Questions and Answers for Pharmacists Regarding Influenza Vaccine and Antivirals

On January 25, 2018, Governor Andrew M. Cuomo issued an Executive Order (EO) permitting pharmacists to administer influenza vaccinations to patients between two years and eighteen years of age through February 23, 2018. The order may be extended for additional 30-day periods if the emergency conditions continue at that time. A copy of the Executive Order can be found at: https://www.governor.ny.gov/sites/governor.ny.gov/files/atoms/files/EO_176.pdf.

This document addresses frequently asked questions about pharmacist administration of influenza vaccine to children under EO No. 176.

Q1: May any pharmacist administer influenza vaccine under these orders?

A1: In New York State (NYS), pharmacists must obtain certification to administer immunizations. To become certified, a pharmacist must:

  • be currently licensed and registered in NYS,
  • provide evidence that an approved immunization course has been completed within the past three years, and
  • provide evidence that they are currently certified in Cardio Pulmonary Resuscitation (CPR) or Basic Life Support (BLS). Pharmacists immunizing children must have completed appropriate CPR or BLS training for this population.

For more information about pharmacist certification to administer immunizations in NYS, including a copy of the application for certification, please refer to the NYS Board of Pharmacy web page at http://www.op.nysed.gov/prof/pharm/pharmimmunizations.htm.

Q2: Will I need a physician's order to administer influenza vaccine to children?

A2: Yes. Pursuant to NYS Education Law, if the Commissioner of Health determines that there is an outbreak of disease, or that there is the imminent threat of an outbreak of disease, then the Commissioner of Health may issue a non-patient specific regimen applicable statewide. Accordingly, to assist pharmacists who decide to vaccinate pursuant to EO No. 176, on January 27, 2018, NYS Commissioner of Health Howard Zucker issued a statewide non-patient specific standing order for NYS pharmacists, with a certificate of administration issued by the NYS Education Department, to administer influenza vaccinations to patients between two years and eighteen years of age, effective until the expiration of EO No. 176 or until the Commissioner's discontinuation of the standing order. A copy of the standing order is available at https://health.ny.gov/prevention/immunization/providers/docs/2018_standing_order.pdf.

Q3: Will I need to administer different influenza vaccines to children than to adults?

A3: It depends on the brand and formulations of vaccine used. Different brands and formulations are licensed for different age ranges. Some influenza vaccines are only licensed for use in adults. Some are licensed for use in all persons aged 6 months or older. Some are licensed for other age ranges (e.g., ages 3 years and up, ages 18-64 years, etc.) Pharmacists should refer to the vaccine age indications as listed at: https://www.cdc.gov/mmwr/volumes/66/rr/rr6602a1.htm#T1_down and on the vaccine package inserts.

In addition, NYS Public Health Law (PHL) § 2112 prohibits the administration of vaccines containing more than trace amounts of thimerosal, a mercury-containing preservative, to children less than 3 years of age and women who know they are pregnant, with certain exceptions. All single-dose preparations of influenza vaccine available in the United States are thimerosal-free, except for one brand which contains trace amounts of mercury (less than 1 microgram of mercury per 0.50 milliliter dose), which is below the thresholds established in PHL § 2112. Therefore, pharmacists and other healthcare providers administering influenza vaccine to children less than 3 years of age and women who know they are pregnant should administer single-dose preparations of influenza vaccine to these populations. For more information about PHL § 2112, see https://www.health.ny.gov/regulations/public_health_law/section/2112/information_for_physicians/.

Q4: Will I need to administer different doses of influenza vaccine to children than to adults?

A4: It depends on the patient's age and the brand of vaccine used. There are three influenza vaccines currently licensed for use in children less than 3 years of age. One of these brands, Fluzone, has a 0.25 mL dose for children aged 6 through 35 months and a 0.5 mL dose for children and adults aged 3 years and older. The other two brands, Flulaval and Fluarix, both have a 0.5 mL dose for all persons aged 6 months and older. All influenza vaccines for persons 3 years of age and older have a 0.5 mL dosage.

Q5: Where can I obtain influenza vaccine for children?

