Professional Practice

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Professional Practice

Information relevant to pharmacy practice such as expanded roles of pharmacists, advancements in pharmacy practice, professional resources to share with patients or enhance practice knowledge and more.

Update in the Management of Clostridium Difficile Infection

By Carly Burns, Pharm.D. candidate 2019 and Jamie George, Pharm.D. candidate 2019, Wayne State University Eugene Applebaum College of Pharmacy and Health Sciences, Detroit

Clostridium difficile infection (CDI) has become the leading cause of nosocomial infection in the United States. Treatment of CDI is costly, and unfortunately, incidence is projected to increase in both the inpatient and outpatient care settings.1,2

C. difficile is transmitted via the fecal-oral route or direct exposure, often by the hands of healthcare workers. In vulnerable individuals, the bacteria can produce two exotoxins (A and B) and cause colitis.2,3 Individuals most at risk of developing infection include those with recent or current antibiotic use, hospital exposure and age greater than 65.3 Prevention of CDI is routed in antibiotic stewardship and appropriate hand hygiene in healthcare personnel. Hand washing with soap and water is preferred over alcohol rubs, as alcohol fails to eliminate spores.2

The gold standard to diagnose CDI involves laboratory fecal testing. These steps should be considered in patients with new-onset diarrhea for whom there is no alternative cause.4 CDI is categorized by the severity of illness. Severe CDI is classified as the presence of leukocytosis (white blood cell count of >15,000 cells/mL) or a serum creatinine level of greater than 1.5 mg/dL (with non-severe CDI failing to meet these criteria). Fulminant CDI is the presence of shock/hypotension, ileus or toxic megacolon.4

Historically, metronidazole was utilized as first-line treatment for CDI due to lower costs and concerns of vancomycin-resistant organisms. However, metronidazole is no longer recommended as initial single-agent therapy in the recent 2017 Infectious Diseases Society of America (IDSA) guideline. This change in practice is based upon numerous trials published since the early 2000s where oral vancomycin was found to be superior to metronidazole in terms of clinical cure and diarrhea resolution.4 One trial conducted by Zar et al. found clinical cure was achieved in only 76 percent of patients receiving metronidazole compared to 97 percent in those receiving vancomycin. A pooled analysis demonstrated increased recurrence of CDI with metronidazole 30 days following treatment completion.5 Increased rates of metronidazole resistance may be in part responsible for these findings. An additional theory takes into consideration the pharmacokinetic profile of the two antibiotics.6 Vancomycin is minimally absorbed into systemic circulation following oral administration and maintains consistently high concentrations in the feces, compared to metronidazole which achieves low fecal concentrations.6

Table 1 delineates the key points of the new CDI treatment recommendations according to the updated IDSA guidelines. Development of new CDI treatments continues to gain considerable interest. Several strategies, including the development of a C. difficile vaccine, are currently undergoing clinical trials due to the increasing incidence of disease and emerging resistance to standard of care.7

Table 1. Treatment for CDI in adult patients4.

Classification

Treatment Recommendation

Strength of Recommendation/ Quality of Evidence

Initial Presentation

 


Non-severe and Severe CDI

Fulminant CDI

  • Vancomycin PO 125mg four times daily x 10 days 

OR

  • Fidaxomicin PO 200mg twice daily x 10 days
  • Vancomycin PO 500mg four times daily +/- Parenteral metronidazole

o Rectal administration for patients with ileus

Strong/High

 


Strong/High

Strong/Moderate

 

Weak/Low

Recurrent CDI

 

Determined by initial antibiotic used

  • Metronidazole initially: Retreat with vancomycin
  • Vancomycin initially:

o Tapered and pulsed regimen of Vancomycin 

OR

o Fidaxomicin

 

Weak/Low

 

Weak/Low

 


Weak/Moderate

Multiple Recurrent CDI

Same as recurrent CDI in addition to:

  • Vancomycin PO x 10 days followed by a 20-day course of rifaximin
  • Fidaxomicin
  • Fecal transplantation

 

Weak/Low

Weak/Low

Strong/Moderate

 

