| 2006N-0465 | Improving Patient Safety by Enhancing the Container Labeling for Parenteral Infusion Drug Products; Public Meeting | ||||||||||||||||||||||
| FDA Comment Number : | EC1 | ||||||||||||||||||||||
| Submitter : | Dr. Dennis Tribble | Date & Time: | 12/28/2006 09:12:37 | ||||||||||||||||||||
| Organization : | ForHealth Technologies, Inc. | ||||||||||||||||||||||
| Category : | Device Industry | ||||||||||||||||||||||
| Issue Areas/Comments | |||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||
| GENERAL | |||||||||||||||||||||||
| The attached document contains examples of relatively small labels that allocate space (more or less) properly for critical information. These labels are small (1 3/4" x 3/4") and are intended for application to SVP's as syringes, yet convey the necessary information clearly, giving appropriate precedence to the most significant information. | |||||||||||||||||||||||
| Question | |||||||||||||||||||||||
| 1. What are the best solutions to differentiate look-alike container labels of premixed LVPs and SVPs containing different medications (among different product lines from the same manufacturer and across different manufacturer product lines)? | |||||||||||||||||||||||
| This discussion needs to be framed within the context that not all LVP's or SVP's are bags. Some of these containers may be vials, syringes, bottles, elastomeric infusers, etc.
This discussion also needs to be framed within the context that premixed LVP and SVP containers are only created when the industry sees a market need, and therefore represent a minority of the dose containers in clinical use. Indeed, even then these products are often over-labeled with patient- specific labeling when issued for use. Within that context, solutions do differentiate labeling include: * limiting information to that which is clinically needed to use the container * emphasizing the key information on which dose selection decisions are based * use of standards in terminology and presentation to ensure that meaning is unambiguous. To that end, the Institute for Safe Medication Practice (ISMP) has identified practices that contribte to safe medication use, including methods of representing drug name, representing dose and concentration, and representing volume. The information critical for selection of the correct product are: Generic Drug Name Dose/Amount Concentration Container volume Lot # (human readable and bar coded) | |||||||||||||||||||||||
| Expiration Date (human readable and bar coded)
Exceptional storage requirements Exceptional warnings/cautions Other information should be relegated to printed enclosures to ensure that the information on the container is clear, readable, and unambiguous. It should also be recognized that warnings are effective in inverse proportion to their frequency. That is, the more often a user encounters warnings on a label, the less likely they are to read them. The adoption of USP <797> as a best practice for generation of these doses in hospitals is leading more and more integrated health systems to centralize their IV preparations into facilities thatpermit the distribution of doses prepared under best practices to all of their facilities regardless of size. In some cases, these pharmacies have been deemed to be manufacturers. Any rules for labeling must take into account the labeling capacities of a pharmacy acting in this capacity and either specifically exempt such pharmacies from some of the rule, or create rules that facilitate this kind of practice. Bar coding has been shown both at the bedside and in the pharmacy to catch and prevent potential medication errors. | ||
| 2. Would the use of color differentiation on labels prevent medication errors? | ||
| Current premixed IV containers use red color to highlight high-risk drugs either because those solutions require precautions during use or because they are unsuitable for direct administration to patients. Because this type of labeling is the exception rather than the rule, this use of color appears to function well.
The other potential use of color is in color coding, where the use of a specific color represents the presence of a specific package, a specific drug, or a specific drug class. In order for this work properly, a user must be able to distinguish the color in the absence of comparison to other colors, which severly limits the pallette of colors that can be used for this purpose. When one further considers the prevalence of color blindness in the population, the list becomes even more circumscribed. It is therefore unlikely that one could identify a color that could unambiguously be associated with a specific infusion premixed product, or even a drug. Such use might be applicable to drug families or classes. It is also well-known that the use of color coding encourages dependence on the color alone, which can lead to medication errors. Unless the use of colors is standardized across vendors, the use of the same color for different purposes by different vendors actually increases the likelihood of medication error. Finally, the use of color coding requires the manufacturer to acquire the additional technology and expence to verify that the color on the labelling is applied according to specifications. To the extent that pharmacies may become manufacturers as noted above, many of these pharmacies lack the capacity to generate and verify color in their labeling. The use of color therefore appears to offer little value beyond its current use. | ||
| 3. What information currently required to appear on intravenous container labels can be elminated or placed elsewhere in order to make room for more important information? | ||
| The list of critical information is described previously in question #1 more or less in order of importance. At least 30%, and as much as 50% of the label real estate should be committed to the drug name and dose or concentration.
