a solution to harness the power of technology and connectivity to transmit knowledge from the healthcare worker right to the patient’s home⁶.

Telemedicine can be defined as “the use of electronic information and communication technologies to provide and support health care when distance separates the participants”². It consists of the virtual interaction, synchronous or asynchronous, between the physician and the patient; whereas telehealth (a term commonly used interchangeably with telemedicine) is the flow of information^6,7. One of the first telemedicine experiences can be traced all the way back to the 1860s, where the telegraph and morse code were used during war to transmit messages from wounded soldiers to the medical teams³. Major inventions followed including the radio, telephone, and television, but it wasn’t until the 20th century that they were repurposed to provide medical care (e.g., to assist sailors when at sea or to provide training to healthcare students). With the age of connectivity starting during the 2000s, telemedicine rapidly expanded with the creation of telephone networks, use of satellites and space technology, and the development of the internet. This rapid evolution allowed telemedicine companies to grow exponentially and evolve into more efficient services³.

With the dependency of telecommunication during the COVID-19 pandemic, an unparalleled opportunity has been presented to consider not only the ethical and legal issues, but also the social concerns that these services bring foward^4,6,7.

Firstly, is an informed consent needed before each telemedicine consult? Will the patient-physician relationship be altered? What are the privacy and confidentiality concerns? How do we identify patients? Do we trust that the patients are who they say they are? Is the patient’s autonomy being respected? How do healthcare providers document each consultation and where will that data be stored? What is the risk of misdiagnosing during a virtual visit? These represent some of the many ethical and legal questions posed that were overshadowed by the urgency of the pandemic.

Secondly, in terms of the main social issues that need to be address, international organisations and governments need to argue and decide whether a low socioeconomic country should spend part of their money on improving telemedicine services rather than on, for example, agricultural insecurity, water safety or education. Health equity and access is a major topic to address, especially for the elderly, disadvantaged and minorities with no access to technology or to an effective connectivity network⁴. How do we reduce these disparities, whilst agreeing on local guidelines to protect the patient’s health and information?

Several guidelines and codes of ethics have been drafted to address these concerns^1,8. However, these guidelines cannot be unanimously adopted by every country due to cultural and socioeconomic differences as well as local stakeholder’s viewpoints⁷. Not all of these questions have answers, and telemedicine services appear to be so vulnerable in every aspect. But is clear that in those countries in which telemedicine is a step forward, efforts need to be put into establishing guidelines that address quality and relationships, access, consent, and privacy; regulatory policies and regulations need to include issues of cybersecurity, licensure, liability, and malpractice⁷.

References

1. American Medical Association (2021). AMA Telehealth quick guide. Accessed 10 July 2020 from https://www.ama-assn.org/practice-management/digital/ama-telehealth-quick-guide
2. Institute of Medicine (US) Committee on Evaluating Clinical Applications of Telemedicine; Field MJ, editor. Telemedicine: A Guide to Assessing Telecommunications in Health Care. Washington (DC): National Academies Press (US); 1996. 1, Introduction and Background. Available from: https://www.ncbi.nlm.nih.gov/books/NBK45440/
3. Jagarapu J, Savani RC. A brief history of telemedicine and the evolution of teleneonatology. Seminars in perinatology. 2021;45(5). doi:10.1016/j.semperi.2021.151416
4. Kaplan B. Ethics, guidelines, standards, and policy: telemedicine, covid-19, and broadening the ethical scope. Cambridge quarterly of healthcare ethics: cq : the international journal of healthcare ethics committees. 2022;31(1):105-118. doi:10.1017/S0963180121000852
5. Kaplan B. Revisiting health information technology ethical, legal, and social issues and evaluation: telehealth/telemedicine and covid-19. International journal of medical informatics. 2020;143:104239-104239. doi:10.1016/j.ijmedinf.2020.104239
6. Nittari G, Khuman R, Baldoni S, et al. Telemedicine practice: review of the current ethical and legal challenges. Telemedicine and e-health. 2020;26(12):1427-1437. doi:10.1089/tmj.2019.0158.
7. Shafizadeh H, Larijani B, Mojtahedzadeh R, Shamsi Gooshki E, Nedjat S. Initial drafting of telemedicine’s code of ethics through a stakeholders’ participatory process. Journal of medical ethics and history of medicine. 2021;14:24-24. doi:10.18502/jmehm.v14i24.8184

World Medical Association (2020). Statement on the Ethics of Telemedicine. Accessed 10 July 2022 from https://www.wma.net/policies-post/wma-statement-on-the-ethics-of-telemedicine/

Physical activity presents as a prevention strategy for numerous chronic health conditions, including coronary heart disease, insulin resistance, hypertension and breast, colon, and endometrial cancer.¹ However, for individuals with existing chronic health conditions, evidence is growing to support the integration of regular exercise into their treatment plans.

Multiple sclerosis

Multiple sclerosis (MS) is a chronic disease that affects the central nervous system, typically resulting in progressive and gradual disability. Approximately 25,600 Australians live with MS.² Diagnosis of MS typically occurs between the ages of 20 and 40 years, and 75% of people with MS are women.² There is currently no cure for MS and current therapies are aimed at easing symptoms and modifying the progression of the disease.

