[BittyBabyGrower]

We are a pediatric hospital and need to have multiple concentrations of certain drugs because our patients come in different sizes. How can we comply with this goal?
When multiple concentrations of a drug are necessary (such as for infants or other special clinical uses), special precautions should be taken to avoid dosing errors. For example, the order should specify actual drug dose, not volume, and write out the dose calculation—including the specific data elements such as the person's weight, dose per unit weight, rate of administration—as part of the order. The reason for this is to provide sufficient information for the pharmacist reviewing the order and preparing the medication, and the nurse administering the medication to re-calculate the dose as a check.

Our pediatric and neonatal units use the "Rule of 6" to calculate patient-specific drug concentrations so that we can use standardized rates of infusion. Is this acceptable?
No. This approach has been extensively reviewed and Joint Commission has concluded that the Rule of 6 and other dosing methodologies that result in individualized (i.e., non-standardized) concentrations are not in compliance with the requirement of goal 3b. [New 3/1/04]

What is the background and rationale for deciding that the Rule of 6 is not acceptable?
While originally developed for use with pressor agents in code situations, its use has extended beyond that. The Rule of 6 allows nurses to quickly approximate a pediatric dose by using a factor of six to adjust the concentration of the drug while keeping the rate constant. This is directly opposed to NPSG requirement #3b. In reviewing this issue specifically, we have found that there is significant evidence that the use of standardized concentrations in pediatrics (in place of the Rule of 6) is not only possible, but results in fewer errors.

Dosing of infusions can occur by one of two means: 1) keep the rate of infusion standardized but vary the concentration, or 2) keep the concentration of the drug standardized but vary the rate of infusion. Nationally, hospitals do it both ways, but are generally consistent in the approach that they use. There is evidence in the literature that limiting and standardizing concentrations (as opposed to the Rule of 6 approach, which uses patient-specific concentrations) is safer and less error-prone. The theoretical basis for error reduction is as follows. Two risk points in IV administration can occur - one at the calculation step (either calculating the proper concentration or the proper rate), and another at the drug preparation/compounding step. Both methods can result in potential errors at the calculation step. However, by standardizing the concentration, one reduces the potential for error at the drug preparation/compounding step. There is clear evidence that pharmacy prepared IV's are more accurate, and many are available premixed from the manufacturer, further minimizing the risk. Another important consideration is that the Rule of 6 is an approximation and can, itself, lead to dosing errors. The Institute for Safe Medication Practices (ISMP) collects data on medication errors nationally in conjunction with United States Pharmacopeia (USP) for the Food and Drug Administration (FDA). They have a significant number of reports of errors due to the use of the Rule of 6.

Also, from an infection control standpoint, the risk of contamination during preparation/compounding is reduced as well. Finally, if all hospitals use the same method, it will reduce errors relating to orientation, training and competence of new and temporary staff. A recent survey of critical care clinicians in children hospitals conducted by the University of Iowa demonstrated that nine of 27 institutions have abandoned the Rule of 6 to use standardized concentrations of drugs, even in neonates. Nine of nine respondents at centers employing standard concentrations exclusively have found the system to be effective. Three of these nine centers specifically noted that they have reviewed the safety impact and have found no change or have seen improvements in safety (based on informal methods [2], or through rigorous research-based assessment [1]). Staff education and ongoing experience were cited as factors that contributed to rapid acceptance of these changes. In some cases, former supporters of Rule of 6 stated that the change to standardized concentrations has been a positive development for their staff and for patient safety. Researchers from the Albany Medical Center have research data showing a significant reduction in errors when switching from the Rule of 6 to the use of standardized concentrations. Their research, including a sample rate table (for dopamine concentration of 1 mg/mL), will be included in a manuscript in an upcoming issue of the Journal of Pediatric Pharmacology and Therapeutics. [New 3/1/04]

This is all new information to us and we have been using the Rule of 6 for many years. To immediately switch to a different approach could introduce new risks. Will there be an opportunity for a more controlled transition?
Yes. To provide for a safe transition to a methodology that uses a limited number of standardized concentrations of drugs, a transition period will be available for those organizations that have been using the Rule of 6 or similar dosing methods that use non-standardized concentrations. For the remainder of 2004, Joint Commission surveyors will accept as evidence of compliance with this requirement, a transition plan with demonstrated progress toward full implementation of the plan by January 1, 2005. Discussions with the American Society of Health System Pharmacists (ASHP), the American Academy of Pediatrics (AAP), the National Association of Children's Hospitals and Related Institutions (NACHRI), specialists in pediatric and neonatal intensive care, and others, will continue in an effort to achieve consensus on the safest approaches and strategies for implementation. Additional information and advice will be provided in updates to these FAQs and in other Joint Commission publications. [New 1/1/04]

Did anyone else have to change over from the rules of 6? We aren't liking it because it does limit how you can titrate the drugs. It can also be a big amount of fluid for a little one and according to our charts, it seems like sometimes you are going from a mod dose of Dopa to nothing. Ugh....I say if it wasn't broke, don't bother it!