Preparation Of Sterile Products Research Articles

Considerations for developing a health-system 503B outsourcing strategy.

In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. To provide guidance for health systems on how to develop a strategy for utilizing 503B outsourcing facilities for sterile product preparation. Health-system pharmacies face an increasingly complex set of challenges related to providing sterile products to patients. New United States Pharmacopeia <797> regulations, increasing drug shortages, and an ongoing pharmacy technician workforce shortage have made sterile compounding more difficult than ever for health-system pharmacies. Outsourcing of production to 503B outsourcing facilities is one strategy pharmacy leaders can use to help navigate these challenges. However, there are many factors to consider when deciding whether to outsource a product and which 503B vendors are safe and reliable. The Cleveland Clinic Health System (CCHS) has developed a robust internal structure to appropriately vet 503B outsourcing facilities for safety and reliability, as well as standardized criteria used to determine which products will be outsourced. This article describes the tools CCHS has used to evaluate 503B outsourcing vendors and to evaluate individual products to determine the pros and cons of outsourcing vs insourcing. Additionally, general considerations regarding outsourcing are described. Outsourcing to 503B facilities can be an effective strategy for navigating sterile compounding challenges but is not without some risk. Pharmacy leaders must develop a standardized approach to thoroughly evaluate 503B vendors and products to ensure their outsourcing strategy is both safe and cost-effective.

ASHP National Survey of Pharmacy Practice in Hospital Settings: Operations and Technology - 2023.

Results of the 2023 ASHP National Survey of Pharmacy Practice in Hospital Settings are presented. Pharmacy directors at 1,497 general and children's medical-surgical hospitals in the United States were surveyed using a mixed-mode method of contact by email and mail. Survey completion was online using Qualtrics. IQVIA supplied data on hospital characteristics; the survey sample was drawn from IQVIA's hospital database. The response rate was 21.6%. Inpatient pharmacists independently prescribe medications in 26.7% of hospitals. Advanced analytics are used in 5.7% of hospitals. Basic analytics are used in 87.3% of hospitals. Pharmacists work in ambulatory or primary care clinics in 54.2% of hospitals operating outpatient clinics. Most hospitals (86.1%) use automated dispensing cabinets as the primary method of maintenance dose distribution. Machine-readable coding is used in 73.6% of hospitals to verify doses during dispensing in the pharmacy. Autoverification functionality in the electronic health record system is used in 73.4% of hospitals. Most hospitals report some integration of pharmacy services to optimize patient care transitions (60.0%), while 24.9% report no integration. Traditional technician activities still predominate, but more advanced roles are emerging. Technologies to assist sterile product preparation are used in 62.8% of hospitals. Drug distribution continues to trend toward decentralized models with medications available closer to patients. Technologies are enabling this transition to occur without a significant negative impact on patient safety. The pharmacy workforce is stable, and more advanced responsibilities are being assigned to pharmacy technicians, enabling pharmacists to increase their clinical role.

Analysis of the methods for projection of spaces for good manufacturing practice

BACKGROUND: In this Paper we will present the evolution of the best practice for biobanks, the technical and medical standards for collecting, processing and storing, as well as the socio-economic standards for biobank management.&#x0D; AIM: The aim of this Thesis is to analyse and to present the methods for projection of spaces for good manufacturing practice.&#x0D; METHODS: The European Union has adopted guidelines for good manufacturing practice which define the requirements for manufacturing of sterile products. In the following text we will describe the details for determining microbiological cleanliness and cleanliness of the particles in the air, on the surfaces, etc.&#x0D; RESULTS: The length of time between the collecting of blood or tissues could affect the final result. The preparation of sterile products requires special conditions, in order the risk of microbiological contamination and certain pyrogenic contaminations to be minimized. We make difference between four levels of guidelines for good manufacturing practice, which in this Paper are taken from the practice of the European Union. Level A is local zone with high-risk procedures, e.g. filling, closing of bottles, opening of ampoules and bottles and making septic connections. Level B is aseptic preparation and filling of the samples. Level C and D are the clean spaces for less critical procedures for preparation of sterile products.&#x0D; CONCLUSION: Technical standards, medical standards, socio-economic standards for biobank management, informatics practices for biobanks, economic recommendations for biobanks have been established, as well as a quality of biobanks has been provided.

