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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 | Pharmacists-Administrative Provisions

 
 
 
Rule
Rule 4729-5-01 | Definitions.
 

As used in Chapter 4729. of the Revised Code:

(A) "Practice of pharmacy" is as defined in division (B) of section 4729.01 of the Revised Code.

(B) The term "dispense" means the final association of a drug with a particular patient pursuant to the prescription, drug 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 delivery system meeting the requirements of rule 4729-5-35 of the Administrative Code, the final association with the name of a particular patient will be deemed to have occurred when the pharmacist has given final approval to the patient specific prescription in the system.

(C) The term "compounding" has the same meaning as defined in division (C) of section 4729.01 of the Revised Code.

(D) "Interpret prescriptions" means the professional judgment of a pharmacist when reviewing a prescription order of a prescriber for a patient.

(E) "To participate in drug selection" means selecting and dispensing a drug product pursuant to sections 4729.38 and 4729.381 of the Revised Code.

(F) "To participate with prescribers in reviews of drug utilization" means monitoring the appropriate use of drugs through communication with the prescriber(s) involved.

(G) "Pharmacist" means an individual who holds a current pharmacist identification card pursuant to section 4729.08 or 4729.09 of the Revised Code; or, pursuant to section 4729.12 of the Revised Code.

(H) "Original prescription" means the prescription issued by the prescriber in writing, an oral or electronically transmitted prescription recorded in writing by the pharmacist, a prescription transmitted by use of a facsimile machine, or a prescription transmitted by a board approved electronic prescription transmission system, each of which is pursuant to rule 4729-5-30 of the Administrative Code.

(I) "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 provide personal review and approval of all professional activities.

(J) "Preprinted order" is defined as a patient specific, definitive set of drug treatment directives to be administered to an individual patient who has been examined by a prescriber and for whom the prescriber has determined that the drug therapy is appropriate and safe when used pursuant to the conditions set forth in the preprinted order. Preprinted orders may be used only for inpatients in an institutional facility as defined in Chapter 4729-17 of the Administrative Code.

(K) "Standing order" will mean the same as the term "protocol".

(L) "Protocol" is defined as:

(1) A definitive set of written treatment guidelines that include definitive orders for drugs and their specified dosages which have been authorized by a prescriber and have been approved by the state board of pharmacy pursuant to section 4729.54 of the Revised Code. A protocol may be used only by licensed health care professionals when providing limited medical services to individuals in an emergency situation when the services of a prescriber are not immediately available; or

(2) A definitive set of written treatment guidelines that include definitive orders for drugs and their specified dosages which have been authorized by a prescriber and have been approved by the state board of pharmacy pursuant to section 4729.54 of the Revised Code. A protocol may be used only by licensed health care professionals when administering biologicals or vaccines to individuals for the purpose of preventing diseases; or

(3) A definitive set of written treatment guidelines that include definitive orders for drugs and their specified dosages which have been authorized by a prescriber and have been approved by the state board of pharmacy pursuant to section 4729.54 of the Revised Code. A protocol may be used only by licensed healthcare professionals when administering vitamin K for prevention of vitamin K deficient bleeding in newborns; or

(4) A definitive set of written treatment guidelines that include definitive orders for drugs and their specified dosages which have been authorized by a prescriber and have been approved by the state board of pharmacy pursuant to section 4729.54 of the Revised Code. A protocol may be used only by licensed healthcare professionals when administering erythromycin for prevention of ophthalmia neonatorum; or

(5) A definitive set of written treatment guidelines that include patient specific and dose specific orders for the administration of a specific drug that have been authorized by a prescriber to be used when the services of that prescriber are not immediately available. The state board of pharmacy must approve the treatment guidelines prior to implementation. To be considered for approval by the board, the treatment guidelines must meet the following requirements:

(a) The drugs shall only be administered by an individual authorized by law to administer the drugs that are listed in the treatment guidelines.

(b) A prescriber must complete an assessment and make a diagnosis prior to ordering a set of treatment guidelines.

(c) The treatment guidelines:

(i) Can only be initiated upon the order of a prescriber, and the prescriber, utilizing positive identification, must create an order in the patient record to acknowledge and document an adjustment made pursuant to the treatment guidelines before another dose or frequency adjustment can be made;

(ii) Shall only apply to adjusting the dose or frequency of the administration of a specific drug that has been previously ordered by a prescriber;

(iii) Apply only to those drugs that may require calculations for specific dose and frequency adjustments which shall be based on objective measures;

(iv) Apply only to those drugs for which the therapeutic dose is significantly lower than the dose expected to cause detrimental adverse effects;

(v) Do not apply to those drugs for which a dosage change selected within the usual normal dose range could cause detrimental adverse effects;

(vi) Can be performed without requiring the exercise of medical judgment;

(vii) Will lead to results that are reasonably predictable and safe;

(viii) Can be performed safely without repeated medical assessments;

(ix) If performed improperly, would not present a danger of immediate and serious harm to the patient.

A protocol may be used only by individuals authorized by law to administer the drugs and to perform the procedures included in the protocol.

Protocols submitted for approval by the state board of pharmacy may be reviewed with the appropriate health care related board prior to any approval by the state board of pharmacy.

(M) "Prescriber" means any of the following:

(1) A person authorized by the revised code to prescribe dangerous drugs as part of their professional practice; or

(2) A pharmacist authorized to manage drug therapy pursuant to a consult agreement but only if specifically authorized in the agreement and to the extent specified in the agreement.

(N) "Positive identification" means a method of identifying an individual who prescribes, administers, or dispenses a dangerous drug.

(1) A method may not rely solely on the use of a private personal identifier such as a password, but must also include a secure means of identification such as 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 prescribed, administered, or dispensed the dangerous drug. The printout must be maintained for three years and made available on request to those individuals authorized by law to review such records; 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, such as a password, for entry into a secure mechanical or electronic system.

(O) "Originating pharmacy", as it relates to central fill pharmacies, means the pharmacy that received the original prescription.

(P) "Personally furnish" means the distribution of drugs by a prescriber to the prescriber's patients for use outside the prescriber's practice setting.

(Q) "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.

(R) "Reported drugs" means all the drugs listed in rule 4729-37-02 of the Administrative Code that are required to be reported to the drug database established and maintained pursuant to section 4729.75 of the Revised Code.

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.01, 4729.27, 4729.28, 4729.54
Five Year Review Date: 5/22/2019
Prior Effective Dates: 9/10/1976, 7/1/1993
Rule 4729-5-07 | Recognized and approved schools of pharmacy.
 

(A) Pursuant to section 4729.08 of the Revised Code, the state board of pharmacy recognizes and approves all pharmacy programs or schools of pharmacy that have candidate or accreditation status with accreditation council for pharmacy education (A.C.P.E.). The board, by resolution, reserves the right to:

(1) Deny the recognition or approval of a pharmacy program or school of pharmacy that meets A.C.P.E. candidate or accreditation status; or

(2) Recognize or approve a pharmacy program or school of pharmacy that does not meet A.C.P.E. candidate or accreditation status.

