During the 2009 H1N1 outbreak, could Virginia paramedics and other EMS providers administer flu vaccines (seasonal or H1N1) under the guidance of their operational medical directors?

Plain-English summary

During the fall 2009 H1N1 influenza outbreak, the federal HHS Secretary declared H1N1 a public health emergency (74 Fed. Reg. 51,153, Oct. 5, 2009). Capacity to administer flu vaccinations was stretched. Delegate Morgan Griffith asked the Attorney General whether Virginia EMS providers (paramedics and other certified emergency medical personnel) could administer H1N1 and seasonal flu vaccinations under the guidance of their EMS agencies' operational medical directors.

Acting AG William Mims concluded that EMS providers may administer those vaccines, but only when designated and authorized by the State Health Commissioner in accordance with §§ 32.1-42.1 and 54.1-3408(P), and only when the Governor has declared a state of emergency or the HHS Secretary has declared a public health emergency, the authorization is necessary to deliver the vaccinations, and the EMS providers have received the required training. When authorized, the EMS providers act under the State Health Commissioner's direction and supervision, not under their EMS agency's operational medical director.

The reasoning starts with the Drug Control Act. Section 54.1-3408(B) authorizes a prescriber to cause drugs to be administered by EMS personnel who are certified and authorized to administer those drugs under Board of Health regulations and who are acting within the scope of certification. But the underlying regulatory definition of "emergency medical services" limits EMS work to "services used in responding to an individual's perceived needs for immediate medical care in order to prevent loss of life or aggravation of physiological or psychological illness or injury." Routine vaccination of healthy people against the flu doesn't fit that definition, the AG concluded.

The Drug Control Act elsewhere enumerates specifically who may administer vaccines:

• Subsection (I) authorizes licensed pharmacists, registered nurses, and (under supervision) LPNs to administer vaccines to adults under prescriber-approved protocols.
• Subsection (T) authorizes persons otherwise authorized to administer controlled substances in hospitals to administer influenza or pneumococcal vaccines under § 32.1-126.4.
• Subsection (W) authorizes pharmacists and nurses to administer influenza vaccine to minors under prescriber-developed guidelines per § 32.1-46.02.

EMS providers don't appear on those lists. Under expressio unius est exclusio alterius (when a statute specifies the manner of doing something, it shows intent to exclude other ways), the AG concluded the General Assembly deliberately left EMS providers off the routine vaccine-administration roster.

The escape valve is subsection (P) and the parallel § 32.1-42.1. Both let the State Health Commissioner authorize persons (which includes EMS providers) to administer drugs (which includes vaccines) when (i) the Governor has declared a disaster or state of emergency, or HHS has declared an actual or potential public health emergency; (ii) the authorization is necessary to permit the provision of needed drugs; and (iii) the persons have received the training necessary to safely administer the drugs. Persons so authorized administer drugs "under the direction, control and supervision of the Commissioner," not under the EMS agency's own medical director.

The opinion footnotes that HHS had in fact declared H1N1 a public health emergency on October 5, 2009. So the trigger was met for H1N1 specifically; the Commissioner's authorization was what then activated EMS providers to administer it.

Currency note

This opinion was issued in 2009. Subsequent statutory amendments, court decisions, or later AG opinions may have changed the analysis. Treat this page as historical context, not current legal advice. Verify current law before relying on any specific rule, deadline, or remedy mentioned here.

Background and statutory framework

Virginia's EMS regulation runs through Title 32.1, Chapter 4, Article 2.1 (§§ 32.1-111.1 to 32.1-111.15). Section 32.1-111.1 defines "emergency medical services personnel" as "persons responsible for the direct provision of emergency medical services in a given medical emergency." The Board of Health's implementing regulations (12 VAC § 5-31-10) define "emergency medical services" as services responding to an individual's perceived need for "immediate medical care in order to prevent loss of life or aggravation of physiological or psychological illness or injury." The definition includes first response, basic life support, advanced life support, neonatal life support, communications, training, and medical control.

The Drug Control Act, Title 54.1, Chapter 34 (§§ 54.1-3400 to 54.1-3472), governs the administration of drugs. "Drug" is defined to include articles or substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease (§ 54.1-3401). Vaccines for mitigation or prevention of disease meet that definition.

Section 54.1-3408(B) addresses EMS specifically: "[A] prescriber may cause drugs and devices to be administered to patients by emergency medical services personnel who have been certified and authorized to administer such drugs and devices pursuant to Board of Health regulations governing emergency medical services and who are acting within the scope of such certification." The AG read this as tied to the regulatory definition of "emergency medical services," which keys to immediate medical care, not routine prevention.

