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NABP e-News: October 14, 2009
Legislation Extending CMS DMEPOS Deadline Passed by House and Senate
Recent legislation that passed through the House and Senate will extend the Centers for Medicare and Medicaid Services (CMS) durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) accreditation deadline for pharmacies to January 1, 2010. Pharmacies awarded DMEPOS accreditation are authorized to bill Medicare Part B for qualifying products and services. CMS reports that the majority of Medicare DMEPOS suppliers, many of which are pharmacies, have met the original deadlines to apply and become accredited, ensuring uninterrupted service to Medicare patients. The deadline extension would provide additional pharmacies the opportunity to secure accreditation by 2010 and provide qualifying DMEPOS products and services to Medicare patients.
Potential Signals of Serious Risks/New Safety Information from AERS Updates
US Food and Drug Administration (FDA) has updated its Web page reporting potential signals of serious risks and new safety information identified from the Adverse Event Reporting System between January and March 2009. For the drugs included, FDA has identified a potential safety issue, not a causal relationship, between the drug and the reported risk. FDA emphasizes that the report should not be used to advise patients to stop taking the medications listed.
FDA Releases Strategic Plan for Delivering Communications to the Public
FDA released a Strategic Plan for Risk Communication that initiates its long term effort to provide to consumers, patients, and health care professionals more effective communications about the products it regulates. The plan outlines 70 actions FDA will take over the next five years, 14 of which the agency plans to implement within the next year. The actions are aimed to strengthen FDA’s risk communications by focusing on three key areas – science, capacity, and policy. The plan takes into account the various audiences FDA must target and the evolving technologies it can use to reach them. For additional information, see the FDA News Release.
FDA Issues Draft Guidance on Risk Evaluation and Mitigation Strategies
A “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications,” the first draft guidance for industry on REMS, was released for comment by FDA on September 30, 2009. REMS requirements must be met for certain drugs and biologics to ensure that benefits outweigh risks in accordance with the FDA Amendments Act of 2007. The REMS draft guidance document includes information about current format and content guides, potential required elements, REMS policies, Web site references, and FDA contacts, as well as an example REMS for a fictitious product. Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.
New USP Standards for Heparin Products May Require Dosage Adjustments
According to an FDA alert, heparin products using new standards began shipping on October 8, 2009, and may require that dosages are adjusted to achieve consistent potency. New manufacturing controls issued by the United States Pharmacopeia were adopted for heparin to guard against potential contamination. Included in the new controls were changes in the unit dose, making heparin about 10% less potent than the former unit used.
Three Additional Facilities Awarded VAWD Accreditation
NABP recently accredited three additional facilities through its Verified-Accredited Wholesale Distributors® (VAWD®) program, bringing the total number of accredited facilities to 372 as of October 8, 2009. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site.
- Kaiser Foundation Hospitals received accreditation for facilities located in Oakland, CA and Downey, CA. The two facilities ship products to Kaiser pharmacies, hospitals and health care facilities, and to an affiliated wholesale distributor in Washington.
- Merit Healthcare International Inc, dba Merit Pharmaceutical, specializes in filling and shipping orders for ascorbic acid. The facility is located in Los Angeles, CA.
