Michigan Office of Administrative Hearings and Rules

MOAHR-Rules@michigan.gov

AGENCY REPORT TO THE

JOINT COMMITEE ON ADMNINISTRATIVE RULES (JCAR)

1. Agency Information

Agency name:

Licensing and Regulatory Affairs

Division/Bureau/Office:

Bureau of Professional Licensing

Name of person completing this form:

Andria Ditschman

Phone number of person completing this form:

517-290-3361

E-mail of person completing this form:

DitschmanA@michigan.gov

Name of Department Regulatory Affairs Officer reviewing this form:

Elizabeth Arasim

2. Rule Set Information

MOAHR assigned rule set number:

2022-2 LR

Title of proposed rule set:

Pharmacy Technicians

3. Purpose for the proposed rules and background:

The purpose of the Board of Pharmacy - Pharmacy Technicians Rules is to regulate the prelicensure

programs, examinations, licensure, licensure renewal, relicensure, continuing education, and

delegation of activities and functions for pharmacy technicians. The proposed rules are intended to:

address the shortage of pharmacy technicians; add a minimum examination passing score; clarify the

licensure requirements; clarify the requirements for licensure by endorsement; clarify the

requirements for a temporary license; review the date of program accreditation; add a process for

rescinding approval of an examination or program; clarify the requirements for relicensure and add

relicensure requirements for individuals licensed in another state; clarify the continuing education

requirements; modify the process for review of continuing education for consistency with the

pharmacist continuing education review process; delete the reference to American Society of Health-

System Pharmacists (ASHP) when used to refer to continuing education; and clarify and broaden the

activities and functions that may be delegated to a pharmacy technician’s scope of practice.

4. Summary of proposed rules:

MCL 24.242 and 24.245

Agency Report to JCAR-Page 2

The proposed rules include the following modifications: all existing board approved pharmacy

technician examinations and programs in this state will be required to be reviewed by the board

before December 31, 2023; all board approved pharmacy technician examinations in this state will

have a 70% passing score; the board will review comprehensive curriculum-based pharmacy

technician education and training programs conducted by a community college; a student in a

pharmacy technician program who is less than 18 years of age may participate in practical training in

a pharmacy; a deficient pharmacy technician program will not accept students until the deficiency is

fixed; licensees may meet the pharmacy ethics and jurisprudence continuing education (CE)

requirement by taking more than 1 course or program; licensees may use the human trafficking

training and implicit bias training toward the required 20 CE hours; a licensee must apply for a

waiver of CE pursuant to the required time requirements; a licensee will be able to use CE earned up

to the date of the filing of the renewal of their license; the 5 hours of CE in live, synchronous, courses

or programs may be earned in-person or virtual; a licensee may only earn 2 CE hours for the

presentation of a CE program that is not a part of the licensee’s regular job description; the review of

pharmacy technician CE courses and programs and pharmacist CE courses and programs will be the

same; a pharmacy technician may qualify to perform final product verification by either work

experience or training; and a pharmacy technician will be allowed to work remotely in a limited

capacity outside of the personal charge of a pharmacist.

5. List names of newspapers in which the notice of public hearing was published and

publication dates:

The Flint Journal: March 12, 2023

The Grand Rapids Press: March 12, 2023

The Mining Journal: March 21, 2023

6. Date of publication of rules and notice of public hearing in Michigan Register:

4/1/2023

7. Date, time, and location of public hearing:

4/6/2023 09:00 AM at Location: 611 W. Ottawa Street, UL-5, Lansing, Michigan , 611 W. Ottawa

Street, UL-5, Lansing, Michigan

8. Provide the link the agency used to post the regulatory impact statement and cost-benefit

analysis on its website:

https://ARS.apps.lara.state.mi.us/Transaction/RFRTransaction?TransactionID=1361

9. List of the name and title of agency representative(s) who attended the public hearing:

Andria Ditschman, Departmental Specialist, Bureau of Professional Licensing

Kerry Przybylo, Manager of Board and Committees, Bureau of Professional Licensing

10. Persons submitting comments of support:

Jonathan McLachlan, Charlie Mollien, and Renee Smiddy submitted comments of support.

11. Persons submitting comments of opposition:

Rose Baran and Renee Smiddy submitted comments in opposition.

12. Persons submitting other comments:

MCL 24.242 and 24.245

Agency Report to JCAR-Page 3

Rose Baran, Deeb Eid, Farah Jalloul, Jonathan McLachlan, Charlie Mollien, Renee Smiddy, and

Maria Young submitted comments with suggested changes to the rules.

13. Identify any changes made to the proposed rules based on comments received during the

public comment period:

Name &

Organization public hearing

Comments made at Written

Agency Rationale Rule number

for Rule Change & citation

and Description changed

of Change(s)

Comments

Made

1

2

Jalloul

Change the

reference from R with the comment (2)

338.7005 to R

338.7004, as R

338.7005 was

rescinded.

The Board agrees R 338.3651a

to update the

reference to the

General Rules as

R 338.7005 was

rescinded.

Jalloul

Change the

The Board agrees R 338.3653

reference from R with the comment (2)

338.7005 to R

338.7004, as R

338.7005 was

rescinded.

to update the

reference to the

General Rules as

R 338.7005 was

rescinded.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 4

3

Eid

Strike (8) from

the proposed

rules.

