Chapter 4729-33 Emergency Medical Services

4729-33-01 Definitions.

As used in Chapter 4729-33 of the Administrative Code:

(A) "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.

(B) "Controlled substance" has the same meaning as in section 4729.01 of the Revised Code.

(C) "Dangerous Drug" has the same meaning as in section 4729.01 of the Revised Code and in rule 4729-9-01 of the Administrative Code.

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

(E) "Medical director" has the same meaning as in rule 4765-10-06 of the Administrative Code.

(F) "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 situation.

(G) "Posting up" means locating an EMS unit containing dangerous drugs at a location other than a location licensed by the board of pharmacy.

(H) "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 pursuant to a formal agreement with the sponsors of the special event.

(I) "Readily retrievable" means all records which are required to be maintained must be provided upon request to the inspector or agent of the board of pharmacy within three working days.

(J) "Responsible person" has the same meaning as in rule 4729-13-01 of the Administrative Code.

(K) "Satellite" means an address licensed by the board as a terminal distributor of dangerous drugs that is separate from the licensed headquarters address of the EMS organization.

(L) "Scope of practice shall be defined as in section 4765.35 of the Revised Code and rule 4765-12- 04 of the Administrative Code for a emergency medical responder, section 4765.37 of the Revised Code and rule 4765-15-04 of the Administrative Code for an emergency medical technician, section 4765.38 of the Revised Code and rule 4765-16-04 of the Administrative Code for an advanced emergency medical technician, and section 4765.39 of the Revised Code and rule 4765-17-03 of the Administrative Code for aparamedic, and rules 4765-6-01 , 4765-6-03 , 4765-6-04 and 4765-6-05 of the Administrative Code.

(M) "Special event" means an event requiring EMS coverage for more than twenty-four hours including, but not limited to, the following:

(1) A county fair.

(2) A weekend festival.

(N) "Standing order" and "protocol" have the same meanings as in rule 4729-5-01 of the Administrative Code.

(O) "Tamper-evident" means the package is sealed 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.

(P) "Terminal distributor of dangerous drugs" has the same meaning as in section 4729.01 of the Revised Code.

Effective: 08/22/2014
R.C. 119.032 review dates: 06/06/2014 and 05/30/2019
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.01 , 4729.51 , 4729.54 , 4729.55
Prior Effective Dates: 8/15/2000, 1/1/2004, 1/1/09

4729-33-02 Licensure.

(A) Any emergency medical service (EMS) organization that desires to stock dangerous drugs shall apply for and maintain a license as a terminal distributor of dangerous drugs. The one location that serves as the main station will be deemed the headquarters location. Any other locations associated with this headquarters where dangerous drugs will be stored will be licensed as "satellites". Only the headquarters location will be charged a license fee or renewal license fee.

(B) Each location, headquarters and satellites, must be licensed as a limited terminal distributor of dangerous drugs and must maintain a current terminal distributor of dangerous drugs license and drug addendum.

(C) An application for licensure must include all of the following:

(1) A completed application;

(2) A compilation of all protocols involving dangerous drugs that have been signed by the medical director and notarized;

(3) A list of drugs referenced in the protocols to be stocked by the EMS organization, signed by the medical director and notarized;

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

(5) A list of any and all formal written mutual aid agreements with other EMS organizations;

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

(D) Each location, headquarters and satellite, may only possess those dangerous drugs that are listed on the drug addendum and only at locations licensed by the board of pharmacy.

(1) A medical director may add dangerous drugs to the drug list by submitting revised, signed and notarized protocols and list of medications, and the addendum update fee.

(2) A medical director may delete dangerous drugs from the drug list by submitting a letter listing the drugs to be deleted.

(E) A new application and fee is required prior to any change of location, addition of a satellite location, change of category, name change, or change of ownership. These changes may be made during the annual renewal period with no additional fee other than the renewal fee.

(F) The responsible person shall provide supervision and control of all locations where dangerous drugs are stored. The responsible person must be a physician licensed pursuant to Chapter 4731. of the Revised Code or a pharmacist licensed pursuant to Chapter 4729. of the Revised Code.

(1) To change the responsible person, the new responsible person must complete and return a notification of change of responsible person form within thirty days by regular mail or verified facsimile transmission.

(2) To change the medical director, the new medical director must submit a signed and notarized letter stating that he/she is accepting responsibility for the EMS organization.

(a) If the new medical director approves of the current protocol and drug list, a signed and notarized letter must be submitted stating the current protocols and drug list on file have been reviewed and are approved by the medical director for use by this EMS organization, or

(b) If the new medical director desires to change the protocols or drug list, the medical director must submit the revised, signed, and notarized protocols and drug list, and the addendum update fee.

(G) Any changes in protocols that involve dangerous drugs must be submitted to the state board of pharmacy prior to the implementation of the protocols involved. The state board of pharmacy may discuss such protocols with the state board of emergency medical, fire and transportation services, state medical board, or other governmental agencies as needed to assure their validity.

(H) Any change of personnel requires a letter from the organization within thirty days of the change listing the type of change (addition, update, or deletion), names of the personnel involved, level of certification, their certification number, and expiration date.

Effective: 08/22/2014
R.C. 119.032 review dates: 06/06/2014 and 05/30/2019
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.51 , 4729.54 , 4729.55
Prior Effective Dates: 8/15/2000, 1/1/2004, 1/1/09

4729-33-03 Security and storage of dangerous drugs.

