This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and
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| Rule |
Rule 4729:5-9-01 | Definitions.
Effective:
February 1, 2022
As used in Chapter 4729:5-9 of the Administrative
Code: (A) "Institutional facility"
means any of the following: (1) A public hospital or
hospital as defined in section 3701.01 or 5122.01 of the Revised
Code. (2) A freestanding
emergency department. (3) A freestanding
inpatient rehabilitation facility or inpatient rehabilitation facility as
defined in rule 3701-83-25 of the Administrative Code. (4) An ambulatory
surgical facility as defined in rule 3701-83-15 of the Administrative
Code. (5) A nursing home
licensed under Chapter 3721. of the Revised Code; (6) An inpatient
psychiatric service provider as defined in rule 5122-14-01 of the
Administrative Code; (7) A facility that
provides medically supervised detoxification services that meets the following
requirements: (a) Patients are administered dangerous drugs to alleviate
adverse physiological or psychological effects incident to withdrawal from the
continuous or sustained use of drugs or alcohol; (b) Patients are under the care of a licensed prescriber
and are provided continuous onsite monitoring by nurses licensed in accordance
with Chapter 4723. of the Revised Code; (c) If the period of detoxification is less than
twenty-four hours, patients shall be transitioned to an inpatient, residential,
or outpatient treatment program; and (d) The facility holds the appropriate license or
certification by the Ohio department of mental health and addiction
services. (8) A residential care facility licensed under Chapter
3721. of the Revised Code that provides skilled nursing care to its residents,
including medication administration as authorized in Chapter 3701-16 of the
Administrative Code, provided the facility meets the following
requirements: (a) The administration of
medication shall be in compliance with this chapter and Chapter 3701-16 of the
Administrative Code, including the requirement to maintain individual
medication records and documentation of medication orders; and (b) The residential care
facility maintains an executed contract or agreement with an institutional
pharmacy for the provision of institutional pharmacy services. The executed
contract or agreement shall be maintained in a readily retrievable
manner. (9) A state or local correctional
facility, as defined in section 5163.45 of the Revised Code; (10) A juvenile correctional facility that
is under the management and control of the department of youth services or a
private entity with which the department of youth services has contracted for
the institutional care; and (11) Any other facility as determined by
the board. (B) "Institutional pharmacy"
means a pharmacy that primarily provides inpatient pharmacy services to an
institutional facility in accordance with this chapter. (C) "Audit trail" means all
materials and documents required for the entire processing of a prescription,
which shall be sufficient to document or reconstruct the origin of the
prescription order, and authorization of subsequent modifications of that
order. (D) "Automated drug storage
system" means a mechanical system used for the secure storage of dangerous
drugs used as floor stock or contingency drugs outside of an institutional
pharmacy that collects, controls, and maintains transaction information and
records. (E) "Contingency drugs" are a
supply of non-patient specific dangerous drugs which may be required to meet
the therapeutic needs of patients or staff when either apply: (1) The institutional
facility's on-site pharmacy is closed or otherwise unavailable to provide
pharmacy services; (2) The institutional
facility does not have an on-site pharmacy. (F) "Dispense" means the final
association of a drug with a particular patient pursuant to a prescription,
medication order, or other lawful order of a prescriber and the professional
judgment of and the responsibility for interpreting, preparing, compounding,
labeling, and packaging a specific drug. In the case of an automated drug storage system
meeting the requirements of rule 4729:5-9-03.4 of the Administrative Code, the
final association with the name of a particular inpatient will be deemed to
have occurred when the pharmacist has given final approval to the patient
specific order in the system. (G) "Electronic drug record keeping
system" means a system of storing drug records electronically and, when
required, capturing positive identification. (H) "Inpatient" means any
person who receives drugs for use while within an institutional
facility. (I) "Licensed health professional
authorized to prescribe drugs" or "prescriber" has the same
meaning as in rule 4729:5-1-02 of the Administrative Code but shall be limited
to a prescriber practicing within the prescriber's applicable scope of
practice. (J) "Medication order" or
"inpatient prescription" means a written, electronic, facsimile, or
oral order for a drug to be dispensed or administered in treating an
inpatient. (K) "OARRS report" means a
report of information related to a specific person generated by the drug
database established and maintained pursuant to section 4729.75 of the Revised
Code. (L) "Outpatient" means any
person who receives drugs for use outside of an institutional
facility. (M) "Medications removed on override
function" or "override medications" means a dangerous drug that
may be removed from floor stock or contingency drugs prior to pharmacist review
because the institutional facility's interdisciplinary committee has
determined that the clinical status of the patient would be compromised by
delay. (N) "Personal supervision" or
"direct supervision" means a pharmacist shall be physically present
in the pharmacy, or in the area where the practice of pharmacy is occurring,
and provides personal review and approval of all professional
activities. (O) "Personally furnish" or
"personally furnishing" means the final association of a drug with a
patient by a prescriber prior to the distribution to a patient for use outside
an institutional facility. A prescriber at an institutional facility who
personally furnishes a dangerous drug shall comply with the requirements of
rule 4729:5-19-02 of the Administrative Code. (P) "Pharmacist" means an
individual who holds a current pharmacist license under Chapter 4729. of the
Revised Code. (Q) "Pharmacy," except when
used in a context that refers to the practice of pharmacy, means any area,
room, rooms, place of business, department, or portion of any of the foregoing
where the practice of pharmacy is conducted. (R) (1) "Positive
identification" means a method of identifying a person that does not rely
on the use of a private personal identifier such as a password, but must use a
secure means of identification that includes any of the following: (a) A manual signature on a hard copy record; (b) A magnetic card reader; (c) A bar code reader; (d) A biometric method; (e) A proximity badge reader; (f) A board approved system of randomly generated personal
questions; (g) A printout of every transaction that is verified and
manually signed within a reasonable period of time by the individual who
performed the action requiring positive identification. The printout must be
maintained for three years and made readily retrievable; or (h) Other effective methods for identifying individuals
that have been approved by the board. (2) A method relying on a
magnetic card reader, a bar code reader, a proximity badge reader, or randomly
generated questions for identification must also include a private personal
identifier for entry into a secure mechanical or electronic
system. (S) "Point of care location"
means a location within an institutional facility that stores dangerous drugs
and all the following apply: (1) The point of care
location is licensed as a terminal distributor of dangerous drugs; (2) The dangerous drugs
are not owned by the institutional facility where the point of care location is
located; (3) The dangerous drugs
stored are owned by another institutional facility licensed as a terminal
distributor of dangerous drugs; and (4) The location may be
used for the administration, personally furnishing, or dispensing of dangerous
drugs, including controlled substances. (T) "Practice of pharmacy" has
the same meaning as in division (B) of section 4729.01 of the Revised
Code. (U) "Readily retrievable" means
that records maintained in accordance with this chapter shall be kept in such a
manner that, upon request, they can be produced for review no later than three
business days to an agent, officer or inspector of the board. (V) "Responsible person" has
the same meaning as defined in rule 4729:5-2-01 of the Administrative Code and
is responsible for the supervision and control of dangerous drugs as required
in division (B) of section 4729.55 of the Revised Code, adequate safeguards as
required in division (C) of section 4729.55 of the Revised Code, security and
control of dangerous drugs, and maintaining all drug records otherwise
required. (W) "Skilled nursing care" has the same meaning
as in section 3721.01 of the Revised Code. (X) "Tamper-evident" means a package, storage
container or other physical barrier is sealed or secured in such a way that
access to the drugs stored within is not possible without leaving visible proof
that such access has been attempted or made.
Last updated February 1, 2022 at 9:19 AM
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Rule 4729:5-9-02 | Institutional pharmacies.
Effective:
February 1, 2022
An institutional pharmacy as defined in rule
4729:5-9-01 of the Administrative Code shall comply with all requirements of
this rule, including all supplemental rules adopted thereunder.
Last updated February 1, 2022 at 9:21 AM
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Rule 4729:5-9-02.1 | Minimum standards for institutional pharmacies.
Effective:
February 1, 2022
(A) Library (1) All pharmacists
working in an institutional pharmacy must be able to access all current federal
and state laws, regulations, and rules governing the legal distribution of
drugs in Ohio, including internet access to the following: (a) The board's website; (b) LAWriter Ohio laws and rules
(http://codes.ohio.gov); (c) The code of laws of the United States of America
(variously abbreviated to Code of Laws of the United States, United States
Code, U.S. Code, U.S.C., or USC); and (d) The code of federal regulations. (2) The pharmacy shall
have access to and utilize the references necessary to conduct a pharmacy in a
manner that is in the best interest of the patients served and to comply with
all state and federal laws, this shall include hard copy or internet access to
appropriate pharmacy reference materials. (3) A pharmacy engaged in
the compounding of dangerous drugs shall have access to all references listed
in rule 4729:7-1-01 of the Administrative Code. (4) All pharmacists
working in a pharmacy shall have access to the telephone number of a poison
control center. (B) Equipment The pharmacy shall carry and utilize the
equipment necessary to conduct a pharmacy in a manner that is in the best
interest of the patients served and to comply with all state and federal
laws. (C) Stock of drugs The stock of drugs shall include such chemicals,
drugs, and preparations sufficient to compound and prepare all types of
prescriptions offered by the pharmacy. (D) Space and fixtures (1) All areas where
drugs, equipment, and devices are stored and prepared shall be dry, well-lit,
well-ventilated, and maintained in a clean, sanitary, and orderly condition.
Storage areas shall be maintained at temperatures and conditions which will
ensure the integrity of the drugs prior to their dispensing or administering as
stipulated by the USP/NF and/or the manufacturer's or distributor's
labeling. (2) All storage areas
shall provide adequate security for all dangerous drugs in accordance with the
requirements of rule 4729:5-9-02.2 of the Administrative Code. (E) Personnel (1) The pharmacy shall be
appropriately staffed to operate in a safe and effective manner pursuant to
section 4729.55 of the Revised Code. (2) An employee of a
pharmacy must be identified by a name tag that includes the employee's job
title. (F) Quality assurance The institutional pharmacy shall implement
quality assurance program that is designed to objectively and systematically
monitor and evaluate the quality and appropriateness of patient care, pursue
opportunities to improve patient care, prevention and detection of drug
diversion, and resolve identified problems.
Last updated February 1, 2022 at 9:21 AM
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Rule 4729:5-9-02.2 | Security, storage and control of dangerous drugs in an institutional pharmacy.
