Safety fear delays generic drugs scheme

Plans to allow pharmacists to save the NHS money by overruling doctors' prescriptions for branded medicines have been delayed after concerns about patient safety and compliance.

Months after the Department of Health was expected to announce detailed guidelines, it is poised instead to launch a formal consultation triggered by criticism from doctors, patients and companies.

The policy, known as generic substitution, is designed to save money by allowing pharmacies to switch from a more expensive branded medicine listed on a prescription to a cheaper generic equivalent.

Doctors already write most prescriptions using the generic drug name, allowing automatic substitution by pharmacists to the cheapest equivalent version, but they retain discretion to demand a particular brand if they believe it has special merit.

The substitution idea, agreed by the pharmaceutical industry as part of a new medicines package negotiated last year with the government, was designed to exploit the fall in the price of drugs once their patents expire and competitors launch lower cost versions.

But a number of groups including patient organisations and trade associations have demand a formal consultation after expressing concerns that generic medicines are not always identical. Some drugs, such as those for epilepsy, produce a different reaction in patients.

Others contain the same chemicals but are formulated in different ways, which may affect patients' compliance with the prescription, such as with a less appetising taste, a larger sized pill or in a liquid rather than solid form.

Officials have told trade organisations that preparations for pandemic flu stalled discussions over how the Department of Health would implement the idea, and they have now decided to launch a formal consultation, further delaying any launch of generic substitution.

Peter Martin, chief operating officer of Norgine, a privately held speciality medicines business, said his company would be likely to discontinue making its treatment for constipation if the substitution plans went ahead.

He argued that patients and nurses knew the advantages of its drug - which proved popular because of a special formulation including its chocolate flavour - but it would be too costly to prove the clinical benefit required to prove its distinctive position.