May 17, 2020

A prescription for the future

Artificial intelligence
Catherine Sturman
3 min
Since the first pharmacy opened in the 1700s, advances in medicine have transformed how we live and manage our health. We are living longer and conditio...

Since the first pharmacy opened in the 1700s, advances in medicine have transformed how we live and manage our health. We are living longer and conditions that were once terminal are now manageable through innovation in medication and the development of drugs.

One area that hasn’t changed so dramatically however is in the area of repeat prescriptions, and how we collect and manage our medication. Almost half of the population are on repeat prescriptions, but for the majority the process to get their medicines is time-consuming and inconvenient. Booking an appointment with your GP, getting a paper slip, finding the time to go to a pharmacy, and queuing up and waiting to receive the same medication month-after-month? The customer deserves more.

Technology has already transformed industries from retail and entertainment to travel and leisure, but it is now starting to make a significant mark on healthcare. From AI doctors and at-home blood tests to online pharmacies and digital therapeutics, the health industry is finally undergoing a profound positive disruption – and its impact is giving power to individuals to access care more easily and conveniently, and helping to ease the strain on an overburdened NHS.

While major breakthroughs in medicine like new drugs tackling problem conditions or artificial intelligence being used to predict the onset of disease will rightly attract headlines, one major area of transformation is in pharmacy.

As patients use personal healthcare devices to gain greater control of their health in the coming decades, online pharmacies will be ideally placed to handle their needs, while community pharmacies will remain crucial for acute healthcare management.

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With the adoption of the NHS Electronic Prescription Service (EPS), managing long-term prescriptions and tracking patient adherence can now be done online. And according to Health Secretary Matt Hancock, it already “saves GPs time, helps to give patients a better, more seamless experience and ensures every pound of taxpayer money is being spent effectively”.

At Pharmacy2U, which was a founding partner to the NHS Electronic Prescription Service, the company seeks to remove the hassle associated with repeat prescriptions by centrally dispensing millions of medicines directly to the doors of NHS patients for free. At its dispensing facility in Leeds, it works to dispense more than 500,000 medicines to patients each month, reducing the time being spent by GPs on filling out paperwork and making it easier for patients – especially those with reduced mobility or with hectic lifestyles – to get their medicines.  

A healthcare centred around the patient is the future of the NHS and the acceleration in the rate of personalisation is paving the way for truly preventative healthcare, but we have barely scratched the surface. Like everything else in the future, the healthcare service will have to adapt to thrive.

Mark Livingstone is the CEO of Pharmacy2U, and on a mission to improve patient access to healthcare and relieve the strain on the NHS. Previously he helped to transform how we watch movies as a co-founder and CEO of LOVEFiLM, and food delivery as a founding investor of Graze.

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Jul 24, 2021

A guide to labelling compliance for medical devices

Susan Gosnell
4 min
A guide to labelling compliance for medical devices
Susan Gosnell, Product Manager at Loftware, explains labelling compliance for small medical device manufacturers

Small medical device manufacturers often find themselves scrambling to achieve the necessary compliance and validation, risking costly mistakes.

Validating systems and processes including labelling, to ensure they are compliant with stringent regulatory standards is tough and can be expensive. Indeed, compliance with the EU’s Medical Device Regulation (MDR) will cost more than 5% of annual sales, according to 48% of 101 companies polled by the German company Climedo Health, in July and August 2020 about their MDR-readiness.

But if companies bungle the software validation process or put incorrect and uncompliant data on the labels themselves, the penalties are likely to be more severe than just making corrections. Health and safety may be put at risk and fines imposed for failing to comply. When it comes to compliance, they may become overwhelmed with regulations in other geographic regions that focus on device traceability, each with a unique device identifier (UDI-like) component to it. 

On the validation front, companies may not be familiar with the software validation process and the multiple tests and documentation necessary for validation are demanding if companies only have a small IT team that is very busy.

Putting a plan in place

MDR-compliant labelling, however, brings with it certain requirements which differ from what is demanded under the FDA’s Unique Device Identification (UDI) system rules. Under MDR, for example, manufacturers must ensure the label specifically states the device is a medical one using an MD symbol in a box. This is only one of many stipulations that usually require redesigned labels.

Small medical device manufacturers who rely on time-consuming and error-prone manual or legacy labelling processes to facilitate these label updates run the risk of mislabelling which can lead to non-compliance.  They may have limited staff and no structured processes around roles and responsibilities when it comes to label design, changes and approval. As project leads work toward a compliant labelling process, it is therefore important to establish defined roles and access for each stage of the process.

When dealing with a compliance initiative, up to date, correct and compliant labelling is imperative. This involves having all the relevant label design elements in place to comply with the EU MDR or FDA regulations. Many times, label templates are hard coded, meaning IT must be involved in making changes. And with IT staff often being tasked with multiple mission-critical projects in the organisation, labelling projects can be delayed. For many small medical device manufacturers who have limited resources, finding a solution can be a challenge.

Why labelling in the cloud offers a roadmap forward

Validation-ready cloud labelling solutions have now emerged to ease compliance with regulations and time-consuming validation requirements. These solutions, built with the needs of regulated companies in mind, digitise the quality control processes and facilitate compliant labelling with role-based access, approval workflows and electronic signatures. Outside of compliance, carrying out labelling in the cloud drives scalability and productivity for small medical device manufacturers and boosts overall efficiency.

The latest cloud labelling solutions integrate with other cloud solutions, allowing for seamless functionality and minimising the need for local infrastructure resources and cost.

When it comes to validation, as with many labelling systems, those hosted in the cloud have vendor-supplied documentation that streamlines the process and significantly eases the burden when it comes to installation qualification (IQ). The manufacturer itself has a much lighter burden and a streamlined path to a validated system and process.

A more relaxed software release schedule eases the validation burden on life sciences companies because the software is updated once a year rather than multiple times. This gives them a continuously updated and maintained labelling solution without increasing the validation workload on their IT staff.  

Future-proof technology

The manufacturer would of course need to work closely alongside the vendor and review the documentation, but, if needed, the vendor is able to do much of the work for them, providing not only the full validation acceleration pack but also professional services to assist with the validation process.

While some medical device manufacturers choose to tackle validation on their own, the vendor supplied validation acceleration pack or documentation helps to simplify the process. Consultancy and advice around validation is usually available from the vendor, tailored to the business’s specific needs.

Given the immense hassles of compliance for small device manufacturers, cloud-based labelling systems offer the benefits of a full label management system while easing compliance and validation. This is a future-proof technology. With a cloud-based labelling system, medical device manufacturers can be confident that they are running the most up-to-date software, enabling them to address the fast-changing new regulations and cope with whatever comes their way. And especially in the current pandemic, when face-to-face meetings are still problematic, it is a perfect way to keep labelling operations moving forward.

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