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Media And Political Bulletin – 01 March 2019

Media and Political Bulletin

1st March 2019

Media Summary

Preparations underway to minimise medicine supply disruption, assures government

Pharmacy Business, Lakshmi PS, 28 February 2019

Pharmacy Business reports that on Monday, the Department of Health and Social Care announced that the government will ensure continued supply of medical products if there is a no-deal Brexit.

The government has already created a logistic hub in Belgium to stockpile vital medical supplies, the Guardian reported. According to this report, the Department of Transport will pay £88.8 million to two companies, Brittany Ferries and Denmark-based DFDS to transport products from the hub for the next six months. Drugs and other medical supplies will be shipped through seven new ferry routes.

“While we never give guarantees, we are confident that, if everyone – including suppliers, freight companies, international partners and the health and care system – does what they need to, the supply of medicines and medical products should be uninterrupted in the event of exiting the EU without a deal,” Health Minister Stephen Hammond said in a statement to the Commons.

UK Government to spend £11m preventing medicine shortages in preparation for no-deal Brexit

Hospital Healthcare Europe, Valeria Fiore, 28 February 2019

Hospital Healthcare Europe reports that the Department of Health and Social Care (DHSC) will spend around £11m on warehouse contracts to store medicines as a contingency measure for a no-deal Brexit.

In October last year, Health and Social Care Secretary Matt Hancock told the Health and Social Care Committee that the Government had issued an invitation to tender for additional storage space to stockpile medicines.

Last month, Health minister Stephen Hammond said the Government had signed a contract worth around £1m to accommodate 5,000 pallets of cold medicines across the UK.

‘Shortage protocols’: How will they help pharmacists cope with supply issues?

The Pharmaceutical Journal, Carolyn Wickware, 28 February 2019

The Pharmaceutical Journal reports that legislation which came into force in February 2019, allowing pharmacists to substitute a different medicine to the one prescribed in the event of a serious shortage, should help mitigate the impact of shortages on patients.

The legislation came into force on 9 February 2019 but, as the first protocol has yet to be issued, the impact of the legislation changes on pharmacists, GPs and patients remains to be seen.

However, the government has written into the new legislation that the protocol provision be reviewed one year after the first protocol is introduced and will look at “any adverse consequences for either the market in prescription-only medicines or patient safety”.

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

Preparations underway to minimise medicine supply disruption, assures government

Pharmacy Business, Lakshmi PS, 28 February 2019

The Department of Health and Social Care on Monday announced that the government will ensure continued supply of medical products if there is a no-deal Brexit.

The government has already created a logistic hub in Belgium to stockpile vital medical supplies, the Guardian reported.

According to this report, the Department of Transport will pay £88.8 million to two companies, Brittany Ferries and Denmark-based DFDS to transport products from the hub for the next six months. Drugs and other medical supplies will be shipped through seven new ferry routes.

“My Department has been working closely with trade bodies, product suppliers, the health and care system in England, the Devolved Administrations (DAs) and the Crown Dependencies, to ensure the continuation of the supply of medicines and medical products to the whole of the UK in the event of a no deal EU Exit,” Health Minister Stephen Hammond said in a statement to the Commons.

“This includes the NHS, social care and the independent sector and covers medicines (prescription, pharmacy and general sales list medicines); medicinal devices and clinical consumables (such as needles and syringes); supplies for clinical trials; vaccines and countermeasures; and blood, tissue and transplant materials.”

Around three-quarters of the medicines and over half of the consumables to the UK come from or via the EU. Reduced traffic flow between the ports of Calais and Dover or Folkestone is a major risk.

The Health Department, together with industry and the health care system, has already analysed 12,300 medicines, close to half a million product lines of devices and clinical consumables, vaccines and other essential non-clinical goods such as linen, scrubs and food.

“While we never give guarantees, we are confident that, if everyone – including suppliers, freight companies, international partners and the health and care system – does what they need to, the supply of medicines and medical products should be uninterrupted in the event of exiting the EU without a deal,” the minister said.

The government emphasised that the unnecessary local stockpiling may cause shortages in other areas and requested patient to order their repeat prescriptions as normal.

