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Quarter One 2012 Volume 30 news Unit Spotlight Not Just a Team — a Family Gastroenterology Associates boasts a supportive nursing staff with a passion for the profession Gastroenterology Associates Endoscopy Manager, Andrea Raincrow-Chisholm, MSN BSN RN CGRN Gastroenterology Associates is a busy practice located in Olympia, WA — a major cultural center of the Puget Sound region. The city’s motto is SPIRIT, an acronym that stands for Service, People, Integrity, Results, Innovation and Team. With a motto like that, Olympia appears to be the perfect home for Gastroenterology Associates. “Our mission is to provide expertise in the diagnosis, treatment, evaluation and management of digestive diseases to the medical community and to provide the highest quality of care to the patient population of the south Puget Sound region,” says Andrea Raincrow-Chisholm, MSN BSN RN CGRN, Endoscopy Manager at Gastroenterology Associates. “We have a strong commitment to provide education in the topics of digestive diseases to our community of colleagues, medical trainees, staff and patients.” Andrea has worked in the GI field since 1999 and began her career in an acute care setting at Providence St. Peter Hospital in Olympia. While there, she worked with three different GI groups — one of which was Gastroenterology Associates. When she was offered a management position to work in an outpatient setting with Gastroenterology Associates in 2010, she appreciated both the opportunity and the challenge. “The staff at Gastroenterology Associates are experts in their area, and they have a great reputation in the community,” Andrea says. At Gastroenterology Associates, Andrea found herself leading a team of GI professionals with a variety of disciplines — RNs, LPNs and GIAs — who all worked together to provide the level of care that bolstered the practice’s stellar reputation. “What I like most is that we’re all in it together, and we help each other — I can’t say it enough about our team,” Andrea says. “We all understand the importance of each of our roles and that patient care is the focus, so we understand how our roles benefit the patient most.” Echoing that sentiment, Sarah Trigg, CGRN, says an important aspect of teamwork at Gastroenterology Associates is humor and a deep level of comfort with her professional colleagues. “We enjoy each other — we’re like family,” Sarah says. “I think that extends to our patient care.” (From the left) Gastroenterology Associates’ Reschal Edwards-Griffen, Melissa Mugartegui and Kayla Peterson. Welcome to 2012! Will this be the year you accept the SGNA call to lead? See page 2. A Strong Support System There are about 35 procedures performed each day at Gastroenterology Associates, with patients arriving at 6:45 am and the last patient discharged around 4:15 pm. Between those hours, there’s very little downtime, but the strong staff support system helps keep operations running smoothly. Inside President’s Perspective . . . . . 2 “If someone gets bogged down in one particular area, another nurse can take over — it’s a fluid team,” Andrea says. “People jump in when they see a need. It’s a very fastpaced area.” Member Spotlight . . . . . . . . . . 5 Continued on page 3 Editor’s Corner . . . . . . . . . . . . . 11 Program Focus . . . . . . . . . . . . . . 6 Product Spotlight . . . . . . . . . . . 7 Leadership Conference . . . . 10 President’s Perspective Quarter One 2012 • Volume 30 Visit: www.sgna.org • [email protected] SGNA News (ISSN 1057-9095) is published quarterly by the Society of Gastroenterology Nurses and Associates, Inc., 401 North Michigan Avenue, Chicago, IL 60611-4267; 312/321-5165 or 800/245-SGNA (7462), Web www.sgna.org/ Copyright 2012©SGNA. Fifteen dollars of annual dues is allotted for a subscription to SGNA News. Periodicals postage paid at Chicago, IL. Postmaster: Send address changes to SGNA News, 401 North Michigan Avenue, Chicago, IL 60611-4267. SGNA is an organization of 8,000+ registered nurses and other healthcare providers functioning in administrative, clinical, educational and/or research roles in the management of individuals with GI health problems. SGNA News is published to provide association and industry information for the benefit of its members. Reference to any company or product within SGNA News should not be considered endorsement or approval. SGNA Mission & Purpose The Society of Gastroenterology Nurses and Associates, Inc., is a professional organization of nurses and associates dedicated to the safe and effective practice of gastroenterology and endoscopy nursing. SGNA carries out its mission by advancing the science and practice of gastroenterology and endoscopy nursing through education, research, advocacy and collaboration, and by promoting the professional development of its members in an atmosphere of mutual support. SGNA Calls You to Accept the Challenge to Lead Leslie E. Stewart, BA RN CGRN, 2011-2012 SGNA President It is so good to have this opportunity to be in touch with you as we welcome in 2012. I have been your President since May 2011, and I must tell you how humbled and honored I am each and every day to have the privilege to represent you in so many different ways. I returned from the Canadian SGNA Annual Conference in beautiful Ottawa, Ontario, where I spent a week with our Canadian sisters and brothers looking at the challenges facing our specialty today and in the coming years. Then I flew off to Stockholm, Sweden, to join the European Gastroenterology Federation at an extraordinary meeting of 3,000 GI physicians and nurses from all over the world sharing and searching for best practices and their own unique ways of attaining excellence in patient care. We are all so different in customs and culture, and yet not really so different at all. We all search for quality. our teams and, unfortunately, to limitations to patients’ access to healthcare. We are asked for quality and excellence and yet told to do more with less. Providing high quality entwined with efficiency is paramount to our ability to survive. SGNA cannot grow or go forward in fear. We can’t stand still with anxiety and permit our organization to join a race to the bottom with those affiliates that are afraid of change, afraid to invest, afraid to disrupt the status quo to build changes in the needs of our specialty and the roles we will need to be ready to play. This is a turbulent time, but this is also an extraordinary time of opportunity. Through ambitious and constructive planning, SGNA will be prepared for these coming challenges and be the recognized leader into the future of GI nursing. SGNA will need your commitment and involvement to make these changes a reality