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

Chapter 4729:1-3 | Administrating and Dispensing

 
 
 
Rule
Rule 4729:1-3-01 | Pharmacist administration of diagnostic tests.
 

(A) A pharmacist may administer clinical laboratory improvement amendments (CLIA) waived diagnostic laboratory testing provided the following conditions are met:

(1) The pharmacy or facility licensed as a terminal distributor of dangerous drugs is certified by the United States department of health and human services (HHS), as a clinical laboratory through the CLIA;

(2) The pharmacy or facility licensed as a terminal distributor of dangerous drugs has obtained a CLIA certificate of waiver from HHS; and

(3) The responsible person of the terminal distributor of dangerous drugs and the terminal distributor of dangerous drugs ensures and documents that all pharmacists conducting CLIA waived tests pursuant to this rule receive appropriate training to conduct testing in a safe and effective manner.

(B) A pharmacist may evaluate the results of a test administered under this rule when advising a patient or a health care professional treating a patient if the test relates to the patient's drug therapy.

(C) This rule applies only to the administration and evaluation of laboratory testing by individuals licensed or registered in accordance with Chapter 4729. of the Revised Code.

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.41
Five Year Review Date: 1/1/2025
Prior Effective Dates: 9/15/2017
Rule 4729:1-3-02 | Immunization administration.
 

(A) A course in the administration of immunizations developed pursuant to division (B)(1) of section 4729.41 of the Revised Code shall meet the following requirements:

(1) The instructor shall be a licensed health care professional and have the appropriate education and experience to teach a course in the administration of immunizations.

(2) The content must meet the standards established for such courses by the centers for disease control and prevention in the public health service of the United States department of health and human services.

(3) The course shall be conducted by an accreditation council for pharmacy education (ACPE) accredited provider.

(4) The course must be a minimum of five hours in length and include the following:

(a) A review of immunology that includes a discussion of the body's immune system reaction to immunizations.

(b) A review of each immunization authorized pursuant to paragraph (G) of this rule that includes the following:

(i) Disease states associated with the immunization;

(ii) Type or nature of activity of the immunization;

(iii) Administration schedules;

(iv) Routes of administration;

(v) Injection sites;

(vi) Dosages;

(vii) Monitoring and treatment of the patient for adverse reactions, including the use of diphenhydramine and epinephrine;

(viii) Patient populations;

(ix) Precautions and contraindications; and

(x) Proper storage requirements for the immunization.

(c) A review of sterile technique in injectable dosage preparation and administration.

(d) A minimum of one hour of instruction and physical participation in administration techniques.

(e) A review of the proper disposal procedures for contaminated needles and immunizations.

(f) A review of the proper procedures for accidental needle sticks.

(5) The course must provide a method to evaluate the successful comprehension of the content.

(6) The course must provide a method to demonstrate the participant has successfully completed the course.

(B) Courses on immunization administration may be reviewed by the state board of pharmacy. A training course that fails to comply with the requirements set forth in this rule shall be considered in violation of this rule.

(C)

(1) Pharmacists seeking to administer any immunization listed in paragraph (G) of this rule that was added after the completion of an initial immunization course shall, at a minimum, conduct a review of appropriate clinical resources to familiarize themselves with all the following prior to the administration of the immunization:

(a) Disease states associated with the immunization;

(b) Type or nature of activity of the immunization;

(c) Administration schedules;

(d) Routes of administration;

(e) Injection sites;

(f) Dosages;

(g) Monitoring and treatment of the patient for adverse reactions;

(h) Patient populations;

(i) Precautions and contraindications; and

(j) Proper storage requirements for the immunization.

(2) Failure to adhere to the standard of care for administration of an immunization shall be considered a violation of this rule and may subject a pharmacist to discipline in accordance with rule 4729:1-4-01 of the Administrative Code.

(D) Pursuant to section 4729.41 of the Revised Code, a physician-established protocol for the administration of immunizations shall include the following:

(1) For each dangerous drug listed in paragraph (G) of this rule:

(a) Name and strength;

(b) Precautions and contraindications;

(c) Intended audience or patient population;

(d) Dosage;

(e) Administration schedules;

(f) Routes of administration; and

(g) Injection sites.

