The U.S. Pharmacopeial Convention (USP) recently updated their General Chapter USP<800> in December of 2019. USP General Chapter 800 sets the standards of how to handle hazardous drugs in clinical pharmacy settings in order to lessen the risk of exposure to healthcare personnel, the environment, and patients. The U.S. Pharmacopeial Convention is a scientific nonprofit organization that is made up of experts who work together with the goal of improving global health through public standards and related programs that help ensure the safety, quality, and benefit of medicine and food. They set standards and give various recommendations on how to improve the safety of various medicinal practices.
USP<800> is part of USP chapters. This specific chapter creates guidelines on how to handle hazardous drugs in a healthcare setting. It’s important to know what classifies as hazardous drugs. The National Institute for Occupational Safety and Health (NIOSH) considers a drug to be hazardous if it exhibits one or more of the following characteristics in humans or animals:
Carcinogenicity - This is the ability or tendency to produce cancer. Carcinogens are substances or exposures that can cause cancer. While it’s impossible to completely eliminate carcinogen exposure, you can and should take steps to reduce the carcinogens you come in contact with.
Teratogenicity - This is the ability to cause defects in a developing fetus. This is a potential side effect present in multiple drugs. A teratogen is something that can cause birth defects or abnormalities in a developing embryo upon exposure.
Developmental Toxicity - This pertains to adverse toxic effects on the developing embryo or fetus.
Genotoxicity - This is the ability of harmful substances to damage genetic information in cells. Exposure to chemical and biological agents can result in genomic instability or epigenetic alterations.
Reproductive Toxicity - This is the adverse effects of a chemical substance on sexual function and fertility in both male and female adults.
Organ Toxicity at Low Doses - When there is serious organ toxicity that is evident when a drug was taken only at a low dose, the drug is considered toxic.
USP 800 Guidelines
USP<800> is the standard that governs hazardous drugs and how they are handled, stored, compounded, dispensed, administered, and disposed of. It is in place to protect personnel and environments from hazardous drug compounding. USP<800> specifically focuses on the safe handling of hazardous drugs to minimize the risk of exposure to patients, healthcare workers, and the environment. There are different requirements for handling hazardous drugs that are listed in USP<800>. It lists the responsibilities of healthcare personnel who handle hazardous drugs, facility and engineering controls, procedures for deactivating, decontaminating, cleaning, spill control, and documentation.
USP<800> standard applies to all healthcare personnel who receive, prepare, administer, transport, and come in contact with hazardous drugs. The policies in USP<800> must be incorporated in occupational safety plans for facilities that handle hazardous drugs. The most basic requirements of USP<800> include the list of hazardous drugs, facility and engineering controls, having competent personnel, practicing safe work practices, the proper use of PPE, and the policies for segregating and disposing of hazardous drugs waste. About 8 million US healthcare workers are potentially exposed to hazardous drugs. To address these risks, USP General Chapter 800 was created. USP does not set or enforce regulations, but some of its standards are enforced by the FDA, state pharmacy boards, and accrediting agencies.
Pill crushers are used by those who cannot swallow whole pills. Pill crushers are medication aids that crush pills so that they can easily be dissolved in liquids and drinks or sprinkled on food. This is very important for those who have difficulty swallowing and for large pills that are harder to swallow. Pill crushers enable people to easily and quickly take their medications. Crushing pills containing hazardous drugs poses risks to the healthcare worker. With conventional crushers like the twist style, mortar and pestle, or those using a pill pouch wherein the pill is crushed, hazardous pill dust can escape into the environment and be inhaled. USP<800> details risk mitigation measures to be employed when crushing pills. Always adhere to “do not crush” lists which detail which medications cannot be crushed.
USP<800> has set guidelines for handling hazardous drugs. If there are hazardous drugs to be crushed, sealed pill crusher systems such as the RxCrush Pill Crushing system reduces the risks of crushing hazardous pills to the healthcare worker. The pill is crushed in a sealed pouch and liquid is mixed in the same sealed pouch before being introduced into the feeding tube. There is no instance where the environment is exposed to dry pill dust. The pouches are tough enough to withstand puncture from repeated crushing and pulverizing cycles on even the hardest pills.
The patented Rx Crush Pill Crusher connects to a liquid filled syringe. After crushing and pulverizing the pill in the 2-stage RxCrush Pill Crusher, liquid from the syringe is added to the pulverized medication in the pouch and shaken to dissolve the medication. No other additional equipment is needed, no cups or stirring utensils. The dissolved medication is ready to be transferred to a feeding tube via the attached syringe. Here is how the Rx Pill Crusher works:
The pill is inserted into the pill pouch through the zip-seal.
A water-filled syringe is connected to the nozzle on the pill pouch. Use the syringe as a handle while crushing the pill.
The zip-seal pouch is then placed under the roller. The roller is used to ensure that the pouch is sealed properly.
The pill crush plate is used to initially crush the pills by moving the handle up and down.
The pouch is moved back under the roller that was used to seal the pouch. Roll over the pill until the pill is pulverized.
Once complete pulverization is accomplished, remove the pouch and syringe assembly from the crusher and inject water from the syringe into the pill pouch.
While the syringe is still attached to the pouch, shake the pill pouch until the medication has been dissolved.
Withdraw the dissolved pill solution from the pill pouch into the syringe. It’s important that the pouch is held up to make sure that all contents of the pouch flow into the syringe.
Detach the syringe from the pill pouch. Hold the syringe tip up so that nothing leaks from the syringe. Attach the syringe to the feeding tube and inject the contents.
If needed, refill the syringe with water, inject into the pouch, and withdraw the contents and transfer them to the feeding tube as many times as necessary to remove all medication from the pouch.
The RxCrush Pill Crushing system reduces the risks inherent in crushing hazardous drugs and is a tool for complying with USP<800>.