Source: https://portal.ct.gov/AG/Opinions/2001-Formal-Opinions/Senator-George-Jepsen-State-Capitol-2001003-Formal-Opinion-Attorney-General-of-Connecticut
Timestamp: 2019-06-24 23:29:31
Document Index: 12540833

Matched Legal Cases: ['art 314', '§ 314', '§ 20', '§ 20', '§ 20', '§ 20', '§ 20', '§ 20', '§ 20', '§ 20', '§ 20', '§ 20', '§ 20', '§ 20', '§ 20', '§ 20', '§ 208', '§ 20', '§ 20', '§ 20', '§ 20', '§19', '§ 19', '§ 1', '§ 1', '§ 4', '§ 20', '§ 321', 'art 208', '§ 208', '§ 20', '§ 20', '§ 20', '§ 20', '§ 20']

Senator George Jepsen State Capitol 2001003 Formal Opinion Attorney General of Connecticut
Current: Senator George Jepsen, State Capitol, 2001-003 Formal Opinion, Attorney General of Connecticut
Senator George Jepsen
In response to your request, this is a formal opinion regarding whether advanced practice registered nurses ("APRNs"), licensed nurse-midwives and physician assistants in Connecticut are authorized to dispense, prescribe and administer the drug mifepristone (brand name "Mifeprex", also known as "RU-486") to women in licensed clinics for the purpose of terminating early pregnancies in a non-surgical manner. On September 28, 2000, the United States Food and Drug Administration ("FDA") approved the use of mifepristone for the medical termination of intrauterine pregnancy through 49 days of pregnancy. The FDA, however, placed certain conditions on the distribution of mifepristone. Among other conditions, the drug will be distributed directly to qualified physicians only; it will not be available from pharmacies. In addition, only "qualified physicians" and other types of health care providers such as APRNs, licensed nurse-midwives and physician assistants, "acting under the supervision" of qualified physicians, may dispense the drug to patients.
Based on my review of the FDA’s memorandum documenting its approval action and the Connecticut statutes and regulations governing the above-listed mid level practitioners, I conclude that APRNs, licensed nurse-midwives and physician assistants who are licensed in Connecticut, may, in accordance with the statutory requirements and conditions that govern their practices, "dispense" mifepristone in a licensed clinic as long as they are acting under the supervision of a physician who is a "qualified physician," as that term is defined by the FDA. The Public Health Code provision limiting the performance of abortions to licensed physicians applies to the performance of surgical procedures, not to the administration of a non-surgical method of terminating a pregnancy.
On September 18, 1996, the FDA issued an Approvable Letter for mifepristone, used in combination with misoprostol, for early medical abortion.1 On September 28, 2000, mifepristone was approved by the FDA for the medical termination of intrauterine pregnancy through 49 days’ pregnancy.
Mifepristone is a drug.2 It is an antiprogestin that interrupts a pregnancy in its early stages. The RU-486 regimen for termination of early pregnancy involves giving a woman 600 milligrams of mifepristone to ingest orally. This is followed, 48 hours later, by the ingestion of 400 micrograms of misoprostol. Misoprostol belongs to a class of drugs known as prostaglandins and is already FDA-approved. When used in conjunction with mifepristone, the misoprostol causes contractions of the uterus, helping to expel the pregnancy. Following the ingestion of these two medications, "the amniotic sac is generally passed as part of a flow of blood and clots several hours after the second medication is taken." Benten v. Kessler, 799 F. Supp. 281, 284 (E. D. N. Y. 1992).
RU-486 is recommended for use only under medical supervision and only up to 49 days from the first day of the last menstrual period. The protocol that has been used in clinical trials requires three visits to a clinic, beginning with thorough counseling, a physical examination and a determination of the length of pregnancy. Also at the first visit, the woman takes three 200-milligram tablets of mifepristone, after which she remains at the clinic under observation for about thirty minutes.
At the second visit, two days later, the woman takes two 200-microgram tablets of misoprostol, under supervision, and remains at the clinic for up to four hours. After two weeks, the woman returns for a follow-up visit to confirm that the procedure is complete.
