Choosing Cost-Effective and Safe Intravenous (IV) Options: FDA Approved, Ready-to-Administer (RTA) Products

Fresenius Kabi Authors: Angie Lindsey, with Medical Contributions by Pashmina Malik, PharmD, MPH

Ready-to-Administer (RTA) Products Defined

The Institute for Safe Medication Practices (ISMP) defines RTA as “an injectable product containing the active drug in solution at the required concentration and volume, presented in the final container (syringe, infusion bag, or elastomeric device) and ready to be administered to the patient.”1 The World Health Organization (WHO) defines RTA as “an injectable medicine that requires no further dilution or reconstitution and is presented in the final container or device, ready for administration or connection to a needle or administration set.”^2,3

GUIDELINES AND RECOMMENDATIONS RELATED TO RTA PRODUCTS^a

Organization/Year	Title	Key Highlights
American Society of Health System Pharmacists (2013)	ASHP Guidelines: Minimum Standards for Pharmacies in Hospitals	Whenever possible, medications should be available for inpatient use in single-unit packages and in RTA form. Manipulation of medications before administration (eg, withdrawal of doses from containers, reconstitution of powdered drug products, labeling of containers, and splitting of tablets) by final users should be minimized.
The Joint Commission (TJC) (2014)	Standards Booster-Pak for Safe Medication Storage 03.01.01	Medications in patient care areas should be available in the most RTA forms commercially available or, if feasible, in unit doses that have been repackaged by the pharmacy or a licensed repackager.
Institute of Safe Medication Practices (ISMP) (2015)	ISMP Guidelines for Adult IV Push Medications	Commercially available, prefilled syringes of medications that are already labeled should be used, when possible. To the greatest extent possible. provide adult IV push medications in RTA form (to minimize the need for manipulation outside of the pharmacy sterile compounding area).
Center for Medicare Management (CMS) (2018)	State Operations Manual Appendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals.	Whenever possible, medications are dispensed in the most RTA form available form available from the manufacturer or, if feasible, in unit doses that have been repackaged by the pharmacy.
Infusion Nursing Society (INS) (2021)	Infusion Therapy Standards of Practice	INS recommends, in adults, using IV push medications in RTA form to minimize the need for manipulation outside the pharmacy sterile compounding area.

Organization	American Society of Health System Pharmacists (2013)	The Joint Commission (TJC) (2014)	Institute of Safe Medication Practices (ISMP) (2015)	Center for Medicare Management (CMS) (2018)	Infusion Nursing Society (INS) (2021)
Title	ASHP Guidelines: Minimum Standards for Pharmacies in Hospitals	Standards Booster-Pak for Safe Medication Storage 03.01.01	ISMP Guidelines for Adult IV Push Medications	State Operations Manual Appendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals.	Infusion Therapy Standards of Practice
Key Highlights	Whenever possible, medications should be available for inpatient use in single-unit packages and in RTA form. Manipulation of medications before administration (eg, withdrawal of doses from containers, reconstitution of powdered drug products, labeling of containers, and splitting of tablets) by final users should be minimized.	Medications in patient care areas should be available in the most RTA forms commercially available or, if feasible, in unit doses that have been repackaged by the pharmacy or a licensed repackager.	Commercially available, prefilled syringes of medications that are already labeled should be used, when possible. To the greatest extent possible. provide adult IV push medications in RTA form (to minimize the need for manipulation outside of the pharmacy sterile compounding area).	Whenever possible, medications are dispensed in the most RTA form available form available from the manufacturer or, if feasible, in unit doses that have been repackaged by the pharmacy.	INS recommends, in adults, using IV push medications in RTA form to minimize the need for manipulation outside the pharmacy sterile compounding area.

