Breaking News for Aug. 23, 2004

August 23, 2004

Breaking News for Aug. 23, 2004

 

BREAKING NEWS

Jury awards $21 million in suit against Walgreens

A Cook County, Illinois, jury has handed over a $21 million judgment against Walgreens in the case of a girl who was paralyzed because of a pharmacy error that occurred five years ago. Tracey Gehrke had filled a prescription for her daughter, Alexandra, at a Walgreens in Elgin. The medicine was supposed to prevent seizures in the girl, who was born prematurely. The pharmacy misfilled her prescription with an adult diabetes drug that left the girl unable to walk or feed herself.

Hurricane Charley hits Fla. pharmacies

Several Florida pharmacies were damaged during Hurricane Charley's destructive march across the state. Two days after the storm, the vast majority of chain drugstores were back in business, some operating on generators or in trailers, according to Danna Droz, executive director of the Florida pharmacy board. She added that pharmacy services were widely available in storm-damaged areas. In addition, Walgreens reminded customers that any Walgreens pharmacy could fill their scripts. CVS distributed free bottled water to residents in the hardest-hit areas and donated $10 coupons that storm victims could redeem at the chain's drugstores. The American Red Cross handed out the coupons, worth $10,000.

Federal policies on controlled substances

DEA has released a pamphlet to help clinicians and law enforcement officials better understand the federal laws and regulations regarding the use of controlled substances in pain management. Developed by DEA, Last Acts Partnership, and the Pain and Policy Studies Group at the University of Wisconsin, "Prescription Pain Medications: Frequently asked questions and answers for health care professionals and law enforcement personnel" aims to clarify federal policies, not present new ones. The document can be downloaded at www.stoppain.org/faq.pdf.

New indication for Topamax

Topiramate (Topamax, Ortho-McNeil Pharmaceuticals) tablets and Sprinkle Capsules have been approved for the prophylaxis of migraine headaches in adults. Topiramate was previously approved as adjunct therapy for adults and pediatric patients two to 16 years old with partial-onset seizures or primary generalized tonic-clonic seizures, and in patients two years of age and older for seizures associated with Lennox-Gastaut syndrome.

Stimulant now OK'd for ADHD in adults

The FDA has approved the single-entity amphetamine product Adderall XR (Shire Pharmaceuticals) for the treatment of attention deficit hyperactivity disorder (ADHD) in adults. This product is the first stimulant approved for this indication. The drug was previously approved for the treatment of ADHD in children.

Reusable pen helps diabetics reach treatment goals

OptiClik reusable pen (Aventis Pharmaceuticals) for the administration of insulin glargine (rDNA origin) (Lantus) for injection has been approved by the FDA. Insulin glargine is indicated for once-daily subcutaneous administration in the treatment of adults with Type 2 diabetes who require basal insulin for the control of hyperglycemia and for adult and pediatric patients six years of age and older with Type 1 diabetes.

Avastin is associated with thromboembolic events

The FDA and Genentech issued an important warning to healthcare professionals regarding evidence of an increased risk of serious arterial thromboembolic events, including cerebrovascular accident, myocardial infarction, transient ischemic attack, and angina related to treatment with bevacizumab (Avastin). The rate of fatal arterial thrombotic events is also increased. A revised package insert for bevacizumab containing more information on arterial thromboembolic events is in development. The MedWatch 2004 safety summary is available at www.fda.gov/medwatch/SAFETY/2004/safety04.htm#avastin.

Schering settlement spells windfall for public hospitals

Hospitals taking part in the 340B drug discount program can expect to receive at least $10.6 million from Schering-Plough, which just conceded that it had underpaid rebates to Medicaid for its Claritin product. The $10.6 million payment is part of a total $345 million settlement Schering has agreed to shell out for its Medicaid best-price violations. The company added that if an audit shows that it owes 340B entities even more than $10.6 million, it would pony up the difference.

MOBIC approved to treat rheumatoid arthritis

Meloxicam (MOBIC, Boehringer Ingelheim Pharmaceuticals) has been approved for the relief of the signs and symptoms of rheumatoid arthritis. Meloxicam was previously approved for the relief of the signs and symptoms of osteoarthritis.

