News

Media And Political Bulletin – 19 October 2018

Media and Political Bulletin

19 October 2018

Media Summary

 

Small children prioritised under emergency protocol to tackle ‘critical’ EpiPen shortage

The Pharmaceutical Journal, no author, 18 October 2018

The Pharmaceutical Journal reported that NHS England has asked all community pharmacists to implement new validation processes for the prescription of adrenaline auto-injectors.

Supplies of adrenaline auto-injectors for children are now “critical” and are being rationed with new national guidance for community pharmacists being introduced across England on 17 October 2018.

Children who weigh 25kg or less who have the “greatest short-term need” should have first call on any 150μg adrenaline auto-injector products available, according to the new protocol from the Department for Health and Social Care (DHSC).

The Falsified Medicines Directive: guidance for wholesalers, distributors and logistics partners

Healthcare Global, Christian Taylor, 19 October 2018

Healthcare Global reports that the Falsified Medicines Directive (FMD) 2011/62/EU comes into force on the 9th February 2019. The legislation aims to prevent counterfeit or unauthorised prescription medicine from entering the legal supply chain, providing greater protection for patients.

At the beginning of the supply chain, the pharmaceutical license holder has responsibility for serialising cartons, sealing the product and then uploading the unique identifiers to the European Hub, known as the European Medicines Verification System (EMVS). At the end, the dispensing healthcare institution must verify and decommission that product against a national hub, known as the National Medicines Verification System (NMVS).

This leaves the middle of the supply chain, where there is also a requirement for wholesalers, distributors and logistics providers to implement a ‘risk-based’ approach to the verification and decommissioning of products passing through their operation. In order to be compliant, manufacturers, wholesalers and distributors alike will have to make changes to their supply chain operations.

Uncertainty surrounding our medicines after Brexit provides another good reason to march

The Independent, no author, 18 October 2018

The Independent reported that in and amongst the abstruse speculation about the length of the Brexit transition period, how the facilitated customs arrangement might work and the true meaning of the “backstop” at the Irish border, sometimes it is worth reminding ourselves of the concrete, real and immediate risks to the UK of leaving the European Union. One such risk is whether we will have a reliable supply of up-to-date medicines and drugs, both in the short and the long term, after Brexit; few issues highlight the short- and long-term costs of leaving the EU more graphically and more personally.

The European Medicines Agency is being transferred from London to Amsterdam, and with it the bulk of the expertise in testing and approval of medicines. If Brexit goes ahead, then the UK will be outside this procedure, one that the UK played a major part in creating and administering. Instead, the British will have no formal role in the approval of new drugs by the EMA – and this will impose additional delays for British patients as a result.

Breakthrough cancer and depression treatments just months away from approval could be delayed by Brexit

The Independent, Alex Matthews-King, 18 October 2018

The Independent also reported that scores of drugs just months away from approval for use by British patients – including breakthrough treatments for depression and cancer – could be delayed indefinitely by Brexit.

Manufacturers who have pending European licences have been told they will have to reapply to the UK’s medicines watchdog if their products have not been approved at the time of Brexit unless a deal is struck on drugs regulation.

Parliamentary Coverage

Westminster Public Accounts Committee, session on “Performance of the Department of Health and Social Care”, 17 October 2018 – Key questions

Ms Phillipson asked whether there was additional capital investment to meet potential costs of Brexit.

Mr Wormald said so far, the only money that had been spent was on the non-medicine supply chain, such as stockpiling equipment. This had been in the ‘low tens of millions’.

Ms Hillier asked what equipment they were stockpiling.

Mr Wormald said they were building a six-week stockpile on all consumables such as gloves, drips, dressings, syringes. This was anything coming from outside of the UK and, in particular, anything coming from the EU. He stated that 56% of medical consumables come from the EU.

Ms Phillipson asked whether they were aware of Trusts stockpiling large items.

Mr Wormald repeated that he was not aware.

