MORE than 200 unlicensed medicinal uses are set to be added to guidelines for drug-prescribing doctors and clinicians across the UK, following campaigning by a Gwent MP.
Torfaen MP Nick Thomas-Symonds’ Off-Patent Drugs bill was talked out of Parliament in 2015, before a government U-turn in January 2016 saw amendments to the law regarding off-label medicines.
On Monday, April 24, the MP chaired the All-Party Parliamentary Group on Off-Patent Drugs, where Kate Towers, the head of content at the British National Formulary, reviewed the medicines pending inclusion in the publication.
Mr Thomas-Symonds said: “Ever since I introduced my Off-Patent Drugs Bill into Parliament, in June 2015, I have campaigned for wider access to off-label drugs where there is sufficient evidence to show their clinical benefits.
“Drugs such as bisphosphonates, where the primary use is in the treatment of osteoporosis, can be very effective at preventing the spread of primary breast cancer to the bone.
“But the problem has been that such drugs are not prescribed as often as they could be, nor are they prescribed on a consistent basis across different parts of the country, and across different health centres.”
The British National Formulary is the “Bible” for those who prescribe drugs, and each medicine will now go through a rigorous evidence-based process considering safety and clinical effectiveness, due to be completed by the end of the year.
Mr Thomas-Symonds added that a series of pledges were put forward in the House of Commons regarding off-label medicines.
“After my Bill was talked out in November 2015, I continued to campaign on the issue, and, in January 2016, the government accepted changes to the law on off-label medicines, and made a series of pledges on the issue in the House of Commons.
“One of those pledges was a promise that evidence would be put together to include legitimate off-label, off-patent uses of drugs in an appropriate registry, the British National Formulary.,” he said.
“This is very important, as it will put the key information to prescribe off-label medicines on the desks of clinicians across the UK.
“Thus, a key aim for me in recent months has been to hold the government to its word.
“I am delighted to see that there has been such progress, from which many patients can benefit in the months and years ahead.”
Melanie Sturtevant, the policy manager at Breast Cancer Now, said: “It’s really encouraging that progress is being made in reviewing off-label treatments for inclusion in the British National Formulary (BNF).
“Inclusion in the BNF can help give healthcare professionals confidence in prescribing drugs that have been proven to be effective in a new use for which they are not licenced.
“It is a vital way to help ensure patients actually benefit from such breakthroughs in research.
“We now hope that crucial unlicensed treatments, such as tamoxifen for preventing breast cancer in women at increased risk – which has been in NICE guidelines since 2013 – will be included in the Formulary as a result.
“Moving forward, we also need to ensure that newly-discovered uses for drugs with robust evidence that are not in clinical guidelines – such as bisphosphonates for preventing secondary breast cancer – are routinely considered for inclusion in the Formulary.”
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