Bill Text: SC H3824 | 2017-2018 | 122nd General Assembly | Amended
Bill Title: Prescription drug monitoring program
Spectrum: Moderate Partisan Bill (Republican 23-3)
Status: (Passed) 2017-05-31 - Act No. 91 [H3824 Detail]
Download: South_Carolina-2017-H3824-Amended.html
AMENDED
May 9, 2017
H. 3824
Introduced by Reps. Henderson, Bedingfield, Fry, Huggins, Johnson, Hewitt, Crawford, Duckworth, Allison, Arrington, Forrester, Tallon, Hamilton, Felder, Elliott, Jordan, B. Newton, Martin, Erickson, Jefferson, Cobb-Hunter, Govan, Long, Putnam, Cogswell and Collins
S. Printed 5/9/17--S. [SEC 5/10/17 12:16 PM]
Read the first time April 5, 2017.
A BILL
TO AMEND THE CODE OF LAWS OF SOUTH CAROLINA, 1976, BY ADDING SECTION 44-53-1645 SO AS TO REQUIRE HEALTH CARE PRACTITIONERS TO REVIEW A PATIENT'S CONTROLLED SUBSTANCE PRESCRIPTION HISTORY, AS MAINTAINED IN THE PRESCRIPTION DRUG MONITORING PROGRAM, BEFORE PRESCRIBING A SCHEDULE II CONTROLLED SUBSTANCE, WITH EXCEPTIONS; TO AMEND SECTION 44-53-1630, AS AMENDED, RELATING TO THE PRESCRIPTION DRUG MONITORING PROGRAM, SO AS TO ADD A DEFINITION OF "PRACTITIONER"; TO AMEND SECTION 44-53-1640, AS AMENDED, RELATING TO THE PRESCRIPTION DRUG MONITORING PROGRAM, SO AS TO MAKE CONFORMING CHANGES; TO AMEND SECTION 44-53-1680, AS AMENDED, RELATING TO PENALTIES FOR VIOLATING REQUIREMENTS OF THE PRESCRIPTION DRUG MONITORING PROGRAM, SO AS TO ESTABLISH A PENALTY IF A PRACTITIONER OR AUTHORIZED DELEGATE FAILS TO REVIEW A PATIENT'S CONTROLLED SUBSTANCE PRESCRIPTION HISTORY, AS MAINTAINED IN THE PRESCRIPTION DRUG MONITORING PROGRAM, BEFORE PRESCRIBING A SCHEDULE II CONTROLLED SUBSTANCE; BY ADDING SECTION 40-15-145 SO AS TO ESTABLISH EDUCATIONAL REQUIREMENTS FOR DENTISTS ADDRESSING THE PRESCRIPTION AND MONITORING OF CERTAIN CONTROLLED SUBSTANCES; TO AMEND SECTIONS 40-37-240, 40-47-965, AS AMENDED, AND 40-51-140, RELATING TO CONTINUING EDUCATION REQUIREMENTS FOR CERTAIN HEALTH CARE PRACTITIONERS, SO AS TO ADD REQUIREMENTS ADDRESSING THE PRESCRIPTION AND MONITORING OF CERTAIN CONTROLLED SUBSTANCES; AND TO AMEND SECTION 40-43-130, RELATING TO CONTINUING EDUCATION REQUIREMENTS FOR PHARMACISTS, SO AS TO ADD REQUIREMENTS ADDRESSING CERTAIN CONTROLLED SUBSTANCES.
Amend Title To Conform
Be it enacted by the General Assembly of the State of South Carolina:
SECTION 1. Article 15, Chapter 53, Title 44 of the 1976 Code is amended by adding:
"Section 44-53-1645. (A) A practitioner, or the practitioner's authorized delegate, shall review a patient's controlled substance prescription history, as maintained in the prescription monitoring program, before the practitioner issues a prescription for a Schedule II controlled substance. If an authorized delegate reviews a patient's controlled substance prescription history, the practitioner must consult with the authorized delegate regarding the prescription history before issuing a prescription for a Schedule II controlled substance. The consultation must be documented in the patient's medical record.