Full Coverage

Small children prioritised under emergency protocol to tackle ‘critical’ EpiPen shortage

The Pharmaceutical Journal, no author, 18 October 2018

Supplies of adrenaline auto-injectors for children are now “critical” and are being rationed with new national guidance for community pharmacists being introduced across England on 17 October 2018.

Children who weigh 25kg or less who have the “greatest short-term need” should have first call on any 150μg adrenaline auto-injector products available, according to the new protocol from the Department for Health and Social Care (DHSC).

Pharmacists are being asked to go through a list of questions with parents or carers before supplying the product to ensure that these priority patients have at least one “in-date” product.

In a statement, the DHSC said: “The dispenser validation protocol should allow pharmacies to deduce whether a prescription should be fulfilled, partially fulfilled or supply should be delayed”.

According to the protocol, the priority is for children weighing less than 25kg to have two 150μg auto-injectors.

Those children who fall into this category who have no other supplies should be given two in-date products.

However, if a child already has another product which is out-of-date but which does not contain precipitate or is discoloured, then the pharmacist should supply just one additional auto-injector.

In cases where a child has one in-date product but no other supplies, then another auto-injector can be supplied. If a child already has an in-date product and a back-up out-of-date product (which does not contain precipitate or is discoloured) then the supply of a second product should be delayed. If a child has two in-date products then the supply should also be delayed.

In cases where a pharmacist can only partially fulfil the prescription, they are being advised to tell patients to return to their prescriber for another one when they no longer have two devices or the supply issues ease.

The DHSC has produced a letter for GPs and pharmacists to give to patients for reassurance which explains the issues behind the shortages.

The shortage of EpiPens was first highlighted in May 2018 when the UK supplier Mylan identified shortcomings owing to manufacturing problems. Pharmacists have been attempting to manage the limited supply for some months since then.

Thorrun Govind, a pharmacist and member of the Royal Pharmaceutical Society England board, welcomed the national protocol. “It’s good to have national guidance, because until now we have just been asking patients when their supply is due to run out and sharing the products that we have got,” she said.

“It’s a difficult situation and these guidelines make it much easier for us now in terms of the conversations we have with patients. There is a lot of emotion around this as you are talking about life and death and many patients have only ever used the same device.

“Pharmacists are the experts to provide patients with advice on how to use auto-injectors, particularly in explaining to patients how to use alternatives should they be switched.”

The products which come under this new protocol are EpiPen Junior 150μg, Jext 150μg and Emerade 150μg auto-injectors. It does not apply to 300μg or 500μg strengths.

The Falsified Medicines Directive: guidance for wholesalers, distributors and logistics partners

Healthcare Global, Christian Taylor, 19 October 2018

The Falsified Medicines Directive (FMD) 2011/62/EU comes into force on the 9th February 2019. The legislation aims to prevent counterfeit or unauthorised prescription medicine from entering the legal supply chain, providing greater protection for patients.

At the beginning of the supply chain, the pharmaceutical license holder has responsibility for serialising cartons, sealing the product and then uploading the unique identifiers to the European Hub, known as the European Medicines Verification System (EMVS). At the end, the dispensing healthcare institution must verify and decommission that product against a national hub, known as the National Medicines Verification System (NMVS).

This leaves the middle of the supply chain, where there is also a requirement for wholesalers, distributors and logistics providers to implement a ‘risk-based’ approach to the verification and decommissioning of products passing through their operation. In order to be compliant, manufacturers, wholesalers and distributors alike will have to make changes to their supply chain operations.

Yet, despite the impending deadline the market doesn’t appear to be advanced enough in its response. When it comes to the practical application of FMD, there are many areas that still cause confusion. Organisations can no longer afford to let these areas act as barriers to implementing robust FMD solutions. Christian Taylor, Serialisation Business Consultant at Zetes clears up some of the key pain points.

