Crucial Important Facts For USP 797 Guidelines for Hospitals

Studies have shown that lack of compliance with the USP Standards by the health-care sector resulted in serious health issues. With cases of drug contamination often being reported it is extremely important for specialty pharmacists to abide by the USP 797 Guidelines for Hospitals for any forms of sterile preparations.

What Is USP?

USP is a non-profit organization or a scientific body that is solely responsible for setting down the standards of drug quality and its related practices.

What Is USP 797?

USP 797 is a chapter in the USP. It offers a set of requirements, procedures, and compliance requirements for the preparation of compounded drugs in a sterile environment. In other words, the purpose of USP 797 is to prevent causing harm and casualty to patients from microbial contamination and also from bacterial endotoxin.

To Whom Does This Standard Apply?

United States Pharmacopeia (USP) provides a set of standards that are applicable to all kind of settings and people who are involved in compounding sterile preparations (CSP) such as, clinics providing treatment to patients, pharmacies, healthcare institutions, etc.

A clinical pharmacy consulting firm can help pharmaceutical organizations to maintain their accreditation or get accredited by the accrediting agency. The firm helps pharmacies to get trained before the accreditation program or before any form of inspection by the pharmacy board.

Ways to Remain Compliance with USP 797

If you want your organization to remain compliant with USP 797 Guidelines for Hospitals, you will need to provide attention to many areas. USP 797 being mainly designed to protect patients as well as pharmacists, attention must be provided to these key areas. They are staff training, determining the risks, and implementation of policies and procedures.

Staff Training:

It is needed by everyone who is involved in sterile compounding practices. Pharmacists to nurses, pharmacy technicians to physicians need to be trained properly on the best practices available. For this, hands on training can be best.

Determining the Risks:

Microbial contamination can occur in three levels. For example, low level compounded sterile preparations can involve simple sterile compounding in an ISO 5 environments like restructuring of lyophilized powder. During medium risk level, compounded sterile preparations are more complicated. During sterile compounding in an ISO 5 environment multiple additives can get aggregated into the infusion device.

Policies and Procedures:

Compounded medicines must be produced in a sterile environment that contains the lowest possible risk of contamination. Monitoring the quality of the compounding room can be done on a monthly basis.

These steps can help CSPs to remain compliant with USP 797 standard with clinical pharmacy consulting and provide the best treatment to patients.

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Important Standards of the USP 797 Guidelines for the Hospitals

The effectiveness of compounding sterile preparations increases when the standards of USP 797 guidelines for hospitals are complied with. Sterile compounding is the practice of preparing medication for patients with specific requirements and catering to their needs. By carefully adhering to the USP standards, pharmaceutical experts can deliver the very best of their services to the patients.

The standards can be divided into three broad categories of personnel, engineering/facility designs and environmental controls.

Personnel Standards

The most important standard, that has to be followed according to USP 797 guidelines for hospitals, is to have well trained and routinely-monitored personnel. Personnel can be one of the first reasons of microbial contamination. Here are the best ways to provide maximum cleanliness.

Wear Sterile Gloves: The maximum amount of contamination that has been noted is because of operators who avoided sterile gloves. Sterile gloves have no other alternatives and their use in regards to sterile compounding should never be compromised.

Garb Properly: Regardless of the risk level in your compounding process, garbing properly is very much necessary. Personnel should always wear face masks, shoe covers, gowns and hair covers to be safe themselves and prevent contamination of the process.

Train, Test and Monitor: The expert compounding personnel are considered to be the best asset for a pharmacy. They should be further trained and evaluated to increase competency and skill to avoid any kind of negative patient outcomes.

Engineering and Facility Designing

This is the second area that requires strict adherence to standards. The following are the fields that need focus for pharmacy performance improvement.

Air Quality: the designing of the air ventilation should be such that it allows next to zero microbial contamination. A high quality design is critical along with its regular maintenance for maximum benefits.

Line of Demarcation: There should be a clear line of demarcation to separate the compounding area from the rest of the area. This standard is however avoided by many leading pharmacies and can be a cause of concern.

Environmental Controls

A good compounding environment should comply with management programs to track even the slightest hint of contamination. Important environmental standards include environmental sampling plan, microbial and particulate monitoring. These standards allow the pharmacy to make the adjustments that might be needed in regards to sterile compounding.

With these standards being complied to, pharmacies can become experts at sterile compounding along with added benefits like pharmacy performance improvement. Trust the best for receiving the best quality care and services.