May 17, 2020

The role of pharma packaging innovation in tackling antibiotic resistance

antibiotics
Supply Chain
Digital health
antibiotics
Rich Quelch, Global Head of Ma...
6 min
 antibiotic resistance
Antimicrobial resistance (AMR) is a complex and global issue, affecting all regions of the world. If current trends continue, it’s believed by 2050 an...

Antimicrobial resistance (AMR) is a complex and global issue, affecting all regions of the world. If current trends continue, it’s believed by 2050 antibiotic resistance will cause more deaths per year than cancer, becoming the world’s biggest killer.

As such, AMR is currently high on the political agenda of nation’s around the world as a sustainable solution is sought to reduce the rate at which antimicrobial pathogens are developing immunity to modern medicine.

However, the role of pharma packaging innovation is rarely discussed. While packaging alone does not hold the answer, it has an important part to play in making sure the healthcare system is part of the solution and not the problem.

Understanding the problem

To have a meaningful debate on the AMR crisis, it’s firstly important to understand the key factors currently contributing to its development.

The following contributors are widely cited as accelerating the rate at which bacteria is becoming immune and the emergence of more resistant strains: pharmaceutical waste; the over-prescribing and lack of access to antibiotic drugs; falsification of medicines; poor hygiene practices and the increase in global trade and travel.

The consequences of AMR are far-reaching, reducing our ability to treat common infectious diseases resulting in prolonged illness, more complications and higher fatality rates; the accelerated spread of infections due to ineffective treatments; compromising advances in medicines because of the risk of infection; and placing increasing financial pressure on global health care systems.

Since the historic United Nations Declaration on AMR was agreed in 2016, efforts have intensified across scientific, political and economic spheres to tackle it. However, evidence suggests while positive steps have been taken to slow the pace of AMR, there’s still a long way to go.

The World Health Organization (WHO) released a progress report in the summer which summarised: “progress with developing and implementing plans is greater in high-income than low-income countries but all countries have scope for improvement. No country is reporting established sustained capacity at scale in all domains”.

If this was a school report it would be “showing promise but must do better”.

Strengthening the frontline

Overuse and incorrect use of antibiotics is a major driver of resistance. A recent UK study estimated a fifth of prescriptions are inappropriately prescribed by GPs for illnesses such as a sore throat, cough, sinusitis and ear infections.

There’s a growing body of evidence suggesting the mismatch between dose amounts and course-length mandated by drug manufacturers and prescribers is leading to a considerable quantity of wasted and redundant antibiotics.

For example, a study published in the Australian and New Zealand Journal of Public Health found out of 32 of the most common antibiotic-prescribing scenarios, 10 had surplus doses left over and 18 had a dosage shortfall, leaving only 4/32 scenarios when the packaging size matched exactly the recommended dosage guidelines.

This is certainly an area where pharma packaging can help by ensuring labelling information corresponds accurately to the latest guidelines. Labelling guidelines also must keep up with wider health trends, such as the continued rise in child and adult obesity, which render recommended dosages outdated very quickly.

See also

Developments in digital packaging technologies are also helping pharmacists and doctors on the frontline monitor usage data and get a clearer picture of compliance trends. “Smart” blister packs are becoming more advanced, utilising built-in microchips to capture use-related data and remind patients when the next dose is due. The data collected from these packs can then be accessed by health professionals to give a clear picture of a patient’s medicine-taking behaviour at home.

Over the next five years, the integration of more advanced digital features into the packaging and delivery systems of antibiotics will become the norm.

Tackling pharmaceutical wastage

According to the UN, the release of antibiotics into the environment is accelerating bacterial evolution and the emergence of more resistant strains.

While the aim of the pharmaceutical industry is to improve public health (while of course turning a profit), a failure to address the environmental impact of antibiotic pollution is undermining efforts. Only recently, The Bureau of Investigative Journalism reported none of the 18 big pharma companies polled would reveal how much antibiotic discharge is released from their factories.

As pharmaceutical waste includes degraded and contaminated products, pharma packaging can play an important role.

In the pharma industry, innovation has always been synonymous with new drug discovery and approval. However, while there’s no arguing about the importance of new antibiotic development in the fight against AMR, the next generation of packaging and delivery systems deserve the same attention.

With AMR placing increasingly complex demands on the supply chain, packaging and delivery components must be precision engineered to ensure antibiotics are delivered and administered to patients as intended. This involves the mass adoption of Quality by Design (QbD).

The underlying principle of QbD is that quality is built into a product from the outset rather than tested during manufacture. Knowledge-based design has a key role to play in establishing “the rulebook” about how a multitude of factors impact safety, efficacy and patient experience.

The pharmaceutical waste includes expired products, dispensed drugs that are unwanted or discontinued, and contaminated medications

Poor quality medicine

A sufficient dose of the right antibiotic medicine early on in an infection will kill susceptible strains and help suppress newly-mutated pathogens from spreading. However, if the medicine being relied upon is poor quality or falsified, the whole treatment process is undermined.

Currently, the sale of counterfeit pharmaceuticals is the world’s largest fraud market, worth more than $200bn per year. However, digital packaging solutions are offering greater supply chain visibility and making falsification harder.

Digital mass serialisation is becoming a popular solution to combat counterfeiting. This involves the generation of a random, pseudo code in a sequential manner by a technology provider entered into their or their customers’ database for later verification. The authentication process matches the unique code on a product to those stored in the database. If the code is present, the product is deemed to be genuine.

Origin has developed Smart-i PharmiTrack technology for the control of physical products in the supply chain and can be applied to any size of batch or even to a single unit measure. This technology can identify the security status and location of your product remotely, at any time, making attempt to seize or introduce falsified medicines into the supply chain much more difficult.

Looking forward

AMR is a complicated and multi-dimensional issue, requiring the collaboration of national governments, NGOs, scientific experts and the general population to solve.

While pharma packaging cannot claim to offer the solution to the AMR crisis, at this point, every stakeholder in the healthcare supply chain has a responsibility to play their part.

What is a terrifying threat may also be an opportunity to drive “health for all” across the world, balancing the many economic, social and health inequalities which continue to exist today.

Credit: Origin

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Jul 24, 2021

A guide to labelling compliance for medical devices

medicaldevices
Technology
healthcare
Compliance
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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