The statement of scope was approved by the governor on December 4, 2012.
Rule No.
Relating to
Electronic prescriptions for schedule II controlled substances.
Rule Type
Permanent.
Finding/Nature of Emergency (Emergency Rule Only)
N/A.
Detailed Description of the Objective of the Proposed Rule
The Wisconsin Pharmacy Examining Board seeks to modify s.
Phar 7.08 (1) and note, ss.
Phar 8.05,
8.07 (2), and
8.09, to allow pharmacists/pharmacies to dispense a Schedule II controlled substance with an electronic prescription by a practitioner, instead of only pursuant to a written order. Further, the Board seeks to modify the above rules to allow pharmacists/pharmacies to dispense a Schedule II controlled substance in emergency cases with the requirement that the prescription is promptly reduced to a written hard copy or electronic record.
2011 Wisconsin Act 159 provides that, except when dispensed directly by a practitioner, other than a pharmacy, to an ultimate user, a Schedule II controlled substance may be dispensed by a pharmacy by either a written hard copy or electronic prescription of a practitioner. Act 159 also provides that when a Schedule II controlled substance is dispensed upon an oral prescription in an emergency, the prescription must be reduced promptly to a written hard copy or electronic record.
Prior to
2011 Act 159, except when dispensed directly by a practitioner, other than a pharmacy, to an ultimate user, no controlled substance included in Schedule II could be dispensed without the written prescription of a practitioner under s.
Phar 8.05 (4). However, in emergency situations, under s.
Phar 8.09, Schedule II controlled substances could be dispensed upon oral or electronic prescription of a practitioner, reduced promptly to writing, and filed by the pharmacy.
As a result of the statutory changes to ss.
450.11 (2),
961.38 (1r), and
961.38 (2), Stats., due the passage of
2011 Act 159, the Board has determined that the above rules must be amended to conform to the revised statutes.
Description of the Existing Policies Relevant to the Rule, New Policies Proposed to be Included in the Rule, and an Analysis of Policy Alternatives
The proposed modifications to s.
Phar 7.08 (1) and note, ss.
Phar 8.05,
8.07 (2), and
8.09 would allow a pharmacy/pharmacist to use modern technology to dispense Schedule II controlled substances in a manner that efficiently meets patient needs by allowing electronic prescriptions for all Schedule II controlled substances and allowing oral prescriptions to be reduced to an electronic record while maintaining public safety.
The Board seeks to conform the above rules to the revised statutes. Moreover, the Board has determined that the rules, as they currently exist, do not grant enough flexibility for patients to have their prescriptions received by the pharmacy of their choice in a timely manner.
The Board has determined that the rule changes will help to cut down on dispensing errors or patients misplacing their written prescription orders by allowing electronic prescriptions for Schedule II controlled substances, rather than only written prescription orders.
Detailed Explanation of Statutory Authority for the Rule (Including the Statutory Citation and Language)
Section
450.02 (3) (a), Stats., authorizes the Board to promulgate rules “[r]elating to the
…distribution and dispensing of prescription drugs." Under s.
450.01 (7), Stats., the definition of dispense “means to deliver a prescribed drug or device to an ultimate user
…" Section
450.02 (3) (d), Stats., authorizes the Board to promulgate rules necessary for the administration and enforcement of Chapters
450 and
961, Stats.
Section
15.08 (5) (b), Stats., allows each examining board to “promulgate rules for its own guidance and for the guidance of the trade or profession to which it pertains and define and enforce professional conduct and unethical practices not inconsistent with the law relating to the particular trade or profession."
Estimate of Amount of Time that State Employees Will Spend Developing the Rule and of Other Resources Necessary to Develop the Rule
30 hours.
List with Description of All Entities that May Be Affected by the Proposed Rule
Pharmacies, pharmacists, and practitioners.
Summary and Preliminary Comparison with Any Existing or Proposed Federal Regulation that Is Intended to Address the Activities to be Regulated by the Proposed Rule
Federal law under
21 C.F.R. Parts 1300,
1304,
1306, and
1311 pertain to the transfer of electronic prescriptions. The Drug Enforcement Administration (DEA) revised its rules, effective June 1, 2010, to provide practitioners with the option of writing prescriptions for controlled substances electronically. The regulations permit pharmacies to receive, dispense, and archive these electronic prescriptions. The regulations provide pharmacies, hospitals, and practitioners with the ability to use modern technology for controlled substance prescriptions while maintaining the closed system of controls on controlled substances dispensing. In effect, federal law permits Wisconsin to allow schedule II controlled substances to be dispensed by a pharmacy upon an oral prescription of a practitioner, that is promptly reduced to a written hard copy or electronic record, and filed by the pharmacy, as provided in
2011 WI Act 159.
Anticipated Economic Impact of Implementing the Rule (Note If the Rule is Likely to Have a Significant Economic Impact on Small Businesses)
Minimal or no economic impact.
Contact Person
Sharon Henes (608) 261-2377.
Safety and Professional Services —
Pharmacy Examining Board
The statement of scope was approved by the governor on December 4, 2012.
Rule No.
Relating to
Return or exchange of health items.
Rule Type
Permanent.
Finding/Nature of Emergency (Emergency Rule Only)
N/A.
Detailed Description of the Objective of the Proposed Rule
The Board seeks to amend s.
