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Media And Political Bulletin – 17 April 2019

Media and Political Bulletin

17 April 2019

Media Summary

FMD blamed for labetalol shortage

Dispensing Doctors’ Association, Ailsa Colquhoun, 17 April 2019

Dispensing Doctors’ Association reports that the DHSC has confirmed that the Falsified Medicines Directive (FMD) is among the factors causing the current labetalol shortages.

In a supply update, the DHSC says supplier Mylan expects delays in resupply until early-mid May, as a result of delays in the serialisation of FMD packs. Another supplier Recipharm is reporting a problem with sourcing the active pharmaceutical ingredient and cannot provide a resupply date.

Prescribers are asked not to commence new patients on the antihypertensive labetalol during this time, and consider alternative treatments during  this time.

Some unlicensed stock is available for import, with lead times of between seven and 21 days.

Government will ‘review its position’ on no-deal Brexit drug stockpiles

The Pharmaceutical Journal, Kathy Oxtoby, 16 April 2019

The Pharmaceutical Journal reports that following the extension to Article 50, the government says it is “considering the impact on our EU exit preparations”. It has said it will “review its position” on drug stockpiles held in case of a no-deal Brexit after the UK agreed an extension to its date for leaving the EU.

Pharmaceutical companies said they wanted clarity on what will happen to no-deal Brexit medicine stockpiles that have been built up following the agreement that the UK may now not leave the EU until October 2019.

GPhC: Online pharmacies must check patient ID before supplying opiates

C+D, Helena Blackstone, 16 April 2019

C+D reports that in its updated guidance for distance-selling pharmacies, the General Pharmaceutical Council (GPhC) said that online pharmacies must “carry out an appropriate identity check” before supplying “certain categories of prescription-only medicines (POMs)”.

Unless safeguards are put in place, the GPhC stressed the following medicines should not be prescribed online: antibiotics; “medicines liable to abuse”, including pregabalin; “medicines that require ongoing monitoring”; and medicinal products, such as Botox.

“Not following this guidance, or not taking the appropriate steps to achieve a desired outcome under our standards, could mean that you fail to meet one or more of the standards for registered pharmacies. This could result in our taking enforcement action,” the GPhC warned.

This was also reported in Pharmacy Business.

 

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

FMD blamed for labetalol shortage

Dispensing Doctors’ Association, Ailsa Colquhoun, 17 April 2019

The Falsified Medicines Directive (FMD) is among the factors causing the current labetalol shortages, the Department of Health and Social Care has confirmed.

In a supply update, the DHSC says supplier Mylan expects delays in resupply until early-mid May, as a result of delays in the serialisation of FMD packs.

Another supplier Recipharm is reporting a problem with sourcing the active pharmaceutical ingredient and cannot provide a resupply date.

Prescribers are asked not to commence new patients on the antihypertensive labetalol during this time, and consider alternative treatments during  this time.

Some unlicensed stock is available for import, with lead times of between seven and 21 days.

  • Levomepromazine 25mg/ml injection is not expected to be back in stock until the end of April. Guidance to support patient management is available online.

Government will ‘review its position’ on no-deal Brexit drug stockpiles

The Pharmaceutical Journal, Kathy Oxtoby, 16 April 2019

Following the extension to Article 50, the government says it is “considering the impact on our EU exit preparations”.

The government has said it will “review its position” on drug stockpiles held in case of a no-deal Brexit after the UK agreed an extension to its date for leaving the EU.

Pharmaceutical companies said they wanted clarity on what will happen to no-deal Brexit medicine stockpiles that have been built up following the agreement that the UK may now not leave the EU until October 2019, more than six months after the original Brexit date of 29 March 2019.

Drugs manufacturers were asked to develop six-week stockpiles for a number of drugs to ensure a continuous supply in the event of a no-deal Brexit.

Following an EU leaders summit on 10 April 2019, an agreement has been put in place with the EU that could extend the Article 50 process so that the UK remains in the EU until 31 October 2019.

Mike Thompson, Chief Executive of the Association of the British Pharmaceutical Industry, said his members wanted to know what happens next.

