Usp 797 beyond use dating
+ Date: - 14.08.2017 - 1194 view
Newton, PhD, FAPhA for his tutelage and forbearance regarding the establishment of beyond-use dating and the fundamentals of chemical drug. Beyond Use Date (BUD) is very different from expiration date. USP Chapter 797 defines BUD as the date or time after which a compounded sterile preparation (CSP) may not be stored or transported and is calculated from the date or time of compounding. Second, USP <797> offers beyond-use dating based on the storage of a preparation, and those time limits must include the time taken to mix the compound all the way up to when the infusion begins or the injection is given. Pharmaceutical Compounding—Sterile Preparations 1.
Possible contamination from nursing and patient manipulation and contamination was not evaluated but may be subjects of future research. Pseudomonas putida septicemia in a special care nursery due to contaminated flush solutions prepared in a hospital pharmacy.
The company indicated that this was most likely a result from a chemical instability with the growth medium and not consistent with a positive indication for contamination (QI Medical, personal communication, February 26, 2008). The incidence of catheter-related infections varies by catheter type, frequency of catheter manipulation, and patient-related factors.
Medium risk products contain more than three commercially available products but the number of manipulations is not specified. Neither organization provides specific guidance on expiration dating once the intravenous drug is dispensed. No other temperature ranges were tested and samples were not tested for fungi. None of the syringes or chamber samples demonstrated contamination, bacterial growth or discoloration after 72 hours.
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When infusions must be changed every 24 to 48 hours it becomes difficult to manage changing CSPs without manipulation or changing of the administration set simultaneously, increasing the likelihood a patient may experience an adverse event. While the CDC recommends that administration sets are not changed more frequently than every 72 hours, the USP recommends a maximum beyond use date of 48 hours.
- Additionally, continuous quality assurance within our department to ensure sterility consistent with our 72-hour BUD is currently being considered.
- All medium and high risk products must be prepared in the pharmacy using aseptic technique by trained personnel.
- All stability information including clinical judgment extrapolations were reviewed and verified by a team of pharmacists.
- Although their intent is the same, USP and the CDC have two sets of standards that are difficult to adhere to when combined in clinical practice for each institution.
- American Society of Health-System Pharmacists.
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DISCLOSURE The authors declare no conflicts of financial interest in any product or service mentioned in the manuscript, including grants, equipment, medications, employment, gifts and honoraria. Despite published guidelines establishing practice standards for compounding sterile products, pharmacy as a profession has not adopted a practice standard for key components of sterile compounding such as minimizing contamination, aseptic technique, and quality assurance.
As a result, our administration sets are often changed more frequently than every 72 hours, contrary to the CDC recommendations, potentially increasing adverse events, workload and cost.Aseptic technique has been identified as the most important variable to minimize contamination.
This study provides sufficient data that these CSPs may be stored using a BUD up to 72 hours for a number of commonly used continuous IV infusions in pediatric patients. This study provides sufficient data that these compounded sterile products may be stored using a beyond use date up to 72 hours for a number of commonly used continuous IV infusions in pediatric patients.
- Pharmacopeia's (USP) General Chapter Sterility Tests.
- USP allows for extension of the BUD for storage prior to administration if the medication is stable and further sterility testing has been performed.
- A BUD only addresses storage conditions before the CSP is attached to the patient and is not to be confused with expiration dating or hang time.
- A brown precipitate was noted in the chamber of dobutamine 6400 μg/mL in normal saline (NS) and dextrose 5% in water (D5W) sample.
- A multistate outbreak of Serratia marcescens bloodstream infection associated with contaminated intravenous magnesium sulfate from a compounding pharmacy.
At our institution, low risk CSPs may contain up to three commercially available products which could have up to three manipulations.
Under these guidelines, beyond use dates (BUD) are assigned to CSPs based on the number of manipulations and contamination risk during drug preparation or storage. We evaluated the sterility of medications that are commonly administered by continuous infusion to pediatric patients.
The likelihood for potential adverse events as a result of more frequent manipulation of infusions and administration sets led our department to investigate extended beyond use dating of commonly used continuous infusions for patients most likely used in the ICU settings. The methodology of our study was not sufficient to extrapolate a conclusion that these CSPs are safe to hang for 72 hours once dispensed from the pharmacy.
