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Media And Political Bulletin – 10 January 2019

Media and Political Bulletin

 10 January 2019

Media Summary

Brexit crisis: Wholesalers may favour ‘owned’ pharmacies

Independent Community Pharmacist, Neil Trainis, 09 January 2019

Independent Community Pharmacist reports that Claire Ward, the Director of Public Affairs at the Pharmacists’ Defence Association, has said she fears community pharmacies could struggle to get hold of medicines with Brexit looming because some wholesalers may not adequately supply them, instead favouring their “vertically-integrated and owned” pharmacies or “best customers.”

In response, Martin Sawer said: “If these reported comments are correct, then they would appear to demonstrate a misunderstanding of how large automated medicines distribution warehouses operate in practice. […] There can be no intervention to favour one order over another in these highly automated processes.”

Proposals to change legislation to ensure drug supply in case of no-deal Brexit could ‘pose risk to patient safety’

The Pharmaceutical Journal, Julia Robinson, 10 January 2019

The Pharmaceutical Journal reports that the Pharmacists’ Defence Association (PDA) has warned that proposals to issue a “serious shortage protocol” would “open the door” to governmental interference in medicines supply.

The PDA has warned that plans to alter the management of drugs supply in the case of a no-deal Brexit could make it possible to sanction medicines supply to patients in non-pharmacy locations, in the absence of any pharmacist input or usual safeguards.

Falsified Medicines Directive to come into force in one month

Pharmacy Business, Kiran Paul, 09 January 2019

Pharmacy Business reports that the Falsified Medicines Directive (FMD) legislation is set to take effect in a month’s time, on 9 February 2019. The regulations dictate that as of the deadline, all in-scope medicines, inclusive of prescription medicines as well as a ‘blacklist’ of over-the-counter (OTC) medicines that are deemed to be at high risk of falsification must have two safety features: a unique identifier (UI) in the form of a 2D data matrix code and an anti-tampering device (ATD).

Anyone authorised to dispense medicines to the public will have to authenticate each pack at the point of dispense by checking the ATD and verifying the UI. The Royal Pharmaceutical Society has come up with an online guide to help its members understand the requirements of the FMD regulations.

 

Parliamentary Coverage

House of Commons Questions

Christine Jardine (Edinburgh West): To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure sufficient stocks of insulin for people with type 1 diabetes, in the event that the UK leaves the EU without a deal.

Stephen Hammond: Insulin is vitally important to millions of people in this country. Our contingency plans aim to ensure that the supply of insulin and other essential medicines to patients is not disrupted in all European Union exit scenarios, including in the event of a ‘no deal’ exit.

On 23 August 2018, the Department wrote to all pharmaceutical companies that supply prescription-only medicines and pharmacy medicines to the United Kingdom that come from, or via, the EU or European Economic Area (EEA) asking them to ensure a minimum of six weeks additional supply in the UK, over and above existing business-as-usual buffer stocks, by 29 March 2019.

On 7 December 2018, the Department wrote to pharmaceutical companies that supply licensed medicines to the UK from or via the EU/EEA, and/or manufacture medicines in the UK, informing them of the updated reasonable worst-case scenario border planning assumptions and asking them about their current transportation routes and their ability to re-route their supply chains if they currently rely on Dover and/or Folkestone.

We have received very good engagement from industry, including companies supplying insulin to the UK, who share our aims of ensuring continuity of medicines supply for patients is maintained and able to cope with any potential delays at the border that may arise in the short term in the event of a ‘no deal’ EU exit.

 

Full Coverage

Brexit crisis: Wholesalers may favour ‘owned’ pharmacies

Independent Community Pharmacist, Neil Trainis, 09 January 2019

Claire Ward, the Director of Public Affairs at the Pharmacists’ Defence Association (PDA), has said she fears community pharmacies could struggle to get hold of medicines with Brexit looming because some wholesalers may not adequately supply them, instead favouring their “vertically-integrated and owned” pharmacies or “best customers.”

Warning community pharmacists are “no longer in control of the supply of medicines to their patients,” Ward (pictured) said that while the government’s instruction last year to pharmacies not to stockpile medicines was understandable, if they do not stockpile they may not be able to rely on some wholesalers to get products to them.

“When the Secretary of State for Health and Social Care was asked about concerns for the availability of medicines, his view was that all will be fine as long as MPs support (Theresa May’s) deal. He urged pharmacy, individuals and business to get behind the (prime minister) to create the much needed certainty. But is that really the case?” Ward told ICP.

“Pharmacists are being placed between a rock and a hard place. Whatever their view on Brexit, the reality is that they are no longer in control of the supply of medicines to their patients.

“They can’t guarantee that there will be availability and equally important, they can’t guarantee the price even if there is availability. So pharmacists will end up having to pay higher prices to supply patients, even when full reimbursement of costs may not be agreed by (the Department of Health and Social Care).

“Right now, independent pharmacists are trying to work out what to do. They have been told not to stockpile and are at risk of investigation if they do. (That is) understandable as the impact of a herd mentality will do much greater damage overall and create earlier and possibly longer shortages.

“But if they don’t stockpile, some wholesalers may not give them adequate supply, perhaps favouring their own vertically-integrated and owned community pharmacies or their best customers. Even if they can get supply in due course, they will be conscious of the costs rising.”

Ward added: “It is all well and good for the secretary of state to ask community pharmacy to support the Brexit deal but few will link their own views to the reality of the situation they are dealing with on a day to day basis. Independent pharmacists feel powerless and at the mercy of the political storm in Westminster and Brussels.”

