Latelines for Dec. 16, 2002
In a letter sent to 18 Florida pharmacies, Healthplan Southeast (HPSE), Hollywood, Fla., said that a recent review of paid claims for the years 1999-2001 "has determined that we have overpaid pharmacy claims ... in error." The letter also states that repayment must be received by Dec. 13 or the amount will be withdrawn from future payments. Kim Cadenhead, president of the North Florida Independent Pharmacy Association, told Drug Topics that HPSE is seeking reimbursement for amounts ranging from $1,658 to $11,119. "They are admitting it was their error. We've contacted the Florida Insurance Commissioner, the Florida Pharmacy Association, and several legislators. A lawyer has also been contacted," she said. A phone call to HPSE was not answered.
Robert Courtney, 50, was sentenced to the maximum of 30 years in prison after pleading guilty last February to adulterating, misbranding, and tampering with the chemotherapy drugs Taxol and Gemzar at his Kansas City, Mo., pharmacy. Although he was sentenced for diluting 158 chemotherapy doses for 34 patients, he has admitted that he began diluting drugs in 1992, affecting up to 4,200 patients, 400 doctors, and 98,000 scripts. Denouncing Courtney's crimes as a "shock to the civilized conscience," U.S. District Judge Ortrie Smith also ordered the ex-R.Ph. to pay a $25,000 fine and $10.4 million in restitution to his victims.
Federal Judge Sylvia Rambo set Dec. 19 as the date she will hear pretrial motions filed by current and former Rite Aid Corp. executives facing criminal fraud charges. Former CFO Frank Bergonzi and pharmacy services manager Eric Sorkin, who is on unpaid leave, are seeking trials separate from those of former chairman/CEO Martin Grass and former general counsel/vice chairman Franklin Brown. The trial is set for March 3. Grass and Brown are trying to suppress taped conversations with former COO Timothy Noonan, who wore a wire for the government after pleading guilty on July 10 to withholding information from internal Rite Aid investigators. If he continues to cooperate, the government will recommend probation for Noonan.
Beginning early next year, British pharmacists and nurses will be able to prescribe medications in partnership with a physician. After diagnosis, patients will no longer have to visit their physician for prescriptions, which will instead be written by qualified R.Ph.s or nurses who have entered collaborative agreements with those doctors. Referred to as "supplementary prescribers," up to 1,000 R.Ph.s and 10,000 nurses will undergo extensive training by the end of 2004.
The Academy of Managed Care Pharmacy has asked the Office of Inspector General to clarify that the formularies managed care organizations develop and rebates they receive from drug manufacturers do not violate federal law. The request followed an OIG draft guidance for drug companies that identified some business practices as risk areas that could run afoul of anti-fraud, abuse, and anti-kickback laws. The AMCP document is posted at www.amcp.org .
The FDA has approved peginterferon alfa-2a (Pegasys, Hoffmann- La Roche) and ribavirin (Copegus, Hoffmann- La Roche) for the treatment of adults with chronic hepatitis C who have compensated liver disease and histological evidence of cirrhosis. Pegasys, a premixed solution, is dosed at 180 mcg as a once-weekly subcutaneous injection. Copegus, available as a 200-mg tablet, is dosed at 800 to 1200 mg taken twice daily in a split dose. The combination therapy was granted priority review status by the FDA. Pegasys is currently available in pharmacies. Copegus will be available in pharmacies early next year. The two products will be sold separately.
Mass-merchandisers Costco Pharmacies, Kmart, Meijer, and ShopKo have agreed to join the electronic prescribing initiative backed by SureScript Systems. The chains will connect through SureScripts' gateway to bring e-Rxing to their 2,050 pharmacies. The agreements follow similar deals SureScripts has struck with two-thirds of drugstore chains and several supermarket chains.
Rite Aid and CVS have agreed to a $2 million settlement of a Pennsylvania class action lawsuit charging that they failed to give accident victims price reductions as mandated by state law. Up to 20,000 accident victims who purchased drugs from Rite Aid or CVS between 1995 and 2002 have until Dec. 31 to file claims for a share of up to $550,000 in cash and up to $750,000 in coupons. Any unclaimed funds will revert to the chains.
