Department of Health
People being treated for cancer are eligible for free prescriptions from 1st April and are being urged to apply for them now. All cancer patients can apply for a 5-year exemption certificate, which will entitle them to all their NHS prescriptions free of charge, not just those relating to cancer. The certificate can be renewed as many times as necessary and will not have to be returned if the patient's condition changes.
The government is also considering abolition of prescription charges for patients with long-term conditions. Professor Ian Gilmore, president of the Royal College of Physicians, is carrying out a review and will give his recommendations in the summer. As part of this review, the Department of Health is hosting a short survey. The survey closes on 27th February. Prescription Charges Review - Web Survey
The DH has published guiding principles to support local decision making about medicines. This includes decisions made as part of the annual operating plan, as well as in-year service developments and individual funding requests (IFRs). The principles are designed to cover all medicines not yet appraised by NICE.
New measures that will permit direct payments for healthcare to patients for the first time have been published in the health bill. The aim is to give patients more choice and greater control over the care they receive and improve the quality of health services. The bill also places a duty on all providers of NHS services to have regard to the NHS Constitution, which secures the enduring principles of the NHS and sets out the rights and responsibilities of patients and staff.
MHRA
Sanofi-aventis, manufacturer of Surmontil 10 and 25mg tablets, has informed the MHRA that there is an error in the patient information leaflet in some batches of 10mg tablets. Affected leaflets refer to an imprint ‘25’ whereas it should state ‘10’.
Leaks have been reported with a number of Sae-Flo MD extension sets with Y-connector (lot number 80623/1) manufactured by Wescott Medical Ltd. Very few of the leaks were detectable during priming. Use of affected devices can lead to inadequate pain relief or treatment of patients.
All Folysil X-TRA indwelling urinary catheters manufactured by Coloplast, Mentor Medical or Porges have been recalled because the fluid in the prefilled syringe packed with the catheter has not been sterilized.
Pfizer, maker of Viagra, is running a hard-hitting cinema and online adverting campaign warning of the dangers of buying prescription-only medicine without a prescription from unregulated sources such as illicit websites. The campaign is in response to research highlighting that more than 330,000 UK men purchase prescription-only medicines from unregulated sources every year.
NICE
NICE is consulting on two guidelines. Its consultation on 'when to suspect child maltreatment' closes on 10 February and the consultation on coeliac disease closes on 12 February.
EMEA
The EMEA’s Committee for Medicinal Products (CHMP) has recommended that infants, children and adolescents are given priority access to Myozyme (alglucosidase alfa), from Genzyme, during an expected supply shortage. Myozyme is used to treat the enzyme-deficiency disorder Pompe disease, and early-onset patients have the most rapid disease progression. Infants, children and adolescents should continue Myozyme treatment without interruption and new treatments should be initiated where necessary. No new treatments should be initiated in adults, and prescribers should consider temporary treatment interruption to treatment unless interruption may have life-threatening consequences.
The first meeting of the new Committee for Advanced Therapies (CAT) was held on 15 and 16 January. This committee will assess the quality, safety and efficacy of advanced therapy medicinal products (ATMPs) and follow scientific developments in the field. ATMPs are medicinal products based on gene therapy, somatic cell therapy or tissue engineering.
FDA
The FDA has issued a reminder about the potential serious hazards of using skin numbing products, also known as topical anaesthetics, for relieving pain from medical conditions and tests. Lidocaine has been studied to see if it may reduce the discomfort of mammography, but the FDA warns that although no serious side effects were reported, the study was not large enough to evaluate whether uncommon but serious reactions could occur following application to a large area of skin.
Following concerns about a possible association between montelukast and behaviour/mood changes, and suicide, the FDA requested that Merck, Astra Zeneca, and Cornerstone Therapeutics therefore classify suicidal events in clinical trials of their products. The data submitted does not suggest that montelukast, zafirlukast or zileuton are associated with suicide or suicidal behaviour, but the FDA cautions that the trials were not designed specifically to examine neuropsychiatric events so it has not yet reached a definitive conclusion on any link to mood and behavioural adverse events. It urges both healthcare professionals and patients to report side effects.
