Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Medical Exemption certificates for cancer patients

As announced last year, prescription charges will be waived for cancer patients from 1st April 2009.

The new exemption category will be added to the existing Medical Exemption Certificate application form (FP92a). New forms will be distributed in February and all old style forms should be destroyed. The new exemption covers people undergoing treatment for cancer, including the effects of cancer or the effects of current or previous cancer treatment.

New forms can be submitted from the 9th February. Those submitted before 24th March will have certificates processed in time for the new exemption start date. Forms received after the 24th March will be processed in normal time frames.

The BBC has published an article today in which the Public Health Minister has encouraged patients to make an appointment with their doctor in order to obtain a certificate. This recommendation is perhaps a little premature and an appointment with a doctor may be unnecessary in order to obtain the certificate.

Action: Clinicians should be aware of this new medical exemption category. Systems should be put into place to manage demand and process new applications.

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UKPDS - 10 year follow up

The New England Journal of Medicine has published 10-year follow up data from the United Kingdom Prospective Diabetes Study (UKPDS). More detail of these studies is available at NPCi.

UKPDS was originally designed to identify optimal management in type 2 diabetes by assessing interventions such as tight blood pressure and tight blood glucose management. The original randomised studies found reductions in macrovascular events were associated with tight blood pressure control but there were only limited reductions on microvascular events with tight blood glucose control.

These new analyses are based on 10-year observational follow up of the same patient cohorts. Assessments were initially conducted in a clinic setting but towards the end of the study with an annual questionnaire.

The follow up of the blood pressure study found that the differences between the two original study arms disappeared within 2 years and unsurprisingly the observed benefits in diabetes-related death, stroke and microvascular outcomes disappeared too.

The follow up of the blood glucose study found that differences in HbA1c disappeared after the first year. Despite this the benefits seen in diabetes-related end points and microvascular disease persisted. Additionally, benefits were seen to emerge over time in terms of myocardial infarction and all-cause mortality. The macrovascular benefits observed with metformin were also seen to persist. This has given rise to a theory of "legacy effects'' or "metabolic memory".

Any conclusions based on these studies should be made with caution. The data are observational and therefore more prone to bias. They also contradict recently published randomised study data that found no macrovascular benefit with tight blood glucose control. It is also worth noting that 'tight control' for the UKPDS was defined as an HbA1c of 7% while recent studies have set tighter targets of approximately 6.5%.

Action: Clinicians should continue to manage all aspects of cardiovascular risk in patients with type 2 diabetes. This includes controlling blood pressure and blood glucose to National targets.

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Cardiac effect of fish oils

The British Medical Journal has published a systematic review and meta-analysis on the effects of fish oil supplementation on mortality and arrhythmias.

The review identified twelve randomised controlled studies involving 32,779 patients and aimed to assess the effect of supplementation on arrhythmic endpoints of sudden cardiac death and pacemaker implantation. Secondary outcomes included all cause and cardiac mortality. In addition, subgroup analyses reviewed the effect of different formulations.

The analysis found no beneficial effect for either arrhythmic outcome or all cause mortality but there was an observed benefit in death from cardiac outcomes. There was no dose response for this outcome based on formulation with respect to EPA and DHA content.

Limitations of the study include wide variability in the fish oil formulation used and statistical heterogeneity among the implantable cardiac defibrillator studies. Additionally, the results are mainly driven by two large studies (Gissi-Prevenzione and JELIS) that account for 92% of the patients reviewed.

Adverse events reported in the studies were usually gastrointestinal in nature and included diarrhoea and dyspepsia.

The authors note that, "the optimal dose or formulation of fish oil is unknown, but it seems reasonable to use a daily formulation similar to that used in the GISSI-Prevenzione trial". They also suggest that future trials might be designed to help clarify the mechanism for the observed benefit in cardiac mortality.

Action: This analysis confirms an association between fish oil consumption and a reduction in cardiac mortality. Clinicians should continue to implement NICE recommendations that encourage adequate dietary intake followed by supplementation in cases where this patients not willing or able to make dietary changes.

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TCAs best in fibromyalgia?

The Journal of the American Medical Association has published the results of a meta-analysis to determine the efficacy of antidepressants in treating the major symptoms of fibromyalgia.

Fibromyalgia is a chronic pain disorder associated with multiple debilitating symptoms and high disease-related costs. This analysis reviewed randomised controlled trials of tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), serotonin and noradrenaline reuptake inhibitors (SNRIs) and monoamine oxidase inhibitors (MAOIs).

Overall, treatment was associated with a statistically significant reduction in pain, fatigue, depressed mood and sleep disturbance. There was also an improvement in health-related quality of life.

When analysed separately, the pain benefit effect size was largest for TCAs (Standardised Mean Difference -1.64, 95% CI –2.57 to –0.71). The effect was moderate with MAOIs (SMD, –0.54; 95% CI, –1.02 to –0.07) and smallest with SSRIs (SMD, –0.39; 95% CI, –0.77 to –0.01) and SNRIs (SMD, –0.36; 95% CI, –0.46 to –0.25). SSRIs were better for depressed mood and SNRIs were better for sleep disturbances.

The authors conclude that antidepressant medication is associated with improvements in outcomes. They also note that all of the studies were relatively short in duration and therefore further work is recommended to examine long term benefits.

Action: Clinicians may find this review useful in aiding treatment choice depending upon symptom presentation. TCAs would appear to be a good first line choice for pain reduction and may have been ranked less effective in depression as a consequence of the low doses used to treat pain symptoms.

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SMC January Update

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

Buprenorphine transdermal patches (Butrans®) has been rejected for the treatment of severe osteoarthritis in adults that is not adequately controlled by non opioid analgesics. The patch was superior to placebo but the manufacturer failed to present a sufficiently robust economic analysis to gain acceptance.

Salmeterol/fluticasone 50/500 micrograms inhaler (Seretide 500 Accuhaler®) has been rejected for the symptomatic treatment of patients with chronic obstructive airways disease (COPD) and a history of repeated exacerbations. Compared to salmeterol alone, there were no significant differences in mortality rates over 3 years.
[UPDATE] - This advice only applies to patients whose pre-bronchodilator FEV1 is between 50% and 60%.

Aliskiren (Rasilez®) has been rejected for the treatment of essential hypertension. The manufacturer failed to present sufficiently robust clinical or economic analysis to gain acceptance.

Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.

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