(B) For the purpose of satisfying the requirements of division (C) of section 4729.08 of the Revised Code, graduates of a school of pharmacy located outside the United States shall establish educational equivalency by obtaining a "Foreign Pharmacy Graduate Examination Commission (FPGEC)" certificate, and by establishing proficiency in spoken English by obtaining the minimum scores required by rule 4729-5-34 of the Administrative Code on the "Test of English as a Foreign Language, Internet-based test (TOEFL iBT)."

(C) The term "United States," as used in paragraph (B) of this rule, shall be deemed to include all states of the United States, the District of Columbia, and all territories and any commonwealths.

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.08, 4729.11, 4729.12
Five Year Review Date: 2/1/2022
Prior Effective Dates: 9/10/1976, 9/1/1985, 10/27/2011
Rule 4729-5-09 | Prescription filing.
 

All original outpatient prescriptions shall be filed in the following manner:

(A) Prescriptions for schedule II controlled substances shall be maintained in a separate prescription file for schedule II prescriptions.

(B) Prescriptions for schedules III, IV, and V controlled substances shall be maintained in a separate prescription file for schedules III, IV, and V prescriptions.

(C) Prescriptions for noncontrolled substances shall be maintained in a separate prescription file for noncontrolled prescriptions.

Prescriptions containing multiple drug orders shall be filed in the most restrictive file. In this case, a mechanism must be in place to allow the immediate retrieval of all prescriptions.

If the prescription records are kept on microfilm, automated data processing retrievable electronic media, or in any form requiring special equipment to render the records easily readable, the registrant shall provide access to such equipment with the records. If any code system is used (other than pricing information), a key to the code shall be provided to make the records understandable.

Supplemental Information

Authorized By:
Amplifies:
Five Year Review Date:
Prior Effective Dates: 9/1/1989
Rule 4729-5-10 | Prescription pick-up station.
 

(A) No pharmacist shall accept prescriptions obtained from a place which offers, in any manner, its services as a "pick-up station" or intermediary for the purpose of having prescriptions filled unless such place is a pharmacy as defined in section 4729.01 of the Revised Code and all of the following apply:

(1) The site is licensed as a terminal distributor of dangerous drugs pursuant to Chapter 4729. of the Revised Code, unless exempted pursuant to section 4729.541 of the Revised Code;

(2) The receipt, storage, control, and distribution of prescriptions are in the full and actual charge of a pharmacist licensed pursuant to Chapter 4729. of the Revised Code;

(3) An appropriate recordkeeping system is in place that will provide accountability for proper receipt, delivery, disposal and return of all prescriptions;

(4) There is a documented method in place to ensure compliance with rule 4729-5-22 of the Administrative Code.

(B) No pharmacist shall dispense dangerous drugs to a place which offers, in any manner, its services as a "pick-up station" or intermediary for the purpose of having prescriptions filled or delivered unless such place is a pharmacy as defined in section 4729.01 of the Revised Code or, if not a pharmacy, all of the following apply:

(1) The site is licensed as a terminal distributor of dangerous drugs pursuant to Chapter 4729. of the Revised Code, unless exempted pursuant to section 4729.541 of the Revised Code or a waiver is granted by the board.

(2) There is clear and convincing evidence that delivery of a prescription medication directly to the patient would result in:

(a) Danger to public health or safety, or

(b) Danger to the patient without increased involvement by a health care professional in the patient's drug therapy.

(3) The receipt, storage, control, and distribution of prescriptions or drugs are in the full and actual charge of a health care professional licensed pursuant to Chapter 4715., 4723., 4729., 4730., 4731., or 4741. of the Revised Code.

(4) An appropriate recordkeeping system is in place that will provide accountability for proper receipt, delivery, disposal and return of all prescription medications. Unless donated to a drug repository program pursuant to section 3715.87 of the Revised Code, a dangerous drug that is not distributed to a patient shall either:

(a) Be returned to the dispensing pharmacy for disposal; or

(b) If the pick-up station is licensed a terminal distributor of dangerous drugs, be disposed of in accordance with rule 4729-9-17 or 4729-9-06 of the Administrative Code.

(5) There is a documented method in place to ensure compliance with rule 4729-5-22 of the Administrative Code.

(C) The state board of pharmacy may restrict a site from acting as a pick-up station if it has clear and convincing evidence that the activities of the pick-up station present the following:

(1) Danger to public health or safety; or

(2) Danger to the patient.

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.27, 4729.28
Five Year Review Date: 6/6/2019
Prior Effective Dates: 3/31/2000
Rule 4729-5-13 | Prescription format.
 

(A) Except as provided in paragraph (F) of this rule, no pharmacist shall dispense dangerous drugs pursuant to a written outpatient prescription unless the following conditions are met:

(1) The prescription is issued in compliance with rule 4729-5-30 of the Administrative Code.

(2) If handwritten or typewritten, there are no more than three noncontrolled substance prescription orders per prescription form.

(3) If preprinted with multiple drug names or strength combinations:

(a) There are no controlled substances among the choices;

(b) There is only one prescription order selected per form.

(B) Except as provided in paragraph (F) of this rule, no prescriber shall write and no pharmacist shall dispense controlled substances pursuant to a written outpatient prescription unless the following conditions are met:

(1) The prescription has been issued in compliance with rule 4729-5-30 of the Administrative Code.

(2) The prescription contains only one prescription order per prescription form, whether handwritten, typewritten, or preprinted.

(3) The quantity has been written both numerically and alphabetically.

(4) If preprinted, there is only one drug and strength combination printed on the form.

(C) A prescription for a controlled substance issued by a medical intern, resident, or fellow as defined in paragraph (B) of rule 4729-5-15 of the Administrative Code may not be dispensed unless the prescription is issued in compliance with this rule and rule 4729-17-13 of the Administrative Code and unless it bears the identification number issued by the employing hospital or institution pursuant to rule 4729-17-13 of the Administrative Code.

(D) A prescription for a controlled substance issued by a staff prescriber of a hospital may not be dispensed unless the prescription is issued in compliance with this rule and rule 4729-17-13 of the Administrative Code and unless it bears the identification number issued by the employing hospital or institution pursuant to rule 4729-17-13 of the Administrative Code.

(E) If a board approved electronic prescription transmission system is used to fax a prescription to a pharmacy, the faxed order is exempt from paragraphs (A) and (B) of this rule. The faxed order must comply with rule 4729-5-30 of the Administrative Code and must be filed in the most restrictive file according to rule 4729-5-09 of the Administrative Code.

(F) For purposes of preprinted prescription forms for hospice care program outpatients, the following conditions apply:

(1) Preprinted prescription forms may contain multiple orders on one form and the prescriber may select as many drug orders as necessary. Additional prescriptions may be manually added to this sheet.

(2) Preprinted forms may not contain prescription orders for schedule II drugs. Schedule II drugs may be manually added to the preprinted forms and signed by the prescriber.

(3) The prescriber shall indicate on each preprinted form the drug orders authorized on the form by either:

(a) Manually indicating the total drug orders authorized on the form; or

(b) Manually initialing each drug order.

(4) All written drug orders must be signed by the prescriber.

(5) All signed prescriptions may be faxed from the prescriber or the hospice location to the pharmacy.

