MOVIPREP Orange, powder for oral solution

Transcription

1 New Medicines Committee Briefing September 2014 MOVIPREP Orange, powder for oral solution MOVIPREP to be reviewed for use within: Primary Care Secondary Care Summary: MOVIPREP is a polyethylene glycol (PEG), non-absorbable isosmotic solution that passes through the bowel without net absorption or secretion. MOVIPREP is a combination of PEG with electrolytes to minimise volume/electrolyte shifts. Adequate bowel preparation can be achieved within 12 hours with MOVIPREP A randomised controlled trial that compared KLEAN PREP to MOVIPREP found that MOVIPREP reduced the volume patients had to drink without compromising efficacy or safety. Consensus guidelines for the prescription and administration of oral bowel cleansing agents stated that no single agent is ideal in all clinical scenarios. Consensus guidelines for the prescription and administration of oral bowel cleansing agents stated that MOVIPREP is less likely to cause hypovolaemia and hyponatraemia. Clinical trials indicate that MOVIPREP is as effective as KLEAN PREP and Picolax. 1

2 Application: Gastroenterology: Consultant submitting application: Clinical Director supporting application: Dr Kar Lau (Consultant Gastroenterologist) Dr Adrian Walker (Medical Director) Dr Lau noted that KLEAN PREP and MOVIPREP are non-absorbable macrogol polymers with little fluid and electrolyte exchange across the colonic bowel wall, when ingested hence reducing the risk of electrolyte imbalance and dehydration. The PEG based bowel preparation currently used for colonoscopy is KLEAN PREP which is a 4 litre preparation. MOVIPREP is manufactured by the same company but is administered as a 2 litres preparation and some patients are unable to tolerate the 4 litres. The combination of ascorbic acid and PEG based bowel preparation reduces the volume patients have to drink without compromising efficacy or safety. Dr Lau also emphasised that MOVIPREP is cost effective as it not only improves compliance and tolerability, it is also less expensive (currently 6.68 while KLEAN PREP is 7.15 excluding VAT). Dr Lau stated that PEGs are relatively safe for patients with electrolyte imbalance and for patients who cannot tolerate significant fluid load including renal failure, congestive heart failure, or advanced liver disease with ascites. A number of papers suggest the smaller volume PEG (MOVIPREP) to be fairly well tolerated. Background: 1 Oral bowel cleansing preparations are used prior to colonic surgery, endoscopic and radiological examination to minimise faecal contamination. Bowel cleansing preparations should be used with caution in patients with fluid and electrolyte disturbances and hypovolaemia should be corrected before administration. There are a number of different oral bowel cleansing agents currently available in the UK such as: KLEAN PREP and MOVIPREP (polyethylene), Fleet Phospho-Soda (sodium dihydrogen phosphate dehydrate and disodium phosphate dodecahydrate), Picolax and Citrafleet (sodium picosulphate and magnesium citrate), Citramag (magnesium carbonate and citric acid). Consensus guidelines for the prescription and administration of oral bowel cleansing agents stated that no single agent is ideal in all clinical scenarios but rather the ideal oral bowel cleansing agent would be convenient to administer, well tolerated, effective in cleansing with an acceptable side effect profile. MOVIPREP and Klean prep are polyethylene glycols (macrogols) that are non-absorbable isosmotic solution that pass through the bowel without net absorption or secretion. This results in significant fluid and electrolyte shift and to achieve desired effect, it needs to be diluted in large volumes of water (2/4 litres) and often carry an unpalatable taste. To enhance compliance, solution is divided into two with initial solution taken on the night prior to the procedure and remaining taken the morning of the procedure. As not all the ingested water stay in the gut lumen, this could result in absorption of water which can lead to water intoxication in predisposed patients. MOVIPREP is a combination of polyethylene glycol with electrolytes to minimise volume/electrolyte shifts. Adequate bowel preparation can be achieved within 12 hours with MOVIPREP which is a significant advantage as you only need 2 litres of water. Below is a summary table from the Consensus Guidelines for the Prescription and Administration of Oral Bowel Cleansing Agents 1 regarding potential advantages and complications of individual oral bowel cleansing agents: 2

