For Your Consideration
Melatonin
Although more than 3 million Americans use melatonin the major sleep societies are reluctant to endorse melatonin for common insomnia. The American Sleep Association and National Sleep Foundation cite conflicting evidence about efficacy while cautiously suggesting that it might help some people. The American Academy of Sleep Medicine (AASM) advises clinicians against recommending melatonin, weighing the overall evidence as “weakly against” its efficacy.
AASM found that a review of randomized, double-blind, placebo-controlled studies of melatonin for insomnia only found a modest reduction in time to fall asleep of approximately 10 minutes which they did not find “clinically significant.” According to AASM’s their recommendation against melatonin’s use does not mean it is proven unsafe or ineffective, just that there was insufficient evidence of its effectiveness.
Melatonin is approved in Europe to treat primary insomnia in older adults and has been shown to help insomnia in children with autism spectrum disorders, adolescents with depression, women with premenstrual dysphoric disorder, patients with hypertension taking beta-blockers, and children with attention deficit hyperactivity disorder.
Melatonin generally has a favorable safety profile, with minor adverse events such as fatigue and sluggishness being short-lived and associated with dose timing. Although there is some evidence of adverse blood pressure and heart rate effects in people with cardiovascular conditions and concurrent antihypertensive medications, it is unclear whether they are because of melatonin or drug interactions. The most common side effects reported were headache, dizziness, nausea and sleepiness.
Recommended dosing is 0.3mg-5mg 1 hour prior to bedtime. A high dose of 10mg has been used for up to 4 weeks but there is no clear clinical evidence that this dose is more effective than 5mg. Higher doses are associated with an increase in incidence of side effects.
Medscape December 5, 2019
National Institutes of Health (NIH) 2015
UpToDate September 13, 2018
Regulatory Center
Addendum of Election of Benefits Statements
As we noted in our June 2019 newsletter CMS was proposing “patient notification of hospice non-covered items, services and drugs.” This was incorporated into the 2020 Final Rule that went into effect on October 1, 2019. However, this patient notification will not go into effect until October 1, 2020. CMS is encouraging hospices to begin developing this addendum earlier rather than later in order to be in compliance by the implementation date of October 1, 2020.
Below are links to the 2020 Final Rule (pertinent pages are 38506-38508) and NHPCO’s PP.
https://www.govinfo.gov/content/pkg/FR-2019-08-06/pdf/2019-16583.pdf
https://www.nhpco.org/wp-content/uploads/2019/08/FY2020-Final-Rule-webinar-handout_080619.pdf
Wise Services
Upcoming Education for 2020
On March 24, 2020 we will be offering the class “Alternate Routes of Drug Administration” at 10:30am Central Time. The class will be 60 minutes and will be online via our RingCentral platform. Registration may be coordinated through your education coordinator or by emailing David Bougher at dbougher@wiseop.com directly.
Class Objectives:
- List the alternate routes of drug administration most commonly used for hospice patients.
- Discuss the advantages/disadvantages to the use of each route.
- Recognize the challenges each method of administration poses to care givers.
- Incorporate the information learned in this presentation to enhance current practice.
Rx Alert
Ranitidine/Zantac
Recall & Shortages
Since November there have been shortages of injectable ranitidine due to production delays and further testing. Glenmark Pharmaceutical Inc found unacceptable levels of N-nitrosodimethylamine (NDMA), a suspected carcinogen, found in both oral and injectable formulations and instituted a voluntary recall. The FDA has asked other companies producing ranitidine to conduct their own testing.
Alternative H₂ blockers include; famotidine (Pepcid), cimetidine (Tagamet), and nizatidine (Axid) all available as OTC.
FDA Alert 12/18/19
Drugs.com 11/13/19
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
NOTE: Items marked with a syringe are new from the previous month’s newsletter
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About the Author
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
Connect
- (800) 856-9757 Ext: 203
- dbougher@wiseop.com
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Wise Clinical Team
Deanna Rice
Vice President
Clinical Services
drice@wiseop.com
(800) 856-9757:
EXT. 216
Tino Vilches
Senior Vice President
Clinical Services
tvilches@wiseop.com
(800) 856-9757:
EXT. 208
Available
Wise Hospice Options Services
Please reach out to your account manager for assistance with maximizing your available services, or for potential upgrades to your current system.
EHR Interface Integrations
Demographic & medication interfaces with over 11 EHR's.
E-Prescribing
Web-based prescribing platform for Schedule II's.
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EHR Medication Profiling
Med reviews done inside your EHR system.
Advanced Reporting
Drill down into your pharmacy utilization trends.
Clinical Education
Hospice oreiented courses designed for your hospice staff.
Pharmacy Network Access
Unrestricted access to every pharmacy within our network.
Web-based Refills
Send and identify available refills for your patient population.
