Licensing and Regulation for Pharmacy Technicians in

MichiganJohn R. Wright

Attorney at LawRogers & Associates, P.C.Attorneys and Counselors

Today’s Presentation

New Law & New Requirements Allegation Investigation Violations Administrative Complaint Compliance Conference Administrative Hearing Disciplinary Subcommittee Sanctions Appeal Reinstatement & Reclassification

Took effect December 22, 2014 Amended Part 177 of the Public Health Code

(Pharmacy Practice and Drug Control) Application, $25 Application Fee, $30 License

Fee High School Diploma or GED Criminal Background Check with

Fingerprinting Examination by Pharmacy Technician

Certification Board (PTCB) or National Health Career Association

New Law & New Requirements

After June 30, 2015, all pharmacy technicians in Michigan must be licensed.

Renewal is every two years by showing: 20 Hours of Continuing Education Passage of a Proficiency Exam

Certification is not required for licensure, but might be required by an employer.

Three types of licenses: Full, Limited and Temporary

New Law & New Requirements

Full Unlimited license

Limited License ($10/year) Employer must verify employment of at least 1,000 hours

over the past two years Only valid while remaining employed by that employer at

that employer’s locations Temporary License ($15)

Only lasts for 210 days Designed to allow an applicant to work during

examination process

A pharmacy technician licensed in another state who currently has a disciplinary sanction on that license, then that person is not eligible for licensure in Michigan. MCL 333.16174(2).

Types of Licenses

Assisting in the dispensing process. Handling transfer of prescriptions, except controlled

substances prescriptions. Compounding drugs. Preparing or mixing intravenous drugs for injection into a

human patient. Contacting prescribers concerning prescription drug order

clarification, which does not include drug regimen review or clinical or therapeutic interpretation.

Receiving verbal orders for prescription drugs, except orders for controlled substances.

MCL 333.17739(a)-(f).

Statutory Definition of Pharmacy Technician Practice

An individual who is licensed or registered under this article shall meet all of the following requirements: Be 18 or more years of age. Be of good moral character. Have a specific education or experience in the health

profession or in a health profession subfield or health profession specialty field of the health profession, or training equivalent, or both, as prescribed by this article or rules of a board necessary to promote safe and competent practice and informed consumer choice.

Have a working knowledge of the English language as determined in accordance with minimum standards established for that purpose by the department.

Pay the appropriate fees as prescribed in this article.

MCL 333.16174(a)-(e).

General Requirements for Licensees

The Regulators

Executive Branch

LARA

BHCS

HPD

Board of Pharmacy

Executive Branch: Governor

Department of Licensing and Regulatory Affairs (LARA)

Bureau of Health Care Services

Health Professions Division

Board of Pharmacy

Michigan Public Health Code, 1978 PA 368, MCL 333.1101 et seq. Article 7: Controlled Substances Article 15: Occupations

Part 161: General Provisions Part 177: Pharmacy Practice and Drug Control

Michigan Administrative Code General Rules: R 338.471 - 338.500 Radiopharmaceuticals: R 338.3001 - 338.3007 Public Participation at Open Board Meetings: R 338.3031 - 338.3031 Continuing Education: R 338.3041 - 338.3045 Centralized Prescription Processing Pharmacies: R 338.3051 - 338.3056 Controlled Substances: R 338.3101 - 338.3199q Animal Euthanasia and Sedation Rules: R 338.3501 - 338.3523 Program for Utilization of Unused Prescription Drugs: R 338.3601 -

338.3643

The Law and The Rules

Anyone can make an allegation as long as it is in writing. MCL 333.16231(1).

The identity of the person filing the allegation is confidential until the Department initiates disciplinary proceedings. MCL 333.16231(6).

The Department keeps record of unsubstantiated allegations for five years. If no other allegations are received in that five year period, it removes the unsubstantiated allegation from the file. MCL 333.16211(5).

Allegation

Allegations over four years old do not have to be investigated under 2(a) or 2(b). MCL 333.16231(3).

Three board members must authorize the investigation. MCL 333.16231(2)(a).

Authorization not necessary if a licensee’s record contains 1 substantiated allegation or 2 or more written investigated allegations from 2 or more individuals or entities received in the previous four years. MCL 333.16231(2)(b).

Allegation

MCL 333.16221 The Department shall investigate all allegations

that constitute a violation of the Code or rules. The Department may investigate activities

related to the practice of pharmacy. The Department may hold hearings, administer

oaths and take testimony. Lists grounds for disciplinary subcommittee

action.

Investigation

A violation of general duty, consisting of negligence, or failure to exercise due care;

Including negligent delegation to or supervision of employees or other individuals;

Whether or not injury results, or; Any conduct, practice, or condition that

impairs, or may impair, the ability to safely and skillfully practice the health profession. MCL 333.16221(a).

Negligence

MCL 16221(b) (i) Incompetence.

“Incompetence” means a departure from, or failure to conform to, minimal standards of acceptable and prevailing practice for a health profession, whether or not actual injury to an individual occurs. MCL 333.16106(1).

(ii) Substance Use Disorder "Substance use disorder" means chronic disorder in which

repeated use of alcohol, drugs, or both, results in significant and adverse consequences. Substance use disorder includes substance abuse. MCL 330.1100d(11).

(iii) Mental/physical inability to safely/competently practice (iv) Declaration of mental incompetence by a court (v) Some misdemeanors, incl. controlled substances crimes (vi) Lack of good moral character

Personal Disqualifications

MCL 16221(b) (vii) Conviction of CSC IV or sexual assault (viii) Conviction of falsifying medical records (ix) Conviction of a misdemeanor or felony involving

fraud in obtaining or attempting to obtain fees related to the practice of a health profession.

