TY - JOUR
AU - Traynor,, Kate
AB - The Pharmaceutical Development Section (PDS) at the National Institutes of Health (NIH) will soon have more elbowroom and improved technology to better serve the medication needs of patients at the world’s largest hospital devoted solely to clinical research. The upgraded $12 million PDS area occupies 12,000 square feet within the NIH Clinical Center, a federally funded facility that serves about 10,000 new patients each year. About half of NIH’s patients participate in the approximately 1500 clinical trials that are in progress at the hospital, and half are involved in so-called natural history studies that further scientists’ understanding of biological processes and disease development. PDS’s staff of 20 pharmacists, chemists, pharmacokineticians, and technicians support clinical studies by producing customized formulations and dosage forms of investigational drugs and placebos. About a third of the clinical studies require this service, according to NIH. The unit also processes and repackages medications received from manufacturers for use in Clinical Center studies. PDS’s work includes analytical and stability testing of the drugs and quality control to ensure that all study medications meet required specifications. “If we’re going to make something, it better be what we say it is,” Pharmacy Chief Robert DeChristoforo said during a tour of the new PDS area. PDS was established in 1956 and has moved several times, most recently occupying—and spilling out from—a long, narrow area in the original Clinical Center building, DeChristoforo said. Physical limitations of the older PDS space made it impossible to fully comply with FDA’s current good manufacturing practice (GMP) standards, DeChristoforo noted. The new area has been built with modern high-efficiency particulate-absorbing filters and has both positive- and negative-pressure rooms to improve safety and help ensure product integrity. The improvements include a new plumbing system through which distilled, reverse-osmosis-filtered water enters the PDS space through stainless steel pipes. The new PDS area will be fully GMP-compliant and subject to inspection by FDA, said Clinical Center Director John Gallin. The staff expect to finish transitioning to the new area by early June. To assist with GMP compliance, the new PDS space has separate rooms or areas dedicated to specific tasks. These include receiving, packaging, labeling, and storage rooms and areas for quarantining products that are awaiting clearance for patient use. Refrigerators and freezers are continuously monitored and networked into the pharmacy’s computers to ensure that storage temperatures remain within specification and product integrity is maintained. Preventing product spoilage is essential because PDS “could have the world’s supply of a drug in our refrigerators,” DeCristoforo said. Most of PDS’s new nonadministrative space is dedicated to drug production and testing, work that administrators expect will proceed faster and more efficiently than in the past. Open in new tabDownload slide Pharmacy Chief Robert DeChristoforo show the new high-capacity capsule-filing machine at the National Institute of Health’s Pharmaceutial Development Section. Open in new tabDownload slide Pharmacy Chief Robert DeChristoforo show the new high-capacity capsule-filing machine at the National Institute of Health’s Pharmaceutial Development Section. Nonsterile areas include dedicated rooms for the production of liquids and ointment product formulations as well as a new capsule-filling machine that can make “about 100,000 capsules” during an eight-hour day, said PDS Chief Robert Grimes Jr. Grimes estimated that about two dozen Clinical Center studies require that level of capacity. A new blender in the powder-mixing room is about 15 times the size of PDS’s previous, 1950’s-era machine. Grimes said the equipment will allow the production of larger batches of tablets and capsules, resulting in a decrease in the number of batch-specific analytical tests that must be performed. A tablet-coating room gives PDS the new capability to produce film-coated tablets. This feature will help the group make placebos that are indistinguishable, including by taste, from active drugs used in Clinical Center studies. “It’s very hard to make a placebo,” Gallin said. “Making a good placebo that looks identical to the real medication is a skill.” DeChristoforo said ingenuity is sometimes needed to make placebos. In at least one instance, he said, PDS needed to make a placebo identical to a commercially manufactured, imprinted tablet. He said PDS purchased a die identical to that used for the commercial product to make the placebo. DeCristoforo said PDS intends to keep the nonsterile areas of the new space as clean as possible, which should make it easier to keep the sterile areas pristine. Aseptic processing of vaccines and parenteral preparations is performed in a negative-pressure room fitted with a vertical-laminar-airflow hood for use with hazardous materials and a horizontal-laminar-airflow hood for nonhazardous work. A pass-through window connects to an adjacent room where materials are sterilized using an autoclave or dry-heat sterilizer. Space is set aside for PDS’s analytical and quality control staff, including five chemists, who test incoming and outgoing pharmaceuticals for purity, quality, compatibility, and stability. A decade ago, this group was responsible for identifying and publishing initial reports of an interaction between St. John’s wort and the antiretroviral drug indinavir. Even earlier, PDS staff contributed to the initial identification of azidothymidine, now known as zidovudine, as a therapy for HIV infection. Gallin said ongoing work at PDS involves helping NIH explore new uses for already-approved drugs. He noted that manufacturers often lack financial incentives to pursue new indications once their products are on the market. But he said NIH can pursue such studies without regard to profits. “There are many drugs out there that we believe can be used in new indications,” Gallin said. Gallin said his vision for PDS includes expanding its work to assist outside researchers, not just NIH clinicians. He said the new space brings PDS into the modern era and hopefully expands the group’s scope. “I don’t know of any other hospital in the country that has a facility like this,” Gallin said. Copyright © 2010 by the American Society of Health-System Pharmacists, Inc. All rights reserved.
TI - NIH modernizes its pharmaceutical development service
JF - American Journal of Health-System Pharmacy
DO - 10.2146/news100034
DA - 2010-05-01
UR - https://www.deepdyve.com/lp/oxford-university-press/nih-modernizes-its-pharmaceutical-development-service-BU0DD21Jjr
SP - 698
VL - 67
IS - 9
DP - DeepDyve
ER -