medsafetyonline

A forum for caregivers and pharmacy professionals concerned with patient and provider safety.

Labeling

Safety and Standardization in Labeling and Repackaging

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Packaging and labeling are believed to be the cause of 33% of medication errors1 and poor label design is cited as a potential cause.2

In 2016, the FDA released guidelines for safe labeling and repackaging acknowledging that improper repackaging of drug products can cause serious adverse events stating, “Because labeling, packaging, and nomenclature have been identified as key system elements that have great influence on medication use, any weaknesses or failure in the design of these elements can cause medication errors that lead to patient harm.”

There are a number of best practices, regulatory, and professional agencies that specify important recommendations regarding labeling and repackaging. Two of our applications were built specifically for labeling and repackaging: RxPACK™ and the RxTOOLKIT® Label Solutions Library include key safety features aligned directly with these recommendations.

Label Design and ISMP

In 2010, the ISMP acknowledged that poor pharmacy label design is directly associated with the increased risk for error and established guidelines for safe medication labeling and design.3 These guidelines include specific recommendations regarding layout, fonts, language, warnings, etc.

Most pharmacy labeling solutions on the market today leave you on your own to figure out how to correctly design and print labels. This can cost valuable time and money!

Using the RxTOOLKIT Label Solutions Library ensures you are using up-to-date professionally designed label templates that follow all of the ISMP guidelines.

We also provide full service training and support. This includes helping you determine which templates you need to get started or designing a new one to meet your exact parameters. We will also help you navigate the many choices for quality printers and label stock.

Standardization of Process and ISMP

The ISMP directly recommends implementation of standardized and mindful drug labeling practices as part of an overall strategy to improve medication adherence and reduce inadvertent medication errors.3

RxPACK™ gets your staff on the same page by establishing a standardized process for verification and documentation. It also pairs seamlessly with the RxTOOLKIT Label Solutions Library to provide easy to find, consistent, and professionally designed label templates. Combining these solutions increases compliance, uniformity, and efficiency while lowering the potential for error.

Expiration Dates and USP

USP General Chapter 795 provides standards for compounding quality non-sterile preparations including provision of general guidelines for assigning beyond-use dates to non-sterile preparations. They specify the expiration date “not exceed (1) 6 months from the date of repackaging; or (2) the manufacturer’s expiration date; or (3) 25% of the time between the date of repackaging and the expiration date shown on the manufacturer’s bulk article container of the drug being repackaged, whichever is earlier.”

Our label templates directly follow USP recommendations and automatically calculate the expiration date even for source ingredients or products.

Logbooks and State Law

Whenever a product or compounded product is packaged for distribution, best practices (and some state laws) require that all information, including for source ingredients, must be documented including: expiration date(s) for final product and source ingredient(s), NDC number, lot number, and preparer’s initials. Typically this information is stored in large binders, making it difficult to store and reference.

With RxPACK™, all relevant information is automatically cataloged and stored in a HIPAA compliant digital logbook. Users can easily find and reference any data element including information on source ingredients.

We recently launched a new site to showcase the many benefits of RxPACK™ and the RxTOOLKIT Label Solutions Library. These tools can help you increase safety and efficiency, and establish standardization and quality control within your labeling and repackaging processes. Please visit rxtoolkitlabels.com for more information and to check out the new site.

 

 

[1] Aspden P, Wolcott J, Bootman L, Cronenwett L, editors. Preventing medication errors. Washington DC: Institute of Medicine of the National Academies; 2006. [2] The variability and quality of medication container labels.Shrank WH, Agnew-Blais J, Choudhry NK, Wolf MS, Kesselheim AS, Avorn J, Shekelle P Arch Intern Med. 2007 Sep 10; 167(16):1760–5. [3] http://www.ismp.org/Tools/guidelines/labelFormats/comments/default.asp

Insulin: One Patient — One Pen

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“Health care has safety and quality problems because it relies on outmoded systems of work. Poor designs set the workforce up to fail, regardless of how hard they try. If we want safer, higher-quality care, we will need to have redesigned systems of care, including the use of information technology to support clinical and administrative processes”. 

This quote is from Crossing the Quality Chasm: A New Health System for the 21st Century, a consensus report from the Committee on Quality of Health Care in America published by the Institute of Medicine in 2001.

The curious thing to me is how when quality fails, it is often the individual practitioner who takes the fall and pays the price. What the Eric Cropp Story has told me is that the system failed him and failed him many times, but he and he alone owned the error. Eric’s tragic error occurred in 2006 and he was convicted and sent to jail in 2009,  8 years after Crossing the Quality Chasm was published in 2001. Apparently, the health care system has yet to embrace the changes recommended in 2001.