(2) The length of time the pharmacist or pharmacy intern under the direct supervision of a pharmacist must observe an individual for adverse effects, which shall be based on appropriate standards of care established by the physician. The location of the observation shall be in the general vicinity of the administering pharmacist or pharmacy intern to allow for on-going evaluation.

(3) A method to address emergency situations including, but not limited to, adverse reactions, anaphylactic reactions, and accidental needle sticks.

(4) A method to notify an individual's physician or the applicable board of health within thirty days after administering an immunization, except for influenza immunizations administered to individuals eighteen years of age and older.

(5) The locations that a pharmacist or pharmacy intern under the direct supervision of a pharmacist may engage in the administration of immunizations.

(E) All physician-established protocols must be signed and dated by the physician prior to implementation and maintained by the terminal distributor of dangerous drugs. The protocols shall be renewed by a physician on a biennial basis.

(1) A physician may sign one protocol for multiple locations licensed as terminal distributors of dangerous drugs.

(2) Each location licensed as a terminal distributor of dangerous drugs shall maintain a copy of the protocol on-site for inspection by an agent, inspector or employee of the state board of pharmacy.

(F) Upon the request of the state board of pharmacy, a pharmacist or terminal distributor of dangerous drugs shall immediately provide the protocols for immunizations. The state board of pharmacy, after review, may approve the protocol or return it to the pharmacist or terminal distributor for revision without approval. If a protocol has been returned for revision without approval, it may not be implemented until the board has granted approval.

(G) A pharmacist may administer the following immunizations in accordance with section 4729.41 of the Revised Code and this rule:

(1) Any immunization or vaccine that is included in either of the following schedules and is administered according to those schedules:

(a) The immunization schedule for persons aged zero through eighteen years recommended by the advisory committee on immunization practices of the centers for disease control and prevention in the United States department of health and human services (1/15/2020).

(b) Except as listed in paragraph (G)(2) of this rule, the adult immunization schedule recommended by the advisory committee on immunization practices of the centers for disease control and prevention in the United States department of health and human services (1/15/2020).

(2) The herpes zoster vaccine according to the age criteria specified in the United States food and drug administration's approved labeling.

(3) Except as provided in paragraphs (G)(4) and (G)(5) of this rule, any other immunization or vaccine recommended by the advisory committee on immunization practices of the centers for disease control and prevention in the United States department of health and human services if administered in accordance with the recommendations adopted by the committee.

(4) The rabies vaccine for post exposure, if all the following are met:

(a) A pharmacist does not provide the initial dose of the rabies post exposure vaccine;

(b) Follow-up doses are administered pursuant to a prescription issued by a prescriber; and

(c) The follow-up doses are administered in accordance with recommendations adopted by the advisory committee on immunization practices of the centers for disease control and prevention in the United States department of health and human services (1/15/2020).

(5) The requirements listed in paragraph (G)(4) of this rule do not apply to the rabies vaccine for preexposure if administered in accordance with recommendations adopted by the advisory committee on immunization practices of the centers for disease control and prevention in the United States department of health and human services (1/15/2020).

(6) Any immunization to an individual eighteen years of age or older pursuant to a prescription if all the following apply:

(a) The pharmacist is authorized to administer the immunization pursuant to a physician-approved protocol established in paragraph (D) of this rule; and

(b) The pharmacist has the required training in accordance with this rule to administer the immunization.

(7) Any immunization approved by the United States food and drug administration for the prevention of COVID-19 in accordance with the limitations set forth in section 4729.41 of the Revised Code.

(H) A pharmacist shall obtain informed consent pursuant to rule 4729:5-5-04 of the Administrative Code to administer an immunization.

(I) Immunization records shall be maintained in accordance with rule 4729:5-5-04 of the Administrative Code.

(J) A pharmacist shall comply with the vaccine information statement requirements of the National Vaccine Childhood Injury Act, 42 USC Section 300aa-26 (12/14/1993).

(K) An immunization or vaccine specified in this rule shall not be administered to any individual who is less than thirteen years of age, except in the following situations:

(1) The immunization for influenza is administered to individuals who are seven years of age or older; or

(2) Pursuant to a prescription from a licensed prescriber, an immunization or vaccine is administered to individuals who are seven years of age or older but not more than thirteen years of age.

