March 2017 Newsletter
Call for Nominations for GSHP Awards


2017 GSHP AWARDS
CALL FOR NOMINATIONS  
 
The Georgia Society of Health-System Pharmacists annually recognizes members for outstanding service and achievements in pharmacy. Very likely, you know someone in GSHP who is deserving of recognition. Every member of GSHP is eligible to nominate or be nominated for one or more awards. Please fill out the nominations form on the next page to nominate yourself or someone you know for the awards listed below. Awards will be presented during the GSHP Annual Meeting to be held at the Omni Amelia Island Resort in Amelia Island, FL on July 8, 2017. Deadline for nominations is May 15, 2017.
    
Pharmacists of the
Year Award
 
     GSHP Pharmacist of the Year Award  is the highest honor GSHP can bestow on any member and is presented to a Georgia health-system pharmacist to honor outstanding service and accomplishments in health-system pharmacy practice as well as participation in GSHP. All GSHP members are eligible for nomination. Nominations should include detailed information concerning the nominee's professional, civic, and other activities. Recipients of the GSHP Pharmacist of the Year Award serve on the Awards Committee for five years following receipt of the award.
 
25-Year Practitioner Awards
 
     25-Year Practitioner Awards  are presented to GSHP members who have actively practiced hospital or health-system pharmacy for 25 years or more. Members are encouraged to nominate peers. Also, they may also nominate themselves for this award unless they are a previous recipient.
 
Outstanding Pharmacy Practitioner Award
 
     The Outstanding Pharmacy Practitioner Award is presented to a health-system pharmacist employed in a staff position. The award recognizes outstanding service to the profession in a non-administrative, non-managerial position.
 
Outstanding Residency Preceptor Award
 
     The Outstanding Residency Preceptor Award is presented to a health-system pharmacy residency preceptor. The award recognizes residency preceptor for outstanding service to the profession by serving as a preceptor to pharmacy residents.
 
Outstanding Pharmacy Professional Representative Award
 
     The Outstanding Pharmacy Professional Representative Award is presented to a representative of a pharmaceutical manufacturer or wholesaler who has made outstanding contributions to health-system pharmacy through service to, participation in, and involvement with GSHP and those practicing as health-system pharmacists.
 
Outstanding Health-System Pharmacy Technician Award
 
     The Outstanding Health-System Pharmacy Technician Award recognizes a health-system pharmacy technician who has demonstrated practice excellence and leadership in the support of implementing pharmaceutical care.
 
Community Service Award
 
     The Community Service Award is presented to a GSHP member for Outstanding service to his/her community. Services rendered are not limited to those as a pharmacist, but include any activities which enhance or improve the quality of life of the community.
 
 
Outstanding Pharmacy Intern/Extern Award
 
     The Outstanding Pharmacy Intern/Extern Award recognizes excellence in our future pharmacists. Nominations may be presented by preceptors, educators, or any other GSHP member who has had direct contact with an intern or extern who has shown exemplary service in this role.
 
 
Outstanding Young Health-System Pharmacist Award
 
     Nominees for the Outstanding Young Health-System Pharmacist Award are not limited by age, but by the length of time in the profession. Nominees should have graduated from a pharmacy school within the past five years. The recipient is chosen based on exemplary service and dedication to the field of health-system pharmacy in this time period.
 
Outstanding Hospital or Health-System Pharmacy Newsletter Award
 
     Recipients are selected for the Outstanding Hospital or Health-System Pharmacy Newsletter Award based on submission and review of the three most recent editions of their newsletter. To be eligible for consideration, the newsletter must be hospital generated and not a purchased newsletter.
 
Best Paper Describing a New Pharmaceutical Care Service
 
     The award for Best Paper Describing a New Pharmaceutical Care Service will be presented based on publications by GSHP members in the pharmaceutical literature. Selection of the recipient is made by the Awards Committee and is based on a review of pharmacy journals and other publications for the 12-month period beginning May 2016 through May 2017.
  
GSHP Pharmaco-economics Research Award
 
     The GSHP Pharmaco-economics Research Award is designed to recognize a GSHP member who has performed a pharmacoeconomic analysis in a particular area of pharmacy practice and to encourage pharmacists to investigate and report the cost benefits of pharmaceutical care through the provision of cost effective pharmacy services. Members performing an analysis or investigation in an area related to the cost effectiveness, cost benefit, or cost utility of a particular medication therapy, type of patient care delivered by pharmacists or some aspect of pharmacy services are eligible.  
 