(6) At the direction of the prescriber, verbal drug orders may be transmitted to the pharmacy by the prescriber's agent, including a hospice nurse, except for schedule II drug orders.

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 3719.06, 4729.37
Five Year Review Date: 9/1/2021
Prior Effective Dates: 9/10/1976, 2/1/2002
Rule 4729-5-14 | Return to Stock in a Pharmacy.
 

(A) As used in this rule, "pharmacy delivery agent" means an employee of the pharmacy, United States postal service or common or contract carrier who delivers dangerous drugs that have been dispensed.

(B) A pharmacy may return dangerous drugs to stock shelves that have been dispensed, but not picked up by or delivered to patients and have never left the prescription department of the pharmacy or the control of the pharmacy delivery agent, if the pharmacy complies with all of the following:

(1) The pharmacy has the capability to place the expiration date, as required by this rule, on the prescription label.

(2) The expiration date on the label shall not exceed the expiration date on the manufacturer's container or one year from the date the drug was originally dispensed and placed in the prescription vial, 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 one year from the date the drug was originally dispensed and placed in the prescription vial, whichever date is earlier. If the prescription container is the manufacturer's original sealed packaging, the expiration date is the expiration date listed on the packaging.

(3) The dangerous drug products returned to stock shelves shall be maintained in the container in which they were filled and shall maintain their original prescription label containing the original expiration date assigned. The label on the container shall not be removed, altered, or replaced with another label or have any other label added, except as follows:

(a) Adding to or modifying the existing label, if the drug name, dose and original expiration date are maintained.

(b) Adding a new label over the existing label on the container. In this instance, the drug shall be verified by a pharmacist or an electronic verification system following the application of the new label. The new label shall include the expiration date assigned on the original label.

(c) A prescription label may be removed if the prescription container is the manufacturer's original sealed packaging and the removal of the label does not remove or otherwise cause to make unreadable the expiration date and lot number on the manufacturer's packaging.

(4) The contents of a prescription vial or container shall not be returned to the manufacturer's stock bottle.

(5) When dispensing medication that was previously returned to stock to another patient, a new container shall be used, or in the case of unit dose or unit of use products, all previous patient information shall be removed.

(6) Drugs returned to stock shelves shall be stored in accordance with rule 4729-9-02 of the Administrative Code. The pharmacy shall develop and implement a policy to ensure that drugs are maintained by pharmacy delivery agents within temperatures as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling.

(7) In the case of recalls, any drugs returned to stock shelves containing the drug affected by the recall shall be removed from the shelves immediately, unless the lot number can be determined.

(8) A dangerous drug that leaves the prescription department of the pharmacy in the custody of a pharmacy delivery agent may only be returned to stock shelves if the drug meets either of the following prior to initially leaving the prescription department:

(a) Each dangerous drug prescription is dispensed in a tamper evident container or package prior to leaving the pharmacy; or

(b) The dangerous drug prescription is dispensed in the manufacturer's original tamper evident packaging.

(9) A dangerous drug prescription that is dispensed and shows any signs of tampering or adulteration shall not be returned to stock shelves.

(C) A dangerous drug that exceeds its assigned expiration date, as described in paragraph (B) of this rule, shall be removed from the area for the storage of drugs used for dispensing and administration in accordance with rule 4729-9-17 of the Administrative Code.

(D) This rule does not apply to drugs dispensed for inpatients pursuant to paragraph (C) of rule 4729-17-01 of the Administrative Code. Drugs dispensed for inpatients may be returned to stock in accordance with rule 4729-9-04 of the Administrative Code.

Supplemental Information

Authorized By: 3715.69, 3719.28, 4729.26
Amplifies: 3715.63, 3719.05
Five Year Review Date: 9/15/2022
Rule 4729-5-16 | Labeling of drugs dispensed on prescription.
 

(A) No drug may be dispensed on prescription unless a label is affixed to the container in which such drug is dispensed and such label includes:

(1) The name and address of the pharmacy as it appears on the terminal distributor of dangerous drugs license;

(2) The full name of the patient for whom the drug is prescribed; or, if the patient is an animal, the full name of the owner and identification of the animal;

(3) The full name of the prescriber;

(4) Directions for use of the drug;

(5) The date of dispensing;

(6) Any cautions which may be required by federal or state law;

(7) The serial number of the prescription;

(8) The proprietary name, if any, or the generic name and the name of the distributor of the drug dispensed; and the strength, if more than one strength of the drug is marketed. The dispensing pharmacist may omit the name and strength of the drug only if the prescriber specifically requests omission in writing in the case of a written prescription, or verbally in the case of an orally transmitted prescription;

(9) The quantity of drug dispensed;

(10) If the drug is compounded, the statement "Compounded Drug Product" or other similar statement shall also be displayed prominently on the label.

(B) The term "affix" means the prescription label must be attached or fastened to the container.

(C) At least the prescription number and the name of the patient must be placed on all prescription containers too small to bear a complete prescription label and dispensed in a container bearing a complete prescription label. The label bearing only the prescription number and the name of the patient does not need to be applied to any product whose function would be impaired by such a label. In all cases, a complete prescription label meeting the requirements of paragraph (A) of this rule must be applied to the container in which such product is dispensed.

(D) This rule does not apply to drugs which are dispensed for use by inpatients of an institutional facility whereby the drug is not in the possession of the ultimate user prior to administration. Such drugs shall be labeled in accordance with rule 4729-17-10 of the Administrative Code.

(E) Labels for a compounded drug products that are prepared in anticipation of a prescription drug order shall comply with the requirements in rule 4729-16-03 of the Administrative Code.

(F) The inclusion of the statement "Compounded Drug Product" or other similar statement as required by paragraph (A)(10) of this rule and paragraphs (L) and (O) of rule 4729-16-03 of the Administrative Code does not apply to non-sterile compounded drugs that are reconstituted in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling.

Supplemental Information

Authorized By: 3715.69, 3719.28, 4729.26
Amplifies: 3715.64, 3719.01, 3719.08, 4729.01, 4729.27, 4729.28, 4729.37, 4729.38
Five Year Review Date: 10/1/2021
Prior Effective Dates: 9/10/1976, 2/1/1998
Rule 4729-5-18 | Patient profiles.
 

All pharmacies shall maintain a patient profile system which shall provide for immediate retrieval of information regarding those patients who have received prescriptions from that pharmacy.

(A) The dispensing pharmacist shall be responsible for ensuring that a reasonable effort has been made to obtain, document, and maintain at least the following records:

(1) The patient's data record, which should consist of, but is not limited to, the following information:

(a) Full name of the patient for whom the drug is intended;

(b) Residential address and telephone number of the patient;

(c) Patient's date of birth;

(d) Patient's gender;

(e) A list of current patient specific data consisting of at least the following:

(i) Known drug related allergies,

(ii) Previous drug reactions,

(iii) History of or active chronic conditions or disease states,

(iv) Other drugs and nutritional supplements, including nonprescription drugs used on a routine basis, or devices;

(f) 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 at least the following information for all of the prescriptions that were filled at the pharmacy within the last twelve months showing:

(a) Name and strength of the drug or device;

(b) Prescription number;

(c) Quantity dispensed;

(d) Date dispensed;

(e) Name of the prescriber;

(f) Directions for use.