The FDA has approved docetaxel (Taxotere, Aventis) as first-line therapy, in combination with cisplatin, in patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The approval was based on a clinical trial of 1,218 patients. This approval makes docetaxel the only agent indicated both for patients with newly diagnosed NSCLC, in combination with cisplatin, and for those with previously treated advanced NSCLC, as a single agent. The Alliance for Lung Cancer Advocacy, Support, and Education is pleased by the new indication for docetaxel, because it may provide a new treatment for a disease that is challenging to manage.
Snyders Drug Stores and Drug Emporium are now accepting the Together Rx card. The card gives eligible seniors and other Medicare-enrollees access to savings on prescription medicines from seven pharmaceutical companies.
The FDA has approved atomoxetine (Strattera, Eli Lilly) for the treatment of ADHD in children, adolescents, and adults. Investigators believe that atomoxetine reduces ADHD symptoms by blocking or slowing the reabsorption of norepinephrine. Atomoxetine is the first ADHD treatment that is not classified as a stimulant under the Controlled Substances Act. It is also the first ADHD therapy proven clinically effective in adults, claims Lilly. The firm expects atomoxetine to be available in pharmacies next month.
The FDA and MedImmune have revised the "Warnings," "Overdosage," and "Post-marketing Experience" sections of the palivizumab (Synagis) labeling to clarify the risk of anaphylaxis based on worldwide postmarketing experience. Following reexposure to palivizumab, very rare cases of anaphylaxis have occurred. Rare severe acute hypersensitivity reactions have also been reported on initial exposure or reexposure to palivizumab. The labeling was also revised to reflect that adverse events after a sixth or greater dose of palivizumab are similar in character and frequency to those after the initial five doses.
The FDA has approved nitazoxanide (Alinia, Romark Laboratories) for the treatment of diarrhea in infants and children infected with the protozoan parasites Cryptosporidium parvum and Giardia lamblia. Nitazoxanide is indicated for use in children one to 11 years of age. It is supplied as a strawberry-flavored powder that should be reconstituted with water. Nitazoxanide is not indicated for HIV-infected or immunocompromised patients. Nitazoxanide is the first and only drug approved for the treatment of Cryptosporidium infection and the first drug approved for the treatment of Giardia infection in more than 40 years. It is expected in pharmacies in February.
CMS has launched a pilot program in seven states to study the best way to help older Medicare beneficiaries quit smoking. Smoking- cessation strategies will be tested in various combinations, including in-person or phone counseling, nicotine patches, an Rx drug, and educational materials. A CMS spokesman told Drug Topics, "Drugs are being supplied through the mail through our contract with our demonstration carrier, Trailblazer Health Enterprises, and Trailblazers' subcontractor AdvancePCS." The Medicare Stop Smoking Program will be conducted in Alabama, Florida, Missouri, Nebraska, Ohio, Oklahoma, and Wyoming. Study results will be available in 2005.
The FDA has approved an oral solution of the SSRI escitalopram (Lexapro, Forest Laboratories) for the treatment of major depressive disorder. Escitalopram was approved last summer in tablet form. This new formulation is expected to provide treatment benefits to a wider range of patients, including older persons and others who have difficulty swallowing tablets. Escitalopram oral solution should be available in pharmacies by the first quarter of 2003.
In the past month, the Institute for Safe Medication Practices has been made aware of two reported cases, one fatal and the other resulting in an apparent permanent disability, of accidental daily administration of oral methotrexate where weekly dosing was intended. The following precautions can help reduce the risk of such an error when oral methotrexate is prescribed:
Prescribers should include a specific clinical indication within the Rx directions.
Alerts should be built into electronic prescribing systems, and pharmacy computers should warn clinicians whenever oral methotrexate is entered.
Community R.Ph.s should consult with the prescriber if the purpose of the medication is not made apparent.
A system should be established to ensure patients receive counseling when picking up new Rxs and refills.
Pharmacists should always review Rx labels with patients and caregivers.
Written drug information leaflets containing information about the weekly dosing schedule should be distributed to patients, along with clear written instructions that name a specific day of the week for taking the tablets.
Marina Marketos. Latelines. Drug Topics 2002;23:9.