​Statement on Security of Medications in the Operating Room

Developed By: ASA House of Delegates/Executive Committee
Committee of Oversight: Quality Management and Departmental Administration
Last Amended: October 18, 2023 (original approval: October 26, 2003)

Preamble

A secure environment^2,3 of care is necessary for medication safety. Medication safety includes the security of oral, sublingual, parenteral, and inhaled pharmaceutical agents used for elective and emergency patient care. A secure physical area ensures the integrity of anesthesia machines as well as other equipment and materials. Security of medications, while maintaining rapid accessibility, in a secure anesthetizing location is essential for patient safety.

Recommended Policies

1. Access to secure anesthetizing locations must be strictly limited to authorized persons.
2. All Schedule II through V medications must be kept in locked enclosed areas when not under the direct control of an anesthesia professional.
3. Anesthesia professionals must have immediate access to drugs and equipment required for emergency patient care.  Procedures designed to prevent unauthorized access to such drugs must not impede this imperative for patient safety.
4. Anesthesia carts and anesthesia machines may remain unlocked, and non-controlled* medications may be left in or on top of unlocked anesthesia carts or anesthesia machines immediately prior to, during, and immediately following surgical cases in a secure anesthetizing location, so long as there are authorized personnel present.

Rationale

1. Because a secure anesthetizing location is a limited-access secure location, it is safe practice for anesthesia professionals to leave non-controlled* medications on the top of their anesthesia carts or anesthesia machines for brief periods (e.g., while going to a nearby holding area to bring a patient into the operating room).
2. At the end of anesthesia cases, when patients are particularly vulnerable, anesthesia professionals dedicate full attention to their patients. This vulnerable period extends from the time the patient emerges from anesthesia until the anesthesia professional transfers care of the patient to recovery personnel. If drugs are locked up during this vulnerable period, provider access to drugs required for emergency patient care is obstructed. Requiring anesthesia professionals to divert attention from patients in order to lock non-controlled* medications in anesthesia carts during the period between emergence from anesthesia and transport of patients out of the operating room jeopardizes patient safety. Therefore, locking non-controlled* medications at this point in the anesthetic is not required.
3. It is necessary and safe practice for non-controlled* medications to be set up for emergency cases (e.g., obstetrics, trauma). If this is a non-secure location, then medications must be made secure ("locked") by a tamper-evident device that can easily be broken by authorized persons.
4. It is necessary and safe practice for emergency anesthesia drugs (e.g., dantrolene for the treatment of malignant hyperthermia) to be kept in a dedicated emergency cart or cupboard and made secure ("locked") by a tamper-evident device that can easily be broken by authorized persons.

*The term "non-controlled" refers to medications that are not Schedule II-V. In some states, anesthesia professionals may need to include reference to Schedule VI medications in their policies and procedures.

Appendix:

1. The Joint Commission and the Center for Medicare Services (CMS) have defined a secure environment. Facility policies and procedures should reference and adhere to these guidelines. Both agencies require that all drugs and biologicals must be kept in a secure area, and locked when appropriate [TJC 03.01.01 EP 3 and CMS Conditions of Participation 482.25(b)(2)(i)].
2. CMS defines a secure area as follows. “A secure area means that drugs and biologicals are stored in a manner to prevent unmonitored access by unauthorized individuals. Drugs and biologicals must not be stored in areas that are readily accessible to unauthorized persons. For example, if medications are kept in a private office, or other area where patients and visitors are not allowed without the supervision or presence of a health care professional (for example, ambulatory infusion), they are considered secure. Areas restricted to authorized personnel only would generally be considered ‘secure areas.’” [CMS Conditions of Participation 482.25(b)(2)(i)].
3. CMS has provided specific guidance on security in the OR environment in the Federal Register on November 27, 2006, Vol. 71, No. 227. The document states the following: “An area in which staff are actively providing patient care or preparing to receive patients, that is, setting up for procedures before the arrival of a patient, would generally be considered a ‘‘secure area.’’ For example, the operating room suite would be considered secure when the suite is staffed and staff are actively providing patient care. When the entire suite is not operational or otherwise not in use, for example, weekends, holidays, and after hours, the suite would not be considered secure. When the suite is closed or otherwise not in use, we would expect all drugs and biologicals to be locked.” The Joint Commission provided similar guidance in the Standards Booster Pak for Safe Medication Storage, published in April, 2014, page 14, that states that “If the individual operating room is part of a larger OR unit that is manned at all times in a fashion that monitors access to the operating room and assures constant surveillance of the anesthesia cart to prohibit access by unauthorized individuals, locking of the cart between cases would not be required.” Non-licensed staff are considered authorized personnel and an area may be considered secure in the presence of non-licensed staff. The CMS Conditions of Participation allows non-licensed personnel access to locked areas if controlled substances are locked to prevent access. [TJC 03.01.01 EP 6 and CMS Conditions of Participation 482.25(b)(2)(iii)].