3 Oral bowel cleansing agent (OBCA) Picolax or Citrafleet (Sodium picosulphate & magnesium citrate) Citramag (magnesium carbonate and citric acid) Klean Prep (polyethylene glycol) MOVIPREP (polyethylene glycol) Fleet Phosphosoda (sodium phosphate) Potential advantages Produces the lowest watery residue: potentially advantageous for radiological investigation. Produces a low watery residue (although not as low as Picolax ) Less likely to cause hypovolaemia Less likely to cause hypovolaemia Bowel preparation can be completed within 12 hrs. Well tolerated Tolerability and ease of use Powder is reconstituted with a low volume of water. It then arms on mixing. Powder is reconstituted with a low volume of hot water. Powder is reconstituted with a high volume of water (up to 4 litres). Powder is reconstituted with moderate volume of water (approx. 2 litres). A low volume of liquid (45ml) is mixed with a low volume of water (120ml). Is a low residue diet advised prior to dosing? Yes Yes Yes Yes No, it is sufficient to simply avoid solid food during the dosing period. Are there complications specific to this OBCA?* 1. Higher risk of hyponatraemia (if excessive water ingestion) than with other OBCAs. 2. Risk of hypermagnesaemia in patients with advanced chronic kidney disease. 1. Higher risk of hyponatraemia (if excessive water ingestion) than with other agents. 2. Risk of hypermagnesaemia in patients with advanced chronic kidney disease. Lowest risk of provoking hypovolaemia and/or hyponatraemia. Lowest risk of provoking hypovolaemia and/or hyponatraemia. 1. Acute phosphate nephropathy. 2. Hypocalcaemia resulting from hyperphosphataemia. 3. Highest risk of hypovolaemia Are there any contraindications specific to this OBCA? + It is particularly important that patients with conditions predisposing to hypovolaemia are evaluated prior to receiving this OBCA. It is particularly important that patients with conditions predisposing to hypovolaemia are evaluated prior to receiving this OBCA. G6PD deficiency. *It should be remembered that the administration of all types of OBCA may be complicated by hypovolaemia and/or electrolyte disturbances (including hypokalaemia, hyponatraemia, hypokalaemia and hypernatraemia). +The following are absolute contraindications to all types of OBCA: gastrointestinal obstruction, perforation or ileus; acute intestinal ulceration; severe inflammatory bowel disease; reduced consciousness; hypersensitivity to any of the ingredients; ileostomy. Should not be prescribed to patients with: hypovolaemia, egfr <60 ml/min/1.73m 2, hepatic cirrhosis, cardiac failure, hypertension, renin-angiotensin blockade. To be used only when other OBCAs are contraindicated. 3

4 Current formulary status: The North Staffordshire Joint Formulary currently lists the following: 1.6 LAXATIVES Bowel cleansing preparations KLEAN PREP Picolax Therapeutic class and mode of action 2 : Osmotic acting laxative The oral administration of macrogol-based electrolyte solutions causes moderate diarrhea and results in rapid emptying of the colon. Macrogol 3350, sodium sulfate and high doses of ascorbic acid exert an osmotic action in the gut, which induce a laxative effect. Macrogol 3350 increases the stool volume, which triggers colon motility via neuromuscular pathways. The physiological consequence is a propulsive colonic transportation of the softened stools. The electrolytes present in the formulation and the supplementary clear liquid intake are included to prevent clinically significant variations of sodium, potassium or water, and thus reduce dehydration risk. Macrogol 3350 is unchanged along the gut. It is virtually unabsorbed from the gastro-intestinal tract. Any macrogol 3350 that is absorbed is excreted via the urine. Ascorbic acid is absorbed mainly at the small intestine level by a mechanism of active transport, which is sodium dependent and saturable. There is an inverse relationship between the ingested dose and the percentage of the absorbed dose. For oral doses between 30 and 180mg an amount of about 70-85% of the dose is absorbed. Following oral intake of up to 12g ascorbic acid, it is known that only 2g is absorbed. After high oral doses of ascorbic acid and when plasma concentrations exceed 14mg/litre, the absorbed ascorbic acid is mainly eliminated unchanged in the urine. Indication 2 : For bowel cleansing prior to any clinical procedures requiring a clean bowel e.g. bowel endoscopy or radiology. Contraindication: Not to be used in patients with known or suspected: - Gastrointestinal obstruction or perforation - Disorders of gastric emptying (e.g. gastroparesis) 4

