Pharmacy News
FDA Drug Safety Communication: Increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections
The U.S. Food and Drug Administration (FDA) is reminding healthc -- September 1, 2010
Full Story >>FDA Drug Safety Communication: Ongoing Safety Review of Stalevo and possible increased cardiovascular risk
August 20, 2010
Full Story >> FDA Proposes Withdrawal of Low Blood Pressure Drug
Companies failed to provide evidence of clinical benefit of mido -- August 16, 2010
Full Story >> Continuous Intraarticular Infusions of Local Anesthetics Linked to Chondrolysis
Cartilage destruction and necrosis have occurred in about three dozen patients who received a continuous intraarticular infusion of a local anesthetic by an elastomeric infusion device for 48 to 72 hours.
Full Story >> Los Angeles Times Profiles Clinical Pharmacist
In one of several articles on pharmacists, the Los Angeles Times focuses on the work of Steven Chen, who is part of a team providing care to patients at a safety net clinic.
Full Story >> Balancing pain management with patient safety
FDA's Woodcock Discusses
Full Story >> Omeprazole Decreases Effectiveness of Clopidogrel, FDA Says
Patients who are taking clopidogrel should avoid the concomitant use of omeprazole, a proton-pump inhibitor, because the latter drug diminishes the antiplatelet effects of clopidogrel, FDA announced November 17.
Full Story >> Sibutramine May Increase Cardiovascular-Event Risk
Preliminary data from a placebo-controlled, 10,000-patient study suggest that the antiobesity drug sibutramine may increase patients' risk of cardiovascular adverse events, FDA announced on Friday.
Full Story >> AJHP Posts Ahead-of-Print Article on Neonatal Medication Dispensing Errors
Five near miss medication errors involving neonatal patients are studied.
Full Story >> American Regent Recalls All Ketorolac Vials
American Regent Inc. on November 3 announced a recall of all of the company's 15-mg/mL ketorolac tromethamine injection for the same reason it recalled all 30-mg/mL vials in mid-October: "the potential that particulates from crystallization may be present
Full Story >> Hospitals Hit with Propofol Shortage
Medical centers nationwide are feeling the pinch on propofol in the wake of recalls by two manufacturers of generic forms of the sedative.
Full Story >> Flu Season Could Be Long, Hard, CDC Says
The Centers for Disease Control and Prevention on October 20 released new data about people recently hospitalized with 2009 H1N1 influenza virus infections and said the agency is preparing for a long, difficult flu season.
Full Story >> New Angiogenesis Inhibitor Approved for Renal Cell Carcinoma
FDA and GlaxoSmithKline on October 19 announced the approval of pazopanib, or Votrient, for the treatment of advanced renal cell carcinoma.
Full Story >> Asthma Leads H1N1 Hospitalization Risk, Preliminary Data Show
Preliminary data from patients hospitalized with 2009 H1N1 influenza virus infection indicate that people with asthma and other underlying health conditions are at increased risk for serious complications.
Full Story >> H1N1 Vaccine Arriving, but Slower Than Hoped
Fewer doses of the pandemic 2009 H1N1 influenza virus vaccine than originally projected will be available by the end of the month, the Centers for Disease Control and Prevention announced Friday.
Full Story >> AJHP Posts Ahead-of-Print Article on Joint Commission Hospital Accreditation Requirements
Full Story >> FDA issues new guidelines on drug disposal.
The FDA has issued new consumer guidelines for disposing of unused or expired medications
Full Story >> FDA Looks Ahead to Withdrawal of Nonprescription Epinephrine Inhalers
FDA is seeking an effective way to inform those who purchase the products that they need to find an alternative remedy for asthma symptoms.
Full Story >> Injectable H1N1 Vaccine Ready This Week, CDC Says
Each state has begun placing orders for 2009 H1N1 influenza vaccines, and injectable forms of the vaccines will become available in states next week, Centers for Disease Control and Prevention Director Thomas R. Frieden told reporters last week.
Full Story >> New genetic test helps determine Plavix response.
40 percent of some patient populations are not responders.
Full Story >> Joint Commission Releases Prepublication Standards for 2010
The Joint Commission recently posted prepublication versions of standards for 2010 that encompass all areas accredited by the organization. The documents will remain online until December 1 or later.
Full Story >> Important change affecting Heparin - Very Important - Please Read.
Change in Reference Standard
Full Story >> FDA Approves New Treatment for Allergic Conjunctivitis
Ista Pharmaceuticals Inc. on September 8 announced that FDA approved the marketing of bepotastine besilate ophthalmic solution, or Bepreve.
Full Story >> Officials Pleased With Initial H1N1 Vaccine Study Results
Early data from U.S. trials of vaccines against the pandemic 2009 H1N1 influenza virus indicate that they are safe and effective at standard dosages, federal officials announced Friday.
Full Story >> Telavancin Approved for Serious Skin Infections
Theravance Inc. on Friday announced that FDA has approved the marketing of telavancin for injection, or Vibativ, for the treatment of complicated skin and skin structure infections in adults.
Full Story >> FDA Gives Specifics on TNF-Blocker-Assosciated Cancers
FDA last week released a question-and-answer document that provides specific information about an agency investigation of 48 cases of malignancies in children and adolescents treated with tumor necrosis factor blockers.
Full Story >> Novartis Warns About Mycophenolate-Mofetil-Related Aplasia
In a carefully worded letter circulated September 3 by FDA, Novartis Pharmaceuticals Corporation warned health care professionals that pure red cell aplasia has occurred in patients treated with a drug that is converted to the active ingredient in Myforti
Full Story >> New Hib Vaccine Gets Accelerated Approval
Hiberix, a tetanus toxoid conjugate Haemophilus influenzae type b (Hib) vaccine from GlaxoSmithKline, was licensed last week under an accelerated process intended to alleviate the ongoing U.S. Hib vaccine shortage.
Full Story >> Patient Deaths from Injection of Topical Epinephrine
Death in Canada demonstrates why all drug containers and devices must be labeled.
Full Story >> New Warnings on Propoxyphene Overdoses
FDA taking action to prevent propoxyphene overdoses
Full Story >> Expect H1N1 Influenza Vaccine To Be Administered This Fall, CDC Says
Frequently asked questions.
Full Story >> Asenapine Approved for Treatment of Schizophrenia, Bipolar Disorder
FDA and Schering-Plough Corporation on Friday announced the approval of asenapine sublingual tablets for the acute treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adults.
Full Story >> Standards Needed for Postoperative Hydration Therapy, ISMP Says
Investigations into the deaths of two six-year-old children have prompted the Institute for Safe Medication Practices to call for the establishment of standards of practice for i.v. hydration therapy in postoperative patients.
Full Story >> Watson Recalls Fentanyl Transdermal System-100
Manufacturer Watson Pharmaceuticals Inc. on August 7 announced a recall of Fentanyl Transdermal System-100 lot 145287A because some of the patches have been leaking fentanyl gel.
Full Story >> FDA Approves Pitavastatin
FDA recently announced the approval of pitavastatin for the improvement of cholesterol levels in patients who have not been able to control their dyslipidemia through diet and exercise.
Full Story >> CDC Advisers Say Half of U.S. Population Should Get Pandemic Vaccine
Advisers to the Centers for Disease Control and Prevention on July 30 recommended which groups should seek immunization when the first batches of pandemic H1N1 influenza virus vaccine become available.
Full Story >> FDA Approves Saxagliptin for Type 2 Diabetes
Bristol-Myers Squibb and AstraZeneca on Friday announced the approval of saxagliptin oral tablets, or Onglyza, to help patients with type 2 diabetes mellitus control their blood glucose.
Full Story >> FDA Patient Safety News
Links to stories found in the August issue of patient safety news.
Full Story >> Brand vs. Generic Drugs
FDA considers generics just as effective as brand-name drugs.
Full Story >> New Automation Helps Patients
Oklahoma town installs first automated prescription drug-dispensing machine.
Full Story >> CDC Releases Seasonal Influenza Vaccination Recommendations
The Centers for Disease Control and Prevention (CDC) on Friday released recommendations for the use of trivalent influenza virus vaccine during the 2009-10 influenza season.
Full Story >> Study Finds Critically Ill Patients Do Better When Pharmacist on Staff
Pharmacist-provided patient care services in the intensive care unit made a significant difference in the outcome of critically ill patients with thromboembolic or infarction-related events.
Full Story >> FDA Lets Propoxyphene Remain on Market
Partly in response to recent public outcry about the need for continued access to pain relievers, FDA has decided not to stop companies from marketing propoxyphene in the United States.
Full Story >> New Drug Approved for Reducing Rate of Angioplasty-Related Clots
Prasugrel, a thienopyridine, has been approved for reducing the rate of myocardial infarctions and strokes in patients with acute coronary syndrome who are undergoing a catheter-based procedure to reopen an occluded coronary artery.
Full Story >> Lantus (insulin glargine)
Observational studies link use to increased risk of cancer.
Full Story >> Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics)
FDA requiring new Black Box Warning
Full Story >> Switches of Antiepileptic Drug Products Come Under Fire
A patient advocacy group's campaign and the media's recent focus on generic drug substitution have increased the need for pharmacists to judge FDA-declared bioequivalent products by more than just price.
Full Story >> Drug Counterfeiting Burden Remains a Guess, Experts Say
The proliferation of counterfeit medications is believed to be a growing problem, but experts acknowledge that a lack of solid data on the scope of counterfeiting poses obstacles to controlling it.
Full Story >> Officials Seize 33 Generic Medications From Michigan Company
U.S. marshals, working with FDA personnel, on May 25 seized $15–20 million worth of generic drugs and drug ingredients from three Michigan manufacturing facilities operated by Caraco Pharmaceuticals Inc., the company announced.
Full Story >> Answers Available to Frequently Asked Questions About USP Chapter 797
Full Story >> Intranasal Zicam Cold Products Pose Hazard to Consumers, FDA Says
FDA last week warned consumers against using three nonprescription zinc-containing intranasal cold remedies that have been reported to cause a loss of the sense of smell, a condition known as anosmia.
Full Story >> FDA Approves Canakinumab for Rare Inflammatory Disorders
For the treatment of the cryopyrin-associated periodic syndromes known as familial cold autoinflammatory syndrome and Muckle-Wells syndrome in patients age four years or older.
Full Story >> Stolen Levemir Vials Resurface in U.S. Market
Novo Nordisk AS announced today that some of the vials of insulin detemir injection previously reported as stolen in North Carolina had been found this week at a medical center in the Houston area.
Full Story >> Prepare Now for Unpredictable Influenza This Fall
No one knows how the influenza H1N1 outbreak will unfold in the United States when influenza season starts this fall, but experts say pharmacists can take important steps now to prepare for whatever lies ahead.