(B) The requirements of this section do not apply to:
(1) a practitioner issuing a prescription for a Schedule II controlled substance to treat a hospice-certified patient;
(2) a practitioner issuing a prescription for a Schedule II controlled substance that does not exceed a five-day supply for a patient;
(3) a practitioner prescribing a Schedule II controlled substance for a patient with whom the practitioner has an established relationship for the treatment of a chronic condition; however, the practitioner must review the patient's controlled substance history maintained in the prescription monitoring program at least every three months;
(4) a practitioner approving the administration of a Schedule II controlled substance by a healthcare provider licensed in South Carolina;
(5) a practitioner prescribing a Schedule II controlled substance for a patient in a skilled nursing facility, nursing home, community residential care facility, or an assisted living facility and the patient's medications are stored, given, and monitored by staff; or
(6) a practitioner who is temporarily unable to access the prescription monitoring program due to exigent circumstances; however, the exigent circumstances and the potential adverse impact to the patient if the prescription is not issued timely must be documented in the patient's medical record.
(C) A practitioner is deemed to be in compliance with this section if the practitioner utilizes technology that automatically displays the patient's controlled substance prescription history from the prescription monitoring program in the practitioner's electronic medical record system. The practitioner must be able to demonstrate that this technology has been deployed in his practice, but no additional documentation is required in the patient's medical record."
SECTION 2. Section 44-53-1630 of the 1976 Code, as last amended by Act 244 of 2014, is further amended to read:
"Section 44-53-1630. As used in this section article:
(1) 'Authorized delegate' means an individual who is approved as having access to the prescription monitoring program and who is directly supervised by an authorized practitioner or pharmacist.
(2) '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)(3) '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)(4) 'Drug control' means the Department of Health and Environmental Control, Bureau of Drug Control.
(4)(5) '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.
(5)(6) 'Practitioner' means an individual authorized pursuant to state and federal law to prescribe controlled substances."
SECTION 3. Section 44-53-1640(A) of the 1976 Code is amended to read:
"(A) The Department of Health and Environmental Control, Bureau of Drug Control may shall 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."
SECTION 4. Section 44-53-1680 of the 1976 Code, as last amended by Act 244 of 2014, is further amended to read:
"Section 44-53-1680.(A) A dispenser or authorized delegate 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 prescription monitoring 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 knowingly uses this prescription monitoring 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) A pharmacist or practitioner, licensed in Title 40, who knowingly discloses prescription monitoring information in a manner or for a purpose in violation of this article shall be reported to his respective board for disciplinary action.
(E) Nothing in this chapter requires a pharmacist or practitioner to obtain information about a patient from the prescription monitoring program. A practitioner or authorized delegate of a practitioner who knowingly fails to review a patient's controlled substance prescription history, as maintained in the prescription monitoring program, or a practitioner who knowingly fails to consult with his authorized delegate regarding a patient's controlled substance prescription history before issuing a prescription for a Schedule II controlled substance, as required by this article, must be reported to his respective board for disciplinary action.
(F) 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."
SECTION 5. Article 1, Chapter 15, Title 40 of the 1976 Code is amended by adding:
"Section 40-15-145. As part of the biennial continuing education required by the board or pursuant to law, including Regulation 39-5, South Carolina Code of State Regulations, a dentist authorized pursuant to state and federal law to prescribe controlled substances shall complete at least two hours of continuing education every two years related to approved procedures of prescribing and monitoring controlled substances listed in Schedules II, III, and IV of the schedules provided for in Sections 44-53-210, 44-53-230, and 44-53-250."
SECTION 6. Section 40-37-240(D)(2) of the 1976 Code is amended to read:
"(2) Continuing education instruction must be on subjects relative to optometry, exclusive of office management or administration, at board-approved and recognized educational seminars and courses or accredited institutions of learning. Four of the forty hours may be for courses directly related to mandated health care programs including, but not limited to, HIPAA, Medicare and Medicaid, and Ethics or Jurisprudence. Sixteen of the forty hours must be pharmacology or pathology related. Satisfactory proof of compliance with this requirement is a prerequisite for biennial license renewal. If an optometrist is authorized pursuant to state and federal law to prescribe controlled substances, two of the requisite hours of continuing education must be related to approved procedures of prescribing and monitoring controlled substances listed in Schedules II, III, and IV of the schedules provided for in Sections 44-53-210, 44-53-230, and 44-53-250."
