Aseptic Technique and USP
This practice protects patients from life-threatening infections that occur when medications get contaminated from unsafe use. Concerns have been raised about whether these guidelines and related policies contribute to drug shortages and increased medical costs to healthcare providers. CDC recognizes the problem of drug shortages; however, such shortages are a result of manufacturing, shipping, and other issues unrelated to the above guidelines http: These outbreaks cause extensive harm to patients, and they are associated with significant healthcare and legal expenses. It is imperative that drug shortages and drug waste concerns are dealt with appropriately and do not lead to unsafe medical practices that impose increased disease risk on patients. These medications typically lack antimicrobial preservatives and can become contaminated and serve as a source of infection when they are used inappropriately. Following the USP standards is imperative, as medication contamination and patient harm can occur when repackaging e. These include one-time use of needles and syringes and limiting sharing of medication vials.
USP and GAP Analysis Survey
There has been some controversy over applying the United States Pharmacopeia USP shelf life rules for compounded pharmaceutical products to allergen extract mixes. These rules require that all compounded mixed materials be disposed of every 28 days due to sterility concerns. The allergy industry has successfully challenged this requirement and made the case that allergen extract mixes are an exception to this rule.
Besides following routine sterile handling aseptic procedures, compounding mixing personnel are also required to pass a Media Fill Test at least annually.
U.S. Pharmacopeial (USP) > Pharmaceutical Compounding-Sterile Preparations. • This checklist is designed to be a tool to guide and aid you to assess your compliance with USP >. • At the end of the checklist, there is a section specifically addressing isolators which includes USP
Results of our survey on drug storage, stability, compatibility, and beyond use dating March 22, ISMP would like to thank the practitioners, mostly pharmacy directors and managers, staff pharmacists, clinical pharmacists, and medication safety pharmacists, who responded to our recent survey on drug storage, stability, and beyond use dating of injectable drugs.
We conducted the survey to learn more about what resources pharmacists rely on to guide drug storage, stability, and beyond use dating. We were specifically interested in learning about conditions that may result in unnecessary waste of drugs during the ongoing drug shortage crisis or waste of very expensive medications given the ever rising cost associated with healthcare. CMS is reviewing this matter further. We are hoping the results of our survey, as described below, provide CMS with some baseline information to support its review process.
About a quarter of respondents reported that, upon request, manufacturers never or rarely provide newer in-house data on extended beyond use dating that differs from the package insert. Numerous respondents also noted that a conflict of interest may exist for the drug company regarding additional drug testing or acknowledgment of external testing related to storage, stability, compatibility, and beyond use dating. They remarked that, once a drug has been approved, the company may have little incentive to conduct additional testing on its products because the results may lead to required, costly labeling package insert changes and a reduction in sales if the beyond use dating is extended.
FDA considers this a practice-related issue. Sixty-one percent of respondents said they feel compelled to discard injectable medications according to the package insert, knowing it differs from information in national compendia.
Find A Test
Under a Creative Commons license Abstract Objectives Intravenous therapy is a complex procedure usually requiring the preparation of the medication in the clinical area before administration to the patient. Breaches in aseptic technique may result in microbial contaminations of vials which is a potential cause of different avoidable infections.
We aimed to investigate the prevalence and pattern of microbial contamination of single- and multiple-dose vials in the largest pulmonary teaching hospital in Iran.
6. Sharp Injury or Body Fluid Exposure Follow-Up Management IV. Standard Precautions for Patient Encounters and for Surgical Procedures Some microorganisms live for days, weeks, or months on an uncleaned or improperly cleaned surface. MRSA, for example, .
Our hospital wants the mixing to be done by a pharmacist, that it is safer and more standardized for patients. What is your take on this? USP is a private entity that develops guidelines for compounding of medications. The Code of Pharmacy has endorsed the USP recommendations and preparation of vaccines is under pharmacy supervision in hospitals. The practice parameters and independent legal review judged that if the policies recommended in the practice parameters are followed these are equivalent to the USP guidelines for allergy vaccines.
I have copied a series of questions from the archives of Ask The Expert that address some of the issues raised by your question. If so, how does one advance the dose if there is a new mix every 30 days? The individual allergist who componds vaccines in the office is not under these guidelines but under the recommendtions of the Joint Task Force who is responsible for our Allergy Parameters.
A beyond-use date BUD is the date or time after which administration of a CSP shall not be initiated and is determined from the date or time the preparation is compounded 1. The BUDs described here are based on the risk of microbial contamination, and assume that the CSP components can remain chemically and physically stable. Storage in a refrigerator or freezer has shown to slow the growth of microorganisms allowing for longer BUDs for CSPs stored under colder temperatures versus controlled room temperature.
Preparation characteristics also play a role in determining BUD. Those characteristics include method of achieving sterility, if sterility testing is performed, and if a preservative is added.