(B) Any information that is given to the pharmacist by the patient or caregiver to complete the patient data record shall be presumed to be accurate, unless there is reasonable cause to believe the information is inaccurate.

(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 a computerized form.

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.26
Five Year Review Date: 11/15/2020
Prior Effective Dates: 9/10/1976, 3/1/1993, 2/1/2005
Rule 4729-5-19 | Serial numbering of prescriptions.
 

All outpatient prescriptions must be serially numbered when entered into the computer system or when dispensed under a manual system.

(A) This number must appear on the original prescription. If an alternate record keeping system is being used pursuant to rule 4729-5-27 of the Administrative Code, the serial number must also appear on the records in this alternate system.

(B) There must be a complete accounting of all numbers used in the serial numbering system.

(C) All prescriptions which are not refillable, either because of the dispensing of all refills or the length of time since issuance, shall be assigned a new serial number upon an authorization for additional dispensings by a prescriber.

Supplemental Information

Authorized By: 3715.69, 3719.28, 4729.26
Amplifies: 3715.64, 3719.05, 3719.07, 3719.13, 3719.27, 4729.37, 4729.55
Five Year Review Date: 10/1/2021
Prior Effective Dates: 1/17/1997, 1/1/2009
Rule 4729-5-20 | Prospective drug utilization review.
 

(A) Prior to dispensing any prescription, a pharmacist shall review the patient profile for the purpose of identifying:

(1) Over-utilization or under-utilization;

(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 requesting and reviewing an OARRS report or another state's report, pursuant to paragraph (D) of this rule, and/or consulting with the prescriber and/or 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 (that is, 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) Prior to dispensing an outpatient prescription for a reported drug as listed in rule 4729-37-02 of the Administrative Code, at a minimum, a pharmacist shall request and review an OARRS report covering at least a one year time period, including a border state's information when the pharmacist is practicing in a county bordering another state if that state's information is available, in any of the following circumstances:

(1) A patient adds a different or new reported drug to their therapy that was not previously included;

(2) An OARRS report has not been reviewed for that patient during the preceding twelve months, as indicated in the patient profile;

(3) A prescriber is located outside the usual pharmacy geographic area;

(4) A patient is from outside the usual pharmacy geographic area;

(5) A pharmacist has reason to believe the patient has received prescriptions for reported drugs from more than one prescriber in the preceding three months, unless the prescriptions are from prescribers who practice at the same physical location;

(6) Patient is exhibiting signs of potential abuse or diversion. This includes, but is not limited to, over-utilization, early refills, appears overly sedated or intoxicated upon presenting a prescription for a reported drug, or an unfamiliar patient requesting a reported drug by specific name, street name, color, or identifying marks.

(E) In the event an OARRS report is not immediately available, the pharmacist shall use professional judgment in determining whether it is appropriate and in the patient's best interest to dispense the prescription prior to receiving and reviewing a report.

(F) A pharmacist may use a delegate to request an OARRS report.

(G) A prescription, to be valid, must be issued for a legitimate medical purpose by an individual prescriber acting in the usual course of his/her professional practice. The responsibility for the proper prescribing is upon the prescriber, but a corresponding responsibility rests with the pharmacist who dispenses the prescription. Based upon information obtained during a prospective drug utilization review, a pharmacist shall use professional judgment when making a determination about the legitimacy of a prescription. A pharmacist is not required to dispense a prescription of doubtful, questionable, or suspicious origin.

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.26
Five Year Review Date: 3/1/2022
Prior Effective Dates: 9/10/1976, 3/1/1993
Rule 4729-5-21 | Manner of processing a prescription.
 

(A) A prescription, to be valid, must be issued for a legitimate medical purpose by an individual prescriber acting in the usual course of his/her 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.

(B) A pharmacist when dispensing a prescription must:

(1) Ensure that patient information is profiled pursuant to rule 4729-5-18 of the Administrative Code;

(2) Perform prospective drug utilization review pursuant to rule 4729-5-20 of the Administrative Code;

(3) Ensure that the drug is labeled pursuant to rule 4729-5-16 of the Administrative Code;

(4) Ensure that a patient is given an offer to counsel pursuant to rule 4729-5-22 of the Administrative Code;

(5) Ensure that a prescription is filed pursuant to rule 4729-5-09 of the Administrative Code.

(C) Prescriptions:

(1) A pharmacist may receive a signed hard copy prescription, an oral prescription, a facsimile of a signed prescription, or a prescription sent using a board approved electronic prescription transmission system. The pharmacist shall follow the prescription record keeping processes noted in paragraphs (C), (D), (E), and (F) of this rule for each of these types of prescriptions received unless utilizing an alternate record keeping system pursuant to rule 4729-5-27 of the Administrative Code that has been approved by the board.

(2) When a pharmacist dispenses a drug pursuant to an original prescription, he/she must record the date of such dispensing and either manually record his/her name or initials on the original prescription or, if approved by the state board of pharmacy, enter his/her positive identification into the computerized record keeping system pursuant to rule 4729-5-27 of the Administrative Code. If an alternate record keeping system is being used pursuant to rule 4729-5-27 of the Administrative Code, the record of dispensing must also be recorded in the alternate record keeping system.

(3) When a pharmacist dispenses a drug pursuant to an authorized refill of a prescription, he/she must record the date of such dispensing and either manually record his/her name or initials on the original prescription or enter such information in an alternate record keeping system or, if approved by the state board of pharmacy, enter his/her positive identification into a computerized record keeping system pursuant to rule 4729-5-27 of the Administrative Code.

(D) Oral prescriptions:

(1) The pharmacist shall make a record of the full name of the prescriber and, if transmitted by the prescriber's agent, the full name of the agent, on the original prescription and, if used, on the alternate system of record keeping. The pharmacist is responsible for assuring the validity of the source of the oral prescription.

(2) Upon receiving a prescription from a recording device, the pharmacist must remove the prescription from the recorder and reduce it to writing. The pharmacist must document on the original prescription the full name of the prescriber and, if transmitted by the prescriber's agent, the full name of the agent. The pharmacist is responsible for assuring the validity of the prescription removed from the recorder.

(3) A licensed pharmacy intern may receive telephone prescriptions and remove prescriptions from a recording device if the pharmacist on duty who is supervising the activity of the intern determines that the intern is competent to perform this function.

(a) The intern shall immediately reduce the prescription to writing, 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 prescription with the supervising pharmacist. Prior to dispensing, positive identification of the intern and the supervising pharmacist shall be made on the prescription to identify the responsibility for the receipt of the oral order.

(b) The supervising pharmacist on duty is responsible for the accuracy of the prescription.

(c) The supervising pharmacist on duty must be immediately available to answer questions or discuss the prescription with the caller.

(E) Facsimile prescriptions:

(1) A facsimile shall only be valid as a prescription if a system is in place that will allow the pharmacist to maintain the facsimile as a part of the prescription record including the full name of the prescriber and, if transmitted by the prescriber's agent, the full name of the agent as well as identification of the origin of the facsimile.

