Simplifying medication storage
In November 2006, CMS changed its requirement for security of medications, stating that nonscheduled drugs must be stored in a secure area and locked when appropriate. All schedule II through V drugs must be locked in a secure area. CMS defined a “secure area” as one in which medications are stored to prevent “unmonitored access by unauthorized individuals.”
CMS also states that medications cannot be stored in areas that are readily accessible to unauthorized individuals. This means that areas restricted to authorized personnel are generally considered “secure areas” under the Conditions of Participation (CoP).
The Interpretive Guidelines provide examples of “secure areas,” highlighting areas that are staffed around the clock with entry and exit limited to appropriate staff and authorized, supervised visitors. These types of secure units include labor and delivery suites and critical care. In its April update to the 2009 standards, The Joint Commission aligned itself with CMS, allowing for medication storage to fall under the “secure” definition as outlined by CMS.
What you can do
If a secure area is defined as one that prevents unmonitored access by unauthorized individuals, then who are “authorized’ individuals? In accordance with state and local law, a hospital can determine who has access to secured areas of medications. Organizations do have the flexibility to determine what personnel can have “authorized” access and must describe these categories of individuals in its policies. Policies should note how authorized personnel are defined as related to access of these locked areas. Consider identifying how authorized personnel function by including this language in written job descriptions.
Make it work for you
These relaxed requirements can work for you by educating your staff and ensuring that all scheduled drugs (i.e., basically narcotics and other controlled substances) are kept locked. Unless your state regulations differ, “double locking” scheduled medications is not required by either CMS or The Joint Commission. The CoP mandate that all scheduled (i.e., controlled) medications remain locked.
Assess the various medication storage areas on patient care units and determine whether there is constant supervision and authorized access. If so, you don’t have to lock up those drugs. Normal saline, antibiotics, or other nonscheduled medications can be stored in a cabinet, shelf, or open rack, provided that area is under supervision at all times. If not, lock them up.
Invest the time
Review current policies and procedures governing the security of drugs and biologicals for your staff. Don’t underestimate the value of talking to staff members, obtaining their input, and observing daily practice in the patient care and procedural areas.
Use this discussion to determine the following:
- How well is the policy understood and executed?
- Does it meet the current clinical and operational needs of patients and staff members?
- Does it define authorized access and contain categories of staff that represent “authorized” access?
- Are medications stored within the line of sight of the staff? Are the medications still secure when staff leave the area? Do visitors have unsupervised access?
Discussion and observation also serves to identify additional educational training needs of staff. Remember that drug security is an essential element to patient safety.
Editor’s note: Laure Dudley, RN, MS, is a consultant with The Greeley Company, a division of HCPro, Inc., in Marblehead, MA.
Adapted from Briefings on The Joint Commission, January 2010.