Perspective - Do ‘generics’ threaten patient safety?

15 January 2010

by Joanne Curran, associate editor, MDDUS 

GETTING value for money has become something of a government mission in these cash-strapped times of recession. And as all political parties make increasingly grim spending cut predictions for the years ahead, the NHS, as Europe’s largest employer, will surely not escape this belt-tightening.

It is this need to cut costs wherever possible that has prompted the latest consultation from the Department of Health. They are keen to increase the use of generic drugs in a bid to cut the annual £9billion bill for branded drugs. Currently around 83 per cent of prescriptions issued by the NHS are for generic drugs but ministers want this to rise by around five per cent. They say the move is “sensible” but it has received mixed reactions from doctors.

Automatic switch
The government has released a list of 40 drugs that – under the proposals – would be automatically switched to generic versions by pharmacists – even when branded drugs are indicated by a GP on the prescription. Pharmacists would also be handed the power to routinely switch the list of drugs to generic versions unless the GP specifically writes the acronym NGS (not for generic substitution) next to the name of the drug on the prescription.

It sounds relatively painless and the DoH say it could save £41million a year. They have already dismissed alternative approaches, including an ‘opt in’ model where the GP would have indicated on the prescription when they think generic drugs would be a suitable alternative to branded medication. They also ruled-out a tick-box system allowing GPs to indicate on a prescription if substitution is suitable, branding it too complicated and expensive.

Instead, the DoH hope publishing a list – which includes common drugs like ramipril, simvastatin and dicofenac – and giving GPs the option to veto substitution via the NGS tag will suit everyone.

Patient safety
Health minister Mike O’Brien insists patient safety is the top priority and, for that reason, drugs with a narrow therapeutic index like epilepsy drugs will not appear on the substitution list.

He said: “Where clinically appropriate, it is only sensible to allow more expensive branded products to be substituted with the same generic medicines which are just as effective as the branded version. Patient safety is always our top priority.

"This consultation includes options that ensure patient safety by limiting generic medicine substitution as appropriate and always giving prescribers the flexibility of opting out so that they can continue to tailor treatment to an individual patient’s clinical need according to their medical history.” Generic substitution, he said, will deliver that all-important “value for money and savings to the NHS”, which will be reinvested in the health service, thus benefiting patient care.

The Royal College of General Practitioners supports the prescription of generic medicines “where appropriate” and has promoted the practice for several years. Chairman Steve Field said the college was considering its response to the DoH consultation and added: “We know that the vast majority of GPs would agree that prescribing generic drugs ultimately saves money for the NHS, whilst not reducing the quality of care provided.” He said the RCGP promotes closer working relations between GPs and pharmacists and that the college was working with the Royal Pharmaceutical Society as part of this drive.

Difficult transition
But not everyone is happy with the proposals. Dr Peter Fellows, a member of the GPC’s prescribing subcommittee and a GP in Lydney, Gloucestershire, said the UK already prescribes more generic drugs than any country in Europe. And he fears the new plans threaten both patient care and the pharmaceutical industry. He said patient care would be put at risk because “most GPs won’t have the time to do it because of the sheer volume of prescriptions they get through”. He added: “The government seems hell-bent on this but it’s an absolute nonsense and an insult to general practice.”

The proposals received a cautious welcome from Dr Bill Beeby from the BMA. He said: “There are difficulties involved in introducing the substitution of generic drugs for branded products and for this to work there will need to be changes to prescription forms and computer systems.” He emphasised the need to focus on patient safety and minimising the chances for errors. He added: “There are certain patient groups, for example those with epilepsy, where changes in medication could have serious consequences. The proposal to target specific drugs where these risks are not present recognises those concerns, but it is still unlikely to be an easy process, and may not be the best way to achieve the desired cost savings."

Mary Baker, president of the European Federation of Neurological Associations warned of a potential risk to the outcomes of “thousands of patients” from the introduction of automatic generic substitution. She said: “It is already difficult for patients with long-term illnesses or with several conditions to keep up with all the different medicines they have to take each day. Complicating this further by introducing automatic generic substitution could make patients even less likely to take their medicines correctly.”

In some cases, substitution is not possible. A number of medicines have no generic equivalent and substitution is not always appropriate on clinical grounds. Richard Barker from the Royal Pharmaceutical Society seemed to be in favour of the move, provided “patients' health and safety is not compromised". Meanwhile, Warwick Smith, director of the British Generic Manufacturers Association, said the proposals offered a "perfect balance" between the need for the NHS to gain maximum value from medicines, and unfounded concerns that patients would lose out. He said: "The reality is that generic medicines are approved to the same standards of safety, quality and efficacy as the equivalent brands and offer cost savings of up to 90 per cent."

The 12 week consultation will close on March 30, 2010.