Latelines for May 6, 2002
In preparation for the development of a national action plan to ensure the appropriate use of therapeutic agents in the elderly, HHS has issued a notice in the April 15 Federal Register calling for comments to be submitted by May 22. HHS wants stakeholders to identify the top three to five priorities to ensure that medications are used properly by seniors and suggest ways this country can pursue these strategies. Comments can be e-mailed to email@example.com.
AstraZeneca has received FDA approval for its new breast cancer drug fulvestrant (Faslodex). Fulvestrant is an estrogen receptor antagonist that works by binding, blocking, and degrading the estrogen receptor. It is not associated with the adverse effects characteristic of cytotoxic chemotherapy. Fulvestrant is administered monthly as an intramuscular injection. In clinical trials, the most common adverse effects of fulvestrant treatment were GI symptoms, headache, back pain, hot flushes, and pharyngitis. Some patients reported injection-site reactions consisting of mild, transient pain and inflammation.
Findings of a study published in the May 1 issue of the Journal of the American Medical Association indicate that the safety of recently approved drugs might remain unknown until the drugs have been available for several years. Investigators evaluated the frequency and timing of discovery of adverse effects discussed in black box warnings or pertaining to drugs that were later withdrawn. They found that serious adverse effects often emerge after FDA approval. Of the 548 chemical entities approved between 1975 and 1999, 56 drugs have acquired a new black box warning or have been withdrawn from the market.
Healthcare professionals have been notified by the FDA about a "Dear Health Care Provider" letter Wyeth sent to members of the American Society of Transplantation and The American Society of Transplant Surgeons. The letter calls their attention to the risk of hepatic artery thrombosis, graft loss, and mortality associated with the use of sirolimus (Rapamune) in de novo liver transplantation. Sirolimus in combination with cyclosporine or tacrolimus was found to increase the incidence of hepatic artery thrombosis in two randomized studies of de novo liver transplant patients. Most cases led to graft loss or death.
Should the FDA maintain its pediatric rule, which requires drugmakers to determine whether their drug products are safe and effective among children? The agency issued an advanced notice of proposed rulemaking in the April 24 Federal Register to solicit comments on this question. Originally, the FDA had decided to suspend the pediatric rule, considering it redundant when drugmakers are already conducting pediatric research to obtain an additional six months of exclusivity for their products. But an outcry from pediatric groups forced the agency to drop the suspension and take the rulemaking route instead.
The FDA has granted marketing approval for the antihypertensive drug olmesartan medoxomil (Benicar), an angiotensin II receptor blocker. Olmesartan medoxomil was discovered and developed by Sankyo Pharma, which chose Forest Laboratories as its co-promotion partner in the United States. The drug can be administered as monotherapy or in combination with other antihypertensive agents. Study results indicate that 20 mg q.d. of olmesartan medoxomil, the recommended starting dose, lowered systolic blood pressure by an average of 15 mmHg and diastolic blood pressure by an average of 12 mmHg. In clinical trials, the only adverse event reported by more than 1% of those receiving olmesartan medoxomil therapy was dizziness.
The Stop & Shop Supermarket chain no longer stocks OxyContin on the pharmacy shelves in its 322 stores in five Northeastern states. The rising number of pharmacy robberies led the Quincy, Mass., chain to drop the painkiller. Pharmacists are contacting patients on OxyContin therapy to inform them of the new policy. OxyContin maker Purdue Pharma plans to meet with Stop & Shop executives to explore possible solutions to the problem.
By a five-to-two vote, the Massachusetts pharmacy board decided to develop a new policy that will allow pharmacies to decide whether or not to stock OxyContin on their shelves. Although the language has not been finalized, the new policy will take effect July 1. Under the current regulation, pharmacies are required to stock common prescription drugs, including OxyContin.
The electronic prescribing firm SureScript Systems has selected NDCHealth as its technology partner to host its transaction engine. SureScript also announced that its implementation guide for NCPDP's Script Version 4.2 is available via e-mail request at firstname.lastname@example.org. NACDS and NCPA created SureScript to facilitate electronic prescribing.
If allowing drugs to be imported from other countries poses a potential threat to patient safety, limiting the practice to drugs from Canada should be secure, since many drugs used in Canada are made in the United States. That's the thinking behind a new bill being spearheaded by Sen. Byron Dorgan (D, N.D.). The bill is designed to salvage The Medicine Equity and Drug Safety Act, which was passed by Congress under the Clinton Administration but not put into practice because of safety concerns. NCPA supports Dorgan's new bill, while PhRMA still believes that letting drugs in through Canada could open the door to counterfeiting.
Consultant pharmacists' performance should be under increased scrutiny by nursing home administration and the public, thanks to a plan the government just launched. Under the plan, consumers can compare the quality of nursing homes by checking out www.medicare.gov or calling 1-(800) Medicare. Nursing homes are compared based on such measures as the percentage of their patients who are in pain or who have bedsores. For now, data are available on six statesColorado, Florida, Maryland, Ohio, Rhode Island, and Washington. Other states and other health providers will be added later on, HHS said.
