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MS patients not accessing the medicines they need

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Six out of 10 eligible people with multiple sclerosis (MS) are not taking a disease modifying drug for their condition, despite meeting national criteria set down by the National Institute for Health and Care Excellence, according to research by the MS Society published last week (26 April 2013) on the eve of national MS Awareness Week.

The MS has launched its "Stop the NHS Lottery" campaign to highlight its finding and is calling for equal access to MS treatments for patients in the UK.

In a statement, NICE pointed out that its recommendations for drugs to be made available on the NHS, which includes MS drugs, should automatically be written into local formularies within 90 days of its guidance being published.

Its deputy chief executive Gillian Leng said: "The NHS has a duty to ensure the rapid uptake of innovative, effective medicines and treatments recommended by NICE. This mandate has been recently legislated in the NHS Constitution for England."


Yellow card champions to be recruited

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A network of pharmacists is being appointed to act as yellow card "champions", with responsibility for promoting the importance of the adverse drug reaction scheme to other health professionals in hospitals across Wales. Local health boards have been invited to nominate a pharmacist to take up the role, which also involves explaining to other NHS staff how the yellow card system works.

Allow technicians to use PGDs, argues Guild

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Pharmacy technicians should be added to the list of registered health professionals eligible to use patient group directions (PGDs) because it would improve patient access and reduce delays in treatment, the Guild of Healthcare Pharmacists has recommended.

The call comes in its official response to proposed good practice guidance for PGDs produced by the National Institute for Health and Care Excellence which was out for consultation until the end of April 2013.

The GHP argues that including hospital pharmacy technicians on the list of approved health professionals makes sense because their role has developed in recent years. "Adding these registered health professionals to the list would enhance patient care by improving access to appropriate medicines and reducing delays in treatment. The skills of these individuals would also be maximised," it suggests.

The GHP also states that PGDs should only ever be used for "distinct patient episodes" because there is a danger that some providers who do not have a referral system or access to a doctor, might use a PGD "as cover" for rare indications.

It says: "The use of PGDs in this situation therefore becomes a substitute for non-medical prescribing which is not in the best interest of patient care. The first question a provider should ask is can the authorisation to supply or administer a medicine be done on a patient specific basis."

The community pharmacy organisation Pharmacy Voice, in its comments on the NICE consultation, highlights cases where the profession uses PGDs to improve patient care.

These include PGDs that allow pharmacists to refer patients directly to a sexual health clinic or to an out-of-hours service; using a PGD to provide influenza vaccination to at risk groups; and providing emergency hormonal contraception.  

It also took the opportunity to complain that the potential of pharmacists working as independent prescribers has not been fully realised. 

See also: Little new in NICE draft guidance on patient group directions

Pharmacists in Wales alerted to health protection duty

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Pharmacists in Wales are being reminded about their health protection responsibilities during the current outbreak of measles, centred on Swansea, the largest outbreak in the UK for over a decade.

In a joint statement issued on 25 April 2013, the chief pharmaceutical officer for Wales and chief executive of the General Pharmaceutical Council said: "During this outbreak pharmacy professionals have a responsibility to protect and promote the health and well-being of patients and the public, and should be taking steps to fulfil these responsibilities. This could include discussing health risks to the individual or the wider public health, and the provision of information about the MMR vaccine to eligible patients."

The statement adds that pharmacy professionals also have a responsibility to promote the importance of immunisation to their own staff, regardless of whether these individuals are regulated by the GPhC or not.

Beware audits of confidential information, warns PSNC

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Community pharmacists are being advised not to allow auditors working for Quintiles access to confidential patient medication records and not to give them data about individual prescribers without the prescriber’s consent.

The Pharmaceutical Services Negotiating Committee said it was concerned about the issue following reports from pharmacists who were worried about giving the auditors access to confidential information.

The PSNC said giving access to the patient medication data would be "unacceptable" to the Information Commissioner. Although practice level prescribing data are publicly available, the prescribing details of individual prescribers are not, and should not be disclosed without consent, it advised.

The PSNC said: "We do not believe that it would be justifiable for the pharmacy to disclose a patient’s sensitive information to a third party to satisfy an audit of stock usage, carried out on behalf of a manufacturer.

