Call To Action Against Inadvertent Switching Of Ciclosporin Formulations With Potential Safety Implications For Transplant Patients

Main Category: Transplants / Organ Donations
Article Date: 29 Sep 2009 - 0:00 PDT

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The ESPRIT* Group of leading UK transplant clinicians, pharmacists, and primary care representatives is calling today for greater awareness of the potential risk to transplant patients of an inadvertent change in their immunosuppressive therapy. This follows the introduction in the UK of Deximune®, a new formulation of the immunosuppressant ciclosporin.

Ciclosporin is a valuable drug in helping prevent rejection following organ transplantation but it is a critical dose drug with a narrow therapeutic window. This means that ensuring individual patients receive the right dose is crucial for the drug to be fully effective: too much may risk toxic effects and too little may lead to an increase in the risk of rejection. Different formulations of ciclosporin are absorbed and metabolised differently in patients and this may lead to different blood concentrations being reached. It is therefore vitally important that patients who have been stabilised and maintained on a particular formulation of ciclosporin are not switched inadvertently between different preparations. To maintain efficacy and ensure safety when switching ciclosporin brands patients need to be closely monitored for side effects, drug concentrations and transplant function.

The ESPRIT Group believes that the simple act of prescribing ciclosporin by a specific brand would ensure that patients are maintained on the formulation on which they were stabilised. Following the launch of the new formulation, the group is reminding clinicians and pharmacists of the importance of the specific guidance provided by the British National Formulary (BNF): 'Because of differences in bioavailability, the brand of oral ciclosporin to be dispensed should be specified by the prescriber1.' In addition, the group has been providing transplant clinics with leaflets, posters and treatment identification cards to help educate patients.

Dr Rod Smith, a Reading GP and representative of the ESPRIT Group, added: 'GPs and nurses are in a prime position to educate and support patients who have been transplanted. The need to raise awareness of this issue is clear: survey data show that over 80% of GPs are unaware of the BNF recommendation suggesting that ciclosporin should be prescribed by brand2. This could clearly impact the health of transplant patients and is something the ESPRIT Group want to communicate to all those involved in the ongoing care of transplant patients.'

Commenting on the importance of heightened awareness of inadvertent switching between ciclosporin formulations, Dr. Donal O'Donaghue, Renal Czar and Consultant Renal Physician, said: 'Now that more than one brand of ciclosporin is available all involved with the care of transplant patients, from hospital specialists to pharmacists, nurses, GPs - and most importantly the patients themselves - need to be fully aware of the need for vigilance with regard to this.'

Some of the most influential patient groups in this area welcome the support being offered by the ESPRIT Group:

Timothy Statham, from the National Kidney Federation (NKF), states: 'The three most valuable assets surrounding a transplant are the donor, the graft itself and the recipient. The protection of all three is paramount. The NKF therefore believes that for Kidney Patients, medicines should only be "switched" by the prescriber themselves and by no one else.'

Alison Rogers, Chief Executive of the British Liver Trust, comments: 'The British Liver Trust welcomes the recommendations of the ESPRIT Group and the opportunity for patients to gain greater access to information that will help to empower them. Encouraging liver patients to be informed about their medication is essential and can ensure they take a greater role in their treatment.'

References:

1. Electronic British National Formulary (eBNF). Available here: http://www.bnf.org/bnf/ Accessed September 2009.
2. Synovate survey, February 2006

Source
The ESPRIT Group