UK Government to spend £11m preventing medicine shortages in preparation for no-deal Brexit

Hospital Healthcare Europe, Valeria Fiore, 28 February 2019

The Department of Health and Social Care (DHSC) will spend around £11m on warehouse contracts to store medicines as a contingency measure for a no-deal Brexit, Hospital Healthcare Europe understands.

In October last year, Health and Social Care Secretary Matt Hancock told the Health and Social Care Committee that the Government had issued an invitation to tender for additional storage space to stockpile medicines.

The measure was implemented to ensure access to medicines in the event of a no-deal Brexit.

The DHSC told our sister publication Healthcare Leader that it “expects to spend around £11m on warehouse contracts to store medicines in preparation for a no-deal Brexit”.

In October, Mr Hancock said he was expecting the value of the contracts to be “in the low tens of millions of pounds”.

He was, however, unable to share a more precise figure and said the Government was buying the space ‘from the market’ and would in some cases have to build new facilities.

Last month, Health minister Stephen Hammond said the Government had signed a contract worth around £1m to accommodate 5,000 pallets of cold medicines across the UK.

Questioned in Parliament last week, Mr Hancock was asked how much the DHSC has already spent on preparing for a no-deal Brexit ‘after activating NHS no-deal contingency plans’. He was also asked “what the overall bill for this will be”.

Diverging from what the DHSC told Healthcare Leader, Mr Hancock specified in Parliament that “around £11m has been spent already”, whereas the DHSC said it is money the department is expecting to spend.

The DHSC was unable to clarify the difference between the two statements at this point.

Mr Hancock said last week: “The NHS is not generally buying the extra medicines that are going into the elongated stockpiles but the pharmaceutical industry is because of course we’ll eventually buy most of those medicines for the NHS.

“So there have been costs in the pharmaceutical industry as well but the cost so far to the taxpayers is £11m and I expect it to remain around that level if not a little higher.”

Last year, Mr Hancock asked pharmaceutical companies to stockpile six weeks’ worth of medicines to prepare for the eventuality of a no-deal Brexit.

The UK is expected to leave the European Union on 29 March and at a press conference in Sharm-el-Sheikh yesterday (25 February) Prime Minister Theresa May said everybody should be focused on leaving with a deal by the set date. Her comments follows calls from MPs to delay Brexit day.

‘Shortage protocols’: How will they help pharmacists cope with supply issues?

The Pharmaceutical Journal, Carolyn Wickware, 28 February 2019

Legislation came into force in February 2019 which allows pharmacists to substitute a different medicine to the one prescribed in the event of a serious shortage.

The number of medicines in short supply has been a persistent thorn in the side of the pharmacy profession for many years. This peaked in November 2017 when the list of medicines in short supply compiled by the Pharmaceutical Services Negotiating Committee (PSNC) grew to include 91 different drugs.

In that same month, 3,000 pharmacies requested concessionary prices from the PSNC— a marked increase from less than 150 pharmacies per month before May 2017. The PSNC told the government in July 2018 that when these supply issues were at their worst, one in ten drugs dispensed by pharmacies were affected.

In an effort to mitigate the impact of shortages on patients, the government launched an “informal consultation” on proposals to amend the Human Medicines Regulations 2019 on 5 December 2018. The proposals would enable the government to issue “serious shortage protocols” (SSPs) allowing pharmacists to switch a patient to a different medication, if the one prescribed is in short supply, without having to refer the patient back to the prescriber.

The amendment passed through the consultation phase and came into force on 9 February 2019.

What will the protocols allow a pharmacist to do?

According to the Department of Health and Social Care (DHSC), if an SSP is issued, pharmacists will be asked to respond to a medicines shortage in one of four ways: dispensing a reduced quantity, a therapeutic equivalent, a generic equivalent or an alternative dosage form of the drug.

Each protocol would set out precisely what action pharmacists can take, under what circumstances and for which patients. Each protocol is also expected to be time limited.

In its response to the consultation on the proposed use of these protocols, the DHSC said those enabling pharmacists to prescribe “either an alternative quantity, strength or pharmaceutical form are likely to be more common than protocols for a therapeutic or generic equivalent”. These, it said, would only be used in “very exceptional circumstances”.

When following the protocol, the pharmacist will be able to make the designated substitution without having to consult with the patient’s prescriber.

When will these protocols be issued?

