Can New Technology Help End Drug Shortages?

3D printing is improving many fields, from architecture to automobiles. What could it do for pharmacy?

Experts at the ASHP Midyear Clinical Meeting & Exhibition's Spotlight on Science answered that very question, painting an exhilarating picture of how 3D pharmaceutical printing and other forms of point-of-care manufacturing could alleviate drug shortages, accelerate personalized medicine, and solve other challenges that have long faced the pharmacy profession.

“Where this technology is headed can be so empowering for our profession,” John J. Lewin, III, chief medical officer of On Demand Pharmaceuticals in Rockville, Maryland, said in the Dec. 11 session.

Lewin recalled giving a presentation on the early stages of this technology at the 2015 Midyear meeting, also held in New Orleans. At the time, he was working at Johns Hopkins Hospital in Baltimore, where his physician colleagues wondered: Why can’t we just make some of these drugs ourselves?

Today, On Demand Pharmaceuticals has developed a packaging system that automatically mixes the right ingredients in the right order to produce sterile medications — similar to a coffee K-Cup, Lewin said — at the point of care. The company also has intelligence tools to identify which medications are best suited for on-demand manufacturing, based on the availability of raw materials and other factors, as well as a quality assurance system that leverages object character recognition and machine learning at the point of care.

Lewin and his co-presenters hope point-of-care drug manufacturing will improve healthcare for military operations across the globe, and even one day help astronauts in space access the medications they need, when they need it.

However, health systems can and should be at the forefront of adopting the technology — because they, as the ones taking care of patients, have the most to gain.

In a six-month pilot program conducted earlier this year, On Demand Pharmaceuticals supported North Mississippi Medical Center (NMMC) in producing about 12,000 doses of compounded sterile products from active pharmaceutical ingredients.

The prefilled syringes contained medications on the Food and Drug Administration’s drug shortage list at the time of compounding, including bupivacaine, lidocaine, and rocuronium. The drugs were compounded onsite under the direct supervision of a pharmacist at NMMC’s main hospital in Tupelo and met state, USP Chapter <797>, and Section 503A standards for quality and safety.

“We really feel excited about the work that we've done there because we were able to implement a really robust quality and regulatory compliance system,” said NMMC Director of Pharmacy Services Wes C. Pitts. “It can be done.”

Anna Worsley elaborated on how FABRX, a biotech company in the United Kingdom, is leveraging 3D pharmaceutical printing to deliver personalized medicine. Automated compounding can be safer for pharmacists and patients, helping to produce right-sized tablets, capsules, and blister packs. The process is also more environmentally friendly than standard manufacturing due to reduced waste and less need to transport products long distances.

Overall, 3D pharmaceutical printing is 10% faster than traditional compounding and yields cost savings of 20% to 40% per capsule, Worsley said. The technology is available for implementation under current U.S. compounding regulations.

In one clinical study at a hospital in Spain, FABRX’s 3D pharmaceutical printing produced chewable tablets in a variety of colors and flavors more palatable to children with maple syrup urine disease, a rare metabolic disorder. Another clinical study in progress at the Gustave Roussy Institute in Paris is testing the combination of tamoxifen with medication to overcome that drug’s side effects, to improve treatment adherence in patients with breast cancer.

Agile, streamlined pharmaceutical manufacturing and distribution models are effective because they disrupt the ecosystem where drug shortages have persisted for more than 20 years, said Lewin. Food and Drug Administration efforts are underway to enable such pharmaceutical models in the United States.

“[Point-of-care manufacturing] is laying the groundwork for a new future where medicine production is in the hands of the healthcare provider,” Lewin said. “When the supply chain fails, we can produce for ourselves.”