• 16 Sep 2018 10:57 PM | Anonymous

    At the MSHP/KCHP Spring Meeting, the pharmacy staff at St. Luke’s Hospital in Kansas City, MO were recognized with the Best Practice Award for their innovative antimicrobial stewardship activities surrounding utilization of rapid diagnostic tests.  Shelby Shemanski, PharmD, BCCCP (Critical Care Pharmacist) and Nick Bennett, PharmD, BCPS (Antimicrobial Stewardship Pharmacist) have graciously shared details of their program with the MSHP membership for those who may be interested in instituting similar practices.

    1.  Please describe the program you started at your institution?
    Bloodstream infections (BSI) represent a significant burden to health care systems and are associated with increased morbidity and mortality. Emergence of rapid diagnostics tests (RDT) have allowed for earlier optimization of therapies for various infections. In 2015, Saint Luke’s Health System (SLHS) launched our centralized Antimicrobial Stewardship Program (ASP) which covers all system hospitals utilizing an electronic medical record (EMR). Concurrently, our microbiology department acquired a new diagnostic technology called MALDI-TOF, which is mass spectrometry microbial identification.  In 2014, the lab had implemented Filmarray PCR for blood cultures, which identifies a large percentage of organisms. In order to maximize the rapidity and understanding of test results, in 2016 microbiology staff began communicating positive blood culture results directly to an ASP pharmacist Monday through Friday, 0700 to 1530, or system pharmacists/residents at Saint Luke’s Hospital all other hours of the week. The goal of our project was to determine if integrating ASP and pharmacy personnel with RDTs would improve outcomes for patients with BSIs.

    2.  How do you (pharmacists) in your program provide care to patients and ensure safe and effective medication therapy?
    Upon receiving a positive blood culture result, pharmacists are expected to review patient-specific data provided in the EMR. This is followed by contacting the appropriate provider with the culture results and suggestions for therapy changes if needed. Pharmacists then place a progress note in the medical record including physician contacted, date and time of communication, and blood culture results. This data is recorded in a database and includes if recommendations were accepted or rejected. All cultures and communications are reviewed by ASP staff the following day or Monday following a weekend to ensure appropriate treatment selections were made or to address issues pharmacists noted in the communication log.

    Prior to 2016, microbiology staff communicated positive blood culture results to nursing staff, who then had to relay the information to the physician. Our process change allowed pharmacists to have a more proactive role in optimizing therapy, but also minimizes nursing interruptions to allow for better patient care.  Additionally, the change supports provider decision making regarding critical patient information. 

    3.  What services have you determined to be essential to support your programs?
    Because our ASP program is not a 24/7 service, we utilize our pharmacy residents and pharmacists at Saint Luke’s Hospital on evening, overnight, and weekend shifts. In addition, the SLHS Innovation Center, a program launched in 2015 to promote innovative care ideas from staff, was an essential resource for this project. Funding from the center allowed us to implement a PGY2-Critical Care Pharmacy Residency.  The intent of funding the PGY-2 position was to support the research and other staffing needs to help get this new process up and running.

    4.  How did you gain support of hospital administrators, physicians, and nursing to implement your program?
    The project was one of two funded projects out of a pool of 53 submissions in 2015.  The Innovation Center is supported on a system level with input from a multidisciplinary group of physicians, pharmacists, administrators and nurses who have ideas to improve efficiency and quality of patient care.  All employees can submit ideas for consideration.  The Innovation center not only provided funding to support the project, but also allocated a project manager and research mentor which were essential to the success of the project.

    5.  What are key barriers that needed to be overcame to start your program?
    The biggest issue we faced was education on the process change, as providers were not accustomed to pharmacists directly communicating critical test results.  Over time, providers understood the value of pharmacist knowledge in microbiology and therapy selection as it relates to blood culture results.  Likewise, nursing staff became less involved with the communication, so we had to devise a method to make the information transparent.  Thus, we developed a progress note titled “critical notification” which is inputted into the progress notes section of the chart after communication with the provider.

    6.  What are some key considerations to gain employee acceptance and buy-in for your program? 
    Make sure you have support from multiple levels ranging from senior leadership, physicians, nursing staff, and your internal staff.  The more people that buy into the value of the service, the less external (or internal) pressure you will receive when making practice changes.  Senior leadership support tends to make process changes happen at a quicker pace and remove barriers that might otherwise slow down progress.

    7.  What benefits have you been able to show with your program?
    We collected and compared pre- (2014, pre-ASP and MALDI-TOF) and post-intervention data (2016) for patients with legitimate positive blood culture results. We found that time to optimal therapy was reduced by 9.2 hours in the 2016 group (p=0.004). There was a trend in reduced inpatient and antimicrobial costs in 2016, with an estimated $110,000 in savings attributed to drug optimization alone. Documented discussions between providers and pharmacists found a high rate of agreement for antimicrobial therapies based on culture results. All recommendations for no change or escalation/dose modification were accepted. Of the 39 proposed de-escalation attempts, only 31 (79.5%) were accepted. Additionally, a physician survey was completed prior to and after our process change. Survey results indicated the new process improved communication amongst clinicians and facilitated a shared-decision making process with a perceived improvement in patient care.

    8.  What are lessons learned while implementing your program that you would like to share with other pharmacists?
    Understand the significant value you bring to the health care team.  Always be looking for ways we can integrate ourselves into current workflows or redesign one to minimize inefficiencies and maximize results.  The health care landscape is constantly shifting.  We as a profession either have to push along with the shift or ahead of it to ensure the value we provide remains visible and desired.  In infectious diseases, RDTs are a perfect example of merging our knowledge of microbiology with therapy optimization for the betterment of patient care.  The technology will continue to advance and it’s our job to help patients get the most from this new technology and support the health care team along the way.

    The MSHP Newsletter Committee would like to thank Shelby and Nick for sharing their practice with the membership!  If you have questions about this practice, or want to share a best practice of your own, please contact Sarah Cook at sarah.cook@ssmhealth.com!

  • 16 Sep 2018 10:50 PM | Anonymous

    Pharmacist Continuing Education: Stress ulcer prophylaxis: Is it still necessary?

    Author: Michael Serlin, PharmD; PGY1 Pharmacy Practice Resident, SSM Health St. Clare Hospital

    Preceptor: Christopher Carter, PharmD, BCCCP; Clinical Pharmacy Specialist - Critical Care, SSM Health St. Clare Hospital

    Program Number: 2018-07-18
    Approval Dates: October 1, 2018 to December 31, 2018
    Approved Contact Hours: One (1) CE(s) per LIVE session.

    Objectives

    1. Demonstrate foundational background knowledge of stress ulcer prophylaxis, particularly in regards to the indications for use and classifications of bleeding.
    2. Analyze and interpret the results of stress ulcer prophylaxis trials.

    Acid-reducing medications like proton pump inhibitors (PPIs) and histamine receptor 2 antagonists (H2RAs) are used commonly for stress ulcer prophylaxis in the inpatient setting. Stress ulcer prophylaxis is indicated for certain subgroups within the critically ill population but up to 71% of general medicine patients receive stress ulcer prophylaxis.1 Though it may reduce bleeding due to stress ulcer formation, stress ulcer prophylaxis may also expose patients to an increased risk of Clostridium difficile infections and ventilator-associated pneumonia due to the creation of a higher-pH environment within the stomach and proximal, small bowel.2

    The goal of this article is to provide information to assist clinicians in exercising stress ulcer prophylaxis stewardship in the inpatient setting by providing adequate background on the risks for stress ulcer formation and a review of the pertinent literature assessing the safety and efficacy of stress ulcer prophylaxis. By practicing good stewardship, clinicians can optimize the benefit of stress ulcer prophylaxis against the risk of adverse events in the appropriate patient populations.

    Stress Ulcer Formation and Enteral Nutrition
    As previously stated, stress ulcer prophylaxis is only indicated in certain critically ill patients. Critically ill patients have a variety of physiologic changes that can increase risk for ulceration. Compared to non-critically ill patients, critically ill patients have an increased gastric acid secretion and impaired blood flow to the gastric mucosa.3 Impaired blood flow to the mucosa can be caused by hemodynamic changes (i.e. hypotension), an imbalance of endothelin-1 and nitric oxide, as well as positive end-expiratory pressure from mechanical ventilation.3 This impaired blood flow can ultimately decrease production of bicarbonate and mucus that would normally provide a protective barrier in the stomach and increase ulceration risk. 

    Although the above physiologic changes can increase the risk of ulceration, it is important to note that altered gastric mucosa does not necessarily cause bleeding. Generally, in order for bleeding to occur, there must be a change in the gastric mucosa and an increased gastric acid secretion.3

    While medications can be used to modify acid secretion, enteral nutrition has been shown to increase gastric mucosal blood flow, as well as modify the imbalance between endothelin-1 and nitric oxide.3

    Types of Upper Gastrointestinal Bleeding
    There are three types of upper gastrointestinal bleeds: occult, overt, and clinically important. An occult bleed is a type of bleed that isn’t symptomatic or visibly seen. An example of occult bleeding is a positive fecal bleeding test. Overt bleeding is a type of bleed that can be visibly seen, such as hematemesis, bloody nasogastric aspirate, or melena. Clinically important bleeding is defined as overt bleeding plus: a spontaneous decrease of greater than 20 mmHg in systolic or diastolic blood pressure, an orthostatic increase in heart rate by 20 beats per minute and a decrease in systolic blood pressure by 10 mmHg, or a decrease in hemoglobin by at least two grams per deciliter or the need to transfuse at least two units of blood within 24 hours of a bleed.4 Clinically important bleeding is associated with increased mortality and increased intensive care unit (ICU) length of stay and is the main target of stress ulcer prophylaxis.4 The incidence of clinically important bleeding in ICU patients without prophylaxis has historically been from 0.1-4%.4

    1999 ASHP Stress Ulcer Prophylaxis Guidelines
    The American Society of Health-System Pharmacists’ stress ulcer prophylaxis guidelines, published in 1999, recommended that stress ulcer prophylaxis be utilized in certain critically ill populations including those that are mechanically ventilated for at least 48 hours and those that have a coagulopathy, including platelet counts less than 50,000 cells/mL3, international normalized ratios (INRs) greater than 1.5, and activated partial thromboplastin time (aPTT) greater than twice the upper limit of normal. These recommendations were based on evidence from cohort studies. Of note, there are two other indications for stress ulcer prophylaxis in the ASHP guidelines that were founded upon expert opinion only. These indications include patients that have had a gastrointestinal bleed within the past year and patients that have at least two of the following characteristics:  Diagnosis of sepsis, ICU stay longer than six days, and those with occult bleeds lasting longer than five days.5

    The ASHP guidelines also provided recommendations for special populations. Based on randomized control trials, stress ulcer prophylaxis is recommended for patients with Glasgow Coma Scale scores less than or equal to 10 and patients with thermal injuries that were greater than 35% of the patient’s body surface area (BSA). Certain populations, including head traumas and spinal cord injuries, had not been well studied when the guidelines were published. Thus, the guidelines stated that prophylaxis might be indicated on the basis of expert opinion.5

    Recently Published Stress Ulcer Prophylaxis Literature
    Selvanderan, et al.- 2016 exploratory trial7
    The article entitled “Pantoprazole or Placebo for Stress Ulcer Prophylaxis (POP-UP): Randomized Double-Blind Exploratory Study” by Selvanderan et al. was a prospective, randomized, parallel-group trial. This exploratory study aimed to establish rates of clinically important bleeding, Clostridium difficile infections, and ventilator-associated pneumonia in critically ill patients with and without prophylaxis of intravenous pantoprazole 40 mg daily.  Patients were eligible for the study if their expected time on mechanical ventilation was at least 24 hours and if they were expected to receive enteral nutrition within at least 48 hours of admission. Patients were ineligible for enrollment if they had used acid-altering medication before admission, were admitted with a gastrointestinal bleed, were using at least 100 mg of prednisolone or an equivalent dose of another corticosteroid, were admitted for gastrointestinal or cardiovascular surgery, were pregnant, were Jehovah’s witnesses, were receiving palliative care, or were an ICU readmission. Categorical data were appropriately analyzed via chi-squared or Fisher’s exact test. Parametric continuous data were analyzed via unpaired t-test and nonparametric continuous data were analyzed via Mann-Whitney U.

