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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...

Are Hospital Safe, (c) Jennifer Pirtle,  Women's Health Magazine, September/October 2005

"Kathy McCabe, 31, had already seen two doctors about the stabbing pain in her stomach. But when it worsened, she headed to the ER near her home in Washington, D.C. After lying on the hospital floor in anguish for more than 2 hours, McCabe was given a CAT scan so doctors could see 3-D images of her organs. The radiologist said the CAT scan showed nothing unusual, so the ER staff gave McCabe two things. A prescription: More painkillers. And directions: Go home. The next day McCabe visited three more doctors. One internist referred her to a surgeon, who wanted her to undergo exploratory surgery. The third doctor, an internist who specialized in geriatric issues, questioned McCabe thoroughly and then urged her to retrieve her CAT scan from the hospital. He took one look at the film and told McCabe that she had advanced diverticulitis, a serious infection of her digestive tract. Worse, her bloodstream was overwhelmed by the resulting bacteria.read more...

"How Safe is Your Hospital" (c) Consumer Reports, January, 2003

"The quality of care you receive during a hospital stay can determine how quickly and how well you recover--or if you recover at all. You might expect consistently good care to be delivered at almost every hospital in a nation with the world's top doctors, most advanced technology, and highest per-capita spending on health care. But when we surveyed and invited e-mails from Consumer Reports readers about their recent hospital experiences, we found enormous variations. They ranged from an Alabama man's smooth-sailing, lifesaving, $1.5 million liver transplant to an 83-year-old Tennessee man's death after a careless emergency-room staff sent him home without treating the broken bones and internal injuries he had suffered from falling down the basement stairs."  read more...

"How safe is your hospital", (c) Sarasota Magazine, January, 2005

"In November, Florida voters approved a state constitutional amendment that finally gives patients the right to review the records of any healthcare facility's or provider's adverse medical incidents, including those that could cause injury or death. Previous law prohibited the practice."  read more...

10 Patient Safety Tips for Hospitals, (c) US Department of Health and Human Services, October, 2007

"Medical errors (or adverse events) can occur at many points in the health care system, particularly in hospitals. These tips for hospitals are from studies by the Agency for Healthcare Research and Quality (AHRQ), which has funded more than 100 patient safety projects since 2001. Many findings from AHRQ research can be put into practice in hospitals by following 10 practical tips."  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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