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Government launches consultation on generic substitution

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Government plans to force pharmacists to routinely substitute branded medicines for generic versions could compromise patient safety, specialist nurses have warned.

The Department of Health has announced it will launch a formal consultation later this year on plans to make the automatic generic substitution of medicines compulsory in UK pharmacies.

Under the proposed changes, pharmacists would be obliged to routinely dispense a generic version of a drug or treatment, regardless of whether the prescriber has specified a brand name product.

Only in cases where a “do not substitute” box has been ticked would the pharmacist not have to replace a branded medicine with a generic one.

Reading University professor of prescribing and medicines management Molly Courtenay said nurse prescribers should ensure they use this option to avoid confusion and to safeguard patients.

“There could be problems with medication adherence if this box is not ticked, particularly in patients for whom nurses frequently prescribe such as those with long term conditions and multiple co-morbidities,” she said.

“Many nurse prescribers are involved in authorising repeat prescriptions and it is their responsibility to make sure that medicines on the repeat prescribing list are acceptable and safe for patients,” she added.

Automatic generic substitution could see some patients effectively switching between medicines that are absorbed at slightly different rates.

Southport community healthcare’s epilepsy specialist nurse Kim Morley said this may not cause problems for some patients but in those with conditions such as epilepsy, where maintaining a precise level of active ingredient in the bloodstream is paramount, it could lead to serious adverse events.

“Epilepsy drugs have different half lives and it is vital to get the balance right,” she said “If blood levels are altered, or a patient forgets to take just one tablet, they could have a seizure.

“Changing their medication could also make patients anxious and fearful which can also bring on a seizure. The charity Epilepsy Action is campaigning for patients with epilepsy to be exempt from generic substitution,” she added.

Generic substitution was originally scheduled to begin in January 2010 as part of a new drug pricing deal with the pharmaceutical industry. However, a DH spokesperson said it would await the outcome of the consultation process before any final decisions are made.

“This a complex issue with many interested stakeholders. We want to make sure we engage with all stakeholders in the best way possible and we therefore intend to formally consult in the autumn on our proposals for implementation,” he said.

“How we implement generic substitution, and to what timetable, will be influenced by the outcome of this consultation process,” he added.

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