Constitutions provide the legal framework for government entities to act. Constitutions often provide protections against certain government actions, such as due process restrictions on state licensure actions against pharmacists. However, constitutions rarely describe specific legal authorizations or restrictions for licensed health care professionals (e.g., whether pharmacists can administer vaccines).

Statutes are laws passed by state legislative bodies that authorize or prohibit certain activities. Statutes can also authorize executive agencies, such as a state health department or licensing authority, to promulgate regulations. Statutes are powerful legal authorities that can significantly change pharmacists’ vaccination authority. However, passing or amending statutes requires opportunity and political will that are not always present.

Regulations are laws promulgated by executive agencies to provide procedural or substantive specifics as to what the law authorizes or prohibits. Regulations are powerful tools to refine pharmacists’ vaccination authority, but new regulations must be consistent with their statutory authorization. For example, a regulation cannot authorize pharmacists to administer the human papillomavirus (HPV) vaccine to minors if the statute restricts pharmacist vaccinations to adult patients. State statutes require executive agencies to undergo a rule-making process before implementing new regulations which can last several months to several years.

Governors can issue executive orders that direct executive agencies’ implementation of their statutory authority. In some cases, statutes will provide governors authority to modify statutory or regulatory requirements in specified circumstances and may allow governors to expand pharmacists’ vaccination authority for outbreak response after declaring a state of emergency. Unlike regulations, these orders have no formal process to implement, revise, or revoke. Consequently, new administrations will frequently summarily revoke old executive orders from previous administrations to promote a new agenda. Executive orders cannot contradict a statute or regulation.

State agencies can provide guidance to aid the public with understanding the requirements of statutes and regulations. Agency guidance must be consistent with existing statutes and regulations. Moreover, courts view agency guidance as persuasive but not binding. In many cases, courts are free to ignore agency guidance when interpreting statutes or regulations.

States can incorporate guidance from external entities, such as nongovernmental organizations or the federal government, into their legal authorities. Some states incorporate the Advisory Committee on Immunization Practices (ACIP)–recommended vaccinations by reference in their statutes and regulations. States that adopt this approach allow statutes and regulations to adapt to advances in practice, industry, and evidence. However, incorporation by reference might be prohibited in some states, and external guidance and recommendations cannot be contrary to the state’s statutes or regulations.

Understanding these authorities is critical to understanding the extent to which pharmacists have the legal authority to improve access to vaccination services.¹⁹ State laws place significant limitations on pharmacists’ scope of practice, including restrictions on the types of vaccines that pharmacists can administer and the patient groups that pharmacists can serve, among other practice requirements.

Statutes and regulations have the most impact and are the most lasting legal authorities on pharmacists’ scope of practice. Examining the changes to these authorities over time would provide important insights on the states’ experience with pharmacists’ vaccination authorities and provides hints of future national trends. We examined statutes and regulations specifically because they are the foundation of pharmacists’ scope of practice authority.

Many states passed laws authorizing pharmacists to administer vaccines to improve vaccination access with the assumption that increased access will improve vaccination rates.² The study of the effect of law on health outcomes, called legal epidemiology, represents a new era in the field of public health law. Legal epidemiology differs from traditional legal research methods, which suffer from transparency and reliability issues, by using scientific research principles to enhance transparency, reliability, and validity of the research results.

With the use of legal epidemiology methods, we created a robust legal dataset that can be used in research to identify the specific attributes of laws that have the greatest effect in achieving the desired outcome. We announced the existence this legal dataset previously (The research protocol for the dataset of pharmacist vaccination laws is available as a Supplemental Appendix online).²⁰ This dataset of pharmacist vaccination laws is publicly available and contains information on more than 200 legal attributes. These data enable ongoing and future research on the specific types of laws that best promote population vaccination and other desired outcomes. Pharmacists, professional associates, and policymakers can use this data and derivative research to better understand how specific types of pharmacist vaccination laws affect health outcomes.¹⁸

Initial searches used specific terms identified in trade organization data, for example, “influenza,” “zoster,” “protocol,” “prescription!,” and “standing order.” These initial searches were deemed to be too narrow. We designed subsequent searches to be comprehensive, repetitive, and redundant.

Laws containing language regulating pharmacists’ vaccination authority must contain a word indicating the regulated profession (i.e., pharmacy, pharmacist) and a word indicating the regulated practice (i.e., vaccination, immunization). Consequently, we used repeated searches containing “pharmac!,” and “vaccin!” or “immuniz!.” We also used searches using “pharmac!,” and “administ!” to capture laws without express vaccination language (e.g., administration of drugs). After we found 1 state regulation that used the colloquialism “flu shot” instead of formal terminology, we searched all jurisdictions for “pharmac!” and “flu” or “shot.”