    There were no significant differences in baseline characteristics or processes of care, including inotrope usage or coagulopathies, in the 108 patients that received placebo and the 106 patients that received pantoprazole.  There was also no significant difference in the number of patients using enteral nutrition in each group. All of the endpoint studied, including clinically important bleeding, ventilator-associated pneumonia, Clostridium difficile infection, overt bleeding incidence, ICU length of stay, and hospital length of stay were found to be nonsignificant between the groups. There were no incidences of clinically important bleeds observed. The incidence of ventilator-associated pneumonia was 1.9% in the pantoprazole group and 0.9% in the placebo group. The incidence of Clostridium difficile infection was 0.9% in the pantoprazole group and 0% in the placebo group.

    These results show that in this population, pantoprazole provided no extra benefit and no harm. These nonsignificant results should be taken in context of the exploratory nature of the trial in that since power was not assessed in the study design, it is possible that the trial was not designed to find a difference if one truly exists.

    Alhazzani, et al.- 2017 pilot trial and meta-analysis2
    The article entitled Withholding pantoprazole for stress ulcer prophylaxis in critically ill patients: a pilot randomized clinical trial and meta-analysis” by Alhazzani et al. was an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial that compared intravenous pantoprazole 40 mg daily to placebo. The study treatment was stopped after death, incidence of gastrointestinal bleeding, or after extubation at the discretion of the treating physician. Patients were included if they were at least 18 years old and were expected to be mechanically ventilated for at least 48 hours. Patients were excluded if they were ventilated before randomization, used PPIs due to an active bleed or for an increased bleeding risk, used dual antiplatelet therapy, were on palliative care, were pregnant, or used PPIs or H2RAs twice daily or more. The primary endpoint was incidence of clinically important gastrointestinal bleeding. The secondary endpoints were similar to those in the trial by Selvanderan et al., including length of stay, incidence of ventilator-associated pneumonia, incidence of Clostridium difficile infection, and morality rates. The trial data was analyzed via Fisher’s exact test and the meta-analysis data was analyzed via DerSimonian and Laird random-effect models.

    There were no significant differences noted in baseline characteristics including H2RA or PPI use before the study, median Acute Physiology and Chronic Health Evaluation II (APACHE II) score, and type of anticoagulants used. The only statistically significant difference noted between the 49 patients in the pantoprazole group compared to the 42 patients in the placebo group was the difference in median hospital length of stay, favoring the placebo group (placebo 25 days (interquartile range, IQR 10-42 days) vs. pantoprazole 27 days (IQR 16-38 days), p=0.049). All other differences in pilot trial results, including differences in mortality, clinically important bleeding incidences, and any bleeding incidences were not found to be statistically significant.

    The meta-analysis performed by Alhazzani et al. reviewed data on incidence of clinically important bleeding and ventilator-associated pneumonia. For the incidence of clinically important bleeding, the authors found no overall significance in the differences between PPIs vs. placebo in the pooled data from five studies (overall OR 0.96; 95% CI 0.24-3.82). The authors also found no statistically significant difference in the pooled data from four studies for ventilator-associated pneumonia (overall OR 1.32; 95% CI 0.68-2.55).

    The results from the pilot trial and the meta-analysis both show no statistically significant differences between PPIs and placebo for clinically important bleeding and infection rates.  Due to the pilot nature of the trial aspect of this article, these nonsignificant results should be interpreted with caution, as power was not assessed or calculated.

    El-Kersh, et al.- 2017 exploratory trial8
    The article entitled “Enteral nutrition as stress ulcer prophylaxis in critically ill patients: A randomized controlled exploratory study” by El-Kersh et al. was a prospective, randomized controlled trial that aimed to determine if stress ulcer prophylaxis is needed in combination with enteral feeding. Enteral nutrition, defined as 25-30 kcal per kilogram per day, was given with intravenous pantoprazole 40 mg daily or placebo. To provide appropriate feeding, gastric residual volumes were checked every four hours. If the residual volume was greater than 400 milliliters or if the patient was hypotensive or hypoxic, feeding was paused to decrease the risk of bowel ischemia. Feeding was resumed once the residual volume was less than 400 milliliters or when deemed appropriate by the treating medical teams. The feeding strategy used in the study aligns with the recommendations provided by the Society of Critical Care Medicine and the American Society for Parenteral and Enteral Nutrition.9 Patients were eligible for enrollment if they were at least 18 years old, expected to be ventilated for at least 48 hours, and had no contraindications for enteral nutrition within 24 hours of ICU admission. Patients were ineligible if they had a gastrointestinal bleed or burn injury upon admission, had head trauma or increased intracranial pressure, had a history of gastrectomy, or were pregnant or lactating.  As with the previous articles, the primary endpoint was incidence of clinically important bleeding. Secondary endpoints included incidence of Clostridium difficile infection, ICU length of stay, and hospital length of stay.

    There were no significant differences found in baseline characteristics, including median Sequential Organ Failure Assessment (SOFA) and Simplified Acute Physiology Score II scores. No differences were found as well in regards to enteral feeding characteristics, including average kcal per kilogram per day given and total enteral nutrition given. Additionally, there were no statistically significant differences in any of the endpoints studied, including the primary endpoint of clinically important bleeding (one incidence in each group; p=0.99) for the 55 patients treated with pantoprazole compared to the 47 patients treated with placebo.

    These results show no extra benefit of administering pantoprazole in mechanically ventilated patients receiving enteral nutrition in regards to clinically important bleeding incidence, incidence of Clostridium difficile infection, and length of stay. As with the other newer trials, the exploratory nature of this study should be considered when interpreting these results.

    Conclusions and recommendations for practitioners
    As mentioned previously, the exploratory and pilot designs of the newly published trials are factors that should not be overlooked when interpreting these results. It is possible that these studies were not powered to find the difference between PPIs and placebo that truly existed. With that said, these new trials offer hope that there may evidence to show a reduced need for stress ulcer prophylaxis. All three studies found no statistical difference when examining stress ulcer prophylaxis in a population in which prophylaxis was originally recommended for in the ASHP guidelines. Until larger, powered studies provide evidence suggesting that stress ulcer prophylaxis is not needed, it is reasonable to still utilize it in critically ill patients that have coagulopathies or that have been ventilated for at least 48 hours. Despite these populations not being a focus of recently published literature, it may be reasonable to utilize prophylaxis in patients with low Glasgow Coma Scale scores and with significant thermal injury. It is difficult to recommend prophylaxis be utilized in the populations that were previously recommended solely based on expert opinion due to the limited evidence for such recommendations. For reasons stated previously, it is also unlikely that stress ulcer prophylaxis is beneficial in many other populations than the critically ill, particularly those admitted to a general unit. Therefore, it is also reasonable that stress ulcer prophylaxis should generally be discontinued in non-critically ill patients.


    References:

    1. Grube RR, May DB. Stress ulcer prophylaxis in hospitalized patients not in intensive care units. Am J Health Syst Pharm. 2007 Jul 1;64(13):1396-400.
    2. Alhazzani W, Guyatt G, Alshahrani M, et al. Withholding pantoprazole for stress ulcer prophylaxis in critically ill patients: a pilot randomized clinical trial and meta-analysis. Crit Care Med 2017;45(7):1121–9.
    3. Buendgens L, Koch A, Tacke T. Prevention of stress-related ulcer bleeding at the intensive care unit: Risks and benefits of stress ulcer prophylaxis. World J Crit Care Med. 2016 Feb 4; 5(1): 57–64.
    4. Alhazzani W, Alshahrani M, Moayyedi P, et al. Stress ulcer prophylaxis in critically ill patients: review of the evidence. Pol Arch Med Wewn. 2012;122(3):107-14.
    5. ASHP Therapeutic Guidelines on Stress Ulcer Prophylaxis. ASHP Commission on Therapeutics and approved by the ASHP Board of Directors on November 14, 1998. Am J Health Syst Pharm. 1999 Feb 15;56(4):347-79.
    6. Cook DJ, Fuller HD, Guyatt GH, et al. Risk factors for gastrointestinal bleeding in critically ill patients. Canadian Critical Care Trials Group. N Engl J Med. 1994 Feb 10;330(6):377-81.
    7. Selvanderan SP, Summers MJ, Finnis ME et al. Pantoprazole or placebo for stress ulcer prophylaxis (POP-UP): Randomized double-blind exploratory study. Crit Care Med. 2016 Oct;44(10):1842-50
    8. El-Kersh K, Jalil B, McClave SA et al. Enteral nutrition as stress ulcer prophylaxis in critically ill patients: A randomized controlled exploratory study. J Crit Care. 2018 Feb;43:108-113.
    9. McClave SA, Taylor BE, Martindale RG, et al. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2016 Feb;40(2):159-211.


  • 16 Sep 2018 10:42 PM | Anonymous

    Authors:  Nicholas Kovarik, PharmD and Samuel Mikovich, PharmD, PGY-1 Pharmacy Residents, SSM Health St. Mary’s Hospital – St. Louis

    Preceptor:  Davina Dell-Steinbeck, PharmD, BCPS, PGY-1 Pharmacy Practice Residency Director, SSM Health St. Mary’s Hospital – St. Louis

    Program Number: 2018-07-18
    Approval Dates: October 1, 2018 to December 31, 2018
    Approved Contact Hours: One (1) CE(s) per LIVE session.

    Learning Objectives

    1. Recall prevention and treatment recommendations made in the 2017 update to the IDSA/SHEA Clostridium difficile guidelines
    2. Identify the appropriate place in therapy for Fecal Microbiota Transplant in the treatment of recurrent infection
    3. Explain the mechanism and different modalities of Fecal Microbiota Transplant in treating recurrent infection
    4. Recall the methods of patient preparation strategies prior to delivery of Fecal Microbiota Transplant
    5. Evaluate the current evidence for using Fecal Microbiota Transplant


    Introduction
    Clostridium difficile infection (CDI) represents a major burden for hospitals in the United States, annually responsible for 500,000 infections1, 30,000 deaths2, and excess inpatients costs of over 4.8 billion dollars3. Clostridium difficile is a Gram positive, spore-forming anaerobe that mediates infection through enterotoxin production (toxins A and B) within the human gut. This organism is the most commonly identified cause of healthcare-associated infection in our country, surpassing infections caused by methicillin-resistant Staphylococcus aureus (MRSA)4. Diagnosis of CDI is based on a combination of clinical and laboratory evidence: the presence of diarrhea defined as ≥ 3 unformed stools within 24 hours and a stool test result positive for the presence Clostridium difficile toxins or DNA.

    The Clostridium difficile guidelines published by the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) were recently updated at the end of 20175. The previous update to these guidelines was performed in 2010, and only focused on adult recommendations6. The new update includes recommendations for children and brings significant changes to the treatment recommendations for adults. This article will highlight some of the major changes made to these guidelines and present the evidence that supports them. A particular focus will be placed on using fecal microbiota transplant, or FMT, to treat CDI. This article will also cover the different administration techniques for FMT. Because CDI significantly affects morbidity and mortality among hospitalized patients, there is a growing effort to find new treatment modalities as well as optimize the old ones. It is therefore essential that pharmacists stay up-to-date on the best practice methods for this disease.

