For your consideration
Medications Approved In 2020
Each year the FDA approves dozens of new medications. Below are some you might see coming to hospice patients in 2021.
Gemtesa (Vibegron)
Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Dosing is 75mg once daily. It is a Beta₃ adrenergic receptor agonist. Most common side effects: headache, UTI, common cold, diarrhea, nausea, and upper respiratory infection. Approved by the FDA in December 2020. Cost for 30 tablets = $488.
Olinvyk (oliceridine)
Indicated for short-term IV treatment of severe acute pain. It is a full opioid agonist. Common side effects: constipation, nausea, CNS depression. Approved by the FDA in August 2020 for use in controlled settings. Equianalgesia is 1mg oliceridine = 5mg morphine. Cost for 10ml (1mg/ml) = $192.
Dosing: use the lowest effective dose for the shortest duration. Individualize. The onset of analgesia: 2–5mins after the initial dose. Initially 1.5mg. For PCA: demand dose is 0.35mg, with a 6min lock-out; may consider 0.5mg if the benefit outweighs the risks. Supplemental doses: 0.75mg may be given 1hr after the initial dose, then hourly thereafter as needed. Max single dose: 3mg. Max total daily dose: 27mg. Use an alternative regimen if analgesia is still required after reaching a cumulative daily dose of 27mg.
Ongentys (opicapone)
Indicated to be used together with carbidopa and levodopa to treat symptoms of “off” episodes (stiffness, tremors, muscle spasms, poor muscle control) in people with Parkinson’s disease. Dosing is 50mg once daily at bedtime. Common side effects: light-headedness, uncontrolled muscle movements, constipation, weight loss. Approved by the FDA in April 2020. Cost for 30 capsules = $700.
Orgovyx (relugolix)
Androgen Deprivation Therapy (ADT) indicated for the treatment of advanced prostate cancer. Approved by the FDA in December 2020 for the treatment of advanced prostate cancer. It’s the first oral hormone therapy approved for prostate cancer. This will not require administration at a health care facility. Has a higher cardiac safety profile than Lupron. Common side effects: flushing, increase blood sugar levels, increased triglycerides, muscle, and joint pain, decreased HgB, tiredness, and constipation. Cost per month = $2300.
Veklury (remdesivir)
Indicated for treating COVID-19 patients 12 years and older and weighing at least 40kg and requiring hospitalization. Should be administered in a hospital or other acute care setting. Lab studies required: eGFR, hepatic tests, and PT. Monitor during treatment. Approved by the FDA in October 2020. Common side effects: nausea and constipation.
Infusion over 30-120 minutes. The initial dose is 200mg then 100mg IV daily for 5 days. If no improvement continue for 5 additional days. The cost is $3120 for a 5-day course of treatment.
Breztri Aerosphere (budesonide, formoterol, glycopyrrolate)
Indicated for the treatment of COPD. This is a long-acting combination corticosteroid, beta₂ and anticholinergic inhaler (MDI). Common side effects: thrush, headache, joint pain, tachycardia, elevated blood sugar, and nausea. Approved by the FDA in July 2020. Cost per month = $720.
For your consideration
The Move to Legalize Psilocybin for Terminally Ill Patients
“Dr. Sunil Aggarwal, a Seattle palliative care physician, and Kathryn Tucker, a lawyer who advocates on behalf of terminally ill patients and chairs a psychedelic practice group at Emerge Law Group, are championing a novel strategy that would make psilocybin available using state and federal “right-to-try” laws that allow terminally ill patients access to investigational drugs.”
Psilocybin is listed as a Schedule I drug and is currently illegal under the US Controlled Substance Act, similar to heroin and LSD. Aggarwal has submitted an application to his state’s Pharmacy Quality Assurance Commission to grow psilocybin mushrooms and administer them for therapeutic use.
The Johns Hopkins Center for Psychedelic and Consciousness Research has published dozens of peer-reviewed studies based on two decades of research. They include studies confirming that psilocybin helped patients grappling with major depressive disorders, thoughts of suicide, and the emotional repercussions of a cancer diagnosis.
Dr. Ira Byock, a palliative care specialist and medical officer for the Institute for Human Caring at Providence St. Joseph Health, commented, “What psychedelics do is foster a frameshift from feeling helpless and hopeless and that life is not worth living, to seeing that we are connected to other people and we are connected to a universe that has inherent connection.” According to Dr. Byock, administering the drugs under controlled circumstances and supervised by a trained guide/therapist have proved to be very safe and effective in relieving existential distress.
To read the entire article go to Medscape “New Legal Push Aims to Speed Magic Mushrooms to Dying Patients” JoNel Aleccia 11/25/20.
regulatory center
Extension of Temporary Suspension of Medicare Sequestration
The CARES Act included a suspension of the 2% sequestration reduction for most Medicare payments. Section 3709 of the CARES Act exempts Medicare from the effects of sequestration from May 1, 2020, through December 31, 2020. The Consolidated Appropriations Act of 2021 (H.R. 133) extends this relief through March 31, 2021.
Hospice Program Integrity
HR 5821 – HOSPICE Act was included, as amended, establishing hospice program survey and enforcement procedures under the Medicare program. This section makes changes to the Medicare hospice survey and certification process to improve consistency and oversight.
- Survey Frequency – Extends the requirement that hospices be surveyed no less frequently than once every 36 months. Makes the “every 36 months” requirement for hospice surveys permanent.
- Surveyor Guidance – Surveys conducted by more than one person will be conducted by a multidisciplinary team. For all surveys conducted on or after October 1, 2021.
- Surveyor Conflict of Interest – States may not use anyone who has been a member of staff of the surveyed hospice within the past two years, or anyone with a financial interest in the hospice, as a surveyor. Beginning on October 1, 2021.
- Surveyor Training Requirements – The HHS Secretary shall provide training for state and national surveyors and any surveyor employed by a national accreditation body. All surveyors must complete training no later than October 1, 2021.
- Survey Transparency – Results of certification surveys done by state or local survey agency and each accreditation body to be published by the HHS Secretary. No later than October 1, 2022.
Updated
Drug Shortage List
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/
The FDA is warning that drug shortages, especially those used to treat critically ill COVID-19 patients, will continue into 2021.
The reasons cited for these shortages are raw materials (27%), manufacturing issues (37%), delays/capacity (27%). Although the FDA has regulatory oversight of the pharmaceutical industry, it cannot require a pharmaceutical company to:
1) Make a drug, even if it is a medically necessary drug.
2) Make more of a drug.
3) Change how much and to whom a drug is distributed.
To close click the X in the top right hand corner.
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
Wise Clinical Leadership
Tino Vilches
Senior Vice President
Clinical Services
tvilches@wiseop.com
(800) 856-9757:
EXT. 208
Deanna Rice
Vice President
Clinical Services
drice@wiseop.com
(800) 856-9757:
EXT. 216
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