Protocol to support reducing the use of and the effective use of laxatives. HaRD CCG employed Pharmacists and Medicines Optimisation Technicians.

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NY&AWC Medicines Management Team Protocol to support reducing the use of and the effective use of laxatives Applies to HaRD CCG employed Pharmacists and Medicines Optimisation Technicians. These protocols are produced by the NY&AWC MM team hosted by HaRD CCG for use by their employed MM team members. They can be adopted for use by other healthcare staff working in GP practices across NY&AWC CCGs but HaRD CCG accepts no responsibility for the use and application of these protocols in these situations. External staff working to these protocols must agree with their own employer whether they are competent and able to work to these protocols. Rationale In many cases, constipation can be prevented using simple dietary and lifestyle changes. Laxatives should be reserved for constipation that has not responded adequately to simple interventions, or for when rapid relief of symptoms is needed. Prolonged treatment is seldom necessary. Patients should therefore be encouraged to manage their constipation through dietary and lifestyle changes. If laxatives are required then they should be used at the lowest effective dose for the shortest period necessary (1, 2). The aim of this protocol is to reduce the use of laxatives by promoting the treatment of constipation through dietary and lifestyle changes. Method 1. Check the practice has agreed to the protocol and a signed copy is in place. 2. Check for any extra exclusions or amendments to the protocol made by the practice. 3. Run a computer search to identify patients who are currently receiving repeat prescriptions for any laxative classified as green in your local CCG formulary (laxatives requiring specialist initiation should be excluded). If this search needs to be stratified further due to generating large patient numbers, then you should consider and agree with the practice to further restrict the search to: a. Those patients on 2 or more laxatives OR b. Those patients prescribed laxatives for more than 3 months 4. Use the data collection form (Appendix 1) and the medical records to record the following: Patient identifier Current prescription Date prescription last issued Age End stage palliative care patient? Active cancer diagnosis? Taking opioid analgesic? Protocol for the more effective use of laxatives Page 1 of 11 NYAWC MMT

Secondary care treatment of bowel disorder? Patient has a stoma? Care home resident? Pregnant? Parkinson s disease? NY&AWC Medicines Management Team Constipating medicines that could be reviewed? If yes, flag to GP for review Both lactulose and macrogol preparation on repeat? If yes flag to GP Letter and leaflet sent to patient? 5. Those patients identified as suitable to be considered for a reduction in their laxative usage (i.e. do not fall into one of the above categories, e.g. end stage palliative care, active cancer diagnosis etc.) should be sent a letter and copies of the information leaflets on constipation and laxatives. This includes patients who are only using laxatives on an occasional basis. 6. Inform relevant practice staff about the project. Any letters to be sent must be ready to be issued at the end of the session. 7. Remove any repeat prescriptions for laxatives that have not been ordered in the last 6 months or other duration agreed with the practice (see points to discuss with practice). 8. Flag any patients prescribed both lactulose and a macrogol preparation on repeat prescription to the GP for review. Lactulose and macrogols are both osmotic laxatives that act by retaining fluid in the bowel to soften the stools. Therefore they both act in the same way and taking both together does not offer any advantage. 9. Flag any patients prescribed both senna and docusate on repeat prescription to the GP for review. 10. Follow-up patients who have been sent a letter and leaflets after 6 months to check if their ordering of laxatives has reduced and if any items can be removed from repeat. 11. If required, record the numbers/patients using an activity log as per local agreement 12. Continue to monitor the long term outcomes of the campaign e.g. cost savings via PPD data, complaints, problems encountered etc. Exclusions 1. End stage palliative patients. 2. Patients under 18 years or over 75 years of age (or other age range agreed with the practicesee points to discuss with practice). 3. Patients with an active cancer diagnosis. 4. Patients currently taking regular opioid analgesics including those receiving regular prescriptions issued acutely. 5. Patients under secondary care for treatment of a bowel disorder. Protocol for the more effective use of laxatives Page 2 of 11 NYAWC MMT

6. Patients with a stoma. NY&AWC Medicines Management Team 7. Patients who are pregnant. 8. Patients with Parkinson s disease. To flag up for special consideration by GP 1. Any patient that you are concerned may be over using laxatives or require further consideration by a GP or other prescriber in order to optimise the management of their constipation. 2. Any patient taking a constipating medicine that could be reviewed. 3. Consider flagging any patient prescribed more than one laxative to their usual GP for review (to be agreed with the practice). Points to discuss with practice 1. Who is the contact in the practice for the project? 2. Agree content of patient letter a possible form of words is attached below. 3. Agree period for which repeat prescriptions can be removed if the patient has not had them issued recently e.g. more than 6 months. 4. Agree which patients to include in the computer search (including age range). 5. Agree whether patients prescribed more than one laxative should be flagged to their usual GP for review. 4. Agree whether to include any patient taking laxatives for constipation secondary to another disease such as: irritable bowel disease, diabetes, hypercalcaemia, hypothyroidism, multiple sclerosis, muscular dystrophy, spinal cord injury, anal fissure, inflammatory bowel disease 6. Agree whether to include patients in Care Home settings 7. Agree whether a when required instruction can be added to the directions of laxatives for patients that are not using them regularly 8. Any practice additions, deletions or amendments to the protocol. Protocol for the more effective use of laxatives Page 3 of 11 NYAWC MMT