Full Story >> Prosecution of Harmful Errors Decided by Outside Forces
Pharmacist-dominated state boards of pharmacy hold sway over a pharmacist's license to practice, but prosecuting attorneys and the general public decide when a harmful medication error was a criminal action.
Full Story >> Atomoxetine (Marketed as Strattera): Serious Liver Injury
FDA continues to receive reports of serious liver injury in patients given atomoxetine. Atomoxetine received FDA approval on November 26, 2002 as the first non-stimulant medication used for the treatment of attention deficit hyperactivity disorder.
Full Story >> Patient Safety News - Volume 2, Number 1, 2009
One way healthcare professionals can receive additional information on the safety of new drugs, biologics, and medical devices, including product recalls, is by watching FDA Patient Safety News.
Full Story >> The Smoking Cessation Aids Varenicline (Marketed as Chantix) and Bupropion (Marketed as Zyban and Generics): Suicidal Ideation and Behavior
A postmarket safety review of varenicline (marketed as Chantix) and bupropion (marketed as Zyban and generics), two products used for smoking cessation, has identified cases where suicidal ideation and behaviors followed the initiation of treatment
Full Story >> Improving Medication Adherence Remains a Challenge for Providers
Taking recommended medications in accordance with prescribers' instructions is akin to flossing one's teeth every day—both are tasks that people know they should do but don't always follow through.
Full Story >> First FDA-Approved Pancrelipase Product May Mark New Era for Providers, Patients
Creon, gives pharmacists who are active in the cystic fibrosis community something new—a pancreatic enzyme product that has passed regulatory muster.
Full Story >> FDA Approves New Ophthalmic Fluoroquinolone
Bausch & Lomb announced that the company has received approval from FDA to market besifloxacin ophthalmic suspension for the treatment of bacterial conjunctivitis.
Full Story >> One Formulary Fits All of VA
The employee-clinicians and approximately 8 million enrollees in the Department of Veterans Affairs (VA) health care system now deal with a single list of medications.
Full Story >> Latest Leapfrog Survey Finds Hospitals Lagging in Quality Goals
The Leapfrog Group's annual hospital survey report, released in April, found that hospitals have a long way to go to fully implement the organization's recommendations.
Full Story >> Comment Period Opens on National Patient Safety Goals
The Joint Commission is seeking comments on proposed revisions to the National Patient Safety Goals.
Full Story >> Group Says Don't Mix PPI With Dual Antiplatelet Therapy After Stenting
The Society for Cardiovascular Angiography and Interventions is urging health care providers to consider prescribing a histamine H2-receptor antagonist instead of a PPI to patients receiving dual antiplatelet therapy after insertion of a coronary stent.
Full Story >> New Atypical Antipsychotic Approved
FDA and Vanda Pharmaceuticals announced last week. Iloperidone will be sold in the United States as Fanapt.
Full Story >> Treat H1N1 Influenza Like Seasonal Flu, CDC Says
People with uncomplicated febrile illness caused by the recently detected H1N1 influenza virus generally do not need antiviral treatment unless they are at high risk for flu-related complications.
Full Story >> Stop Erlotinib Therapy If Certain Adverse Events Occur
The development of a gastrointestinal perforation, a severe skin condition, or eye pain is cause for stopping a patient's erlotinib therapy.
Full Story >> Officials Confident of Current Antiviral Supply
Homeland Security Secretary Janet Napolitano said April 30 that the federal government expects its current stockpile of antivirals to be sufficient should the current influenza outbreak become a pandemic.
Full Story >> H1N1 Resource Center Features Most Current Drug Information
ASHP's H1N1 Flu Resource Center has the most up-to-date drug information on the appropriate uses of antivirals to treat patients with confirmed cases of 2009 H1N1 influenza.
Full Story >> Should the "Sacred Cow" of Near Universal Drug Order Review be Gored?
Pharmacy Practice News
Are the days of near universal drug order review (NUPOR) numbered? Proponents say the strategy helps to ensure safe medication use; critics say pharmacists' time could be better spent elsewhere.
Full Story >> Cash-Strapped Hospitals Can Save by Outsourcing 340B Drug Discount Plan
Pharmacy Practice News
Several hospitals have achieved impressive savings and staff efficiencies by outsourcing their participation in the federal 340B drug discount program.
Full Story >> Fixes for an Imperfect Med Safety System
Simply adopting bar-coding technology is not enough to combat medication errors: even the best systems inevitably fall short of expectations if pharmacists fail to work closely with nurses and other stakeholders to fine-tune the technology.
Full Story >> Ceftriaxone Product Information Update
Kevin Doherty, Pharm.D.
New information on the use in neonates and calcium containing IV solutions.
Full Story >> Supply of Pharmacists in Work Force Has Improved, Government Says
A new report from the federal government states that the shortage of pharmacists in the work force has eased in recent years, with the situation now a "moderate shortfall" rather than a "dynamic shortage."
Full Story >> Some Patients May Receive Too Much Information About Prescriptions
There was a time in the late 1930s when FDA did not want patients to understand anything about the risks or benefits associated with their prescription drugs.
Full Story >> Record Number of Pharmacists Entering Residencies
A record number of pharmacists will participate in rigorous postgraduate training following a competitive 2009 ASHP Resident Matching Program.
Full Story >> Massachusetts Pharmacy Board Practices Examined
Story on how unresponsive one State Board of Pharmacy is to patient complaints and medication errors is shocking.
Full Story >> U.S. Preventive Task Force Recommends Aspirin for Certain Adults
Men ages 45-79 years should use aspirin to reduce the risk of myocardial infarction if they have a high likelihood of benefiting from the chemoprevention and little potential for gastrointestinal hemorrhage.
Full Story >> Don't Reuse Insulin Pens Among Patients, FDA Says
Health care providers who reuse the same insulin pen to administer doses to more than one patient risk transmitting hepatitis viruses, HIV, and other bloodborne pathogens, FDA announced March 19.
Full Story >> FDA Seeks Comments on Clinical Pharmacology Labeling Recommendations
FDA is seeking comments on proposed recommendations for the content of the clinical pharmacology section of labeling for drugs and biological products.
Full Story >> Medication Safety Is Focus of New AHRQ Web M&M
The new edition of Morbidity and Mortality Rounds on the Web, from the Agency for Health Care Research and Quality.
Full Story >> FDA Warns of MRI Burn Risk for Transdermal Patches
FDA wants patients who wear medication-containing transdermal patches to remove them before undergoing a magnetic resonance imaging scan.
Full Story >> Metoclopramide Labeling Must Emphasize Neurologic Risks
Labeling for products that contain the gastrointestinal motility drug metoclopramide must include a new boxed warning about the risk of neurologic symptoms that can occur with chronic use, FDA announced last week.
Full Story >> Close Vote by FDA Advisers Favors Propoxyphene Withdrawal
A bare majority of FDA advisers greed that propoxyphene-containing products should be removed from the U.S. market because they offer little benefit and may harm patients.
Full Story >> European Regulators Say Efalizumab's Benefits No Longer Outweigh Risks
European Commission says Raptiva outweights benefits.
Full Story >> Study: Dallas doctors helping drive Medicare deficit higher
Full Story >> Violence Against Pharmacists Under Study by NIOSH
The National Institute for Occupational Safety and Health (NIOSH) is developing recommendations to protect pharmacists and other health care workers from homicides and injuries associated with robberies and assaults.
Full Story >> FDA Says Zonisamide Can Cause Metabolic Acidosis
A review of "updated clinical data" by FDA has prompted the agency to declare that treatment with the antiseizure drug zonisamide can cause metabolic acidosis, with children apparently at greater risk than adults.
Full Story >> New Gout Treatment Approved
Febuxostat, a xanthine oxidase inhibitor, for the reduction of elevated serum uric acid levels in patients with gout was approved by the FDA.
Full Story >> US Court of Federal Claims dismisses vaccine link to autism.
Full Story >> Study suggests over 90 percent of patients who believe they are allergic to penicillin are not.
In a study "of 150 emergency patients," investigators found that "more than 90 percent of patients who reported an allergy to the antibiotic did not have a positive skin-test result."
Full Story >> Reexamine Need for Proton-Pump Inhibitor in Clopidogrel Users, FDA Advises
ASHP NewsLink
(PPIs) may interfere with the antiplatelet effect of clopidogrel.
Full Story >> FDA Issues Early Communication for Xigris
ASHP NewsLink
FDA has issued an Early Communication about an investigation into potential problems for patients who take drotrecogin alfa (activated) and have sepsis and baseline bleeding risk factors.
Full Story >> Clinicians Ignore Most e-Prescribing Alerts
ASHP NewsLink
A large study of electronic prescribing in the outpatient setting suggests that prescribers override most warnings that indicate a medication allergy or drug interaction, according to a report in the February 9 Archives of Internal Medicine.
Full Story >> Wide range of antidepressants to carry new warnings of potentially deadly side effect.
ASHP Daily Briefing
Malignant neuroleptic syndrome has been linked to the use of these drugs.
Full Story >> FDA, CDC to support research into new efforts to prevent unintentional opioid overdoses.
"Federal agencies are collaborating to address... the growing number of unintentional overdoses linked to" opioids.
Full Story >> Two Companies Recall Dozens of Products
A pair of subsidiaries of KV Pharmaceutical announced the recall of dozens of drug products due to potential manufacturing problems, according to the companies involved.
Full Story >> New Pharmaceutical Product Approvals, 2008
FDA in 2008 approved the marketing of an assortment of 34 unique new molecular entities, vaccines, imaging agents, and blood products--5 more than the previous year's total.
Full Story >> Withdraw Propoxyphene from the U.S. Market, ASHP Tells FDA
The Food and Drug Administration should pull propoxyphene from the U.S. market because of its lack of efficacy and potential patient risks that outweigh any potential benefit, ASHP testified to two of the agency's committees on January 30.
Full Story >> New Fibromyalgia Treatment Receives FDA Marketing Approval
ASHP NewsLink
FDA has given marketing approval for a new pharmaceutical treatment option for patients who have fibromyalgia, according to an announcement by Cypress Bioscience Inc. and Forest Laboratories Inc.
Full Story >> Lilly agrees to pay $1.42 billion to settle a probe into alleged improper marketing of Zyprexa.
ASHP Daily Briefing
Full Story >> Pfizer may fire almost a third of its U.S. sales force.
ASHP Daily Briefing
Full Story >> Physician testifies Seroquel may substantially raise diabetes risk.
