The Importance of Medical Labeling Compliance

Preventing harm from medications or adverse drug events (ADEs) remains a top patient safety priority, not only in hospitals but across the continuum of care for patients. Yet, despite this priority and other error reduction efforts, medication errors are the number one error in health care.¹ In fact, in a review of 91 direct observation studies of medication errors in hospitals and long-term care facilities, investigators estimated median error rates of 8% to 25% during medication administration.² Poor labeling was cited as a central cause.³ And although there is no silver bullet when it comes to preventing medication errors, these studies reinforce the importance of medical labeling compliance to elevate medication safety and comply with The Joint Commission standards.

Which Medication Labeling Issues are Frequently Scored?

The Joint Commission (TJC), the American Society of Health-System Pharmacists (ASHP) and the United States Pharmacopeia (USP) are just a few of the many organizations with standards that direct proper medication labeling. Even with these guidelines and the protocols organizations establish for their respective operations, medication labeling remains an area that is often cited for compliance violations. Frequently scored standards fall into these six areas:

1. Storage and organization
2. High-alert drugs and controlled substances
3. Look-alike sound-alike drugs
4. Labeling medications
5. Medication preparation
6. Medication administration

1) Storage and Organization

Organizing and safely storing medications starts with unpacking boxes when they arrive in the receiving area, labeling shelves and ensuring medications are in their proper place. This is one of the first priorities cited in TJC standard MM.03.01.01- the organization safely stores medications. Surveyors don’t want to see boxes of unorganized medications stored on the pharmacy floor. Plus, when labeling shelves, don’t forget about the refrigerators and freezers.

Freezer storage is especially important for vaccines that require sub-zero temperatures. In addition, they also require documentation in a contingency plan in the event of a power outage or other emergencies that make them inoperable.

In addition, emergency medications, which include code carts and other portable transportation devices such as boxes, bags and trays, must be kept up to date - no expired drugs or supplies are allowed. Yet these mobile systems, that exist throughout a facility, frequently contain violations that are waiting to happen, most often in the form of expired drugs.

2) High Alert Drugs and Controlled Substances

Critical to any organization's safety standards, and essential to TJC standard MM.01.01.03, is a process for managing high-alert and hazardous medications. Although the error potential with high-alert drugs is no greater than any other category, the ramifications are much greater if one does occur, thus so is the compliance scrutiny.

Medical labeling compliance guidelines for high-alert drugs should include:

• Keeping signage and reminders consistent
• Placing signage and reminders at eye level
• Labeling the products on the shelves to correlate with the signage

In addition, don’t rely only on barcode scanning. Although scanning is an important safety step, signage is still required to remind staff that the medications are high-alert. Lastly, separate the drugs in storage using ‘high-alert’ bins.

3) Look-Alike Sound-Alike Drugs

There are now nearly 250 different medications on the Institute for Safe Medication Practices (ISMP) list of look-alike sound-alike drugs. Some of these also fall into the high-alert medication category. Although the prevalence of this problem isn’t new, it remains one that is difficult to prevent. It’s estimated to cause 7% of near misses and between 6.2% and 14.7% of all medication error events. Addressing the safe use of look-alike/sound-alike medications is the purpose of standard MM.01.02.01.

Taking steps that include applying look-alike sound-alike labels to drug containers and also separating them on the shelves or pockets of automated dispensing cabinets have proven to reduce mistakes.

Labeling Medications

For medication standard MM.05.01.09, The Joint Commission uses the term “medications are labeled”. It includes:

• All medications or solutions, including anesthesia medications
• Obvious situations
• Operating Room and other procedural settings

Plus, the label must be applied to medications immediately before or after filling a container. In addition, it’s not acceptable to use prelabeled empty syringes or containers.