    Recurrence
    A major contributing factor to CDI’s large healthcare burden is the high rate of recurrence. Rates of CDI recurrence have steadily increased over the years, and around 25% of patients treated with metronidazole or vancomycin for an initial episode will develop a recurrent infection7. Once a patient has one recurrence, the risk for a second recurrence skyrockets up to 65%8. Risk factors for recurrence include older age (≥ 65), continued antibiotic use, use of acid-suppressing medications, previous exposure to fluoroquinolones, and strain type5. Historically, metronidazole has been the mainstay of treatment for patients hospitalized with CDI, but high rates of recurrence prompted the changes to the IDSA guidelines that will be discussed later on.

    NAP-1 strain
    One reason for high recurrence rates and increasing disease severity is the emergence of the North American pulsed-field Type 1 strain (NAP-1/BI/027). The NAP-1 strain is a hypervirulent strain of Clostridium difficile that is associated with more severe symptoms, higher recurrence rates, and increased mortality. The emergence of this strain is hypothesized to be due to the overuse of fluoroquinolone antibiotics. In an epidemiologic study performed in the U.S. including over 2,000 CDI cases, investigators found that 28.4% of cases were due to this hypervirulent strain9.


    2017 Update to IDSA/SHEA Guidelines

    Prevention
    The updated IDSA guidelines make many recommendations related to prevention methods for CDI. Some of the more relevant recommendations encompass hand hygiene methods, antimicrobial stewardship efforts, and the use of probiotics and proton pump inhibitors. The latest evidence suggests that although washing your hands with soap and water is preferred in times of CDI outbreaks or direct contact with a stool specimen, using alcohol-based products is just as effective to prevent transmission of disease. Adding to the evidence in favor of antimicrobial stewardship in healthcare organizations, the guidelines strongly recommend implementation of a stewardship program. This section of the guideline details that restriction of high-risk antibiotics such as fluoroquinolones, clindamycin, and cephalosporins should be considered. Although there has been evidence to show an association between PPI use and CDI, the panel noted there is insufficient evidence for discontinuation of PPIs as a measure for preventing CDI. This recommendation stems from the lack of causal data, as only observational studies have been performed. However, they do note that unnecessary PPIs should always be discontinued. Similarly, the guidelines do not recommend using probiotics to prevent CDI due to the lack of high quality evidence.

    Treatment: Adult Recommendations5 (Table 1)
    The biggest change in the treatment of CDI in the guideline update is the deletion of metronidazole as a first-line recommended agent. This change comes with the addition of fidaxomicin as a first-line agent in its place. Metronidazole is now only recommended if vancomycin or fidaxomicin are contraindicated or unavailable. Initial data comparing metronidazole and vancomycin performed in the 1980s and 1990s showed similar efficacy10. However, randomized controlled trials more recently have shown that vancomycin use is associated with significantly higher clinical cure rates and lower recurrence rates compared to metronidazole11. Additionally, guidelines mention to avoid repeated or prolonged courses of metronidazole due to the risk of irreversible neurotoxicity.

    Fidaxomicin, marketed as Dificid®, was FDA approved in 2011. As shown in Table 1, it is now recommended first-line as an alternative to vancomycin for initial non-severe and severe infections. Fidaxomicin has mechanistic advantages over vancomycin. It has been found to be more potent in vitro than vancomycin, has high fecal concentrations, long post-antibiotic effect, and restricted activity against normal gut flora12. There are two major trials that have directly compared vancomycin to fidaxomicin (Table 2)13,14. Both of these randomized controlled trials compared vancomycin 125 mg PO QID for 10 days vs. fidaxomicin 200 mg PO BID for 10 days. Results of these two trials show no difference in clinical cure rates, but do show a statistically significant decrease in recurrent rates in the fidaxomicin group (25% vs. 15%, 27% vs. 13%). One major consideration when using fidaxomicin is the price, as it is significantly more expensive than vancomycin.

    Another change from the 2010 update is the management of recurrent infections (Table 3). The previous update recommended treating the first recurrent episode with the same agent as the initial episode. For the first recurrence, the 2017 update recommends using a tapered and pulsed dosing strategy (if standard dosing vancomycin was used initially) or switching agents. For the second and subsequent recurrences, the 2017 update does have the recommendation of using fecal microbiota transplant.

    Fecal Microbiota Transplant Mechanism
    The human gastrointestinal tract contains over 1,100 different bacterial species and over 1014 individual bacteria15. Although there are many roles of these bacteria, one that applies specifically to CDI is the ability to kill pathogens through competitive exclusion. When antibiotics interfere with this diverse group of bacteria, foreign pathogens such as Clostridium difficile can take residence. Although the exact mechanism for recurrent CDI is not fully understood, it is thought that a large part is due to a decreased microbial diversity within the gut. A study performed in 2008 evaluating the microbial diversity of feces in patients with recurrent CDI found a drastic decrease in diversity16. The concept of FMT works on this exact principle, that instillation of bacteria from a healthy individual via stool will restore the diversity of a patient with a damaged gut microbiota.

    Regulation
    FMT is defined by the FDA as a biological agent which is not FDA-approved. When treating recurrent CDI, an Investigation New Drug (IND) permit is encouraged but not required for physicians. However, the FDA is looking to regulate FMT and may eventually require an IND permit for use. Under current regulation, a licensed physician must comply with the following rules if they are to use FMT without an IND permit:

    1. The licensed health care provider treating the patient obtains adequate consent from the patient or his or her legally authorized representative for the use of FMT products. The consent should include, at a minimum, a statement that the use of FMT products to treat C. difficile is investigational and a discussion of its reasonably foreseeable risks
    2. The FMT product is not obtained from a stool bank
    3. The stool donor and stool are qualified by screening and testing performed under the direction of the licensed health care provider for the purpose of providing the FMT product for treatment of the patient.

    Guideline Recommendation
    FMT is now recommended by the 2017 update as an option for second and subsequent recurrence of CDI (strong recommendation, moderate quality of evidence). It is included in the treatment algorithm along with three antibiotic options (weak recommendations, low quality of evidence). The opinion of the panel is that appropriate antibiotic treatments for at least two recurrences should be tried before performing FMT, meaning it would have to be at least the patient’s fourth episode. However, the authors note that there is no evidence to support the number of failed antibiotic therapies.

    FMT Protocol
    There are a few different delivery modalities in which FMT can be performed. To begin, a donor must provide fecal material for preparation. In 2013, several medical societies including IDSA and American College of Gastroenterology (ACG) jointly released a consensus statement for guidance on donor screening and stool testing for FMT.17 It is preferred that a donor is an intimate, long-time partner of adult patient, first-degree relative, close friend, or well-screened donor. Donor exclusion consists of the following:

    • History of antibiotic treatment during the preceding three months of donation
    • History of intrinsic gastrointestinal illness such as inflammatory bowel disease
    • History of autoimmune illness or ongoing immune modulating therapy
    • History of chronic pain syndromes such as fibromyalgia
    • Metabolic syndrome, obesity, or malnutrition
    • History of malignant illness of ongoing oncologic therapy

    Patients should also be screened for hepatitis A, B, C, HIV, and syphilis within 4 weeks of donation as well as Clostridium difficile toxin B and culture for enteric pathogens.

    Options to deliver FMT include nasogastric tube administration, nasoduodenal delivery, nasojejunal delivery, colonoscopy, retention enema, or oral capsules. Each delivery method carries a risk such as aspiration with nasogastric tube delivery or colon perforation with colonoscopy delivery. Overall, physicians should use their clinical judgment to determine the best method of administration for FMT.

    Patients must undergo preparation before FMT. While there is heterogeneity within practices, there are a few common practices in FMT protocols. The preparation considerations from OpenBiome will be discussed.18 First, it is commonly practiced to discontinue anti-CDI antibiotics 48 hours before FMT. This is to ensure the antibiotics do not impact the transferred microbiota. Next, a standard large volume bowel preparation is suggested for both upper and lower gastrointestinal delivery. There is anecdotal evidence to suggest limited bowel preparation or no preparation yields equally effective results, but evidence is lacking to support this. If a patient is receiving FMT via lower gastrointestinal delivery, loperamide is an option for prolonging fecal retention. Again, there is limited evidence to suggest superiority over no loperamide use. Finally, some clinicians will administer a proton pump inhibitor for upper gastrointestinal delivery the evening before FMT and the morning of the procedure to lessen the impact of gastric acid on the donor microbiota during FMT.

    Summary of Evidence
    Given the nature of the process, randomized controlled trials with FMT are difficult to perform. Anecdotal reporting of FMT has touted high success rates with a benign safety profile. However, most of this literature stems from case studies and retrospective reviews. There are several randomized controlled trials published regarding FMT for treatment of CDI. The first prospective trial investigating FMT was published in 2013 by van Nood et al. In this study, FMT and vancomycin were directly compared for treatment of recurrent CDI in 43 patients.19 Patients either received 14 days of oral vancomycin, vancomycin with bowel lavage, or 4 days of oral vancomycin followed by bowel lavage and subsequent FMT delivery via nasodudodenal tube. 81% of patients in the FMT group had sustained resolution of diarrhea after the first fecal infusion while 27% of patients treated with vancomycin had symptom resolution. Other trials have also been performed comparing FMT to other CDI treatment options or evaluating different FMT delivery modalities.20-23 A summary of select trials are available in Table 4 of the appendix.

    A few meta-analysis and systematic reviews have been performed to evaluate the efficacy of FMT. One was performed by Quraishi et al. finding FMT to be more effective than vancomycin in treating recurrent and refractory CDI (RR: 0.23 95%CI 0.07-0.80).24 There also was a significant difference in efficacy observed between lower gastrointestinal delivery of FMT vs upper gastrointestinal delivery 95% (95%CI 92%-97%) vs 88% (95%CI 82%-94%) respectively (P=.02). Lastly, across studies, administering consecutive courses of FMT after a failure of the first FMT was found to have an incremental effect. 

    Conclusion
    Overall, FMT has proven to be a highly effective, low risk treatment option for a serious infection. Patient acceptance of FMT has generally been well received throughout the literature. Currently, FMT is recommended to be used after antibiotics have failed to resolve CDI. The utilization of FMT is increasing in the U.S. and with this use, there are more questions that arise. Is there a place for FMT earlier in therapy? Would this therapy potentially replace the use of antibiotics to treat CDI? Which delivery method is truly most efficacious to administer FMT? With time and more studies, the use of FMT can become more optimized to improve patient care.

