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Safety fears over pharmacist generic substitution plans

By Nigel Praities

Pharmacists will be allowed to routinely dispense generic treatments even when GPs specify a branded product from next year, as part of a new deal on drug pricing.

The Department of Health expects the proposals to being 5% year-on-year savings on the annual NHS drugs bill.

Generic substitution will be allowed from January 2010 as part of the agreement with the pharmaceutical industry, with GPs having to tick a box to prevent pharmacists from replacing a proprietary medicine with a generic alternative.

Certain exemptions will be made ‘on clinical grounds', but the Government warns ‘adjustments' to the scheme will have to be made if too many GPs tick the do not substitute box, ‘to correct any under- or over-delivery'.

That raises the prospect GPs could lose the right to prevent pharmacists overruling their selection, at least in some clinical areas.

Dr Bill Beeby, chair of the GPC clinical and prescribing subcommittee, said the plan represented a ‘fundamental shift' that had significant risk for patients.

‘In practice this is going to be very difficult to work and it is very difficult to understand how they are going to get significant savings. The idea of global generic substitution does not have a lot of mileage these days, because so much prescribing is done generically already.'

Dr Henry Smithson, a GP in Escrick, North Yorkshire and chair of the NICE epilepsy guideline development group, said inappropriate generic substitution for certain drugs, including epilepsy formulations, could may cancel out any savings gained.

‘If chemists change these formulations and the patient has a seizure, then legal action may result with the accompanying costs,' he said.

Pharmacy leaders also expressed concern. Steve Churton, president of the Royal Pharmaceutical Society of Great Britain, said a number of medicines either had no generic equivalent, or were not appropriate for substitution, such as slow-release formulations.

‘There needs to be clear guidance for prescribers and pharmacists on when generic substitution is appropriate and patients must be provided with relevant advice and reassurance from their pharmacist,' he said.

The Government's deal includes a cut in the cost of drugs to the NHS of 3.9% from February 2009 and more flexible pricing arrangements where pharmaceutical companies can supply drugs to the NHS at lower prices initially.

Health Secretary Alan Johnson welcomed the scheme as ‘delivering value for money for the NHS and the tax payer'.

Where generic substitution may be inappropriate

Epilepsy medications: NICE advise continuing the same formulation of anti-epileptic drugs to avoid the possible risk of changes in bio-availability and risk of seizures

Antiarrhythmic/ anticoagulation drugs: Often have a narrow therapeutic index, above which efficacy is seen and below which toxicity is avoided

Asthma/ COPD inhalers: design and method of operation often differ between dry powder inhalers

Statins: Recent data suggest high-dose simvastatin treatment may increase the risk of myopathy

Hydrocortisone: branded versions are often cheaper than generic versions

Statins are one of the categories of drug over which there is concern about pharmacists switching patients to a generic alternative Statins are one of the categories of drug over which there is concern about pharmacists switching patients to a generic alternative

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