- Updated hypertension guideline confirms lower CVD risk threshold.
- Final guidance recommends:
- Olaparib for maintenance treatment of BRCA mutation-positive advanced ovarian, fallopian tube or peritoneal cancer through CDF after first-line platinum-based chemotherapy
- Dapagliflozin with insulin for type 1 diabetes in adults.
- Medical device alert issued for microneedling pens - Dermapen 3 and Dermapen Cryo Sterile single use needle cartridge tips due to risk of infection.
- Shortage of Evorel hormone replacement therapy patch range.
- New measures recommended to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases.
- Guidance for managing medicines in the community published.
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE
UPDATED HYPERTENSION GUIDELINE CONFIRMS LOWER CVD RISK THRESHOLD
NICE has published updated guideline on the diagnosis and treatment of hypertension in people aged 18 and over, including people with type 2 diabetes. The final guideline confirms the lower CVD risk threshold at which treatment for hypertension should be considered, in discussion with patients. It recommends that blood pressure lowering drugs should be offered to people aged under 80 with a diagnosis of stage 1 hypertension who have an estimated 10-year risk of CVD of 10% or more. This is a reduction from the 20% CVD risk threshold for treatment recommended in NICE’s 2011 guideline. The guideline also continues to use a blood pressure reading of 140/90mmHg and above as being the level used to define hypertension. New and updated recommendations also include:
- starting antihypertensive drug treatment
- monitoring treatment and blood pressure targets
- choosing antihypertensive drug treatment (treatment steps 1 to 4)
- who to refer for same-day specialist review
The guideline updates and replaces NICE guideline CG127. It also updates and replaces the section on blood pressure management in the NICE guideline on type 2 diabetes in adults (NG28). NICE has also produced a guideline on hypertension in pregnancy.
OLAPARIB RECOMMENDED THOUGH CDF FOR MAINTENANCE TREATMENT OF SOME GYNAECOLOGICAL CANCERS AFTER RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY
NICE has published final guidance which recommends olaparib (Lynparza), for use within the Cancer Drugs Fund as an option for the maintenance treatment of BRCA mutation‑positive, advanced (FIGO stages 3 and 4), high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to first-line platinum-based chemotherapy in adults. It is recommended only if the conditions in the managed access agreement for olaparib are followed. There are currently no maintenance treatments for BRCA mutation-positive advanced ovarian, fallopian tube or peritoneal cancer after a positive response to first-line platinum-based chemotherapy. Olaparib is currently recommended after three or more lines of platinum-based chemotherapy. NICE says using olaparib earlier in the treatment pathway would be an important development because earlier use can achieve the greatest benefit and may have the potential to cure the disease. An ongoing clinical trial shows that olaparib delays disease progression. But it is not known whether people having olaparib live longer because people in the trial have not been followed up for long enough. The currently available clinical trial evidence does not show a significant difference in overall survival between olaparib and placebo. This makes the estimates of cost effectiveness very uncertain. For these reasons, NICE is not recommending olaparib for routine use in the NHS. However, if olaparib increases the length of time people live it has the potential to be cost effective. Therefore, it is recommended for use in the Cancer Drugs Fund, while further data are collected.
DAPAGLIFLOZIN WITH INSULIN RECOMMENDED FOR TYPE 1 DIABETES IN ADULTS
NICE has published evidence-based recommendations which recommends dapagliflozin (Forxiga) with insulin for treating type 1 diabetes in adults with a body mass index of at least 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy, only if:
- they are on insulin doses of more than 0.5 units/kg of body weight/day and
- they have completed a structured education programme that is evidence based, quality assured, delivered by trained educators and includes information about diabetic ketoacidosis, such as:
- how to recognise its risk factors, signs and symptoms
- how and when to monitor blood ketone levels
- what actions to take for elevated blood ketones
- treatment is started and supervised by a consultant physician specialising in endocrinology and diabetes.
