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Articles on USP 797 

Pharmacy Facts Architectural and environmental changes required for USP 797, Health Facilities management Magazine,  July, 2005
By William N. Bernstein, AIA, ACHA

"Endorsed by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) with an aggressive compliance schedule, USP 797 has received great attention from hospital administrative, clinical and pharmacy staff."  read more...

Communication Breakdowns and Improperly Programmed IV Pumps Cause Harmful Medication Errors in Hospital Intensive Care Units,
United States Pharmacopeia (USP), 2/15/06

"Largest National Data Set of Intensive Care Unit (ICU)Medication Errors Identifies Areas Needing Improvement - Rockville, Md., February 15, 2006—The United States Pharmacopeia (USP) today announced that communication failures and improper programming of IV pumps are among the leading causes of harmful medication errors in a hospital’s Intensive Care Unit (ICU)."  read more...

Revising the Medicare Model Guidelines,
United States Pharmacopeia (USP), 2/06

"In addition to creating the Model Guidelines, the Medicare Modernization Act also designates USP "to revise such classification from time to time to reflect changes in therapeutic uses of covered part D drugs and additions of new covered part D drugs." The links below provide additional information regarding USP's approach to the revision process."  read more...

USP Offers Consumer Tips to Help Avoid Dangerous Medication Errors During Radiological Procedures,
United States Pharmacopeia (USP), 1/25/06

"300 Million Radiological  Procedures Performed Each Year; Informed Consumers Can Help Reduce High Error Rate - Many patients think that radiological services are noninvasive routine procedures with little to no medication risk. The truth is, radiological services (which are much more than just x-rays and MRIs) include complex procedures that may use high-risk drugs. A recent report from the United States Pharmacopeia (USP) showed that harmful medication errors occur seven times more often in radiological services than in the overall healthcare system. Fortunately, informed consumers can take steps to protect themselves."   read more...

"Medication Errors in Intensive Care Units",
(c) United States Pharmacopeia (USP), 2/15/06

"The below information represents a small portion of data and information contained in USP's most recent MEDMARX Data Report: A Chartbook of 2000–2004 Findings from Intensive Care Units and Radiological Services"   read more...

A Primer on USP Chapter <797> and the USP Process for Drug and Practice Standards, 13-Sep-2004 

"In January 2004 Chapter <797> in the United States Pharmacopeia 27 became the first practice standards for sterile pharmacy compounding in US history that may be enforced by the US Food and Drug Administration. Dr. Newton is chairman and Mr. Trissel is a member of the 2000–2005 Sterile Compounding Committee of the Council of Experts of the United States Pharmacopeial Convention. Dr. Newton and Mr. Trissel are not available to interpret Chapter <797> to persons or organizations outside the United States Pharmacopeial Convention."
Read more...

USP Chapter 797: Establishing a practice standard for the profession of pharmacy - 13-Sep-2004 

"No one single event is having an impact on the profession of pharmacy as is USP General Tests and Assays Chapter <797> Pharmaceutical Considerations-Sterile Preparations. In the coming years, pharmacy will be able to look back at the year 2004 and realize that the role of pharmacists and technicians is not limited to just compounding sterile preparations but requires the employment of the art and science of contamination and engineering controls to ensure that extemporaneously- prepared compounds are accurate and sterile."  Read more...

Sterile Product Compounding: Developing Quality Based Standards for Pharmacy Practice - 1-Sep-2004 

"Compounding pharmacists and pharmacies are invaluable in delivering patient-specific health care in the United States. Today, pharmacists continue a centuries-old tradition of extemporaneously compounding medications because many physicians choose to prescribe compounding drugs for there patients." Read more...

Particle Monitoring to Meet USP <797>

"The United States Pharmacopoeia (USP) recently released procedures and requirements for compounding sterile preparations. General chapter <797>, titled “Pharmaceutical Compounding – Sterile Preparations,” states that sterile compounding procedures require clean facilities, specific training for operators, air quality evaluations, and a sound knowledge of sterilization and stability principles. The nature of defining how these preparations shall be manufactured is related to the potential risk to patients should errors occur."  Read more...

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