News

HDA UK Media and Political Bulletin – 25 November 2021

Media Coverage

Digitising the pharma supply chain
Pharmaceutical Technology, Abi Millar, 25 November 2021

Pharmaceutical Technology (PT) reports on how the Covid-19 pandemic has highlighted the need for security and traceability at every step of the drug supply chain.

PT describes the challenges the pharmaceutical supply chain faced during Covid-19, such as drug shortages as manufacturers faced disruptions to their supply of raw materials. As the vaccination programme got under way, the cold chain came into focus, as the scale and urgency of the rollout placed existing systems under pressure. PT also highlights the difficulties facing the sector following the exit from the EU’s Falsified Medicines Directive (FMD).

However, PT writes that these disruptions can also be framed as an opportunity. Blockchain company FarmaTrust, for example, has called on the UK Government to modernise the system. Their CEO, Raja Sharif, said: “While we currently have an active fake medicines risk for the UK – especially with the scale of the Covid-19 immunisation programme – it is also an ideal moment to re-evaluate our entire medicines supply chain.”

GPhC may issue further regulatory guidance if hub-and-spoke law changes
Chemist + Druggist, Eliza Loukou, 24 November 2021

The Chemist + Druggist reports that the General Pharmaceutical Council (GPhC) will consider whether “additional guidance is required” should the law change so that the hub-and-spoke model can be rolled out across all pharmacies.

The comments were made by the GPhC’s CEO Duncan Rudkin at a Sigma webinar on the hub-and-spoke model last week. Following the passing of the Medicines and Medical Devices Bill in February, the Department of Health and Social Care (DHSC), now has the power to change legislation so that all community pharmacies can operate a hub-and-spoke dispensing model, regardless of whether they are part of a chain or are independent.

Mr Rudkin told delegates that in preparing for the potential change in the law, the GPhC might issue additional guidance, setting out the regulator’s expectations for pharmacies and pharmacists in more detail.

Parliamentary Coverage

There was no parliamentary coverage today. 


Full Coverage

Digitising the pharma supply chain
Pharmaceutical Technology, Abi Millar, 25 November 2021

Since the start of the pandemic, the pharmaceutical supply chain has been under scrutiny. Never much of a talking point in the past, it is now firmly on the public’s radar, and the associated challenges are barely out of the news.

In the early days of Covid-19, the main problem was drug shortages, as manufacturers faced disruptions to their supply of raw materials, and factories closed around the world. Later, this affected the companies developing vaccines, which needed hard-to-source equipment such as filters and bioreactor bags. In some cases, companies lacked full visibility of their stock.

Then, as vaccination programmes got underway, the cold chain came into focus. Despite herculean efforts from all concerned, the scale and urgency of the rollout placed existing systems under pressure.

“The cold chain maintains medicines at the correct temperature throughout their journey, so healthcare professionals can be sure they are fit for purpose and safe to use,” says Checkit healthcare transformation partner Mike Hobby.

“Items like vaccines pass through a lot of stages, overseen by a lot of different people, on their way from manufacturer to patient. You need to know there was consistency throughout that time period.”

Pharma supply chains, he explains, depend on a complex set of processes, often involving a range of participants spread across numerous locations. Success hinges on the right people doing the right things, in the right place and at the right time.

“Historically it has been difficult to track what’s happening at each stage, owing to a lack of remote oversight and over-reliance on manual checks and paperwork that tends to be siloed. That’s a particular concern when you’re dealing with temperature-critical medicines such as vaccines,” he says.

Regulatory limbo

In the UK, these kinds of challenges have been compounded by Brexit. On 1 January 2021, the UK bade goodbye not only to the EU, but also to the EU’s Falsified Medicines Directive (FMD).

A legislative safeguard, the FMD ensures medicines supplied in Europe are exactly what they seem to be. Each pack is given a barcode, which hospitals and pharmacies must scan at the point of dispensing. As a result, fake or substandard medicines will have a harder time entering the pharma supply chain.

Since the start of the year, end-users in the UK have been automatically disconnected from the system, prompting concerns about the security of the UK drug supply. A new bill, the Medicines and Medical Devices Act 2021, aims to fill the ‘regulatory gap’ around falsified medicines, but its wording is controversial and progress has been slow.

According to the Royal Pharmaceutical Society, this state of limbo ‘could leave the UK vulnerable to an influx of counterfeit medicine’.

Technology to the rescue

Of course, as is so often the case in times of crisis, it is possible to frame these disruptions as an opportunity. Blockchain company FarmaTrust has called on the UK government to modernise the system. If achieved, this would bring the UK’s drug security ahead of Europe. It would even surpass the US, where the Drug Supply Chain Security Act is speeding up the transition to a digital supply chain.

