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, emergency medical technician-intermediates, 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 emergency medical technician-intermediate as defined in rules 4765-16-01 and 4765-16-02 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(G) Any non-controlled dangerous drug that is outdated may be returned to the supplier where the drug was obtained or may be disposed of in the proper manner.

(H) Any controlled substance that is outdated may be returned to the supplier where the drug was obtained.

(I) Destruction of outdated controlled substances may only be done by a state board of pharmacy agent or by prior written permission from the state board of pharmacy office.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 emergency medical technician-intermediate, as defined in rules 4765-16-01 and 4765-16-02 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.

R.C. 119.032 review dates: 09/26/2008 and 09/26/2013

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