Prescription Monitoring Act
SECTION 1. Chapter 53, Title 44 of the 1976 Code is amended by adding:
Prescription Monitoring Program
This article may be cited as the ‘South Carolina Prescription Monitoring Act’.
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.
Section 44‑53‑1630. As used in this section:
(1) ‘Controlled substances’ means those substances listed in Schedules II, III, and IV 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–IV 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–IV 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.
(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, and IV 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 following information must be submitted for each prescription:
(a) dispenser DEA registration 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 DEA registration number;
(l) date prescription issued by prescriber.
(2) A dispenser shall submit the information required pursuant to subsection (B)(1) in accordance with transmission methods and protocols provided in the ‘ASAP Telecommunications Format for Controlled Substances, May 1995 Version’, developed by the American Society for Automation in Pharmacy, 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.
(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 and 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 Subsection.
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.
Drug control may promulgate regulations setting forth the procedures and methods for implementing this article.
(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 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.
(D) Nothing in this chapter requires a pharmacist or practitioner to obtain information about a patient from the prescription monitoring program. A pharmacist or practitioner does not have a duty and must not be held liable in damages to any person in any civil or derivative criminal or administrative action for injury, death, or loss to person or property on the basis that the pharmacist or practitioner did or did not seek or obtain information from the prescription monitoring program. A pharmacist or practitioner acting in good faith is immune from any civil, criminal, or administrative liability that might otherwise be incurred or imposed for requesting or receiving information from the prescription monitoring program.”
For additional information, contact: E-mail or telephone (803) 896-0688