Expanding Practitioner Scopes of Practice During Public Health Emergencies: Experiences from the 2009 H1N1 Pandemic Vaccination Efforts

Abstract

In a public health emergency involving significant surges in patients and shortages of medical staff, supplies, and space, temporarily expanding scopes of practice of certain healthcare practitioners may help to address heightened population health needs. Scopes of practice, which are defined by state practice acts, set forth the range of services that licensed practitioners are authorized to perform. The U.S. has had limited experience with temporarily expanding scopes of practice during emergencies. However, during the 2009 H1N1 pandemic response, many states took some form of action to expand the practice scopes of certain categories of practitioners in order to authorize them to administer the pandemic vaccine. No standard legal approach for expanding scopes of practice during emergencies exists across states, and scope of practice expansions during routine, nonemergency times have been the subject of professional society debate and legal action. These issues raise the question of how states could effectively implement expansions for health services beyond administering vaccine and ensure consistency in expansions across states during catastrophic events that require a shift to crisis standards of care. This article provides an overview of scopes of practice, a summary of the range of legal and regulatory approaches used in the U.S. to expand practice scopes for vaccination during the 2009 H1N1 response, and recommendations for future research.

During a catastrophic public health emergency, such as a severe influenza pandemic or a wide-area anthrax attack, the provision of health care would change dramatically. Because of significant shortages of staff, supplies, and space and surges in patient volume, the focus of care would be on population health and on fairly allocating scarce resources.^1-3 Healthcare staffing resources would quickly become overwhelmed. To best meet patient needs in this shift to crisis standards of care, some national-level emergency planning efforts have recognized the option of temporarily expanding scopes of practice of certain practitioners to increase the number and flexibility of healthcare practitioners who can respond.^1,2 This article provides a summary of scopes of practice and state-level authority to vaccinate and presents an overview of scope of practice expansions used by states for vaccination during the 2009 H1N1 pandemic response to illustrate the wide range of approaches used by states to increase vaccinator numbers. It also offers recommendations for future research and action.

Scopes of Practice

Scopes of practice set forth the range of services that licensed practitioners are authorized to perform.^4,5 They are defined by practice acts and rules of a state's practitioner boards (eg, board of physicians) and, therefore, may vary by state and be modified by state legislatures.^4-6 According to one definition, scope of practice “defines those health care services a physician or other health care practitioner [eg, pharmacist, nurse practitioner, physician assistant] is authorized to perform by virtue of professional license, registration, or certification… [and] should be based on appropriate education, training, and experience.”⁴ Depending on the state and profession, “[s]ome practitioners are authorized to practice independently within their scope of practice and others are required to work under the supervision of or in collaboration with a licensed physician or other health care practitioner.”⁴ Scopes of practice are influenced by a range of factors (eg, workforce needs, financial motivations, consumer demand) and may also overlap due to some professions' sharing skills and procedures.^4,5

Practice scopes define which practitioners are authorized to administer vaccines in states. Physicians, nurses, and pharmacists most commonly administer immunizations, but, depending on the state, other types of practitioners, such as emergency medical technicians (EMTs), may also be authorized to vaccinate. Scopes of practice for various health professions authorized to vaccinate set forth such conditions as the types of vaccines (eg, influenza, hepatitis B) a particular provider may administer,⁷ for which age group the vaccinator may administer vaccine (eg, ≥14 years),⁸ and under which conditions they are permitted to administer vaccine (eg, with a physician's written protocol or standing medical order).⁹

The pharmacist profession provides an example of the complexity and variety of states' scopes of practice for vaccination. Pharmacists may now vaccinate in all 50 states and the District of Columbia, but limits on their authority to vaccinate vary by state.¹⁰ Some states have no age restriction for patients to whom pharmacists may administer vaccine.¹¹ In other states, the age ranges vary, such as ≥18 years or ≥14 years of age, or ≥10 years of age for influenza vaccine but ≥18 years of age for other vaccines.¹¹ Several states allow pharmacists to administer only influenza and/or pneumococcal vaccine, while others have no restrictions on the type of vaccine.¹¹ Despite the state-level differences, the profession has become increasingly interested in administering vaccines.¹²

