New TPN pharmacy regs call for better labeling
ASPEN focuses on patient care and consistency among pharmacies
It's time your pharmacy took a long hard look at its operations. At least that is the recommendation of the American Society for Parenteral & Enteral Nutrition (ASPEN) in its recently released total parenteral nutrition (TPN) guidelines. Three years in the making, Safe Practices for Parenteral Nutrition provides pharmacists with standard guidelines on labeling, compounding, formulating, stabilizing, and filtering. A lack of such standards and the resulting inconsistencies among pharmacies led to several patient deaths and a U.S. Food & Drug Administration safety alert in 1994.
The guidelines were created by ASPEN's National Advisory Group (NAG) that was formed in response to the 1994 patient deaths and that reviewed comments from 800 professionals and health organizations across the country.
Even though they are guidelines and not requirements, your pharmacy may be held accountable for not following them if they become a plaintiff's evidence of the accepted standard of care during a lawsuit against your company. (For more information on meeting the standards, see p. 63.)
"ASPEN formed this committee of pharmacists to take a look at pharmacy practices and whether there needed to be specific guidelines, standards of practice, or recommendations made to make practices more consistent," says Jay Mirtallo, MS, RPh, FAHSP, BCNSP, specialty practice pharmacist in surgery/nutrition at The Ohio State University Medical Center in Columbus and a member of the NAG, specifically created to address the issues raised in the FDA safety alert.
"These guidelines have established a standard language for labels so nutrient content is expressed in the same manner," says NAG home care representative Barbara McKinnon, PharmD, BCNSP, director of business development for Nova Factor, a biotech company in Memphis, TN. "So when patients transfer from one setting to another, everyone can clearly understand what was intended."
After three years of work, the NAG found that five areas needed attention:
1. Labeling.
Labeling of TPN formulations will likely cause the most change for home infusion providers, says McKinnon.
"Everyone labeled however was most convenient for them," she says. "If I labeled in final percentage and you labeled in initial ingredients, and we didn't understand what the other meant, that led to problems."
Because the labels did not specify whether ingredients were labeled by final percentage or initial ingredients, confusion often arose.
"The area that got the most comments and where we've had the most discussion when we've held open forums has been labels, mostly because it's been the most problematic area," notes Mirtallo.
He points out that the current health care environment in which patients often change care settings - and thus pharmacies - creates confusion.
For example, one pharmacy might label a TPN solution according to the volume of a 50% dextrose product used to compound the formulation. Another pharmacy might label the solution as the final percentage concentration diluted with all the other additives.
"So if one label reads 50% where the final concentration is actually 5%, if the label is misinterpreted, the patient could get a 10-fold error in the dextrose concentration," says Mirtallo.
The potential harm from such an error is obvious. "We found that the misreading and misrepresentation of labels of what was actually in a TPN prescription had caused patient harm when patients had transferred from one environment to the next," says Mirtallo. "That is the area on which we spent the most time and feel strongest about in regard to making sure there is consistency across health care environments."
As the NAG reviewed practices among committee members as well as pharmacies outside the committee, Mirtallo says there was a wide variety of TPN labeling practices. So the NAG had to settle on one standard for labeling TPN formula.
"The logic we followed was that the label should be consistent so a person can interpret what the consistency of the products are and verify the dosages against the patient's body weight," he says. Labels should now list the final TPN nutrient content and doses per day, based on a 24-hour admixture system in grams or milligrams.
The other change made was for labels to specify a patient weight.
"Weight should be listed for both adults and pediatrics so somebody can take that label and verify the dosage against the weight as being appropriate for the patient," says Mirtallo.
The recommendation doesn't necessarily call for wholesale changes, though.
"The guidelines' intent is you can label in the way you've always labeled, whatever is convenient for you and whatever you have used," says McKinnon. "In addition, what we've really asked is practitioners employ a second column on the label that is in the common translation language, so the prescription can be clearly understood if the patient readmits or the patient from the hospital comes back home. So it's just a matter of reformatting their label."
2. Compounding.
ASPEN's TPN guidelines recommend that if a change in pharmacy processes takes place or a period of time has gone by without an evaluation of those processes, then pharmacists should evaluate them periodically in relation to the most current available literature from the manufacturer of products being mixed in the pharmacy.
Mirtallo says that mixing products with one another is common practice in pharmacy processes, but it has the potential to cause patient harm when it comes to TPN admixtures.
"With TPN, the manufacturers don't have good stability data for products that are not their own, so we have made a strong recommendation that if products are mixed - for example, if they use a dextrose formulation from one manufacturer and an amino acid and fat emulsion from a different manufacturer - that there is literature from the manufacturers that those are stable when mixed together," notes Mirtallo.
If the manufacturers' literature does not state such, the new guidelines recommend you don't mix manufacturer's brands and products, unless you have done your own stability studies.
3. Formula.
Pharmacists are responsible for providing the patient with a complete, balanced formulation that will provide the proper amount of nutrients, thus, avoiding a deficiency or toxicities from an overdose.
"We included what we thought were consistent guidelines for patients with normal renal functions and normal liver functions so the pharmacists can have a starting point and then individualize the formulation for patients based on other disease state conditions," says Mirtallo.
Pharmacists can now use the ASPEN guidelines as a starting point for TPN content and simply adjust the formulation depending on the diagnosis of each patient and their increased or decreased needs for particular nutrients.
4. Stability.
The stability of each admixture can vary widely, depending on the base components used as well as the time period for which they will be stored. Pharmacists should use the manufacturers' most recent literature to ensure stability.
5. Filtering.
While labels had the most diversity among pharmacies, filtering provided the most controversy.
"There is not a lot of literature on whether filters are needed," says Mirtallo. "But since the FDA 1994 safety alert specified that filters be used for TPN, and because there is no literature to the contrary that it's safe not to, we have a final recommendation that filters be used for TPN administration."
The filter size will vary depending on whether there is a fat emulsion involved in the admix.
There's no enforcement committee that will ensure pharmacies are following ASPEN's TPN pharmacy guidelines. But Mirtallo says to be prepared to suffer the consequences if you ignore the guidelines.
"These are now in publication and are recommendations for safe practices," he says. "If there are any problems for a pharmacy and a legal court case developed, this may well be established as a legal practice guideline or standard, and if the pharmacy isnin compliance with what is stated here, they will have to have literature justification for their own processes that document what they're doing is safe."
McKinnon notes that following the guidelines will benefit your patients.
"There have been instances, and we document them in the recommendations, of patient harm that occurred when these guidelines were not followed," she says. "It is in everyone's best interest that we all provide the best practice we can, and I don't think these guidelines will be difficult or cumbersome for anyone."
For a copy of the recommendations, contact ASPEN at (301) 587-6315, or visit its Web site at www.clinnutr.org.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content