Evidence from the clinical trials shows small improvements in blood glucose (HbA1c levels) and weight loss, and very small improvements in quality of life, when dapagliflozin plus insulin is compared with placebo plus insulin in adults with type 1 diabetes and inadequate blood glucose control despite optimised insulin therapy. The company extrapolates the effects of the small improvement in HbA1c level with dapagliflozin seen at one year in the trials to a lower risk of long-term complications over a patient's lifetime. In the company's scenario that assumes no benefit from improved HbA1c levels beyond the trial period (one year), the cost-effectiveness estimate for dapagliflozin plus insulin compared with insulin alone is within the range that NICE normally considers an acceptable use of NHS resources. NICE cautions that due to the increased risk of diabetic ketoacidosis, dapagliflozin should be stopped if blood glucose control does not improve.
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY
MEDICAL DEVICE ALERT ISSUED FOR MICRONEEDLING PENS: DERMAPEN 3 AND DERMAPEN CRYO STERILE SINGLE USE NEEDLE CARTRIDGE TIPS
The Medicines and Healthcare products Regulatory Agency has issued a medical device alert for microneedling pens Dermapen 3 and Dermapen Cryo Sterile single use needle cartridge tips due to a risk of injury or infection. Healthcare professionals are advised not use affected devices as they have been manufactured to unknown standards and their safety cannot be verified. Furthermore, healthcare professionals are advised to:
- Identify and not use any affected devices
- Circulate this medical device alert and ensure all device users are aware they should stop using these devices
- Contact manufacturer/distributor for further advice
- Report suspected or adverse events involving these devices through the local incident reporting system and/or national incident reporting authority as appropriate: Yellow Card Scheme in England or the appropriate authority in Scotland, Northern Ireland and Wales.
SPECIALIST PHARMACY SERVICE
SHORTAGE OF EVOREL HORMONE REPLACEMENT THERAPY PATCH RANGE
The Specialist Pharmacy Service (SPS) has announced Evorel Conti and Evorel Sequi. patches are due to go out of stock from mid-September. The estradiol only patches (Evorel 25, 50, 75 and 100) are due to go out of stock from the beginning of October. SPS has reported that Janssen is unable to provide resupply dates at present. SPS has produced a memo as guidance for alternative treatments in the interim.
EUROPEAN MEDICINES AGENCY
NEW MEASURES RECOMMENDED TO AVOID POTENTIALLY FATAL DOSING ERRORS WITH METHOTREXATE FOR INFLAMMATORY DISEASES
The European Medicines Agency has recommended new measures to prevent serious and potentially fatal errors with the dosing of methotrexate for treating inflammatory diseases such as rheumatoid arthritis, psoriasis and Crohn’s disease. The recommendations result from a review of reports that patients are using methotrexate incorrectly despite previous measures to prevent errors. The EMA advises that for inflammatory conditions, methotrexate must be used just once a week. Using methotrexate more frequently than intended can result in serious side effects. The review found that the error in dosing frequency can occur at any step from prescribing the medicine to the patient taking it. The new measures to prevent errors include restricting who can prescribe these medicines, making warnings on the packaging more prominent and providing educational materials for patients and healthcare professionals. In addition, to help patients follow the once-weekly dosing, methotrexate tablets will be provided in blister packs and not in bottles (or tubes). The measures were agreed after consultation with patients and healthcare professionals.
ROYAL PHARMACEUTICAL SOCIETY
GUIDANCE FOR MANAGING MEDICINES IN THE COMMUNITY PUBLISHED
The Royal Pharmaceutical Society (RPS) has partnered with the Royal College of GPs to produce guidance on how to manage medicines in adults receiving social care in the community. RPS say the tips are part of the ‘Involved and informed: good community medicines support’ campaign from NICE, which aims to promote the safe and effective use of medicines in the community, so patients achieve better outcomes with a reduced risk of medicine-related harm. It also encourages health professionals to take specific actions from NICE's guideline and quality standard on managing medicines in the community.