The Pharmacist Immunizer: Professional Advancements Facilitated by an Evolving Legal Framework

Pharmacists have legal and/or regulatory authority to administer immunizations to patients in all 50 states, the District of Columbia, and Puerto Rico (see lead article in this report, “Authority and Scope of Vaccination: How States Differ”). With the authority to immunize, pharmacists have increased public access to wellness programs and improved health care outcomes. Since the early 1990s, various state-based statutory laws and regulations allowing pharmacists to administer immunizations have gradually evolved; today, they are solidly in place. Although the extent of pharmacists’ authority varies state by state, advancements have been made in modernizing states’ scope of practice laws and regulations. These advancements have allowed pharmacists to expand immunization offerings and work in tandem to support the health care community in a multidisciplinary manner. Pharmacist immunizing authority has evolved in 3 major areas.

Expanding Range of Vaccines

The first area involves an increase in the number of types of vaccines that a pharmacist is permitted to administer. In the beginning, pharmacists were authorized only to immunize against the influenza virus. Today, pharmacists have much more authority to administer various types of vaccines, including pneumococcal; zoster; tetanus and diphtheria toxoids/tetanus toxoid reduced diphtheria toxoid, and acellular pertussis; human papillomavirus; hepatitis B; measles, mumps, and rubella; and meningococcal, among others. This expanded authority to administer a broader range of vaccines allows more access to health care for patients at their local pharmacies, which is a safe and convenient way for them to receive immunizations in their community.

Broadening Age Groups

The second developing area relates to the age of the patient to whom the pharmacist may administer a given immunization. Initially, pharmacists were limited to treating adults (individuals 18 years or older). That has since changed; many jurisdictions now extend immunization authority to patients who are minors—even to very young children. When the revolutionary idea of allowing a pharmacist to administer vaccines was set in motion, the thought process was to allow the pharmacist to serve a more patient-centered role that was not directly linked to the traditional dispensing process typical of a pharmacy practice. Because immunization by the pharmacist was a new concept, there were restrictions based on patient age and the types of vaccines that could be administered. When the public, as well as legislators and regulators, trusted that the process could take place with limited risk, expansion of these services was allowed. A contributing factor was the public policy concept of allowing patients to have greater accessibility to a health care provider in the pharmacy. This translated into an expanded array of immunizations that could be administered to patients as well as a decrease in the age requirements for patient eligibility to be immunized by the pharmacist health care provider. In 2012, fewer than 15 states permitted pharmacists to administer a vaccination to a patient of any age. Today, that number has nearly doubled and is expected to continue to grow as new pharmacist-friendly immunizing legislation and regulation is adopted across the United States.

Independent Administration by Pharmacists

The third major area that has evolved is in allowing pharmacist independence in the overall immunization process, an important legal trend that gives autonomy to pharmacists. The initial immunizations provided by pharmacists were limited to those patients who had the required prescriptions in hand. Later, protocol-based methods allowed a pharmacist to administer an immunization without a prescription, so long as there was a state-mandated collaborative protocol (or agreement) that was delegated by an authorized health care practitioner, such as a physician. Finally, in some states, the pharmacist has independent prescribing authority and is not required to depend on a practitioner’s prescription at all, nor on a protocol-based method for immunizing.

Summary

Pharmacists are now allowed to screen patients for vaccines, make recommendations, and prescribe a vaccine before administering it. They are engaging in direct patient care that provides immediate access to immunizations without the patient having to go to a different provider-based clinic or hospital to obtain this service. This legal trend is enabling the pharmacist to offer services to patients that go well beyond the traditional role of preparing and dispensing a drug product.

Ned Milenkovich, PharmD, JD, is chair of the health care law practice at Much Shelist PC in Chicago and vice chair of the Illinois State Board of Pharmacy.