The purpose of this rule is to set standards for
pharmacy technician training programs to ensure that graduates of the programs
have the basic knowledge and experience in general pharmacy to practice in most
pharmacy settings.
(A) The state board of pharmacy hereby
approves the following pharmacy technician training programs:
(1) A pharmacy technician
training program that holds a current accreditation from the American society
of health-system pharmacists/accreditation council for pharmacy
education.
(2) A program of training
for pharmaceutical technicians conducted by a branch of the Armed Forces of the
United States, the Indian health service of the United States department of
health and human services, or the United States department of veterans
affairs.
(3) An employer-based
training program that meets the requirements in paragraph (B) of this
rule.
(4) A pharmacy technician
training program offered by an Ohio public high school as part of a
career-technical education program approved by the Ohio department of education
pursuant to section 3317.161 of the Revised Code. Each career-technical
education program shall require approval by the state board of pharmacy in
accordance with standards adopted by the board. Instructions for obtaining
board approval will be made available on the board's website:
www.pharmacy.ohio.gov.
(5) Successful completion
of a doctor of pharmacy (PharmD) program from an approved school of pharmacy in
accordance with rule 4729-5-01 of the Administrative Code if the
applicant's graduation date is within five years of an application for
registration.
(6) Held an active
pharmacist or pharmacy intern license or registration in good standing from a
licensing agency of any state or jurisdiction for at least one year within five
years of an application for registration.
(B) An employer-based training program
shall comply with all the following:
(1) The program shall
have a program director. The program director and the employer licensed as a
terminal distributor of dangerous drugs shall be accountable for the overall
quality of the employer-based training program.
The program director shall be a licensed
pharmacist in this or any other state that is in good standing.
(2) The program shall
consist of didactic and practical experience training, as follows:
(a) A didactic training component that includes, at a minimum,
instruction in all of the following:
(i) Mathematical
calculations essential to the duties of a pharmacy technician;
(ii) Federal and state
laws, rules, and regulations that affect pharmacy practice, including specific
laws, rules, and regulations which address the use of technicians;
(iii) Medical and
pharmaceutical terminology, symbols, and abbreviations used in the practice of
pharmacy and components of a prescription;
(iv) Preparation,
packaging, labeling, and proper storage of dangerous drugs;
(v) Knowledge and skills
in areas of science relevant to the pharmacy technician's role, including
pharmacology;
(vi) Medication safety
and error prevention;
(vii) Maintaining
confidentiality of patient information, including the Patient Rights and Health
Insurance Portability and Accountability Act (HIPAA);
(viii) Ethical and
professional standards of practice;
(ix) Recordkeeping and
inventory control; and
(x) Patient and caregiver
communication, including communicating with diverse populations.
(b) Didactic training may include self-directed learning
experiences, including but not limited to home study, computer programs,
internet or web-based courses, or any other coursework approved by the program
director.
(c) The program shall ensure the required didactic training
evaluates a participant's knowledge of the topics listed in paragraph
(B)(2)(a) of this rule. The evaluation must include an examination consisting
of a minimum of ninety questions in accordance with testing guidelines adopted
by the board. The employer shall have procedures that ensure the security and
integrity of the examination materials, describe the testing format, and define
the successful completion of an examination, which must be at least
seventy-five per cent. The examination shall consist primarily of multiple
choice, essay, or short answer questions. The questions on the examination
shall not be given to the examinee prior to taking the examination. The answers
to the examination must not be given to the examinee prior to or during the
examination. The examinee shall agree in writing not to share the questions or
answers to the examination with any other person.
(d) The didactic training requirements in paragraph (B)(2)(a) of
this rule are waived if the trainee has a current pharmacy technician
certification from an organization that has been recognized by the
board.
(e) Three hundred hours of practical experience in a pharmacy
under the direct supervision of a licensed pharmacist that directly relates to
the activities permitted in paragraph (B) of rule 4729:3-3-01 of the
Administrative Code.
(3) A written or
electronic record of training and education shall be maintained as part of the
training program that documents the completion of the training requirements,
including the number of practical experience hours completed.
(4) It shall be the
responsibility of the terminal distributor of dangerous drugs providing
employer-based training to ensure that the documentation provided to pharmacy
technician trainees accurately reflects the completion of an approved training
program. Failure on the part of the terminal distributor of dangerous drugs to
ensure the accuracy of training documentation shall be considered a violation
of rule 4729:5-4-01 of the Administrative Code.
(5) The program director must ensure that
regular and ongoing assessments of program effectiveness are conducted and use
the evaluations for continuous improvement of the program. Measures shall
include, but are not limited to, the following:
(a) Program completion; and
(b) Program participant satisfaction.
(6) The program shall maintain the
following records for a minimum of three years and shall be furnished to the
state board of pharmacy within three business days of receipt of a request from
the board:
(a) All technician training records and evaluations;
(b) Program assessments conducted in accordance with this
rule.
(7) Employer-based training programs may
be subject to audit to ensure compliance with the requirements of this
rule.