SECTION 7. Section 40-47-965(B)(3) of the 1976 Code is amended to read:
"(3) every two years, the physician assistant shall provide documentation of four continuing education contact hours in prescribing controlled substances acceptable to the board related to approved procedures of prescribing and monitoring controlled substances listed in Schedules II, III, and IV of the schedules provided for in Sections 44-53-210, 44-53-230, and 44-53-250;"
SECTION 8. Section 40-51-140 of the 1976 Code is amended to read:
"Section 40-51-140. A person licensed to practice podiatry must pay an annual a biennial renewal license fee which must be established in regulation by the board, annually biennially must complete twelve twenty-four hours of continuing medical education through a program approved by the South Carolina Board of Podiatry Examiners, and must submit documentation to the board of completion of this education. If a podiatrist is authorized pursuant to state and federal law to prescribe controlled substances, two of the requisite biennial hours of continuing education must be related to approved procedures of prescribing and monitoring controlled substances listed in Schedules II, III, and IV of the schedules provided for in Sections 44-53-210, 44-53-230, and 44-53-250. If the renewal fee is not accompanied with the appropriate continuing education documentation, the license may not be renewed and is considered late and subject to the penalties promulgated by the board in regulation. This continuing education requirement takes effect and applies to licenses being renewed beginning in 1997. If the renewal fee is not paid within two months after the date of notification by the secretary department that the fee is due, the license of the person failing to pay shall be considered late and a penalty imposed as determined by regulation. After an additional sixty days a nonrenewed license must be suspended or revoked and must be reissued only by a majority vote of the Board of Podiatry Examiners and upon payment of a late fee and penalties established by the board."
SECTION 9. Section 40-43-130(B) of the 1976 Code is amended to read:
"(B) Each licensed pharmacist, as a condition of an active status license renewal, shall complete fifteen hours (1.5 CEU's) of American Council on Pharmaceutical Education (ACPE) accredited continuing pharmacy education or continuing medical education (CME), Category I, or both, each license year. Of the fifteen hours, a minimum of six hours must be obtained through attendance at lectures, seminars, or workshops. At least fifty percent of the total number of hours required must be in drug therapy or patient management. and at least one hour must be related to approved procedures for monitoring controlled substances listed in Schedules II, III, and IV of the schedules provided for in Sections 44-53-210, 44-53-230, and 44-53-250."
SECTION 10. A. Section 40-43-82(C) of the 1976 Code is amended to read:
"(C)(1) Notwithstanding any other provision of this chapter, a supervising pharmacist may authorize a certified pharmacy technician to perform any of the following actions including, but not limited to:
(1)(a) receive receiving and initiate initiating verbal telephone orders;
(2)(b) conduct conducting one time prescription transfers;
(3)(c) check checking a technician's refill of medications if the medication is to be administered by a licensed health care professional in an institutional setting; and
(4)(d) check checking a technician's repackaging of medications from bulk to unit dose in an institutional setting.
(2) Nothing in this section prevents the Board of Pharmacy from establishing duties for a certified technician; provided, however, that a certified technician is prohibited from checking another technician's fill, refill, or repackaging of medications for delivery to a patient in an outpatient setting."
B. Section 40-43-82 is amended by adding an appropriately lettered new subsection to read:
"( ) Pharmacy technicians are exempt from continuing education requirements for the first renewal period following initial registration."