Section 54.1-3408 also enumerates specific vaccine-administration authorities: (I) pharmacists, registered nurses, and supervised LPNs administering vaccines to adults under protocol; (T) hospital controlled-substance personnel administering influenza or pneumococcal vaccines; (W) pharmacists and nurses administering influenza vaccine to minors. None of those subsections includes EMS providers.

Section 54.1-3408(P) is the emergency override. It allows the State Health Commissioner to authorize administration of drugs by persons (any persons trained to do so) during a declared emergency, with the Commissioner's protocols controlling. Section 32.1-42.1 mirrors that language in the public health emergency response chapter.

The opinion applies the canon expressio unius est exclusio alterius (citing Commonwealth v. Brown via Grigg v. Commonwealth): when the General Assembly carefully lists who may do something, the omission of others is intentional. So EMS providers were deliberately left off the vaccine-administration list except during a declared emergency.

Common questions

Can an EMS agency's operational medical director (who is a physician) just write a standing order authorizing the agency's paramedics to give flu shots?

Not under normal conditions. The opinion is clear that § 54.1-3408(B) tied to the regulatory definition of EMS does not cover routine vaccination, and the AG read the statutory carve-outs (subsections (I), (T), (W)) as exclusive lists that don't include EMS providers. The operational medical director's standing-order authority is limited to drugs administered as part of immediate medical care.

Once the Commissioner authorizes EMS providers, who actually controls what they do?

The Commissioner. Section 54.1-3408(P) and § 32.1-42.1 both say persons authorized under the emergency provisions administer drugs "under the direction, control and supervision of the State Health Commissioner." That means the Commissioner's protocols govern, not the EMS agency's standard medical control framework.

Does this apply to other vaccines, like measles or tetanus?

The opinion is keyed to flu vaccines because that was the question. The reasoning would extend to other vaccines: under normal conditions, EMS providers are not on the statutory list of vaccine administrators; under a declared emergency, the Commissioner may authorize them.

What kind of training is required?

The statute requires that EMS providers "have received the training necessary to safely administer or dispense the needed drugs or devices." Section 32.1-42.1 requires the Commissioner, in consultation with the Department of Health Professions, to develop protocols that "address the required training of such persons and procedures for such persons to use in administering or dispensing drugs or devices." The training content is set by Commissioner protocol, not by the EMS agency.

Did the Commissioner ever actually authorize EMS providers to administer H1N1 vaccinations in 2009?

The opinion does not say. It outlines the legal mechanism, but whether the Commissioner exercised that authority for the 2009 H1N1 response is a separate factual question.

Citations

• Va. Code Ann. § 32.1-42.1 (Commissioner authority during declared emergency)
• Va. Code Ann. §§ 32.1-111.1 to 32.1-111.15 (statewide EMS framework)
• Va. Code Ann. § 32.1-111.1 (defining "emergency medical services personnel")
• Va. Code Ann. § 54.1-3408(B) (EMS administration of drugs within scope of certification)
• Va. Code Ann. § 54.1-3408(I) (pharmacist and nurse vaccine administration)
• Va. Code Ann. § 54.1-3408(P) (emergency authorization for drug administration)
• Va. Code Ann. § 54.1-3408(T), (W) (hospital and minor-flu-vaccine authorizations)
• 12 Va. Admin. Code § 5-31-10 (defining "emergency medical services")
• Commonwealth v. Brown, 259 Va. 697, 529 S.E.2d 96 (2000) (expressio unius est exclusio alterius)
• 74 Fed. Reg. 51,153 (Oct. 5, 2009) (HHS Secretary declaration of H1N1 as public health emergency)

Source

• Landing page: https://www.oag.state.va.us/annual-reports-opinions/official-opinions
• Original PDF: https://www.oag.state.va.us/files/Opinions/2009/09-076-Griffith.pdf

Original opinion text

COMMONWEALTH OF VIRGINIA
Office of the Attorney General
William C. Mims, Attorney General

October 23, 2009

The Honorable H. Morgan Griffith
Member, House of Delegates
P.O. Box 1250
Salem, Virginia 24153

Dear Delegate Griffith:

I am responding to your request for an official advisory opinion in accordance with § 2.2-505 of the Code of Virginia.

Issue Presented

You ask whether Virginia law permits emergency medical services ("EMS") providers[1] to administer the H1N1 and seasonal flu vaccinations under the guidance of their respective operational medical directors.