References NY&AWC Medicines Management Team 1. Laxatives- NHS choices. [Online] http://www.nhs.uk/conditions/laxatives/pages/introduction.aspx. 2. Laxatives- Evidence context- NICE. [Online] https://www.nice.org.uk/advice/ktt1/chapter/evidence-context. 3. Constipation - NICE CKS. [Online] http://cks.nice.org.uk/constipation#!scenariorecommendation:3. Practice agreement to use of this protocol Please detail any amendments to the protocol here/or attach a copy of agreed changes: Signature of practice prescribing lead/ manager Practice name Date Signed on behalf of NYAWC MMT Please note that the practice representative signing this protocol agrees to take responsibility for the notification of all relevant practice staff Document version control Protocol for the more effective use of laxatives Page 4 of 11 NYAWC MMT

Possible letter NY&AWC Medicines Management Team Dear ~[Title/Initial/Surname] The practice is currently reviewing all patients who receive regular repeat prescriptions for laxatives. We note from your records that you are prescribed [insert name of laxative(s)] on your repeat prescription. Ideally laxatives should only be used occasionally and for short periods of time. Prevention is the best way of dealing with constipation so we recommend you try and prevent it by following the dietary and lifestyle advice in the enclosed leaflet. As with all medicines, it is best to use the lowest effective dose to control your symptoms and avoid side effects. If your symptoms are controlled at present we recommend you try gradually reducing your laxative dose to the minimum required. If you are taking a combination of laxatives, then reduce and stop one laxative at a time. Begin by reducing stimulant laxatives which may include Bisacodyl, Senna, Docusate Sodium and Sodium Picosulfate first, if possible. If you are able to achieve this, then you may be able to stop your laxative altogether and only use it for short term bouts of constipation. Please be aware that it can take several months to be successfully weaned off all laxatives. You may find that you do not need to order your laxatives every month or as often as you did in the past. Please ensure you only order medicines you actually need, in order to reduce waste. If you have any queries regarding this letter please contact [insert name of contact, practice] and or [insert email of local CCG patient relations team] All medicines should be safely stored out of the reach of children. Yours sincerely, ~ [Usual GP/Registered GP/GP Prescribing Lead/Other] Agreement to letter Signature of practice prescribing lead/ manager Practice name Date Signed on behalf of NYAWC MMT Please detail any amendments to the letter here/or attach a copy of agreed changes: Protocol for the more effective use of laxatives Page 5 of 11 NYAWC MMT

NY&AWC Medicines Management Team Document version control Version State changes New version Actioned by Protocol for the more effective use of laxatives Page 6 of 11 NYAWC MMT

Appendix 1- Data Collection Form; Effective use of Laxatives NY&AWC Medicines Management Team Patient identifier: Name of laxative(s) Date prescription last issued Age in years End stage palliative? Active Cancer diagnosis? Taking opioid analgesic? Secondary care treatment of bowel disorder? Patient has a stoma? Pregnant? Parkinson s disease? Constipating medicines that could be reviewed? If yes, flag to GP for review Both lactulose/macrogol or senna/docusate on repeat? If yes flag to GP Leaflets and letter sent? Protocol for the more Effective use of Laxatives Page 7 of 11 NYAWC MMT updates and amendments, including updated hyperlinks. Please use the online version to ensure use of the latest version.

Lifestyle advice continued Eat foods containing plenty of fibre. Fibre from food stays in your gut and adds bulk and softness to the stools. You may have some bloating and wind at first, and it can take up to four weeks to help your constipation. So it is best to increase your fibre slowly and make it a long term change. You will also need to drink lots of water with your high fibre foods. High-fibre foods include: Fruit and vegetables. Aim to eat at least five portions of different fruit and vegetables each day Oats, nuts and seeds Wholegrain cereals, bran and wholemeal pasta, bread etc * Sorbitol is a sugar, which soften the stools and acts like a natural laxative. Sorbitol is found in fruits (and juices) such as apples, apricots, gooseberries, grapes (and raisins), peaches, pears, plums, prunes, raspberries and strawberries. The amount of sorbitol is about 5-10 times higher in dried fruit. * Sometimes bran and wholemeal may cause more bloating and cramps and worsen constipation in patients with IBS More information available at: www.patient.co.uk/health/constipation-inadults-leaflet www.nhs.uk/conditions/constipation www.bladderandbowelfoundation.org Re-produced with kind permission and courtesy of Rotherham CCG Medicines Management Team Patient Information Leaflet Constipation