Experts warn of varying levothyroxine products

The American Thyroid Association (ATA) and the American Association of Clinical Endocrinologists (AACE) warned patients and clinicians that Abbott Laboratories' brand-name levothyroxine preparation Synthroid may be as much as 12.5% more potent than Sandoz' new generic levothyroxine preparation. ATA and AACE advised clinicians to alert patients that their levothyroxine preparation might be switched at the pharmacy, encourage patients to remain on their current levothyroxine preparation when possible, and make sure patients understand that if they receive a new levothyroxine preparation, they must repeat a thyroid-stimulating hormone blood test four to six weeks later.

Patient assistance program responds to community needs

Bayer Biological Products recently launched a patient assistance initiative for eligible patients in the United States receiving treatment with Antihemophilic Factor (Recombinant) (Kogenate) Formulated with Sucrose. The Bayer Kogenate Assure Program (BKAP) consists of four components: a coupon-based program; a patient assistance program; an insurance support program; and HELPline, a service that will answer questions about eligibility, enrollment, and general reimbursement issues. HELPline can be reached at 1-(800) 288-8374.

New treatments out for radioactive contamination

Pentetate calcium trisodium (Ca-DTPA) and pentetate zinc trisodium (Zn-DTPA), both from Hameln Pharmaceuticals of Germany, have been approved by the FDA for the treatment of internal contamination with plutonium, americium, or curium. Release of these radioactive elements could occur through terrorist attacks using a radiation dispersal device, or "dirty bomb."

Vermont to sue FDA over Rx importation

Vermont plans to become the first state to sue the FDA for denying its request to import medications from Canada. The FDA rejected the state's request for permission to set up a Canadian drug importation program last December. Gov. James Douglas said the agency's safety-related reasons for the turndown were unsubstantiated, leaving him no choice but to pursue a legal remedy.

CafeRx dishes up e-prescribing

Leading healthcare IT companies and groups have formed a coalition to promote and facilitate electronic prescribing among physicians, payers, and pharmacists. Announced at an educational meeting of NCPDP, CafeRx will lobby federal and state governments to adopt mandates that facilitate e-prescribing, educate physicians and their staffs to debunk myths about e-prescribing, and offer specific plans to eliminate barriers to adoption. The coalition's guiding principles are posted at www.caferx.org.

Medicare grants new designation for Gliadel wafer

Guilford Pharmaceuticals announced that polifeprosan 20 (Gliadel Wafer) with carmustine implant has been assigned to a new diagnosis-related group (DRG) by CMS. The new group, DRG 543 (Implantation of Chemotherapeutic Agents or Acute Complex Central Nervous System Principal Diagnosis), will take effect on Oct. 1 and is expected to improve access to polifeprosan wafer by providing increased payment to hospitals that provide the product to Medicare beneficiaries. The polifeprosan wafer is approved for use in newly diagnosed patients with high-grade malignant glioma as an adjunct to surgery and radiation, and in patients with recurrent glioblastoma multiforme as an adjunct to surgery and radiation.

Warnings section of Risperdal label revised

The FDA and Janssen Pharmaceutica have revised the "Warnings" section of the labeling for risperidone (Risperdal) to describe the increased risk of hyperglycemia and diabetes in those taking the drug. The FDA has asked all manufacturers of atypical antipsychotic medications to add this warning statement to the labeling. The MedWatch 2004 safety summary, including links to the revised labeling and a revised version of a Dear Healthcare Professional letter originally distributed in November 2003, is available at www.fda.gov/medwatch/SAFETY/2004/safety04.htm#risperdal.

Seniors want Medicare Rx fixed

Nearly half of Medicare beneficiaries have an unfavorable view of the Medicare Rx benefit set to debut in 2006, and 66% want Congress to fix problems in the law, according to a national survey of 1,223 beneficiaries conducted by the Kaiser Family Foundation and the Harvard School of Public Health. While 47% had an unfavorable view of the benefit, 26% had favorable opinions, and 25% didn't have enough information to offer an opinion. When asked about the Medicare Rx discount card program, 53% of the respondents said they're not worth the trouble and 60% said they don't have a card and don't plan to get one. Nearly 80% of the respondents favor legalizing drug importation from Canada.