“While we currently have an active fake medicines risk for the UK – especially with the scale of the Covid-19 immunisation programme – it is also an ideal moment to re-evaluate our entire medicines supply chain,” said FarmaTrust CEO Raja Sharif. “With Brexit, the UK has the opportunity to implement the world’s safest medicine supply chain.”

In essence, this would mean using blockchain-based technologies to heighten security and visibility. Supply chain participants would be able to track every step in the medicine’s journey, including the exact details of its shipping and storage conditions, and that record would be impossible to falsify.

Together with a number of industry partners, FarmaTrust is working on a pilot project to develop the UK’s first blockchain-based pharma supply chain. The consortium has been awarded £53m of government money, from UK Research and Innovation (UKRI) and the Made Smarter initiative, and aims to create a blueprint for a ‘connected network of smart factories’.

“Blockchains are currently in the hype cycle,” comments Nitin Dsouza, head of international supply chain at global digital consultancy Publicis Sapient. “However, as more and more companies trial and adopt it, it has the potential to be one of the key technologies for visibility.”

How the digital supply chain might work

Although a blockchain-based system may be a few years away, the pharma supply chain is already benefitting from a wide range of digital technologies. The idea is to enable end-to-end tracking and planning, provide full visibility, and automate what were formerly manual processes.

“Technology is evolving to not only provide real-time data on the condition of temperature-critical medicines, but also to prompt, guide and log the actions people may need to take in response to any problematic variation,” says Hobby.

“These new tools can actually tell you how long you’ve got until the vaccine expires, so you’re wasting as little as possible and building confidence in the supply chain journey of any particular batch, without having to travel between sites to check.”

As an example, many cold chain companies now embed temperature sensors in their boxes. These sensors can be connected to telematics to provide you with updates in real time.

“These same technologies can enable tracking of individual vials from manufacturer to patient,” says Dsouza. “On the supply side, items can be tracked by linking purchase order data, transport order data, warehouse tracking systems and in-transit telematics. The data sets that are generated are huge, but the use of cloud-based scalable databases makes it easier to filter the key insights.”

Pharma companies themselves are using digital tools to help with demand planning, ensuring they stock the right amounts of inventory. Amit Nastik, global head of strategy & operations and local markets manufacturing at Novartis Technical Operations (NTO), says that Novartis is working to streamline and digitise this process.

“We are using predictive analytics and artificial intelligence to generate forecasts,” he says. “This has helped make us less vulnerable to unanticipated change. We are working to build a fully-connected supply chain by using new technologies like AI to drive greater efficiency across our own operations.”

Why go digital?

Without a doubt, the pandemic has been a learning opportunity for pharma companies and their logistics partners. Whether it’s about keeping vaccines frozen or keeping counterfeit drugs well away from patients, technology can play an important role even in the absence of regulation.

Hobby says there are so many benefits to digital supply chains, it would be surprising if they didn’t become more prevalent. As well as strengthening patient safety, you’re making life easier for healthcare professionals and everyone else involved in the pharma supply chain.

“You’re taking away the manual monitoring burden from busy staff, who need to focus directly on patient care,” he says.

“You’re building a better audit trail for compliance, with accurate evidence and specific workflows for corrective action, and making trend analysis possible. You’re reducing the cost of lost medicine – not only the cost of the medicine itself but the associated costs of reordering, longer lead times and rebooking of patient appointments.”

Digital supply chains, then, could be truly transformative for the pharma industry at large – and certainly one of the better things to emerge from the confluence of Brexit and Covid-19.

GPhC may issue further regulatory guidance if hub-and-spoke law changes
Chemist + Druggist, Eliza Loukou, 24 November 2021

The General Pharmaceutical Council (GPhC) will consider whether “additional guidance is required” should the law change so that the hub-and-spoke model can be rolled out across all pharmacies, the regulator’s CEO Duncan Rudkin has said.

Mr Rudkin spoke at a Sigma webinar on the hub-and-spoke model last week (November 16), alongside representatives from the Department of Health and Social Care (DH) and the National Pharmacy Association (NPA).

Following the passing of the Medicines and Medical Devices Bill in February, the DH now has the power to change legislation so that all community pharmacies can operate a hub-and-spoke dispensing model, regardless of whether they are part of a chain or an independent.

Responding to a question from C+D on how the regulator is preparing for this potential change in the law, Mr Rudkin told delegates that the GPhC might issue additional guidance, as it has done in the past with other “particular topics”.

The additional guidance, Mr Rudkin continued, would set out the regulator’s expectations for pharmacies and pharmacists in more detail.

