Chapter 4729:4-1 Probation Committee

4729:4-1-01 Definitions - impaired licensees, registrants and probation.

As used in division 4729:4 of the Administrative Code:

(A) "Substance abuse/chemical dependency" means a substance use disorder as defined by the "Diagnostic and Statistical Manual of Mental Disorders" (DSM-5) or any official supplement thereto (10/16/2016).

(B) "Impaired licensee or registrant" means a licensee or registrant who, because of his/her mental illness, habitual or excessive use or abuse of drugs or alcohol, use of psychoactive substances, or use of other substances that impair the ability to practice, is rendered unable to practice pharmacy or conduct authorized activities within a pharmacy with requisite judgment, skill, competence, or safety to the public.

(C) "Approved treatment provider" means a designated treatment program pursuant to section 4729.18 of the Revised Code and rule 4729:4-1-03 of the Administrative Code.

(D) "Approved monitoring program" means a board approved and designated monitor pursuant to section 4729.18 of the Revised Code and rule 4729:4-1-06 of the Administrative Code.

(E) "Intervenor" means a person who is employed by or affiliated with an approved treatment provider or an approved monitoring program and participates in a process whereby a licensee or registrant alleged to be impaired is confronted to evaluate the presence of impairment and, if indicated, who refers the licensee or registrant for assessment and treatment of the impairment.

(F) "Referral for assessment" means a process whereby an intervenor or designated person who has reason to believe that a licensee or registrant is impaired directs that individual to be examined for diagnosis and treatment.

(G) "Treatment assessor" means any of the following:

(1) An individual who is licensed under Chapter 4731. of the Revised Code as a doctor of medicine or a doctor of osteopathic medicine and surgery and who is a certified addiction specialist; or

(2) An individual who is licensed by the Ohio chemical dependency professionals board as a licensed independent chemical dependency counselor, licensed chemical dependency counselor 3 or 2 pursuant to Chapter 4758. of the Administrative Code and, who by training and experience, can make an assessment of a licensee or registrant's impairment.

(H) "Individualized treatment plan" is a document which shall provide for inpatient treatment, outpatient treatment, family therapy, psychotherapy, professional support groups, twelve-step programs, aftercare including support and self-help groups, monitoring programs consisting of random, chain of evidence drug screens, and work site review. Such services and other services may be determined by an approved treatment provider.

(I) "Treatment contract" means a document which outlines the individualized treatment plan, the requirement to cease practice, the requirement for compliance by the impaired licensee or registrant, and the requirement for notification of the board for non-compliance or relapse pursuant to section 4729.18 of the Revised Code.

(J) "Inpatient treatment" shall consist of placing the licensee or registrant in an approved treatment provider facility that will provide lodging and food, as well as care and treatment for detoxification and rehabilitation as indicated by the treatment contract.

(K) "Outpatient treatment" shall consist of the licensee or registrant not residing in an inpatient treatment facility but who is participating in aftercare, twelve-step programs, professional support group (if available), and monitoring programs consisting of random, chain of evidence drug screens and work site review, to establish compliance.

(L) "Designated person" for an approved treatment provider or approved monitoring program is an individual who shall be in full and actual charge of the treatment or monitoring program including, but not limited to, the following:

(1) Ensuring the provider has the necessary facilities and personnel to provide services;

(2) Maintaining records; and

(3) Notification of the board when required.

(M) "Twelve-step program" means a self-help program such as alcoholics anonymous or narcotics anonymous or a related organization that addresses substance use disorders and promotes sobriety and recovery through peer group support, self-help, and anonymity, and which is based on an abstinence model of recovery. An impaired licensee or registrant shall be required to personally attend face-to-face twelve-step programs not less than three documented meetings each week, on separate days. Meetings that occur online, telephonically, or via other electronic means shall not be counted towards the minimum requirement.

(N) "Aftercare" is a counselor-facilitated group meeting which directly responds to problems relating to the ongoing treatment and monitoring of the licensee or registrant's sobriety, and should extend for a minimum of twelve months.