FDA gives nod to expanded indication for Humira

The FDA has approved adalimumab (Humira, Abbott Laboratories) to improve physical function in adult patients with moderately to severely active rheumatoid arthritis. Adalimu-mab was previously approved to reduce the signs and symptoms and inhibit the progression of structural damage in adult patients with moderate to severely active RA who have had an inadequate response to one or more disease-modifying antirheumatic drugs.

OIG posts audit report on oxygen-related DME

The Office of Inspector General (OIG) has posted an audit report of Medicaid payments for oxygen-related durable medical equipment and supplies. The audit found that Medicaid paid providers in six out of nine states about $12.7 million more than Medicare would have paid. OIG's analysis in 41 other states demonstrated that significant additional savings are possible. OIG recommended that CMS instruct state agencies that limit Medicaid rates to Medicare reimbursement levels to apply Medicaid payment limits correctly. OIG added that CMS should alert the remaining state agencies to the opportunity to reduce their Medicaid payments to Medicare allowable amounts. The audit can be found at http://oig.hhs.gov/oas/reports/region5/50300018.pdf.

VA to change medication rule

The Department of Veterans Affairs has proposed amending its rule to clarify that it is permissible for patients to receive medications from any healthcare professional authorized to prescribe, instead of just physicians. The proposed rule states that VA can administer medication only on the basis of a written order from an authorized healthcare professional and that telephonic orders would have to be countersigned by the prescribing healthcare professional within 24 hours.

Cymbalta gets green light for major depressive disorder

Duloxetine (Cymbalta, Eli Lilly) has been approved by the FDA for the treatment of major depressive disorder. The drug is a selective serotonin and norepinephrine reuptake inhibitor and a less potent inhibitor of dopamine reuptake. It is expected to be available in pharmacies by the end of this month.

California board opposes import Web site

The California pharmacy board is opposed to a bill that would require the state to set up a Web site directing residents to Canadian mail-order pharmacies. Only pharmacies licensed in their respective provinces could be listed on the site, and patients would be required to have a script from a U.S. doctor, according to the bill. The pharmacy board opposes the bill because the FDA does not sanction drug reimportation.

New York sues Express Scripts

New York's attorney general sued Express Scripts, charging that the PBM defrauded the state of up to $100 million over five years. The suit alleges that Express Scripts did not pass along rebates as required by its contract to administer the state employee drug benefit plan, inflated the cost of generic drugs, and switched patients to drugs that earned Express Scripts money from manufacturers. Express Scripts strongly denied the allegations and said it would "vigorously" defend itself in court.

Man who killed Rite Aid manager gets death sentence

Christopher Kennedy, who gunned down a Rite Aid store manager during a robbery last year, was sentenced to death by a Common Pleas Court Jury. Kennedy, 22, was convicted of first-degree murder, robbery, conspiracy, and weapons offenses in the death of Michael Richardson, 35, a father of five, who managed the Rite Aid branch at 12th Street and Girard Avenue in Philadelphia.

Survey says: R.Ph. shortage easing at supermarkets

Supermarket pharmacy staffing is improving, according to the latest Food Marketing Institute "Report from the 2004 Supermarket Pharmacy Survey." The report also revealed the following: Supermarkets are increasingly reaching pharmacy consumers by marketing their stores as a one-stop, whole-health solution; only 13% of food retail companies reported the need to reduce pharmacy hours due to a lack of R.Ph. staffing in 2003, down 33.3% from the year before; more than 70% of the surveyed firms have enhanced the skills of their pharmacy techs through training and certification programs; food retailers reported a 30% increase in the use of interactive voice response, and an additional 56% plan to install IVR by the end of the year; 87% of the surveyed companies now have Web sites; nearly 20% of survey participants reported having the ability to receive e-prescriptions from physicians, and an additional 44% plan to have this service by the end of this year.

 

Breaking News for Aug. 23, 2004. Drug Topics Aug. 23, 2004;148:8.