National MS Society invests $7 million in research for nerve-repair treatments
NEW YORK — The National Multiple Sclerosis Society is putting $7 million toward research into ways to speed repair of the nervous system in patients with MS, the organization said Friday.
The society said the money would support 15 new research projects focusing on innovative approaches to repairing the coating of myelin that protects nerve fibers; the coating is destroyed in patients with MS, leading to nerve damage, and finding ways to restore and protect it is a key research priority for the group. The new investments, in commercial and academic research, total $37.8 million.
"The idea of rebuilding the nervous system and protecting it from ongoing MS damage was just a dream a few years ago," National MS Society chief research officer Timothy Coetzee said. "Now, because of efforts by the research community as well as focused investments by the society, we can see a future where people with MS will have treatments that could restore what’s been lost."
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NASP plans new specialty pharmacy practice parameters
ALEXANDRIA, Va. — A professional organization for specialty pharmacy plans to develop pharmacy practice parameters in about 20 therapeutic categories focused on disease management.
The National Association of Specialty Pharmacy said Thursday that each disease category has specific requirements allowing for appropriate intake, clinical management, fulfillment and outcomes, and this spectrum of responsible care, based on peer-reviewed and accepted standards, leads to better patient outcomes and appropriate evidence for manufacturers, payers and providers. The group said it expected the healthcare community to incorporate the parameters into patient registries that will be utilized across the country, allowing access to product and payment information as the industry evolves.
"Our goal as an organization is to establish practice parameters that encompass clinical guidelines, existing standards and measures, benefit design, as well as management and information technology to measure adherence and outcomes," NASP CEO Gary Cohen said. "We will collaborate with other stakeholders to utilize existing and emerging guidelines and adapt them to the specific needs of the specialty pharmacy community. Specialty pharmacists are playing a more integral role in the collaborative care model and will be a key driver of successful patient outcomes. It is important that we develop practice parameters through consensus panels with key opinion leaders and subject matter experts."
NASP said it would incorporate information from such organizations as URAQ and the Pharmacy Quality Alliance. The group will also engage various audiences — such as specialty pharmacists, drug makers, specialty pharmacy executives, payers, reimbursement consultants, disease-specific organizations and patient advocacy groups — to complete the project, parameters of which will include information technology, adherence and outcomes metrics.
Reports: Bill to extend federal regulations for compounding pharmacies expected to pass House, Senate
NEW YORK — Legislation to allow the Food and Drug Administration to strengthen its regulatory powers over compounding pharmacies is expected to pass both houses of Congress after committees agreed on it Thursday, according to published reports.
Reuters reported that House and Senate committees had agreed on a bill: the Drug Quality and Security Act. The bill was proposed in response to last year’s outbreak of fungal meningitis, traced to the Framingham, Mass.-based New England Compounding Center. Dozens of people died, and hundreds more were sickened as a result of the outbreak, linked to contaminated injectable steroids used to treat chronic pain. Subsequent inspections of the NECC found widespread contamination in the laboratory and disregard for sanitation.
The kind of compounding done at the NECC, known as sterile compounding, differs from traditional compounding. While the latter involves pharmacists mixing medications from simple ingredients under instructions from physicians — for example, topical creams and mouthwashes — sterile compounding involves the mixture of injected drugs and must be done under strict adherence to sterilization protocols.
The law would distinguish the two types of compounding and focus on pharmacies that engage in sterile compounding and ship their drugs across state lines, while pharmacies that do traditional compounding would continue to be regulated by state boards of pharmacy, according to Reuters.
Another bill in the Senate — the Pharmaceutical Quality, Safety and Accountability Act — would require pharmacies that prepare sterile drugs, prepare them in advance of receiving a prescription or dispense them across state lines to register as "compounding manufacturers." But some pharmacists have criticized that bill. A poll by compounding supplies manufacturer PCCA found that more than 40% of compounding pharmacies would be forced to change current business practices in order to remain as "traditional" compounding pharmacies.