Policy Advisory

Policy Advisory Joint Policy 2012-02 and FAQs on Pharmacist Administration of Vaccines

Date: 04/03/2012
Organization: Board of Registration in Pharmacy
Drug Control Program
Referenced Sources: 105 CMR 700.00: Implementation of MGL c.94C
M.G.L. Chapter 111, Section 24M

The Massachusetts Department of Public Health (MDPH or the Department), through the Drug Control Program, Immunization Program and Board of Registration in Pharmacy, is making adult vaccines more accessible by allowing administration by pharmacists.  Qualified pharmacists may administer to adults 18 years of age and older certain vaccines included in the Recommended Adult Immunization Schedule approved by the U.S. Centers for Disease Control and Prevention (CDC).

Regulations of the MDPH, Drug Control Program at 105 CMR 700.004(B)(6) permit pharmacists, who have completed a duly accredited training course, to administer vaccines designated by the Department.

Table of Contents

Vaccines covered by this policy

Vaccines covered under this policy are those vaccines included in the Recommended Adult Immunization Schedule – United States, 2011 approved by the Advisory Committee on Immunization Practices (ACIP) of the CDC. The Recommended Adult Immunization Schedule is published as: Centers for Disease Control and Prevention. Recommended Adult Immunization Schedule---United States, 2011. MMWR 2011;60(4) and may be found on the CDC website. The vaccines designated by the Department for administration by pharmacists include the following:

  • Influenza
  • Tetanus, diphtheria, pertussis (Td/Tdap)
  • Varicella
  • Human papillomavirus (HPV)
  • Zoster
  • Measles, mumps, rubella (MMR)
  • Pneumococcal polysaccharide vaccine (PSV23)
  • Meningococcal
  • Hepatitis A
  • Hepatitis B
  • Inactivated Polio Vaccine (IPV)

Vaccine recipients covered by this policy

Under this policy, qualified pharmacists are authorized to administer vaccines included in the Department’s designated list to adults 18 years of age and older.

Requirements for vaccine administration

  1. To administer vaccines, a prescription, physician directive or standing order is required
  2. To administer single dose emergency epinephrine, a standing order is required
  3. Model standing orders for all vaccines included in the Recommended Schedule; emergency standing orders for the treatment of adverse events following vaccination; and General Protocols for Vaccine Storage, Administration, Standing Orders and Mass Immunization Clinics are available at the MDPH website
  4. Federal Law requires that a vaccine provider give a patient or legal representative the appropriate Vaccine Information Statement (VIS) whenever a vaccine is administered. Find more information about VIS.

Communications

  1. A notification/record of immunization should be provided to the patient’s physician. http://www.immunize.org/catg.d/p2023.pdf
  2. The pharmacist may consider using the opportunity of the patient encounter to ask if the patient has been seen by the patient’s primary care provider within the past year (or other appropriate time frame) and, if not, to encourage the patient to make an appointment with the primary care provider 's practice.
  3. See no. 7. on the Massachusetts Immunization Information System.

Reporting of adverse events

The National Childhood Vaccine Injury Act (NCVIA) requires healthcare providers to report to the Vaccine Adverse Event Reporting System (VAERS) (http://vaers.hhs.gov/index):

  • Any adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine; or
  • Any adverse event listed in the VAERS Table of Reportable Events Following Vaccination that occurs within the specified time period after vaccination.

Training

  1. Pharmacists administering vaccines must attend and pass an accredited training course meeting the requirements of 105 CMR 700.004(B)(6)(c)1. These courses include, but are not necessarily limited to:
    • Pharmacy Based-Immunization Delivery (Live Training Seminar) 
      • ACPE Universal Activity Number: 202-000-11-135-L01-P (202-999-11-135-L01-P if hosted by an APHA license partner)
      • APHA website at www.aphanet.org
    • New Advances in Influenza Vaccination – a multimedia CE Program for Pharmacists.
  2. All such courses must, at a minimum, be accredited by the U.S. Centers for Disease Control and Prevention, the Accreditation Council for Pharmacist Education (CPE) (www.acpe-accredit.org/), or similar health authority or professional body, and include pre-administration education and screening, vaccine storage and handling, administration of medication, record-keeping and reporting of adverse events.
  3. Information on other accredited courses is available through professional organizations, colleges and other sources.
  4. Proof of training must be kept on file in the pharmacy.
  5. Current CPR certification is recommended.

Participation in the Massachusetts Immunization Information System (MIIS)

In June 2010, legislation was passed requiring all licensed health care providers who administer immunizations to report vaccines administered to the immunization registry such data related to immunizations as the Department determines is necessary for disease prevention and control (M.G.L. Chapter 111, Section 24M).  After the system is rolled out, MDPH will be developing requirements about reporting. MIIS staff in collaboration with professional organizations will update pharmacies when this occurs. More information about the MIIS can be found at Massachusetts Immunization Information System (MIIS).

Resources

FAQs

1. What are current vaccination rates for adults in Massachusetts?

While Massachusetts has often led the nation in childhood vaccination rates, vaccination rates for adults have lagged behind. See table below.