ASHP Daily Briefing
Full Story >> FDA Updates Information on Combination Statin Product
Greg Lavine
Following up on an Early Communication from last January, FDA issued a MedWatch notice January 8 advising patients to continue taking the combination product ezetimibe and simvastatin, which is marketed as Vytorin.
Full Story >> Cephalon pays states to settle off-label marketing allegations.
ASHP Daily Briefing
Full Story >> FDA to convene meeting of outside advisers to discuss safety, effectiveness data for Darvon.
ASHP Daily Briefing
Full Story >> FDA asks panel of heart doctors for help reviewing blood-thinning drug prasugrel.
ASHP Daily Briefing
Full Story >> Tinzaparin may increase mortality risk in elderly patients with renal insufficiency.
ASHP Daily Briefing
Full Story >> Some physicians may be unaware of risk of tendon side effects from fluoroquinolone antibiotics.
ASHP Daily Briefing
Full Story >> Researchers say Fosamax may increase risk of osteonecrosis of the jaw.
ASHP Daily Briefing
Full Story >> Voluntary moratorium on branded gifts by pharmaceutical companies set to begin Jan. 1.
ASHP Daily Briefing
Full Story >> FDA to consider updating Plavix labeling.
ASHP Daily Briefing
Full Story >> Cancer outpatient medication errors may be more common than previously thought, data indicate.
ASHP Daily Briefing
Full Story >> FDA approves Lusedra and Pegintron/Rebetol.
ASHP Daily Briefing
Full Story >> Number of new drugs approved by the FDA increased in 2008.
ASHP Daily Briefing
Full Story >> FDA requests data on J&J's plan for informing physicians, patients of potential ustekinumab risks.
ASHP Daily Briefing
Full Story >> Sales of Zetia and Vytorin dropped significantly in November.
ASHP Daily Briefing
Full Story >> FDA orders new warnings for drugs used to treat epilepsy.
ASHP Daily Briefing
Full Story >> New breakpoints may increase use of intravenous penicillin in invasive pneumococcal disease, CDC says.
ASHP Daily Briefing
Full Story >> ASHP, healthcare organizations release guidelines regarding IV medication errors.
ASHP Daily Briefing
Full Story >> FDA approves Genzyme's plerixafor.
ASHP Daily Briefing
Full Story >> FDA panel says Serevent and Foradil should not be used for asthma.
ASHP Daily Briefing
Full Story >> FDA Wants Stronger Warnings on Phosphate-Containing Bowel Cleansers
ASHP NewsLink
Full Story >> Joint Commission Calls Attention to Technology-Related Adverse Events
ASHP NewsLink
Full Story >> High doses of thiamine may reverse the onset of early diabetic kidney disease, researchers say.
ASHP Daily Briefing
Full Story >> NYTimes argues drugmakers' ties to physicians may hinder the use of generic drugs.
ASHP Daily Briefing
Full Story >> Tinzaparin Ups Death Risk for Some Elderly Patients, FDA Says
Kate Trayor - ASHP
A preliminary review of data from a European clinical trial has prompted FDA to warn that tinzaparin may be deadly for patients with impaired kidney function who are 70 years or older.
Full Story >> FDA grants orphaned drug status to pralatrexate for treatment of lymphomas
ASHP Daily Briefing
Full Story >> FDA grants priority review to ibritumomab tiuxetan as second-round therapy for non-Hodgkin lymphoma.
ASHP Daily Briefing
Full Story >> Malaria drug receives expedited FDA review.
ASHP Daily Briefing
Full Story >> Research suggests tasimelteon may be able to reset the body's circadian rhythms.
ASHP Daily Briefing
Full Story >> Internists Group Issues Guidelines on 2nd-Generation Antidepressants
ASHP NewsLink
Full Story >> Pharmacists Provide Academic Detailing to South Carolina Health Care Providers
ASHP NewsLink
Full Story >> Promacta Approved for Blood Disorder
ASHP NewsLink
Full Story >> Western drugmakers face increasing scrutiny over clinical trials conducted in developing countries.
ASHP Daily Briefing
Full Story >> FDA delays approval of Basilea's antibiotic.
ASHP Daily Briefing
Full Story >> Some health systems abolishing free medication samples.
ASHP Daily Briefing
Full Story >> Unfavorable industry-sponsored drug studies given to the FDA may go unpublished, study suggests.
ASHP Daily Briefing
Full Story >> FDA to launch study on whether TV drug advertisements should urge patients to report side effects.
ASHP Daily Briefing
Full Story >> Fourteen widely prescribed medications may need more evidence for off-label use, study suggests.
ASHP Daily Briefing
Full Story >> FDA approves of tapentadol hydrochloride for relief of moderate to severe acute pain.
ASHP Daily Briefing
Full Story >> FDA delayed at least 10 new drugs since August.
ASHP Daily Briefing
Full Story >> Consumer group says Avandia should be removed from market.
ASHP Daily Briefing
Full Story >> CDC finds no substantial links between Gardasil and several serious side effects.
ASHP Daily Briefing
Full Story >> Flu shots should be required for physicians, healthcare professionals, group says.
ASHP Daily Briefing
Full Story >> Study suggests NSAIDs may increase the risk for GERD.
ASHP Daily Briefing
Full Story >> FDA Approves Silodosin for Treatment of Enlarged Prostate
CHERYL A. THOMPSON
Watson Pharmaceuticals Inc. on October 8 announced that FDA had approved the marketing of silodosin, or Rapaflo, to treat the signs and symptoms of benign prostatic hyperplasia.
Full Story >> Lawmakers send letter to Bayer seeking information regarding Aspirin with Heart Advantage.
ASHP Daily Briefing
Full Story >> CPOE implementation challenges could prompt medication errors, group warns.
ASHP Daily Briefing
Full Story >> Studies suggest three-drug combination may improve survival of patients implanted with drug-coated stents.
ASHP Daily Briefing
Full Story >> Antibiotic use may not prompt C. difficile infections, researchers suggest.
ASHP Daily Briefing
Full Story >> Herceptin has changed the nature of breast cancer, experts say.
Full Story >> TJC Anticoagulation Sentinel Event Alert
Read The Joint Commissions sentinel alert for anticoagulants.
Full Story >> Lawsuit alleges Pfizer urged suppression of unfavorable medical studies.
ASHP Daily Briefing
Pfizer accused of holding back negative studies or spinning negative data.
Full Story >> Rituximab may delay the progression of leukemia, study suggests
ASHP Daily Briefing
A late-stage study found that MabThera, in combination with chemotherapy, significantly improved progression-free survival in patients with relapsed or refractory chronic lymphocytic leukemia.
Full Story >> FDA says preliminary data reveal no increased stroke risk for patients taking Spiriva.
ASHP Daily Briefing
The AP (10/8) reports that, according to the Food and Drug Administration (FDA), "New data show no increased risk of stroke for patients using" tiotropium, "an inhaler drug."
Full Story >> The Eyes Have It!
Results of a two year, multicenter, randomized efficacy study show favorable results in the use of 2% pirenzepine ophthalmic gel in children who suffer from myopia.
Full Story >> To Treat or not to Treat?
Rob Stein - Washington Post
The use of cold medications intended for children has been the cause of much debate within the medical community.
Full Story >> Romiplostim-Newly Approved Drug for the Treatment of ITP
The treatment of immune thrombocytopenic purpura (ITP) has been enhanced by FDA’s recent approval of Nplate (romiplostim).
Full Story >> New Issue of Drug Safety Newsletter Available From FDA
Link to Volume 1 Issue 4
Full Story >> Internists Issue Guideline on Pharmacotherapy To Prevent Fractures
Click "Full Story" for link to full article text.
Full Story >> Company Warns Against Intraarticular Injections of Phosphocol
CHERYL A. THOMPSON
Covidien and its imaging solutions group Mallinckrodt Inc. want clinicians to know that the off-label injection of chromic phosphate P 32 suspension, or Phosphocol P 32, into a joint may increase the patient's risk for leukemia.
Full Story >> Researchers suggest beta blockers should not be used as first-line treatment for hypertension.
American Society of Health-System Pharmacists
Full Story >> Drugmaker launches website on medication safety
Pfizer Inc. sponsers new website.
Full Story >> FDA approves first anti-nausea patch for patients undergoing chemotherapy.
American Society of Health-System Pharmacists
Sancuso (granisetron transdermal system)
Full Story >> Article discusses debate surrounding safety and usefulness of Vytorin, Zetia.
American Society of Health-System Pharmacists
No proof Vytorin increases life expectancy or decreases heart disease but possible link to cancer being debated.
Full Story >> Rosuvastatin calcium may be no more effective than placebo, research suggests.
American Society of Health-System Pharmacists
Crestor showed no improvement over placebo for 4,574 patients.
Full Story >> Physicians recommend restrictions on thiazolidinediones due to increased risk of heart failure.
American Society of Health-System Pharmacists
Full Story >> FDA Approves Thrombopoiesis-Stimulating Agent
Cheryl A. Thompson
Amgen Inc. and FDA on Friday announced the approval of romiplostim, or Nplate, a drug that directly stimulates the bone marrow to produce platelets.
Full Story >> States Battle To Protect Physicians from Drug-Data Mining
Matthew Perrone - Assicuated Press
Several states are trying to limit the amount of prescription data that companies can mine for information about prescribers' habits.
Full Story >> Deaths from Severe Acute Pancreatitis Reported with Exenatide Use
Brooke F. Emmons
While FDA alerted health care professionals last fall of a possible connection between the use of exenatide and the development of acute pancreatitis, none of the pancreatitis cases reported to the agency involved severe disease . . . until now.
Full Story >> Eyrthropoiesis Stimulating Agents Labeling Update
Amgen and Ortho Biotech have made changes to labeling and patient information for darbepoetin alfa and epoetin alfa.
Full Story >> BYETTA LINKED TO PANCREATITIS
FDA Receives Reports of 6 Cases of Hemorrhagic or Necrotizing Pancreatitis since October 2007
Full Story >> FDA Issues Reminder About Simvastatin and Risk of Rare Muscle Disease
Greg Lavine
Despite revisions to simvastatin's labeling in 2002, federal officials continue to receive reports of a rare muscle condition, rhabdomyolysis, occurring in some patients taking the drug along with amiodarone, according to an FDA MedWatch issued August 8.
Full Story >> Old Diseases Pose New Infection Threats
Kate Traynor
Mosquitoes and other insects that spread disease to humans are increasingly appearing in new places on the planet, and the phenomenon may bode ill for human health in the United States and elsewhere.
Full Story >> Contrast Agent Approved for Liver Imaging
Cheryl A.Thompson
FDA in early July approved the marketing of gadoxetate disodium, a gadolinium-based contrast agent, for use during magnetic resonance imaging of the liver in adults. The product, known as Eovist, will be available this summer.
