Once is Enough - The Pharmacist's Role in Getting Bowel Preparation Right

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2 Once is Enough - The Pharmacist's Role in Getting Bowel Preparation Right ACTIVITY DESCRIPTION KM is a 57 year old male with a colorectal exam scheduled. He has no history of stomach problems and this appears to be a routine cancer screening. He is uncomfortable with the procedure and very worried about the prep. He recalls that his wife had to be re-scheduled several times because she did not get the bowel preparation right. She was miserable throughout the experience. He would like advice on how to ensure than he only has to go through the process once. Appropriate education and counseling prior to bowel preparation can make a big difference in achieving adequate cleansing. Many factors such as patient preferences, past experience, comorbid medical conditions and current medications can impact the choice of bowel preparation. The pharmacist must understand the pharmacological options to include appropriate instructions, comparative safety, adverse effects, and considerations for use in specific populations. Once an appropriate bowel preparation has been selected, patient education on compliance and specific guidance for appropriate administration significantly improves the likelihood of a successful colonoscopy. TARGET AUDIENCE The target audience for this activity is pharmacists, pharmacy technicians, and nurses in hospital, community, and retail pharmacy settings. LEARNING OBJECTIVES After completing this activity, the pharmacist will be able to: Outline the importance of adequate bowel cleansing prior to colonoscopy and factors associated with inadequate cleansing Compare and contrast the options for bowel preparations and their administration requirements, comparative safety and efficacy, adverse effects, and considerations for use in specific populations Identify key patient counseling points for bowel preparation to include patient education on compliance and guidance for appropriate administration ACCREDITATION Pharmacy PharmCon, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Nursing PharmCon, Inc. is approved by the California Board of Registered Nursing (Provider Number CEP 13649) and the Florida Board of Nursing (Provider Number ). Activities approved by the CA BRN and the FL BN are accepted by most State Boards of Nursing. CE hours provided by PharmCon, Inc. meet the ANCC criteria for formally approved continuing education hours. The ACPE is listed by the AANP as an acceptable, accredited continuing education organization for applicants seeking renewal through continuing education credit. For additional information, please visit: Universal Activity No.: H01-P Credits: 1.0 contact hour (0.1 CEU) Release Date: 12/15/2016 Offline Date: 12/15/2016 Expiration Date: 10/28/2018 ACTIVITY TYPE Knowledge-Based Live Webinar FINANCIAL SUPPORT BY PharmCon, Inc.

3 Ellen Jett Wilson, RPh, PhD Adjunct Professor, College of Southern Maryland ABOUT THE AUTHOR Ellen Wilson is a freelance educator based in Greenville, SC. She received a B.S. in Pharmacy and a PhD in Pharmaceutical Sciences from the University of South Carolina. Her pharmacy practice experiences include retail, hospital, and consulting pharmacy. She also has nearly ten years of collegiate teaching experience at both four-year and two-year institutions. Currently, she teaches online chemistry courses and writes pharmacy continuing education. Ellen lives in Greenville with her husband, two daughters, one cocker spaniel, and a once-stray cat. She is an active volunteer at both church and school, enjoys gardening and backyard birding, and is trying to master the art of French cooking. FACULTY DISCLOSURE It is the policy of PharmCon, Inc. to require the disclosure of the existence of any significant financial interest or any other relationship a faculty member or a sponsor has with the manufacturer of any commercial product(s) and/or service(s) discussed in an educational activity. Ellen Jett Wilson reports no actual or potential conflict of interest in relation to this activity. Peer review of the material in this CE activity was conducted to assess and resolve potential conflict of interest. Reviewers unanimously found that the activity is fair balanced and lacks commercial bias. Please Note: PharmCon, Inc. does not view the existence of relationships as an implication of bias or that the value of the material is decreased. The content of the activity was planned to be balanced and objective. Occasionally, faculty may express opinions that represent their own viewpoint. Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not intended as a substitute for the participant s own research, or for the participant s own professional judgement or advice for a specific problem or situation. Conclusions drawn by participants should be derived from objective analysis of scientific data presented from this activity and other unrelated sources. Neither freece/pharmcon nor any content provider intends to or should be considered to be rendering medical, pharmaceutical, or other professional advice. While freece/pharmcon and its content providers have exercised care in providing information, no guarantee of it s accuracy, timeliness or applicability can be or is made. You assume all risks and responsibilities with respect to any decisions or advice made or given as a result of the use of the content of this activity.