Beyond-Use Dating Validation See “Sterility Testing” Above USP > puts pharmacy prepared CSPs into 3 categories based on the difficulty of maintaining sterility and potential for patient harm: Low-risk, medium-risk, and high-risk. Refer to the definitions in > to determine which category describes a particular compounding.
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Find A Test
The container used depends on the physical and chemical properties of the compounded preparation. Sterility Assurance of sterility in a compounded sterile preparation is mandatory. Stability Criteria and Beyond-Use Dating The beyond-use date is the date after which a compounded preparation is not to be used and is determined from the date the preparation is compounded. Because compounded preparations are intended for administration immediately or following short-term storage, their beyond-use dates may be assigned based on criteria different from those applied to assigning expiration dates to manufactured drug products.
Usp sterility dating admin Based on the most careful measurements usp sterility dating to date, when Kate took him home to meet her parents, based compendia information recommends a longer beyond use dating.
Relates to State Board of Pharmacy, relates to sterile compounding, relates to permits. The bill contains the following provisions. The bill provides a definition for “compounding pharmacy” and describes sterile compounding pharmacies and non sterile compounding pharmacies. Beginning with appointments made on or after January 1, , the bill adds a physician and an advanced practice registered nurse to the Maine Board of Pharmacy, decreases the number of pharmacist members from 5 to 3.
MN H Pharmacy Regulation Pending – Carryover Changes licensing requirements for pharmacies, drug manufacturers, and wholesale drug distributors, requires all licensed pharmacies to comply with federal laws and state laws and rules related to operation of a pharmacy, requires out-of-state pharmacies dispensing drugs to residents of Minnesota to comply with federal laws related to operation of a pharmacy.
MN H Health Pending – Carryover Relates to health, changes licensing requirements for businesses regulated by the Board of Pharmacy, clarifies requirements for compounding, makes changes to the prescription monitoring program. MN S Health Pending – Carryover Relates to health, changes licensing requirements for businesses regulated by the Board of Pharmacy, clarifies requirements for compounding, makes changes to the prescription monitoring program. MS S State Board of Pharmacy Registration Failed Defines the term non-traditional compounding pharmacy and require all legal entities engaging in this practice to register with the state board of pharmacy.
UT S 14 Pharmacy Practice Act Enacted Amends the Pharmacy Practice Act, defines research using pharmaceuticals, exempts research using pharmaceuticals from licensure to engage in the practice of pharmacy, telepharmacy, or the practice of a pharmacy technician, exempts research using pharmaceuticals from licensure to act as a pharmacy, makes technical corrections. VA H Compounding Pharmacies Enacted Relates to compounding pharmacies, clarifies the definition of compounding and adds a requirement for a current inspection report for registration or renewal of a registration for a nonresident pharmacy, provides that the compounding of an inordinate amount of a preparation where there is not historical pattern of prescriptions to support an expectation of receiving a valid prescription for the preparation shall constitute manufacturing of drugs.
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We bring the highest level of quality and attention to detail to our clients to assure that their analytical method development and validation projects are successfully executed. There are standard organisms used for this test. Testing to show the preservative is effective should include out to and including the beyond use date. In addition to the standard organisms, it is always good practice but not required to test the effectiveness of the preservative against organisms isolated from the facility in which the product is compounded.
A compounding uses USP > standards and focuses on customized, patient-specific compounding dispensed only upon prior receipt of a prescription.
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Science and Technology for the Hospital Pharmacist
Definitions Asepsis is the state of being free from the presence of pathogenic microorganisms. Sepsis is the state of being contaminated by pathogenic microorganismsSepticemia is the presence of microorganisms in the bloodSeptic shock is the condition of overwhelming infection of the blood by septicemia. Aseptic technique is the procedure used to maintain an aseptic environment in which to compound sterile products CSPsAseptic technique strives to maintain surgical asepsis.
By contrast, room air is classified as ISO9 which is no more than 1, , , particulates per cubic meter. Smooth walls with panels locked and sealedVinyl covered floor with seals heated togetherJoints and junctures between walls and ceilings must be chauked with no visible cracks. Area immediately next to LAFW hoods is called buffer areaIf all risk levels are compounded clean and ante rooms must be separated.
These are the guidelines setup by USP for expiration dates as long as the chemical stability is appropriate. You can choose to ignore them however, you will then fall into USP 71 jurisdiction which then requires that sterility testing be done.
Classification of air cleanliness. For example, particles of 0. Barrier isolators provide a suitable environment by restricting any ambient air from the work chamber. These systems are not as sensitive to external environments as the HEPA-filtered unidirectional airflow units. Several aspects of barrier isolation and filtered unidirectional airflow in work environment must be understood and practiced in the compounding process.
Policies and procedures for maintaining and working in the prescribed conditions for aseptic processing must be prepared, updated, maintained, and implemented and are determined by the scope and risk levels of the activities undertaken in the SP compounding operation.