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| Trends in the Prescribing of Antacids and Ulcer Healing Drugs in England (Chart 1) |
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| Ulcer healing drugs are the top BNF section by cost for GPs in England. In the year to March 2000, £451 million was spent on ulcer healing drugs (8% of total prescribing costs). Managing patients with dyspepsia is an important part of most GPs' workloads. It is estimated that up to 40% of the adult population suffer from dyspepsia in any one year. About 10% of the population seek their GP's advice for dyspeptic symptoms each year and about 10% of these are referred on for a specialist opinion. The main causes of dyspepsia are gastro-oesophageal reflux disease (GORD) 15 to 25%, gastric and duodenal ulcers 15 to 25%, and stomach cancer 2%. The remainder (up to 60%) is classified as non-ulcer dyspepsia (NUD)1. |
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| Endoscopy - Urgent referral for further investigation such as endoscopy is strongly recommended for patients aged over 55 years with recent onset of dyspepsia (symptoms first presented less than 1 year ago) and/or continuous symptoms. Patients of any age who have any of the following ALARM Symptoms should be referred immediately: Anaemia (iron deficiency), Loss of weight (unexplained), Anorexia, Recurrent problems, Melaena, Swallowing problem2. |
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| Eradication of Helicobacter pylori - Eradication is recommended for all H. pylori positive patients with peptic ulcer (both duodenal and gastric ulcers). Results of trials of eradicating H. pylori in NUD are equivocal3. There may be some small benefit in terms of reduced symptoms but it may not be a cost-effective option. |
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| Trends in Spending on Antacids and Ulcer Healing Drugs in England (Chart 2) |
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| 50 to 70% of patients with NUD will continue to have symptoms of dyspepsia after eradication of H. pylori4. Near patient testing for H. pylori using serum antibodies is insufficiently sensitive and specific, but urea breath tests are more accurate. |
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| Triple therapy should be used for eradicating H. pylori. Suitable antibiotics are metronidazole (or tinidazole), amoxycillin and clarithromycin. Local geographical prevalence of antimicrobial resistance will determine whether it is best to start with a regimen based on metronidazole or clarithromycin. These two antibiotics should not be used together because of the risk of resistance developing5. |
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NICE guidance - July 2000 saw the publication, by NICE, of the technology appraisal guidance on the use of proton pump inhibitors (PPIs) in the treatment of dyspepsia1. The following summarises the main NICE recommendations:
- Patients with documented duodenal or gastric ulcers should be tested for H. pylori and, where positive, eradicating the infection is recommended. Long term acid suppressing therapy should not be used. Patients who are negative or who remain symptomatic after eradication therapy should be prescribed the optimal dose of a PPI if healing is required. Once healing has been achieved or for conditions where it is not required the lowest dose of the PPI that provides effective relief of symptoms should be used.
- Patients who have documented ulcers caused by non-steroidal anti-inflammatory drugs and who have to continue with NSAID therapy (e.g. patients with severe rheumatoid arthritis) should be prescribed an acid suppresser, usually a PPI. Once the ulcer has healed, the patient, wherever possible, should have the dose stepped down to a maintenance dose.
- Patients who have severe GORD symptoms or a proven pathology (oesophageal ulceration, Barrett's oesophagus) should be treated with a healing dose of a PPI until symptoms have been controlled. After this has been achieved, the dose should be stepped down to the lowest dose that maintains control of the symptoms. Should symptoms re-appear the higher dose should be recommenced. In complicated oesophagitis (stricture, ulcer, haemorrhage), the full dose should be maintained. Patients with mild GORD symptoms and/or those who do not have a proven pathology can frequently be managed by alternative therapies (at least in the first instance) including antacids, alginates or H2-receptor antagonists (H2RAs).
- Patients diagnosed with NUD should not be routinely treated with PPIs. Should the symptoms appear to be acid-related, an antacid or the lowest dose of an acid suppresser to control the symptoms should be prescribed. If the symptoms do not appear to be acid-related, an alternative therapeutic strategy should be employed.
- Patients presenting in general practice with mild symptoms of dyspepsia may be treated on either a "step-up" or a "step-down" basis.
- In circumstances where it is appropriate to use a PPI and where healing is required, the optimal dose to achieve this should be prescribed initially. Once healing has been achieved, or for conditions where it is not required, the lowest dose of the PPI that provides effective symptom relief should be used.
- The least expensive appropriate PPI should be used.