    References:
    1. Lessa FC, Mu Y, Bamberg WM, et al. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015; 372:825-834.
    2. Hall AJ, Curns AT, McDonald LC, et al. The roles of Clostridium difficile and norovirus among gastroenteritis-associated deaths in the United States, 1999-2007. Clin Infect Dis. 2012; 55:216-223.
    3. Dubberke ER, Olsen MA. Burden of Clostridium difficile infection on the healthcare system. Clin Infect Dis. 2012; 55(2):S88-S92.
    4. Centers for Disease Control and Prevention. Emerging Infections Program-healthcare-associated infectious projects. 2015. Available at: http://www.cdc.gov/hai/eip/index.html.
    5. McDonald LC, Gerding DN, Johnson S, et al. Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society for America (IDSA) and Society of Healthcare Epidemiology of America (SHEA). Clin Microbiol Infect. 2018; XX (00): 1–48.
    6. 6. Cohen SH, Gerding DN, Johnson S, et al. Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2010 Update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol. 2010; 31(5):431-455.
    7. Aguado JM, Anttila VJ, Galperine T, et al. Highlighting clinical needs in Clostridium difficile infection: the views of European healthcare professionals at the front line. J Hosp Infect. 2015; 90:117-125.
    8. McFarland LV, Elmer GW, Surawicz CM. Breaking the cycle: treatment strategies for 163 cases of recurrent Clostridium difficile disease. Am J Gastroenterol. 2002; 97:1769–1775.
    9. See I, Mu Y, Cohen J, et al. NAP1 strain type predicts outcomes from Clostridium difficile infection. Clin Infect Dis. 2014; 58(10):1394-1400.
    10. Wenisch C, Parschalk B, Hasenhündl M, et al. Comparison of vancomycin, teicoplanin, metronidazole, and fusidic acid for the treatment of Clostridium difficile-associated diarrhea. Clin Infect Dis. 1996; 22:813–818.
    11. Johnson S, Louie TJ, Gerding DN, et al. Vancomycin, metronidazole, or tolevamer for Clostridium difficile infection: results from two multinational, randomized, controlled trials. Clin Infect Dis 2014; 59:345–54
    12. Mullane, K. Fidaxomicin in Clostridium difficile infection: latest evidence and clinical guidance. Ther Adv Chronic Dis. 2014; 5(2):69-84.
    13. Louie TJ, Miller MA, Mullane KM, et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Enlg J Med. 2011; 364:422-431.
    14. Cornely OA, Crook DW, Esposito R, et al. Fidaxomicin versus vancomycin for infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial. Lancet Infect Dis. 2012; 12:281-289.
    15. Qin J, Li R, Raes J, et al. A human gut microbial gene catalogue established by metagenomics sequencing. Nature. 2010; 464(7285):59.
    16. Chang JY, Antonopoulos DA, Kalra A, et al. Decreased diversity of the fecal Microbiome in recurrent Clostridium difficile-associated diarrhea. J Infect Dis. 2008; 197(3):435.
    17. Relman D, Vender RJ, Rustgi AK, Wang KK, Bousvaros A. 2013. Current consensus guidance on donor screening and stool testing for FMT. American Gastroenterological Association, Bethesda, MD. https://www.gastro.org/research/Joint_Society_FMT_Guidance.pdf.
    18. Kassam Z. OpenBiome. Clinical primer: position statement for fecal microbiota transplantation administration for recurrent clostridium difficile infection. Available at https://static1.squarespace.com/static/50e0c29ae4b0a05702af7e6a/t/5807a4cd1b631b90a05c911f/1476895949876/Clinical+Primer.pdf
    19. Van Nood E, Vrieze A, Nieuwdorp M, et al. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013; 368:407–415.
    20. Cammarota G, Masucci L, Ianiro G, et al. Randomised clinical trial: faecal microbiota transplantation by colonoscopy vs. vancomycin for the treatment of recurrent Clostridium difficile infection. Aliment Pharmacol Ther. 2015; 41:835–843.
    21. Youngster I, Sauk J, Pindar C, et al. Fecal microbiota transplant for relapsing Clostridium difficile infection using a frozen inoculum from unrelated donors: a randomized, open-label, controlled pilot study. Clin Infect Dis. 2014; 58:1515–1522.
    22. Lee CH, Steiner T, Petrof EO, et al. Frozen vs fresh fecal microbiota transplantation and clinical resolution of diarrhea in patients with recurrent Clostridium difficile infection: a randomized clinical trial. JAMA. 2016; 315:142–149.
    23. Kelly CR, Khoruts A, Staley C, et al. Effect of fecal microbiota transplantation on recurrence in multiply recurrent Clostridium difficile infection: a randomized trial. Ann Intern Med. 2016; 165:609–16.
    24. Quraishi MN, Widlak M, Bhala N, et al. Systematic review with meta-analysis: the efficacy of faecal microbiota transplantation for the treatment of recurrent and refractory clostridium difficile infection. Aliment Pharmacol Ther. 2017;46(5):479 – 493.

    Appendix

    Table 1. IDSA/SHEA Treatment Recommendations for Initial Episode of CDI in Adultsa

    Table 2. Comparison of Fidaxomicin versus Vancomycin for Treatment of CDI

    Table 3. IDSA/SHEA Treatment Recommendations for Recurrent Episode of CDI in Adultsb

    Table 4. Studies Evaluating Efficacy of FMT for CDI




  • 16 Sep 2018 9:54 PM | Anonymous

    Marijuana in Missouri-What Missouri Pharmacists Should Know
    Authors: Sierra Richard, PharmD Candidate, Sarah Cox, PharmD, MS and Mary Durham, PharmD, MS, BCPS

    Epidiolex
    On June 25, 2018, the Food and Drug Administration (FDA) approved the first drug containing a “purified drug substance derived from marijuana”, Epidiolex. This new medication differs from medications such as dronabinol and nabilone that are synthetic derivatives of marijuana based on how the medication is manufactured.1 Epidiolex is a cannabidiol oral solution approved for the treatment of two forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two year of age and older. Both syndromes occur early in childhood and pediatric pharmacists and community pharmacists may start seeing prescriptions for Epidiolex in this population soon. At the time of approval, Epidiolex is the only FDA approved medication for Dravet syndrome giving this population a proven treatment option for the first time.2 However, another medication for the treatment of Dravet Syndrome, Diacomit (stiripentol) was approved by the FDA on August 20, 2018 which may influence the use of Epidiolex in practice.3

    Legal Challenges
    Dispensing this medication may come with legal questions. First, cannabidiol (CBD) is a schedule I substance under the Controlled Substances Act. Since Epidiolex was approved, the Drug Enforcement Agency (DEA) has ninety days from the time of FDA approval to reconsider the schedule of CBD to legally allow Epidolex to be administered.2 The ninety-day deadline is September 23, 2018. At the time of writing, no statements regarding the marijuana rescheduling process have been published. Additionally, Missouri state law restricts the use of CBD oil. Under current state regulations, patients who have an intractable epilepsy may be approved for a Missouri Hemp Extract Registration Card after receiving a signed statement from a licensed Missouri neurologist indicating that the patient may benefit from the hemp extract treatment. This waver allows patients who are 18 year or older, or the parent or legal guardian of a minor to legally possess more than twenty ounces of CBD oil containing less than 0.3% tetrahydrocannabinol [THC] (the psychoactive component of cannabis). There are two licensed facilities in Missouri that can dispense CBD oil. The Missouri Hemp Extract Registration card is valid for one year and may be renewed by the neurologist annually. Since the program’s inauguration in 2014, 331 cards have been issued and 148 remain active. Of the currently active cards, 125 are for the treatment of minors.4

    In December of 2016 the DEA established a new drug code for marijuana extract which would improve tracking of these products. However, in their statement, they reinforced that extracts of marijuana were still classified as a schedule I controlled substance.5 Prior to this, the part of the marijuana plant that hemp was extracted from (the stalk) was excluded from the Controlled Substance Act definition of marijuana.6 Despite these regulations, many stores in Missouri cities, including Columbia, have started selling cannabis extract without a Missouri Hemp Extract Registration Card or any medical oversight.7

    Legal challenges surrounding possession of Epidiolex2 or other CBD4 oil products may bring new complexities in the care of institutionalized patients. Current regulatory status should be considered when assessing the addition of a CBD oil product to the pharmacy formulary, or developing a protocol to accommodate dispensation of a patient’s home therapy. Every step in the medication use process should be assessed, taking into account high risk points for diversion including procurement and storage, unit dose dispensation of an oral liquid controlled substance, administration, documentation, and waste. Understanding the legality of CBD possession by specific patients4 is paramount to maintaining compliance with current state and federal regulations; this may dictate the fine line between whether a patient has a product lawfully or illicitly, and the role of the pharmacist to facilitate access to safe and appropriate therapy.

    Pros and Cons of Medical Marijuana
    Research conducted regarding medical marijuana has shown that it can help reduce pain and nausea for patients suffering from cancer and other illnesses in addition to reducing the number of seizures in patients who are refractory to other treatment options.8 Additionally, a study published in the August 2014 edition of JAMA Internal Medicine found that states with legalized medical marijuana had decreased opioid related deaths compared to states where it was not legal between 1999 and 2010.9

    However, concerns arise on the long-term effects of marijuana. Reduced regulations likely would lead to increased access to minors. Current research has shown that chronic marijuana use by pre-adolescents and those in their early 20s can lead to a diminished IQ, increased risk of dropping out of school, and increased risk of respiratory problems. Furthermore, there is mixed evidence on the safety of operating a motor vehicle after using marijuana. This becomes increasingly difficult to determine as the metabolites of marijuana remain in the body for days to weeks after use. 8


    What does this mean for Missouri pharmacists?
    Currently, Missouri pharmacies can legally dispense synthetic THC derivatives such as dronabinol and nabilone given that they are classified as schedule III and schedule II medications, respectively. However, with the FDA approval of Epidiolex it is possible that the DEA schedule of marijuana could change. In addition, there are will be three initiatives supporting medical marijuana legalization on the Missouri ballots in November10. If legislative changes occur, institutions may need to consider updating policies regarding the handling of CBD oil.


    Resources:

    1. marinol.com [Internet]. North Chicago (IL): AbbVie Inc.; c2017 [cited 2018 Sep 2]. Available from: http://www.marinol.com/hcp/differences-from-medical-marijuana

    2. fda.gov [Internet]. Silver Spring (MD): U.S. Food and Drug Administration; c2018 [cited 2018 Sep 2]. Available from: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611046.htm

    3. fda.gov [Internet]. Silver Spring (MD): U.S. Food and Drug Administration; c2018 [cited 2018 Sep 2]. Available from: https://www.fda.gov/Drugs/InformationOnDrugs/ucm618455.htm

    4. health.mo.gov [Internet]. Jefferson City (MO): Missouri Department of Health & Senior Services; c2014 [updated 2018 June 30; cited 2018 Sep 2]. Available from: https://health.mo.gov/about/proposedrules/hempextract.php

    5. gpo.gov [Internet]. Springfield (VA): U.S. Department of Justice Drug Enforcement Administration; c2016 [cited 2018 Sep 2]. Available from: https://www.gpo.gov/fdsys/pkg/FR-2016-12-14/pdf/2016-29941.pdf?utm_campaign=subscription%20mailing%20list&utm_source=federalregister.gov&utm_medium=email

    6. deadivision.usdoj.gov [Internet]. Springfield (VA): U.S. Department of Justice Drug Enforcement Administration; c1990 [cited 2018 Sep 2]. Available from: https://www.deadiversion.usdoj.gov/21cfr/21usc/802.htm

    7. columbiatribune.com [Internet]. Columbia (MO): Columbia Tribune; c2017 [cited 2018 Sep 2]. Available from: http://www.columbiatribune.com/news/20171223/stores-sell-cannabis-extract-despite-state-regulations

    8. health.usnews.com [Internet]. Washington, D.C.: U.S. News & World Report; [cited 2018 Sep 2]. Available from: https://health.usnews.com/health-news/patient-advice/articles/2016-10-12/marijuanas-public-health-pros-and-cons

    9. Bachhuber M. Medical Cannabis Laws and Opioid Analgesic Overdose Mortality in the United States, 1999-2010. JAMA Intern Med [Internet]. 2014 [cited 2018 Sep 2]; 174(10): 1668-1673. Available from: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1898878

    10. www.sos.mo.gov [internet]. Jefferson City (MO): Missouri Secretary of State; [cited 2018 Sep 9]. Available from: https://www.sos.mo.gov/default.aspx?PageId=9456


  • 08 Aug 2018 11:06 AM | MSHP Office (Administrator)

    UMKC School of Pharmacy

    As usual, we have been very busy at the UMKC School of Pharmacy!  While it would be impossible here to describe all that has been going on, I would like provide a brief update on recent activities at the school.