4 - Once is Enough The Pharmacist's Role in Getting Bowel Preparation Right Activity ACCREDITATION Universal Activity Number L01 Activity INSTRUCTION Faculty Credits 1.0 contact hour(s) Ellen Jett Wilson, RPh, PhD Adjunct Professor, College of Southern Maryland Faculty Disclosure Dr. Wilson has no actual or potential conflicts of interest in relation to this activity. Learning OBJECTIVES Outline the importance of adequate bowel cleansing prior to colonoscopy and factors associated with inadequate cleansing Compare and contrast the options for bowel preparations and their administration requirements, comparative safety and efficacy, adverse effects, and considerations for use in specific populations Identify key patient counseling points for bowel preparation to include patient education on compliance and guidance for appropriate administration Legal DISCLAIMER The material presented here does not necessarily reflect the views of PharmCon, Inc. or the companies that support educational programming. A qualified healthcare professional should always be consulted before using any therapeutic product discussed. Participants should verify all information and data before treating patients or employing any therapies described in this educational activity. FACULTY: Ellen Jett Wilson, RPh, PhD 12/15/ Objectives Why Colonoscopy? Outline the importance of adequate bowel cleansing prior to colonoscopy and factors associated with inadequate cleansing Compare and contrast options for bowel preparations, their adminstration requirements, comparative safety and efficacy, adverse effects, and consideration for use in specific populations Identify key patient counseling points for bowel preparation including patient education on compliance and guidance for appropriate administration Colorectal cancer is the 2 nd leading cause of cancer death in the US In 2015, it is estimated that 133,000 will be diagnosed 50,000 will die Colonoscopy is an important diagnostic and preventive tool 12/15/ /15/

5 Screening Guidelines USPSTF, ACS, ACR, ACG, NCCN, ACP US Multi-Society Task Force AGA, ACG, ASGE Screening should begin at age 50 and continue until age 75 Colonoscopy every 10 years What Do Patients Say About Colonoscopy? The actual test isn't scary The procedure was benign The procedure is a breeze I remember nothing about the procedure 12/15/ /15/ Why Bowel Prep? Physician must have a clear view of the colon Detect polyps 5mm or larger Poor preparation 20-25% Increased procedure time Increased complications Missed polyps Repeated procedures What Do Patients Say About Colonoscopy Prep? Tastes like turned (spoiled) Gatorade 45 min later (I timed it) I was dashing to the toilet with my ipad in hand Watch out for the blow out! You sure that is just a gallon? the prep the whole house remembers! 12/15/ /15/

6 What Does Dave Barry Say About Colonoscopy Prep? which comes in a box large enough to hold a microwave oven. [it] tastes and here I am being kind like a mixture of goat spit and urinal cleanser, with just a hint of lemon. There are times when you wish the commode had a seat belt. You eliminate everything. And then,.. as far as I can tell, your bowels travel into the future and start eliminating food that you have not even eaten yet. Risk Factors for Inadequate Prep Patient compliance not completing the prep Male sex High BMI/obesity Neurologic diseases, stroke, diabetes Anticholinergic drugs, narcotics, decreased motility Previous colon surgery Cirrhosis 12/15/ /15/ Polyethylene Glycol & Electrolyte Solution (PEG-ES) Indications/MOA/Onset Bowel cleansing prior to colonoscopy Induces catharsis by strong electrolyte and osmotic effects Onset of action ~1 hour Contraindications hypersensitivity, intestinal blockage or obstruction, gastric retention, bowel perforation, toxic colitis, and toxic megacolon 12/15/ /15/

7 Available PEG-ES Products Special Populations Formulation Brand Name(s) Notes PEG g sodium sulfate 22.72g sodium bicarbonate 6.72g sodium chloride 5.84g potassium chloride 2.98g PEG g sodium sulfate 22.74g sodium bicarbonate 6.74g sodium chloride 5.86g potassium chloride 2.97g CoLyte GaviLyte-C PEG-3350&Electrolytes (various generics) GoLYTELY GaviLyte-G PEG-3350&Electrolytes (various generics) 4L jugs, citrus berry, lemon lime, cherry and pineapple flavors 4L jugs, lemon flavor 4L jugs, various flavors 4L jugs, pineapple flavor 4L jugs, lemon flavor 4L jugs, various flavors Formulation Brand Name(s) Notes PEG g sodium bicarbonate 5.72g sodium chloride 11.2g potassium chloride 1.48g NuLYTELY GaviLyte-N TriLyte Various generics 4L jugs, cherry, lemon-lime, orange, and pineapple flavor packs 4L jugs, lemon flavor 4L jugs with flavor packs 4L jugs, cherry, lemon-lime, orange, and pineapple flavor packs Elderly, diabetic, hypertensive, cardiac, and renal patients No dyes, no sugar, no glucose, 52% less salt 12/15/ /15/ Preparation for Administration Dosing Regimen for 4L Preps Using the container provided, add lukewarm water up to the 4L mark Shake vigorously May store in the refrigerator Use within 48 hours Drink 8oz (240mL) every 10 minutes until 4L are consumed or the effluent is clear It is better to drink the 8oz doses rapidly than to sip small amounts over a longer period of time May also see split dosing regimens Day 1: 2-3L of solution Day 2: 1-2L of solution 12/15/ /15/