In our institution, this allows for a more convenient and consistent change of both administration sets and continuous infusions at 72 hours to potentially minimize adverse events, workload and cost. In our institution, this data used in conjunction with clinical judgment and hospital policy allows for a more convenient and consistent change of both administration sets and continuous infusions at 72 hours to minimize potential adverse events, workload and cost.
However, in order to comply with both standards, our institution was faced with a therapeutic dilemma in which some clinical judgment was required. However, there was no contamination or bacterial growth in the sample and the syringe showed no visible precipitate or color change. IV admixture contamination rates: Traditional practice site versus a class 1000 cleanroom.
One sample from each solution was tested using a full filtration contamination growth medium chamber (QT Micro Systems #TM6000, QI Medical, Inc. Outbreak of Pseudomonas putida bacteraemia in a neonatal intensive care unit. Patient morbidity and mortality associated with contaminated and improperly prepared sterile products has captured national attention. Pediatric hospitals are faced with additional challenges due to the uniqueness of their patient population.
And tryptic soy broth for aerobic and facultative testing.Any visible discoloration suggesting physical instability was also evaluated.Any visible discoloration suggesting physical instability was also evaluated.
IV admixture contamination rates: Traditional practice versus a class 1000 cleanroom. IV solutions were mixed by only one certified pharmacy technician (CPT) using sterile technique in a laminar flow hood in accordance with USP guidelines. IV solutions were mixed using sterile technique in the laminar flow hood in accordance with USP guidelines. In 2001, The United States Pharmacopeia (USP) began its efforts to establish an enforceable standard for pharmacies that prepare CSPs.
Since more frequent manipulation of infusions and administration sets may predispose the patient to hemodynamic instability, infection, air emboli and other adverse events we chose to evaluate the 72-hour sterility of common continuous infusions shown to be stable for at least 72 hours. Some clinical judgment was made for extrapolation of stability using available data of concentrations that were not our institution specific standards.
Centers for Disease Control and Prevention. Cluster of Pseudomonas aeruginosa catheter-related bloodstream infections traced to contaminated multidose heparinized saline solutions in a medical ward. Common IV continuous infusions used in pediatric patients were identified and evaluated. Compared to adults, pediatric patients typically require special compounds and dilutions that are often not available through regular manufacturers.
Per USP, pharmacy provides a BUD in accordance with the standard up to a maximum of 48 hours based on contamination risk. Pharmacopeia's (USP) General Chapter Pharmaceutical Compounding-Sterile Preparations. Pharmacopeia's (USP) Revised General Chapter Pharmaceutical Compounding-Sterile Preparations. Positive and negative controls were used for sampling comparison and training was provided by the microbiology company to the study pharmacist and CPT.
At our institution, we change administration sets every 72 hours per CDC recommendations and hospital policy. Because frequent manipulation of infusion and administration sets may predispose the patient to adverse events, we evaluated sterility for extended beyond use dating up to 72 hours. Bethesda, MD: American Society of Health-System Pharmacists; 2005. Bethesda, MD: American Society of Health-System Pharmacists; 2006.
USP 797 provides specific requirements for the sterile preparation of CSPs and also requires that all personnel involved in the preparation process are adequately educated and trained. USP allows some clinical judgment from the pharmacist when assigning BUD, however, to extend beyond the 48-hour maximum, further sterility testing in accordance with USP must be performed. USP chapter 797: establishing a practice standard for compounding sterile preparations in pharmacy.
As a result, hospital pharmacies serving pediatric patients are commonly asked to prepare specialized compounds which may increase the risk of contamination and limit the quality of these products.
By establishing a 72-hour BUD for CSPs, the pharmacy workload would likely be decreased and cause a reduction in drug cost associated with more frequent compounding and wastage. C for the duration of the 14-day evaluation period. Centers for Disease Control and Prevention (CDC) Pseudomonas bloodstream infections associated with a heparin/saline flush–Missouri, New York, Texas, and Michigan, 2004–2005.
Recently, USP published final revisions for practice standards which will be mandated by regulatory agencies for health care settings that compound sterile products including: hospitals, community pharmacies, home infusion services, ambulatory care services, physician offices and nursing homes.