As for IV solutions, when they are prepared for a specific patient, the solution container must be labeled with the name, strength, amount of all additives, diluents, date prepared, and a revised expiration date. Plus, when preparing individualized medications for multiple patients, the label also includes the following⁴:

• The patient's name
• The location where the medication is to be delivered (e.g. patient room)
• Directions for use and applicable accessory and cautionary instructions (e.g. keep refrigerated, etc.)

5) Medication Preparation

Given the volume of work, it’s easy to see how medication preparation areas become cluttered. The same can be said for preparing medications or batches of syringes hours in advance, spiking IV bags for anticipated needs and saving unused medications for later. But each one increases the potential for error and would be cited during a survey.

Unlabeled medications are another hot spot. Lee Murdaugh, Director of Accreditation and Medication Safety for Cardinal Health Innovative Delivery Solutions, stresses timely medication labeling and recommends this:

“If it hits the table it needs a label.”

As for The Joint Commission standards, they expect all stored medications and the components used in their preparation labeled with the contents, expiration date, and any applicable warnings.

6) Medication Administration

In his book The Checklist Manifesto, author Atul Gawande details the evolution of the checklist in healthcare settings and its impact on improving patient safety. Although the checklist may be best known for use in surgery, it’s also a useful tool to ensure safe medication administration practices including:

• Comparing the Medication Administration Record (MAR) to ensure it matches the patient wristband and an additional form of patient identification
• Verifying that the medication selected matches the medication order and product label
• Confirming the strength, dose, route, date and time of administration have been noted
• Ensuring medications haven’t exceeded expiration and beyond use dates (BUDs)
• Rechecking high-alert medications to validate accuracy
• Checking for allergies

As for the medication itself, each unit of medication must contain specific information on the label, including medication name, strength, lot and control number, and expiration or beyond-use date if the drug is compounded.

Further, medication labels are also an effective way to enhance the checklist by adding visual queues that inform caregivers. For example:

• Using IV line and tubing labels to guide the right route of administration
• Applying expiration and BUD labels applied to medication containers
• Adding allergy alert labels on wristbands and charts
• Including look-alike sound-alike or TALLman labels on appropriate drugs to minimize confusion

USP <797>

Plus, USP <797> standards are set to go into effect on November 1, 2023. Although it isn’t a frequently scored standard, it will likely be another area for increased attention from surveyors. This article details the expectations for pharmacy compounding operations and some of the medical labeling steps that will apply. 

Get Rid of Stupid Stuff

A model originated by Hawaii Pacific Health called “Getting Rid of Stupid Stuff” (GROSS) is a model for improving both patient safety and the burden on clinicians. Medical labeling represents a companion model, “Use Simple Stuff Effectively” (USE). Labels don’t contain artificial intelligence (AI) or new cutting-edge technology, they just represent a tried and true way to improve medication safety and help meet compliance guidelines.

United Ad Label

United Ad Label is an expert at using labels to ensure you meet compliance guidelines. Contact us to learn more.

¹ McMains Vanessa, Johns Hopkins study suggests medical errors are third-leading cause of death in U.S., Johns Hopkins University, HUB, May 3, 2016, https://hub.jhu.edu/2016/05/03/medical-errors-third-leading-cause-of-death/

²MacDowell Paul PharmD, BCPS, Cabri Ann, PharmD, Davis Michaela, MSN, RN, CNS, Medication Administration Errors, PSNet, March 12, 2021, https://psnet.ahrq.gov/primer/medication-administration-errors#:~:text=In%20a%20review%20of%2091,%E2%80%9325%25%20during%20medication%20administration

³Young J, Prescription Drug Labeling Medication Errors: A Big Deal for Pharmacists, National Library of Medicine, 2010 Jan-Mar, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3035877/#:~:text=According%20to%20the%20Institute%20of,with%20and%20comprehension%20by%20patients

⁴ Medication Labeling – IV Solutions Retrieved From Stock Supply, The Joint Commission, October 26, 2021, https://www.jointcommission.org/standards/standard-faqs/critical-access-hospital/medication-management-mm/000002188/