The Scottish Medicines Consortium (SMC) has issued its monthly advice on new medicines.
Trospium chloride (Flotros®) has been accepted for the symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder. It is noted that this product is a lower cost alternative to an existing trospium preparation.
Aliskiren (Rasilez®) has been rejected for the treatment of essential hypertension. It is noted that blood pressure reductions are comparable to existing agents but effects on mortality and long-term morbidity are currently unknown. The clinical and economic analyses presented were insufficient to gain acceptance.
Sildenafil (Revatio®) has been restricted for use in patients with pulmonary arterial hypertension (PAH) classified as WHO functional class II, to improve exercise capacity provided that treatment is initiated by specialists working in the Scottish Pulmonary Vascular Unit or similar specialists.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for February 2010 (PDF).
This issue contains drug safety advice informing clinicians about a new oral liquid formulation of tacrolimus (Modigraf®) with particular attention drawn to the requirement of careful monitoring if switching formulation.
The Yellow Card update section notifies readers of a recent issue identified within the Royal Mail where some cards have been returned to the sender. If you have had a card returned, or if you have submitted a card and not received an acknowledgement letter, you should resubmit the report.
This section also contains a review of the reporting information for swine flu vaccines and antiviral medication. The safety profile is reassuring since the "number and the nature of suspected adverse effects reported are very much as we expected at this stage in the immunisation campaign".
The Hot Topic section provides an update on safety information for orlistat (Xenical® and Alli®) including to some potential drug interactions with levothyroxine and antiepileptic agents. This section also informs readers of the license extension for nicotine replacement therapy (NRT) products to include harm reduction as it is now widely accepted that there are no circumstances in which it is safer to smoke than to use NRT.
Finally, the Stop Press section reminds readers of the recent withdrawal of sibutramine (Reductil®) after a review identified that the cardiovascular risks of treatment outweigh its benefits.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
The Journal of the Canadian Medical Association has published a cost-efficacy analysis of self-monitoring of blood glucose in patients with type 2 diabetes mellitus managed without insulin.
Data from the United Kingdom Prospective Diabetes Study (UKPDS) was used to forecast diabetes-related complications based upon a modest reduction of 0.25% in HbA1c that could be expected in patients using testing strips.
The analysis identified an increment cost utility ratio of Can$113,643/QALY (quality adjusted life-year). The analysis also reports the number needed to treat (NNT) to prevent specified diabetes related complications over a 40 year period. The lowest NNT reported is 266 for myocardial infarction, based on the reported cost of $0.40 per strip this intervention would cost Can$1,553,440.
The authors conclude that, "use of blood glucose test strips for frequent self-monitoring is unlikely to represent efficient use of finite health care resources". They also note that less frequent monitoring or a reduced test strip price would improve cost-effectiveness.
This study details some limitations such as the use of HbA1c as a surrogate for diabetes-related complications, the limitation of using the UKPDS data to model potential health benefits and the lack of a measure for hypoglycaemia.
Action: This study is consistent with existing analyses. Clinicians should continue to discourage regular and frequent self monitoring in patients with non-insulin treated type 2 diabetes.
The Lancet has issued a full retraction of the Early Report title "Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children". This is the paper widely credited with raising concerns with the safety of the MMR vaccination.
The paper was partly retracted in 2004 when 10 of the 12 original authors wished to "make it clear that in this paper no causal link was established between MMR vaccine and autism as the data were insufficient".
This full retraction has been made in light of the information considered by the General Medical Council (GMC) during a Fitness to Practice hearing that has identified that several of the claims made in the original article, in particular the method of referral to the clinic and ethical approval for the investigations, were false. It should be noted that the GMC investigation only reviewed how the research was conducted, not whether the findings were valid. It would seem that The Lancet now has sufficient concerns about the conduct of the study to retract it completely.
The retraction has also been reported around the world in the general media (BBC, NYTimes, LATimes and Sydney Morning Herald).
Action: Clinicians should be aware of this retraction. Papers making reference to this study should be viewed cautiously.
The Department of Health (DH) has announced an ambitious strategy to halve the number of smokers by 2020.
More than 80,000 deaths each year are linked to smoking and smoking related illnesses costs the NHS £2.7 billion a year. Additionally, the DH notes that research has shown that 7 in 10 smokers want to quit.
The DH has made the following commitments:
- Stopping young people being recruited as smokers by cracking down on cheap illicit cigarettes. Immediate investment in extra overseas officers will stop 200 million cigarettes entering the UK every year
- Every smoker will be able to get help from the NHS to suit them if they want to give up - new types of support will be available at times and in places that suit smokers
- The Government will carefully consider the case for plain packaging
- Stopping the sale of tobacco from vending machines – a significant source of tobacco for young people
- Protecting everyone, especially children, from the harms of second-hand smoke by promoting smokefree homes and cars and reviewing smokefree law. This review will include, for example, whether to extend legislation from enclosed public places and workplaces to areas like entrances to buildings
Action: Clinicians should be aware of this strategy. These changes, if realised, will likely results in greater demand on smoking cessation services.