Development of Guidelines for Accurate Measurement of Small Volume Parenteral Products Using Syringes.

Background: Syringes are commonly used in pharmacy compounding for the measurement of small volumes, especially in the preparation of sterile products for injection and infusion. However, there are no current official guidelines for the proper use of syringes in measuring small volumes. Objective: The purpose of this project was to determine the accuracy and precision of commercially available syringes in measuring small volumes during sterile product preparation to make recommendations for syringe size selection. Methods: To assess precision and accuracy of syringes, 3 separate investigators measured 5%, 10%, or 20% (n = 30 each) of the volume of a 1-, 3-, 5-, 10-, or 20-mL syringe with an attached 18G, 1½" needle by drawing sterile water for injection from a vial. Delivered volumes were measured gravimetrically using an electronic balance and converted to volume using the specific gravity of water (1.0). Accuracy is represented as the mean and standard deviation, while precision is represented as percent relative standard deviation. Differences were assessed using a 1-way analysis of variance with Bonferroni adjustments and significance set at P < .05. Results: Precision and accuracy were highly variable and often significantly (P < .05) different compared to the theoretical volume delivered both within and between investigators. An increased likelihood of unacceptable error (>5%) was observed when less than 20% of the labeled capacity of a syringe was measured. Mean percent error ranged from 1.4% to 18.6%, despite manufacturer specification of ±5% accuracy, suggesting proper technique as a major factor in small-volume measurements. Conclusion: In addition to proper, validated training of syringe users, we recommend that users measure no less than 20% of the indicated volume of the syringe while choosing syringes as close as possible to the desired measurement. When possible, very small volumes should be diluted to meet the minimum volume of the smallest syringe available. Implementation of these recommendations will improve accurate dosing and, ultimately, patient safety.

Evaluation of gravimetric-based technology-assisted workflow for nonhazardous sterile product preparation

The impact of a gravimetric-based technology-assisted workflow (TAWF) system on the nonhazardous compounded sterile product (CSP) error capture rate, production times, and pharmacy staff perceptions of compounding methods was evaluated. For 2 weeks prior to TAWF implementation, staff used a punch clock to document production times with a volumetric method. Preimplementation error data were captured in a previous study; TAWF software captured error and time data in the postimplementation period. An online staff survey was administered before and 90 days after TAWF implementation to evaluate perceptions of the 2 methods. The error capture rates were 0.47% in the preimplementation period and 41.48% in the postimplementation period. The median time to prepare CSPs was significantly shorter in the preimplementation period versus the postimplementation period (p < 0.0001). The median time to check CSPs was significantly shorter at both 90 days (p < 0.0001) and 180 days (p = 0.0006) after TAWF implementation. When asked if the current method was the safest and the most accurate method for preparation, staff members' perceptions improved from neutrality to agreement when the TAWF was implemented. Staff members were in agreement that the volumetric method was faster than the gravimetric TAWF method but were neutral as to whether the latter was the preferred compounding method. The study results indicated that gravimetric-based TAWF preparation of nonhazardous CSPs is slower than manual volumetric preparation but can improve the error capture rate. Staff perceived the gravimetric TAWF method to be the safest and most accurate for producing CSPs.

ASHP national survey of pharmacy practice in hospital settings: Monitoring and patient education-2018.

The results of the 2018 ASHP national survey of pharmacy practice in hospital settings are presented. Pharmacy directors at 4,897 general and children's medical-surgical hospitals in the United States were surveyed using a mixed-mode method of contact by mail and email. Survey completion was online using Qualtrics. IMS Health supplied data on hospital characteristics; the survey sample was drawn from IMS's hospital database. The response rate was 16.6%. The percentage of hospitals that routinely have pharmacists assigned to provide drug therapy management has increased. Transitions-of-care processes have generally increased over the last 6 years. The percentage of hospitals with pharmacists in a wide variety of clinic types and clinical practice areas has increased over the last 2 years. Opioid stewardship programs are emerging in many U.S. hospitals, with pharmacists participating or taking the lead in program implementation. Outsourcing of compounded sterile product preparation is common. The proportion of hospitals not using any technology when compounding sterile preparations has declined. Pharmacy departments commonly track and monitor trends for administrative, operational, quality, and outcome metrics. Pharmacists continue to improve drug therapy monitoring for patients in U.S. hospitals. They are also responding to public health issues related to medication use. These advancements include taking an active role in opioid stewardship programs, safe compounding of sterile medications for patients, and reducing the need for hospital-based care.