8 Poll Question #1 Poll Question #1 Traditional 4-Liter colonoscopy preparations contain this type of osmotic laxative: A. Bisacodyl electrolyte solution B. Magnesium citrate C. Polyethylene glycol and electrolytes D. Milk of magnesia Traditional 4-Liter colonoscopy preparations contain this type of osmotic laxative: A. Bisacodyl electrolyte solution B. Magnesium citrate C. Polyethylene glycol and electrolytes D. Milk of magnesia 12/15/ /15/ Low-Volume PEG Formulations Formulation Brand Name(s) Notes PEG g sodium sulfate 7.5g sodium chloride 2.691g potassium chloride 1.105g PEG g Sodium bicarbonate 2.86g Sodium chloride 5.6g Potassium chloride 0.74g PLUS 1-5mg bisacodyl delayed-release tablet PEG g (no electrolytes) MoviPrep Gavilyte-H Miralax (various generics) 2L volume + 1L of clear fluids of patient s choice, contains aspartame, lemon flavor 5mg bisacodyl + 2L, lemon-lime, cherry, orange, pineapple In 2L of sports drink Preparation for Administration Low Volume PEG-ES Using the container provided, mix the contents of Pouch A and Pouch B and add lukewarm water to the fill line Mix the solution until dissolved May store in the refrigerator Use within 24 hours A B 1L 12/15/ /15/

9 Split-Dose Regimen for Low-Volume PEG-ES Evening before colonoscopy (10-12 hours before Dose 2) Drink 8oz every 15 minutes until 1L is consumed followed by 16oz (0.5L) of clear liquid of choice Morning of colonoscopy (at least 3.5 hours prior to procedure) Drink 8oz every 15 minutes until 1L is consumed followed by 16oz (0.5L) of clear liquid of choice, consumed at least 2 hours before procedure Evening Only Alternative Dosing for PEG-ES Evening before colonoscopy (at least 3.5 hours before bedtime Drink 8oz every 15 minutes until 1L is consumed Dose 2 (~90 minutes after starting Dose 1) Drink 8oz every 15 minutes until 1L is consumed followed by 1L of clear liquid of choice, consumed before going to bed 12/15/ /15/ Preparation for Administration PEG-ES + Bisacodyl Add flavor pack of choice Fill container to the 2L mark with lukewarm water Shake vigorously until mixed May store in the refrigerator Use within 48 hours Dosing Regimen for PEG-ES + Bisacodyl Take 5mg bisacodyl tablet Swallow whole, do not crush or chew Dissolve the PEG for solution in 2L of water Wait for BM/max of 6 hours Drink 8oz of solution every 10 minutes (2L) 12/15/ /15/

10 Preparation for Administration of PEG Alone Add 238g of PEG-3350 to 64oz of sports drink and shake vigorously to mix No red or purple flavors! May be refrigerated Dosing Regimen for PEG Alone Drink 32oz on the night before, followed by 32oz on the morning of procedure OR Drink 64oz on the night before the procedure 12/15/ /15/ Sodium Phosphate Oral Tablet Formulation Brand Name(s) Notes Sodium phosphate, dibasic gm Sodium phosphate, monobasic 1.102gm OsmoPrep (Visicol ) Total of 32 tablets and 2L of clear liquid Black Box Warning There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products for colon cleansing prior to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long-term dialysis. While some cases have occurred in patients without identifiable risk factors, patients at increased risk of acute phosphate nephropathy may include those with increased age, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, or baseline kidney disease, and those using medicines that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal antiinflammatory drugs [NSAIDs]). 12/15/ /15/