Full Story >> CMS Announces Prospective Payment System Final Rule for 2009
Full Story >> Decrease in Medical Residents’ Work Hours Fails to Decrease Mistakes, Study Finds
HRC Alert
Full Story >> Congress Easily Overrides Medicare Veto
By Michael Abramowitz and Paul Kane
President Bush sought to block a bill aimed at forestalling an 11 percent cut in payments to doctors taking care of Medicare patients, but Congress quickly overrode his veto.
Full Story >> Hospital Says its Pharmacy Error Led to Infant ODs
By CHRISTOPHER SHERMAN, Associated Press Writer
A hospital in Corpus Christi, Texas said that a mixing error that led to a blood thinner overdose in as many as 17 infants was caused by its pharmacy. Two of the babies involved have died.
Full Story >> Drug Industry in U.S. Will Pare Gifts to Physicians
By Robert Greene and Alex Nussbaum
The U.S. pharmaceutical industry revised its code of conduct, banning gifts to doctors such as pens, mugs, and restaurant meals.
Full Story >> FDA Proposes New Drug Labeling Rules for Pregnancy Information
GREG LAVINE
FDA officials are proposing an overhaul to the 29-year-old letter system for indicating drug-related risks and concerns for pregnant patients.
Full Story >> Safety Group Says Varenicline Poses Dangers besides Psychiatric
CHERYL A. THOMPSON
Blurred vision, seizures, and sudden loss of consciousness have occurred during varenicline therapy yet no official warnings exist to alert physicians and users, the Institute for Safe Medication Practices announced May 21.
Full Story >> New Drug To Restore Bowel Function Approved Under New FDA Rules
GREG LAVINE
FDA on May 21 approved a new drug to help restore normal bowel function after some types of abdominal surgery under new rules that allow several safety-related restrictions.
Full Story >> CDC Recommends Universal Zoster Vaccination for People 60 or Older
Full Story >> Inspect All Storage Areas for Recalled Heparin Products, FDA Says
Cheryl A. Thompson
FDA on May 9 asked health professionals and facilities to examine all drug and device storage areas, including automated drug storage cabinets, emergency kits, and dialysis units, to ensure that they do not contain recalled heparin products.
Full Story >> Public Health Services Declares 7 Medications First Line for Smoking Abstinence
Clink on "Full Story" for link to PHS's 2008 guidelines for treatment of smoking dependence.
Full Story >> Wal-Mart Supersizes Drug Discounts
Plan now allows for 90 supply of some medications at a reduced co-pay.
Full Story >> Measles Resurgence Worries Health Officials
The United States is in the midst of its largest measles outbreak since 2001, and experts fear the situation will worsen without efforts to eliminate pools of unvaccinated Americans.
Full Story >> Hospital Inspectors Eye Black-Box Warnings
Cheryl A. Thompson - American Society of Health-System Pharmacis
The federal government expects hospitals participating in the Medicare and Medicaid programs to have systems in place to minimize adverse events from medications that carry a higher-than-usual risk for untoward outcomes.
Full Story >> CMS Corrects Misstatement on Erythropoiesis-Stimulating Agents
An informational document issued earlier this year by the Centers for Medicare and Medicaid Services misstated one set of conditions that makes treatment with an erythropoiesis-stimulating agent reasonable and necessary for Medicare beneficiaries with sec
Full Story >> FDA Approves New Rotavirus Vaccine
GREG LAVINE
FDA announced the approval of a second oral vaccine to prevent rotavirus infection in infants and children.
Full Story >> Relenza Labeling Revised on Neuropsychiatric Event Reports
KATE TRAYNOR
FDA announced that new safety warnings about neuropsychiatric adverse events have been added to the labeling for GlaxoSmithKline's antiinfluenza drug zanamivir.
Full Story >> Record Number of Pharmacy Graduates to Enter Pharmacy Residencie
American Society of Health-Systems Pharmacists
Full Story >> Cardiovascular Risk of Celecoxib in 6 Randomized Placebo-Controlled Trials. The Cross Trial Safety Analysis
Circulation
Full Story >> Ziagen® May Increase Heart Attack Risk.
A study published online in The Lancet indicates that Ziagen® (abacavir, GlaxoSmithKline) almost doubled patients’ chances of heart problems
Full Story >> Relenza® Warning Updated
GlaxoSmithKline has announced changes to the Warnings and Precautions sections of prescribing information for Relenza®.
Full Story >> ACC Panel Knocks Vytorin®/Zetia®
A panel of cardiologists called on prescribers to sharply curtail their use of Vytorin®.
Full Story >> Nurses Risk Cross-Contamination by Borrowing Insulin Pens
Institute for Safe Medication Practices (ISMP)
The Institute for Safe Medication Practices (ISMP) has heard that nurses at one hospital have been administering insulin doses by using pens belonging to other patients. This practice, ISMP said, may introduce biological contamination into the insulin sol
Full Story >> Repeat Regranex Applications May Increase Cancer-Death Risk
CHERYL A. THOMPSON
There may be evidence that repeat applications of Regranex, or becaplermin, gel increase patients' risk of death from cancer, FDA announced March 27.
Full Story >> FDA Looking at Possible Suicide Risk for Singulair
GREG LAVINE
FDA is investigating a possible association between the use of an asthma drug and suicide, according to a recent MedWatch notice.
Full Story >> Free Drug Samples May Increase Expenses for Patients
GREG LAVINE
According to a new study, if there is no such thing as a free lunch, then there may be no such thing as a free drug sample.
Full Story >> Early Evidence Suggests Stroke Risk With Spiriva HandiHaler
GREG LAVINE
FDA released an Early Communication regarding a potential increased stroke risk for users of the Spiriva HandiHaler, which is used to treat chronic obstructive pulmonary disease.
Full Story >> Treanda Approved for Chronic Lymphocytic Leukemia
KATE TRAYNOR
Cephalon Inc. announced Thursday that FDA has approved bendamustine hydrochloride for injection, an alkylating agent, for the treatment of chronic lymphocytic leukemia.
Full Story >> New Fibrin Sealant Receives FDA Approval
GREG LAVINE
FDA approved a new product from Baxter Healthcare Corp. Thursday that will be used to help attach skin grafts to burn patients, the agency and company announced.
Full Story >> Heparin Contaminant Is Man-Made Substance, FDA Says
KATE TRAYNOR
Up to half of the active pharmaceutical ingredient in some batches of heparin that have been associated with severe adverse events consists of a chemically altered form of chondroitin sulfate, FDA announced March 19.
Full Story >> Firm Recalls Heparin Premix I.V. Solutions
CHERYL A. THOMPSON
B. Braun Medical Inc. announced March 21 that it is recalling 23 lots of heparin in 5% dextrose injection or 0.9% sodium chloride injection because the heparin in those products has a contaminant.
Full Story >> UCB Recalls Neupro Patch Because of Possible Clinical Problem
CHERYL A. THOMPSON
Brussels-based UCB announced March 20 that some of its Neupro rotigotine transdermal systems distributed in the United States may have "reduced clinical performance."
Full Story >> Lipid-Lowering Study Raises Issues of Therapy's Value
Cheryl A. Thompson
The finding of no statistically significant difference between the effects of simvastatin and ezetimibe-simvastatin on the major arteries to the head has put pharmacists in the position of reassuring patients about their lipid-lowering therapy.
Full Story >> FDA Approves Levoleucovorin
Kate Traynor
Levoleucovorin for injection, a single-isomer version of the folate analog leucovorin, has been approved for use as rescue therapy in patients with osteosarcoma treated with high-dose methotrexate.
Full Story >> Tiotropium Safety Monitoring Identifies Possible Increased Risk of Stroke
Boehringer Ingelheim and FDA notified healthcare professionals that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take Spiriva®.
Full Story >> Talecris Revises Directions for I.M. Immune Globulin Syringes
CHERYL A. THOMPSON
A second ready-to-administer immune globulin product from Talecris Biotherapeutics Inc. has new directions for use.
Full Story >> Internists Find Weak Evidence on Dementia Medications
Click on Full Story for link to study and practice guidelines.
Full Story >> Heart, Stroke Groups Update Stroke Secondary Prevention Guidelines
Click on Full Story for link to study.
Full Story >> Bristol-Myers Squibb Stops Selling Testolactone
The company recently announced that it stopped U.S. sales of the aromatase inhibitor, which is a Schedule III controlled substance.
Full Story >> Tamiflu Concerns for Young Patients Continue
GREG LAVINE
FDA and Roche Laboratories Inc. are reminding health care professionals to watch for neuropsychiatric events in patients taking oseltamivir phosphate, which has the brand name Tamiflu.
Full Story >> FDA Finds Contaminant in Baxter's Heparin
KATE TRAYNOR
FDA's investigation into the cause of adverse events in patients who received Baxter International Inc.'s heparin products is focusing on a contaminant found in some batches of the drug.
Full Story >> Cost Per Dose May Influence How Patients React to Drugs
By Rita Rubin, USA TODAY
A new study suggests that patients who took identical placebos were more likely to report better pain relief from a drug they believed cost more per dose than the cheaper drug.
Full Story >> Tamper Resistant Prescription Pads Implemented
The Centers for Medicare & Medicaid Services’ (CMS) regulation requiring the use of tamper resistant prescription pads for Medicaid beneficiaries will go into effect on April 1, 2008.
Full Story >> Baxter Recalls All Heparin except Premix IV Solutions in Bags
Cheryl A. Thompson
With FDA's assurance that there is an adequate supply of heparin products in the U.S. market, Baxter International Inc. on February 28 announced a recall of all lots and dosage units of its multidose and single-dose heparin sodium injection.
Full Story >> Wyeth Offers New Treatment for Major Depressive Disorder
Greg Lavine
Wyeth Pharmaceuticals announced Friday it has received FDA approval to market a new drug, under the brand name Pristiq, for the treatment of major depressive disorder in adults, according to a company statement. Pristiq has the generic name desvenlafaxine
Full Story >> Rilonacept Approved To Treat Rare Inflammatory Syndromes
Cheryl A. Thompson
Regeneron Pharmaceuticals Inc. and FDA on February 27 announced that the agency had approved rilonacept, or Arcalyst, for the treatment of two cryopyrin-associated periodic syndromes in patients age 12 years or older.
Full Story >> New Medication Guide Issued for Avandia®
The FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern.
Full Story >> Generic Manufacturer APP Scaling Up Heparin Production, Implementing Direct Shipment
Kate Traynor
APP Pharmaceuticals Inc. of Schaumberg, Illinois, is stepping up production of multidose vials of heparin sodium injection to avert a potential shortage of the drug, the company stated February 18.
