USP 797 Article
USP 797 and how is it going to affect pharmacies in US:
By Jeffrey Becker
Picture
the surgeon in the sterile operating room gowned from head to toe and
mouth covered. It is a common sight to see the protective clothing for
the protection of the patient on the operating table. But what about
the pharmacist working behind the scenes; shouldn’t the same amount of
gowning and sterility be a requirement in the pharmacy also?
To answer that question, let's examine USP 797
USP
797 or officially as it is called USP chapter 797(1), is a
comprehensive regulation that governs a wide range of pharmacy policies
and procedures. It is intended both to cut down on contamination
transmitted to patients through pharmaceutical products and to better
protect staff working in pharmacies in the course of their exposure to
pharmaceuticals.
What is USP?
The USP (US Pharmacopoeia)
simply, is a private organization formed in 1820. Current members of
this organization include many members of accredited schools of
medicine and pharmacy, state medical and pharmacy associations,
government agencies, consumer organizations and other esteemed health
organizations.
And what is this USP 797?
USP Chapter
797(1), enacted January 1, 2004, is the first enforceable standards for
sterile compounding. Sterile compounding is generally maintained by a
pharmacist who is responsible to make sure every aspect of sterile
compounding, from the proper storage of chemicals to sterility testing
of the finished product, is followed according to aseptic protocol.
Sterility testing is done on all of our sterile compounds, chosen to be
risky by the United States Pharmacopoeia, before being dispensed to the
patient. All testing is acknowledged and maintained on file, which can
give the physician confidence in the quality of our sterile
preparations.
Having followed years of patient safety
recommendations and professional guidelines, the intent of USP 797 is
to set forth the procedural and practical requirements for safe
compounding of sterile preparations. A compounded sterile preparation
(CSP) is a prescribed quantity unit that:
Is prepared according to the manufacturer's labeled instructions
Contains non-sterile ingredients or uses non-sterile components or devices that need to be sterilized before use
Is a biologic, diagnostic, drug, nutrient, or pharmaceutical that matches either of these characteristics
Examples
include baths and soaks for live organs and tissues, implants,
inhalations, injections, powder for injection, irrigations, metered
sprays, and ophthalmic and optic preparations.
The Chapter’s
requirements are applicable in all practice settings where sterile
preparations are compounded, raising concern among many facilities
regarding the cost and difficulty of compliance. These concerns mainly
are that of increased cost of construction and maintenance of the extra
buffer zones in the hospitals and pharmacies.
On the other hand,
its requirements extend to architectural and environmental areas also.
As a result, hospital design, construction and operations professionals
also need to become familiar with it. This familiarization is very
necessary because these professionals ultimately will be responsible
for compliance of the required clinical or pharmaceutical zones to be
prepared and designed accordingly.
Authorized 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.
U.S.
Pharmacopoeia (USP) has issued this. The regulation governs any
pharmacy that prepares "compounded sterile preparations" (CSPs). Many
pharmacies fit this description. Moreover, many large hospitals have
several pharmacies--main one and several satellite pharmacies--that
will be affected
But USP 797 is not some of the things that it’s rumored to be:
USP
797 does not require sophisticated clean rooms to be installed. What
the guideline does require is environmental controls – specifically, a
separate area for compounding that meets a defined level of
cleanliness, and monitoring to ensure that control is maintained. Once
the initial concerns over the cost and difficulty in meeting USP797’s
requirements have passed, patients and staff alike will be better off
as a result.
How this regulation is working on the related medical and pharmacy organizations?
USP
797 has been approved and adopted by several states and is currently
under review by many others (check with your state Board of Pharmacy).
States have the option to adopt 797 precisely or to edit the standards
into pharmacy regulations (Missouri and Texas have sterile compounding
regulations. New Jersey requires that the buffer zone be ISO 6 / Class
1,000).
Additionally, the Joint Commission on Accreditation of
Healthcare Organizations (JCAHO) is enforcing USP Chapter 797 within
their standards. The JCAHO may require stricter compliance to 797 than
the state Board of Pharmacy.
USP Chapter 797, as it applies to
clean rooms (Buffer Zones), is general in nature but refers to the
International Standards Organization, ISO-14644 standard for clean
rooms. All Sterile compounding is to be performed in an ISO 5 (class
100) environment that is surrounded by an ISO 8 (Class 100,000) Buffer
Zone (clean room), ISO 7 (Class 10,000) in 2006. A barrier isolator
does not have to be contained in an ISO-rated space unless recommended
by the manufacturer.
