The Top 10
What has been happening in the world of pharmacy? Here’s our pick of must-read news from the past month.
1. Risk of heart problems prompts withdrawal of OTC diclofenac
Oral diclofenac, used for short-term pain relief, will no longer be available as an over-the-counter (OTC) pharmacy medicine in the UK because of a small risk of heart problems, the Medicines and Healthcare products Regulatory Agency (MHRA) announced on 14 January 2015.
Diclofenac was switched to a pharmacy (P) medicine in 2008, but in August 2013, the MHRA consulted on whether it should revert to a prescription-only medicine (POM) following a European review that found there was a small but significant increased risk of cardiovascular side effects associated with the drug.
Subsequently, the UK’s Commission on Human Medicines (CHM) concluded that these side effects cannot be ruled out even when diclofenac is taken for a short time or at a lower dose, and advised that it is no longer suitable as a P medicine.
Pharmacists had 48 hours from 14 January 2015 to act on the decision and remove OTC diclofenac tablets from pharmacy shelves. Diclofenac topical gels remain available from pharmacies.
Source: Wikimedia Commons
2. NHS England drops therapies from cancer drugs fund
A total of 25 clinical indications will be removed from the government’s cancer drugs fund (CDF) list from 12 March 2015.
The removal of drugs that are eligible for funding through the CDF, including treatments for breast, lung, colorectal and pancreatic cancers, follows an expert panel’s review of the current 84 approved indications.
The changes do not apply to patients already receiving treatment via the fund, which was set up in 2010 to provide patients access to a number of cancer drugs not routinely available on the NHS.
NHS England says the review, expected to save around £80m, was triggered because the fund had become unaffordable. It took into account the drug’s clinical benefit, survival and quality of life of patients, drug toxicity and safety, level of unmet need and the average cost per patient.
The revised list of approved indications and drugs coincided with the announcement that the fund’s budget will increase from £280m to an estimated £340m from April 2015.
3. EMA recommends liraglutide as weight loss drug
The European Medicines Agency is recommending that the injectable drug liraglutide (Saxenda) should be granted a marketing authorisation as a weight loss product.
It should only be offered to adults who have a body mass index of more than 30 or between 27 and 30 if they also have a weight-related condition. Treatment should stop if body weight has not reduced by at least 5% within 12 weeks.
Liraglutide, a glucagon-like-peptide-1 (GLP-1) receptor agonist, is currently approved across Europe for the treatment of type 2 diabetes.
The recommendation came a month after the US Food and Drug Administration approved the weight loss product.
4. Pharmacists’ registration exam set to become more clinical
The General Pharmaceutical Council has announced plans to make the assessment papers that pre-registration pharmacists take to qualify more clinical in focus in order to produce more clinically competent pharmacists.
The one-day assessment, which has retained more or less the same format since it was introduced in 1993, will require candidates to apply knowledge to clinical cases.
Pre-registration pharmacists will not be able to bring in copies of the British National Formulary (BNF) and the BNF for Children. Instead, they will be expected to rely on information from photographs, patient information leaflets and other “artefacts”, such as patients’ medicine charts.
5. More UK patients eligible for costly hepatitis C treatments
The National Institute for Health and Care Excellence (NICE) has broadened its draft recommendations for simeprevir and sofosbuvir to cover more people with hepatitis C. However, patients may have to wait until August 2015 for sofosbuvir because NICE has extended the length of time that NHS England has to comply with its recommendations. And simeprevir will be available only under a ‘pay if you clear’ deal agreed with the manufacturer.
Final draft guidance recommends simeprevir (Olysio, Janssen), in combination with peginterferon alfa and ribavirin, for treating genotype 1 and genotype 4 hepatitis.
And latest draft guidance for sofosbuvir (Sovaldi, Gilead Sciences) extends its use in combination with peginterferon alfa and ribavirin to certain patients with genotype 4, 5 and 6 as well as 1, 2, and 3.
Final guidance is due in February 2015.
Meanwhile, the European Medicines Agency has approved AbbVie’s Viekirax (ombitasvir, paritaprevir and ritonavir) together with Exviera (dasabuvir) for the treatment of hepatitis C genotype 1 with or without ribavirin and licensed Viekirax with ribavirin for genotype 4 HCV.
