Chapter 4729:5-14 Emergency Medical Services

4729:5-14-01 Emergency medical services - definitions.

As used in Chapter 4729:5-14 of the Administrative Code:

(A) "Business day" means any day other than Saturday, Sunday or a holiday recognized by the state of Ohio on which the offices of the board of pharmacy are not open for business.

(B) "Certificate to practice" means the level to which an individual is trained and licensed as defined in sections 4765.01, 4765.011 and 4765.30 of the Revised Code and rule 4765-1-01 of the Administrative Code.

(C) "Direct supervision" or "personal supervision" means EMS organization personnel shall be physically present at the licensed location or within the immediate proximity of an EMS unit to deter and detect the diversion of dangerous drugs.

(D) "Electronic signature" means any of the following attached to or associated with an electronic drug administration record by EMS organization personnel to authenticate the drug administration record:

(1) A private, unique personal identifier and secure passcode consisting of a combination of letters, numbers, and symbols that is adapted or executed by an individual as that individual's electronic signature.

(2) An electronic image of an individual's handwritten signature that is captured following drug administration and is created by using a writing apparatus (i.e. stylus). The signature shall be legible and include the person's first name, last name and credentials.

(3) Any other method approved by the board.

(E) "Emergency medical service organization" or "EMS organization" has the same meaning as in section 4765.01 of the Revised Code.

(F) "Medical director" means a physician to whom an EMS organization has designated, pursuant to section 4765.42 of the Revised Code, to perform the duties of medical director including establishing medical protocols that must be followed in the delivery of emergency medical services.

(G) "Mutual aid" means a formal written agreement between two or more EMS organizations to assist in emergency medical coverage in the other's usual area of coverage, including having access to dangerous drugs during the emergency.

(H)

(1) "Positive identification" means a method of identifying EMS personnel that does 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.

(I) "Posting up" means locating an EMS unit containing dangerous drugs at a location other than a location licensed by the board of pharmacy for less than twenty-four hours and where the EMS unit is under the direct supervision of the EMS personnel on duty.

(J) "Posting up at a special event" means locating an EMS unit containing dangerous drugs at a location other than a location licensed by the board of pharmacy for more than twenty-four consecutive hours pursuant to a formal agreement with the sponsors of the event and where the EMS unit is under the direct supervision of the EMS personnel on duty.

(1) Posting up at a special event requires notification to the board. Notification shall be provided prior to the special event in a manner determined by the board.

(2) The requirements of this paragraph do not apply in the event of an emergency management assistance compact or an emergency declared by the governor.

(K) "Protocol" or "standing order" means a definitive set of written treatment guidelines that include definitive orders for drugs and their specified dosages which have been authorized and signed by the EMS organization's medical director. A protocol may be used only by licensed or certified EMS personnel, in accordance with the individual's scope of practice, when providing limited medical services to individuals in an emergency.

(L) "Readily retrievable" means that records maintained in accordance with this chapter shall be kept in such a manner that they can be separated out from all other records and, upon request, produced for review no later than three business days to an agent, officer or inspector of the board.

(M) "Responsible person" has the same meaning as defined in agency 4729 of the Administrative Code and is responsible for the supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of section 4729.55 of the Revised Code, security and control of dangerous drugs and maintaining all drug records otherwise required.

(N) "Satellite" means a location licensed by the state board of pharmacy as a terminal distributor of dangerous drugs that is separate from the licensed headquarters of the EMS organization.

(O) "Scope of practice" has the same meaning as defined as in section 4765.35 of the Revised Code and rule 4765-12-04 of the Administrative Code for an emergency medical responder or first responder, section 4765.37 of the Revised Code and rule 4765-15-04 of the Administrative Code for an emergency medical technician or emergency medical technician-basic, section 4765.38 of the Revised Code and rule 4765-16-04 of the Administrative Code for an advanced emergency medical technician or emergency medical technician-intermediate, and section 4765.39 of the Revised Code and rule 4765-17-03 of the Administrative Code for a paramedic or emergency medical technician-paramedic.

(P) "Tamper-evident" means a package, storage container or other physical barrier is sealed or secured in such a way that access to the drugs stored within is not possible without leaving visible proof that such access has been attempted or made.

Replaces: 4729-33-01, 4729-33-05

Effective: 3/1/2018
Five Year Review (FYR) Dates: 03/01/2023
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.51, 4729.54, 4729.55
Prior Effective Dates: 08/15/2000, 01/01/2004, 1/1/09, 08/22/2014

4729:5-14-02 Licensure.

