Hot off the press for September 5, 2005

September 5, 2005

• Hurricane displaces pharmacy students
• Wholesalers are meeting customer needs in New Orleans
• New Orleans hospitals forced to evacuate
• Most want DTC advertising banned for Rx drugs
• Albuminar recalled
• Indictments handed down on counterfeit Lipitor
• Tech firms partner for electronic health record
• Cholestyramine for oral suspension gets FDA nod
• FDA MedWatch issues warning for Trypan
• FDA recalls Medline alcohol-free mouthwash, hygiene kits

Hurricane displaces pharmacy students
Pharmacy students at the University of Louisiana College of Pharmacy facility in downtown New Orleans will have to finish their semester at another location. "We have 40% of the class rotating through New Orleans," said Michael B. Cockerham, M.S., Pharm.D., assistant dean. Cockerham said the New Orleans site would be shut down due to damage from Hurricane Katrina and students would have to finish out the semester at satellite campuses around the state and at the main campus in Monroe. The challenge is to get courses lined up and faculty resituated so students can still graduate in the spring, he said. "The faculty will take on an extra load," he added. Fortunately, all of the pharmacy students were evacuated before the storm hit and no students or faculty were injured; however, some faculty members lost their homes. The semester had already begun when the hurricane hit the Gulf Coast last week. Back to top

Wholesalers are meeting customer needs in New Orleans
Against all odds, drug wholesalers are meeting the needs of customers in the New Orleans area in the aftermath of Hurricane Katrina. In the case of Cardinal Health, four facilities took direct hits, but, according to spokeswoman Angela Gardner, "no service was interrupted." Gardner added that two nuclear pharmacies, a medical products and services distribution facility, and one pharmaceutical distribution facility were impacted. Working with backup generators, the pharmaceutical distribution facility that supplies medications to retail and hospital pharmacies was able to serve customers with help from other Cardinal facilities in the region, she said. Cardinal received orders for two-month supplies of medications from its New Orleans hospital customers. She described the situation as dire, citing communication problems and retail pharmacies in the city being under water.

James Larkin, a spokesman for McKesson, said that the San Francisco-based wholesaler is helping local relief agencies in the New Orleans area by providing helicopter deliveries of emergency supplies, including pharmaceuticals, to hospitals and triage centers. The company is also offering free 24-hour nurse hotline information in Louisiana and Mississippi. Back to top

New Orleans hospitals forced to evacuate
Most of the hospitals in downtown New Orleans have either evacuated or are making plans to close their doors and send patients to other facilities. Tenet Healthcare evacuated three of its five facilities in New Orleans. HCA (Hospital Corporation of America) evacuated two hospitals in New Orleans and one in Gulfport, Miss. Charity Hospital and Tulane University Hospital airlifted patients to Texas Children's Hospital in Houston. Only Ochsner Hospital (8 ft. above sea level) is fully operational. While most hospitals in the region ordered extra supplies and medication prior to the storm, five days after the storm, they were starting to run out of provisions, including fuel for generators. The Georgia Pharmacy Association, through its disaster relief volunteer system, is gearing up to address medication needs of patients from the New Orleans area who are expected to arrive at shelters throughout the state. Back to top

Most want DTC advertising banned for Rx drugs
Should manufacturers wait for at least a year after they launch a drug before advertising it to consumers? Drug Topics posed this question as an Instant Poll on its Web site in August and received the following responses:

• 22% said Yes, that's a good idea
• 3% said one year is not enough, it should be two or more years
• 7% said No, manufacturers should be able to advertise it right away, as they do nowothe majority (58%) said direct-to-consumer advertising should be banned for prescription drugs.

A total of 321 people responded to our survey. Back to top

Albuminar recalled
ZLB Behring issued a U.S. recall of two lots of Albuminar, its 25% albumin product. The affected lots are C934009 and C934110. The recall was initiated after the firm discovered a defect in the stopper of a vial in Japan that was from the same batch as the stoppers distributed in the United States. The defect could allow the vial to break. Back to top