in practice. We need you to take that courageous step to “Find the Leader in You and Make the Choice to Lead.” SGNA will 2011–2012 Officers President Leslie E. Stewart, BA RN CGRN President-Elect Phyllis Malpas, MA RN CGRN Secretary Betty McGinty, MS HSA BS RN CGRN Treasurer Jane Harker, MS BSN RN CGRN Immediate Past President Peggy Gauthier, MS BSN RN CGRN Directors Kimberly Foley, BSN RN CGRN Lisa Fonkalsrud, BSN RN CGRN LeaRae Herron-Rice, MSM BSN RN CGRN Colleen Keith, MSN RN CGRN Jo Sienknecht, RN CGRN Conrad Worrell, RN CGRN Speaker of the House Of Delegates Catherine Collins, MBA BSN RN CGRN Vice-Speaker of the House Of Delegates LeaAnne Myers, RN BS CGRN Newsletter Editor Kathy Vinci, RN CGRN Journal Editor Kathy A. Baker, PhD RN ACNS-BC CGRN FAAN Executive Director Dale West, CAE 2 | Quarter One 2012 “With your courage and your passion, we have nothing to fear as we embrace the initiatives that will drive SGNA into the future.” Everywhere I have gone, I see evidence of apprehension. We live in turbulent times that are complicated by the turmoil of our global economy. Healthcare must face many fears and anxieties as we march through this demanding decade. Many economists claim that we are back into a serious recession and predict that we are actually facing a global depression. We see that jobs are being slashed, layoffs are occurring, institutions are closing. Limited or declining funding is impacting every aspect of our specialty — from physician reimbursement to the selection of who is being trained as endoscopy personnel on provide you with much opportunity to build the excellence and high quality that the future will demand for our organization as well as for each of us to attain success. SGNA calls upon you to take that courageous step to be an active participant in our future. We must build our leaders faster than ever before to be passionate champions ready to meet these challenges. On the national, regional and personal level, there are many opportunities. Continued on page 11 Unit Spotlight Not Just a Team — a Family Continued from page 1 But even in the most efficient working environments, things don’t always go as planned. Just as Andrea admires her team’s GI knowledge, she’s just as proud when a nurse knows when to ask for help. She says her team realizes when it’s necessary to transfer patients to nearby Providence St. Peter Hospital. Those assessment skills, she says, are crucial to being an optimal caregiver. “Even though we’re an outpatient unit and don’t see some of the same kind of action like in a hospital, when a critical situation does arise, the nurses are professional in their assessments and in making the right decisions,” Andrea says. “Our staff is on top of it.” An Emphasis on Education and Certification Of Gastroenterology Associates’ nine-member registered nursing staff, five are certified. “When you work in GI, you want to learn as much as you can,” Andrea says. “You want to be knowledgeable and a resource. Education is important to me, and we want that confidence to educate not only our patients but our staff as well.” As an incentive to achieve certification, Gastroenterology Associates pays for the testing fees and provides an hourly stipend. To further show its commitment to education, the practice has sent up to three nurses to SGNA’s Annual Course each year — and last fall, it sent 10 Endoscopy staff to SGNA’s Pacific Northwest regional conference. (Seated from left to right) Deb Boes, RN; Beth Jones, CGRN; Andrea Raincrow-Chisholm, MSN BSN RN CGRN, Endoscopy Manager; Sarah Trigg, CGRN; Joann Grimes, LPN; (standing from left to right) Sendija Piliaris, CGRN, Endoscopy Charge Nurse; Kelly Auvinen, CGRN, Quality Assurance Manager; Jessica Daubert, LPN; Benjamin Merrifield, MD, Endoscopy Medical Director; Sariah Murdock, RN/ Lead RN; Luann Byrd, GIA; Jennifer Smith, GIA; Amber Quade, LPN; Susan Landkamer-Rivera, GIA; Indietta Burton, Lead GIA; Mallory Peters, GIA/Support Assist; James Kruidenier, MD, Endoscopy Medical Director; Haiden Darst-McCray, Patient Care Coordinator; Reagan Meyer, LPN; Kristina Hudnell, RN; Judith Hicks, RN. “After getting my certification, I not only felt proud, but it also gave me a sense that I just became something more than an endoscopy nurse,” Sandy says. “It does not make me think that I know everything or should know everything about GI nursing, but I do have this knowledge about where to find the right information or guide others in the right direction. Becoming credentialed in GI nursing has helped me grow in my nursing career and feel more professional in what I do — in what I love to do.” Sandy says certification has given her more knowledge about GI disorders and has “Getting certi fied was one of the biggest accomplishments and greatest moments in my life.” The willingness to learn, grow and share knowledge with others is the practice’s key to success, according to Sendija (Sandy) Piliaris, CGRN, Gastroenterology Associates’ charge nurse. allowed her to become a resource to her patients, physicians and co-workers — and that’s in addition to the invaluable personal gratification it has afforded her. Continued on page 10 Gastroenterology Associates Core Endoscopy Center Staff Andrea Raincrow-Chisholm, MSN BSN RN CGRN, Endoscopy Manager Kelly Auvinen, CGRN, Quality Manager Sendija Piliaris, CGRN, Charge Nurse Deb Boes, RN Indietta Burton, GIA Haiden Darst-McCray, Patient Care Coordinator Luann Byrd, GIA Jessica Daubert, LPN Joann Grimes, LPN Kristina Hudnell, RN Beth Jones, CGRN Susan Landkamer-Rivera, GIA Reagan Meyer, LPN Sariah Murdock, RN Mallory Peters, Support Assist Amber Quade, LPN Jennifer Smith, GIA Sarah Trigg, CGRN On-call Endoscopy Center Staff: Jeanie Earls, RN; Kim Fraser, GIA SGNA News | 3 Make the choice to attend THE premier event for GI/endoscopy nursing professionals! Sgna PReSentS… Finding the Leader in You Making the ChoiCe to Lead We all can make a difference — commit to delivering excellence and advance your professional growth. Mark your calendars for: SGNA 39th Annual Course | May 18–23, 2012 | Phoenix, Arizona Member Spotlight You Get What You Give Eileen Babb’s SGNA involvement has helped her become a GI resource for patients, fellow nurses and physicians Eileen Babb, BSN RN CGRN CFER When Eileen Babb, BSN RN CGRN CFER, reflects on why she most enjoys being an SGNA member, she rattles off some of the usual suspects: the educational opportunities, networking events and keeping up-to-date on the latest technology and standards of practice. She also mentions SGNA’s award and scholarship opportunities through its education and research initiatives. In fact, it was through a scholarship stipend awarded by her region and national SGNA that Eileen