(A) An EMS organization that possesses dangerous drugs shall apply for and maintain a license as a terminal distributor of dangerous drugs with an emergency medical services classification.

(1) The location that serves as the main station of the EMS organization will be deemed the headquarters.

(2) Any satellite location associated with the headquarters of the EMS organization where dangerous drugs will be stored must be licensed as a terminal distributor of dangerous drugs.

(B) An application for licensure shall include all the following:

(1) A completed application;

(2) A copy of the organization's protocols signed by the medical director;

(3) A list of the dangerous drugs, or drug list, that may be possessed and administered by EMS organization personnel, expressed in standard dose units, signed by the medical director;

(4) A list of personnel employed, including volunteers, by the EMS organization who may access and administer dangerous drugs, which includes the name of each employee or volunteer, level of certification, certification number, and expiration date; and

(5) The fee for the appropriate category of licensure.

(C) Each location, headquarters and satellite, may only possess those dangerous drugs that are on the drug list submitted to the board pursuant to paragraph (B)(3) of this rule and only at locations licensed by the state board of pharmacy.

(1) A medical director may modify the drugs that may be possessed and administered by EMS organization personnel by submitting a new drug list to the state board of pharmacy in a manner determined by the board.

(2) A modification to the drug list shall require an update to the EMS organization's protocols. Any updates or changes to the protocols shall only be submitted to the board upon request.

(D) If there is a change of the medical director of an EMS organization, the new medical director shall submit notification, in a manner determined by the board, no later than five business days following the change. Notification shall include a current drug list signed by the new medical director.

(E) Any change of the EMS organization's personnel list shall be updated within thirty days of a change of personnel. Any change of personnel shall only be submitted to the board upon request.

(F) An EMS organization shall maintain a current copy or have access to a current copy of the organization's protocols, personnel list and drug list at each licensed location.

Replaces: 4729-33-02

Effective: 4/2/2018
Five Year Review (FYR) Dates: 04/02/2023
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.51, 4729.54, 4729.55
Prior Effective Dates: 08/15/2000, 01/01/2004, 01/01/2009, 08/22/2014, 4/10/16

4729:5-14-03 Security and control of dangerous drugs.

(A) The security and control of dangerous drugs is the responsibility of the responsible person on the terminal distributor of dangerous drugs license. The responsible person may delegate the day-to-day tasks to EMS organization personnel who hold appropriate certification/licensure to access the dangerous drugs for which the personnel are responsible. A responsible person shall comply with the requirements set forth in agency 4729 of the Administrative Code.

(B) A licensed EMS organization shall provide effective controls and procedures to deter and detect the theft and diversion of dangerous drugs.

(C) All dangerous drugs must be secured in a tamper-evident manner with access limited to EMS personnel based on certification status, except for the following if stored in a sealed, tamper-evident manner:

(1) Solutions labeled for irrigation use;

(2) Dextrose solutions;

(3) Saline solutions;

(4) Lactated ringers;

(5) Sterile water; and

(6) Naloxone hydrochloride.

(D) Only the following may have access to any controlled substances maintained by the EMS organization:

(1) A paramedic or emergency medical technician-paramedic certified in accordance with section 4765.30 of the Revised Code;

(2) An advanced emergency medical technician or emergency medical technician- intermediate certified in accordance with section 4765.30 of the Revised Code; and

(3) Licensed prescribers, nurses or pharmacists who are employed or affiliated with the EMS organization.

(E) Other EMS organization personnel may have access to controlled substances only under the direct supervision of the individuals listed in paragraph (D) of this rule.

(F) Administration of dangerous drugs by EMS personnel is limited to the individual's scope of practice based upon certification level and either:

(1) The protocols established by the organization's medical director; or

(2) A verbal order by a prescriber received in-person or over an electronic communications device.

(G) All areas where dangerous drugs and devices are stored shall be dry, well-lighted, well- ventilated, and maintained in a clean and orderly condition. Storage areas shall be maintained at temperatures which will ensure the integrity of the drugs prior to their use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling unless otherwise directed by the board.

(H) A dangerous drug that reaches its expiration date is considered adulterated and must be separated from active stock to prevent possible administration to patients. Adulterated drugs shall be stored no longer than one year from the date of adulteration or expiration by the EMS organization. Adulterated drugs shall be stored in a manner that prohibits access by unauthorized persons.

(I) A non-controlled dangerous drug that is expired may be returned to the supplier where the drug was obtained or may be disposed of in a manner that renders the drug unavailable and unusable.

(J) Unless the EMS organization is registered with the United States drug enforcement administration (DEA), any controlled substance that is expired shall be returned to the hospital acting as the EMS organization's responsible DEA registrant.