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| Charts 1 and 2 show National trends in prescribing of drugs for dyspepsia over the last 5 years. Prescribing of ulcer healing drugs has increased by 36%, whilst spending on these drugs has risen by 14%. For the quarter to June 1995 almost two-thirds of prescriptions were for H2RAs and one third for PPIs but 5 years later this pattern has reversed. PPIs now account for almost three-quarters of spending on ulcer healing drugs. Prescribing of antacids and other related drugs for dyspepsia has fallen by 10% in the last 5 years whilst spending on these drugs has shown an 8% increase. |
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| Proton pump inhibitors - Prescriptions for PPIs have increased by 139% to 2.6 million in the quarter to March 2000. Spending on PPIs has increased by 61% to £80 million per quarter. Omeprazole is still the most frequently prescribed PPI (49% items, 57% spending), followed by lansoprazole (41% items, 35% spending). |
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| H2-receptor antagonists - Prescriptions for H2RAs have fallen by 20% over the last 5 years to 1.5 million in the quarter to March 2000 with a corresponding decrease of 36% in spending to £29 million. Ranitidine accounts for 61% of H2RA prescriptions (65% of spending), compared to 26% of items and 23% of spending for cimetidine |
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| Cisapride - Just over 84,500 prescriptions were written for cisapride in the quarter to March 2000 at a cost of £1.8 million. However the Medicines Control Agency suspended the product licences for cisapride in July 2000. Patients should be changed to alternative treatments. |
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| Variation Between Health Authorities in Spending on Ulcer Healing Drugs (January to March 2000 - Chart 3) |
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| Antacids and other drugs for dyspepsia - For this BNF section compound alginic acid preparations are the most commonly prescribed, 84% of items (1.5 million) and 89% of spending (£5.4 million in the quarter to March 2000). Prescribing of compound alginic acid preparations has hardly changed over the last 5 years (1% increase) whilst spending has risen by 16%. |
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| Lifestyle modifications - Patients should be reminded that lifestyle changes: smoking cessation avoidance of alcohol and aggravating foods such as fats, weight reduction and raising the head of the bed may help to relieve some symptoms of dyspepsia. |
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| Prescribing indicators - A recent article in the British Medical Journal discussed the validity of prescribing indicators based on PACT data for measuring quality or cost of prescribing6. Two indicators for ulcer healing drugs were rated as having face validity for measuring cost (NIC/ DDD for ulcer healing drugs) and quality (DDD/ STAR-PU for ulcer healing drugs) respectively. Values for these indicators at practice, primary care group and health authority level can be obtained from the PPA's Prescribing Toolkit. All primary care groups who have access to NHSnet can use the Prescribing Toolkit by contacting the PPA. |
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| Use of ulcer healing drugs (DDD/STAR-PU) is highest in the North and North West of England and lowest in the Midlands and the South. Spending on ulcer healing drugs shows a different geographical pattern - spending (NIC/DDD) is lowest in the North and in Hertfordshire with areas of higher spending throughout the rest of England. This reflects differences in the types of ulcer healing drug prescribed. Health authorities with high use but lower spending are using relatively more H2RAs than those with high use and high spending (see Chart 3). |
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| NICE have estimated that if the advice in their technology appraisal is fully implemented, the usage of PPIs would fall by at least 15%. Primary care groups should review their current practice in the use of PPIs against the NICE Guidance. To enable clinicians to audit their own compliance with the Guidance, it is recommended that treatment plans be recorded for each patient with dyspepsia1. |
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References
1. National Institute for Clinical Excellence. Guidance on the use of proton pump inhibitors in the treatment of dyspepsia. Technology Appraisal Guidance No.7, July 2000.
2. Department of Health. Referral guidelines for suspected cancer. www.dh.gov.uk/assetRoot/04/01/44/21/04014421.pdf.
3. Danesh J, Pounder RE. Eradication of Helicobacter pylori and non-ulcer dyspepsia. Lancet 2000;355:766-767.
4. Veldhuyzen van Zanten SJO. Treating non-ulcer dyspepsia and H pylori. BMJ 2000;321:648-649.
5. De Boer WA, Tytgat GNJ. Treatment of Helicobacter pylori infection. BMJ 2000;320:31-34.
6. Campbell SM, Cantrill JA, Roberts D. Prescribing indicators for UK general practice: Delphi consultation study. BMJ 2000;321:425-428.
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Summary
- Most patients with dyspepsia do not have a specific diagnosis for their symptoms.
- Refer urgently for further investigation patients aged over 55 years with recent onset of dyspepsia or continuous symptoms.
- Refer immediately for further investigation patients with ALARM symptoms.
- Eradicate H. pylori in all H.pylori positive patients with peptic ulcer.
- Do not routinely treat patients with non-ulcer dyspepsia with PPIs.
- In circumstances where it is appropriate to use a PPI and where healing is required, prescribe the optimal dose to achieve this initially.
- Once healing has been achieved, or for conditions where it is not required, use the lowest dose of the PPI that provides effective symptom relief.
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