Unauthorized Access to Medications

Our consultant teams are observing medication rooms and other storage areas that may be
accessible to unauthorized individuals. Specifically, medication rooms, which may be locked,
are also accessible to EVS staff, Facilities maintenance teams, and Materials Management staff
delivering non-pharmaceutical supplies. These rooms often have medications accessible in
unlocked cabinets. Organizations are not able to articulate how these medications are
protected from tampering or pilfering. Per Centers for Medicare and Medicaid Services (CMS)
State Operations Manual (SOM) – Hospitals, under §482.25(b)(2)(i) – All drugs and biologicals
must be kept in a secure area, and locked when appropriate. This means that a secure area is
where 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. All controlled medications must be locked; however,
organizations are allowed a degree of flexibility with the storage of non-controlled drugs and
biological agents. An area where staff are actively providing care to patients or preparing to
receive patients, such as setting up for a procedure before a patient’s arrival, would generally
be considered a secure area. When a patient care area is not staffed, both controlled and non-
controlled substances are expected to be locked up. Organizations should review the
interpretive guidelines in the SOM under §482.25(b)(2)(i). It provides additional examples for
consideration. Additionally, organizations should risk-assess their medication storage practices
to identify security vulnerabilities and address them through policy and procedures.