(O) "Professional support group" is a group of peers meeting to discuss the problems specific to recovery and re-entry to practice of the licensee or registrant.

(P) "Relapse" means any use of, or obtaining for the purpose of using, drugs, alcohol, psychoactive substances, or any use of other substances that impair the ability to practice; it also includes a positive drug screen or a return to a pattern of impairment activities which affects the licensee or registrant's ability to practice. Relapse also refers to a mental health or mental illness episode that impacts or impairs the ability to practice pharmacy or conduct authorized activities within a pharmacy with the requisite judgment, skill or competence to ensure the safety of the public.

Replaces: 4729-6-01

Effective: 9/15/2017
Five Year Review (FYR) Dates: 09/15/2022
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.121, 4729.01, 4729.18
Prior Effective Dates: 7/1/92, 2/1/02, 4/27/07, 08/22/2014

4729:4-1-02 Applicability.

(A) No person, except an approved treatment provider, shall purport to be or operate as a treatment facility for the purpose of administering care in the detoxification and rehabilitation of an impaired licensee or registrant.

(B) The rules in this division of the Administrative Code are applicable to all licensed pharmacists, pharmacy interns, and any other board licensees or registrants, including pharmacy technician trainees, registered pharmacy technicians and certified pharmacy technicians.

(C) Should the board have reason to believe that a pharmacist, pharmacy intern or other licensee or registrant suffers from impairment because of conduct or behavior committed or displayed by the individual, the board may compel the individual to be examined by an approved treatment provider. If the licensee or registrant fails to submit to an assessment as ordered by the board, or if the assessment discloses impairment, or if there is an admission of impairment, or if the board has other reliable, substantial, and probative evidence demonstrating impairment, the board may:

(1) Refer the licensee or registrant for treatment;

(2) Initiate action against the licensee or registrant pursuant to Chapters 119., 3719.

and 4729. of the Revised Code; or

(3) Summarily suspend the license or registration of an individual pursuant to rule 4729:4-1-07 of the Administrative Code if the licensee or registrant's continued practice poses a danger of immediate and serious harm to others.

(D) Before being eligible to apply for reinstatement of a license or registration suspended because of impairment, the licensee or registrant must demonstrate to the board that he/she possesses the requisite judgment, skill, and competence to ensure public safety. Such demonstration shall include, but not be limited, to the following:

(1) Certification from an approved treatment provider that the licensee or registrant:

(a) Has signed a treatment contract and is participating in and complying with an individualized treatment plan;

(b) Has successfully completed any required inpatient treatment;

(c) Is actively participating in or has successfully completed an outpatient treatment program;

(d) Has demonstrated he/she has continued to be alcohol, drug, and psychoactive drug free, as well as free from mind-altering, mood-changing substances, by random, chain of evidence drug screens for a period of time as determined by the board at the time of the suspension;

(e) Has been evaluated by an approved treatment provider who has made a clear determination, documented in a written statement, that the licensee or registrant is eligible to return to practice.

(2) Certification that the licensee or registrant has met all requirements of the board order and satisfactory evidence has been submitted to the board, including, but not limited, to the following:

(a) A copy of the signed and agreed to treatment contract;

(b) Written reports and documentation from the approved treatment program and monitoring program;

(c) Written reports, on a form designated by the board, from the licensee or registrant describing recovery progress.

Replaces: 4729-6-02

Effective: 9/15/2017
Five Year Review (FYR) Dates: 09/15/2022
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.121, 4729.18
Prior Effective Dates: 7/1/92

4729:4-1-03 Requirements for approved treatment providers.

(A) An approved treatment provider, as defined in rule 4729:4-1-01 of the Administrative Code, shall meet or exceed the following requirements:

(1) Certification, as determined by the board, by the Ohio department of mental health and addiction services pursuant to Chapter 5119. of the Revised Code.

(2) Any other treatment provider approved by the board, to include:

(a) An out-of-state provider, when treatment has already been initiated or completed; or

(b) Any provider not certified in accordance with paragraph (A)(1) of this rule.