Full Story >> Congressman Plans To Introduce Technician Law; ASHP To Launch Drive
By Kevin McCoy and Erik Brady, USA TODAY
According to USA Today, U.S. Representative Steven LaTourette of Ohio on February 26 will introduce legislation setting mandatory education, training, and regulatory standards for all pharmacy technicians.
Full Story >> Additional Antihemophilic Factor To Be Available
Cheryl A. Thompson
FDA announced February 21 that it approved the license for Wyeth Pharmaceuticals Inc. to manufacture Xyntha, a recombinant antihemophilic factor produced without plasma and albumin.
Full Story >> Drug doesn't help prevent migraine after all
Oxcarbazepine, an antiepileptic drug, may not be effective at preventing migraine headaches, according to a new study.
Full Story >> Wisconsin firm tied to troubled blood drug
David Greising and Bruce Japsen - Chicogo Tribune
FDA inspections under fire after Chinese plant is found to have made key ingredient in Baxter's popular thinner, heparin
Full Story >> Many lawsuits against pharmacies settled in silence
Erik Brady and Kevin McCoy USA Today
A series of stories in USA Today examines medication errors in community pharmacies.
Full Story >> International Diabetes Study Results Contradict US Trial on Death Risk
Large international study contradicts findings of U.S. sponsered trial.
Full Story >> Study: One in ten patients gets drug error at Mass. community hospitals
Patricia Wen - Boston Globe
Study examines six community hospitals in Mass.
Full Story >> Report Deems Pharmacists Successful Providers of Patient Care Services
American Society of Health-Systems Pharmacists
Pharmacists successfully resolved nearly 800 drug therapy problems, according to a recently released evaluation of the Medicare program.
Full Story >> New Budget Offers Modest Increase in FDA Funding
American Society of Health-Systems Pharmacists
The Food and Drug Administration (FDA)funding increase in President Bush’s proposed budget for fiscal year 2009 may not be enough to ensure that the agency has the resources it needs to effectively monitor drug safety.
Full Story >> Flu Cases Mount, Vaccine Not Well Matched to U.S. Virus Strains
Lisa Schnirring
Seasonal influenza is on the rise, and the federal government on Friday acknowledged that two of the three virus strains in this season's flu vaccine do not match currently circulating viruses.
Full Story >> Intensive Glycemic Control Harms High-Risk Patients with Diabetes
Rob Stein - Washington Post Staff Writer
The federal government announced February 6 that it has stopped using intensive glycemic control in the Action to Control Cardiovascular Risk in Diabetes trial because of more deaths in that treatment group than the one receiving standard therapy.
Full Story >> Baxter's Multiple-dose Vial Heparin Linked to Severe Allergic Reaction
FDA advises health care practitioners to switch suppliers and limit use of drug until problem identified
Full Story >> NEW DRUGS & DEVICES
TSHP E-News
Full Story >> Doctor Accused of Leak to Drug Maker
Stephanie Saul - New York Times -- January 31, 200
A reviewer for the New England Journal of Medicine forwarded to GlaxoSmithKline a prepublication copy of a report questioning the safety of the diabetes medication rosiglitazone, the New York Times reported.
Full Story >> Zotarolimus-Eluting Stent Gets FDA Approval
Kate Traynor
FDA on Friday approved the marketing of a coronary stent from Minneapolis-based Medtronic Inc. that elutes the drug zotarolimus, a new molecular entity available only as part of the drug–device combination product.
Full Story >> FDA Warns of Suicide Risk with Antiepileptic Drugs
Greg Lavine
FDA on January 31 released an analysis showing similar worries for patients of all ages taking drugs that treat epilepsy along with psychiatric disorders and other conditions.
Full Story >> FDA Issues Safety Warning for Chant
Greg Lavine
A review of nearly 40 patients who committed suicide while or after taking the smoking-cessation drug varenicline prompted FDA to issue a safety alert to health care providers February 1.
Full Story >> FDA Claims No New Safety Concern for Vytorin
Cheryl A. Thompson - American Society of Health-System Pharmacis
Despite what FDA officials acknowledged Friday as an unexpected result from a study of ezetimibe and simvastatin, they said the agency does not have a specific concern about the combination product Vytorin, which contains the two drugs.
Full Story >> Bayer Pulls Liquid Sargramostim from U.S. Market
Kate Traynor
Bayer HealthCare Pharmaceuticals has withdrawn from the market the company's liquid formulation of sargramostim, sold as Leukine, because the product has been linked to reports of fainting and other adverse events.
Full Story >> FDA Approves New HIV Drug for Marketing
Greg Lavine
FDA on January 18 announced that etravirine tablets have been approved for marketing as a treatment for HIV infection in adults. The drug will be marketed by Tibotec Therapeutics Corporation as Intelence.
Full Story >> Treat Invasive Aspergillosis with Voriconazole, Specialists Say
The Infectious Diseases Society of America recently updated its practice guidelines on the management of aspergillosis and now recommends voriconazole for the primary treatment of invasive disease in most patients.
Full Story >> New Drug and Biological Product Approvals, 2007
Kate Traynor
FDA last year cleared for marketing 29 new molecular entities and new biological products.
Full Story >> FDA Says Edetate Mix-Ups Can Be Deadly
Greg Lavine
At least two reported deaths since 2005 resulting from confusion in using two similarly named drugs--edetate disodium and edetate calcium disodium--prompted FDA on January 16 to issue a Public Health Advisory.
Full Story >> Recommendations for Use of Quadrivalent Meningococcal Conjugate Vaccine (MCV4)
ACIP revised its recommendation to state that MCV4 is preferable to MPSV4 for vaccination of children aged 2--10 years who are at increased risk for meningococcal disease.
Full Story >> Meta-analysis: Vitamin D Compounds in Chronic Kidney Disease
The meta-analysis of 76 randomized trials found that Vitamin D compounds do not consistently reduce PTH levels, and beneficial effects on patient-level outcomes are unproven.
Full Story >> Long term pharmacotherapy for obesity and overweight: updated meta-analysis
A British Medical Journal (BMJ) meta-analysis of three anti-obesity drugs (orlistat, sibutramine, and rimonabant) modestly reduce weight, have differing effects on cardiovascular risk profiles, and have specific adverse effects.
British Medical Journal N
Full Story >> FDA Clears First Quick Test for Drug-Resistant Staph Infections
The Food and Drug Administration has just approved the first rapid blood test for methicillin-resistant Staphylococcus aureus.
Full Story >> Adverse Effects of Combination Angiotensin II Receptor Blockers Plus Angiotensin-Converting Enzyme Inhibitors for Left Ventricular Dysfunction
Although current heart failure guidelines do not recommend concurrent use of angiotensin II receptors blockers and angiotensin-converting enzyme inhibitors, this strategy has gained popularity among clinicians.
Full Story >> No Difference in Risk for Thrombocytopenia During Treatment of Pulmonary Embolism and Deep Venous Thrombosis With Either Low-Molecular-Weight Heparin or Unfractionated Heparin
Abstract of the Metaanalysis
Full Story >> Nation's Hospital Bill
Jumped by 7% in 2005
THEO FRANCIS
A handful of high-cost and high-volume conditions helped drive the national hospital bill up 7% in 2005.
Full Story >> Minimize ESAs When Thromboembolism Risk Is High, Oncology Group Says
When prescribing epoetin or darbepoetin to patients with cancer, carefully weight the risks of thromboembolism.
Full Story >> Blood Volume Expander Licensed
KATE TRAYNOR
FDA licensed the synthetic product Voluven, a 6% hydroxyethyl starch injection, for the prevention and treatment of dangerously low blood volume.
Full Story >> Gene Screen Asian Patients before Starting Carbamazepine
KATE TRAYNOR
Patients of Asian ancestry are at increased risk for dangerous skin reactions to the anticonvulsant drug carbamazepine.
Full Story >> First Drug Approved for Treatment of Phenylketonuria
CHERYL A. THOMPSON
FDA approved the marketing of a drug that may help up to half of U.S. patients with phenylketonuria, an inborn metabolic disorder that can lead to mental retardation and other neurologic problems.
Full Story >> Interrupt Deferasirox Therapy If Liver Enzymes Rise, Novartis Says
CHERYL A. THOMPSON
Novartis has strengthened its warning about the possibility of liver failure occurring during therapy with deferasirox.
Full Story >> New Beta-Blocker Gets FDA Approval
KATE TRAYNOR
A new beta-blocker from Mylan and Forest Laboratories was approved last week for marketing in the United States, FDA announced.
Full Story >> FDA Says Fentanyl Patches Still Used Inappropriately
KATE TRAYNOR
FDA on December 21 reiterated a warning issued more than two years ago about dangers associated with the inappropriate use of fentanyl transdermal patches.
Full Story >> Pharmacists Want FDA to Create New Intermediate Drug Category
KATE TRAYNOR
During a public meeting in November, pharmacists and pharmacy associations voiced support for the creation of an intermediate class of drugs that could be dispensed by a pharmacist without a prescription.
Full Story >> Trade Group Says Thwarting Drug Counterfeiters Remains Challenging
KATE TRAYNOR
Counterfeiting schemes involving pharmaceutical products are growing in sophistication, even as manufacturers adopt new technologies to tackle the problem, according to a French organization that monitors global trade issues.
Full Story >> Community-Acquired Skin Infections Remain Treatable
CHERYL A. THOMPSON
As news about methicillin-resistant Staphylococcus aureus infections in schools and other community settings seemingly circulated nonstop this past fall, health experts worked to calm the public.
Full Story >> USP Releases Chapter 797 Revision
CHERYL A. THOMPSON
The new version of United States Pharmacopeia chapter 797, "Pharmaceutical Compounding--Sterile Preparations," became publicly available Monday and goes into effect June 1, 2008.
Full Story >> FDA Investigating Psychiatric Events among Chantix Users
Kate Traynor
FDA is investigating cases of suicidal thoughts and aggressive behavior in patients who have taken the smoking-cessation drug varenicline, sold by Pfizer as Chantix.
Full Story >> Physician Gives Behind-the-Scenes Look at Speaking Engagements
New York Times
In an essay for the New York Times Magazine, a private-practice psychiatrist described his experience as a paid lunchtime speaker for a drug company.
Full Story >> ASHP Responds to Medication Errors Harming Actor's Babies
The recent medication error involving dangerous doses of heparin to the newborn children of actor Dennis Quaid highlight the continuing imperative to make real progress in eliminating medication errors.
Full Story >> Label All Drug-Containing Syringes, ISMP Advises
ISMP
The Institute for Safe Medication Practices reminds pharmacists that unlabeled drug-containing syringes pose a danger throughout the hospital, not just the surgical suite.