To nominate someone, go to https://www.surveymonkey.com/r/2017gshpawards


Save the Date

GSHP Summer Meeting

July 7-9, 2017 
Omni Amelia Island Resort 
Amelia Island, FL


Hotel Reservations 


A wall calendar with tear-away pages, and words that read Save the Date
Clinical Articles
New Therapies for the Treatment of Irritable Bowel Syndrome with Diarrhea

Authors: Amy Matthews, Student Pharmacist Mercer University, Jessica Proctor, Student Pharmacist Mercer University, and Kendra Manigault, PharmD., BCPS, BCACP, CDE, Clinical Assistant Professor, Mercer University
                          
Background:
The prevalence of Americans affected by irritable bowel syndrome (IBS) is estimated to be around 35 million by the American Gastroenterological Association (AGA). 1 IBS is a bowel disorder characterized by abdominal pain and abnormal bowel patterns, in the absence of any particular reason. 2 IBS is often diagnosed based on patient symptoms using the Manning or Rome III criteria. Per the Rome III criteria, an IBS diagnosis requires patients to have 3 months of symptoms with at least 3 days of abdominal pain or discomfort per month with at least two of the following features: symptom improvement with defecation, onset associated with a change in the frequency of the stool, and/or onset associated with a change in the form or appearance of the stool. 2 Based on the principal bowel pattern, IBS is further categorized into diarrhea-predominant (IBS-D), constipation-predominant (IBS-C), or mixed (IBS-M) if bowel habits fluctuate between diarrhea and constipation. Patients with IBS-D often report their altered bowel habits (e.g. increased loose stool frequency and urgency) have a large impact on daily life leading to a decreased quality of life. 3 Additionally, IBS can result in bloating, fecal incontinence, and reduced productivity. 1,3 The pathophysiology of IBS-D is unknown, but thought to be multifactorial, in that it involves a variety of body systems and activities, including visceral hypersensitivity, genetics, environment, motility, dietary intolerance, microbiology of the gut, and the overall mind-gut axis. 2,3
 
Several drug therapies are used for symptom relief in the treatment of IBS-D including: anti-diarrheals, antispasmodics, 5-HT3 receptor antagonists, and tricyclic antidepressants (TCAs). Anti-diarrheals such as loperamide work by stimulating opioid receptors to delay intestinal transit and strengthen the rectal sphincter tone. 3 Loperamide helps with acute episodes and prevention; however, it does not assist in relieving the pain or bloating associated with IBS-D. Antispasmodics (i.e. hyoscyamine, dicyclomine), competitively inhibit muscarinic receptors, yielding a constipating effect and may also alleviate some of the pain associated with IBS-D. Alosetron is the only 5-HT3-receptor antagonist FDA approved for the treatment of IBS-D. It exerts its effects through regulation of visceral pain and slowing colonic and intestinal transit. 3,4 Alosetron is approved only in women due to a lack of clinical evidence demonstrating efficacy in men. After a brief period of time on the market, alosetron was withdrawn due to severe adverse events associated with its use (e.g. constipation and ischemic colitis). It was later reapproved in women with severe IBS-D symptoms not relieved by conventional therapies who are enrolled in a prescribing program. 3 TCAs (e.g. amitriptyline and desipramine) have shown some benefit in relieving the overall symptoms of IBS-D. These agents seem to lessen the patient's perception of visceral pain, alter gastrointestinal (GI) transit time, and help to treat any underlying emotional struggles that may be associated with the condition. 3
 
 
Unfortunately, many patients require multiple agents for symptom relief and despite treatment, some patients still continue to struggle with debilitating symptoms. A recent survey conducted by the AGA found that less than 40% of patients taking prescription medications for the treatment of IBS-D were "very satisfied" with their treatment. 7 This emphasizes the clear need for new options in the treatment of IBS-D. In 2015, Xifaxan © (rifaximin) and Viberzi
© (eluxadoline) were FDA approved for the treatment of adults with IBS-D. 5 Unlike many of the current treatment options, these agents more directly target the proposed physiologic mechanisms thought to cause IBS-D. Additional treatment options under investigation for IBS-D include: ramosetron, disodium cromoglycate (DSCG) and fecal microbiota. 3
 