"Prescribers may consider that their individual prescribing should be treated as confidential information, and not be disclosed to an auditor funded by a pharmaceutical supplier."

According to the PSNC, the audits are being carried out by Quintiles on behalf of drug manufacturers in order to collect data to support medicines quota arrangements.

Quintiles, according to the PSNC, claimed the audits allow pharmacies to make sure they have accurate stock information and helps manufacturers meet pharmacy stock demands.

Avoid "honorary contracts" with Quintiles

The PSNC has held back from advising pharmacists to boycott the Quintiles audits.

It suggested that pharmacists disclose details of prescriptions dispensed, omitting patient data, and should seek consent from local prescribers before disclosing any details about their prescribing patterns.

Pharmacists should not enter into any "honorary contracts" with Quintiles even though the company, according to the PSNC, has said the contract would prevent disclosure of confidential information by its auditors.

Steve Lutener, the PSNC’s head of regulation, told PJ Online: "[The] PSNC was first alerted to these arrangements at the end of last year [2012], and although third party audits funded by manufacturers (as we believe is the case with at least some of the Quintiles audits) are not new, this is the first time we are seeing the use of ‘honorary contracts’.

"Although we have received only a few reports from pharmacies to date we want to ensure that if other pharmacies are approached they have our views and are aware of the issues if they are asked to disclose confidential or sensitive information. Contractors will then be able to consider for themselves the measures that must be put in place where they are permitting an audit of their records."

Changes made to payment criteria in Scotland

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Criteria linked to some payments made to community pharmacists in Scotland have been temporarily changed pending the outcome of talks between Community Pharmacy Scotland and the Scottish Government on the final financial settlement for 2013-14.

The target monthly phasing payment (CMS) is increased from April 2013 by 50 per cent but the conditions of the payments for April and May have been changed, according to details in an NHS Circular published by the Scottish Government this week (29 April 2013).

Temporary changes are also being introduced from July to the criteria pharmacists have to meet in order to receive the quality and efficiency payment. The criteria relate to the percentage of claims for payment that are made electronically.

Stroke risk campaign launched in pharmacies across Wales

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All 714 community pharmacies in Wales are taking part in a month-long campaign to encourage people to visit their local pharmacy in order to lower their risk of stroke.

During May, community pharmacies will carry out medicines use reviews to remind customers with high blood pressure and atrial fibrillation that they are at higher risk of stroke, and advise them how best to control their conditions. Pharmacists will also be signposting how to recognise the signs of a stroke using the F.A.S.T. stroke recognition test, which involves assessing the following aspects:

  1. Face: Has their face fallen on one side? Can they smile?
  2. Arms: Can they lift both arms and keep them there?
  3. Speech: Is their speech slurred?
  4. Time: Time to call 999

Launched today (2 May 2013) by Public Health Wales, Community Pharmacy Wales, the Stroke Association and Wales’s seven health boards, the campaign is backed by new health minister for Wales Mark Drakeford. He said: "This campaign brings together two important strategic government health policies: greater use of community pharmacies and working with others to promote better public awareness of stroke risk factors."

Cochrane rejects evening primrose oil for eczema

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Evening primrose oil and borage oil are not effective treatments for eczema, according to a Cochrane systematic review (Cochrane Database of Systematic Reviews 2013, issue 4). Further studies on their use in eczema "would be hard to justify," the study authors say.

Both evening primrose oil and borage oil contain gamma linolenic acid, which was at one time thought to reduce inflammation in eczema. Borage oil has a higher concentration of this essential fatty acid.

The review assessed 27 placebo-controlled trials (involving 1,596 adults and children) from 12 countries: 19 studies were with evening primrose oil and eight with borage oil. Neither oil was associated with significant improvement over placebo in eczema symptoms as reported by patients or doctors.

The studies lasted three to 24 weeks. Adverse effects were mild, similar to placebo and mainly gastrointestinal. The reviewers point out that it has been reported that evening primrose oil may increase bleeding for patients taking warfarin.

An evening primrose oil product (Epogam) was licensed for symptomatic treatment of eczema, but the licence was withdrawn in 2002 on grounds of unproven efficacy.


