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News in brief

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FMD compliance to be part of pharmacy inspections

Existing pharmacy inspection processes will be used to monitor pharmacies’ compliance with the Falsified Medicines Directive (FMD), the General Pharmaceutical Council (GPhC) has announced.

The GPhC said jointly with the Medicines and Healthcare products Regulatory Agency (MHRA) that if a pharmacy is found not to be meeting the FMD standards for registered pharmacies, and “where a contributing factor relates to breaches of the new safety feature provisions”, the GPhC will use its regulatory powers “to make sure that pharmacies take action to meet the standards and requirements under legislation”.

The “safety features” referred to form part of the FMD.

The two bodies state that it is the MHRA’s responsibility to take any enforcement action on FMD, which could include enforcement notices or even criminal prosecution “for the most serious, persistent breaches”.

 

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  • FMD compliance to be part of pharmacy inspections

    Existing pharmacy inspection processes will be used to monitor pharmacies’ compliance with the Falsified Medicines Directive (FMD), the General Pharmaceutical Council (GPhC) has announced.

    The GPhC said jointly with the Medicines and Healthcare products Regulatory Agency (MHRA) that if a pharmacy is found not to be meeting the FMD standards for registered pharmacies, and “where a contributing factor relates to breaches of the new safety feature provisions”, the GPhC will use its regulatory powers “to make sure that pharmacies take action to meet the standards and requirements under legislation”.

    The “safety features” referred to form part of the FMD.

    The two bodies state that it is the MHRA’s responsibility to take any enforcement action on FMD, which could include enforcement notices or even criminal prosecution “for the most serious, persistent breaches”.

     

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  • Data on NHS medicinal cannabis prescribing expected by end of March 2019

    NHS England has established a system to monitor the prescribing of cannabis-based products for medicinal use, with the first data expected by the end of March 2019, health minister Steve Brine says.

    Brine was responding to a question from Jim Cunningham MP, following concerns that despite the legal change to the status of medical cannabis, very few, if any, NHS prescriptions have been written.

    Medical cannabis became available for prescribing on 1 November 2018, but since then press reports have suggested that only a handful of patients have been issued prescriptions, and they have been via private doctors.

    NHS-commissioned interim guidance on the use of cannabis-derived medical products, produced by the British Paediatric Neurology Association (BPNA) and the Royal College of Physicians (RCP), has been criticised as too restrictive, leaving consultant doctors — the only doctors allowed to prescribe the drugs — unwilling to do so.

    Genevieve Edwards, director of external affairs at charity the MS Society, told The Pharmaceutical Journal that, as far as the Society was aware, no patient with multiple sclerosis has been able to access a cannabis-based medicine since the law changed — a situation she described as “incredibly frustrating”.

    In north London, the North Central London (NCL) Joint Formulary Committee announced that unlicensed cannabis-based medicinal products (CBMPs) will not be prescribed in its region until the committee had completed an evaluation of their use, which is due to take place in January 2019. Until then, CBMPs “will not be available to prescribe or supply in North Central London”.

     

     

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  • Opioid prescribing highest in more deprived regions of England, study shows

    Opioid prescribing in general practice is highest in North West England and the East Midlands, mirroring general geographical health inequalities, a study published in the International Journal of Drug Policy has found.

    The researchers used publicly available data from 2015 to calculate the total amount of opioid prescriptions dispensed for each practice and analysed it alongside data from the Index of Multiple Deprivation (IMD), a UK government qualitative study of deprived areas in England.

    The three highest areas for GP opioid prescribing were NHS Blackpool clinical commissioning group (CCG), NHS St Helens CCG — both in North West England  — and NHS Lincolnshire East CCG in the East Midlands.

    Lower socioeconomic status, smoking, obesity and depression were all found to be significantly associated with increased opioid prescriptions. For every decrease in IMD decile, there was a significant increase in opioid use by 1.0 DDD (95% confidence interval 0.89–1.2; P< 0.001) per 1,000 registrants per day.

     

     

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  • Pharmacy sector 'deploying all necessary resources' to prevent Brexit medicines shortages, as government deal voted down

    Following the historic parliamentary defeat of the government’s Brexit withdrawal agreement, the Pharmaceutical Services Negotiating Committee (PSNC) has said it is “deploying all necessary resources” to ensure patients do not run short of medicines when the UK leaves the EU.

    Speaking after the government defeat on 15 January 2019 — and with less than three months until the agreed Brexit date of 29 March 2019 — Simon Dukes, chief executive of the PSNC, said pharmacy negotiators would continue to work with the Department of Health and Social Care (DHSC) to plan for all potential scenarios, including a no-deal Brexit.

    “Given the ongoing uncertainty, this work is now more critical than ever and the PSNC will be deploying all necessary resources to it,” he said.

