11 minute read
The case for mobile cleanrooms
Could a Mobile Cleanroom Be a Solution for Your Pharmacy?
Between 2018 and 2020, the Smilow Cancer Network of Yale New Haven Health underwent a major expansion, which included adding new cleanrooms and expanding existing ones at several locations within the network of 14 cancer centers and the flagship Smilow Cancer Hospital.
“At the time, we had a total of 22 cleanrooms supporting the network,” said Howard Cohen, MS, RPh, FASHP, who retired last year as the executive director of oncology pharmacy services at Yale New Haven Health, in New Haven, Conn. “At the Smilow Cancer Hospital, for example, we had a large oncology pharmacy on the eighth floor of the hospital that needed to be totally renovated because it didn’t meet any of the new standards set by U.S. Pharmacopeia Chapters <797> and <800>. It was a very busy pharmacy, compounding 400 to 500 doses a day, and we had no other place to mix our hazardous drugs while it was being renovated. We couldn’t shut down compounding, and we knew that trying to segment the existing cleanroom—compounding in one half while renovating the other half—really wouldn’t work. We’d be risking sterility and a lot of other issues. So we started looking for an alternative.”
The solution? A mobile cleanroom. Several vendors, including Germfree and Cleanroom Design LLC, offer a variety of temporary cleanroom options, with some literally on wheels and able to be parked outside a facility for as long as a facility needs them, and other modular options that can be built off-site and configured for a variety of sizes and layouts before delivery to your institution.
“It was the perfect solution for us,” said Cohen, who commissioned Germfree to customize a special version of their standard 53-foot mobile trailer compounding pharmacy for the cancer hospital. “Their usual layout is segmented into two hazardous hoods and two nonhazardous, with anterooms and workrooms. For the oncology pharmacy in the cancer hospital, we went with four hazardous hoods.”
Smilow’s specialized unit, located near the loading dock, enabled the hospital to totally take down its existing pharmacy and convert everything to the mobile unit. “We had to go from six biological safety cabinets to two, but we expanded our hours of operation and changed our workflow to accommodate our needs, and relied on other existing cleanrooms throughout the institution to do some of our nonhazardous compounding,” Cohen said.
Strict State Standards Met
In addition to the unit at the main cancer hospital, Cohen estimates he used three or four additional mobile cleanrooms over the course of the system’s renovations. “Our state is very strict with its pharmacy standards, and we had both the Connecticut Drug Control Division [which oversees licensing for pharmacies and pharmacists] and the Department of Health in to approve our use of the mobile units, and they were blown away. They said they were outstanding.”
The publication of USP’s revised Chapter <800> in 2016, followed by revisions to <797> in 2019—even though implementation has been delayed—kicked off a wave of interest in mobile cleanrooms. “Everybody realized that they were nowhere near compliant and would have to do a significant amount of remodeling to become compliant for hazardous drug compounding,” said Jerry Siegel, PharmD, the vice president at Safe Medication Management Associates and a clinical associate professor at The Ohio State University College of Pharmacy, in Columbus. “To fill their hazardous compounding needs during renovation, many institutions have elected to commission a mobile or modular unit that they can have on-site.”
Natural disasters such as hurricanes and earthquakes, as well as the COVID-19 pandemic, also have increased demand for mobile and modular cleanrooms.
HyperRAB®
Rabies Immune Globulin (Human)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use HYPERRAB® safely and effectively. See full prescribing information for HYPERRAB. HYPERRAB [rabies immune globulin (human)] solution for infiltration and intramuscular injection Initial U.S. Approval: 1974
HYPERRAB is a human rabies immune globulin indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies. Limitations of Use Persons previously immunized with rabies vaccine that have a confirmed adequate rabies antibody titer should receive only vaccine. For unvaccinated persons, the combination of HYPERRAB and vaccine is recommended for both bite and nonbite exposures regardless of the time interval between exposure and initiation of postexposure prophylaxis. Beyond 7 days (after the first vaccine dose), HYPERRAB is not indicated since an antibody response to vaccine is presumed to have occurred.
--------------DOSAGE AND ADMINISTRATION------------For infiltration and intramuscular use only. Administer HYPERRAB within 7 days after the first dose of rabies vaccine.
Postexposure prophylaxis, along with rabies vaccine, after suspected exposure to rabies HYPERRAB 20 IU/kg body weight OR 0.0665 mL/kg body weight Single dose • Administer as soon as possible after exposure, preferably at the time of the first rabies vaccine dose. • Infiltrate the full dose of HYPERRAB thoroughly in the area around and into the wound(s), if anatomically feasible. • Inject the remainder, if any, intramuscularly.