Response

It is my opinion that emergency medical service providers may only administer vaccinations for the H1N1 flu or the seasonal flu when designated and authorized by the State Health Commissioner in accordance with §§ 32.1-42.1 and 54.1-3408(P).

Applicable Law and Discussion

The issues you raise are questions requiring the interpretation of Virginia statutes. It is well settled that "the primary objective of statutory construction is to ascertain and give effect to legislative intent."[2] "The plain, obvious, and rational meaning of a statute is to be preferred over any curious, narrow, or strained construction."[3] When the language of a statute is plain and unambiguous, a court is bound by the plain meaning of that language.[4] It is presumed "that the General Assembly acted with full knowledge of the law in the area in which it dealt."[5] The courts "assume that the legislature chose, with care, the words it used when it enacted the relevant statute."[6]

The Drug Control Act[7] governs the administration of certain drugs and vaccinations. The only provision of the Act that addresses EMS providers is § 54.1-3408(B), which provides, in part, that

a prescriber[8] may cause drugs and devices to be administered to patients by emergency medical services personnel who have been certified and authorized to administer such drugs and devices pursuant to Board of Health regulations governing emergency medical services and who are acting within the scope of such certification.

The regulations promulgated by the Board of Health define "emergency medical services" or "EMS" to mean:

the services used in responding to an individual's perceived needs for immediate medical care in order to prevent loss of life or aggravation of physiological or psychological illness or injury including all of the services that could be described as first response, basic life support, advanced life support, neonatal life support, communications, training and medical control.[9]

Article 2.1, Chapter 4 of Title 32.1, §§ 32.1-111.1 through 32.1-111.15 (codified in scattered sections), contains Virginia's laws governing statewide emergency medical services. Section 32.1-111.1 of Article 2.1 defines "emergency medical services personnel" to mean "persons responsible for the direct provision of emergency medical services in a given medical emergency." Consequently, EMS providers may only provide emergency medical services in an emergency situation and may only administer drugs when responding to an individual's need for "immediate medical care."[10] While EMS providers, such as certified paramedics and advanced life support providers, administer drugs, and start intravenous fluids, they do so in the provision of "immediate medical care" to "prevent loss of life or aggravation of physiological or psychological illness or injury."[11] It strains the definition to assert that the administration of the H1N1 and seasonal flu vaccination may be construed as a requirement for an individual's "immediate medical care."

The General Assembly clearly intends that the Drug Control Act limit the persons who are authorized to administer vaccinations. Section 54.1-3408 of the Act specifically authorizes the administration of vaccinations by certain individuals:

I. A prescriber may authorize, pursuant to a protocol approved by the Board of Nursing, the administration of vaccines to adults for immunization, when a practitioner with prescriptive authority is not physically present, (i) by licensed pharmacists, (ii) by registered nurses, or (iii) licensed practical nurses under the immediate and direct supervision of a registered nurse. A prescriber acting on behalf of and in accordance with established protocols of the Department of Health may authorize the administration of vaccines to any person by a pharmacist or nurse when the prescriber is not physically present.

....

P. In addition, this section shall not prevent the administration or dispensing of drugs[12] ... by persons if they are authorized by the State Health Commissioner in accordance with protocols established by the State Health Commissioner pursuant to § 32.1-42.1 (i) when the Governor has declared a disaster or a state of emergency or the United States Secretary of Health and Human Services has issued a declaration of an ... actual or potential public health emergency; (ii) it is necessary to permit the provision of needed drugs or devices; and (iii) such persons have received the training necessary to safely administer or dispense the needed drugs or devices. Such persons shall administer or dispense all drugs or devices under the direction, control and supervision of the State Health Commissioner.

....

T. Persons who are otherwise authorized to administer controlled substances in hospitals shall be authorized to administer influenza or pneumococcal vaccines pursuant to § 32.1-126.4.

....

W. A prescriber, acting in accordance with guidelines developed pursuant to § 32.1-46.02, may authorize the administration of influenza vaccine to minors by a licensed pharmacist, registered nurse, or licensed practical nurse under the direction and immediate supervision of a registered nurse, when the prescriber is not physically present. [Emphasis added.]

The General Assembly did not specifically authorize EMS providers to administer vaccinations through the Drug Control Act. The Supreme Court of Virginia has held that "'[w]hen a legislative enactment limits the manner in which something may be done, the enactment also evinces the intent that it shall not be done another way.'"[13] The General Assembly expressly states the persons authorized to administer vaccinations and the circumstances under which EMS providers may administer drugs. Thus, EMS providers generally are not authorized to administer vaccinations such as the seasonal flu vaccine.