Effective:
February 1, 2022
(A) All areas of an institutional pharmacy shall be capable of
being secured by key, or other effective mechanism, to prevent access by
unauthorized personnel. (1) Except as provided in paragraph (C)(5) of
this rule and rule 4729:5-9-03.1 of the Administrative Code, only a licensed
pharmacist may have access to keys, alarm codes, or other methods of gaining
access to the pharmacy when the pharmacy is closed. (2) Keys to the pharmacy maintained on-site that
are not in the possession of a licensed pharmacist shall be secured to prevent
unauthorized access. (3) All combinations or access codes, including
alarm codes, shall be changed upon termination of employment of an employee
having knowledge of the combination or access code. (B) Except as provided in rules 4729:5-9-02.10 and 4729:5-9-03.1
of the Administrative Code, a pharmacist shall provide supervision of the
dangerous drugs, exempt narcotics, D.E.A. controlled substance order forms, and
all records relating to the distribution of dangerous drugs, except where the
board has granted a permission for such records to be stored at a secure
off-site location in accordance with this chapter, at all times in order to
deter and detect theft or diversion. (C) Except as provided in rule 4729:5-9-02.10 of the
Administrative Code, in the absence of a licensed pharmacist, an institutional
pharmacy must be secured by either: (1) A physical barrier (i.e. barricade) with
suitable locks approved by the board. Except for extraordinary circumstances
beyond the pharmacy's control, a pharmacy shall notify the board of any
installation or modification to a physical barrier prior to
implementation. (2) An alarm system approved by the board that is
monitored by a central station for control and can detect unauthorized access
to the pharmacy. The alarm system shall be tested on a biannual basis. The
pharmacy or the entity that manages security for the pharmacy shall maintain
testing records for three years from the date of testing and shall make such
records readily retrievable. The pharmacy shall be responsible for obtaining
testing records if such records are maintained by a third-party. Except for
extraordinary circumstances beyond the pharmacy's control, a pharmacy
shall notify the board of any installation or modification to an alarm system
prior to implementation. This notification requirement does not apply if a
pharmacy also utilizes an approved physical barrier in accordance with
paragraph (C)(1) of this rule. (3) Except as provided in paragraph (C)(5) of
this rule and rule 4729:5-9-03.1 of the Administrative Code, only a pharmacist
may have access to an institutional pharmacy or stock of dangerous drugs or
assume responsibility for the security of dangerous drugs, hypodermics, and any
other item or product that requires the supervision or sale by a
pharmacist. (4) All schedule II controlled substance
dangerous drugs shall be stored in a securely locked, substantially constructed
cabinet or safe and shall not be dispersed through the stock of dangerous
drugs. The cabinet or safe shall remain locked and secured when not in use.
Schedule III through V controlled substance dangerous drugs may be stored with
Schedule II controlled substance dangerous drugs. (5) Any designated area located outside an
institutional pharmacy at the location licensed as a terminal distributor of
dangerous drugs intending to be used for the storage of D.E.A. controlled
substance order forms, records relating to the distribution of dangerous drugs,
except where the board has granted a permission for such records to be stored
at a secure off-site location pursuant to this chapter of the Administrative
Code, shall be secured by an physical barrier with suitable locks to detect
unauthorized entry. (6) Dangerous drugs maintained outside of an
institutional pharmacy but located on the premises of an institutional facility
shall comply with the security and control requirements set forth in this
chapter of the Administrative Code. (D) Refrigerators and freezers used for the storage of dangerous
drugs by an institutional pharmacy shall comply with the
following: (1) Maintain either of the following to ensure
proper refrigeration and/or freezer temperatures are maintained: (a) Temperature logs with,
at a minimum, daily observations; or (b) A temperature
monitoring system capable of detecting and alerting staff of a temperature
excursion. (2) The pharmacy shall develop and implement
policies and procedures to respond to any out of range individual temperature
readings or excursions to ensure the integrity of stored drugs. (3) The pharmacy shall develop and implement a
policy that no food or beverage products are permitted to be stored in
refrigerators or freezers used to store drugs. (E) In accordance with section 3719.172 of the Revised Code, an
institutional pharmacy shall develop and implement policies to prevent
hypodermics from theft or acquisition by any unauthorized person. (F) Adulterated drugs, including expired drugs, shall be stored
in accordance with rule 4729:5-3-06 of the Administrative Code. (G) Disposal of non-controlled dangerous drugs shall be conducted
in accordance with rule 4729:5-3-06 of the Administrative Code. (H) Disposal of controlled substance dangerous drugs shall be
conducted in accordance with rule 4729:5-3-01 of the Administrative
Code. (I) Upon the initial puncture of a multiple-dose vial containing
a drug, the vial shall be labeled with a beyond-use date or date opened. The
beyond-use date for an opened or entered (e.g., needle punctured) multiple-dose
container with antimicrobial preservatives is twenty-eight days, unless
otherwise specified by the manufacturer. A multiple-dose vial that exceeds its
beyond-use date shall be deemed adulterated.
Last updated February 1, 2022 at 9:22 AM
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Rule 4729:5-9-02.3 | Record keeping at an institutional pharmacy.
Effective:
February 1, 2022
(A) An institutional pharmacy shall
document, using positive identification, the licensed or registered individuals
responsible for performing the following activities authorized under Chapter
4729. of the Revised Code and agency 4729 of the Administrative
Code: (1) Medication order or
prescription information entered into the record keeping system. This provision
shall take effect one-year from the effective date of this rule. (2) Verification by the
pharmacist of the prescription information entered into the record keeping
system. (3) Drug utilization
review in accordance with rule 4729:5-9-02.6 of the Administrative Code, which
shall be captured as a standalone action or as part of either: (a) The pharmacist verification of prescription information
as required by paragraph (A)(2) of this rule; or (b) The dispensing process in paragraph (A)(4) of this
rule. (4) Dispensing, except
that a pharmacist shall not be required to perform a check of dangerous drugs
prior to distribution if the drug is dispensed in accordance with
either: (a) Paragraph (F)(5) of this rule; or (b) In accordance with rule 4729:5-3-17 of the
Administrative Code. (5) Compounding in
accordance with Chapter 4729:7-2 of the Administrative Code. (6) Administering
immunizations pursuant to section 4729.41 of the Revised Code. (7) Administering other
injectable drugs pursuant to section 4729.44 of the Revised Code. (8) Prescription
information transcribed from an order received by telephone or recording
device. (9) Any changes or
annotations made to a prescription or medication order. (B) An institutional pharmacy shall
maintain the following records: (1) All medication orders
issued in accordance with rule 4729:5-9-02.7 of the Administrative Code.
(2) Records of drugs
dispensed shall including all the following: (a) The name, strength, dosage form, route of
administration, and quantity of drugs dispensed; (b) The date of dispensing; (c) The name of the inpatient to whom, or for whose use,
the drug was dispensed; and (d) The positive identification of the individuals involved
in the dispensing process in accordance with paragraph (A)(1) of this
rule. (C) An institutional pharmacy shall
maintain records of all drugs dispensed to outpatients pursuant to rule
4729:5-5-04 of the Administrative Code. (D) An institutional pharmacy shall
maintain records of all drugs repackaged pursuant to rule 4729:5-9-02.12 of the
Administrative Code. (E) An institutional pharmacy shall
maintain records of all drugs compounded pursuant to Chapter 4729:7-2 of the
Administrative Code. (F) An institutional pharmacy shall
maintain records for the distribution of non-patient specific dangerous drugs
to other areas of the institutional facility for administration or use, which
shall include all the following: (1) The name, strength,
dosage form, and amount of drug distributed. (2) The area receiving
the drug. (3) The date
distributed. (4) Except as provided in
paragraph (F)(5) of this rule, the positive identification of the pharmacist
checking the dangerous drugs prior to distribution. Such documentation shall be
maintained for a period of three years in a manner that is readily
retrievable. (5) A pharmacist shall
not be required to perform a check of dangerous drugs prior to distribution if
all the following apply: (a) The drugs are
distributed in accordance with paragraph (A)(2)(a) of rule 4729:5-3-17 of the
Administrative Code. (b) The drugs are stored or will be stored in an automated
drug storage system that utilizes barcode system to track and correctly
identify drugs stored within the system. (c) A pharmacist has conducted an initial check of every
barcode to ensure they have been assigned correctly to the appropriate drug.
The initial check shall be documented using positive identification and
maintained for a period of three years in a manner that is readily retrievable.
(d) The pharmacy develops and implements a policy that
includes all the following: (i) Verification by a
pharmacist, documented using positive identification, prior to any changes to
barcodes, additions to the formulary, or modification of a drug's
national drug code (NDC). Any change shall be documented using positive
identification and maintained for a period of three years in a manner that is
readily retrievable. (ii) Requiring a
pharmacist to document using positive identification the addition of auxiliary
barcodes to drugs. Such documentation shall be maintained for a period of three
years in a manner that is readily retrievable. (iii) A process to
immediately alert the pharmacy of an error resulting from an incorrect barcode
or a barcode override to ensure the accuracy of the system. (iv) Prohibits a pharmacy
technician or pharmacy intern from moving or modifying any barcodes inside the
system. Any modifications may only be done by a pharmacist and shall be
documented using positive identification. Such documentation shall be
maintained for a period of three years in a manner that is readily
retrievable. (6) For non-controlled dangerous drugs:
the identification of the facility personnel receiving the drug or authorized
personnel stocking the automated drug storage system. (7) For controlled substance dangerous
drugs: the positive identification of the facility personnel receiving the drug
or authorized personnel stocking the automated drug storage
system. (G) Records of receipt of dangerous drugs
shall contain the name, strength, dosage form, and quantity of the dangerous
drugs received, the name and address of the seller, the name and address of the
recipient, and the date of receipt. (H) Records of temperature control
monitoring described in paragraph (D) of rule 4729:5-9-02.2 of the
Administrative Code shall include any of the following: (1) For temperature logs,
either: (a) The date and time of observation, the full name or the
initials of the individual performing the check, and the temperature recorded;
or (b) For systems that provide automated temperature
monitoring, maintain a report that provides, at a minimum, the date and time of
observation and the temperature recorded. (2) For temperature
monitoring systems capable of detecting and alerting staff of a temperature
excursion, maintain reports that provide information on any temperature
excursion that includes the date, time, temperature recorded, and length of
each excursion. (I) Records of dangerous drugs disposed
from inventory, other than controlled substances, shall contain the name,
strength, dosage form, and quantity of the dangerous drug disposed, the date of
disposal, the method of disposal, and, if disposal is performed on-site, the
positive identification of the licensed health care professional that performed
the disposal. (J) Records of controlled substance drug
disposal shall comply with the requirements of rule 4729:5-3-01 of the
Administrative Code. (1) If the disposal of
controlled substance drug inventory is performed on-site in an institutional
pharmacy, records shall also include the positive identification of two
licensed or registered healthcare professionals conducting and witnessing the
disposal, one of whom shall be a pharmacist. (2) If conducting the
disposal of an unused portion of a controlled substance resulting from
administration to a patient in an institutional pharmacy, records shall also
include the positive identification of two licensed or registered healthcare
professionals conducting and witnessing the disposal. (K) Controlled substance inventory
records shall be maintained in accordance with rule 4729:5-3-07 of the
Administrative Code. (L) Records of transfers to other
terminal distributors of dangerous drugs, including sales conducted in
accordance with rule 4729:5-3-09 of the Administrative Code, shall contain the
name, strength, dosage form, and quantity of the dangerous drug transferred,
the address of the location where the drugs were transferred and the date of
transfer. (M) All institutional pharmacy records
required in accordance with this chapter shall be maintained under appropriate
supervision and control to restrict unauthorized access. (N) All institutional pharmacy records
maintained in accordance with this chapter shall be uniformly maintained for a
period of three years. Except as provided in paragraph (N)(3) of this rule, all
records shall be made readily retrievable. (1) Computerized drug
record keeping systems or subsequent storage of such records, must be
retrievable via digital display, hard copy printout, or other mutually
agreeable transfer medium. (2) If a computerized
drug record keeping system is being utilized, the method(s) of achieving
positive identification must be approved, in a manner determined by the board,
prior to implementation or any subsequent modification. (3) Record keeping
systems shall provide immediate retrieval via digital display and hard copy
printout or other mutually agreeable transfer medium of information for all
prescriptions, or medication orders, dispensed within the previous twelve
months, and shall provide in a manner that is readily retrievable information
on all prescriptions dispensed beyond the previous twelve months but within the
previous three years. (4) All computerized
record keeping systems shall be able to capture records edited by authorized
personnel and maintain an audit trail as defined in rule 4729:5-9-01 of the
Administrative Code. (5) All paper records
maintained electronically shall be scanned in full color via technology
designed to capture information in one form and reproduce it in an electronic
medium presentable and usable to an end user. (6) All computerized
record keeping systems, including systems used to store scanned paper records,
shall have daily back-up functionality to protect against record loss and
security features to prevent unauthorized access. (O) (1) Except as provided
for in paragraph (O)(2) of this rule, all records maintained in accordance with
this chapter shall be maintained on-site. (2) An institutional
pharmacy located in this state intending to maintain records at a location
other than the location licensed by the state board of pharmacy shall send a
request in a manner determined by the board. The board will provide written or
electronic notification to the institutional pharmacy documenting the approval
or denial of the request. A copy of the board's approval shall be
maintained at the licensed location. Any such alternate location used to store
records shall be secured and accessible only to authorized representatives or
contractors of the terminal distributor of dangerous drugs.
