22nd July 2014 SE1 7 JN Abiodun Aderogba Reclassification Unit MHRA Room 3-M 151 Buckingham Palace Road London SW1W 9SZ CONSULTATION DOCUMENT: ARM 88; NEXIUM CONTROL 20MG GASTRO-RESISTANT TABLETS REQUEST TO CLASSIFY A PRODUCT AS GSL Response from the Guild of Healthcare Pharmacists Thank you for the opportunity to respond to this consultation. The Guild of Healthcare Pharmacists represents UK wide around 4,000 pharmacists including the majority of hospital pharmacists, pharmacists employed by NHS Primary Care organisations and pharmacists employed by other public bodies such as Prisons and the Care Quality Commission. The Guild is part of the health sector of the union Unite. We do not support this reclassification request for the reasons given below. Our response has been endorsed by the Royal Pharmaceutical Society: We are concerned that the availability of Nexium Control Gastro-resistant tablets will lead to increased and uncontrolled accessibility resulting in inappropriate use and patients experiencing potential but avoidable adverse effects. There are reports of PPIs causing a range of adverse effects that include alteration of absorption of vitamins and minerals, metabolic effects on bone density, alteration of pharmacokinetics/ pharmacodynamics and related drug interactions (e.g. methotrexate), or alterations of intended effect, infection risk (C difficile) and hypersensitivity response. Whilst the cause of these effects is not clear and the evidence base to support a clear association for harm is variable, we feel that professional intervention is required before the public purchase and use these medicines or waste their money when less costly but equally beneficial and potentially safer options are available. Initial treatment should include lifestyle modifications (such as smoking cessation, dietary changes, weight loss, and reduction in alcohol intake), which could be promoted through consultation with a community pharmacist. There is an overuse of PPIs in the treatment of common heartburn. Examination of the use of PPIs in the USA shows that the relatively high advertising, and promotion to doctors, has led to PPIs being among the highest-selling classes of medicines with $9.5 billion in sales last year, and, according to IMS Health, Nexium is the top-selling of all medicines, earning $6.2 billion in 2013. The pharmacist is in a position to offer advice on appropriate medication if this is necessary. Antacids and histamine-2 receptor antagonists may help in milder cases of gastro-oesophageal reflux disease. It is President: Dave Thornton Professional Secretary: Barry Corbett Email: [email protected] Website: www.ghp.org.uk 1 acknowledged that PPIs achieve better gastric acid control for longer duration than do histamine-2 receptor antagonists, and provide more rapid symptom relief and are more effective at healing damaged tissue but it is appropriate for health professionals to provide evidence-based patient education and counselling on available treatments. Further, there is very little guidance about how to stop PPIs. These medicines should not be stopped suddenly as rebound hyperacidity can cause unbearable heartburn. Patients who take PPIs for a long time can really suffer and the excess acid production can last for several weeks. Gradual withdrawal over two or three months may be necessary. Pfizer’s claim that the selfselection OTC model proposed for Nexium Control is centred on the OTC labelling ensuring appropriate and safe self-selection by consumers is very questionable in our view. In conclusion, the potential adverse effects of PPIs should be not overlooked but put in perspective relative to the vast numbers of patients who use them. The clinical risk/benefit of any medical intervention should be evaluated for each patient to determine appropriate use of therapy. The patient should be encouraged to discuss their specific concerns with a health professional whenever they experience reflux symptoms. Acid-suppressive drugs should be used in vulnerable individuals only when necessary and with the lowest possible dose. Not everyone who experiences heartburn needs a PPI. The use of PPIs would be increased through greater accessibility of Nexium as a GSL medicine, leading to increased profitability to Pfizer but not necessarily appropriate or safe treatment for patients and with greater cost to the public. The clinical effects should always be reviewed and attempts made to stop any therapy that may not be needed. These important interventions would not be possible if this PPI was changed to a GSL classification. Reliance on OTC labelling for ensuring appropriate and safe selfselection by consumers is totally inadequate for this type of medicine. We hope these comments are of assistance. Our reply may be made freely available. Yours faithfully Barry Corbett Professional Secretary Guild of Healthcare Pharmacists Graeme Richardson Chair of Practice Guild of Healthcare Pharmacists 2
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