Bill could force many compounding pharmacies to give up practice, survey finds
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."
Teva launches generic version of Astellas’ Adenoscan
JERUSALEM — Teva Pharmaceutical Industries has become the first to launch a generic drug for treating certain heart patients, the company said.
Teva announced the launch of adenosine injection, a generic version of Astellas Pharma’s Adenoscan. The drug is used in combination with thallium-201 in patients undergoing myocardial perfusion scintigraphy who are unable to exercise adequately.
Adenoscan had sales of $65 million during the 12-month period ended in June, according to IMS Health. As the first company to file for approval of the generic, Teva has 180 days in which to market the generic exclusively, according to Food and Drug Administration regulations.
Cancer organizations see big uptick in health insurance marketplace usage by decade’s end
WASHINGTON — Next year, 7 million people will be using health insurance marketplaces, and that figure will nearly quadruple in five years, according to a coalition of cancer-focused organizations.
Patient Services Inc., which includes 18 partnering cancer and patient advocacy organizations, announced Wednesday the launch of the Cancer Insurance Checklist, designed to help people with cancer, a history of the disease or those at risk of getting it, choose insurance plans in the state-based health insurance marketplaces, which will open on Oct. 1.
According to PSI, by the end of the decade, 27 million people will be in health insurance marketplaces, and PSI said the checklist would empower thousands of people whose lives have been influenced by cancer amid the implementation of the Patient Protection and Affordable Care Act. The checklist guides consumers to review the coverage within each insurance plan they are considering, including coverage for services provided by their healthcare team, where care is delivered, medications and various common cancer treatments and services they may need.
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