Latelines for April 15, 2002
The high courts in Illinois and Massachusetts ruled within days of each other that R.Ph.s have a duty to warn patients. In the Illinois case, Happel v. Wal-Mart Stores Inc., the plaintiff, who is allergic to NSAIDs, alleges that the pharmacy failed to warn of a foreseeable allergic reaction to ketorolac. The case was sent back to a lower court for hearing. In Cottam v. CVS Pharmacy, the Massachusetts Supreme Court ruled that if a pharmacy provides patients information on side effects, then it has a duty to "provide complete warnings and information" about all possible side effects.
Aventis Pharmaceuticals has informed healthcare professionals that its antithrombolytic drug enoxaparin (Lovenox) is not recommended for those with prosthetic heart valves because of thrombosis risk. Appropriate changes to product labeling have been made. These labeling changes also describe congenital anomalies in fetuses associated with maternal enoxaparin use and nonteratogenic effects of enoxaparin on pregnant women and fetuses. Reported congenital anomalies include cerebral and limb anomalies, and nonteratogenic effects include fetal death and maternal hemorrhaging.
Ortho-McNeil Pharmaceuticals is advising women taking norethindrone (ORTHO MICRONOR) that the Detailed Patient Labeling for the drug is incorrect. The instructions incorrectly state that "if you miss any of pills 22 through 28, you will still be protected." Women taking progestin-only oral contraceptives should take one pill q.d., without breaks, for maximum efficacy, according to the company. Women who miss a pill should take the missed dose as soon as possible (a backup method of birth control should be used in the next 48 hours) and continue to take one pill q.d. Those who miss more than one pill should use a backup method of birth control and contact a physician or nurse immediately. Shipments of ORTHO MICRONOR have been suspended until the patient labeling has been revised and can be shipped with the product.
California has ordered health plans to cover emergency contraception (EC). Prodded by Gov. Gray Davis, who is up for reelection, the state Department of Managed Health Care reminded managed care groups that they must cover all forms of FDA-approved contraception in drug benefit plans. Pharmacists may dispense EC to walk-in patients under protocol with a physician, but only about 700 of the state's 15,000 R.Ph.s have completed training to qualify for EC prescriptive authority. If a woman cannot find a plan-approved pharmacy to dispense EC, the plan must cover dispensing by a non-network provider.
Kathleen Jaeger has been named president and CEO of GPhA. A pharmacist and an attorney, Jaeger has extensive legal experience with food and drug law and has been a longtime consumer and industry advocate. She has testified before state legislative and regulatory bodies on issues affecting the industry. Jaeger, who took the helm at GPhA on April 15, replaced William Nixon, who recently resigned to pursue other interests.
RxHub, an e-prescribing venture formed by three PBMs, wants to collaborate with SureScript Systems, a similar firm created by NCPA and NACDS. At the recent NCPDP annual meeting in Phoenix, RxHub CEO James Bradley said they have to collaborate to avoid confusing physicians or forcing them to choose between the two firms. SureScript v.p. Bob Beckley said his firm would be open to cooperation, but its business goals would have to be aligned with RxHub's, which is currently not the case. He said SureScript's goal is direct communication between physicians and R.Ph.s without intermediaries.
Pharmacy owners and drugstore chains shouldn't worry about getting through red tape to apply for a one-year extension of the October 2002 deadline to begin filing Rx claims using the Version 5.1 standard, Marilyn Abramovitz told attendees at the NCPDP annual meeting. A senior health insurance specialist at HHS, she said that the extension form will take about "five minutes" to complete, and "no request for an extension will be denied." She added, "Don't lose any sleep over it. CMS will announce when you have to apply, and there will be ample time. CMS has to apply for an extension, too."
An enhanced version of McKesson Corp.'s Select Generics program, OneStop Generics, will allow community pharmacies to purchase all their generics from one company. The new program gives participating pharmacies a 20% broader selection of generic drugs eligible for rebates. In return for buying all their generics from one firm, pharmacies will be eligible for compliance-based rebates. The 8,000 retail pharmacies already using Select Generics will automatically be converted to the OneStop Generics program.