The DHSC has said it will issue protocols to manage supply issues “in case of a serious shortage, if it would help manage the supply situation”. It has not given any kind of threshold for when one might be issued but said a protocol “would be developed with input from clinicians” and “after discussion with the manufacturer”.

However, the DHSC has specified that not all drugs will be eligible for certain types of protocols. For example, it has said that therapeutic or generic switching will not be suggested for treatments for epilepsy or those “requiring biosimilar products where the medicines that are prescribed need to be prescribed by brand for clinical reasons”.

“In these cases, patients would always be referred to the prescriber for any decision about their treatment before any therapeutic or generic alternative is supplied,” the government has said.

The ability to issue protocols is just one part of a larger move to temper price increases from pharmaceutical manufacturers. In 2017, the DHSC was given special powers enabling it to instruct manufacturers to reduce the price of a generic medicine or introduce other controls on their branded products in cases where it thinks drug companies are charging “unreasonable” prices for generics.

Are these protocols being rushed through because of Brexit?

Not exactly. In answer to the responses from pharmacy bodies, the government clarified: “Whilst this proposal was prompted by the EU exit work it was not linked to a no deal EU exit.”

It added: “Regardless of whether a shortage of a medicine is caused by a no deal EU exit or something else, an SSP can be a useful tool for managing any shortage and mitigating any impact on patients.”

However, the consultation and subsequent legislative change has been extraordinarily quick, with an implementation date a month before the UK is due to leave the EU. With many predicting chronic medicines shortages in the event of a no-deal Brexit, its speed and timing is unlikely to be a coincidence.

Mark Koziol, chair of the Pharmacists’ Defence Association (PDA), said that while the Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board “made slow and incomplete progress on decriminalising inadvertent dispensing errors … this proposal expects a rushed discussion and implementation at an infinitely faster pace to make a significant change because of Brexit deadlines”.

What have the professional bodies said?

These types of drug switching protocols have been called for in the past by the PSNC and the Royal Pharmaceutical Society (RPS) so the amendment was welcomed by the professional bodies. In their respective responses to the government consultation, both bodies said they were generally “supportive” of the legislative changes and “welcomed” the use of SSPs.

Sibby Buckle, vice chair of the RPS English Pharmacy Board, had already called for therapeutic substitution powers to come into effect before the UK leaves the EU. The PSNC said on 28 November 2018 that pharmacists should be able to automatically substitute an alternative medicine if they cannot dispense the prescribed item, in an effort to help deal with possible drugs shortages after Brexit.

The PDA, however, warned that the ability to issue protocols would “open the door” to governmental interference in medicines supply and “pose a risk to patient safety”.

It added in its consultation response that the government “must ensure that safeguards are in place to prevent inappropriate use of SSPs for factors unrelated to EU withdrawal”.

What do doctors think?

The British Medical Association (BMA) has not published its full response to the government’s proposals, instead releasing a statement criticising the move towards dispensing therapeutic equivalents without consulting a GP.

The statement said the BMA leaders “do not agree” with dispensing a therapeutic equivalent “as a blanket approach”.

“Patients have idiosyncratic responses to drugs within the same class, and the pharmacist will not know what has already been used,” it explained. “This would, effectively, be a new prescription.”

Instead, the BMA said it would “accept a pharmacist amending the prescription only after discussion with the prescriber, including information about medicines availability”.

Andrew Green, GP committee clinical and prescribing lead at the BMA, said that while the legislation “is intended to minimise disruption to patients, GPs and pharmacists in the event of a serious shortage”, the BMA “[does] not believe that it is appropriate for pharmacists to change patients from one drug to a different one without authorisation from an independent prescriber”.

What happens next?

The legislation came into force on 9 February 2019 but, as the first protocol has yet to be issued, the impact of the legislation changes on pharmacists, GPs and patients remains to be seen.

However, the government has written into the new legislation that the SSP provision be reviewed one year after the first protocol is introduced and will look at “any adverse consequences for either the market in prescription-only medicines or patient safety”.

There is also the threat of a legal challenge. The Good Law Project has said it will start judicial review proceedings if the DHSC fails to remove the amendments in legislation by 25 February 2019, claiming that the government’s initial consultation — which lasted one week from 5–12 December 2018 — was “insufficient and unlawful”.

Media And Political Bulletin – 01 March 2019

From Factory to Pharmacy

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