The National Institute of Health and Clinical Excellence has published new guidance for the month of September 2010. This month there is one clinical guideline that impacts upon primary care.
The Pregnancy and complex social factors guideline (QRG) provides advice in addition to the current Antenatal Care guideline for pregnant women who may need additional support.
Situations where women who may require additional input, support and effort to maintain antenatal contact include:
- substance misuse
- recent arrival as a migrant
- asylum seeker or refugee status
- difficulty speaking or understanding English
- age under 20
- domestic abuse
Action: Clinicians should be aware of this guideline and of local services that can provide appropriate and additional levels of support.
The NHS Central Alerting System has issued an alert advising that the European Committee on Medicinal Products for Human Use has recommended the suspension of the marketing authorisations for rosiglitazone (Avandia®, Avandamet®) across the European Union.
The full content of the alert will be available tomorrow but registered users and those who receive CAS alerts by email will be able to access the content now. The European Medicines Agency will also
Clinicians are advised to put in place a system to ensure that all patients are reviewed and changed to another suitable treatment in line with NICE recommendations. This could be at the next routine appointment, or sooner if this will reduce patient anxiety.
Patients are advised to continue with their treatment but should contact the healthcare professional supervising their diabetic treatment.
Action: Clinicians should be aware of this product withdrawal. Patients being prescribed rosiglitazone should be identified and contacted to discuss any necessary changes to treatment.
Update: The European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) websites both now contain infomation about the recommendation for the withdrawal.
Clinical Knowledge Summaries (CKS) has been further updated in September 2010 for the following clinical areas:
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.
The British Medical Journal has published the results of a meta-analysis that reviews the effect of glucosamine, chondroitin or the two in combination on joint pain and on radiological progression of disease in osteoarthritis of the hip or knee.
The review aimed to identify large randomised controlled trials (more than 200 participants) that assessed the effect of glucosamine, chondroitin or their combination with placebo or head to head in patients with osteoarthritis of the knee or hip. 10 such studies were identified involving 3,803 patients. The studies were reviewed for a primary outcome of pain relief with a secondary outcome of minimal width of joint space.
When comparing the pain efficacy for any active treatment with placebo all of the effect lines crossed the boundary from minimal clinically important difference. When comparing joint space the effect lines crossed the line of no effect. The review also identified that sponsored studies were more likely to report a larger effect compared to studies operated independently.
The authors conclude that active treatment does "not reduce joint pain or have an impact on narrowing of joint space". They further advise that the cost of these treatments should not be covered by health organisations and that new treatment initiations should be avoided.
Action: The National Institute for Health and Clinical Excellence (NICE) guideline on osteoarthritis advises against prescribing glucosamine or chondroitin products. This analysis indicates that this advice is justified.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on new medicines.
Dronedarone (Multaq®) has been accepted for restricted use in adult clinically stable patients with a history of, or current non-permanent atrial fibrillation when conventional first-line anti-arrhythmic medicines are ineffective, contra-indicated or not tolerated. Treatment should also be started by a specialist.
Esomeprazole (Nexium®) has been accepted for restricted use for the treatment of gastro-oesophageal reflux disease (GORD) in children 1 to 11 years old when licensed doses of a generic proton pump inhibitor have been ineffective.
Agomelatine (Valdoxan®) has been rejected following a resubmission for the treatment of major depressive episodes in adults. the economic analysis was not sufficiently robust to gain acceptance.
Febuxostat (Adenuric®) has been accepted for restricted use in the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence, of tophus and/or gouty arthritis) when treatment with allopurinol is inadequate, not tolerated or contraindicated.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.