(K) Except as provided in paragraph (L) of this rule, disposal of controlled substances shall be conducted in accordance with rule 4729:5-3-01 of the Administrative Code by individuals listed in paragraph (D) of this rule.

(L) The unused portion of a controlled substance resulting from administration to a patient from a licensee's stock or emergency supply may be destroyed using an on-site method. The on-site method does not have to meet the definition of non-retrievable in rule 4729:5-3-01 of the Administrative Code but must render the drug unavailable and unusable.

Destruction of partially used controlled substances shall be conducted by two licensed/certified healthcare personnel, one of whom shall meet the qualifications listed in paragraph (D) of this rule.

(M) Any dangerous drug showing evidence of damage or tampering shall be removed from active stock and replaced immediately. The drug shall be stored no longer than one year from the date of discovery of tampering or damage by the EMS organization and shall be stored in a manner that prohibits access by unauthorized persons.

(N) If there is a recall of oxygen by the manufacturer, all portable oxygen tanks affected by the recall shall be handled in accordance with the manufacturer's recall instructions.

Replaces: 4729-33-03

Effective: 3/1/2018
Five Year Review (FYR) Dates: 03/01/2023
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.51, 4729.54, 4729.55
Prior Effective Dates: 08/15/2000, 01/01/2004, 05/22/2014, 2/17/2017

4729:5-14-04 Record keeping.

(A) All EMS organizations shall keep a record of all dangerous drugs received, administered, sold, transferred, destroyed, disposed or used.

(B) Records of receipt shall contain a description of all dangerous drugs received, the kind and quantity of dangerous drugs received, the name and address of the persons from whom received, and the date of receipt.

(C) Except as provided in paragraph (C)(1) of this rule, all records of receipt, distribution, administration, selling, disposing, destroying or using dangerous drugs shall be maintained for a period of three years at the place where the dangerous drugs are located.

Records from satellites may be stored at the EMS organization headquarters if prior approval, in a manner determined by the board, is obtained by the EMS organization.

(D) Records of administering dangerous drugs shall be legible and shall contain the first and last name of the EMS personnel who administered the drug, name of the EMS organization, name and strength of the drug administered, date of administration, time of administration, amount of the dose administered, the name or other means of identifying the patient, such as medical record number or run number, and the identification of the individual administering the drug using either of the following methods:

(1) An electronic signature in a computerized recordkeeping system; or

(2) Any form of positive identification.

(E) Records of the disposal or destruction of non-controlled dangerous drugs shall contain the name, strength, dosage form, and quantity of the dangerous drug disposed, the date of disposal, the method of disposal, and, if disposal is performed on-site, the positive identification of the EMS personnel who disposed of the drugs.

(F) Except as provided in paragraph (F)(1) of this rule, records for the disposal of controlled substance drugs shall be maintained in accordance with rule 4729:5-3-01 of the Administrative Code and, if disposal is performed on-site, the positive identification of the EMS personnel who disposed of the drugs.

Records for the disposal or destruction of the unused portion of a controlled substance resulting from administration to a patient from a licensee's stock or emergency supply shall contain the name, strength, dosage form, and quantity of the dangerous drug disposed, the date disposed, the method of disposal and the positive identification of the EMS personnel who disposed of the drugs.

(G) All records maintained in accordance with this rule shall be uniformly maintained and readily retrievable.

(H) Except as provided in paragraph (H)(1) of this rule, an EMS organization shall conduct an annual inventory of all controlled substances in accordance with agency 4729 of the Administrative Code.

Notwithstanding any other provision of the Administrative Code, this paragraph does not apply to an EMS utilizing a 1:1 exchange system with a hospital acting as its responsible DEA registrant.

(I) All records maintained pursuant to this rule may be electronically created and maintained, provided that the system that creates and maintains the electronic record does so in accordance with the following:

(1) All paper records shall be scanned in full color via technology designed to capture information in one form and reproduce it in an electronic medium presentable and usable to an end user;

(2) A record or image once created shall be unalterable but may be annotated as necessary so long as the original record or image is still available for review and the individual that made the annotation is noted;

(3) Contains security features to prevent unauthorized access to the records; and

(4) Contains daily back-up functionality to protect against record loss.

(J) Records of oxygen transfilling shall include the manufacturer's lot number of the oxygen used for transfilling the portable oxygen tanks.

Replaces: 4729-33-04

Effective: 3/1/2018
Five Year Review (FYR) Dates: 03/01/2023
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.51, 4729.54, 4729.55
Prior Effective Dates: 08/15/2000, 01/01/2006, 01/01/2009