HDA UK Media And Political Bulletin – 11 January 2017

Jeremy Hunt slams subsidies for ‘clustered’ pharmacies

Chemist and Druggist, Annabelle Collins, 10 January 2017

Jeremy Hunt has claimed that “40% of pharmacies are clustered in groups of three or more”, asserting that the NHS should discontinue subsidizing pharmacies that are within such close proximity. Mr Hunt underscored: “Our reforms are designed to ensure that where there is only one local pharmacy that people can access, that pharmacy is protected”. Mr Hunt’s comments were issued at a parliamentary debate, during which Mr Hunt stressed the importance of community pharmacy making “efficient savings”, as with “all parts of the NHS”.

Global Firms ‘Could Follow European Medicines Agency out of UK’

Press Association, Josie Clarke, 10 January 2017

Concerns have been raised that international companies could follow the European Medicines Agency (EMA) out of the UK if it chooses to move away after the Brexit furore. The political difficulties for the European Commission to have one of its primary agencies outside the EU was highlighted by Sir Michael Rawlins, chairman of the UK’s Medicines and Healthcare Regulatory Agency (MHRA). Previously, Sir Michael has said the MHRA is “certainly not” prepared to take responsibility for many roles currently provided by the EMA.

Parliamentary Coverage

Scottish Parliament, Written Answers, 9 January 2017

Anas Sarwar (Glasgow, Scottish Labour,): To ask the Scottish Government what safeguards are in place to ensure that the security measures specified by the UK Government for the transportation of controlled drugs are adhered to by (a) NHS boards and (b) private and independent pharmacies. [S5W-05312]

Shona Robison: The Scottish Government issued guidance to NHS Scotland following the introduction of the Health Act 2006 by the UK Parliament and the governance arrangements for controlled drugs which the Act and subsequent relevant Regulations put in place:- www.sehd.scot.nhs.uk/mels/CEL2007_14.pdf www.sehd.scot.nhs.uk/mels/CEL2008_07.pdfThe legislation requires all healthcare organisations holding stocks of controlled drugs to appoint Accountable Officers responsible for the safe, appropriate and effective management and use of controlled drugs. In NHS Scotland, Controlled Drugs Accountable Officers (CDAOs) are responsible for ensuring the safe management and use of controlled drugs within their organisation. CDAOs should ensure that their own organisation, and those providing services to their organisation, have adequate and up-to-date Standard Operating Procedures (SOPs) in relation to controlled drugs. The CDAO Network publishes and updates guidance on good practice in the management of controlled drugs in primary care, including monitoring, auditing and reporting:- www.knowledge.scot.nhs.uk/media/CLT/ResourceUploads/4055959/Primary_Care_Guide_Scotland_v.2.0_171114.pdfIn addition, the General Pharmaceutical Council (GPhC), the pharmacy regulator in Great Britain, sets standards for all registered pharmacies which includes requirements for medicines to be stored securely and supplied safely to patients, and for each pharmacy to identify and manage risks associated with the service they provide. GPhC inspections cover the full range of services a pharmacy provides, including any medicine delivery services. The GPhC also shares intelligence and works collaboratively with various regulatory bodies and organisations across Great Britain, such as the Home Office, the Medicines and Healthcare Products Regulatory Agency (MHRA) and local Controlled Drug Accountable Officer Networks to help achieve collective patient safety and public protection aims.

Full Coverage

Global Firms ‘Could Follow European Medicines Agency out of UK’

Press Association, Josie Clarke, 10 January 2017

 

An expert has raised concerns that international companies could follow the European medicines regulator out of the UK if it chooses to move away after Brexit.

Professor Sir Michael Rawlins, chairman of the UK’s Medicines and Healthcare Regulatory Agency (MHRA), said he “assumes” the European Medicines Agency (EMA) will leave its base at London’s Canary Wharf, where it employs 800 people.

 

Speaking to the Lords Science and Technology Committee on the impact of Brexit on standards regulation. Sir Michael said: “It seems to me politically difficult for the European Commission to have one of its significant agencies outside the borders of the EU. I assume it will go.”

He said such a move would be “a great loss for a number of reasons”, adding: “One of the reasons why international companies have put their base in the UK is because of the closeness of the regulator.

