Media And Political Bulletin-03 January 2018

Media and Political Bulletin

03 January 2018

Media Summary

Fake fentanyl tablets

NPA, Leyla Hannbeck, 02 January 2018

The NPA has published a letter from their Director of Pharmacy and Medication Safety Officer warning that the Metropolitan Police has seized a ‘significant quantity of fraudulent tablets in London, under the brand name of Perocet.’

The letter states that these fake tablets contain only fentanyl as the active ingredient, as opposed to genuine Percocet tablets, which contain a combination of oxycodone and paracetamol. Fake Percocet tablets have been in circulation in North America for some time; however, this is the first time it has been found in the UK. An image of the fake Percocet tablets has been made available by Public Health England.

Although it is more likely that fake Percocet tablets will be available outside of the reputable medicines supply chain, all pharmacy teams should be aware of this threat.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

Fake fentanyl tablets

NPA, Leyla Hannbeck, 02 January 2018

It has come to my attention that the Metropolitan Police has seized a significant quantity of fraudulent tablets in London, under the brand name of ‘Percocet’. These fake Percocet tablets contained only fentanyl as the active ingredient; genuine Percocet tablets contain a combination of oxycodone and paracetamol. Furthermore, Percocet is not a licensed brand in the UK. Fake Percocet tablets have been in circulation in North America for some time; however, this is the first time it has been found in the UK. An image of the fake Percocet tablets has been made available by Public Health England.

Although it is more likely that fake Percocet tablets will be available outside of the reputable medicines supply chain, I would advise that all pharmacy teams be made aware of this new threat.

With Falsified Medicines Directive (FMD) coming into force on 9 February 2019, I will continue to highlight all relevant patient safety matters, in-line with my role as Medication Safety Officer for pharmacies with less than 50 branches in England.

For further information please contact the NPA Pharmacy Services team on 01727 891800 or email at pharmacyservices@npa.co.uk.

Wholesalers: Brexit ‘highly likely’ to cause stock shortages

Chemist & Druggist, Beth Kennedy, 3 November 2016

C&D reports on HDA UK warning that the UK leaving the single market could lead to drug shortages. Parallel imports would no longer be “easily and swiftly” imported in the UK and drugs could be more expensive as a result. Finally, the ease of employing EU nationals could also be affected and the healthcare sector “benefits from skilled workers from the EU”.

The full letter is available on the HDA’s website here.

 

Can EU laws tackle smuggling and forging?

EU Observer, Craig Storbie, 3 November 2016

The EU Observer discusses the effectiveness of EU regulation in tackling the issue of illicit trade in contraband and counterfeit goods. The Falsified Medicines Directive is the first regulation of this type which aims to tackle illicit trade of counterfeit medicines, through harmonised, pan-European measures that control and monitor the trade pathway and authentication of medicines. However, the path to implementing FMD is hurdled with financial and logistical challenges, especially for small to medium sized enterprises.

 

Labour calls for end to pharmacy cuts in the commons

Pharmacy Biz, Neil Trainis, 3 November 2016

Pharmacy Biz reports on a House of Commons debate during which Labour MP’s called for community pharmacy funding cuts to be scrapped. Shadow health secretary Jonathan Ashworth was particularly vocal in his criticism of the cuts and of the Community Health and Social care Minister David Mowat, who had promised that he would take the time to ensure the government’s efficiency measures were “the correct decision.”

Pharmacy Biz further reports that Ian Strachan, Chairman of the NPA, welcomed this support.

 

Parliamentary Coverage

Scottish Parliament, Priority Health & Pharma: “To ask the Scottish Government what information it has regarding the number of counterfeit medical products …” , 1 November 2016

 

Neil Findlay (Lothian, Scottish Labour): To ask the Scottish Government what information it has regarding the number of counterfeit medical products and medicines that have been seized in the last 10 years.

 

Shona Robison: The Medicines and Healthcare products Regulatory Agency is responsible for regulating medicines, medical devices and blood components in the UK, and the Scottish Government does not therefore hold the information sought.

 

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House of Commons, Drugs: UK Trade with EU, 3 November 2016  

 

Daniel Zeichner: What assessment he has made of the potential merits of different possible trading arrangements with the EU for pharmaceuticals exports after the UK leaves the EU.