Although the Drug Control Act does not authorize EMS providers to administer H1N1 and seasonal flu vaccinations under normal conditions, there are circumstances which may permit EMS providers to administer such vaccinations. Section 32.1-42.1 permits the State Health Commissioner (the "Commissioner") to authorize persons, which would include EMS providers, to administer vaccinations in accordance with established protocols:

when (i) the Governor has declared a disaster or a state of emergency or the United States Secretary of Health and Human Services has issued a declaration of an actual or potential bioterrorism incident or other actual or potential public health emergency; (ii) it is necessary to permit the provision of needed drugs or devices; and (iii) such persons have received the training necessary to safely administer or dispense the needed drugs or devices. Such persons shall administer or dispense all drugs or devices under the direction, control and supervision of the Commissioner. For purposes of this section, "administer," "device," "dispense," and "drug"[14] shall have the same meaning as provided in § 54.1-3401. The Commissioner shall develop protocols, in consultation with the Department of Health Professions, that address the required training of such persons and procedures for such persons to use in administering or dispensing drugs or devices.[15] [Emphasis added.]

Thus, the Commissioner may authorize EMS providers to dispense and administer vaccinations when: (1) it is in response to a declared state of emergency or declared public health emergency;[16] (2) it is necessary to permit the provision of the vaccinations; and (3) EMS providers have received the necessary training to administer the drugs. Should the Commissioner authorize EMS providers to administer such vaccinations, they would be under the "direction, control and supervision of the" Commissioner[17], not that of their respective EMS agency's operational medical directors.

Conclusion

Accordingly, it is my opinion that emergency medical service providers may only administer vaccinations for the H1N1 flu or the seasonal flu when designated and authorized by the State Health Commissioner in accordance with §§ 32.1-42.1 and 54.1-3408(P).

Thank you for letting me be of service to you.

Sincerely,

William C. Mims

1. For purposes of this opinion, an EMS provider is "a person who holds a valid certification issued by the Office of EMS." 12 VA. ADMIN. CODE § 5-31-10 (2008).
2. Turner v. Commonwealth, 226 Va. 456, 459, 309 S.E.2d 337, 338 (1983).
3. Commonwealth v. Zamani, 256 Va. 391, 395, 507 S.E.2d 608, 609 (1998).
4. Cummings v. Fulghum, 261 Va. 73, 77, 540 S.E.2d 494, 496 (2001); Earley v. Landsidle, 257 Va. 365, 370, 514 S.E.2d 153, 155 (1999); Ragan v. Woodcroft Vill. Apartments, 255 Va. 322, 326, 497 S.E.2d 740, 742 (1998).
5. Philip Morris USA, Inc. v. Chesapeake Bay Found., Inc., 273 Va. 564, 576, 643 S.E.2d 219, 225 (2007).
6. Barr v. Town & Country Props., Inc., 240 Va. 292, 295, 396 S.E.2d 672, 674 (1990); see also Jackson v. Fid. & Deposit Co., 269 Va. 303, 313, 608 S.E.2d 901, 906 (2005) (noting assumption that legislature chooses, with care, words that it uses).
7. VA. CODE ANN. §§ 54.1-3400 to 54.1-3472 (2009) (codified in scattered sections).
8. A "prescriber" is "a practitioner who is authorized pursuant to §§54.1-3303 and 54.1-3408 to issue a prescription." Section 54.1-3401.
9. 12 VA. ADMIN. CODE § 5-31-10 (emphasis added).
10. Id.
11. Id.
12. "'Drug' means ... articles or substances intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease[.]" Section 54.1-3401 (emphasis added). It is my opinion that in the context of mitigation and prevention of disease, a vaccination for influenza would meet the definition of a drug.
13. Commonwealth v Brown, 259 Va. 697, 705, 529 S.E.2d 96, 100 (2000) (quoting Grigg v. Commonwealth, 224 Va. 356, 364, 297 S.E.2d 799, 803 (1982) (explaining maxim expressio unius est exclusio alterius)).
14. See supra note 12.
15. I note that the language in § 32.1-42.1 mirrors that of § 54.1-3408(P) regarding public health emergencies.
16. I note that the United States Secretary of Health and Human Services has issued a declaration determining "that 2009 H1N1 influenza constitutes a public health emergency." 74 Fed. Reg. 51153, 51156 (Oct. 5, 2009), available at http://frwebgate3.access.gpo.gov/cgi-bin/PDFgate.cgi?WAISdocID=06216920089+0+2+0&WAISaction=retrieve.
17. Sections 32.1-42.1, 54.1-3408(P).