(2) The pharmacist must record the prescription in writing pursuant to section 4729.37 of the Revised Code or store the facsimile copy in such a manner that will allow retention of the prescription record for three years from the date of the last transaction.

(F) Electronic prescriptions:

(1) Electronic prescriptions may be received by a pharmacy if the electronic prescription transmission system has been approved by the state board of pharmacy.

(2) A pharmacy desiring to receive electronic prescriptions directly into its computer system must obtain approval from the state board of pharmacy. The original prescription information received from the prescriber must be saved and a hardcopy prescription must be printed to document the dispensing. The hardcopy prescription must be filed in the prescription file pursuant to rule 4729-5-09 of the Administrative Code.

(3) A pharmacy computer system meeting the requirements of 21 C.F.R. 1311 (04/01/13) shall be considered approved by the state board of pharmacy.

(G) A pharmacist may not dispense a dangerous drug for the first time beyond six months from the date of issuance of a prescription.

(H) The quantity dispensed shall be considered the quantity prescribed unless the quantity dispensed on a:

(1) New prescription is less than the quantity prescribed, the pharmacist shall note the quantity dispensed on the original prescription. If the quantity dispensed on a new prescription is greater than the quantity prescribed, the pharmacist shall also record on the original prescription the name of the authorizing prescriber, the full name of the agent of the prescriber if applicable, the quantity authorized to be dispensed, and the date that the authorization was obtained.

(2) Refill prescription is less than the quantity prescribed, the pharmacist shall note the quantity dispensed on the original prescription or enter the quantity dispensed on an alternate record pursuant to paragraph (F) of rule 4729-5-27 of the Administrative Code. If the quantity dispensed on a refill prescription is greater than the quantity prescribed, the pharmacist shall also record the name of the authorizing prescriber, the full name of the agent of the prescriber if applicable, the quantity authorized to be dispensed, and the date that the authorization was obtained.

(I) Where a prescription is written using a generic name, or where the pharmacist dispenses an equivalent drug product pursuant to the provisions of sections 4729.38 and 4729.381 of the Revised Code, the brand name or drug name and name of the manufacturer or distributor of the drug or the national drug code (NDC) number of the drug dispensed must be recorded on the record of dispensing by the pharmacist.

(J) A pharmacist who modifies a patient's drug therapy pursuant to a consult agreement and is:

(1) Also responsible for the dispensing of the drug to the patient must include on the drug order the name of the physician who originally prescribed the drug, sign the pharmacist's full name, and be in compliance with this rule in the same manner as the prescriber.

(2) Not responsible for the dispensing of the drug to the patient may transmit the order to a pharmacy by acting as an agent of the physician. Such pharmacist must personally transmit the order verbally or by facsimile to another pharmacist and be in compliance with this rule.

(K) A pharmacist may document their own administration of an immunization, or an immunization administered by a pharmacy intern they are supervising, on a prescription form, which may be assigned a number for record keeping purposes. This documentation is in addition to the record keeping requirements noted in rule 4729-5-27 of the Administrative Code.

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.28, 4729.37, 4729.38, 4729.381, 4729.39, 3719.05
Five Year Review Date: 5/22/2019
Prior Effective Dates: 4/27/2007
Rule 4729-5-22 | Patient counseling.
 

(A) A pharmacist or the pharmacist's designee shall personally offer to provide the service of counseling pursuant to paragraph (B) of this rule to the patient or caregiver whenever any prescription, new or refill, is dispensed. A pharmacist shall not be required to counsel a patient or caregiver when the patient or caregiver refuses the offer of counseling or does not respond to the written offer to counsel. If the patient or caregiver is not physically present, the offer to counsel shall be made by telephone or in writing on a separate document accompanying the prescription or incorporated as part of documentation, in a conspicuous manner, that is included with the prescription. A written offer to counsel shall include the hours a pharmacist is available and a telephone number where a pharmacist may be reached. The telephone service must be available at no cost to the pharmacy's primary patient population.

(B) In the event a patient or caregiver accepts an offer to counsel or requests counseling, a pharmacist, or an intern under the personal supervision of a pharmacist, shall counsel the patient or caregiver. Such counseling may include, but is not limited to, the following:

(1) The name and description of the drug;

(2) The dosage form, dose, strength, frequency, route of administration, and duration of drug therapy;

(3) The intended use of the drug and the expected action;

(4) Special directions and precautions for preparation, administration, and use by the patient;

(5) Common adverse effects or interactions and therapeutic contraindications that may occur, including possible methods to avoid them, and the action required if they occur;

(6) Techniques for self-monitoring drug therapy;

(7) Proper storage and disposal;

(8) Prescription refill information;

(9) Action to be taken in the event of a missed dose; and

(10) The pharmacist's comments relevant to the individual's drug therapy, including other necessary information unique to the specific patient or drug.

(C) Other forms of information may be used when appropriate to supplement the counseling by the pharmacist or intern. Examples of forms that may be used include, but are not limited to, drug product information leaflets, pictogram labels, and video programs.

(D) Patient counseling shall not be required for inpatients of an institutional facility as defined in rule 4729-17-01 of the Administrative Code.

(E) Notwithstanding rule 4729-5-01 of the Administrative Code, "personal supervision", as used in paragraph (B) of this rule, means that a pharmacist is on the premises at all times and is aware of all counseling activities performed by the pharmacy intern. A pharmacist who has accepted responsibility for the supervision and training of a pharmacy intern is responsible for all acts performed by the pharmacy intern working under the pharmacist's supervision.

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.26
Five Year Review Date: 9/15/2022
Prior Effective Dates: 9/10/1976
Rule 4729-5-24 | Prescription copy.
 

(A) A pharmacist may transfer a copy of a prescription; a pharmacist may refill a copy of a prescription; such actions must be in accordance with the following unless otherwise approved by the state board of pharmacy:

(1) Copies of prescriptions shall be transferred only between pharmacists except as provided in paragraph (G) of this rule; copies of prescriptions for controlled substances pursuant to sections 3719.41, 3719.43, and 3719.44 of the Revised Code shall be communicated directly between two pharmacists and shall be transferred only one time. However, pharmacies electronically sharing a real time, online database may transfer a controlled substance prescription up to the maximum number of refills permitted by law and the prescriber's authorization pursuant to paragraph (A)(3) of this rule.

(2) The copy transferred shall be an exact duplicate of the original prescription except that it shall also include:

(a) Serial prescription number assigned to the prescription;

(b) Name and address (and "D.E.A." number for controlled substance prescriptions) of the pharmacy transferring the copy;

(c) Date of issuance of the prescription;

(d) Date of original dispensing of the prescription;

(e) Original number of refills;

(f) Date of last refill;

(g) Number of valid refills remaining; and

(h) The full name of the transferring pharmacist.

(3) The pharmacist transferring a copy of a prescription must:

(a) Cancel the original prescription by writing the word "void" on the face of the prescription in such a way as to avoid destroying any of the original information contained on the prescription;

(b) Record on the reverse side of the original written prescription:

(i) The date of transfer;

(ii) His/her signature; and

(iii) The name and address (and "D.E.A." number for controlled substance prescriptions) of the pharmacy receiving the prescription and the full name of the pharmacist receiving the prescription.