Therefore, in clinical practice at our institution, the nursing staff often use the BUD assigned by the pharmacy as the “expiration date. Thirty-five common intravenous (IV) continuous infusions using 94 standard concentrations and diluents were identified. This includes, first, the stability of the drug and then the sterility of the drug.
At our institution, all pharmacists and technicians are tested for sterile technique at least annually for competency.
Stability of high-concentration dopamine hydrochloride, norepinephrine bitartrate, epinephrine hydrochloride, and nitroglycerin in 5 dextrose injection. Sterility results are summarized in. Sterility testing began within 60 minutes after preparation of each solution. The King Guide to Parenteral Admixtures Internet Edition. The authors would also like to thank Richard Osteen, RPh, for his expert review and helpful suggestions for this manuscript.
- A sample from each solution was tested for contamination or bacterial growth at 72 hours.
- A thorough search through primary literature and standard references was done to verify stability.
- ASHP guidelines on quality assurance for pharmacy-prepared sterile products.
- Additionally, ICU patients are often colonized with hospital-acquired organisms.
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Compounding sterile products is a major component of hospital pharmacy practice. Contamination risk was assigned by the number of manipulations required to make a CSP and designated as low, medium or high. Continuous and diligent monitoring of line infections by our infection control team can provide needed quality assurance to determine this need for the future.
Lower contamination risk is provided when using premixed solutions or commercially available products as a result of less manipulation. MMWR Morb Mortal Wkly Rep. Medications were excluded for short stability (less than 72 hours), short durations of use, or high cost. Medications were excluded for short stability, short durations of use or high cost.
None of the syringes or chambers resulted in contamination, bacterial growth or discoloration after 72 hours. Nosocomial infections caused by likely multi-drug resistant Gram-negative bacteria such as Enterobacter cloacae, Pseudomonas aeruginosa, Pseudomonas putida, and Serratia marcescens are well described in pediatric patients due to contaminated compounded sterile products (CSPs). Once dispensed from the pharmacy, USP 797 guidelines no longer apply.
For example, if stability was documented for a concentration both less than and greater than our standard, then our standard concentration was reported to be stable. Further recommendations on hang times or expiration dating may be better explained by the CDC or the Infusion Nurses Society (INS); however, to our knowledge no specific recommendations are suggested to date. Guidelines for the prevention of intravascular catheter-related infections.
The intensive care unit (ICU) setting often carries a higher risk of infection due to increased use of central as opposed to peripheral line placement, the need for frequent manipulation, and extended durations of use for indwelling lines. The intent of these practice guidelines is to prevent morbidity or mortality as a result of contamination or improperly prepared CSPs.
In response, both the United States Pharmacopeia (USP) and Centers for Disease Control (CDC) have published recommendations in an effort to minimize the risk of infection. Increasing patient morbidity and mortality associated with contamination or improper preparation has prompted national attention. Int J Hyg Environ Health. Likewise, neither addresses the length of time that a bag containing medication for continuous infusion may hang once administration to the patient has begun.
Both syringe and chamber were examined by the study pharmacist for growth or turbidity (indicating a positive growth) at 72 hours and then daily up to 14 days. Both the USP and CDC have common initiatives to prevent the likelihood of contaminated CSPs or catheter-related infections through a variety of pertinent and evidence-based recommendations. Bouallègue O, Mzoughi R, Weill FX.
The purpose of this study was to establish a longer BUD for common continuous infusions used in the pediatric population to propose an evidence-based standard for our institution that would allow both drug and administration sets to be changed no more frequently than every 72 hours, when appropriate, to better comply with both the CDC and USP recommendations. The syringes were kept at 22. There are two major factors in establishing CSP beyond use dating.
In 2002, the Centers for Disease Control and Prevention (CDC) published enforceable guidelines for adult and pediatric patients for the prevention of intravascular catheter-related infections. In order to minimize the risk for infection, the CDC recommends that administration sets are changed no more frequently than every 72 hours.
Each infection increases the risk of mortality and health care costs. Earlier versions of this work were presented as a poster at the 16 th Annual Meeting of the Pediatric Pharmacy Advocacy Group, Portsmouth, VA, September 2007. Enterobacter cloacae bloodstream infections in pediatric patients traced to a hospital pharmacy. For CSPs with the lowest risk, a BUD maximum of 48 hours may be assigned, given it is stable when stored at room temperature, unless further sterility testing is done.