11 Sodium Phosphate Tablet Dosing Sulfate Salt Solution Evening before colonoscopy 4 tablets with 240mL(8oz) of clear liquid every 15 minutes x 5 doses (1.2L total) 3-5 hours before colonoscopy 4 tablets with 240mL(8oz) of clear liquid every 15 minutes x 3 doses (0.74L total) Formulation Brand Name Notes Sodium sulfate 17.5gm Potassium sulfate 3.13gm Magnesium sulfate 1.6gm Suprep Bowel Prep Kit 2-6oz bottles of oral solution to be diluted 1-16oz dosing cup 12/15/ /15/ Sulfate Salt Solution Dosing Stimulant/Osmotic Laxative Evening before colonoscopy Drink 16oz diluted prep plus 32oz of clear liquid within one hour (1.4L total) Day of colonoscopy (10-12 hours later) Repeat, (1.4L total) Formulation Brand Name(s) Notes Citric acid 12gm Magnesium oxide 3.5gm Sodium picosulfate 10mg Prepopik MgO 2-5oz packets to dilute 1-5oz/8oz dosing cup Flavor packets, orange and cranberry 12/15/ /15/

12 Preferred Dosing for Stimulant/Osmotic Laxative Evening before colonoscopy 1 packet in 5oz cold water followed by 5-8oz drinks (1.35L total) 5 hours before colonoscopy 1 packet in 5oz cold water followed by 3-8oz drinks (0.9L) Alternate Dosing for Stimulant/Osmotic Laxative Evening before colonoscopy, 4-6PM 1 packet in 5oz cold water followed by 5-8oz drinks (1.35L total) 6 Hours later, 10-12PM 1 packet in 5oz cold water followed by 3-8oz drinks (0.9L) 12/15/ /15/ Precautions Use With Caution Impaired gag reflex Renal impairment Ulcerative colitis Bowel obstruction or perforation Precautions Have Been Reported Fluid/electrolyte imbalance Arrhythmias Seizures Ischemic colitis 12/15/ /15/

13 Special Populations--Pediatrics Special Populations-Geriatrics Formulation Brand Name(s) Notes PEG g sodium bicarbonate 5.72g sodium chloride 11.2g potassium chloride 1.48g NuLYTELY GaviLyte-N TriLyte Various generics Approved in patients 6 months of age and older 25mL/kg/hr until clear Bowel Preparation PEG-ES (older formulations) PEG-ES (newer formulations) PEG-ES plus bisacodyl Notes Upper GI bleeding, esophogeal perforation, dyspnea, pulmonary edema, aspiration No differences May be less effective in patients 65 12/15/ /15/ Special Populations-Geriatrics Special Populations Pregnancy and Lactation Bowel Preparation Sodium phosphate tablets Sodium sulfate solution CA/MgO/sodium picosulfate Notes No difference, older may be more susceptible to nephrotoxicity No difference in split-dosing, more vomiting in evening only dosing No difference Pregnancy Risk Factor C PEG-ES, bisacodyl, sodium phosphate, sodium sulfate All are probably compatible with breast feeding 12/15/ /15/

14 Special Populations Pregnancy and Lactation Pregnancy Risk Factor B Citric acid/magnesium oxide/sodium picosulfate Undetectable in breast milk Adverse Reactions >10% PEG-Electrolyte Solutions GI Abdominal distention (~60%), anorectal pain (~50%), nausea (14-50%), abdominal pain (6-40%), hunger (30%), vomiting (7-12%) CNS Sleep disorder (35%), rigors (34%), malaise (>18%) Endocrine & Metabolic Increased thirst (~45%) 12/15/ /15/ Adverse Reactions Non-PEG Preparations Sodium Phosphate Tablets Sulfate Salt Solutions CA/MgO/Na picosulfate Bloating 31-47% 40% --- Nausea 26-35% 36% 3% Abdominal Pain 23-30% 36% --- Vomiting 4-7% 8% 1% Incidence of Headache Bowel Prep % PEG-ES 2% Sodium Phosphate tablets? Sodium sulfate solution 1% CA/MgO/Na picosulfate 1.6% I had dehydration headaches and it took a few days to get back in some semblance of intestinal order. 12/15/ /15/