was able to attend the 2011 SGNA Annual Course. This year, Eileen will be at the flagship event again — as a Program Committee member who planned the educational offerings of the SGNA 39th Annual Course. “Collaborating with a team of experts from all over the country in planning the educational content of our Annual Course and gathering top-notch speakers to educate us has been very rewarding to me,” Eileen says. “There are so many opportunities for volunteer participation on committees and task forces regionally and nationally. You can influence policy and legislation by being more involved.” Eileen, who has been an SGNA member since 2003, discovered the value of the Society early on in her membership and experiences those benefits all the more since getting involved within SGNA. What most attracted her are the educational resources — and education is one of the main reasons she was Keeping on top of trends and developments in the industry is especially important in her leadership roles. Eileen says she pays particular attention to the changing dynamics of healthcare finances and delivery through value-based purchasing and Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS). She also says she’s seeing more quality and safety improvement initiatives, and that more endoscopy units are being accredited and more nurses are getting certified. “I �ound that endosco �y was a natural fi t �or me. I love the great � �end o � critical-thinking skills and technical skills in this nursing specialty.” drawn to the gastroenterology field in the first place. Eileen’s GI/endoscopy nursing journey began in 1999 when she was invited by a mentor to observe a few cases in the endoscopy suite. From there, she earned her certification in gastroenterology nursing in 2003 and flexible endoscope reprocessing in 2009. “I found that endoscopy was a natural fit for me,” Eileen says. “I love the great blend of critical-thinking skills and technical skills in this nursing specialty. Compared to other nursing specialties, it is very fast paced, yet quality and patient safety are always at the forefront. Patient education is also a biggie.” Eileen, who is the team leader of the endoscopy department at Chesapeake Regional Medical Center in Chesapeake, VA, first began getting involved in SGNA by planning educational events for her region, Old Dominion SGNA (ODSGNA). Today, she is the PresidentElect of ODSGNA. These trends not only strengthen the GI field but, more importantly, help improve patient outcomes. “Because of grassroots effort by local GI/ endoscopy units and public awareness initiatives by SGNA and ASGE, I am seeing more people getting screened for colon cancer,” she says. “It is very gratifying to be a part of the effort to reduce the death rate for the number two cancer killer in America.” For Eileen, education isn’t simply about what she learns — it’s even more so about how she uses her knowledge. By getting involved in SGNA and becoming certified, she has the support, opportunities and expertise to be a true fountain of knowledge for her colleagues and patients. “I have better self-confidence and have tremendously increased my knowledge base by becoming an SGNA member and obtaining my certifications in gastroenterology nursing and flexible endoscope reprocessing,” she says. “I am a resource not just to my co-workers but to physicians. I feel that I am improving patient outcomes and patient satisfaction.” SGNA News | 5 Program Focus First-person Glimpses at Present With Success “I feel that the Present With Success presentation is one that is particularly important for anyone in a leadership position within the organization. One of the leadership responsibilities is to present information relative to the workings of the organization to the membership in a concise, coherent manner. Although I have given PowerPoint® presentations many times, I learned much about how to dress correctly for various situations, how to prepare for the presentation and many successful methods for delivery. The facilitators were excellent. The material was presented in a fast-paced, but clear and organized fashion that allowed for dialogue between the facilitator and the participants. It was a humbling experience to be videotaped, but the feedback was presented in a positive manner that encouraged all to work toward being a better speaker. SGNA Offers Volunteer Leaders Present With Success Pilot Program Training Due to the generous support of Boston Scientific, SGNA partnered with BRODY Professional Development to offer Present With Success, an interactive training workshop on Thursday, November 3, 2011, prior to the SGNA Leadership Conference. The Present With Success training is a one-day, highly interactive program that focuses on the effective development and delivery of presentations by breaking down the techniques of organizing, developing and delivering audience-centered content. The program includes participant manuals and jump drives that include program materials and resources. The trainees also participated in a pre-program webinar to maximize individual coaching during the training session. With continued support from Boston Scientific, SGNA and BRODY will look to offer ongoing education through live programs and webinars for SGNA members, customers and speakers. The goal of this training is to meet the educational needs of those looking for management, leadership and professional development content. Below is some feedback from training participants: Attendance at this program has provided me with many tools to use in my future presentations to both members of the leadership team as well as in other arenas.” “Great material. Dynamic instructor. Critiquing our presentations really works and makes the class meaningful.” — Jane Harker, MS BSN RN CGRN 2011-2012 SGNA Treasurer “The Present With Success session is an invaluable tool and opportunity for each of us who has the opportunity to participate. For me, I learned several things, and became open to a new way of thinking about presentations! In a much broader way, I began to grasp that many of the common interactions we encounter are actually ‘presentations’ of ourselves, our thoughts and our ideas. If we consider them that way, our communication becomes clearer, more to the point and more likely able to communicate what we are really trying to say! The practical portions of the presentation were outstanding and on-the-ground helpful, using real tools and actual opportunity to practice, critique and practice again. All in all, this was a valuable and useful experience. —Phyllis Malpas, MA RN CGRN 2011-2012 SGNA President-Elect 6 | Quarter One 2012 “Highly recommend this course to anyone who does public speaking.” “I was very