(a) An employer-based training program subject to audit shall
provide all requested documentation demonstrating compliance with this rule
within thirty days of a request by the board.
(b) Unless an extension is granted, failure to provide the
requested documentation within thirty days of a request by the board may result
in the suspension of the approval status of the training program.
(c) After reviewing the training program, the board may return it
to the employer for revision. Failure to make the necessary revisions may
result in the suspension of the approval status of the training
program.
(d) The approval status of a training program may be reinstated
only after the employer meets the requirements of this rule and any additional
requirements as determined by the board.
(C) In order to perform non-sterile drug
compounding, a pharmacy technician trainee shall complete the following
training requirements prior to compounding non-sterile
preparations:
(1) Training shall comply
with the requirements set forth in the United States pharmacopeia chapter
<795>, as defined in rule 4729:7-1-01 of the Administrative
Code.
(2) If preparing
non-sterile hazardous compounded drugs in accordance with rule 4729:7-2-03 of
the Administrative Code, the training shall also comply with the applicable
requirements set forth in United States pharmacopeia chapter <800>, as
defined in rule 4729:7-1-01 of the Administrative Code.
(3) If preparing
non-sterile radiopharmaceuticals in accordance with rule 4729:5-6-03 of the
Administrative Code, the training shall also comply with the applicable
requirements set forth in United States pharmacopeia chapter <825>, as
defined in rule 4729:5-6-01 of the Administrative Code.
(4) Non-sterile drug compounding training
shall be obtained through completion of a site-specific, structured on-the-job
didactic and experiential training program and shall not be transferable to
another practice site, except between practice sites under common ownership and
control.
(5) When the responsible person or a
pharmacist designated by the responsible person is satisfied with the
employee's knowledge and proficiency, the responsible person or the
responsible person's designee will sign the documentation records to show
that the employee was appropriately trained in accordance with this
paragraph.
(6) Ensuring pharmacy technician trainees
are properly trained shall be the responsibility of the terminal distributor of
dangerous drugs and the licensee's responsible person.
(7) All training requirements set forth
in this paragraph shall be appropriately documented and made readily
retrievable for immediate inspection by an agent of the state board of
pharmacy. Documentation shall be maintained by the terminal distributor of
dangerous drugs for a minimum of three years.
(8) The training required pursuant to
this paragraph may be used to meet the practical experience hours required in
paragraph (B)(2)(e) of this rule.
(D) In order to perform sterile drug
compounding, a pharmacy technician trainee shall complete the following
training requirements prior to compounding sterile preparations:
(1) Training shall comply
with the requirements set forth in the United States pharmacopeia chapter
<797>, as defined in rule 4729:7-1-01 of the Administrative Code.
(2) If preparing sterile
hazardous compounded drugs in accordance with rule 4729:7-2-03 of the
Administrative Code, the training shall also comply with the applicable
requirements set forth in United States pharmacopeia chapter <800>, as
defined in rule 4729:7-1-01 of the Administrative Code.
(3) If preparing sterile
radiopharmaceuticals in accordance with rule 4729:5-6-03 of the Administrative
Code, the training shall also comply with the applicable requirements set forth
in United States pharmacopeia chapter <825>, as defined in rule
4729:5-6-01 of the Administrative Code.
(4) Sterile drug compounding training
shall be obtained through completion of a site-specific, structured on-the-job
didactic and experiential training program and shall not be transferable to
another practice site, except between practice sites under common ownership and
control.
(5) When the responsible person or a
pharmacist designated by the responsible person is satisfied with the
employee's knowledge and proficiency, the responsible person or the
responsible person's designee will sign the documentation records to show
that the employee was appropriately trained in accordance with this paragraph.
(6) Ensuring pharmacy technician trainees
are properly trained shall be the responsibility of the terminal distributor of
dangerous drugs and the licensee's responsible person.
(7) All training requirements set forth
in this paragraph shall be appropriately documented and made readily
retrievable for immediate inspection by an agent of the state board of
pharmacy. Documentation shall be maintained by the terminal distributor of
dangerous drugs for a minimum of three years.
(8) The training required pursuant to
this paragraph may be used to meet the practical experience hours required in
paragraph (B)(2)(e) of this rule.
(E) A terminal distributor of dangerous drugs and the
licensee's responsible person shall be responsible for the implementation
of additional training that is of appropriate breadth and depth to clearly
address the competencies for a technician trainee to safely and effectively
work in a specific practice setting.
(F) Unless otherwise approved by the board, a board approved
training program is only valid for application as a registered pharmacy
technician or certified pharmacy technician in accordance with rule 4729:3-2-01
of the Administrative Code if the program was completed within five years of an
application for registration.
(G) Paragraph (F) of this rule does not apply in the following
circumstances:
(1) An applicant for
registration has been actively practicing as a pharmacy technician in this or
another state within one year of application to the board; or
(2) An applicant has
maintained a current pharmacy technician certification from an organization
that has been recognized by the board.
(H) An individual may sit for an examination to obtain a pharmacy
technician certification from an organization that has been recognized by the
board at any time.
