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.
Study design:
- 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.
Study methodology:
- 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.
The manufacturer of orlistat (Xenical®) has written to healthcare professionals advising that there is a stock shortage of this product.
The shortage is due to manufacturing issues and the manufacturer has now exhausted supplies in their distribution centres. There are likely to be some supplies currently in the wholesaler chain and on pharmacy shelves. The letter does not give an explicit indication when supplies will resume but the manufacturer states it "will issue further communications over the next few weeks".
Action: Clinicians should be aware of this expected shortage. Alternative treatment options are limited so it may be prudent to limit new initiations and to advise existing patient to try alternative outlets when caching prescriptions.
Update: The Pharmaceutical Services Negotiating Committee have reported on this same issue but have noted that generic alternatives are available. This may limit any impact of this shortage.
The British Journal of Clinical Pharmacology has published the results of a study that aimed to assess the relationship between use of selective serotonin reuptake inhibitors (SSRIs) and injurious falls in nursing home residents with dementia. A press release has also been issued which has raised awareness in the general media (BBC).
This paper reviewed daily drug use and daily falls as recorded in 248 nursing home residents for a two year period starting January 2006. The average age of the study group was 82. This daily data collection results in a 85,074 person-day dataset. 152 residents sustained 683 falls, with 38 individuals falling on one occasion and 114 individuals falling more than once. The fall incidence was 2.9 falls per person per year.
SSRIs were used on a total of 11,105 person-days of the analysis period. A significant association was found between the risk of an injurious fall and increasing age, antidepressant use and antipsychotic use.
Dose-response relationships were also assessed by correcting drug dosage to a proportional "daily defined dose". Daily defined dose is a measure of drug consumption produced by the World Health Organization. Data models for a typical 85 year old female resident showed that, compared with non-use of an SSRI, a 0.25 proportional dose increased the risk of an injurious fall by 31%. A 0.5 proportional dose increased risk by 73% and 1.0 proportional use increased the risk by 198%. This risk increased even further with concomitant use of other sedatives or hypnotics.
The authors note that the study may be limited due to the data coming from a single nursing home establishment and that there were no users of fluoxetine or escitalopram during the study period.
The authors conclude that, "even at low doses, SSRIs are associated with increased risk of an injurious fall in nursing home residents with dementia".
Action: Clinicians should be aware of this new research linking SSRIs with falls. It may be prudent to consider the risk of falls and use the lowest effective dose of SSRIs when treating depression in elderly patients with dementia.
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