1. Exporting

The main issue with exporting is organisations knowing when they should decommission a product, although it’s still unclear as to whether it needs to be done at goods in or goods out. The key is for organisations to choose a solution that can consolidate medicines to a single reference or shipper case, capturing data within the normal workflow. This enables automated decommissioning of a product at an appropriate point, such as fulfilling the customer order.

Consolidation allows organisations to associate “child” items with a “parent” case. Warehouse operatives will be able to scan the barcode on a case and capture the identity of all of its contents with complete confidence. Ultimately, if a business invests in an FMD solution that has the capability to provide consolidation, it will simplify the process and remove unnecessary complexities when decommissioning products for export. In addition, maximising the efficiency of operations in line with managing FMD compliance – no matter when the decommissioning needs to take place.

2. Managing Article 23

Article 23 outlines that the Member States may require a wholesaler and distributor to verify and decommission a medicinal product before it supplies that product to an institution other than a dispensing hospital or pharmacy. Examples of those institutions include but aren’t limited to; universities, veterinarians and government bodies all of which wouldn’t necessarily have the authority to log into the national hub to decommission a product.

The onus, therefore, is on the wholesaler and distributor to identify which of their customers fall under Article 23. To ensure compliance, organisations need to be able to look through their customer base identify them within the normal workflow and automate triggers for decommissioning. Wholesalers, distributors and logistics should invest in an FMD solution that integrates with its warehouse management system (WMS) to flag to the operator what actions need to happen on any particular pick.

If automated alerts are sent, signalling when an order is being picked for an Article 23 customer, operational staff will know that they need to decommission the product. Organisations shouldn’t find themselves in a situation where an employee on the warehouse floor is making decisions that affect the legal standing of the business.

3. Handling samples

It’s common practice for pharmaceutical organisations to send samples to medical authorities or healthcare professionals. Depending on where those samples are going they will be sent from different parts of the business. For example, if a sample is going to the Medicines and Healthcare products Regulatory Authority (MHRA) it may be sent by the quality assurance (QA) department, whereas a product going straight to a healthcare professional would come from the commercial team. Essentially, businesses will be taking medicinal products out of the usual logistics supply chain.

Regardless, FMD still applies and organisations will need to have full visibility of when those drugs have left the supply chain and confirm they’ve been decommissioned. Currently, many organisations will be reliant on manual checks against multiple manufacturer systems. Under FMD, organisations will need to ensure they invest in a system that provides automated workflows, designed around the correct type of sampling for the business. If a sample is being handled, the system should be able to verify and/or decommission a product no matter where it’s coming out of the business.

4. Quarantine and destruction

Current destruction requirements are far less demanding than they will be under FMD. As it stands, just because a product is in quarantine that doesn’t mean it’s going to be immediately destroyed, and this is where it can get confusing. But, contrary to what some businesses may think, they can avoid a complete overhaul of current business practice.

In order to be compliant with FMD, businesses need to have the capability to track which products have been placed in quarantine and of those, confidently report which ones have been decommissioned and destroyed. If organisations already have a solution that is capable of consolidation, the destruction can happen as a software function and the physical destruction processes needn’t change.

Automated workflow

Putting confusion aside, organisations should proactively be looking to implement solutions that create minimum disruption to current working processes, drive efficiencies and are simple to use every day. Whilst some of the details around the legislation will require further clarification, businesses need to ensure they have a robust solution in place to ensure compliance and remove any chance for human error.

From Batch to Unit level visibility

The important thing for organisations to consider at this time is that currently, no one is handling the data of individual products on the line. In order to be compliant and report to the national hubs, wholesalers, distributors and logistics partners are going to have to review current processes and ensure they can handle data for any single unit within their operations.

Visibility imperative

Behind this legislation, there are distinct efficiency and quality advantages to be found. Wholesalers, distributors and logistics partners should use this opportunity to improve capability within the warehouse and business operations. Building a comprehensive and agile visibility layer on existing processes and cross-functional systems. This will not only ensure compliance by the 9th February 2019, but these infrastructures can be built upon further, putting organisations in a better position to react to any further regulation changes with ease.

