ORDERS:
PUBLIC HEARING REPORT OF THE ADMINISTRATIVE LAW JUDGE
Pursuant to S.C. Code Ann. §§ 1-23-110 and 1-23-111 (Supp. 2000), a public hearing was held on December 14, 2000, at
the Administrative Law Judge Division ("Division") in Columbia, South Carolina to determine the "need and
reasonableness" of the proposed regulation. The proposed regulation will allow nurse practitioners with prescriptive
authority to provide drug samples to patients when acting within the scope and standards of their practice.
The South Carolina Department of Labor, Licensing, and Regulation, the State Board of Nursing ("Board"), and interested
persons presented testimony and written materials relating to the proposed regulation, all of which were incorporated into
the record of the hearing.
The following Proponents of the proposed regulation participated in the public hearing:
Richard P. Wilson, Esq., Deputy General Counsel, South Carolina Department of Labor, Licensing, and Regulation
Judith C. Thompson, Executive Director, South Carolina Nurses Association
Stephanie Burgess, FNP, Advanced Practice Nurse Council for South Carolina
D. Michael Stout, M.D., Executive Vice President for Medical Affairs
Alice F. Wyatt, FNP, Lexington Women's Care
Aaron J. Kozloski, Esq., General Counsel, South Carolina Medical Association
Martha S. Bursinger, Administrator, Board of Nursing
The following Opponents of the proposed regulation participated in the public hearing:
Charles Turner, Vice Chairman, South Carolina Board of Pharmacy
Jayne Gayman, South Carolina Society of Health-System Pharmacists
FINDINGS
Based upon the statements, testimony, exhibits, written comments, and applicable law, I find and conclude the following:
1. The Notice of Drafting of the proposed regulation was published in the State Register on September 22, 2000.
2. The Board filed an Agency Transmittal Form with the Division on October 3, 2000.
3. The Notice of Proposed Regulation was published in the State Register on October 27, 2000, which included a synopsis
of the proposed regulation and the "Notice of Public Hearing and Opportunity for Public Comment."
4. The Board complied with all notice and procedural requirements of the Administrative Procedures Act and the
Division's Rules of Procedure.
5. A public hearing to allow the Board's presentation and public comment was conducted on December 14, 2000, pursuant
to S.C. Code Ann. § 1-23-111 (Supp. 2000), at which time the undersigned received oral testimony, exhibits, and written
comments from the Board and interested persons.
6. During the hearing, the Board introduced the text of proposed regulation 91-6(k)(6), which provides:
The nurse practitioner or clinical nurse specialist who holds prescriptive authority may request, receive, and sign for
professional samples, except for controlled substances in Schedules II through IV, and may distribute professional samples
to patients as listed in the approved written protocols, subject to federal and state regulations.
7. As stated in the Preamble to the proposed regulation contained in Document No. 2577 of the State Register, Vol. 24,
Issue 10, dated October 27, 2000, the purpose of the proposed regulation is to "allow nurse practitioners with prescriptive
authority to provide drug samples to patients when acting within the scope and standards of their practice."
8. The Opponents of the proposed regulation are not opposed specifically to giving Nurse Practitioners the authority to
distribute drug samples. The Opponents instead are opposed generally to the expansion of the practice of distributing drug
samples.
9. The Opponents assert that while distributing drug samples to a particular patient might be cost-efficient for that patient at
the time, the practice of distributing drug samples is not cost-efficient over time. Pharmaceutical companies spend
approximately $4.9 billion annually to promote their products through sample distribution. The companies then increase
the cost of the product to absorb the cost of distributing free samples. Distributing sample medications also encourages the
use of more expensive medications. While the patient may save money during the first period of taking sample
medications, when the patient begins paying for the medication, it will actually cost more than purchasing a generic
medication the entire time.
10. The Opponents also assert that they are concerned for the safety of the consumers of this state. The Opponents
specifically argue that drug samples may be stored in ways that compromise the integrity of the medication, drug samples
are not packaged in childproof containers, drug samples do not provide instructions specific to the patient's usage, and
patients may receive improperly labeled, packaged, deteriorated, outdated, or unrecorded drugs.
11. The Opponents also assert that when a patient receives a drug sample, the patient does not receive the benefit of having
a pharmacist detect errors in the dosage, medication interactions, and potential adverse drug reactions.
12. S.C. Code Ann. §§ 40-33-10 to -1130 (Supp. 2000) created the State Board of Nursing and authorized the Board to
promulgate regulations necessary to carry out the provisions of Chapter 33 of Title 40.