    UMKC School of Pharmacy at MSU:  After six years of hard work by UMKC and MSU faculty and staff, as well as support from the state of Missouri and many hard-working legislators, we have come through on our promise to provide pharmacy education in Southwest Missouri.  Our first cohort of 31 students graduated from our Springfield location in May.  Prior to graduation, most of the students had secured jobs in and around Southwest Missouri.  This group of outstanding students included many who would not have been able to pack up and move to our sites in Kansas City or Columbia in order to attend pharmacy school.  Special thanks go to all who made this happen, but especially our friends and colleagues at Missouri State University.  President Clif Smart and Provost Frank Einhellig and all of the folks there who worked with us to make dreams come true.

    “APhA-ASP National Champions”.  If ESPN would cover pharmacy student competitions, then the entire country, even those outside the pharmacy world, would know the dominance of the UMKC chapter of the American Pharmacists Association-Academy of Student Pharmacists (APhA-ASP)!  This year, our chapter was once again recognized as the number one chapter in the country!  This is the second time since 2012 that our chapter has been recognized by APhA as the number one chapter, and every year in between they have been among the top seven or four chapters in the nation.  Our students are clearly having a huge impact on the health and wellness of people in our country, and especially throughout central and southwestern Missouri as well as the Kansas City area.  We are proud that they continue to bring such positive national attention to UMKC.  We also had national APhA awards provided to individual UMKC student pharmacists including:  Sara Massey (Class of 2018) received the John A. Gans Scholarship from the APhA Foundation; Sierra Woods (Class of 2019) received the APhA Good Government Student Pharmacist of the Year.

    Outstanding Faculty Advisors.  I often get asked by other deans of pharmacy around the country about the keys to the success of our student chapter of APhA-ASP, and the answer is simple:  it’s clearly the outstanding faculty advisors they have.  Special thanks go to the mentorship provided by Drs. Kelly Cochran, Kathryn Holt, Lisa Cillessen, Angela Brownfield, Sarah Cox, Heather Taylor, Andrew Bzowyckyj, and Cameron Lindsey.  All of these faculty are well-known nationally for leading our students, but we are particularly pleased that Dr. Valerie Ruehter received the APhA-ASP Outstanding Chapter Advisor Award—the top advisor in the country!

    Other National Student Awards.  Our students received many other national awards.  Marian Lyford (Class of 2018) was recognized by the United States Public Health Service with the 2018 Excellence in Public Health Pharmacy Award.  Also, Dion Tyler (Class of 2018) and his interprofessional team of health care student finished 3rd at the annual CLARION National Competition at the University of Minnesota.

    Faculty and Staff Focus on Student Success!  While we are absolutely elated that our students rake in all the national awards, the truth is their greatest accomplishment is graduation.  For that ultimate measure of student success, we are forever grateful for the hard work and dedication of our staff and faculty.  We are also proud of our student success numbers where 94.4 % of the students who entered our program in 2014 graduated on time in 2018.  While we do not yet have NAPLEX pass rates from them, we do know that for 2017 graduates—97.5 % of whom graduated on time—92% passed the NAPLEX on first sitting.

    Faculty Accolades.  Many of our faculty have received substantial accolades in the last year, far too many to list all here.  Among our clinical faculty, some of the accomplishments included:  Dr. Andy Smith was named a Fellow of the American College of Clinical Pharmacy; Dr. Heather Taylor became a Board-Certified Pharmacotherapy Specialist; Dr. Heather Lyons-Burney was named MPA Faculty Member of the Year and received the Jefferson Award, a national program started by Jacqueline Kennedy in 1972 that honors everyday heroes in our community; Dr. Paul Gubbins published a book as Editor entitled Drug Interactions in Infectious Disease: Mechanisms and Models of Drug Interactions, 4th Ed.; Dr. Maureen Knell co-authored a publication in Pain Medicine this year that is receiving significant attention locally and nationally for understanding opioid prescribing patterns; Drs. Angela Brownfield, Paul Gubbins, and Valerie Ruehter received the Award for Excellence in Scholarship in Experiential Education from the American Association of Colleges of Pharmacy; and Dr. Kendall Guthrie was elected to serve on the Board of Directors of the MPA.

    There are many other great accomplishments of our students faculty in the past year.  If you can make time to come by and see us, we’d be happy to tell you all about it.  You are all welcome to visit the school anytime at our sites in Kansas City, Columbia, and/or Springfield.  We also appreciate your assistance in identifying any students who might be interested in pursuing pharmacy careers.  Just let us know, we love to talk to anyone about our great profession! 

    Best wishes to everyone in MSHP!

    Russell B. Melchert, Ph.D.
    Dean of Pharmacy and Professor


  • 23 Jul 2018 10:39 AM | MSHP Office (Administrator)

    UMKC School of Pharmacy - SSHP

    Authors:  Anna Parker and Jordyn Williams, UMKC SSHP Chapter Presidents

    The spring and summer semesters at the UMKC School of Pharmacy are a little more relaxed than our fall semester. In February, our Columbia campus teamed up with MMSHP and the Ronald McDonald House to prepare meals for patients and families receiving care at the Women and Children's Hospital. It was a great time serving the local community through the event.  The Columbia campus also participated in a pull tab collection competition with local hospitals to raise money for the Ronald McDonald House.  All together, they were able to collect over 30 pounds of pull tabs.  Aside from that, we held our monthly general meetings during the spring semester with visiting speakers to share their experiences working as health-system pharmacists. Dr. Rachel Howland from Truman Medical Center visited during one of our last meetings and presented a very unique patient case. All of the attendees enjoyed hearing how Dr. Howland handled the case with her healthcare team and was able to provide appropriate pharmacological care.  The meeting and case presentation helped show students the vital role a clinical pharmacist can play in patient care.

    This summer the SSHP executive team is busy gearing up for our main events that happen in the fall semester. Residency program directors should be on the lookout for their invitation to attend Residency Roundtable, which will take place on September 29th at each UMKC campus. Our Clinical Skills Competition and membership drive will also be taking place this coming fall.

    The Kansas City campus would like to extend a warm welcome to Dr. Jeremy Hampton, who will be serving as our new advisor this year. We would also like to thank Dr. Tatum Mead and Dr. Stephanie Schauner for their time serving as advisors in Kansas City. We are thankful for your involvement with SSHP and wish you the best! All three campuses are excited to start the new school year in August and are ready to see our chapter grow, serve, and learn.


  • 17 Jul 2018 12:35 PM | Anonymous

    Pharmacogenomics in Pain Management

    Author: Lance Schneider, PharmD, PGY2 Internal Medicine Pharmacy Resident, University of Missouri Health Care, Columbia, MO

    Preceptor: Ryan Camden, PharmD, BCPS, PGY2 Internal Medicine Residency Program Director, University of Missouri Health Care, Columbia, MO

    Program Number: 2018-07-16

    Approval Dates: August 1, 2018 - November 1, 2018

    Approved Contact Hours: One (1) CE(s) per LIVE session.


    Learning Objectives:

    1. Describe what pharmacogenomics is and how it relates to medication therapy management.

    2. Review the Centers for Disease Control and Prevention guideline for prescribing opioids for chronic pain.

    3. Discuss current pharmacogenomic dosing guidelines.

    4. Evaluate current literature regarding utilization of pharmacogenomics for opioid prescribing.


    Introduction

    Conventional clinical use of drug therapy is based primarily on a ‘one size fits all’ model, meaning medications are utilized and prescribed based off of population outcomes from clinical trials. Pharmacogenomics is the study of how personal genetic traits affect an individual’s response to drug therapy. Clinically, this is the direction medicine is heading and can have a huge impact on patient care. By testing a patient’s DNA for certain genetic variations and combining that information with available medication databases clinicians can personalize a medication regimen to maximize efficacy and safety. For example, approximately 20-40% of the population will have a suboptimal response to clopidogrel due to variations in the CYP2C19 gene.1 Knowing a patient has this variation prior to medication initiation would allow physicians to start an alternative and more efficacious antiplatelet agent. Currently, utilization of pharmacogenomics for patient specific medication regimens is not widespread. Antimicrobials, chemotherapy, and psychotropics are the drug classes with the most pharmacogenomic information available. Opioids have not been in the forefront of pharmacogenomic testing, however, with the recent Centers for Disease Control and Prevention (CDC) campaign to help control the prescription opioid epidemic pharmacogenomics could play an important role in pain management.

    CDC Guideline for Prescribing Opioids for Chronic Pain

    In response to the quintupling of opioid prescriptions in the U.S. from 1999 to 2016 the CDC has developed a campaign to help combat misuse and overprescribing of opioids. Not coincidentally, prescription opioid overdose deaths during this time-frame similarly increased without an overall change in the amount of pain reported.2 More than 40% of all U.S. opioid overdose deaths in 2016 involved a prescription opioid with more than 46 people dying every day from overdoses involving prescription opioids.3 The CDC sought out to improve opioid prescribing safety and efficacy through the development of clinical practice guidelines. These guidelines, which can be found online at https://www.cdc.gov/drugoverdose/pdf/Guidelines_Factsheet-a.pdf, provide twelve recommendations for health-care providers. These recommendations are broken into three separate sections: determining when to initiate or continue opioids for chronic pain, opioid selection, dosage, duration, follow-up, and discontinuation, and assessing risk and addressing harms of opioid use.4 As pharmacogenomics is still a relatively new field with a limited amount of data, especially regarding opioids, the CDC has yet to implement any recommendations regarding pharmacogenetic testing for opioid utilization.

    What is Pharmacogenomics?

    Pharmacogenomics is the study of how a person’s genetic makeup (-genomics) can affect their response to a drug (pharmaco-), leading to variations in efficacy and adverse drug effects.5 The idea of pharmacogenomics is far from new, with documentation of landmark discoveries dated from at least the 1950s. However, the rate of new discoveries has significantly increased since the completion and publication of the Human Genome Project (HGP) in 2003.6 The HGP was a collaborative research program with the goal to complete the mapping and understanding of all the genes of human beings. It has truly carved a new path into the future of medicine, giving insights that will help to treat, cure and prevent diseases.7

    There are approximately 20,500 genes that make up the human genome. Everyone has two copies of each gene, one inherited from each parent, which are the codes that direct cells how to make proteins. Variations in this genetic code through various mechanisms such as single nucleotide polymorphisms (SNPs), copy number variations (CNVs), insertions, or deletions can lead to differences in response to a medication. Alterations in safety and efficacy arise when these genetic variations occur in genes that code for proteins that effect the pharmacokinetics of medications – absorption, distribution, metabolism, and excretion.1

    Pharmacogenomic Dosing Guidelines

    The lack of clinical prescribing information regarding pharmacogenomics is a primary contributor to the hesitancy of utilization by health-care providers. For example, the U.S. Food and Drug Administration (FDA) has put out a reference of pharmacogenomic biomarkers in drug labeling with over 100 different medications, but only some of them have actionable recommendations based on the biomarker information. One of the best, and most complete references is PharmGKB. PharmGKB is a National Institute of Health (NIH) funded resource that provides information about how human genetic variation affects response to medications. It incorporates multiple dosing guidelines from various professional societies including the Clinical Pharmacogenetics Implementation Consortium (CPIC), the Royal Dutch Association for the Advancement of Pharmacy – Pharmacogenetics Working Group (DPWG), and the Canadian Pharmacogenomics Network for Drug Safety (CPNDS). Drug label information and primary literature are also included to provide genotype-specific dosing recommendations. 1

