Wednesday, 9 December 2009

Bedtime reading: drug safety update Ciclosporin

Ciclosporin must be prescribed and dispensed by brand name. The medicines and healthcare products regulatory agency issued a drug safety update at the beginning of December emphasising the importance of prescribing and dispensing Ciclosporin by name. Ciclosporin has a narrow therapeutic index which means that the dose has to be very carefully adjusted to ensure the blood and tissue levels are spot on, not just close, and patients should be stabilised on a single brand of Ciclosporin because switching between different types or formulations without close monitoring may lead to clinically important changes in blood levels even if the same dose is taken. For kidney transplant recipients that risks rejections or toxicity from the Ciclosporin. All products that contain Ciclosporin are interchangeable ONLY if careful therapeutic monitoring takes place. Prescribing and dispensing of Cyclosporin should therefore be by brand name to avoid inadvertent switching. Patients as well as prescribers and pharmacists should be fully aware of the brand prescribed. It’s important for patients to challenge the prescriber of pharmacist if a different brand or formulation seems to have been provided eg if the drugs look different in colour or shape or even when the box or packing have changed. If switching of a patient stabilised to one brand of Cyclosporin is unavoidable, the patient should be closely monitored for side effects. Ciclosporin drug concentrations, serum creatinine levels, blood pressure and transplant function must be monitored if a switch is to be made.