II. Conditions Imposed by the FDA
The FDA approved mifepristone under Title 21, Subpart H of Part 314 of the Code of Federal Regulations. This subpart applies to certain new drugs that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments. 21 C. F. R. § 314.500. Subpart H applies when the FDA has concluded that a drug product that has been shown to be effective can be safely used only if distribution or use is restricted. According to the FDA, the termination of unwanted pregnancy is a serious condition and the meaningful benefit over existing surgical abortion is the avoidance of a surgical procedure, rendering RU-486 within the scope of Subpart H. September 28, 2000 Memorandum from the FDA to the Population Council (the "Memorandum").
Pursuant to the above regulatory authority, the FDA has imposed certain conditions that apply to prescribing, distributing, administering/dispensing mifepristone. The FDA’s restrictions focus on the qualifications of the physicians who may receive the Mifeprex from the manufacturer and the procedures for dispensing the drug. For example, mifepristone may be distributed only to qualified physicians and not to other types of health care professionals, such as APRNs, nurse-midwives and physician assistants. Mifepristone will not be available in pharmacies.
Moreover, although only physicians may receive the Mifeprex, the FDA Memorandum concludes that "[t]his does not preclude another type of health care provider, acting under the supervision of a qualified physician, from dispensing the drug to patients, provided state law permits this." Memorandum at 4-5.3 The FDA also set forth its requirements for what constitutes a "qualified physician." These requirements must be met by those physicians who wish to prescribe mifepristone.
The sponsor of the RU-486 application to the FDA, also known as the Applicant, is the Population Council. The manufacturer is Danco Laboratories ("Danco"). As noted in the Preamble to the final rule adopting Subpart H, the FDA clarified that any restrictions on the use of a drug "will be tailored to the specific safety issue raised by the particular drug or biological product and agreed to by the applicant at the time of approval." 57 Fed. Reg. 58942 (Dec. 11, 1992). The restrictions, therefore, are imposed on the sponsor, i.e., the sponsor is responsible for ensuring that the drug is prescribed and distributed in accordance with the FDA’s instructions or conditions. In this case, the Population Council agreed to the FDA restrictions; consequently, the burden is on the Population Council to ensure that the FDA’s restrictions accompanying the use of RU-486 are followed.
In accordance with the above, the FDA, the Population Council and Danco have determined that prescribing physicians must enter into a Prescriber’s Agreement with Danco prior to establishing an account and receiving Mifeprex. By signing the Prescriber’s Agreement, the physician agrees to meet specified qualifications and follow specific guidelines for use. The physician agrees that, if these guidelines are not followed, Danco may discontinue distribution of the Mifeprex to that physician.
The Prescriber’s Agreement states that, under federal law, Mifeprex must be provided by or under the supervision of a physician who meets the following qualifications:
Ability to provide surgical intervention in cases of incomplete abortion or severe bleeding or have made plans to provide such care through other qualified physicians and assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.
Has read and understood the prescribing information of Mifeprex, which information is attached to the Prescriber’s Agreement.
In addition to these qualifications, the Prescriber’s Agreement states that Mifeprex must be provided
in a manner consistent with the following guidelines:
Under federal law, each person must be provided with a Medication Guide. You must fully explain the procedure to each patient; provide her with a copy of the Medication Guide and PATIENT AGREEMENT, give her the opportunity to read and discuss them, obtain her signature on the Patient Agreement and sign it yourself.
The patient’s follow-up visit at approximately 14 days is very important to confirm that a complete termination of pregnancy has occurred and that there have been no complications. You must notify Danco Laboratories in writing as discussed in the Package Insert under the heading DOSAGE AND ADMINISTRATION in the event of an on-going pregnancy which is not terminated subsequent to the conclusion of the treatment procedure.
Each package of Mifeprex has a serial number. As part of maintaining the complete records for each patient, you must record this serial number in each patient’s record.
While serious adverse events associated with the use of Mifeprex are rare, you must report any hospitalization, transfusion or other serious event to Danco Laboratories, identifying the patient solely by package serial number to ensure confidentiality.
Prescriber’s Agreement (emphasis added).