 

Department for International Trade

Greg Hands: The pharmaceutical sector is strategically important for the United Kingdom and we are having an active and ongoing dialogue with industry. We want the best possible arrangements for trade in all goods and services with the EU, including the pharmaceutical sector.

 

Full Coverage

Wholesalers: Brexit ‘highly likely’ to cause stock shortages

Chemist & Druggist, Beth Kennedy, 3 November 2016

There is a “high probability” that Britain’s exit from the European Union (EU) will lead to medicines shortages, wholesalers have warned.

Parallel imports would no longer be “easily and swiftly” imported into the UK if it leaves the single market, the Healthcare Distribution Association (HDA) said on Monday (October 31).

Leaving the European Economic Area could also lead to more expensive drugs due to losing the trading benefits of being part of the single market, the HDA warned in an open letter to the government.

Wider consequences

The HDA said it is concerned Brexit could affect the ease of employing EU nationals. The healthcare sector – including community and hospital pharmacy – “benefit from skilled workers from the EU”, it stressed.

British patients could also experience delays in receiving the latest treatments when the European Medicines Agency moves its headquarters from London to an EU country, the HDA added.

Last month, Sigma director Rajiv Shah warned that the falling value of the pound and potential rise in importing fees could cost pharmacies around £2,400 a year.

Over-the-counter medicines manufacturers have already become more expensive in the wake of the Brexit vote, he told delegates at Avicenna’s annual UK conference.

 

Can EU laws tackle smuggling and forging?

EU Observer, Craig Storbie, 3 November 2016

The European Union has a fight on its hands, and this time we aren’t talking about Brexit. The battle is against the illicit trade in contraband and counterfeit goods and the culprits are organised crime and even terrorists, its prime beneficiaries.

According to a report published by the OECD and the EU’s Intellectual Property Office in April 2016, imports of counterfeited and pirated goods have doubled in less than a decade and are worth nearly $500 billion a year, or around 2.5% of global imports.

Perhaps surprisingly for most people, the two most frequently smuggled product sectors in Europe are pharmaceuticals and tobacco. Research from KPMG showed that one in every 10 cigarettes smoked is from illicit sources, while the European Commission estimates that globally 10,000 deaths each year can be attributed to falsified medicines.

Not only does the illicit trade sell dangerous products, which puts consumers at risk, and fund serious crime, but it also costs governments billions of euros in lost tax revenue.

The EU is determined to tackle this problem by introducing legislation that seeks to improve track and trace and authentication of the most commonly smuggled products. Businesses from different sectors have also voluntarily tested and introduced measures against this criminal practice that erodes their revenue and reputation.

But the question remains, can EU legislation really be effective in tackling the problem? Especially one that often originates beyond Europe’s borders?

The Falsified Medicines Directive (FMD) was the first piece of European legislation designed to specifically tackle illicit trade through harmonised, pan-European measures that control and monitor the trade pathway and authentication of medicines.

Coming into force in 2019, its key requirements are that all medical products for sale in the EU carry a unique identifier (a 2D data matrix code and human readable information) that can be scanned at fixed points along the supply chain and have visible tamper evident features on the pack.

Manufacturers will be responsible for uploading the unique and serialised product identifier via a European hub to country-based national data repositories. The FMD requires verification of the safety features, including the serialised product identifier, at least once before the product leaves the supply chain, normally by pharmacies at point of dispensation.

But will it work? From the outset those involved in the pharmaceutical supply chain – brand manufacturers, wholesalers, traders and pharmacies – have argued that they should take the initiative on creating and developing existing serialisation technology and databases for them to then input unique serial numbers into an EU Hub database.

This will then supply the numbers to a stakeholder-led database in the local market. Sounds complicated, but this ensures ownership of commercial data – like pharmacy dispensing data – is retained by those who put it there in the first place.

The challenge is that manufacturers need to design their serialisation and compliance infrastructure both for the extreme scalability challenges presented by the FMD and the flexibility required to serve the member states.

For many larger pharmaceutical manufacturers serialisation was already implemented but for small to mid-size entities who do not have the infrastructure or resources readily available to create a bespoke solution or to integrate with an Enterprise Resource Planning system, this will be a significant cost and logistical challenge. There are also concerns that member states will not have their own systems ready for 2019.

A small price to pay

The main burden however will fall on pharmacies, including hospital pharmacies, which will be required to scan barcodes, check tamper-proof devices and decommission medicines at the point of dispensation.

