While the Food & Drug Administration has always been deeply concerned with drug safety, the organization is taking new and improved measures to pay closer attention to this issue, said Scott Gottlieb, M.D., Deputy Commissioner for Medical and Scientific Affairs at FDA.
As a physician at Eli Lilly & Co., the manufacturer of Xigris (drotrecogin alfa [activated]), I am responding to an article that appeared in your Aug. 21 issue, referencing a pharmacy technician who created a "Xigris calculator."
Drug delivery systems are hot. As they expand into more and more therapeutic categories, they are altering the status quo of drug administration for an increasing number of patients. They are also fueling a need for patient education, a need that is perhaps unobtrusively shaping the face of pharmacy.
In some patients with acute myocardial infarction (MI), the use of sirolimus (Rapamune, Wyeth)-eluting stents drastically reduced the rate of in-stent restenosis at one year, compared with uncoated, bare-metal stents, according to the results of a new study.
The 2006 World Congress of Cardiology (WCC) was host to more than 25,000 cardiologists this year. Noteworthy among the thousands of presentations were several large-scale drug trials, most of which evaluated agents affecting the renin-angiotensin system (RAS).
Medication safety experts nationwide were dismayed but not surprised upon hearing the tragic news that three premature infants died after receiving a fatal dose of heparin at Methodist Hospital in Indianapolis. Three other pediatric patients who also received inappropriate doses of heparin were transferred to Riley Hospital for Children in Indianapolis where they were reported to be in critical condition at press time.
In a recently issued policy statement, the Drug Enforcement Administration proposed a new rule that would ease current restrictions on prescribing Schedule II controlled substances. Under the new rule, doctors will be able to prescribe 90-day supplies of Schedule II medications such as OxyContin (oxycodone, Purdue Pharma), methylphenidate HCl, and codeine. The public can submit comments about the new rules through Nov. 6.
Should pharmacy benefit management programs meet quality standards? URAC, a Washington, D.C.-based healthcare quality group, has formed a Pharmacy Benefit Management Standards Committee to look into this matter. Its goal is to develop an accreditation program for PBMs and health plans alike.
From pills to patches, from implants to Plan B going OTC, women have more contraceptives to choose from today than ever before.
New evidence indicates that traditional diuretics may be more harmful than beneficial for heart failure patients, while some drugs currently contraindicated could be beneficial. These nuggets and more were presented at the Heart Failure Society of America's 10th annual meeting in Seattle last month.
Closing the only pharmacy in Holly Ridge, a small town in eastern North Carolina, was not an easy decision for Randy Spainhour. The 58-year-old pharmacist knew that the closest pharmacy was 15 miles away and that it would put a big strain on many of his customers. "I felt I had no choice," he insisted. "It was either that or going bankrupt."
Invasive fungal infections will have less of a fighting chance now that a new antifungal has been approved by the Food & Drug Administration. Posaconazole (Noxafil, Schering-Plough), available as an oral suspension, is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients 13 years of age and older who are immunocompromised, such as hematopoietic stem cell transplant recipients with graft-versus-host disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy.
If you want to understand the immediate impact of Wal-Mart's recent announcement that it will charge only $4 per prescription for nearly 300 generic drugs, just ask Nick Patel, R.Ph. Patel's West Coast Pharmacy, Tampa, Fla., is located one block from a Wal-Mart location and suddenly finds itself at the epicenter of a new healthcare debate. "I've had people come in with the list," Patel reported to Drug Topics. "But so far, I haven't lost any customers." Like many in the industry-especially those in the Tampa area-Patel is watching closely to see what happens next.
Specialized Pharmacy Services and its parent corporation, Omnicare Inc., have agreed to pay $52.5 million to settle one of the largest Medicaid fraud cases in Michigan. The company was charged with billing Medicaid for medication dispensed to beneficiaries who were deceased and failing to credit Medicaid for drugs that were not consumed, among other charges. As a result of the settlement, a Corporate Integrity Agreement will be in place for two years; it is designed to improve the company's Medicaid billing practices and to demonstrate the company's commitment to comply with Medicaid pharmacy policy and procedure.
