The Royal Pharmaceutical Society of Great Britain has produced a summary of the changes in Controlled Drug Regulations that will affect pharmacists in England.
The summary provides an overview detailing the changes that are being implemented, when they are being implemented and also recognises if the change is a legal requirement or good practice. The summary is also broken down into four topic areas:
- Record Keeping
- Inspection and Monitoring
- Other areas
Action: This document is a useful summary of the CD regulatory changes. Clinicians may also find it helpful to know when the changes are likely to be implemented.
The National Prescribing Centre has published a MeReC Extra covering recent developments in cardiovascular evidence around statin prescribing.
The first part of the publication covers the recent NICE Guidance on statins that has been covered already. Based upon the clinical evidence and costs of acquisition it is suggested that a reasonable first choice would be simvastatin 20mg or 40mg.
The publication also covers the recently published IDEAL Study1. This study has been covered on this site. The MeReC discusses in detail the design and findings of the study concluding that aggressive lipid lowering should be considered in context of other interventions to reduce cardiovascular risks (for example smoking cessation, blood pressure control, antiplatelets, diet and exercise). The conclusion is that simvastatin 20mg or 40mg is an appropriate first choice for patients with cardiovascular disease.
Action: Clinicians involved in the treatment of patients with cardiovascular disease would benefit from reading this concise summary of the latest evidence and guidance.
- Pedersen TR, Faergeman O, Kastelein JJP, et al. High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction. JAMA2005:294:2437-45
The patent for the proton pump inhibitor (PPI) lansoprazole expired recently and several generic version are now available. In response to this the Drug Tariff has been updated to reflect a lower price for this drug.
It has been added to Category M of the tariff and this has dramatically reduced the price. 28 capsules of the 15mg and 30mg strength cost £4.57 and £6.73 respectively.
Some patients may have been changed from lansoprazole to omeprazole before this price reduction. A rapid change back to lansoprazole may cause confusion and should be undertaken with caution.
Action: This price change now places lansoprazole as the PPI of choice. Care should be taken switching back to lansoprazole therapy in patients who have recently undergone a change.
The Department of Health have written to healthcare professionals to deactivate the NICE guidance for use of antivirals in the treatment and prophylaxis of influenza.
As reported earlier this year, the NICE Guidance was activated by the Department of Health in response to rising levels of influenza in the community.
The most recent data suggests that influenza rates have now fallen below the threshold and therefore the guidance has been deactivated. A communication has been sent to clinicians throughout the NHS.
Action: Clinicians should stop prescribing antivirals for the treatment and prevention of influenza.
The BBC and other media companies have been heavily reporting the outcomes of the ASTEROID Trial. This trial has been made available online by the Journal of the American Medical Association along with the accompanying editorial.
The trial examined the effect of very high dose statin therapy (rosuvastatin 40mg) on the progression of atherosclerosis with the objective of assessing if therapy could regress the atherosclerosis. Athersclerosis was assessed as baseline and after 24 months using intravenous ultrasound.
349 patients completed the study. The average reduction in low-density lipoprotein cholesterol (LDL-C) was 53.2% and there were statistically significant but modest reductions in three pre-specified efficacy parameters of atheroma volume. The parameters and reductions were:
- Percent Atheroma Volume reduced by 0.98%
- Atheroma Volume in most diseased area reduced by a median of 9.1%
- Total Atheroma Volume reduced by a median of 6.8%
Initially, 507 patients were recruited to the study 63 suffered adverse events after at least one dose leading to withdrawal from the study. In total, 127 patients dropped out of the study. Some reporting of the study has reported that "four out of five patients (78%) demonstrated some reduction in the level of atherosclerosis" however correcting this figure to an intention to treat value shows the true level of efficacy to be 49%.
The conclusion of the paper and the editorial raise the need for further studies since this work is not linked to reduced numbers of clinical outcomes such as myocardial infarctions and strokes. Echoing this position, the British Heart Foundation issued a press release calling for further studies to confirm that these changes actually save lives.
Action: This study does not change current practice but does raise possibilities that require further investigation. Simvastatin remains the first line choice as lipid lowering agent.