(3) Any treatment provider must be approved prior to a licensee or registrant participating in the program, unless the board finds exceptional circumstances exist, in which case the board may approve the treatment provider during or after treatment.

(B) An intervenor associated with an approved treatment provider shall:

(1) Respond to information from concerned individuals;

(2) Ascertain validity of the information received;

(3) Assess the situation and, if the licensee or registrant is showing evidence of impairment, the intervenor shall refer the individual for evaluation;

(4) If the licensee or registrant fails to comply within one week to a referral for evaluation, the intervenor must report the name of the individual to the board within one business day.

(C) A treatment assessor associated with an approved treatment provider shall evaluate a licensee or registrant referred to the approved treatment provider to determine if the licensee or registrant has a substance use disorder related impairment.

(1) If such an impairment exists, the approved treatment provider shall formulate the licensee or registrant's individualized treatment plan as defined in rule 4729:4-1-01 of the Administrative Code. The specific requirements shall be determined by an assessment of psychological, physical, developmental, family, social, environmental, recreational, and professional needs. The individualized treatment plan shall be part of a treatment contract which the impaired licensee or registrant must sign. If the impaired licensee or registrant fails to sign the treatment contract and enter treatment within forty-eight hours of the determination that the licensee or registrant needs treatment, the approved treatment provider must report the name of the licensee or registrant to the board within one business day.

(D) The designated person for the approved treatment provider shall:

(1) Establish a system of records that will provide for complete information about an impaired licensee or registrant from intervention through the rehabilitation stage;

(2) Establish treatment contracts meeting the requirements of this division and a system of follow up to determine compliance by the impaired licensee or registrant with the treatment contract;

(3) Ensure the confidentiality of the impaired licensee or registrant, except:

(a) If the licensee or registrant fails to comply within one week to a referral for evaluation;

(b) If the impaired licensee or registrant fails to sign the contract and enter treatment within forty-eight hours of the determination that the licensee or registrant needs treatment;

(c) If the impaired licensee or registrant does not suspend practice on entering treatment;

(d) If the impaired licensee or registrant does not comply with the terms of the treatment contract;

(e) If the impaired licensee or registrant resumes practice before the approved treatment provider or monitoring program has made a clear determination that the licensee or registrant is capable of practicing;

(f) If the impaired licensee or registrant suffers a relapse at any time.

(4) Notify the state board of pharmacy within one business day if the licensee or registrant violates any provision of this rule.

Replaces: 4729-6-03

Effective: 9/15/2017
Five Year Review (FYR) Dates: 09/15/2022
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.121, 4729.18
Prior Effective Dates: 7/1/92, 2/1/02, 4/27/07, 8/22/14

4729:4-1-04 Monitoring contracts.

(A) Within one week of completing treatment, in the absence of extenuating circumstances, the licensee or registrant shall enter into a monitoring contract with an approved monitoring program regardless of whether the licensee or registrant is under a period of suspension or probation.

(B) The monitoring program contract shall include all of the following requirements:

(1) Group therapy, support groups, or, when appropriate, individual counseling, or a combination thereof.

(2) Periodic, random, unannounced blood and/or urine screens at a frequency of at least monthly and sixteen times per year for the length of the contract, unless otherwise approved by the board or the board's probation committee and to provide additional random, observed urine and/or blood samples as may be requested by the intervenor or designated person.

(a) The urine sample must be given within twelve hours of notification.

(b) The dilution standard will be creatinine clearance and/or specific gravity.

(c) Results of all drug screens must be negative and the refusal of a drug screen or a diluted drug screen is equivalent to a positive result. Any positive results, including those which may have resulted from ingestion of food but excluding false positives which resulted from medication legitimately prescribed, indicates a violation of the contract and shall be reported to the board or the board's probation committee.

(d) In the event of a negative diluted screen, a hair sample test must be completed at the cost of the probationer in a time frame consistent with the drug laboratory's recommended policy, but in any event no later than twelve days after the negative diluted screen.

