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This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and universities.

Chapter 4729:5-9 | Institutional Facilities

 
 
 
Rule
Rule 4729:5-9-01 | Definitions.
 

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

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 3719.01, 4729.01
Five Year Review Date: 2/1/2027
Prior Effective Dates: 9/1/1985, 3/13/1995, 4/28/2016
Rule 4729:5-9-02 | Institutional pharmacies.
 

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

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.55
Five Year Review Date: 2/1/2027
Rule 4729:5-9-02.1 | Minimum standards for institutional pharmacies.
 

(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

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.55
Five Year Review Date: 2/1/2027
Rule 4729:5-9-02.2 | Security, storage and control of dangerous drugs in an institutional pharmacy.
 

(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 pharmacys 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

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 3719.09, 4729.28, 4729.51
Five Year Review Date: 2/1/2027
Prior Effective Dates: 9/10/1976
Rule 4729:5-9-02.3 | Record keeping at an institutional pharmacy.
 

(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 drugs 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

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 3719.09, 4729.28, 4729.51
Five Year Review Date: 2/1/2027
Prior Effective Dates: 3/1/1999
Rule 4729:5-9-02.4 | Dispensing of controlled substances by an institutional pharmacy.
 

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

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 4729.54
Five Year Review Date: 2/1/2027
Rule 4729:5-9-02.5 | Patient profiles.
 

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

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.54
Five Year Review Date: 2/1/2027
Rule 4729:5-9-02.6 | Pharmacist drug utilization review.
 

(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

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.26
Five Year Review Date: 2/1/2027
Rule 4729:5-9-02.7 | Medication orders for inpatients and outpatient prescriptions.
 

(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

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.54
Five Year Review Date: 2/1/2027
Rule 4729:5-9-02.8 | Labeling of prescriptions for patients.
 

(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

Supplemental Information

Authorized By: 3715.69, 3719.28, 4729.26
Amplifies: 3715.64, 3719.08
Five Year Review Date: 2/1/2027
Prior Effective Dates: 9/1/2016
Rule 4729:5-9-02.9 | Licensure of outpatient institutional pharmacies.
 

(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

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 3719.01, 4729.01
Five Year Review Date: 2/1/2027
Rule 4729:5-9-02.10 | Temporary absence of a pharmacist in an institutional pharmacy.
 

(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

Supplemental Information

Authorized By: 3719.28. 4729.26
Amplifies: 4729.28, 4729.51
Five Year Review Date: 2/1/2027
Prior Effective Dates: 9/15/2017
Rule 4729:5-9-02.11 | Dispensing customized patient medication packages by an institutional pharmacy.
 

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

Supplemental Information

Authorized By: 3715.69, 3719.28, 4729.26
Amplifies: 3715.64, 3719.08
Five Year Review Date: 2/1/2027
Prior Effective Dates: 1/1/2010
Rule 4729:5-9-02.12 | Drugs repackaged or relabeled by an institutional pharmacy.
 

(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

Supplemental Information

Authorized By: 3715.69, 3719.28, 4729.26
Amplifies: 3715.64, 3719.08
Five Year Review Date: 2/1/2027
Prior Effective Dates: 1/1/2010
Rule 4729:5-9-02.13 | Institutional central fill pharmacies.
 

(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

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 4729.54, 4729.55
Five Year Review Date: 2/1/2027
Rule 4729:5-9-02.14 | Remote medication order processing.
 

(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 pharmacists 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 pharmacys 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

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.26, 3719.28
Five Year Review Date: 11/30/2026
Rule 4729:5-9-02.15 | Remote order entry - technicians.
 

(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

Supplemental Information

Authorized By: 4729.94, 4729.26
Amplifies: 4729.90, 4729.96, 4729.95, 4729.94, 4729.93, 4729.921, 4729.92, 4729.91, 4729.901
Five Year Review Date: 11/30/2026
Rule 4729:5-9-03 | Institutional facilities.
 

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

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.55
Five Year Review Date: 2/1/2027
Rule 4729:5-9-03.1 | Contingency drugs in an institutional facility and emergency access to an institutional pharmacy.
 

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 facilitys 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

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 4729.28, 4729.51
Five Year Review Date: 2/1/2027
Rule 4729:5-9-03.2 | Security, storage and control of dangerous drugs in an institutional facility.
 

(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

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 3719.09, 4729.28, 4729.51
Five Year Review Date: 2/1/2027
Prior Effective Dates: 9/1/1985, 1/10/1996
Rule 4729:5-9-03.3 | Record keeping in an institutional facility.
 

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 patients 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

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 3719.09, 4729.28, 4729.51
Five Year Review Date: 2/1/2027
Prior Effective Dates: 7/1/1991
Rule 4729:5-9-03.4 | Automated drug storage systems in an institutional facility.
 

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

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 3719.09, 4729.51
Five Year Review Date: 2/1/2027
Rule 4729:5-9-03.5 | Hospital self-service employee prescription kiosks.
 

(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

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.54
Five Year Review Date: 2/1/2027
Rule 4729:5-9-03.6 | Point of care locations in an institutional facility.
 

(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

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 3719.09, 4729.28, 4729.51
Five Year Review Date: 2/1/2027