GROUP PROTOCOL FOR THE MANAGEMENT OF CONSTIPATION IN PATIENTS IN CLOZAPINE CLINICS. Version 1 (reviewed unchanged January 2018)

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GROUP PROTOCOL FOR THE MANAGEMENT OF CONSTIPATION IN PATIENTS IN CLOZAPINE CLINICS Version 1 (reviewed unchanged January 2018) RATIFYING COMMITTEE Drugs and Therapeutics Group DATE ORIGINALLY 29 th October2014 RATIFIED REVIEWED 25 th January 2018 PROPOSED REVIEW DATE October 2020 MAUP EXPIRES January 2021 EXECUTIVE SPONSOR Chief Medical Officer LEAD AUTHOR Ray Lyon Chief Pharmacist - Strategy KEY POLICY ISSUES: Key indication for the use of senna in clozapine clinics What follow up is needed in the community Staff eligible to work under the protocol If you require this document in an alternative format, ie easy read, large text, audio, Braille or a community language please contact the Pharmacy Team on 01243 623349.

GROUP PROTOCOL FOR THE MANAGEMENT OF CONSTIPATION IN CLOZAPINE CLINICS Version: 1 October 2014 (reviewed unchanged January 2018) Group Protocol originally drawn up by: Name Jermine Clarke Lesley Ball Zo Payne Ray Lyon Title Clozapine Clinic Nurse Clozapine Clinic Nurse Practice Development Nurse Chief Pharmacist - Strategy Reviewed by: Ray Lyon Chief Pharmacist - Strategy Group Protocol authorised by: (on behalf of the Trust). Chief Medical Officer Chief Nursing Officer Chief Pharmacist Rick Fraser Diane Hull Ray Lyon Appointed Practitioner in Charge (on behalf of the ward) Date Protocol originally agreed October 2014 Date protocol reviewed January 2018 Proposed review date October 2020 Date Protocol expires January 2021 This protocol relates to the clozapine clinic at:

GROUP PROTOCOL FOR THE MANAGEMENT OF CONSTIPATION IN PATIENTS IN CLOZAPINE CLINICS 1. CLINICAL CONDITION 1.1 Clinical condition Passage of hard stools less frequently than the patient s own normal pattern. General information about constipation and how it can be treated, and its more serious complications can be found here: www.nhs.uk/conditions/constipation/pages/introduction.aspx 1.2 Inclusion Criteria Patients on clozapine. Patients with symptoms of constipation. The patient can swallow tablets Checklist for constipation Patient reports no bowel action for 2 3 days or passage of painful, hard stools/need to strain. Patient reported signs of constipation such as straining on defecation, abdominal distension, discomfort and feelings of incomplete evacuation. Patient reports of faecal incontinence (the leakage of liquid stools) Observed signs of constipation such as flatulence, faecal odour, abdominal distension, increased bowel sounds, visible peristalsis, pain, faecal smelling breath and vomiting. Patient reported signs of chest infection such as difficulty breathing, cough, sputum production, coughing up blood, respiratory distress, wheeze, use of accessory muscles or cyanosis. See exclusion criteria below. In addition to this the patient may also have a raised temperature. 1.3 Exclusion Criteria Patients not on clozapine. The patient cannot swallow tablets. Patient reporting signs of chest infection, (because constipation can rarely cause pneumonia). See checklist above. Patient already taking a stimulant laxative.