Last updated February 1, 2022 at 9:20 AM
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Rule 4729:5-9-02.4 | Dispensing of controlled substances by an institutional pharmacy.
Effective:
February 1, 2022
All controlled substances dispensed in quantities
exceeding a seventy-two-hour supply shall be packaged in tamper-evident,
unit-of-use containers except when unit-of-use packaging is not available
including, but not limited to, multi-dose liquids and injectables.
Last updated February 1, 2022 at 9:22 AM
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Rule 4729:5-9-02.5 | Patient profiles.
Effective:
February 1, 2022
All institutional pharmacies shall maintain a
patient profile system which shall provide for immediate retrieval of
information regarding those patients who have received medications from that
pharmacy. (A) All patient profile systems shall maintain, at a
minimum, the following data: (1) The patient's data record, which shall consist of,
but is not limited to, the following information: (a) Full name of the
patient for whom the drug is intended. (b) Patient's date
of birth. (c) Patient's
gender, if provided. (d) A list of current
patient specific data consisting of at least the following, if made known to
the pharmacist or agent of the pharmacist: (i) Drug related allergies; (ii) Previous drug reactions; (iii) History of or active chronic conditions or disease
states; and (iv) Other drugs, including nonprescription drugs, devices
and nutritional supplements used on a routine basis. (e) The pharmacist's
comments relevant to the individual patient's drug therapy, including any
other necessary information unique to the specific patient or
drug. (2) The patient's drug therapy record, which shall
contain the following information for all medications dispensed by the pharmacy
within the last twelve months. (a) The original
medication order; (b) Date and time of
issuance of the medication order by the prescriber; (c) Full name of the
prescriber; (d) The prescriber's
credential (MD, NP, PA, etc.); (e) Directions for
use; (f) The proprietary name,
if any, or the generic name and the name of the distributor or national drug
code of the drug or device dispensed; and (g) The strength, dosage
form, route of administration, and quantity of the drug or device
dispensed. (B) An institutional pharmacy shall make a reasonable
effort to obtain a patient's medical history necessary to conduct a
prospective drug utilization review. (C) The patient profile shall be maintained for a period of
not less than one year from the date of the last entry in the profile record.
This record may be a hard copy or maintained as a part of computerized
system.
Last updated February 1, 2022 at 9:22 AM
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Rule 4729:5-9-02.6 | Pharmacist drug utilization review.
Effective:
February 1, 2022
(A) Except as provided in paragraph (F) of this rule, prior
to dispensing any initial medication order or medication order change, a
pharmacist shall conduct a prospective drug utilization review of the patient
profile for the purpose of identifying the following: (1) Over-utilization or under-utilization of medications
dispensed in the institutional facility; (2) Therapeutic duplication; (3) Drug-disease state contraindications; (4) Drug-drug interactions; (5) Incorrect drug dosage; (6) Drug-allergy interactions; (7) Abuse/misuse; (8) Inappropriate duration of drug treatment;
and (9) Food-nutritional supplements-drug
interactions. (B) Upon identifying any issue listed in paragraph (A) of
this rule, a pharmacist, using professional judgment, shall take appropriate
steps to avoid or resolve the potential problem. These steps may include, but
shall not be limited to, the following: (1) Requesting and reviewing an OARRS report or another
state's prescription drug monitoring report; (2) Consulting with the prescriber; or (3) Counseling the patient. (C) Prospective drug utilization review shall be performed
using predetermined standards consistent with, but not limited to, any of the
following: (1) Peer-reviewed medical literature (i.e. scientific,
medical, and pharmaceutical publications in which original manuscripts are
rejected or published only after having been critically reviewed by unbiased
independent experts); (2) American hospital formulary service drug information;
and (3) United States pharmacopeia drug
information. (D) Based upon information obtained during a prospective
drug utilization review, a pharmacist shall use professional judgment when
making a determination about safe and appropriate use and the legitimacy of a
medication order. A pharmacist shall not dispense a dangerous drug from a
medication order or prescription of doubtful, questionable, or suspicious
origin. (E) The requirement to conduct a prospective drug
utilization review in accordance with paragraph (A) of this rule does not apply
to drugs personally furnished or administered from floor stock, contingency
drugs, or an automated drug storage system in either of the following
circumstances: (1) A prescriber controls the ordering, preparing, and
administering of the drug; or (2) Delay would harm the patient. (F) A
pharmacist shall conduct a retrospective review of medication orders within a
reasonable amount time and make a determination about the safe and appropriate
use and the legitimacy of the order in either of the following
circumstances: (1) Any drug removed from the pharmacy or contingency stock
in accordance with rule 4729:5-9-03.01 of the Administrative Code;
and (2) The use of override medications as defined in paragraph
(M) of rule 4729:5-9-01 of the Administrative Code. (G) An institutional facility shall develop and implement
policies and procedures to require pharmacists to report unsafe or
inappropriate prescribing or dosing by prescribers to the appropriate oversight
committee.
Last updated February 1, 2022 at 9:23 AM
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Rule 4729:5-9-02.7 | Medication orders for inpatients and outpatient prescriptions.
Effective:
February 1, 2022
(A) Dangerous drugs shall be dispensed by
a pharmacist for inpatients pursuant to an original patient-specific order
issued by a prescriber or a protocol or pre-printed order as authorized in
accordance with rule 4729:5-3-12 of the Administrative Code. All controlled
substance prescriptions or medication orders shall be issued in accordance with
21 CFR part 1306 (7/1/2019) and 21 CFR part 1311 (7/1/2019). (1) Medication orders for
inpatients of an institutional facility transmitted to a pharmacy by use of an
electronic drug record keeping system may be considered an original order for
the dispensing of drugs. Access to such system for entering and transmitting
original orders shall be restricted to personnel authorized in accordance with
written policies and procedures of the institutional facility. If the
authorized personnel entering the order into the system is not the prescriber,
there shall be a system in place requiring the positive identification of the
prescriber for each order within a reasonable period of time which shall be
made readily retrievable. (2) Oral orders issued by
a prescriber for inpatients of an institutional facility may be transmitted to
a pharmacist by personnel authorized in accordance with written policies and
procedures of the institutional facility. Such orders shall be transcribed by
the pharmacist, noting the full name(s) of the authorized personnel
transmitting the order. Oral orders issued by a prescriber and transmitted by
authorized personnel shall be verified by the prescriber using positive
identification within a reasonable time and as required by the written policies
and procedures of the facility. Authorized personnel at an institutional
facility may transcribe an oral order of a prescriber, including those received
telephonically, in accordance with rule 3701-16-09 or 3701-17-13 of the
Administrative Code and transmit the written transcription to the pharmacy by
facsimile machine or electronic prescription transmission system in accordance
with written policies and procedures of the institutional facility. The
transcribed order shall include the positive identification of the authorized
facility personnel who transcribed and transmitted the order to the pharmacy.
(a) Oral orders for non-controlled substances issued by a
prescriber for inpatients of an institutional facility may be transmitted to a
pharmacy intern by personnel authorized by, and in accordance with, written
policies and procedures of the facility if the pharmacist on duty who is
personally supervising the activity of the intern determines that the intern is
competent to perform this function. (i) The intern shall
immediately transcribe the order, document the full name of the prescriber and,
if transmitted by the prescriber's agent, the full name of the agent and
shall review the order with the pharmacist on duty. Prior to dispensing,
positive identification of the intern and the pharmacist on duty shall be
recorded to identify the responsibility for the receipt of the oral
order. (ii) The pharmacist on
duty is responsible for the accuracy of the prescription. (iii) The pharmacist on
duty must be immediately available to answer questions or discuss the
prescription with the prescriber or the prescriber's agent. (b) Oral orders for non-controlled substances issued by a
prescriber for inpatients of an institutional facility may be transmitted to a
certified pharmacy technician in pursuant to rule 4729:3-3-04 of the
Administrative Code by personnel authorized by, and in accordance with, written
policies and procedures of the facility. Oral orders issued by a prescriber and
transmitted by authorized personnel shall be verified by the prescriber using
positive identification within a reasonable time and as required by the written
policies and procedures of the facility. (3) Medication orders for
inpatients of an institutional facility transmitted to a pharmacy by use of a
facsimile machine shall be transmitted by personnel authorized by, and in
accordance with, written policies and procedures of the facility. Telephonic orders transcribed by authorized
residential care facility personnel and transmitted to a pharmacy by use of a
facsimile machine shall comply with the requirements of rule 3701-16-09 or
3701-17-13 of the Administrative Code and the policies and procedures of the
institutional facility. A facsimile shall only be valid as an order if
a pharmacy retains a printed copy of a facsimile prescription or an electronic
copy of the facsimile prescription in accordance with paragraph (B) of this
rule. (B) All non-controlled hard copy
medication orders, including facsimiles, may be electronically maintained,
provided that the system creates and maintains electronic records in accordance
with the following: (1) All hard copy
medication orders for non-controlled dangerous drugs may be electronically
filed and then destroyed after one hundred and eighty days from the date of
creation or receipt. Disposal of the hard copy shall use a secure method of
destruction to ensure privacy and confidentiality of the contents. (2) All hard copy
medication orders electronically filed in accordance with this rule shall be
scanned front and back in full color (i.e. retains color information and/or
color graphics in the document) via technology designed to capture information
in one form and reproduce it in an electronic medium presentable and usable to
an end user. Prior to scanning, the written or faxed order shall be clearly
notated to indicate it has been received by the pharmacy in a manner that does
not destroy any of the original information contained on the prescription but
prevents the unauthorized duplication of the prescription. (3) A record or image
once created shall be unalterable but may be annotated as necessary so long as
the original record or image is still available for review and the individual
that made the annotation is noted. (4) The electronic form
shows the exact and legible image of the original hard copy medication
order. (5) All hard copy orders
filed electronically in accordance with this rule shall be deemed the original
prescription. (C) All orders for drugs for inpatients
shall include the following: (1) Name of
patient; (2) Name, strength, and
dosage form of drug; (3) Directions for use,
including route of administration; (4) Date
prescribed; (5) The ordering
prescriber's positive identification, which may be maintained in the
patient's medical record at the institutional facility; and (6) If applicable, the
positive identification of the authorized individual transmitting the order on
behalf of the prescriber. (D) An institutional pharmacy shall
develop and maintain written stop order policies or other methods of assuring
that drug orders are not continued inappropriately in accordance with the
status of the patient. (E) Drugs may be dispensed for
outpatients by an institutional pharmacy pursuant to an original prescription
of a prescriber in accordance with rule 4729:5-5-15 of the Administrative Code.
