Latelines for Sept. 16, 2002
A health insurance plan in western Pennsylvania is the target of a suit by 16 independent pharmacies. The UPMC Health Plan/Best Health Care of Western Pennsylvania, a Medicaid HMO program, notified pharmacies that, due to a processing error in 2001 and early 2002, it must cut their prescription reimbursements to make up for its losses. The pharmacies want to stop UPMC from cutting their pay, since the health plan had admitted the pharmacies were not at fault yet are being told to bear the brunt of the costs. The pharmacies expect that 60 to 100 more pharmacies will join their suit. At a court proceeding early this month, UPMC agreed to a delay in implementing reimbursement cuts so the plaintiffs could present their case without fear of a major blow to their finances. UPMC also reassured plan members that they would not be affected by the suit.
The Bush Administration's latest Rx discount card plan, discussed in a final rule in the Sept. 4 Federal Register, will face a legal challenge courtesy of NCPA and NACDS. The two groups won a court injunction last March that stopped Bush's first discount card on the basis that the Administration lacked authority from Congress to set up such a Medicare-endorsement program. They are seeking to extend that original injunction to the new proposal. The plan calls for card sponsors to win rebates from drug companies for estimated savings of 10% to 13%.
The Bush Administration's final rule creating a discount Rx card program for seniors was applauded by the Pharmaceutical Care Management Association, which represents PBMs and mail-service pharmacy. While still studying the rule to determine what's required of card sponsors, PCMA believes the discount card program lays the groundwork for a Medicare drug benefit.
Pfizer, which already has a Sharing the Care program, which offers free drugs to the needy via clinics, and a prescription discount card program, has launched a third initiative called Connection to Care. Under this program, single people who make less than $16,000 annually and families with annual incomes of less than $25,000 who have no health insurance are eligible for free drugs from Pfizer for such diseases as diabetes, hypertension, and depression. The New York company said that its three programs make available more than 30 Pfizer drugs to more than 27 million Americans on a gratis or reduced-cost basis. For more information on Connection to Care, call (800) 707-8990.
The FDA announced that biologics, formerly reviewed and approved by the Center for Biologics Evaluation & Research (CBER) and the Center for Drug Evaluation & Research (CDER), would be consolidated under CDER. The agency hopes this consolidation will speed up the approval of biotech products. After the shift, CBER will handle only such categories as vaccines, blood safety, gene therapy, and tissue transplantation. The FDA expects to develop an implementation plan by January. The biotech industry said it is pleased with the FDA plan.
The Data Standard Maintenance Organizations rejected the 5.1 electronic telecommunications standard for billing R.Ph. services that was created by the National Council for Prescription Drug Programs. The turndown leaves X12N 837 as the standard for electronic billing for such professional services. The use of X12N, which is also the standard for physician professional services claims, was championed by NCPA.
Omnicare has extended its bid to acquire NCS Healthcare. Omnicare's offer of $3.50 per share of NCS Healthcare stock, which was scheduled to expire at midnight on Sept. 5, has been extended to midnight on Sept. 19.
Keith Saylor, a pharmacist who worked at Rite Aid in Barbourville, Ky., claims that the chain mishandled medicines and exposed prescriptions to extreme heat and cold during shipping. Earlier this year, the R.Ph. filed suit against Rite Aid, saying the company discriminated against him, denied him breaks, and retaliated against him because of certain health problems. Sarah Datz, a Rite Aid spokeswoman, told Drug Topics, "We ship our drugs according to all federal and state regulations. We have a refrigerated tote test in place in 20 stores in the Lexington area. This test is a part of our ongoing supply chain initiative, and we expect to roll that program out to other stores in mid-September. Regarding Saylor's employment claims, this lawsuit was filed by a disgruntled employee who had many personal issues with Rite Aid, and Mr. Saylor's claims regarding employment issues were dismissed by the judge."
Researchers are questioning the effectiveness of OTC nicotine replacement therapy (NRT) in increasing long-term success in smoking cessation, according to a recent study in JAMA. Using data from the California Tobacco Surveys, the researchers found that between 1992 and 1999, cessation attempts among California smokers increased by 61.4% and NRT use among quitters increased by 50.5%. Use of NRT increased short-term cessation success in moderate to heavy smokers in each survey year. However, a long-term cessation advantage was observed only before NRT became widely available OTC. In 1999, no advantage for pharmaceutical aid users was observed over either the short or long term for the nearly 60% of California smokers classified as light smokers.
A new study confirms that medication errors take place all too often in the nation's health facilities. The study used an observation technique to assess the drugs dispensed in 36 accredited and nonaccredited hospitals and nursing homes in Georgia and Colorado. It found that almost one out of five doses dispensed were wrong. The most frequent errors were wrong time (43%), omission (30%), wrong dose (17%), potential adverse drug events (7%), and unauthorized drug (4%). The study was conducted by Kenneth N. Barker, Ph.D., of Auburn University, and his colleagues, who verified the research findings of the trained observers. For more information on the study, see the Sept. 9 issue of The Archives of Internal Medicine.