In addition to scope of practice variations across states and professions during normal, nonemergency care situations, no standard or consistent approach to expanding scopes of practice exists during emergencies. Therefore, during an emergency that affects multiple states at the same time, such as an influenza pandemic, each state may ultimately take different actions to respond. Some states may decide not to expand scopes of practice for any practitioners. Those states that decide to implement expansions of practice scopes may, for example, adopt different approaches to the type of practitioner(s) they authorize to act outside of the normal scope, the types of “new” services they may provide only during the emergency, or the level of supervision required. Further complicating such scenarios are the differences in states' legal approaches to responding to health emergencies.^2,13 Therefore, the required mechanisms (eg, public health emergency declaration, executive order) that allow temporary expansions, as well as their dates of enactment and termination, may also vary across states.

2009 H1N1 Pandemic Vaccination

Methodology

The H1N1 pandemic provides an illustration of practice expansions for influenza vaccine administration. To assess the extent of expansions during the H1N1 response, we conducted an internet search of the 2009 H1N1 pandemic, health department, public safety, and/or gubernatorial websites in all 50 states and the District of Columbia, as well as the Association of State and Territorial Health Officials (ASTHO) website,¹⁴ to identify states that expanded scopes of practice for vaccination during the pandemic response. For those states that were found to have expanded practice scopes for vaccination, we identified and reviewed the legal and regulatory mechanisms for the expansions, as well as the conditions and limits of the expansions, by looking at laws and regulations through the states' websites. Officials from several state health departments were contacted by e-mail to clarify information found online.

Findings

The 2009 H1N1 influenza response provides an example of the wide variation that can occur at the state level when practice scopes are temporarily expanded to address local medical and public health workforce shortages during emergencies. At least 14 states (and DC) that we reviewed took some action related to scope of practice expansions during the pandemic, but across these states no common, consistent approach was used. There were significant differences in the legal and regulatory mechanisms used to implement the expansions, as well as in the ranges, conditions, and time frames of them.

Legal and regulatory approaches to expand scopes of practice included, but were not limited to, executive order,¹⁵ gubernatorial proclamation,¹⁶ state department of health proclamation,¹⁷ board of pharmacy order,¹⁸ emergency regulation,¹⁹ and expansion of the local emergency medical services (EMS) authority.²⁰ Most of the actions were limited, such as expanding the age range of patients to whom pharmacists could administer vaccine¹⁸ or authorizing EMTs to vaccinate.²¹ However, others authorized multiple types of practitioners (eg, physician assistants, pharmacists, podiatrists, midwives, dentists, certain dental hygienists, specialist assistants, and advanced EMTs) to administer the H1N1 vaccine.²²

Conditions for providing services under the expansions varied but included acting under a protocol (ie, without a physician's individual prescription),²³ under the direction of a medical director,¹⁷ or after receiving training.^17,21 Limitations could have several conditions. For example, in Indiana, if the pharmacist administered an influenza immunization according to a protocol, then the conditions varied by type of vaccine.¹⁸ For the injectable H1N1 vaccine, the age range was from 9 years of age up to 18 years, “if the pharmacist receives the consent of a parent or legal guardian, and the parent or legal guardian is present at the time of immunization.”¹⁸ For the nasal H1N1 live virus vaccine, the age range was 2 years of age but less than 18 years with the same requirements for parental/legal guardian consent and presence as for the injectable vaccine, or 18 years.¹⁸ In New York, specific conditions were outlined in an executive order by type of practitioner.²²

Several states offered online, just-in-time instruction programs to train practitioners on vaccine administration.^24,25 The effective start and termination dates of the expansions varied (eg, December 14, 2009, to June 30, 2010; November 6, 2009, to February 8, 2010).^15,18,26,27 Examples of different approaches taken to expand vaccination scopes of practice by 15 of the states (including DC) that we reviewed are briefly outlined in Table 1. Following are short case studies of scope of practice actions taken in 3 states during the pandemic:

Table 1.