This post is about another potential system failure that could cause harm.

 

Chronology of Events

  1. November, 2006, The Institute for Safe Medication Practices (ISMP) published a Medication Safety Alert titled “PEN injectors: Technology is not without imPENding risks”. This first warned of impending problems with using this new type of technology.
  2. May, 2008, The Institute for Safe Medication Practices (ISMP) published a Medication Safety Alert titled “Considering Insulin Pens for Routine Hospital Use? Consider this….” This safety alert warned of potential hazards of using these pens, particularly the risk of cross contamination potential if the pens are not properly labeled.
  3. March, 2009, it was reported that 2,114 people may have been put at risk of AIDS and hepatitis by sharing insulin pens and cartridges in two Army hospitals in US.
  4. July, 2010, the FDA published a FDA Consumer Alert titled “Insulin Pens are Not for Sharing”.
  5. May, 2012, The Department of Health and Human Services (CMS) issues a Memorandum to all State Survey Agency Directors titled “Use of Insulin Pens in Health Care Facilities”. Among the discussion recommendations is “Insulin pens must be clearly labeled with patient/resident’s name or other identifiers to verify that the correct pen is used on the correct patient/resident.”
  6. February, 2013, ISMP publishes Medication Safety Alert titled “Hospital Should Reconsider Insulin Pen Use, Says ISMP”.
  7. In July, 2013, The American Society of Health System Pharmacists publishes an article titled “Biological contamination of insulin pens in a hospital setting”. The findings of that article were that of 125 insulin pens tested, 7 tested positive for cells or hemoglobin.

Plenty of evidence that a process change is in order and that a redesigned system of care, including the use of information technology should be developed to support clinical and administrative processes.

 

Magnitude of the Problem

According to the US Department of Health and Human Services, among hospital acquired infections, blood borne pathogen infections are a significant cause of morbidity and mortality. At any given time, about 1 in 20 inpatients has an infection related to hospital care.

From cdc.gov: “Applying two different Consumer Price Index (CPI) adjustments to account for the rate of inflation in hospital resource prices, the overall annual direct medical costs of HAI to U.S. hospitals ranges from $28.4 to $33.8 billion (after adjusting to 2007 dollars using the CPI for all urban consumers) and $35.7 billion to $45 billion (after adjusting to 2007 dollars using the CPI for inpatient hospital services). After adjusting for the range of effectiveness of possible infection control interventions, the benefits of prevention range from a low of $5.7 to $6.8 billion (20 percent of infections preventable, CPI for all urban consumers) to a high of $25.0 to $31.5 billion (70 percent of infections preventable, CPI for inpatient hospital services).”

Click here to download the CDC Clinical Reminder PDF.

 

Current System of Care Solutions Fall Short

Floor Stock Dispensing

Many institutions will have insulin pens available as a floor stock item in their Automated Dispensing Cabinets (ADC). The problem with this method of drug distribution is having a reliable procedure for the labeling of pens by the nurse at the time of retrieving the pen from the cabinet. I am aware of the label printing capability of the Omnicell system. To utilize this Omnicell capability, it appears that all of the cabinets must be upgraded to the newest Omnicell operating system and that the printing of the expiration date is limited to just one expiration date for all insulin pens. We understand that the room temperature expiration date is tied to a group of drugs and not to the individual drug. This results in the printing of the shortest expiration date (14 days) for all insulin pens, even an individual pen with a longer expiration date of 28 days must be printed with a 14 day expiration date, resulting in the potential waste of 50% of the drug.

Pharmacy Patient Dispensing

If the insulin pen is dispensed directly from the pharmacy, the pens must be labeled with Patient Name / MRN, room temperature expiration date and the time of dispensing. If this is done by the Pharmacy Operating System, one of the problems is finding space on the insulin pen to place the label without obstructing important information on the insulin pen label. Placing the label on the removable cap is a patient safety liability in that caps can be interchanged between patients.

 

Enhanced System of Care Solution

RxTOOLKIT Patient Specific Pen Label

RxTOOLKIT has developed a Patient Specific Insulin Pen Label designed to improve the safe administration of insulin pens if this manner of dispensing is chosen.

While we are not advocating the use of any one process or application, what we want to say is “Let’s do something to remove this patient safety exposure”.

This is an important ongoing patient safety issue and medsafetyonline.org is excited to hear from other health professionals. We invite you to please share your challenges and/or successes with all our visitors. Together we can pool our knowledge, improve the safety of our patients, and protect our health care colleagues.