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NICE guidance on paracetamol could increase risk of harm to patients, warn experts

Exclusive NICE is facing mounting pressure to rethink its advice that paracetamol should not be used routinely in patients with osteoarthritis, with the RCGP warning it will impose a ‘massive workload exercise’ on GPs and other experts warning it could increase risks to patients.

Pulse has learnt that the RCGP, the Primary Care Rheumatology Society (PCRS) and the British Society of Rheumatology have all written to NICE to strongly criticise its draft recommendation that paracetamol should no longer be prescribed routinely for pain relief in patients with osteoarthritis,which was first issued last summer.

In its official response to NICE on the proposals, the PCRS said the advice would remove paracetamol as the ‘cornerstone’ of pharmacological self-management of pain and might increase the use of opiates.

The RCGP said the guidance would have ‘enormous, far-reaching consequences’ and warned NICE had not considered how widely paracetamol and paracetamol-containing preparations were used by this population of patients.

The draft guideline was issued last August and almost immediately ran into trouble, with the UK medicines regulator the MHRA saying at the time that there was ‘no new evidence’ to support the draft guidance.

The Scottish Intercollegiate Network (SIGN) launched new guidance last month on chronic pain, which continues to recommend using paracetamol first-line in osteoarthritis.

Dr Martin Johnson, RCGP clinical champion for chronic pain, questioned the decision in the RCGP’s official response to the NICE consultation, stating: ‘I would like more evidence around the efficacy and safety concerns.’

He added: ‘If we are to advise the many millions of people to reduce their paracetamol (and co-codamol etc), exactly what advice would we give them and over what time scale? This will be a massive workload exercise.’

Speaking to Pulse, Dr Johnson said the guidance would have ‘enormous, far-reaching consequences’.

He said: ‘If NICE are saying something different to SIGN and MHRA and everyone else that is going to cause confusion. They should do something unusual and have a further stakeholder meeting and talk about how they are going to tackle this issue – to show the evidence they are looking at and ask what others think.’

‘It would be great if they did something rather than just launch it, particularly for primary care where most of the prescribing is done but also for pharmacists who are going to get a lot of flak over this – pharmacists and dispensers are going to need to have a lot of education.’

The PCRS response said that such a significant step needed a full review of analgesics including combined opiate and paracetamol preparations.

It continued: ‘We feel that if this step was deemed necessary either on grounds of lack of effectiveness or on safety grounds then the MHRA should be involved to advise on the continued licence indications and over-the-counter status of paracetamol.’

‘In its current form we feel this guidance could increase the inappropriate [use of] opiate and combined preparations, with greater risks to patients.’

A spokesperson from SIGN told Pulse it had not changed its position on the safety of paracetamol and was continuing to recommend the usual dose of paracetamol of between 1,000 and 4,000 mg per day in osteoarthritis – and not a low dose of 1,000 mg per day as it had originally published in new chronic pain guidance last month.  

The spokesperson said NICE’s evaluation of the evidence on paracetamol underestimated the benefits of the drug, while the evidence of its harm ‘was weak and likely due to confounding’.

She said: ‘We understand the guideline group for the revised NICE osteoarthritis guidance excluded some studies that were considered before and this resulted in a smaller effect size for benefit than where all the studies were considered. As a result of this the effect size for paracetamol is not very great and smaller than, for example, with NSAIDs. However this has always been the case.’

‘We gather that another reason for advising against paracetamol was observational studies, which suggested that paracetamol might be associated with an increased risk of gastrointestinal events and cardiovascular events. However when one looks at these studies there is a strong possibility that the apparent association is due to the fact that patients treated with paracetamol have been selected for this treatment because they are high risk to start with.’  

The BMA did not submit a consultation response to NICE, but Dr Bill Beeby, deputy chair of the BMA’s clinical and prescribing subcommittee, told Pulse GPs would not necessarily change their practice even if NICE went ahead with the recommendation.

He said: ‘Of course if there is strong evidence of harm then of course we need to change. It’s just that at the moment that evidence doesn’t seem to be compelling.’

NICE refused to comment at this stage on whether it would be revising the draft advice on use of paracetamol.

A NICE spokesperson said: ‘In developing the guideline update we take all consultation responses received on the consultation draft into account, and no further comment is made on the development of guidance in the interim. The final guideline update is due to be published in February.’


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