Ocriplasmin launched for vitreomacular traction

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Patients with the eye condition vitreomacular traction can now be treated with a new medicine, ocriplasmin.

It is available from Alcon Laboratories and marketed as Jetrea. Detachment of the vitreous from the retina is a natural process in people aged over 65 years. However, when the vitreous of the eye only partially detaches from the retina it can lead to vitreomacular traction. This can cause the vitreous to split, the retina to detach, or a macular hole. Commonly, patients report a decrease in vision or visual distortion.

Ocriplasmin is a truncated form of the human protein plasmin, produced using recombinant DNA technology in a Pichia pastoris (yeast) expression system. It is a protease and has proteolytic activity. When injected into the eye it is thought that it targets the fibres that hold the vitreous to the retina in vitreomacular traction, so freeing the vitreous from the retina. Up until now, the only treatment option had been vitrectomy surgery or to "watch and wait".

Ocriplasmin intravitreal injection was compared with placebo injection in 652 patients. More people at day 28 had resolved vitreomacular traction in the ocriplasmin group (26.5 per cent) compared with placebo (10.1 per cent; P<0.001). This difference continued to be significant through to month 6.

All of the side-effects reported in association with ocriplasmin were ocular and generally resolved within two to three weeks after injection. Very common side effects were vitreous floaters, eye pain and conjunctival haemorrhage.

The National Institute for Health and Care Excellence is due to publish its technology appraisal of the medicine in October 2013.

Product details

Action: proteolytic activity against the fibres that hold the vitreous to the retina.

Dose: 0.125mg in 0.1ml of diluted solution, administered by intravitreal injection to the affected eye as a single dose.

NHS list price: 0.2ml x 0.5mg (one vial, singe use), £2,500

Legal category: POM 

 

New UK vaccination programme launched

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A new immunisation schedule in the UK that aims to improve protection against diarrhoea, influenza, shingles and meningitis C has been launched following advice from the Joint Committee on Vaccination and Immunisation.

A rotavirus vaccination programme will start in July 2013 for children under four months, with the aim of reducing hospital admissions in under-fives by 70 per cent.

Two-year-olds will be offered a nasal flu vaccine from September 2013, with pilots for secondary school children in 2014 in order to roll out the programme nationwide in 2015.

September also sees a shingles vaccination programme for people aged 70 years, with a catch-up programme for those aged up to 79 years.

The current meningitis C booster jab for four-month-olds is also to be replaced by a new teenage booster given at age 12-13 years, starting in the 2013-14 academic year.

Scott-Thomas appointed to Welsh Pharmacy Board

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Suzanne Scott-Thomas, chief pharmacist and medicine management lead for Merthyr and Cynon Localities, Cwm Taf Health Board, was appointed a member of the Welsh Pharmacy Board at its meeting last week (23 April 2013).

She replaces Don Hughes, clinical director of pharmacy and medicines management at Betsi Cadwaladr University Health Board, who resigned in January for personal reasons.

Public Health England reveals its priorities

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Public Health England has revealed its priorities for the coming years, which broadly encompass protecting health and addressing inequalities. It also states that: "Improvement in the public’s health has to be led from within communities, rather than directed centrally."

From 1 April 2013, PHE became England’s expert public health agency. In the "Our priorities" document issued last week (26 April 2013), PHE states its five overarching priorities (see panel).

Although pharmacy is not specifically mentioned, PHE says one if its "early actions" will be to support nationwide programmes that in turn support healthy lifestyles, behavioural change, early diagnosis and intervention. Implementing NHS Healthchecks, accelerating efforts to promote smoking cessation and tackling antimicrobial resistance are other PHE early actions. Over the next six months, the agency has said it will be "working with everyone to refine its thinking" and will set its ambitions for the next three years.

PHE is charged with providing advice to NHS England and will also provide evidence and advice on local health needs to local authorities and, via the health and wellbeing boards, to clinical commissioning groups. There will be 15 local PHE centres throughout England that will ensure advice, expertise and services commissioned are all tailored to local needs, it says.

PHE’s five priorities

1. Helping people to live longer and more healthy lives by reducing preventable deaths.

2. Reducing disease and disability burden by focusing on conditions that have the biggest impact, eg, dementia and drug dependency.