    “Our focus will remain on contingency planning with the DHSC to ensure that patients can continue to access the medicines they need, when they need them, and that the impact on community pharmacies is minimised.”

    Dukes also revealed that government Brexit planning had delayed negotiations on community pharmacy funding and the future role of the sector.

    “This is not an exclusive problem to pharmacy but we are concerned that this delay is now likely to continue,” he said.

    Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, said that “with time running out, we hope parliament will come together and quickly find a solution to the stalemate and reassure patients that medicines will not be disrupted come March 2019”.

    He reiterated that a no-deal Brexit would prove “extremely challenging” and the focus of pharmaceutical companies was on making sure that medicines and vaccines got to patients whatever the Brexit outcome.

    The European Federation of Pharmaceutical Industries and Associations (EFPIA) is calling on negotiators to agree on a series of actions that need to be taken to protect patients, including discussions between relevant authorities and the sector to coordinate contingency plans, such as putting fast-track lanes or priority routes for medicines into ports and airports and exploring the possibility of exempting active pharmaceutical ingredients and raw materials for medicines from border checks to ensure manufacturing of medicines continues with limited disruption.

    The government has asked drugs manufacturers to maintain a rolling six-week stockpile of medicines for six months in the event of a no-deal Brexit.

    In addition, GPs and community pharmacies were told not to stockpile additional medicines beyond their business as usual stock levels. The DHSC also said there was “no need” for clinicians to write longer NHS prescriptions and that the public should be discouraged from stockpiling.

    The Department of Health and Social Care (DHSC) has launched a consultation on the introduction of a “strict protocol” to allow pharmacists to dispense an alternative medicine if the prescribed drug is unavailable.

    The DHSC has said that a protocol would be issued in case of a serious national shortage, such as following a no-deal Brexit, and allow pharmacists to dispense in accordance with the protocol, rather than the prescription, without having to contact the patients’ GP.

    The government added that the protocol would clearly indicate which alternative medicines can be dispensed and to which patients.

    The protocol may allow pharmacists to respond to a shortage in four ways, including dispensing a reduced quantity, a therapeutic equivalent, a generic equivalent or an alternative dosage form.

    In a statement, the Royal Pharmaceutical Society said: “We support pharmacists using their professional judgment to decide on what medicine to dispense. Pharmacists will work with doctors to make sure any communication about changes to medicines is clear.”

    The Pharmaceutical Services Negotiating Committee has already proposed that community pharmacists should be able to automatically substitute an alternative medicine if they cannot dispense the prescribed item, to help deal with any possible drugs shortages post-Brexit.

    This followed on from a similar suggestion from Sibby Buckle, vice chair of the Royal Pharmaceutical Society (RPS) English pharmacy board and chair of the RPS pharmacy digital forum.

     

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  • Shared decision-making and older people should be medicines safety priorities, survey respondents say

    Transitions of care and shared decision making should be the highest priority for the NHS Improvement’s national Medicines Safety Programme, the Royal Pharmaceutical Society (RPS) has said.

    But the RPS did not support suggestions from NHS Improvement that a nominated pharmacist should be designated to manage medicines during patient transitions between all care settings.

    NHS Improvement launched a survey to gather views on its proposals for priority-setting in December 2018, in advance of the launch of its national Medicines Safety Programme in April 2019.

    It asked for feedback from individuals and organisations on its suggestions for making improvements in safety across six “headline” areas.

    In its response, the RPS rated anticoagulants as the lowest priority, owing to the fact that pharmacists are already involved in the use of anticoagulants, including early detection of atrial fibrillation.

    The RPS did not identify NHS Improvement’s proposal to have a nominated pharmacist designated to manage medicines during patient transition as a priority.

     

     

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  • Pharmacy Schools Council expresses concern over GPhC education proposals

    “Appropriate funding” and enhanced quality assurance of preregistration providers is necessary for greater integration between academic study and practical preregistration experience for pharmacists in training is to be successful, the Pharmacy Schools Council (PhSC) has warned.

    The PhSC concerns follow the publication of General Pharmaceutical Council (GPhC) proposals to develop a single set of standards for the five-year period of education and pre-registration training undertaken prior to the registration assessment.

    The GPhC said a greater focus on clinical and interpersonal skills is needed, which will be driven by much stronger integration between academic study and practical pre-registration experience.

    The PhSC welcomed greater integration in principle, but said it was “concerned about the lack of detail [in the consultation] or any suggestion about how such a major change can be achieved”.

     

     

     

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Students taking exam

Majority of NHS preregistration training providers achieve 100% pass rate in June 2018 assessment

17 JAN 2019

NHS preregistration training providers continue to out-do other providers in the registration assessment, with most achieving 100% pass rates for first-attempt candidates, according to figures from the General Pharmaceutical Council.