Examples of Actions Taken to Expand Scopes of Practice During the 2009 H1N1 Pandemic for Vaccine Administration, by State

State	Practitioner(s)	Scope of Practice Expansion(s)	Approach
California	Paramedics	Expanded paramedic scope of practice to permit administration of vaccines under a local optional scope of practice.	Local EMS act²⁰
District of Columbia	Pharmacists	Permitted pharmacists to administer pneumococcal and influenza vaccinations, including H1N1, to any person age 18 and older pursuant to a written protocol and standing order with a DC-licensed physician.	Municipal regulation rule³⁵
Georgia	Pharmacists; registered nurses	Allowed physicians to enter into protocol agreements with pharmacists and registered nurses to allow the ordering and dispensing of influenza vaccine without a physician's individual prescription; physicians could not order more than 10 standing orders with these practitioners within the same county or adjacent county to the physician's primary place of business; addressed corporate entities (eg, drugstores).	Legislation²³
Illinois	EMTs (intermediate and paramedic); pharmacists; dentists; certain medical, nursing, and pharmacy students	Modified existing EMS act to authorize those licensed or certified under the act to administer H1N1 and seasonal influenza vaccines according to state department of public health instructions after completing a training program; modified scope of practice for licensed pharmacists to permit them to administer H1N1 and seasonal influenza vaccine to people ≥9 years of age.	Gubernatorial proclamation;¹⁶ department of public health proclamation;¹⁷ department of financial and professional regulation proclamation³⁶
Indiana	Pharmacists	Expanded the age range of individuals for which pharmacists can provide vaccine by type of vaccine.	Board of pharmacy order¹⁸
Louisiana	Pharmacists	Authorized certain pharmacists to administer influenza vaccinations by protocol rather than by a written physician prescription.	Emergency order and protocol²⁶
Maine	Pharmacists	Authorized pharmacists to administer all forms of influenza vaccine, as well as other types of vaccines, to a person ≥ 9 years of age with a prescription.	Legislation and emergency rules^37,38
Maryland	EMTs (paramedic); cardiac rescue technicians (CRTs); pharmacists	Authorized EMTs-P and CRTs to administer H1N1 vaccine to public safety personnel, healthcare providers, and the general public; granted licensed, certified pharmacists authority to vaccinate adolescents ages 13 and older.	Executive orders;^30,31 secretary of health and mental hygiene order³²
Massachusetts	Dentists; paramedics; pharmacists; medical and nursing students	Authorized the commissioner of public health to designate certain healthcare professionals and medical and nursing students to administer seasonal influenza and H1N1 vaccine.	Emergency regulations¹⁹
Minnesota^a		Expanded the existing authority of the commissioner of health to authorize any person, including, but not limited to, certain EMTs, dentists, pharmacists, podiatrists, and veterinarians, to administer vaccinations when a local board of health requests the commissioner's assistance to respond to events threatening public health.	Legislative expansion of existing authority³⁹
New York	Physician assistants; pharmacists; podiatrists; midwives; dentists; dental hygienists; specialist assistants; advanced EMTs	Allowed certain healthcare practitioners to administer seasonal and H1N1 influenza vaccine at points of dispensing (PODs) under limited circumstances.	Executive order²²
North Carolina	Unlicensed assistive personnel	Allowed licensed nurses to delegate technical (not professional judgment or decision-making) aspects of administration of vaccines during defined immunization campaigns to unlicensed assistive personnel consistent with agency policy and procedure.	Board of nursing position statement⁴⁰
Ohio	EMTs (intermediate and paramedic)	Authorized EMTs-I and EMTs-P to perform H1N1 immunizations and administer H1N1-related drugs under physician medical direction and appropriate training.	Emergency proclamation⁴¹
Texas	Pharmacists	Authorized pharmacists to administer influenza vaccine to individuals over the age of 7 years without an established physician-patient relationship.	Legislation⁴²
Washington	Certain EMS personnel	Clarified that EMS providers may vaccinate only under certain conditions, including a local or state declaration of an emergency under RCW 38.52, the local declaration is by the local executive, an emergency incident mission number has been issued, the EMS providers are registered as emergency workers under state law, and the EMS providers are acting under the direction of the director of local or state emergency management or the appointed incident commander.	Letter/memo⁴³

However, no requests were received for assistance rhar required the Commissioner of Health to invoke Minn. Star. $144.4197 to expand scopes of practice during the H1N1 pandemic. Personal communication, Minnesota Department of Health, Office of Legislative Relations. June 21, 2010.

