Pharmaceutical Services
Policies and Procedures — Security of Anesthesia
Medications
Preamble
Anesthesiologists use medications both to sedate or anesthetize patients
and to relieve pain, most commonly with controlled substances from DEA
Schedules II, III and IV. Anesthesiologists also administer medications
to manage the neuromuscular system, cardiovascular system and pulmonary
system: drugs used for these purposes must be immediately available at
all times in any active anesthetizing location. Limiting access to these
resuscitation drugs even for a few seconds could seriously compromise
patient safety. Any protocols or procedures designed to prevent tampering
with or diversion of anesthesia medications must permit immediate access
to resuscitation drugs, consistent with federal regulations (42 C.F.R.
§462.25(b) (2)) that were revised effective January 26, 2007.
Purpose
This policy provides that medications shall be stored securely to protect
the safety of patients and the public health while allowing appropriate
access by authorized personnel.
Pharmacy Policies
Pharmacy is ultimately responsible for the storage, dispensing and inventory
control of all perioperative medications.
Coordination with Anesthesiology Policies
The Department of Anesthesiology is responsible for the safety of patients
under its care. Pharmacy and Anesthesiology will together ensure that
medication security policies proposed by either service (1) maintain patient
safety, (2) do not conflict with each other and (3) comply with federal
and state regulations.
Controlled and Noncontrolled Medications
Drugs used in anesthesiology are divided into controlled (DEA Schedules
II, III and IV) and noncontrolled substances. (For the purpose of this
policy on medication security, ephedrine and propofol are treated like
controlled substances.)
Procedures and Definitions
1. All anesthesia medications will be kept in
a secure area.
2. Controlled substances must be locked within a secure area.
“Secure Area”
A Suite or Unit is secure when it is locked, or when the Suite/Unit is
in active use and access and egress is monitored and restricted to authorized
personnel. Procedures to ensure that only authorized personnel (see below)
and patients have access to secure areas are described in the Facilities
Policies and Procedures.
A. All active operating room (O.R.) suites are considered secure areas
when they are staffed and being used to provide patient care, as long
as they are accessible only to authorized personnel (see below). When
the entire O.R. Suite is closed and not staffed, it may be considered
secure if it is locked.
B. The Procedure Units listed below are considered secure areas during
regular hours when they are staffed and being used to provide patient
care, as long as they are accessible only to authorized personnel. When
the Units are closed, they will be considered secure only if they are
locked.
• Postanesthesia Care Unit
• Labor and Delivery Unit
• Surgical Intensive Care Unit
• Radiology
• Interventional Radiology
• Cardiac Catheterization Lab
• Endoscopy Unit
Security of NONCONTROLLED Medications
When the O.R. Suite or Procedure Unit is in use and access is restricted,
NONCONTROLLED anesthesia 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 an O.R. so long as there are authorized
operating room personnel in the O.R. suite.
If access to any Unit is not restricted to authorized personnel, medications
must be kept in a cart, cabinet or individual procedure room to which
access is controlled or which is locked if not in active use (i.e., awaiting
a scheduled or emergency case, being used for a case, or during turnover
or cleanup from a case).
The O.R. Suite is locked at all times when it is not in use. Anesthesia
carts and/or individual O.R.s in a locked O.R. Suite may themselves be
locked but are not required to be locked.
When the individual O.R. or procedure room in which medications are kept
is not in active use, it is not considered secure even though the O.R.
suite or the Procedural Unit is actively staffed and access restricted.
Noncontrolled medications must be alternatively 1) locked in the anesthesia
cart in the unused room, 2) secured by locking the individual room in
which they are located or 3) moved to a secure room within the O.R. Suite
or Procedure Unit.
Security of CONTROLLED Substances
CONTROLLED Substances are kept under lock and key in all locations at
all times. The sole exception is for controlled substances under the direct
control of the anesthesiologist or other clinician involved in the immediate
administration of the drug.
“Authorized Personnel”
The following are considered “authorized personnel”:
• Members of the medical, clinical (including residents and
medical students, anesthesia and O.R. nurses, anesthesia and O.R. technicians
and student nurses) and pharmacy staff with patient care responsibilities
in the secure area;
• Housekeeping, engineering and security staff and orderlies when
needed to perform their assigned duties;
• Visitors (including technical consultants and drug and equipment
manufacturer representatives) when under the supervision or in the presence
of a medical or clinical staff member;
• Government and accreditation organization representatives when
they are performing their regulatory responsibilities.
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