apprehensive about attending this class, but [the instructor] made it easy and fun. I learned so much and am so glad I attended.” “[The instructor’s] passion and commitment really engages the audience. I believe the real-time critique and suggestions were invaluable as opposed to evaluations after the fact.” “This was an excellent resource for SGNA, personal and professional life.” Product Spotlight SGNA: Helping You Become Certified As always, SGNA remains committed to helping GI/endoscopy nurses become certified or recertified. SGNA has two exciting new resources for this effort: one is the GI/Endoscopy Nursing Review: Certification Study Manual, and the second is the live GI/Endoscopy Certification Review Course at the SGNA 39th Annual Course. Announcing the SGNA GI/Endoscopy Nursing Review: Certification Study Manual Use this new manual to enhance your studying as you prepare for the CGRN certification exam. Designed to help you plan and prepare for certification, the GI/ Endoscopy Nursing Review is your gateway to other resources in the SGNA library. Highlights of this new manual include: • Time Study Manager keeps you on track with key dates and milestones as you prepare for the certification exam. • Easy Topic Tabs make it simple to find sections of information and organize your study plan. • Test your knowledge with the Preassessment Questions to self-assess before you begin to study. • Check your comprehension with Module Review Questions following each section of information and Postassessment Questions at the end of the manual when your review is complete. • Cost: $75-SGNA member / $150-Non-member To order, visit the SGNA Marketplace at www.sgna.org or call 800/245-SGNA (7462). Remember, log in with your membership information to receive your discount of 50 percent off the list price! Contact SGNA Headquarters at [email protected] with any questions. Attend the live GI/Endoscopy Certification Review Course at the Annual Course The GI/Endoscopy Nursing Review Course is a 1.5-day course on Saturday, May 19 and Sunday, May 20, 2012, at the SGNA Annual Course in Phoenix, AZ. The course will GII G GI / Endoscopy Nursing Review Certification St udy Manual provide an overview of key areas related to GI/endoscopy nursing practice and tips on how to prepare for ABCGN’s CGRN certification exam. overview of key areas related to GI/endoscopy and the nursing practice. The Review Course is also valuable for attendees interested in receiving an • Cost: $225-SGNA member / $325-Non-member • Attendees will earn 11.25 GI-specific contact hours Sign Up for May 2012 CGRN Certification Exam! Visit the ABCGN Web site at www.abcgn.org to sign up online for the May 2012 CGRN Certification Exam! The application window will remain open until February 29, 2012. SGNA News | 7 In nearly 30% of patients with ulcerative colitis (UC), the disease starts as proctitis1 Prescribe Asacol® HD for patients with moderately active UC In clinical studies of moderately active UC, 70% (273/389) of patients in ASCEND III2 and 72% (89/124) of patients in ASCEND II3 achieved overall improvement at 6 weeks with Asacol® HD at 4.8 g/day Asacol® HD at 4.8 g/day has been studied in patients with proctitis3 Asacol® HD at 4.8 g/day: effective across disease extent in patients with moderately active UC3 Overall improvement* by extent of disease† at 6 weeks3 Patients improved (%) 80 60 75% 70% 70% 74% 40 * In ASCEND II, overall improvement was determined by the Physician’s Global Assessment (PGA), which encompasses the clinical assessments of rectal bleeding, stool frequency, and sigmoidoscopy findings. The Patient’s Functional Assessment (PFA) was also included. † Extent-of-disease data are from ASCEND II. Patients with proctitis were not included in ASCEND III. 20 0 Proctitis n=20 Proctosigmoiditis n=30 Left-sided colitis n=47 Pancolitis n=27 Extent of disease Indication Asacol® HD (mesalamine) delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis (UC). The recommended dose in adults is two 800 mg tablets TID, with or without food, for a total daily dose of 4.8 g. The safety and efficacy of Asacol® HD beyond 6 weeks has not been established. Selected Safety Information Asacol® HD is contraindicated in patients with hypersensitivity to salicylates. There are no adequate and well-controlled studies in pregnant women; therefore, Asacol® HD should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when using Asacol® HD in nursing women, in patients with liver disease, and in patients with known renal dysfunction or history of renal disease. It is recommended that all patients have an evaluation of renal function prior to initiation of and periodically while on Asacol® HD therapy. Acute exacerbation of colitis symptoms can also occur. Serious adverse events may occur with Asacol® HD. In clinical trials, Asacol® HD was generally well-tolerated. The most common adverse reactions (observed in >2% of patients) were headache, nausea, nasopharyngitis, abdominal pain, and exacerbation of UC. One Asacol® HD 800 mg tablet has not been shown to be bioequivalent to two Asacol® (mesalamine) delayed-release 400 mg tablets. References: 1. About ulcerative colitis and proctitis. Crohn’s and Colitis Foundation of America Web site. http://www.ccfa.org/info/about/ucp. Updated January 3, 2011. Accessed October 27, 2011. 2. Sandborn WJ, Regula J, Feagan BG, et al. Delayed-release oral mesalamine 4.8 g/day (800-mg tablet) is effective for patients with moderately active ulcerative colitis. Gastroenterology. 2009;137(6):1934-1943. 3. Hanauer SB, Sandborn WJ, Kornbluth A, et al. Delayed-release oral mesalamine at 4.8 g/day (800 mg tablet) for the treatment of moderately active ulcerative colitis: the ASCEND II trial. Am J Gastroenterol. 2005;100(11):2478-2485. Please see Brief Summary of Full Prescribing Information on the following page. Please see Full Prescribing Information at www.asacolhd.com. Asacol® is a registered trademark of Medeva Pharma Suisse AG, used under license by Warner Chilcott Company, LLC. © Warner Chilcott 3189 November 2011 Printed in USA Asacol® HD (mesalamine) delayed-release tablet for oral administration BRIEF SUMMARY: Consult the package insert for complete prescribing information 1 INDICATIONS AND USAGE Asacol HD is indicated for the treatment of moderately active ulcerative colitis. Safety and effectiveness of Asacol HD beyond 6 weeks has not been established. 2 DOSAGE AND ADMINISTRATION For the treatment of moderately active ulcerative colitis, the recommended dose of Asacol HD in adults is two 800 mg tablets to be taken three times daily with or without food, for a total daily dose of 4.8 g, for a duration of 6 weeks. Asacol HD use beyond 6 weeks has not been evaluated. Asacol HD should be swallowed whole without cutting, breaking, or chewing. One Asacol HD 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets [see Clinical Pharmacology (12.3)]. 