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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

SMC Update

The Scottish Medicines Consortium (SMC) has issued its monthly advice on new medicines.

Lumiracoxib (Prexige)® has been accepted for use on the NHS in Scotland for patients where a COX-II Inhibitor is appropriate. Lumiracoxib should not be used in patients with established cardiovascular disease (including ischaemic heart disease, cerebrovascular disease, peripheral arterial disease and moderate or severe congestive heart failure).

Sildenafil (Revatio) has been restricted to use in patients with pulmonary artery hypertension (PAH) classified as WHO functional class III to improve exercise tolerance. The Summary of Product Characteristics recommends that treatment with this drug should be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension. This would appear to restrict prescribing to secondary care settings at the present time.

Action: Clinicians should be aware of the recommendations of the SMC. As already discussed, the place in therapy for lumiracoxib is likely to be very restricted. The use of sildenafil for PAH appears to be restricted to secondary care.

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CHARISMA Lacking

The CHARISMA Study has been made available online by the New England Journal of Medicine.

The study compared clopidogrel and aspirin to aspirin alone in 15,603 patients who had clinical cardiovascular disease or were at high risk of suffering a first event. These patients were then followed up for about 2 years for myocardial infarction, stroke or cardiovascular death.

At the end of the study there was no significant difference between the two groups in the primary outcome. There was a tendency to harm in the group that received clopidogrel and aspirin as there were a greater number of cases of severe bleeding, however this was not statistically significant.

Clopidogrel and aspirin therapy is of benefit in certain situations such as following a stent insertion but this study demonstrates that there is no reason to add clopidogrel to aspirin therapy as there is no incremental benefit for the patient but there may be an increased risk of harm.

Action: Clinicians who prescribe antiplatelets for primary and secondary prevention of uncomplicated cardiovascular disease should avoid using clopidogrel and aspirin in combination.

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Prescription Price up 15p

The Department of Health has issued a press release stating that the price of an NHS prescription in England is to rise by 15p to £6.65 with effect from 1st April 2006.

The price of pre-payment certificates will also rise to £34.65 for a four-month certificate and £95.30 for a twelve-month certificate.

The BBC has also reported the increase quoting a health minister stating the rise is below the rate of inflation. Despite this some national bodies have again asked if the system is fair or if it is a tax on the sick.

Action: Clinicians may need to be aware of the current NHS prescription charge.

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Prempak-C Shortage

The manufacturer of Conjugated Estrogens / Norgestrel (Prempak-C)® has written to clinicians to inform them of stock shortages.

The letter from the Medical Director states that there is a short-term production difficulty that is affecting supplies. They are working urgently to resolve the manufacturing difficulties and they provide a website address for weekly updates.

Prempak-C is licensed for hormone replacement therapy (HRT) in oestrogen deficiency and for prevention of osteoporosis in high-risk women who cannot take alternative products. The findings of the Women's Health Initiative have restricted the place of HRT products since many expected benefits of HRT were not demonstrated in real life studies while many of the harms remain.

Action: The shortage of Prempak-C is an opportunity to review the need for treatment. Prescribing should be stopped where the risks now outweigh the benefits of treatment.

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NSAIDs and Myocardial Infarction

Bandolier has reviewed an observational study examining the association between NSAIDs and myocardial infarction that was originally published in the Archives of Internal Medicine.

The study collected data on 10,280 myocardial infarctions and compared these patients with ten controls matched for age and sex. Prescription data were collected for NSAIDs, Coxibs and high-dose aspirin.

Prescriptions were categorised as follows:

  • New - first prescription filled within 30 days
  • Current - prescription filled within 30 days
  • Recent - prescription filled within 30-90 days
  • Past - prescription not filled within 90 days

Coxib and NSAID use was higher in all categories of patient when comparing cases to controls. The adjusted relative risk was higher and statistically significant for all drugs other than naproxen and celecoxib, although this may be due to the small number of cases identified (26 and 71 respectively).

Confounders in the study include failure to collect data on lifestyle, diet or the dosage of the NSAID or coxib. Despite these flaws the study raises questions about the cardiovascular safety of all NSAIDs (selective and non-selective).

Action: Clinicians should always consider the risks of NSAIDs before prescribing and during medication reviews. The risk consideration should include assessment of cardiovascular, renal and gastrointestinal risks.

If NSAID therapy is necessary follow the MHRA advice and:

  • use the lowest risk NSAID
  • at the lowest dose
  • for the shortest possible duration

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