3. Protecting the country from infectious disease and environmental hazards, including antimicrobial resistance.

4. Supporting families to give children and young people the best start in life.

5. Improving health in the workplace by encouraging employers to support their staff.  

Welsh roadmap to capitalise on pharmacy’s strong position

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A strategic roadmap for pharmacy in Wales, recommending how to integrate pharmacy into local care plans and meet the needs of patients, is to be created by the Welsh Pharmacy Board and the Welsh Pharmaceutical Committee.

The roadmap has come in response to the Welsh Government’s Health and Social Care Committee’s report last year (2012), which found that community pharmacy is embedded into communities in a way that other healthcare services are not.

The five-to-ten-year plan aims to make even more of this strong position, with chairman of the WPB Mair Davies saying: "The report’s central message was the need to make more of pharmacy’s penetration into local communities and to exploit its potential as a key constituent of joined-up healthcare.

"This strategic roadmap will set out how this can be achieved [and] be an invaluable tool for NHS planners, commissioners and health boards. It will help them work out which pharmacy services to deliver, where and when, to meet the needs of their population. It will define what needs to be done to make sure that patients derive the maximum benefit from pharmacy in Wales."

The specifics of the roadmap will be discussed at a preliminary meeting in June 2013. A WPB spokeswoman said that although the roadmap has "no direct link" to the Royal Pharmaceutical Society’s Commission on Future Models of Care launched on 17 April by the English Pharmacy Board, it is thought that the two will "inform each other".

Reported closure of Surrey and Sussex CSU denied

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NHS England has denied that it is to close Surrey and Sussex Commissioning Support Unit, but says it is "looking into the viability" of continuing with it as a stand-alone unit.

According to a Surrey and Sussex CSU spokeswoman: "The Surrey and Sussex CSU and NHS England identified a number of risks around the longer term sustainability of the CSU and came to the conclusion it is not sustainable as an independent organisation. The CSU is now working collaboratively with local clinical commissioning groups (CCGs) to work through the potential options to find the best solution for managing commissioning support services in Surrey and Sussex."

However, she added: "Surrey and Sussex CSU is currently viable and will continue to provide services to customers and ensure business continuity in the immediate term until a longer term solution is put in place over the coming months."

In November 2012, the unit lost the business of three of its CCGs when Surrey Downs CCG and Surrey Health CCG decided to work with Commissioning Support South CSU, and North West Surrey moved to a London-based CSU. At the time, Joe McGilligan, chair of East Surrey CCG, was reported as saying that the loss of business had left the CSU "in trouble" and made it "difficult" for the organisation to present a viable offer to his CCG.

The CSU then saw a change in leadership in March, when managing director Clodagh Warde-Robinson moved to NHS England to work on the programme to enable the externalisation of CSUs. She was replaced by Robert Garner as interim managing director, who had previously headed up the Norfolk and Waveney CSU.

Discrimination claims in Boots pay row deemed too late

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Discrimination claims brought against Boots by 159 current and former staff, as part of an ongoing tussle over premium payment cuts, have been thrown out by the judge for having been filed too late.

According to the claimants, Boots’s decision to reduce Sunday and bank holiday payments for employees who had joined the company before 2000 amounted to indirect discrimination on the grounds of age and sex. Boots argued that the claims should have been filed within three months of the first pay deduction, which was in June 2011.

In an employment tribunal pre-hearing review last week (25–26 April 2013), the judge agreed that the claims should have been submitted to the tribunal earlier, and put a halt to their further progress through the courts.

In an earlier tribunal hearing, held last April, the judge ruled that the reduction of premium payments equated to the unlawful withholding of wages, and ordered that the 45 claimants — 19 of whom were PDA Union members — should be recompensed and have their previous rates reinstated (PJ 2012;288:546). A further 140 PDA Union members then came forward to pursue similar claims (PJ 2012;289:483).

Although these 140 pharmacists can still pursue claims of unlawful deduction of wages, they cannot expect to automatically receive the same recompense that the claimants were offered in April’s hearing, the PDA Union explains in an update posted online today (3 May 2013).

"The same judge will have to decide whether these employees waivered their right to bring a claim — ie, they accepted the new contractual terms by working to them without expressing any objection in the form of a grievance or bringing legal proceedings.