The Board agrees R 338.3654

with the comment (8)

to delete (8) for

Referencing

national

the reasons

submitted by the

standards, exams commenter, and

such as the PTCB replaces the

or NHA

certification

current proposed

language with

exams, no longer language that a

use percentile-

based scoring.

pharmacy

technician

More modern-day program must

psychometric include a

standards call for proficiency

scaled scoring examination

where a passing scoring procedure

percentage is not with their

stagnant. Holding proficiency

other “board

approved

proficiency

exams” to an

arbitrary 70%

standard is not

consistent with

examination

application, which

will be reviewed

by the Board with

the examination,

as the Board is

concerned that the

other parts of the program has a

regulation which scoring process in

allow for national place, not that it

standards. To fall has a specific

in line with these minimum score.

standards, it is

suggested to

remove and not

include an

arbitrary passing

% number that is

not backed by

evidence or

examination

standards

nationally.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 5

4

Smiddy

This provision

states that a

The Board agrees R 338.3655

with the comment (6)

student in a board that (6) should be

-approved

pharmacy

technician

program is

clarified by

deleting “and not

eligible for” to

clarify that a

exempt from, and student in a

not eligible for, pharmacy program

licensure while in can apply for a

the program.

“Not eligible for”

sounds like

temporary license.

students are not

eligible to receive

temporary

licenses while in

a training

program.

5

Mollien

I recommend the The Board agrees R 338.3655

Board change this with the comment (7)

rule to align with to limit students to

DLEO to only

permit

individuals 16

years or older to

individuals 16 or participate in

17 years old to

participate in

training in a

pharmacy

practical training technician

in the pharmacy. program.

6

Smiddy

Commenter

requests a

The Board agrees R 338.3655

that “practical

(7)

definition of

training” should

practical training. be clarified to

“practical hands-

on training.”

MCL 24.242 and 24.245

Agency Report to JCAR-Page 6

7

Smiddy

Commenter

recommends

pharmacy

The Board agrees R 338.3655

with the comment (8)

that the date to

technician

require

programs be

reevaluated

reevaluation of a

program should be

within one-year delayed until 1

of the rules set

promulgation

date. This will

allow program

administrators

year after

promulgation of

the rules to give

programs more

time to adjust to

and community any new

partners

requirements in

additional time to the rules.

communicate the

reevaluation

timeframe with

stakeholders.

8

Mollien

Clarify how the The Board agrees R 338.3655

program has an with the comment (9)

opportunity to

that if the

demonstrate that Department

it is not deficient determines that the

to the Board, not deficiencies are

just the

Department.

not resolved that

the Board will

determine if the

deficiencies exist

and if approval

should be

withdrawn.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 7

Do not allow a The rule should be R 338.3665

9

Baran

limited licensee clarified to make it (b)(ii)(A)

to provide final clear that by

product

proposing to

verification.

delete “limited”

Clarify that only the Board was

a full licensee can intending that a

provide the

function. By

licensee with a

limited license

deleting the term could participate

“limited” in the in final product

rule, the Board is verification. The

allowing a

language will be

limited licensee modified to state

to provide final in the positive who

product

can handle the

verification and a function as

limited licensed follows: “The

technician is not licensed pharmacy

equivalent to a

full pharmacy

technician

technician holds a

current full or

limited pharmacy

technician license

in this state.” A

limited licensee

may have similar

experience to

someone with a

full license and the

decision to

license.

delegate is still

made by the

pharmacist who

should evaluate

whether the

pharmacy

technician can

handle the

function.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 8

Do not allow a The rule should be R 338.3665

10

Baran

limited licensee clarified to make it (b)(ii)(B)

to provide final clear that

product

“licensed

verification.

Clarify and

pharmacy

technician,”

change to “holds consistent with the

a current full

pharmacy

previous provision

clarification,

technician license means both a full

only.”

licensed pharmacy

technician and a

limited pharmacy

technician.

11

Baran

Only allow a full The rule should be R 338.3665

licensee, not a

temporary,

limited or

clarified to make it (b)(ii)(B)(1)

clear that the

1,000 hours of

student, to

work may be

acquire the hours acquired while the

or training

necessary to

provide final

product

licensee holds a

full license,

limited license,

temporary license,

verification. By or is a student in a

deleting the terms pharmacy

“not” and

technician

“limited” in the program.

rule, the Board is

allowing the

work hours to be

acquired while

the individual has

any type of

pharmacy

technician license

or is a student.

12

Mollien

Rule 338.3665(c) The Board accepts R 338.3665

(ii)(B) says the

supervising

pharmacist is

“fully

the comment to

delete (B) that the

supervising

(c)(ii)(B)

pharmacist is

responsible” for “fully responsible”

the remote

technician’s

practice and

for the remote

technician’s

practice and

MCL 24.242 and 24.245

Agency Report to JCAR-Page 9

accuracy. As

written, this

accuracy, as the

pharmacist will be

appears to permit delegating to the

the board to

discipline a

supervising

pharmacy

technician so they

are responsible to

pharmacist for an be sure the

error or behavior pharmacy

of the pharmacy technician is

technician in all trained to handle

situations. This

level of

the function and

the rule also

responsibility

misapplies and

speaks to the

oversight required

exceeds statutory by the pharmacist.

requirements

under MCL

333.16215. The

pharmacist’s

responsibility and

the pharmacy

technician’s

performance of a

delegated task

responsibility are

not the same.

Instead, line (c)

(ii)(B) of this rule

should be deleted

since

MCL333.16215

already applies or

changed to reflect

and not exceed

the

responsibilities

under MCL

333.16215.

14.Date report completed:

5/25/2023

MCL 24.242 and 24.245