Maryland

Prior to the 2009 H1N1 pandemic, EMTs-Paramedic (EMTs-P) were authorized under Maryland law to administer influenza and hepatitis B vaccine and tuberculosis skin testing to public safety personnel in nonemergency environments.⁷ Pharmacists were authorized to administer vaccines to adults.²⁸ On May 1, 2009, Maryland's governor declared a health emergency.²⁹ The governor issued an executive order on November 6, 2009, granting the Secretary of the Maryland Department of Health and Mental Hygiene (DHMH) the authority to authorize additional categories of health practitioners with appropriate training and experience to administer the H1N1 vaccine.¹⁵ In addition, the order permitted EMTs-P and licensed Cardiac Rescue Technicians (CRTs) to administer H1N1 vaccine to public safety personnel, healthcare providers, and the general public. In accordance with the governor's executive order (which was renewed on December 11, 2009, and again on January 8, 2010), the DHMH secretary also issued an order on December 11, 2009 (renewed on January 14, 2010), to allow licensed, certified pharmacists to vaccinate individuals ages 13 and older.^30-32

On February 8, 2010, DHMH announced that the governor's order declaring a public health emergency had expired because the pandemic ceased to be “a serious and continuing public health emergency.”²⁷ The agency also announced that the secretary's order authorizing EMTs-P and CRTs to administer H1N1 vaccine to the general public had expired.²⁷ Therefore, EMTs-P in Maryland are no longer permitted to vaccinate the general public, CRTs are no longer permitted to administer vaccines, and pharmacists may no longer vaccinate those aged 13 to 17 years against H1N1.

New York

Physicians, certified nurse practitioners, pharmacists, and nurses are authorized to administer vaccines under existing New York State law.³³ On October 28, 2009, New York's governor declared a disaster emergency under an executive order.²² The intent was to give local health departments additional flexibility and personnel to “quickly and efficiently vaccinate as many individuals as possible” when H1N1 vaccine became readily available, after the health departments reported that their existing workforces were not sufficient to execute the mass vaccination campaign.^33,34 The executive order suspended a section of state law to enable other types of healthcare workers—physician assistants, specialist assistants, dentists, certain dental hygienists, pharmacists, midwives, podiatrists, and advanced EMTs—to administer H1N1 and seasonal influenza vaccine after undergoing training and while working under the direction of the state or county health departments' mass vaccination clinics.^22,33 For each of these professions, specific conditions were outlined in the order. The order, which had a 30-day time frame, specified that it “shall not expand the scopes of practice of these professionals to allow them routinely to administer vaccinations, but rather will allow them to vaccinate only under the extremely limited circumstances described in and for the duration of this Order.”²²

Ohio

Under Ohio law, the scope of practice for first responders, EMTs-Basic (EMTs-B), EMTs-Intermediate (EMTs-I), or EMTs-P may be expanded to allow them to perform immunizations and administer drugs (in relation to the emergency) when the governor issues a declaration of an emergency that affects the public's health.²¹ These providers must be under physician medical direction and also receive training. On April 28, 2009, the Ohio governor signed a proclamation of emergency to authorize state agencies and personnel to assist with receiving and moving H1N1 influenza medicine and supplies.⁴⁴ On October 7, 2009, the governor issued an emergency proclamation regarding the H1N1 vaccine and authorized an expansion in the scope of practice of EMTs-I and EMTs-P to administer H1N1 immunizations and drugs.⁴¹ The state provided eligible EMTs with a comprehensive online training module.²⁵ The EMTs administered vaccine at school clinics, served as community advocates by distributing H1N1 vaccine fliers, and assisted in crowd management for vaccine lines.⁴⁵

Discussion

Because there have been few disasters that require practitioners to act outside of their normal duties to meet urgent patient needs, the U.S. has had limited experience with temporarily expanding scopes of practice during public health emergencies. The 2009 H1N1 influenza pandemic provides an example of such an emergency, with some states using scope of practice expansions for vaccination to maximize the use of healthcare practitioners and supplement provider shortages across states. The experience of administering H1N1 pandemic vaccine illustrates the wide variation and complexity in state approaches to expanding scopes of practice during emergencies for just one type of healthcare service.