Sterile compounding or the cleaning of the room or the zone to be used medically or pharmaceutically is done for the
proper storage of chemicals and other serious medical and
pharmaceutical procedures by sterility testing of the finished product.
It is followed according to aseptic (free of disease-causing
micro-organisms) protocol. It’s done by custom made machines and by the
use particular prescribed chemicals and sterilizing agent compounds
according to USP.
What is the Buffer zone?
A “Buffer
Zone” in the simplest form, is an environment that separates the
compounding room from the surrounding ambient area and is to be
constructed from low-particle-generating materials that can withstand
continuous cleaning. ISO standards require that the buffer zone be
maintained under positive pressure and that airborne particles be
limited in compliance with ISO 8 requirements. ISO 7 (Class 10,000)
will be required in 2006.
You may be able to meet the specified
standards with as little as a fresh coat of paint (water-based epoxy),
the addition of 1, 2 or 3 new wall.
The relevance of the buffer zone
or room can be understood as the Pharmacists and other medical
practitioner are being asked to implement and improve the air
environment surrounding the production of hazardous drugs.
Different
hazardous process and drug compounding ought to be done in a biological
safety cabinet, vented and ventilated 100 percent to the outside,
according to The National Institute for Occupational Safety and Health
(NIOSH), as prescribed in September 2004.(4)
A clean room is the
best way to create the buffer room or zone. It fundamentally consists
of smooth, impermeable floor, walls and ceiling with appropriate vents
and doors, to support the heart of a clean room, the HVAC with HEPA
filters, which controls the air pressure, creating the ISO Class 7
during operation. It also maintains the desired temperature and
humidity.
How is USP797 going to affect the pharmacies and other related organization in US?
In
general, its felt in the response to various surveys that; chapter 797
would negatively affect workload and pharmacy's ability to provide
sterile preparations in a timely manner. Conversely, respondents
replied that the new standard would have a positive effect on the
quality of care provided by the hospital. By and large, 45.3% of
respondents reported plans to build a clean room, and 21.7% reported
plans to obtain new equipment to comply with chapter 797. Furthermore,
42.3% of respondents had decreased the quantity of high-risk
compounding. Respondents also reported that their pharmacy's budget had
increased in order to comply with chapter 797. The most common
requirements with which respondents were not willing to comply were
validating the accuracy of automated compounding devices, sterilizing
products and equipment before entering the clean room, rotating the
type of disinfectants, and prohibiting use of cosmetics by staff.
What’s the conclusive reaction as a result?
USP
chapter 797 standards have influenced the compounding practices of
hospital pharmacies nationwide, including a decrease in the compounding
of high-risk preparations, an increase in budgetary allocations, and
implementation of better quality assurance practices. Larger hospitals
tended to implement more changes than did smaller hospitals, and there
remains room for improvement overall.
From the public's perspective,
recent incidents of contaminated sterile products causing patient harm
and death have given the profession of pharmacy a negative reputation.
These incidents occurred because recommended published compounding
guidelines were not followed, particularly guidelines addressing
quality assurance and personnel training. Chapter 797 was developed to
eliminate the risk of patient harm due to improperly compounded sterile
preparations, but it is unknown how an enforceable standard will
influence the changes that FDA, JCAHO, and the public demand.
Previous
national surveys have shown that, hospital-pharmacies do not routinely
comply with published guidelines for compounding sterile preparations.
In the most recent national survey evaluating compliance with the
American Society of Health-System Pharmacists (ASHP) Guidelines on
Quality Assurance for Pharmacy-Prepared Sterile Products, only 5.2% of
pharmacies were fully compliant with garb attire requirements for
compounding low-risk preparations. Additionally, only 4.7% of hospital
pharmacies were fully compliant with documentation procedures for
high-risk preparations. The national surveys have also found that
larger hospitals are more compliant with guidelines than are smaller
hospitals.[12-15] Since, there are more smaller hospitals in the
country than larger hospitals, implementing chapter 797 will be a
significant challenge for the profession of pharmacy.
In simple
words USP797 is going to increase the cost and expenditure on the
pharmacy and medical care facilities but it is going to ultimately
benefit the public as well as private health services and products used
clinically for the purpose.