5 - Ileus - Phenylketonuria (due to presence of aspartame) - Glucose-6-phosphate dehydrogenase deficiency (due to presence of ascorbate) - Hypersensitivity to any of the ingredients - Toxic megacolon which complicates very severe inflammatory conditions of the intestinal tract including Crohn's disease and ulcerative colitis. - Unconscious patients Caution: MOVIPREP should be administered with caution to fragile patients in poor health or patients with serious clinical impairment such as: - impaired gag reflex, or with a tendency to aspiration or regurgitation - impaired consciousness - severe renal insufficiency (creatinine clearance <30ml/min) - cardiac impairment (NYHA grade III of IV) - dehydration - severe acute inflammatory disease The presence of dehydration should be corrected before the use of MOVIPREP. Semi-conscious patients or patients prone to aspiration or regurgitation should be closely observed during administration, especially if this is via a nasogastric route. If patients develop any symptoms indicating shifts of fluid/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, cardiac failure), plasma electrolytes should be measured and any abnormality treated appropriately. In debilitated fragile patients, patients with poor health, those with clinically significant renal impairment and those at risk of electrolyte imbalance, the physician should consider performing a baseline and posttreatment electrolyte and renal function test. If patients experience symptoms such as severe bloating, abdominal distention, abdominal pain or any other reaction which makes it difficult to continue the preparation, they may slow down or temporarily stop consuming MOVIPREP and should consult their doctor. Adverse effects Diarrhea is an expected outcome of bowel preparation. Due to the nature of the intervention, undesirable effects occur in the majority of patients during the process of bowel preparation. Whilst these vary between preparations, nausea, vomiting, bloating, abdominal pain, anal irritation and sleep disturbance commonly occur in patients undergoing bowel preparation. As with other macrogol containing products, allergic reactions including rash, urticaria, pruritus, angioedema and anaphylaxis are a possibility. 5

6 Very common: abdominal pain, nausea, abdominal distension, anal discomfort, malaise, Common: vomiting, dyspepsia, sleeping disorder, headache, dizziness, tiredness, rigors, thirst, hunger Drug interactions Oral medication should not be taken within one hour of administration of MOVIPREP as it may be flushed from the gastro-intestinal tract and not absorbed. The therapeutic effect of drugs with a narrow therapeutic index or short half-life may be particularly affected. Storage: Sachets are to be stored below 25 C while the reconstituted solution may be refrigerated. Dosage and administration 2 : Adults and elderly: A course of treatment consists of two litres of MOVIPREP. It is strongly recommended that one litre of clear liquid, which may include, water, clear soup, fruit juice without pulp, soft drinks, tea and/or coffee without milk, is also taken during the course of treatment. A litre of MOVIPREP consists of one 'Sachet A' and one 'Sachet B' dissolved together in one litre of water. This reconstituted solution should be drunk over a period of one to two hours. This should be repeated with a second litre of MOVIPREP. This course of treatment can be taken: either divided as one litre of MOVIPREP in the evening before and one litre of MOVIPREP in the early morning of the day of the clinical procedure, or in the evening preceding the clinical procedure. There should be at least one hour between the end of intake of fluid (MOVIPREP or clear liquid) and the start of colonoscopy. No solid food should be taken from the start of the course of treatment until after the clinical procedure. Children: Not recommended for the use in children below 18 year of age, as MOVIPREP has not been studied in the paediatric population. Content: The ingredients of MOVIPREP are contained in two separate sachets. Sachet A contains the following active substances: Macrogol 3350: 100g; sodium sulphate anhydrous: 7.500g; sodium chloride: 2.691g and potassium chloride: 1.015g 6