(x) “Sister State Action” (xi) Some misdemeanors related to safe practice (xii) Conviction of practicing pharmacy under the

influence (xiii) Conviction CSC 1, II, III or a subsequent offense

Personal Disqualifications (cont.)

MCL 16221(c) (i) Fraud or deceit in obtaining or renewing a license or

registration. (ii) Permitting a license or registration to be used by an

unauthorized person. (iii) Practice outside the scope of a license. (iv) Obtaining, possessing, or attempting to obtain or

possess a controlled substance or a drug without lawful authority; or selling, prescribing, giving away, or administering drugs for other than lawful diagnostic or therapeutic purposes.

Prohibited Acts

MCL 16221(d) (i) False or misleading advertising. (ii) Dividing fees for referral of patients or

accepting kickbacks on medical or surgical services, appliances, or medications purchased by or in behalf of patients.

(iii) Fraud or deceit in obtaining or attempting to obtain third party reimbursement.

Unethical Business Practices

MCL 16221(e) (i) Misrepresentation to a consumer or

patient or in obtaining or attempting to obtain third party reimbursement in the course of professional practice.

(ii) Betrayal of a professional confidence. (iii) Promotion for personal gain of an

unnecessary drug, device, treatment, procedure, or service.

(iv) (Stark law restated)

Unprofessional Conduct

(g) Failure to report a change of name or mailing address within 30 days after the change occurs. Verify a license: http://w3.lara.state.mi.us/free/ Change an address: http://www.michigan.gov/elicense Pharmacists: Data Change/Duplicate License Request

Form Pharmacy facility: Relocation Application

(h) A violation, or aiding or abetting in a violation, of this article or of a rule promulgated under this article.

(i) Failure to comply with a subpoena Additional violations in subsections (j) through (t)

Other

Administrative ComplaintSTATE OF MICHIGAN

DEPARTMENT OF LICENSING AND REGULATORY AFFAIRSBUREAU OF HEALTH CARE SERVICES

BOARD OF PHARMACYDISCIPLINARY SUBCOMMITTEE

 In the Matter ofAlias FakenameLicense No. 01-23-456789  /

Complaint No. 98-76-54321   

ADMINISTRATIVE COMPLAINT  Answer Due

in 30 Days!

MCL 333.16231(5) A compliance conference can take place before or after an

administrative complaint is filed. The licensee may attend and may be represented by an attorney. Department staff may attend. A member of the Board of Pharmacy may attend who is not on

the Disciplinary Subcommittee (DSC). The parties are required to attempt to reach an agreement. If the parties reach an agreement, they will submit a Consent

Order and Stipulation to the DSC. No transcript is made. All records and documents involved are confidential.

Compliance Conference

Michigan Administrative Hearing System (MAHS). 611 W. Ottawa, 2d Fl, Lansing, MI 48909  Phone (517) 335-2484 

Proceedings governed under the Administrative Procedures Act, 306 PA 1969, MCL 24.201 et seq.

Held in front of an Administrative Law Judge (“ALJ”).

Held in an informal setting. Relaxed Rules of Evidence. MCL 24.275

Administrative Hearing

Appointed by the Chair of the Board of Pharmacy. 2 Public Members (Non-Pharmacists). 3 Professional Members. Chair of the DSC must be a public member. MCL

333.16216(4). Majority vote, affirmative vote by at least 1 public member. Department may overrule DSC. MCL 333.16216(5). Decisions published on LARA website. MCL 333.16216(6). No conflict of interest allowed. MCL 333.16216a. May rely and act upon results, information and evidence

received as the result of an inspection. MCL 333.7515(2).

Disciplinary Subcommittee

MCL 333.16226 Denial of an application Reprimand Administrative Fine Probation Limitation (Must be accompanied by probation) Suspension Revocation Permanent Revocation Restitution ALL are reported to the National Practitioner

Data Bank

Sanctions

A decision by the DSC is appealed by right directly to the Court of Appeals. MCL 333.16237(6).

A decision by the full board is appealed by right to the Ingham County Circuit Court. MCL 24.301-6. An appeal of a decision from the circuit court

goes to the Court of Appeals. An appeal of a decision of the Court of Appeals

goes to the Michigan Supreme Court. An appeal from the Michigan Supreme Court

goes to the Supreme Court of the United States.

Appeal

A license that is revoked or suspended longer than six months may be reinstated. MCL 333.7315-6; 333.16245-9. “6+1” = Suspended for six months and a day. 1996 AACS R

338.1635(3), (5). Guidelines adopted November 4, 1996.

Community service or professional volunteer activity Substance abuse treatment (if applicable) Outpatient treatment for mental health (if applicable) Complied with terms of discipline including payment of fines Continuing education or consumption of current literature Clinical training, remedial education or refresher course Evaluation of professional skills by a qualified individual Good faith desire to be restored to the practice of pharmacy

Criminal background check by fingerprinting. Required probation for one year upon reinstatement. Limitation Reclassification. MCL 333.16249.

Reinstatement & Reclassification

New Law & New Requirements Allegation Investigation Violations Administrative Complaint Compliance Conference Administrative Hearing Disciplinary Subcommittee Sanctions Appeal Reinstatement & Reclassification

Overview

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QUESTIONS?

THANK YOU!

John R. WrightRogers & Associates, P.C.Attorneys and Counselors

jwright@healthlex.comMetro Detroit: (248) 702-6350

Great Lakes Bay: (989) 272-4434