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NABP e-News: March 20, 2008
NABP Convenes Stakeholder Teleconference to Set Internet Pharmacy Standards
NABP convened a teleconference on March 12, 2008, to solicit stakeholder input on the establishment of minimum operating standards for Internet pharmacies. NABP is developing these standards to readily and reliably distinguish legitimate Internet pharmacies from Web sites offering prescription medications illegally. Once final, the criteria will serve as the backbone of the Association’s Internet Drug Distributor Identification program. This initiative, currently in development, is intended to assist the states in their efforts to establish and maintain controls over the Web-based distribution of prescription medications and to hold Internet drug distributors accountable for meeting patient safety standards. Teleconference participants included representatives of state boards of pharmacy, retail pharmacy, pharmacy associations, pharmacy manufacturers, Food and Drug Administration, and Drug Enforcement Administration.
'60 Minutes' Expose Highlights Medical Errors; Quaid Recounts Heparin Overdose in Newborn Twins
In a March 16, 2008 episode of the CBS news program "60 Minutes," actor Dennis Quaid recounted the heparin overdose that nearly killed his newborn twins four months ago. At that time, a nurse at Cedars-Sinai Medical Center in Los Angeles, CA, inadvertently gave the babies an adult dose of heparin, equal to approximately 1,000 times the pediatric Hep-Lock dose prescribed to keep IV lines open. The infants recovered, but Quaid has taken up the cause of reducing hospital errors, and he is suing Baxter Healthcare Corporation, the manufacturer of the drug. He also is establishing a foundation to fund efforts to reduce medical errors.
Heparin Contamination Linked to 19 Deaths, Hundreds of Allergic Reactions in United States
Following reports linking heparin to 19 deaths and hundreds of severe allergic reactions in the United States, Food and Drug Administration (FDA) announced that all heparin products being imported into the United States would be stopped and tested for a possibly dangerous contaminant. FDA inspectors in China found the contaminant in 20 of the 28 lots of the drug’s active ingredient inside a plant that supplied it to much of the American market. Drug manufacturer Baxter Healthcare Corporation has recalled all of its multi-dose and single-use vials of heparin sodium for injection and its heparin lock flush solutions. Alternate heparin manufacturers are expected to be able to increase heparin production sufficiently to supply the US market. More information is available on the FDA Web site at www.fda.gov/cder/drug/infopage/heparin/default.htm.
FDA Takes Next Step to Establish Offices in China
Food and Drug Administration (FDA) has received approval from the US State Department to establish eight full-time permanent FDA positions at US diplomatic posts in the People's Republic of China, pending authorization from the Chinese government. FDA plans to hire and place FDA staff in China over the next 18 months. In addition, FDA plans to hire five local Chinese nationals to work with the new FDA staff at the US Embassy in Beijing and the US Consulates General in Shanghai and Guangzhou. The permanent offices in China will also allow greater access for inspections and greater interactions with manufacturers to help ensure that products shipped to the United States meet US standards for safety and manufacturing quality. More information on the Memoranda of Agreement signed in December 2007 between the US and the People's Republic of China is available at www.hhs.gov/news/press/2007pres/12/pr20071211a.html.
West Virginia Legislature Approves Bill to Let Pharmacists Administer Immunizations
On March 11, 2008, the governor of West Virginia received a bill from the state legislature that would allow pharmacists to immunize adult patients against influenza, pneumonia, hepatitis A and B, tetanus and herpes zoster. The bill would require pharmacists to complete a course approved by the West Virginia Board of Pharmacy based on standards established by the Center for Disease Control and Prevention, and maintain basic life-support certification approved by the American Red Cross or American Health Association. Should the governor sign this bill into law, West Virginia would become the 48th state to allow pharmacists to immunize patients.
FDA Issues Draft Guidance on Labeling for Hypertension Drugs
FDA has announced the availability of a draft guidance for industry entitled "Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims." This draft guidance is intended to assist applicants in developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension. Because blood pressure control is well established as beneficial in preventing serious cardiovascular events, FDA maintains that the appropriate use of these drugs can be encouraged by making the connection between lower blood pressure and improved cardiovascular outcomes more explicit in labeling. FDA is accepting comments on the draft guidance by May 12, 2008. More information is available in the Federal Register (Docket No. FDA-2008-D-0150) at www.fda.gov/OHRMS/DOCKETS/98fr/E8-5083.htm.
FDA Alerts Public to Adverse Events Associated with Tussionex Pennkinetic
FDA announced that it has received numerous reports of adverse events, including death, associated with the misuse and inappropriate use of Tussionex Pennkinetic extended-release suspension. These reports reveal that physicians and other health professionals are sometimes prescribing, and patients are sometimes taking, more than the recommended dose or taking the medication more frequently than every 12 hours. The reports also show that Tussionex is sometimes prescribed or given to children less than 6 years old, for whom this medication is not approved. More information is available on the FDA Web site.
NABP Awards VIPPS Accreditation to Prime Therapeutics LLC
NABP recently accredited Prime Therapeutics LLC through its Verified Internet Pharmacy Practice Sites™ (VIPPS®) program. To be VIPPS-accredited, a pharmacy must comply with the licensing and inspection requirements of its state and of each state to which it dispenses medications. In addition, it must meet VIPPS criteria, which address such issues as the patient’s right to privacy, authentication and security of prescription orders, adherence to a recognized quality assurance policy, and provision of meaningful consultation between patients and pharmacists. Based in Eagan, MN, Prime Therapeutics provides pharmacy benefit services to approximately 12.5 million individuals nationwide. Its client base includes Blue Cross and Blue Shield plans, employer and union groups, and third-party administrators. Prime Therapeutics fills approximately 12,000 prescriptions daily. A complete list of VIPPS-accredited pharmacies is available under Accreditation on the NABP Web site.
Three Additional Facilities Awarded VAWD Accreditation
NABP recently accredited three new facilities through its Verified-Accredited Wholesale Distributors® (VAWD®) program, bringing the total number of accredited facilities to 254 as of March 14, 2008. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site.
- Bellco Drug Corporation (BDC) distributes over 20,000 branded, generic, and biotech pharmaceuticals, vaccines, and health and beauty care products. In business since 1955, BDC distributes to independent and chain retail pharmacies, government agencies, and institutional pharmacy markets. The company received accreditation for its Amityville, NY facility.
- Bound Tree Medical, LLC, supplies emergency medical products including prescription and Schedule II and IV controlled substances, as well as general merchandise, to emergency medical service agencies in 13 western states, Alaska, and Hawaii. The company received accreditation for its Visalia, CA facility.
- Medical General Corporation, dba MCG Supplies Inc, specializes in the sale of disposable medical products such as bandages and syringes to physicians’ offices in Indiana, Illinois, and Kentucky. Lidocaine 2cc vials are the only prescription product the business handles. The company received accreditation for its Evansville, IN facility.