(L) For each immunization administered to an individual by a pharmacist, other than an immunization for influenza administered to an individual eighteen years of age or older, the pharmacist shall notify the individual's family physician or, if the individual has no family physician, the board of health of the health district in which the individual resides or the authority having the duties of a board of health for that district under section 3709.05 of the Revised Code. The notice shall be given not later than thirty days after the immunization is administered. Notification shall be conducted using one of the following methods that is capable of confirming delivery of the required notification:

(1) Electronic mail;

(2) Interoperable electronic medical records system;

(3) Facsimile;

(4) Electronic prescribing system;

(5) Electronic pharmacy record system;

(6) Documented verbal communication; or

(7) Any other method of notification that might reasonably be expected to allow for the confirmed transmission of the required notification.

(M) A pharmacist administering immunizations in accordance with this rule shall receive and maintain certification to perform basic life-support procedures by successfully completing a basic life-support training course certified by the American red cross, American heart association or other training course approved by the board. Certification shall be obtained and maintained through courses that are conducted in-person or, at a minimum, offer an in-person training component.

(N) A pharmacist who completed a course in the administration of immunizations that complied with the training requirements in effect immediately prior to the adoption of this rule shall be deemed in compliance with division (B)(1) of section 4729.41 of the Revised Code.

(O) A pharmacist shall maintain the following records on file at the location(s) where the pharmacist administers immunizations in accordance with this rule:

(1) Proof of successful completion of a training course specified in paragraph (A) of this rule; and

(2) Proof of maintenance of certification to perform basic life-support procedures in accordance with paragraph (M) of this rule.

Supplemental Information

Authorized By: 4729.26, 4729.41
Amplifies: 4729.41
Five Year Review Date: 12/1/2025
Prior Effective Dates: 6/21/2009
Rule 4729:1-3-03 | Administration of dangerous drugs by injection.
 

(A) A pharmacist licensed under Chapter 4729. of the Revised Code may administer, by injection, any of the following dangerous drugs if the dangerous drug that is to be administered has been prescribed by a physician and the individual to whom the dangerous drug was prescribed has an ongoing relationship with the physician, an advanced practice registered nurse who has entered into a standard care arrangement with the physician, or a physician assistant who has entered into a supervision agreement with the physician:

(1) An opioid antagonist used for treatment of drug addiction and administered in a long-acting or extended-release form. An opioid antagonist may also be administered for the treatment of alcohol dependence in accordance with approved labeling by the United States food and drug administration.

(2) An antipsychotic drug administered in a long-acting or extended-release form.

(3) Hydroxyprogesterone caproate for pregnant women.

(4) Medroxyprogesterone acetate for non-pregnant women.

(5) Cobalamin, to include: cyanocobalamin, hydroxocobalamin or any other vitamin B12 injection approved by the United States food and drug administration.

(6) Any other dangerous drugs authorized for pharmacist administration pursuant to section 4729.45 of the Revised Code.

(B) To be authorized to administer drugs pursuant to this rule, a pharmacist shall comply with all the following:

(1) Successfully complete a course in the administration of drugs that satisfies the requirements pursuant to paragraph (L) of this rule.

(2) Receive and maintain certification to perform basic life-support procedures by successfully completing a basic life-support training course certified by the American red cross, American heart association or other training course approved by the board. Certification shall be obtained and maintained through courses that are conducted in-person or, at a minimum, offer an in-person training component.

(3) Practice in accordance with a protocol that meets the requirements of paragraphs (F) and (G) of this rule.

(C) Each time a pharmacist administers a drug pursuant to this rule, the pharmacist shall comply with all the following:

(1) For each drug administered by a pharmacist to an individual who is eighteen years of age or older, the pharmacist shall obtain written permission from the individual.

(2) For each drug administered by a pharmacist to an individual who is under eighteen years of age, the pharmacist shall obtain written permission from the individual's parent or other person having care or charge of the individual.

(3) For each drug administered by a pharmacist to an individual who lacks the capacity to make informed health care decisions, the pharmacist shall obtain written permission from the person authorized to make such decisions on the individual's behalf.

(4) Permission obtained in accordance with this paragraph shall also include notification of the patient's right to request a private area in accordance with paragraph (J) of this rule.

