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Media And Political Bulletin -15 January 2019

Media and Political Bulletin

14 January 2019

Media Summary

Should pharmacies trade medicines between themselves?

Chemist and Druggist, Thomas Cox, 11 January 2019

 

Chemist and Druggist includes a comment from Martin Sawer, Executive Director of the HDA, about his views on PSNC’s suggestion that regulations should be relaxed to allow pharmacists to trade medicines after Brexit.

 

Martin Sawer said that the HDA would support the idea of pharmacies being able to trade between themselves, should medicines supply be impacted post-Brexit.

 

“Pharmacy-to-pharmacy trading is a good contingency [plan]. It means borrowing stock and paying it back – you return the same medicine when you get some more,” he 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.”

 

Parliamentary Coverage

House of Commons, Tabled and Written Questions, 11 January 2019

 

Wayne David, MP: To ask the Secretary of State for Health and Social Care, what consultation his Department has undertaken on proposals for the introduction of Serious Shortage Protocols for medicines.

 

Wayne David, MP: To ask the Secretary of State for Health and Social Care, what the timeframe is for the introduction of Serious Shortage Protocols for medicine.

 

Wayne David, MP: To ask the Secretary of State for Health and Social Care, what safeguards his Department has put in place to ensure that medical Serious Shortage Protocols do not pose risk to the well-being of patients.

 

Answered by Steve Brine: The Department engaged with a wide range of stakeholder representative bodies about the proposals and also conducted a written consultation. The Department received 47 responses to its written consultation including from industry, patients’, pharmacists’ and doctors’ representative bodies. The responses to the consultation were broadly supportive.

 

The Statutory Instrument is expected to be laid shortly and come into force before 29 March. Any serious shortage protocol would be developed with and signed off by clinicians. Only if clinicians deem it appropriate, an alternative quantity, strength, pharmaceutical form or medicine can be dispensed in line with the protocol.

 

A protocol is only one of the tools that can be used to manage shortages. The Department manages shortages in collaboration with manufacturers and suppliers, the National Health Service and the Medicines and Healthcare products Regulatory Agency and will continue to do so. A protocol would only be introduced in case of a serious shortage, if it would help manage the supply situation and if clinicians think it is appropriate, taking account of the risks to and well-being of patients and after discussion with the manufacturer and/or marketing authorisation holder.

Any serious shortage would be time limited and the protocol itself would indicate the period during which it has effect.

Full Coverage

Should pharmacies trade medicines between themselves?

Chemist and Druggist, Thomas Cox, 11 January 2019

 

As PSNC suggests regulations should be relaxed to allow pharmacies to trade medicines after Brexit, C+D asks three contractors – and the wholesaler body – for their views

 

With just 77 days until the UK’s exit from the European Union, and Prime Minister Theresa May yet to secure parliament backing for her Brexit deal, the Department of Health and Social Care (DH) has ramped up its contingency planning.

 

As part of a raft of proposals suggested by the Pharmaceutical Services Negotiating Committee (PSNC) last month to ensure continuity of medicines supply post-Brexit – whether a deal is secured or not – it has called for the DH to “relax the restrictions on pharmacy-to-pharmacy wholesale dealing without wholesaler dealer licenses”, to allow pharmacies “to trade stock between them at a local level”.

 

This would “allow medicines to reach those patients who most need them, without regulatory barriers”, PSNC says.

 

Pharmacists were able to trade medicines under certain circumstances without a wholesaler licence until 2012, when the Medicines and Healthcare products Regulatory Agency revoked the legislation.

 

So, would pharmacies welcome the opportunity to swap stock between them once again? C+D asks three contractors and the head of the wholesaler’s body – the Healthcare Distribution Association (HDA) – for their thoughts.

 

“We don’t need any more pressure at this time”

Michael Lennox, chief officer of Somerset local pharmaceutical committee, tells C+D that he “would welcome the opportunity for the regulations to allow us to better support patients”.

 

“If Brexit were to have an impact, then I think we would need to change the framework,” he says. “We don’t need any more pressure at the minute.”

 

“Things will get worse”

Alan Kurtz, owner of Fishers Pharmacy in south London, says: “I don’t see any reason why we shouldn’t be able to help one another in order to be able to help patients.”

 

Mr Kurtz explains that his pharmacy has been struggling with medicines shortages for “years”, which has been “very difficult”, and he has “no doubt things will get worse”.