SECTION 11. Section 40-43-86(B)(4)(b) of the 1976 Code is amended to read:
"(b) The pharmacist-in-charge shall develop and implement written policies and procedures to specify the duties to be performed by pharmacy technicians. The duties and responsibilities of these personnel shall be consistent with their training and experience. These policies and procedures shall, at a minimum, specify that pharmacy technicians are to be personally supervised by a licensed pharmacist who has the ability to control and who is responsible for the activities of pharmacy technicians and that pharmacy technicians are not assigned duties that may be performed only by a licensed pharmacist. One pharmacist may not supervise more than three a total of four pharmacy technicians at a time; through June 30, 2006, at least one of these three technicians must be state-certified, and after June 30, 2006, at least two of these three technicians must be state-certified, including both state certified and non-state certified technicians. One pharmacist may not supervise more than two non-state certified technicians at a time. If a pharmacist supervises only one or two pharmacy technicians, these technicians are not required to be state-certified. Pharmacy technicians do not include personnel in the prescription area performing only clerical functions, including data entry up to the point of dispensing, as defined in Section 40-43-30(14)."
SECTION 12. Section 40-43-130(G) is amended by adding an appropriately numbered new item to read:
"( ) Pharmacy technicians are exempt from continuing education requirements while enrolled in a pharmacy technician program, as well as during the first renewal period following successful completion of the program."
SECTION 13. Chapter 43, Title 40 of the 1976 Code is amended by adding:
"Section 40-43-75. (A) For purposes of this section:
(1) 'Renal dialysis facility' or 'RDF' means an outpatient facility that treats and offers staff-assisted dialysis or training and support services for self-dialysis patients to end-stage renal disease patients, as defined by Centers for Medicare and Medicaid Services. An RDF may be composed of one or more fixed buildings, mobile units, or a combination of them, as defined in R. 61-97. An RDF must be certified by Medicare to provide dialysis-related services to ESRD patients and must have a medical director licensed as a physician, pursuant to Chapter 47, Title 40, on staff.
(2) 'End-stage renal disease' or 'ESRD' means the disease state, and associated conditions, defined under 42 C.F.R. 406.13 and the United States Social Security Act.
(B) An RDF may deliver a legend drug or device to a patient of an RDF if:
(1) the drug or device is for home use by the patient or for administration in the facility as required by the prescriber's order or prescription;
(2) the drug or device is dispensed to the RDF by a properly licensed resident or nonresident pharmacy licensed by the board or administered by a properly licensed healthcare practitioner;
(3) the drug or device is dispensed by the pharmacy pursuant to a valid prescription issued by a licensed practitioner, as defined in Section 40-43-30(45);
(4) the drug or device delivered by the RDF is properly labeled in accordance with state and federal law;
(5) the drug or device is held by the RDF in a secure location in an area not accessible to the public, and packages containing drugs or devices are delivered by RDF staff, unopened, to the patient;
(6) the patient is given a choice of receiving the drug or device from the RDF, at their home, or from another agent;
(7) the drugs exclude controlled substances; and
(8) the RDF maintains policies and procedures concerning how it will receive, store, maintain, and return any drugs or devices that are not picked up by the patient and returned to the dispensing pharmacy.
(C) The provisions of this section do not waive any other requirements to obtain licensure, permits, or certification as required by law to possess legend drug products. A facility engaged in an activity related to the delivery or distribution of legend drugs still shall hold the requisite licensure or drug permits required by law."
SECTION 14. Section 40-43-86(P) of the 1976 Code is amended to read:
"(P) If a pharmacist receives a request for a prescription refill and the pharmacist is unable to obtain refill authorization from the prescriber, the pharmacist may dispense, a one-time emergency refill once within a twelve-month period, of up to a seventy-two hour an emergency refill of up to a ten-day supply of the prescribed medication if:
(1) the prescription is not for a controlled substance;
(2) the medication is essential to the maintenance of life or to the continuation of therapy;
(3) in the pharmacist's professional judgment, continuing the therapy for seventy-two hours up to ten days will produce no undesirable health consequences or cause physical or mental discomfort;
(4) the pharmacist properly records the dispensing; and
(5) the dispensing pharmacist notifies the prescriber of the emergency dispensing refill and the amount of the refill, not to exceed a ten-day supply, within seventy-two hours a reasonable time, but no later than ten-days after the one-time emergency once in twelve months refill dispensing."
SECTION 15. 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 16. This act takes effect upon approval by the Governor.
