Amendment ASA1-AB628

LRBs0492/3

MDK&JS:jlg:ijs

1997 - 1998 LEGISLATURE

ASSEMBLY SUBSTITUTE AMENDMENT 1, TO 1997 ASSEMBLY BILL 628

March 3, 1998 - Offered by Representatives Albers and Underheim.

AB628-ASA1,1,6 An Act to amend 450.01 (1), 450.02 (3) (intro.) and 450.08 (2) (a); and to create 450.01 (1) (c), 450.01 (16) (k), 450.01 (22), 450.02 (2g), 450.02 (2m), 450.035, 450.085 and 628.36 (2m) (a) 2m. of the statutes; relating to: the administration of drug products and devices and vaccines by pharmacists, continuing education for pharmacists, creating a pharmacist advisory council and granting rule-making authority.

The people of the state of Wisconsin, represented in senate and assembly, do enact as follows:

AB628-ASA1, s. 1 Section 1. 15.407 (6) of the statutes is created to read:

AB628-ASA1,1,11 15.407 (6) Pharmacist advisory council. There is created a pharmacist advisory council in the department of regulation and licensing and serving the pharmacy examining board in an advisory capacity. The council shall consist of the following members appointed for 3-year terms:

AB628-ASA1,2,2 (a) Two pharmacists licensed under ch. 450 appointed by the chairperson of the pharmacy examining board.

AB628-ASA1,2,4 (b) One physician licensed under subch. II of ch. 448 appointed by the chairperson of the medical examining board.

AB628-ASA1,2,6 (c) One nurse licensed under ch. 441 appointed by the chairperson of the board of nursing.

AB628-ASA1, s. 2 Section 2. 450.01 (1) of the statutes is amended to read:

AB628-ASA1,2,10 450.01 (1) "Administer" means the direct application of a vaccine or a prescribed drug or device, whether by injection, ingestion or any other means, to the body of a patient or research subject by any of the following:

AB628-ASA1,2,11 (a) A practitioner or his or her authorized agent; or .

AB628-ASA1,2,12 (b) The A patient or research subject at the direction of the a practitioner.

AB628-ASA1, s. 3 Section 3. 450.01 (1) (c) of the statutes is created to read:

AB628-ASA1,2,14 450.01 (1) (c) A pharmacist.

AB628-ASA1, s. 4 Section 4. 450.01 (16) (k) of the statutes is created to read:

AB628-ASA1,2,17 450.01 (16) (k) Administering prescribed drug products and devices under s. 450.035 (1r) and, pursuant to vaccination protocols, vaccines.

AB628-ASA1, s. 5 Section 5. 450.01 (22) of the statutes is created to read:

AB628-ASA1,2,22 450.01 (22) "Vaccination protocol" means a written protocol agreed to by a physician, as defined in s. 448.01 (5), and a pharmacist that establishes procedures and record-keeping and reporting requirements for the administration of a vaccine by a pharmacist for a period specified in the protocol that may not exceed 2 years.

AB628-ASA1, s. 6 Section 6. 450.02 (2g) of the statutes is created to read:

AB628-ASA1,3,2 450.02 (2g) (a) The pharmacy examining board shall, after consultation with the medical examining board and the board of nursing, promulgate rules that establish criteria for approving courses under ss. 450.035 (1r) and (2) and 450.085 (1).

AB628-ASA1,3,9 (b) The board shall promulgate rules that establish requirements and procedures for the administration of a drug product or device, as defined in s. 450.035 (1g), by a pharmacist under s. 450.035 (1r). Notwithstanding s. 15.08 (5) (b), the board may promulgate rules under this paragraph only if the rules are identical to rules recommended by the pharmacist advisory council. The board may amend or repeal rules promulgated under this paragraph only upon the recommendation of the pharmacist advisory council.

AB628-ASA1, s. 7 Section 7. 450.02 (2m) of the statutes is created to read:

AB628-ASA1,3,13 450.02 (2m) The board shall periodically prepare and distribute letters, bulletins or other types of notice to pharmacists that identify the courses that are approved for purposes of ss. 450.035 (1r) and (2) and 450.085 (1).

AB628-ASA1, s. 8 Section 8. 450.02 (3) (intro.) of the statutes is amended to read:

AB628-ASA1,3,15 450.02 (3) (intro.) The board may adopt promulgate rules:

AB628-ASA1, s. 9 Section 9. 450.025 of the statutes is created to read:

AB628-ASA1,3,21 450.025 Pharmacist advisory council. The pharmacist advisory council shall recommend rules for promulgation by the board under s. 450.02 (2g) (b) and may recommend the amendment or repeal of any rules promulgated under s. 450.02 (2g) (b). A unanimous vote of the members of the pharmacist advisory council is required for the council to make a recommendation under this section.

