While the practice of hospital pharmacy differs from institution to institution, the extemporaneous compounding of sterile preparations is one area in which most organizations share similar experiences. Compounded sterile preparations are the lifeline of inpatient care, be they produced on demand to meet patient-specific needs or as anticipatory compounding to supply projected requests. Thus, pharmacy’s responsibility for maintaining compounding sterility in the face of a disaster is intrinsic to maintaining patient care.
The pharmacy department at Brigham and Women’s Hospital (BWH), a tertiary academic medical center located in Boston, Massachusetts, operates three certified cleanrooms and follows United States Pharmacopeia (USP) chapters <797> and <800> as standard operating procedure. In compliance with local regulations, pharmacy staff engages in sterile-to-sterile pharmaceutical compounding of hazardous and non-hazardous medications, which provide support for upwards of 800 inpatient beds, an emergency department, and a comprehensive surgical services center. In 2019, the pharmacy department produced over 130,000 patient-specific compounded sterile products and just under 200,000 units of compounded sterile medications for anticipatory needs. Per USP requirements, compounding personnel must be properly garbed to enter the cleanroom in accordance with standard operating procedures.1
In March 2020, as the Office of Health and Human Services executed the public health emergency order in preparation for the first surge of COVID-19 patients, the pharmacy department began developing contingency plans to ensure adequate inventory levels of supplies to maintain sterile compounding practices. Specifically addressed was the strain on the personal protective equipment (PPE) supply chains as the surge began to impact the availability of disposable supplies utilized in support of sterile compounding practices.
Standard Policies and Procedures
The compounding areas at BWH consist of a central positive pressure cleanroom, a negative pressure cleanroom dedicated to chemotherapy and other hazardous compounding, and an infusion pharmacy cleanroom, which includes both positive pressure and negative pressure suites.
In the positive pressure cleanroom, the gowning procedure encompasses hospital-issued scrubs, hair cover and beard cover if applicable, face mask, gowning hood, two pairs of shoe covers, a sterile coverall, and a pair of sterile nitrile gloves. In addition to the aforementioned garb, staff members who compound in a negative pressure cleanroom space are also required to don a chemotherapy protective gown, a second pair of sterile nitrile gloves, and a third pair of shoe covers. All of these items, with the exception of the sterile laundered coveralls, are disposable and must be thrown out upon each exit from the cleanroom, with a fresh set of PPE required for each re-entry. Prior to the COVID-19 pandemic, the average usage of disposable PPE totaled 9,100 items per week (see TABLE 1).
In addition, 150 sterile laundered coveralls are used in the cleanrooms each week. An outside vendor delivers the coveralls weekly and simultaneously collects the soiled coveralls for processing. After undergoing cleaning, irradiation, and sterilization, the coveralls are returned to BWH in individual packages. Since the coveralls circulate within our institution only, there were no associated shortages or supply issues.
BWH utilizes an external vendor for cleaning services, which take place seven days per week and up to twice daily in high traffic areas. Daily cleaning practices consist of a disinfectant (rotated monthly) followed by sterile isopropyl alcohol on all surfaces. Weekly cleaning practices include the addition of a sporicidal agent on all surfaces, including walls and ceilings. Due to the frequency of cleaning and the rigorous gowning protocol, additional cleanroom cleaning was not deemed necessary in response to the COVID-19 pandemic.
Core cleaning products were not affected by pandemic-related shortages with the exception of sterile isopropyl alcohol spray bottles and pre-saturated sterile isopropyl alcohol wipes. These shortages were mitigated through intermittent shipping and varying brand usage of the sterile isopropyl alcohol products.
Contingency Plans for Conservation
A conservation map was created to guide our response to product shortages (see TABLE 2). For all items, the back-up supply is defined as a 4-week inventory on hand, whereas critical low is defined as less than 2 weeks of inventory remaining. Typically, items are sourced through a single vendor. However, as weekly allotments slowed, it became apparent that disposable items would need to be ordered from multiple sources.
Additionally, a supply of non-nitrile sterile gloves was purchased to supplement non-hazardous compounding practices. This allowed us to conserve a larger stockpile of sterile nitriles gloves for hazardous compounding. Designated cleanroom PPE was stored in a secure location with limited staff access. Other key items such as masks, hand sanitizer, and all-purpose disinfectant wipes were also placed in a secure location with access limited to pharmacy administration only. The pharmacy quality assurance coordinator was assigned to manage and monitor the full inventory.
Activating Conservation Methods
On April 16, 2020, the first conservation methods were initiated to address the mask shortage. The decision was made to allot one mask to each compounding staff member per 8-hour shift. First, we established an approximate daily and weekly mask count based on standard staffing numbers in order to determine how many masks would be required per shift. That supply was then allotted per cleanroom by the leadership team. The staff pharmacist was responsible for distribution throughout the shift. This conservation process remained in effect until October 23, 2020, when the on-hand supplies reached a steady state, and sufficient product was readily available from outside vendors.
Although the original conservation planning targeted PPE, as the pandemic continued, it became apparent that additional, non-conventional conservation methods were necessary to manage the diminishing supply of hand sanitizer and disinfectant wipes. To address these shortages, pharmacy staff began compounding hand sanitizer for department use in March. This bolstered the supply; the in-house compounded sanitizer was utilized throughout the non-compounding areas of the pharmacy, which allowed us to reserve the commercial hand sanitizer for cleanroom use. When the commercial hand sanitizer availability stabilized in late July, pharmacy stopped compounding it.
Prior to the pandemic, pre-saturated sterile isopropyl alcohol wipes were used throughout the department to sanitize surfaces such as desks, keyboards, and phones. In late March, supplies of all-purpose disinfectant wipes were purchased for department use instead. As we had no purchase history with these products, we had to rely on a combination of sources including wholesalers, direct orders, and a variety of brands to obtain a sufficient supply, which allowed us to preserve the sterile isopropyl alcohol products for cleanroom use only. Large tubs of wipes were repackaged into smaller containers, which were reused throughout this process. By August, the process of repackaging wipes ceased; however, the department continues to use all-purpose disinfectant wipes on shared non-cleanroom work surfaces, thus reserving pre-saturated sterile isopropyl alcohol wipes for cleanroom use only.
A cohesive strategy for disaster planning and emergency preparedness is vital to equip health care professionals with the resources needed to combat the unexpected.2 From the administration of medications and vaccinations to the safeguarding of PPE and general supplies, pharmacists along with pharmacy technicians and other pharmacy support staff, play an integral role in maintaining the infrastructure of patient care during natural disasters, pandemics, and public emergencies.3,4 Even as the COVID-19 pandemic continues to stress resources, pharmacy departments will continue to provide essential services to patients.
Caryn Belisle, BS Pharm, RPh, MBA, is the director of pharmacy regulatory compliance, quality, and safety at Brigham and Women’s Hospital (BWH) in Boston, Massachusetts. She has served as president of the Massachusetts Society of Health-System Pharmacists (MSHP), and presently serves on the House of Delegates for the American Society of Health-System Pharmacists.
Keely K. Kwok, BS, CPhT, is the quality assurance coordinator at BWH. She received her BS in both microbiology and food science and technology from the University of Massachusetts Amherst. Keely has an extensive microbiology background, with a strong knowledge in cGMP, GLP, Code of Federal Regulations, and USP chapters <797>, <800>, <71>, <85>, and <1116>. Her expertise also includes cleanroom and aseptic gowning, garbing, and processing standards.
Megan Rocchio, PharmD, BCPS is a pharmacy supervisor and PGY1 residency coordinator at BWH. From 2015 through 2020, she oversaw sterile compounding operations in the pharmacy department.
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