South Carolina General Assembly
116th Session, 2005-2006

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Bill 3803

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COMMITTEE REPORT

May 11, 2005

H. 3803

Introduced by Reps. Edge and Wilkins

S. Printed 5/11/05--H.    [SEC 5/12/05 2:24 PM]

Read the first time March 29, 2005.

            

THE COMMITTEE ON WAYS AND MEANS

To whom was referred a Bill (H. 3803) to amend the Code of Laws of South Carolina, 1976, by adding Article 15, Chapter 53, Title 44 so as to enact the South Carolina Prescription Monitoring Act authorizing, etc., respectfully

REPORT:

That they have duly and carefully considered the same and recommend that the same do pass with amendment:

Amend the bill, as and if amended, Section 44-53-1620 page 1, beginning on line 41 by deleting /or other licit drugs of abuse/ so when amended Section 44-53-1620 reads:

/Section 44-53-1620.    This article is intended to improve the state's ability to identify and stop diversion of prescription drugs in an efficient and cost effective manner that will not impede the appropriate medical utilization of licit controlled substances./

Amend the bill further, by deleting Section 44-53-1640 beginning on page 2 and inserting:

/Section 44-53-1640.    (A)    The Department of Health and Environmental Control, Bureau of Drug Control may establish and maintain a program to monitor the prescribing and dispensing of all Schedule II, III, IV, and V controlled substances by professionals licensed to prescribe or dispense these substances in this State.

(B)(1)    A dispenser shall submit to drug control, by electronic means, information regarding each prescription dispensed for a controlled substance. The information submitted for each prescription must include, but is not limited to:

(a)    dispenser identification number;

(b)    date drug was dispensed;

(c)    prescription number;

(d)    whether prescription is new or a refill;

(e)    NDC code for drug dispensed;

(f)    quantity dispensed;

(g)    approximate number of days supplied;

(h)    patient name;

(i)     patient address;

(j)     patient date of birth;

(k)    prescriber identification number;

(l)        date prescription issued by prescriber;

(m)    source of payment for prescription.

(2)    A dispenser shall submit the information required pursuant to subsection (B)(1) in accordance with transmission methods and frequency established by drug control, but shall report at least every thirty days, between the 1st and the 15th of the month following the month the prescription was dispensed.

(3)    Drug control may issue a waiver to a dispenser who is unable to submit prescription information by electronic means. The waiver may permit the dispenser to submit prescription information by paper form or other means if all information required pursuant to subsection (B)(1) is submitted in this alternative format./

Amend the bill further, Section 44-53-1650(D)(4) page 4, line 5 after /drugs/ by inserting /and/ so when amended Section 44-53-1650(D)(4) reads:

/(4)    a local, state, or federal law enforcement or prosecutorial official engaged in the administration, investigation, or enforcement of the laws governing licit drugs and who is involved in a bona fide specific drug related investigation involving a designated person;/

Amend the bill further, Section 44-53-1680(B) and (C) on page 4, line 40 and on page 5, line 3 after /person/ by inserting /or persons/ and on page 5 lines 1, 2, 6, and 7 by deleting /five/ and inserting /ten/ so when amended Section 44-53-1680(B) and (C) read:

/(B)    A person or persons authorized to have prescription monitoring information pursuant to this article who knowingly discloses this information in violation of this article is guilty of a felony and, upon conviction, must be fined not more than ten thousand dollars or imprisoned not more than ten years, or both.

(C)    A person or persons authorized to have prescription monitoring information pursuant to this article who uses this information in a manner or for a purpose in violation of this article is guilty of a felony and, upon conviction, must be fined not more than ten thousand dollars or imprisoned not more than ten years, or both./

Renumber sections to conform.

Amend title to conform.

ROBERT W. HARRELL, JR. for Committee.

