Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create medication tailored to the needs of a certain individual. Compounding includes the combining of two or more drugs. A drug may be compounded for a patient who cannot be treated with an FDA-approved medication, such as patients who have allergies to a certain dye and needs medication to be made without it, or a patient who cannot swallow a tablet or capsule and needs the medication in liquid form. Compounding is extremely important in serving every patient's needs. However, some compounders engage in activities that put the patient at risk or they undermine the drug approval process. Consumers and health professionals rely on the drug approval process for verification of the safety, effectiveness, and quality of compounded drugs. Compounded drugs can serve as a very important medical need for patients, but they also lack the same quality, safety, and assurance that approved drugs have. This is why it’s important to follow the guidelines set by the USP in General Chapter 795, USP<795>, to help ensure the patient’s benefit and to reduce any risks of contamination, infection, or incorrect dosing. The USP General Chapter 795 provides quality standards for compounding nonsterile preparations.
Compounding medication can be a complicated and nuanced process, with the possibility of devastating results for any transgression. The USP<795> Pharmaceutical Compounding - Nonsterile Preparations standards address the inherent risk in compounding pharmacy medications in a non-sterile environment. The following are the key areas of focus included in USP<795>:
Training and Documentation of Competence - Skilled and trustworthy staff are essential to safe nonsterile compounding. It’s important for clinical staff to have the necessary training to ensure that they know the key steps required to perform nonsterile compounding. Utilizing the USP chapters as a guide will ensure that every clinical staff member meets the minimum requirements. Employees need to be familiar with the USP<795> and each of the procedures related to compounding. It’s also important to continually track their competence and improvements. Expertise is not something achieved immediately; it can grow as long as it is cultivated over time but it can also be lost if it isn’t. This is why regularly reviewing and documenting your staff’s skills can ensure a safe practice. Pharmacies must deliver closed-loop, on-demand training for sterile compounding.
Compounding Ingredients - Pharmacists can only produce medication with the ingredients they are given. If they start creating medication using inferior ingredients, they will only be able to deliver inferior medicine. It’s important to track and review the quality of your active pharmaceutical ingredients (API). An easy way to ensure that you are using approved and accepted ingredients is to ensure that they are a USP, NF, or Food Chemical Codex substance that was manufactured in an FDA-Registered Facility. If you purchase ingredients from a non-FDA vendor, it is your responsibility to obtain a Certificate of Analysis and to avoid terms like “chemical grade” or “not for human use.” Aside from your active pharmaceutical ingredients, you’ll also need to ensure the quality of your additional substances (inactive ingredients), your vehicle (the carrier in which your ingredients are dissolved), and your water. Water needs to be purified for use in compounds and for the best results. Even high-quality ingredients can also degrade over time so it’s important to follow the expiration date included in the bulk ingredients. If there is no expiration date listed, the standard practice is to not exceed three years from the date of receipt. Proper labeling and tracking of your ingredients is also key to ensuring quality medication.
Facilities - Your ingredients and training may not be effective if you are compounding medication in an unsuitable environment. You should be practicing in a space that is specifically designated for nonsterile compounding and there should be no other pharmaceutical tasks done in this space. In this space, there needs to be access to a sink with hot and cold water, a hand and eyewash station, soap, single-use towels, and a plumbing system. The appropriate heating, cooling, and ventilation systems also need to be ensured as humidity can have an impact on the quality of the medication you produce. Your space should be well-lit, clean, orderly, and have enough space for your ingredients and equipment. Following these standards will prevent cross-contamination.
Equipment - The equipment you use and wear for nonsterile compounding should be used and designed specifically for the compounding process. Sterile PPE isn’t necessarily required, but personnel needs to be protected from possible chemical exposure, and the medicine that the patients will need to take needs to be protected from the personnel. Barrier systems are needed for compounding as practitioners are one of the main sources of contamination. Hair bonnets, face masks, gloves, and gowns are important to have on hand and must be used while compounding. If you are performing specialty compounding including hazardous drugs or antibiotics, there should be specific equipment dedicated to such tasks or present equipment must be cleaned thoroughly after every use. You may also opt to use spatulas, beakers, flasks, bags, and more to reduce the possibility of cross-contamination.
Pharmacy Documentation - A master formulation record will include your drug compound recipes along with your compounding record, which are the steps taken to create the compounded drug. The master formulation is the foundational recipe for every drug you create while the compounding record is the documentation of each instance you create a drug. The name, strength, dose, quality developed, sources, lot numbers and expiration date, and the name of the practitioners who prepared, inspected, and approved the product should be included.
Quality Control - You must take every precaution to prevent a potential problem before it happens. It’s much better if a compounder can reference standard operating procedures, a master formulations record, and compounding records to ensure that his or her output is consistent. Pharmacy quality assurance goes one step further in establishing control procedures to inspect and approve the final product. Well-trained practitioners should be able to assess the final product and identify if there is anything wrong with it. Any reported problems must be fixed and investigated. It’s important to track all of these so that you may recognize and track trends and prevent these errors in the future.
Pill crushers are medication aids that pulverize pills so that they can easily be dissolved in drinks, liquid or mixed into 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 and others who have difficulty ingesting medications.
USP<795> has provided guidelines and standards for compounding quality nonsterile preparations. These guidelines ensure that there is as little risk of contamination as possible and also ensure that the compounded drugs created by practitioners are safe, effective, and of quality. One of the key areas noted by the USP<795> was the importance of having equipment specifically for the compounding process. Rx Crush was able to create a pill crushing device that follows the USP<795> guidelines as the individual pouches ensure that there will be no cross-contamination. RX Crush was able to create a design where a sealed pill crushing system delivers medication directly into a feeding tube. They are compliant with the USP<795> guidelines. The Rx Crush Pill pouch is sealed by a zip seal and is attached to a syringe on the other end. This ensures that the risk of contamination and infection is reduced while pulverizing pills. The pouches used are tough enough to withstand the possibility of being punctured from repeated crushing and pulverizing cycles on even the hardest pills.
The patented Rx Crush Pill Pouch connects 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:
The pill is inserted into the pill pouch through the zip-seal bag.
The water-filled syringe will be connected to the nozzle on the pill pouch.
The zip-seal pouch is then placed under the roller. The roller is used to ensure that the pouch is sealed properly.
Next the pill crush plate will be used to crush the pills by moving the handle up and down. This is an effective way of breaking larger or harder pills.
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 will be injected into the pill pouch.
While the syringe is still attached to the pouch, the pill pouch will be shaken until the medication has been dissolved.
The dissolved pill solution will be drawn 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.
The syringe will be detached from the pill pouch while the pouch and syringe are held horizontally. The syringe can then be attached to the fittings on a feeding tube and the contents ejected from the syringe.
The syringe will be refilled with water, injected into the pouch, and the contents will be withdrawn and transferred to the feeding tube multiple times to remove all pill particles from the pouch.