All outpatient prescriptions dispensed by an institutional pharmacy shall
comply with the following outpatient pharmacy requirements: (1) Labeling requirements
in accordance with rule 4729:5-5-06 of the Administrative Code; (2) Record keeping
requirements in accordance with rule 4729:5-5-04 of the Administrative
Code; (3) Patient counseling
requirements pursuant to rule 4729:5-5-09 of the Administrative
Code; (4) Prescription filing
requirements pursuant to rule 4729:5-5-03 of the Administrative
Code; (5) Manner of processing
requirements pursuant to rule 4729:5-5-10 of the Administrative
Code; (6) Serial numbering
requirements pursuant to rule 4729:5-5-13 of the Administrative
Code; (7) Pick-up station
requirements pursuant to rule 4729:5-5-14 of the Administrative
Code; (8) Patient profile
requirements pursuant to rule 4729:5-5-07 of the Administrative
Code; (9) Reporting of all
drugs pursuant to division 4729:8 of the Administrative Code; and (10) Prospective drug
utilization review requirements pursuant to rule 4729:5-5-08 of the
Administrative Code. (F) Outpatient prescriptions may be
transferred by an inpatient pharmacy to an outpatient pharmacy in accordance
with rule 4729:5-5-11 of the Administrative Code. (G) A pharmacist may modify an outpatient
prescription pursuant to rule 4729:5-5-16 of the Administrative
Code. (H) An original signed prescription for a
schedule II controlled substance prepared in accordance with federal and state
requirements and issued for a resident in a long-term care facility may be
transmitted by the prescriber or the prescriber's agent to the dispensing
pharmacy by facsimile. The facsimile shall serve as the original written
prescription and shall be received and maintained pursuant to rules 4729:5-5-10
and 4729:5-5-15 of the Administrative Code. The original signed prescription
must remain with the patient's records at either the prescriber's
office or the long-term care facility. (I) A prescription or medication order,
to be valid, must be issued for a legitimate medical purpose by an individual
prescriber acting in the usual course of the prescriber's professional
practice. The responsibility for the proper prescribing is upon the prescriber,
but a corresponding responsibility rests with the pharmacist who dispenses the
prescription. An order purporting to be a prescription issued not in the usual
course of bona fide treatment of a patient is not a prescription and the person
knowingly dispensing such a purported prescription, as well as the person
issuing it, shall be subject to the penalties of law. (J) A pharmacy providing emergency kits
for use by a nursing home or residential care facility pursuant to rule
4729:5-9-03.1 of the Administrative Code must receive a valid outpatient
prescription issued in accordance with rule 4729:5-5-15 of the Administrative
Code prior to the administration of the initial dose of a controlled substance
drug contained in the kit. The pharmacy providing the emergency kit shall be
responsible for generating and maintaining a record of the dispensing of the
initial dose of a controlled substance drug obtained from the kit in compliance
with the record keeping requirements set forth in rule 4729:5-9-02.3 of the
Administrative Code.
Last updated February 1, 2022 at 9:20 AM
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Rule 4729:5-9-02.8 | Labeling of prescriptions for patients.
Effective:
February 1, 2022
(A) All dangerous drugs dispensed for use by inpatients in an
institutional facility, whereby the drug is not in the possession of the
ultimate user prior to administration, shall meet the following
requirements: (1) The label of a single unit package of an
individual-dose or unit-dose system of packaging of drugs shall
include: (a) The non-proprietary or
proprietary name of the drug; (b) Dosage form and route
of administration; (c) The strength and
volume, where applicable, of the drug; (d) The control number and
expiration date; (e) National drug code,
universal product code, or formulary code, if applicable, which may be embedded
in a barcode or quick response (QR) code on the label; (f) Identification of the
manufacturer, packer or distributor, or, if the repackager is the dispensing
pharmacy, identification of the repackager shall be by name or by the final
seven digits of their terminal distributor of dangerous drugs license number,
and such identification shall be clearly distinguishable from the rest of the
label; and (g) Special storage
conditions, if required. (2) At least the name of the patient must be
placed on all medication containers too small to bear a complete label and
dispensed in a container bearing a complete label. (B) All drugs dispensed to inpatients for self-administration or
dispensed for outpatient use shall be labeled in accordance with rule
4729:5-5-06 of the Administrative Code. (C) Prior to dispensing, admixtures of parenteral solutions shall
bear a distinctive label indicating: (1) The patient's full name; (2) The name and amount of the parenteral
solution; (3) The name and amount of the drug(s)
added; (4) The expiration date or beyond-use
date; (5) The name and address of the institutional
pharmacy; (6) Cautionary statements, if
required. (D) Supplemental labels created by a pharmacy that contain a
barcode or QR code for the purpose of identifying a drug shall contain a means
of identifying the positive identification of the pharmacist responsible
for: (1) Association of the barcode to the drug
product; (2) Association of the label to the drug
product.
Last updated February 1, 2022 at 9:23 AM
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Rule 4729:5-9-02.9 | Licensure of outpatient institutional pharmacies.
Effective:
February 1, 2022
(A) As used in this rule,
"outpatient institutional pharmacy" means a pharmacy located within
or on the campus of an institutional facility that provides outpatient pharmacy
services which is physically separate from, and not contiguous to, the area in
which inpatient pharmacy services are provided. (B) An outpatient institutional pharmacy
shall have a separate terminal distributor of dangerous drugs license in
addition to the license for the institutional facility or pharmacy. An
outpatient institutional pharmacy shall comply with the requirements of Chapter
4729:5-5 of the Administrative Code.
Last updated February 1, 2022 at 9:24 AM
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Rule 4729:5-9-02.10 | Temporary absence of a pharmacist in an institutional pharmacy.
Effective:
February 1, 2022
(A) A pharmacist practicing within an
institutional facility may temporarily leave the pharmacy to engage in the
practice of pharmacy within the institutional facility without closing the
pharmacy and removing staff from the pharmacy if the practicing pharmacist can
ensure there are adequate security measures and policies to maintain the
security of the drug stock in the pharmacist's absence. (B) If in the pharmacist's
professional judgment they determine, for reasons of security or otherwise,
that the pharmacy should close during the pharmacist's absence, then the
pharmacist shall close the pharmacy and remove all staff from the pharmacy
during the pharmacist's absence. (C) During the pharmacist's absence,
no dangerous drugs shall be dispensed unless the pharmacist has conducted a
final association of the drug with a patient and has complied with all other
applicable rules prior to dispensing a dangerous drug. (D) During such times that the pharmacist
is temporarily absent from the pharmacy, the pharmacy staff may continue to
perform the non-discretionary duties authorized in accordance with Chapter
4729. of the Revised Code and agency 4729 of the Administrative Code. However,
any duty performed by any member of the staff shall be reviewed by the
pharmacist upon the pharmacist's return to the pharmacy. (E) The institutional facility shall have
written policies and procedures regarding the operation of the pharmacy during
the temporary absence of the pharmacist. The policies and procedures shall
include the authorized duties of pharmacy staff, the pharmacist's
responsibilities for checking all work performed by staff, and the
pharmacist's responsibility for maintaining the security and control of
the drug stock. (F) Unless otherwise authorized in agency
4729 of the Administrative Code, this rule does not permit non-pharmacist
personnel from having unsupervised access to drug stock when an institutional
pharmacy is closed.
Last updated February 1, 2022 at 9:24 AM
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Rule 4729:5-9-02.11 | Dispensing customized patient medication packages by an institutional pharmacy.
Effective:
February 1, 2022
In lieu of dispensing two or more dangerous drugs
in separate containers, a pharmacist practicing at an institutional pharmacy
may dispense a customized patient medication package. A customized patient
medication package is a package for a specific patient comprising a series of
containers and containing two or more prescribed solid oral dosage forms that
complies with the following requirements: (A) The package is designed, or each
container is labeled, to indicate the day and time or period of time when the
contents within each container are to be taken by the patient. (B) The number of drugs placed in each container cannot
exceed the capability of the container to prevent damage to the dosage
forms. (C) The quantity of the package dispensed may not be more
than a thirty-one-day supply. (D) The labels must be of sufficient size to properly and
clearly label a thirty-one-day or less supply with all information required in
accordance with this chapter of the Administrative Code, including the use of
accessory labels. When a customized medication packaging is utilized, including
dispensing of single unit packages, the drugs shall be dispensed in a container
or package with an affixed label containing the following
information: (1) Identification of the dispensing pharmacy; (2) The patient's full name; (3) The date of dispensing; (4) The non-proprietary and/or proprietary name of the
drug; (5) National drug code, universal product code, or
formulary code, if applicable, which may be embedded in a barcode or quick
response (QR) code on the label; (6) The strength of the drug; (7) The pharmacy's expiration date or beyond-use date,
which shall not exceed the expiration date on the manufacturer's container
or six months from the date the drug was originally packaged, whichever date is
earlier. If multiple manufacturer containers are used, the expiration date
shall not exceed the expiration date on the manufacturer's container that
will expire first or six months from the date the drug was originally
repackaged, whichever date is earlier. (E) All drugs dispensed to inpatients for
self-administration or dispensed for outpatient use shall also be labeled in
accordance with rule 4729:5-5-06 of the Administrative Code. (F) Dangerous drugs which have been dispensed in a
customized patient medication package may only be returned to stock or
re-dispensed in accordance with all the following: (1) The drugs have not been in the possession of the
ultimate user; and (2) The drugs have not been placed in the same container
with another dangerous drug (i.e. did not come into direct contact with a
different drug within the same container). (G) The containers of a package are sealed or secured in
such a way that access to the drugs stored within is not possible without
leaving visible proof that such access has been attempted or made. (H) Any pharmacy dispensing customized patient medication
packages in accordance with this rule must implement policies and procedures
that will exclude drugs having any of the following characteristics from such
packaging: (1) The U.S.P. monograph or official labeling requires
dispensing in the original container, unless there is documentation from the
manufacturer stating otherwise; (2) The drugs or dosage forms are incompatible with
packaging components or each other; (3) The drugs are therapeutically incompatible when
administered simultaneously; (4) The drugs require special packaging.
