Latelines for Aug. 5, 2002
The U.S. Court of Appeals for the Sixth Circuit in Cincinnati has overruled a federal judge's decision in the case of Deborah Mowery. An R.Ph. who worked at the chain for 12 years, Mowery brought a suit against Rite Aid in September 1999, alleging that she was paid less than comparable male employees. Mowery appealed a federal judge's ruling that said she didn't have a case. The Appellate Court has ruled in favor of hearing the case.
As of Jan. 1, 2003, foreign-educated R.Ph.s must have earned their degrees from five-year programs in order to apply for certification by NABP's Foreign Graduate Examination Committee. The change applies to foreign-educated candidates who earn a pharmacy degree after the 2003 deadline. About 40% of foreign pharmacy programs currently offer a five-year curriculum. Foreign grads must be certified before they can be licensed to practice in the United States.
The Senate has approved a proposal (S. 2244) that would let pharmacists, wholesalers, and individuals reimport drugs from Canada. However, prospects of actual implementation are iffy. The catch is an amendment, introduced by Sens. Thad Cochran (R, Miss.) and John Breaux (D, La.), giving the HHS secretary the authority to stop reimportation if he thinks it poses a threat to public safety. With the FDA on record as opposing the move on grounds that Canada could be a conduit for counterfeit drugs, experts believe the outlook for the proposal is uncertain.
Abbott Laboratories' Synthroid (levothyroxine sodium tablets, USP) has finally received FDA approval, after being on the market for almost half a century. The FDA required the manufacturer to file an NDA for the thyroid disease treatment after it had been on the market for years. The same process is now under way for digoxin elixir and digoxin tablets. Manufacturers of the tablets had until July 26 to comply with the demand for an NDA or ANDA or face the possibility of regulatory action, while digoxin elixir was given more timeuntil June 28, 2004. Digoxin elixir won a two-year reprieve, since there are no such approved products on the market, whereas approved digoxin tablets are available from GlaxoSmithKline (Lanoxin) and Bertek/Amide (Digitek).
CMS has announced it intends to expand Medicare coverage of neuromuscular electrical stimulation (NMES) to assist patients who have spinal cord injuries in walking. According to a CMS spokesman, "If a patient goes to physical therapy for three months" and can demonstrate that he or she will benefit from continued use at home, "CMS will cover NMES as durable medical equipment." Medicare will create a new code for this coverage, which is expected to become effective within six to seven months.
The Institute of Medicine has chosen six dietary supplements to study as part of a new evaluation program it has developed for the FDA. The six supplements, which may pose health hazards, will serve to test the framework for determining the safety of supplements. The supplements selected are chaparral, chromium picolinate, glucosamine, melatonin, saw palmetto, and shark cartilage. The final version of the report is expected to go to the FDA in the fall.
Tegaserod (Zelnorm, Novartis) has received FDA approval, making it the first prescription medication approved for the short-term treatment of women with irritable bowel syndrome whose primary bowel symptom is constipation. Tegaserod is the first of the serotonin-4 receptor agonists (5-HT4 agonist), a new class of drugs developed to target the GI tract. In clinical studies, adverse effects that occurred more often with tegaserod compared with placebo were headache and diarrhea.
Washington R.Ph.s have threatened to stop taking Medicaid Rxs if the state goes through with reimbursement cuts set to take effect Aug. 1. The state legislature lowered payments for brands by 3% and for generics by 44% in an effort to shave $22 million off the drug budget. Officials said if pharmacies drop out of Medicaid, they will give beneficiaries transportation to other pharmacies or tell them to use mail order.
Eli Lilly & Co. reached a settlement with several states over charges related to revealing the e-mail addresses of about 670 Prozac patients in a message sent to users of its prozac.com e-mail alert service. The drug company, which attributed the goof to a programming error, agreed to beef up its standards relating to privacy protection, training, and monitoring and pay the states $160,000 to settle the case.
While the VA and the Department of Defense have taken steps individually and jointly to reduce their drug expenditures, they could wring even more discounts by pooling their purchase of brand-name drugs. However, to do this effectively, the two groups need to address differences in their respective patient populations, national formularies, and prescribing/dispensing practices. VA patients, mostly seniors, visit VA providers, but DOD beneficiaries, younger and more demographically diverse, use both military and private physicians and pharmacies. So testified Cynthia Bascetta, director of health care-veterans' health and benefits issues, before the House Subcommittee on National Security, Veterans Affairs, and International Relations last month.
Virginia's new prescription drug monitoring program (PDMP) will cover only the southwestern part of the state, track Schedule II controlled substances, and be implemented if funding is available. These are some provisions of Senate Bill 425 just signed by the governor. Separately, the American Alliance of Cancer Pain Initiatives just released a statement expressing concern that PDMPs could constrain doctors from prescribing narcotics for pain management. AACPI believes that no new PDMPs should be established until existing information sources have been fully utilized.