6.2 Adverse Reaction Information from Other Sources In addition to the adverse reactions reported above in clinical trials involving the Asacol HD tablet, the adverse events listed below have been reported in controlled clinical trials, open label studies, literature reports, or foreign and domestic marketing experience with Asacol 400 mg tablets or other products that contain or are metabolized to mesalamine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Body as a Whole: Facial edema, edema, peripheral edema, asthenia, chills, infection, malaise, pain, neck pain, chest pain, back pain, abdominal enlargement, lupus-like syndrome, drug fever (rare). Cardiovascular: Pericarditis (rare), pericardial effusion, myocarditis (rare), vasodilation, migraine. Gastrointestinal: Dry mouth, stomatitis, oral ulcers, anorexia, increased appetite, eructation, 4 CONTRAINDICATIONS Asacol HD is contraindicated in patients with hypersensitivity to salicylates or aminosalicylates pancreatitis, cholecystitis, gastritis, gastroenteritis, gastrointestinal bleeding, perforated peptic ulcer (rare), constipation, hemorrhoids, rectal hemorrhage, bloody diarrhea, tenesmus, or to any of the components of Asacol HD tablets. stool abnormality. 5 WARNINGS AND PRECAUTIONS Hepatic: There have been rare reports of hepatotoxicity, including jaundice, cholestatic 5.1 Renal Impairment jaundice, hepatitis, and possible hepatocellular damage including liver necrosis and liver Renal impairment, including minimal change nephropathy, acute and chronic interstitial failure. Some of these cases were fatal. Asymptomatic elevations of liver enzymes which nephritis, and, rarely, renal failure, has been reported in patients taking products such as usually resolve during continued use or with discontinuation of the drug have also been Asacol HD that contain or are converted to mesalamine. reported. One case of Kawasaki-like syndrome, that included changes in liver enzymes, was also reported. It is recommended that all patients have an evaluation of renal function prior to initiation of Hematologic: Agranulocytosis (rare), aplastic anemia (rare), anemia, thrombocytopenia, Asacol HD and periodically while on therapy. Exercise caution when using Asacol HD in leukopenia, eosinophilia, lymphadenopathy. patients with known renal dysfunction or history of renal disease. Musculoskeletal: Gout, rheumatoid arthritis, arthritis, arthralgia, joint disorder, myalgia, In animal studies (rats, mice, dogs), the kidney was the principal organ for toxicity [see hypertonia. Nonclinical Toxicology (13.2)]. Neurological/Psychiatric: Anxiety, depression, somnolence, insomnia, nervousness, confusion, emotional lability, dizziness, vertigo, tremor, paresthesia, hyperesthesia, peripheral neuropathy 5.2 Exacerbation of Ulcerative Colitis Symptoms (rare), Guillain-Barré syndrome (rare), and transverse myelitis (rare). Exacerbation of the symptoms of colitis has been reported in 2.3% of Asacol HD-treated patients in controlled clinical trials. This acute reaction, characterized by cramping, abdominal Respiratory/Pulmonary: Sinusitis, rhinitis, pharyngitis, asthma exacerbation, pleuritis, bronchitis, eosinophilic pneumonia, interstitial pneumonitis. pain, bloody diarrhea, and occasionally by fever, headache, malaise, pruritus, rash, and Skin: Alopecia, psoriasis (rare), pyoderma gangrenosum (rare), erythema nodosum, acne, conjunctivitis, has been reported after the initiation of Asacol HD tablets as well as other dry skin, sweating, pruritus, urticaria, rash. mesalamine products. Symptoms usually abate when Asacol HD tablets are discontinued. Special Senses: Ear pain, tinnitus, ear congestion, ear disorder, conjunctivitis, eye pain, 5.3 Hypersensitivity blurred vision, vision abnormality, taste perversion. Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have Renal/Urogenital: Renal failure (rare), interstitial nephritis, minimal change nephropathy [see a similar reaction to Asacol HD tablets or to other compounds that contain or are converted Warnings and Precautions (5.1)], dysuria, urinary frequency and urgency, hematuria, to mesalamine. epididymitis, decreased libido, dysmenorrhea, menorrhagia. Laboratory Abnormalities: Elevated AST (SGOT) or ALT (SGPT), elevated alkaline phosphatase, 5.4 Pyloric Stenosis elevated GGT, elevated LDH, elevated bilirubin, elevated serum creatinine and BUN. Patients with pyloric stenosis may have prolonged gastric retention of Asacol HD tablets, which could delay release of mesalamine in the colon. 7 DRUG INTERACTIONS No formal drug interaction studies have been performed using Asacol HD with other drugs. 5.5 Use in Hepatic Impairment There have been reports of hepatic failure in patients with pre-existing liver disease who have 8 USE IN SPECIFIC POPULATIONS been administered mesalamine. Caution should be exercised when administering Asacol HD to 8.1 Pregnancy patients with liver disease. Pregnancy Category C: There are no adequate well controlled studies of Asacol HD use in pregnant women. Limited published human data on mesalamine show no increase in the 6 ADVERSE REACTIONS The most serious adverse reactions seen in Asacol HD clinical trials or with other products that overall rate of congenital malformations. Some data show an increased rate of preterm birth, stillbirth, and low birth weight; however, these adverse pregnancy outcomes are also contain or are metabolized to mesalamine were: associated with active inflammatory bowel disease. Animal reproduction studies of • Renal impairment, including renal failure (rare) [see Warnings and Precautions (5.1)] mesalamine found no evidence of fetal harm. However, dibutyl phthalate (DBP) is an inactive • Acute exacerbation of colitis [see Warnings and Precautions (5.2)] ingredient in Asacol HD’s enteric coating, and in animal studies at doses >80 times the • Hypersensitivity reactions [see Warnings and Precautions (5.3)] human dose based on body surface area, maternal DBP caused external and skeletal 6.1 Clinical Trials Experience malformations and adverse effects on the male reproductive system. Asacol HD should be Because clinical trials are conducted under widely varying conditions, adverse reaction rates used during pregnancy only if the potential benefit justifies the potential risk to the fetus. observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials Mesalamine crosses the placenta. In prospective and retrospective studies of over 600 women of another drug and may not reflect the rates observed in practice. exposed to mesalamine during pregnancy, the observed rate of congenital malformations was Asacol HD has been evaluated in 896 patients with ulcerative colitis in controlled studies. not increased above the background rate in the general population. Some data show an Three six-week, active-controlled studies were conducted comparing Asacol HD 4.8 g/day increased rate of preterm birth, stillbirth, and low birth weight, but it is unclear whether this with Asacol (mesalamine) 2.4 g/day as control in patients with mildly to moderately active was due to underlying maternal disease, drug exposure, or both, as active inflammatory bowel ulcerative colitis. In these studies, 727 patients were dosed with the Asacol HD tablet and disease is also associated with adverse pregnancy outcomes. 