A5: Information on purchasing vaccine is available from the Influenza Vaccine Availability Tracking System at https://www.izsummitpartners.org/ivats/ or from your usual distributors. Influenza vaccine is available, but pharmacies may not be able to get every brand and/or presentation, and they may have to purchase from a different source or from more than one distributor. In addition, pharmacies located in NYS outside of New York City (NYC) that expect to vaccinate children less than 19 years of age who are uninsured, underinsured, American Indian or Alaska Native, or enrolled in either Medicaid or Child Health Plus may enroll in the NYS Vaccines for Children (VFC) Program to receive VFC influenza vaccines for these children at no charge. Pharmacies located in NYC may find information about the NYC VFC online at https://www1.nyc.gov/site/doh/providers/nyc-med-cir/vaccines-for-children-program.page or by calling 347-396-2400.

NYS VACCINES FOR CHILDREN (VFC) PROGRAM

Q6: How can I apply to join the NYS VFC Program?

A6: In order to join the NYS VFC Program, pharmacies operating in NYS outside of NYC must complete a NYS VFC Provider Agreement and Profile Form (https://www.health.ny.gov/forms/doh-3836.pdf) and a Storage and Handling Plan (https://www.health.ny.gov/prevention/immunization/vaccines_for_children/docs/storage_and_handling_plan.pdf) and either email the completed forms to the NYSDOH at nyvfc@health.ny.gov or fax them to (518) 449-6912. Facilities applying to join the NYS VFC must agree to comply with all NYS and federal VFC program requirements, must maintain an active NYS Health Commerce System account and register with the New York State Immunization Information System (NYSIIS) if they do not already have a NYSIIS account, and must designate a Medical Director/Provider of Record, as described in Answer 8 below, a Vaccine Coordinator and a Backup Coordinator. In addition, the Provider of Record, Vaccine Coordinator and Backup Coordinator must complete all required trainings for newly enrolling NYS VFC providers at https://www.health.ny.gov/prevention/immunization/vaccines_for_children/vaccine_personal.htm#training.

Pharmacies applying to join the NYS VFC Program should indicate on page 5 of their application that they are a "Specialty Provider" offering only influenza vaccine to VFC-eligible children.

For more information about the NYS VFC Program, visit www.health.ny.gov/vfc, call 1-800-543-7468 (1-800-KID-SHOT) or email nyvfc@health.ny.gov.

For more information about the NYC VFC Program, visit https://www1.nyc.gov/site/doh/providers/nyc-med-cir/vaccines-for-children-program.page or call 347-396-2400.

Q7: The NYS VFC Provider Agreement and Profile form indicates that I should report the number of children that received vaccinations at my facility during the previous 12 months. How can I estimate that number when my pharmacy has not previously administered vaccines to children?

A7: Please list your best estimate of your anticipated pediatric patient population for influenza vaccine in the "Provider Population" table located on page 6 of the NYS VFC Provider Agreement and Profile form.

Q8: Who should I list as the Medical Director on page 1 of the NYS VFC Provider Agreement and Profile Form?

A8: List a pharmacist or other healthcare provider authorized to administer vaccines to children who will be responsible for ensuring that the pharmacy complies with NYS and federal VFC requirements (Provider of Record). The Provider of Record is not required to be a physician.

Q9: Are pharmacies required to have a freezer in order to join the NYS VFC Program?

A9: No. Pharmacies joining the NYS VFC as a "Specialty Provider" will only offer influenza vaccine through the NYS VFC and, therefore, will not be required to have a freezer.

Q10: Are pharmacies required to have a digital data logger in order to join the NYS VFC Program?

A10: Yes. Effective January 1, 2018, the CDC requires all VFC providers to have a digital data logger in all units as well as a backup digital data logger. For more information about the data logger requirement, visit https://www.health.ny.gov/prevention/immunization/vaccines_for_children/storage_and_handling.htm#dataloggers or email dataloggers@health.ny.gov.

Q11: Which children are eligible to receive NYS VFC vaccine?

A11: Children are eligible to receive NYS VFC vaccine at no charge if they are:

  • Uninsured (do not have health insurance),
  • Underinsured (have commercial health insurance but the insurance does not cover the vaccine being administered, in this case influenza vaccine, or the insurance caps coverage at a certain amount or number of visits [VFC-eligible once that cap has been exceeded]),
  • Native American or Alaska Native,
  • Medicaid-enrolled or Medicaid-eligible, or
  • Enrolled in Child Health Plus.

VFC providers must screen each child for eligibility to receive VFC vaccine and document the screening results at each immunization visit. VFC vaccine may not be administered to children who are not VFC-eligible.

