Microsoft powerpoint - unlicensed meds gp talk 0407.ppt

• Introduction• Unlicensed medicines vs ‘off-label’ prescribing• Legislation• Legal responsibility• Professional guidance• Risks and risk management• Take-home points• Questions • A patient brings a note to your practice from a paediatric cardiologist in which you are asked to take over the prescribing of an combination product containing hydrochlorothiaizde and spironolactone for a child with a congenital heart malformation. • Would you agree to take on prescribing responsibility • What would be consequences for you and the patient • A consultant in child and adolescent mental health, to whom you have a referred an 11-year-old child with an autism spectrum disorder who has been displaying violent and aggressive behaviour in school, contacts you to request that you would adopt shared care prescribing for her, now that her condition has been stabilised on treatment with psychosocial therapy and low-dose risperidone.
• Would you agree to take on prescribing responsibility • What would be consequences for you and the patient • Medicines Act (1968) – determines licensing – do not reflect established current knowledge – do not include well proven uses of a drug – are at variance e.g. one branded product has two licensed uses but Legal responsibility lies with person signing the prescription Manufacturer likely liable only if harm results from a defect in the product Absence of licensed indication doesn’t imply absence of evidence e.g. spironolactone for heart failure, fluticasone for COPD May be helpful to recognise a spectrum of risk – From ‘near-label’ to speculative eccentricity Consider context – commonplace in children/elderly What is the extent of the issue within UK McIntyre J et al. Arch Dis Child 2000;83:498-501 • Single practice study (Midlands, 1997) – 1175 children (65% <12s on practice list) poorly represented in clinical trials and the effectiveness of treatment is less certain.
that older patients will receive worthwhile benefits from drug treatment, particularly in terms of reduced risk of stroke. • Offer patients over 80 years of age the same treatment as patients over the age of 55, taking account of co-morbidity and polypharmacy Stewart C. Int J Pharm Pract 2003; 11: R81 • Audit of prescribing of atypicals to 374 patients in – 48% olanzapine, 28% risperidone, 21% quetiapine, 2.6% • 53% initiated by specialists, 20% by GP led with advice • Out of 188 patients who were switched from a typical to an atypical, 72% complied with NICE guidelines for the switch Fountoulakis KN. Ann Gen Hosp Pharm 2004; 3: 4 “…the current review proved that data are few
and can not really support an evidence based
recommendation…. it is impressive that the
number of papers without experimental

data are four times more in comparison to
the experimental ones, and forty times
those with controlled double-blind

All may not be well in the house of love….
From NPSA website - 6th October 2005 Emma died at the age of 5 from complications of adrenal-
suppression, she took between 500 and 2000 micrograms
of fluticasone every day for several years. She died in 2001.
Sheriff’s Investigation: Criticisms of Emma’s treatment and care
– “The GP and the consultant were both aware that Emma was taking high levels of the inhaled steroid and both believed that even though these high levels of steroid were not ideal, the medication prescribed did not pose a threat to Emma’s health” Failure to anticipate a rare adverse event – “.neither Emma’s GP nor her specialist had personal experience of adrenal suppression or adrenal failure in clinical practice, both believed the risk was sufficiently small to be disregarded” – “GlaxoSmithKline the drug’s manufacturer had promoted the drug as the drug of choice for managing severe childhood asthma. The advertising slogans stressed the safety of the drug and its use with children” Off-label prescribing – some common examples OCD, panic disorder, social phobia, PTSD, GAD • Products derived from licensed medicines – e.g. extemporaneously dispensed liquid formulation • Products unrelated to any licensed medicine • Products being used in clinical trials – being imported and used on a named-patient basis • Little prescribing of unlicensed medicines in mental • Prescriber carries responsibility for patient’s welfare • May be called upon to justify actions in event of ADR • Two main ways through which compensation may be • Common law duty to take reasonable care • Act in a way consistent with practice of responsible body of their peers of similar professional standing (‘The Bolam Principle’) • Prescribers must understand the product and act responsibly with reasonable care and skill • “A doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art” • Product liability arising under the Consumer • Defective product which does not provide the safety • Principally affects manufacturers of drugs Principles of unlicensed prescribing for children (Joint RCPCH/ NPPG) • Prescribe on the basis of evidence of benefit (and • Prescribers should have access to good quality • NHS organisations should support practice • Be satisfied that an alternative, licensed medicine • Be satisfied that there is a sufficient evidence base and/or experience of using the medicine to demonstrate its safety and efficacy • Take responsibility for prescribing the unlicensed or off-label medicine and for overseeing the patient’s care, including monitoring and any follow up treatment • Record the medicine prescribed and the reasons for choosing this medicine in the patient’s notes.
Risk Action
Take comprehensive medication history – check for previous adequate trial of licensed alternative Familiarise self with evidence of efficacy Advise the patient of unlicensed status, esp where new/investigational medicine or serious risk of ADR not obtained and
• Unlicensed prescribing is commonplace in mental • Be aware of licensed indications but… • Consider licensing issues in context of wider evidence base, patient preferences, and clinical judgement • Obtain informed consent whenever possible and • Monitor closely, withdraw if ineffective


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