Last updated February 1, 2022 at 9:24 AM
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Rule 4729:5-9-02.12 | Drugs repackaged or relabeled by an institutional pharmacy.
Effective:
February 1, 2022
(A) As used in this rule,
"repackaging" means the act of taking a finished drug product from
the container in which it was distributed by the original manufacturer and
placing it into a different container without further manipulation of the drug.
Repackaging also includes the act of placing the contents of multiple
containers (e.g., vials) of the same finished drug product into one container,
as long as the container does not include other ingredients. If a drug is
manipulated in any other way, including if the drug is reconstituted, diluted,
mixed, or combined with another ingredient, that act is not considered
repackaging. (B) The following rule applies to
dangerous drugs repackaged by an institutional pharmacy. The rule does not
apply to any of the following: (1) Repackaging drug
products for use in animals; (2) Repackaging
non-dangerous drug products; (3) Radiopharmaceuticals
as defined in Chapter 4729:5-6 of the Administrative Code; (4) Repackaging conducted
by outsourcing facilities or repackagers licensed in accordance with section
4729.52 of the Revised Code; (5) Removing a drug
product from the original container at the point of care (e.g., patient's
bedside) for immediate administration to a single patient after receipt of a
valid patient-specific prescription or order for that patient (e.g., drawing up
a syringe to administer directly to the patient); (6) Upon receipt of, or
in anticipation of, a valid patient-specific prescription or medication order,
a licensed pharmacy removing from one container the quantity of non-sterile
drug products (e.g., oral dosage forms) necessary to fill the prescription and
placing it in a different container to dispense directly to the patient;
and (7) Investigational new
drugs being studied under an investigational new drug application.
(C) Drugs repackaged by an institutional
pharmacy shall comply with the following: (1) Unless otherwise
specified in the individual monograph or in the absence of stability data to
the contrary, the beyond-use date shall be not later than the expiration date
on the manufacturer's container or one-year from the date the drug is
repackaged, whichever is earlier. Sterile compounded drug preparations shall
comply with paragraph (C)(2) of this rule. (2) Sterile compounded
drug preparations shall comply with United States pharmacopeia chapter
<797> as referenced in rule 4729:7-1-01 of the Administrative
Code. (D) Labels of drugs repackaged by and stored within a
pharmacy prior to being dispensed shall contain, but not be limited to, the
following: (1) Name of drug,
strength, and dosage form; (2) National drug code or
universal product code, if applicable, which may be embedded in a barcode or
quick response (QR) code on the label; (3) The identification of
the repackager by name or by the final seven digits of their terminal
distributor of dangerous drugs license number; (4) Pharmacy control
number; and (5) The beyond-use date
of the repackaged drug in accordance with the guidance listed in paragraph (C)
of this rule. (E) All drugs dispensed to inpatients for
self-administration or dispensed for outpatient use shall also be labeled in
accordance with rule 4729:5-5-06 of the Administrative Code. (F) A record of all drugs repackaged and stored within a
pharmacy prior to being dispensed shall be kept for at least three years or one
year past manufacturer's expiration date, whichever is greater. This
record shall include, at a minimum, the following: (1) Name of drug,
strength, dosage form, and quantity; (2) National drug code or
universal product code (UPC), if applicable, which may be embedded in a barcode
or quick response (QR) code on the label; (3) Manufacturer's
or distributor's control number; (4) Manufacturer's
or distributor's name, if a generic drug is used, or if not using NDC or
UPC; (5) Pharmacy control
number; (6) Manufacturer's
or distributor's expiration date; (7) The pharmacy's
beyond-use date in accordance with the guidance listed in paragraph (C) of this
rule; (8) The positive
identification of the individual responsible for the repackaging of the drug;
and (9) The positive
identification of the pharmacist conducting the final verification of the
repackaged drug to confirm the accuracy of the drug and conformity to the
requirements of this rule prior to dispensing or distribution. (G) Supplemental labels created by a pharmacy that contain
a barcode or QR code for the purpose of identifying a drug shall contain a
means of identifying the positive identification of the pharmacist responsible
for: (1) Association of the
barcode to the drug product; (2) Association of the
label to the drug product.
Last updated February 1, 2022 at 9:25 AM
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Rule 4729:5-9-02.13 | Institutional central fill pharmacies.
Effective:
February 1, 2022
(A) As used in this chapter: (1) "Central fill pharmacy" means a pharmacy
licensed as a terminal distributor of dangerous drugs acting as an agent of an
originating pharmacy to fill or refill a medication order. A central fill
pharmacy may be used to replenish automated drug storage systems and automated
pharmacy systems. (2) "Originating pharmacy" means an
institutional pharmacy licensed as a terminal distributor of dangerous drugs
that uses a central fill pharmacy to fill or refill medication order. A central
fill pharmacy may be used to replenish automated drug storage systems and
automated pharmacy systems. (B) A
central fill pharmacy and originating pharmacy may process a request for the
filling or refilling of a medication order received by an originating pharmacy
pursuant to the following requirements: (1) The central fill pharmacy either has the same owner as
the originating pharmacy or has a written contract with the originating
pharmacy outlining the services to be provided and the responsibilities of each
pharmacy in fulfilling the terms of the contract in compliance with federal and
state law, rules and regulations. (2) The central fill pharmacy shall maintain a record of
all originating pharmacies, including name, address, terminal distributor
number, and, if applicable, drug enforcement administration registration
number, for which it processes a request for the filling or refilling of a
medication order received by the originating pharmacy. The record shall be made
readily retrievable and maintained for a period of three years. (3) The central fill pharmacy and originating pharmacy
shall have access to common electronic files as part of a real time, online
database or have appropriate technology to allow secure access to sufficient
information necessary or required to dispense or process the medication
order. (4) The originating pharmacy shall comply with the minimum
required information for a patient profile pursuant to rule 4729:5-9-02.5 of
the Administrative Code prior to sending a medication order to the central fill
pharmacy. (5) The originating pharmacy shall remain responsible for
compliance with the dangerous drug dispensing requirements of this chapter and
the compounding requirements of Chapter 4729:7-2 of the Administrative Code
that are not assumed in writing by the central fill pharmacy. (6) The prescription label attached to the container shall
contain the name and address of the originating pharmacy and the name of the
central fill pharmacy. If applicable, the date on which the medication order
was dispensed shall be the date on which the central fill pharmacy filled the
order. (7) The originating pharmacy shall maintain the original of
all medication orders received for purposes of filing and record keeping as
required by state and federal law, rules, and regulations. (8) The central fill pharmacy shall maintain all original
fill and refill requests received from the originating pharmacy and shall treat
them as original and refill medication orders for purposes of filing and record
keeping as required by state and federal law, rules, and regulations.
(9) The central fill pharmacy and originating pharmacy
shall each maintain records to capture the positive identification of the
licensed or registered individuals responsible for performing respective
activities in accordance with rule 4729:5-9-02.3 of the Administrative Code.
(10) The central fill pharmacy and originating pharmacy
shall adopt a written quality assurance program for pharmacy services designed
to objectively and systematically monitor and evaluate the quality and
appropriateness of patient care, pursue opportunities to improve patient care,
resolve identified problems, and ensure compliance with this rule. The quality
assurance plan shall be reviewed and updated annually. (C) Dangerous drugs may be returned by the originating
pharmacy to the central fill pharmacy for the purpose of being returned to the
central fill pharmacy's stock shelves in accordance with the following:
(1) The central fill pharmacy complies with the
requirements of rule 4729:5-3-16 of the Administrative Code; and (2) The originating and central fill pharmacy are under
common ownership and control. (D) An originating pharmacy may return dangerous drugs
received by a central fill pharmacy to stock shelves in accordance with rule
4729:5-3-16 of the Administrative Code. (E) All written documentation required by this rule shall
be maintained for three years from the date of execution or review and shall be
made readily retrievable. (F) An institutional pharmacy may utilize a central fill
pharmacy to dispense outpatient prescriptions in accordance with rule
4729:5-5-19 of the Administrative Code. (G) Drugs that are repackaged or relabeled by a central
fill pharmacy shall comply with the requirements of rule 4729:5-9-02.12 of the
Administrative Code.
Last updated February 1, 2022 at 9:25 AM
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Rule 4729:5-9-02.14 | Remote medication order processing.
