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What is the Hang Time for Functional Formularies?

4 min read

According to the manufacturer, all Functional Formularies enteral formulas are approved for a 12-hour hang time at ambient room temperatures. This specification refers to the duration their open tube-feeding products can be safely administered, clarifying a term often confused with the processes of a pharmacy benefit manager's drug list.

Quick Summary

The hang time for Functional Formularies' tube-feeding products is 12 hours, a specific safety guideline for infusion at room temperature. This is distinct from the entirely different concept of a drug formulary managed by an insurance provider.

Key Points

  • 12-Hour Hang Time: Functional Formularies' products are approved for a 12-hour hang time for infusion after opening, based on microbial safety tests.

  • Microbial Safety: This hang time is a patient safety measure designed to prevent the growth of bacteria in the formula at room temperature.

  • Not a Drug Formulary: The term should not be confused with a traditional pharmaceutical formulary, which is a list of covered prescription drugs managed by an insurance plan.

  • Proper Handling is Key: To ensure safety, follow specific handling instructions, including not exceeding the 12-hour limit and properly storing any unused portions.

  • Manufacturer Specific: Hang time can vary significantly between different products and manufacturers, so always consult the specific product's guidelines.

  • Different Context: The concept of 'hang time' in this case is a clinical nutrition concern, unlike a PBM's formulary, which is a cost and coverage management tool.

In This Article

Understanding Hang Time in Enteral Nutrition

In the context of enteral nutrition, specifically with tube feeding, "hang time" is a critical safety measure. It refers to the maximum period of time an enteral formula can safely be administered once the container seal has been broken and it has been 'hung' for infusion. This guideline is primarily concerned with minimizing the risk of microbial contamination and subsequent bacterial growth, which can cause significant health problems for a patient receiving tube feedings. The hang time can vary depending on the product type and handling procedures, with ready-to-use formulas typically having a longer allowable duration than those prepared from powders or with added ingredients.

The Specifics for Functional Formularies Products

Functional Formularies is a company specializing in organic, whole-food, and plant-based feeding tube formulas. They explicitly state that their enteral products, such as Liquid Hope® and Nourish®, are approved for a 12-hour hang time. This approval is based on independent, third-party microbial assessments that confirm no harmful microbial activity occurs within this timeframe at ambient room temperatures. It is important to note that this specific 12-hour hang time applies to their sealed, ready-to-use pouches. If any ingredients, including water, are added to the formula, the hang time may be reduced and the mixture may require re-blending to prevent separation. Proper handling and storage are crucial to maintaining the product's safety and nutritional integrity.

Comparison: Enteral Feeding Hang Time vs. Drug Formularies

There is a common point of confusion due to the name "Functional Formularies," which sounds similar to the pharmaceutical term "formulary." However, these two concepts are entirely unrelated. To clarify the difference, let's compare them directly.

Feature Hang Time for Functional Formularies Drug Formulary (PBM)
Core Concept Maximum time an opened formula can safely hang for infusion. A list of prescription drugs covered by an insurance plan.
Context of Use Enteral nutrition, specifically tube-feeding products from the company Functional Formularies. Managed care pharmacy, insurance plans, and Pharmacy Benefit Managers (PBMs).
Primary Purpose Patient safety by preventing microbial growth in open formulas. To manage drug costs and promote cost-effective medication use.
Governing Body Manufacturer-specified, based on microbial testing and safety standards. Pharmacy and Therapeutics (P&T) committees of PBMs and health plans.
Variables Product type (e.g., ready-to-use vs. reconstituted), ambient temperature. Drug tiers, utilization management (PAs, quantity limits), and negotiated rebates.

What is a Drug Formulary?

To further dispel any confusion, it is helpful to understand what a drug formulary is. In the pharmaceutical and insurance industry, a formulary is a dynamic list of prescription drugs covered by a health plan. This list is developed and maintained by a Pharmacy and Therapeutics (P&T) committee, comprising doctors, pharmacists, and other healthcare experts. The committee evaluates drugs based on their clinical effectiveness, safety, and cost to decide on their inclusion and placement within a multi-tiered system. Different tiers determine the patient's out-of-pocket costs, with lower-tiered generics being less expensive than higher-tiered brand-name or specialty drugs. PBMs manage these formularies and negotiate with drug manufacturers to secure discounts, which further influences which drugs are covered and at what cost. Crucially, a drug formulary has no connection to the microbial safety of a tube-feeding product.

Best Practices for Safe Enteral Feeding

Adhering to manufacturer guidelines is essential for patient safety, especially when dealing with vulnerable patient populations. Here are some best practices for managing enteral formula hang time:

  • Always read and follow the manufacturer's instructions: Different products, even from the same company, can have different specifications.
  • Maintain proper hygiene: Thoroughly wash hands and ensure a clean preparation area to minimize contamination.
  • Label the formula pouch: Clearly mark the start time of the infusion to avoid exceeding the 12-hour hang time.
  • Store unopened pouches correctly: Keep unopened pouches at room temperature, away from extreme heat or cold, to maintain their integrity.
  • Dispose of unused formula: After the 12-hour window has passed, any remaining formula in the pouch should be discarded to prevent bacterial growth.
  • Understand storage versus hang time: An opened pouch of Functional Formularies formula, if stored properly in a sealed container in the refrigerator, can last for a certain period (e.g., 48 hours for Keto Peptide), but must be brought back to room temperature and used promptly once hung for infusion.

Conclusion: Clarifying the Terminology

The distinction between a product's 'hang time' and an insurance 'formulary' is clear. For users of Functional Formularies' products, the 12-hour hang time is a vital safety guideline for administering the product once opened. This is a clinical concern about microbial growth in enteral nutrition, not a policy decision about drug coverage. Understanding this specific terminology ensures patients and caregivers can confidently and safely use these whole-food formulas as part of their nutritional care plan. For more information, refer to the manufacturer's official FAQ section on their website.(https://www.functionalformularies.com/ufaqs/how-long-are-hang-times-and-storage-7/)

Frequently Asked Questions

All enteral formulas from Functional Formularies, such as Liquid Hope® and Nourish®, are approved for a 12-hour hang time for administration at ambient room temperature, based on independent microbial safety testing.

Hang time refers to the maximum period of time an open container of enteral formula can be safely infused or administered to a patient via a feeding tube before there is a risk of harmful bacterial growth.

No, they are two completely different concepts. Functional Formularies is a company name for a brand of enteral nutrition products. A drug formulary is a list of covered prescription medications managed by a health insurance plan or a Pharmacy Benefit Manager (PBM).

Exceeding the hang time increases the risk of microbial contamination and the growth of harmful bacteria. To ensure patient safety, any formula hanging for longer than the recommended time should be discarded.

After opening, if the formula is not used immediately for a 12-hour infusion, it should be stored in a closed container in the refrigerator and used within the manufacturer's specified period (e.g., 48 hours for Keto Peptide). It must be brought back to room temperature before administration.

Hang time can vary based on several factors, including the formula's composition, the type of packaging (open vs. closed system), and whether the formula is reconstituted or ready-to-use. Manufacturers test their specific products to determine the safest hang time.

A P&T (Pharmacy and Therapeutics) committee is a group of clinicians, including pharmacists and physicians, who evaluate and select the drugs for a health plan's formulary. This committee is unrelated to the hang time of enteral feeding products.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.