            

STATEMENT OF ESTIMATED FISCAL IMPACT

ESTIMATED FISCAL IMPACT ON GENERAL FUND EXPENDITURES:

$0 (No additional expenditures or savings are expected)

ESTIMATED FISCAL IMPACT ON FEDERAL & OTHER FUND EXPENDITURES:

A Cost of Federal and/or Other Funds (See Below)

FIRST YEAR GENERAL FUNDS: $0

FIRST YEAR FEDERAL AND/OR OTHER FUNDS: $395,345

ANNUAL TOTAL THEREAFTER: $395,345

EXPLANATION OF IMPACT:

Department of Health & Environmental Control

The department plans to use one-time federal grant funds, unexpended asset forfeiture funds and revenue from annual fees generated by the drug control program to pay the cost of operating this program. The department's Bureau of Drug Control estimates that operating costs for a full year would be $395,345 ($174,200 in Personal Services for 3.00 FTEs and $221,145 in operating expenses). There is no cost to the General Fund of the State.

The Department of Labor, Licensing, and Regulation

The department reports that this bill will have no impact on the General Fund of the State, or on federal and/or other funds.

Approved By:

Don Addy

Office of State Budget

A BILL

TO AMEND THE CODE OF LAWS OF SOUTH CAROLINA, 1976, BY ADDING ARTICLE 15, CHAPTER 53, TITLE 44 SO AS TO ENACT THE SOUTH CAROLINA PRESCRIPTION MONITORING ACT AUTHORIZING THE DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL, BUREAU OF DRUG CONTROL TO ESTABLISH A PROGRAM TO MONITOR THE PRESCRIBING AND DISPENSING OF SCHEDULE II-V CONTROLLED SUBSTANCES AND TO PROVIDE THE MANNER AND PROCEDURES UNDER WHICH DISPENSERS ARE TO PROVIDE SUCH INFORMATION, TO PROVIDE FOR THE USE AND CONFIDENTIALITY OF THIS INFORMATION, AND TO PROVIDE PENALTIES FOR VIOLATIONS.

Be it enacted by the General Assembly of the State of South Carolina:

SECTION    1.    Chapter 53, Title 44 of the 1976 Code is amended by adding:

"Article 15

Prescription Monitoring Program

Section 44-53-1610.    This article may be cited as the 'South Carolina Prescription Monitoring Act'.

Section 44-53-1620.    This article is intended to improve the state's ability to identify and stop diversion of prescription drugs in an efficient and cost effective manner that will not impede the appropriate medical utilization of licit controlled substances or other licit drugs of abuse.

Section 44-53-1630.    As used in this section:

(1)    'Controlled substances' means those substances listed in Schedules II, III, IV, and V of the schedules provided for in Sections 44-53-210, 44-53-230, 44-53-250, and 44-53-270.

(2)    'Dispenser' means a person who delivers a Schedule II-V controlled substance to the ultimate user, but does not include:

(a)    a licensed hospital pharmacy that distributes controlled substances for the purpose of inpatient hospital care or dispenses prescriptions for controlled substances at the time of discharge from the hospital;

(b)    a practitioner or other authorized person who administers these controlled substances; or

(c)    a wholesale distributor of a Schedule II-V controlled substance.

(3)    'Drug control' means the Department of Health and Environmental Control, Bureau of Drug Control.

(4)    'Patient' means the person or animal who is the ultimate user of a drug for whom a prescription is issued or for whom a drug is dispensed, or both.

Section 44-53-1640.    (A)    The Department of Health and Environmental Control, Bureau of Drug Control may establish and maintain a program to monitor the prescribing and dispensing of all Schedule II, III, IV, and V controlled substances, and any additional drugs identified by drug control that demonstrates a potential for abuse, by professionals licensed to prescribe or dispense these substances in this State.

(B)(1)    A dispenser shall submit to drug control, by electronic means, information regarding each prescription dispensed for a controlled substance. The information submitted for each prescription must include, but is not limited to:

(a)    dispenser identification number;

(b)    date drug was dispensed;

(c)    prescription number;

(d)    whether prescription is new or a refill;

(e)    NDC code for drug dispensed;

(f)    quantity dispensed;

(g)    patient name;

(h)    patient identification number;

(i)     patient address;

(j)     patient date of birth;

(k)    prescriber identification number;

(l)        date prescription issued by prescriber;

(m)    person who receives the prescription from the dispenser, if other than the patient;

(n)    source of payment for prescription.