The European Commission estimated average costs at €530 a year for each pharmacy, with a particular burden on smaller family run businesses lacking the economies of scale.

This may seem a small price to pay for patient safety but the difficulties surrounding implementation could be argued to be the result of the European Commission not taking sufficient time to consult with industry, especially smaller players, and not sufficiently understanding the logistical and cost implications of reporting and storing data across multiple systems, which requires open standards and interoperable solutions in order to be effective.

The European Commission is currently working on a second piece of legislation designed to tackle the trade in counterfeit and contraband goods, the Tobacco Products Directive Articles 15 (Track & Trace) and 16 (Security Feature) and is consulting with stakeholders, including the industry and supply chain, on the implementing Acts covering these articles, with submissions due by 4 November.

As with the FMD, the challenge is to ensure that a system dealing with product in the billions is sufficiently flexible and interoperable to allow international tracking and tracing distributors, beyond EU borders, to integrate with other product sectors, and manufacturers to continue to be involved in the authentication process.

Moreover, fair market competition among services providers based on best in class and latest technologies should be encouraged rather than undermined.

The European Union is at its most effective when it pools resources across member states to address a multinational problem like the trade in illicit goods. However, it must always remember that (unlike some of its parts) it is not an island, and that for its legislation to be effective it must also be flexible and adaptable, encouraging effective implementation rather than formal box ticking within and beyond its member states.

Craig Stobie is director – global sector management and development at Domino Printing Sciences

 

Labour calls for end to pharmacy cuts in the commons

Pharmacy Biz, Neil Trainis, 3 November 2016

Labour attempted to raise the pressure on the government to reverse its decision to slash community pharmacy funding and called for pharmacies to be protected from closure yesterday during a heated House of Commons debate.

The shadow health secretary Jonathan Ashworth led Labour’s assault on the measures which will see funding for community pharmacy reduced by £113 million in 2016/17 and a further £95 million in 2017/18. The funding changes will start from December 1.

Ashworth first attacked the cuts themselves which he said threatened to cause a reduction in pharmacy services and bring about the closure of pharmacies before criticising the way the government went about introducing the cuts.

In particular he was critical of the community health and social care minister David Mowat for breaking a promise made during this year’s Royal Pharmaceutical Society conference to take time to ensure the government’s efficiency measures were “the correct decision.”

Ashworth said: “That this House notes that community pharmacies are valued assets that offer face-to-face healthcare advice which relieves pressure on other NHS services; calls on the government to rethink its changes to community pharmacy funding; and further calls on the government to ensure that community pharmacies are protected from service reduction and closure and that local provision of community pharmacy services is protected.”

He added: “Now we have a new Minister, and we are delighted to ​welcome the hon. Member for Warrington South (David Mowat) to his place – not least because in one of his first interventions when he was allowed out, he visited the Royal Pharmaceutical Society’s annual conference in September and said he was delaying the cuts.

“He said: ‘I think it is right that we spend the time, particularly me as an incoming minister, to make sure that we are making the correct decision.’ He continued by saying that ‘what we do is going to be right for you, is going to be right for the NHS and right for the public more generally.’

“When the Minister came before the House last month we found out that, far from having listened, taken account of various consultations and decided to do what was best for the NHS, he intended to impose a 12% cut on current levels to pharmacy budgets for the remainder of this financial year – giving pharmacists just six weeks’ notice – and a 7% cut the year after that.”

The Labour MP Michael Dugher used the Commons to criticise Mowat and his predecessor Alistair Burt for what he perceived as unclear thinking over the impact of the cuts on community pharmacy.

“It is a pleasure to follow the right hon. Member for North East Bedfordshire (Alistair Burt), who tried to be extremely helpful to the current minister – most ex-ministers have ex-ministeritis and tend to be extremely unhelpful to current ministers, but not so the right hon. Gentleman,” Dugher said.

“However, he did use that figure of 3,000 pharmacies – one in four – facing closure. He has attempted to qualify it now, and his defence seems to be that he made the estimate without properly thinking it through. To that extent, there is remarkable continuity with his successor, who makes a number of assertions without remotely thinking them through.”

Following the Commons debate Dugher, the MP for Barnsley East, warned the cuts will force the closure of hundreds of pharmacies in Yorkshire.

“Ministers are pursuing a scorched earth policy that is bad for Barnsley and will force the closure of hundreds of pharmacies in Yorkshire and thousands across the country,” he said.