Effective:
November 30, 2021
(A) As used in this rule: (1) "Remote
medication order processing" means the processing of a medication order
for an institutional pharmacy licensed as a terminal distributor of dangerous
drugs by a remote pharmacist. Remote medication order processing does not
include the dispensing of a drug, but may include receiving, interpreting,
evaluating, clarifying, and approval of medication orders. Additionally, remote
medication order processing may include order entry, other data entry,
performing prospective drug utilization review, interpreting clinical data,
performing therapeutic interventions, providing drug information services, and
authorizing release of the medication for administration. The requirements of
this rule shall be limited to the processing of medication orders dispensed in
or into this state. (2) "Remote
pharmacy" means either: (a) A pharmacy licensed as a terminal distributor of
dangerous drugs that dispenses dangerous drugs; or (b) A pharmacy licensed as a limited category II terminal
distributor of dangerous drugs that does not stock, own, or dispense any
dangerous drugs and whose sole business consists of entry, review, and/or
verification of prescriber orders and consulting services under contract for
institutional pharmacies in this state. (3) "Remote
pharmacist" means any of the following: (a) If performing remote
medication order processing in this state: an Ohio licensed pharmacist, either
employed or a contract employee of an institutional pharmacy or remote
pharmacy, who either processes orders from a remote site, which may include the
pharmacist's residence or other location where the pharmacist and the
institutional or remote pharmacy can ensure the confidentiality and integrity
of patient information, or on the premises of a remote pharmacy or
institutional pharmacy; or (b) If performing remote
medication order processing outside of this state: a pharmacist licensed or
registered in the state where the remote medication order processing is
occurring, either employed or a contract employee of an institutional pharmacy
or remote pharmacy who holds a nonresident pharmacy license in accordance with
Chapter 4729:5-8 of the Administrative Code, who either processes prescriptions
from a remote site, which may include the pharmacist's residence or other
location where the pharmacist and the institutional or remote pharmacy can
ensure the confidentiality and integrity of patient information, or on the
premises of a remote pharmacy or institutiona pharmacy. A pharmacist shall only be permitted to
conduct remote medication order processing within the United States, to include
the District of Columbia, the Commonwealth of Puerto Rico or a territory or
insular possession subject to the jurisdiction of the United States. (B) An institutional pharmacy may
outsource medication order processing to a remote pharmacy provided the
pharmacies are under common ownership or control or the institutional pharmacy
has entered into a written contract or agreement with a pharmacy that outlines
the services to be provided and the responsibilities and accountabilities of
each party to the contract or agreement in compliance with federal and state
law, rules, and regulations. (C) The institutional pharmacy and remote
pharmacy must maintain a copy of the contract or agreement in a readily
retrievable manner for inspection and review by an agent, inspector, or
employee of the board. (D) An institutional pharmacy utilizing
remote medication order processing shall ensure that all remote pharmacists
providing such services have been trained on the institutional pharmacy's
policies and procedures relating to medication order processing. The training
of each pharmacist shall be documented. (1) Such training shall
include, but is not limited to, policies on drug and food allergy
documentation, abbreviations, administration times, automatic stop orders,
substitution, and formulary compliance. The institutional pharmacy and the
remote pharmacy shall jointly develop a procedure to communicate changes in
policies and procedures related to medication order processing. (2) A terminal
distributor of dangerous drugs may utilize one training program for all
institutional pharmacies under the terminal distributor's common ownership
and control. (E) An institutional pharmacy utilizing
remote pharmacists shall maintain or have access to a record of the name and
license number of each pharmacist, evidence of current pharmacist licensure in
the state where the pharmacist is performing remote order processing, and the
address of each location where the pharmacist will be providing remote
medication order processing services. (F) An institutional pharmacy shall
ensure that any remote pharmacist shall have secure electronic access to the
institutional pharmacy's patient information system and to other
electronic systems that the on-site pharmacist has access to when the pharmacy
is open. (G) The remote pharmacist must be able
to contact the prescriber issuing a medication order to discuss any concerns
identified during the pharmacist's review of patient information and the
medication order. A procedure must be in place to communicate any problems
identified with the prescriber and the nursing staff providing direct patient
care. (H) Each remote entry record must comply
with all record keeping requirements for institutional pharmacies, including
capturing the positive identification of the remote pharmacist involved in the
review and verification of the medication order. (I) An institutional pharmacy utilizing
remote medication order processing is responsible for maintaining records of
all medication orders entered into their information system, including orders
entered by a remote pharmacist. The system shall have the ability to audit the
activities of the remote pharmacists. (J) An institutional pharmacy utilizing
remote medication order processing services shall develop and implement a
policy and procedure manual. A remote pharmacy shall maintain a copy of those
portions of the policy and procedure manual that relate to the remote
pharmacy's operations. Each manual shall include all the following:
(1) Outline the
responsibilities of the institutional pharmacy and the remote pharmacy;
(2) Include a list of the
names, addresses, telephone numbers, and all license numbers of the
pharmacies/pharmacists involved in remote medication order processing; and
(3) Include policies and
procedures for: (a) Protecting the confidentiality and integrity of patient
information; (b) Ensuring that no patient information is duplicated,
downloaded, or removed from the institutional pharmacy's patient
information system; (c) Maintaining appropriate records of each pharmacist
involved in order processing; (d) Complying with federal and state law, rules, and
regulations; (e) Reviewing written policies and procedures at least
every three years, or upon the implementation of a significant change of
written policies and procedures, and documentation of the review;
and (f) Annually reviewing the competencies of pharmacists
providing remote order entry processing services.
Last updated November 30, 2021 at 8:29 AM
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Rule 4729:5-9-02.15 | Remote order entry - technicians.
Effective:
November 30, 2021
(A) As used in this rule: (1) "Direct
supervision" and "personal supervision" have the same meaning as
in rule 4729:3-1-01 of the Administrative Code. (2) "Remote order
entry" means the entry of medication orders for an inpatient pharmacy
licensed as a terminal distributor of dangerous drugs by a remote technician
under the direct supervision or remote supervision of a pharmacist. Remote
order entry does not include dispensing, interpreting, evaluating, or approval
of medication orders or any other activities not permitted by state or federal
laws, rules, and regulations. Remote order entry may include clarifying orders
and other data entry, including the processing of insurance coverage. The
requirements of this rule shall be limited to the entry of orders dispensed in
or into this state. (3) "Remote
pharmacy" means either: (a) A pharmacy licensed as a terminal distributor of
dangerous drugs that dispenses dangerous drugs; or (b) A pharmacy licensed as a limited category II terminal
distributor of dangerous drugs which does not stock, own, or dispense any
dangerous drugs, and whose sole business consists of entry, review, and/or
verification of prescriber orders and consulting services under contract for
institutional pharmacies in this state. (4) "Remote
supervision" means that a pharmacist directs and controls the actions of
remote technicians through the use of technology that ensures a supervising
pharmacist can meet the requirements listed in this paragraph. A pharmacist
providing remote supervision shall: (a) Be readily available to answer questions of a remote
technician; and (b) Be fully responsible for the practice and accuracy of
the remote technician. (5) "Remote
technician" means any of the following: (a) If performing remote order entry in this state: an Ohio
registered certified pharmacy technician, registered pharmacy technician, or
pharmacy technician trainee, either employed or a contract employee of an
inpatient pharmacy or remote pharmacy, who either conducts order entry from a
remote site, which may include the technician's residence or other
location where the technician and the outpatient or remote pharmacy can ensure
the confidentiality and integrity of patient information, or on the premises of
a remote pharmacy or institutional pharmacy; or (b) If performing remote
order entry outside of this state: a pharmacy technician who meets the
following criteria: (i) The pharmacy technician licensed or registered in the
state where the remote order entry is occurring, or if working in a state that
has not yet implemented a technician registration process, has received
training and is working as a pharmacy technician in accordance with of the laws
and regulations of their state of practice; and (ii) The pharmacy technician is either employed or a
contract employee of an institutional pharmacy or remote pharmacy who holds a
nonresident pharmacy license in accordance with Chapter 4729:5-8 of the
Administrative Code, who either conducts order entry from a remote site, which
may include the technician's residence or other location where the
technician and the outpatient or remote pharmacy can ensure the confidentiality
and integrity of patient information, or on the premises of a remote pharmacy
or institutional pharmacy. (c) A nonresident
pharmacy shall be responsible for ensuring all actions performed by an
unregistered technician comply with the applicable requirements for conducting
remote order entry. (d) A remote technician shall only be permitted to conduct
remote order entry within the United States, to include the District of
Columbia, the Commonwealth of Puerto Rico or a territory or insular possession
subject to the jurisdiction of the United States. (B) An institutional pharmacy may
outsource order entry to a remote pharmacy provided the pharmacies are under
common ownership or control or the institutional pharmacy has entered into a
written contract or agreement with a pharmacy that outlines the services to be
provided and the responsibilities and accountabilities of each party to the
contract or agreement in compliance with federal and state statutes and
regulations. (C) The inpatient pharmacy and remote
pharmacy must maintain a copy of the contract or agreement in a readily
retrievable manner for inspection and review by an agent, inspector, or
employee of the board. (D) An inpatient pharmacy utilizing
remote order entry shall ensure that all remote technicians providing such
services have been trained on the inpatient pharmacy's policies and
procedures relating to order entry. (1) The training of each
remote technician shall be documented. The inpatient pharmacy and the remote
pharmacy shall jointly develop a procedure to communicate changes in policies
and procedures related to order entry. (2) A terminal
distributor of dangerous drugs may utilize one training program for all
inpatient pharmacies under the terminal distributor's common ownership and
control. (E) An inpatient pharmacy utilizing
remote technicians shall maintain or have access to a record of the name and
address of each technician, evidence of current licensure or registration, and
the address of each location where the technician will be providing remote
order entry services. (F) The inpatient pharmacy shall ensure
that any remote technician shall have secure electronic access to the inpatient
pharmacy's patient information system and to other electronic systems that
an on-site technician has access to when the pharmacy is open. (G) Each remote entry record must comply
with all recordkeeping requirements for inpatient pharmacies, including
capturing the positive identification of the remote technician involved in the
entry of the medication order. (H) An inpatient pharmacy utilizing
remote order entry is responsible for maintaining records of all orders entered
into their information system, including orders entered by a remote
technician. (I) An inpatient pharmacy utilizing
remote order entry services shall develop and implement a policy and procedure
manual. A remote pharmacy shall maintain a copy of those portions of the policy
and procedure manual that relate to the remote pharmacy's operations. Each
manual shall include all the following: (1) An overview of the
responsibilities of the inpatient pharmacy and the remote
pharmacy; (2) A list of the names,
addresses, telephone numbers, and all license numbers of the pharmacies and
remote technicians involved in remote order entry; and (3) Policies and
procedures for: (a) Protecting the confidentiality and integrity of patient
information; (b) Ensuring that no patient information is duplicated,
downloaded, or removed from the inpatient pharmacy's patient information
system; (c) Maintaining appropriate records of each technician
involved in order entry; (d) Complying with federal and state statutes and
regulations; and (e) Reviewing written policies and procedures at least
every three years or upon the implementation of a significant change of written
policies and procedures and documentation of the review. (J) A pharmacy intern that is licensed in
this or any other state may engage in remote order entry pursuant to the
requirements of this rule.
Last updated November 30, 2021 at 8:29 AM
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Rule 4729:5-9-03 | Institutional facilities.
Effective:
February 1, 2022
An institutional facility as defined in rule
4729:5-9-01 of the Administrative Code shall comply with all requirements of
this rule, including all supplemental rules adopted thereunder.
Last updated February 1, 2022 at 9:26 AM
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Rule 4729:5-9-03.1 | Contingency drugs in an institutional facility and emergency access to an institutional pharmacy.
