The FDA has approved Tercica's Increlex (mecasermin [rDNA origin] injection) for the long-term treatment of growth failure in children with severe primary IGF-1 (insulin-like growth factor-1) deficiency (IGFD) or with growth hormone gene deletion who have developed neutralizing antibodies to growth hormone. Increlex is identical to IGF-1, the natural hormone produced in the body that has a broad range of activity central to growth and metabolism.
Hurricane displaces pharmacy students Wholesalers are meeting customer needs in New Orleans New Orleans hospitals forced to evacuate Most want DTC advertising banned for Rx drugs Albuminar recalled Indictments handed down on counterfeit Lipitor Tech firms partner for electronic health record Cholestyramine for oral suspension gets FDA nod FDA MedWatch issues warning for Trypan FDA recalls Medline alcohol-free mouthwash, hygiene kits
Hospitals are seeing the advent of a new generation of systems in the context of computerized physician order entry (CPOE) that are more user-friendly and yield a quicker return on investment (ROI). Several products have evolved in the marketplace. These products are called Paperless Pharmacy Order Systems (PPOSs). They provide a paperless environment in pharmacy and a work-flow engine between pharmacists and clinicians.
Insomnia, a common sleep disorder, affects more than 70 million Americans. According to the National Sleep Foundation's 2005 Sleep in America poll, about 75% of adults have experienced a symptom of a sleep problem a few nights a week or more in the past year.
Automation governs medication-dispensing systems in many health systems, enhancing safety and efficiency-as long as the computers that operate the systems don&t crash. A growing trend in automation aggressively addresses this problem by allowing vendors to remotely monitor automation computer servers in real time, preventing crashes before pharmacists even know there&s a problem.
Given that errors involving intravenous medications may carry the greatest risk of morbidity and mortality, health professionals are welcoming the advent of smart pumps with programmable safety features that alert hospital staff to potential errors in IV infusions. Implementing such systems involves getting technology vendors, along with pharmacy, nursing, and medical staffs, to communicate with each other so that infusion systems and medical records systems work together.
At Saint Francis Hospital and Medical Center in Hartford, Conn., the pharmacy department has been ahead of the technology curve for quite some time compared with most other hospitals. That's evident from a visit Drug Topics editors paid recently to the hospital.
Patients taking the blood-thinning medication warfarin have fewer complications when managed by a specialized anticoagulation service than do those who receive usual care from their physicians. That was a finding of a study conducted by Kaiser Permanente's Clinical Pharmacy Anticoagulation Service.
Of the 1,100 public hospitals that treat a disproportionately large share of indigent patients and that are eligible to participate in the federal government's 340B drug discount program, about 700 are not enrolled. This means that up to 63% of disproportionate share hospitals (DSHs) are not taking advantage of potential discounts.
Patients requiring immune globulin (IG) are finding the therapy difficult to acquire because of tightening supplies of the plasma-derived biologic and new, lower Medicare reimbursements, according to patient groups and industry analysts.
New guidelines for the management of heart transplant patients are coming from the International Society for Heart & Lung Transplantation (ISHLT). "The last version of the currently advocated guidelines was approved in consensus form in 1992," said Mandeep Mehra, M.D., an ISHLT board member and the head of the division of cardiology at the University of Maryland School of Medicine in Baltimore. "Since that time, the management of congestive heart failure [CHF] has changed dramatically," he said.
A 75-year-old woman, G.D., is in the ER for chest pain that has now been diagnosed as heartburn. She is given lansoprazole (Prevacid, TAP) samples. Five months ago she had an acute myocardial infarction (MI) with stent placement. She was discharged on a daily regimen of clopidogrel (Plavix, Sanofi-Aventis) 75 mg, aspirin 80 mg, ezetimibe (Zetia, Merck/Schering-Plough) 10 mg, atorvastatin (Lipitor, Pfizer) 20 mg, sublingual nitroglycerin, metoprolol timed-release 50 mg, and valsartan (Diovan, Novartis) 160 mg.
This year's American Academy of Neurology (AAN) meeting featured key drug trials for diseases ranging from epilepsy to Alzheimer's disease (AD) to multiple sclerosis (MS). About 1% of all children up to the age of 16 are affected by epilepsy. Despite broadened and improved pharmacologic options, about 25% of these are refractory to standard therapy. Oxcarbazepine (Trileptal, Novartis), a newer antiepileptic drug (AED), has been assessed and found to be safe and effective both as monotherapy and adjunctive therapy in children.
