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HCS CSSB 196(FIN) am H: "An Act relating to establishing a controlled substance prescription database."

00 HOUSE CS FOR CS FOR SENATE BILL NO. 196(FIN) am H 01 "An Act relating to establishing a controlled substance prescription database." 02 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF ALASKA: 03 * Section 1. AS 08.80.030(b) is amended to read: 04 (b) In order to fulfill its responsibilities, the board has the powers necessary 05 for implementation and enforcement of this chapter, including the power to 06 (1) elect a president and secretary from its membership and adopt rules 07 for the conduct of its business; 08 (2) license by examination or by license transfer the applicants who are 09 qualified to engage in the practice of pharmacy; 10 (3) assist the department in inspections and investigations for 11 violations of this chapter, or of any other state or federal statute relating to the practice 12 of pharmacy; 13 (4) adopt regulations to carry out the purposes of this chapter; 14 (5) establish and enforce compliance with professional standards and 15 rules of conduct for pharmacists engaged in the practice of pharmacy;

01 (6) determine standards for recognition and approval of degree 02 programs of schools and colleges of pharmacy whose graduates shall be eligible for 03 licensure in this state, including the specification and enforcement of requirements for 04 practical training, including internships; 05 (7) establish for pharmacists and pharmacies minimum specifications 06 for the physical facilities, technical equipment, personnel, and procedures for the 07 storage, compounding, and dispensing of drugs or related devices, and for the 08 monitoring of drug therapy; 09 (8) enforce the provisions of this chapter relating to the conduct or 10 competence of pharmacists practicing in the state, and the suspension, revocation, or 11 restriction of licenses to engage in the practice of pharmacy; 12 (9) license and regulate the training, qualifications, and employment of 13 pharmacy interns and pharmacy technicians; 14 (10) issue licenses to persons engaged in the manufacture and 15 distribution of drugs and related devices; 16 (11) establish and maintain a controlled substance prescription 17 database as provided in AS 17.30.200. 18 * Sec. 2. AS 17.30 is amended by adding a new section to read: 19 Article 4A. Controlled Substance Prescription Database. 20 Sec. 17.30.200. Controlled substance prescription database. (a) The 21 controlled substance prescription database is established in the Board of Pharmacy. 22 The purpose of the database is to contain data as described in this section regarding 23 every prescription for a schedule IA, IIA, IIIA, IVA, or VA controlled substance under 24 state law or a schedule I, II, III, IV, or V controlled substance under federal law 25 dispensed in the state to a person other than those administered to a patient at a health 26 care facility. The Department of Commerce, Community, and Economic Development 27 shall assist the board and provide necessary staff and equipment to implement this 28 section. 29 (b) The pharmacist-in-charge of each licensed or registered pharmacy, 30 regarding each schedule IA, IIA, IIIA, IVA, or VA controlled substance under state 31 law or a schedule I, II, III, IV, or V controlled substance under federal law dispensed

01 by a pharmacist under the supervision of the pharmacist-in-charge, and each 02 practitioner who directly dispenses a schedule IA, IIA, IIIA, IVA, or VA controlled 03 substance under state law or a schedule I, II, III, IV, or V controlled substance under 04 federal law other than those administered to a patient at a health care facility, shall 05 submit to the board, by a procedure and in a format established by the board, the 06 following information for inclusion in the database: 07 (1) the name of the prescribing practitioner and the practitioner's 08 federal Drug Enforcement Administration registration number or other appropriate 09 identifier; 10 (2) the date of the prescription; 11 (3) the date the prescription was filled and the method of payment; this 12 paragraph does not authorize the board to include individual credit card or other 13 account numbers in the database; 14 (4) the name, address, and date of birth of the person for whom the 15 prescription was written; 16 (5) the name and national drug code of the controlled substance; 17 (6) the quantity and strength of the controlled substance dispensed; 18 (7) the name of the drug outlet dispensing the controlled substance; 19 and 20 (8) the name of the pharmacist or practitioner dispensing the controlled 21 substance and other appropriate identifying information. 22 (c) The board shall maintain the database in an electronic file or by other 23 means established by the board to facilitate use of the database for identification of 24 (1) prescribing practices and patterns of prescribing and dispensing 25 controlled substances; 26 (2) practitioners who prescribe controlled substances in an 27 unprofessional or unlawful manner; 28 (3) individuals who receive prescriptions for controlled substances 29 from licensed practitioners and who subsequently obtain dispensed controlled 30 substances from a drug outlet in quantities or with a frequency inconsistent with 31 generally recognized standards of dosage for that controlled substance; and