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. Centers for Disease Control and Prevention. Health Care Associated Infections. CDC website. https://www.cdc.gov/hai/organisms/cdiff/cdiff_clinicians.html. Updated Sept. 23, 2015. Accessed Aug. 12, 2018.
  3. Leffler DA, and Lamont JT. Clostridium difficile Infection. N Engl J Med. 2015; 372:1539-1548.
  4. 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 of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. 2018;66(7):e1–e48.
  5. Zar FA, Bakkanagari SR, Moorthi K, et al. A Comparison of Vancomycin and Metronidazole for the Treatment of Clostridium difficile–Associated Diarrhea, Stratified by Disease Severity. Clin Infect Dis. 2007;45(3):302-307.
  6. Chahine EB. The Rise and Fall of Metronidazole for Clostridium difficile Infection. Ann Pharmacother. 2018;52(6):600–602.
  7. Peng Z, Ling L, Stratton CW, et al. Advances in the diagnosis and treatment of Clostridium difficile infections. Emerg Microbes Infect. 2018;7(1):15.
Posted in: Professional Practice
Whole Health and Pharmacy Integration

By Carson Hutchinson, Pharm.D., and Samantha Edgar, Pharm.D., PGY1 pharmacy residents, Aleda E. Lutz VA Medical Center, Saginaw

Whole Health is an approach to healthcare that empowers and equips patients to take charge of their health and well-being and live their life to the fullest.1 It involves focusing on the person as a whole including their well-being, self-care, complementary therapies and medical care. All medical professionals should be involved in order to have a successful Whole Health implementation. This includes physicians, pharmacists, nurses, dietitians, mental health professionals, chaplains and any other team member, all working for the patient’s goals.3 Whole Health is a complete shift in culture at the Veteran Affairs.

 

Through Whole Health, patients are encouraged to become a more active partner in their healthcare plans and empower them to improve their health.1 Along with current health issues the patient is facing, the mission of Whole Health also includes preventative care to lower future disease risk and the focus is to increase longevity of high quality life. 

Patients are generally seen in the clinic only a few times a year for a limited amount of time at each visit. Due to this, it is imperative for patients to build and practice routine self-care skills between visits. In Whole Health, self-care skill areas include: working your body, surroundings, personal development, food and drink, recharge, family, friends and co-workers, spirit and soul and power of the mind.1 Patients are encouraged to start by focusing on two or three of these areas and then expand further.2 The Personal Health Plan (Figure 1) is a necessary tool within Whole Health and allows patients to map out their goals with their providers.2 It is personalized, proactive and patient driven, and it links self-care, professional care and community care.

Figure 1: Personal Health Plan (from the VHA Office of Patient Centered Care & Cultural Transformation)

Because Whole Health is a complete shift in culture at the Veteran Affairs, it is necessary to have all healthcare providers educated properly. Aleda E. Lutz Veterans Affairs Medical Center was selected to be a flagship facility for Whole Health integration. Initial intensive training involved select clinicians who became leaders and coaches for Whole Health. Thereafter, all employees received half-day trainings which continue at this time. Training objectives include gaining an understanding of the vision of Whole Health, enhancing resilience and innate healing, collaborating with veterans to find proactive opportunities that support a healing response, mindful awareness and changing the conversation clinicians have with veterans to be grounded with what matters to the Veteran in his/her life.1   

As an easily accessible healthcare professional, pharmacists can play a crucial role in aiding a patient through Whole Health. Medication counseling is an opportunity to teach patients the purpose, benefit and importance of their medications. This means going deeper than simply stating “this medication is for your heart,” but to actually explain its mechanism, expanding on other benefits this medication can provide and why certain side effects or drug interactions may occur. In turn, patients will have the knowledge to feel better equipped to take charge of their health, becoming more active participants in making their Personal Health Plan a reality.  

It takes all medical professionals to support Whole Health. Amongst these medical professionals, pharmacists are equipped for this culture change. Each patient and their journey toward Whole Health is different, and it is important to be able to aid these patients however necessary.