7 Sachet B contains the following active substances: Ascorbic acid: 4.700g and sodium ascorbate: 5.900g The concentration of electrolyte ions when both sachets are made up to one litre of solution is as follows: Sodium: mmol/l (of which not more than 56.2mmol is absorbable); sulphate: 52.8 mmol/l; chloride: 59.8 mmol/l; potassium: 14.2 mmol/l and ascorbate: 29.8 mmol/l Sachet A contains 0.233g of aspartame. Overdose: In case of gross accidental overdose, where diarrhea is severe, conservative measures are usually sufficient; generous amounts of fluid, especially fruit juices, should be given. In the rare event of overdose provoking severe metabolic derangement, intravenous rehydration may be used. NICE Guidance published No Cochrane No Efficacy: 1 MOVIPREP versus KLEAN PREP. 3 Ell C et al in a randomised controlled trial compared the efficacy, safety, and patient acceptability of MOVIPREP (a 2 Litre solution of Polyethylene glycol (PEG) plus ascorbic acid against KLEAN PREP (a 4 Litre PEG with electrolytes) for bowel cleansing before colonoscopy in 308 patients. Adult inpatients aged year requiring complete colonoscopy were recruited to the study from 15 German hospitals from June 2002 to December Consenting adult inpatients scheduled to undergo colonoscopy were randomized in a 1:1 ratio to receive either 2 litre MOVIPREP or 4 litre KLEAN PREP. Treatments were allocated using a computer-generated, randomized code list with a block size of 4. Both bowel cleansing preparations were divided into two equal doses taken on the evening before colonoscopy (up to 22:00 hour) and on the morning of the procedure (at least 1 hour before colonoscopy). Participants receiving MOVIPREP took one sachet dissolved in 1 L of water followed by at least 0.5 L of clear fluid at each administration (i.e., total dose of 2 L cleansing solution). Those receiving standard KLEAN PREP took two sachets dissolved in 2 L of water at each administration (i.e., total dose of 4 L cleansing solution). All patients received a standardized diet before the colonoscopy. They had a normal breakfast and a light lunch on the day before the procedure, but no solid food was permitted from then on until after the colonoscopy. Liquid food (e.g. clear soup or yoghurt) was permitted for the evening meal. The primary outcome measure was the overall quality of colon preparation assessed by an independent expert panel that reviewed videotapes of procedures unaware of the treatment allocation (i.e., the study was singleblind for the videotape review). Bowel cleansing success was assessed via videotapes by independent, blinded expert panel members. Statistical non-inferiority was predefined as a difference of <15% in the 7