(A) Overall supervision and control of dangerous drugs is the responsibility of the responsible person. The responsible person may delegate the day-to-day tasks to the emergency medical service (EMS) organization personnel who hold appropriate certification to access the dangerous drugs for which they are responsible.

(B) All dangerous drugs must be secured in a tamper-evident setting with access limited to EMS personnel based on their certification status except for sealed, Tamper-evident solutions labeled for irrigation use. All registrants shall provide effective and approved controls and procedures to deter and detect theft and diversion of dangerous drugs.

(C) Only emergency medical technician-paramedics, advanced emergency medical technicians, registered nurses, physicians, and pharmacists who are associated with that EMS organization may have access to any controlled substances maintained by the EMS organization. Other persons employed by the EMS organization may have access to controlled substances only under the direct and immediate supervision of an emergency medical technician-paramedic, an advanced emergency medical technician as defined in Chapter 4765-16 of the Administrative Code, a registered nurse, or a physician in emergency situations.

(D) Administration of dangerous drugs by EMS personnel is limited to the scope of practice, as determined by the state board of emergency medical services, for the individual's certification level and the protocols as established by the medical director or when the individual is acting within their certification level pursuant to direct prescriber's orders received over an active communication link.

(E) All dangerous drugs will be maintained in a clean and temperature-controlled environment.

(F) Any dangerous drug that reaches its expiration date is considered adulterated and must be separated from the active stock to prevent possible administration to patients.

(G) Any non-controlled dangerous drug that is outdated may be returned to the supplier where the drug was obtained or may be disposed of in the proper manner.

(H) Any controlled substance that is outdated may be returned to the supplier where the drug was obtained.

(I) Destruction of outdated controlled substances may only be done by a state board of pharmacy agent or by prior written permission from the state board of pharmacy office.

(J) Destruction of partially used controlled substances can be accomplished, with the appropriate documentation, by two licensed health care personnel, one of which must have at least an advanced emergency medical technician, as defined in Chapter 4765-16 of the Administrative Code, level of training.

(K) Any loss or theft of dangerous drugs must be reported upon discovery, by telephone, to the state board of pharmacy, local law enforcement and, if controlled substances are involved, to the drug enforcement administration. A report must be filed with the state board of pharmacy of any loss or theft of the vehicle or storage cabinets containing dangerous drugs used by the EMS organization.

(L) Any dangerous drug showing evidence of damage or tampering shall be removed from stock and replaced immediately.

Effective: 05/22/2014
R.C. 119.032 review dates: 03/07/2014 and 05/22/2019
Promulgated Under: 119.03
Statutory Authority: 4729.26 , 3719.28
Rule Amplifies: 4729.51 , 4729.54 , 4729.55
Prior Effective Dates: 8/15/2000, 1/1/2004

4729-33-04 Record keeping.

(A) All emergency medical service (EMS) organizations are required to keep complete and accurate records for at least three years of receipt, use, administration, destruction, and waste of dangerous drugs. These records must be readily available for inspection by state board of pharmacy agents or inspectors as per section 3719.27 of the Revised Code and rule 4729-5-29 of the Administrative Code.

(B) Records from satellites may be stored at the headquarters if prior notice is sent to the board office. A letter requesting storage of records at the headquarters must be sent to the state board of pharmacy office by verifiable delivery. The board will notify the organization of the board's approval or denial of the request within sixty days.

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

(D) If there is a recall of oxygen by the manufacturer, all portable oxygen tanks that may have any of that lot number shall be dealt with according to the manufacturer's recommendations; but, in all such cases, such portable oxygen tanks must be purged and then refilled.

(E) A readily retrievable record of controlled substances shall be kept containing documentation of administration, use, or waste of the controlled substances. Such records shall contain at least the following information:

(1) The name, strength, and quantity of the controlled substance administered, used, or wasted;

(2) The date of administration, use, or waste;

(3) The name or other means of identifying the patient, such as medical record number or run number;

(4) The signature and identification number of the individual administering the controlled substance;

(5) In the case of waste, the signatures and identification numbers of both individuals involved in wasting the controlled substance.

(F) If a computerized record keeping system is being utilized to document any drug transactions, including but not limited to the receipt, use, administration, destruction, and wastage, then the system must have "positive identification", pursuant to paragraph (N) of rule 4729-5-01 of the Administrative Code, of the individual responsible for the drug transaction and be approved by the state board of pharmacy.

R.C. 119.032 review dates: 09/03/2014 and 06/29/2019
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.51 , 4729.54 , 4729.55
Prior Effective Dates: 8/15/2000, 1/1/2006, 01/01/2009

4729-33-05 Posting up.

(A) Except when "posting up at a special event", "posting up" must be a temporary, short-term location of the EMS unit for less than twenty-four hours where the EMS unit is under constant supervision of the EMS personnel on duty, including but not limited to:

(1) Local school sports event;

(2) Coverage of a station pursuant to a written mutual aid agreement.

(B) "Posting up at a special event" requires prior written notification to, and approval from, the state board of pharmacy office. This notification must include the name and location of the event, dates of the event, and name and telephone number of the contact person of the EMS unit.

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

Effective: 08/22/2014
R.C. 119.032 review dates: 06/06/2014 and 05/30/2019
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.51 , 4729.54 , 4729.55
Prior Effective Dates: 8/15/2000, 1/1/09