III. State Law Regarding Scope of Practice of APRNs,
Nurse-Midwives and Physician Assistants
Under Connecticut law, an APRN "performs acts of diagnosis and treatment of alterations in health status, as described in subsection (a) of this section, and shall collaborate with a physician licensed to practice medicine in this state." Conn. Gen. Stat. § 20-87a (b). 4 If the APRN practices in certain settings set forth in the statute, 5 the APRN "may, in collaboration with a physician licensed to practice medicine in this state, prescribe, dispense, and administer medical therapeutics and corrective measures." Id. 6 If the APRN does not practice in one of the enumerated settings, then the APRN may, "in collaboration with a physician licensed to practice medicine in this state, prescribe and administer medical therapeutics and corrective measures and may dispense drugs in the form of professional samples in accordance with sections 20-14c to 20-14e . . . ." Id.7
The APRN’s specific authority to prescribe, dispense and administer drugs is found in section 20-94b. It provides that an APRN licensed pursuant to section 20-94a, "may prescribe, dispense, and administer drugs. . . ." (emphasis added). If the APRN also maintains certification from the American Association of Nurse Anesthetists, this includes controlled substances in schedules II, III, IV or V. If the APRN does not maintain such certification, the APRN may prescribe controlled substances in schedule II or III that are "expressly specified in written collaborative agreements pursuant to subsection (b) of section 20-87a." Conn. Gen. Stat. § 20-94b.
Section 20-87a (b) defines "collaboration," for purposes of this subsection, as follows:
a mutually agreed upon relationship between an advanced practice registered nurse and a physician who is educated, trained or has relevant experience that is related to the work of such advanced practice registered nurse. The collaboration shall address a reasonable and appropriate level of consultation and referral, coverage for the patient in the absence of the advanced practice registered nurse, a method to review patient outcomes and a method of disclosure of the relationship to the patient. Relative to the exercise of prescriptive authority, the collaboration between an advanced practice registered nurse and a physician shall be in writing and shall address the level of schedule II and III controlled substances that the advanced practice registered nurse may prescribe and provide a method to review patient outcomes, including but not limited to, the review of medical therapeutics, corrective measures, laboratory tests and other diagnostic procedures that the advanced practice registered nurse may prescribe, dispense and administer.
In order to be licensed as an APRN, an individual must (1) be eligible for a license as a registered nurse in this state; (2) hold and maintain current certification as a nurse practitioner, a clinical nurse specialist or a nurse anesthetist from one of the following national certifying bodies that certify nurses in advance practice: The American Nurses’ Association, the Nurses’ Association of the American College of Obstetricians and Gynecologists Certification Corporation, the National Board of Pediatric Nurse Practitioners and Associates or the American Association of Nurse Anesthetists; (3) have completed thirty hours of education in pharmacology for advanced nursing practice; and (4) if first certified by one of the foregoing certifying bodies after December 31, 1994, hold a master’s degree in nursing or in a related field recognized for certification as either a nurse practitioner, a clinical nurse specialist, or a nurse anesthetist by one of the foregoing certifying bodies. Conn. Gen. Stat. § 20-94a (a).8
B. Nurse-Midewives
"Nurse-midwifery" is defined as "the management of care of essentially normal newborns and women, antepartally, intrapartally, postpartally and gynecologically, occurring within a health care team, directed by a qualified obstetrician-gynecologist." Conn. Gen. Stat. § 20-86a (1). The term "directed" "does not necessarily imply the physical presence of an obstetrician-gynecologist while care is being given by a nurse-midwife." Conn. Gen. Stat. § 20-86b. A nurse-midwife is defined by statute as "a person who has demonstrated competence to practice nurse-midwifery through successful completion of an educational program accredited by the American College of Nurse-Midwives and who is certified by the American College of Nurse-Midwives, and is licensed under the provisions of this chapter." Conn. Gen. Stat. § 20-86a (2).
In order to obtain a license to practice nurse-midwifery, an individual must (1) be eligible for a registered nurse license in this state; (2) hold and maintain current certification from the American College of Nurse-Midwives; and (3) have completed thirty hours of education in pharmacology for nurse-midwifery. Conn. Gen. Stat. § 20-86c.
A nurse-midwife must have a "clinical practice relationship" with an obstetrician-gynecologist that "shall be based on mutually agreed upon medical guidelines and protocols." Conn. Gen. Stat. § 20-86b. Such protocols "shall be filed with the Department of Public Health" and "contain a list of medications, devices and laboratory tests which may be prescribed, dispensed or administered by the nurse-midwife." Id. (emphasis added). The nurse-midwife statutes do not limit the location at which licensed nurse-midwives may prescribe, dispense or administer medications.