(5) In the case of an opioid antagonist, obtain, in accordance with paragraph (D) of this rule, test results indicating that it is appropriate to administer the drug to the individual if either of the following is to be administered:

(a) The initial dose of the drug;

(b) Any subsequent dose, if the administration occurs more than thirty days after the previous dose of the drug was administered.

(6) Observe the individual to whom the drug is administered to determine whether the individual has an adverse reaction to the drug.

(7) Notify the physician who prescribed the drug within seven days that the drug has been administered to the individual. Notification of the physician shall be conducted using one of the following methods that is capable of confirming delivery of the required notification:

(a) Electronic mail;

(b) Interoperable electronic medical records system;

(c) Facsimile;

(d) Electronic prescribing system;

(e) Electronic pharmacy record system;

(f) Documented verbal communication; or

(g) Any other method of notification that might reasonably be expected to allow for the confirmed transmission of the required notification.

(D) A pharmacist may obtain the test results described in paragraph (C)(5) of this rule:

(1) From the prescribing physician or the physician's agent; or

(2) By ordering blood and urine tests for the individual to whom the opioid antagonist is to be administered.

(E) If a pharmacist orders blood and urine tests pursuant to paragraph (D) of this rule, the pharmacist shall evaluate the results of the tests to determine whether they indicate that it is appropriate to administer the opioid antagonist. A pharmacist's authority to evaluate test results pursuant to this rule does not authorize the pharmacist to make a diagnosis.

(F) A physician-established protocol for the administration of dangerous drugs in accordance with section 4729.45 of the Revised Code shall include the following:

(1) For the dangerous drugs listed in paragraph (A) of this rule:

(a) Name and strength;

(b) Precautions and contraindications;

(c) Intended audience or patient population;

(d) Dosage;

(e) Administration schedules;

(f) Routes of administration;

(g) Injection sites; and

(h) The type of tests that may be ordered in accordance with paragraph (E) of this rule.

(2) The length of time the pharmacist must observe an individual for adverse effects, which shall be based on standards of care established by the physician. The location of the observation shall be in the general vicinity of the administering pharmacist to allow for on-going evaluation.

(3) A method to address emergency situations including, but not limited to, adverse reactions, anaphylactic reactions, and accidental needle sticks.

(4) The locations that a pharmacist shall engage in the administration of dangerous drugs in accordance with paragraph (J) of this rule.

(5) Specify procedures to be followed by a pharmacist when administering epinephrine, diphenhydramine, or both, to an individual who has an adverse reaction to a drug administered by the pharmacist.

(G) All physician-established protocols pursuant to this rule and section 4729.45 of the Revised Code shall comply with the following:

(1) The protocol shall be signed and dated by the physician prior to implementation and shall be readily available to the administering pharmacist. The protocol shall be renewed by the physician on a biennial basis.

(2) A physician may sign one protocol for multiple locations licensed as terminal distributors of dangerous drugs.

(3) Each location licensed as a terminal distributor of dangerous drugs shall maintain a copy of the protocol on-site for inspection by an agent, inspector or employee of the state board of pharmacy.

(4) The protocol must be established by a physician who has a scope of practice that includes treatment of the condition for which the individual has been prescribed the drug to be administered.

(H) Upon the request of the state board of pharmacy, a pharmacist or terminal distributor of dangerous drugs shall immediately provide the protocols for administration of drugs in accordance with this rule. The state board of pharmacy, after review, may approve the protocol or return it to the pharmacist or terminal distributor for revision without approval. If a protocol has been returned for revision without approval, it may not be implemented until the board has granted approval.

(I) A pharmacist may administer epinephrine or diphenhydramine, or both, to an individual in an emergency situation resulting from an adverse reaction to a drug administered by the pharmacist.

(J) Dangerous drugs administered in accordance with this rule shall be administered in a location that ensures the privacy and dignity of the patient and is consistent with state and federal privacy laws and regulations. When necessary to protect patient privacy, or if requested by the patient, this shall include a private area located outside of the pharmacy.

(K) Administration records shall be maintained in accordance with rule 4729:5-5-04 of the Administrative Code.

(L) A course in the administration of dangerous drugs developed pursuant to section 4729.45 of the Revised Code shall meet the following requirements:

(1) The course shall be conducted by an accreditation council for pharmacy education (ACPE) accredited provider.

