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.
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.
A 63-year-old Hispanic man, P.C., seen in your diabetes clinic, is complaining of burning and aching in his legs and feet. His current daily drugs include glipizide ER (Glucotrol XL, Pfizer) 10 mg, pioglitazone (Actos, Takeda) 45 mg, metformin ER (Glucophage XR, Bristol-Myers Squibb) 500 mg, escitalopram (Lexapro, Forest) 10 mg, atorvastatin (Lipitor, Pfizer) 40 mg, ezetimibe (Zetia, Merck/ Schering-Plough) 10 mg , aspirin 325 mg, and ramipril 10 mg. Although his current fasting blood glucose is 100, his A1c=9. Upon questioning him, you find he has not been taking his medicine regularly since he lost his job and insurance last spring. What do you recommend?
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.
Through-the-roof liability costs are convincing many hospitals to take measures to limit induced labor and the use of associated drugs, particularly the hormone oxytocin. "Inducing labor before 39 weeks places both mother and child at increased risk," said Kathy Connolly, assistant VP of risk management at Premier Inc., an alliance of 1,500 nonprofit hospitals.
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.
Through-the-roof liability costs are convincing many hospitals to take measures to limit induced labor and the use of associated drugs, particularly the hormone oxytocin. "Inducing labor before 39 weeks places both mother and child at increased risk," said Kathy Connolly, assistant VP of risk management at Premier Inc., an alliance of 1,500 nonprofit hospitals.
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.
The entire pediatrics program at Stony Brook University Hospital in Suffolk County, N.Y., has recently come under scrutiny following the deaths of three children there between May and July of this year. On Aug. 14, the New York State Department of Health issued a cease-and-desist order against the hospital's pediatric cardiac surgery and catheterization programs, and on Aug. 18, the health department fined the hospital the maximum amount of $38,000 for 19 violations associated with these fatalities. An administrative court hearing at which the hospital may challenge the cease-and-desist order was scheduled for Sept. 28.
Intelligent Hospital Systems plans to release within a year-into two North American hospitals-a machine capable of filling intravenous bags and syringes. The Canadian medical device company said final testing of its Robotic IV Automation System (RIVA) was scheduled to begin in August. If testing goes as planned, the system will be ready for use at Winnipeg's St. Boniface General Hospital in early November.
In the past, pharmacists played a somewhat limited role in the care and treatment of brain cancer. But all that is changing.
Although computerized physician order entry (CPOE) offers the potential to save lives and reduce medical costs, it hasn't yet garnered widespread acceptance. According to the results of a questionnaire administered in a study by Harvey Murff, M.D., of Brigham & Women's Hospital in Boston and Joseph Kannry, M.D., of Mount Sinai-NYU Health Systems in New York, published in the Journal of the American Medical Informatics Association, one of the biggest obstacles to acceptance is the difficulty of executing tasks "in a straightforward manner." Physicians find it takes longer to type prescriptions into the system than it does to write prescriptions on a pad in the traditional way.
Intelligent Hospital Systems plans to release within a year-into two North American hospitals-a machine capable of filling intravenous bags and syringes. The Canadian medical device company said final testing of its Robotic IV Automation System (RIVA) was scheduled to begin in August. If testing goes as planned, the system will be ready for use at Winnipeg's St. Boniface General Hospital in early November.
Almost 70% of minor surgeries are now performed in surgical centers, physicians' offices, and hospital outpatient departments. Procedures including cardiac catheterizations and colonoscopies can be done using sedatives such as midazolam and fentanyl instead of general anesthesia.
A 28-year-old African-American man with sickle cell disease, B.B., will be admitted to your hospital to undergo a hip replacement. B.B. has a significant chronic pain problem and uses a regular schedule of controlled-release oxycodone 60 mg every 12 hours plus oral transmucosal fentanyl 400 mcg (Actiq, Cephalon) for breakthrough pain crises (less than two doses per day). He is controlled at a pain level of 2; he also takes hydroxyurea 2,000 mg/day. The surgeon asks you about dealing with B.B.'s pain medications in preparation for surgery. Should drugs be held, decreased, or continued as usual?
The American Society of Clinical Oncology (ASCO) recently updated its guidelines for the use of hematopoietic colony-stimulating factors (CSFs). The 2005 update committee unanimously agreed that the reduction in febrile neutropenia (FN) was an important clinical outcome that justified the use of CSFs, regardless of impact on other factors, when the risk of FN was approximately 20% and no other equally effective regimen that did not require CSFs was available. The first guidelines were published in 1994, and they were updated in 1996, 1997, 2000, and, most recently, 2005.
Can society countenance paying $161,000 a year for treating one cancer patient, as was estimated for one new drug? And again and again for many patients? If newer agents cost 500 times the older ones, can we cover them? What if, due to new agents, some cancers become more like other chronic diseases, where expensive treatment continues for a lifetime?
The Joint Commission on Accreditation of Healthcare Organizations is looking for a few good hospitals. A few good psychiatric hospitals, that is. JCAHO is rolling out its first-ever hospital-based performance measures for inpatient psychiatric care for a year-long trial run starting in January 2007. Final measures will be released in October 2008.
Data from a new study funded in part by the Agency for Healthcare Research & Quality (AHRQ) revealed a robust reduction in patients' blood sugar levels when pharmacists or nurses were utilized as case managers who made independent decisions regarding medication use instead of waiting for physician approval.
An incident that tied a compounded drug solution to three deaths and eight acute illnesses has captured the attention of both the media and the many pharmacists who regularly compound critical care drug products for hospital use.
Pneumonia is a disease that accounts for greater than 750,000 hospitalizations in Americans 65 years of age and older, with a mortality rate of approximately 7% and 12% within 30 days of onset. Since the late 1990s, the National Pneumonia Project of the Centers for Medicare & Medicaid Services has promoted hospital practices associated with improved outcomes, one of which is antibiotic administration within a specified time of hospital admission. CMS, along with other organizations, uses this as a performance measure and currently recommends that patients with pneumonia receive antibiotics within four hours of arrival at the hospital.
ASHP's revised guidelines on the handling of hazardous pharmaceuticals could not have come at a more opportune time. As chemotherapy agents become more powerful and chemotherapy administration shifts from the inpatient setting to physician offices and infusion centers, controlling occupational exposure to hazardous drugs has taken on a new urgency.
As antimicrobial resistance continues to increase inexorably, the good news is that so far there are very few clinical situations for which there are no therapeutic options, said Robert Moellering Jr., M.D., researcher at Harvard Medical School. "But we are getting very, very close," he warned.
