Missouri Board of Pharmacy COVID-19 Updates (12-28-2020)

Missouri DCI sent this bulletin at 12/28/2020 03:40 PM CST

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Missouri Board of Pharmacy

COVID-19 Updates (12-27-2020)

 

COVID-19 Vaccine FAQ

Can Pharmacists Administer COVID-19 vaccines?

Yes.  Pharmacists can order and administer COVID-19 vaccines under the emergency Declaration issued by the United States Department of Health and Human Services (HHS) pursuant to the Public Readiness and Emergency Preparedness Act (PREP Act). 

Governor Parson has also issued an emergency waiver, authorizing pharmacists to administer HHS authorized COVID-19 vaccines: (1) under a statewide standing order issued by the Missouri Department of Health and Senior Services (DHSS) or (2) pursuant to a protocol with a Missouri-licensed physician.  All HHS requirements apply to COVID-19 vaccines administered under the emergency waiver, including, all training and reporting requirements.  DHSS standing orders are available on DHSS’ website (Note:  DHSS has issued separate standing orders for the Pfizer and Moderna vaccine).

Do I Need A Physician Protocol?

A protocol is optional for COVID-19 vaccines.   Once again, pharmacists can choose to order/administer COVID-19 vaccines directly under HHS’ authority, or under DHSS’ statewide standing order, or under a physician protocol.   HHS requirements would apply under either option.

Do I Need To File A Notification of Intent?

No.  A Notification of Intent (NOI) is not required for COVID-19 vaccines.  

Can Licensees from Other States Administer COVID-19 vaccines in Missouri?

Pharmacists, intern pharmacists or pharmacy technicians that are not licensed in Missouri can administer COVID-19 vaccines in the state if the licensee/registrant holds a current and active pharmacist, intern pharmacist or pharmacy technician license/registration in their home state that is in good standing, and the individual is assisting:

  • A Missouri licensed pharmacy, or
  • A hospital or medical care facility licensed by the Missouri Department of Health and Senior Services, or the Missouri Department of Mental Health, or
  • A hospital or medical care facility owned by the state of Missouri.

Non-resident individuals must be assisting one of the above entities and cannot independently administer COVID-19 vaccines in Missouri.  [See approved Emergency Waiver]. 

Prior to practicing in Missouri, non-Missouri licensees have to submit an Emergency Practice Form that is available on the Board’s website (no fee applies).  See the Board’s 3-23-20 statement for additional guidance. 

Can pharmacy technicians and intern pharmacists administer COVID-19 vaccines?

Yes.  HHS’ emergency declarations allow pharmacy technicians and intern pharmacists to administer COVID-19 vaccines under a pharmacist’s supervision.  Technicians/intern pharmacists must comply with all HHS requirements, including, any mandated training. A Notification of Intent (NOI) does not have to be filed with the Board.  Additional Board guidance on intern pharmacist and pharmacy technician vaccine activity is available on the Board’s website.

ShowMeVax Reporting?

HHS’ Declaration requires licensees to report COVID-19 vaccines to ShowMeVax.  The Missouri Department of Health and Senior Services has confirmed that patients may not opt out of having their COVID-19 vaccination reported to ShowMeVax.  CDC requires all COVID-19 vaccinations to be reported within 24 hours. See ShowMeVax’s website for ShowMeVax registration information.

Board COVID-19 Resources

Recent Emergency Rules

20 CSR 2220-5.020 (Drug Distributor Licensing Requirements)

Effective November 13, 2020, 20 CSR 2220-5.020 (Drug Distributor Licensing Requirements) has been amended by emergency rule to provide that a Missouri drug distributor license is not required for the following activities:

  • The sale, purchase, or transfer of a drug or vaccine received from or on behalf of a federal, state, or municipal entity for the purpose of treating or immunizing patients during a state or federally declared disaster or emergency; or
  • The sale, purchase, or transfer of a drug or vaccine subject to an emergency use authorization issued by the United States Food and Drug Administration for a public health emergency.

The emergency rule was published in the December 1, 2020, Missouri Register (see copy attached).

20 CSR 2220-6.040 (Administration by Medical Prescription Order)

To accommodate other medication demand, 20 CSR 2220-6.040 (Administration by Medical Prescription Order) has been amended by emergency rule to allow pharmacists to delegate administration of medication by prescription order to a qualified Missouri pharmacy technician, if the technician:

  1. Holds an active pharmacy technician certification issued by a certification entity accredited by the National Commission for Certifying Agencies (e.g., PTCB, NHA/ExCPT),
  2. Has assisted in the practice of pharmacy as a registered pharmacy technician in the state of Missouri for a minimum of one (1) year,
  3. Has an initial and, if applicable, annual documented assessment of competency in medication administration,
  4. Has successfully completed a certificate program in medication administration and emergency procedures, that complies with 20 CSR 2220-6.040(3)(E); and
  5. Holds a current healthcare provider level cardiopulmonary resuscitation (CPR) certification or Basic Life Support certification issued by the American Heart Association, the American Red Cross, or an equivalent organization. The certificate program must have included an in-person skills assessment.

Proof of the technician’s compliance/training must be maintained in the pharmacy’s records for a minimum of two (2) years.

The emergency amendment became effective on December 11, 2020, and is available on the Board’s website (see copy attached).  Pharmacists are still responsible for ensuring technicians are safely administering medication in compliance with recognized standards of practice.  Additionally, the supervising pharmacist must be physically present, on-site when the technician is administering.

(A similar emergency amendment for 20 CSR 2220-6.050 (Immunization by Protocol) is in the rule review process but is not currently effective.  Monitor the Board’s website for additional updates)

BNDD Fall 2020 Newsletter Available

The Bureau of Narcotics and Dangerous Drugs (BNDD) Fall 2020 newsletter is available here.