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Safe practice environment chapter proposed by USP

From the December 4, 2008 issue

The United States Pharmacopeia (USP) recently published its proposed new General Chapter (1066) on Physical Environments That Promote Safe Medication Use. The chapter describes the optimal physical environment needed to promote accurate medication use and how anyone involved in the process can establish a safer workplace. When justified by evidence and expert opinion, standards are provided in five key areas—illumination, interruptions and distractions, sound and noise, physical design and organization, and medication safety zones.  

Illumination. Improper lighting has been a contributing factor in some medication errors. USP cites two examples: one case where poor lighting led to the incorrect attachment of tubing to a patient controlled analgesia (PCA) unit, causing the medication to run onto the floor; and another case in which 10 mg dicyclomine capsules were used to fill a prescription for 20 mg capsules due to poorly lit pharmacy shelves. Numerous studies have shown that proper lighting improves accuracy and efficiency of medication-related tasks. Studies have also found that lighting levels need to be increased for workers older than 45 years and when visual fatigue rises near the end of the work shift. Based on the relationship between lighting levels and errors, USP recommends the following steps to promote safety.

  • Use fluorescent cool white deluxe lamps or compact fluorescent lamps.
  • Use adjustable 50-watt high-intensity task lights in areas where critical tasks are performed, including on mobile medication carts, automated dispensing cabinets (ADCs), and in patient rooms for nighttime administration.
  • Position all lighting to avoid glare on computer monitors.
  • Provide magnifying glasses to read labels with very small script.
  • Clean lighting fixtures routinely (lighting levels can decrease by 25% over 2 years without cleaning).
  • Ensure illumination levels of around 100 foot candles (lumens per square foot) in areas where critical tasks are performed in the pharmacy and on patient care units. (A table of recommendations appears in the chapter.)
  • Periodically measure lighting using an illuminance meter. Place the meter in key areas with the worker standing in a normal working position. To measure light in medication storage areas, take readings on the top, middle, and bottom shelves.

Interruptions and Distractions. MEDMARX data show that distractions are a causative factor in about 45% of medication errors. Coworkers asking for assistance were the most frequent sources of interruptions in one pharmacy study. Because individuals have differing levels of distractibility, preventing interruptions and distractions is best accomplished by providing staff with the ability to control their exposure to disturbances. To maximize staff concentration when performing critical tasks, USP recommends the following.

  • Minimize the potential for distractions in critical medication use areas.
  • Teach workers to avoid interrupting coworkers for non-urgent reasons while they are performing medication-related tasks. Techniques include visual cues (e.g., nurse wearing an orange safety vest when administering medications), physical barriers, and checklists to focus and refocus attention.

Sound and Noise. Noise can interfere with effective work performance and pose a health hazard to hospitalized patients. Hospitals are particularly noisy, with studies reporting an average of 45-65 dB of noise with peaks between 85-90 dB. Noise levels at shift change have been recorded as high as 113 dB, well above the peak levels set by the Environmental Protection Agency (EPA) (45 dB day/35 dB night) and World Health Organization (35 dB of background noise in patient rooms). In fact, the EPA requires ear protection for workers exposed to sound levels averaging 90 dB. Out of 58 studies reviewed by USP, 29 showed that noise impaired performance, but seven showed it improved performance. For example, in one of the seven studies, unpredictable but controllable sounds improved prescription filling accuracy, which may indicate that some environmental stimuli are needed to maintain proper alertness and attention. To maintain a safe level of noise, USP recommends the following steps.

  • Sound levels in medication use areas should be at the level of conversation, 50 dB, slightly higher than the EPA recommendation to ensure critical verbal information can be heard accurately. Total elimination of noise is not feasible or desirable.
  • Provide a quiet area for staff to use during critical medication-use tasks.
  • Reduce noise and other sensory interference by employing activities, tools, and design principles such as installing materials that absorb sound (e.g., ceiling, wall materials, carpeting if permitted by infection control). Acoustical engineers can identify additional methods for noise reduction.
  • Periodically measure sound levels in work areas using meters capable of reading from 0-200 decibels (dB). Measurements should be taken holding the meter away from the body while standing in a working position and pointing the meter at the source of sound.

Physical Design and Organization of Workspace. The physical design and organization of the workspace can influence staffs’ ability to use information and perform tasks. For example, the height of counters and drug storage areas can influence visibility, and studies have shown that dispensing errors occur more frequently when medications are stored on cluttered shelves because the items are more difficult to differentiate. The design of the workspace can also contribute to poor lighting conditions, distractions and interruptions, high noise levels, and unsafe medication safety zones—environmental factors discussed elsewhere. To reduce the risk of errors, USP suggests the following steps.

  • Keep areas where medications are stored organized and uncluttered, with at least 1 inch between distinct drugs.
  • Ensure that the height of work counters and supply areas enhances efficiency of tasks and visibility of products.
  • When possible, employ adjustable fixtures (e.g., task lights, counters, screens) to promote efficiency, visibility, and safety.

Medication Safety Zone. USP defines a medication safety zone as any critical area where medications are prescribed, transcribed, prepared, and administered. Examples include work surfaces in a medication room or counter tops on medication carts or ADCs, locations where prescribing decisions are made, pharmacies, and patients’ bedsides or homes where medications are administered. Medication errors have been linked to the physical design of medication safety zones as well as error-prone methods used within these zones to carry out medication-use activities. Using principles described in human factors literature, USP recommends the following when designing medication safety zones and performing the work that occurs within them.

  • Design drug preparation areas so that critical processes are conducted in a manner similar to work in the cockpit of an airplane, with the information necessary to make decisions readily available, in a user-friendly format, and all together (e.g., drug and patient information in the same area) to support fact finding.
  • Arrange information and components within safety zones in a manner that promotes correct choices and decreases distractions according to the following principles:
    • Importance Principle: Place important components in convenient locations (e.g., locate information regarding equipment function and trouble-shooting near or on equipment).
    • Frequency of Use Principle: Locate frequently used items in areas where they can be easily found to help prevent workarounds.
    • Function Principle: Group items that are related to a function together, such as syringes, needles, and alcohol swabs.
    • Sequence of Use Principle: Place items in an order that supports the sequence needed to perform the task correctly (e.g., sterile gloves encountered first when opening dressing change kit).
  • Standardize the design of bedside medication administration areas so that information and supplies can be readily located.
  • Standardize medical equipment (e.g., infusion pumps) to reduce mistakes during operation.
  • Employ technologies such as ADCs, electronic prescribing, bar-coding, and electronic medical records.
  • Use constraints (limit access/use) and forcing functions (design aspect that allows correct performance only) to reduce errors with high-alert medications (e.g., sequester neuromuscular blocking agents in an intubation kit to prevent accidental administration to unventilated patients).
USP urges healthcare practitioners to participate in this important standard-setting chapter by providing comments and spreading the word to colleagues. To view the full chapter, visit: USPNF/pf/whatsInside.html. Comments should be submitted to Colleen E. Brennan, RPh, at by February 15, 2009
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