We identified historical versions of laws with the use of Westlaw’s annotations (e.g., to identify renumbered laws), Westlaw’s historical archives (e.g., to obtain prior text), and, in rare cases, publicly available state regulatory and legislative resources (e.g., to identify or reconstruct earlier text when the Westlaw resources were exhausted). The earliest law we identified was from 1971, but most jurisdictions did not have relevant laws before 1990. We ended our search for historical laws when a jurisdiction’s laws no longer contained relevant text. For example, New York defined the practice of pharmacy in 2008 as including the administration of “drugs, medicines, and therapeutic devices,” but the earlier version of the law, in effect since 1971, did not include a provision relating to the administration of substances. We retained this 1971 law to capture the status of law before the introduction of administration authority and to indicate that no earlier versions of this New York law were relevant to pharmacists’ vaccination authority.

We used a 4-stage coding process to develop the coding questions to analyze the laws. The 4 stages were: 1) development of a question set; 2) testing questions on a batch of legal provisions; 3) analysis of question adequacy; and 4) revision of questions. This iterative process resulted in 10 revisions to the coding questions and identified 220 legal variables of pharmacist vaccination authority.

Each jurisdiction’s laws were coded against these 220 legal variables by trained legal researchers using Public Health Law Research’s policy surveillance tool Workbench. All laws in effect on January 1, 2014, and later were redundantly coded by 2 blinded legal researchers. For the laws in effect before 2014, 2 blinded legal researchers coded 10 jurisdictions and a single legal researcher coded the remaining 41 jurisdictions’ laws. Coding meetings determined consensus codes when redundant coding was used.

The 220 distinct attributes fall within 4 broad categories of pharmacist vaccination law variables. The first category covers the fundamental questions of whether pharmacists can administer substances generally and administer vaccines specifically. The second category addresses additional practice requirements for pharmacists who administer vaccines, including: 1) training and education; 2) state certification or notification; 3) record-keeping; 4) reporting; 5) liability insurance; 6) patient notification; 7) facility requirements for administration; and 8) authorizations for pharmacists to opt out of vaccination services. The third category relates to requirements for a third-party prescriber authorization for vaccine administration, including provisions that grant pharmacists prescriptive authority, require a patient-specific third-party prescriber authorization, and permit use of general authorizations to vaccinate a specified group of patients (e.g., standing orders). The fourth category covers restrictions (i.e., patient age, vaccines, modes of vaccine administration) that are specific to a type of authorization.

Public Health Law Research conducted independent evaluation and quality control for the final dataset values with the use of comparison data from 2 different secondary sources.^23,24 Independent evaluators compared 2 random samples of our findings (25 states each) with data from these 2 secondary sources. The independent evaluators found 1 coding difference for each of the secondary sources, but determined that these differences were due to differences in coding scheme (as opposed to coding error).²⁰

We evaluated a subset of this dataset’s attributes to determine whether jurisdictions expanded or restricted pharmacist vaccination authorities over time (i.e., those attributes that relate to the substantive scope of practice rather than practice requirements such as reporting or recordkeeping). To accomplish this, we used Microsoft Excel to assess whether each change in the law was an expansion, restriction, regulatory clarification, or no change to the scope of pharmacist vaccination authority using the following groups of legal variables:

Vaccine authorization type (3 variables)

Changes to the laws were coded as regulatory clarifications if the change was a regulatory change occurring subsequent to a statutory change that was ambiguous or silent, or that otherwise deferred to executive agencies for clarification. The first change in a jurisdiction’s law expressly authorizing vaccination was omitted from this analysis. Changes were deemed to be unclear if they included at least 1 criterion indicating an expansion and 1 indicating a restriction of vaccination authority. The full dataset, codebook, protocol describing the validation process, and full text of all included laws are publicly available (the protocol is included as a Supplemental Appendix to this article online).²⁰

We identified 47 jurisdictions with express language relating to pharmacists’ authority to administer vaccines. The remaining 4 jurisdictions (AL, MS, TN, and WA) had laws authorizing pharmacists to administer drugs. The legal definition of “drugs” in all of these states include substances that are intended for use in the “prevention of disease” or “intended to affect the structure or any function of the body.”^30–33 We did not find legal language prohibiting pharmacists from vaccinating in these states.

The longitudinal analysis revealed widespread adoption of laws authorizing administration pursuant to general authorizations and a recent trend to grant pharmacists prescriptive authority to administer vaccines without a third-party prescriber authorization. Despite an increasing number of jurisdictions with express vaccination laws, the number of jurisdictions requiring pharmacists to have a patient-specific order has remained relatively stagnant (Figure 1).

