1. Actions for Commissioning Teams Laxative Prescribing in Adults – Slide Set July 2013

2. Key Messages (1) Ensure a clear diagnosis of constipation before considering a laxative –Misconceptions about normal bowel function can lead to excessive laxative use. –Misuse of laxatives may lead to hypokalaemia, diarrhoea and dehydration. Identify cause of constipation (e.g. obstruction, medications, dehydration, pregnancy, spinal compression) and treat underlying cause, if possible. A laxative is not always required for constipation. –Adopt a stepwise approach to the management of constipation starting with diet and lifestyle. If appropriate, encourage patient to increase dietary fibre, ensure adequate fluid intake, increase activity. –A toolkit designed to encourage hydration best practice in the care of older people in care homes is available from Water UK. Review and if possible adjust any constipating medication (see next slide).

3. Constipating Drugs Drugs which may cause constipation include: –Opioids –Antacids containing aluminium –Antidepressants, especially tricyclic antidepressants –Antiepileptics (e.g. carbamazepine, gabapentin, oxcarbazepine, pregabalin, phenytoin) –Antihistamines (especially older sedating ones) –Antimuscarinics (e.g. procyclidine, oxybutynin) –Antipsychotics –Antispasmodics (e.g. dicycloverine, hyoscine) –Antiparkinsonism drugs including those with anticholinergic effects (e.g. benztropine, orphenadrine, procyclidine) and dopamine agonists –Calcium supplements –Diuretics (secondary to dehydration) –Iron supplements –Proton pump inhibitors –Verapamil

4. Key Messages (2) Although laxatives should generally be avoided in adults, they may be appropriate if: –dietary and lifestyle measures are unsuccessful –rapid relief of symptoms is required –a constipating drug is being taken which cannot be stopped (e.g. an opioid) –straining will exacerbate a medical condition (e.g. angina) or increase risk of rectal bleeding. Periodically reassess the ongoing need for laxatives. Where constipation in adults is not induced by chronic illness or necessary drug therapy, laxatives should generally be used for a short time. Avoid long-term use. –Laxatives may be gradually withdrawn when regular bowel movements occur without difficulty.

5. Choice of Laxative Very few studies have compared the various classes of laxatives. Choice of agent will generally depend on cause of constipation, individual preference, potential side effects, time to effect and cost. Some points to consider when choosing a laxative are: –Bulk-forming laxatives (e.g. ispaghula husk, methylcellulose, sterculia) are a useful first- line choice for those who are unable to get enough fibre in their diet. May take several days to have a full effect. Only use if fluid intake is adequate. Not appropriate for opioid- induced constipation. –Osmotic laxatives include lactulose and macrogols. Lactulose takes up to 48 hours to act, unsuitable for “when required” use. Some patients find it unpalatable and side effects include flatulence, cramps, abdominal distension. Lactulose should be avoided in adults with constipation-predominant irritable bowel syndrome is it may cause bloating. Macrogols are relatively expensive and some patients find it difficult to drink the prescribed volume. –Stimulant laxatives such senna, bisacodyl, glycerol suppositories are licensed only for short-term use. Chronic use may cause diarrhoea and hypokalaemia. –Co-danthramer and co-danthrusate are indicated only in terminally ill people (dantron is genotoxic and carcinogenic in rodent studies)

6. Newer Drugs for Constipation Prucalopride is a 5HT 4 receptor agonist. NICE recommend that it should only be considered as an option for women: –with chronic constipation if they have tried at least two different types of laxatives at the highest possible recommended doses for at least six months and this has not helped their constipation and –an invasive treatment for constipation is being considered. Linaclotide is a new first-in-class, oral guanylate cyclase-C receptor agonist for treatment of moderate-to-severe irritable bowel syndrome with constipation in adults. Midlands Therapeutics Review and Advisory Committee (MTRAC) advice for linaclotide: –Linaclotide may be prescribed in the limited number of patients in whom all other treatment options have been ineffective or contraindicated. –There are no data comparing linaclotide with other treatments for irritable bowel syndrome with constipation e.g. laxatives, antispasmodics or antidepressants. –There are no long-term data for the efficacy of this treatment.

