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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

NICE osteoporosis guidance unchanged

The National Institute for Health and Clinical Excellence (NICE) has complied with a Court of Appeal ruling and reconsidered the evidence for preventing fractures in patients with osteoporosis.

The original court ruling found the NICE had failed to fully explain its decision on a specific analysis of hip fractures from a research study carried out by the manufacturer of strontium ranelate (Protelos®). The actual recommendations were not questioned by the court. The court ruled that NICE must reconsider and reissue the guidance.

NICE has now reissued the osteoporosis - primary prevention and osteoporosis - secondary prevention including strontium ranelate. The guidelines are unchanged after the review.

Action: Clinicians should be aware that these guidelines are now published and implement any necessary changes to practice.

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NSAID and PPI combination launched

A combination of naproxen and esomeprazole (Vimovo®) has been launched with a license for use in symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. The product license specifically aims the product at people who are at risk of developing a non-steroidal anti-inflammatory (NSAID) related gastric or duodenal ulcer when treatment with lower doses of naproxen or other NSAIDs has been insufficient. The Summary of Product Characteristics (SPC) is available now.

The product contains 500mg of naproxen (NSAID) and 20mg of esomeprazole, a proton pump inhibitor (PPI), in each tablet with a recommended daily dose of one tablet twice daily. The esomeprazole ingredient envelopes an enteric coated core containing the naproxen and the former is released first with the naproxen made available in the small intestine. Due to the modified release characteristics of this product it would be unsuitable for treating acute pain where a rapid onset is desired.

This product will cost £14.95 for 60 tablets. Comparative costs to enteric coated naproxen and alternative PPIs are listed below based on the January Drug Tariff:

  • Naproxen enteric coated 500mg tablets (56) - £5.17
  • Omeprazole 20mg capsules (28) - £1.68
  • Omeprazole 40mg capsules (7) - £1.85
  • Lansoprazole 30mg capsules (28) - £2.08
  • Esomeprazole 20mg tablets (28) - £18.50
  • Esomeprazole 40mg tablets (28) - £25.19

Action: Naproxen, or an alternative NSAID, could be co-prescribed with an alternative PPI at lower cost. This product may be useful in patients already on a combination of naproxen and esomeprazole in doses equivalent to this product when switching would be less expensive.

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1,000 post milestone

I've just reached a significant milestone. The last post was number 1,000!

So that's 1,000 healthcare and medicines related posts in about 5 and a half years.

And while I'm reporting such figures there are

- over 500 comments from
- nearly 45,000 unique visitors
- from at least 156 countries in all corners of the world
- and over 10,000 spam comments

Unsurprisingly, Google provided the most search engine referrals (over 30,000 in 2010) to the site with Yahoo! in second place but a massive margin. But most visitors (over 90%) come straight here!

When I started this blog I really had no plans or expectations of where it might lead so I had no idea that I would end up here.

There are two things that give me immense satisfaction from running this site though.

The first is that the National Prescribing Centre incorporated a blog into their interactive site based on the success this site.

The second is the occasional feedback I get from readers telling me that what I write is useful to them and is helping them in their work.

So, if you like what I do here post me a comment below and to use the words of Frankie Howerd, "If you've enjoyed it, tell your friends!".

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NICE Guidance - January 2011

The National Institute of Health and Clinical Excellence has published new guidance for the month of January 2011. This month there is one clinical guideline and one technology appraisal that impact upon primary care.

The anxiety clinical guideline is a partial update (PDF). It provides evidence-based advice on the care and treatment of adults with generalised anxiety disorder or panic disorder with or without agoraphobia.

The technology appraisal reviews (PDF) the role of aripiprazole for schizophrenia in people aged 15 to 17 years. Aripiprazole is recommended when risperidone is contraindicated, poorly tolerated or provides inadequate control of symptoms.

Action: Clinicians should be aware of these recommendations and implement any necessary changes to practice.

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Dronedarone linked to liver injury

The manufacturer of dronedarone (Multaq®) has written to healthcare professionals warning of severe liver injury associated with use of the drug. The Medicines and Healthcare products Regulatory Agency (MHRA) have also issued a warning (PDF).

Dronedarone is licensed for use in clinically stable patients with a history of or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or lower ventricular rate.

Cases of liver injury have been reported with 2 cases requiring transplantation. Liver function tests are advised before starting treatment, on a monthly basis for 6 months, at 9 and 12 months after initiation and periodically thereafter. Patients who are already on treatment should also undergo liver function testing based on this advised frequency of testing.

If alanine transferase (ALT) is elevated to greater than three times the upper limit of normal the level should be rechecked within 48-72 hours and if confirmed treatment should be withdrawn.

Action: Clinicians should be aware of this warning and the new monitoring requirements. The manufacturer will be updating the prescribing information shortly.

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