8 lower limit of the 97.5% confidence interval for treatment difference. Patient views on the preparations were elicited. The degree of cleansing was recorded individually for each bowel segment (rectum, sigmoid colon, descending colon, transverse colon, and ascending colon). Each segment was rated using a 5-point scale: 4 - very good - colon empty and clean; 3 - good - presence of clear liquid in the gut; 2 moderate - presence of brown liquid or small amounts of semisolid residual stool, fully removable by suction or displaceable, thus allowing a complete visualization of the underlying mucosa; 1 - bad presence of semisolid stool, only partially removable with a risk of incomplete underlying mucosal visualization; 0 - very bad presence of semisolid or solid stool, colonoscopy incomplete or had to be stopped. The overall quality of colonic cleansing was based on the assessment of the individual segments using a scale of A, all segments clean (i.e., scores of 3 or 4 in all segments); B, residual brown liquid or suctionable semisolid stool (i.e., a score of 2) in at least one segment; C, partially removable stool preventing complete visualization of mucosa (i.e., a score of 1) in at least one segment; or D, at least one segment could not be examined due to the presence of solid stool (i.e., a score of 0). A grade of either A or B was defined, a priority, as successful colon cleansing. A total of 359 participants received the study medication (180 MOVIPREP, 179 KLEAN PREP ) and, therefore, comprised the intention-to-treat (ITT) population. Per protocol (PP) population used for the non-inferiority analysis comprised 308 individuals (153 MOVIPREP, 155 KLEAN PREP. The main reason for exclusion from the PP population was lack of useable videotape, which prevented reviewer assessment in 33 cases. Successful gut cleansing (grade A or B) was achieved in 136 of 153 (88.9%) of the MOVIPREP group and 147 of 155 (94.8%) of the KLEAN PREP group, (mean difference 5.9%). The difference (lower limit of the 1- sided 97.5% CI of 12.0%) fell within the predefined limit for non-inferiority. Clinical and laboratory parameters showed no difference in safety profile. Patient ratings of acceptability and taste were better for the MOVIPREP group than for the KLEAN PREP group (P < 0.025). Most patients consumed at least 75% of the solutions but more patients in the MOVIPREP group reported consuming all the solution (P = 0.035). The overall acceptability of the gut cleansing regimen was assessed by patients using visual analogue scores ranging from 0 (excellent) to 100 (very bad). The mean acceptability score was significantly better (i.e., lower) for MOVIPREP than for KLEAN PREP (27.6±14.8 vs 34.2±19.2, P<0.025). Patients who received MOVIPREP also rated the taste better than those who received KLEAN PREP (47% vs 21%), while the proportions of patients rating the taste as bad were 12% and 26%, respectively (P < 0.025). Patients were asked if they had problems taking the entire dose using a 3-point verbal scale and more patients receiving MOVIPREP reported no problems (74%) compared to those receiving KLEAN PREP (53%) (P < 0.05), while the proportions reporting many problems with drinking the whole preparation were 4% and 8%, respectively (P = 0.195). Safety Both treatments were generally well tolerated. No serious adverse events were reported. In the MOVIPREP group, 142 adverse events were reported in 73 patients (40.6%) and in the KLEAN PREP, 174 adverse events were reported in 86 patients (47.8%) by investigators in the patient record forms. The most common 8

9 adverse events were malaise, nausea, abdominal pain, and vomiting. The numbers of cases of vomiting or malaise were similar in both treatment groups (malaise: MOVIPREP 38, KLEAN PREP 36; vomiting: 14 and 25, respectively) as were the numbers of cases of nausea (35 vs 42) or abdominal pain (24 vs 30). Seven patients in the MOVIPREP group and six in the KLEAN PREP group withdrew from the study because of an adverse event. The authors concluded that combination of ascorbic acid and PEG-based bowel preparation (MOVIPREP ) reduced the volume patients had to drink without compromising efficacy or safety. The low-volume preparation was more acceptable to patients, and should, therefore, improve effectiveness in routine practice. 2 MOVIPREP versus Picolax 4 Worthington et al in a single blind, parallel randomised controlled trial compared the efficacy, safety and acceptability of MOVIPREP to Picolax for bowel cleansing in 65 adult patients scheduled to undergo colonoscopy. This is a one year study in an endoscopy unit in UK. Eligible patients were randomly allocated either 2 litre PEG + Asc (32 patients) or sodium picosulphate + magnesium citrate (33 patients) on a 1:1 basis. Both groups were given two sachets of powder to be reconstituted with water. MOVIPREP group reconstituted with first sachet with 1 litre of water which was taken in the evening on the day prior to the colonoscopy and the second taken in the morning of the day of the colonoscopy, finishing at least 1 hour prior to the start of the colonoscopy. Patients were advised to take at least 500ml of additional clear fluid after each dose. The picolax group reconstituted each sachet with 150ml of water. Both doses were taken on the day prior to the colonoscopy. Patients were advised to drink additional water or other clear fluid at a rate of 250ml/hour while the bowel cleansing effect persisted. The volume of additional fluid was not monitored. Patients recorded in the patient diary card details of bowel preparation taken and an acceptability questionnaire. The colonoscopist was blinded to the questionnaire and patient study data. The colonoscopist recorded the degree of bowel cleansing for each 6 bowel segments (rectum, sigmoid colon, descending colon, transverse colon, ascending colon and caecum), the endpoint of the colonoscopy and if the ileo-caecal junction was visualised. 5 point score (4 to 0)was used to assess the bowel segments: 4 - colon empty and clean; 3 presence of clear liquid in the bowel, but easily removed by suction; 2 presence of brown liquid or small amounts of semisolid residual stool, fully removable by suction or displaceable; 1 presence of semisolid stool, only partially removable with a risk of incomplete visualisation of bowel mucosa; 0 presence of semisolid or solid stool consequently colonoscopy was incomplete or had to be stopped. Grade A: all colon segments with a score of 3 or 4; Grade B: at least one colon segment with a score of 2; Grade C: at least one colon segment with a score of 1; Grade D: at least one colon segment with a score of 0. Grade A or B was considered as a successful bowel preparation while C or D was considered as a failure. There was a higher incidence of abnormal findings in the MOVIPREP group compared with Picolax group (37.5% vs 12.1%). The bowel preparation treatment was a success in 27 (84%) patients in the MOVIPREP group and 24 (72.7%) patients in the Picolax group. The difference between the two group was not statistically significant (p = 0.367). 15 patients (46.9%) in the MOVIPREP group had an overall grade A compared to 5 patients (15.2%) in the Picolax group. The overall distribution of grades between the two 9