7. Laxatives: Costs and Time to Effect ClassDrugBrand Daily Dose Time to Effect Cost for 28 days 5HT 4 -receptor agonist PrucaloprideResolor® tablets2mg _ £59.52 Bulk-forming Laxatives Ispaghula huskFybogel® sachets2 sachets2-3 days£4.11 SterculiaNormacol® granules10g2-3 days£3.84 MethylcelluloseCelevac® tablets2g2-3 days£3.22 Ispaghula huskIspagel® sachets2 sachets2-3 days£3.15 Osmotic Laxatives MacrogolMovicol® sachets2 sachets2-3 days£12.47 MacrogolLaxido Orange® sachets2 sachets2-3 days£9.97 Sodium citrate enemaMicolette® enema1 enema8-12 hours£9.24 Lactulosegeneric oral solution20mlup to 2 days£3.72 Stimulant Laxatives Sennageneric tablets15mg8-12 hours£11.21 Glycerol suppositorygeneric suppository4g15-60 min£8.52 Sodium picosulphateDulcolax Pico Perles® capsules10mg6-12 hours£6.43 Senna and ispaghula huskManevac® granules8g8-12 hours£5.03 Sodium picosulphateDulcolax Pico Liquid®10ml6-12 hours£4.11 DocusateDioctyl® tablets200mg12-72 hours£3.91 Bisacodylgeneric tablets10mg6-12 hours£1.92 Guanylate cyclase-C receptor agonist LinaclotideConstella® capsules290mcg _ £37.56 Prices: MIMS and Drug Tariff July 2013

8. Laxative waste in care homes It is recommended that care homes have a robust ordering system and checking process to ensure that laxatives and other medicines are only ordered if needed. In some care homes “as required” (prn) medicines including laxatives are routinely ordered on a monthly basis even if they have not been used up. Unused supplies are discarded. In some circumstances, unused laxatives and other medicines can be “carried forward” from one cycle to the next. –For example “prn” medicines which have been dispensed in their original packaging for residents, may be retained until the expiry date. –Guidance on when it is appropriate to “carry over” prescribed medicines is available in the West Midlands Care Homes Action Resource Toolkit.

9. References 1.Laxatives. British National Formulary 2013 65 2.The management of constipation. MeReC Bulletin. Vol 21. National Prescribing Centre 2011 http://www.npc.nhs.uk/merec/therap/other/resources/merec_bulletin_vol21_no2.pdf http://www.npc.nhs.uk/merec/therap/other/resources/merec_bulletin_vol21_no2.pdf 3.Palliative cancer care - constipation. Clinical Knowledge Summaries 2013 http://cks.nice.org.uk/palliative-cancer-care- constipation#!scenariorecommendation:2http://cks.nice.org.uk/palliative-cancer-care- constipation#!scenariorecommendation:2 4.Irritable bowel syndrome (CG61). National Institute for Health and Clinical Excellence 2008 http://www.nice.org.uk/CG061http://www.nice.org.uk/CG061 5.Constipation (women) - prucalopride (TA211). National Institute for Health and Clinical Excellence 2010 http://guidance.nice.org.uk/TA211 http://guidance.nice.org.uk/TA211 6.Clinical Knowledge Summaries. Constipation. 2013. http://cks.nice.org.uk/constipationhttp://cks.nice.org.uk/constipation 7.Trueman P, Taylor D.G, Lowson, K et al. (2010) Evaluation of the scale, causes and costs of waste medicines. Report of DH funded national project. Technical Report. York Health Economics Consortium and The School of Pharmacy, University of London., York and London. http://eprints.pharmacy.ac.uk/2605/1/Evaluation_of_NHS_Medicines_Waste__web_publication_version.pdf http://eprints.pharmacy.ac.uk/2605/1/Evaluation_of_NHS_Medicines_Waste__web_publication_version.pdf 8.MTRAC. Linaclotide for the treatment of irritable bowel syndrome with constipation. June 2013 http://www.keele.ac.uk/media/keeleuniversity/fachealth/fachealthsop/mtrac/documents/summary/Linaclotide%20verdict%20and %20summary%203.pdf http://www.keele.ac.uk/media/keeleuniversity/fachealth/fachealthsop/mtrac/documents/summary/Linaclotide%20verdict%20and %20summary%203.pdf

10. Other Reports Available 10 Reviews of developments in five key therapeutic areas that together account for approximately ¾ of prescribing spend A number of cost-effective prescribing options for practices to consider across many therapeutic areas Quarterly financial overview presenting the “Top 20” BNF Chapters, Sections and Chemicals by spend and number of prescriptions Monthly spread sheet providing practice level updates and comparisons across a range of QIPP and local indicators, with printable reports at individual practice level Monthly update of local prescribing indicators at a CCG level, showing variation over time Quarterly update of key mental health prescribing indicators compared across primary care and mental health trusts Annual analysis of prescribing information to support QIPP

11. Actions for Commissioning Teams www.pctsla.org medman@keele.ac.uk more open-access materials and data for subscriber CCGs are available from our website