Full Story >> FDA-MedWatch- Chantix (Varenicline)-FDA Reviewing Post Marketing Cases Describing Suicidal Ideation And Occasional Suicidal Behavior
FDA MedWatch
FDA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken Chantix.
Full Story >> Essential Hypertension Responds Similarly to ACEIs, ARBs
A government-funded review of the evidence on angiotensin-converting-enzyme inhibitors and angiotensin II-receptor antagonists found that the two groups of drugs performed equally well in treating essential hypertension.
Full Story >> Hospitals Need to Improve Medication Reconciliation, Joint Commission Says
Kate Traynor
In general, hospitals accredited by the Joint Commission fared poorly last year at meeting the provisions of the accrediting agency's national patient safety goal on medication reconciliation, according to a report released today by the organization.
Full Story >> CMS Adopts Process for Evaluating Official Compendia
A new rule recently issued by the Centers for Medicare and Medicaid Services will ensure that patient care involving the off-label use of medications will be guided by objective, evidence-based drug information, a move championed by ASHP.
Full Story >> FDA Advisers Wary of Expanding Quetiapine Use
FDA advisers unanimously agreed that the drug should not be used as a first-line monotherapy for major depressive disorder or generalized anxiety disorder.
Full Story >> New CML Therapy Approved
KATE TRAYNOR
FDA recently approved the marketing of nilotinib oral capsules, a tyrosine kinase inhibitor developed by Novartis, for the treatment of certain patients with advanced chronic myelogenous leukemia.
Full Story >> Law Gives FDA New Enforcement Clout
KATE TRAYNOR
More than two years after problems with Merck's rofecoxib product, Vioxx, turned a public spotlight on drug safety, FDA has gained new powers to regulate medications after they reach the market.
Full Story >> CMS Final Rules Published: Mixed Results for Pharmacists
ASHP Press Release
There's good news and bad news for pharmacists in the final rule published last week by the Centers for Medicare and Medicaid Services in its "Final Changes to the Hospital Outpatient Prospective Payment System and CY 2008 Payment Rates."
Full Story >> Patient Enrollment in the Aprotinin Treatment Group Arm of BART Study Stopped
VHA E-News
Health care professionals who are considering using Trasylol should be aware of the risks and benefits.
Full Story >> 'Next-Generation' Polymer Approved as Phosphate Binder
Cheryl A. Thompson
Genzyme Corporation on October 22 announced that FDA approved the marketing of sevelamer carbonate, or Renvela, for the control of serum phosphorus concentrations in patients with chronic kidney disease who are undergoing hemodialysis or peritoneal dialys
Full Story >> Scarce pandemic vaccine to be given in order
Anita Manning - USA Today
In the early weeks of a flu pandemic, the first to receive scarce supplies of vaccine will include the military, medical and emergency workers, pregnant women and babies — nearly 23 million people — under a draft federal plan.
Full Story >> Updates to CPT Codes Provide New MTMS Opportunities for Pharmacists
The Pharmacist Services Technical Advisory Coalition recently obtained approval for permanent CPT codes for billing pharmacists’ medication therapy management services.
Full Story >> Chlorhexidine Gluconate Baths Effective in Preventing Infections in MICU
This study found that in medical intensive unit patients, the use of chlorhexidine gluconate (CHG) in daily baths resulted in less primary bloodstream infections compared to patients who bathed with soap and water. Archives of Internal Medicine
Full Story >> Asthma Care Gets Comprehensive Update
Cheryl A. Thompson
The National Asthma Education and Prevention Program on August 29 released what the federally funded group called "the first comprehensive update in a decade" of guidelines for the diagnosis and management of asthma.
Full Story >> Sildenafil, Tadalafil, Vardenafil Linked to Sudden Hearing Problems
Cheryl A. Thompson
FDA announced October 18 that the labeling for erectile dysfunction drugs in the class known as selective phosphodiesterase inhibitors now "more prominently" display the potential risk of sudden hearing loss in users.
Full Story >> FDA Approves New Breast Cancer Treatment
Cheryl A. Thompson
Bristol-Myers Squibb and Company announced October 16 that FDA approved the marketing of ixabepilone for the treatment of certain types of metastatic or locally advanced breast cancer. The drug is sold under the brand name Ixempra Kit.
Full Story >> Zoledronic Acid and Clinical Fractures and Mortality after Hip Fracture
New England Journal of Medicine
Yearly intravenous zoledronic acid (5mg) within 90 days after surgical repair of hip fracture in conjunction with supplemental vitamin D and calcium decreased rates of new clinical fracture and mortality from any cause with a median follow-up of 1.9 years
Full Story >> Statin Use Reduces Decline in Lung Function
American Journal of Respiratory and Critical Care Medicine
Investigators showed that the cholesterol-lowering drugs reduced the decline of lung function in older adults and that this benefit was modified by smoking status.
Full Story >> Influence of Renal Function on the Efficacy and Safety of Fondaparinux Relative to Enoxaparin in Non–ST-Segment Elevation Acute Coronary Syndromes
Annals of Internal Medicine
Fondaparinux may have benefits over enoxaparin when used for non-ST segment elevation acute coronary syndrome.
Full Story >> Infant Cold Remedies To Exit Market
Several major manufacturers of nonprescription drug products are voluntarily withdrawing from the market cough and cold preparations labeled for use in children less than two years old, the Consumer Healthcare Products Association announced October 11.
Full Story >> Microbubble Contrast Agents Linked to Deaths, Serious Reactions
FDA
Eleven people have died after receiving erflutren lipid microsphere injectable suspension or perlutren protein-type A microspheres for injection as part of echocardiography.
Full Story >> Doripenem Becomes 4th Carbapenem on U.S. Market
Cheryl A. Thompson
Ortho-McNeil Pharmaceutical Inc. announced Monday that FDA has approved the marketing of Doribax, or doripenem, for the treatment of complicated intraabdominal and urinary tract infections in adults.
Full Story >> AHRQ: Decline in Selected Inpatient Mortality Rates
Latest report from the Agency for Healthcare Research and Quality shows improved patient outcomes over a ten year period.
Full Story >> More Hospitals Lag Than Leap on Quality
By Theo Francis
41 hospitals spotlighted in the Leapfrog Groups latest report.
Full Story >> Drugs That Go Untaken
By Katherine Hobson
Too often, lifesaving medicine is prescribed but not used
Full Story >> FDA Investigates Atrial Fibrillation in Bisphosphonate Users
Cheryl A. Thompson
FDA continues to investigate the association between the use of bisphosphonates and the onset of atrial fibrillation.
Full Story >> Generic Drug Approvals Up, but Backlog Persists
Kate Traynor
Officials at FDA's Office of Generic Drugs approved a record number of marketing requests during the 2007 fiscal year, but the office is unable to keep pace with the number of applications that it receives.
Full Story >> FDA Seeks Public Input on 'Behind-the-Counter' Drugs
FDA considers a third category of medication control prescription only, over the counter, and behind the counter.
Full Story >> Program gives pharmacists more clout in patient care
Julie Appleby, USA TODAY
Across the country pharmacists are helping physicians manage drug therapy for patients with chronic diseases.
Full Story >> Firms Issues Joint Letter on Gadolinium-Based Contrast Agents
Nephrogenic systemic fibrosis due to gadolinium based contrast agents.
Full Story >> NGC Releases Lipid Management Guidelines for Adults
Click on "full story" for guideline link.
Full Story >> Medical Illiteracy Can be Deadly for Older Patients
VHA E-News
Study published in the Archives of Internal Medicine indicated that giving an elderly patient written instructions about their medical treatment may not be enough.
Full Story >> ISMP Reviews Fatal Fluorouracil Overdose
The August 2006 death of a Canadian woman with cancer who received four days' worth of fluorouracil in four hours was reviewed by the Institute for Safe Medication Practices, which also offered six "safe practice recommendations."
Full Story >> IV Haloperidol Linked to Dangerous Heart Rhythms
Cheryl A. Thompson
Patients receiving "high" doses of injectable haloperidol, particularly by the i.v. route, which is an off-label practice.
Full Story >> Health Care Workers Urged To Get Vaccinated Against Flu
Kate Traynor
Infectious-disease experts who attended a media briefing September 19 in Washington, D.C., decried the nation's low influenza vaccination levels and singled out health care workers as a group that needs to improve its vaccination rate.
Full Story >> Roche Again Revises Ceftriaxone Labeling
KATE TRAYNOR
Roche Laboratories, in a Dear Healthcare Professional letter dated August 2007, announced further changes to the labeling for Rocephin, the company's ceftriaxone for injection product.
Full Story >> FDA Panel Vote Is a Win for Amgen, J&J
ANNA WILDE MATHEWS
Panel voted 14-5 against a proposed reduction in the FDA's recommended top target for anti-anemia drugs.
Full Story >> Joint Commission Proposes Revisions to Medication Management Standards
Proposed revisions in Medication Management Standards are open to public comments.
Full Story >> Updated pharmacogenomics labeling information for Coumadin
Patient's genetic code determines therapeutic response to Coumadin.
Full Story >> CMS Launches Physician Quality Reporting Initiative
Voluntary program may result in higher reimbursement for physicians.
Full Story >> FDA, Cephalon Warn of Deaths from Improper Fentora Use
Kate Traynor
Failures to strictly follow instructions for Fentora fentanyl buccal tablets are behind recently reported deaths and other adverse events in patients who received the product.
Full Story >> New Joint Commission Rule Seeks Safer Anticoagulation
Bruce & Joan Buckley - Pharmacy Practice News
The Joint Commission’s sole medication-related National Patient Safety Goal (NPSG) for 2008 tackles one of healthcare’s thorniest issues: how to manage anticoagulant therapy safely.
Full Story >> Suicide Rate, Antidepressant Use in Youths Head Opposite Directions
Cheryl A. Thompson - American Society of Health-System Pharmacis
The suicide rate among U.S. youths and young adults age 10–24 years increased by 8% over the same time that antidepressant prescribing decreased.
Full Story >> FDA Approves Dexrazoxane Product for Extravasation
Kate Trayor - American Society of Health-System Pharmacists
FDA this week announced the approval of Totect, a kit containing dexrazoxane for injection, for the treatment of extravasation in patients undergoing anthracycline chemotherapy.
Full Story >> National Asthma Education and Prevention Program Updates Guidelines for Asthma Management
The Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma -- Full Report, 2007.
Full Story >> Medicare Says It Will not Cover Hospital Errors
Robert Pear - NY Times
In a significant policy change, administration officials say that Medicare will no longer pay the extra costs of treating preventable errors, injuries and infections that occur in hospitals.
