ProStrakan Group plc, an international pharmaceutical company based in the UK, has announced that it has chosen RelayHealth Pharmacy Solutions as its connectivity partner and McKesson Specialty Care Solutions to administer its U.S. Food and Drug Administration (FDA)-approved Abstral Risk Evaluation and Mitigation Strategy (REMS) program.
Abstral® is a rapidly disintegrating sublingual tablet formulation of fentanyl citrate indicated for the management of breakthrough pain in cancer patients 18 years and older who are already receiving, and are already tolerant to, opioid analgesics for their underlying persistent cancer pain.
Through RelayHealth's innovative approach to leveraging its network, coupled with the extensive REMS experience of McKesson Specialty Care Solutions, the Abstral REMS program is the first technology-advanced REMS solution of its kind. The Abstral REMS program enables retail pharmacy participation in REMS programs without disrupting workflows.
"RelayHealth's innovative connectivity technologies in pharmacies and McKesson Specialty Care Solutions' deep REMS experience is an excellent fit for our Abstral REMS program," said Abid Karim, President of Global Commercial Operations, ProStrakan.
The FDA requires pharmaceutical manufacturers to ensure that the benefits of a marketed drug or biological product outweigh the risks to consumers. For some classes of drugs, the FDA has stipulated the institution of a REMS program to help minimize a patient's chance of experiencing adverse effects while undergoing therapy.
McKesson Specialty Care Solutions is a pioneering partner to pharmaceutical manufacturers in the development and execution of complex REMS programs, many of which require intense monitoring and controlled distribution to specialty pharmacies. This requirement makes it more difficult for patients to obtain prescriptions than from their neighborhood retail pharmacy. By leveraging RelayHealth's pharmacy network, ProStrakan is able to make Abstral available for dispensing through retail pharmacy locations.
U.S. retail pharmacy prescription claims - including Medicare Part D claims - are processed over the RelayHealth Pharmacy Solutions network. The Abstral REMS program uses real-time, electronic dispensing "triggers" via the network to verify enrollment of the prescriber and pharmacy, and support patient enrollment and verification. RelayHealth connectivity also helps prompt the pharmacist to provide a Medication Guide and counseling to enable safer use during the prescription's drug life cycle. Because prescription claims are auto-adjudicated in real time before being dispensed to patients, RelayHealth can embed business rules to identify whether all safe-use conditions and requirements of the program have been met without disrupting the pharmacist's workflow.
"ProStrakan's desire to expand Abstral's availability to patients within their communities is laudable," said Jeff Felton, president, RelayHealth Pharmacy Solutions. "The Abstral REMS program will make it possible for a patient prescribed the drug as an important part of cancer pain therapy to have their prescription filled at a local retail pharmacy that is enrolled in the Abstral REMS program. We are pleased to collaborate with ProStrakan in helping identify and monitor medication compliance and assisting individuals manage their pain and treatment progress more safely and effectively."
The ProStrakan Abstral REMS program is further supported by McKesson Specialty Care Solutions, which manages some of the industry's most rigorous REMS programs mandated by the FDA to-date. Its integrated REMS support solutions include strategic consultation, design and implementation, FDA submission assistance, registries, clinical data collection and risk monitoring, extensive program reporting, and managed distribution. With the aid of RelayHealth's expansive pharmacy network reach, McKesson enables pharmaceutical manufacturers to create REMS programs that enhance their relationships with retail pharmacies, expand patient access to important drug therapies, and attain a higher level of patient safety and outcomes.
ProStrakan Group plc is a rapidly growing specialty pharmaceutical company engaged in the development and commercialization of prescription medicines for the treatment of unmet therapeutic needs in major markets. ProStrakan's head office is located in Galashiels in Scotland. The company’s development capabilities are centered in Galashiels and Bedminster, New Jersey, USA. Sales and marketing of ProStrakan's portfolio of products are handled by commercial subsidiaries in the UK, US, France, Germany, Spain, Italy and other EU countries.
www.prostrakan.com
McKesson Specialty Care Solutions, a division of McKesson Corporation, is one of the largest distributors of specialty pharmaceuticals, biologics and rheumatology drugs to community-based specialty practices. Its leading Onmark GPO, competitive contract pricing and industry-leading technology, complemented by clinical data and tools, help specialty practices understand and manage their costs, strengthen their financial performance and focus on what they do best - delivering high-quality patient care. McKesson Specialty Care Solutions is the sole distributor of vaccines across the country for the CDC's Vaccines for Children Program, and a leader in the development, implementation and management of FDA-mandated Risk Evaluation and Mitigation Strategies (REMS) for manufacturers. For more information, visit www.mckesson.com/specialty.
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