Hospital pharmacies to go high-tech and decentralizedMarch 19th 2007
Hospitals and other healthcare facilities of the future will look more like hotels or office buildings and less like the institutional and often inconveniently designed buildings that many think of today, said Greg Lasker, an assistant professor of building construction management at Purdue University in West Lafayette, Ind. According to Lasker, Clarion North Medical Center in Carmel, Ind., is a precursor of what hospitals of the future will look like.
AHRQ issues two guides on osteoarthritisMarch 5th 2007
The Agency for Healthcare Research & Quality (AHRQ) recently released guides for clinicians and consumers on the use of analgesics for treating pain associated with osteoarthritis (OA). The guides draw on a report, called "Comparative Effectiveness and Safety of Analgesics for Osteoarthritis," based on a review of 351 published research studies. It represents the most comprehensive analysis to date of analgesics for osteoarthritis pain.
FDA proposes new rules for investigational drugsFebruary 5th 2007
The Food & Drug Administration recently proposed regulatory changes to make investigational drugs more widely and easily available to seriously ill patients with no other treatment options. The proposal also clarifies the circumstances and the costs for which a pharmaceutical company can charge for developmental drugs. The proposed regulations were published in the Dec. 14 issue of the Federal Register. They are described in detail at http://www.fda.gov/cder/regulatory/applications/IND_PR.htm and are open for comment for 90 days.
New law increases access to opioid treatmentFebruary 5th 2007
President George W. Bush recently signed into law H.R. 6344, The Office of National Drug Control Policy Reauthorization Act of 2006. The law raises from 30 to 100 the number of patients a physician may treat for opioid addiction with buprenorphine (Subutex, Reckitt Benckiser Pharmaceuticals) C-III sublingual tablets or buprenorphine/naloxone (Suboxone, Reckitt Benckiser Pharmaceuticals) C-III sublingual tablets. Buprenorphine is the only controlled medication to receive Food & Drug Administration approval for this indication.
Congress urges reform for Epogen reimbursementJanuary 22nd 2007
Last month, the House Ways and Means Committee held a hearing on patient safety and quality issues regarding end-stage renal disease (ESRD) treatment. In his opening remarks, outgoing committee chairman Rep. Bill Thomas (R, Calif.) acknowledged that Medicare payments for the treatment of ESRD increased by almost 50% between 1998 and 2003. In fact, epoetin alfa (Epogen, Amgen) has been identified as the single largest drug expenditure in Medicare Part B each year.
Lyme disease guidelines spark controversyJanuary 22nd 2007
Last fall, the Infectious Diseases Society of America (IDSA) released updated guidelines for the diagnosis and treatment of Lyme disease. (See Drug Topics, Nov. 20, 2006, "Updated Lyme disease guide clarifies confusion".) Approximately one month later, Connecticut attorney general Richard Blumenthal issued a Civil Investigative Demand (CID) to look into possible antitrust violations by IDSA in connection with exclusionary conduct and monopolization in the development of its Lyme disease guidelines.
FDA approves first generic 5-HT-3 antagonistJanuary 8th 2007
The Food & Drug Administration has approved ondansetron injection, USP (TEVA-SICOR Pharmaceuticals). The pro- product, AP-rated and equivalent to GlaxoSmithKline's Zofran, is the first generic 5-hydroxytryptamine-3 (5-HT-3) receptor antagonist to receive FDA approval. It is indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV) and the prevention of postoperative nausea and vomiting (PONV).
Guidelines updated for treatment of Alzheimer'sDecember 11th 2006
An expert panel convened by the Alzheimer?s Drug Discovery Foundation recently released consensus recommendations on the treatment of Alzheimer?s disease and related dementias (ADRD) in managed care. The guidelines were published as a supplement to the American Journal of Geriatric Pharmacotherapy.
COPD gains first nebulized beta2 agonistNovember 20th 2006
Arformoterol (Brovana, Sepracor) inhalation solution, 15 mcg, is the first inhaled long-acting beta2-adrenergic agonist to be approved for use with a nebulizer. It was approved for long-term, twice-daily (morning and evening) maintenance treatment of bronchoconstriction in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The company plans to launch the product during the second quarter of 2007.
New tablet manages breakthrough painNovember 20th 2006
The Food & Drug Administration recently approved fentanyl buccal tablets (Fentora, Cephalon) for the management of breakthrough pain in cancer patients who are already receiving and who are tolerant to opioids for their underlying persistent cancer pain. Fentora is the first and only buccal tablet approved for this indication and is the first tablet formulation of the opioid fentanyl. It is also the first new medication approved for the treatment of breakthrough pain in opioid-tolerant patients with cancer since 1998.
Updated Lyme disease guide clarifies confusionNovember 20th 2006
The Infectious Diseases Society of America (IDSA) recently updated its guidelines for the management of patients with Lyme disease, human granulocytic anaplasmosis (HGA, formerly known as human granulocytic ehrlichiosis), and babesiosis. Gary Wormser, M.D., lead author, said the guidelines were updated in response to mounting concern and confusion regarding Lyme disease. Wormser, who is also the chief of the division of infectious disease and vice-chairman of the department of medicine at the New York Medical College in Valhalla, went on to point out that the updated document differs from the previous guidelines, released in 2000, in several ways.
Research advancing on best leukemia regimensNovember 6th 2006
One of the benefits of using targeted therapies such as imatinib (Gleevec, Novartis) in treating cancer is that they seem to be fairly well tolerated. Indeed, it may be beneficial to investigate combining them with cytotoxic chemotherapy, or even other targeted therapies, to see if patients' clinical outcomes can be improved, said B. Douglas Smith, M.D., an assistant professor of oncology at the Johns Hopkins University School of Medicine in Baltimore.
Pediatric deaths bring hospital unwanted attentionOctober 9th 2006
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.
Task force issues report on safe sedation practicesSeptember 18th 2006
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.
R.Ph.s can play pivotal role in management of stable anginaNovember 22nd 2004
Chest pain is exceeded only by abdominal pain as the reason people visit their local emergency department. The American Heart Association (AHA) estimates that 6.8 million Americans have chronic stable angina (CSA). In 1999, the American College of Physicians (ACP) and the American College of Cardiology (ACC) and AHA developed joint guidelines on the management of patients with CSA. ACC/AHA updated these guidelines in 2002, and ACP recognized the document as a scientifically valid, high-quality review of the evidence and background paper.
Once a largely unrecognized disorder, irritable bowel syndrome (IBS) is becoming increasingly prevalent in the United States. According to the International Foundation for Functional Gastrointestinal Disorders (IFFGD), IBS affects 10% to 15% of all Americans, and it is more prevalent in this country than either asthma or diabetes. The foundation said that it is the most common condition diagnosed by gastroenterologists and one of the most widespread disorders seen by primary care physicians.