(A) Pursuant to rule 4729-5-11 of the Administrative Code, the supervision and control of dangerous drugs is the responsibility of the responsible person. The responsible person may delegate the day-to-day tasks to 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, emergency medical technicians-intermediate (advanced emergency medical technicians), registered nurses, physicians, and pharmacists who are associated with the 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 emergency medical technicians-intermediate (advanced emergency medical technician) as defined in section 4765.01 of the Revised 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 shall 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(G) Any non-controlled dangerous drug that is outdated may be returned to the supplier where the drug was obtained or may be disposed of in the proper manner.
(H) Any controlled substance that is outdated may be returned to the supplier where the drug was obtained.
(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 emergency medical technicians-intermediate ( advanced emergency medical technician), as defined in section 4765.01 of the Revised Code, level of training.
(K) Any theft or significant loss of dangerous drugs shall be reported in accordance with rule 4729-9-15 of the Administrative Code. A report must be filed with the state board of pharmacy of any loss or theft of a vehicle or storage cabinet 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.
Five Year Review (FYR) Dates: 11/29/2016 and 02/17/2022
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, 5/22/2014