 
Rifaximin (Xifaxan®):
Rifaximin is a non-absorbable oral antibiotic that covers both gram negative and gram-positive bacteria. In addition to reducing bacteria, rifaximin also alters the bacterial composition of the gut. As discussed, one theory of the etiology of IBS-D is the alteration of the microbiome of the gut; therefore, rifaximin is thought to alleviate this imbalance. The recommended treatment dose of rifaximin for IBS-D is 550 mg three times daily for 14 days. 6 Clinical trials have demonstrated that a two-week course of rifaximin can help to improve symptoms such as rectal urgency, abdominal pain and bloating, and stool consistency for an average of 10 weeks. Rifaximin can be repeated up to two times in patients who experience a recurrence of symptoms. The most common adverse effects of therapy are nausea, headache, peripheral edema, dizziness, and fatigue. 3,6
 
Rifaximin's efficacy in treating adults with IBS-D was evaluated in 3 randomized, multi-center, double-blind, placebo-controlled trials; TARGET-1, 2, and 3. The TARGET-1 and TARGET-2 trials were identical in design and evaluated the efficacy of a 14-day course of rifaximin treatment. The TARGET-3 trial evaluated re-treatment with rifaximin in patients who experienced symptom recurrence after an initial course of rifaximin therapy. 5        
The TARGET-1 and TARGET-2 trials included a total of 1,258 adults with IBS-D. Participants were randomly assigned to receive either rifaximin 550 mg or placebo by mouth three times daily for two weeks; participants were then followed for 10 weeks after treatment. The primary endpoint was the number of patients to achieve adequate symptom relief for at least two of four weeks during the month following a 14-day treatment course with rifaximin 550 mg by mouth three times daily. 7 The number of patients achieving the primary endpoint was significantly higher in those who received rifaximin, as compared to placebo in each trial (TARGET-1: 40.8% rifaximin vs. 31.2% placebo, p=0.01; TARGET-2: 40.6% rifaximin vs. 32.2% placebo, p=0.03). There were no significant differences found between the safety profiles of rifaximin and placebo and no deaths were reported. 7

The TARGET-3 trial included a total of 2,579 adults with IBS-D. All patients received open-label treatment with rifaximin 550 mg by mouth three times daily for two weeks. Patients were assessed for response to treatment after 4 weeks of no treatment therapy. Patients identified as responders were then followed for IBS symptoms (i.e. abdominal pain or mushy/watery stools) for up to 20 treatment-free weeks. 7 Patients whose IBS symptoms returned, were randomized to the double-blind, placebo-controlled repeat treatment phase. The primary endpoint was the proportion of patients responding to re-treatment with rifaximin. Response was defined as an improvement in abdominal pain and stool consistency.The number of patients to achieve adequate symptom relief was significantly higher in those who received rifaximin as compared to placebo (38 % vs 31% respectively; p<0.05). 7 A total of 1,074 patients responded to initial treatment of rifaximin; 636 patients relapsed and were randomized to the repeat treatment phase. Thirty-six of 308 (11.7%) patients randomized to the placebo cohort and 56 of 328 (17.1%) patients randomized to the rifaximin cohort responded to the first repeat treatment and did not have recurrence of signs and symptoms through the treatment-free follow-up period. To date, overall data results from this study have not been published.
 
 
Eluxadoline (Viberzi®):
Eluxadoline is a peripherally acting mixed mu-opioid receptor agonist, delta opioid receptor antagonist, and kappa opioid receptor agonist. It acts locally on mu-opioid receptors in the gastrointestinal tract, which slows gastrointestinal (GI) motility and reduces visceral sensations and secretions. 8 This leads to a reduction of abdominal pain and diarrhea associated with IBS-D. Eluxadoline is a controlled substance (CIV) due to its mechanism of action and subsequent potential for abuse. Eluxadoline is indicated for the treatment of adults with IBS-D; however, there are several populations where eluxadoline use is contraindicated.
8 These populations include: patients with known or suspected biliary duct obstruction, patients with sphincter of Oddi disease or dysfunction, patients who abuse alcohol (consume > 3 alcoholic drinks per day), patients with a history of pancreatitis, patients with severe hepatic impairment, or patients with a history of chronic or severe constipation. The recommended dose for most patients is 100 mg by mouth twice daily with food. Dose reduction to 75 mg by mouth twice daily is recommended in those patients who do not have a gallbladder, are unable to tolerate the 100 mg dose, are concomitantly taking an OATP1B1 inhibitor (e.g. gemfibrozil, ritonavir, rifampin) or have mild to moderate hepatic impairment. The most common adverse effects of therapy are constipation, nausea, abdominal pain, and upper respiratory infection. 8

