Patients will be at risk unless drug rules are overhauled, experts warn

Patients are being put at risk by excessive red tape blocking access to affordable, licensed drugs, experts have warned as rules on unlicensed medicines come under fresh scrutiny.

Dr Sharma: 'Now is the ideal time to re-evaluate the balance from focusing on the cost to focusing on safety'
Dr Sharma: 'Now is the ideal time to re-evaluate the balance from focusing on the cost to focusing on safety'

The use of unlicensed medicines is being re-examined as a legal challenge begins over the use of cheap unlicensed therapy in place of the licensed drug ranibizumab (Lucentis) and the GMC halts its plans to ease barriers on using unlicensed drugs.

A leading GP researcher, a GP prescribing lead and a team from Manchester University have all said the current situation shows the need for a rethink of drug research and licensing.

Dr Paul Wallace, who oversees primary care work at the National Institute for Health Research, said there needed to be ‘an appropriate balance between minimising costs and ensuring safety is not compromised’.

‘The current system is weighted too heavily towards the latter,’ he told GP. ‘More flexible systems are needed to ensure that costs are reduced as much as possible without compromising safety.’

‘Clearly the drug companies have an interest in ensuring that their licensed products retain a monopoly position for as long as possible, but responsible companies will readily understand the need to reduce the costs to the NHS where this is appropriate.’

Manchester GP Dr Anita Sharma, who represents her LMC on Oldham's medicines management committee, said the move to clinical commissioning offered the opportunity to reassess the situation.

‘With the transition from PCTs to GP clinical commissioning groups, now is the ideal time to re-evaluate the balance from focusing on the cost to focusing on safety,’ she said.

Dr Sharma said she was surprised clinicians had agreed even if pressurised to prescribe an unlicensed drug and would not herself prescribe an unlicensed drug when a licensed alternative was available.

‘Prescribing an unlicensed drug because it is less expensive will certainly achieve some savings, but this a myopic vision,’ she said. ‘Imagine if this results in patient's harm including hospital admission – is this a risk worth taking?’

Nobel Prize winner Professor Sir John Sulston and colleagues from Manchester University said the current systems were putting patients’ lives at risk.

‘These not only impose unnecessary financial costs on healthcare systems, they have detrimental effects on hundreds of millions of people, and for too many remain literally a matter of life and death,’ they said.

Dr Wallace and the Manchester team’s warnings came after drug company Novartis began judicial proceedings against Southampton, Hampshire, Isle of Wight and Portsmouth (SHIP) PCT cluster.

Novartis is seeking to stop the cluster funding age-related macular degeneration treatment using unlicensed bevacizumab in place of the licensed treatment ranibizumab (Lucentis).

The action follows news that the GMC has halted its plans to support wider use of off-label or unlicensed drugs.

The GMC had concerns the changes would breach EU rules and it is now seeking further advice and examining whether to amend its guidance on ‘off-label’ drug use.

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