Hot off the press for November 21, 2005

November 21, 2005

DEA proposes hike in fees Novartis recalls three products VA revises co-pay for outpatient drugs E-Rxing initiative requires pharmacy link Baxter to withdraw infusion pump Organon launches DTC campaign for NuvaRing FDA approves dosing change for cholesterol drug Consumer groups file lawsuit over dual eligibles ModernHEALTH acquires BioFusion Euflexxa launched for osteoarthritis knee pain Pharmacies must register to dispense isotretinoin FDA approves new indication for Merck's Invanz King reaches Medicaid settlement Unusual process used in denying OTC Plan B CDC: Provide materials when giving flu shots ASHP urges Medicare patients to choose carefully McKesson shuns secondary Rx sources Drug importation efforts lacking, says GAO California R.Ph.s honor Mayer

November 21, 2005

DEA proposes hike in fees
DEA is planning to raise its fees for registrants again. For pharmacies that dispense controlled substances, their annual fee is expected to rise from $130 to $191, a difference of $61. Likewise, narcotic treatment programs, as proposed by DEA, will see a hike from $130 to $191. Distributors of controlled substances, on the other hand, could see fees climb from $813 to $1,193, while manufacturers of controlled substances might see an even stiffer jump—by $761 to $2,386. DEA said it last adjusted the fee schedule for controlled substance handlers in October 2003. The new fee increases are designed to cover inflation and increases in program costs, the agency explained. This DEA notice was posted in the Nov. 16 Federal Register. Those wishing to comment should contact DEA by Jan. 17. Back to top

Novartis recalls three products
Novartis has recalled three products—two from its ophthalmic division, the other in nutrition. The two ophthalmic drugs, recalled for sterility problems, are GenTeal Gel and GenTeal GelDrops. Both are OTCs for relieving dry eye. Five lots of the GenTeal Gel are being recalled. They are Lot #Z12468, 10 ml, expiration date 01/2006; Lot #Z12912, 3.5 ml, expiration date 03/2006; Lot #Z12900, 10 ml, expiration date 04/2006; Lot #Z13161, 10 ml, expiration date 05/2006; and Lot #Z13314, 3.5 ml, expiration date 06/2006. Only two lots are recalled for the GenTeal GelDrops. They are Lot #51139, 15 ml, expiration date 07/2007; and Lot #51283, 25 ml, expiration date 07/2007. For more information, call 1-(866) 393-6336. The nutrition product being recalled is Diabetisource AC 1.5-Liter bottles in Lot 2135L. The enteral feeding formula contains sodium and calcium caseinate, which could trigger an allergic reaction in those who are sensitive to milk. For more information, call 1-(800) 333-3785. Back to top

VA revises co-pay for outpatient drugs
VA outpatient prescription co-pays will be going up by $1 as of Jan. 1, 2006. However, this increase applies only to veterans who haven't been seriously injured as a result of their service, the so-called Priority Groups 2 to 6. For these patients, the cap on their annual out-of-pocket expenses for VA medicine will also be changing—to $960 per year, up $120 from the previous level. For veterans who have suffered no injury related to their service—namely, Priority Groups 7 and 8—their co-pays will also increase, but there is no cap on their annual payments for outpatient medicine. Finally, for veterans who have been seriously hurt during their service—Priority Group 1—there will be no change whatsoever in their drug benefit. VA added that not all Rx drugs would be subject to the $1 co-pay increase. Exceptions include medications to treat Agent Orange and service-connected disabilities. The $1 co-pay increase is the first in four years for the VA. Back to top

E-Rxing initiative requires pharmacy link
Health insurer Highmark has donated $26.5 million to foster e-prescribing among Pennsylvania physicians. The Pittsburgh Foundation will use the funds for an e-prescribing initiative that will be the first in the nation to require the capability for two-way electronic communication between the physician and the pharmacy. Back to top

Baxter to withdraw infusion pump
Baxter Healthcare has sent a field corrective action letter to customers announcing that it plans to voluntarily withdraw its 6060 Multi-Therapy Infusion Pump from the marketplace over the next 12 months. During this time, Baxter will continue to manufacture and sell disposable sets and support customers with service maintenance as they transition to alternate pumps. Baxter's letter informed customers of potential issues when the 6060 infusion pump is used to deliver pain management medications in the patient-controlled analgesia (PCA) profile, as well as in administering critical medications. While the probability of occurrence of these issues is remote, Baxter is warning against the use of the pump in the PCA profile. In addition, the company has recommended that an alternative device be used when an interruption of critical therapy could cause immediate harm. Back to top