References:

  1. U.S. Department of Veteran Affairs. Whole Health: Information For Veterans. http://projects.hsl.wisc.edu/SERVICE/veteran-materials/new/WHItStartsWithMe_508.pdf.
  2. U.S. Department of Veteran Affairs. Passport to Whole Health. http://projects.hsl.wisc.edu/SERVICE/key-resources/Passport%20to%20WH,%203rd%20edition,%202018%20FINAL.pdf.
  3. U.S. Department of Veteran Affairs. VHA Whole Health: Personalized Health Planning Staff Guide. http://projects.hsl.wisc.edu/SERVICE/key-resources/VA%20Whole%20Health%20-%20Personalized%20Health%20Planning%20Staff%20Guide.pdf.
Posted in: Professional Practice
Stopping Bugs and Saving Drugs: Opportunities for Pharmacists - U.S. Antibiotics Awareness Week, Nov. 12-18, 2018

By Jaclyn Skradski, Pharm.D., MPH, clinical pharmacist, UP Health Systems, Marquette; Rachel MacLeod, Pharm.D., PGY2 infectious disease resident, Munson Medical Center, Traverse City and Elaine M. Bailey, Pharm.D., executive director, Michigan Antibiotic Resistance Reduction Coalition

“When I woke up just after dawn on Sept. 28, 1928, I certainly didn’t plan to revolutionize all medicine by discovering the world’s first antibiotic, or bacteria killer. But I suppose that was exactly what I did.” These are the words of Alexander Fleming, the Scottish scientist who first discovered penicillin. In the 90 years since that fateful discovery, many more antibiotics have come to market, and antimicrobial therapy has become a mainstay of modern medicine. However, these vital medications are threatened by antibiotic resistance, a growing public health threat that is in part driven by overuse and inappropriate prescribing. It has been estimated that at least 30 percent of antibiotic prescriptions in the outpatient setting are unnecessary; more recent data suggests this percentage may be even higher, especially for upper respiratory tract infections which are commonly viral in nature.1,2 In addition, it is thought that at least half of outpatient antibiotic prescriptions are suboptimal regarding drug selection, dosing or duration. Similarly, it is estimated that 30 percent of antibiotic use in hospitals is unnecessary or incorrectly prescribed, and use of broad-spectrum antibiotics, such as carbapenems and vancomycin, are on the rise. Ultimately, antibiotic resistance causes more than two million illnesses and over 23,000 deaths each year in the United States. and one in five emergency department visits for adverse drug reactions are due to antibiotics.3

The Centers for Disease Control and Prevention (CDC) has advocated for appropriate antibiotic use for many years. In September 2018, the CDC and partners launched the Antimicrobial Resistance (AMR) Challenge at the United Nations General Assembly, inviting healthcare organizations, pharmaceutical industries and governments worldwide to submit commitments to fighting antimicrobial resistance. Many organizations have already committed to improvements in infection prevention and antibiotic use, tracking and investment in therapeutic and diagnostic developments. The CDC recently launched a four-part, online continuing education (up to eight hours) series titled “CDC’s Antibiotic Stewardship Training Series.” The course reviews the emerging threats of antibiotic resistance and addresses how antimicrobial stewardship in a variety of settings (outpatient, dentistry, emergency departments, hospitals and nursing homes) is essential to fighting antibiotic resistance. The program and other free CE programs can be found on the CDC website at www.CDC.gov/antibiotic-use/community/for-hcp/continuing-education.html.

An important initiative sponsored by the CDC is an annual observance known as U.S. Antibiotic Awareness Week (formerly “Get Smart About Antibiotics Week”), which takes place Nov. 12 to 18. Antibiotic Awareness Week is a great time to promote appropriate prescribing in your practice setting, and the CDC’s website has several resources available for pharmacists looking to help curb inappropriate prescribing practices. Resources include multimedia educational tools for various patient populations, counseling strategies for patients that may be frustrated by not receiving an antibiotic prescription, stewardship program examples and more. Antibiotic awareness can be spread in a multitude of ways, whether directly at your site of work through setting up table clinics with educational information or at home via posting on a favorite social media site. Further ideas to celebrate the week can be found on the CDC website at www.CDC.gov/antibiotic-use/week/index.html.