Centralized preparation of chemotherapy for remote administration.

Increasingly stringent pharmacy standards for preparation of sterile products necessitated a review of the feasibility of continuing to maintain chemotherapy sterile production facilities across the provincial cancer programme. The concept of centrally produced chemotherapy that could be shipped to various locations as a remote service delivery model was explored. Key planning principles were established and detailed processes were developed to test this change in service delivery at one small cancer centre. Following the successful implementation and evaluation of the remote service delivery model at one centre, the programme was rolled out to an additional four centres.

Evaluation of a gravimetric-based technology-assisted workflow system on hazardous sterile product preparation.

The impact of a gravimetric-based technology-assisted workflow (TAWF) system on hazardous compounded sterile product (CSP) production time, staff perception of safety, and job satisfaction was evaluated. For 2 weeks before implementation of a gravimetric-based TAWF, staff utilized an automated punch clock to document the time to prepare and check CSPs compounded volumetrically. Simultaneously, an anonymous, online survey was e-mailed to staff to evaluate their perceptions regarding the safety of volumetric preparation and satisfaction with their role preparing CSPs. At 30 and 90 days postimplementation of the TAWF, staff completed identical follow-up surveys to evaluate safety and satisfaction using the gravimetric-based TAWF. The TAWF software captured product preparation and check times postimplementation. Data regarding the accuracy of compounding were collected postimplementation and compared to accuracy data available in the published literature. The median time to prepare CSPs preimplementation (n = 643) was 445 seconds versus 359 seconds (n = 728) 90 days after implementation of the gravimetric-based TAWF (p < 0.001). The median time to review and check CSPs was 45 seconds before implementation and 19 seconds 90 days after implementation (p < 0.01). Survey respondents preferred to use the TAWF to compound CSPs over volumetric preparation. There was no difference in respondents' perception of safety and accuracy of the TAWF preimplementation versus postimplementation. The gravimetric-based TAWF preparation of hazardous CSPs was faster and more accurate than manual volumetric preparation and improved staff perception regarding the accuracy of the CSP preparation process.

Hyperinflation of Isoproterenol

The hyperinflation of isoproterenol, a 75-year-old drug, in early 2015 was unbelievable. The attention of health-care professionals, health system administrators, legislators, and the general public was quickly focused on Valeant Pharmaceuticals, purchaser of several generics solely to raise their price. With isoproterenol easily launched toward the top of drug expenditures, pharmacists in many hospitals were forced to engage stakeholders in the investigation and implementation of alternatives, explore utilization and optimize inventory, reduce cost through sterile product preparation, where possible, restrict use to settings that were beneficial to their budget, and become legislative advocates. The alternatives drugs and strategies will be reviewed.

Parenteral product error detection before and after implementation of intravenous workflow management technology.

To assess the difference in pharmacy error detection rates when using a manual process compared to an intravenous workflow management system for the preparation of parenteral medications. Baseline error data were collected by staff using a standard form over a four-day time period before intravenous workflow management system implementation and compared to 48 weeks of electronically collected data following implementation. The chi-square test was used for statistical comparisons. The ability to detect an error during the intravenous preparation process increased immediately following implementation, but this difference was not sustained and was not statistically different when the entire post-implementation time period was compared to the baseline sample. The most prevalent errors at baseline were wrong drug amount (36.4%) and wrong base solution (22.7%). Post-implementation product expiration (26.1%), wrong diluent or base (17.9%), and wrong drug amount (19.2%) were the most prevalent errors. Barcode scanning technology detected 60% of the errors during the post-implementation period. A decrease in error detection over time was observed post-implementation and was attributed to corrections and additions to the intravenous workflow management library and better prospective identification of potential errors by staff as they adjusted to the system. The use of serial imaging enabled pharmacists to detect errors prospectively, which may have previously been undetected using the traditional intravenous preparation process. The implementation of intravenous workflow management technology was unable to detect a statistically significant greater percentage of sterile product preparation errors compared with the baseline time period. Statistical significance was achieved during three of the first four months following implementation ( P < 0.05); however, this statistically significant increase was not maintained when the entire post-implementation sample was included.

