Descriptive Report of Individual State Responses to Personal Protective Equipment Shortages for Pharmacy Practice During the Covid-10 Pandemic.

The objective of this study was to describe the response by state boards of pharmacy pertaining to personal protective equipment shortages during the early phase of the COVID-19 pandemic. All webpages of state boards of pharmacy were independently reviewed for written guidance pertaining to personal protective equipment conservation strategies in sterile compounding and deviations from United States Pharmacopeia General Chapter <797> standards; each guidance was then reviewed for referenced sources. Of 52 state pharmacy regulatory bodies, 38 (73.08%) provided guidance to modifying personal protective equipment use during sterile compounding activities to mitigate supply shortages. The references for each guidance varied, however, most referenced CriticalPoint, LLC or the United States Pharmacopeia. A few of the guidance documents from boards also permitted other deviations from United States Pharmacopeia Chapter <797> standards. Early in the pandemic, pharmacists within sterile compounding practices had to conserve personal protective equipment while mitigating contamination risk. Pharmacists looked to state boards of pharmacy for guidance. This report shows a high level of state response to the personal protective equipment shortage induced by the pandemic.

Evaluation of telepharmacy and the use of a gravimetric technology-assisted workflow system for remote sterile product pharmacist checks.

PURPOSE: To evaluate the impact of remote sterile product pharmacist checks when used with a gravimetric-based technology-assisted workflow (TAWF) system on product checking accuracy, pharmacist review time, workload sharing, cost savings, and staff perceptions. METHODS: A double-arm, prospective study was conducted at 4 pharmacy locations for a 90-day period. Each compounded sterile product (CSP) checked by a remote pharmacist was also checked by a local pharmacist at the site of CSP preparation. An anonymous, online survey was emailed to staff before and after implementation to evaluate perceptions of the accuracy, timeliness, safety, potential impact, and value of the remote process. RESULTS: There was no statistically significant difference in the numbers of errors detected through the remote process and through the current, nonremote process (P = 0.177). The median pharmacist review time in the local process was significantly lower (P < 0.001). Remote pharmacists in the study workflow verified 30.4% of the total number of CSPs verified in the 90-day period. Annualized cost savings were calculated to be $23,770.08. Percent agreement increased from the preimplementation to the postimplementation period for survey questions about the safety of the remote process, opportunity for workload sharing, and optimization of current workflow. Percent agreement decreased for questions about the accuracy, timeliness, and value of the remote process and its impact on job security. CONCLUSION: The study demonstrated that with use of a gravimetric-based TAWF system, there was no difference in the accuracy and safety of sterile product pharmacist checks performed remotely and those performed at the product preparation site. In addition, the remote process allows for opportunities for workload sharing and cost savings.

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

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Financial Effect of a Drug Distribution Model Change on a Health System.

Background: Drug manufacturers change distribution models based on patient safety and product integrity needs. These model changes can limit health-system access to medications, and the financial impact on health systems can be significant. Objective: The primary aim of this study was to determine the health-system financial impact of a manufacturer's change from open to limited distribution for bevacizumab (Avastin), rituximab (Rituxan), and trastuzumab (Herceptin). The secondary aim was to identify opportunities to shift administration to outpatient settings to support formulary change. Methods: To assess the financial impact on the health system, the cost minus discount was applied to total drug expenditure during a 1-year period after the distribution model change. The opportunity analysis was conducted for three institutions within the health system through chart review of each inpatient administration. Opportunity cost was the sum of the inpatient administration cost and outpatient administration margin. Results: The total drug expenditure for the study period was $26 427 263. By applying the cost minus discount, the financial effect of the distribution model change was $1 393 606. A total of 387 administrations were determined to be opportunities to be shifted to the outpatient setting. During the study period, the total opportunity cost was $1 766 049. Conclusion: Drug expenditure increased for the health system due to the drug distribution model change and loss of cost minus discount. The opportunity cost of shifting inpatient administrations could offset the increase in expenditure. It is recommended to restrict bevacizumab, rituximab, and trastuzumab through Pharmacy & Therapeutics Committees to outpatient use where clinically appropriate.