Licensing and Regulation of the Practice of Pharmacy in

MichiganJohn R. Wright

Attorney at LawRogers Mantese & Associates, P.C.

Today’s Presentation

Administrative Inspection Allegation Investigation Violations Administrative Complaint Compliance Conference Administrative Hearing Disciplinary Subcommittee Sanctions Appeal Reinstatement & Reclassification

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

Board of Pharmacy has authority to inspect. MCL 333.17722(a). Inspection is requirement for licensure. MCL 333.7303(7). A licensed pharmacist cannot refuse entry for an authorized

inspection. MCL 333.7405(1)(c). Inspection agents may:

(a) Execute and serve search warrants, arrest warrants, administrative inspection warrants, subpoenas, and summonses issued under the authority of this state.

(b) Seize property pursuant to this article. (See 333.7522(a)) (c) Perform other law enforcement duties the administrator or the

department of commerce designates. MCL 333.7502. Administrative inspection warrants. MCL 333.7504.

Inspection

Rule 23f. The board or a board inspector may enter, at reasonable times, any

building, place, or facility which is owned or controlled by any applicant for, or holder of, a license to make an inspection which is reasonably necessary to enable the board to determine whether the applicant possesses the necessary qualifications and competence for the license sought or to determine whether a license holder is, and has been, complying with the acts and rules enforced by the board. The inspection shall be carried out in a reasonable manner and shall concern only matters relevant to the applicant's or license holder's manufacturing or wholesale distributing of drugs saleable on prescription only. The inspection shall not extend to any of the following information: (a) Financial data. (b) Sales data other than shipment data. (c) Pricing data. (d) Personnel data other than data as to the qualifications of personnel

performing functions subject to the acts and rules enforced by the board. (e) Research data.

1980 AACS R 338.493f

Inspection per Administrative Rule

With an administrative inspection warrant, an agent can: (a) Inspect and copy records required to be kept by Article 7. (b) Inspect, within reasonable limits and in a reasonable manner,

controlled premises and all pertinent equipment, finished and unfinished material, containers, and labeling found therein and, except as provided in subsection (5) [below] all other things therein, including records, files, papers, processes, controls, and facilities bearing on violation of this article.

(c) Inventory any stock of a controlled substance therein and obtain samples thereof. MCL 333.7507(3)(a)-(c).

An inspection authorized by this section shall not extend to financial data or sales data, other than shipment data or pricing data, unless the owner, operator, or agent in charge of the controlled premises consents in writing. MCL 333.7507(5).

With an Inspection Warrant

Inspection without a warrant, only: (a) If the owner, operator, or agent in charge of the

controlled premises consents. (b) In situations presenting imminent danger to health or

safety. (c) In situations involving inspection of conveyances if there

is reasonable cause to believe that the mobility of the conveyance makes it impracticable to obtain a warrant.

(d) In any other exceptional or emergency circumstance where time or opportunity to apply for a warrant is lacking.

(e) In any other situation in which a warrant is not constitutionally required. MCL 333.7507(4)(a)-(e).

Without an Inspection Warrant

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 Fakename, R.Ph. License 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. NEW: Department may overrule DSC. MCL 333.16216(5). NEW: 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

Administrative Inspection 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 Mantese & Associates, P.C.

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

Great Lakes Bay: (989) 272-4434