MHRA Arm88 Request toreclassify Nexium Control 20mg Gastro

22nd July 2014
SE1 7
Abiodun Aderogba
Reclassification Unit
Room 3-M
151 Buckingham Palace Road
London SW1W 9SZ
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]
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