H. B. 2879

(By Delegates Border, Michael
and H. White)
[Introduced March 16, 2001; referred to the
Committee on Finance.]

A BILL to amend and reenact sections three, four and five, article nine, chapter sixty-a of the code of West Virginia, one thousand nine hundred thirty-one, as amended, all relating to the controlled substances monitoring act; changing the program to a target program; adding Schedule III and IV controlled substances to the program for targeted monitoring; making the program contingent on funding; requiring annual program reporting; exempting program information from freedom of information act; and granting immunity to pharmacists refusing to dispense prescription controlled substances under certain circumstances.

Be it enacted by the Legislature of West Virginia:
That sections three, four and five, article nine, chapter sixty-a of the code of West Virginia, one thousand nine hundred thirty-one, as amended, be amended and reenacted, all to read as follows:
ARTICLE 9. CONTROLLED SUBSTANCES MONITORING.

§60A-9-3. Reporting system requirements; implementation; central repository requirement.

(a) On or before the first day of May, one thousand nine hundred ninety-six, the board of pharmacy shall implement a program wherein a central repository is established and maintained which shall contain such that contains the information as is required by the provisions of this article regarding Schedule II targeted controlled substances prescriptions written or filled in this state. On or before the first day of July, two thousand one, the board of pharmacy shall implement procedures to change the program to a targeted program and add specific Schedule II, Schedule III and Schedule IV controlled substances prescriptions written or filled in this state. In implementing this program, the board of pharmacy shall consult with the division of public safety West Virginia state police, the licensing boards of practitioners affected by this article and affected practitioners. Criteria used by the board of pharmacy to determine individual controlled substances prescription targeted drugs shall, in the discretion of the board, include any of the following factors:
(1) Clinical abuse or misuse;
(2) Over utilization or under utilization;
(3) Therapeutic duplication;
(4) Drug-disease contraindication;
(5) Drug-drug interaction;
(6) Incorrect drug dosage or duration of drug treatment; or
(7) Any significant change in drug, dose or direction.
(b) The program authorized by subsection (a) of this section shall be cooperatively developed and operated in conjunction with the West Virginia University School of Pharmacy, and shall be designed to minimize inconvenience to patients, prescribing practitioners and pharmacists while effectuating the collection and storage of the required information. The board of pharmacy shall allow reporting of the required information by electronic data transfer where feasible, and where such is infeasible, on reporting forms promulgated by the board of pharmacy. The information required to be submitted by the provisions of this article shall be required to be filed no more frequently than once in a two-month period.
(c) The program authorized by subsection (a) of this section shall also provide for the reimbursement, in whole or in part, of the costs reasonably and necessarily incurred by pharmacists or pharmacies in modifying software in conformance with the reporting requirements of this article. Provided, That the total expenditures for reimbursements shall not exceed twenty-five thousand dollars The board of pharmacy is hereby authorized to promulgate an emergency legislative rule to effectuate the reimbursement provisions of this section in accordance with the provisions of chapter twenty-nine-a of this code. The board of pharmacy shall provide for the electronic transmission of the information required to be provided by this article by and through the use of a toll-free telephone line.
(d) Continued operation of the controlled substances monitoring program is contingent upon available funding from legislative appropriations, federal grants or fees as authorized by legislative rule.
(e) The board of pharmacy shall file a report with the Legislature on or before the first day of January, two thousand two, and annually thereafter, which is to include information on the effectiveness of the program; the number of substances monitored; the cost of monitoring by classification; the total number of actions taken as a result of information received through the program, including, but not limited to, disciplinary actions, prosecutions and convictions; and any recommendations for additional modifications to this program.
§60A-9-4. Required information.
(a) Whenever a medical services provider dispenses a controlled substance listed in the provisions of section two hundred six, article two of this chapter, targeted by the board of pharmacy or whenever a prescription for such controlled substances is filled by: (i) A pharmacist or pharmacy in this state; (ii) a hospital, or other health care facility, for out-patient use; or (iii) a pharmacy or pharmacist, licensed by the board of pharmacy, but situated outside this state for delivery to a person residing in this state, the medical services provider, health care facility, pharmacist or pharmacy shall, in a manner prescribed by rules promulgated by the board of pharmacy under this article, report the following information, as applicable:
(1) The name, address, pharmacy prescription number and DEA controlled substance registration number of the dispensing pharmacy;
(2) The name, and address and date of birth of the person for whom the prescription is written;
(3) The name, address and drug enforcement administration controlled substances registration number of the practitioner writing the prescription;
(4) The name and national drug code number of the Schedule II controlled substance dispensed;
(5) The quantity and dosage of the Schedule II targeted controlled substance dispensed;
(6) The date the prescription was filled; and
(7) The number of refills, if any, authorized by the prescription.
(b) The board of pharmacy may prescribe by rule promulgated under this article the form to be used in prescribing a Schedule II substance the targeted controlled substances if, in the determination of the board, the administration of the requirements of this section would be facilitated.

§60A-9-5. Confidentiality; limited access to records; period of retention; no civil liability for required reporting; pharmacist immunity for refusal to prescribe.

The information required by this article to be kept by the board of pharmacy shall be confidential and shall be open to inspection only by inspectors and agents of the board of pharmacy, members of the division of public safety West Virginia state police expressly authorized by the superintendent to have access to the information, duly authorized agents of licensing boards of practitioners authorized to prescribe Schedule II targeted controlled substances and persons with an enforceable court order or regulatory agency administrative subpoena. The board shall maintain the information required by this article for a period of no less than five years. Notwithstanding any provisions of this code, data obtained under the provisions of this article may be used for compilation of educational, scholarly or statistical purposes as long as the identities of persons or entities remain confidential. No individual or entity required to report under section four of this article shall be subject to a claim for civil damages or other civil relief for the reporting of information to the board of pharmacy as required under, and in accordance with, the provisions of this article. All information which contains the identification of individual patients or practitioners or other entities or from which their identities could be derived, is not subject to the freedom of information act set forth in article one, chapter twenty-nine-b of this code. No pharmacist licensed under article five, chapter thirty of this code may compound or dispense any prescription order which, in his or her professional judgment or opinion, contains any error, irregularity or ambiguity, or which in his or her professional judgment or opinion may not be issued for a legitimate medical purpose. A pharmacist who refuses to compound or dispense a prescription order pursuant to the provisions of this section shall have absolute immunity from liability or any cause of action as the result of such act or omission.


NOTE: The purpose of this bill is to

modify the controlled substances monitoring act to expand the coverage and to allow for targeting for specific drugs of abuse.
Strike-throughs indicate language that would be stricken from the present law, and underscoring indicates new language that would be added.