(c) Except, if an alternate record keeping system is being used pursuant to rule 4729-5-27 of the Administrative Code, copies of prescriptions may be transferred by a pharmacist if the prescription record in the system is invalidated to prevent further dispensing at the original site. The prescription record in the system must contain the date of transfer, full name of pharmacist making transfer, full name of pharmacist receiving the prescription, and the name and address of the pharmacy receiving the copy. Also, original written prescriptions for controlled substances must be canceled as required in paragraphs (A)(3)(a) and (A)(3)(b) of this rule.

(4) The pharmacist receiving a copy of a prescription must:

(a) Exercise reasonable diligence to determine validity of the copy;

(b) Reduce an oral prescription to writing by recording all of the information transferred (must include all information required in paragraph (A)(2) of this rule) and write the word "transfer" on the face of the prescription;

(c) Record date of transfer on the face of the prescription.

(B) A prescription copy may be transferred between two pharmacies if the two pharmacies are accessing the same prescription records in a centralized database or pharmacy computers linked in any other manner. The computerized systems must satisfy all information requirements of paragraphs (A)(2) and (A)(3)(c) of this rule. This shall include invalidation of the prescription record in the system to prevent further dispensing at the original site and, if a controlled substance prescription, the canceling of the original written prescription as required in paragraphs (A)(3)(a) and (A)(3)(b) of this rule. A system must be in place that will allow only authorized access to these computerized prescription records by a pharmacist and indicate on the prescription record when and by whom such access was made.

(C) A prescription copy may be transferred between two pharmacists by the use of a facsimile machine. This facsimile may be considered to be a copy of a prescription if all information requirements of paragraph (A) of this rule, including invalidation of the original prescription or computer records, are met. A system must be in place that will show on the facsimile positive identification of the transferring and receiving pharmacists which must become a part of the prescription record. Facsimile copies must be recorded in writing pursuant to section 4729.37 of the Revised Code, or stored in such a manner that will allow retention of the prescription record for three years from the date of the last transaction.

(D) Information on a prescription is the property of the patient and is intended to authorize the dispensing of a specific amount of medication for use by the patient. Original copies of prescriptions shall be maintained by pharmacies for the purpose of documenting the dispensing of drugs to a particular patient.

(1) In the event that the pharmacy is not able to provide the medication when needed by the patient pursuant to an authorized refill, the pharmacist shall, upon the request of the patient, transfer the prescription information to the pharmacy designated by the patient.

(2) No pharmacy shall refuse to transfer information about a previously dispensed prescription to another pharmacy when requested by the patient. Prescription information shall be transferred in accordance with this rule as soon as possible in order to assure that the patient's drug therapy is not interrupted.

(E) Prescriptions entered into a computer system but not dispensed may be transferred to another pharmacy if all of the following conditions are met:

(1) The complete prescription information has been entered into the computer system;

(2) The information is displayed on the patient's profile;

(3) There is positive identification, either in the computer system or on the hard copy prescription, of the pharmacist who is responsible for entering the prescription information into the system;

(4) The original prescription is filed in accordance with rule 4729-5-09 of the Administrative Code;

(5) All requirements of this rule are met for the transfer of the prescription.

(F) Transfer of prescription information between two pharmacies which are accessing the same real time, online database pursuant to the operation of a board approved central filling operation shall not be considered a prescription copy and, therefore, is not subject to the requirements of this rule.

(G) A licensed pharmacy intern may send or receive copies of prescriptions pursuant to the following:

(1) The pharmacist on duty who is supervising the activity of the intern will determine if the intern is competent to send or receive a prescription copy.

(2) The pharmacist on duty who is supervising the activity of the intern is responsible for the accuracy of a prescription copy that is sent or received by an intern.

(3) The supervising pharmacist must be immediately available to answer questions or discuss the prescription copy that is sent or received by an intern.

(4) The intern may not send or receive a prescription copy for a controlled substance.

(5) The pharmacist or intern receiving a prescription copy from an intern must document the full names of the sending intern and his/her supervising pharmacist. The receiving intern shall immediately reduce the prescription copy to writing and shall review the prescription with the supervising pharmacist. Prior to dispensing, positive identification of the intern and the supervising pharmacist shall be made on the prescription to identify the responsibility for the receipt of the copy.

(6) The pharmacist or intern sending a prescription copy to an intern must document the full names of the receiving intern and his/her supervising pharmacist. There must be documented positive identification of the sending intern and his/her supervising pharmacist who authorized the transfer of the prescription copy.

(7) The approved intern and the supervising pharmacist must meet all the requirements of this rule.

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 3719.05, 4729.37
Five Year Review Date: 10/1/2020
Prior Effective Dates: 8/1/1984, 2/1/2003, 6/16/2011
Rule 4729-5-26 | Partial dispensing of schedule II controlled substances.
 

(A) A valid prescription for a schedule II controlled substance may be partially dispensed if all of the following apply:

(1) For a terminally ill patient or a patient residing in a long term care facility, in accordance with 21 C.F.R. 1306.13 (03/31/2010), the following must be observed:

(a) Prior to a partial dispensing of a schedule II controlled substance, the pharmacist must confirm that the patient is "terminally ill" or a patient residing in a "long term care facility" and note this on the prescription;

(b) The total quantity dispensed in all partial dispensings shall not exceed the total quantity prescribed; and

(c) The remaining portions of a partially dispensed schedule II controlled substance prescription shall be filled not later than sixty days after the date on which the prescription is written.

(2) For a patient who is not terminally ill or residing in a long term care facility, the following must be observed:

(a) The partial dispensing shall be requested by the patient or the prescriber that issued the prescription;

(b) The total quantity dispensed in all partial dispensings shall not exceed the total quantity prescribed; and

(c) The remaining portions of a partially dispensed schedule II controlled substance prescription shall be filled not later than thirty days after the date on which the prescription is written.

(B) The partial dispensing of a schedule II prescription can only occur at the pharmacy where the original prescription is on file.

(C) At the time of partial dispensing of a schedule II controlled substance, the following must be noted on the back of the original prescription or within an alternate record keeping system pursuant to rule 4729-5-27 of the Administrative Code: the date dispensed, quantity dispensed, remaining quantity authorized to be dispensed, prescription number of this partial dispensing if different, and the manual initials or other form of positive identification of the dispensing pharmacist.

(D) If an alternate record keeping system is being used and the system will not permit refills of schedule II controlled substances, a new prescription number for the partial dispensing must be assigned.

(1) A notation must also be made in the database that identifies this new prescription number as a partial dispensing and provides the serial number of the original prescription.

(2) A prescription bearing the new serial number must be placed in the schedule II file. The prescription for each partial filling must also show the serial number of the original prescription.

Supplemental Information

Authorized By: 3719.28
Amplifies: 3719.05, 3719.07, 3719.13, 3719.27
Five Year Review Date: 3/1/2022
Prior Effective Dates: 4/27/2007
Rule 4729-5-27 | Record keeping.
 

