The ongoing imbroglio over New England Compounding Center and the outbreak of spinal meningitis from contaminated dosages from that now-defunct company calls into question a host of activities around the pharmacy practice of compounding drug products. In most cases, the compounded product is tailored to individual patients; but even so, there are situations that call for compounded products to be produced in volume, especially for large hospital systems handling many patients at a given time. Clinics that don’t operate large-scale internal pharmacy operations, out of necessity, outsource the compounding to others in these cases. But the NECC scandal is opening up that decision to review.
“We’ve had directors of pharmacy calling us lately, saying ‘Our exposure is too great to these risks; I don’t want to be the pharmacy director who decided not to do automation,’” says Bill Shields, global VP of marketing for Intelligent Hospital Systems (IHS; Winnipeg, MB). The company has marketed a machine, called RIVA, since 2008, and although it recently counted its millionth dosage produced, is in use in only 27 locations worldwide. IHS has just announced a partnership with a software developer, Cato Software Solutions (Vienna, Austria; US HQ in New York) that has developed a chemotherapy and hazardous-drug medication management solution, Chemocato; this software will be integrated with RIVA IV, the company’s latest offering, to automate production of those compounded products.
Potentially, automation systems like RIVA could replace a significant portion of the compounding business outsourced to pharmacies with an in-house system under a hospital’s direct control. The expense of the automation machine could be offset by the volume of dosages it handles—but therein lies the rub. As the NECC scandal shows, high-volume compounding puts pharmacies in the purview of FDA as a drug manufacturer. Hospitals could go that route, says Shields, but it’s also possible that if a facility using the automation system only distributes within the state in which it is located, it could avoid FDA oversight. Moreover, a RIVA production run can handle both a variety of dosages of single drugs, or multiple drugs without cross-contamination, he says.
In either case, IHS says that it has the leading technology in this field, being the only fully automated system, with a contained, laminar airflow workspace, and automated labeling and barcoding. It can produce both syringes and IV bags. The company recently received a top rating from KLAS, a healthcare-automation evaluation service. Shields adds that the company is having conversations with several major pharma companies, who might decide to supply bulk shipments of certain compounds to hospitals employing such automation systems.