 

“It worked well before”

Indira Panchal, owner of four pharmacies in Bedford, says while it is a “good time” for pharmacies to be able to trade medicines to help ease shortages, it is “short-sighted” that the change is only under consideration now.

 

Ms Panchal says owners of a single pharmacy would particularly benefit from PSNC’s proposal, as they are unlikely to have their own wholesaler’s license.

 

Wholesalers: “Good contingency planning”

 

HDA executive director Martin Sawer tells C+D that his organisation – which represents wholesalers – would also support the idea of pharmacies being able to trade between themselves, should medicines supply be impacted post-Brexit.

 

“Pharmacy-to-pharmacy trading is a good contingency [plan]. It means borrowing stock and paying it back – you return the same medicine when you get some more,” Mr Sawer explains.

 

“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.”

 

Serious shortage protocol

 

While PSNC continues to discuss the impact of Brexit with the DH via its Brexit forum, the DH expects to lay legislative changes for its “serious shortages protocol” before parliament this month.

 

The DH is seeking to amend the Human Medicines Regulations 2012 to enable pharmacists to dispense an alternative in accordance with the protocol, rather than the prescription, and without having to contact a GP, in the event of a serious medicines shortage.

 

The DH insists the regulations “will come into force before March, regardless of the situation with Brexit”, and told C+D it is still reviewing responses to its consultation.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Media and Political Bulletin

15 January 2019

Media Summary

Pharmacy minister committed to reforming category M pricing

Chemist and Druggist, Thomas Cox, 14 January 2019

Chemist and Druggist reports that Pharmacy Minister, Steve Brine, has revealed that the government is committed to pursuing a number of reimbursement reforms in community pharmacy, including changes to category M.

Mr Brine said that the reimbursement reforms include “changes to category M for certain generic medicines to better reflect their market price”, and “changes to the way category A prices are set”.

The government is “taking steps to improve the prescription ordering journey to maximise patient choice and convenience”, he said.

Pharmacists at risk of prosecution under DH’s shortages solution

Chemist and Druggist, Vincent Forrester, 14 January 2018

Chemist and Druggist also reports on the fact that amending regulations to allow pharmacists to dispense an alternative in cases of medicines shortages could result in pharmacists breaking the law, according to sector bodies.

The proposed amendments to the Human Medicines Regulations 2012, which the Department of Health and Social Care said will go before parliament “towards the end of the month”, would allow pharmacists to dispense an alternative in accordance with a “serious shortage protocol”, rather than the prescription, without contacting the GP, in the event of a national medicines shortage.

In their responses to the consultation, the PDA, the PSNC and the AIMP separately expressed concerns that the amendments do not protect pharmacists from breaching section 64 of the Medicines Act 1968, which prevents the sale of “any medicinal product which is not of the nature or quality demanded by the purchaser”.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

Pharmacy minister committed to reforming category M pricing

Chemist and Druggist, Thomas Cox, 14 January 2019

The government is committed to pursuing a number of reimbursement reforms in community pharmacy, including changes to category M, Steve Brine has said.

In its long-term plan, published last week (January 7), NHS England said it aims to “explore further efficiencies” in community pharmacy, by reforming the sector’s “reimbursement and wider supply arrangements”.

Pharmacy minister Mr Brine has since revealed that the reimbursement reforms include “changes to category M for certain generic medicines to better reflect their market price”, and “changes to the way category A prices are set”.

Responding to a written question from Labour MP for Darlington Jenny Chapman last week (January 10), Mr Brine referred to “a number of reimbursement reforms”, which were originally outlined in the 2016-17 pharmacy funding contract for England (see below).

Mr Brine also said the DH has “recently committed to reforming reimbursement for specials”.

The government is “taking steps to improve the prescription ordering journey to maximise patient choice and convenience”, he said

The DH continues to engage with Theresa May’s cabinet on the role of community pharmacy and “the important contribution of pharmacy teams as outlined in the NHS long-term plan”, Mr Brine added.

PSNC welcomes commitment to reforms

The Pharmaceutical Services Negotiating Committee (PSNC) director of pharmacy funding Mike Dent said his organisation “welcomes the minister’s confirmation that the government remains committed to these reimbursement reforms, some of which we agreed to review as part of a previous funding settlement”.

“We are keen to begin funding negotiations for 2019-20 as soon as possible,” he added.