The following record keeping requirements do not apply to records relating to the practice of pharmacy for an inpatient as defined in rule 4729-17-01 of the Administrative Code.

(A) There must be positive identification of the pharmacist or pharmacists responsible for performing all activities relating to the practice of pharmacy including, but not limited to:

(1) Prescription information entered into the record keeping system;

(2) Prospective drug utilization review;

(3) Dispensing;

(4) Patient counseling;

(5) Administering adult immunizations;

(6) Prescription information reduced to writing from an order received by telephone, facsimile, or recording device.

(B) Records of dispensing must provide accountability and ensure that patients do not receive more drugs than intended by the prescriber.

(C) All records relating to the practice of pharmacy shall be uniformly maintained for a period of three years, be readily available, and promptly produced upon request for inspection by a state board of pharmacy officer, agent, and/or inspector during regular business hours.

(D) All prescriptions or other records relating to the practice of pharmacy, which are required to be kept for three years according to section 4729.37 of the Revised Code, may be microfilmed or placed on electronic, magnetic media. The microfilm or electronic, magnetic media used for this purpose must comply with the "International Standards Organization" standards of quality approved for permanent records. Such records are subject to all other paragraphs of this rule.

(E) Any pharmacy intending to maintain records relating to the practice of pharmacy at a location other than the place licensed with the state board of pharmacy must first send written notification to the state board of pharmacy. The request shall contain the terminal distributor of dangerous drug name and license number of the requestor and the name and address of the alternate location. The state board of pharmacy office will send written notification of the approval or denial of the request. A copy of the board's approval shall be maintained with other records relating to the practice of pharmacy. Any such alternate location shall be secured and accessible only to representatives of the terminal distributor of dangerous drugs.

(F) Alternate record keeping systems include, but are not limited to, the following:

(1) A system that utilizes the original hard copy prescription to document the initial dispensing of a prescription, but utilizes a computerized system to dispense refills that does not document the positive identification of the pharmacist responsible for the practice of pharmacy. In order to document positive identification, this system would require the manual signature or initials of a pharmacist on a hard copy record as indicated in paragraph (I) of this rule.

(2) A computerized system that documents the positive identification of the pharmacist responsible for the practice of pharmacy. If this method is used, it must be approved by the board and provide a daily backup.

(3) Any record keeping system approved by the board.

(G) All computerized record keeping systems must be capable of providing immediate retrieval (via digital display and hard copy printout or other mutually agreeable transfer medium) of patient profile information for all prescriptions filled within the previous twelve months and retrieval within three working days, excluding weekends and holidays, of all prescriptions dispensed within the previous three years. This information shall include at least, but is not limited to, the following data:

(1) The original prescription number;

(2) Date of issuance of the original prescription order by the prescriber;

(3) Date of dispensing by the pharmacist;

(4) Full name and address of the patient;

(5) Full name and address of the prescriber;

(6) Directions for use;

(7) The name, strength, dosage form, and quantity of the drug prescribed;

(8) The quantity dispensed if different from the quantity prescribed;

(9) If utilizing a board approved system pursuant to paragraph (F)(2) of this rule, there must be positive identification documented within the system of the pharmacist responsible for prescription information entered into the computer system, the pharmacist responsible for prospective drug utilization review as defined in rule 4729-5-20 of the Administrative Code, and the pharmacist responsible for dispensing;

(10) The total number of refills authorized by the prescriber;

(11) The refill history of the prescription as defined in paragraph (H) of this rule.

(H) The refill history of the prescription must include, but is not limited to:

(1) The prescription number;

(2) The name and strength of the drug dispensed;

(3) The date of refill;

(4) The quantity dispensed;

(5) If utilizing a board approved system pursuant to paragraph (F)(2) of this rule, there must be positive identification documented within the system of the pharmacist responsible for prospective drug utilization review as defined in rule 4729-5-20 of the Administrative Code and the pharmacist responsible for dispensing for each refill;

(6) The total number of refills dispensed to date for that prescription order.

(I) Hard copy documentation as required pursuant to paragraph (F)(1) of this rule must be provided by each individual pharmacist who makes use of such system by one of the following methods:

(1) A hard copy printout of each day's prescription refill data that shall include, at a minimum, the following data:

(a) Date of dispensing;

(b) Prescription number;

(c) Patient name;

(d) Name, strength (if applicable), and quantity of drug;

(e) Identification of pharmacy and pharmacist;

(f) Identification of controlled substances.

This printout must be verified, dated, and signed by each individual pharmacist who dispensed a prescription that day. The pharmacist must verify that the data on the printout is complete and correct and sign a statement to that effect on the document as he/she would sign a check or legal document (e.g., J. H. Smith or Jane H. Smith). These documents must be maintained in chronological order in a separate file at the licensed location where the drug was dispensed for a period of three years from the date of dispensing. If the printout is prepared at a location other than that where the drug was dispensed, the printout must be provided to the licensed location within three working days, excluding holidays and weekends, of the date on which the drugs were dispensed. Such printouts must be verified and signed by each pharmacist who dispensed drugs within twenty-four hours of the date the printout is received;

(2) A tamper evident log book in which shall be entered, at a minimum, the date of dispensing and prescription number. The dispensing pharmacist must manually record his/her name or initials on each log book entry at the time of dispensing each refill; or

(3) Each individual pharmacist involved in dispensing drugs must enter into a tamper evident log book, at a minimum, the following data for each prescription refilled:

(a) Date of dispensing;

(b) Prescription number;

(c) Patient name;

(d) Name, strength (if applicable), and quantity of drug;

(e) Identification of the pharmacist;

(f) Identification of controlled substances.

Each individual pharmacist involved in dispensing drugs must review this information at the end of each day and then must sign a statement in the log book attesting to the fact that the prescription information entered into the computer that day and recorded in the log book has been reviewed by him/her and is correct as shown.

(J) In addition to the immediate retrieval and production of patient profile information required by paragraph (G) of this rule, a pharmacy that utilizes a computerized record keeping system must be able to:

(1) Produce:

(a) An electronic record in a character-delimited or fixed-width ASCII text file or other mutually acceptable format that contains any requested data fields the user pharmacy is responsible for maintaining pursuant to all federal and state laws, rules and regulations; and

(b) A hardcopy printout sorted by any requested data fields that the user pharmacy is responsible for maintaining pursuant to all federal and state laws, rules, and regulations.

(2) Provide, within three working days of a request by an individual authorized by law to access such records, any requested:

(a) Printout; or

(b) Electronic record and a definition file describing the file layout and column width, if applicable.

(K) In the event that the computerized record keeping system experiences down time, a record of all refills dispensed during such time must be recorded on the back of the original prescription. The refill information must be entered into the computerized record keeping system as soon as it is available for use. During the time the computerized record keeping system is not available, prescriptions may be refilled only if, in the professional judgment of the pharmacist, the number of refills authorized by the prescriber has not been exceeded.