Known sensitivity to senna. Known history of intestinal obstruction and/or current significant abdominal pain with abdominal distension and/or vomiting and absence of flatulence. Senokot (senna) syrup, for diabetic patients (due to sugar content). Patients with a history of laxative abuse. Patients under 18 years of age. 1.4 Action to be taken if patient is excluded from treatment under protocol Immediately contact GP (or GP on-call service out of hours) if there are signs of chest infection otherwise Consult with the patient s GP 9.00 am 5.00 pm Monday to Friday. Provide advice regarding high fibre diet, increasing fluid intake and increasing exercise if appropriate. 1.5 Action to be taken if patient refuses treatment under protocol Provide advice regarding high fibre diet, increasing fluid intake and increasing exercise if appropriate. Inform the care coordinator and ask them to discuss with the patient s GP if problem continues. 2. STAFF AND LOCATION 2.1 Location 2.2 Staff Clozapine clinics trustwide. Qualified nursing staff that have been signed off as competent by the Appointed Practitioner in Charge of the clozapine clinic, following training and successful completion of the 'Key Aspects of Pharmacy' questionnaire for senna. 2.3 Continued Training Requirements. Not required unless changes to protocol 3 TREATMENT 3.1 Name of medicine Senna or Senokot

3.2 Legal status (POM, P or GSL) GSL (General sales list) 3.3 Dose or dose range and criteria for determining dose 1 2 tablets daily, preferably given at night. Recommend the patient takes 2 tablets unless patient s normal regime specifies otherwise or particularly strong effect of higher dose previously. 3.4 Method of route of administration Oral 3.5 Frequency of administration Only to be given once daily (maximum dose). 3.6 Quantity to supply Supply one bottle of two tablets and recommend the patient takes the recommended dose at bedtime. If the dose recommended is one, the patient should be advised to destroy the unwanted tablet by flushing it down the toilet. 3.7 Follow-up treatment Document the supply of senna in the patient s electronic record. Inform the patient s consultant or deputy that the patient has constipation and a dose of senna has been supplied and the care coordinator asked to follow up the patient initially. Contact the patient s care co-ordinator to: o Inform them that senna has been supplied. o Ask them to confirm with the patient whether they had a bowel movement. o Ask them to reinforce the advice regarding; diet, fluid intake etc. (as above). o Ask them to encourage the patient to see their GP if the problem is not resolved. Document the conversation with the care coordinator. Inform the GP that senna has been supplied and that the care coordinator will be following up the patient initially.

Reinforce the advice regarding: diet, fluid intake and exercise on a regular basis. 3.8 Side effects and potential drug interactions May cause abdominal cramp. 3.8 Instruction on identifying and managing possible adverse outcomes Ask the care coordinator to follow up and report back any adverse effects. Ask the care coordinator to discuss any adverse effects with the patient s GP and record this in the patient s electronic record. 3.9 Arrangement for referral for urgent medical advice Contact the patient s GP in normal working hours Contact the on call GP service outside working hours. 4. INFORMATION AND DOCUMENTATION 4.1 Advice (including written advice) to be given to patient or carer before or after treatment. A letter explaining this information is attached with this protocol. Verbal instruction of drug being administered. Advise that urine may become cloudy/discoloured. Advise that senna usually takes up to 8 12 hours to have effect. Advise the patient or carer to inform the care co-ordinator of any bowel action or abdominal pain when contacted. Provide patient information leaflet on constipation. 4.2 Details of treatment records required. Record entry in Carenotes. This should record the presence of constipation, and senna supplied in line with MAUP (or equivalent statement). Record discussion with the care coordinator and any other healthcare professional if appropriate. 5. MANAGEMENT AND MONITORING 5.1 Advisory group approving the protocol Drugs and Therapeutics Group

5.2 Lines of accountability Clinic manager Clinical Service Managers. 5.3 Method to report any adverse drug reactions to the doctor Communicate with the patient s GP and the clozapine clinic. 5.4 Audit Arrangements Clinical audit. 5.5 Review Date and by Whom Every three years by the Drugs and Therapeutics Group or earlier if significant new evidence on senna use is made available. 6. Staff authorized to work under the Group Protocol I have read the group protocol and agree to use it: - Nurses agreeing to and authorized to work under the protocol Appointed Practitioner in Charge assessing competence Name Signature Name Signature Date

