Latelines for March 5, 2001
The Bush Administration is reopening for public comment final medical record privacy regulations that several pharmacy groups said would cause unnecessary dispensing delays. The rules, issued by HHS in December, were scheduled to take full effect in 2003. AMCP, APhA, ASCP, and NACDS were among dozens of health-care groups maintaining that many of the protections were complicated, burdensome, and would interfere with patient care. HHS secretary Tommy Thompson announced the regulatory delay along with one for another last-minute Clinton Administration rule designed to protect the rights of Medicaid patients in managed care plans.
Problems linked to prescription drugs resulted in 218,000 U.S. patient deaths and cost the economy $177 billion in 2000, according to an update of a 1995 study on drug-related morbidity and mortality in ambulatory settings. That initial research, by J. Lyle Bootman, Ph.D., and Jeffrey A. Johnson, Ph.D., of the University of Arizona pharmacy school, estimated the number of patient deaths at 198,000 and the economic impact at $76.7 billion. Researchers from the same school, Frank R. Ernst, Pharm.D., and Amy J. Grizzle, Pharm.D., did the new study. The most significant Rx problems they identified were untreated indication, improper drug selection, subtherapeutic dosage, failure to receive drugs, overdosage, adverse drug reactions, and drug use without indication. Hospital and long-term care admissions accounted for 87% of the costs. The study is being published in the March/ April Journal of the American Pharmaceutical Association.
AstraZeneca has been granted FDA approval to market a new proton pump inhibitor (PPI). Nexium (esomeprazole magnesium), is cleared for the treatment of heartburn and other symptoms associated with GERD and for the healing and maintenance of healing of erosive esophagitis. It is also indicated in combination with amoxicillin and clarithromycin for eradication of H. pylori in patients with duodenal ulcer. Esomeprazole is the first agent to be developed as an optical isomer and is the mirror image of AstraZeneca's other PPI, omeprazole (Prilosec).
Pharmacies, health plans, and others will have to pay transaction fees if they are to use a new system, called RxHub, that three pharmacy benefit managers are establishing. Designed to provide physicians with a standardized link with PBMs, health plans, and pharmacies so they can prescribe electronically, RxHub is a joint effort of AdvancePCS, Express Scripts, and Merck-Medco. The three PBMs explain that RxHub will provide physicians with clinical and health plan information, so they can prescribe appropriate drugs that are on the formulary. This will save pharmacists' time by reducing the need for many calls between pharmacies and physicians and reduce drug errors by eliminating handwritten Rxs. In return for these benefits, RxHub will charge pharmacies and others a transaction fee of 25 cents to $1 per Rx.
The Advisory Committee on Immunization Practices has issued new guidelines for the use of the influenza vaccine for the 2001-2002 flu season. High-risk patients have now been broken down into three groups: people who are 65 years or older or people younger than 65 who have a high-risk condition; the newly formed second group, 50- to 64-year-olds who have a high prevalence of chronic medical conditions; and health-care workers and household members who have contact with high-risk people. Other changes included vaccine coverage levels categorized by race and ethnicity, and a reference to the use of oseltamivir (Tamiflu) for prophylaxis against the flu in persons 13 years or older.
The FDA has approved Novartis' rapid-onset, long-lasting bronchodilator, Foradil Aerolizer 12-mcg (formoterol fumarate inhalation powder), for the maintenance treatment of asthma and prevention of reversible obstructive airways disease. It is also indicated for the acute prevention of exercise-induced bronchospasm in adults and children 12 years of age and older. Foradil capsules are delivered, twice daily, via a new device called the Aerolizer Inhaler, which allows patients to "see, hear, and feel" that they have correctly taken their medication.
New Jersey authorities are seeking to revoke the license of a Paterson pharmacist involved in a fatal chemotherapy drug error (Drug Topics, Jan. 1). The victim, Ximena Clavijo, was prescribed 190 mg of lomustine to be taken over a period of six weeks for her brain cancer, but the Rx label indicated the dose was to be taken every day. After her death, her family sued the R.Ph. and the pharmacy. The Clavijo case is the first time the state has sought to revoke an R.Ph.'s license for an Rx error.