A physician assistant is a person who:
(A) Functions in a dependent relationship with a physician licensed pursuant to this chapter and (B) is licensed pursuant to section 20-12b to provide patient services under the supervision, control, responsibility and direction of said physician.
Conn. Gen. Stat. § 20-12a (5).
the exercise by the supervising physician of oversight, control and direction of the services of a physician assistant. Supervision includes but is not limited to: (A) Continuous availability of direct communication either in person or by radio, telephone or telecommunications between the physician assistant and the supervising physician; (B) active and continuing overview of the physician assistant’s activities to ensure that the supervising physician’s directions are being implemented and to support the physician assistant in the performance of his services; (C) personal review by the supervising physician of the physician assistant’s practice at least weekly or more frequently as necessary to ensure quality patient care; (D) review of the charts and records of the physician assistant on a regular basis as necessary to ensure quality patient care; (E) delineation of a predetermined plan for emergency situations; and (F) designation of an alternate licensed physician in the absence of the supervising physician.
Conn. Gen. Stat. § 20-12a (7). The "supervising physician" is responsible for the supervision of services rendered by a physician assistant and must be licensed in the State of Connecticut. Conn. Gen. Stat. § 20-12a (6). The supervising physician must register with the Department of Public Health pursuant to section 20-12c of the Connecticut General Statutes and comply with all of the requirements of said section.9
In order to obtain a physician assistant license in Connecticut, an individual must (1) hold a baccalaureate or higher degree in any field from a regionally accredited institution of higher education; (2) have graduated from an accredited physician assistant program; (3) have passed the certification examination of the national commission; (4) have satisfied the mandatory continuing medical education requirements of the national commission for current certification by such commission and have passed any examination or continued competency assessment the passage of which may be required by the national commission for maintenance of current certification by such commission; and (5) have completed not less than sixty hours of didactic instruction in pharmacology for physician assistant practice approved by the Department of Public Health. Conn. Gen. Stat. § 20-12b (a).
Physician assistants may perform medical functions delegated to them by a supervising physician when the supervising physician is satisfied with the physician assistant’s ability and competence; when the delegation is consistent with the health and welfare of the patient and sound medical practice; and when the functions "are performed under the oversight, control and direction of the supervising physician." Conn. Gen. Stat. § 20-12d (a). The functions that may be performed under such delegation are those that are (1) within the scope of the supervising physician’s license; (2) within the scope of the physician’s competence, as evidenced by such physician’s postgraduate education, training and experience; and (3) within the normal scope of such physician’s actual practice. Id. These delegated functions "shall be implemented in accordance with written protocols established by the supervising physician." Id.
A physician assistant may, "as delegated by the supervising physician within the scope of such physician’s license, (A) prescribe and administer drugs, including controlled substances in schedule IV or V in all settings," and may, under those same conditions,
dispense drugs, in the form of professional samples as defined in section 20-14c, as amended, or when dispensing in an outpatient clinic as defined in the regulations of Connecticut state agencies and licensed pursuant to subsection (a) of section 19a-491 that operates on a not-for-profit basis, or when dispensing in a clinic operated by a state agency or municipality.
Under the physician assistant statutes, therefore, assuming there is proper delegation by the supervising physician and the other statutory conditions are met, a physician assistant may prescribe and administer drugs and, under certain statutorily specified circumstances, dispense them.
In conclusion, under the specific conditions and requirements set forth in the respective sections of the Connecticut General Statutes, APRNs, licensed nurse-midwives and physician assistants may prescribe, administer and, in certain settings, dispense medication or drugs. Since mifepristone is a drug, these health professionals, when all statutory conditions and requirements are met, may prescribe, administer, and, in certain settings, dispense it in accordance with state law. As a result of the federal FDA conditions, however, the role of these mid- level clinicians is more limited with regard to the drug mifepristone.
III. The Role of APRNs, Nurse-Midwives and Physician Assistants in
the Provision of RU-486
Under Connecticut law, the above clinicians may prescribe, administer and dispense medication in accordance with their respective statutory authority. In the case of Mifeprex, however, the FDA has intervened and has specifically limited the prescriptive authority to physicians. Mifeprex must be "directly distributed to qualified physicians, as opposed to other types of health care professionals (midwives, physician’s assistants, nurse practitioners, etc.)." Memorandum at 4. Accordingly, while these providers may, under certain conditions, prescribe drugs under state law, the FDA restrictions preclude them from prescribing mifepristone. Only physicians may sign a Prescriber’s Agreement with Danco.