The Michigan Antibiotic Resistance Reduction Coalition (MARR) is a non-profit organization that seeks to improve the use of antimicrobial agents in communities throughout the state of Michigan through the collaborative educational efforts of academic, government and community partners. One of the more recent initiatives of the MARR Coalition is addressing antibiotic stewardship in dentistry. Dentists are responsible for prescribing about 10 percent of all outpatient antibiotic prescriptions, equating to nearly 25 million prescriptions annually. Slow uptake of guidelines recommending less prophylactic antibiotic use, coupled with a lack of guidelines on managing specific dental infections, accounts for much of the inappropriate prescribing. Brochures were developed to target dental patient populations on the safe use of antibiotics. Provider commitment posters have also been developed for utilization in dental offices. These items, found on the MARR Coalition website at www.MI-MARR.org, make for perfect handouts and displays in dental offices and can be provided upon request.

A legacy MARR Coalition initiative is educational programming developed for the public. There are several school-aged children programs that are freely accessible for anyone to teach students of all ages the differences between bacteria and viruses, how to prevent infection, when treatment for illness is necessary and explanations of antibiotic resistance. Pharmacy students throughout Michigan have been instrumental in sharing the MARR Coalition programs and share that the experience helped them build their skill set as future educators and healthcare professionals.

Antibiotic awareness week is the perfect time to set up a MARR presentation in your community. Anyone can be a MARR ambassador, and it is a great way to volunteer and become involved in the community! All information can be accessed online at the MARR website.

Dr. Tom Frieden, the former director of the CDC, has said, “If we use antibiotics when not needed, we may not have them when they are most needed.” Take time during this Antibiotic Awareness Week to get involved in stopping bugs and saving drugs!

References:

  1. Fleming-Dutra KE, Hersh AL, Daniel J, Shapiro DJ, et al. JAMA. 2016;315(17):1864-1873.
  2. Palms DL, Hicks LA, Bartoces M, et al. Comparison of antibiotic prescribing in retail clinics, urgent care centers, emergency departments, and traditional ambulatory care settings in the United States. JAMA Intern Med. 2018;178(9):1267-1269.
  3. Geller AI, Lovegrove MC, Shehab N, et al. National Estimates of Emergency Department Visits for Antibiotic Adverse Events Among Adults-United States, 2011-2015. J Gen Intern Med. 2018;33(7):1060-1068.
Posted in: Professional Practice
What’s New with the Flu? Influenza Vaccine 2018-19 Update

By Lindsey Ghiringhelli, Pharm.D., BCGP, LTC consultant pharmacist, Pharmerica, Midland

Flu season is upon us again! To better protect against circulating flu viruses, the B/Victoria component and the influenza A (H3N2) were changed. This year’s recommended influenza vaccines include the inactivated quadrivalent influenza vaccine (IIV4) the inactivated trivalent (IIV3), the recombinant quadrivalent (RIV4) and the live-attenuated quadrivalent (LAIV4) nasal spray. The Centers for Disease Control and Prevention (CDC) recommends that everyone receive an influenza vaccine by the end of October.

Among the available trivalent vaccines are a high-dose product (Fluzone) with four times the amount of antigen and a vaccine with an adjuvant (Fluad), both available for patients over 65. The CDC estimates that 80 to 90 percent of flu-related deaths occur in patients aged 65 and over. The goal of these vaccines is to elicit a stronger immune response in the elderly population. The high dose vaccine has been associated with stronger immune response than the regular dose vaccine in the elderly, but the CDC indicates that studies are ongoing and is not recommending one vaccine over the over for elderly patients.

Though the CDC did not feel that the live-attenuated influenza vaccine (FluMist nasal spray) would be effective enough for use last year, it has made the cut for this flu season. It is approved for patients aged two to 49, but the American Academy of Pediatrics and American Academy of Family Physicians recommend reserving it for age-appropriate patients who refuse the injection. This vaccine is contraindicated in pregnancy, immunocompromised patients or those in close contact with immunocompromised patients, children aged two to four years with asthma, recent antiviral use (within 48 hours) or history of severe allergic reaction to any vaccine component. Please see the product labeling for additional precautions.