NCPA and NACDS are planning joint sponsorship of a symposium on unit-of-use. The meeting is slated to be held this spring in Washington, D.C., Drug Topics learned at the NCPA/CDMA Rx Expo 2001 meeting held recently in Las Vegas. Calvin Anthony, CEO of NCPA, said that a study on unit-of-use has been prepared by David Brushwood of the University of Florida and is being conducted through the Institute for the Advancement of Community Pharmacy. "We'll have someone from the manufacturing and wholesale side as well as practitioners. It's a fact-finding mission pertaining to unit-of-use. We're investigating how it pertains to safety and workforce benefits. European countries use unit-of-use, and it has worked for them. That's not to say it's a solution to all issues, but it's worthy of discussion and review. We've talked to pharmaceutical companies. They are open to looking at it," he said.
AmeriSource Health Corp. has launched a series of collaborative initiatives with NCPA on behalf of community pharmacists. The partnership was announced at NCPA/CDMA Expo 2001. As part of the alliance, AmeriSource, a distributor of pharmaceuticals and related health-care solutions, will use its sales representatives and its database of independent community pharmacists to actively promote membership in NCPA. AmeriSource and NCPA have also agreed to collaborate on several clinical education initiatives. Calvin Anthony, CEO of NCPA, told conference attendees, "We hope to have similar arrangements with other wholesalers."
NCPA's Special Committee on Innovation & Technology held its inaugural meeting at NCPA/CDMA Rx Expo 2001 in Las Vegas. NCPA fifth v.p. Bruce Roberts, Pharm.D., is chairman of the committee. Roberts is owner of Leesburg pharmacy, Leesburg, Va. Commenting on the committee's task, Calvin Anthony, NCPA CEO, said that "the committee will give recommendations on central fill, e-prescribing, robotics, and a whole slate of things."
The National Home Infusion Association (NHIA) elected a new president at its 10th annual conference held in conjunction with the NCPA/CDMA Expo 2001 meeting. The new president is Kenneth R. Speidel, Pharm.D., director of pharmacy services, clinical pharmacology/ infusion therapy at Ritzman Infusion Services, Akron, Ohio, who will serve a one-year term. He succeeds Tony Powers, Pharm.D., president, Medical Alternatives, Memphis.
B. Braun Medical has received FDA approval for cefuroxime and dextrose in the company's Duplex container, a drug delivery system designed for drugs with limited stability after mixing. The drug has the same indications as GlaxoSmithKline's cephalosporin antibiotic Zinacef (cefuroxime for injection), including treatment of infections of the lower respiratory tract, urinary tract, skin and soft tissue, bone, and joint, along with sepsis, gonorrhea, and meningitis. It will be available in a 750-mg or 1.5-gm strength in a 50-ml dextrose injection.
Twenty-seven people received prescribed controlled substances to end their lives under Oregon's physician-assisted suicide law last year, according to the state Health Division. This was the same number as in 1999. Their median age was 69, and 21 had end-stage cancer. All had health insurance, and 23 were in hospice care before their deaths. The Bush Administration is expected to reverse the Clinton Administration's policy that permitted Oregon M.D.s to prescribe controlled substances under the provisions of the state's assisted-suicide law. A court battle is likely.
Amgen is warning health-care providers to check Epogen (epoetin alfa) and Neupogen (filgrastim) for possible product tampering. The company disclosed Feb. 13 that the contents had been removed from eight vials of different lots of the products and replaced with an aqueous solution. "The vials were resealed in an apparent effort to conceal product theft," the company said. The replacement solution, which was found to be nontoxic, was not used because a crusty white material or particulate matter was observed in the solution. The lots involved were P000839 and P000841 (Epogen) and P000928 and P000698 (Neupogen).
NACDS has joined an international effort to place an RFID tag (a computer chip that can emit a radio frequency) inside every consumer goods package. The chip will uniquely identify each product, including Rxs, throughout the distribution process. The chain drug group is supporting the plan being advanced through the Massachusetts Institute of Technology's Auto-ID Center. One potential benefit is that distributors and retailers will be able to instantly determine who made the product, when, and where.