The University of the Pacific is launching a combined Doctor of Pharmacy and Master of Business Administration (Pharm.D./M.B.A.) degree program. The degree, which will be offered beginning this fall, will be granted jointly by the Thomas J. Long School of Pharmacy & Health Sciences and the Eberhardt School of Business. Phil Oppenheimer, dean of the Thomas J. Long School of Pharmacy & Health Sciences, announced the new program at FMI's Supermarket Pharmacy Conference held recently in Orlando, Fla. He told Drug Topics, "We felt there was a need in society today to have a select group of people who are well trained not only in the healthcare profession but also in business."
After reviewing a supplemental NDA for alosetron (Lotronex, GlaxoSmithKline) as treatment for diarrhea-predominant irritable bowel syndrome in women, an FDA advisory panel recommended that the FDA consider reintroduction of the drug under certain restrictions to be determined by the agency and GlaxoSmithKline. This marks the first time an FDA advisory panel has recommended reintroduction of a banned drug. A risk management plan proposed by GlaxoSmithKline includes enhanced warnings in product labeling; restricted eligibility for prescribers and patients; mandatory patient counseling; directions for active management and follow-up of patients; and measures to document and evaluate plan compliance as well as educate prescribers, pharmacists, and patients about the plan.
Postmarketing reports of serious thrombotic events (vascular occlusion) that may be associated with the administration of immune globulin intravenous (human) (IGIV) have prompted Baxter and the American Red Cross to issue Dear Health Care Professional letters. The letters note that precautionary statements have been added to the labeling of Baxter's Gammagard S/D and the American Red Cross' Polygam S/D. These statements advise physicians to exercise caution in administering IGIV to patients with cardiovascular disease or previous thrombotic events. Both Baxter and the American Red Cross identify rapid infusion of IGIV as a risk factor for thrombotic events and urge clinicians to follow the instructions given in the package insert when administering IGIV.
Ovusoft, Hampton, Va., is offering a fertility-planning software as a package insert to B-D Consumer Healthcare's Digital Basal Thermometer. The firm claims that the FDA-approved OTC software application differs from ovulation kits and fertility monitors in that it allows a woman to directly and accurately track her own natural fertility signs on a daily basis. The application also provides instant access to patient fertility records for physicians so they can evaluate possible infertility issues, according to Ovusoft.
Prescription drug costs are one of the main reasons workers' compensation expenses are rising, according to the Hartford Financial Services Group. Rx drugs have accounted for nearly one-half the rise in workers' comp costs over the past year and nearly 67% over the past two years, according to a Hartford analysis of its clients' Rx claims.
Merck & Co. filed with federal regulators for an initial public offering of stock in its Merck-Medco Managed Care subsidiary. In the filing, the drug company anticipated selling $1 billion worth of stock in the PBM. Merck-Medco expects to change its name to MedcoHealth Solutions. Merck will retain an 80.1% share in MedcoHealth but plans to give its shares to Merck stockholders in a tax-free deal within 12 years of the IPO.
The FDA and Danco Laboratories have issued a Dear Health Care Provider letter to make clinicians aware of new safety information regarding mifepristone (Mifeprex). According to the letter, Danco has received a few reports of ruptured ectopic pregnancies. Confirmed or suspected ectopic pregnancy is a contraindication for the use of mifepristone and should be ruled out prior to treatment. The letter reports that two cases of systemic bacterial infection following administration of misoprostol (Cytotec, Searle) and mifepristone have been reported and urges clinicians to be alert to the possibility of infection. A myocardial infarction has been reported in a 21-year-old patient three days following mifepristone administration.
A public health advisory has been issued by the FDA to notify healthcare providers about recent outbreaks of lower respiratory tract colonization and infection with Burkholderia cepacia. The colonization and infection are attributable to contaminated bottles of multidose albuterol sulfate. Colonization or infection most often occurred in the ICU in patients receiving mechanical ventilation. The advisory reminds healthcare professionals of measures to reduce the risk of contamination and subsequent outbreaks.
Based in Tampa, Fla., Accentia Inc. is the newest entrant in the growing specialty pharmacy market. Formed by The Hopkins Capital Group, Accentia will give biotech drug companies a pathway for marketing, sales, and distribution of new or established specialty pharmaceuticals prescribed for patients with chronic diseases.
The FDA has approved changes to the prescribing information for rofecoxib (Vioxx) to include results from the VIGOR study, Merck has announced. Rofecoxib 25 mg once daily has also received FDA approval for the relief of the signs and symptoms of rheumatoid arthritis in adults. Rofecoxib is now the first and only COX-2 inhibitor proven to reduce the risk of GI side effects compared with the NSAID naproxen.
The FDA ruled that nicotine-laced lollipops compounded by pharmacies are illegal because the nicotine being used has not been tested for safety. Charging that they had sold lollipops without a script, the FDA ordered three pharmacies to immediately stop selling the product in their stores and on the Internet. The lollipops are intended for smokers trying to quit, but critics contended children could mistake them for candy. The FDA also declared lip balm with nicotine illegal and is investigating nicotine water and nicotine lozenges.
Latelines. Drug Topics 2002;9:7.