Research PaperDiscuss USP Chapter <797> and the importance of the standards that were created, focus on revisions made in 2008 (include requirements for garbing, environmental quality control, beyond

The Old Vs. The New: Providing safer drug compounding Techniques to enhance patient and healthcare worker safety

Safer Medication, Healthier Living

Vondra Wesley

Rasmussen Student

The Old Vs. The New: Providing safer drug compounding Techniques to enhance patient and healthcare worker safety

USP 797 VS USP 800

Safer Medication, Healthier Living
Sterile Preparations are needed to protect the health of patients by reducing the potential for microbial contamination caused by unsanitary environments and toxic microorganisms.
The New era of safer and enhanced health protocols to protect the consumer and the healthcare industry.

Reducing Contamination

The policy requires environmental rules to include a separate area for compounding that meets a strict level of cleanliness and monitoring for regulation obedience.

The Anteroom
The Cleanroom

The anteroom is located in a secure area and ensures a safe airflow barrier zone between the controlled pressurized room and an unclean area.

This designated area is for use by Pharmacy compounding personnel to exercise personal sterilizing procedures before entering the Cleanroom to compound medications. In this area garbing is performed, but when USP 800 starts a more sterile process will exist with improvements to sterile safety garments.

This area is used to perform sterilization procedures on any equipment or supplies required to complete compounding

Preventing Pharmacist error

Pharmacy management is required to practice the standards set by U.S. Pharmacopeia (USP) Chapter 797. It defines the process, procedures and compliance prerequisites for pharmacies participating in compounding sterile preparations (CSPs).

The pharmacist is to keep accurate records of all compounding practices, medication changes, and updates and stay informed of any drug changes, interactions or adverse effects. 2. Pharmacists are to ensure that all compounding staff receive proper training in sterile compounding

USP 797 means Accountability

Pharmacists will be deemed accountable to the compliance requirements located in USP 797.

As the educated professionals in sterile compounding, the maximum levels of accountability rest upon the pharmacist. Quality Control

a structure of maintaining standards in manufactured products by testing a sample of the output against the specification.

The pharmacist must ensure that each component has its correct identity, quality, and purity

Preserving appropriate cleanliness conditions, labeling, and instructions for proper clinical administration.

Quality assurance (QA) is a method of counteracting errors and imperfections in factory-made products and stopping complications when supplying solutions or services to customers or patients.

Quality Assurance reports conducted to check for accuracy and precision of measuring, weighing and strength of ingredients

Ensure proper sterile techniques were applied both before and after compounding procedure and the monitoring of the quality of the air flow in the compounding area to filter out potential hazards and contaminants. Conclusion With the ever-growing population increase we have, also comes the potential for more diseases and illnesses. New drugs and compounds are constantly on the rise of production. With this increase the need for advances to the sterility, productivity and overall protection of the integrity of medications is essential. Sterile Compounding is an unseen essential that we don’t normally consider. But it is just as important for a lot of patients who may not be able to be administered oral medications. Compounding is a reliable source, but it can only be beneficial upon proper production and properly maintained in a sterile environment. Now chapter USP 797 and 800 come into force. They both require strict regulations including the environment in which the medications are developed. Methods of sterility in production, accurate records of ingredients, storage, beyond use dates, the safety of human consumption is of chief importance. The training of pharmaceutical staff in aseptic preparations and its policies and procedures are required. For the consumer to maintain healthy living while on medication, the medications have to be safe.