-----------DOSAGE FORMS AND STRENGTHS----------
300 IU/mL solution for injection supplied in 1 mL, 3 mL and 5 mL single-dose vials.
--------------------CONTRAINDICATIONS---------------------
None.
• Severe hypersensitivity reactions, including anaphylaxis, may occur with HYPERRAB. Have epinephrine available immediately to treat any acute severe hypersensitivity reactions. • HYPERRAB is made from human blood; it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
The most common adverse reactions in >5% of subjects in clinical trials were injection site pain, headache, injection site nodule, abdominal pain, diarrhea, flatulence, nasal congestion, and oropharyngeal pain.
To report SUSPECTED ADVERSE REACTIONS, contact Grifols Therapeutics LLC at 1-800-520-2807 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
• Repeated dosing after administration of rabies vaccine may suppress the immune response to the vaccine. • Defer live vaccine (measles, mumps, rubella) administration for 4 months.
Building a Cleanroom Compliance Team
In the wake of a series of four audits from different regulatory agencies between June 2016 and August 2017, each resulting in various recommendations, including an FDA Form 483 observation report, Michigan Medicine decided that its network of 21 compounding pharmacy locations needed oversight by a dedicated, in-house team of compounding compliance experts.
“Most of the time, compounding compliance in academic medical centers is handled by an administrative leader in the department or the person responsible for supervising the compounding facility itself,” said Bruce Chaffee, PharmD, Michigan Medicine’s director of pharmacy analytics, quality, regulatory and safety. “Before this team was formed, we operated in a very similar way: Each of our compounding areas had a supervisor, and compliance was folded into their duties supervising operations and staff. Some of the work was outsourced, such as sampling being done by a certifier.”
To lead the initial four-person compounding compliance team, Chaffee recruited pharmacy manager Jamie Tharp, PharmD, to serve as Compounding Compliance Team (CCT) manager. They then added three more team members: a lead pharmacist with both operational compounding experience and background knowledge in regulatory standards, as well as technical writing skills; and two pharmacy technicians with sterile compounding experience who were also senior enough to have experience with coaching and mentoring.
“Our primary focus at the beginning was education, facilities and equipment enhancements, policy revisions and insourcing of our own media fill testing and environmental sampling,” Tharp said. “We spent a lot of our effort during the first year after the team was created in educating all of the compounders across our 21 sites.”
A Major Undertaking
With approximately 335 of Michigan’s pharmacy full-time equivalents participating in compounding or supervision of compounding areas, that was a major undertaking. Most of those staff members completed approximately 24 hours of continuing education on sterile compounding during the team’s first year. All compounders were required to complete a media fill challenge overseen by CCT members to be credentialed.
Existing policies and procedures were not robust enough for regulatory compliance purposes, so the CCT purchased draft compounding standard operating procedures from an outside vendor, and then invested significant time in adapting them to Michigan Medicine’s circumstances. The result was eight general compounding policies covering seven areas, each accompanied by associated work procedures, quick tip sheets and documentation forms. Also included were 10 miscellaneous compounding-related policies and four related safety and quality assurance policies for medication safety, adverse drug reactions, drug recalls and incident reporting.
The team also spent much of the first year focused on centralizing all of the academic medical center’s many records related to compounding. “We were able to centralize all of our certification records, environmental monitoring records and personnel monitoring records,” Tharp said. “These records are now in a logically organized database that can easily be searched to answer questions, such as how we managed excursions.”
About a year after the CCT was put in place, Michigan Medicine had return visits from the FDA and two other regulators who had audited the facility—the state of Michigan and the Joint Commission. “They were very impressed with the progress we had made,” Chaffee said. “In their interviews, they could clearly see how knowledgeable our staff were, and they were easily able to access all our records in the one-stop shop of our centralized database. They saw what a huge investment of time and effort we had made.”
As of April 2021, Michigan Medicine had no outstanding issues in need of regulatory corrective action with any agencies, added Chaffee and Tharp, whose team described their revamped compounding program in the American Journal of Health-System Pharmacy (2020;77[11]:882-891).
Based on the initial success of the CCT, Michigan Medicine’s Department of Pharmacy requested that the team be expanded from focusing solely on sterile compounding to include hazardous drug handling and nonsterile compounding. Two more pharmacists and three more pharmacy technicians were added as part of that effort.