^aTable modified from Malik et al.³

Safety of Intravenous (IV) Push Administration and Use of RTA products

Higher rates of errors (48%-81%) have been reported for IV medications compared with other routes of medication administration.^3,4 There are many factors that can contribute to this, including multiple complex steps required for preparation and administration of IV medications.⁵ Reported errors related to the preparation of IV push medications include incorrect or missing syringe labeling, contamination, and the potential for dosing errors.⁵ The errors related to IV administration can potentially result in increased risk of patient harm due to the immediate bioavailability of medications given via IV route and narrow therapeutic range, and there can be challenges in immediate reversal of systemic effects.^4,6

Published reviews have reported that use of RTA prefilled syringes can reduce the number of errors and related patient harm. This can also have a positive impact on clinical workflows and cost containment efforts.^5,7,8 Hertig et al. demonstrated a 2.5% error rate in the RTA arm compared to a 10.4% error rate in the traditional vial and syringe method arm in his observational study.⁵ Moreover, use of RTA products have shown to reduce pharmaceutical waste, risk of drug diversion and are reported to be cost-effective when compared to traditional vial and syringe methods.^9,10

In another workflow time study, the authors concluded that significant costs are associated with pharmaceutical product waste and the workforce time waste associated with the waste disposal process. Optimizing product sizes and presentations to commonly used doses in clinical practice can help reduce the financial burden. The authors also reported that the risk of drug diversion can be reduced by addressing the pharmaceutical waste.⁹ A recent publication on RTA cost-effectiveness by Arora, A et al. demonstrated a 94% reduction in errors in the RTA arm compared to traditional vial & syringe and due to the decrease in medication errors that lead to adverse events, the use of RTA was estimated to save $2.9 million per year based on 15,727 administrations.¹⁰

During the third consensus conference on the Safety of Intravenous Drug Delivery Systems, an expert panel rated manufacturer-prepared RTA products as the safest option of the available IV drug delivery systems due to their continuous quality assurance during product production. The panel also mentioned that sometimes the lack of availability of preferred systems might pose a challenge in adoption.11 Utilization of RTA products becomes even more important during high-stress situations or through longer-term disruptions such as during the early phase of the COVID-19 pandemic and in subsequent surges. The conditions and impact of the COVID-19 pandemic have put additional stress in the healthcare environment which can increase the risk of errors. RTA is an ideal option for safe IV push medication administration in these types of increased stress situations. Use of RTA may help increase efficiency, reduce errors, and potentially related patient harm.³

Manufacturer Prepared RTA Syringes and How They Are Unique

Manufacturer prepared RTA syringes are approved by the US Food and Drug Administration (FDA), which means the label, drug, syringe components, and manufacturing protocols undergo a vigorous review process. Simplist^® ready-to-administer prefilled syringes (Fresenius Kabi, Lake Zurich, IL) are FDA approved and manufactured in a facility in Wilson, NC using current good manufacturing practices (cGMP) and state-of-the-art manufacturing equipment for filling and packaging. This highly automated and FDA regulated manufacturing process allows for large batch production of standardized doses of prefilled syringes that have 24- to 36-month shelf life, making it possible to maintain sizeable inventory reserves of these critical medications to support consistent supply. Prefilled syringes and other RTA devices also help to improve standardization, as they are labeled and barcoded¹² to help verification of proper drug and dose prior to administration, promoting safe medication delivery.

RFID Smart-labeled Medications

Fresenius Kabi is also making substantial investments to produce RFID smart-labeled vials and syringes to help support more precise inventory management and eliminate tedious manual tagging and data entry.¹³ Many healthcare groups, including the ASHP Foundation, are evaluating the use of RFID technology to help improve patient safety by reducing medical errors.^14,15 RFID is a passive technology, making it appealing for the anesthesia workflow. Interoperability is paramount as more use cases are identified for RFID in the hospital setting.

Choosing Cost-Effective and Safe Intravenous (IV) Options: FDA Approved, Ready-to-Administer (RTA) Products

Ready-to-Administer (RTA) Products Defined

GUIDELINES AND RECOMMENDATIONS RELATED TO RTA PRODUCTS^a

Safety of Intravenous (IV) Push Administration and Use of RTA products

Manufacturer Prepared RTA Syringes and How They Are Unique

RFID Smart-labeled Medications

Connect with us

For Additional Information

Choosing Cost-Effective and Safe Intravenous (IV) Options: FDA Approved, Ready-to-Administer (RTA) Products

Ready-to-Administer (RTA) Products Defined

GUIDELINES AND RECOMMENDATIONS RELATED TO RTA PRODUCTSa

Safety of Intravenous (IV) Push Administration and Use of RTA products

Manufacturer Prepared RTA Syringes and How They Are Unique

RFID Smart-labeled Medications

Connect with us

For Additional Information

GUIDELINES AND RECOMMENDATIONS RELATED TO RTA PRODUCTS^a