Aseptic preparation of parenteral medicinal products in healthcare establishments in Europe

In many cases, parenteral medicines with a marketing authorisation cannot be administered directly to patients, that is, they are not presented in ready-to-administer form. Before administration to patients, these medicines...

Aseptic simulation test for cytotoxic drug production in isolators

The results of a media-fill test (MFT) study to validate processes for cytotoxic drug preparation inside and outside aseptic compounding isolators are presented. Using an MFT protocol adapted to institution-specific production conditions, the pharmacy team at a hospital in France performed a series of tests to verify the efficacy of decontamination and sterile compounding procedures, as required by French compendial standards, while assessing the performance of its team of 12 isolator operators; all operators were tested on three occasions, producing 10 MFT samples per test for a total of 30 samples per operator. The team also tested alternative compounding systems (i.e., two closed-system transfer devices and a classic spike system) for use during power outages or other emergencies precluding drug preparation within isolators. MFTs were performed using a standard tryptone soy broth-based test kit under worst-case conditions. The hospital's facilities for cytotoxic drug preparation were found to be in conformance with applicable sterility standards. Bacterial growth was not detected in any of the MFT samples produced by isolator operators during the study (total n = 360). In one instance, an MFT sample prepared using a closed-system transfer device was found to be contaminated due to improper cleaning of the medication vial, highlighting the importance of strict adherence to proper decontamination procedures. A hospital's practices for preparation of sterile products according to applicable good manufacturing guidelines, as well as emergency procedures for cytotoxic drug preparation outside isolators, were validated by the results of an MFT study.

Comparison of pharmacy services at critical access hospitals and other rural and small hospitals in Illinois

The results of a survey evaluating pharmacy services and technology use at critical access hospitals (CAHs) and other small and rural hospitals in Illinois are reported. A mail survey was sent to pharmacy directors at 86 CAHs and other rural and small hospitals in Illinois not designated as CAHs. Independent sample t tests and chi-square statistics were used to compare CAHs and non-CAHs in areas such as pharmacy services, staffing, use of technology, and sterile compounding practices. The survey response rate was 46.5%, with usable data received from 40 hospitals. Analysis of the survey data indicated that hospitals designated as CAHs were significantly less likely than non-CAHs to have automatic therapeutic interchange policies (p = 0.012) and more likely to conduct pharmacist-provided educational programs on medication costs for physicians and other health care personnel (p = 0.037). Relative to non-CAHs, CAHs were significantly less likely to have automated dispensing cabinets (p = 0.016) and to out-source the preparation of sterile products to offsite vendors (p = 0.012); pharmacy directors at CAHs were less likely to report the use of technology for remote medication order entry or review (p = 0.038). At both types of facilities, pharmacists typically have both distributive and clinical responsibilities, and patient-specific clinical pharmacy services (e.g., patient education or counseling, other drug therapy monitoring, medication reconciliation, pharmacokinetic consultations) are offered at similar frequencies. A survey of pharmacy departments at small and rural hospitals in Illinois determined that there were more similarities than differences between CAHs and non-CAHs. The survey indicated significant differences in dispensing processes, the use of technology and drug policy tools, and outsourcing of sterile product preparation.

Developing entry-level competencies in sterile product preparation: An emerging challenge for pharmacy schools and experiential practice sites

Factors influencing the decision of hospital experiential sites to allow advanced pharmacy practice education (APPE) students to compound parenteral admixtures during their rotation experience were evaluated. A survey was sent via e-mail to APPE sites used by Illinois Pharmacy Coalition schools in spring 2011. One preceptor from each site was identified to complete the survey. Of the 166 surveys delivered, 89 responses (53.6%) were obtained, and 1 participant opted out. Forty respondents (45%) reported an average daily census of ≤ 100 patients. The majority of respondents (n = 49, 55%) had an average daily census of at least 100 patients. The majority of the reporting facilities (n = 38, 43%) were classified as community nonteaching hospitals. All of the practice sites had a cleanroom, a compounding aseptic isolator (glove box), or both. A total of 19 respondents (21%) indicated that their facilities did not permit APPE students to prepare sterile admixtures. Extensive training requirements established by hospitals was the most common reason cited for not allowing students to prepare admixtures (63%), followed by liability concerns (56%) and the cost and time associated with media-fill and glove fingertip testing (38% and 31%, respectively). The results of a survey of preceptors at a sample of APPE practice sites indicated that 21% did not allow pharmacy students to prepare sterile admixtures. Extensive training requirements, liability concerns, and the cost and time associated with media-fill and glove fingertip testing were cited as the most common reasons for not allowing students to prepare admixtures.