The FDA is seeking public comment on what promotional claims dietary supplement companies should be allowed to make on the effects of their products. The agency won't allow the firms to say their supplements can cure a disease, but treatment of symptoms is permissible. The 90-day comment period opened Feb. 22.
Rx makers spent $1.9 billion on direct-to-consumer ads in the first nine months of last yearas much as they did in all of 1999the pharmaceutical consulting firm Scott-Levin reported. The five most advertised Rxs to consumers were Vioxx (rofecoxib, Merck), Prilosec (omeprazole, AstraZeneca), Claritin (loratadine, Schering-Plough), Paxil (paroxetine, GlaxoSmithKline), and Viagra (sildenafil, Pfizer).
Get used to the shortage of adult tetanus vaccine. Manufacturer Aventis Pasteur said it's expected to last for about a year. What set off this shortage was the decision of another manufacturer, Wyeth Lederle, to stop making the vaccine, which takes up to 11 months to produce. The shortage has prompted Aventis to restrict sales of the premium product. Hospitals can buy up to 100 doses, and clinics 50, per week under Aventis' rationing plan. CDC has recommended that people traveling to developing countries where tetanus and pertussis are widespread should be the first to get the vaccine. Next in line are wound victims who need the drug to protect themselves against tetanus infection.
The Texas attorney general has upheld the state pharmacy board's decision that all narrow therapeutic index Rxs may be switched with a generic. Provisions of a law that required the pharmacy board in consultation with the medical examiners board to develop a list of Rxs that could not be substituted was met, Attorney General John Cornyn ruled. In their professional judgment, the boards concluded there were no such Rxs, he said.
Aventis Behring has chosen Priority Healthcare and Caremark as the preferred providers to its AB Choice program, designed to improve the quality of life of hemophilia patients. These two specialty pharmacy providers were selected because they met Aventis' rigorous criteria, such as the ability to provide 24-hour support, help patients track their reimbursement status, and provide other ancillary services. Patients who take part in the AB Choice program can still use other pharmacies, though, for their blood plasma products, and these products need not be limited to Aventis' line.
APhA is taking over the Glaxo Wellcome Pathway Evaluation Program for Pharmacy Professionals, an interactive program designed to help students with career decisions and specialty selections. Glaxo's merger with SmithKline Beecham triggered a review that decided the program needed an administrative home more closely linked to the profession, said Margaret Dardess, v.p. for communications at GlaxoSmithKline.
ConsumerLab.com has found that only 14 of 27 products evaluated in its Multivitamin and Multimineral Product Review achieved full "CL Approved Quality" status. Problems found among products included less than the claimed amounts of ingredients, inadequate ability to disintegrate, and ingredient levels exceeding new Tolerable Upper Intake Levels (ULs). Levels above the UL can be toxic. Other findings are available at www.consumerlab.com.
The FDA has approved AstraZeneca's orally disintegrating version of its migraine drug for adults, Zomig (zolmitriptan). The new treatment option, which will be known as Zomig-ZMT 2.5 mg, is an orange-flavored tablet, which disperses in seconds on the tongue, with saliva triggering a mild effervescent reaction. The drug is quickly released in the mouth and swallowed easily without the need for water.
NCPA's disease management arm, the National Institute for Pharmacist Care Outcomes (NIPCO), has partnered with Amgen to train community pharmacists in the use of biotech drugs to manage rheumatoid arthritis. The 15-hour certificate program will be offered in print, live, and on-line formats.
OraPharma's Arestin (minocycline HCl microspheres) has been approved by the FDA and will soon be available in dentists' offices. Arestin is indicated for the adjunctive treatment of adult periodontitis following scaling and root planing. It uses patented microsphere technology to deliver the antibiotic minocycline beneath the gums and does not require mixing or refrigeration, allowing dentists to optimize patient chair time.
Marina Marketos. Latelines. Drug Topics 2001;5:9.