Three of the nation's leading medical error prevention experts have criticized a report by the Agency for Healthcare Research and Quality. Lucian Leape, M.D., and Donald Berwick, M.D., of Harvard University's School of Public Health, and David Bates, M.D., of Harvard Medical School, said that the government-commissioned report on the reduction of medical errors ignores commonsense low-tech methods, such as the use of checklists, counting surgical sponges, and having a pharmacist on call in hospitals at all times. In a related development, beginning in January 2003, the more than 17,000 JCAHO-accredited healthcare organizations will be evaluated for compliance with recommendations or implementation of patient safety goals. JCAHO said that confusion in identifying patients, medication mix-ups, improving the safety of infusion pumps, and improving the safety of high-alert medications will be among the focus of its 2003 National Patient Safety Goals.
Some Missouri state officials and advocacy groups for the elderly say large generic drugmakers are not participating in the state's prescription drug program. This could lead to higher drug costs for seniors. AARP claimed that some drug manufacturers have refused to participate in the Missouri SenioRx Program because it requires them to pay a 15% rebate. While 1,400 pharmacies and 100 drug manufacturers take part in the program, AARP said major generic drug companiesGeneva Pharmaceuticals of New Jersey, Pittsburgh-based Mylan Laboratories, and TEVA Pharmaceuticals USAhave refused to offer their products.
Eighty percent of patients entering a hospital have concerns about medications, according to an ASHP survey of 1,004 adults. The chief worries were drug interactions (70%), medication mix-ups (69%), potential side effects (67%), and drug cost (67%). Eighty-three percent of those polled were interested in having a pharmacist work closely with them and their doctor to monitor their medications, and 93% of that group would support adding such R.Ph. services as a new Medicare benefit.
Abbott Laboratories has pledged to affix unit-of-use bar codes to all its injectable drugs and IV solutions by early next year as part of an industry-led initiative to help reduce Rx errors. Currently, 45% of Abbott's 1,000 injectable drugs and IV solutions are bar-coded. About 25% of the products will use Reduced Space Symbology, the technology that can bar-code items as small as a pen cap.
The Massachusetts Pharmacists Association called for the governor to veto a cut in Medicaid's Rx reimbursement and a new tax on non-Medicaid prescriptions. The state expects to save $60 million by cutting reimbursement and another $36 million from the tax. In response to the proposal, Walgreens has threatened to take its 90 drugstores out of Medicaid. The threat underscores the association's warning that patients may be denied access and pharmacies may close because the new tax would have to be paid by pharmacies and the uninsured.
Sens. Diane Feinstein (D, Calif.) and Tim Hutchinson (R, Ark.) are planning to introduce legislation called the CLEAN-UP Meth Act. Section 305 of the bill would eliminate the fed-eral "safe harbor" for OTCs that contain pseudoephedrine (PSE), thereby subjecting those products to a 9-gm retail sales threshold for DEA registration, record-keeping, and reporting. Under current law, a retailer is exempt from DEA registration if it sells OTC drug products containing PSE in blister packs containing less than 3 gm of the base ingredient.
Researchers at the Albert Einstein College of Medicine, Bronx, N.Y., surveyed 100 local pharmacies to determine whether they carried asthma equipment and would accept Medicaid as payment. Slightly more than half of the pharmacies surveyed carried a nebulizer machine, 40% carried peak flow (PF) meters, and only 24% carried child-size PF meters. Pharmacies also reported having misconceptions about Medicaid reimbursement for asthma equipment, such as believing special documentation was required or that the equipment was not covered by Medicaid.
Phar-Mor Corp., which filed for bankruptcy protection in September, has selected a winning bidder to purchase the insolvent company's assets. Phar-Mor's remaining 73 stores will be closed as part of the roughly $141 million sale to a group that includes the Pittsburgh-based Giant Eagle supermarket chain. The winning bid came from a joint venture of Giant Eagle, CVS Corp., and investment firms Ozer Group of Boston and Hilco Merchant Resources of Chicago. Giant Eagle and CVS will take over the prescription lists at the remaining stores and hire up to 80 Phar-Mor pharmacists. Giant Eagle will also give preferential hiring status to hundreds of Phar-Mor's employees. The investment firms will liquidate Phar-Mor's inventory.
Rasburicase (Elitek) has been approved for the initial management of plasma uric acid levels in pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. Marketed by Sanofi-Synthelabo, the drug rapidly converts uric acid into allantoin, which is excreted by the kidneys. It is expected to become available in August.
DEA is temporarily placing several drugs under Controlled Substances Schedule I. The products include 2,5-Dimethoxy-4-(n)-propylthiophenethyla-mine (2C-T-7), benzylpiperazine (BZP), and trifluoromethylphenyl piperazine (TFMPP). DEA explained that the three products have often been abused and have no approved therapeutic value. DEA plans to issue a final order shortly.
Pharmacists at 47 Pathmark stores in New York City and four suburban counties are expected to approve a new contract, thereby averting a strike. Laurie Vallone, v.p. of the pharmacy division at 1199/SEIU, the union representing the R.Ph.s, told Drug Topics, "The members are very satisfied. We got the necessary contributions to maintain our benefits. Over four years pharmacists will get a 17% increase, and techs and warehouse workers will get a 16% increase. In the last year of the contract, we have a job security fund which provides that no member can be laid off during the life of the contract." Commenting on the contract agreement, Pathmark spokesman Rich Savner said, "We believe there was a fair resolution to the main issues, which were wages and benefits."
Latelines. Drug Topics 2002;15:9.