“The expertise and dedication front-line healthcare staff out in our communities supporting the NHS will be replaced by empty shopfronts, with patients forced to travel further for the medicine and advice they need.

“MPs must send a message to the government to think again and drop these flawed plans for the sake of the health of more than two million people who have already signed the biggest ever healthcare petition opposing to their plans.”

Bitter Pills

3 June 2016, The Times, Leader Comment

 

The Times comments on an investigation into drug pricing practices led by the publication which reveals that the price to the NHS of medicines reaching a mature stage of the retail cycle is increasing. It particularly questions the loopholes in the NHS’s drug-purchasing policy.

 

Counterfeit medicines are a growing threat to global health, WHO meeting hears

2 June 2016, The Pharmaceutical Journal

 

The Pharmaceutical Journal reports on a session at the WHO annual assembly Zuzana Kusynova, policy adviser at the International Pharmaceutical Federation (FIP) warned of the increasing threat of substandard and counterfeit medicines to global health. While there are no good estimates on the frequency of falsified medicines, more information on the frequency of substandard medicines is available. Member states should report incidents to the WHO in a systematic manner.

 

Chemist and Druggist and The Pharmaceutical Journal review the responses published by pharmacy bodies to the Department of Health consultation on its proposed efficiency savings.

 

Parliamentary Coverage

 

There is no Parliamentary coverage today.

 

Full Coverage

Bitter Pills

3 June 2016, The Times, Leader Comment

 

The National Health Service deserves better than this. When prescription drugs come out of patent they are supposed to start costing the NHS less than they did during the period when they were available from only one supplier. Our investigation today, however, reveals that the price to the NHS of some of the medicines reaching a mature stage of their long and complex retail cycle is actually increasing. Increasing, furthermore, dramatically, and in some cases scandalously. Over the past five years, 32 drugs have gone up in price by more than 1,000 per cent.

 

The extra cost to the NHS of these hikes is in excess of £262 million a year. No relevant authority appears to have identified the trend towards what one expert has called, with evident justification, “extortionate” price rises. Even if these extraordinary figures have been noted among the myriad number-crunchers both in Whitehall and the upper echelons of the service itself, no effective remedial action on their part is yet detectable.

 

Politicians, managers and quangocrats, who are paid handsomely to deliver value for money to taxpayers, seem remarkably relaxed about pills costing 5p each one year, then costing £3 each five years later. They should be anything but. As our story explains, £262 million a year is equivalent to hiring another 7,000 junior doctors. The NHS is a huge, some would say unwieldy, organisation. Its £116 billion budget accounts for almost one fifth of annual public expenditure in the UK. There is a temptation to view what is in absolute terms an enormous sum as a relatively insignificant percentage of overall costs. This temptation must be resisted.

 

Just as its custodians must be monitored to ensure the NHS is as cost-efficient as possible, the service’s suppliers cannot be allowed to exploit its size nor its mission. Clearly a degree of exploitation has taken place. The various pharmaceutical entrepreneurs involved have not broken the law. What they have done, however, realising spectacular profits in the process, is to make use of a loophole in the NHS’s drug-purchasing policy. This loophole exists not because of a failure to employ market forces but rather because, in a system predicated on the smooth operation of those forces, they are nowhere to be seen.

 

The government is mindful of the dangers of monopoly provision and has correctly insisted that drugs under patent and some branded drugs should be subject to a profit cap, albeit a voluntary one. Drugs out of patent, once their generic name has been substituted for their brand, become free from these controls. If any firm can supply any product, the reasoning goes, competition will suppress the price of that product.

 

The reality is that some entrepreneurs have bought up the exclusive rights to market certain drugs. Typically those which, superseded by modern versions, no longer provide sufficient profit to interest big pharma yet which nonetheless continue to be prescribed by GPs. Such physicians are acting out of legitimate, indeed, quite possibly lifesaving, concern. Some victims of chronic conditions, hypertension or malfunctioning thyroid glands, for example, suffer side-effects from the new generation drugs. They must therefore remain on the original medication supplied by a manufacturer who can name his price. An unforgivably high price, as it turns out.

 

The solution to this is straightforward. Suppliers of out-of-patent niche medicines to the NHS should be contracted on the basis of tendering for the business at an agreed price. The issuing of blank cheques should cease. As for the entrepreneurs in question, we note that some make much of their credentials as philanthropists. Let them now go about proving those credentials, many times over.

