If your pharmacy, both on Oahu and the neighbor islands, haven't heard from the DOH by Friday, January 8th, please also complete the survey to be contacted by the DOH. https://hawaiicovid19.com/vaccine/  or click link here: Survey of Independent Practice Sites for COVID-19 Vaccination Program (office.com)

For members of the general public and clinicians who have questions, please call the DOH COVID-19 line at 808-586-8332.

1/2021

11/2020

9/2020-11/15/2020

NCPA has prepared information for pharmacies claiming reimbursement for administering COVID-19 vaccines during the public health emergency. Click here for more information.

UPDATE: ACIP recommendations for the J&J vaccine - overall benefit outweighs risk

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Johnson and Johnson COVID-19 Vaccine Health Alert

• On 4/13/2021, the CDC and FDA issued a statement to pause further use of the Johnson and Johnson COVID-19 vaccine after reviewing data involving six cases, out of nearly 7 million doses so far in the US, were reported of cerebral venous sinus thrombosis in women between the ages of 18 and 48 with symptoms occurring 6 to 13 days after vaccination. These blood clots are extremely rare.
• The CDC is recommending monitoring for signs and symptoms of a clot for those who received the J&J vaccine. However, the risk of developing a clot is very low for those who received a dose within 3 weeks. There have been no matching reports for the Pfizer or Moderna vaccines. 
• On 4/14/2021, the ACIP held a public meeting which can be watched here. They will reconvene in the next 2 weeks to review any additional data. Click here for the FDA/CDC Joint Media Call.
• Dr. Fauci's video about the J&J vaccine pause.
• Additional information about the safety of COVID-19 vaccines can be found here.
• ACOG Guidance

Two revisions made to the Moderna COVID-19 Vaccine

• Number of doses per vial increased to 15 (from 10)
• Storage changes: Expiration increased from 12 hours to 24 hours under proper storage; expiration increased from 6 hours to 12 hours for punctured vials.

CMS released updates to the Coverage and Reimbursement of COVID-19 vaccines, vaccine administration, and cost sharing

Enroll as a COVID-19 Vaccination Provider

Janssen COVID-19 Vaccine (adenovirus vector)

EUA Fact Sheet for Providers

EUA Fact Sheet for Recipients and Caregivers

Adverse events

Preparation and Storage

ACIP recommendations

Understanding and Explaining Viral Vector COVID-19 Vaccines

In APhA's February 26th weekly open forum, John Grabenstein, RPh, PhD, FAPhA covers key attributes of the Janssen COVID-19 vaccine. 

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. 

5) FDA allows more flexible storage and transportation for Pfizer COVID-19 vaccine

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.

• 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.

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. 

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. 

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). 

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.

What's Operation Warp Speed. Click here to learn more.

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. 

Well-Child Visit Brochure

Template Referral Form Well-Child Visit

Well-Child Checkup Letter

Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act

**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

Take Action! Contact Congress today! 

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.

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.

ASHP announced Midyear Clinical Meeting and Exhibition will transition to a virtual platform on December 6-10, 2020. Visit their website for more information.

Pharmacists and pharmacy technicians added to HEROES Act 

H.R.6800 - Emergency supplemental appropriations for the fiscal year ending September 30, 2020.