Members of the public, including the GSD Opposition, have questioned as to why the GHA no longer prescribes Lidocaine patches. As previously announced, the GHA has entered into and now completed a complete review of the medicines permitted to be prescribed on the GPMs arrangements. This process has involved experienced specialists reviewing the lists of medicines being used and making recommendations which bring the approved list in line with what is seen as effective clinical practice. The clinicians have been consulted on every chapter as they have been completed, and given usually three months to raise any concerns before these chapters came into force.
There is then a very clear and transparent appeals process to enable specific patient needs to be addressed. Rather than being seen as weakness the GHA sees this as strength: where it can be identified there is clinical need for flexibility then that is shown, through a peer review process, whilst keeping the general position in place reducing the use of medicines of limited clinical value. This work has been undertaken by reference to best practice and guidance in the NHS, using guidance issued by NICE and other authoritative bodies, and some key tertiary centres. This practice should be welcomed by all.
The policy governing the operation of the formulary and its key committee has been shared with all clinicians (including community pharmacies) as part of the consolidated formulary, which is now being placed on the GHA intranet.
Lidocaine Patches are a topically applied analgesic product which is only approved for use in the treatment of Post Herpetic Neuralgia by the MHRA (PHN). This product was reviewed by the NHS in 2017 and recommended as an item which should not be prescribed, being deemed of limited value clinically outside its licensed indication. This guidance remains in force and indeed has been further tightened by the formulary committees working in the NHS to the point where it has currently very limited use in the NHS and often for very short periods (10 days or less). The Committee which covers the Guys and St Thomas’s NHS Trust reviewed its policy in June 2022 and now only permits its use for PHN and focal neuropathic pain with allodynia, started by their specialist pain team.
The GHA has adopted a very similar policy, restricting its use to these two conditions, and has indeed approved its use for PHN since the policy came in. Lidocaine patches have been historically used in Gibraltar for many other conditions, for which the evidence base is very weak so cannot be endorsed for use. These conditions include low back pain, and musculoskeletal pain, where the evidence supporting its use in these conditions is not sufficient to justify its continued use.
The formulary development has been a major change in the way the GHA operates its approvals for the use of medicines, and there is now real oversight of what is prescribed for what condition, when and in some cases by who.
The committee always tries to ensure that appropriate alternatives are suggested when declining requests, but these may not be an alternative medicine. Conditions like low back pain do not respond to medicines well, and not all usually after 3 months, so prescribing another medicine then is not appropriate and alternative interventions will need to be accessed. Sometimes the medicines are archaic and then a review of the medication is what is required rather than continuation of the existing prescription.
The GHA will continue to review and refine its formulary, in the light of the changing evidence/science underpinning medicines use, or changes in the guidance published. The Committee overseeing this process, meets monthly and is scrupulous in examining all the request for change and additions placed before it. Its recommendations are then shared with the GHA Executive team who then ratify (or otherwise) the recommendations.
The GHA is very empathetic to patients’ needs and is trying to ensure it can move resources from those of limited clinical value to those medicines of higher clinical value, as these resources can only be used once. The GHA believes that this process has enabled it to support patients with high demand clinical needs with newer and more effective medicines. This reduces the potential toxicity of the treatments so there is less iatrogenic disease, achieves better long term outcomes, and reduces the need for routine blood tests, which if it had not done this would have been even more challenging.
The Director General, Prof Patrick Geoghegan, commented: ‘The GHA has carried out a major exercise in the reform of the medicines used on the GPMS scheme supported by its clinicians, using the published evidence and guidance to inform its decisions, whilst being sympathetic to patients’ views. Where there has been good evidence to support individual cases, this has been heard and the policy adapted, which is about showing empathy for patient concerns. The fact that appeals are successful is showing evidence of informed patient-specific decision-making, not always a one-size-fits-all approach.
‘As I have said all along, it is the clinicians who are making the decisions on the most effective approach, including drug prescribing for the people of Gibraltar. The GHA is here to help, but we ask the public to listen and collaborate with the clinical advice given.’