Q12: If a child has health insurance that is out-of-network, can they be considered "underinsured" for VFC purposes, and be administered VFC vaccine?

A12: No. The federal VFC program does not consider children with out-of-network insurance to be underinsured for the purposes of VFC eligibility. NYS Education Law § 6801 and associated regulations at 8 NYCRR § 63.9 require pharmacists to inform patients, or the persons legally responsible for the patients, of the total costs of the immunization or immunizations, subtracting any health insurance subsidization, prior to administering the immunization. In the case where the patient's health insurance is out-of-network or the immunization is otherwise not covered by the patient's health insurance, the pharmacist must inform the patient, or other person legally responsible for the patient when the patient is incapable of consenting to the immunization, that the immunization may be covered when administered by a primary care physician or health care practitioner. If the parent consents to immunization despite having out-of-network health insurance, then the pharmacist must administer private vaccine.

Q13: I am out of stock of private vaccine but have VFC vaccine in stock. May I borrow VFC vaccine for administration to non-VFC eligible patients until such time that my delivery of private vaccine arrives?

A13: No. VFC vaccine may not be borrowed for private use.

NEW YORK STATE IMMUNIZATION INFORMATION SYSTEM (NYSIIS)

Q14: Do I need to report doses administered to children to the NYSDOH?

A14: Yes. As described in PHL § 2168, pharmacists must report all immunizations administered to persons less than 19 years of age to the New York State Immunization Information System (NYSIIS) within fourteen days of administration, except for vaccines administered in New York City (NYC), which must be reported to the City Immunization Registry (CIR).

For more information about NYSIIS, visit https://www.health.ny.gov/prevention/immunization/information_system/, call (518) 473-2839 or email nysiis@health.ny.gov. For information about the CIR, visit http://www.nyc.gov/health/cir or call (347) 396-2400.

Q15: How can I get a NYSIIS account and get started reporting?

A15: You must have a HCS account (https://commerce.health.state.ny.us/public/hcs_login.html). If you need to create an account, visit www.health.ny.gov/prevention/immunization/information_system/providers/hpn_account_instructions.htm. Once you have an account established, you must complete NYSIIS online training to be granted access to NYSIIS. This should be completed by the pharmacy manager/pharmacist in charge (must be licensed).

There will be a registration form to fill out before the training will begin. Once you have completed training an email will be sent to you, granting access. You may call 518-473-2839 to expedite your access.

For pharmacists administering vaccine in NYC, if you do not already have a CIR account, please call 347-396-2400 or visit https://a816-healthpsi.nyc.gov/OnlineRegistration/dohmh/DOHMHService.action to obtain a new account or to reset your password.

INFLUENZA ANTIVIRAL MEDICATIONS

Q16: Where can I find information about the current national antiviral drug supply?

A16: CDC is in regular contact with influenza antiviral manufacturers regarding supply and other issues, and maintains a webpage (https://www.cdc.gov/flu/professionals/antivirals/supply.htm) detailing the current supply. As of 1/29/2018, some manufacturers are reporting delays in filling orders and CDC is aware of spot shortages of antiviral drugs, specifically generic versions of oseltamivir capsules and suspension, in some places experiencing high influenza activity. Pharmacies and others attempting to make bulk purchases of influenza antiviral drugs may need to call more than one distributor or manufacturer to locate medications available for purchase in the short term. Manufacturers' contact information is listed on CDC's website.

Q17: Can pharmacists compound an oral oseltamivir suspension from capsules?

A17: Yes. When a prescription is written for oseltamivir suspension and the commercially manufactured product is unavailable, the State Education Department's Board of Pharmacy has advised that pharmacists in NYS are permitted to compound using oseltamivir 75mg capsules. The ability to compound is based on immediate need and the unavailability of commercially-manufactured oral suspension. In these cases, the pharmacist should annotate on the prescription that an emergency exists and the commercially-manufactured oral suspension is not available. A separate order from the prescriber is not required. Directions for compounding are included in the FDA-approved manufacturer package inserts.

Q18: Can oseltamivir capsules be opened and mixed with liquids if a child cannot swallow capsules?

A18: Yes. If a child's provider prescribes oseltamivir capsules and the child cannot swallow capsules, the prescribed capsules may be opened, mixed with a thick sweetened liquid, and given that way. CDC provides instructions at https://www.cdc.gov/flu/antivirals/mixing_oseltamivir_qa.htm.