Effective:
February 1, 2022
In the absence of an available on-site pharmacy,
drugs prescribed for patient treatment in an institutional facility may be
obtained in the following manner: (A) Contingency drugs, as defined in rule 4729:5-9-01 of the
Administrative Code, may be made available to licensed health care
professionals authorized pursuant to the Revised Code to administer drugs
during the professional's practice. (B) An institutional facility maintaining contingency drugs shall
hold a license, which may include a campus license, as a terminal distributor
of dangerous drugs. (C) An institutional pharmacy may serve as the license holder for
an institutional facility, if all the following apply: (1) The institutional pharmacy maintains a
terminal distributor of dangerous drugs license on behalf of the institutional
facility. (2) The institutional pharmacy and institutional
facility maintain an executed contract or agreement outlining the services to
be provided and the responsibilities of each party in fulfilling the terms of
the contract or agreement in compliance with federal and state law, rules, and
regulations. The executed contract or agreement shall be maintained in a
readily retrievable manner. (D) An institutional facility with an on-site pharmacy, including
institutional facilities under a campus license, shall develop and implement a
policy whereby a licensed pharmacist shall be made available for emergencies
when the institutional pharmacy is closed. The pharmacist may be made available
via telephone or other form of electronic communication. (E) Contingency drugs shall be stored in accordance with the
security requirements of rule 4729:5-9-03.2 of the Administrative
Code. (F) The entity holding the terminal distributor of dangerous
drugs license for an institutional facility's contingency stock
shall: (1) Designate personnel who are authorized to
access to the contingency drug supply; (2) Determine, in conjunction with the
appropriate interdisciplinary committees, the drugs that are to be included in
the contingency drug supply; (3) Ensure that such drugs are properly labeled
and packaged in amounts sufficient for the immediate treatment of
patients; (4) Ensure the security and control of the
contingency drugs in accordance with the requirements set forth in paragraph
(E) of this rule; (5) Institute record keeping procedures to comply
with the requirements set forth in rule 4729:5-9-03.3 of the Administrative
Code; (6) Develop and implement procedures for the
inspection of the contingency drug inventory to ensure proper utilization and
replacement of the drug supply; and (7) Comply with all applicable requirements for
dangerous drugs in accordance Chapter 4729:5-9 of the Administrative Code and
all other requirements for holding a terminal distributor of dangerous drugs
license in accordance with agency 4729 of the Administrative Code. (G) An institutional facility may maintain an emergency kit
(e-kit) containing controlled substances provided by a licensed pharmacy to
withdraw medication to treat the immediate needs of a patient until
patient-specific controlled substance medication is physically delivered to the
facility by the pharmacy. If a multi-dose medication is removed from the
emergency kit, it shall be labeled to include the patient's
name. (1) The pharmacy providing the emergency kit must
receive a valid outpatient prescription issued in accordance with rule
4729:5-5-15 of the Administrative Code prior to the administration of
medication removed from the kit. (2) The pharmacy providing the emergency kit
shall be responsible for generating and maintaining a record of the dispensing
of the medication obtained from the kit in compliance with the record keeping
requirements set forth in rule 4729:5-9-02.3 of the Administrative
Code. (3) The institutional facility and institutional
pharmacy shall comply with all other state and federal requirements for
controlled substances maintained in emergency kits (e-kit). (H) If a dangerous drug is not available from the contingency
drug stock and such drug is required to treat the immediate needs of a patient
whose health would otherwise be jeopardized, the drug may be obtained from an
on-site institutional pharmacy pursuant to written policies and procedures
adopted by the terminal distributor of dangerous drugs. The policies and
procedures shall: (1) Identify the personnel authorized to access
the pharmacy and the conditions under which access may be gained to the
pharmacy. (2) Ensure a minimum of two employees of the
institutional facility, one of whom shall be a prescriber or nurse licensed
pursuant to Chapter 4723. of the Revised Code, to accompany and witness the
activity of each other when accessing the pharmacy. (3) Provide a written or electronic record
documenting emergency access to the pharmacy. Such record shall include the
names, titles, and positive identification of all institutional personnel
accessing the pharmacy, date and time of access, the name and quantity of drugs
obtained, the name of the patient, and the name of the ordering prescriber.
Such records shall be maintained for three years and made readily
retrievable. (4) The written or electronic record of each
access to the institutional pharmacy made in accordance with paragraph (H)(3)
of this rule shall be filed no later than the next business day with the
institutional facility's responsible person or the responsible
person's designee and maintained by the institutional pharmacy for three
years. (I) An institutional pharmacy may be accessed in the event of a
fire, flood, natural disaster, or other exigent circumstance pursuant to
written policies and procedures adopted by the terminal distributor of
dangerous drugs. The policies and procedures shall: (1) Identify the personnel authorized to access
the pharmacy and the conditions under which access may be gained to the
pharmacy. (2) Ensure a minimum of two employees of the
institutional facility, one of whom shall be a prescriber or nurse licensed
pursuant to Chapter 4723. of the Revised Code, to accompany and witness the
activity of each other when accessing the pharmacy. (3) Provide a written or electronic record
documenting emergency access to the pharmacy. Such record shall include the
names, titles, and positive identification of all institutional personnel
accessing the pharmacy, and the date and time of access. If dangerous drugs are
removed from the pharmacy, the name and quantity of drugs removed, the name of
the patient (if applicable), and the name of the ordering prescriber (if
applicable). Such records shall be maintained for three years and made readily
retrievable. (4) The written or electronic record of each
access to the institutional pharmacy made in accordance with paragraph (I)(3)
of this rule shall be filed no later than the next business day with the
institutional facility's responsible person or the responsible
person's designee and maintained by the institutional pharmacy for three
years.
Last updated February 1, 2022 at 9:26 AM
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Rule 4729:5-9-03.2 | Security, storage and control of dangerous drugs in an institutional facility.
Effective:
January 23, 2023
(A) As used in this rule, "blind
count" means a physical inventory taken by a person authorized by the
institutional facility's responsible person who performs a physical
inventory without knowledge of or access to the quantities currently shown on
electronic or other inventory systems. (B) Except as provided in this rule, all
non-controlled dangerous drugs, including those dispensed by an institutional
pharmacy to inpatients, shall be stored in a secure area to deter and detect
unauthorized access. (C) Non-controlled dangerous drug
emergency or contingency kits may be secured using a tamper-evident method.
Drugs stored using a tamper-evident method shall be routinely inspected to
detect unauthorized access in accordance with a policy developed by the
facility. The policy shall be made readily retrievable. (D) All controlled substance dangerous
drugs, including those dispensed by an institutional pharmacy to inpatients,
maintained in areas outside of the institutional pharmacy that are not stored
as part of an automated drug storage system, shall meet the following
requirements, unless stored as part of an automated drug storage system that
meets the requirements of paragraph (E) of this rule: (1) The drugs shall be a
securely locked in a substantially constructed cabinet or safe to deter and
detect unauthorized access. (2) At every change of
shift, a reconciliation shall be conducted by both the departing and incoming
licensed health care professional responsible for the security and control of
the drugs in the area in which they are stored and shall include the
following: (a) A physical count and reconciliation of the controlled
substances and proof-of-use sheets or electronic records to ensure the
accountability of all doses; (b) An inspection of the packaging to ensure its
integrity; (c) The positive identification of the persons conducting the
reconciliation; and (d) The immediate reporting of any unresolved discrepancy to the
appropriate personnel within the institution, including the responsible person
or the responsible person's designee. (e) Paragraph (D)(2)(a) of this rule does not apply to emergency
or contingency drug kits secured using a tamper-evident method. (3) All controlled
substances shall be packaged in tamper-evident containers, except multi-dose
liquids and injectables where unit-of-use packaging is not
available. (4) Maintain a record
keeping system for each drug in accordance with rule 4729:5-9-03.3 of the
Administrative Code. (E) All controlled substance dangerous
drugs, including those dispensed by an institutional pharmacy to inpatients,
maintained in areas outside of the institutional pharmacy that are stored in an
automated drug storage system shall meet the following
requirements: (1) All controlled
substances stored in automated drug storage systems shall be limited to one
drug and strength at a time. (2) For automated drug
storage systems that cannot limit access to one dose at a time, authorized
personnel shall conduct a blind count each time a controlled substance is
removed from the system. (3) The automated drug
storage system shall be securely locked and substantially constructed to deter
and detect unauthorized access. (4) The system shall
document the positive identification of every person accessing the system and
shall record the date and time of access. (5) The institutional
facility shall maintain a recordkeeping system in accordance with rule
4729:5-9-03.3 of the Administrative Code. (6) At least annually,
the responsible person shall cause a reconciliation of all controlled
substances within an automated drug storage system to be conducted. The
reconciliation shall include the following: (a) A physical count and reconciliation of the controlled
substances to ensure the accountability of all doses; (b) An inspection of the packaging to ensure its
integrity; (c) The positive identification of the persons conducting the
reconciliation; and (d) The immediate reporting of any unresolved discrepancy to the
appropriate personnel within the institution, including the responsible person
or the responsible person's designee. (F) Access to controlled substances shall
be restricted to health care professionals authorized pursuant to the Revised
Code to administer controlled substances as part of the professional's
scope of practice. (G) All areas where dangerous drugs are stored shall be dry,
well-lit, well-ventilated, and maintained in a clean and orderly condition.
Storage areas shall be maintained at temperatures and conditions which will
ensure the integrity of the drugs prior to use as stipulated by the USP/NF
and/or the manufacturer's or distributor's labeling. Refrigerators
and freezers used for the storage of drugs shall comply with the
following: (1) Maintain either of
the following to ensure proper refrigeration and/or freezer temperatures are
maintained: (a) Temperature logs with, at a minimum, daily observations;
or (b) A temperature monitoring system capable of detecting and
alerting staff of a temperature excursion. (2) The terminal
distributor shall develop and implement policies and procedures to respond to
any out of range individual temperature readings or excursions to ensure the
integrity of stored drugs. (3) The terminal
distributor shall develop and implement a policy that no food or beverage
products are permitted to be stored in refrigerators or freezers used to store
drugs. (H) In accordance with section 3719.172 of the Revised Code, an
institutional facility shall develop and implement policies to prevent
hypodermics from theft or acquisition by any unauthorized person. (I) Adulterated drugs, including expired drugs, shall be stored
in accordance with rule 4729:5-3-06 of the Administrative Code. (J) Disposal of non-controlled dangerous drugs shall be conducted
in accordance with rule 4729:5-3-06 of the Administrative Code. (K) Disposal of controlled substance dangerous drugs shall be
conducted in accordance with rule 4729:5-3-01 of the Administrative
Code. (L) Upon the initial puncture of a multiple-dose vial containing
a drug, the vial shall be labeled with a beyond-use date or date opened. The
beyond-use date for an opened or entered (e.g., needle punctured) multiple-dose
container with antimicrobial preservatives is twenty-eight days, unless
otherwise specified by the manufacturer. A multiple-dose vial that exceeds its
beyond-use date shall be deemed adulterated. (M) Uncompleted prescription blanks shall be secured when not in
use and access shall be limited to personnel authorized in policy by the
institutional facility. (N) Personnel authorized by the responsible person may have
access to D.E.A. controlled substance order forms only under the personal
supervision of a prescriber. D.E.A. controlled substance order forms shall be
secured when not in use.
Last updated January 23, 2023 at 8:54 AM
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Rule 4729:5-9-03.3 | Record keeping in an institutional facility.