Donald Goldmann, M.D., who has studied antibiotic resistance for 20 years, said community-acquired methicillin-resistant Staphylococcus aureus (MRSA) is infiltrating hospitals and "it is a pandemic that will not be controlled. It is going to fundamentally alter how we use antibiotics and how we attempt to control them."
When the Medicare Part D program starts up next year, one group that will be monitoring the quality of services provided by pharmacists is made up of the state-based quality improvement organizations (QIOs). So reported Karen Bell, M.D., M.S., division director of the Quality Improvement Group at the Centers for Medicare & Medicaid Services.
While the Medicare Part D drug benefit is still on track to begin on Jan. 1, 2006, another CMS program that was scheduled to kick off then—Medicare Part B's competitive acquisition program (CAP)—will now have a delayed start. Two days before all bids to the CAP program were due to the Centers for Medicare & Medicaid Services, as outlined in an interim rule published in the July 6 Federal Register, the agency announced that it's returning all the bids it has received and suspending the bidding process. CMS explained that it is setting back the program in order to make it more attractive and efficient.
The perfect storm of rising prescription volume and ever more drugstores in search of professional staff has driven the median income of staff pharmacists above $93,000, according to a survey from Mercer Human Resource Consulting.
The Center for Medicare & Medicaid Services is now reviewing proposals from prescription drug plans (PDPs) interested in becoming Medicare Part D sponsors. At the same time, pharmacies are receiving contracts as competing PDPs build the pharmacy networks needed to implement their proposals.
Parmacists could begin selling generic versions of brand-name biologics between 2007 and 2012. So projected speakers at the American Association of Pharmaceutical Sciences' 2005 National Biotechnology Conference, held recently in San Francisco. But the new versions of insulin, human growth hormone, and other products, while less expensive than innovator products, won't be the 70% to 90% less that the industry has come to expect from generics.
Sometime in the next year—when details are ironed out—QLT Inc., Vancouver, Canada, plans to launch Aczone (dapsone 5% gel) for the topical treatment of acne vulgaris. The product was approved in July, but QLT is pondering how best to work with the labeling required by the Food & Drug Administration. "We might wait [to launch] until we have phase IV data," said Mohammed Azab, M.D., chief medical officer of QLT. Phase IV trials evaluating this issue are slated to begin this year.
Over the past five years, the number of counterfeit drug cases in the United States has skyrocketed. Between 2000 and 2004, the number of counterfeit drug cases initiated by the Food & Drug Administration's Office of Criminal Investigations rose by more than 900%, from just six cases in 2000, to 58 cases in 2004.
DEA has issued a final rule regarding the reporting of theft of controlled substances (CSs). DEA said pharmacists should notify DEA in writing of any theft or significant loss of CSs within one business day of discovery of the incident.
The FDA has issued a Public Health Advisory highlighting the risk of sepsis in patients undergoing medical abortion using Danco Laboratories' mifepristone (Mifeprex) and misoprostol in a manner that is not consistent with the approved labeling.
The Medicare Part D prescription drug benefit remains on track to debut next Jan. 1, but questions abound. Independents and smaller chains worry about access as pharmacy benefit managers and prescription drug plans (PDPs) pressure pharmacies to sign preferred provider network contracts.
CDC director Julie Gerberding, M.D., and Surgeon General Richard Carmona, M.D., were among the Health & Human Services officials touting the Medicare Part D benefit at the Massachusetts College of Pharmacy and Health Sciences in Worcester during a national bus tour.
In a controversial move, the Food & Drug Administration notified manufacturer NitroMed Inc., Lexington, Mass., in June, that its lead drug, BiDil (isosorbide dinitrate/ hydralazine), has been approved for the treatment of heart failure in African-Americans.
The generic pharmaceutical industry is poised for tremendous growth over the next several years. Industry observers expect several factors to drive the market, including: the Medicare Part D prescription drug plan, generic versions of innovator drugs that are coming off patent, industry consolidation, and growth in the biogeneric field. Kathleen Jaeger, president and CEO of the Generic Pharmaceutical Association (GPhA), spoke with Drug Topics recently about some of the hot issues impacting the generic pharmaceutical industry.
As the countdown on different statin drugs' licenses continues, so do the plans for generic formulations. A generic formulation for simvastatin (Zocor) has received tentative approval, and others are expected to follow.