    Opioids with Pharmacogenomic Information

    Pharmacogenomic information is scarce regarding opioids and most data come from case control studies and case reports. Codeine and tramadol are the only two opioid medications with pharmacogenomic biomarkers in the drug labeling. The pharmacogenomic information on these medications are in relation to CYP2D6.8 CPY2D6 is an enzyme within the cytochrome P450 (CYPs) superfamily of microsomal drug-metabolizing enzymes. CYPs possess many physiological functions including synthesis of steroid hormones, cholesterol and other fatty acids, and bile acids, and metabolism of exogenous and endogenous substances including drugs and toxins.9 There have been 57 cytochrome P450 genes identified in humans with a small number appearing to contribute to the metabolism of drugs, mainly CYP1, CYP2, and CYP3 families.10 Each CYP gene is given a number associated with a specific group within the gene family, a letter representing the gene’s subfamily, and a number assigned to the specific gene within the subfamily. Therefore, CYP2D6 is the cytochrome P450 gene in group 2, subfamily D, and gene 6.9

    Codeine is metabolized by CYP2D6 into morphine, a much more potent opioid. An individual carrying a normal CYP2D6 genotype, also known as an extensive metabolizer (77-92% of patients), will have normal morphine formation and thus the label recommendations for dosing may be followed. Genetic polymorphisms of the CYP2D6 gene result in clinically significant phenotypes: ultra-rapid metabolizer (1-2% of patients), intermediate metabolizer (2-11% of patients), and poor metabolizer (5-10% of patients). Poor metabolizers will lack efficacy while ultra-rapid metabolizers are at a higher risk of toxicity due to the increased formation of morphine following codeine administration. The FDA Label has been updated to include the safety concerns related to ultra-rapid metabolizers; respiratory depression, extreme sleepiness, and confusion. Additionally, death has occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism. Lastly, ultra-rapid metabolizing women who are breastfeeding will have higher than expected serum morphine levels leading to potentially high levels within the breastmilk. For these reasons, codeine is not recommended in ultra-rapid metabolizers. 1,8

    Tramadol, similar to codeine, is metabolized by CYP2D6 into a more potent active metabolite, O-desmethyltramadol (M1). Tramadol has the same considerations as codeine in regards to the different genotypes. In addition to ultra-rapid metabolizers, tramadol has FDA labeling information regarding poor metabolizers. A phase 1 pharmacokinetic study in healthy subject poor metabolizers revealed an approximately 20% higher serum concentration of tramadol with a 40% lower serum concentration of M1. An important consideration for both tramadol and codeine is drug-drug interactions with CYP2D6 inhibitors such as fluoxetine. With the known alterations from varying genotypes safety and efficacy of these opioids could be affected greatly with the concomitant use of CYP2D6 inhibitors, even in extensive metabolizers. 1,8

    Opioid Pharmacogenomics in Cancer Patients

    Opioid analgesics are widely used for the treatment of chronic pain in patients with cancer. Efficacy and safety of these opioids vary widely between patients, and despite their utilization a significant number of patients still experience moderate to severe pain.11 These factors contribute to cancer patients being an optimal population for opioid pharmacogenomic research.

    Andreassen et al. identified CYP2D6 polymorphisms in patients being treated with oxycodone for cancer pain to evaluate an association between observed pharmacokinetic alterations and the pharmacodynamic response. CYP2D6 is responsible for metabolizing approximately 11% of the parent compound oxycodone into the more potent oxymorphone.12 The study included 27 poor metabolizers (PM), 413 extensive metabolizers (EM), and 10 ultra-rapid metabolizers (URM). PM patients had a statistically significant lower serum concentration oxymorphone to oxycodone ratio than EM and URM (0.0028, 0.0172, and 0.244; p = <0.05). This pharmacokinetic difference did not correlate with pharmacodynamic outcomes. The median pain intensity was 4 on the numerical rating scale for PM and URM, and 3 for EM with a non-significant difference between groups (p = 0.8). Differences in pain intensity (p = 0.7), nausea (p = 0.6), and cognitive function (p = 0.8) were also non-significant.13

    In 2015, Bell et al. performed a clinical review of current pharmacogenomic studies in patients with cancer pain. This review focused on the four most studied pharmacogenomic markers in opioid therapy. Adenosine triphosphate-binding cassette, sub-family B, member 1 (ABCB1), also known as P-glycoprotein, is a transporter that facilitates absorption, distribution, and elimination of opioids within the body including transport across the blood-brain barrier. CYPs, as previously described, are responsible for the metabolism of medications. Specifically, CYP3A4 plays an important role in methadone, oxycodone, hydrocodone, and fentanyl, while CYP2D6 influences codeine, hydrocodone, oxycodone, and tramadol. Another enzyme involved in metabolism is the catechol-O-methyltransferase (COMT) enzyme responsible for metabolizing catecholamines, which play an integral role in pain modulation. Lastly, the µ-opioid receptor gene (OPRM1) is the primary binding site for endogenous opioid peptides and opioid analgesics, thus making it a good target to evaluate for genetic variations and opioid response. The summary of select genetic variants within these targets associated with response in cancer pain have varying outcomes (Table12). Several studies included in the review indicated certain polymorphisms, such as OPRM1 A118G, require statistically different opioid dosages, while other studies looking at the same polymorphism demonstrated no difference. This lack of reproducibility is one of the major flaws associated with opioid genetic research. 12

    In the largest study to date in this population, Klepstad et al. set out to validate previously tested SNPs associated with cancer pain and opioid efficacy, such as OPRM1 A118G. This was a 17 center study in 11 European countries in adult patients who were using an opioid for moderate to severe pain (step III at the World Health Organization [WHO] treatment ladder for cancer pain). Of the 2201 patients included in analysis, the primary opioids were morphine (n = 827), oxycodone (n = 445), fentanyl (n = 695), or other opioids (n = 234). The median opioid dose per patient was 180 mg morphine equivalence/24 hours. One-hundred and twelve SNPs from 25 genes were tested with none showing a statistically significant association with opioid dose requirements. 11

    Conclusions

    Utilization of pharmacogenomics has grown substantially in recent years and will continue to develop as additional information becomes available in the near future. Improvement in clinical outcomes utilizing patient specific medication therapies through pharmacogenomics is promising and is already being observed in several fields such as infectious diseases, oncology, and psychiatry. Utilization of pharmacogenetic testing for opioid prescribing in pain management is not routinely recommended due to limited evidence demonstrating disparate results. Further research is needed to elucidate the clinical relevance and cost-effectiveness of pharmacogenetic testing for opioid therapy.

    Click here to Submit for CE Credit

    References

    1. M. Whirl-Carrillo, E.M. McDonagh, J. M. Hebert, L. Gong, K. Sangkuhl, C.F. Thorn, R.B. Altman and T.E. Klein. "Pharmacogenomics Knowledge for Personalized Medicine" Clinical Pharmacology & Therapeutics (2012) 92(4): 414-417.

    2. Centers for Disease Control and Prevention. Opioid Overdose: Prescribing Data. https://www.cdc.gov/drugoverdose/data/prescribing.html. Accessed May 22, 2018.

    3. Centers for Disease Control and Prevention. Opioid Overdose: Prescription Opioid Overdose Data. https://www.cdc.gov/drugoverdose/data/overdose.html. Accessed May 22, 2018.

    4. Centers for Disease Control and Prevention. Opioid Overdose: CDC Guideline for Prescribing Opioids for Chronic Pain. https://www.cdc.gov/drugoverdose/prescribing/guideline.html. Accessed May 22, 2018.

    5. U.S. Food and Drug Administration. Pharmacogenomics: Overview of the Genomics and Targeted Therapy Group. https://www.fda.gov/Drugs/ScienceResearch/ucm572617.htm. Accessed May 23, 2018.

    6. Felcone LH. Pharmacogenomics: Where Will It Take Us? Biotechnology Healthcare. 2004;1(3):18-28.

    7. An Overview of the Human Genome Project. National Human Genome Research Institute (NHGRI). https://www.genome.gov/12011238/an-overview-of-the-human-genome-project/. Accessed May 23, 2018.

    8. Center for Drug Evaluation and Research. Science & Research (Drugs) - Table of Pharmacogenomic Biomarkers in Drug Labeling. U S Food and Drug Administration Home Page. https://www.fda.gov/Drugs/ScienceResearch/ucm572698.htm. Accessed May 25, 2018.

    9. What is pharmacogenomics? - Genetics Home Reference. U.S. National Library of Medicine. https://ghr.nlm.nih.gov/primer/genomicresearch/pharmacogenomics. Accessed May 25, 2018.

    10. Wilkinson GR. Drug metabolism and variability among patients in drug response. N Engl J Med. 2005;352(21):2211–21.

    11. Klepstad P, Fladvad T, Skorpen F, et al. Influence from genetic variability on opioid use for cancer pain: A European genetic association study of 2294 cancer pain patients. Pain. 2011;152(5):1139-1145. doi:10.1016/j.pain.2011.01.040.

    12. Bell GC, Donovan KA, Mcleod HL. Clinical Implications of Opioid Pharmacogenomics in Patients with Cancer. Cancer Control. 2015;22(4):426-432. doi:10.1177/107327481502200408.

    13. Andreassen TN, Eftedal I, Klepstad P, et al. Do CYP2D6 genotypes reflect oxycodone requirements for cancer patients treated for cancer pain? A cross-sectional multicentre study. European Journal of Clinical Pharmacology. 2012;68(1):55-64. doi:10.1007/s00228-011-1093-5.

    Appendix 1:


    Bell GC, Donovan KA, Mcleod HL. Clinical Implications of Opioid Pharmacogenomics in Patients with Cancer. Cancer Control. 2015;22(4):426-432. doi:10.1177/107327481502200408.

  • 17 Jul 2018 12:25 PM | Anonymous

    Pharmacists’ Role in Pain Management and Combatting the Opioid Epidemic

    Authors: Samantha Breckenridge, Pharm.D. Candidate 2019, UMKC School of Pharmacy

    Bradley Erich, Pharm.D. Candidate 2019, UMKC School of Pharmacy

    Maureen Knell, Pharm.D., BCACP, UMKC School of Pharmacy

    Turn on your television or scroll through the internet, it won’t take long to see headlines related to the “opioid epidemic” or “opioid addiction”. Take a step further, a google search of “opioid” suggests topics such as crisis, abuse, and dependence, to note a few. Behind the media stir lies a deeply rooted issue that requires intervention from many angles. Since 1999, the number of opioid prescriptions in the United States has quadrupled.1 While one may think this indicates better pain control, the amount of pain reported by Americans has remained the same. In that same time frame, 165,000 deaths have been attributed to prescription opioid overdose alone.1

    There are many Americans dealing with severe pain due to various causes, each deserving of safe and adequate pain relief. Opioid painkillers are known to be effective in the acute treatment of severe pain, but there is little to no evidence to support their long-term usage.1 With an increased duration of exposure to these medications comes an increased risk of dependence and addiction.1 The Centers for Disease Control and Prevention evaluated data from roughly 1.3 million patients who underwent or are currently undergoing opioid therapy. Patients were more likely to continue opioid pain reliever therapy when the first, acute prescription exceeded 10 or 30 days.2 The Centers for Disease Control and Prevention guidelines advocate that sufficient pain relief in an acute setting is often achieved with a three-day supply of an opioid prescription and that patients rarely require more than seven days.1 Having extra, unused opioid pills not only leads to an increased risk that the patient will consume more than needed, but it also leads to the risk of friends and/or family having access to a prescription not intended for them. In 2013 and 2014, there were 10.7 million people aged 12 or older who misused prescription painkillers. Of those, 50.5% reported having obtained the medications through a friend or family member for free.3

    Increasing awareness of the opioid epidemic has led to speculation on who is to blame and demands for a quick fix to the problem. However, this is a nationwide issue that will require thoughtful problem-solving by various entities working together to enhance future safety while providing adequate pain management. As of April 2018, twenty-eight states have enacted legislation regarding opioid limits, requirements, or guidance.4 Prescription health plans around the country are also implementing similar quantity limits. The Food & Drug Administration (FDA) is encouraging the drug industry to develop abuse-deterrent opioid dosage forms.5 Lastly, the Drug Enforcement Administration (DEA) is decreasing Annual Production Quotas (APQs) of opioids by 20% to be made in 2018.6

    Although there are multiple efforts being made to curb opioid abuse via various mechanisms, these efforts are not without flaws. For instance, many hospitals and health systems are experiencing critical shortages in injectable opioids which may effectively delay patient care and leave patients in pain before action can be taken. According to the American Society of Health Systems Pharmacists (ASHP)7, intermittent shortages of specific injectable opioid products may lead to substitution with other more readily available products. Unfortunately, opioids are not all interchangeable, making improper conversions and substitutions possible, which may lead to risking patient safety. While opioid side effect profiles remain similar, there may be differences between medications. Therefore, patient monitoring is of paramount importance during this conversion to avoid severe side effects such as respiratory depression.

