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Advice highlights risk of Automatic Generic Substitution

A drug safety warning from the MHRA on the dangers of switching immunosuppressants calls into question the safety of the Department of Health’s proposal for Automatic Generic Substitution.

Automatic Generic Substitution is a scheme proposed by the Department of Health whereby pharmacists could be obliged to substitute a generic version of a medication, even if a prescription were for a specific brand. The advice from the MHRA is that all products that contain ciclosporin, one of four classes of immunosuppressants, must be prescribed and dispensed by brand name, to minimize the risk of inadvertent switching between brands.

Ciclosporin is used for the prevention and treatment of transplant rejection, psoriasis, atopic dermatitis, rheumatoid arthritis and nephritic syndrome. Switching can lead to clinically important changes in bioavailability, which could potentially lead to a transplant rejection [1,2].

The principle of not switching between different brands or generics due to changes in bioavailability has also been highlighted by the National Patient Safety Agency (NPSA), who recently issued guidelines for the treatment of bipolar disorder with lithium [3]. The NPSA stated that systems should be in place to identify and deal with the numerous medicines that might adversely interact with lithium therapy.

This resonates with a drive from a group of multidisciplinary healthcare professionals and patient groups who have highlighted the risks of generic substitution in the paper ‘Automatic generic substitution – clinical implications for patients’. The paper reports that generic substitution has the potential to be disruptive to the medication regimens of any patients and impact upon adherence.

There is also potential for under treatment or adverse events in some individuals. The Department of Health is holding a public consultation, open until 30 March; the group urges the Department of Health to reconsider the proposal altogether.

Timothy F. Statham OBE, Chief Executive of the National Kidney Federation, said: ‘Treating renal patients is extremely complicated – some take up to 24 medications per day. They have to take so many drugs that no substitution is safe; any changes to their treatment must be decided by the originating prescriber and no one else. We welcome the warning from the MHRA, and urge the Department of Health to exclude all renal patients if Automatic Generic Substitution is to go-ahead.’


1 MHRA. Drug Safety Update, December 2009.
2 Taber, D.J. et al. (2005) 'Does bioequivalence between modified ciclosporin formulations translate into equal outcomes?' Transplantation 80: 1633–1635.
3 National Patient Safety Agency. (2009) 'Close monitoring of patients prescribed lithium will reduce harm'.

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