Latelines for July 15, 2002
Most pharmacists responding to a Drug Topics Instant Poll are in favor of a Senate bill (S. 2244) that would let R.Ph.s and wholesalers reimport American-made drugs exported to Canada. Posted in June, the poll drew 60% Yes votes, 36% No votes, and 4% Don't knows. A total of 836 people responded. Pharmacists' views on this issue contrast sharply with those of consumers. A survey of 1,000 consumers, conducted by PhRMA, found that while many expressed initial support of reimporting American-made Rx drugs and importing foreign-made Rx drugs, they reversed their stance when reminded about issues of safety, health regulations, and risk of terrorist tampering. A summary of the poll findings may be accessed on-line at the PhRMA Web site: www.phrma.org .
Starting last month, Roche began shipping isotretinoin (Accutane) in a new product blister package containing both the MedGuide and the Accutane Survey Enrollment Form. The new packaging is intended to ensure that proper safety information automatically reaches all patients taking isotretinoin. Pharmacies can continue to dispense their current supply of isotretinoin and MedGuides. Existing packages need not be returned, because they conform to FDA regulations. The new packaging eliminates the need for distribution of a separate MedGuide with each prescription, because the MedGuide and the Accutane Survey Enrollment Form are combined into one document. The Accutane Survey Enrollment Form is perforated at the bottom of the MedGuide, so that it can be torn off and submitted. Pharmacists should continue to dispense isotretinoin only when the Rx bears an Accutane Qualification Sticker. R.Ph.s can call (800) 93-ROCHE if they have any questions.
AMA is for it. Organized pharmacy and union groups are against. The issue in question is the Medicare Modernization & Prescription Drug Act (H.R. 4954) just passed by the Republican-led House of Representatives. Opponents of the bill consider it inadequate to meet the medication needs of seniors and favor an alternative proposal by the Democratic-led Senate. The House and Senate bills are miles apart, and a compromise must be reached before a final bill is passed. The House bill earmarks $310 billion for Rx benefits over 10 years, while the Senate version more than doubles the amount to about $800 billion.
Infliximab (Remicade, Centocor) received marketing approval from the FDA to provide long-term remission-level control of the debilitating symptoms of Crohn's disease (CD). It is the first and only biologic approved to reduce the signs and symptoms of CD and induce and maintain remission in those with moderate to severely active forms of the disease who have not responded adequately to conventional therapy.
Pharmacists who are already dispensing drugs from a preferred drug list for Medicaid patients in their state, or those who are about to do so, may have to halt the practice. That's because PhRMA has filed a federal suit, seeking a preliminary injunction to block such a program under way in Michigan. The association also wants HHS secretary Tommy Thompson to stop approving preferred drug lists in other states. At present, 11 other states are preparing to launch this program. PhRMA said Medicaid patients deserve access to all drugs, not just those on the preferred list. But states want to set up these quasi-formularies to wrest discounts from manufacturers.
Nature's Way Products is recalling four lots of its 100-count nettle capsules because the product contains excessive amounts of lead. People, especially children, who consume high levels of lead can suffer serious damage to their central nervous systems. The affected lots of the product were distributed nationwide, primarily in health food retail establishments between October 2001 and May 2002. The lot numbers affected by this recall are 131237, 131238, 140738, and 215229. For more information, visit www.fda.gov/medwatch/SAFETY/2002/safety02.htm#nettle .
The Florida attorney general's office is investigating whether Eli Lilly & Co. violated the state's unfair-trade law when Lilly sales personnel allegedly mailed free samples of Prozac to patients taking other antidepressants. Lilly was sued by a recipient of the mailing in state court in Ft. Lauderdale. The class action suit, which also names as plaintiffs three physicians in a Ft. Lauderdale medical practice, the hospital with which they are affiliated, and Walgreens, alleges that they violated the patients' privacy rights. In defense, Walgreens said the chain "did not provide any patient information to Lilly or to the doctors involved and does not provide patient-specific information to any outside business. The Prozac Rxs we filled were legitimate Rxs received from physicians and were filled at one Walgreens store where staff decided on their own to participate in this program. This was not a Walgreens corporate program, and our involvement in the program has ended.
The boxed warning, warnings, and precautions sections of the prescribing information for irinotecan (Camptosar, Pharmacia) have been revised to identify patients at higher risk of severe toxicity, clarify guidelines for dose modification, and augment the information about managing therapy-related toxicities. Irinotecan is approved as part of therapy for first-line treatment of metastatic colorectal cancer in combination with 5-FU and leucovorin (LV) and for the treatment of metastatic colorectal cancer that has recurred or progressed following initial treatment with 5-FU and LV.
The National Institutes of Health has summarily halted a large study on hormone replacement therapy because it found that a combination of estrogen and progestin is significantly linked with an increase in breast cancer in postmenopausal women. Experts warn that pharmacists can expect questions from their women patients about the study, which will be published in the July 17 issue of JAMA.
According to a study published in the Journal of the American College of Cardiology, the time required to begin the treatment of heart attack patients could be reduced by more than half by having the clot- dissolving drug reteplase (Retavase, Centocor) administered by EMS personnel rather than waiting until patients arrived at a hospital. The investigators found that for patients receiving pre-hospital treatment, the median time from the arrival of EMS to the first injection of reteplase was 31 minutes. This was less than half the median time of 63 minutes it took to start in-hospital thrombolytic treatment in a cohort of historical control patients admitted to the same facilities during the year before the study started.
A Court of Appeals in New Orleans is reviewing a suit filed by two individuals against Texas Tech University School of Pharmacy and certain faculty members for discrimination based on disability. Besides the school, faculty members named in the suit include Arthur Nelson, Robert Supernaw, Quentin Smith, Cynthia Raehl, Roland Patry, and Cab Bond. The school has denied charges of discrimination and requested dismissal of the suit based on sovereign immunity under the 11th Amendment. However, legal experts assert that if the school and the state win their request for immunity, it would keep every Texan with any type of disability from suing any state agency when these citizens believe they've been subject to disability discrimination.
The label for tamoxifen (Nolvadex, AstraZeneca) has had a boxed warning added to it and the warnings section strengthened. The FDA and AstraZeneca made the revisions to warn healthcare professionals about the risk of serious and potentially fatal events for women with ductal carcinoma in situ and women at increased risk for breast cancer who use the drug. If these women are taking or considering tamoxifen therapy to reduce their risk of invasive breast cancer, they should discuss the potential benefits versus the potential risks with their physician.
Marina Marketos. Latelines. Drug Topics 2002;14:5.