Organon launches DTC campaign for NuvaRing
Organon USA announced the launch of the first nationwide direct-to-consumer (DTC) ad campaign for the contraceptive NuvaRing (etonogestrel/ethinyl estradiol vaginal ring). The campaign was developed to educate consumers on the benefits and risks of NuvaRing, a low-dose contraceptive option. The campaign consists of 60-second TV commercials, which are running nationwide on primetime daytime and cable programming, complemented by targeted print placements and electronic medium. The campaign is slated to run into 2006. Back to top

FDA approves dosing change for cholesterol drug
The FDA has approved a supplemental New Drug Application for a new dosing regimen and label change for Antara (fenofibrate) 43-mg and 130-mg capsules, according to Reliant Pharmaceuticals. Patients can now take the 130-mg capsules with or without food, based on clinical data demonstrating efficacy on all lipid parameters whether the drug was taken with or between meals. Back to top

Consumer groups file lawsuit over dual eligibles
Eight consumer groups have filed a federal lawsuit alleging that HHS has failed to include adequate safeguards to ensure that beneficiaries eligible for Medicare and Medicaid will not lose Rx coverage on Jan. 1. Fearing some beneficiaries will die, the suit seeks a system guaranteeing that dual eligibles retain Medicaid coverage until they are enrolled in a Medicare Part D plan that meets their medication needs. Back to top

ModernHEALTH acquires BioFusion
ModernHEALTH, Monrovia, Calif., has acquired BioFusion, a specialty home infusion pharmacy located in Torrance, Calif. BioFusion provides high-tech infusion services to chronic patients in need of IVIG therapy in their home. ModernHEALTH provides specialized pharmacy services to facilities, residents, and individuals. Back to top

Euflexxa launched for osteoarthritis knee pain
Ferring Pharmaceuticals has launched Euflexxa (highly purified hyaluronan) for the treatment of pain caused by knee osteoarthritis. It is the first and only non-avian-derived hyaluronic acid indicated for a three-injection treatment regimen for patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics. Back to top

Pharmacies must register to dispense isotretinoin
The FDA's iPLEDGE risk management program requires pharmacies to register to dispense isotretinoin products. Prescribers, patients, and wholesalers must also register. Beginning Dec. 30, pharmacies that don't sign up will not be able to order Accutane, Amnesteem, Claravis, or Sotret and will have to return all unused products to the manufacturer. After a pharmacy registers for the program, the responsible site pharmacist must complete the process to activate the pharmacy as a dispensing site. Pharmacies can register by going to www.gao.gov/cgi-bin/getrpt?GAO-06-109. Back to top

CDC: Provide materials when giving flu shots
CDC has issued a notice regarding finalized influenza vaccine materials. Beginning no later than Jan. 1, 2006, each healthcare provider who administers any trivalent influenza vaccine to any children or adults in the United States shall provide copies of vaccine information materials prior to immunization to them. The materials include "Inactivated Influenza Vaccine: What You Need to Know" and "Live, Intranasal Influenza Vaccine: What You Need to Know." CDC has also revised the "Instructions for the Use of Vaccine Information Statements." This CDC notice was published in the Nov. 10 Federal Register. For more information, call (404) 639-8200. Back to top

ASHP urges Medicare patients to choose carefully
Medicare beneficiaries mulling over Part D should consider whether Rx plans cover medication therapy management (MTM) services provided by pharmacists, according to ASHP. Plans with R.Ph.-provided MTM services can help enrollees avoid drug interactions and adverse reactions from multiple medications, ASHP advised. Back to top

McKesson shuns secondary Rx sources
McKesson Corp. has decided to purchase drugs only from the manufacturer or the manufacturer's designated sole distributor. The top three wholesalers—McKesson, AmerisourceBergen, and Cardinal—which account for 90% of medicines distributed in the United States, have now all taken steps to cut off purchases through secondary sources. The secondary market creates an opening for the introduction of counterfeit products into the Rx supply chain. Back to top

Drug importation efforts lacking, says GAO
Federal efforts to stem illegal drug importation are not effective, according to a GAO report. Reliable data about how many drug packages are shipped into the United States annually are lacking, and the information gap prevents regulators from targeting prevention efforts. The report noted that the FDA is hampered by a law mandating that when a drug package is intercepted, the addressee must be given a chance to prove that it can be brought into the country. Back to top

California R.Ph.s honor Mayer
The California Pharmacists Association has bestowed its Hall of Fame Award on Frederick S. Mayer, R.Ph., for his long history of service and achievement in health care and his advocacy for pharmacy and the role of pharmacists in public health. Mayer, who is president of the nonprofit Pharmacist Planning Service Inc., is a longtime member of the Drug Topics Editorial Board. During the past 125 years, CPhA has given only 11 Hall of Fame Awards. Back to top