PHARMACY

NASP plans new specialty pharmacy practice parameters

BY Alaric DeArment

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.

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Reports: Bill to extend federal regulations for compounding pharmacies expected to pass House, Senate

BY Alaric DeArment

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. 

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Bill could force many compounding pharmacies to give up practice, survey finds

BY Alaric DeArment

HOUSTON — A bill under consideration by the Senate could force more than 40% of compounding pharmacies to abandon compounding, according to a new survey.

PCCA, a company that supplies ingredients, equipment, education and training to independent compounding pharmacies, announced the results of a survey of nearly 800 pharmacists regarding S. 959, the Pharmaceutical Quality, Security and Accountability Act. Slightly more than 41% of respondents also said that the bill would force them to change current business practices in order to remain as a "traditional" compounding pharmacy; about 29% either would not have to change or didn’t know if they would.

S. 959 requires pharmacies engaging in three common practices regulated under state law to register as "compounding manufacturers." Pharmacies included under the bill include those that prepare sterile preparations for human use, prepare them in advance of receiving a legal prescription order or dispense them outside the state in which they’re located.

PCCA said that the bill, despite being proposed to improve the safety of compounded drugs, would force many pharmacies to make choices that it said would decrease the safety of compounded medications and reduce patients’ access to compounded drugs.

The bill was proposed by Sen. Tom Harkin, D-Iowa, in response to last year’s contamination scandal centered on the New England Compounding Center, which resulted in a nationwide outbreak of fungal meningitis that sickened hundreds and killed dozens. The outbreak led to calls for stricter regulations of compounding pharmacies, particularly those that engage in sterile compounding of injected drugs. Sterile compounding differs from non-sterile compounding in that the latter typically involves the making of suppositories, ointments and other simple preparations by a pharmacist for a single patient under orders from a physician. Sterile compounding typically involves specialty drugs.

"The sponsors of S. 959 claim that this legislation will not affect community pharmacies," PCCA president Jim Smith said. "In fact, 41% of the respondents to this survey meet the bill’s criteria for ‘manufacturing.’ The survey showed that pharmacies would be either forced to give up their pharmacy business or make painful changes to their business that would greatly reduce access to compounded preparations."

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