    Another challenge for patients, pharmacists, and other members of the healthcare team is quantity limits and formulary restrictions that may force providers to change a patient’s well controlled chronic pain regimen. During this transition, the patient could suffer from opioid withdrawal from chronic therapy, in addition to poor pain control.

    The aforementioned concerns and considerations that have arisen throughout the opioid epidemic raise the question: What can healthcare professionals such as pharmacists do about it?

    In terms of injectable opioids, ASHP makes recommendations for pharmacists in order to help mitigate this impact. These steps include switching therapy to a clinically appropriate oral or enteric opioid formulations, whenever possible; Engage the institution’s experts on pain and palliative care to further develop guidance and formulate strategies for dealing with intermittent shortages; And ensure relevant institutional pain medication guidelines are up to date, to name a few.7 Additionally, there are programs such as ASHP’s Pain Management Certificate program that equip pharmacists with the skills to provide appropriate and effective pain management for patients suffering from chronic pain. Programs like these provide pharmacists with proficiency in pain management including treatment with non-opioids that can ensure proper pain control while reducing the risk for inappropriate use of opioids.12

    Pharmacists in the community and ambulatory care setting have a unique opportunity to work with prescribers and patients to assess opioid pain management. They can provide education for appropriate use, assess for dangerous use, and offer innovative options such as tapering opioid plans and finding the lowest effective opioid dose when quantity limits or access to opioids becomes an issue. In these settings, pharmacists can also make an impact by showing empathy to patients who have relied on opioids for a long time for pain management and are not aware of other options that can help control their pain safely and effectively. Through advanced knowledge about pain control learned in schooling, residencies, and unique opportunities like ASHP’s Pain Management Certificate program, pharmacists in these settings are also able to offer alternatives to opioids such as non-opioid pharmacologic agents and non-pharmacologic therapies to help in controlling chronic or acute pain.

    Pharmacists also play an integral role in pain management through transitions of care. Some of these roles include medication reconciliation, drug monitoring and assessment during hospitalizations, patient and healthcare provider education, discharge counseling, post-discharge follow-up and counseling. These roles in transitions of care can help in potentially minimizing medication errors while ensuring safe, appropriate, and effective use of medications throughout the patient care continuum.8

    Additionally, pharmacists in Missouri are able to dispense naloxone, a competitive opioid antagonist, to patients who are eligible through screening. This Missouri law authorizes pharmacists to dispense nasal or intramuscular naloxone without a prescription by standing order issued by the Missouri Department of Health and Senior Services or by protocol with a physician.9 The law offers pharmacists a unique role in screening eligible patients for potential naloxone use, education regarding the risk factors for overdose, signs and symptom of overdose, overdose response steps, and the administration of naloxone.9 Naloxone is also fully or partially covered by many insurances including Medicare, Medicaid, and commercial insurance carriers.13,14

    Missouri pharmacies may now voluntarily collect medications from the public for destruction that are in compliance with CSR 2220-2.095. While this law does not apply to controlled substances (e.g. opioids), it is a step in the right direction for disposal of medications after they are expired or no longer needed to avoid diversion. Pharmacists may also provide patients with information on disposal of opioids through rxdrugbox.org or medreturn.com, which offer locations such as community pharmacies and law enforcement agencies to dispose of their medications (including controlled substances) safely. The United States FDA also provides guidance on disposal of medications, as there can be misconceptions about the disposal of various formulations and types of medications.15 There are also multiple innovative ways to dispose of controlled substances that do not have to be flushed or thrown away in other household garbage. In early 2018, Wal-Mart began using a technology called DisposeRx that they dispense with opioid prescriptions. According to the manufacturer, when this powder is poured into a prescription bottle with warm water, it ultimately enables patients to dispose of leftover medications in their other household garbage.10 Mallinckrodt Pharmaceuticals provides medication disposal pouches that contain active carbon that inactivates any medication when mixed with water. Mallinckrodt provides a complimentary six pouches to patients who request through their website, in addition to providing pouches to local health departments and other community outreach programs.11

    While there is no single way that pharmacists, patients, and other healthcare professionals can tackle the opioid epidemic, there are multiple ways that all who are involved can take action. Pharmacists play an integral role in educating patients and communicating with other healthcare professionals on the proper use of opioids and other pain medications, in addition to ensuring appropriate medication use. Patients also have opportunities to take action, from properly disposing their unneeded/unused medications, to storing their medications safely and securely in a locked medication box or other storage area where they cannot be diverted or accidentally ingested by children. Patients also have the opportunity to carry naloxone for a family member or friend who may need it in the case of an overdose emergency. Collectively, these actions can aid in decreasing the inappropriate use of opioids while still ensuring adequate pain control for patients.

    References:

    1. Factsheet CDC Guideline for Prescribing Opioids for Chronic Pain. Centers for Disease Control and Prevention website. www.cdc.gov/drugoverdose/pdf/guidelines_at-a-glance-a.pdf Updated August 29, 2017. Accessed June 10, 2018.

    2. Shah A, Hayes CJ, Martin BC. Characteristics of initial prescription episodes and likelihood of long-term opioid use — United States, 2006–2015. MMWR Morb Mortal Wkly Rep 2017; 66: 265–269. DOI: http://dx.doi.org/10.15585/mmwr.mm6610a1

    3. Lipari RN, Hughes A. How people obtain the prescription pain relievers they misuse. The CBHSQ Report. 2017. URL: www.samhsa.gov/data/sites/default/files/report_2686/ShortReport-2686.html

    4. Prescribing Policies: States Confront Opioid Overdose Epidemic. National Conference of State Legislatures website. http://www.ncsl.org/research/health/prescribing-policies-states-confront-opioid-overdose-epidemic.aspx Published April 5, 2018. Accessed June 11, 2018.

    5. Abuse-Deterrent Opioid Analgesics. U.S. Food & Drug Administration website. https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm600788.htm Updated April 23, 2018. Accessed June 11, 2018.

    6. Quotas - 2017. DEA Diversion Control Division. https://www.deadiversion.usdoj.gov/fed_regs/quotas/2017/fr1108.htm. Published November 8, 2017. Accessed June 11, 2018.

    7. Injectable Opioid Shortage FAQ. ASHP. 2018. https://www.ashp.org/Drug-Shortages/Shortage-Resources/Injectable-Opioid-Shortages-FAQ. Accessed June 11, 2018.

    8. Sourial M. The Pharmacist's Role in Pain Management During Transitions of Care. U.S. Pharmacist – The Leading Journal in Pharmacy. https://www.uspharmacist.com/article/the-pharmacists-role-in-pain-management-during-transitions-of-care. Published August 18, 2017. Accessed June 11, 2018.

    9. Board of Pharmacy. Missouri Department of Agency. https://www.pr.mo.gov/pharmacists-naloxone.asp. Accessed June 11, 2018.

    10. Solving the Problems of Drug Disposal. DisposeRx™. https://disposerx.com/. Accessed June 11, 2018.

    11. Safe Medication Disposal. Inclusion and Diversity at Mallinckrodt Pharmaceuticals. http://www.mallinckrodt.com/corporate-responsibility/safe-drug-disposal. Accessed June 11, 2018.

    12. New ASHP Certificate Program Offers Advanced Training in Pain Management. ASHP. March 2018. https://www.ashp.org/news/2018/03/16/new-ashp-certificate-program-offers-advanced-training-in-pain-management. Accessed June 11, 2018.

    13. NARCAN® NASAL SPRAY AFFORDABILITY. NARCAN®(naloxone HCl) Nasal Spray. https://www.narcan.com/affordability. Accessed June 20, 2018.

    14. EVZIO2YOU. EVZIO®. https://www.evzio.com/patient/evzio2you/. Accessed June 20, 2018.

    15. Center for Drug Evaluation and Research. Safe Disposal of Medicines - Disposal of Unused Medicines: What You Should Know. US Food and Drug Administration Home Page. https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm. Accessed June 21, 2018.


  • 17 Jul 2018 12:15 PM | Anonymous

    Medication Saving Behaviors in Older Adults: Identifying and Managing a Barrier to Effective Healthcare

    Authors: Kristin Hegna, PharmD, St. Louis College of Pharmacy, Resident at UnityPoint – Meriter

    Melanie VanDyke, PhD, St. Louis College of Pharmacy, Associate Professor and Licensed Psychologist

    Medication hoarding in older adults is a barrier to effective healthcare that is difficult to define, identify, and manage. The DSM-5 classifies hoarding disorder as a problem with discarding possessions (regardless of their value) because of feeling the need to save things and experiencing distress about their disposal. Hoarding disorder is further characterized by clutter that interferes with the use of living space and clinically significant distress or functional impairment.1 Excessive clutter may create an unsafe living environment and pose both tripping and fire hazards. Medication hoarding differs somewhat from generalized hoarding behavior: medications have inherent value, and medication hoarding may not substantially contribute to household clutter. However, the accumulation of unused or expired medications in the home carries the additional risk of accidental (or intentional) medication misuse and diversion.2 

    In order to identify and manage medication hoarding, healthcare providers have a new tool: the Medication Saving Behaviors (MSB) scale. The 6-item MSB scale was developed and validated with a population of women who manage medications for their older family members.3 Key components of MSB include distress in acquiring, storing, and discarding medications; avoidance of medication disposal; and difficulties with medication management due to the quantity of medications in the home. Of note, this accumulation of medication may impact both the patient and their family.

    Identifying MSB in the Health-System Setting

    The ability to identify problematic medication accumulation is challenging in the inpatient setting, where medications are handled by hospital staff and providers may not have knowledge of the patient’s household supply of medication. However, medication reconciliation serves as an opportunity to identify at-risk patients. In line with the 2017 Joint Commission’s National Patient Safety Goals, medication reconciliation is critical in identifying and resolving discrepancies in medication use.4 Ideally, providers should contact their patients and the family members involved in patient care. This communication provides insight into the difficulties associated with medication management, including the acquisition, storage, and disposal of drugs.

    In addition, a Brown Bag Review of a patient’s supply of medications provides an important safety check. A potential “red flag” for identifying MSB is the presence of expired and leftover (no longer prescribed) medications, as MSB are correlated with the quantity of expired and leftover medications in community dwelling older adults. However, the number of prescribed medications is not associated with MSB,3 so a patient should not be identified as at-risk for medication hoarding based solely on having more medications prescribed.  Therefore, a thorough review of all of the medications in the patient’s home is recommended to assess the risks of MSB.

