Latelines for Aug. 19, 2002
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DEA has published a final rule regarding the registration and reregistration fees charged to those who manufacture, distribute, and dispense controlled substances. Despite objections from several groups, including the AMA, NCPA, NWDA, and others, to the way DEA determined these fees, first proposed in 1993, the agency declared that the fee schedule would remain the same as previously announced. For dispensers and practitioners, it's $70 annually; for distributors, $438; and for manufacturers, $875. The final rule was published in the Aug. 9 Federal Register.
A national poll of more than 1,000 consumers found that more than 80% prefer an electronic prescribing system that allows physicians to send Rxs directly to community pharmacies rather than go through an HMO or insurer. The survey was sponsored by SureScript Systems, conducted by Harris Interactive, and released at the NACDS Pharmacy Conference in San Diego this month.
Technology vendor ProxyMed has signed an agreement with Rite Aid to boost physician-pharmacy electronic connectivity. Under the agreement, physicians who use ProxyMed's ProxyNet healthcare transaction-processing network can have access to Rite Aid's 3,500 pharmacies to exchange electronic prescription messages. ProxyMed claims this deal reinforces ProxyNet's position as the nation's "largest production e-prescribing network." Both ProxyMed and Rite Aid will market the connectivity service to doctors in markets where the chain is dominant.
HHS has released a prepublication draft of its final rules on the Health Insurance Portability & Accountability Act, governing patient privacy, marketing practices, and other areas. Most pharmacy groups are pleased with the final regulations, which have dropped a requirement for pharmacists to obtain prior patient consent before health information for treatment could be disclosed, thus averting a delay in the delivery of services. Differences remain, however, between the federal rule and state laws. Another concern: Some view the marketing provisions as being too liberal.
FDA has proposed a rule regarding the labeling of aluminum in small-volume parenterals (SVPs) and pharmacy bulk packages (PBPs) used in total parenteral nutrition. If the SVPs and PBPs contain 25 mcg per liter or less of aluminum, the immediate container label may state the product "contains no more than 25 g/L of aluminum" instead of stating the exact amount of the substance it contains. FDA said this proposal is a revision of an earlier one, published on Jan. 26, 2000, requiring the product's maximum level of aluminum to be stated on the label. The agency said it took this action in response to a request from industry. Comments to this Aug. 12 Federal Register proposal should be submitted to FDA by Oct. 28.
Independent pharmacists are upset over Geneva Pharmaceuticals' decision to limit the distribution of its generic Augmentin (amoxicillin/clavulanate potassium) to chain warehouses that order directly from the manufacturer. The Novartis affiliate said it came to this decision because it has a limited supply of the antibiotic. A Geneva spokeswoman told Drug Topics that a court decision to invalidate GlaxoSmithKline's patents on Augmentin happened so quickly that it resulted in an earlier than expected product launch for the generic firmhence the inadequate supply. To appease its customers, Geneva is working with its Austrian supplier, Biochemie, to boost production of the anti-infective. Two other manufacturers, TEVA and Ranbaxy, have plans to launch their own generic Augmentin, but neither is on the market yet. APhA has denounced Geneva's limited distribution. The association asked: If some health plans mandate the use of generics but pharmacies are unable to get the generic Augmentin, are they expected to absorb the price difference?
CMS plans to issue a national coverage determination for intravenous levocarnitine (Carnitor Injection, Sigma Tau Pharmaceuticals) in those who are undergoing dialysis for end-stage renal disease (ESRD). When finalized, the determination will reimburse two groups of ESRD patients: those on dialysis for a minimum of three months who have signs and symptoms of erythropoietin-resistant anemia and those with recurring hypotension on hemodialysis that is unresponsive to the usual course of treatment. Coverage will be discontinued if no improvement is shown within six months of initiation of therapy.
SureScript Systems has named Kevin Hutchinson CEO of the electronic prescribing venture formed last August by NCPA and NACDS. Prior to joining SureScript, Hutchinson was COO of MedicaLogic/ Medscape. His 20-year career includes positions with IBM and Oracle Corp. He also served as v.p. of business operations for VHA Inc., helping to create an information technology practice to assist member hospitals in selecting and using emerging technology.
Following NCS HealthCare's acceptance of a merger offer from Genesis Health Ventures and refusal to consider a competing bid from Omnicare, Omnicare has contacted NCS' board of directors to purchase all of the long-term care pharmacy chain's outstanding shares of Class A and Class B common stock for $3.50 per share. According to Omnicare, the offer "represents a significant premium for NCS stockholders." Omnicare is now, under the Hart-Scott-Rodino Act, filing a notification with the FTC and the Department of Justice that would permit it to acquire all outstanding NCS Class A and Class B common stock. NCS is the fourth-largest institutional pharmacy provider in the United States.
The American Pharmaceutical Association and the University of Tennessee's Health Science Center have launched the APhA Immunization Drug Information Service. The service provides pharmacists with access to up-to-date evidence-based vaccine and immunization-related information. The Web site can be accessed at www.aphanet.org. Pharmacists should select the pharmaceutical care icon, the immunization information link, and then the information central link.
Abbott Laboratories has been ordered by the FDA to improve its reporting of adverse events related to its drugs. According to a warning letter from the agency, Abbott did not report "serious and unexpected" adverse events associated with several drugs, including sibutramine (Meridia) and ritonavir (Norvir). The letter, citing reporting processes and not product safety, said that the company failed to meet FDA's 15-day deadline for reporting adverse events 18 times between Jan. 1, 2000, and Oct. 31, 2001. In many cases, poor internal communication was responsible for the missed deadlines. FDA also found that some report information submitted by Abbott was inaccurate and inconsistent with company records.
ChainDrugStore.net, the on-line communications network for the retail pharmacy industry, is expanding its product-related marketing and merchandising network to reach independent pharmacies and individual chain stores. ChainDrugStore.net offers information on the following: new product launches, pricing updates, indication changes, recall/safety information, updates regarding supply conditions, and compliance and persistence programs. According to ChainDrugStore.net, there are no fees for independents or retail chains. The site is supported by subscription fees paid by the suppliers on the site who create and deliver content.
Marina Marketos. Latelines. Drug Topics 2002;16:5.