By Yvette Martyn
A warning from the medicines regulator on the dangers of switching immunosuppressants has cast doubt over the safety of Government plans for automatic generic substitution by pharmacists.
The Medicines and Healthcare products Regulatory Agency warned the immunosuppressant, cyclosporine, should be left out of plans for a pharmacist to substitute a drug for a generic version even if a doctor has prescribed a brand.
The MHRA has stated that including cyclosporine in the scheme would mean patients could receive a different brand of the drug. This could lead to changes in bioavailability and patients may suffer a transplant rejection as a result.
The National Kidney Federation agree with the warning, chief executive, Timothy Statham 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.’
The Department of Health said they have built in safeguards in the proposal which would allow a prescriber to insist a particular brand is not changed, a spokesperson said: ‘The Department’s preferred approach, option three, contains mechanisms to ensure patients continue to receive the most appropriate treatment and prescribers can continue to use their clinical judgement in prescribing medicines according to the needs of individual patients.’
Warning on generic substitution for renal patients