A systematic review published in 2013 examined 54 studies and found strong evidence that moderate intensity exercise performed two times per week increases aerobic capacity and muscular strength in MS patients with mild to moderate disability.³ The authors concluded that exercise training is effective for improving aerobic capacity and muscular strength and may improve mobility, fatigue, and health-related quality of life for people living with MS.³

It appears that the benefits of exercise for people living with MS is not limited to functional capacity and health-related quality of life. Several studies have demonstrated a positive impact of exercise on cognitive status of people living with MS⁴, as well as a lower annual relapse rate in people living with MS.⁵   

Type 2 Diabetes

Type 2 diabetes, a condition in which the body becomes resistant to the normal effects of insulin and gradually loses the capacity to produce enough insulin in the pancreas, has strong genetic risk factors and is often associated with modifiable lifestyle risk factors. In 2017-8 it was estimated that 4.9% of Australia’s total population had diabetes and approximately 1.2 million hospitalisations were associated with diabetes.⁶ Complications associated with type 2 diabetes include stroke, lower limb ischemia, nephropathy, retinopathy, and diabetic maculopathy.⁷ There is a high incidence of other risk factors for these complications among patients with type 2 diabetes e.g., hypertension, hyperlipidaemia, and cardiac and endothelial dysfunction.⁷  

The idea of exercise as treatment for type 2 diabetes is not new, and there is an international consensus that physical activity, along with diet and pharmaceuticals, are the foundations in the treatment of type 2 diabetes.⁸ There is extensive literature demonstrating the positive effects of exercise on metabolic control, fitness, muscle strength and motivation in patients with type 2 diabetes.⁹ Furthermore, regular exercise has several documented effects that are important for patients with type 2 diabetes such as reduction in systolic blood pressure and improvements in cardiac and endothelial vasodilatory function.⁹

Dementia

Dementia describes a collection of symptoms that are caused by disorders affecting the brain. Dementia affects thinking, behaviour, and the ability to perform everyday tasks and due to the aging population, the number of people with dementia is constantly increasing.¹⁰ Estimations from Dementia Australia suggest that 487,500 Australians are currently living with dementia, and that the age of onset of dementia is gradually declining.¹¹ A major challenge concerning dementia treatment is the management of neuropsychiatric symptoms such as agitation, anxiety, and depression, all of which are associated with low quality of life and increased caregiver burden.¹⁰

A recent systematic review including 13 studies and 1925 dementia patients demonstrated that regular aerobic exercise performed three to five times per week has a positive effect on neuropsychiatric symptoms.¹¹ Interestingly the review demonstrated that combined exercise programs (aerobic and resistance exercise) did not appear to be as effective as aerobic exercise alone. Nevertheless, the study determined that resistance training programs are beneficial for dementia patients with mobility problems, with demonstrated reductions in symptoms of depression and behavioural problems.

The evidence pertaining to the benefits exercise as a treatment for chronic health conditions is growing rapidly and is not limited to the conditions discussed in this article. There is existing and emerging evidence relating to a wide range on chronic diseases including chronic obstructive pulmonary disease, asthma, osteoporosis, polycystic ovarian syndrome, obesity, Parkinson’s disease, depression, and anxiety.⁹ Indeed, further work is required to determine the efficacy and safety of exercise prescription for specific chronic health conditions. Nevertheless, perhaps a scenario where we see exercise prescription integrated into the treatment guidelines for most chronic health conditions is not too far away.

Sarah Joyce, PhD (Senior Consultant at My Medical Department)   

References

1. Booth FW, Roberts CK, Laye MJ. Lack of exercise is a major cause of chronic diseases. Compr Physiol. 2012;2(2):1143-211.
2. What is Multiple Sclerosis (MS)? MS Australia. https://www.msaustralia.org.au/what-is-multiple-sclerosis-ms/. Accessed July 8, 2022.
3. Latimer-Cheung AE, Pilutti LA, Hicks LA, Martin Gini KA. Effects of Exercise Training on Fitness, Mobility, Fatigue, and Health-Related Quality of Life Among Adults with Multiple Sclerosis: A Systematic Review to Inform Guideline Development. Arch. Phys. 2013; 94(9): 1800-1823.
4. Kalron A, Zeilig G. Efficacy of exercise intervention programs on cognition in people suffering from multiple sclerosis, stroke and Parkinson’s disease: A systematic review and meta-analysis of current evidence. NeuroRehabilitation. 2015;37(2):273–89.
5. Pilutti LA, Platta ME, Motl RW, Latimer-Cheung AE. The safety of exercise training in multiple sclerosis: a systematic review. J Neurol Sci. 2014; 343(1–2):3–7.
6. Diabetes. Australian Institute of Health and Welfare. https://www.aihw.gov.au/reports/diabetes/diabetes/contents/how-many-australians-have-diabetes/type-2-diabetes. Accessed July 8, 2022.
7. Goyal R, Jialal I. Diabetes Mellitus Type 2. Treasure Island (FL): StatPearls Publishing; 2022. https://www.ncbi.nlm.nih.gov/books/NBK513253/. Accessed July 8, 2022.
8. American Diabetes Association. Clinical practice recommendations. Diabetes Care. 2002:S1-s147.
9. Pedersen BK, Saltin B. Exercise as medicine – evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015; 25(S3):1-72.
10. Kouloutbani K, Venetsanou F, Markati A, Karteroliotis K, Politis A. The effectiveness of physical exercise interventions in the management of neuropsychiatric symptoms in dementia patients: A systematic review. International Psychogeriatrics. 2022;34(2)177-190.
11. Dementia Statistics. Dementia Australia. https://www.dementia.org.au/statistics. Accessed July 8, 2022.