(2)    A dispenser shall submit the information required pursuant to subsection (B)(1) in accordance with transmission methods and frequency established by drug control, but shall report at least every thirty days, between the 1st and the 15th of the month following the month the prescription was dispensed.

(3)    Drug control may issue a waiver to a dispenser who is unable to submit prescription information by electronic means. The waiver may permit the dispenser to submit prescription information by paper form or other means if all information required pursuant to subsection (B)(1) is submitted in this alternative format.

Section 44-53-1650.    (A)    Prescription information submitted to drug control is confidential and not subject to public disclosure under the Freedom of Information Act or any other provision of law, except as provided in subsections (C) and (D).

(B)    Drug control shall maintain procedures to ensure that the privacy and confidentiality of patients and patient information collected, recorded, transmitted, and maintained is not disclosed, except as provided for in subsections (C) and (D).

(C)    If there is reasonable cause to believe a violation of law or breach of professional standards may have occurred, drug control shall notify the appropriate law enforcement or professional licensure, certification, or regulatory agency or entity and shall provide prescription information required for an investigation.

(D)    Drug control may provide data in the prescription monitoring program to the following persons:

(1)    a practitioner or pharmacist who requests information and certifies that the requested information is for the purpose of providing medical or pharmaceutical treatment to a bona fide patient;

(2)    an individual who requests the individual's own prescription monitoring information in accordance with procedures established pursuant to state law;

(3)    a designated representative of the South Carolina Department of Labor, Licensing and Regulation responsible for the licensure, regulation, or discipline of practitioners, pharmacists, or other persons authorized to prescribe, administer, or dispense controlled substances and who is involved in a bona fide specific investigation involving a designated person;

(4)    a local, state, or federal law enforcement or prosecutorial official engaged in the administration, investigation, or enforcement of the laws governing licit drugs who is involved in a bona fide specific drug related investigation involving a designated person;

(5)    the South Carolina Department of Health and Human Services regarding Medicaid program recipients;

(6)    a properly convened grand jury pursuant to a subpoena properly issued for the records;

(7)    personnel of drug control for purposes of administration and enforcement of this article;

(8)    qualified personnel for the purpose of bona fide research or education; however, data elements that would reasonably identify a specific recipient, prescriber or dispenser must be deleted or redacted from such information prior to disclosure. Further, release of the information only may be made pursuant to a written agreement between qualified personnel and the department in order to ensure compliance with this subdivision.

Section 44-53-1660.    Drug control may contract with another agency of this State or with a private vendor, as necessary, to ensure the effective operation of the prescription monitoring program. A contractor shall comply with the provisions regarding confidentiality of prescription information in Section 44-53-1650 and is subject to the penalties specified in Section 44-53-1680 for unlawful acts.

Section 44-53-1670.    Drug control may promulgate regulations setting forth the procedures and methods for implementing this article.

Section 44-53-1680.    (A)    A dispenser who knowingly fails to submit prescription monitoring information to drug control as required by this article, or who knowingly submits incorrect prescription information, is guilty of a misdemeanor, and upon conviction, must be fined not more than two thousand dollars or imprisoned not more than two years, or both.

(B)    A person authorized to have prescription monitoring information pursuant to this article who knowingly discloses this information in violation of this article is guilty of a felony and, upon conviction, must be fined not more than five thousand dollars or imprisoned not more than five years, or both.

(C)    A person authorized to have prescription monitoring information pursuant to this article who uses this information in a manner or for a purpose in violation of this article is guilty of a felony and, upon conviction, must be fined not more than five thousand dollars or imprisoned not more than five years, or both."

SECTION    2.    If any section, subsection, paragraph, subparagraph, sentence, clause, phrase, or word of this act is for any reason held to be unconstitutional or invalid, such holding shall not affect the constitutionality or validity of the remaining portions of this act, the General Assembly hereby declaring that it would have passed this act, and each and every section, subsection, paragraph, subparagraph, sentence, clause, phrase, and word thereof, irrespective of the fact that any one or more other sections, subsections, paragraphs, subparagraphs, sentences, clauses, phrases, or words hereof may be declared to be unconstitutional, invalid, or otherwise ineffective.

SECTION    3.    This act takes effect upon approval by the Governor.

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