Zetes is a technology company headquartered in Brussels and has more than 1,200 employees in 22 countries across EMEA with a revenue of €269.3mn in 2017.  Specialising in supply chain optimisation and citizen identification solutions, the business helps organisations achieve agility, visibility and traceability.

Uncertainty surrounding our medicines after Brexit provides another good reason to march

The Independent, no author, 18 October 2018

In and amongst the abstruse speculation about the length of the Brexit transition period, how the facilitated customs arrangement might work and the true meaning of the “backstop” at the Irish border, sometimes it is worth reminding ourselves of the concrete, real and immediate risks to the UK of leaving the European Union. One such risk is whether we will have a reliable supply of up-to-date medicines and drugs, both in the short and the long term, after Brexit; few issues highlight the short- and long-term costs of leaving the EU more graphically and more personally.

The European Medicines Agency is being transferred from London to Amsterdam, and with it the bulk of the expertise in testing and approval of medicines. If Brexit goes ahead, then the UK will be outside this procedure, one that the UK played a major part in creating and administering. Instead, the British will have no formal role in the approval of new drugs by the EMA – and this will impose additional delays for British patients as a result.

Thus dozens of drugs said to be mere months away from their approval will now have to wait for it from a presently underpowered UK agency, the Medicines and Healthcare products Regulatory Agency (MHRA). Of course, the British could simply accept the approval of the EMA as read – but then what is the point of Brexit? It is hardly an example of “taking back control”.

Sick Britons who need to take drugs for depression and prostate cancer, for example, may well need to wait longer than they otherwise would because of the fact of EU withdrawal, despite the government’s assurances about being ready for a hard Brexit.

Nor is there much confidence that the UK will even be able to stockpile existing approved drugs for use after a disorderly Brexit. Sir Chris Wormald, the permanent secretary at the Department of Health and Social Care, has told the House of Commons Exiting the European Union Committee that he cannot be confident that essential medicines will still be available in such a turn of events, describing the challenge as “extremely difficult”.

He added that the department has major concerns about staff shortages and the treatment of British travellers to the EU after Brexit – whatever particular shape that withdrawal took.

It was revealed in July that the government had asked drugs companies to stockpile six weeks of extra supplies, although the Brexit secretary, Dominic Raab, said that such arrangements need not “scare people”.

But they do, and understandably so. The UK is a major power in the pharmaceuticals industry. With European partner companies and governments, the arena of drugs and medical research is one where the EU has achieved much for its citizens. When we visit other EU nations for business or on holiday, or even to settle, we largely need not worry about getting treated quickly and efficiently. That does not seem to be the case under some of the Brexit scenarios now being discussed.

When something as fundamental as life and health is concerned, British citizens should expect their politicians and civil servants to be able to offer them reassurance and guarantees. As it is, we have only expressions of diffidence, a request to private companies and wishful thinking that some sort of deal will be reached in the end. Another reason, then, and a powerful one, for people to be given a Final Say on this increasingly shambolic, and hazardous, Brexit.

Breakthrough cancer and depression treatments just months away from approval could be delayed by Brexit

The Independent, Alex Matthews-King, 18 October 2018

Scores of drugs just months away from approval for use by British patients – including breakthrough treatments for depression and cancer – could be delayed indefinitely by Brexit, The Independent can reveal.

Manufacturers who have pending European licences have been told they will have to reapply to the UK’s medicines watchdog if their products have not been approved at the time of Brexit unless a deal is struck on drugs regulation.

As of 28 September there were more than 70 drugs awaiting approval, including a cutting-edge skin cancer immunotherapy, a cannabis-based treatment for childhood epilepsy, and new antibiotics.

Jonathan Ashworth MP, Labour’s shadow health and social care secretary, said: “NHS bosses admitted this week they are having sleepless nights over what Brexit will mean for access to medicines. Now we find out that unless ministers get a grip, patients could wait longer and longer for life-saving treatments because of Brexit chaos. No one put that on the side of a bus.”