6. Safinamide recommended for Parkinson’s disease
A medicine that allows Parkinson’s disease (PD) patients to spend more of the day symptom-free has been recommended for approval by the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency.
Safinamide has been endorsed by the CHMP for the treatment of adult patients with idiopathic Parkinson’s disease as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD drugs in patients with mid-to-late-stage fluctuating disease.
David Kearney, senior pharmacist in neurology at University Hospitals of Leicester NHS Trust, says that although safinamide’s licence is limited, it is indicated for a significant group of patients who are “difficult to manage effectively”.
The CHMP’s decision now needs to be approved by the European Commission.
Safinamide is an alpha-aminoamide that inhibits monoamine oxidase-B, sodium channel blockade and modulates release of glutamate with resulting dopaminergic and non-dopaminergic effects. The medicine is available in two strengths, 100mg and 50mg, both taken once daily.
7. Pharmacists set to be drafted into dozens of A&E departments
Pharmacists are set to work alongside emergency department staff at up to 36 A&E units across England from March 2015 in an expansion of an NHS pilot programme.
Health Education England (HEE) is asking Local Education and Training Boards (LETBs) to seek expressions of interest from local NHS trusts to take part in the national emergency department pharmacy pilot initiative, part of NHS England’s urgent and emergency care review.
The HEE pilot will explore the potential of clinical pharmacists to improve emergency care.
Each pilot will run for five weeks, and participating employers will nominate pharmacists from their trust to take part.
8. NICE offers advice on gastro-oesophageal reflux in children
The National Institute for Health and Care Excellence (NICE) has published its first clinical guideline on the management of gastro-oesophageal reflux disease (GORD) in infants and children.
The guideline, which was developed by the National Collaborating Centre for Women’s and Children’s Health, emphasises the distinction between gastro-oesophageal reflux (GOR) — which NICE says is currently over-treated — and the pathologic variant, GORD.
“It can be difficult to differentiate between ‘normal’ episodes of reflux and more serious GORD, but this new NICE guideline will support medical professionals to make the correct diagnosis,” says Mark Baker, director for the Centre for Clinical Practice at NICE.
9. Intensive glycaemic therapy for type 1 diabetes cuts risk of death
Intensive glycaemic therapy for patients recently diagnosed with type 1 diabetes resulted in a decreased rate of long-term mortality compared with patients given conventional therapy, according to research published on 6 January 2014 in JAMA.
Researchers tracked the mortality and specific causes of death of 1,441 patients with type 1 diabetes mellitus for an average of 27 years until the end of 2012.
The study divided patients into two groups – one received intensive therapy for an average of 6.5 years with the aim of achieving blood sugar control close to non-diabetic levels. The second group received conventional therapy aimed at avoiding hypoglycaemia.
Among 1,429 participants there were 107 deaths, of which 64 (8.8%) were in the conventional therapy group and 43 (6%) were in the intensive therapy group (hazard ratio 0.67; 95% confidence interval 0.46-0.99; P=0.045).
“These results reinforce the appropriateness of intensive therapy for those with type 1 diabetes,” says lead researcher Trevor Orchard, from the University of Pittsburgh.
Source: GlaxoSmithKline (GSK)
10. GSK changes colour of Relvar Ellipta inhaler
GlaxoSmithKline (GSK) is changing the colour of its Relvar Ellipta inhaler (fluticasone furoate/vilanterol) from blue to yellow, including the packaging, after respiratory health professionals and patient organisations warned that patients could be confused by its colour and think the device is a “reliever” inhaler.
Concerns were first raised by health professionals in February 2014. They warned that use of the colour blue for the mouthpiece cover of both strengths of the Relvar Ellipta inhaler (92µg/22µg and 184µg/22µg), and on the label and outer packaging of the lower strength inhaler, could pose a safety risk. In the UK, it is common practice to describe short-acting beta2-agonist inhalers such as salbutamol and terbutaline as “blue” or “reliever” inhalers.
As well as changing the colour of the inhaler, GSK is improving the legibility of the wording, and adding colour flashes to indicate strength (green for the standard dose, red for the higher dose).
GSK expects yellow Relvar Ellipta to be available early in 2015.
Citation: Clinical Pharmacist DOI: 10.1211/CP.2015.20067704
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