(L) A pharmacy purging a computerized record keeping system of prescription records must develop a method of record keeping capable of providing retrieval (via digital display, hard copy printout, or other mutually agreeable transfer medium) within three working days, excluding holidays and weekends, of prescription order information for all prescriptions filled or refilled within the previous three years. This information shall include, at a minimum, the following data:

(1) Pharmacy name and address;

(2) Original prescription number;

(3) Date of issuance of the original prescription order by the prescriber;

(4) Date of original dispensing by the pharmacist;

(5) Full name and address of the patient;

(6) Full name and address of the prescriber;

(7) Directions for use;

(8) Name, strength, dosage form, and quantity of the drug prescribed;

(9) Quantity dispensed if different from the quantity prescribed;

(10) Total number of refills authorized by the prescriber;

(11) Total number of refills dispensed to date for that prescription order;

(12) Date of each refill;

(13) Name or initials of each individual dispensing pharmacist.

(M) A log must be maintained of all changes made to a prescription record after the prescription has been dispensed. Such log may be accessible to the pharmacist for review, but shall be protected from being altered in any way. The log must contain at least, but is not limited to, the following:

(1) Date and time of change;

(2) Changes made;

(3) Pharmacist making the change.

(N) Prescriptions entered into a computer system but not dispensed must meet all of the following conditions:

(1) The complete prescription information must be entered in the computer system;

(2) The information must appear in the patient's profile;

(3) There is positive identification, in the computer system or on the hard copy prescription, of the pharmacist who is responsible for entering the prescription information into the system; and

(4) The original prescription is filed according to rule 4729-5-09 of the Administrative Code.

(O) Records shall be maintained for three years on all immunizations administered pursuant to section 4729.41 of the Revised Code and rule 4729-5-38 of the Administrative Code and must include at least the following information:

(1) Full name and address of the patient;

(2) Patients date of birth or age;

(3) Patients gender;

(4) Patients applicable allergy information;

(5) Date of administration;

(6) Name, strength, and dose of the immunization administered;

(7) Lot number and expiration date of the immunization;

(8) Route of administration;

(9) Location of the injection site;

(10) Positive identification of the administering pharmacist or the administering pharmacy intern and supervising pharmacist;

(11) Positive identification of the patient, parent, or legal guardian of the patient who gives informed consent to administer an immunization.

(P) A pharmacist or pharmacy intern under the direct supervision of a pharmacist who administers an immunization pursuant to section 4729.41 of the Revised Code and rule 4729-5-38 of the Administrative Code shall maintain and immediately make available, upon the request of the state board of pharmacy, the following records:

(1) Documentation of the successful completion of a board approved course in the administration of immunizations;

(2) Documentation of current certification to perform basic life support procedures pursuant to division (B)(2) of section 4729.41 of the Revised Code.

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 3719.05, 3719.07, 3719.13, 3719.27, 4729.27, 4729.37
Five Year Review Date: 1/20/2019
Prior Effective Dates: 1/17/1997
Rule 4729-5-28 | Central fill pharmacies.
 

(A) As used in this rule:

(1) "Central fill pharmacy" means a pharmacy or central filling operation licensed as a terminal distributor of dangerous drugs acting as an agent of or under contract with an originating pharmacy to fill or refill a prescription. A central fill pharmacy may also be the originating pharmacy pursuant to paragraph (L) of this rule.

(2) "Originating pharmacy" means a pharmacy licensed as a terminal distributor of dangerous drugs that uses a central fill pharmacy to fill or refill a prescription order and pursuant to paragraph (O) of rule 4729-5-01 of the Administrative Code.

(B) An originating pharmacy may outsource prescription filling or refilling to a central fill pharmacy provided the pharmacies have the same owner or the pharmacies have entered into a written contract or agreement. The contract or agreement shall outline the services to be provided and the responsibilities and accountability of each pharmacy to comply with federal and state laws, rules and regulations.

(C) A central fill pharmacy and originating pharmacy shall comply with all applicable federal laws and regulations, including those specified in Federal Register Citation 68 FR 37405 (July 24, 2003.)

(D) The originating and central fill pharmacies must 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 prescription.

(E) An originating pharmacy using a central fill pharmacy is responsible for maintaining records of the processing of all prescriptions entered into its information system including prescriptions filled or refilled at a central fill pharmacy. The pharmacist at the originating pharmacy must comply with the minimum required information for a patient profile pursuant to rule 4729-5-18 of the Administration Code prior to sending a prescription to the central fill pharmacy. The information system must have the ability to audit the activities of the individuals at the central fill pharmacy filling the originating pharmacy's prescriptions.

(F) The prescription label of a centrally filled prescription shall display the name and address of the originating pharmacy, pursuant to paragraphs (A)(1) and (A)(10) of rule 4729-5-16 of the Administrative Code. The label shall also display the name of the central fill pharmacy.

(G) The serial number used by the central fill pharmacy shall be the same as the originating pharmacy if in accordance with paragraph (D) of rule 4729-5-19 of the Administrative Code.

(H) Unless the central fill pharmacy operates pursuant to paragraph (L) of this rule, the originating pharmacy shall designate staff members to be responsible for signing for the receipt of prescriptions delivered from the central fill pharmacy. The receipt must be maintained as part of the prescription records.

(I) All central fill pharmacies providing central prescription filling processing services to pharmacies in Ohio shall be licensed as a terminal distributor of dangerous drugs.

(J) The originating pharmacy and central fill pharmacy shall maintain a policy and procedure manual, which shall be available for inspection by a state board of pharmacy designated agent. The manual shall include all of the following:

(1) Outline the responsibilities of each of the pharmacies;

(2) Include a list of the name, address, telephone numbers, and all license/registration numbers of the pharmacies participating in the central fill prescription filling; and

(3) Include policies and procedures for:

(a) Protection of the confidentiality and integrity of patient information;

(b) Maintenance of appropriate records to identify the method(s) of positive identification used, as defined in paragraph (N) of rule 4729-5-01 of the Administrative Code, and specific activity(ies) of each pharmacist who performed any processing;

(c) Compliance with federal and state laws, rules and regulations;

(d) Operation of a continuous quality improvement 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, and resolve identified problems; and

(e) Annual review of the written policies and procedures and documentation of such review.

(K) No medication shall be returned to the central fill pharmacy by the originating pharmacy. This paragraph does not apply if a central fill pharmacy operates in accordance with paragraph (L) of this rule and the dangerous drugs have not left the custody of the central fill pharmacy.

(L) A central fill pharmacy may dispense a prescription directly to a patient pursuant to the following requirements:

(1) A drug utilization review is conducted pursuant to a written contract or agreement in accordance with rule 4729-5-20 of the Administrative Code and is appropriately documented by a pharmacist using positive identification as defined in rule 4729-5-01 of the Administrative Code;

(2) Patient counseling is provided pursuant to a written contract or agreement in accordance with rule 4729-5-22 of the Administrative Code;

(3) The dispensing software shall utilize positive identification as defined in rule 4729-5-01 of the Administrative Code to distinguish between the practice of pharmacy conducted at the central fill pharmacy, the originating pharmacy and any contracted location;

(4) The dispensing is conducted in accordance with all applicable state and federal laws, regulations and rules.

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 4729.54, 4729.55
Five Year Review Date: 8/15/2021