3D illustration of a clostridium difficile bacteria
David Bougher

David Bougher

Hospice Pharmacy Insights in November 2019

New this month: Updates to management of Clostridium Difficile, regulatory relief final rule: provisions to promote efficiency, transparency, and burden protection, and an updated drug shortage list.
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For Your Consideration

Updates to Management of Clostridium Difficile

In February 2018, the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) released an update in the clinical practice guidelines for CDI in adults and children, which included new recommendations. The biggest change from the previous guideline involves the initial treatment of CDI.

The CDC estimates that C difficile affects a half-million people each year, and 20% of those affected may become infected again. It is reported that 1 in 11 people over the age of 65 years died of a healthcare-associated C difficile infection (CDI) within a month of diagnosis. Risk factors for C difficile include antibiotic use, age older than 65 years, recent hospitalizations, a weakened immune system, and previous CDI or known exposure. The highest risk of CDI occurs during and in the first month after antibiotic exposure. Extended antibiotic use and use of multiple antibiotics further increase the risk of CDI. Chemotherapy, gastrointestinal surgery, and use of acid-suppressing medications like proton pump inhibitors or histamine-2 blockers are risk factors as well.

Metronidazole is no longer recommended as first-line therapy for adults. Oral vancomycin and fidaxomicin are now supported as first-line options for both non-severe and severe initial episodes of CDI. This change stems from evidence that either option ensures resolution of symptoms and sustained resolution one month after treatment. Metronidazole is only recommended for nonsevere initial episodes when patients are unable to obtain or be treated with oral vancomycin or fidaxomicin.

Approximate Retail Pricing:

• Vancomycin (oral) 125mg 4x daily for 10days = $600

• Fidaxomicin/Dificid (oral) 200mg 2x daily for 10 days = $3900

As stated above, metronidazole is used when vancomycin or fidaxomicin are unavailable. Vancomycin and fidaxomicin have a better cure rate than metronidazole but, in our opinion metronidazole may be prudent as first-line treatment for CDI symptom management based upon where an individual is in their disease trajectory and their overall prognosis. 

• Metronidazole (oral) 500mg tid x10 days = $40

For the complete article by Kimberly E. Ng, PharmD, BCPS follow this link

https://www.medscape.com/viewarticle/913901_1

Clinical Definition Supportive Clinical Data Recommended Treatment for C. Diff
Initial episode, nonsevere Leukocytosis with a white blood cell count of <15,000 cells/mL and a serum creatinine level <1.5 mg/dL
  • Vancomycin 125 mg given 4 times daily for 10 days, OR
  • Fidaxomicin 200 mg given twice daily for 10 days
  • Alternate if above agents are unavailable: metronidazole 500 mg 3 times per day by mouth for 10 days
Initial episode, severe Leukocytosis with a white blood cell count of ≥15,000 cells/mL and a serum creatinine level >1.5 mg/dL
  • Vancomycin 125 mg 4 times per day by mouth for 10 days, OR
  • Fidaxomicin 200 mg given twice daily for 10 days
Initial episode, fulminant Hypotension or shock, ileus, megacolon
  • Vancomycin 500 mg 4 times per day by mouth or nasogastric tube. If ileus, consider adding rectal instillation of vancomycin. IV metronidazole 500 mg every 8 hours should be administered together with oral or rectal vancomycin, particularly if ileus is present.
First recurrence
  • Vancomycin 125 mg given 4 times daily for 10 days if metronidazole was used for the initial episode, OR
  • Use a prolonged tapered and pulsed vancomycin regimen if a standard regimen was used for the initial episode (e.g.,125 mg 4 times per day for 10–14 days; then 2 times per day for a week; then once per day for a week; and then every 2 or 3 days for 2–8 weeks) OR
  • Fidaxomicin 200 mg given twice daily for 10 days if vancomycin was used for the initial episode
Second or subsequent recurrence
  • Vancomycin in a tapered and pulsed regimen, OR
  • Vancomycin 125 mg 4 times per day by mouth for 10 days followed by rifaximin 400 mg 3 times daily for 20 days, OR
  • Fidaxomicin 200 mg given twice daily for 10 days, OR
  • Fecal microbiota transplantation

Treatment recommendations from the 2018 Guidlines

Regulatory Center

Regulatory Relief Final Rule: Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction

On September 30, CMS published a final rule on regulatory burden (PDF) relief which: 

• Defers hospice aide training and competencies to state licensure requirements. If there are no state requirements, hospices will still be required to ensure that their hospice aides meet Federal standards for hospice aide training. 

• Removes requirements to have a person on the hospice staff that has specialty knowledge of hospice medications. 

• Follows the statutory requirement in the SUPPORT Act that the hospice must share the written policies and procedures for drug disposal in the home with patients, families and caregivers. However, CMS encourages hospices to develop easily understood materials that explain safe storage, use, and disposal of controlled drugs to patients, their families, and caregivers in addition to meeting the statutory requirement. 

• Removes requirements for hospices to explicitly coordinate with SNF/NF and ICF/IID staff for orientation of facility staff. 5. Changes in emergency preparedness requirements for hospice inpatient facilities and home-based hospice care.

NHPCO Regulatory Alert October 4, 2019

 
Updated

Drug Shortages

These shortages are due either from manufacturing delays or shortage of raw ingredients. This is not an inclusive list, but the listed drugs may be used for hospice patients, especially in the inpatient setting. For a complete list of drugs on shortage follow this link:

 https://www.ashp.org/drug-shortages/current-shortages/drug-shortages-list?page=CurrentShortages

Items marked with a syringe are new from the previous month’s newsletter

About the

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David Bougher

Senior VP of Regulatory Affairs

David is a seasoned veteran of the hospice world and an essential member of the Wise Hospice Options clinical team. 

Education

RN, BSN

Experience

Former hospice COO

20 Years of education & training experience

10 Years of experience at Wise Hospice Options

Wise Clinical Team

Deanna Rice

Pharmd
Vice President Clinical Services

drice@wiseop.com

(800) 856-9757 – EXT. 216

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Tino Vilches

RPh
Senior vice president clinical services

tvilches@wiseop.com

(800) 856-9757 – EXT. 208

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