(2) The course must include the following components:

(a) A minimum of an hour and a half (0.15 C.E.U.s) of live or home study coursework for each category of dangerous drug listed in paragraph (A) of this rule that is covered by the course and shall include:

(i) A review of the conditions treated or prevented;

(ii) Mechanisms of action;

(iii) Routes of administration;

(iv) Injection sites and ensuring patient privacy;

(v) Dosages and administration schedules;

(vi) Monitoring and treatment of the patient for adverse reactions, including the use of diphenhydramine and epinephrine;

(vii) Patient populations;

(viii) Precautions and contraindications; and

(ix) Proper storage requirements.

(b) A minimum of thirty minutes (0.05 C.E.U.s) of live or home study coursework that includes:

(i) A review of sterile technique in injectable dosage preparation and administration;

(ii) A review of the proper disposal procedures for contaminated needles and dangerous drugs; and

(iii) A review of the proper procedures for accidental needle sticks.

(c) A minimum of one hour (0.1 C.E.U.s) of live and supervised physical participation in administration techniques for the categories of drugs covered by the course.

(d) If the course includes instruction on administration of an opioid antagonist, a minimum of one hour (0.1 C.E.U.s) of live or home study coursework that includes a review of the tests necessary to comply with paragraph (C)(5) of this rule and the evaluation of such tests.

(3) A pharmacist is not required to meet the training requirements of paragraph (L)(2)(b) of this rule if the pharmacist has met the training requirements in paragraphs (A)(4)(c), (A)(4)(e) and (A)(4)(f) of rule 4729:1-3-02 of the Administrative Code;

(4) A pharmacist is not required to meet the training requirements of paragraph (L)(2)(c) of this rule if all of the following apply:

(a) The pharmacist has met the training requirements in paragraph (A)(4)(d) of rule 4729:1-3-02 of the Administrative Code; and

(b) The instruction on administration techniques provided in accordance with rule 4729:1-3-02 of the Administrative Code includes the same techniques necessary to administer each category of dangerous drug covered by the training.

(5) The course must provide a method to evaluate the successful comprehension of the content.

(6) The course must provide a method to demonstrate the pharmacist has successfully completed the course.

(7) All live coursework shall be taught by an instructor that is a licensed health care professional who has the appropriate education and experience to teach a course in the administration of the dangerous drugs included in the categories listed in paragraph (A) of this rule.

(M) Courses may be reviewed by the state board of pharmacy. A training course that fails to comply with the requirements set forth in this rule shall be considered in violation of this rule.

(N) A pharmacist who has not successfully completed a course in drug administration that meets the requirements set forth in this rule must complete a course that meets the requirements specified in this rule prior to the administration of a dangerous drug listed in paragraph (A) of this rule.

(O) A pharmacist shall maintain the following records on file at the location(s) where the pharmacist administers dangerous drugs in accordance with this rule:

(1) Proof of successful completion of a training course specified in paragraph (L) of this rule; and

(2) Proof of maintenance of certification to perform basic life-support procedures in accordance with paragraph (B)(2) of this rule.

Supplemental Information

Authorized By: 4729.26, 4729.45
Amplifies: 4729.01, 4729.54, 4729.55
Five Year Review Date: 12/1/2025
Rule 4729:1-3-04 | Dispensing of naloxone by pharmacists.
 

(A) A pharmacist may dispense naloxone without a prescription to either of the following in accordance with a protocol specified in paragraph (B) of this rule:

(1) An individual who there is reason to believe is experiencing or at risk of experiencing an opioid-related overdose;

(2) A family member, friend, or other person in a position to assist an individual who there is reason to believe is at risk of experiencing an opioid-related overdose.

(B) A physician-established protocol for the dispensing of naloxone by a pharmacist or pharmacy intern under the direct supervision of a pharmacist shall include, but is not limited to, the following:

(1) A description of the clinical pharmacology of naloxone.

(2) Indications for use of naloxone as rescue therapy, including criteria for identifying persons eligible to receive naloxone under the protocol.

(3) Precautions and contraindications concerning dispensing naloxone.

(4) Naloxone products authorized to be dispensed, including all of the following information:

(a) Name of product;

(b) Dose;

(c) Route of administration and required delivery device; and

(d) Directions for use.

