Michigan Office of Administrative Hearings and Rules

611 W. Ottawa Street

Lansing, MI 48909

Phone: 517-335-8658 Fax: 517-335-9512

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:

2020-29 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:

clarify the type of examination required for licensure; clarify the licensure requirements; clarify the

requirements for licensure by endorsement; clarify the requirements for a temporary license; add the

minimum requirements for a pharmacy technician education or training program; clarify the

requirements for relicensure; clarify the continuing education requirements; clarify the process for

review of continuing education; and clarify 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 will clarify the requirements and process of applying for a pharmacy technician

license; require Board approved pharmacy technician programs to be accredited; limit the time a

pharmacy technician student may participate in pharmacy technician activities while in a pharmacy

technician program; review pharmacy technician employer programs and examinations every 5 years;

require all applicants for relicensure to show good moral character and submit their fingerprints;

require all applicants to take human trafficking training; require continuing education to be met with

courses and programs instead of taking a proficiency examination; require 1 hour in ethics and

jurisprudence in each renewal cycle; modify the continuing education approval process; and allow

pharmacy technicians to assist in technology assisted final product verification.

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

publication dates:

Marquette Mining Journal – January 5, 2021; Flint Journal – January 5, 2021; Grand Rapids Press –

January 5, 2021

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

1/15/2021

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

1/19/2021 01:00 PM at The public hearing will be held virtually via Zoom to receive public

comments while complying with measures designed to help prevent the spread of Coronavirus

Disease 2019 (COVID 19). , https://us02web.zoom.us/j/89584407954?

pwd=R0ZmOGhNUmw5Z24xZ3g4a2UveGx4dz09 Password for video connection: 759646 Phone

number: 877-336-1831

Conference Code for audio connection: 486917

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=157

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

Kerry Przybylo, Manager; Andria Ditschman, Senior Policy Analyst; Weston MacIntosh, Senior

Policy Analyst; and LeAnn Payne, Board Support.

10. Persons submitting comments of support:

No persons submitted comments in support.

11. Persons submitting comments of opposition:

The following persons sent comments in writing:

Rose M. Baran, PharmD, MA, Assistant Professor, College of Pharmacy, Ferris State University;

Deeb D. Eid, PharmD, RPh; and

Brian Sapita, Government Affairs Manager, Michigan Pharmacists Association (MPA).

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

public comment period:

MCL 24.242 and 24.245

Agency Report to JCAR-Page 3

Name &

Comments made at Written

Agency Rationale Rule number

Organization public hearing

Comments

for change

& citation

changed

1

Deeb E. Eid

Number (2) in

this section is

confusing

Delete (2) as the R 338.3654

Public Health

Code (Code)

(2)

because if you

reference MCL

333.17739a (1)

(d)(iv) the

language is

specific to

requires an

employer-based

proficiency

examination to

cover the topics

listed in the Code,

“employer-based it does not require

training program a national

examination”

recognized

within statute, so pharmacy

it does not line up technician

with a nationally examination to

recognized exam cover the topics in

as currently

mentioned.

the Code.

Delete current

proposed

language for (2).

MCL 24.242 and 24.245

Agency Report to JCAR-Page 4

Certification

2

Deeb D. Eid

Delete (4) as a

R 338.3654

(4)

exams are usually proficiency

only accredited if examination

they on the

should not be

national level.

required to meet

Exams like PTCB program

and NHA go

accreditation

through their own standards and,

set of

therefore, the

accreditations for provision should

the exams

be deleted.

themselves

(ANSI and

NCCA).

Employer based

training program

exams would

very unlikely

reach this level of

accreditation

because they are

not on the

national level.

Removal of

“accreditor’s

accreditation” in

(4).

MCL 24.242 and 24.245

Agency Report to JCAR-Page 5

3

Deeb D. Eid

Numbers (5) and The questions on R 338.3654

(6) are non- an accredited (5) and (6)

feasible because a nationally

national recognized

certification exam pharmacy

program (such as technician

PTCB or NHA) is proficiency

not going to

submit an

examination do

not need to be

application to the reviewed by the

Board. In

addition,

Board. The Board

can rely on the

providing a copy accreditation

of the process.

examination with Therefore,

correct answers changes to (5) and

for a national

(6) have been

certification exam made as a

(such as PTCB or nationally

NHA) would

compromise the pharmacy

exam. Each of technician

these companies proficiency

recognized

have question

bank systems,

etc. so they

examination

should be

submitted by an

would never be application to the

able to provide Department with

this to the board proof of

without

accreditation in

completely

compromising

their entire

order to be

considered Board

approved, and

business model. further that

Removal of

modifications to

language relating the examination

to a nationally

recognized

do not need review

by the Board.

certification exam However, if the

in (5) and (6).

accreditation is

lost, the

examination will

no longer be

considered Board

approved.

