4 Operations & Management
Pharmacy Practice News • May 2021
Sterile Compounding
Could a Mobile Cleanroom Be a Solution for Your Pharmacy?
B
etween 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
HyperRAB
-----------DOSAGE FORMS AND STRENGTHS---------300 IU/mL solution for injection supplied in 1 mL, 3 mL and 5 mL single-dose vials.
HIGHLIGHTS OF PRESCRIBING INFORMATION
--------------------CONTRAINDICATIONS--------------------None.
Rabies Immune Globulin (Human) 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 ----------------INDICATIONS AND USAGE------------------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 HYPERRAB • Administer as soon prophylaxis, 20 IU/kg as possible after along with body weight exposure, preferably rabies OR at the time of the first vaccine, after 0.0665 mL/kg rabies vaccine dose. suspected body weight • Infiltrate the full exposure to dose of HYPERRAB Single dose rabies thoroughly in the area around and into the wound(s), if anatomically feasible. • Inject the remainder, if any, intramuscularly.
-------------WARNINGS AND PRECAUTIONS-------------• 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. --------------------ADVERSE REACTIONS--------------------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. --------------------DRUG INTERACTIONS------------------• 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.
Grifols Therapeutics LLC Research Triangle Park, NC 27709 USA U.S. License No. 1871
3054805 Revised: 11/2019
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. see MOBILE, page 10