(5) Any patient instructions in addition to the patient training specified in this rule and rule 4729:2-3-04 of the Administrative Code.

(C) A pharmacist who dispenses naloxone pursuant to this rule shall instruct the individual to whom naloxone is dispensed verbally or in writing to summon emergency services as soon as practicable either before or after administering naloxone.

(D) Except as provided in paragraph (E) this rule, a pharmacist or a pharmacist's designee that is appropriately trained shall provide in-person training, unless the in-person training requirement is waived by the board, and written educational materials to the individual to whom naloxone is dispensed that includes all the following:

(1) Risk factors of opioid overdose;

(2) Strategies to prevent opioid overdose;

(3) Signs of opioid overdose;

(4) Steps in responding to an overdose;

(5) Information on the naloxone dispensed;

(6) Procedures for administering the naloxone dispensed;

(7) Proper storage and expiration of the naloxone dispensed; and

(8) Information on where to obtain a referral for substance abuse treatment.

(E) Patient training as required by paragraph (D) of this rule is not required if the patient has previously received training and all the following apply:

(1) The patient is offered training and refuses;

(2) The pharmacist or pharmacist designee has documentation confirming training pursuant to this rule has been provided within the previous twelve months;

(3) A pharmacist who dispenses naloxone pursuant to this rule shall still instruct the individual to whom naloxone is dispensed verbally or in writing to summon emergency services as soon as practicable either before or after administering naloxone.

(F) If training conducted pursuant to paragraph (D) of this rule is offered by a pharmacist's designee, the pharmacist shall not be required to counsel a patient or caregiver pursuant to rule 4729:5-5-09 of the Administrative Code if the patient or caregiver refuses the offer of counseling or does not respond to the written offer to counsel.

(G) A terminal distributor of dangerous drugs shall ensure that all pharmacists that dispense naloxone pursuant to this rule are trained on the use of naloxone and can meet the training requirements listed in paragraphs (C) and (D) of this rule.

(H) A terminal distributor of dangerous drugs shall ensure that all pharmacist designees are trained on the use of naloxone and can meet the training requirements listed in paragraph (D) of this rule.

(I) A pharmacist may document on a prescription form the dispensing of naloxone by the pharmacist or a pharmacy intern supervised by the pharmacist. The form may be assigned a number for record-keeping purposes.

(J) All physician-established protocols must be signed and dated by the physician prior to implementation and maintained by the terminal distributor of dangerous drugs. The protocols shall be renewed by a physician on a biennial basis.

(1) A physician may sign one protocol for multiple locations licensed as terminal distributors of dangerous drugs.

(2) Each location licensed as a terminal distributor of dangerous drugs shall maintain a copy of the protocol on-site for inspection by an agent, inspector or employee of the state board of pharmacy.

(K) Any pharmacy that dispenses naloxone pursuant to section 4729.44 of the Revised Code shall notify the board, in a manner determined by the board, within thirty days of establishing a protocol. A pharmacy that no longer dispenses naloxone pursuant to section 4729.44 of the Revised Code shall notify the board, in a manner determined by the board, within thirty days of discontinuation.

(1) Except in the event of a drug shortage, a pharmacy submitting notification of naloxone dispensing shall ensure naloxone is made available in accordance with this rule.

(2) A pharmacy that has submitted notification of naloxone dispensing shall provide initial training to all new employees and annual training to existing employees on the availability of naloxone dispensing pursuant to a protocol. Employees requiring training in accordance with this paragraph shall include: pharmacists, pharmacy interns, certified pharmacy technicians, registered pharmacy technicians, pharmacy technician trainees, and support personnel, as defined in rule 4729:3-1-01 of the Administrative Code, that have direct contact with the public. Training documentation records shall be maintained for a period of three years and shall be made readily retrievable.

(L) Paragraph (K) of this rule does not apply to institutional pharmacies that provide naloxone to inpatients or patients upon discharge.

Supplemental Information

Authorized By: 4729.44, 4729.26
Amplifies: 4729.44
Five Year Review Date: 12/1/2025
Prior Effective Dates: 7/17/2015 (Emer.), 10/16/2015
Rule 4729:1-3-05 | Therapeutic diabetic shoes.
 