732 patients were dosed with the Asacol 400 mg tablet. (One Asacol HD 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets [see Clinical Pharmacology Reproduction studies with mesalamine were performed during organogenesis in rats and rabbits at oral doses up to 480 mg/kg/day. There was no evidence of impaired fertility or harm (12.3)].) to the fetus. These mesalamine doses were about 1.6 times (rat) and 3.2 times (rabbit) the The most common reactions reported in the Asacol HD group were headache (4.7%), nausea recommended human dose, based on body surface area. (2.8%), nasopharyngitis (2.5%), abdominal pain (2.3%), exacerbation of ulcerative colitis Dibutyl phthalate (DBP) is an inactive ingredient in Asacol HD’s enteric coating. The human (2.3%), diarrhea (1.7%), and dyspepsia (1.7%); Table 1 enumerates adverse drug reactions daily intake of DBP from the maximum recommended dose of Asacol HD tablets is about that occurred in the three studies. The most common reactions in the primary efficacy 48 mg. Published reports in rats show that male rat offspring exposed in utero to DBP population of patients with moderately active ulcerative colitis (602 patients dosed with (≥100 mg/kg/day, approximately 17 times the human dose based on body surface area), Asacol HD and 618 patients dosed with the Asacol 400 mg tablet) were the same as all display reproductive system aberrations compatible with disruption of androgenic dependent treated patients. The majority of adverse reactions with Asacol HD in the double-blind, development. The clinical significance of this finding in rats is unknown. At higher dosages active-controlled trials were mild or moderate in severity and were reversible. (≥500 mg/kg/day, approximately 84 times the human dose based on body surface area), Discontinuations due to adverse reactions occurred in 3.9% of patients in the Asacol HD group additional effects, including cryptorchidism, hypospadias, atrophy or agenesis of sex accessory and in 4.2% of patients in the Asacol 400 mg tablet comparator group. The most common organs, testicular injury, reduced daily sperm production, permanent retention of nipples, and cause for discontinuation was gastrointestinal symptoms associated with ulcerative colitis. decreased anogenital distance are noted. Female offspring are unaffected. High doses of DBP, administered to pregnant rats was associated with increased incidences of developmental Severe adverse reactions occurred in 7.6% of patients in the Asacol HD group and in 7.6% abnormalities, such as cleft palate (≥630 mg/kg/day, about 106 times the human dose, based of patients in the Asacol 400 mg tablet comparator group. Most of these reactions were on body surface area) and skeletal abnormalities (≥750 mg/kg/day, about 127 times the gastrointestinal symptoms related to ulcerative colitis. Serious adverse reactions occurred in human dose based on body surface area) in the offspring. 0.8% of patients in the Asacol HD group and in 1.8% of patients in the Asacol 400 mg tablet comparator group. The majority involved the gastrointestinal system. 8.3 Nursing Mothers Mesalamine and its N-acetyl metabolite are excreted into human milk. In published lactation Table 1. Adverse Reactions Occurring in 1% or More of All Treated Patients studies, maternal mesalamine doses from various oral and rectal formulations and products (Three studies combined; Intent-to-treat population) ranged from 500 mg to 3 g daily. The concentration of mesalamine in milk ranged from non-detectable to 0.11 mg/L. The concentration of the N-acetyl-5-aminosalicylic acid Asacol* Asacol HD* metabolite ranged from 5 to 18.1 mg/L. Based on these concentrations, estimated infant daily 2.4 g/day 4.8 g/day doses for an exclusively breastfed infant are 0-0.017 mg/kg/day of mesalamine and (400 mg Tablet) (800 mg Tablet) 0.75-2.72 mg/kg/day of N-acetyl-5-aminosalicylic acid. Caution should be exercised when MedDRA Preferred Term (N=732) (N=727) Asacol HD is administered to a nursing woman. Headache 4.9 % 4.7 % Dibutyl phthalate (DBP), an inactive ingredient in the enteric coating of Asacol HD tablets, Nausea 2.9 % 2.8 % and its primary metabolite mono-butyl phthalate (MBP) are excreted into human milk. In Nasopharyngitis 1.4 % 2.5 % pregnant rats, DBP causes fetal reproductive system aberrations in male offspring [see Abdominal pain 2.3 % 2.3 % Pregnancy (8.1)]. The clinical significance of this has not been determined. Ulcerative Colitis 2.7 % 2.3 % 8.4 Pediatric Use Diarrhea 1.9 % 1.7 % Safety and effectiveness of Asacol HD in pediatric patients have not been established. Dyspepsia 0.8 % 1.7 % 8.5 Geriatric Use Vomiting 1.6 % 1.4 % Clinical studies of Asacol HD did not include sufficient numbers of subjects aged 65 and over Flatulence 0.7 % 1.2 % to determine whether they respond differently than younger subjects. Other reported clinical Influenza 1.2 % 1.0 % experience has not identified differences in response between the elderly and younger Pyrexia 1.2 % 0.7 % patients. In general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients should be considered when Cough 1.4 % 0.3 % prescribing Asacol HD. Reports from uncontrolled clinical studies and postmarketing reporting N = number of patients within specified treatment group systems for Asacol (mesalamine) suggested a higher incidence of blood dyscrasias, i.e., % = percentage of patients in category and treatment group agranulocytosis, neutropenia, pancytopenia, in patients who were 65 years or older. Caution * One Asacol HD 800 mg tablet has not been shown to be bioequivalent to should be taken to closely monitor blood cell counts during mesalamine therapy. two Asacol 400 mg tablets [see Clinical Pharmacology (12.3)]. Mesalamine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken when prescribing this drug therapy. It is recommended that all patients have an evaluation of renal function prior to initiation of Asacol HD therapy and periodically while on Asacol HD therapy [see Warnings and Precautions (5.1)]. 