(3) Mandatory participation in alcoholics anonymous, narcotics anonymous, or a similar twelve-step program, or its equivalent, as set forth in rule 4729:4-1-01 of the Administrative Code.

(a) To obtain the signatures of either the secretary or chairperson of the meeting for attendance verification or, in the absence of both, a meeting representative.

(b) To be responsible for keeping a personal record of names and phone numbers of the persons signing attendance verification at meetings.

(c) To record meeting attendance dates in a chronological order and collect the attendance verification signatures at the meeting.

(d) To attend another meeting that same week in order to meet the quota of meetings for the week if attendance verification is not obtained.

(e) To obtain a sponsor and home group in a twelve-step program, or its equivalent, as set forth in rule 4729:4-1-01 of the Administrative Code that is not a representative of the monitoring program by a date specified by the approved monitor.

(4) Abstinence from use of alcohol and from use of drugs, except those prescribed, administered or personally furnished by a licensed prescriber who has knowledge of the patient's history and of the disease of addiction, or those administered by another person so authorized by law during a medical emergency.

(a) To notify the intervenor or designated person in advance and provide documentation of the need for any medication (to include a copy of the prescription or note from the prescriber) within forty eight hours of receipt of treatment, if any mood altering and/or potentially addictive medications are required or recommended by the prescriber.

(b) To renew verification with the intervenor or designated person every ninety days if the need for medication is ongoing.

(c) To update medication list with the intervenor or designated person any time a new prescription or over-the-counter medication is added.

(d) To abstain from dispensing own prescriptions.

(e) To avoid exposure to anything that may cause drug screen tests to be positive, including "hemp oil," "coca tea," and poppy seeds.

(f) To abstain from using ethyl alcohol in any form including, but not limited to, the following:

(i) Alcohol free wine or beer;

(ii) Over-the-counter drugs containing alcohol, cough syrups or their similar drugs or supplements;

(iii) Mouthwash or other hygiene products containing ethanol, including sanitizing hand or body gels;

(iv) Foods or beverages containing alcohol; and

(v) Any other form of ethyl alcohol.

(5) Acknowledgment of the relinquishment of the right to self-medicate other than use of single entity over-the-counter non-steroidal anti-inflammatories or acetaminophen.

(6) Regular contact with a licensed chemical dependency counselor, or with a physician qualified by training or experience, or both, to treat chemically dependent persons, who assumes responsibility for monitoring defined aspects of aftercare contract compliance, and who agrees to:

(a) Report any noncompliance to the approved monitoring program; and

(b) Report any relapse to the approved monitoring program and the board.

(7) A length of contract specified with a minimum of at least five years and at least fifty-two weekly aftercare sessions, with missed sessions to be made up.

(8) Professional therapy, where indicated, to resolve family and work-related issues.

(9) Treatment of any ongoing medical problems to be managed by a licensed prescriber. Treatment of any conditions requiring the use of a mind-altering, mood-changing substance shall require consultation with a physician qualified by training or experience, or both, to provide medical care to chemically dependent persons.

(a) Agreement to identify a single primary care physician and utilize that physician (or physician to whom referred) exclusively for all medical care for the duration of the contract.

(b) Agreement for identified physician to share with approved monitor information on any drugs prescribed or, if over-the-counter drugs, approved, and the information pertinent to recovery and/or compliance with the contract.

(c) Intervenor or designated person approved surgery packet prior to any non-emergency medical procedures.

(10) Referral to other forms of extended care, when indicated.

(11) Any required supervision or restrictions of practice during aftercare.

(12) Personal contact with the assigned intervenor once a week, leaving a message shall not meet the personal contact requirement.

(13) An agreement to attend the pharmacist peer assistance group meetings each month for the duration of the contract, unless otherwise excused by the designated person or the designated person's designee.

Effective: 9/15/2017
Five Year Review (FYR) Dates: 09/15/2022
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.121, 4729.18

4729:4-1-05 Probation.