(A) Pursuant to section 4779.02 of the Revised Code, a pharmacist may fit and measure individuals for therapeutic diabetic shoes and shoe inserts and may dispense those shoes and shoe inserts.

(B) A pharmacist shall not provide any other services that are authorized under Chapter 4779. of the Revised Code.

Supplemental Information

Authorized By: 4729.26
Amplifies: 4779.02
Five Year Review Date: 4/1/2024
Prior Effective Dates: 10/5/2015
Rule 4729:1-3-06 | Dispensing of epinephrine autoinjectors by pharmacists.
 

(A) A pharmacist may dispense an epinephrine autoinjector without a prescription to either of the following in accordance with a protocol specified in paragraph (B) of this rule:

(1) An individual who there is reason to believe is experiencing or at risk of experiencing anaphylaxis if the pharmacy affiliated with the pharmacist has a record of previously dispensing epinephrine to the individual in accordance with a prescription issued by a licensed health professional authorized to prescribe drugs; or

(2) An individual acting on behalf of a qualified entity, as defined in section 3728.01 of the Revised Code.

(B) A physician-established protocol for the dispensing of epinephrine autoinjectors by a pharmacist or pharmacy intern under the direct supervision of a pharmacist shall include, but is not limited to, the following:

(1) Indications for use of epinephrine autoinjectors, including criteria for identifying persons eligible to receive an autoinjector under the protocol.

(2) Precautions and contraindications related to the dispensing of epinephrine autoinjectors.

(3) Epinephrine autoinjectors authorized to be dispensed, including all the following information:

(a) Name of product;

(b) Dose;

(c) Quantity to be dispensed; and

(d) Directions for use.

(4) Any patient instructions in addition to the training specified in this rule and rule 4729:2-3-06 of the Administrative Code.

(C)

(1) A pharmacist who dispenses an epinephrine autoinjector pursuant to this rule shall instruct the individual to whom the epinephrine autoinjector is dispensed, either verbally or in writing, to summon emergency services as soon as practicable either before or after administering epinephrine.

(2) A pharmacist who dispenses an epinephrine autoinjector to an individual identified in paragraph (A) of this rule shall provide notification of the dispensing to the individual's primary care provider, if known, or to the prescriber who issued the individual the initial prescription for an epinephrine autoinjector. Notification shall be conducted using one of the following methods that is capable of confirming delivery of the required notification:

(a) Electronic mail;

(b) Interoperable electronic medical records system;

(c) Facsimile;

(d) Electronic prescribing system;

(e) Electronic pharmacy record system;

(f) Documented verbal communication;

(g) Any other method of notification that might reasonably be expected to allow for the confirmed transmission of the required notification.

(D) When a pharmacist dispenses an epinephrine autoinjector pursuant to this rule, the pharmacist, or pharmacy intern under the direct supervision of a pharmacist, shall provide to the person receiving the device instruction on the proper method of administering epinephrine with the device.

(E) A terminal distributor of dangerous drugs shall ensure that all pharmacists that dispense epinephrine autoinjectors pursuant to this rule are trained on the use of epinephrine and can meet the training requirements listed in paragraphs (C) and (D) of this rule.

(F) A pharmacist may document the dispensing of an epinephrine autoinjector by the pharmacist or pharmacy intern under the direct supervision of the pharmacist on a prescription form. The form may be assigned a number for record-keeping purposes.

(G) This rule does not affect the authority of a pharmacist to:

(1) Dispense a new prescription or refill for epinephrine; or

(2) Contact a prescriber to obtain a new oral prescription for an epinephrine autoinjector in accordance with the applicable provisions of division 4729:5 of the Administrative Code.

(H) All physician-established protocols must be signed and dated by the physician prior to implementation and maintained by the terminal distributor of dangerous drugs. The protocols shall be renewed by a physician on a biennial basis.

(1) A physician may sign one protocol for multiple locations licensed as terminal distributors of dangerous drugs.

(2) Each location licensed as a terminal distributor of dangerous drugs shall maintain a copy of the protocol on-site for inspection by an agent, inspector or employee of the state board of pharmacy.

Supplemental Information

Authorized By: 4729.26, 4729.47
Amplifies: 4729.47
Five Year Review Date: 1/18/2025