When contacted by ICP, Martin Sawer, Executive Director of the Healthcare Distribution Association which represents pharmaceutical wholesalers, said: “If these reported comments are correct, then they would appear to demonstrate a misunderstanding of how large automated medicines distribution warehouses operate in practice.

“I would like to offer Claire the opportunity to visit a large wholesaler’s service centre to see the orders from all types of pharmacies, from individual independents to large integrated chains, being dealt with in a matter of seconds. There can be no intervention to favour one order over another in these highly automated processes.

“In fact, the issue of real concern should be if we get to a no-deal Brexit scenario, which I very much hope we do not, then all players up and down the medicines supply chain must be able to work together to agree protocols to ensure patients receive the vital medicines they require.

“That is why HDA is a member of the Pharmacy Brexit Forum, which meets regularly with the (Department of Health and Social Care).”

Ward, a former Labour MP, said May’s struggle to force her European Union withdrawal deal through parliament “should concern us all” given the growing uncertainty around the supply of medicines into the UK. The government today lost by 11 votes in the Commons as it attempts to push ahead with the deal.

“The government’s no-deal preparations should concern us all. Just a matter of weeks away and we have no certainty about how medicines will come into the UK if we have exited without a deal,” Ward said.

“The possibility of a dedicated port simply to receive freight ships full of medicines is being discussed but I can’t help remain concerned about supply. We already have some significant shortages and we haven’t even agreed on a Brexit deal or no deal.”

The government has been consulting on proposals to allow pharmacists to substitute prescriptions without contacting patients’ GPs and dispense reduced quantities of medicines as it seeks to avoid a shortage post-Brexit.

Ward said it was “a shame” it had taken “this sort of national crisis to recognise that pharmacists should be given greater power to make decisions in the best interests of patients.”

She added: “But like most policy changes which are Brexit-related, they have their origins in a knee-jerk reaction to the risks being posed. It will of course be pharmacists that are answering to patients when medicines are not available and substitutions are made.”

Ward said the PDA “will be making the case for very clear lines of responsibility to ensure that pharmacists are not at the brunt end of these changes.”

Proposals to change legislation to ensure drug supply in case of no-deal Brexit could ‘pose risk to patient safety’

The Pharmaceutical Journal, Julia Robinson, 10 January 2019

The Pharmacists’ Defence Association has warned that proposals to issue a “serious shortage protocol” would “open the door” to governmental interference in medicines supply.

Plans to alter the management of drugs supply in the case of a no-deal Brexit could make it possible to sanction medicines supply to patients in non-pharmacy locations, in the absence of any pharmacist input or usual safeguards, the Pharmacists’ Defence Association (PDA) has warned.

In December 2018, prompted by preparations for Brexit, the Department of Health and Social Care (DHSC) launched a consultation on enabling ministers to alter the Human Medicines Regulations 2012 to issue a “serious shortage protocol” in case of a national shortage.

Such a protocol would enable community pharmacists and other dispensers to dispense in accordance with the protocol rather than the prescription without having to contact a patient’s GP, including substituting medicines.

The government is also proposing that ministers should be able to continue to make changes to the Human Medicines Regulation 2012 in relation to serious shortages caused by the UK’s exit from the EU.

But the PDA has expressed concerns that the changes in legislation could “pose a risk to patient safety” and would “open the door” to governmental interference in medicines supply.

It also said that it would be time consuming for frontline staff to explain to patients why their medication has been changed if a medicine substitution is needed and that pharmacists would need to liaise with GPs about the changes to ensure continuity of care.

“We were concerned by the government’s view that no such pharmacist/GP liaison would be required and that, as a result, the changes would amount to a ‘positive impact’,” said the PDA in its response.

The PDA also highlighted that the government had “overlooked” the fact that other areas of legislation would need to be amended — namely, the Human Medicines Regulations 2012 Section 17 and the Medicines Act 1968 Section 64 — in order to make it lawful for a pharmacist to substitute a medicine.

It recommended that the government “ensure that safeguards are in place to prevent inappropriate use of serious shortage protocols for factors unrelated to EU withdrawal”.

A spokesperson for the DHSC said that it was currently reviewing the responses to the consultation and that any protocol would be developed and signed off by “highly specialised clinicians” to ensure the system is “robust and safe”.

“In the event of a shortage of any medicine it’s vital that patients continue to receive the high level of treatment they expect,” they said.

“These are sensible proposals that should reduce the time taken for alternatives to be provided to patients and make it easier for clinicians to deliver the appropriate treatment.”

The DHSC also said that, for a number of patients, including those with epilepsy, a serious shortage protocol would not be appropriate and, as a result, these individuals would not be affected by any changes to legislation.

Falsified Medicines Directive to come into force in one month

Pharmacy Business, Kiran Paul, 09 January 2019

The Falsified Medicines Directive (FMD) legislation, biggest change to supply chain in decades which will affect all community pharmacists, hospitals and dispensing doctors, is set to take effect in a month’s time, on 9 February 2019.

The regulations dictate that as of the deadline, all in-scope medicines, inclusive of prescription medicines as well as a ‘blacklist’ of over-the-counter (OTC) medicines that are deemed to be at high risk of falsification must have two safety features: a unique identifier (UI) in the form of a 2D data matrix code and an anti-tampering device (ATD).

Anyone authorised to dispense medicines to the public will have to authenticate each pack at the point of dispense by checking the ATD and verifying the UI.

The Royal Pharmaceutical Society has come up with an online guide to help its members understand the requirements of the FMD regulations.

The UK FMD Working Group for Community Pharmacy, which includes major trade and professional associations, has also issued a guidance last year on the implementation of the regulations.

Media And Political Bulletin – 10 January 2019

From Factory to Pharmacy

As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.

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