10 OVERDOSAGE There is no specific antidote for mesalamine overdose and treatment for suspected acute severe toxicity with Asacol HD should be symptomatic and supportive. This may include prevention of further gastrointestinal tract absorption, correction of fluid electrolyte imbalance, and maintaining adequate renal function. Asacol HD is a pH dependent delayed release product and this factor should be considered when treating a suspected overdose. Single oral doses of 5000 mg/kg mesalamine suspension in mice (approximately 4.2 times the recommended human dose of Asacol HD based on body surface area), 4595 mg/kg in rats (approximately 7.8 times the recommended human dose of Asacol HD based on body surface area) and 3000 mg/kg in cynomolgus monkeys (approximately 10 times the recommended human dose of Asacol HD based on body surface area) were lethal. 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Dietary mesalamine was not carcinogenic in rats at doses as high as 480 mg/kg/day, or in mice at 2000 mg/kg/day. These doses are approximately 0.8 and 1.7 times the 4.8 g/day Asacol HD dose (based on body surface area). Mesalamine was not genotoxic in the Ames test, the Chinese hamster ovary cell chromosomal aberration assay, and the mouse micronucleus test. Mesalamine, at oral doses up to 480 mg/kg/day (about 0.8 times the recommended human treatment dose based on body surface area), was found to have no effect on fertility or reproductive performance of male and female rats. 13.2 Animal Toxicology and/or Pharmacology In animal studies (rats, mice, dogs), the kidney was the principal organ for toxicity. (In the following, comparisons of animal dosing to recommended human dosing are based on body surface area and a 4.8 g/day dose for a 50 kg person.) Mesalamine causes renal papillary necrosis in rats at single doses of approximately 750 mg/kg to 1000 mg/kg (1.3 to 1.7 times the recommended human dose). Doses of 170 and 360 mg/kg/day (about 0.3 and 0.6 times the recommended human dose) given to rats for six months produced papillary necrosis, papillary edema, tubular degeneration, tubular mineralization, and urothelial hyperplasia. In mice, oral doses of 4000 mg/kg/day (approximately 3.4 times the recommended human dose) for three months produced tubular nephrosis, multifocal/diffuse tubulo-interstitial inflammation, and multifocal/diffuse papillary necrosis. In dogs, single doses of 6000 mg (approximately 6.25 times the recommended human dose) of delayed-release mesalamine tablets resulted in renal papillary necrosis but were not fatal. Renal changes have occurred in dogs given chronic administration of mesalamine at doses of 80 mg/kg/day (0.5 times the recommended human dose). 17 PATIENT COUNSELING INFORMATION • Instruct patients to swallow the Asacol HD tablets whole, taking care not to break, cut, or chew the tablets, because the outer coating is an important part of the delayed-release formulation. • Inform patients that if they are switching from a previous oral mesalamine therapy to Asacol HD they should discontinue their previous oral mesalamine therapy and follow the dosing instructions for Asacol HD. Inform patients that they should not substitute one Asacol HD tablet with two Asacol 400 mg tablets [see Dosage Forms and Strengths (3) and Clinical Pharmacology (12.3)]. • Inform patients that intact, partially intact, and/or tablet shells have been reported in the stool. Instruct patients to contact their physician if this occurs repeatedly. • Instruct patients to protect Asacol HD tablets from moisture. Instruct patients to close the container tightly and to leave any desiccant pouches present in the bottle along with the tablets. • Advise women who are pregnant, breastfeeding, or of childbearing potential that Asacol HD contains dibutyl phthalate, which caused malformations and adverse effects on the male reproductive system in animal studies. Dibutyl phthalate is excreted in human milk. Marketed by: Warner Chilcott (US), LLC Rockaway, NJ 07866 1-800-521-8813 0783G130 January 2011 © Warner Chilcott Asacol® is a registered trademark of Medeva Pharma Suisse AG, used under license by Warner Chilcott Company, LLC. Leadership Conference – In-Depth A Look Back at the 2011 SGNA Leadership Conference Shelley Riddle, BA MBA LPN Shelley Riddle, BA MBA LPN In November 2011, the SGNA regional leaders came together for the 15th Annual SGNA Leadership Conference. Regional Society president-elects and fellow regional officers traveled to Rosemont, IL, for a one day leadershipbuilding seminar. President Leslie E. Stewart, BA RN CGRN, gave an empowering presentation titled “SGNA Quest for Quality” to kick off the conference. Leslie’s presentation rolled out the new 2012-2014 Strategic Plan and the direction our organization is taking to strengthen the voice of GI nursing. President-Elect Phyllis Malpas, MA RN CGRN, concluded the conference with her exciting and motivational presentation on the importance of mentoring to produce and encourage excellent leaders. Not only did attendees learn a great deal, but they also caught on to Malpas’ contagious spirit and passion for SGNA. In addition to the outstanding educational presentations, this leadership-building weekend dually served as a great networking opportunity. We had an interactive networking breakout session, during which attendees were able to sit with their regional divisions and discuss some hot-topic issues occurring within their region and the GI/endoscopy profession. Regional officers also had the chance to network with SGNA National Board members and learn about the path each board member took to get to where they are today. There are many roads toward becoming a leader, and many were explored during the Leadership Conference this year. Attendees left the conference with valuable information to bring back to their respective regions, including the new Infection Prevention Champions Program, an overview of regional budgeting, details on how to submit an abstract for the Annual Course and information on SGNA’s nominations and elections process. Those are a few highlights, but every presentation was truly thought provoking and meaningful. Attend Leadership Conference at Annual Course There will be a condensed version of the Leadership Conference at the 39th Annual Course on Friday, May 18, 2012, from 8 am to noon. Please look for more information in the Annual Course Advance Program, available for download on the SGNA Web site. representatives for their participation during the weekend. Finally, a special thank you goes out to Medivators for their generous support of the Leadership Conference. I would like to take this opportunity to thank the Regional Societies Committee for the hard work and dedication it took to put on this event, as well as the regional Not Just a Team — a Family Continued from page 3 “Getting certified was one of the biggest accomplishments and greatest moments in my life,” Sandy says. Like Sandy, fellow Gastroenterology Associates nurse Beth Jones, CGRN, says getting certified provides both professional and personal fulfillment. “Initially, in 2005, when I became certified, it was for my own satisfaction. It was tangible ‘proof’ that I was up-to-date and knowledgeable in the field of GI,” Beth says. “This gives me self-confidence and credibility in the eyes of my patients and co-workers.” 