The FDA Memorandum, however, specifically provides that this "does not preclude another type of health care provider, acting under the supervision of qualified physicians, from dispensing the drug to patients, provided state law permits this." Id. at 4-5.
The FDA’s definition of "dispense to patients" is different from the state-law definition of "dispense." Under state law, the definition of "dispense" specifically provides that the term "does not include the acts of delivering of a drug or device to a patient or of administering the drug or device to the patient." Conn. Gen. Stat. § 20-571 (9). The federal definition of "dispense" is the "act of delivering a prescription drug to a patient . . . [b]y a licensed practitioner or an agent of a licensed practitioner, either directly or indirectly, for self administration by the patient . . . ." 21 C. F. R. § 208.3 (b).
Based on the above, it appears that the state-law definition of "administer" is more parallel to the federal definition of "dispense." "Administer" is defined as "the direct application of a drug or device to the body of a patient . . . by injection, inhalation, ingestion or any other means." Conn. Gen. Stat. § 20-571 (a). Accordingly, for purposes of interpreting whether mid-level clinicians have the authority to "dispense" mifepristone pursuant to the FDA conditions, the question becomes whether, under state law, they have the authority to "administer" drugs. Based on the statutory provisions set forth above, APRNs, nurse-midwives and physician assistants may, under different conditions, administer drugs, including Mifeprex..
As set forth above, state law provides that licensed physician assistants provide patient services "under the supervision, control, responsibility and direction" of the supervision physician. Conn. Gen. Stat. § 20-12a (5). The term "supervision" is defined by statute. Conn. Gen. Stat. § 20-12a (7). Under the "oversight, control and direction of the supervising physician," physician assistants may administer drugs "as delegated by the supervising physician within the scope of such physician’s license." Conn. Gen. Stat § 20-12d (a). Although APRNs and nurse-midwives are authorized by state law to administer drugs without the "supervision" of a physician, if they wish to administer Mifeprex, in accordance with the conditions imposed by the FDA, they must do so under the "supervision" of a "qualified physician."
The FDA does not define the term "supervision." It is unclear, therefore, what level of physician involvement the FDA contemplated when it authorized the dispensing of mifepristone by health care providers "acting under the supervision of a qualified physician." As long as the requirements of state law are met by the mid-level clinician with regard to physician involvement, it is up to the physician and Danco whether said involvement is sufficient to meet the FDA’s supervision requirement.
IV. Interface with Section 19-13-D54 of the Public Health Code
Having concluded that APRNs, licensed nurse-midwives and physician assistants are authorized under state law to dispense mifepristone as a drug, the issue arises whether, in this situation, where the result of the administration of the drug results in the termination of an early pregnancy, there is a conflict with a state Public Health Code provision requiring that abortions be done only by individuals who are licensed to practice medicine and surgery in this state.10
The state Public Health Code provides that "[n]o abortion shall be performed at any stage of pregnancy except by a person licensed to practice medicine and surgery in the state of Connecticut." Conn. Agencies Regs. §19-13-D54 (a). Subsection (d) of the regulation provides that "[a]ll outpatient clinics operated by corporations or municipalities where abortions are performed shall develop standards to control the quality of medical care provided to women having abortions."11 Although verifying the pregnancy and determining its duration are standards that apply to any type of examination or procedure if a woman is pregnant, the majority of the standards in the regulation demonstrate that the Department of Public Health (the "Department") wrote the standards to apply to an operation or surgical procedure. For example, the regulation requires the development of standards concerning "(2) pre-operative instruction and counseling; (3) operative permission and informed consent; (4) pre-operative history and physical examination; (5) pre-operative laboratory procedure for blood Rh factor . . . (8) receiving and recovery room facilities; (9) a standard operating room; (10) post-operative counseling . . . ." Conn. Agencies Regs. § 19-13-D54 (d) (emphasis added).