Cleanroom Manager ‘Can’t Do it All’
“Having dedicated staff focused on cleanroom compliance, whether it’s one person or a whole team of people like Michigan has, is imperative nowadays,” observed Caryn Belisle, RPh, MBA, the director of pharmacy regulatory compliance, quality and safety at Brigham and Women’s Hospital, in Boston. “You can’t expect your cleanroom manager to do it all. You need someone outside the cleanroom’s day-to-day operations who is focused on quality and compliance. First, it’s just too much for one person to have to keep their eye on, and second, it’s always good to separate your quality from your operations when you are compounding significant amounts of product, either patient-specific or batch.”
Internal audits are highly beneficial, Belisle added. “You can observe your trends in environmental monitoring, but you need to also get out of your chair and watch the staff gown and garb, and see how they’re behaving in the cleanroom. At Brigham, we perform monthly quality rounds. We have a team, including our quality assurance coordinator, cleanroom manager, one of our technician trainers and me, observe, talk to front-line staff, watch their performance and get a sense of the challenges they are facing in their day-to-day work.”
: HBB Services Solution Source
3 Tips for Effective Quality Control
One key to a successful cleanroom quality control effort is to take a multipronged approach, including the following elements: 1. A dedicated housekeeping team. “Our
four housekeepers receive specialized training and only clean pharmacy spaces,” said Bruce Chaffee, PharmD, Michigan Medicine’s director of pharmacy analytics, quality, regulatory and safety. “We have seen significant improvements in the cleanliness of those spaces.” 2. An oversight committee. This group
includes pharmacy senior leaders; operational leaders; and representatives from infection prevention, compliance, facilities and systems monitoring, and maintenance. “It’s important to have these checks and balances for tough policy decisions that may not be popular with operations because they change workflow and may be challenging to implement,” Chaffee said. 3. A training space. “What really impressed me was that they were able to keep a decommissioned pharmacy for a training facility where people can practice gowning and garbing, and training and testing can be done,” said Caryn Belisle, RPh, MBA, the director of pharmacy regulatory compliance, quality and safety at Brigham and Women’s Hospital, in Boston. “You see this in the 503B industry, but it’s something most hospital pharmacies can only dream of.” —G.S. —Gina Shaw
The sources reported no relevant fi nancial disclosures.
THE MCMAHON GROUP, LLC McMAHON PUBLISHING McMAHONMED.COM
Sales, Production and Editorial Offices: 545 West 45th Street, 8th Floor, New York, NY 10036 Telephone: (212) 957-5300 CT Office: 83 Peaceable Street, Redding, CT 06896
Copyright © 2021 McMahon Publishing, New York, NY 10036. All rights reserved. Pharmacy Practice News is published bimonthly by McMahon Publishing. POSTMASTER: Send address changes to Pharmacy Practice News, Circulation Dept., 545 W. 45th St., 8th Floor, New York, NY 10036.
We endeavor to obtain relevant financial disclosures from all interviewees and rely on our sources to accurately provide this information, which we believe can be important in evaluating the research discussed in this publication.
WANT TO SUBSCRIBE? CHANGE YOUR ADDRESS? HERE’S HOW
Selected U.S. hospital pharmacists and health care personnel re ceive Pharmacy Practice News free of charge. If you are a hospital pharmacist and do not receive the publication, you must add your professional address or make your address change directly with Pharmacy Practice News Circulation Dept., 545 W. 45th St., 8th Floor, New York, NY 10036. You can also fax your request to (815) 366–8297, or send it via email, circulation@mcmahonmed.com. If you are not a hospital pharmacist but would like to re ceive Pharmacy Practice News, please send a check for $70.00 (U.S.) or $90.00 (outside U.S.) for a year’s subscription pay able to Specialty Pharmacy Continuum to McMahon Pub lishing, 545 West 45th St., 8th Floor, New York, NY 10036. Please allow 8 to 12 weeks for delivery of the first issue. In dividual issues are $9.00 (U.S.) or $12.00 (outside U.S.).
McMahon Publishing is a 48-year-old, family-owned medical publisher of clinical newspapers and specialty periodicals, and creates compelling medical education programs and custom publications. As the second largest publisher of medical newspapers, McMahon produces Anesthesiology News, Gastroenterology & Endos copy News, General Surgery News, Infectious Disease Special Edition, Pain Medicine News, Phar macy Practice News and Specialty Pharmacy Continuum.
