The National Institute of Health and Clinical Excellence (NICE) has published new guidance for the month of January 2012. This month there is one clinical guideline and two technology appraisals that impact upon primary care.
The updated Epilepsy clinical guideline now includes several newer anti-epileptic drugs that have been introduced since the original guideline. New recommendations include:
- Basing therapeutic choice on the presenting epilepsy syndrome or presenting seizure type(s) where the syndrome type is unclear.
- Advising women and girls of the possible risk of malformation and neuro-developmental impairment in an unborn child when sodium valproate is used.
- Only prescribe buccal midazolam or rectal diazepam for use in the community for individuals who have had a previous episode of prolonged or serial convulsive seizures.
Roflumilast has been reviewed in a technology appraisal for the management of severe chronic obstructive pulmonary disease. The drug is only recommended as part of a research study (clinical trial) that is investigating using roflumilast at the same time as a bronchodilator.
Apixaban has also been reviewed in a technology appraisal for the prevention of venous thromboembolism after total hip or knee replacement in adults. The treatment has been recommended as an option based on greater efficacy and lower acquisition costs than some alternatives. Primary care may be asked to issue treatment completions.
Action: Clinicians should be aware of this new guidance and implement any necessary changes to practice.
The Chief Medical Officer for England has been reported to be contacting healthcare professionals about vitamin D deficiency after recent research found that many healthcare professionals were unaware of current recommendations. According to NHS choices, several newspapers and other news outlets carried this story (BBC).
Current advice (PDF) highlights which groups are at risk of vitamin D deficiency, sources of vitamin D in the diet as well as from skin exposure to sunlight and recommends daily intake levels of vitamin D in those at risk of deficiency.
It also describes access to supplements, via Healthy Start if eligible or the alternatives depending on local arrangements if individuals are not eligible. Healthy Start Vitamins are allowed on NHS prescription.
Action: Clinicians should be aware of these recent reports and current recommendations.
The National Prescribing Centre has published a MeReC Bulletin (PDF), the first in a series of three, that focuses on the therapeutic areas of the QIPP agenda.
The topics covered in this bulletin are:
- Non-steroidal anti-inflammatory drugs
- Antibiotic prescribing - especially quinolones and cephalosporins
- High dose inhaled corticosteroids in asthma
For each of the therapeutic topic areas the evidence base is summarised and current prescribing data are reviewed.
Action: Clinicians who prescribe in any of the areas above and who are striving to deliver value for money while maintaining or improving the quality of care will find this information is useful and informative.
There are many terms used to describe the design of clinical trials. There are efforts to reduce inadequate reporting in clinical trial reports and increase transparency thus aiding interpretation, for example the CONSORT Group. Some of the terms used are as follows.
- Superiority study - aims to demonstrate that one treatment is better than another active treatment or a placebo.
- Non-inferiority study - aims to demonstrate that one treatment is not worse than another active treatment within a defined acceptable level of clinical inferiority.
- Equivalence study - aims to demonstrate that two interventions are equivalent to each other within a defined acceptable level of clinical difference.
- Observational - the study watches what happens rather than directly offering interventions.
- Experimental - the study actively provides an intervention, typically this is a randomised controlled trial.
- Randomisation - participants in the study are randomly assigned to treatment groups rather than being selected. This helps to reduce selection bias.
- Retrospective - looks at events that have already happened. This method usually employs healthcare system databases.
- Prospective - looks at what happens to patient populations as time passes.
Level of 'Blinding':
- Open - participants, the clinicians conducting the study and the study assessors all know which intervention group a patient is in.
- Single blind - the participants don't know which intervention group (treatment or placebo) they are in.
- Double blind - neither the participants nor the clinicians conducting the study know which intervention group individual patients are in.
- Triple Blind - neither the participants, the clinicians conducting the study nor the study assessors know which intervention group individual patients are in.
Action: A better understanding of these terms will allow clinicians to interpret the relevance and impact of clinical studies.
The European Medicines Agency (EMA) has recommended (PDF) that the marketing authorisations for all meprobamate containing medicines are suspended over the next 15 months.
A recent review looked at all available data on the safety and efficacy of these medicines. It was concluded that there is a risk of serious and potentially fatal side effects even when taking this drug under normal conditions of use. The risks were even higher in cases of unintended overdose due to the narrow therapeutic window.
The EMA are advising doctors to stop prescribing meprobamate over the next 15 months and to consider using alternative treatments in line with national recommendations. Patients are to discuss their treatment at their next routine appointment.
Action: Clinicians should be aware of this recommendation. Meprobamate is not widely used but it may be prudent to search clinical systems to identify those patients affected by this recommendation.