medicines - Neighbourhood Retailer

CBI comments on proposals for medicines coming into NI

Linda Stewart — Fri, 17 Dec 2021 16:42:03 +0000

The CBI has commented on an EU commitment that medicines entering Northern Ireland from Great Britain will not need additional labelling or testing.

Medicines will continue to be available in Northern Ireland at the same time as in the rest of the UK, the European Union (EU) has said.

The protocol means Northern Ireland is still inside the EU’s pharmaceutical regulatory system, but it gets most of its medicines from Great Britain, which is not.

The EU says its new proposals mean medicines entering NI from GB will not need additional labelling or testing.

Sean McGuire, CBI Europe Director, said: “The CBI and wider industry have been calling for greater certainty on the movement of medicines between GB and NI – today’s announcement from the EU looks like a welcome step in that direction.

“Industry will now examine the detail on this complex and sensitive issue.

“Businesses urge both sides to work together and agree lasting, durable solutions to unlock the remaining issues with the Protocol.”

European Commission Vice-President Maroš Šefčovič said a commitment to ensure the supply of medicines into Northern Ireland was being turned into “a lasting solution”.

He said the protocol “has the flexibility to work on the ground”.

For generic drugs like paracetamol, the UK regulator can continue to approve drugs for NI and companies in GB can continue to use the the same pack and leaflet for all parts of the UK, with no need for NI-specific packaging.

All regulatory functions, like batch testing, will remain wherever they are now in the UK – with no need to relocate any testing facilities from GB to NI.

For new medicines, like cancer drugs, any product authorised in the UK can be supplied to NI, until the relevant authorisation is also given in the EU.

The EU says this “bridging solution” is in addition to the existing compassionate and emergency use early access mechanisms under EU law.

For all types of medicines, no manufacturing authorisation or import licence will be required for bringing medicines into NI from the rest of the UK.

In addition, EU medicine unique identifiers won’t have to be removed from products transiting through GB to NI and the reaffixed when entering NI.

However this derogation is only for three years, which the EU says will allow more time for industry to adapt.

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Brexit talks on NI medicine supplies expected to continue into the new year

Linda Stewart — Fri, 17 Dec 2021 11:18:05 +0000

UK sources says there has been no breakthrough on EU-UK talks to reach agreement on medicine supply for Northern Ireland, with negotiations now expected to continue into the new year.

The recent talks between the UK and EU focused on how to guarantee the supply of medicines from GB to Northern Ireland, with issues surrounding the effects of the Northern Ireland Protocol, a part of the Brexit deal which means Northern Ireland remains covered by the EU’s pharmaceutical regulations.

The Northern Ireland Protocol was agreed by the UK and EU in 2019 as a way to avoid a hardening of the Irish land border.

Goods can flow freely between the Republic of Ireland and Northern Ireland, but goods arriving from the rest of the UK are subject to controls to ensure they comply with EU standards.

As Northern Ireland receives most of its medicines from suppliers in Great Britain, pharmacies could face difficulties in supply when a grace period on the changes ends in January.

Ireland’s Foreign Affairs Minister has said Brussels is “anxious” to move ahead unilaterally by changing its laws if the UK does not agree an approach.

Meanwhile, goods exported from Ireland to Great Britain will be temporarily exempted from new border controls on EU-GB trade, which take effect on 1 January.

The government said the move was a “pragmatic act of goodwill” which can help maintain space for continued negotiations on the NI Protocol.

Lord Frost said those negotiations would not be definitively completed by 1 January.

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Community pharmacists to cease providing medicines in compliance aids

Linda Stewart — Mon, 22 Nov 2021 15:34:23 +0000

Community pharmacists in Northern Ireland have voted overwhelmingly to cease providing medicines in compliance aids such as medicines trays for new patients from 1^st December 2021, citing persistent and widespread workforce pressures.

At a meeting of community pharmacist contractors last week, 97% voted to close the medicine adherence service to new patients from the start of next month.

Faced with mounting pressures and without the appropriate investment, community pharmacists have serious concerns about their ability to continue providing this non-commissioned service, that is delivered largely on a goodwill basis, Community Pharmacy NI said.

The service involves community pharmacists supporting patients in the community to manage their medicines, and involves an in-depth pharmacist consultation, continuous monitoring, medicines provision in a specialised container, and regular and ongoing collaboration between a patient, their family and the pharmacist.

Community pharmacists have continually warned that due to sustained workforce pressures and increasing staffing shortages, they would reach a point at which they could no longer accept new patients if they were to ensure the safe delivery of commissioned core services, including the dispensing of medicines and Covid-19 vaccination and Booster services.

Increasing pressures

Chief Executive of Community Pharmacy NI, Gerard Greene said: “Due to increasing pressures, community pharmacists must prioritise core services and the contractor vote to cease providing new patients requiring non-commissioned compliance aid services was not taken lightly.

“We are now in a position which no community pharmacist wants to be in, but continuing to accept new patients whilst managing an already demanding workload, coupled with severe workforce shortages would put both patient safety and commissioned pharmacy services at risk.

“Community pharmacists are an essential part of the delivery of the adherence service, using their clinical skills at a community level to support patients in managing their medicines safely. They want to continue to support their patients but only via a service commissioned and appropriately funded by the Health and Social Care Board.”

Community Pharmacist Peter Rice said: “As essential primary healthcare providers, it deeply concerns me that we have arrived at this point, but my staff are stretched extremely thinly, and we cannot continue to take-in new patients for the service without the appropriate resources in support.

“As part of this service, we have been assisting patients, often those who are elderly, to safely manage their medicines at home and in the community, reducing the need for patients to be transferred to other settings such as hospitals. It is worrying that by not commissioning this service, there could be additional and avoidable hospital pressures.

“We are continually approached by new patients and their families who want to avail of the medicines adherence service, and as healthcare providers we want to help. Without the support from the Department to do this, we have to protect core services until a solution can be found.”

Caption: Chief Executive of Community Pharmacy NI, Gerard Greene

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