"Boots will argue that these individuals are simply jumping on the bandwagon after the success of the original claimants and, whilst the judge may well accept Boots’s position, we will do all that we can to convince him otherwise to ensure that everyone can benefit from the original decision," the update says.

At least one of the former employees dismissed by Boots for refusing to agree to the new pay terms is still planning to pursue a claim of unfair dismissal, PJ Online has learnt.


Where next for Francis?

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“We all know deep down that there’s a little bit of Mid Staffs in every trust.” A senior pharmacist told The Journal this at a Royal Pharmaceutical Society event this week. It is a bold statement — uncomfortable, stomach-turning and most likely true.

It is tempting to seek to distance yourself from the Mid Staffs mess — to claim that that kind of catastrophic neglect could not possibly happen in your patch. Mid Staffs is an extreme case that highlights how wrongly things can go when organisational culture is fundamentally flawed and cash trumps care. But, painful as it might be, clinicians and managers should get as close as they can to QC Robert Francis’s report.

It is a call for action to ensure patients are considered first and foremost in the delivery of care. Ways that pharmacy can make a real impact post-Francis were the focus of the RPS event, held at the Law Society in London. The meeting brought together around 80 leaders and practitioners to discuss the implementation of the inquiry’s recommendations through professional leadership.

Counsel to the Francis inquiry QC Tom Kark spoke at the event, where he acknowledged the lack of consultation with pharmacy throughout the inquiry. Keith Ridge, chief pharmaceutical officer for England, set out some of the Government’s next steps in the context of pharmacy and medicines optimisation.

The event really came alive in breakaway sessions, where participants collaborated to come up with actions in eight key areas: safety, information, transparency, accountability, consistency, assurance, culture change and strengthened regulation. If the outputs of the sessions are anything to go by, the RPS should be able to produce a hugely relevant report for the profession. But the discussion did not stop at the door and The Journal was impressed when, on Twitter (#RPSFrancis), RPS member Aamer Safdar made public his own personal pledges. He was part of the discussion about leading on safety, and we summarise his commitments here:


• To improve patient experience by giving patients information and explaining when things go wrong

• To empower trainees and staff to report incidents and poor practice; not to accept or tolerate poor practice

• To ask staff how they define their professional roles; what are their boundaries and when do they think it is not their problem?

• To ask staff how they define patient safety and what they would be happy to get into trouble over with regard to patient safety

• To inform students and trainees of pharmacists’ role in patient safety; what are their responsibilities and accountabilities?


He challenges colleagues to come up with their own pledges. At the very least, we say, pharmacists should read as much of the Francis report as they can bear.

 

Latest GLP-1 agonist boasts administration and cost benefits

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A third glucagon-like peptide-1 agonist, lixisenatide (Lyxumia), was launched by Sanofi in London yesterday (30 April 2013) after receiving its European marketing authorisation in February. The injection is licensed for use in combination with oral antidiabetic medicines or basal insulin, or both, when control of blood glucose levels has not been achieved in patients with type 2 diabetes.

Like liraglutide (Victoza), a GLP-1 agonist launched in 2009, lixisenatide requires once-daily injection. However, according to Anthony Barnett, emeritus professor of medicine at the University of Birmingham, the new drug has a different activity profile, with a more profound lowering effect on post-prandial glucose. Speaking at the launch, he said that although head-to-head trials comparing liraglutide and basal insulin combination treatment with lixisenatide plus insulin had not been conducted, “in theory, you might not get as profound an effect on HbA1c [with liraglutide], but that has not been tested in practice”. In addition, he pointed out that use of liraglutide with insulin is currently unlicensed.

A head-to-head study has, however, been carried out with exenatide (Byetta), the first GLP-1 agonist launched, and which requires twice-daily dosing. (A once-weekly product, Bydureon, is available but is not currently licensed for combination with insulin.) The currently unpublished study, conducted by Sanofi and which involved 634 people, demonstrated non-inferiority, the company claims.

What may attract prescribers is that Sanofi has priced lixisenatide over 25 per cent cheaper than Victoza (at a 1.2mg daily dose).