Section 19-13-D54 of the Public Health Code became effective February 25, 1974, approximately one year following the United States Supreme Court decision in Roe v. Wade, 410 U. S. 113 (1973). Although a few states had legalized abortion by that time, Roe v. Wade, in holding that the constitutional right to privacy included a woman’s right to choose whether to continue a pregnancy, ensured that abortion was legal in every state.
Courts, when construing statutes and regulations, consider their history, language, the purpose they are designed to serve and the circumstances surrounding their enactment. Bahre v. Hogbloom, 162 Conn. 549, 551, 295 A. 2d 547 (1972). In determining their purpose and scope, courts are to make "every part operative and harmonious with every other part insofar as is possible since the letter of a law or its literal meaning is not in all cases a correct guide to the intent and true sense of the lawmaker." Id. Unless otherwise indicated, words are to be given their common, ordinary and accepted meaning. See Conn. Gen. Stat. § 1-19 (a); Caldor, Inc. v. Heffernan, 183 Conn. 566, 570 (1981); Carlson v. Kozlowski, 172 Conn. 263, 266, 374 A. 2d 207 (1977).
In 1974, at the time the Public Health Code regulation was enacted, it would not have been contemplated by the Department that a pill would be administered to terminate a pregnancy. Clinical trials on RU-486 did not begin until 1981 in Geneva; France did not approve it until 1988. Indeed, the regulation uses the words "operation," "pre-operative" and "operating room," and "recovery room," all of which pertain to surgery.12
Undoubtedly, the purpose of enacting section 19-13-D54 was to protect women from undergoing surgical procedures by those untrained and unqualified individuals who were performing illegal abortions under unsanitary conditions prior to the Roe v. Wade decision. Although it is clear that section 19-13-D54 of the Public Health Code prohibits APRNs, nurse-midwives and physician assistants from performing surgical abortions, there is no reason to conclude that this section should be interpreted to limit their statutory authority to prescribe, administer or dispense a drug, even though the drug may be used for the purpose of terminating an early pregnancy in a non-surgical manner.
All of the mid-level professions at issue here became licensed and authorized to prescribe, administer or dispense medications in the State of Connecticut after 1974. The APRN and nurse-midwife licensing provisions were not enacted until 1989. See Pub. Act 89-389, §§ 1, 7. Physician assistant licensure did not go into effect until 1990. Pub. Act 90-211, § 4. Other than for controlled substances, there are no statutory or regulatory limitations on the types of drugs that these clinicians may administer; those decisions are made by the clinician and the physician in the context of a working relationship. It does not seem reasonable to conclude that the Department, more than twenty-five years ago and before the existence of non-surgical abortion and licensure for these allied health professionals, intended to restrict the practices of these professionals by prohibiting them from administering the drug mifepristone.
As a matter of state law, therefore, section 19-13-D54 of the Public Health Code must be interpreted to mean that no individuals other than licensed physicians may perform surgical abortions. This interpretation allows the state to give effect to both the statutes that authorize the prescribing, administering and dispensing of drugs by APRNs, nurse-midwives and physician assistants and the regulation that authorizes only licensed physicians to perform abortions. In conclusion, the section of the Public Health Code providing that only licensed physicians may perform abortions does not preclude APRNs, nurse-midwives and physician assistants from administering mifepristone in accordance with the scope of their respective practices and the conditions set forth by the FDA. Section 19-13-D54 pertains only to the performance of surgical procedures.
1An Approvable Letter is an action often used by the FDA to indicate that safety and efficacy data have passed agency review, but that additional information must be submitted before final approval is granted
2Under the state and federal definitions, which are virtually identical, mifepristone is a drug because it is "(B) an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;" or "(C) an article, other than food, intended to affect the structure or any function of the body of humans or any other animal." Conn. Gen. Stat. § 20-571 (11); 21 U. S. C. § 321. The FDA, by asserting jurisdiction over mifepristone, has also concluded that mifepristone is a drug
3Under Part 208 of the FDA’s regulations concerning Medication Guides for Prescription Drug Products, "dispense to patients" is defined as
the act of delivering a prescription drug to a patient or an agent of the patient either (1) By a licensed practitioner or an agent of a licensed practitioner, either directly or indirectly, for self-administration by the patient, or the patient’s agent, or outside the licensed practitioner's direct supervision; or (2) by an authorized dispenser under a lawful prescription of a licensed practitioner.