As of 2016, 10 jurisdictions permitted pharmacists to administer a vaccine without a third-party prescriber authorization in some circumstances (AZ, CA, ID, LA, ME, MT, NH, SD, WV, WY). Thirty-five jurisdictions had laws that permit use of general authorizations, such as standing orders, to vaccinate patients (AK, AR, AZ, CA, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, MD, ME, MN, MO, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, VT, WI, WV). Five jurisdictions had statutes or regulations that do not specifically authorize the use of general authorizations or grant prescriptive authority (CO, CT, MA, MI, NE); however, the laws in these states did not expressly prohibit general authorizations, either.

Our analysis also revealed a dramatic decrease in minimum patient age restrictions. In 2005, 19 jurisdictions had express patient age restrictions, with an average minimum age of 16.8 years (median 18, mode 18; 10 states did not have express patient age restrictions). By 2016, the average minimum age dropped to 8.76 years (median 7, mode <1) and the number of jurisdictions with express age restrictions increased to 39 (8 states did not have express patient-age restrictions). This drop in average age restrictions indicates that more states are adopting or amending laws that permit pharmacists to vaccinate younger patients.

As of 2016, 7 jurisdictions limited pharmacist vaccinations to adult patients (CT, DE, FL, MA, NY, VT, WV). The remaining states had minimum patient age restrictions of 14 years (HI, NC), 12 years (ID, MT, SC), 10 years (IL), 9 years (KY, MD, PA, RI), 7 years (AR, LA, ME, NJ, OH, OR, WY), 6 years (AZ, IA, KS, MN, WI), 5 years (ND), and 3 years (CA). Eight jurisdictions had laws with language indicating no minimum patient age restriction (AK, DC, GA, IN, MO, NH, NV, VA), and 8 states (CO, MI, NE, NM, OK, SD, TX, UT) did not mention patient age restrictions (AL, MS, TN, and WA do not have express vaccination laws).

We also identified a clear trend for jurisdictions to authorize pharmacists to administer more vaccines (Figure 2). Three types of laws contributed to this trend: laws that expressly list vaccines pharmacists are authorized to administer; laws that authorize administration of any ACIP-recommended vaccine; and laws that do not have express language restricting the authority to administer specific vaccines. Changes to vaccine restrictions were common among pharmacist vaccination laws.

Recently, many jurisdictions have removed vaccine-identifying language in favor of language that authorizes any ACIP-recommended vaccine or does not expressly limit the administration of any vaccine. In 2016, 8 states authorized the administration of ACIP-recommended vaccines (CT, FL, ID, MD, ME, NC, OH, SC), 10 states had laws with language indicating that there are no restrictions on vaccine types (AR, AZ, HI, IA, IN, MN, ND, NM, NV, RI), and 21 states did not have language in statutes or regulation to indicate restrictions on vaccine types (AK, CA, CO, DC, DE, IL, KS, KY, LA, MI, MT, NE, NJ, OK, OR, PA, TX, UT, VA, VT, WI).

Numerous studies have identified the importance of state laws to pharmacist-administered vaccinations.^2,3,17,19,34 We are aware of no other study of state pharmacist vaccination laws that measures more state law requirements (more than 200) over a greater time period. We make this data publicly available in recognition that future research is critical to understanding the types of laws that best facilitate increased vaccination rates.²⁰ However, we note that this research reveals a number of important preliminary findings relating to the impact of state law on vaccination rates.

The literature indicates that the first significant pharmacist vaccination programs occurred in the mid-1990s. Our data include laws in effect before the 1990s. These laws do not expressly mention vaccine administration. However, they do contain language that could be interpreted to authorize vaccination. For example, many laws authorize the administration of “drugs,” which are often legally defined so broadly (e.g., substances that prevent disease or “affect the structure or any function of the body”) that vaccines could reasonably be included. These laws in effect before the first major pharmacist vaccination programs in the 1990s were included for completeness.

This study evaluates only state statutes and regulations relating to pharmacists’ vaccination authority. Although statutes and regulations form the foundation of pharmacists’ legal authority, they are not the only relevant authorities that impact variations in pharmacist practice between jurisdictions (see above). Moreover, states with broadly worded laws could provide expansive interpretations of the law through agency guidance. For example, Washington was among the first states to permit pharmacists to administer vaccines, but it is 1 of the 4 states that does not have express vaccination language (it authorizes drug administration). State agencies have the authority to provide pharmacists guidance on how to interpret laws, but this informal guidance cannot contradict the state statutes or regulations. Similarly, expert organizations (e.g., ACIP) provide recommendations on vaccine administration, but state statutes and regulations ultimately limit pharmacists’ ability to follow these recommendations as well.