10 groups was statistically significant (p = 0.018) in favour of better overall cleansing in the MOVIPREP group specifically in the ascending colon (p = 0.024) and caecum (p = 0.003). Picolax patients found the taste better than those in the MOVIPREP group (p < 0.001) Picolax group were willing to consider taking a repeat preparation if required (p = 0.035) and found it easier to continue with their usual activities (p = 0.079). 2 patients in the Picolax group required a repeat colonoscopy while none in MOVIPREP group needed a repeat colonoscopy. Safety The two most common symptoms reported in both MOVIPREP and Picolax group prior to colonoscopy were headache (9 vs 11 patients respectively) and nausea (6 vs. 4 patients). The authors concluded that MOVIPREP is as effective as Picolax in bowel cleansing in terms of grading as overall success or failure. 3 MOVIPREP with bisacodyl versus Klean Prep 5 Brahmania M. et al in a single blinded non inferior randomised controlled single centred trial examined the bowel cleansing efficacy and patient tolerability of split dose 2 litre MOVIPREP with 15 mg bisacodyl against split dose 4 litre Klean prep in 325 patients undergoing elective outpatient colonoscopy. The main outcome measurement was the efficacy and tolerability of MOVIPREP with 15mg bisacodyl. The efficacy was assessed by using the Boston bowel preparation scale while patient satisfaction and tolerability were assessed by using a short survey. Both groups were asked to take clear liquid diet starting 11am the day before their procedure. The MOVIPREP group were instructed to take 15mg bisacodyl at 2pm the day before the procedure, then start drinking the first 1 litre of the prepared MOVIPREP solution 6 hours later while the Klean prep group stated the first 2 litre solution around 3pm. On the day of procedure, the MOVIPREP and Klean prep groups finished the remaining 1 and 2 litre solutions respectively 4 hours before their colonoscopy appointment. Endoscopists were blinded to the bowel preparation until completion of the study. The Boston bowel preparation scale (BBPS) is a 10 point scale that assesses 3 segments of the colon from 0 to 3. Scores of 8 or higher were considered as excellent, while 6 or higher are generally thought to provide a good visualisation of colon. The Ottawa bowel preparation scale (OBPS) was used to confirm the BBPS and is based on 14 point scale with 0 being the best score. A total of 325 patients were included in the ITT analysis with 318 patients included in PP analysis (159 patients on each arm). The primary endpoint of the trial was bowel cleansing efficacy rate by BBPS score of 8 or higher. The authors assumed 4 litre Klean prep is 85% efficacious in achieving an excellent equivalent BBPS score 8 or higher and that a 10% difference between groups would constitute a minimal clinically meaningful difference in the rates of efficacy between the two preparations. The secondary outcome was patient tolerability of and satisfaction with MOVIPREP with bisacodyl based on a 6 question survey. The MOVIPREP + bisacodyl regimen was not significantly different from Klean prep regimen in terms of efficacy in achieving an excellent preparation as per BBPS scoring or 8 or more. There was also no 10