Nursing homes accredited by JCAHO make significantly fewer medication errors than facilities that are not accredited. That's the conclusion of a new study completed by LTCQ Inc., an independent informa-tion services company. The study also found that accredited providers are associated with significantly fewer complaints, substantiated allegations, and high-level health-related deficiencies than their nonaccredited counterparts. These findings were reported by JCAHO.
Counseling patients for an average of 6.1 minutes and filling their prescriptions in less than 15 minutes are some reasons Medicine Shoppe was named the pharmacy with the highest-rated customer satisfaction scores in the country. Other companies that were honored were Brooks, among chains; Kroger, among supermarkets; and Target, among mass-merchandisers. These are some highlights of the just-released 2002 WilsonRx Pharmacy Satisfaction report, prepared by Wilson Health Information.
Satisfaction with its pharmacy benefit and wealth of options helped Kaiser Health Plan to preserve its status as the No. 1 insurance program in the country. This is the second year in a row Kaiser has maintained this exalted perch. The 2002 WilsonRx Survey, which measured perceptions of plan enrollees, also reveals which plans are rated best by region and by diseases. For more information, visit www.wilsonrx.com .
The European Society of Cardiology (ESC) recently issued updated guidelines for the treatment of unstable angina and non-Q-wave MI, collectively known as acute coronary syndrome (ACS). The guidelines now recommend at least nine months of clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi Pharmaceuticals) therapy in addition to standard therapy, including aspirin, to treat ACS patients with unstable angina or non-Q-wave MI. The ESC guidelines also recommend clopidogrel therapy for patients managed with drug therapy alone or for those who also undergo percutaneous coronary intervention. This past March, the American College of Cardiology and the American Heart Association also issued updated guidelines advocating the use of clopidogrel, in combination with aspirin, to treat persons with unstable angina or non-Q-wave MI.
Wyeth Pharmaceuticals announced that it has revised the package inserts for Prempro, Premphase, and Premarin to reflect recent safety information from the Women's Health Initiative (WHI) study. Physicians have been notified of the update by mail. In addition to the WHI findings, the revised labels also state that these products are not indicated for coronary heart disease prophylaxis, the use of these products should be limited to the shortest appropriate duration and should be periodically reevaluated, and alternative treatments should be considered when using these products for the prevention of postmenopausal osteoporosis.
Sales in U.S. retail pharmacies rose 14% and topped $140 billion during the June 2001-June 2002 period, according to IMS Health. Central nervous system drugs were the top sellers, accounting for $30 billion in sales fueled by a 16% increase. Cardiovascular drugs accounted for $26 billion in sales, up 14%. The biggest percentage sales spike was in blood agents, which grew by 32%.
AstraZeneca recently announced that the FDA has approved an sNDA for anastrozole (Arimidex) for the adjuvant treatment of hormone receptor-positive early breast cancer in postmenopausal women. The FDA based its approval on findings from the ATAC (Arimidex, Tamoxifen, Alone or in Combina- tion) studythe world's largest breast cancer treatment study. Anastrozole showed a statistically sig- nificant improvement in recurrence-free survival compared with tamoxifen (Nolvadex, AstraZeneca). It is the first and only drug to show an improvement over tamoxifen in this setting. The FDA approved the new indication for anastrozole through its accelerated-approval process. Anastrozole was originally approved in 1996 as the first nonsteroidal aromatase inhibitor for the treatment of hormone receptor-positive advanced breast cancer in postmenopausal women. The drug was approved in 2000 for first-line treatment of hormone receptor-positive advanced breast cancer in postmenopausal women.
The FDA has given the green light to Roche Diagnostics for its Accu-Chek Compact Blood Glucose Monitoring System for alternative site testing (AST). The system allows users to draw blood samples from their fingertips, palms, forearms, upper arms, thighs, or calves.
The American Academy of Pediatrics has come out with new recommendations on the treatment of head lice in time for the start of school. AAP recommends the use of Permethrin 1% since it has low toxicity and does not cause allergic reaction in patients with plant allergies. The product is a cream rinse applied to hair that is first shampooed with a nonconditioning shampoo, then towel-dried. AAP added that it does not think manual removal of nits after medication for killing lice is given is necessary to prevent spread of this health hazard.
Roche plans to notify physicians and other healthcare professionals that a small number of people have committed suicide after taking its antimalarial mefloquine (Lariam). Although Roche and the FDA maintain no association has been made between suicides and mefloquine therapy, in July Roche revised the label and the PI to acknowledge that "rare cases of suicidal ideation and suicide have been reported." These revisions will be publicized in the forthcoming "Dear Doctor" letter.
The newly elected president of the International Pharmaceutical Federation (FIP), Jean Parrot of France, proposed goals for his four-year term of office during a press conference at FIP's recent annual meeting in Nice, France. "We must make the voice of pharmacists heard .... The time has come for us to strongly assert our specific role, together with the other organizations which work in the interest of health, such as WHO and the representatives of other health professions," Parrot said. He noted that a positive working environment and ethical guidelines are necessary to help R.Ph.s perform their work confidently and serve their patients well. The challenges of e-commerce, pandemics in developing countries, and poor hygiene due to water supply were mentioned as challenges to good pharmaceutical care. FIP represents 80 organizations around the world.
Latelines. Drug Topics 2002;18:7.