AB628-ASA1, s. 10 Section 10. 450.035 of the statutes is created to read:

AB628-ASA1,3,24 450.035 Administration of drug products and devices; vaccines. (1g) In this section, "drug product or device" does not include a vaccine.

AB628-ASA1,4,9 (1r) A pharmacist may not administer by injection a prescribed drug product or device unless he or she has successfully completed a course of study and training in injection technique conducted by a course provider approved by the American Council on Pharmaceutical Education or the board. A pharmacist may administer a prescribed drug product or device under this subsection only in the course of teaching self-administration techniques to a patient. A pharmacist who administers a prescribed drug product or device under this subsection shall comply with the requirements and procedures established in rules promulgated by the board under s. 450.02 (2g) (b).

AB628-ASA1,4,15 (2) A pharmacist may not administer a vaccine unless he or she has successfully completed 12 hours in a course of study and training, approved by the American Council on Pharmaceutical Education or the board, in vaccination storage, protocols, injection technique, emergency procedures and record keeping and has satisfied the requirements specified in sub. (2t). A pharmacist may not administer a vaccine under this subsection to a person who is under the age of 18.

AB628-ASA1,4,17 (2m) A pharmacist may not delegate to any person any administration of a prescribed drug product or device or vaccine under sub. (1r) or (2).

AB628-ASA1,4,19 (2t) A pharmacist may not administer a vaccine under sub. (2) unless he or she satisfies each of the following:

AB628-ASA1,4,23 (a) The pharmacist has in effect liability insurance against loss, expense and liability resulting from errors, omissions or neglect in the administration of vaccines in an amount that is not less than $1,000,000 for each occurrence and $2,000,000 for all occurrences in any one policy year.

AB628-ASA1,5,3 (b) The pharmacist maintains proof that he or she satisfies the requirement specified in par. (a) and, upon request, provides copies of such proof to the department or the board.

AB628-ASA1,5,6 (3) A pharmacist who successfully completes a course of study and training specified in sub. (1r) or (2) shall maintain proof of completion and, upon request, provide copies of such proof to the department or the board.

AB628-ASA1, s. 11 Section 11. 450.08 (2) (a) of the statutes is amended to read:

AB628-ASA1,5,14 450.08 (2) (a) A pharmacist's license may be renewed by complying with continuing education requirements under s. 450.085 and paying the applicable fee specified under s. 440.08 (2) (a) on or before the applicable renewal date specified under s. 440.08 (2) (a). Failure to obtain renewal within the time period specified under this paragraph terminates the right of the person to be licensed as a pharmacist, and such right can only be acquired by passing an examination to the satisfaction of the board.

AB628-ASA1, s. 12 Section 12. 450.085 of the statutes is created to read:

AB628-ASA1,5,24 450.085 Continuing education. (1) An applicant for renewal of a license under s. 450.08 (2) (a) shall submit proof that he or she has completed, within the 2-year period immediately preceding the date of his or her application, 30 hours of continuing education in courses conducted by a provider that is approved by the American Council on Pharmaceutical Education or in courses approved by the board. Courses specified in ss. 450.035 (1r) and (2) are courses in continuing education for purposes of this subsection. This subsection does not apply to an applicant for renewal of a license that expires on the first renewal date after the date on which the board initially granted the license.

AB628-ASA1,6,3 (2) The board may waive all or part of any requirement in sub. (1) if it finds that exceptional circumstances such as prolonged illness, disability or other similar circumstances have prevented a pharmacist from meeting the requirement.

AB628-ASA1, s. 13 Section 13. 628.36 (2m) (a) 2m. of the statutes is created to read:

AB628-ASA1,6,6 628.36 (2m) (a) 2m. "Pharmaceutical services" do not include the administration of a drug product or device or vaccine under s. 450.035.

AB628-ASA1, s. 14 Section 14 . Nonstatutory provisions.

AB628-ASA1,6,11 (1) The pharmacy examining board shall submit in proposed form the rules required under section 450.02 (2g) (a) of the statutes, as affected by this act, to the legislative council staff under section 227.15 (1) of the statutes no later than the first day of the 6th month beginning after the effective date of this subsection.

AB628-ASA1,6,15 (2) The pharmacy examining board shall submit in proposed form the rules required under section 450.02 (2g) (b) of the statutes, as affected by this act, to the legislative council staff under section 227.15 (1) of the statutes no later than the first day of the 12th month beginning after the effective date of this subsection.

AB628-ASA1,6,19 (3) Notwithstanding section 15.407 (6) (intro.) of the statutes, as created by this act, the initial members of the pharmacist advisory council shall be appointed no later than the first day of the 2nd month beginning after the effective date of this subsection for the following terms: