Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Calcium supplementation prevents fractures

According to a meta-analysis published in the Lancet this week, calcium supplementation (alone and in combination with vitamin D) was associated with a 12% risk reduction in fractures (p=0·0004).

This risk reduction was calculated from trials conducted in people aged 50 years or older reporting fractures as an outcome (17 studies including 52,625 patients). Additionally, in trials reporting bone mineral density as an outcome (23 trials including 41,419 patients), treatment was associated with a reduced rate of bone loss of 0·54% (95% CI: 0·35-0·73; p<0·0001) at the hip and 1·19% (95% CI: 0·76-1·61%; p<0·0001) in the spine. Calcium supplementation appears to be an effective preventive treatment for osteoporosis in people aged 50 years or older.

The expected guidance from the National Institute for Health and Clinical Excellence (NICE) for primary prevention and secondary prevention of osteoporosis in postmenopausal women has been delayed by appeals.

Action: While awaiting full publication of the NICE guidance, clinicians may wish to consider prescribing adequate calcium supplements (those containing 1200 mg of calcium and 800 IU of vitamin D) as a minimum intervention in patients at risk of osteoporotic fractures.

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MHRA issues lumiracoxib advice

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued interim advice restricting the use of lumiracoxib following concerns over liver safety.

A letter will be sent from the manufacturer to healthcare professionals advising that lumiracoxib is now contraindicated in patients:

  • with any current hepatic disease
  • with prior drug-induced significant (>3x Upper Limit of Normal) elevations of transaminases
  • with liver transaminases >1.5xULN before treatment, or >3xULN during treatment
  • taking other medicines associated with clinically significant hepatotoxicity

In addition, monitoring of liver function (LTFs) is advised as follows:

  • Perform baseline LFTs before starting treatment (see third contraindication above)
  • Repeat LFTs monthly during continued treatment
  • Stop treatment if transaminases >3xULN, repeat in 7 days if transaminases >2xULN
  • Conduct LFTs for patients reporting any systemic illness whilst taking lumiracoxib

There have been no reported fatalities in the UK linked to lumiracoxib perhaps because this drug has not been widely used; the MHRA estimate some 5,400 patients have been prescribed lumiracoxib in the last year in the UK compared to over 7 million patients globally since launch in July 2005. European Regulatory Authorities may amend this advice following a full review of risks and benefits of lumiracoxib in September.

Action: Previous advice suggested that it was difficult to foresee a place in therapy for lumiracoxib. Clinicians should be aware of this new advice. Monitoring should be conducted as specified and treatment changed to safer alternatives where possible.

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August CKS Update

Clinical Knowledge Summaries (CKS) has been updated in August for the following clinical areas:

The update also provides information about the forthcoming availability of the CKS Clinical Summaries through hand held devices and pointers to information about the new Medicines and Healthcare products Regulatory Agency Drug Safety Update. These updates will also be available via the KnowledgePlus section of the CKS site.

Action: Clinicians who see patients with any of these conditions may find the updated information useful when reviewing current clinical practice.

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August NICE Guidance

The National Institute of Health and Clinical Excellence has published new guidance for the month of August.

Included in this months guidance are Clinical Guidelines covering chronic fatigue syndrome / Myalgic encephalomyelitis and urinary tract infection in children.

The Quick Reference Guide (QRG) for chronic fatigue syndrome contains information about general principles of care and management strategies. This includes the following list of medications that should not be used to treat the condition.

  • Monoamine oxidase inhibitors
  • Glucocorticoids (such as hydrocortisone)
  • Mineralocorticoids (such as fludrocortisone)
  • Dexamphetamine
  • Methylphenidate
  • Thyroxine
  • Antiviral agents

The QRG for urinary tract infection (UTI) in children contains information on initial diagnosis, acute management, imaging tests, surgical intervention and follow up. Together, these sections provide a comprehensive treatment pathway detailing specific actions based upon a child's age, symptoms, symptom severity and urine dipstick results.

Action: Clinicians who diagnose and treat patients with chronic fatigue syndrome or who see children with symptoms of a UTI will find these guidelines useful. They contain a wealth of useful information to aid diagnosis and management.

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Online Pharmacies unsafe?

An analysis of more than 3,000 online pharmacies has revealed that consumers are being exposed to significant risks, both medically and financially. The research was conducted by MarkMonitor and has been reported on the BBC.

The study found that:

  • Many online pharmacies are not accredited and therefore may not be operating a genuine pharmacy business
  • 10% of the sites clearly stated that no prescription was required for supply of a prescription only medication
  • More than half were not adequately storing customers' private data, including banking details
  • Cost differences between accredited sites and non-accredited sites are indicative of fake or expired products

The Medicines and Healthcare products Regulatory Agency (MHRA) has jurisdiction over British-based pharmacies but cannot close down pharmacies based abroad. The Royal Pharmaceutical Society of Great Britain (RPSGB) maintains a register of all pharmacies in England Scotland and Wales, including those based online. A logo scheme is planned that will allow consumers to verify registration details and should be operational by the end of the year.

Action: Clinicians should encourage patients to use reputable sources for their medications. Consumers who choose to use an online pharmacy should ensure that the site is being operated by a legitimate retail pharmacy business.

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