Recent MHRA advice on the treatment of patients with ciclosporin has highlighted the potential dangers of automatic generic substitution, according to European speciality pharma Norgine.

Late last year the UK regulator issued advice to doctors that the immunosuppressant ciclosporin must be prescribed and dispensed by brand name, as small differences in bioavailability between different formulations of the drug can alter blood concentrations in patients stabilised on a specific brand, leading to potentially serious complications such as transplant rejection in renal patients.

And because of potential fluctuating bioavailability between the different forms of ciclosporin patients taking the drug could be at risk under the government’s proposals for automatic generic substitution, whereby pharmacists are required to dish out cheaper generic version of medicines even if doctors have specifically prescribed their branded counterparts, Norgine claims.

Government plans for automatic generic substitution are currently up for consultation until March, and if the scheme is ultimately given the go-ahead then all renal patients should be excluded from the policy, says Timothy Statham OBE, head of the National Kidney Federation.

“Treating renal patients is extremely complicated – some take up to 24 medications per day,” he explained. “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”, he stressed.

The dangers of changes in bioavailability from switching between different versions of a medicine have also been highlighted by the National Patient Safety Agency, which has recently issued guidelines for the treatment of bipolar disorder with lithium to avoid such scenarios.

Negative impact
In addition, a group of multidisciplinary healthcare professionals and patient groups - funded by Norgine - published its fears over the risks of generic substitution last Summer in the paper Automatic generic substitution – Clinical implications for patients, claiming that the scheme could end up confusing patients, disrupting drug regimens and thereby affect compliance and treatment outcomes.

The DH, however, insists that increasing the proportion of generic prescriptions by just 5% could save the NHS some really big bucks which could be redirected into patient care. According to Health Minister Mike O’Brien, generic substitution will “deliver value for money and savings to the NHS which will go directly back into health services, ultimately benefiting patients and improving the care they receive.”