NHS Specialist Pharmacy Service NSAIDS – efficacy and safety Expert speaker Slide set Key content from the NPC NSAIDS QIPP slides is gratefully acknowledged.

NHS Specialist Pharmacy Service NICE CG 177: Osteoarthritis Feb 2014 All oral NSAIDs/COX-2 inhibitors have analgesic effects of a similar magnitude. They vary in their potential GI, liver and cardio- renal toxicity. When choosing the agent and dose, healthcare professionals should take into account individual patient risk factors, including age. Consideration should be given to appropriate assessment and/or ongoing monitoring of these risk factors.

NHS Specialist Pharmacy Service Efficacy of NSAIDs – BNF March 2015 About 60% of patients will respond to any NSAID.About 60% of patients will respond to any NSAID. Those who do not respond to one may well respond to another.Those who do not respond to one may well respond to another. Pain relief starts from the first dose, with full analgesic effects obtained within a week.Pain relief starts from the first dose, with full analgesic effects obtained within a week. Anti-inflammatory effects may not be achieved for up to three weeks.Anti-inflammatory effects may not be achieved for up to three weeks.

NHS Specialist Pharmacy Service What about paracetamol? HOWEVER: NICE review identified reduced effectiveness of paracetamol in OA, which should be taken into account in routine prescribing practice *Awaiting full evidence review*..consider offering paracetamol for pain relief… regular dosing may be required Paracetamol and/or topical NSAIDs should be considered ahead of oral NSAIDs, COX-2 inhibitors or opioids.

NHS Specialist Pharmacy Service NSAID adverse effects in an older population of an average primary care group (PCG) Based on an average PCG of 100,000 patients where 3,800 over 65s take NSAIDs Bandolier 2000;79: 6-8 EventCases per year Upper GI bleed18 Acute renal failure10 Congestive heart failure22

NHS Specialist Pharmacy Service GI adverse effects Risk factors include:Risk factors include: -Age over 65 -History of GI bleed or ulcer -Concurrent use of drugs that increase the risk of GI adverse events -Heavy smoking or alcohol use -Prolonged NSAID use -Particular NSAID and high dose -Serious co-morbidity

NHS Specialist Pharmacy Service Age Chance of GI bleed due to NSAID Risk in any one year Chance of death due to NSAID GI bleed Risk in any one year in in 12, in in in in 3353 >75 1 in in 647 [Bandolier NSAIDs and adverse effects]

NHS Specialist Pharmacy Service Reducing GI risk Ibuprofen Celecoxib co-prescribed with a proton-pump inhibitor Oral NSAIDs or coxibs should be co-prescribed with a proton-pump inhibitor, choosing the one with the lowest acquisition cost. [NICE CG177: Osteoarthritis. 2014]

NHS Specialist Pharmacy Service Renal risks: MHRA Drug Safety Update May 2009 Ongoing reports of renal failure in patients taking NSAIDs. NSAID use accounts for approximately 15% of all cases of drug-induced acute renal failure. Patients at risk of renal impairment or failure (particularly elderly people) should avoid NSAIDs if possible. If NSAID is essential, renal function should be monitored during treatment. Contributing risk factors include co-administration of ACE inhibitors, A2RAs and diuretics.

NHS Specialist Pharmacy Service CV risks Painkiller heart alert ‘A painkiller taken by millions can increase the risk of heart attack and stroke by 40 per cent, a study has found.’ 29 September 2011

NHS Specialist Pharmacy Service MHRA October 2006 Non-selective NSAIDs – small increased risk of thrombotic events (eg, heart attack or stroke). Coxibs – about three additional thrombotic events per 1000 patients per year in the general population. Diclofenac – thrombotic risk profile similar to that of at least one coxib (etoricoxib). Naproxen and ibuprofen (1200 mg or less) no increased risk.

NHS Specialist Pharmacy Service MHRA January 2010 NSAIDs and CV risk in the general population Two important studies since 2006 found a very small increase in the risk of cardiovascular events. This may apply to all users of NSAIDs, not only those with baseline cardiovascular risk factors after relatively short-term NSAID use (that may increase with increasing duration of use).

NHS Specialist Pharmacy Service DICLOFENAC – MHRA June 2013 Contraindicated in established: - ischaemic heart disease - congestive heart failure - cerebrovascular disease - peripheral arterial disease. Switch such patients at next routine appointment. Only initiate diclofenac after careful consideration if significant risk factors for CV events.

NHS Specialist Pharmacy Service OTC oral diclofenac: MHRA recall January 2015 Legal status now POM again

NHS Specialist Pharmacy Service ETORICOXIB Arcoxia® is contraindicated if uncontrolled hypertension (greater than 140/90 mmHg). Regular BP monitoring required during treatment. 3% of NSAID prescription items, 13% of prescription costs.

NHS Specialist Pharmacy Service

Medicines management options for local implementation Two prescribing comparators: 1.How much NSAID per patient? 2.What proportion of total NSAID prescribing is for ibuprofen and naproxen?

NHS Specialist Pharmacy Service Local prescribing data [insert local data here]

NHS Specialist Pharmacy Service Summary – MeReC Extra 30 Nov 2007 Consider individual patient risk factors and safety profiles of individual NSAIDs. Lowest effective dose for shortest period of time. Low-dose ibuprofen (equal to or less than 1200 mg per day) first choice NSAID: low GI and CV risk. Low-dose ibuprofen or naproxen 1000 mg per day for patients with CV risk. Consider a PPI with any NSAID to reduce the risk of adverse GI effects, particularly if high GI risk (includes anybody aged 65 years or older) and long-term NSAID users.