No standard legal approach for expanding scopes of practice for vaccination during emergencies exists in states. While some states may have preexisting laws or regulations for expanding practice scopes that are triggered upon the declaration of an emergency (or may already authorize a sufficient range of practitioners to administer vaccine during routine, nonemergency care), others may have to draft or issue special emergency declarations or orders to expand scopes of practice. States need some level of flexibility to best address local disaster needs and work within existing laws and regulations. However, having to draft and implement special orders during an emergency could delay the response. Also, inconsistencies across states in terms of which professions may vaccinate and under what conditions (eg, standing medical orders, age restrictions) may lead to significant response inefficiencies that could have a negative effect on public health. For example, such variations could result in response delays due to having to follow a variety of sometimes complex state legal and regulatory approaches for retail pharmacy chains operating in multiple states. Furthermore, the differences may be confusing for the public.

The variations in approaches and implementation for vaccination also raise the question of how smoothly broader practice expansions—that is, for healthcare services beyond vaccination—for a wider range of health practitioners could be executed in crisis situations. As with the case of administering vaccine, no standard legal approach for expanding scopes of practice exists across states. Response consistency across health facilities and jurisdictions is critical, though, for the equitable provision of care.¹ Such inconsistencies can negatively affect public health by slowing responses and leading to care inequities. For healthcare practitioners who are volunteering out-of-state during an emergency, they may also lead to confusion about liability protections.⁴⁶ Assessing which approaches work well, why some approaches may face implementation challenges, and which types of expansions practitioners are comfortable with and the public is willing to accept could aid in developing best practices for states. Resolving these legal and practice issues in advance of disasters and increasing legal consistency in extending practice for a range of healthcare providers and services would lead to efficiencies in response that could mitigate morbidity and mortality during emergencies.

An issue that could further complicate the use of practice expansions during emergencies is that changes in scopes of practice “are among the most highly charged policy issues facing state legislators and health care regulators.”⁴ Expanding practice scopes during routine times has been the subject of legal action and debate, as some professions have concerns about overlap with their own scope of practice.^5,6,47 Administering vaccine appears to be a relatively noncontroversial area of overlap in practice scope. However, based on the ongoing debate in some professional societies, other areas of practice will likely be more challenging.

Expanding the pool of immunizers during health emergencies could have several important public health implications. When sufficient quantities of vaccine are available, increasing the number of qualified vaccinators could result in increased vaccination rates and speed of vaccine administration. This, in turn, could lead to improved population health by decreasing vaccine-preventable morbidity and mortality. Lessons from the H1N1 pandemic could potentially have even broader population health implications. Public health agencies face serious workforce shortages.^48-50 Adult immunization rates are so low that they annually lead to an “estimated 40,000 to 50,000 preventable deaths … and $10 billion in preventable health care costs.”⁵¹ Permanently expanding certain practitioners' practice scopes to administer influenza and possibly other vaccines could help address some public health workforce shortage issues, which would likely contribute to increased vaccination rates and lower incidence of vaccine-preventable diseases. It could also ensure that states have a cadre of professionals ready to respond without the requirement of special legal action and training during an emergency necessitating mass vaccination.

Our research was intended only to provide an overview of states' approaches to expanding scopes of practice for H1N1 vaccination efforts and the variation in these actions. To further assess the feasibility and acceptability of expanding practitioner scopes of practice for vaccination (as well as for other types of healthcare services during emergencies) and to ensure a more comprehensive analysis of all states' actions during the H1N1 response, additional research is needed. To better understand the practical, legal, and regulatory successes and challenges associated with expanding scopes of practice during the H1N1 response, in-depth interviews should be conducted with key informants (eg, state legal counsel, professional board officials, etc) in each state involved in expanding scopes of practice. An assessment of the number of additional vaccinators—by type of practitioner—that the expansions made available and the resulting impact on vaccination rates would provide an example of how successful this strategy could be for future emergencies. Interviewing practitioners who were temporarily authorized to administer H1N1 vaccine would provide insight into their perspective. Querying states that chose not to temporarily expand scopes of practice for immunization could shed additional light on challenges and feasibility with the approach. Finally, research is needed to identify state legal and regulatory concerns with expanding scopes of practice beyond vaccination during situations requiring a shift to crisis standards of care and to assess states' perceptions of whether practice scope expansions could help address public health workforce shortages for routine immunizations.