15 Poll Question #2 What kind of adverse effects are most commonly reported by patients taking a colonoscopy preparation? A. CNS adverse effects B. GI adverse effects C. Endocrine and metabolic adverse effects D. Most patients do not experience any adverse effects from colonoscopy prep Poll Question #2 What kind of adverse effects are most commonly reported by patients taking a colonoscopy preparation? A. CNS adverse effects B. GI adverse effects C. Endocrine and metabolic adverse effects D. Most patients do not experience any adverse effects from colonoscopy prep 12/15/ /15/ Counseling Points The Day Before the Colonoscopy Oral medications may not be absorbed properly if taken within one hour of starting colonoscopy prep Discontinue other laxatives during prep Avoid alcohol one day before starting prep and until after procedure increased risk of dehydration Discontinue preparation and contact health care provider for hives, rash, or other allergic reactions Most will allow a light breakfast then clear liquids Stop solids 3-4 hours prior to the start of prep Absolutely no food 2 hours prior to start of prep Only clear liquids after start of prep and until after the colonoscopy 12/15/ /15/

16 What is a Clear Liquid? Follow the Directions Water, flavored water Coffee or tea no creamer Clear broth Clear soda Clear juices (no pulp) Apple, pear, white grape, white cranberry Strained limeade or lemonade (no pulp) Gelatin with no fruit/topping Popsicles with no fruit pieces No purple or red dyes/drinks Now I have finished a procedure that is supposed to take four and a half hours in just under ten minutes. --Jeff Foxworthy 12/15/ /15/ What to Expect The first bowel movement may occur within one hour, plan to be near a bathroom Bowel movements will continue for some time, be sure to wear comfortable clothes that are easy to take on and off Rectal irritation may occur, it could help to have wipes available for comfort Have a book, a tablet, a laptop or some other distraction nearby to occupy your time both in and out of the bathroom What to Expect Abdominal bloating and distention may occur before the first bowel movement. If pain and distention are severe, stop drinking PEG temporarily or drink each portion at longer intervals until the symptoms diminish If severe symptoms continue, notify health care provider 12/15/ /15/

17 Product-Specific Counseling Points PEG-ES Low Volume (MoviPrep ) contains phenylalanine, use with caution in patient s with G6PD deficiency due to the presence of sodium ascorbate and ascorbic acid Pouch A + Pouch B AND additional fluids Sodium phosphate tablets (OsmoPrep ) Be sure to drink 8oz of liquid/4 tablets Sulfate salt solution (Suprep ) The solution must be diluted Stimulant/Osmotic laxative (Prepopik ) Remember to drink the additional clear liquids Q&A 12/15/ /15/

18 Exam Questions: 1. Colorectal cancer is the leading cause of cancer death in the US: a. 1 st b. 2 nd c. 3 rd d. 4 th 2. Most screening guidelines agree that colorectal screening should begin at age and continue through age. a. Begin at age 40 and continue through age 65 b. Begin at age 45 and continue through age 70 c. Begin at age 50 and continue through age 75 d. Begin at age 55 and continue through age Which is the following is a risk factor for having an inadequate bowel preparation? a. Male sex b. Concomitant therapy with anticholinergics or narcotics c. Co-morbid conditions such as stroke and diabetes d. All of the above 4. Many colonoscopy preparations contain which laxative combination? a. Bisacodyl solution and electrolytes b. Polyethylene glycol and electrolytes c. Magnesium citrate and electrolytes d. Milk of magnesia and polyethylene glycol

19 5. Elderly patients, diabetics, patients with hypertension, and renal patients should be considered for a colonoscopy preparation that does not contain: a. Polyethylene glycol b. Sodium chloride c. Sodium bicarbonate d. Sodium sulfate 6. True or False: When taking a colonoscopy preparation, it is better for patients to drink each portion of preparation solution at once than to slowly sip on each portion. a. True b. False 7. colonoscopy preparation. Patients must drink 4L of preparation solution in order to achieve an adequate preparation. a. True b. False 8. This colonoscopy preparation comes with a black box warning about acute phosphate nephropathy. a. A b. Citric acid, magnesium phosphate, and sodium picosulfate for solution c. Oral sodium phosphate d. Polyethylene glycol and electrolyte solution 9. The most commonly reported adverse effect reported with colonoscopy preparation is: a. CNS side effects such as sleep disturbance b. GI side effects such as abdominal distention and pain, nausea and vomiting, anorectal pain c. Endocrine or metabolic side effects such as thirst d. Most patients do not experience any adverse effects with colonoscopy preparation

20 10. The term clear liquid includes all of the following except: a. Water and flavored water b. Black coffee or tea c. Cherry or fruit punch flavored powdered beverages d. Clear sodas