(A) Probation will be reviewed by members of the board's probation committee and board staff. When a licensee or registrant is placed on probation, the board shall require, at a minimum, the following probationary and limiting terms:

(1) Compliance with all federal, state, and local laws, and all rules governing practice in Ohio.

(2) Submission of quarterly declarations on a form approved by the board or the board's probation committee stating, under penalty of perjury, whether there has been compliance with all conditions of probation and, if applicable, treatment.

(3) Periodic appearances before the board or its representatives as requested.

(4) A minimum five-year contract with an approved monitoring provider, unless otherwise exempted by the board.

(5) Compliance with all terms of the approved monitoring contract, which shall include all terms set forth in rule 4729:4-1-04 of the Administrative Code.

(6) Prior notification to the board or the board's probation committee of departures or absences in excess of three days from Ohio. Periods of departure or absence shall not reduce the probationary term, unless otherwise determined by motion of the board or the board's probation committee, for absences of three months or longer in instances where the board can be assured that probationary monitoring is otherwise being performed.

(7) Inability to engage in a consult agreement, unless otherwise approved by the board or the board's probation committee.

(8) As designated in the board's order, submission of observed urine, blood, or hair samples upon request of the approved monitoring program or board, and without prior notice, at the cost of the licensee or registrant.

(9) Compliance with any employer provided drug or alcohol screens.

(10) When deemed appropriate by the board or the board's probation committee, undertaking psychiatric evaluation, and, where appropriate, continuing treatment acceptable to the board, with evidence of compliance to be provided in each quarterly report.

(11) Copies of the board order or settlement agreement to be provided by the individual to all of the following during the effective period of the board order or settlement agreement:

(a) All employers or prospective employers and all persons and entities that provide the individual chemical dependency treatment or monitoring; and

(b) By certified mail, the proper licensing authority of any state or jurisdiction in which the individual holds or applies for any professional license.

(12) Continuing compliance with the terms of the monitoring contract entered into with the treatment provider and approved monitoring provider, provided, that where terms of the monitoring contract conflict with the terms of the settlement agreement or board order, the terms of the settlement agreement or board order shall control.

(13) Continuing authorization, through appropriate written consent forms, for disclosure by the treatment provider and/or approved monitor to the board, to treating and monitoring physicians, and to others involved in the monitoring process, of information necessary for those individuals to fulfill their respective duties and obligations.

(14) Minimum probationary term of at least five years, unless otherwise approved by the board.

(15) No requests by the probationer for modifications to probationary terms for at least three years, however, limited, isolated deviations from the probationary terms may be granted with the approval by the board or its probation committee in exceptional circumstances.

(16) Self-reporting of any violation of one or more terms of probation.

(B) Periods during which the probationer is not in compliance with all probationary terms shall toll the length of time of probation during which the probationer was out of compliance. The board shall issue a resolution setting forth the minimum length of time each violation will toll the probationary term. The resolution shall be updated as necessary and available on the board's web site, www.pharmacy.ohio.gov. The board may implement additional disciplinary action in addition to or instead of tolling probation.

Effective: 9/15/2017
Five Year Review (FYR) Dates: 09/15/2022
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.121, 4729.18

4729:4-1-06 Requirements for approved monitoring programs.

(A) An approved monitoring program, as defined in rule 4729:4-1-01 of the Administrative Code, must be approved by the state board of pharmacy and shall meet or exceed the following requirements:

(1) Have board approved policies and procedures which shall include, but not be limited to, the following:

(a) The program's standards and procedures for care;

(b) The program's standards and training/approval process for personnel.

(2) Have personnel including, but not limited to, an intervenor and a designated person as defined in rule 4729:4-1-01 of the Administrative Code.

(B) An intervenor associated with an approved monitoring program shall:

(1) Respond to information from concerned individuals;

(2) Ascertain validity of the information received;

(3) Assess the situation and, if the licensee or registrant is showing evidence of impairment, the intervenor shall refer the individual for evaluation;

(4) If the licensee or registrant fails to comply within one week to a referral for evaluation, the intervenor must report the name of the licensee or registrant to the board within one business day.