Full Story >> Medical Errors: Doctors are human and make mistakes too
Doctors experience significant distress when they do make a error, according to a new study of more than 3,100 doctors in the United States and Canada.
Full Story >> FDA Licenses Human Thrombin Product (Evithrom)
Kate Trayor - American Society of Health-System Pharmacists
Evithrom is the first human thrombin product to be approved in more than 50 years and the only such product that is currently licensed in the United States.
Full Story >> Judge certifies class action against McKesson
Health Imaging News
A U.S. District judge yesterday certified a class-action lawsuit against McKesson for allegedly conspiring to inflate the average wholesale price (AWP) of prescription drugs.
Full Story >> Oseltamivir Remains Primary Recommended Antiviral for Bird Flu
Twenty two page recommendation from the World Health Organization
Full Story >> Obesity Rates in America Climb
Link to "Trust for America's Health Reports"
Full Story >> Painkiller Sales in 2004 Nearly Double of 1997
Frank Bass - Associated Press
Link to Miami Herald & Associated Press investigation of increased use of painkillers.
Full Story >> Updated ACCE Guidelines on Managing Diabetes Mellitus
View entire update.
Full Story >> New Class of Antihypertensives Drugs Available
VHA E-News
Aliskiren, approved by the Food and Drug Administration in March, 2007, is the first in a new class of antihypertensives called direct renin inhibitors.
Full Story >> Codeine Products Should be Avoided in Breastfeeding Mothers
VHA E-News
FDA warns that use of codeine products by some breastfeeding mothers may lead to life-threatening side effects in nursing babies.
Full Story >> New Warfarin Labeling Encourages Genetic Testing of New Users
FDA News
The Dosage section of the labeling for warfarin products now tells prescribers to consider using lower starting doses for patients with certain variations in the genes encoding cytochrome P-450 isoenzyme 2C9 and vitamin K epoxide reductase complex subunit
Full Story >> Patient Death Prompts Kaletra Oral Solution Warning
Heather M. Groeschen - American Society of Health-System Pharmac
An accidental overdose of Kaletra, or lopinavir and ritonavir, solution caused a 44-day-old infant born at 30 weeks' gestation to die from cardiogenic shock, according to a letter from Abbott Laboratories posted on the FDA website August 14.
Full Story >> Report Estimates True Tachyphylaxis Rates during Continuation Treatment with Newer Antidepressants
Heather M. Groeschen - American Society of Health-System Pharmac
The majority of relapses during continuation treatment with new-generation antidepressants may occur in patients who did not actually respond to the medication, according to a meta-analysis published in the August issue of the Journal of Clinical Psychiat
Full Story >> These Drugs Are for Colds, Not Fidgets
Leslie Berger - New York Times
Cold medicines often miss used by parents to calm restless children.
Full Story >> Manufacturers of Some Thiazolidinedione Drugs to Strengthen Warning on Heart Failure Risk
VHA E-News
Black boxed warning of heart failure risks being added to entire thiazolidinedione class of antidiabetic drugs.
Full Story >> American Heart Groups Revise Guidelines on Unstable Angina, Non-ST-Elevation MI
VHA E-News
Full Story >> FDA Says Red Yeast Supplements Illegally Contain Lovastatin
Kate Trayor - American Society of Health-System Pharmacists
FDA last week warned two companies to immediately stop promoting and selling red yeast products that contain the cholesterol-lowering drug lovastatin.
Full Story >> Uncertain Effects of Rosiglitazone on the Risk for Myocardial Infarction and Cardiovascular Death
George A. Diamond, MD; Leon Bax, MSc; and Sanjay Kaul, MD
Recent meta-analysis showing a link between the use of rosiglitazone and increased cardiovascular events is questioned by this study published in the Annals of Internal Medicine.
Full Story >> FDA Examining Possible Heart Risks of Omeprazole, Esomeprazole
Kate Trayor - American Society of Health-System Pharmacists
FDA announced that it is reviewing all available safety data on omeprazole and esomeprazole after information emerging in clinical trials of the drugs hinted that they might put patients at risk for cardiovascular events.
Full Story >> Experts to FDA: Let Avandia Stay
Donna Young - American Society of Health-System Pharmacists
Advisers Call for Stronger Warnings, More Data.
Full Story >> Study finds medicine misuse occurs all too frequently
LAURAN NEERGAARD - Associate Press
Millions may not be taking their drugs properly, according to report
Full Story >> Reminder: "The Advisory Committee on Immunization Practices recommends the routine use of Tdap vaccines"
Centers for Disease Control
Combined Tetanus, Diphtheria and Pertussis (Tdap) Vaccines
Full Story >> FDA Allows Limited Tegaserod Availability
Kate Trayor - American Society of Health-System Pharmacists
FDA announced July 27 that tegaserod maleate, a product formerly marketed by Novartis as Zelnorm, is being made available to certain patients through a treatment investigational new drug protocol.
Full Story >> Baxter Recall Woes Mount
Kate Trayor - American Society of Health-System Pharmacists
FDA on Friday announced a new class 1 recall of six models of Baxter Colleague and Flo-Gard volumetric infusion pumps because repair and service records for the devices have been falsified.
Full Story >> Oral Diabetes Drugs Perform Roughly Equally, Researchers Found
Agency for Healthcare Research & Quality
Published evidence through January 2006 suggests that thiazolidinediones, second-generation sulfonylureas, metformin, and repaglinide, when taken alone, produced similar absolute reductions in glycosylated hemoglobin.
Full Story >> Venous Thromboembolism in the Outpatient Setting
Arch Intern Med. 2007;167:1471-1475.
Full Story >> Rofecoxib and Cardiovascular Adverse Events in Adjuvant Treatment of Colorectal Cancer
Abstract - New England Journal of Medicine
Full Story >> FDA Nanotechnology Report Outlines Scientific, Regulatory Challenges
FDA News
(FDA)'s Nanotechnology Task Force released a report that recommends the agency consider developing guidance and taking other steps to address the benefits and risks of drugs and medical devices using nanotechnology.
Full Story >> Antidepressant-Induced Liver Injury
Psychiatry - Abstract
Study shows most antidepressant agents have potential to damage liver.
Full Story >> Ongoing, preventable fatal events with fentanyl transdermal patches are alarming!
Institute for Safe Medication Practices
Despite warnings from the FDA, manufacturers, and various patient safety agencies, fentanyl transdermal patches continue to be prescribed inappropriately.
Full Story >> Reducing Inappropriate Antimicrobial Use in EDs Possible but Challenging
Kate Trayor - American Society of Health-System Pharmacists
The latest results from a study designed to reduce the inappropriate prescribing of antimicrobials in hospital emergency departments (EDs) describe some progress as well as challenges to achieving significant and consistent change.
Full Story >> Venous Thromboembolism Risk Common in Inpatients, Researchers Say
Cheryl A. Thompson - American Society of Health-System Pharmacis
Nearly one in three medical and surgical patients who spend at least two days in the hospital are at risk of venous thromboembolism (VTE).
Full Story >> Antibiotics Won't Prevent Urinary Tract Infections in Kids: Study
Amanda Gardner - Washington Post
Giving antibiotics to prevent recurrent urinary tract infections in small children won't help and may even hurt.
Full Story >> Pharmacy Computer System Safety Workgroup Results Released by Patient Safety Authority in Supplementary Advisory
Patient Safety & Health Care
The results show pharmacy computer systems in Pennsylvania facilities are not detecting unsafe drug orders as well as they could be.
Full Story >> FDA-MedWatch- Rocephin (ceftriaxone sodium)- Contraindications, Warnings, Precautions, Adverse Reactions, Dosage And Administration Sections of Labeling Revised
FDA-MedWatch -- 07/05/2007
Rocephin (ceftriaxone)must not be mixed or administered simultaneously with calcium-containing solutions or products, even via different infusion lines.
Full Story >> Drug Sales Reps Sue Drug Companies For Unfair Labor Practices
TSHP E-News
Abbott Laboratories was hit with a class-action lawsuit on June 28 from current and former drug sales reps, claiming that the company has violated state and federal overtime laws.
Full Story >> Keeping Patients’ Details Private, Even From Kin
Jane Gross - New York Times
Has government regulations made it safer to just say no?
Full Story >> Is Daptomycin the First-Line Choice for Battling MRSA?
Jan Greene - Pharmacy Practice News
As methicillin resistance continues to climb, infectious disease experts debate optimal management strategies.
Full Story >> Drug Innovation On the Decline
Cornelia Kean - Pharmacy Practice News
The number of new drugs entering the U.S. market has declined sharply in the past decade.
Full Story >> CDC Updates Flu Vaccination Recommendations
Kate Trayor - American Society of Health-System Pharmacists
Health care facilities may want to consider the level of influenza vaccine coverage among staff as a formal measure of patient safety.
Full Story >> Patient Death Prompts Colistimethate Warning
Kate Trayor - American Society of Health-System Pharmacists
FDA this week issued a public health advisory after receiving a report of a patient who died after using a nebulizer containing an antiinfective drug that is labeled for injection only.
Full Story >> Antidepressants may increase birth defects
TSHP E-News
Two new studies, published on June 28 in the New England Journal of Medicine, found elevated risks of birth defects associated with certain antidepressants when taken by pregnant women.
Full Story >> Hazardous Drugs List May Increase Substantially
VHA/Novation News
Comments to NIOSH must be received by September 20th.
Full Story >> FDA Approves Patient-Operated Dispensing Device
Donna Young - American Society of Health-Systems Pharmacists
FDA has granted marketing approval for an in-home electronic drug dispensing device that gives pharmacists and other health care providers the ability to remotely manage a patient's drug therapy.
Full Story >> Pfizer's Lyrica OK'd for Fibromyalgia
Donna Young - American Society of Health-System Pharmacists
Regulators cleared the way for Pfizer to market its prescription drug pregabalin, or Lyrica, for the management of fibromyalgia, a disorder characterized by pain, fatigue, muscle stiffness, and sleep problems.
Full Story >> 2008 Joint Commission Safety Goal Targets Anticoagulants
Cheryl A. Thompson - American Society of Health-System Pharmacis
The Joint Commission has selected safer anticoagulant use as a National Patient Safety Goal for 2008.
Full Story >> UCSF study questions drug trial results
When drug companies sponsor research, their products more likely to perform well
Victoria Colliver - San Francisco Chronicle
Money talks -- and very loudly when a drug company is funding a clinical trial involving one of its products.
Full Story >> Pay Shows Scant Effect On Medical Treatment
Thomas Burton & Theo Francis - Wall Street Journal
A central premise of the government's Medicare planners in recent years has been a concept called "pay for performance" -- the idea that medical care can be improved by financially rewarding better treatment.