 

Counterfeit medicines are a growing threat to global health, WHO meeting hears

2 June 2016, The Pharmaceutical Journal

 

Substandard and counterfeit medicines pose a growing threat to global health and greater global efforts are needed to counter the problem, experts have warned at an international forum.

 

Speaking at a session on 27 May 2016 at the annual assembly of the World Health Organization, Zuzana Kusynova, policy adviser at the International Pharmaceutical Federation (FIP), which represents pharmacists and pharmaceutical scientists, said it was important to safeguard the legitimate supply chain of medicines.

 

“It was vital for pharmacists to refer cases to authorities if they find suspected cases of substandard, spurious, or counterfeit medicines,” she added.

 

These products are known as SSFFC — substandard, spurious, falsely labelled, falsified and counterfeit medicines — and can affect both branded and generic products.

 

Hans Hogerzeil, professor of global health at the University of Groningen in the Netherlands, pointed out that there are no good estimates on the frequency of falsified medicines, but that “we have some information on the frequency of substandard medicines”.

 

The WHO says there are many estimates of the scope and scale of the market in SSFFC medical products but little validated evidence to underpin those estimates.

 

Since 2013, when the WHO asked member states to report SSFFC incidents in a systematic format, more than 1,114 medical products have been reported covering main therapeutic categories. If any of the notifications pose a serious threat to global health, the WHO issues a global medical product alert.

 

PSNC, RPS and Pharmacy Voice to join forces and publish forward view for community pharmacy

2 June 2016, The Pharmaceutical Journal, Ingrid Torjesen

 

The Pharmaceutical Services Negotiating Committee (PSNC) has announced it is working with Pharmacy Voice, a trade association which represents community pharmacy in England, and the Royal Pharmaceutical Society to develop a ‘Community Pharmacy Forward View’ that will articulate how they believe “the community pharmacy network can best support the high performing, affordable health and care system envisaged in the NHS’s ‘Five year forward view’”.

 

The new plans for the future of community pharmacy, for which no publication date has been given, come after the PSNC says its counterproposals for making savings to the community pharmacy budget, submitted to the Department of Health in April 2016, have been rejected by the government.

 

The UK government’s proposals, announced in December 2015, involve slashing £170m from England’s community pharmacy budget from October 2016, sparking fears that around 3,000 pharmacies could close as a result.

 

The PSNC, the negotiating body for community pharmacy contractors in England, has since sought to examine the plans in more detail, but says its efforts “have been thwarted” by the government’s reluctance to be forthcoming about its policies.

 

Alastair Buxton, director of NHS services at the PSNC, says: “The forward view is not a piece of work designed as an alternative to the counterproposal that the PSNC presented as part of its discussions with the Department of Health and NHS England. Instead, it provides a broader and longer term shared vision for community pharmacy.”

 

The PSNC says its original counterproposals urged officials to consider for the first time the potential demand on the NHS that would result if patients could no longer rely on their local pharmacy for urgent medicine supply.

 

“We have been unable to obtain confirmation from the government of the scale of closures of community pharmacies it wishes to achieve,” the PSNC says, adding that it is willing to discuss a reduction in numbers where this could be done without detriment to patient choice and access to pharmacy services.

 

“The reluctance to explain the policies is, we believe, driven by a desire to avoid the opposition that they would provoke, and to forestall the argument that pharmacies that become unviable should be compensated.”

 

It has also sought access to information on the anticipated cost savings associated with the plan to drive automated remote dispensing and a reduction in pharmacies. “Officials have said informally that there is none,” the PSNC says.

 

In its response to the government’s planned cuts, published on 26 May 2016, the Royal Pharmaceutical Society (RPS) emphasised that the proposed cut in contractual funding will reduce the potential for community pharmacists to deliver additional value in the community with a knock on effect of increasing pressure on GPs, hospital emergency departments and other urgent care services.

 

Sandra Gidley, chair of the RPS England Pharmacy Board, says: “We are in no doubt that hastily implemented funding cuts to community pharmacy will mean greater costs for the NHS in the long term. There is a strategic imperative for the NHS to improve capacity and capability to support older people and those with long-term conditions.

 

“This, coupled with an emphasis on prevention of ill health, means we need to invest in community pharmacy, expand roles and enable better care,” she adds.

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