Training of Spanish sterile preparations technicians working in hospital pharmacy: comparison with the requirements of the American pharmacopea (USP)

BackgroundThe Spanish law indicates that sterile preparations technicians must have a minimum level of education. However, the requirements demanded by the USP are stricter than Spanish law, and, in some...

Lessons learned from a pharmacy practice model change at an academic medical center

The development and implementation of a new pharmacy practice model at an academic medical center are described. Before the model change, decentralized pharmacists responsible for order entry and verification and clinical specialists were both present on the care units. Staff pharmacists were responsible for medication distribution and sterile product preparation. The decentralized pharmacists handling orders were not able to use their clinical training, the practice model was inefficient, and few clinical services were available during evenings and weekends. A task force representing all pharmacy department roles developed a process and guiding principles for the model change, collected data, and decided on a model. Teams consisting of decentralized pharmacists, decentralized pharmacy technicians, and team leaders now work together to meet patients' pharmacy needs and further departmental safety, quality, and cost-saving goals. Decentralized service hours have been expanded through operational efficiencies, including use of automation (e.g., computerized provider order entry, wireless computers on wheels used during rounds with physician teams). Nine clinical specialist positions were replaced by five team leader positions and four pharmacists functioning in decentralized roles. Additional staff pharmacist positions were shifted into decentralized roles, and the hospital was divided into areas served by teams including five to eight pharmacists. Technicians are directly responsible for medication distribution. No individual's job was eliminated. The new practice model allowed better alignment of staff with departmental goals, expanded pharmacy hours and services, more efficient medication distribution, improved employee engagement, and a staff succession plan.

Effects of a new sterile product preparation and delivery process on operational efficiency and cost

Process changes in a hospital pharmacy's batch preparation of sterile products to reduce product and human resource waste are described. The pharmacy information system and direct observation were used in the collection of data on the existing i.v. room process, which generated batches of drug products every 12 hours. The daily numbers of doses prepared and doses credited, the percentage of doses credited, the cost of wasted doses, and the number of pharmacy technician hours wasted in the process were recorded. After a change to every-4-hour batch preparation and a modification of the schedule for delivering products to nursing units, data were again collected to determine savings of waste and costs. Fewer doses were prepared daily in the new batch process. The percentage of doses credited daily decreased from 26% to 18%, and pharmacy technician workload decreased by 3.05 hours. The reductions in waste led to a projected annual product cost saving of $122,000 and a workload reduction of 0.5 technician full-time equivalent. The implementation of a new i.v. room batch process improved operational efficiency by reducing the production of waste and led to a substantial projected annual cost saving.

Survey of Sterile Admixture Practices in Canadian Hospital Pharmacies: Part 2. More Results and Discussion