KEY ASPECTS OF PHARMACY QUESTIONNAIRE (To be completed without access to the Protocol or drug text books, eg BNF.) Key aspects of pharmacy for Senna Professional's name: Grade: 1. Symptoms/criteria under which the patient will be eligible for treatment under the Protocol 2. Forms and strengths available 3. Mode of action 4. Exclusion criteria 5. Dose 6. Route of administration 7. What potentially significant side effects and drug interactions are there? 8. What written/verbal advice must be given to the patient/carer on the identification and management of significant potential side effects? I confirm that at the time of completion the answers provided showed an acceptable level knowledge. Name: Designation: Signature: Date:

Constipation Constipation is the term used to describe difficulty going to the toilet or opening the bowels. We probably all suffer from this for short periods during our lives, but for some it becomes a chronic or recurrent problem. What is normal? Some people would regard it as normal to open their bowels three or four times a day, while for others normality would be once a week. Certainly, the human body can function quite well at either extreme, but most people probably open their bowels every day or every couple of days. It is wise not to get obsessed by the need to open the bowels daily, but if you experience a change of bowel habit that persists then you should seek the advice of your doctor. Cause Change of diet or dehydration and a change of daily schedule may lead to constipation. Certain medications, especially clozapine and some pain killers may lead to problems. Sometimes the cause is a bowel disorder, but this is the exception, rather than the rule. General Background Over recent years it has become apparent that people who eat more fibre are less prone to various bowel diseases and also are likely to be healthier in other ways. Fibre tends to diminish transit time (ie the length of time it takes for something that is eaten to pass right through the system) and thus reduce constipation. Funnily enough, if you take more fibre it will tend to normalise bowel habit, and may well cut down the frequency of motions in somebody tending towards diarrhoea. In general it is wise to eat small meals often and plenty of fresh fruit and vegetables, as well as having plenty to drink (one and a half to three litres of fluid daily). Foods containing fibre include brown rice, wholemeal pasta, wholemeal/brown bread, potatoes with their jackets, etc. It is also wise to take regular exercise or at least remain active. You should not make a habit of putting off the "call of nature", as this can make the body's natural functions more sluggish. If you require this document in an alternative format, i.e. easy read, large text, audio, Braille or a community language please contact the Pharmacy Team on 01243 623349.

Treatment Sometimes people become so constipated that they or their doctor feel that other action is required. There are various medicines/tablets to help constipation (laxatives): Fibre supplements, which come as powder, which makes up a small drink, granules, tablets containing bran or indeed raw bran. Osmotic laxatives, which act by drawing more fluid into the bowel. Irritative preparations which tend to introduce contractions of the bowel eg Senna. You may need to use one or more of these together. October 2014 - reviewed unchanged January 2018 Review January 2021

Insert address Dear Dr (insert GP Name) On (insert date) a patient from your practice (insert patient name, address Dob and NHS Number) presented with the following symptoms of constipation (delete as applicable) Patient reported no bowel action for 2 3 days or passage of painful, hard stools/need to strain. Patient reported signs of constipation such as straining on defecation, abdominal distension, discomfort and feelings of incomplete evacuation. Patient reported faecal incontinence (the leakage of liquid stools) Observed signs of constipation such as flatulence, faecal odour, abdominal distension, increased bowel sounds, visible peristalsis, pain, faecal smelling breath and vomiting. Patient reported signs of a chest infection such difficulty breathing, cough, sputum production, coughing up blood, respiratory distress, wheeze, use of accessory muscles or cyanosis. Patient had a raised temperature. As part of our protocol for management of constipation, the patient was given (insert senna dose) and advised to Contact the GP surgery to make an appointment discuss this. Eat small meals often and plenty of fresh fruit and vegetables. Have plenty to drink (one and a half to three litres of fluid daily). Eat more foods containing fibre, including brown rice, wholemeal pasta, wholemeal/brown bread and potatoes with their jackets left on. Take regular exercise or at least remain active. Not make a habit of putting off the "call of nature. The patient s consultant psychiatrist has been notified. Please contact (insert name and contact number) if you would like further information Yours Sincerely