Sir Chris Wormald, permanent secretary at the Department of Health and Social Care

DHSC to consult with pharmaceutical industry over generics price limiting powers

17 JAN 2019By Carolyn Wickware

The Department of Health and Social Care will consult with the pharmaceutical industry over its plans to use new powers limiting the price of generics, the department’s permanent secretary has said.

Older person recieving flu vaccine

First cell-based quadrivalent vaccine available for 2019/2020 flu season

17 JAN 2019

A new cell-based seasonal influenza vaccine has been issued marketing approval by the European Commission and will be available for the 2019/2020 flu season.

Bar code scanning medicine

MHRA confirms it will consider UK version of Falsified Medicines Directive

15 JAN 2019

With less than a month until the Falsified Medicines Directive is implemented on 9 February 2019, the Medicines and Healthcare products Regulatory Agency has confirmed that if there is a no-deal Brexit it will consider a UK-only version of the EU law.

NICE office logo

NICE rejects 'promising' new treatment for migraine

11 JAN 2019

The first monoclonal antibody therapy for migraine prevention has not been recommended by the National Institute for Health and Care Excellence on the grounds that it is not cost effective.

General pharmaceutical council logo

GPhC opens consultation on education and training standards for pharmacists

9 JAN 2019

The General Pharmaceutical Council has opened its consultation on the initial education and training standards for pharmacists.

Ian Hudson, chief executive officer of the Medicines and Healthcare products Regulatory Agency

Government publishes additional no-deal Brexit medicines regulation guidance

9 JAN 2019

More information on how medicines, medical devices and clinical trials would be regulated following a no-deal Brexit has been issued by the Department of Health and Social Care.

Asthma injection

Third biological treatment for severe asthma approved by NICE

4 JAN 2019

An injectable drug for patients who struggle to control their asthma with inhalers has been approved by the National Institute for Health and Care Excellence.

Oxycodone paracetamol percocet pill bottle

Pharmacies warned of fake tablets containing fentanyl

4 JAN 2019

Counterfeit tablets that contain the opioid fentanyl have been found in the UK for the first time.

Junel Ahmed, former president of the BPSA

BPSA president steps down owing to 'conflicting priorities'

4 JAN 2019

The president of the British Pharmaceutical Students’ Association, Junel Ahmed, has stepped down from his role with immediate effect.

Buckingham Palace

Pharmacists recognised in 2019 New Year's Honours list

2 JAN 2019

Three pharmacists and one former pharmacist have been recognised in the UK government’s 2019 New Year’s Honours list.

Busy hospital waiting room

Pharmacists should manage medicines during transitions of care to improve medicines safety, NHS Improvement proposes

20 DEC 2018

A nominated pharmacist should be designated to manage medicines during patient transitions between all settings, NHS Improvement has proposed as part of a consultation on medicines safety.

Emollient being put on hand with psoriasis

Emollient packaging should include fire risk warning, says MHRA

19 DEC 2018

People who use emollient creams to treat dry and itchy skin conditions should be warned about the potential fire hazard, the Medicines and Healthcare products Regulatory Agency has said.

Cannabis oils

Royal College of GPs produces interim guidance on medical cannabis

18 DEC 2018

The Royal College of GPs has published interim guidance for GPs on the use of medical cannabis products.

pharmacist holding antibiotics

General prescribing levels drive antibiotic prescribing in primary care, study finds

18 DEC 2018

Interventions to optimise antibiotic prescribing need to target general prescribing behaviour more widely, researchers have concluded.

Student studying

University of Sussex confirms closure of MPharm course

14 DEC 2018

The University of Sussex has confirmed that it is to close its Master of Pharmacy course.

PJ mind the gap

Twitter chat on the ethnicity pay gap in pharmacy to be held

12 DEC 2018By

On Wednesday 12 December 2018 at 20:00 (GMT), The Pharmaceutical Journal will be hosting an hour-long Twitter chat to discuss the issue of ethnicity and pay in UK pharmacy using #PJMindTheGap.

sheffield city town hall

Pharmacists in GP surgery scheme achieves almost blanket coverage in city

12 DEC 2018By Kathy Oxtoby

A programme designed to increase joint working between community pharmacists and GPs has deployed a pharmacist in all but two of a city’s GP surgeries.

General Pharmaceutical Council

No mentoring required for prescribers who supervise independent pharmacy prescriber trainees

5 DEC 2018

Prescribers who will supervise pharmacist independent prescribers in training will not have to be mentored, contrary to earlier proposals, the General Pharmaceutical Committee has proposed

Epipen Autoinjector Adrenaline Epinephrine

Supply of adrenaline auto-injectors returns to normal

29 NOV 2018

The interim protocol for the dispensing of adrenaline 150 microgram auto-injectors will cease to be in effect from 29 November 2018, the NHS has said.

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