Pharmacies in England will not receive any funding increase for 2018-19. Mr Brine also said last week that the DH “will be seeking to renegotiate the community pharmacy contractual framework” and is “committed to working closely with PSNC to better utilise the reach and skill set of pharmacy teams”.

Last week, sector bodies, including the Company Chemists’ Association and the National Pharmacy Association, said community pharmacy needs to be fairly remunerated in order to meet the priorities of the long-term plan.

Pharmacists at risk of prosecution under DH’s shortages solution

Chemist and Druggist, Vincent Forrester, 14 January 2018

Amending regulations to allow pharmacists to dispense an alternative in cases of medicines shortages could result in pharmacists breaking the law, sector bodies have said.

The proposed amendments to the Human Medicines Regulations 2012, which the Department of Health and Social Care (DH) said will go before parliament “towards the end of the month”, would allow pharmacists to dispense an alternative in accordance with a “serious shortage protocol”, rather than the prescription, without contacting the GP, in the event of a national medicines shortage.

The DH stressed last month (December 7) that the amendments “will come into force before March, regardless of the situation with Brexit”, but the proposals have been “prompted by the preparations for the UK’s exit from the EU”, it said in its consultation letter.

In their responses to the consultation, the Pharmacists’ Defence Association (PDA), the Pharmaceutical Services Negotiating Committee (PSNC) and the Association of Independent Multiple Pharmacies (AIMp) separately expressed concerns that the amendments do not protect pharmacists from breaching section 64 of the Medicines Act 1968, which prevents the sale of “any medicinal product which is not of the nature or quality demanded by the purchaser”.

Not covered by dispensing error defence

David Reissner, consultant at law firm Charles Russell Speechlys LLP and a director of AIMp, said the DH’s rush to implement the amendments ahead of Brexit means the proposed “new powers don’t address every potential pitfall for pharmacists, pharmacy staff and pharmacy owners”.

If a patient was harmed as a result of an alternative being supplied under the DH’s instructions, pharmacy staff would not be able to use the defence from criminal prosecution for an inadvertent dispensing error, which came into force last year, he explained.

“As a result, some pharmacists may be hesitant about providing an alternative, even though permitted to do so,” Mr Reissner told C+D.

“A pharmacy owner who provides an alternative medicine under a serious shortage protocol will also be in breach of the NHS terms of service in England,” he added. “So the DH will be reliant on NHS England taking a common-sense view about the breach.”

In its response to the government’s “informal consultation” on the proposed changes, AIMp highlighted the case of Martin White, a pharmacist in Northern Ireland who was prosecuted in 2016 under section 64 and given a suspended prison sentence for accidentally dispensing propranolol instead of prednisolone in the hours before a patient’s death in 2014.

AIMp stressed that the DH should ask the Crown Prosecution Service not to press charges in cases “where a pharmacist has genuinely purported to exercise his or her professional skill and judgement when seeking to act in accordance with [the DH’s instructions]”.

In addition, the Company Chemists’ Association (CCA) – which represents the UK’s largest multiples – said in its response that pharmacists should not be sanctioned if acting in accordance with the DH’s shortages protocols breaches the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 – a point reiterated by AIMp.

Queries and clarifications

Pharmacy bodies also drew attention to other issues with the proposed legislative changes.

Gareth Jones, head of corporate affairs at the National Pharmacy Association, said allowing pharmacies to substitute medicines was “a good start”, but insufficient to deal with shortages.

“Pharmacies should be able to share medicines with each other if one or more pharmacies runs short of a particular line,” he said.

In addition, the PDA claimed that the changes could sanction the supply of medicines to patients in “non-pharmacy locations”, thus risking their safety.

PSNC, the CCA and the Royal Pharmaceutical Society argued that the legislation should be amended to allow pharmacists to dispense medicines of alternative strengths, not merely “a different quantity or dosage form”.

PSNC and the CCA also agreed that pharmacists should be given the power explicitly to substitute between branded medicines.

The DH responds

Responding to a question on the legislative amendments in parliament last week (January 11), pharmacy minister Steve Brine said the DH had received 47 written responses to its consultation, which were “broadly supportive” of the proposals.

The DH told C+D it was unable to comment on specific concerns, because the responses to its consultation are still being considered.

“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,” it said.

“We are currently reviewing the responses to the consultation and no decision has yet been made. Any protocol would be developed and signed off by highly specialised clinicians to ensure the system is robust and safe.”

Media And Political Bulletin -15 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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