Indictments handed down on counterfeit Lipitor
The FDA and the U.S. Attorney for the western district of Missouri in Kansas City have announced the indictments of a drug repackager, two wholesalers, and 11 individuals involved in the sale of counterfeit Lipitor. The charges include conspiracy to sell counterfeit, stolen, illegally imported, and misbranded drugs. The conspiracy charges also involve the manufacture of counterfeit Lipitor at a facility in Central America, the purchase of genuine Lipitor intended for distribution in South America, and the illegal importation into the United States of both products. According to the indictment, Kansas City-based drug wholesaler Albers Medical Distributors distributed more than $20 million in illegally imported and counterfeit Lipitor that was sold to H.D. Smith Wholesaler Drug Co. Smith distributed the Lipitor tablets throughout the United States. The counterfeit Lipitor was repackaged by Med-Pro, a drug repackager in Lexington, Neb. All three participants in this scheme were named in the indictment, and it is believed that these counterfeit Lipitor products are out of circulation. The indictment alleges that members of the conspiracy distributed pharmaceuticals stolen from GlaxoSmithKline and Roche Pharmaceuticals and counterfeited drugs. Back to top

Tech firms partner for electronic health record
Sun Microsystems and InstantDx have partnered to provide a physician-based electronic health record that supports sharing of clinical data and electronic prescribing across the healthcare industry. NACDS president-CEO Craig Fuller applauded the electronic partnership for giving the doctor and pharmacist real-time access to patient information. Back to top

Cholestyramine for oral suspension gets FDA nod
The FDA has approved Par Pharmaceutical's cholestyramine for oral suspension, 4 gm resin/9 gm powder, and cholestyramine for oral suspension (light), 4 gm resin/5 gm powder. Cholestyramine is the generic version of Bristol-Myers Squibb's Questran Powder and Questran Light Powder for oral suspension and is used for the treatment of primary hypercholesterolemia. Cholestyramine for oral suspension (regular and light) will be available in multiple-dose containers providing 4 gm resin/scoopful and single-use packets containing 4 gm resin/packet. Back to top

FDA MedWatch issues warning for Trypan
The FDA and Custom Rx Compounding Pharmacy has notified ophthalmologists, consumers, and other healthcare professionals nationwide about a recall of Trypan Blue 0.06% Ophthalmic Solution, intended for use in the eyes during cataract surgery. According to the FDA, the solution may be contaminated with P. aeruginosa, a strain of bacteria that, if applied to the eyes, might lead to serious injury, including possible blindness. Custom Rx Pharmacy is asking that all unexpired syringes be collected and returned to the pharmacy. The product was distributed to hospitals and clinics in the District of Columbia, Illinois, Maryland, Michigan, Minnesota, Nebraska, North Dakota, and Pennsylvania. The recall includes, but may not be limited to, the following lot numbers: 05042005:86@17, 05252005:36@13, 06282005:91@27, 08012005:63@24, and 08182005:43@17. The FDA and Custom Rx Compounding Pharmacy has notified ophthalmologists, consumers, and other healthcare professionals nationwide about a recall of Trypan Blue 0.06% Ophthalmic Solution, intended for use in the eyes during cataract surgery. According to the FDA, the solution may be contaminated with P. aeruginosa, a strain of bacteria that, if applied to the eyes, might lead to serious injury, including possible blindness. Custom Rx Pharmacy is asking that all unexpired syringes be collected and returned to the pharmacy. The product was distributed to hospitals and clinics in the District of Columbia, Illinois, Maryland, Michigan, Minnesota, Nebraska, North Dakota, and Pennsylvania. The recall includes, but may not be limited to, the following lot numbers: 05042005:86@17, 05252005:36@13, 06282005:91@27, 08012005:63@24, and 08182005:43@17. Back to top

FDA recalls Medline alcohol-free mouthwash, hygiene kits
The FDA is notifying the public of a nationwide voluntary recall of alcohol-free mouthwash and hygiene kits containing mouthwash distributed by Medline Industries, Mundelein, Ill., because of the potential contamination with Burkholderia cepacia. Consumers and healthcare providers who have Medline brand alcohol-free mouthwash should stop using the product immediately and check to see whether it is being recalled. Recalled products can be identified by the lot code stamped on the bottom of the bottle. Product lot numbers beginning 0503 through 0508 are affected. Additionally, affected product can be identified by checking for the identification code RA05CRR on the lower portion of the back display panel on the product label. The recall includes the following products: Alcohol-free Mouthwash, Medline Label, 2 oz., Reorder number: MDS095029; and Alcohol-free Mouthwash, Medline Label, 4 oz., MDS095030. The Medline-labeled mouthwash packaged in 2- and 4-oz bottles was recently recalled by the manufacturer, Carrington Laboratories Inc., Irving, Texas. The mouthwash may also be found in certain Medline Personal Hygiene Hospital Admission Kits. Back to top