Massachusetts Adult Immunization Rates for Select Vaccines Results from the 2010 BRFSS

Ever had Zoster 60+ y/o

16%

Ever had Tdap 18+ y/o

16%

Hep B series 18+ y/o

42%

Ever had HPV females 18-26 y/o

50%

Ever had PPV23 18-64 y/o w/ diabetes

55%

Hep B  high risk 18+ y/o

61%

2. What can be done to increase adult vaccination rates?

There are many reasons for low vaccination rates among adults that have to do with the knowledge, beliefs, and practices of both providers and consumers. What is known, however, is that a person is most likely to be vaccinated if a vaccine is recommended by a trusted health care provider and the vaccine is offered on the spot.1 See graph below.

Influenza vaccination coverage among pregnant women by provider recommendation and offer, mid-November 2011

Influenza vaccination coverage among pregnant women by provider recommendation and offer, mid-November 2011

Source: CDC web site www.cdc.gov/flu/professionals/vaccination/pregnant-women.htm

3. Why pharmacists as vaccinators?

All 50 states authorize pharmacists to administer vaccines with specific authority varying by state.2 Vaccination by pharmacists is convenient, efficient, and cost-effective.3 In one study, individuals aged 65 years and older who lived in states where pharmacists could provide vaccines had significantly higher influenza vaccine rates than individuals of this age who resided in states where pharmacists could not provide vaccines.4 A 4-year pilot project in Massachusetts in which pharmacists administered more than 9,000 doses of flu vaccine demonstrated that pharmacists could safely administer vaccines and those consumers were very satisfied with the experience of being vaccinated by pharmacists.5 The success of the pilot led to general authorization of pharmacist administration of influenza vaccine in Massachusetts.

Offering vaccination in non-traditional settings can enhance the capacity of the health care system to effectively deliver vaccines to adults by increasing the number and types of sites where adults can receive vaccine.6 Pharmacists, along with primary care providers, employers, local public health, and commercial vaccinators are necessary to ensure that all adults have access to all the recommended vaccines.

4. What are the requirements for a pharmacist to administer vaccine?

The pharmacist must have a prescription, physician directive, or standing order in order to administer vaccine.

Moreover, the pharmacist is required to receive standardized training in accordance with Department regulations at 105 CMR 700.004(B)(6)(c)1.

The goals of training programs are to:

  • Provide comprehensive immunization education and training
  • Provide pharmacists with the knowledge, skills, and resources necessary to establish and promote a successful immunization service
  • Teach pharmacists to identify at-risk patient populations needing immunizations
  • Teach pharmacists to administer immunizations in compliance with legal and regulatory standards

There are three components to the certificate training program:

  • 12 hour (1.2 CEU) self-study modules with case studies and assessment exam
  • 8.0 hour (0.80 CEU) live seminar with final exam
  • Hands-on assessment of intramuscular and subcutaneous injection technique

There are additional self-study resources.

5. How will primary care providers receive information about vaccines administered to their patients by pharmacists?

The Massachusetts Department of Public Health is in the process of rolling out a statewide Immunization Information Registry (MIIS).  As providers, including pharmacists, are enrolled into the MIIS, they will be required by law (M.G.L. Chapter 111, Section 24M) to report immunization information for all patients to the MIIS. For more information on the MIIS, go to www.mass.gov/dph/miis.

6. What is the regulatory authority for this policy?

Department regulations at 105 CMR 700.004(B)(6) permit a pharmacist to “administer influenza vaccine and other immunizations designated by the Department”.  The list of immunizations in the policy constitutes those “designated by the Department”.

7. Will pharmacy students and interns be allowed to administer vaccines?

No.  Regulations only permit registered pharmacists to administer vaccines and do not extend to students or interns.

8. Are pharmacists required to report adverse events?

Yes.  Federal rules, along with this policy, require healthcare providers, including pharmacists, to report certain adverse events to the national reporting system (Vaccine Adverse Event Reporting System, VAERS).

9. Whose job is it to advise patients on their immunization needs?

In order to increase vaccination rates and ensure that adults are protected against vaccine-preventable diseases, every member of the health care team, including pharmacists, must take responsibility for assessing the immunization status and administering needed vaccines at every health care encounter.

Downloads for Joint Policy 2012-02 and FAQs on Pharmacist Administration of Vaccines

  1. CDC. Influenza Vaccination Coverage Among Pregnant Women – U.S. 2010--11 Influenza Season. MMWR 2011:60(32);1078-1082. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6032a2.htm
  2. MC Rothholz.  Pharmacists as partners in adult vaccinations. Presented to the National Adult Immunization Coordinators Partnership. August 2011. http://www.ct.gov/dph/lib/dph/infectious_diseases/immunization/naicp/pharmacists_and_adult_immunizations_final.pdf
  3. J Fontanesi, JD Hirsch, SM Lorentz, DA Bowers, J Shafrin. Comparison of Pharmacists and Primary Care Providers as Immunizers. Am J Pharm Benefits. 2009;1(3):150-157. http://www.ajmc.com/media/pdf/AJPB_Fall_Fontanesi_1-3.pdf
  4. TE. Steyer, KR Ragucci, WS Pearson, AG Mainous. The role of pharmacists in the delivery of influenza vaccinations. Vaccine 2004; 22:1001-1006. http://www.ncbi.nlm.nih.gov/pubmed/15161077
  5. J Calomo, et al.  An overview of pharmacy-based influenza vaccination programs in Massachusetts. NE J Pharm. 2004:35-39.
  6. CDC. Adult immunization programs in non-traditional settings: quality standards and guidance for program evaluation: Report of the National Vaccine Advisory Committee. MMWR 2000;49(No. RR-1):1-13.  http://www.cdc.gov/mmwr/pdf/rr/rr4901.pdf
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