The safety and efficacy of eluxadoline in the treatment of IBS-D was evaluated in two randomized, multi-center, double-blind, placebo-controlled, parallel-group studies, IBS-3001 and IBS-3002. 9 The primary endpoint was the number of patients who achieved an overall response to therapy of decreased abdominal pain and improved stool consistency on the same day, for ≥ 50% of the days, during weeks 1-12 and 1-26. The decrease in abdominal pain and improvement in stool consistency were defined as ≥ 30% reduction from the patient's baseline average score of worst abdominal pain and a stool-consistency score of <5 on the Bristol Stool Form Scale, respectively. Symptoms were reported daily by patients using an electronic diary. 9
 
Overall, a total of 2,425 adults were evaluated, with 1,280 in IBS-3001 trial and 1,145 in IBS-3002 trial. Both studies began with a 26-week double blind, placebo-controlled period in which participants were randomized to receive either oral eluxadoline 75 or 100 mg twice daily or placebo twice daily. During this period, participants were also allowed to utilize the anti-diarrheal loperamide, as needed. The IBS-3001 study followed the initial 26-week period with an additional 26-weeks of double-blind treatment for safety assessment plus another 2 weeks of follow-up after completion of treatment. 9 The IBS-3002 study followed the initial 26-week period with 4 weeks of single-blinded placebo withdrawal to evaluate rebound symptoms. The number of patients to achieve the overall response endpoint at 12 weeks was significantly higher in those who received either dose of eluxadoline, as compared to placebo. In the IBS-3001 trial, the endpoint was achieved by 23.9% of patients who received 75 mg of eluxadoline and 25.1% of those who received 100 mg of eluxadoline, as compared to 17.1% who received placebo (p=0.01 for comparison of 75 mg dose with placebo; p=0.004 for comparison of 100 mg dose with placebo). 9 In IBS-3002, the same endpoint was achieved by 28.9% of those who received 75 mg of eluxadoline and 29.6% of those who received 100 mg of eluxadoline, as compared to 16.2% who received placebo (p<0.001 for both comparisons). At 26 weeks, the number of patients who achieved the primary endpoint was significantly higher than placebo in patients who received the 100 mg dose of eluxadoline in both studies (p<0.001 in both studies); the difference between patients who received the 75 mg dose of eluxadoline and placebo was significant only in the IBS-3002 study (IBS-3001: p=0.11; IBS-3002: p=0.001) 9. In addition, patients who received either dosage of eluxadoline reported greater reductions in stool frequency and urgency, as well as greater improvements in quality of life, as compared to placebo.

Conclusion:
IBS-D can be disabling, resulting in discomfort, diminished productivity, and reduced quality of life. Rifaximin and eluxadoline are major advancements in the treatment of IBS-D; however, more research is needed to develop additional options for healthcare providers to effectively treat patients.
 
References:
  1. IBS in America Survey Summary Findings. American Gastroenterological Association, 2015. www.gastro.org. Accessed February 19, 2016.
  2. Fabel PH, Shealy KM. Chapter 23. Diarrhea, Constipation, and Irritable Bowel Syndrome. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. eds.
    Pharmacotherapy: A Pathophysiologic Approach, 9e. New York, NY: McGraw-Hill; 2014. http://accesspharmacy.mhmedical.com/content.aspx?bookid=689&Sectionid=45310478. Accessed February 19, 2016.
  3. Judy Nee, Mohammed Zakari & Anthony J Lembo (2015) Current and emerging drug options in the treatment of diarrhea predominant irritable bowel syndrome. Expert Opinion on Pharmacotherapy, 16:18, 2781-2792.
  4. Lotronex [package insert]. Roswell, GA. Sebela Pharmaceuticals, Inc; 2016.
  5. FDA Approves Two Therapies to Treat IBS-D. Press Release. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm448328.htm Accessed March 3, 2016.
  6. Xifaxan [package insert]. Raleigh, NC. Salix Pharmaceuticals, Inc; 2015.
  7. Pimentel M, Lembo A, et al. Rifaximin Therapy for Patients with Irritible Bowel Syndrome without Constipation.
    NEJM. 2011; 364(3): 22-32.
  8. Viberzi [package insert]. Cinncinnati, OH. Actavis; 2015.
  9. Lembo A, Lacy B, Zuckerman M, et al. Eluxadoline for Irritable Bowel Syndrome with Diarrhea.
    NEJM. 2016; 374(3): 242-253.