Phar 7.04 (1) (e) 2., which defines “secured institutional health care patient" by references to Wis. Stat. s. 938.02 that were either repealed, recreated, or renumbered in
2005 Wis. Act 344. The changes proposed by this scope statement would further amend the terms in s.
Phar 7.04 (1) (e) 2. to match the terms referenced in Wis. Stat. s.
938.02 and also repeal the Note following s.
Phar 7.04 (1) (e) 2.
Description of the Existing Policies Relevant to the Rule, New Policies Proposed to be Included in the Rule, and an Analysis of Policy Alternatives
The policies upon which s.
Phar 7.04 (1) (e) 2. rest have not changed since the time this rule was originally promulgated. This rule-making is proposed strictly for the purpose of making the administrative rule consistent with the statutes referenced therein.
Detailed Explanation of Statutory Authority for the Rule (Including the Statutory Citation and Language)
Section
15.08 (5) (b), Stats. Each examining board: shall promulgate rules for its own guidance and for the guidance of the trade or profession to which it pertains and define and enforce professional conduct and unethical practices not inconsistent with the law relating to the particular trade or profession.
Section
450.02 (3), Stats. The board may promulgate rules: (a) Relating to the manufacture of drugs and the distribution and dispensing of prescription drugs. (b) Establishing security standards for pharmacies. (c) Relating to the manufacture, distribution and dispensing of hypodermic syringes, needles and other objects used, intended for use or designed for use in injecting a drug. (d) Necessary for the administration and enforcement of this Chapter and Ch.
961, Stats. (e) Establishing minimum standards for the practice of pharmacy. (f) Establishing procedures for identifying pharmacists impaired by alcohol or other drugs or physical or mental disability or disease and for assisting those pharmacists in obtaining treatment.
Estimate of Amount of Time that State Employees Will Spend Developing the Rule and of Other Resources Necessary to Develop the Rule
20 hours.
List with Description of All Entities that May Be Affected by the Proposed Rule
No entities will be affected by the proposed amendments to s.
Phar 7.04 (1) (e) 2., as neither the statutory reference changes, nor the changes in terminology have any substantive effect.
Summary and Preliminary Comparison with Any Existing or Proposed Federal Regulation that Is Intended to Address the Activities to be Regulated by the Proposed Rule
There are no federal regulations comparable to s.
Phar 7.04 (1) (e); the Wisconsin statutes and rules involved in this proposed rule-making set forth definitions of terms applicable to Wisconsin only.
Anticipated Economic Impact of Implementing the Rule (Note If the Rule is Likely to Have a Significant Economic Impact on Small Businesses)
None.
Contact Person
Sharon Henes, (608) 261-2377.
Safety and Professional Services —
Pharmacy Examining Board
The statement of scope was approved by the governor on December 4, 2012.
Rule No.
Relating to
Pharmacy technicians.
Rule Type
Permanent.
Finding/Nature of Emergency (Emergency Rule Only)
N/A.
Detailed Description of the Objective of the Proposed Rule
The Pharmacy Examining Board seeks to add two requirements for a person to qualify as a “pharmacy technician" under s.
Phar 7.015 (1): the person must be 18 years of age or older and the person must have a high school diploma or equivalent education.
Description of the Existing Policies Relevant to the Rule, New Policies Proposed to be Included in the Rule, and an Analysis of Policy Alternatives
The Board is authorized to promulgate rules establishing the minimum standards for the practice of pharmacy, which includes the supervision of pharmacist support personnel. Pharmacy technicians are non-pharmacists and non-pharmacist-interns who are considered pharmacy support personnel. In order to better protect the public, the Board is seeking to amend s.
Phar 7.015 to create a new provision requiring that pharmacies may only hire pharmacy technicians meeting the following minimum requirements: the person must be 18 years of age or older and the person must have a high school diploma or equivalent education.
A similar rule was previously adopted by the Board under ss.
Phar 7.095 (7) (a) and
(b), regarding the operation of remote dispensing sites. This rule requires that pharmacy technicians and pharmacy interns employed at a remote dispensing site be 18 years of age or older and have a high school diploma or equivalent education.
Detailed Explanation of Statutory Authority for the Rule (Including the Statutory Citation and Language)
Section
450.02 (3) (a), Stats., authorizes the Board to promulgate rules “[r]elating to the
… dispensing of prescription drugs." Moreover, s.
450.02 (3) (e), Stats., authorizes the Board to promulgate rules “[e]stablishing the minimum standards for the practice of pharmacy." The “practice of pharmacy" is defined under s.
450.01 (16) (g), Stats., to include the “[s]upervision of pharmacist support personnel."
Section
15.08 (5) (b), Stats., allows each examining board to “promulgate rules for its own guidance and for the guidance of the trade or profession to which it pertains and define and enforce professional conduct and unethical practices not inconsistent with the law relating to the particular trade or profession."
Estimate of Amount of Time that State Employees Will Spend Developing the Rule and of Other Resources Necessary to Develop the Rule
20 hours.
List with Description of All Entities that May Be Affected by the Proposed Rule
Pharmacies, supervising and/or managing pharmacists, and Department of Safety and Professional Services credentialing personnel.
Summary and Preliminary Comparison with Any Existing or Proposed Federal Regulation that Is Intended to Address the Activities to be Regulated by the Proposed Rule
None.
Anticipated Economic Impact of Implementing the Rule (Note If the Rule is Likely to Have a Significant Economic Impact on Small Businesses)
No economic impact or minimal economic impact.
Contact Person
Kris Anderson, DSPS (608) 261-2385.