“Companies are doing everything they can to protect the supply of medicines whatever the Brexit outcome. As part of this they have increased stocks of medicines in line with government guidance.

“With the extension of Article 50, we will work with government to consider how best to prepare and review whether current plans for a no-deal Brexit are still appropriate.”

Warwick Smith, director general of the British Generic Manufacturers Association, said: “We will work with the government and other stakeholders carefully to review the revised position. In the meantime, current guidance will remain in place.”

Meanwhile, Niall Dickson, Co-Chair of the Brexit Health Alliance — which represents the NHS Confederation, the Academy of Medical Royal Colleges, and many other healthcare bodies — said the end of the immediate threat of a no-deal Brexit was “a relief”.

“But of course the extension leaves that as one potential outcome, which means everyone involved in healthcare must continue to prepare for this possibility and keep contingency plans in place,” he said.

“We are now in a ‘phoney war’ and the risk is complacency — the system needs to assume we could crash out and do everything we can to make sure patients are protected if that happens.”

A spokesperson for the Department of Health and Social Care said: “Leaving the EU with a deal remains the government’s priority.

“We are considering the impact on our EU exit preparations and are working closely with our stakeholders to review our position.”

GPhC: Online pharmacies must check patient ID before supplying opiates

C+D, Helena Blackstone, 16 April 2019

Online pharmacies must verify the identity of a patient before supplying opiates or medicines for diabetes, epilepsy and asthma, the regulator has said.

Online pharmacies must “carry out an appropriate identity check” before supplying “certain categories of prescription-only medicines (POMs)” (see below), the General Pharmaceutical Council (GPhC) said in updated guidance for distance-selling pharmacies published today (April 16).

It gave the example of NHS Digital’s identity verification and authentication standard for digital health and care services, which it said “provides a consistent approach to identity checking across online digital health and care services”, to ensure patients only receive medicines that are “safe and clinically appropriate for them”.

Unless safeguards are put in place, the GPhC stressed the following medicines should not be prescribed online: antibiotics; “medicines liable to abuse”, including pregabalin; “medicines that require ongoing monitoring”; and medicinal products, such as Botox.

“These safeguards include making sure the prescriber proactively shares all relevant information about the prescription with their GP after seeking the patient’s consent,” it said.

Online pharmacies will also have to supply more details about where the online service and its healthcare professionals are based and how they are regulated. They must also ensure prescribers operating outside of the UK are working to the UK’s prescribing guidelines, the GPhC said.

“Not following this guidance, or not taking the appropriate steps to achieve a desired outcome under our standards, could mean that you fail to meet one or more of the standards for registered pharmacies. This could result in our taking enforcement action,” the GPhC warned.

The regulator will be checking the new guidance is being adhered to in its pharmacy inspections, GPhC chief executive Duncan Rudkin said.

“We support pharmacy services being provided in innovative ways, including online, as long as the services are safe and effective for people. But providing pharmacy services online carries particular risks, which need to be successfully managed,” he added.

“People can be put at serious risk if they are able to obtain medicines that are not appropriate for them.”

CCA: ID checks are “additional burden”

Malcolm Harrison, chief executive of the Company Chemists’ Association (CCA) – which represents the UK’s largest multiples and supermarket pharmacies – said “the introduction of identity checks will likely place an additional burden on patients and pharmacy services”.

“We recognise that checks are needed for some medicines to ensure that the risks associated with online provision are managed, as well as those in traditional face-to-face pharmacy settings,” he said.

However, the CCA is “concerned that the guidance lacks the clarity to enable providers to make the necessary informed and accurate decisions about which checks would be required for different classifications of medicines”.

“It will be important for regulators to monitor the impact of the introduction of any new verification measures, to ensure that people still receive their medicines in a safe and timely way.”

Both the National Pharmacy Association and the Royal Pharmaceutical Society welcomed the introduction of identity checks.

Online pharmacy UK Meds came under fire in a BBC investigation last year, after a former opiate addict was able to order 100 dihydrocodeine 30mg tablets by submitting false medical information and without any interaction with a healthcare professional.

Media And Political Bulletin – 17 April 2019

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