Millions of doses of medications are compounded each year in the United States. Its estimated that as many as 190,000,000 are prepared each year. Drug compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of a specific individual. This process provides access to patients who may not use commercially available drugs due to allergies, rare diseases, or dosing requirements. Some medications are required to be sterile, such as medication that is administered through injection, intrathecal (injection in the spine), intraocular (injection in the eye), and intravenous infusion (IV). It’s important to understand the risks present in compounding medication and why it’s important to have standards established for the patient’s safety and for the safety of health care workers. Having medication compounded without following specific standards or guidelines could lead to contaminated, sub-potent, or super potent medication which can expose patients to a significant risk of adverse events or even death.
The United States Pharmacopeia Convention (USP) is a scientific nonprofit organization dedicated to ensuring the quality of the American drug supply. They have created chapter USP<797> which outlines the required procedures for compounding sterile drug preparations. This applies to all pharmacies that produce compounded sterile preparations (CSPs), such as those in retail settings, hospitals, radio/nuclear pharmacies, ambulatory care centers, long-term care facilities, and other environments such as chemotherapy units, hospital nursing stations, and operating rooms and even for patients being treated at home.
USP<797> was first implemented and published in the United States Pharmacopeia and National Formulary (USP-NF) on January 1, 2004. USP<797> establishes a standard of practice. It provides a foundation under which regulatory agencies, specifically the state-level department of public health and board of pharmacy, can pursue pharmacies for unsafe compounding practices. This chapter is specifically designed to prevent patient harm and fatality from microbial contamination (non sterile), excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in CSPs. The Joint Commission actively enforces the USP<797> as required by many state boards of pharmacy. A nationwide meningitis outbreak in 2012 due to improper sterile compounding led many state-level pharmacy laws and regulations to be updated to require USP<797> compliance.
USP<797> covers the compounding of both hazardous and nonhazardous drugs with a focus on the protection of sterile compounds and environments from contamination. This standard was put in place to ensure patient safety and to reduce any risks associated with compounding pharmaceuticals, including contamination, infection, and incorrect dosage. This standard helps guarantee that patients receive quality drugs that are free from any contaminants. This standard applies to all pharmacies that produce compound sterile preparations (CSPs). The ultimate goal of the set standards is to prevent health issues to patients that can be caused by microbial contamination, bacterial endotoxins, variation in the strength of ingredients, and chemical and physical contaminants.
- Training - Mainly USP<797> focuses on personnel training for the preparation of sterile CSPs. To maintain CSPs in an ISO Class 5 environment, staff must be trained in best practices and the basic competencies related to CSPs. Personal Protective Equipment (PPE) is required in an ISO Class 5 environment at all times. Other important elements of personnel training include antiseptic hand washing, disinfecting nonsterile compounding areas, proper measurement and identification of ingredients, proper aseptic handling of products, proper labeling and packaging of CSPs, and sterilization of high-risk CSPs.
- Policies and Procedures - USP<797> outlines areas that require policies and procedures to ensure drug and patient safety. These areas include environmental quality and control, finished preparation release checks and tests, maintaining sterility, purity, and stability of dispensed and distributed CSPs, and a quality assurance program.
Under USP<797>, there are guidelines on cleaning and disinfecting. The pharmacy and areas where medications are stored, compounded, dispensed, prepared, and administered must be clean. The staff are only allowed to use organization-approved cleaning procedures and cleaning agents. Drug preparation, packaging, and dispensing devices, like pill-crushers, need to be cleaned after each use and disinfected if necessary. Pill crushers are medication aids that pulverize pills so that they can easily be dissolved in drinks or sprinkled on food. This is very important for those who have difficulty swallowing and for large pills that are harder to swallow. It’s important to have pill crushers as they are a necessity that enables people to easily and quickly take their medications. Pill crushers are an excellent item for the elderly but other people can benefit from it too.
USP<797> sets guidelines for compounding both hazardous and nonhazardous drugs to protect sterile compounds and environments from contamination. The guidelines, when followed, guarantee patients receive quality drugs that are free from any contaminants. RxCrush was able to create a design where a sealed pill crushing system delivers medication directly into a feeding tube. RxCrush Pill Pouches are compliant with USP<797> guidelines. The RxCrush Pill pouch is sealed by a zip seal and is attached to a syringe on the other side. This ensures that the risk of contamination and infection is reduced while pulverizing pills. The pouches used are durable enough to withstand the possibility of being punctured from repeated crushing and pulverizing cycles on even the hardest pills.
The patented RxCrush Pill Pouches connect to a syringe. Liquid from the syringe is added in with the crushed medication which is safely contained inside the pill pouch. No other additional equipment is needed. The dissolved medication is ready to be transferred to a feeding tube via the attached syringe.
Here’s a look into how the Rx Pill Crusher Works:
- First, the pill(s) are inserted into the pill pouch into the opening of the zip-seal bag.
- The water-filled syringe is attached to the ENFit nozzle on the pill pouch, either directly with an ENFit syringe or with an adapter if using a non-ENFit syringe.
- 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 crush the pills by moving the handle up and down, crushing or breaking down the pills. By nibbling at the pills a larger number or harder pills can be broken down.
- The pouch is moved back under the roller that was used to seal the pouch. It will then be rolled back and forth to further pulverize the pills.
- Once further pulverization has been done, the pouch will be removed from the crusher, and water from the attached syringe is injected into the pill pouch.
- With the syringe attached to the pouch, shake the solution in the pouch until the medication has been dissolved.
- Draw the dissolved solution from the pill pouch into the syringe. It’s important that the pouch is held up and the syringe down, to make sure that all contents of the pouch flow into the syringe.
- Detached the syringe with the dissolve medication from the pill pouch while holding the pouch down the syringe up. The syringe can then be attached and the contents may be injected into a feeding tube.
- Refill the syringe with water again and inject into the pouch. Repeat the dissolving steps to evacuate as much of the remaining medication as possible and transfer to the feeding tube.