Effective:
February 1, 2022
This rule applies to records for dangerous drugs,
including those dispensed by an institutional pharmacy to inpatients,
maintained in areas outside of the institutional pharmacy by an institutional
facility. (A) An institutional facility shall
maintain a record of all dangerous drugs administered to patients that includes
all the following information: (1) Name of the
patient; (2) Name, strength,
dosage form, route of administration, and quantity of the dangerous drugs
administered; (3) Date and time the
dangerous drugs were administered; (4) The positive
identification of the person removing the dangerous drug for patient
administration; (5) Positive
identification of the personnel administering the drug; and (6) For controlled
substance dangerous drugs: (a) If removed from a secured location, the positive
identification of the person removing the controlled substance for patient
administration; and (b) The disposal of an unused portion of a controlled
substance conducted in accordance with paragraph (J) of rule 4729:5-9-03.2 of
the Administrative Code. (B) Records of dangerous drugs personally
furnished at an institutional facility shall contain the name, strength, dosage
form, and quantity of the dangerous drugs personally furnished, the name,
address and date of birth of the person to whom or for whose use the dangerous
drug were personally furnished, the positive identification of the prescriber
personally furnishing the drug, the date the drug is personally furnished and,
if applicable, the date the drug is received by the patient or patient's
caregiver. (C) Records of receipt shall contain the
name, strength, dosage form, and quantity of the dangerous drugs received, the
name and address of the seller, the name and address of the recipient, and the
date of receipt. (D) Records of transfers to other
terminal distributors of dangerous drugs, including sales conducted in
accordance with rule 4729:5-3-09 of the Administrative Code, shall contain the
name, strength, dosage form, and quantity of the dangerous drug transferred,
the address of the location where the drugs were transferred and the date of
transfer. (E) Records of temperature control
monitoring described in paragraph (F) of rule 4729:5-9-03.2 of the
Administrative Code shall include any of the following: (1) For temperature logs,
either: (a) The date and time of observation, the full name or the
initials of the individual performing the check, and the temperature recorded;
or (b) For systems that provide automated temperature
monitoring, maintain a report that provides, at a minimum, the date and time of
observation and the temperature recorded. (2) For temperature
monitoring systems capable of detecting and alerting staff of a temperature
excursion, maintain reports that provide information on any temperature
excursion that includes the date, time, temperature recorded, and length of
each excursion. (F) Records of dangerous drugs disposed
from inventory, other than controlled substances, shall contain the name,
strength, dosage form, and quantity of the dangerous drug disposed, the date of
disposal, the method of disposal, the positive identification of the licensed
health care professional that performed the disposal. (G) Records of dangerous drugs
administered by a health care professional, acting within the
professional's scope of practice, who is not a prescriber shall include
documentation of an order issued by a prescriber or protocol authorizing the
administration of the drug. An order that is a permanent part of the
patient's medical record shall be deemed to meet the requirements of this
paragraph. Orders for the administration of dangerous drugs shall be documented
using positive identification. All orders for drugs for inpatients shall
include the following: (1) Name of
patient; (2) Name, strength, and
dosage form of drug; (3) Directions for use,
including route of administration; (4) Date prescribed;
and (5) The ordering
prescriber's positive identification. (H) Records of controlled substance drug
disposal shall comply with the requirements of rule 4729:5-3-01 of the
Administrative Code. (1) If the disposal of
controlled substance drug inventory is performed on-site, records shall also
include the positive identification of two licensed healthcare professionals
conducting and witnessing the disposal, one of whom shall be the responsible
person or the responsible person's designee. (2) If conducting the
disposal of an unused portion of a controlled substance resulting from
administration to a patient, records shall also include the positive
identification of two licensed healthcare professionals conducting and
witnessing the disposal. (I) Controlled substance inventory
records shall be maintained in accordance with rule 4729:5-3-07 of the
Administrative Code. (J) All records required in accordance
with this chapter shall be maintained under appropriate supervision and control
to restrict unauthorized access. (K) All records maintained in accordance
with this rule shall be readily retrievable and shall be kept on-site for a
period of three years. (1) A terminal
distributor intending to maintain records at a location other than the location
licensed by the state board of pharmacy must notify the board in a manner
determined by the board. (2) Any such alternate
location shall be secured and accessible only to authorized representatives or
contractors of the terminal distributor of dangerous drugs. (L) All records maintained pursuant to
this rule may be electronically created and maintained, provided that the
system that creates and maintains the electronic record does so in accordance
with the following: (1) Complies with the
requirements of this rule; (2) All paper records
shall be scanned in full color via technology designed to capture information
in one form and reproduce it in an electronic medium presentable and usable to
an end user; (3) Contains security
features, such as unique user names and passwords, to prevent unauthorized
access; and (4) Contains daily
back-up functionality to protect against record loss.
Last updated February 1, 2022 at 9:27 AM
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Rule 4729:5-9-03.4 | Automated drug storage systems in an institutional facility.
Effective:
February 1, 2022
All automated drug storage systems utilized by an
institutional facility shall comply with the following: (A) Except as provided in paragraph (B)
of this rule, the computer program used to access all drugs within the
automated drug storage system shall have an electronic timeout of sixty seconds
of inactivity. (B) For an automated drug storage system
used exclusively for administering anesthesia drugs that is under the immediate
supervision of a licensed healthcare provider authorized to administer such
drugs, the computer program used to access all drugs within the automated drug
storage system shall have an electronic timeout of no more than sixty minutes
of inactivity, unless an alternative method to ensure the security of the drug
stock is approved by the board. (C) The institutional facility shall
develop and implement policies and procedures for all automated drug storage
systems that include the following: (1) Provide for a written
or electronic record documenting access to the automated drug storage system.
Such record shall include the names, titles, and positive identification of all
personnel accessing medications, date and time of access, the name and quantity
of drugs obtained, and the name of the patient. All records shall be maintained
in accordance with paragraphs (K) and (L) of rule 4729:5-9-03.3 of the
Administrative Code. (2) Provide security
controls to prevent diversion of the drugs. (3) Develop policies and
procedures to track access to emergency override access keys. (4) Provide procedures
for the inspection of the systems to ensure proper utilization and replacement
of the drug supply. (5) If override
medications are utilized, the institutional facility shall develop and
implement a policy that describes the types of medication overrides that will
be reviewed for appropriateness and the frequency of the reviews. (6) All policies and
procedures required in accordance with this paragraph shall be maintained in a
readily retrievable manner.
Last updated February 1, 2022 at 9:28 AM
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Rule 4729:5-9-03.5 | Hospital self-service employee prescription kiosks.
Effective:
February 1, 2022
(A) As used in this rule: (1) "Hazardous
drug" means any drug listed in table one on the national institute for
occupational safety and health's list of antineoplastic and other
hazardous drugs in healthcare settings as referenced in rule 4729:7-1-01 of the
Administrative Code. (2) "Hospital"
means a public hospital or hospital as defined in section 3701.01 or 5122.01 of
the Revised Code. (3) "Self-service
employee prescription kiosk" or "kiosk" means a self-service
kiosk for the pickup of new or refill prescriptions only for hospital employees
and their family members. (B) A self-service employee prescription
kiosk shall meet all the security requirements of this rule and be located
either: (1) On the campus of a
hospital licensed as a terminal distributor of dangerous drugs and located in
the immediate proximity of a pharmacy, unless otherwise approved by an agent of
the board; or (2) At a location that is
licensed as a terminal distributor of dangerous drugs that not located on the
campus of a hospital but is owned by the hospital. (C) Only a dangerous drug prescription
dispensed by a hospital-owned pharmacy may be provided to the patient or
employee representative of the patient via a self-service kiosk. A kiosk shall
not provide any of the following: (1) Any drug that must be
refrigerated; or (2) Any hazardous drug,
except for conventionally manufactured hazardous drugs that are tablets or
capsules that do not require any further manipulation other than counting or
repackaging. (D) A kiosk located in accordance with
paragraph (B)(2) of this rule shall be placed in an area that is restricted to
hospital employees and is secured by both a physical barrier with suitable
locks and an electronic barrier to detect unauthorized entry. (E) All kiosks shall be continuously
monitored by one or more video cameras that possess the capability of having
its picture recorded. The video camera(s) shall provide one hundred percent
video coverage of the kiosk. Camera recordings shall be maintained for at least
ninety days and shall made available within three business days of a request by
an agent of the state board of pharmacy. The kiosk location must have adequate
lighting to produce clear digitally recorded and still picture
production. (F) A kiosk shall only be stocked by a
hospital employed pharmacist, pharmacy intern, certified pharmacy technician,
registered pharmacy technician or pharmacy technician trainee. (G) A dispensing pharmacy described in
paragraph (C) of this rule shall maintain an appropriate recordkeeping system
that will provide accountability for proper receipt of all prescriptions
provided to a patient or employee representative of the patient via a
self-service kiosk. (H) A kiosk shall employ a method of
two-factor authentication to identify a patient or employee representative of
the patient such that a finished prescription is delivered from a kiosk only to
its intended recipient. (I) A kiosk must prominently display
notification that patient counseling is available pursuant to rule 4729:5-5-09
of the Administrative Code. Counseling may be provided by a pharmacist
reachable at a toll-free telephone number who has access to the patient
profile. Instructions on how to contact a pharmacist via toll-free telephone
must be displayed by the kiosk and must also be printed on the customer receipt
or included with the patient instructions. (J) A self-service employee prescription
kiosk shall meet all the following: (1) Is electronically
protected against unauthorized access; (2) Be bolted to the
floor or installed in a wall; (3) Be constructed in
such manner as to prevent tampering, break-in and theft of inventory;
and (4) Is able to
either: (a) Sound an alarm if a break-in is attempted;
or (b) Transmit a notification to on-site security if a
break-in is attempted. (K) Prior to the deployment of a kiosk,
the responsible person at the location licensed as a terminal distributor of
dangerous drugs shall test the kiosk to ensure that it releases drugs properly.
The responsible person shall monitor performance of the kiosk on an ongoing
basis and test the kiosk for accuracy whenever any change or upgrade is
made. (L) All drugs and devices in a kiosk
shall be maintained in a clean and orderly condition. Kiosks shall be
maintained at temperatures which will ensure the integrity of the drugs as
stipulated by the USP/NF and/or the manufacturer's or distributor's
labeling. (M) Dangerous drugs stored in a kiosk
that are not picked up by a patient may be returned to stock shelves in
accordance with rule 4729:5-3-16 of the Administrative Code. (N) Prior to the operation of a kiosk,
the board shall receive a request for approval from the responsible person on
the terminal distributor of dangerous drugs license. Upon notification, the
board shall conduct an inspection of the area where the kiosk shall be located
and review system specifications to determine if it meets the requirements of
this rule. (O) If an inspection does not result in
the approval of a kiosk, the responsible person named on the terminal
distributor of dangerous drugs license may request an in-person meeting with
the board to appeal the denial.
Last updated February 1, 2022 at 9:28 AM
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Rule 4729:5-9-03.6 | Point of care locations in an institutional facility.
Effective:
January 23, 2023
(A) "Point of care location"
has the same meaning as in rule 4729:5-9-01 of the Administrative
Code. (B) Dangerous drugs maintained at a point
of care location shall be in a securely locked, substantially constructed
cabinet, including an automated drug storage system, or safe to deter and
detect unauthorized access. (C) The responsible person for the point
of care location shall be an employee of the institutional pharmacy that owns
the drug stock and shall be responsible for all the following: (1) Designating those who
may obtain access to the drug stock; (2) Determining, in
conjunction with the appropriate interdisciplinary committees, the drugs that
are to be included at the point of care location; (3) Providing controls to
prevent the diversion of the drug stock; (4) Instituting record
keeping procedures to account for drugs removed from the point of care location
and for capturing the positive identification of the person who obtained the
drugs from the point of care location; and (5) Providing procedures for the
inspection of the point of care location to ensure proper utilization and
replacement of the drug stock. (D) If dangerous drugs that are
controlled substances are stored at the point of care location, the owner of
the drug stock shall either: (1) Obtain a drug
enforcement administration (DEA) registration for the point of care location;
or (2) Utilize the DEA
registration of the institutional facility where the point of care location is
located. The institutional facility where the point of care location is located
shall be responsible for compliance with all federal and state laws, rules, and
regulations relating to the possession and use of controlled
substances. (E) This rule does not apply to
pharmacy-supplied contingency drugs in an institutional facility licensed as a
terminal distributor of dangerous drugs. (F) An institutional point of care
location shall comply with the requirements of rules 4729:5-9-03.2 and
4729:5-9-03.3 of the Administrative Code.
Last updated January 23, 2023 at 8:55 AM
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