Conclusion

The approaches of states described in this article demonstrate that temporarily expanding scopes of practice to improve vaccine access is considered to be a feasible and important public health response strategy. However, expanding scopes of practice during health crises, even if temporarily, should be used only to maintain or improve access to health care and be provided by practitioners with the appropriate level of training and oversight. Emergency practice expansions should “ensure that the public is protected from unscrupulous, incompetent and unethical practitioners; offer some assurance to the public that the regulated individual is competent to provide certain services in a safe and effective manner; and provide a means by which individuals who fail to comply with the profession's standards can be disciplined.”⁵²

While some states appeared to successfully expand scopes of practice for administering influenza vaccine during the 2009 H1N1 pandemic, the approach was not used to its full potential because ample supplies of H1N1 vaccine became available as vaccine demand started to decrease. In addition, any inefficiencies and confusion resulting from the diverse approaches, conditions, and time frames for expanding scopes of practice for vaccination are not known to have seriously affected the recent pandemic response. However, they could lead to significant response challenges, delays in providing care, and confusion during more catastrophic public health emergencies. Therefore, planning for temporarily expanding healthcare practitioner scopes of practice for disasters and assessing the extent to which states should align their approaches is needed now, before the next crisis occurs.

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State of Ohio. Proclamation of Emergency. April 28, 2009. http://www2a.cdc.gov/phlp/docs/H1N1%20Influenza%20SNS%20042809.pdf. 2010 June 28.

45.

Cunningham

. Panelist, H1N1 Vaccination Campaigns: Integrated Communication, Distribution, and Administration Strategies. Institute of Medicine Regional Workshop Series: Raleigh, NC, April 15, 2010.

46.

See, e.g.National Conference of Commissioners on Uniform State Laws. Uniform Emergency Volunteer Health Practitioners Act. November 1, 2007. http://www.uevhpa.org/DesktopDefault.aspx?tabindex=1&tabid=69. 2010 July 3.

47.

Sorrel

. Organized medicine pushes back on expansions of scope of practice. Am Med News, January 18, 2010. http://www.ama-assn.org/amednews/2010/01/18/prl20118.htm. 2010 July 27.

48.

Perlino

. The Public Health Workforce Shortage: Left Unchecked, Will We Be Protected? American Public Health Association, September 2006. http://www.apha.org/NR/rdonlyres/8B9EBDF5-8BE8-482D-A779-7F637456A7C3/0/workforcebrief.pdf. 2010 July 27.

49.

National Association of County and City Health Officials. Local Health Department Job Losses and Program Cuts: Overview of Survey Findings from January/February 2010 Survey, May 2010. http://www.naccho.org/topics/infrastructure/lhdbudget/upload/Job-Losses-and-Program-Cuts-5-10.pdf. 2010 July 27.

50.

“In Los Angeles County, public health nurses who normally staff a [screening] clinic … for tuberculosis, treat teens for sexually transmitted diseases, and vaccinate children against illnesses, were pulled off those duties to help staff H1N1 vaccination clinics.” Trust for America's Health. Shortchanging America's Health: A State-by-State Look at How Public Health Dollars Are Spent and Key State Health Facts, March 2010. http://healthyamericans.org/assets/files/TFAH2010Shortchanging05.pdf. 2010 July 27.

51.

Trust for America's Health, Infectious Diseases Society of America, Robert Wood Johnson Foundation. Adult Immunization: Shots to Save Lives, February 2010. http://healthyamericans.org/report/73/adult-immunization-2010. 2010 July 27.

52.

Schmitt

, Shimberg

. Demystifying Occupational and Professional Regulation: Answers to Questions You May Have Been Afraid to Ask. Council on Licensure, Enforcement and Regulation. 1996, cited in National Council of State Boards of Nursing. Changes in Healthcare Professions' Scope of Practice: Legislative Considerations. October 2009. https://www.ncsbn.org/ScopeofPractice.pdf. 2010 July 27.