The 1996 Guidelines for Preparation of Sterile Products in Pharmacies of the Canadian Society of Hospital Pharmacists (CSHP) represent the current standard of practice for sterile compounding in Canada. However, these guidelines are practice recommendations, not enforceable standards. Previous surveys of sterile compounding practices have shown that actual practice deviates markedly from voluntary practice recommendations. In 2004, the United States Pharmacopeia (USP) published its "General Chapter <797> Pharmaceutical Compounding-Sterile Preparations", which set a more rigorous and enforceable standard for sterile compounding in the United States. To assess sterile compounding practices in Canadian hospital pharmacies and to compare them with current CSHP recommendations and USP chapter <797> standards. An online survey, based on previous studies of sterile compounding practices, the CSHP guidelines, and the chapter <797> standards, was created and distributed to 193 Canadian hospital pharmacies. A total of 133 pharmacies completed at least part of the survey, for a response rate of 68.9%. All respondents reported the preparation of sterile products. Various degrees of deviation from the practice recommendations were noted for virtually all areas of the CSHP guidelines and the USP standards. Low levels of compliance were most notable in the areas of facilities and equipment, process validation, and product testing. Availability in the central pharmacy of a clean room facility meeting or exceeding the criteria of International Organization for Standardization (ISO) class 8 is a requirement of the chapter <797> standards, but more than 40% of responding pharmacies reported that they did not have such a facility. Higher levels of compliance were noted for policies and procedures, garbing requirements, aseptic technique, and handling of hazardous products. The survey methods for this study and results relating to policies, personnel, raw materials, storage and handling, facilities and equipment, and garments were reported in Part 1. Part 2 reports results relating to preparation of aseptic products, expiry dating, labelling, process validation, product testing and release, documentation, records, and disposal of hazardous pharmaceuticals. It also highlights some of the key areas where there is considerable opportunity for improvement. This survey identified numerous deficiencies in sterile compounding practices in Canadian hospital pharmacies. Awareness of these deficiencies may create an impetus for critical assessment and improvements in practice.

Survey of Sterile Admixture Practices in Canadian Hospital Pharmacies: Part 1. Methods and Results

The 1996 Guidelines for Preparation of Sterile Products in Pharmacies of the Canadian Society of Hospital Pharmacists (CSHP) represent the current standard of practice for sterile compounding in Canada. However, these guidelines are practice recommendations, not enforceable standards. Previous surveys of sterile compounding practices have shown that actual practice deviates markedly from voluntary practice recommendations. In 2004, the United States Pharmacopeia (USP) published its "General Chapter <797> Pharmaceutical Compounding-Sterile Preparations", which set a more rigorous and enforceable standard for sterile compounding in the United States. To assess sterile compounding practices in Canadian hospital pharmacies and to compare them with current CSHP recommendations and USP chapter <797> standards. An online survey, based on previous studies of sterile compounding practices, the CSHP guidelines, and the chapter <797> standards, was created and distributed to 193 Canadian hospital pharmacies. A total of 133 pharmacies completed at least part of the survey, for a response rate of 68.9%. All respondents reported the preparation of sterile products. Various degrees of deviation from the practice recommendations were noted for virtually all areas of the CSHP guidelines and the USP standards. Low levels of compliance were most notable in the areas of facilities and equipment, process validation, and product testing. Availability in the central pharmacy of a clean room facility meeting or exceeding the criteria of International Organization for Standardization (ISO) class 8 is a requirement of the chapter <797> standards, but more than 40% of responding pharmacies reported that they did not have such a facility. Higher levels of compliance were noted for policies and procedures, garbing requirements, aseptic technique, and handling of hazardous products. Part 1 of this series reports the survey methods and results relating to policies, personnel, raw materials, storage and handling, facilities and equipment, and garments. Part 2 will report results relating to preparation of aseptic products, expiry dating, labelling, process validation, product testing and release, documentation, records, and disposal of hazardous pharmaceuticals. It will also highlight some of the key areas where there is considerable opportunity for improvement. This survey identified numerous deficiences in sterile compounding practices in Canadian hospital pharmacies. Awareness of these deficiencies may create an impetus for critical assessment and improvements in practice.

Sterile Preparation Evolves: A USP &lt;797&gt; Implementation Story

The United States Pharmacopeia (USP) revised and renumbered the chapter describing sterile product preparation. Renumbering the document resulted in enforceable requirements for sterile preparation. This document, the infamous Chapter &lt;797&gt;, will improve sterile preparation in many institutions. The regulation change was a result of contaminated preparations following attempts to standardize sterile guidelines. The process to understand, review, plan, and implement change and improvement in sterile preparation process is an initially vast, but ongoing task. The journey of USP &lt;797&gt; implementation at Oregon Health &amp; Science University (OHSU) involved education, gap analysis, reorganization, and training. Sections of Chapter &lt;797&gt; posed particular challenges and issues in areas including environmental and equipment, product preparation, storage, and dating, as well as, personnel training and testing. Financial implications of fully implementing the recommendations can be overwhelming. Regardless, institutions must start the process by working in their current environment, while maintaining focus on a vision of a fully compliant sterile product preparation system.