11 significant difference in efficacy between the two regimens according to OBPS. A score of 4 or lower was considered excellent preparation and non-inferiority of MOVIPREP remained after adjusting for age, sex and endoscopist. The MOVIPREP appeared to be non-inferior to Klean prep in clearing the ascending colon according to the OBPS in the PP analysis (p = 0.034). After adjusting for age, sex and timing of procedure, there was no significant difference in overall adverse incidence between the MOVIPREP + bisacodyl group and the Klean prep group (49.7% vs. 47.8%, p = 0.736) respectively. There was no significant difference in both groups in the proportion of patients that consumed less than 80% of the bowel preparation (1.9% vs 3.8%, p = 0.502). The MOVIPREP patients found it easy and acceptable taking the preparation (89.9% vs 74.8%, p<0.001) and were willing to repeat the same preparation (98.7% vs 73.6%, p< 0.001). Cost Current Price (excl.vat) Medicine Description UHNS Drug Tariff MOVIPREP 4-SACHET PACK!(2 each of Sachet A and B) (4) CITRAFLEET!ORAL SACHETS (2 sachets) CITRAMAG!SACHETS (10 sachets) (2 sachets - UHNS MFU) 3.10 (10 sachets) FLEET PHOSPHO-SODA ORAL SOLUTION (2x45mL) KLEAN-PREP WARD PACK 4 SACHET UNIT PICOLAX SACHETS (2 SACHETS) (UHNS MFU) Expenditure in primary and secondary care for 12-month period (July 2013-June 2014): Expenditure for Jul13-Jun14: Medicine Description UHNS Lloyds epact Expenditure (VAT included) Expenditure (VAT not included) Based on Total Act Cost (VAT not included) UHNS Acute Trust TOTAL MOVIPREP SACHET CITRAFLEET SACHET CITRAMAG SACHET FLEET PHOSPHO-SODA ORAL SOLUTION KLEAN-PREP SACHET PICOLAX SACHET 13, , , , Expenditure for July 13 June 14: Medicine NORTH STAFFORDSHIRE CCG Based on Total Act Cost (VAT not included) STOKE ON TRENT CCG Based on Total Act Cost (VAT not included) CCG TOTAL MOVIPREP SACHET CITRAFLEET SACHET CITRAMAG SACHET

12 FLEET PHOSPHO-SODA ORAL SOLUTION KLEAN-PREP SACHET PICOLAX SACHET TOTAL , References Consensus Guidelines for the Prescription and Administration of Oral Bowel Cleansing Agents developed by: The Association for Coloproctology of Great Britian and Ireland for The Royal College of Surgeons; The British Society of Gasteroenterology; The British Society of Gastrointestinal and Abdominal Radiology; The Renal Association; The Royal College of Radiologists. MOVIPREP Orange, powder for oral solution. ) Summary of Product Characteristics. Norgine (UK) Ltd. Last updated 21/01/2013 accessed via 06/08/14 Ell C, Fischbach W. et al. Randomized Trial of Low-Volume PEG Solution Versus Standard PEG + Electrolytes for Bowel Cleansing Before Colonoscopy. Am J Gastroenterol 2008; 103: Worthington J, Thyssen G, Chapman R et al. A randomised controlled trial of a new 2 litre polyethylene glycol solution versus sodium picosulphate + magnesium citrate solution for bowel cleansing prior to colonoscopy. Curr Med Res Opin 2007; 24 (2): Brahmania M, Ou G. et al. 2 L versus 4 L of PEG electrolytes for outpatient colonic preparation: a randomised, controlled trial. Gastrointest Endosc 2014; 79: Produced by Sr. Maria Chidiamara Njoku Primary Care/Secondary Care Interface Pharmacist University Hospital of North Staffordshire Telephone: Maria.Njoku@uhns.nhs.uk Produced for use within the NHS. Not to be reproduced for commercial purposes. 12