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Safety and compliance fears delay UK’s generics substitution Posted 09/10/2009

Plans to allow pharmacists to save the UK’s National Health Service (NHS) money by overruling doctors' prescriptions for branded medicines have been delayed after concerns about patient safety and compliance.

Months after the UK’s 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 automatic 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 demanded 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 UK’s Department of Health would implement the idea, and they have now decided to launch a formal consultation, further delaying any launch of generic substitution.

The UK’s Department of Health plans to conduct a full, formal consultation on the arrangements for the implementation of automatic generic substitution this autumn.

This will be welcome news to many who have serious concerns about the clinical implications that compulsory generic substitution would have for patients.

The decision follows representations made by patients, healthcare professionals and pharmaceutical companies opposed on several grounds to the Association of the British Pharmaceutical Industry’s proposal, initially rejected but subsequently accepted by the UK’s Department of Health, to introduce automatic generic substitution in January 2010.

The intention to conduct a formal consultation will be welcomed by many stakeholders who have petitioned the UK’s Department of Health to go public on the proposal to ensure that the practical impact of generic substitution on patient outcomes, as well as safety, concordance and the NHS medicines bill, is considered.

Earlier this year, the paper Automatic Generic Substitution: Clinical implications for patients highlighted the need for public consultation. The paper was written and endorsed by a multidisciplinary group of healthcare professionals and patient groups, while pharma manufacturer Norgine, a privately held speciality medicines business, provided funding for the group.

In addition, a growing number of parties have signed a petition calling for public consultation, hosted at http://petitions.number10.gov.uk/genericsubst/.

Mr Peter Martin, Chief Operating Officer of Norgine, 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. He said that it is vital that all stakeholders continue to raise issues with the Department of Health to ensure that all angles are covered in the proposed formal consultation. “We will continue to work with industry partners, healthcare professionals, professional bodies and patient groups to ensure that all voices are heard. We want to ensure the best outcomes for the patients and for the taxpayer,” said Mr Martin.

Mr Martin continued, “It is hoped that these open discussions, focusing on the key area of patient safety, will prevent the proposal of automatic generic substitution from being implemented in the UK.”

Source: Financial Times; Pharmajobs Home Page News

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