 

 
Clinical Update: IDSA/ATS HAP/VAP Guidelines (updated July 2016)
 
 
Laura Hill Bannister
PharmD Candidate, 2017
University of Georgia
 
Reviewed by: Christopher Bland, Pharm.D., FCCP, FIDSA, BCPS
 
 
It had been eleven years since the last update, but in July the Infectious Diseases Society of America (IDSA) and the American Thoracic Society (ATS) released the new Hospital-acquired (HAP) and Ventilator-associated (VAP) pneumonia guidelines. There were three major revisions to the 2005 version: the implementation of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology for evaluation of all available evidence, the removal of the concept of healthcare-associated pneumonia (HCAP), and the emphasis on local antibiograms to guide healthcare professionals with respect to the optimal choice of empiric antibiotics.
The rationale for the HCAP designation in the 2005 guidelines was for patients thought to be at high risk for multi-drug resistant (MDR) organisms. It was unanimously agreed upon to remove the concept of HCAP from the guidelines due to increasing evidence that many patients defined as having HCAP are not at high risk for MDR pathogens, leading to increased prescribing of broad-spectrum antimicrobials. Although interaction with the healthcare system is potentially a risk for MDR pathogens, underlying patient characteristics are also important independent determinants. Even if HCAP would be considered as a separate entity, it was thought that this could be included in the upcoming community-acquired pneumonia (CAP) guidelines because patients with HCAP frequently present from the community and are cared for initially in emergency departments, as do patients with CAP.
In the treatment of VAP, the guidelines suggest prescribing two antipseudomonal agents from different classes if the patient has risks for MDR pathogens or if more than 10% of the isolates in the unit are resistant to the choice of antipseudomonal antibiotic. They recommended avoiding aminoglycosides if possible (especially as monotherapy); however widespread fluoroquinolone resistance may necessitate aminoglycoside usage. MRSA coverage is suggested in VAP patients with a risk factor for methicillin-resistance or if the unit the patient is being treated in has more than a 10-20% prevalence of MRSA among all Staphylococcus aureus isolates. However, the guidelines do not give preference to the use of vancomycin or linezolid for MRSA coverage in VAP. It is suggested that the choice should be guided by patient-specific factors such as blood cell counts, concurrent prescriptions for serotonin-reuptake inhibitors, renal function, and cost.
Whether or not the patient is at high risk of mortality is an additional decision point for empiric antibiotic treatment for patients with HAP. The guidelines consider patients with ventilator support or septic shock due to HAP at high risk of mortality. Patients with no MRSA risk factors and who are not at high risk of mortality need coverage for MSSA and one antipseudomonal agent. Those with MRSA risk factors but who are not at high risk of mortality need coverage for MRSA and one antipseudomonal agent. Lastly, patients with both MRSA risk factors and high risk of mortality need coverage for MRSA and two antipseudomonal agents.
Other updates include the recommendation to refrain from using biomarkers (procalcitonin, C-reactive protein, Clinical Pulmonary Infection Score) to make the decision to initiate antibiotic therapy and to rely on clinical criteria alone. The authors give a weak recommendation that for patients with HAP/VAP, antibiotic dosing should be determined using PK/PD data (antibiotic blood concentrations, extended and continuous infusions, and weight-based dosing for certain antibiotics) rather than the manufacturer's prescribing information. The duration of therapy for both HAP and VAP is strongly recommended to be seven days, even for Pseudomonas aeruginosa infections which is a change from the previous 2-week recommendation for these isolates. With these new updates the authors hope to minimize exposure to unnecessary antibiotics and reduce the development of antibiotic resistance while adequately treating patients.
 
1 Kalil A, Metersky M, Klompas M, et al. Management of Adults with Hospital-acquired and Ventilator-associated Pneumonia: 2016 Clinical Practice Guidelines by the Infectious Diseases Society of America and the American Thoracic Society. Clinical Infectious Diseases. 2016. DOI: 10.1093/cid/ciw353

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