Latelines for June 17, 2002
As part of a $500 million agreement with the FDA over manufacturing problems, Schering-Plough has dropped 72 drugs. The drug company had not been marketing the mostly older products, which were available only through its Kenilworth Pharmaceuticals division, said a Schering spokesman. Discontinued products include Theo-Dur extended-release tablets, Proventil Syrup and Proventil/albuterol tablets, Gyne-Lotrimin 3-day combo pack, and Lotrimin Lotion. To view a complete product list, go to www.fda.gov/cder/dmpq, then scroll down and click on "Schering-Plough-FDA Consent Decree."
A bill designed to legally protect information about medical errors that are voluntarily reported to patient safety organizations was introduced in the Senate. The bill, S. 2590, is intended to amend Title IX of the Public Health Service Act to provide for the improvement of patient safety and to reduce the incidence of events that adversely affect patient safety. Sen. John Breaux, (D, La.), one of the bill's cosponsors, said that medical personnel are reluctant to report mistakes because they fear being sued. The bill is modeled, in part, after the confidential reporting system used by the aviation industry. JCAHO has come out in support of the bill.
The FDA announced that it has approved the supplemental NDA permitting the marketing of alosetron (Lotronex, GlaxoSmithKline). A risk management program, implemented by Glaxo, will include a prescribing program for physicians who wish to prescribe alosetron. Pharmacists will be required to provide patients with a copy of an FDA-approved medication guide when dispensing the drug and will be asked to fill only prescriptions that display a prescribing program sticker from an enrolled physician. The approved indication has been narrowed to only the treatment of women with severe, diarrhea- predominant irritable bowel syndrome who have failed to respond to conventional IBS therapy. The drug was previously withdrawn from the market because GlaxoSmithKline and the FDA could not agree on a risk management plan after the drug was associated with several patient deaths.
The label for simvastatin (Zocor, Merck) has been changed to include a warning about a potentially dangerous drug interaction with amiodarone (Cordarone, Wyeth), Merck announced. Those taking amiodarone should not take simvastatin in dosages above the suggested starting dose of 20 mg.
The California Pharmacists Association joined a coalition for the legalization of needles to help stop the spread of AIDS and hepatitis C. The healthcare advocates are urging passage of the Pharmacy Syringe Sale and Disease Prevention Act, which permits R.Ph.s to sell up to 30 syringes without a script to adults 18 years or older. California is one of only six states that still require an Rx for syringes.
Methylphenidate extended-release capsules (Ritalin LA, Novartis Pharmaceuticals) have received marketing approval for the treatment of attention deficit hyperactivity disorder (ADHD), Novartis, Elan Corp., and Celgene Corp. have announced. The drug uses a proprietary drug delivery technology from Elan called SODAS. Anorexia, insomnia, sore throat, headache, and vomiting were among the most commonly reported adverse events. The drug is available in 20-, 30-, and 40-mg beaded capsules for oral dosing.
Thomson Medical Economics launched PDRxpress, a Web-based system that allows manufacturers to electronically submit official new drug product labeling and labeling updates. Developed in cooperation with several drug companies, PDRxpress will ultimately make approved entries available for electronic distribution via www.pdr.net and via PDR on CD-ROM. The initiative is part of the Montvale, N.J., firm's response to an industry competition to create a paperless labeling system that will deliver up-to-date information to every U.S. dispensing site.
The consumer advocacy group Public Citizen has released a database of 6,700 questionable doctors who have been disciplined by medical or osteopathic boards in 12 states. A total of 271 doctors were disciplined for misprescribing or overprescribing drugs. Other misdeeds included substance abuse, sexual misconduct, and criminal convictions. The data- base can be searched free of charge at the www.questionabledoctors.org Web site.
In the wake of a Supreme Court decision that left compounding in regulatory limbo, the FDA issued a guidance on what factors the agency will consider when exercising its enforcement discretion. Enforcement action triggers include compounding drugs in anticipation of receiving Rxs, compounding drugs withdrawn from the market, compounding commercially available drugs, using commercial-scale manufacturing or testing equipment, and compounding drugs for resale. The FDA guidance is on the Web at www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm .
NACDS has launched a new Web site to promote Pharmacies of Promise, a national initiative of the chain drugstore industry to support, mentor, and reach out to youth in America. The site, www.pharmaciesofpromise.org, includes an on-line newsletter reporting on Pharmacies of Promise programs at chain pharmacies across the nation. It also offers tools and resources for pharmacies as they develop youth programs and outreach initiatives.
According to a new survey by Express Scripts, rofecoxib (Vioxx, Merck) and celecoxib (Celebrex, Pharmacia) are often prescribed when cheaper drugs may be as effective. This use of the more expensive compounds instead of less expensive alternatives such as naproxen or ibuprofen contributes to rising healthcare costs. Furthermore, the investigators found that 76% of Rxs written for rofecoxib and celecoxib are for those at no risk for side effects from less expensive therapies.
In order to be able to protect people in a bioterrorism attack, the FDA will now be able to approve certain drugs based solely on animal studies if it would not be possible or ethical to test them in humans. The drugs would treat or prevent potentially lethal or disabling toxicity from chemical, biological, or nuclear agents, such as nerve gas or smallpox.
The chief executives of two pharmacy associations are paid well above the median compensation of $321,538 earned by the chiefs of health-related associations, according to IRS filing data reported in National Journal. NACDS president/CEO Craig Fuller was paid a salary of $710,824 in fiscal 2000. He ranked 27th among the top 50 association executives, based on salary alone. APhA executive v.p. John Gans earned a total of $528,898, including $471,975 in salary and $56,923 in benefits and allowances. The top compensation of $6 million went to the head of the securities dealers association.
CMS' decision this past September to expand Medicare coverage of home-testing for blood coagulation testing equipment becomes effective on July 1. The coverage is expected to expand the market for companies that produce these test kits, such as International Technidyne. The firm said that frequent testing is known to improve therapeutic outcomes for patients with mechanical heart valves who take oral anticoagulation medications.
LATELINES. Drug Topics 2002;12:7.