| 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."
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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."
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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."
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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."
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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."
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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)."
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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."
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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."
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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"
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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."
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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."
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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."
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