(C) The designated person for the limited approved treatment provider shall:

(1) Ensure confidentiality of the impaired licensee or registrant, except:

(a) If the licensee or registrant fails to comply within one week to a referral for evaluation; or

(b) If the impaired licensee or registrant suffers a relapse at any time during or following rehabilitation.

(2) Notify the state board of pharmacy within one business day if the licensee or registrant violates any portion of this rule.

Replaces: 4729-6-05

Effective: 9/15/2017
Five Year Review (FYR) Dates: 09/15/2022
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.121, 4729.18
Prior Effective Dates: 4/27/07

4729:4-1-07 Summary suspension of a licensee or registrant.

(A) An impaired licensee or registrant may be summarily suspended without a prior hearing pursuant to section 3719.121 of the Revised Code if, in the opinion of the board, the impaired licensee or registrant poses a danger of immediate and serious harm to others by:

(1) Refusing to seek evaluation, treatment, and rehabilitation for a substance abuse/chemical dependency related impairment;

(2) Not signing and/or complying with the treatment contract from an approved treatment provider or monitoring program;

(3) Resuming practice before the approved treatment provider or monitoring program has made an assessment and recommends that the licensee or registrant is capable of practicing;

(4) A relapse, as defined in rule 4729:4-1-01 of the Administrative Code, of substance abuse/chemical dependency at any time.

(B) An impaired licensee or registrant may be summarily suspended without a prior hearing pursuant to section 3719.121 of the Revised Code if a the licensee or registrant is guilty of a felony drug abuse offense as defined in section 2925.01 of the Revised Code.

Replaces: 4729-6-10

Effective: 9/15/2017
Five Year Review (FYR) Dates: 09/15/2022
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.121, 4729.18
Prior Effective Dates: 7/1/92

4729:4-1-08 Probation committee.

(A) The probation committee shall consist of two board members appointed by the board president. One alternate board member will be selected in order to perform probation committee functions when an appointed member has a conflict of interest or is unavailable. Each appointee will serve for a period of two years and, at least one of the committee members appointed should include a board member who has previously served on the committee.

(B) The probation committee shall approve the form and content of the probation report document, which probationers will be required to submit.

(C) Board staff shall review probationer reports and refer reports that meet criteria designated by the probation committee to the committee for review.

(D) The probation committee shall meet at least annually with each probationer on a schedule to be determined based, in part, on reports, the probationer's length of time on probation, and/or substantive violations of probation.

(E) The probation committee shall review probationer reports to ensure a probationer possesses the requisite judgment, skill, and competence necessary to ensure public safety in the practice of pharmacy.

(F) The probation committee shall be responsible for all of the following:

(1) Reviewing referrals from treatment providers and recovery monitors as to matters of non-compliance;

(2) Reviewing complaints received by the board regarding a probationer's actions;

(3) Reviewing deviation requests from board orders and approving, denying, or modifying requests;

(4) Reviewing self-reports of non-compliance that do not pose a danger of immediate and serious harm to others;

(5) Issuing warning letters to probationers for non-substantive violations of board orders.

(G) Any information received by the probation committee which indicates a substantive violation of probation may have occurred shall be referred to the compliance and enforcement department for investigation.

(H) The compliance and enforcement department will notify the probation committee when a new and/or active investigation begins on a probationer.

(I) Any reports or complaints received by the board or the probation committee that indicate a potential danger of immediate and serious harm to others will be immediately referred to the compliance and enforcement department for potential summary suspension.

(J) Pursuant to section 4729.17 of the Revised Code, the probation committee will conduct a hearing in accordance with Chapter 119. of the Revised Code to close probation and will make a recommendation to the full board as to whether the probationer's case should be closed as successfully completed.

Replaces: 4729-2-05

Effective: 8/1/2017
Promulgated Under: 111.15
Statutory Authority: 4729.26
Rule Amplifies: 4729.16
Prior Effective Dates: 10/8/2016