Explore the Risks

Each Step in
Compounding
Adds Complexity⁵

Compounding of chemotherapy drugs, including drug dilution and reconstitution, is a multistep process with risks inherent at each step

Process complexity

Preparing cytotoxic drugs such as gemcitabine involves several steps and the use of personal protective equipment, with risk of error and exposure at each step^1,2,5

Variability

Human error in compounding can result in serious quality problems―such as contamination or too much active ingredient―that may harm the patient⁸

Exposure

The CDC estimates about 8 million US healthcare workers are potentially exposed to hazardous drugs or drug waste⁹

CDC=Centers for Disease Control and Prevention.

The risks of exposure

Workplace exposure to chemotherapy drugs has been associated with a variety of medical conditions.¹⁰

ORGAN TOXICITY

INFERTILITY

MISCARRIAGE

CANCER

Chemotherapy risk of exposure to human body

HAIR LOSS

ALLERGIC-TYPE REACTIONS

SKIN RASHES

CHROMOSOMAL DAMAGE

Adapted from National Institute for Occupational Safety and Health (NIOSH)⁶

Latest standards in workplace safety

“It is essential to minimize exposure to all hazardous drugs.”

-Occupational Safety and Health Administration (OSHA)¹¹

Occupational Safety and
Health Administration

has established it is essential to minimize exposure to chemotherapy drugs, noting many governmental and professional organizations have contributed substantial quantities of scientific investigation results, “best practices,” and policy recommendations¹¹
The introduction of United States Pharmacopeia (USP) 797 and USP 800

established practice and quality standards for handling chemotherapy drugs to promote patient safety, worker safety, and environmental protection⁶

Safety Guidelines

Organizations increasingly call for using the most ready-to-administer drug products available^12-14

2013

The Joint Commission

Medications in patient care areas should be available in the most ready-to-administer forms commercially available.

2016

Institute for Safe
Medical Practices

Commercially prepared, premixed parenteral products should be used to the maximum extent, whenever possible.

2018

American Society of
Health-System Pharmacists

Whenever possible, medications should be available for inpatient use in ready-to-administer packaging without further manipulation by the person administering the medication.

The need for a ready-to-infuse formulation

Compounding cytotoxic drugs requires a multistep process that presents multiple opportunities for error, contamination, and accidental exposure.⁵

Using ready-to-infuse formulations eliminates steps in gemcitabine preparation^1-3

Lyophilized
powder
Concentrated
solution
Ready-to-infuse
formulations

Lyophilized
powder
- Reconstitution
- Withdrawal of required dose
- Admixture in diluent
- Administer to patient
Concentrated
solution
- Withdrawal of required dose
- Admixture in diluent
- Administer to patient
Ready-to-Infuse
formulations
- Select required dose
- Administer to patient

Explore the Risks

Each Step inCompoundingAdds Complexity5