A new era is coming for the Medicaid program-one that will spare the state and federal governments from overpaying for drugs and provide more pricing transparency to all parties involved.
Hoping to stem a new season of confusion over Medicare's Part D prescription drug benefit, the Centers for Medicare & Medicaid Services is asking pharmacists to prepare patients for the upcoming enrollment period.
The Medicare Modernization Act (MMA) set minimum federal standards for prescription drug coverage. Plans wanting to participate in the program could offer the standard benefit or a variation that was approved as actuarially equivalent by CMS. Most plans elected to modify the standard design with their own formularies and combination of enhanced benefits. Each plan sought the right combination of premium level, benefit package, formulary structure, and tiered co-pays that they believed would attract and keep an acceptable share of the market while generating a profit to the plan.
On behalf of the Senior Outpatient Medication Safety (SOS Rx) Coalition, the National Consumers League (NCL) recently commissioned Harris Interactive to conduct three surveys, one each of patients taking oral anticoagulants, their caregivers, and physicians who frequently prescribe these medications. The survey was made possible by an unrestricted educational grant from AstraZeneca.
Picture this: A patient who is taking the blood-thinning medication Coumadin (warfarin sodium, Bristol-Myers Squibb) visits his community pharmacy to have his blood checked. The pharmacist makes sure his dosage is correct and that his blood isn't getting too thin or too thick.
Mail-order pharmacies may not always provide the lowest costs for employers, despite conventional wisdom to the contrary, according to Michael Johnsrud, associate director of the Center for Pharmacoeconomic Studies at the University of Texas at Austin College of Pharmacy.
For the fifth consecutive year, consumer satisfaction with pharmacies has risen, according to the 2006 Pharmacy Satisfaction Digest. Ninety-eight percent of respondents reported that they were either highly satisfied or satisfied with their pharmacy, up from 95% in 2002. Moreover, the number of respondents indicating that they were highly satisfied rose to 58%, a gain of 5% over the 2005 results and 13% higher than the 2002 results.
When Gov. Jon Corzine recently signed the New Jersey Prescription Drug Retail Price Registry bill into law, he hailed it as a "significant step toward making health care more affordable." The law creates a database of prices for the 150 most common prescription drugs. Consumers will be able to access the database via a toll-free telephone number or search it on-line. Despite the Governor's optimism, however, many pharmacists doubt the law will have much impact on either pharmacists or consumers.
With conflicting statements from the Food & Drug Administration, Centers for Medicare & Medicaid Services, and a Federal District Court judge, the definition and legality of pharmacy compounding once again seems headed to the Supreme Court or Congress for sorting out.
Like it or not, accreditation is expanding from acute care to other healthcare settings, so get ready for it.
A public interest law firm has sued the government over the restrictions placed on pharmacists and other healthcare providers in helping Medicare beneficiaries choose a Part D plan. The suit claims that the rules in the marketing guidelines are a violation of free speech.
With dramatic demographic shifts under way in this country, pharmacies should tailor their marketing to multiethnic groups.
We know that about 400,000 people in the United States currently suffer from multiple sclerosis (MS), and it's more common in women and Caucasians. We also know that early treatment of the condition makes a difference. Recently, we've read that Biogen Idec and Elan Corp. were given the go-ahead to reintroduce natalizu-mab (Tysabri) for the treatment of relapsing forms of MS. But beyond that, we haven't heard too much lately regarding the treatment of this devastating disease. What, if anything, coming down the pipeline looks promising? Here are a few of the possibilities.
All symptomatic patients with HIV disease should begin antiretroviral therapy right away, according to new guidelines published by the International AIDS Society-USA and presented at the International AIDS Conference held in August in Toronto. Based on several new developments, the revision marks the seventh time since 1996 that the organization has updated its recommendations for HIV treatment.