    Clinical Implications of MSB

    Older adults are at a higher risk of adverse events due to increased use of medications, and older adults with hoarding disorder report a greater number of chronic medical conditions and a higher risk of falls.5 Since MSB are significantly related to generalized hoarding behaviors,6 the potential for exposure to unsafe medications is particularly relevant in older adults with hoarding disorder.  Therefore, healthcare providers may consider asking patients with a history of hoarding behaviors about their current MSB. 

    Additionally, MSB are significantly correlated with medication adherence problems.6 The Adherence to Refills and Medications Scale (ARMS) is an important tool for patients with chronic diseases states and low literacy levels.  For instance, research using the ARMS demonstrates that patients with coronary heart disease who have better medication adherence show significantly better blood pressure control over patients who are less adherent. 7 Medication nonadherence is a known barrier to effective healthcare, resulting in higher rates of morbidity, mortality, and an estimated annual cost of $100-$300 billion USD.8 Due to the relationship between MSB and medication adherence problems, medication hoarding may worsen health outcomes and increase healthcare costs.

    Management of MSB in the Health-System Setting

    Just as it is difficult to identify MSB during an inpatient visit, the management of MSB within the health-system setting is likely to be challenging. Hoarding and other chronic conditions require long-term follow-up after hospitalization. When a patient identifies hoarding behaviors, a health-system pharmacist may ask follow-up questions about medication storage and adherence. During transitions of care, it may be helpful to counsel all patients who are prescribed risky medications, such as opioids, about safe storage and disposal practices.  This communication is not consistently practiced: a study of more than 1000 adults with recent opioid medication use  found that just over half of the patients recalled receiving information on safe storage (51%) or proper disposal (55%), with pharmacists being the medical professional most likely to address these issues.9

    In addition to direct patient care, a health-system pharmacist may provide additional services to support family caregivers, particularly when frequent medication changes are made. Medication regimens that were adjusted four or more times in the previous year were significantly related to decreased adherence.10 Another factor related to MSB and poor adherence is caregiver self-efficacy. Caregivers who are less confident in their ability to handle medication-related hassles reported more MSB, worse medication adherence, and more medication-related hassles.6 Pharmacists have the opportunity to reduce caregiver burden by providing thorough discharge counseling, clear medication instructions, safe storage and disposal information, and positive feedback to caregivers about specific strategies they use successfully. By supporting family caregivers, pharmacists may ultimately reduce MSB and improve health outcomes. 

    Further research is required to create a standardized approach for identifying and managing patients with MSB.  By recognizing the risk factors of MSB, providers can target at-risk patients and their families for appropriate interventions. Healthcare providers may improve medication adherence and reduce the risk of medication misuse and diversion by successfully addressing MSB.

    Pharmacists who are interested in discussing medication hoarding or want an updated version of the scale, please contact Melanie.VanDyke@stlcop.edu.

    References:

    1. American Psychiatric Association.  Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington, VA: American Psychiatric Association; 2013

    2. Disposal of unused medicines: What you should know. U.S. Food and Drug Administration website https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm. Updated June 13, 2018. Accessed June 26, 2018.

    3. VanDyke MM, Steffen A. Medication savings behaviors of older adults: Scale developed to assess family caregiver perspectives. Clin Gerontol. 2017;40(4):258-267. doi: 10.1080/07317115.2016.1276114

    4. National patient safety goals effective January 2017: Hospital accreditation program. The Joint Commission website https://www.jointcommission.org/assets/1/6/NPSG_Chapter_HAP_Jan2017.pdf. Accessed June 26, 2018.

    5. Diefenbach GJ, DiMauro J, Frost R, et al. Characteristics of hoarding in older adults. Am J of Geriatr Psychiatry. 2013;21(10). doi: 10.1016/j.jagp.2013.01.028.

    6. VanDyke MM, Chow M, Dinh A, et al. Presentation: Medication hoarding: Women managing medications for older family members identify a hoarding-related risk factor. Poster presented at: Anxiety and Depression Association of America and St. Louis College of Pharmacy Student Research Symposium; 2018 Apr; Washington D.C. and St. Louis, Missouri.

    7. Kripalani S, Risser J, Gatti ME, et al. Development and evaluation of the Adherence to Refills and Medications Scale (ARMS) among low-literacy patients with chronic disease. Value Health. 2009;12(1):118-123. doi: 10.1111/j.1524-4733.2008.00400.x.

    8. Neiman AB, Ruppar T, Ho M, et al. CDC Grand Rounds: Improving Medication Adherence for Chronic Disease Management — Innovations and Opportunities. MMWR Morb Mortal Wkly Rep 2017;66. DOI: http://dx.doi.org/10.15585/mmwr.mm6645a2.

    9. Kennedy-Hendricks A, Gielen, A, McDonald E, et al. Medication Sharing, Storage, and Disposal Practices for Opioid Medications Among US Adults. JAMA Intern Med. 2016;176(7):1027-1028. doi:10.1001/jamainternmed.2016.2543.

    10. Choe E, VanDyke M, Griggs, et al. Presentation: Assessing potential caregiver strategies associated with improved medication adherence in a community-based sample of older adults.  Poster presented at: St. Louis College of Pharmacy Student Research Symposium; 2017 Apr; St. Louis, Missouri.

  • 17 Jul 2018 12:03 PM | Anonymous

    Saint Louis College of Pharmacy SSHP

    Author: Hubert Kusdono, St. Louis College of Pharmacy SSHP Chapter President

    Throughout the Spring Semester of the 2017-2018 academic year, the STLCOP SSHP chapter aimed to build upon and expand its initiatives with regards to community outreach and health-system service, professional development, and networking opportunities for its student members.

    To kick off its Community Outreach Initiative, STLCOP SSHP introduced a new fundraising event called Pants with a Purpose – an event which would eventually be an outstanding highlight in the chapter’s many successes throughout the semester. This fundraising event was publicized to STLCOP students and faculty, in which for every pair of sweatpants purchased, another pair would be donated to the St. Patrick’s Center for the Homeless. Other essential items and basic necessities were also donated to help improve the health of the less fortunate in the St. Louis community.  Through this community outreach event, the chapter was able to donate about $1800 in clothing and household needs. The Ronald McDonald House Community Outreach Event was another fundraising opportunity for STLCOP SSHP members, which was held in collaboration with SIUE SSHP. During this event, students volunteered their services to cook and prepare meals for patients’ families at the Ronald McDonald House. Blankets for Cancer Patients was another health-system service and volunteer opportunity for students to make tie-knot blankets for oncology patients in St. Mary’s Hospital. The Sweet Babies Volunteer event was an opportunity for students to volunteer at St. Mary’s Neonatal Intensive Care Unit, as well as take a tour of the facility. Cancer Care Packages was another well-received, recurring event where students were able to make cancer-care packages and hand-deliver them to patients at Siteman Cancer Center. This provided students, who haven’t already done so already, with the opportunity to tour Siteman’s outpatient infusion center and learn about oncology pharmacy from the pharmacists who worked there.

    As part of the Community Outreach Initiative, the STLCOP chapter held numerous health and vaccination clinics throughout the spring semester, where students were able to talk to patients regarding their medication adherence, diabetes, asthma, hypertension management, and vaccination history. These series of health clinics was a great opportunity for students, who were learning about how to administer blood pressure in some of their classes, to implement and enhance their skills by obtaining blood pressure from real patients in the community. Additionally, the chapter held a series of vaccination clinics and training sessions for students who wanted to practice administering vaccines. These clinics were held across various Shop N’ Save and Walgreens pharmacies throughout the greater St. Louis area, and students were given the opportunity to promote the importance of yearly flu shots and timely vaccinations, such as the Shingrix vaccine for Shingles. Students were thus able to implement what they had learned regarding how to administer vaccinations in a real-life setting, where they were able to interact with patients while doing so and impart their knowledge to the community.

    As part of the chapter’s spring semester initiatives for professional development, STLCOP SSHP held a Residency Preparation Program which included a CV Review event and Mock Interview.  Students were able to have their CV’s and resumes reviewed and critiqued by various faculty members. STLCOP SSHP believes that it is important for students to develop their CV’s and resumes early in their professional years, as it can only benefit them as they may apply to various jobs and internship opportunities throughout their years in pharmacy school. During the Mock Interview Practice Sessions, students were able to partake in a residency, fellowship, or job interview simulation conducted by various pharmacy practice faculty. This gave students the opportunity to sharpen their interviewing skills and know what kind of questions to expect in a potential residency interview. Faculty provided feedback to students and also answered questions regarding their potential career path into different pharmacy specialties.

    STLCOP SSHP also aimed to continue providing students with ample networking opportunities with practicing pharmacists. During the Practice Advancement Initiative (PAI) Week in February, the chapter expanded its yearly series of health-system panels by introducing a Residency Director's Roundtable for the first time. Students were able to network and connect with directors from residency programs and hospitals throughout the St. Louis area. This provided students with a unique opportunity to learn about what residency programs seek and expect from their candidates. The chapter also arranged a Clinical Roundtable networking event, where students were able to learn about the daily duties and roles of a clinical pharmacist, the impact that clinical pharmacists make in patient-centered care, and the different pharmacy specialties that students can pursue in pharmacy. The chapter also hosted several panels, seminars, and Lunch N’ Learns, where students were able to hear about interesting and important topics in healthcare such as hypertension management, skin cancer, and home infusion pharmacy.

    Overall, the STLCOP SSHP chapter was successful in introducing new events and expanding upon previously successful ones in light of its new initiatives for community outreach and service, professional development, and networking. The chapter hopes to build upon every aspect in its ultimate goal to introduce and prepare student pharmacists for the residency preparation process that lies ahead, and hopes that it can continue to serve as a resource for students who seek to develop their knowledge and skills as aspiring pharmacists.

    UMKC School of Pharmacy

    Authors:  Anna Parker and Jordyn Williams, UMKC SSHP Chapter Presidents

    The spring and summer semesters at the UMKC School of Pharmacy are a little more relaxed than our fall semester. In February, our Columbia campus teamed up with MMSHP and the Ronald McDonald House to prepare meals for patients and families receiving care at the Women and Children's Hospital. It was a great time serving the local community through the event.  The Columbia campus also participated in a pull tab collection competition with local hospitals to raise money for the Ronald McDonald House.  All together, they were able to collect over 30 pounds of pull tabs.  Aside from that, we held our monthly general meetings during the spring semester with visiting speakers to share their experiences working as health-system pharmacists. Dr. Rachel Howland from Truman Medical Center visited during one of our last meetings and presented a very unique patient case. All of the attendees enjoyed hearing how Dr. Howland handled the case with her healthcare team and was able to provide appropriate pharmacological care.  The meeting and case presentation helped show students the vital role a clinical pharmacist can play in patient care.

    This summer the SSHP executive team is busy gearing up for our main events that happen in the fall semester. Residency program directors should be on the lookout for their invitation to attend Residency Roundtable, which will take place on September 29th at each UMKC campus. Our Clinical Skills Competition and membership drive will also be taking place this coming fall.

    The Kansas City campus would like to extend a warm welcome to Dr. Jeremy Hampton, who will be serving as our new advisor this year. We would also like to thank Dr. Tatum Mead and Dr. Stephanie Schauner for their time serving as advisors in Kansas City. We are thankful for your involvement with SSHP and wish you the best! All three campuses are excited to start the new school year in August and are ready to see our chapter grow, serve, and learn.


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