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has said in the event of a no deal it hoped to be able to use the work already completed by the European agency.

However, it was unable to give guarantees that there would not be some delays or additional costs for companies which reapply, though it would try to “streamline the process”.

The Belgian pharmaceutical company Janssen – part of Johnson and Johnson – produces two of the drugs in the list that have the most excitement surrounding them.

One, a game-changing ketamine-derived “nasal spray”, has the potential to relieve severe depression and suicidal thoughts within hours, in patients who are resistant to first and second-choice treatments.

There were 2,944 patients admitted with recurrent depressive disorders in the UK in 2016, and this accounted for nearly 162,000 NHS bed days.

Clinical trials have shown the effects of the esketamine – part of the recreational drug’s molecule – spray, last much longer than conventional treatments, and act in hours rather than days.

Oxford University professor Rupert McShane, who has pioneered ketamine-assisted treatment and sits on Janssen’s advisory board, told The Independent: “We badly need better therapies for treatment resistant depression.

“The number of people who could benefit is large. Exactly how large will depend on where it is positioned in the care pathway, if it is routine third-line therapy then the number could potentially be very large.”

Janssen is also seeking a European license for the prostate cancer drug apalutamide.

Trial results earlier this year showed apalutamide was able to stop the disease from spreading for three years in men whose tumours had stopped responding to treatment, double the current standard treatment.

Prostate cancer kills more than 11,000 men in the UK every year, and around 10,000 are thought to be living with advanced forms of the disease.

At the time of apalutamide’s final trial results, Professor Malcolm Mason from Cancer Research UK said the findings “very welcome” as there are limited options for these men and delaying the disease spreading may also increase survival.

Janssen told The Independent the MHRA has suggested it will be able to use some of the work done by the EMA if the company reapplies. “For ongoing licence applications, where the decision phase has not been reached by the EMA, we would need to resubmit our application to the MHRA,” a spokesperson said.

“The MHRA’s intention is to complete any assessment that they take over mid-process, aligning with the EMA’s assessment to date.”

However, there are no guarantees that data will automatically be handed over.

Speaking to the House of Commons on Exiting the European Union Committee earlier in October, Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, said:

He told MPs: “In a no deal we do not have the agreements that we have in the withdrawal agreement with the regulator, and therefore the transfer of information between the two regulators is at some risk.”

Even if there is a smooth handover, it is likely there could easily be delays to the process as the MHRA tries to get to grips with its new responsibilities.

Some manufacturers may also not immediately reapply to have their medicines approved by the UK – a significantly smaller market than the EU.

The application process costs hundreds of thousands of pounds and can nearly a year from the process once the evidence review begins – with up to 18 months in the pre-submission process.

Evidence reviews can take up to 210 days for the Committee for Medicinal Products for Human Use to review the scientific evidence and give a recommendation, after which the European Commission has 67 days to approve it.

Currently licensing a single medication costs a minimum of €286,900 (£251,855) and spending a similar amount for the UK’s population is likely to put off some manufacturers.

This is compounded by the fact that there is no guarantee a drug will be offered by the NHS, which assesses medicines based on cost-effectiveness instead of just safety and performance grounds.

An MHRA spokesperson said the government “remains confident” it will strike a deal with the EU to “help ensure patients continue to have timely access to safe medicines”.

The agency told The Independent that where medicines have passed the evidence review stage, it will be able to give an opinion in lieu of the European Commission; where the evidence review is not finished, it will try to use the work already done.

“We do not want or expect a no deal. However, it is the duty of a responsible government to continue to prepare for a range of potential outcomes including the unlikely event of no deal,” it added.

“Whatever the outcome of the negotiations, we will continue to ensure that UK patients are able to access the best and most innovative medicines and be assured that their safety is protected.”

Media And Political Bulletin – 19 October 2018

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