Healthcare providers were notified by the FDA and Bristol-Myers Squibb of the potential for lactic acidosis as an adverse effect of stavudine (Zerit) therapy. Rapidly ascending neuromuscular weakness, comparable with the clinical presentation of Guillain-Barré syndrome, has been reported in HIV-infected patients receiving stavudine in combination with other antiretroviral drugs. Most cases were reported in the setting of lactic acidosis or symptomatic hyperlactatemia, and some cases were fatal.
Pfizer has alerted health professionals about clarifications to the labeling of Geodon (ziprasidone HCl) Capsules. The antipsychotic should not be given with dofetilide, sotalol, quinidine, other Class Ia and III antiarrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol, or tacrolimus. Ziprasidone is also contraindicated with drugs found to prolong the QT interval.
In a black market drug case that grew out of a Kansas City R.Ph.'s dilution of chemotherapy drugs, technician Stuart Smith pleaded guilty to selling drugs he stole from the Colorado hospital where he worked, and R.Ph. Gary Ravis, Leawood, Kan., was sentenced to six months of home detention, five years probation, and a $250,000 fine for receiving stolen drugs from that hospital. Smith faces up to three years in prison and a fine of $250,000, as well as having to make restitution for the drugs he stole, valued between $120,000 and $200,000. The drug diversion cases stemmed from the investigation of Robert Courtney, the R.Ph. in the dilution case, who agreed to cooperate as part of a deal to plead guilty.
The Academy of Managed Care Pharmacy is hoping pharmacists will endorse, pilot, and adopt its Pharmacy's Framework for Drug Therapy Management in the 21st Century, which debuted at AMCP's annual meeting in Salt Lake City this month. A tool to help pharmacists in various settings assess and improve their performance, the product can be ordered from AMCP; the first copy is free, and subsequent copies cost $25. Executive director Judith Cahill also told the 2,600 attendees that the Rx Benefits Coalition would shortly be holding six briefings on the Hill; topics will include the use of generics, mail order, formularies, and disease management.
New York's Medicaid program failed to collect between $14 million and $20 million in drug rebates, according to an audit conducted by the state comptroller in cooperation with the HHS Office of Inspector General. Instead of pursuing rebates, the state health department relied on drug manufacturers to remit appropriate amounts and did not have a working Medicaid accounting system, the auditors concluded.
Walgreens has launched a new benefit program for senior patients. The Walgreens Senior Dividends card will earn participants cash dividends each time they pay for new or refilled prescriptions at any Walgreens pharmacy. Patients 55 and older who don't have Rx insurance and don't participate in a government assistance plan are eligible to enroll in the free program. When a cardholder purchases an Rx, the card will be credited with a dollar amount equal to 10% of the retail Rx price. Each subsequent Rx purchase increases the balance on the card at the same rate. Customers can use the balance to pay for any purchases (except selected items prohibited by law).
The Department of Veterans Affairs has backed off plans to limit prescribing by pharmacists at VA medical centers (Drug Topics, March 18). Proposed regs limiting VA pharmacists to the prescribing authority allowed by the states in which they were licensed would have curtailed most pharmacy-run patient care clinics. In late March, VA secretary Anthony Principi delayed implementation of the proposed regs until 2004 and directed VA to come up with a uniform national prescription authority for nonphysician providers.
Jamey Phillip Sheets, 32, an R.Ph. who co-owned a pharmacy involved in compounding tainted injectable drugs responsible for three meningitis fatalities last May, has committed suicide. Sheets, who was married and had two young children, was found dead with six high-dose fentanyl patches stuck on his neck and chest. He had been the co-owner of Doc's Pharmacy in Walnut Creek, Calif., at the time of the meningitis outbreak that hospitalized 13 others. He was facing a 90-day license suspension, five years of probation, and payment of $37,159 for the cost of the investigation and prosecution of the case.
Latelines. Drug Topics 2002;8:9.