| Topic |
Brief Description |
Last Updated |
| COVID-19 mRNA vaccine updates |
1) The CBC updated clinical considerations for the COVID-19 mRNA vaccines in the United States included:
- Recommendations on interval between first and second dose
- Recommendations on interchangeability of vaccine productions
- Updates on vaccination in person with a history of COVID-19, dermal fillers, and vaccine excipients.
2) The FDA updated the Pfizer-BioNTech EUA labeling with guidance regarding withdrawal of doses from vaccine vials. Low dead-volume syringes and/or needles should be used to consistently withdraw 6 full doses. Do not combine remaining volumes from multiple vials.
3) APhA's Know the Facts on Minimizing COVID-19 Vaccine Dose Variability.
4) USP's COVID-19 Vaccine Handling: Operational Considerations for Healthcare Practitioners, includes guidance on pre-drawing vaccine doses and storing within syringes.
|
1/2020 |
| Federal Student Loans |
Biden signs federal student loan forbearance through September 2021!
|
1/2020 |
| National Strategy for the COVID-19 Response and Preparedness |
|
1/2021 |
| FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines | FDA |
Reducing the vaccine dose violates the EUA and impacts liability of the administrator/facility. FDA issued a strong statement stating to only follow the dosing in the EUA.
|
1/2021 |
| Clinician Resources |
APhA At-A-Glance: COVID-19 Vaccine here. *Note: In the table, the ACIP interim recommendations for use were switched. Correction: Pfizer-BioNTech for persons > 16 years of age and Moderna for persons > 18 years of age for prevention of COVID-19.
|
12/2020 |
| FDA issues EUA for COVID-19 Vaccines |
Pfizer's COVID-19 Vaccine - FDA approves EUA
Moderna's COVID-19 Vaccine - FDA approves EUA
Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine. Click here to read the clinical trial published in the NEJM on 12/10/2020.
Safety and Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine. Click here to read the clinical trial published in the NEJM on 12/30/2020.
|
12/2020 |
| FDA issues EUA for monoclonal antibodies for treatment of COVID-19 |
- EUA issued for casirivimab and imdevimab to be administered for mild to moderate COVID-19 in adults and pediatric patients < 12 years old weighing at least 40 kg with positive results of direct SARS-COV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65+ years of age or who have certain chronic medical conditions. Click here for press release.
- EUA issued for baricitinib (Olumiant), in combination with remdesivir (Veklury) for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients > 2 years of age requiring supplemental oxygen, invasive mechanical ventilation, or ECMO. Baricitinib is not authorized or approved as a stand alone treatment for COVID-19. Click here for more info.
- EUA issued for bamlanivimab for the treatment of mild to moderate COVID-19 in adult and pediatric patients < 12 years old and weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalizations. This includes those who are > 65 years old or who have chronic medical conditions. Click here.
- FDA approved the first treatment for COVID-19: remdesivir (Veklury) for use in adult and pediatric patients < 12 years old and weighing at least 40 kg for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Click here.
|
11/2020 |
| Amazon Prescription Delivery |
Amazon is entering the pharmacy business with a new offering called Amazon Pharmacy, allowing customers in the United States to order prescription medications for home delivery, including free delivery for Amazon Prime members.
Amazon currently does not have licensure to access pharmacy services in Hawaii, but it is expected in the future.
|
11/2020 |
| Increased Access to Future COVID-19 Vaccines |
Independent pharmacies and regional chains will also be part of the federal pharmacy program, further increasing access to the COVID-19 vaccine across the country.
|
11/2020 |
| COVID-19 vaccine-specific CPT codes |
AMA published an update to the CPT-code set that includes new vaccine-specific codes to report immunizations for the novel coronavirus (SARS-COV-2).
|
11/2020 |
| Forth COVID-19 Interim Final Rule |
Press Release Summary (issued 10/28/2020)
- CMS removes administrative barriers to eliminate potential delays to patient access to a lifesaving vaccine.
- Any FDA or EUA COVID-19 vaccine will be covered.
- The COVID-19 vaccine will be free for patients and providers. Providers will be paid an establishment fee for administration for Medicare patients, and a "reasonable" administration fee is suggested for Medicaid and commercial plans.
- If a patient is enrolled in a Medicare Advantage (MA) plan, the COVID-19 vaccine provider should bill Medicare Part B.
- Additional information on how to fill for uninsured patients through HRSA will be forthcoming.
- Pharmacies providing COVID-19 vaccine to Medicare patients must be an enrolled Medicare provider or as mass immunizer with Medicare. Enrollment link
- Toolkit for state Medicaid, providers, and others
- Nursing Home Resource
- CMS COVID-19 Office Hours Calls (twice a month on Tuesdays from 5-6PM EST or 12-1PM HST). Information here.
|
11/2020 |
| Operation Warp Speed |
What's Operation Warp Speed. Click here to learn more.
|
10/2020 |
| Expanded Access to COVID-19 Vaccines & Tests |
HHS issued guidance-PDF under the PREP Act authorizing qualified pharmacy technicians and State-authorized pharmacy interns to administer childhood vaccines, COVID-19 vaccines when made available, and COVID-19 tests, all subject to several requirements.
|
10/2020 |
| Well-Child Test tools provided by APHA, NASPA, NCPA |
Well-Child Visit Brochure
Template Referral Form Well-Child Visit
Well-Child Checkup Letter
|
9/2020 |
| Administration Action to Expand Access to Vaccines |
Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act
|
9/2020 |
| COVID-19 Vaccine Allocation Discussion |
**TIME SENSITIVE**
Public Listening Session 9/2/2020 - visit the website to register!
Written Comment Period for Discussion Draft - 9/1/2020 - 9/4/2020
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9/2020-9/4/2020 |
| Adovate for Provider Status |
Take Action! Contact Congress today!
|
9/2020 |
| CARES ACT 2020 |
On Aug. 8, 2020, President Trump directed the Secretary to continue to suspend loan payments, stop collections, and waive interest on ED-held student loans until Dec. 31, 2020.
|
8/2020 |
| Access to Childhood Vaccines |
HHS expanded access to childhood vaccinations during the COVID-19 pandemic. After appropriate training, the pharmacist and pharmacy intern, under direct supervision of a pharmacist, is authorized to order and administer vaccines to ages 3-18 years old. Further requirements is explained in the amendment.
|
8/2020 |
| Midyear Clinical Meeting and Exhibition |
ASHP announced Midyear Clinical Meeting and Exhibition will transition to a virtual platform on December 6-10, 2020. Visit their website for more information.
|
8/2020 |
| COVID-19 Vaccine Guidance |
Authorization for Licensed Pharmacists to Order and Administer COVID-19 Vaccines under the PREP Act |
6/20/20 |
| COVID-19 Testing Form |
Pharmacies will need a CLIA Waiver to participate in testing. Fill out a form and mail it in to your state. |
4/2020 |
| HEROES Act of 2020 |
Pharmacists and pharmacy technicians added to HEROES Act
H.R.6800 - Emergency supplemental appropriations for the fiscal year ending September 30, 2020.
|
4/2020 |