The drug name should be the generic name, using tall man lettering as appropriate. The dose specification and concentration should follow ISMP rules. Depending on the pre-mix, either the dose/amount or the concentration may | ||
| need to be pre-eminent. An antibiotic infusion, for example, should have the dose amount be pre-eminent since it is intended for infusion in its entirety. A vasoactive drip, on the other hand, is dosed by rate, and so the concentration is probably more important than the total amount in the container.
Standardized format facilitates reading and leverages user reading habits. One proposed format would be: NDC (human-readable) Drug Name Dose Concentration Volume Lot (human-readable) Expiration (human-readable) Barcode(s) Warnings (in black box) Storage Drug Name should be in a large font (30% - 50% of height of label) using normal (black on white) printing and tallman lettering where appropriate. Dose/Amount and concentration should be printed in the same sized font printed in reverse (white on black). Warnings should appear sparingly and be enclosed in a black box. It is preferable to have the NDC, lot number and expiration date in a single bar code so the information can be read in a single scan. The current practice of placing that information in two or more bar codes leads to scanning problems, which leads to compliance problems. Orientation of the bar code on the container must ensure that the bar code continues to be readable as the container empties. | ||
| 4. How does the lack of standardization in the expression of medication concentrations on labels contribute to error? | ||
| Concentration should specify the amount of drug in each mL of solution.
Concentration should follow ISMP rules, subject to the caveat that those rules sometimes predict the use of units of measure that are not in common use. For example, ISMP rules would prefer 100 mcg/mL to 0.1 mg/mL. However, if clinicians are accustomed to the 0.1 mg/mL concentration expression, asking them to perform the conversion in their heads could lead to a medication error. | ||
| 5. How do the similar labels for Sterile Wtaer for Injeciton, Sterile Water for Irrigation, and Sterile Water for Inhalation lead to medication errors (i.e., deaths in someinstances have been reported)? | ||
| This question must be framed within the context that Sterile Water in any form is generally not suitable for direct administration to a patient. It is intended to serve as a base for pharmaceutical compounding. This is an example of a product where a highly visible warning is appropriate to alert the user that this product is not suitable for direct administration to a patient.
The most effective prevention of this type of error probably rests in container packaging. The presence of unique containers that require unique apparatus to access them is the most likely method to force a user's attention to the fact that the container is inappropriate to their purpose. Pont-of-care bar coding, as well as bar coding verification of dispensing steps in the pharmacy would be useful in preventing these kinds of errors. | ||
| 6. What strategies are there to prevent inadvertent administration of solutions not intended for parenteral IV use? | ||
| This is a place
where the creation of a new graphic, somewhat like the skull and crossbones
for poisons, might be appropriate for placement on such containers so that
users readily see it being marked as unsuitable for administration to patients.
IN-line barcoding process control during dispensing and administration would also help catch these errors. | |||
| 7. What are the
regulatory, technological and resource (cost) barriers that would need to
be eliminated to correct the challenges identified today, if any? | |||
| Regulatory: serious
consideration of removing information from the container label and placing
it on paper lableing in cases or cartons to make space for critical information
of sufficient size. Technical: Bar code technology that can report NDC, lot number and expiration date in a single scan. Current technology for 2-D bar codes is expensive. | |||
| 2006N-0465-EC1-Attach-1.PDF | |||