4

Deeb D. Eid

Educational

There needs to be R 338.3655

MCL 24.242 and 24.245

Agency Report to JCAR-Page 6

programs often

a clear distinction (1)(a)

are conducted by within the

schools, colleges, language to ensure

vocational there is no mix up

programs, and/or of expectations for

specific entities. this section.

o Training

programs are

Adding “including

an employer-based

often conducted training program”

or held by

employers,

helps to clarify

that this type of

associations, and program is

other entities. considered a

o Trainings can training program.

also be internal

for employers

and employers

Therefore, (a) will

read:

(a) A pharmacy

often do not have technician

formal

program including

“education”

programs.

an employer-based

training program

• There needs to that is accredited

be clear by the

distinction within accreditation

the language to

council American

ensure there is no Society of Health-

mix up of

System

expectations for Pharmacists/Accre

this section.

ditation Council

for pharmacy

education

Pharmacy

Education (acpe)

Pharmacy

Technician

Accreditation

Commission

(ASHP/ACPE).

Add the United

States Department

of Education to

broaden the

entities that may

offer accreditation.

MCL 24.242 and 24.245

Agency Report to JCAR-Page 7

Move towards

5

6

Deeb D. Eid

Add the United

R 338.3655

unifying language States Department (1)(b)

with other parts of Education to

(U.S. Dept of

Education) and

delete

broaden the

entities that may

offer accreditation.

“pharmacist.”

(4): There needs (4): There needs to R 338.3655

to be a clear be a distinction in (4) and (8)

distinction within the language to

the language to ensure there are

ensure there is no clear expectations

mix up of as it applies to

expectations for different types of

this section. programs,

(8): Of note, there therefore, (4) will

are no published be deleted and the

studies/evidence language will be

to showcase that moved to (1) to

accreditation

apply to programs

standards lead to that are accredited.

increased patient

safety or to show (8): Requiring all

that accredited vs programs to be

non-accredited

education or

accredited, as

required in (8),

training leads to does not allow for

less harm. the Board to

o Patient safety is consider other

the key piece to programs as well,

consider as therefore, deletion

accreditation is a of (8) allows

costly, time

extensive, and

challenging

process to

programs that are

not accredited to

still apply for

approval.

maintain.

The deletion of (4)

and (8) require a

modification to (7)

(delete the

reference of (4) -

(8) and replace

with “this rule.”)

A reference to a

7

Brian Sapita

MPA would

R 338.3665(i)

suggest that the second pharmacy and (v)

MCL 24.242 and 24.245

Agency Report to JCAR-Page 8

rules are more

technician is

precise on the use needed in the rule

of a second

licensed

pharmacy

to clarify that there

will be two people

involved in the

technician during process which

the technology- allows the first

assisted final

product

verification

process.

Currently as

written we

pharmacy

technician to

process the

prescription and

the second

licensed pharmacy

believe the rules technician to

could be provide final

misconstrued that verification.

a single

pharmacy

Therefore, (i) will

read as follows: (i)

technician would “A second

be allowed to

licensed pharmacy

process an entire technician verifies

medication order the work of the

from start to

finish without

any checks or

balances. Our

suggested

first licensed

pharmacy

technician to

perform final

product

wording changes verification.”

are below:

(i) A licensed

pharmacy

Further (v) will

read as follows:

“The second

technician

licensed pharmacy

verifies the work technician

of a second

licensed

pharmacy

technology-

assisted final

product

technician.

(v) The

technology-

assisted final

product

verification is

subject to all of

the following

requirements:”

verification after

being verified by

a second licensed

pharmacy

technician is

MCL 24.242 and 24.245

Agency Report to JCAR-Page 9

subject to all of

the following

requirements:

13.Date report completed:

5/6/2021

MCL 24.242 and 24.245