Patients with egg allergies are still recommended to receive the influenza flu vaccine. Patients who have developed only hives with egg exposure may receive any recommended vaccine. Those who report any other symptoms related to egg exposure, such as angioedema, respiratory distress, recurrent emesis, etc, should receive any appropriate vaccine under the supervision of a healthcare provider, in an inpatient or outpatient setting, who can recognize and manage severe allergic reaction. A prior severe allergic reaction to the influenza vaccine is a contraindication to future influenza vaccinations. There are two vaccines available which do not use any egg in their manufacturing processes, Flucelvax and Flublok, which can be offered to accommodate patient preference. Since the recombinant vaccine (Flublok) does not use any animal products, it may also be preferred for strict vegans.

Remind your patients, family and friends to vaccinate as soon as possible because it can take up to two weeks for antibodies to fully develop. Wash your hands frequently and stay home or wear a mask if you are sick. Though there are many different types of flu vaccines, the most important thing is that everyone over six months of age receives a flu vaccine every year. The vaccine protects you and everyone around you.

References

  1. Centers for Disease Control and Prevention. Influenza vaccines – United States, 2018-2019 influenza season. CDC website. https://www.cdc.gov/flu/protect/vaccine/vaccines.htm. Updated Sept. 5, 2018. Accessed Oct. 7, 2018.
  2. Centers for Disease Control and Prevention. Frequently Asked Flu Questions 2018-2019 Influenza Season. CDC website. https://www.cdc.gov/flu/about/season/flu-season-2018-2019.htm. Updated Aug. 30, 2018. Accessed Oct. 7, 2018.
  3. Centers for Disease Control and Prevention. Prevention and control of seasonal influenza with vaccines: recommendations of the advisory committee on immunization practices – United States, 2018-19 influenza season. CDC website. https://www.cdc.gov/mmwr/volumes/67/rr/rr6703a1.htm?s_cid=rr6703a1_w. Updated Aug. 24, 2018. Accessed Oct. 7, 2018.
  4. Pharmacist’s Letter. Flu Vaccines for 2018-2019. Therapeutics Research website. http://pharmacistsletter.therapeuticresearch.com/pl/ArticlePDF.aspx?cs=&s=PL&DocumentFileID=0&DetailID=341001&SegmentID=0 . October 2018.
Posted in: Professional Practice
New Drug Update: Toujeo Max SoloStar®

By Thy Mai, Pharm.D., pharmacy resident, SpartanNash, Grand Rapids


 

In October 2017, the Food and Drug Administration (FDA) approved Sanofi's Toujeo® (insulin glargine 300 units/mL) Max SoloStar®. This new pen is the highest capacity long-acting insulin pen currently available on the market. This new pen device option is available for patients who require more than 80 units per dose. With the ability to deliver a dose of up to 160 units/mL, the Toujeo Max Solostar® pen may help reduce the number of injections needed to deliver the required dosage for some adults with diabetes. Depicted in the chart below are the differences between the two Toujeo® pen options.

Toujeo Max SoloStar®

Toujeo SoloStar®

Dose adjusted by: 2 units

Dose adjusted by: 1 unit

Max dose: 160 units per injection

Max dose: 80 units per injection

Cartridge: 900 units

Cartridge: 450 units

3 mL and 900 units per pen

1.5 mL and 450 units per pen

1 box contains 2 pens (6 mL and 1800 units total) per box

1 box contains 3 pens (4.5 mL and 1350 units total) per box

 





The new Toujeo Max SoloStar® pen device still offers the same qualities as the Toujeo® pen such as:

  • Same pen size
  • 5-second hold time
  • 42-day shelf life
  • Lowest injection volume of any basal insulin

References:

1.      Toujeo Max Solostar® [package insert]. Bridgewater, NJ: Sanofi; 2018.

Posted in: Professional Practice
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