What is constipation? Constipation is common. Usual symptoms include stools (faeces or motions) becoming hard, and difficult or painful to pass. The time between toilet trips increases compared with your usual pattern. You may also feel bloated and feel sick if you have severe constipation. Type 1, 2 or 3 on the Bristol stool chart show some level of constipation. Note: there is a large range of normal bowel habit, from 2-3 times per day to 2-3 times per week. It is a change from your usual pattern and the hardness and pain passing the stools that defines constipation. What causes constipation? Not eating enough fibre (roughage) is a common cause (See below) Not drinking enough, as stools require water to keep them soft and easily passed (See below) Some medicines can cause constipation as a side-effect. For example, painkillers like cocodamol, codeine and morphine slow down your gut movements, and you may need a laxative to start it moving again. You may wish to check the patient information leaflet or with your Pharmacist. Various medical conditions can cause constipation. For example, an underactive thyroid, irritable bowel syndrome, and conditions that reduce your mobility and exercise. Pregnancy. Hormonal changes in pregnancy can slow down the gut movements, and in later pregnancy, the baby pushes the bowels making it more difficult for the stools to move. Unknown cause (idiopathic) Some people have a good diet, drink a lot of fluid, do not have a disease or take any medication that can cause constipation, but still become constipated. Their bowels are said to be underactive. This is common (up to 1 in 6 people) and mostly occurs in women. This condition starts in childhood or early adulthood, and persists throughout life. What can I do to reduce my constipation? (Lifestyle advice) Have plenty to drink. Aim to drink about 8-10 cups (2 litres) of fluid per day. This will allow some to stay in the gut and soften the stools. Most drinks will do, but alcoholic drinks can be dehydrating. Exercise regularly. Keeping your body active helps to keep your gut moving. It is well known that people with low mobility or bed-bound (even if just temporary) are more likely to get constipated. Toileting routines. Do not ignore the feeling of needing the toilet. Some people suppress this feeling if they are busy. It may result in a backlog of stools which is difficult to pass later. As a rule, it is best to try going to the toilet first thing in the morning or about 30 minutes after a meal. This is because the movement of stools through the lower bowel is greatest in the mornings and after meals. How you sit on the toilet is also important. A small footstool under your feet may help the passage of stools. Relax, lean forward and rest your elbows on your thighs. You should not strain and hold your breath to pass stools.

How long should I take a laxative for? Most people only need to take a laxative for a short time, to get over a bout of constipation. Once the constipation eases, you can normally stop the laxative. Some situations that laxatives may be needed for longer periods are: On long term pain relief Long standing Irritable Bowel Syndrome Conditions that effect the movement of the gut (e.g. damaged nerves) Chronic constipation caused by long standing mobility problems or diet restrictions In these situations laxatives should not be stopped suddenly, as this could mean severe constipation and blockage of the bowel by hard stools (impaction). Impaction needs to be treated, using much higher doses of laxatives, and then a normal maintenance dose of laxatives used to keep the bowels moving. More information available at: www.patient.co.uk/health/laxatives www.nhs.uk/conditions/laxatives Re-produced with kind permission and courtesy of Rotherham CCG Medicines Management Team Patient Information Leaflet Laxatives

Which laxatives should I take? Most laxatives are taken by mouth. The choice of laxative usually depends on the symptoms of constipation that you have. If stools are hard, then softeners or bulk-forming laxatives are used. If you have slow gut movements, then a stimulant laxative is used (e.g. as result of painkillers or other medication). Sometimes, suppositories or enemas are needed if the lower bowel (rectum) needs emptying. Softeners: docusate sodium capsules & arachis (peanut) oil enemas These allow water to get into and soften the stools, as well as lubricating them to make them more slippery and easier to pass. Docusate capsules work within two to three days, and the enemas over-night. Bulk-forming laxatives (fibre): Ispaghula husk (Fybogel ) These increase the bulk and softness of your stools. Your gut muscles can then squeeze the stools along and out of the body more easily. They have some effect within 12 to 24 hours but their full effect may take several days or weeks to develop. You MUST drink plenty of fluid while taking this laxative as it may cause a blockage in the gut High doses of the macrogol osmotic laxatives are used to treat severe constipation and impaction ONLY under medical advice. Osmotic laxatives: lactulose, macrogols (Movicol ) If you are pregnant or breast-feeding there are a number of laxatives that are safe to take. Your doctor or pharmacist can advise you about which ones to use. Common side-effects of all laxatives include flatulence, cramps, diarrhoea, nausea, and bloating. Most side-effects can be reduced by starting off on a low dose and increasing the dose gradually. Stimulant laxatives: bisacodyl tablets, senna tablets or glycerin suppositories These laxatives irritate the nerves in the large bowel and rectum making the muscle in your gut to work harder than usual. Stimulant laxatives usually work within 8 to 12 hours. A bedtime dose is recommended as you are likely to feel the urge to go to the toilet sometime the following morning. These laxatives attract water into the large bowel. They can easily cause stools to become too soft, and the dose should be increased or decreased to produce soft but formed stools. They can take two to three days to have their full effect. You MUST drink plenty of fluid while taking this laxative to prevent dehydration. This laxative will pull water out of your body if there is not enough already in your bowel