10 | Quarter One 2012 Advancing the Practice with SGNA In addition to attending the Annual Course and regional conferences, Andrea uses the SGNA Web site as a top resource to learn best practices from other GI nurses from around the nation. As the infection control officer for Gastroenterology Associates, she often takes advantage of this benefit. “SGNA is invaluable for finding out what people in the GI world are doing in terms of infection control,” Andrea says. “I was on a discussion forum on the SGNA Web site where I had access to ideas that I hadn’t thought about. It’s just a wonderful resource.” Andrea uses much of the information she draws from SGNA’s Web site when contributing to team processes that affect the entire staff of physicians, nurses and techs. This supports their collaboration to explore the reasons behind their common practices and helps to decide what they can do better. It’s in this setting that the Gastroenterology Associates team comes together to develop and refine ways to deliver the high standard of care that patients in Olympia depend upon. “It’s great to be a part of this team — kicking around ideas and improving the process together,” Andrea says. “It doesn’t matter your role or title; everyone has a good idea.” Editor’s Corner Celebrate the Art of GI Nursing Kathy Vinci, RN CGRN, SGNA News Editor GI Nurses and Associates Day is March 28, 2012 – it’s a day to celebrate our yearlong dedication to the art of GI nursing. GI Nurses and Associates Day takes place the fourth Wednesday every March, which coincides with National Colorectal Cancer Awareness Month in March. Screening for colon cancer is a part of our job as GI nurses, but it is just the tip of the iceberg. Our role as GI nurses also includes ERCPs, endoscopic ultrasound, liver biopsies, paracentesis, endoscopies, breath tests, peg placement and bronchoscopes. We are caring for inpatients and outpatients at the same time. As part of our profession, we not only care for the patient’s intra-procedure, but we also provide a large amount of patient education regarding the procedure, the medications and the diagnosis. A lot of our units are on call 24/7. We are dedicated to providing high quality healthcare to our patients with gastrointestinal diseases. Every day, we demonstrate our professionalism, compassion and expert knowledge while caring for our GI patients. We should be proud of ourselves and congratulate ourselves on a job well done. I hope you show pride in the GI profession by celebrating GI Nurses and Associates Day this year. One way to participate is by making a poster for the cafeteria in your hospital. Having a luncheon for all the staff or having a dinner with a speaker is also a way to celebrate your day. You may also want to order a free GI Nurses and Associates Day kit, which has a GI poster and other celebratory materials in it, courtesy of our corporate sponsor Warner Chilcott. (See the enclosed poster for more details or visit www.sgna.org/GINAD for information on ordering your kit and other ideas on how to celebrate.) Whichever way you choose to celebrate your special, well-deserved day, I hope you have a happy GI Nurses and Associates Day. March 28 Proud to be GI GI Nurses & Ass ocIAtes DAy 20 12 Don’t forget to let SGNA know what your unit did for GI Nurses and Associates Day by writing to us and sending photos to [email protected]. We may publish your celebration story in SGNA News, on the Web site or display your pictures at the Annual Course! GI Nurses and Associates Day is generously supported by Warner Chilcott. SGNA Calls You to Accept the Challenge to Lead Continued from page 2 • Volunteer and serve on a national or regional committee or task force. You will be part of the team that will build the future of SGNA. • Vote for your future leaders. Make the decision to run for office but also use your vote to elect those who you know are good leaders. • In our Strategic Plan for 2012-2014, we focus on many of the issues that are at the forefront of controversy within our healthcare arena today, such as colorectal cancer awareness and infection prevention. There will be many growth opportunities in both committees and task forces that will bring these goals to reality. With your expertise and interest, SGNA will continue to grow to be the experts within the GI specialty. • Prepare yourself for quality leadership by attaining higher levels of education to be an expert resource. Demand excellence and quality in all your actions. National certification validates your knowledge and demonstrates your commitment to excellence. We must prepare quality minded leaders who foster an environment in which every member of the team contributes to collective success. As we build quality as our chief focus to building our professional future, we will be building extraordinary care for all of our collaborative partners and professional peers to look to our practice standards for our successful evidence-based knowledge and researched outcomes. I call upon you all to be involved in this future, to volunteer, to lead where you stand driving quality forward. With your courage and your passion, we have nothing to fear as we embrace the initiatives that will drive SGNA into the future. I look forward to seeing you all in Phoenix in May 2012! SGNA News | 11 Periodicals 401 North Michigan Avenue Chicago, IL 60611-4267 Phone: 312/321-5165 Fax: 312/673-6694 800/245-SGNA (7462) [email protected] www.sgna.org Pass It On Visit the New SGNA Career Center Today! SGNA’s new Career Center provides added usability for our job seekers and employers, making it even easier to connect people together. Check it out today and take advantage of: • Free résumé posting • Access to the National Healthcare Career Network (NHCN) • Easily manage job applications • Ability to save jobs To jumpstart your career or find the perfect candidate, visit careers.sgna.org! 12 | Quarter One 2012 Share what’s happening in our community Pass along your copy of SGNA News or leave it in your unit’s breakroom so more people in your unit can celebrate the SGNA community!