21 C. F. R. § 208.3(b).
4Subsection (a) defines the practice of nursing by a registered nurse as "the process of diagnosing human responses to actual or potential health problems, providing supportive and restorative care, health counseling and teaching, case finding and referral, collaborating in the implementation of the total health care regimen, and executing the medical regimen under the direction of a licensed physician or dentist."
5Those settings are (1) an institution licensed pursuant to subsection (a) of section 19a-491 as a hospital, residential care home, health care facility for the handicapped, nursing home, rest home, mental health facility, substance abuse treatment facility, infirmary operated by an educational institution for the care of students enrolled in, and faculty and staff of, such institution or facility operated and maintained by any state agency and providing services for the prevention, diagnosis and treatment or care of human health conditions, or (2) an industrial health facility licensed pursuant to subsection (h) of section 31-374 which serves at least two thousand employees, or (3) a clinic operated by a state agency, municipality, or private nonprofit corporation, or (4) a clinic operated by any educational institution prescribed by regulations adopted pursuant to section 20-99a . . . .
6There is no statutory definition of "medical therapeutics and corrective measures." "Therapeutics" is defined in the medical dictionary as "the practical branch of medicine concerned with the treatment of disease." Stedman’s Medical Dictionary 1587 (25th ed. 1990). "Corrective" means "counteracting, modifying, or changing what is injurious." Id. at 358. "Injure" means "to wound, hurt, or harm." Id. at 786.
7"Administer" is defined as "the direct application of a drug or device to the body of a patient or research subject by injection, inhalation, ingestion or any other means." Conn. Gen. Stat. § 20-571 (1). "Dispense" means "those acts of processing a drug or device for delivery or for administration for a patient pursuant to a prescription," consisting of six elements. "'Dispense does not include the acts of delivering a drug or device to a patient or of administering the drug or device to the patient." Conn. Gen. Stat. § 20-571 (9).
Section 20-14d provides that, "[n]otwithstanding any provision of the general statutes, no drug may be dispensed by a prescribing practitioner except in accordance with the provisions of this section and sections 20-14c, 20-14f and 20-14g, as amended by this act." APRNs, nurse-midwives and physician assistants are "prescribing practitioners." See Conn. Gen. Stat. § 20-14c (3). Section 20-14c (1) defines "dispense" as having the same meaning as provided in section 20-571 (9) of the Connecticut General Statutes, which is set forth above.
Section 20-14d, however, does not address the definition of administer. The only definition of "administer" is that which is set forth in section 20-571, which applies to sections 20-570 to 20-630, inclusive, unless the context otherwise requires. There is no definition of "administer" in section 20-14c that applies specifically to prescribing practitioners in other sections of the statutes.
8Subsection (b) of this section provides a mechanism for registered nurses who were practicing as APRNs in a nurse practitioner role starting January 1, 1990 and ending January 1, 1992 and who are unable to obtain certification as a nurse practitioner from one of the national certifying bodies to become licensed as APRNs.
9A supervising physician "maintains the final responsibility for the care of patients and the performance of the physician assistant." Conn. Gen. Stat. § 20-12c (a). Supervising physicians must have a current and unrestricted license to practice medicine in Connecticut. Physicians against whom professional disciplinary action is pending or who are the subject of an unresolved complaint, in this state or any other state or territory, cannot be registered as supervising physicians. Id. Supervising physicians may supervise as many physician assistants "as is medically appropriate under the circumstances," but no more than six full-time people at a time. In addition, the supervision must be "active and direct, and at the specific location in which the physician assistant is practicing." Conn. Gen. Stat. § 20-12c (b).
10Pursuant to section 19a-36 of the Connecticut General Statutes, the "Commissioner of Public Health shall establish a Public Health Code and, from time to time, amend the same." The Public Health Code contains certain regulations that "provide for the preservation and improvement of the public health." Id.
11Neither the Public Health Code nor the state statutes define the term "abortion."
12An "operation" is defined in the medical dictionary as "any surgical procedure." Stedman’s Medical Dictionary 1089 (25th ed. 1990). "Surgery" is "the treatment of disease, injury or deformity by means of manual and instrumental procedures." Ida Fox, et al., Attorney’s Illustrated Medical Dictionary S82 (1997).