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Media And Political Bulletin – 22 February 2019

Media and Political Bulletin

22 February 2019

Media Summary

10,000 pharmacies expected to be FMD compliant by end of month

Chemist+Druggist, Thomas Cox, 22 February 2019

Chemist+Druggist reports that according to Martin Sawer, all major wholesalers are already compliant with the Falsified Medicines Directive, and around 10,000 pharmacies will be by the end of February, with another 1,400 pharmacies in the process of registering.

The data shows that all wholesalers and approximately half of hospital pharmacies have registered with SecurMed, Mr Sawer explained. GP surgeries were delayed in registering, as they were agreeing a way of including the FMD model in their NHS systems, he added. But Mr Sawer expects “they’ll be ramped up pretty quick”, while registrations of dispensing doctors are “climbing”, he said.

Brexit could disrupt medicine supplies for six months – minister

Pharmaphorum, Richard Staines, 21 February 2019

A government minister has warned that a no-deal Brexit could disrupt medicines supplies to the UK for at least six months because of delays as they are shipped across the channel, instead of the previously estimated six weeks.

This stemmed from a letter from MP Stephen Hammond, sent this month, written in response to questions from the House of Lords EU Home Affairs Sub-Committee about access to medical supplies if no deal is reached by 29th March. Delays could affect “critical” prescription-only and pharmacy drugs, and UK manufacturers, Hammond warned in the letter.

 

Parliamentary Coverage

House of Commons Questions – 21 February 2019

Julie Elliott (Sunderland Central):

  • To ask the Secretary of State for Health and Social Care, what definition will be used by the Government to determine a serious shortage of a medicine that will be used to trigger a Serious Shortage Protocol for a medicine under the Human Medicines (Amendment) Regulations 2019.
  • To ask the Secretary of State for Health and Social Care, what data source will be used to monitor stocks and availability of medicines in order to determine the need for a Serious Shortage Protocol under the Human Medicines (Amendment) Regulations 2019.
  • To ask the Secretary of State for Health and Social Care, with reference to the Human Medicines (Amendment) Regulations 2019, what process will be followed to consult with relevant health care professionals in the development of advice contained in a Serious Shortage Protocol.
  • To ask the Secretary of State for Health and Social Care, with reference to the Human Medicines (Amendment) Regulations 2019, what methods the Government plans to use to whether a Serious Shortage Protocol is necessary; what information such a decision would be based on; what level of consultation with medical experts the Government plans to seek on such protocols; and how the Government plans to engage in such consultation.

Steve Brine: The Department has well established processes to manage and mitigate the small number of medicine supply problems that may arise at any one time due to manufacturing or distribution issues and this has always been the case. The Department receives regular reports from the pharmaceutical industry about issues which may potentially interrupt the supply of medicines that may affect United Kingdom patients.

From January this year, it became a mandatory requirement that pharmaceutical companies must report this information to us in a timely manner.

A Serious Shortage Protocol (SSP) is an additional tool to manage and mitigate medicine shortages. It would only be used in the exceptional and rare situation when other measures have been exhausted or are likely to be ineffective.

In the case of a serious shortage, a SSP would only be issued by Ministers if clinicians advised that it was appropriate and after discussion with the manufacturer and/or marketing authorisation holder.

 

Full Coverage

10,000 pharmacies expected to be FMD compliant by end of month

Chemist+Druggist, Thomas Cox, 22 February 2019

All major wholesalers are already compliant with the Falsified Medicines Directive, and around 10,000 pharmacies will be by the end of February, according to the wholesaler body.

The EU’s anti-counterfeit legislation, the Falsified Medicines Directive (FMD) – which came into force on February 9 – requires all pharmacies to be able to scan barcodes on medicines packaging at the point of dispensing.

To meet the directive, pharmacies have to register with SecurMed, the non-profit organisation managing the UK’s medicine verification systems.

The number of community pharmacies registered climbed less than 6,300 on February 12 to 8,600 by Tuesday (February 19), according to the SecurMed website.

Martin Sawer, Executive Director of wholesaler body the Healthcare Distribution Association (HDA), claimed there are another 1,400 pharmacies in the process of registering. He predicts “about 10,000 locations in community pharmacy will probably be registered by the end of the month”.

SecurMed approval means the organisation has successfully tested a pharmacy’s link to the UK hub, Mr Sawer told C+D after his presentation at the Sigma conference in Muscat, Oman, on Monday (February 18).

The data shows that all wholesalers and approximately half of hospital pharmacies have registered with SecurMed, Mr Sawer explained.

GP surgeries were delayed in registering, as they were agreeing a way of including the FMD model in their NHS systems, he added.

But Mr Sawer expects “they’ll be ramped up pretty quick”, while registrations of dispensing doctors are “climbing”, he said.

“Community pharmacy is doing a good job,” he added.

Brexit could disrupt medicine supplies for six months – minister

Pharmaphorum, Richard Staines, 21 February 2019

A no-deal Brexit could disrupt medicines supplies to the UK for at least six months because of delays as they are shipped across the channel, instead of the previously estimated six weeks, a government minister has warned.

The website Hospital Pharmacy Europe reported that manufacturers may have to rethink logistics arrangements to avoid the delays when medicines are shipped via crossings at Dover and Folkestone.

It cited a letter from MP Stephen Hammond, sent this month, written in response to questions from the House of Lords EU Home Affairs Sub-Committee about access to medical supplies if no deal is reached by 29th March.

Delays could affect “critical” prescription-only and pharmacy drugs, and UK manufacturers, Hammond warned in the letter.

Flying medicines in by air freight is one option under consideration to avoid delays maintain the supply, but Hammond gave no further information about which medicines would be prioritised.

In the letter he said the Department of Health and Social Care is exploring this option, but said arrangements with air freight companies are commercially confidential.

The warning emerged as the UK government rushes emergency legislation through Parliament to ensure medicines regulation continues in the increasingly likely event of a no-deal Brexit.

The UK’s Medicines and Healthcare Products Regulatory Agency has already drawn up plans for a new system if the UK does not agree a way for it to work with European regulator after Brexit.

It’s hoped that a deal would allow for a transition period lasting until at least the end of next year that would give the UK time to agree details of new regulatory arrangements with European colleagues.

UK pharma is also concerned that the UK could drop out of a Europe-wide initiative to crack down on fake medicines as a result of Brexit.

Arrangements under the falsified medicines directive (FMD) came into effect this month allowing medicines to be traced along the supply chain using a special barcode.

But it is not clear whether the system will be in place in April as Brexit would require the UK to leave the system.

Dr Rick Greville, director of supply chain at the Association of the British Pharmaceutical Industry (ABPI), said: “Billions of packs of medicines travel around the EU annually, destined for over 500 million patients. This new system means that patients across Europe will have the best protection from fake medicines in the world.

“It would be an absolute travesty if NHS patients aren’t part of a system specifically designed to protect them. But that’s exactly what could happen in a ‘no deal’ Brexit. It is just another reason why we urgently need a Brexit deal.”

Media And Political Bulletin – 22 February 2019

From Factory to Pharmacy

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