The Irish Medicines Board has decided to support generic substitution.
According to IMB Chief Executive Pat O'Mahony, "While the IMB ... has no involvement in product pricing structures or agreements, we welcome any initiative that improves value for money and ensures the continued provision of innovative medicines as they become available.”
“Value” to whom? And, last time we looked, such a policy actually strikes against innovation.
Mr. O’Mahony would be wise to remember the old Irish proverb, “Everyone is wise until he speaks.”
In the meantime, just across the Irish Sea in Great Britain, our regulatory cousins at the MHRA have are concerned about generic substitution as well – specifically for oral tacrolimus. The MHRA says it has received 12 case reports of prescribing or dispensing errors associated with the immunosuppressant, oral tacrolimus, which has a narrow therapeutic index.
There are three different oral formulations of tacrolimus available in the UK, but they are not interchangeable, and switching between them should only be performed under the close supervision of a transplant specialist, the MHRA recommends. The reports have included four cases of acute rejection reaction, three cases of increased drug levels, and two cases of increased creatinine.
Generic drugs are a hugely important part of the healthcare paradigm – but bioequivalence cannot be ignored.