Richard Brice, a GP with a special interest in diabetes and clinical commissioner in Kent, said at the launch: “[Lixisenatide] should enable more people access to this newer class of therapy with the same amount of money. This has got to be an advantage in today’s financial climate when we are trying to give everyone the best possible care with ever more challenging budgets.“

Professor Barnett argued that 40 to 50 per cent of patients could be treated with GLP-1 agonists and suggested that the low uptake was due in part to them being from a relatively new class of drug, partly because of cost concerns, but also because of an inactivity among many health professionals.

“Traditionally diabetes management is [about] waiting for failure – we wait until the HbA1c is up in the sky then we bring in the next therapy. [The National Institute for Health and Care Excellence] itself says this is bad medicine – it’s setting up our patients for long-term complications. We need to be getting in earlier with effective treatment.”

Product details

Action: GLP-1 receptor agonist
Dose: 10mcg once daily within an hour before the first meal of the day, increased to a maintenance dose of 20mcg once daily after 14 days
NHS list price: 14 x 10mcg doses (1 pre-filled pen), £27.07; 28 x 20mcg doses (2 pre-filled pens), £54.14; 14 x 10mcg doses (1 pre-filled pen) plus 14 x 20mcg doses (1 pre-filled pen), £54.14
Legal category: POM

 

NHS 111 service deemed "unacceptable" in some areas

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Some providers of the NHS 111 non-emergency phoneline in England have been delivering an "an unacceptable service", according to Dame Barbara Hakin, interim chief operating officer of NHS England.

In a recent board paper, NHS England admits that the urgent care phoneline — which is being rolled out across the country to replace NHS Direct, and includes GP out-of-hours telephone access — is "still fragile in a number of areas". It adds: "Each NHS England regional director has been asked to put in place additional assurances about delivery [to] secure safe roll out of 111 across England by the end of the summer."

According to the paper, these assurance efforts will include an urgent review of the sustainability of the current model of service into 2014.

"It is important that NHS England continues to work with clinical commissioning groups to stabilise those providers that have failed to deliver their 111 service," says Dame Barbara, "as well as ensure those areas yet to go live are in a safe and fit state to do so."

See also:NHS 111 rollout delayed

Advise patients of perampanel’s effect on contraceptives choice

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Pharmacists should ensure that women with epilepsy who are prescribed higher doses of perampanel (Fycompa) are aware of the drug’s impact on progestogen-containing contraceptives and are given appropriate advice, according to the Drug and Therapeutics Bulletin.

May’s DTB Select highlights recent advice from the Faculty of Sexual and Reproductive Healthcare’s clinical effectiveness unit, which states that the efficacy of oral contraceptives, transdermal patches, vaginal rings and progestogen-only implants may be reduced by enzyme inducers such as perampanel.

The FSRH says that the efficacy of the progestogen-only injectable or intrauterine methods is not affected by enzyme-inducing drugs, and advises that women taking perampanel should ideally switch to one of these methods. It adds that where perampanel 12mg/day is expected to be used for less than two months and women do not wish to switch to a different contraceptive method, these women will need to take additional contraceptive precautions during treatment and for 28 days after stopping perampanel.

Taking the drug at doses of 4 to 8mg per day is not thought to have a significant impact on progestogen-containing contraceptives, according to Fycompa’s summary of product characteristics.

See also:
Perampanel for partial onset epilepsy to be launched next month
Perampanel: a weapon against epilepsy

Clearer career pathways called for in public health

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The need for clearer career pathways for public health specialists is addressed in a public health workforce strategy, published by the Department of Health last week (3 May 2013).

The strategy, "Healthy lives, healthy people", covers themes such as career pathways, public health workforce data, regulation of public health specialists, education and training, and leadership. It acknowledges that public health practitioners come from a wide range of backgrounds, including community pharmacy, and says it is important that the skills and contribution of these practitioners are properly recognised.

The strategy also states that Public Health England will work with Health Education England to identify a lead local education and training board for public health, to provide a focus both on the specialist public health workforce and on public health capacity within the wider workforce.

The impact of the strategy will be monitored and a review conducted in 2015 to identify any further actions that might be needed.

See also: HLPs key to forging pharmacy’s public health role

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