01 (4) individuals who present forged or otherwise false or altered 02 prescriptions for controlled substances to a pharmacy. 03 (d) The database and the information contained within the database are 04 confidential, are not public records, and are not subject to public disclosure. The board 05 shall undertake to ensure the security and confidentiality of the database and the 06 information contained within the database. The board may allow access to the 07 database only to the following persons, and in accordance with the limitations 08 provided and regulations of the board: 09 (1) personnel of the board regarding inquiries concerning licensees or 10 registrants of the board or personnel of another board or agency concerning a 11 practitioner under a search warrant, subpoena, or order issued by an administrative law 12 judge or a court; 13 (2) authorized board personnel or contractors as required for 14 operational and review purposes; 15 (3) a licensed practitioner having authority to prescribe controlled 16 substances, to the extent the information relates specifically to a current patient of the 17 practitioner to whom the practitioner is prescribing or considering prescribing a 18 controlled substance; 19 (4) a licensed or registered pharmacist having authority to dispense 20 controlled substances, to the extent the information relates specifically to a current 21 patient to whom the pharmacist is dispensing or considering dispensing a controlled 22 substance; 23 (5) federal, state, and local law enforcement authorities may receive 24 printouts of information contained in the database under a search warrant, subpoena, 25 or order issued by a court establishing probable cause for the access and use of the 26 information; and 27 (6) an individual who is the recipient of a controlled substance 28 prescription entered into the database may receive information contained in the 29 database concerning the individual on providing evidence satisfactory to the board that 30 the individual requesting the information is in fact the person about whom the data 31 entry was made and on payment of a fee set by the board under AS 37.10.050 that

01 does not exceed $10. 02 (e) The failure of a pharmacist-in-charge, pharmacist, or practitioner to submit 03 information to the database as required under this section is grounds for the board to 04 take disciplinary action against the license or registration of the pharmacy or 05 pharmacist or for another licensing board to take disciplinary action against a 06 practitioner. 07 (f) The board may enter into agreements with (1) dispensers in this state that 08 are not regulated by the state to submit information to and access information in the 09 database, and (2) practitioners in this state to access information in the database, 10 subject to this section and the regulations of the board. The board shall prohibit a 11 dispenser that is not regulated by the state from accessing the database if the dispenser 12 has accessed information in the database contrary to the limitations of this section, 13 discloses information in the database contrary to the limitations of this section, or 14 allows nonauthorized persons access to the database. 15 (g) The board shall promptly notify the president of the senate and the speaker 16 of the house of representatives if, at any time after the effective date of this Act, the 17 federal government fails to pay all or part of the costs of the controlled substance 18 prescription database. 19 (h) An individual who has submitted information to the database in 20 accordance with this section may not be held civilly liable for having submitted the 21 information. Nothing in this section requires or obligates a dispenser or practitioner to 22 access or check the database before dispensing, prescribing, or administering a 23 medication, or providing medical care to a person. Dispensers or practitioners may not 24 be held civilly liable for damages for accessing or failing to access the information in 25 the database. 26 (i) A person who has reason to believe that prescription information from the 27 database has been illegally or improperly accessed shall notify an appropriate law 28 enforcement agency. 29 (j) The board shall notify any person whose prescription information from the 30 database is illegally or improperly accessed. 31 (k) In the regulations adopted under this section, the board shall provide

01 (1) that prescription information in the database shall be purged from 02 the database after two years have elapsed from the date the prescription was 03 dispensed; 04 (2) a method for an individual to challenge information in the database 05 about the individual that the person believes is incorrect or was incorrectly entered by 06 a dispenser. 07 (l) A person 08 (1) with authority to access the database under (d) of this section who 09 knowingly 10 (A) accesses information in the database beyond the scope of 11 the person's authority commits a class A misdemeanor; 12 (B) accesses information in the database and recklessly 13 discloses that information to a person not entitled to access or to receive the 14 information commits a class C felony; 15 (C) allows another person who is not authorized to access the 16 database to access the database commits a class C felony; 17 (2) without authority to access the database under (d) of this section 18 who knowingly accesses the database or knowingly receives information that the 19 person is not authorized to receive under (d) of this section from another person 20 commits a class C felony. 21 (m) To assist in fulfilling the program responsibilities, performance measures 22 shall be reported to the legislature annually. Performance measures may include 23 outcomes detailed in the federal prescription drug monitoring program grant regarding 24 efforts to; 25 (1) reduce the rate of inappropriate use of prescription drugs by 26 reporting education efforts conducted by the Board of Pharmacy; 27 (2) reduce the quantity of pharmaceutical controlled substances 28 obtained by individuals attempting to engage in fraud and deceit; 29 (3) increase coordination among prescription drug monitoring program 30 partners; and 31 (4) involve stakeholders in the planning process.

01 (n) In this section, 02 (1) "board" means the Board of Pharmacy; 03 (2) "database" means the controlled substance prescription database 04 established in this section; 05 (3) "knowingly" has the meaning given in AS 11.81.900; 06 (4) "pharmacist-in-charge" has the meaning given in AS 08.80.480. 07 * Sec. 3. The uncodified law of the State of Alaska is amended by adding a new section to 08 read: 09 REPORT TO THE LEGISLATURE. (a) The Board of Pharmacy shall, by the first day 10 of the First Regular Session of the Twenty-Sixth Alaska State Legislature, submit a report to 11 the legislature that 12 (1) identifies how the controlled substance prescription database would be 13 designed, identifies the measures that would be undertaken to limit, identify, and log 14 unauthorized accesses to the information in the database, discloses where the database would 15 be maintained and the persons that would be allowed access to the database, and identifies 16 best practices of other states that have implemented similar databases; 17 (2) identifies measures that would be undertaken to ensure the privacy of the 18 records maintained in the database; 19 (3) identifies possible alternatives for including information in the database as 20 opposed to including all prescription information automatically in the database. This should 21 include whether other states have alternatives for inclusion of prescription information in the 22 database. 23 (b) The Board of Pharmacy shall submit the report required under (a) of this section 24 to the senate secretary and the chief clerk and shall notify the members of the legislature that 25 the report is available.