Broaden inspectors’ skills

The GPhC will also expand “the range of skills available” to inspection teams either “directly or through on-call support”, Mr Rudkin told delegates.

This will ensure inspectors know “the right technical questions to ask when they’re seeking assurance around how people are applying the standards” in the context of hub and spoke.

The regulator will expect businesses implementing hub-and-spoke dispensing “to be ready to explain” how they intend to “use system changes to actively promote professionalism” and “uphold the ability of pharmacy technicians to live up to their professional obligations”, Mr Rudkin said.

The GPhC is also in “detailed discussions” with the Medicines and Healthcare products Regulatory Agency (MHRA), he added, regarding “the interface” between the regulator’s and the MHRA’s requirements.

Follow the GPhC’s standards

Those unsure of the GPhC’s requirements for pharmacies interested in hub-and-spoke dispensing should consult the regulator’s standards for pharmacy professionals and the standards for registered pharmacies, Mr Rudkin advised.

These will provide “an essential framework for you to think through the issues in designing your models if you go down this road”, he noted.

Mr Rudkin highlighted that “making and using appropriate records” and “communicating effectively with others involved in the person’s care” – as advised by the standards for pharmacy professionals – would be important in the hub and spoke context.

The standards for registered pharmacies – which the GPhC uses to inspect pharmacies – “can be used as a framework for risk assessment and risk management”, Mr Rudkin said, as was done in the development of vaccination sites.

He highlighted principles four and five, which call for storing medicines and medical devices securely until they are supplied to the patient and ensuring that business systems are “safe and fit to use”.

Principle one will be “very relevant to the hub and the spoke and the relationship between them”, Mr Rudkin continued, as the guidance advises pharmacies to have “clear definitions of the roles and accountabilities of the people involved in providing and managing pharmacy services”.

Mr Rudkin emphasised that patients should always be able to get help in the event of something going wrong. “The arrangements between the pharmacy parties” should never leave a patient “stranded” while “the hub and spoke [point] their finger at each other”, he said.

The GPhC “is very committed to using its regulatory levers and influence to really be proactive in enabling and supporting responsible innovation”, Mr Rudkin noted.

However, “there will be limitations to the kind of topics that we would get involved in”, he added. “We certainly wouldn’t regard it as part of our role to arbitrate between businesses in commercial issues between them.”

No date confirmed for hub-and-spoke consultation

On November 11, the DH published the results of an eight-week consultation it ran in 2016, which included questions on the hub-and-spoke model.

Claymore Richardson, senior policy manager at the DH, emphasised during the webinar that the publication of the DH’s response to the 2016 consultation does not mean it is starting from scratch on the upcoming consultation.

The DH reviewed its 2016 consultation to identify the “main areas for further discussion” for hub-and-spoke dispensing, Mr Richardson told delegates, and subsequently progressed to “pre-consultation engagement” by holding several workshops.

These outlined the main themes to be addressed in the DH’s next consultation on hub and spoke, including concerns over accountability and transparency.

The finalised DH proposals will be published and tested in “a full public consultation”, Mr Richardson said.

“We do not have a date for consultation yet confirmed”, he stressed, though the DH is “moving in that direction”.

“No assumption that hub and spoke will reduce costs”

Gareth Jones, head of corporate affairs at the NPA, told delegates that it was up to individual businesses to implement hub and spoke in the future and assess whether the model would benefit them.

In response to Mr Jones’s comments, DH principal pharmacist Susan Grieve stressed that the DH is not “forcing anybody to do this”.

She added that the DH would be publishing an impact assessment alongside the consultation, which would outline its “view” on different businesses’ feasibility in implementing the system.

However, Mr Jones argued that there is not “a huge business incentive for independent pharmacies” to introduce the model.

“I don’t see [hub and spoke] revolutionising pharmacy practice within multiples either”, Mr Jones continued, as pharmacies within the same legal entity using hub-and-spoke services have reported that long, complicated prescriptions “often can’t be handled at the hub in an automated way”.

He added that he was not seeing lots of investment into the hub-and-spoke model from the multiples, “which would be a sign that they thought it was working really well for them”.

C+D revealed last year that Lloydspharmacy had reviewed the number of branches suitable for its hub-and-spoke model after finding that it only works for “some” pharmacies.

Meanwhile, speaking at the Pharmacy Show in October, Numark managing director Jeremy Meader said that while the model has “proved very successful” for Rowlands, independents or small pharmacy chains may find an alternative solution “easier”.

HDA UK Media and Political Bulletin – 25 November 2021

From Factory to Pharmacy

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