 

“That’s a great worry. Will they move to wherever the regulator goes?”

Sir Michael has previously said the MHRA is “certainly not” prepared to take responsibility for many roles currently provided by the EMA.

 

Asked by the committee on Tuesday if the UK would wish to replicate the EMA if it moved, he said: “We would continue unless we could come to some arrangement but we would no longer do the detailed scientific assessments, for which we are paid for. They would go too.”

Asked if the UK would simply “rubber-stamp” decisions made elsewhere, he said: “There are complications with just rubber-stamping … you would emasculate the MHRA and the UK would not have a strong regulator.”

 

But he said it was unlikely that consumers would see any change to the work of the MHRA after Brexit.

 

“Our job at the MHRA is to ensure that devices and medicines are of good quality and safe. I would hope that whatever happens we would provide that service ongoing.”

At present, when a company wants EU market authorisation for a new drug it goes to the EMA, which decides whether to approve a drug.

Detailed scientific evaluations are conducted, about 40% by the MHRA, and it is paid a fee.

Sir Michael has previously said 85% of the MHRA’s expenditure comes from fees and the rest comes from the Department of Health, adding: “We would have to get public money or we wouldn’t be able to register new drugs.”

 

April 2016 NCSO/Price Concessions update

22 April 2016, PSNC

 

The Department of Health granted the following price concessions for April 2016:

The price concession only applies to the month that it is granted.

 

Drug Pack size Price concession
Bumetanide 1mg tablets 28 £2.05
Celiprolol 400mg tablets 28 £39.65
Cimetidine 400mg tablets 60 £19.99
Desmopressin 10micrograms/dose nasal spray (new) 60 dose £24.00
Flecainide 50mg tablets 60 £7.50
Flecainide 100mg tablets 60 £6.83
Fludrocortisone 100mcg tablets (new) 100 £96.00
Lamotrigine 5mg dispersible tablets sugar free 28 £7.50
Mefenamic acid 500mg tablets 28 £10.25
Nitrofurantoin 100mg tablets (new) 28 £12.50
Nitrofurantoin 50mg tablets (new) 28 £11.50
Pioglitazone 15mg tablets 28 £19.20
Pioglitazone 30mg tablets 28 £24.32

Please note that PSNC cannot provide details of generic products that are suspected of being affected by generic supply problems unless and until the Department of Health grants a concession. No additional endorsements are required for price concessions.

If you have problems obtaining a Part VIII product or problems obtaining the product at the set Drug Tariff price, please report the issue to PSNC using the online feedback form on the PSNC Website.

If you have been able to source the product, please provide full details of the supplier and price paid. PSNC will investigate the extent of the problem and if appropriate discuss the issue with the Department of Health.

Any further concessions will be posted here on the website.

 

NICE publishes CD guidance

25 April 2016, Dispensing Doctor, Alisa Colquhoun

 

NICE has published new guidance on the safe use and management of controlled drugs. The guidance incudes advice such as prescribing no more than 30 days’ worth of a CD.

 

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Parliamentary Coverage

 

There is no Parliamentary Coverage today.

 

Full Coverage

NICE publishes CD guidance

25 April 2016, Dispensing Doctor, Alisa Colquhoun

 

Guidance on the safe use and management of controlled drugs has been published by NICE.

The new guidance contains information on the following areas:

·         Developing and establishing systems and processes for organisations

·         Record keeping

·         Risk assessment

·         Processes for reporting controlled drug‑related incidents

·         Prescribing controlled drugs

·         Obtaining and supplying controlled drugs

·         Administering controlled drugs

·         Handling controlled drugs

·         Monitoring the use of controlled drugs

The guidance includes advice such as prescribe no more than 30 days’ worth of a CD. If a larger quantity is prescribed, the reasons for this should be documented in the person’s care record. A seven year review of medicines-related safety incidents concerning controlled drugs in England and Wales concludes that five commonly used controlled drugs were responsible for 113 incidents (88.4%) leading to serious harm (death and severe harm) with overdose accounting for 89 (69.5%) of the 128 incidents of serious harm.

A link to the NICE CD guidance has been placed in our library of controlled drugs resources.

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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