13. An agency is implicitly authorized to interpret, clarify, and explain statutes by prescribing regulations for the complete
and consistent operation and enforcement of the law within its expressed general purpose. An administrative regulation is
valid so long as it is reasonably related to the purpose of the enabling legislation. Young v. S.C. Dep't of Highways and
Public Transp., 287 S.C. 108, 336 S.E.2d 879 (Ct. App. 1985); Hunter & Walden Co. v. S.C. State Licensing Bd. for
Contractors, 272 S.C. 211, 251 S.E.2d 186 (1978). A regulation which is beyond the authorization of the agency's
enabling legislation or which materially alters or adds to the law is invalid. Society of Prof'l Journalists v. Sexton, 283
S.C. 563, 324 S.E.2d 313 (1984); Banks v. Batesburg Hauling Co., 202 S.C. 273, 24 S.E.2d 496 (1943).
14. S.C. Code Ann. § 1-23-111(B) (Supp. 2000) requires the Administrative Law Judge to issue a written report that
includes "findings as to the need and reasonableness of the proposed regulation based on an analysis of the factors listed in
Section 1-23-115(C) . . . and other factors as the presiding official identifies and may include suggested modifications to
the proposed regulations in the case of a finding of lack of need or reasonableness."
15. According to the Proponents, this proposed regulation is necessary because it would increase patient access to
medications. For uninsured or fixed income patients, the proposed regulation would allow Nurse Practitioners to give free
drug samples so that patients could begin medical treatment immediately without waiting for the next paycheck to fill a
prescription. For indigent patients, the proposed regulation would allow Nurse Practitioners to give drug samples to
patients who otherwise would not have access to medical treatment. For patients who have limited transportation or who
live in rural areas miles from a pharmacy, the proposed regulation would allow Nurse Practitioners to give patients drug
samples so that they can begin medical treatment immediately until they can get to the pharmacy to fill the prescription.
16. The Proponents also assert that the proposed regulation is necessary because it would allow better treatment of the
patient. Nurse Practitioners would be able to make sure the patient does not have adverse reactions to a particular drug
before prescribing a full prescription. The Nurse Practitioners also would be able to let the patient take two different types
of medication so that the Nurse Practitioner could prescribe the medication that works better. The Nurse Practitioners also
would be able to determine medication efficacy for patients who need long-term medication regimens. The Nurse
Practitioners also would be able to give out samples when pharmacists or physicians are not on site, which is often the
situation in many satellite offices or remote nurse-managed centers.
17. "Reasonableness" is defined as "[f]air, proper, just, moderate, suitable under the circumstances. . . . [n]ot immoderate or
excessive, being synonymous with rational, honest, equitable, fair, suitable, moderate, tolerable." Black's Law Dictionary,
1265 (6th ed. 1990). The word has been further defined to mean "agreeable to reason under the facts and circumstances."
Ellis v. Taylor, 311 S.C. 66, 427 S.E.2d 678 (Ct. App. 1992).
18. Allowing Nurse Practitioners to provide free drug samples to patients is entirely suitable under the circumstances in
which they currently practice. The proposed regulation merely allows Nurse Practitioners to provide free samples of the
medications for which they already have the authority to write prescriptions. As one Proponent testified, this is the "next
logical step" for nurses in advanced practice. I agree.
19. I am impressed by the extensive certifications and educational requirements involved in being a Nurse Practitioner. To
be officially recognized as a Nurse Practitioner, one must be licensed as a registered nurse, must be certified by a national
credentialing organization, and must have a master's degree in nursing. In order to obtain prescriptive authority, the Nurse
Practitioner initially must complete 45 contact hours of education in pharmacotherapeutics and thereafter must complete 15
contact hours of continuing education in pharmacotherapeutics every two years. The proposed regulation is more than
reasonable considering the educational requirements Nurse Practitioners must complete in order to even have prescriptive
authority.
20. While I understand the concerns of the Opponents of the proposed regulation, those concerns deal with the distribution
of free drug samples in general. The Opponents offered no evidence explaining why Nurse Practitioners in particular
should not be allowed to provide drug samples. The Opponents instead indicated support and respect for Nurse
Practitioners and their role in the delivery of quality health care.
21. Based upon the above Findings, I find that it is within the authority of the Board to promulgate this proposed regulation
and that the regulation is both reasonable and needed in order to enhance the availability of appropriate drug therapies for
all patients of health care providers in this state.
__________________________________
MARVIN F. KITTRELL
Chief Administrative Law Judge
February 28, 2001
Columbia, South Carolina |