Full Story >> In Health Care, Cost Isn’t Proof of High Quality
Reed Abelson - New York Times
Stark evidence that high medical payments do not necessarily buy high-quality patient care is presented in a recently released hospital study.
Full Story >> ASHP Releases Vision for Pharmacy Work Force in Hospitals and Health Systems
American Society of Health-Systems Pharmacists
The American Society of Health-System Pharmacists has released a land-mark vision document for the future of the pharmacy work force in hospitals and health systems.
Full Story >> FDA Investigating Propofol-Related Illnesses
Kate Trayor - American Society of Health-System Pharmacists
FDA has received reports over the past few months describing cases of fever, chill, and body aches in several "clusters" of patients shortly after the administration of the anesthesia drug propofol.
Full Story >> Lung Disorder Drug Approved
Donna Young - American Society of Health-System Pharmacists
FDA has granted marketing approval for ambrisentan, or Letairis, an endothelin-receptor antagonist indicated for the once-daily treatment of pulmonary arterial hypertension (PAH).
Full Story >> Cephalon's Nuvigil Wins U.S. Approval
Donna Young - American Society of Health-System Pharmacists
Cephalon Inc. today announced that it has received U.S. marketing approval for armodafinil, or Nuvigil, an oral medication indicated to treat adults with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy,
Full Story >> ASHP Seeks Member Input on Draft Comments to Joint Commission
Full Story >> Experts Probe Safety Concerns of Anemia Drugs
Donna Young - American Society of Health-System Pharmacists
FDA is grappling with how best to ensure that patients receiving drugs to correct anemia or raise hemoglobin levels are not exposed to serious adverse effects.
Full Story >> A.S.P.E.N. Statement on Parenteral Nutrition Standardization
Full Story >> New Perspective Urged to Combat Resistant Microbes
Kate Trayor - American Society of Health-System Pharmacists
Policymakers should regard antimicrobial effectiveness as a national resource
Full Story >> Urgent Bulletin—Update on Standard MM 4.10
The Joint Commission
The Joint Commission will now permit organizations to implement the two exceptions in Standard MM 4.10, EP 1 more broadly in order to minimize treatment delays and patient back-up.
Full Story >> FDA Urges Avoiding Toothpaste from China; May Affect Custom Kits from Novation Suppliers
VHA E-News
The Food and Drug Administration (FDA) recently issued a warning to consumers regarding toothpaste coming from China.
Full Story >> Closing smaller neonatal units could save thousands each year, report finds
Associated Press
Thousands of sickly newborns could be saved each year if officials closed some of the nation’s smaller neonatal intensive care units.
Full Story >> FDA Provides List of IVIG Products, Indications
Now in one place, the complete list of 12 FDA-licensed i.v. immune globulin products and their indications for use.
Full Story >> New Hay Fever, Hives Treatment Approved
Donna Young - American Society of Health-System Pharmacists
FDA approves levocetirizine dihydrochloride, or Xyzal, an oral antihistamine for the relief of symptoms associated with seasonal and perennial allergic rhinitis and uncomplicated skin manifestations of chronic idiopathic urticaria.
Full Story >> Torisel Approved for Advanced Kidney Cancer
Kate Trayor - American Society of Health-System Pharmacists
FDA announced that the agency has approved the marketing of temsirolimus injection, or Torisel, for the treatment of patients with advanced renal cell carcinoma.
Full Story >> FDA announced the approval of LybreL
Kate Trayor - ASHP
FDA announced the approval of Lybrel, Wyeth Pharmaceuticals' combination oral contraceptive regimen that is designed to suppress menstruation.
Full Story >> Deferasirox Linked to Fatal Renal Failure, Cytopenias
Cheryl A. Thompson - American Society of Health-System Pharmacis
An unspecified number of patients who received the oral iron-chelating agent deferasirox have died of acute renal failure or conditions resulting from insufficient blood cells.
Full Story >> Many Products Containing Sustained Release Guaifenesin Ordered off the Market
Donna Young - American Society of Health-System Pharmacists
Regulators today told manufacturers of hundreds of unapproved drug products containing guaifenesin in "timed-release" form that they have 90 days to stop making those products.
Full Story >> FDA Mulls Over Paperless Labeling
Donna Young - American Society of Health-System Pharmacists
Electronic medication package inserts (PIs), or "paperless" labeling, would give health care providers immediate access to the most current prescribing information.
Full Story >> Medicare May Limit Anemia-Drug Money
Jennifer Corbett Dooren & Marilyn Chase - Wall Street Journal
The government proposed limiting Medicare payments for use of antianemia drugs by Amgen Inc. and Johnson & Johnson.
Full Story >> FDA Requests Boxed Warning Addition to Gadolinium-Based Contrast Agents
FDA requests a boxed warning about the risk of nephrogenic systemic fibrosis (NSF)for all gadolinium-based contrast agents (GBCAs).
Full Story >> Sanofi-Aventis' Lovenox® Approved for Additional Indication.
The FDA recently approved Lovenox (enoxaparin sodium injection), for the treatment of patients with acute ST-segment elevation myocardial infarction (STEMI).
Full Story >> Rosiglitazone May Increase MI Risk, Data Suggest
Cheryl A. Thompson - American Society of Health-System Pharmacis
Study results released online today by the New England Journal of Medicine suggest that patients taking rosiglitazone to manage their type 2 diabetes mellitus have an increased risk of myocardial infarction (MI).
Full Story >> FDA Approves First U.S. Vaccine for Humans Against the Avian Influenza Virus H5N1
FDA
The Food and Drug Administration (FDA) announces the first approval in the United States of a vaccine for humans against the H5N1 influenza virus, commonly known as avian or bird flu.
Full Story >> Use of Statins Could Cut Lung Cancer Risk
Chest.2007; 131: 1282-1288
Full Story >> OxyContin maker and executives plead guilty to misleading public
Associated Press
The Connecticut maker of the powerful painkiller OxyContin and three of its current and former executives pleaded guilty to misleading the public about the drug’s risk of addiction.
Full Story >> FDA Approves First Parkinson's Patch
Cheryl A. Thompson - American Society of Health-System Pharmacis
Patients in the early stage of Parkinson's disease now have a once-daily alternative to swallowing their medication.
Full Story >> Heart Failure Patients Benefit with Pharmacist's Care
Kate Trayor - ASHP
A pharmacist-managed education program for patients with heart failure resulted in lower hospitalization rates and emergency-room visits for patients and improved medication adherence, according to a report in the May 15 Annals of Internal Medicine.
Full Story >> Results from the SURVIVE Trial Show No Difference in All-Cause Mortality Between Levosimendan and Dobutamine in Acute Decompensated Heart Failure
VHA Pharmacy E-News
Full Story >> CVS seeks to open clinics in its stores
Liz Kowalczyk - Boston Globe
Could "Minute Clinic" be the trend of the future?
Full Story >> ACTION NEEDED TO PREVENT DANGEROUS HEPARIN-INSULIN CONFUSION
From ISMP May 3, 2007 issue
Heparin and insulin mix ups are more common than one thinks and can be fatal for patients.
Full Story >> Breast Cancer Decline Tied to Drop in HRT Use
Kate Trayor - ASHP
A rapid U.S. decline in the use of hormone replacement therapy (HRT) since 2002 may have prevented thousands of cases of breast cancer.
Full Story >> Anemia Drug Use Highest in For-Profit Dialysis Centers
Donna Young ASHP
Epoetin alfa, marketed as Epogen by Amgen and Procrit by Ortho Biotech, is the largest single drug expenditure for Medicare
Full Story >> Illicit Fentanyl Suspected in Opioid Overdoses
Cheryl A. Thompson - American Society of Health-System Pharmacis
The Drug Enforcement Administration (DEA) on Monday said it had "strong indication" that hundreds of confirmed fentanyl-related deaths in the Middle Atlantic States and Midwest in 2005 and 2006 were connected to illicit manufacturing activities, not drug
Full Story >> FDA Declines to Approve Merck's Arcoxia
Donna Young - American Society of Health-System Pharmacists
Merck's hopes to market its latest arthritis drug in the United States were dashed today when FDA issued the company a "non-approvable" letter for etoricoxib, or Arcoxia.
Full Story >> Fluoroquinolones No Longer Advised for Gonorrhea
Donna Young - ASHP -- April 18, 2007
The Centers for Disease Control and Prevention (CDC) is no longer recommending fluoroquinolones to treat gonococcal infections.
Full Story >> Surgical Units Have High Potential for Harmful Medication Errors, USP Says
Cheryl A. Thompson - American Society of Health-System Pharmacis
Medication use in hospital surgical suites and related patient care areas lacks comprehensive oversight, increasing the chance of harmful errors, the United States Pharmacopeia (USP) announced in releasing its newest report on patient safety.
Full Story >> "Drugs don't work in patients who don't take them"
Rita Rubin USA Today -- April 3, 2007
Only about half of people with chronic health conditions continue to take medication as directed.
Full Story >> Some Hospitals Call 911 to Save Their Patients
Reed Abelson - New York Times -- Published April 2, 2007
That happened recently in Texas, where a 44-year-old man named Steve Spivey developed breathing problems after spine surgery.
Full Story >> FDA Approves Drug to Treat Rare Hemoglobinuria
Cheryl A. Thompson - American Society of Health-System Pharmacis
Eculizumab, a monoclonal antibody that targets part of the body's immune system, was approved for use in the treatment of patients with the rare disorder known as paroxysmal nocturnal hemoglobinuria.
Full Story >> Routine Aspirin or Nonsteroidal Anti-inflammatory Drugs for the Primary Prevention of Colorectal Cancer: U.S. Preventive Services Task Force Recommendation Statement
U.S. Preventive Services Task Force
The USPSTF recommends against the routine use of aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) to prevent colorectal cancer in individuals at average risk.
Full Story >> Regulators Consider Intermediate Class of Drugs
Cheryl A. Thompson - American Society of Health-System Pharmacis -- March 28, 2007
FDA is examining whether it would be possible through regulations to create an intermediate or third class of drugs, the agency's director of pharmacy affairs announced this week.
Full Story >> Safety Experts Call for Accountability from FDA, Drug Firms
Donna Young - American Society of Health-System Pharmacists -- March 28, 2007
When pharmaceutical firms withhold from the public study results that do not support the company's claims about a drug's efficacy or safety, FDA takes no action.
Full Story >> Anemia Drugs under Scrutiny by Congress, CMS
Donna Young - American Society of Health-System Pharmacists -- March 28, 2007
The Centers for Medicare and Medicaid Services (CMS) on March 14 announced that, "in light of" the new black-box warning in ESA product labeling, it is "closely" reviewing all Medicare policies related to the administration of the products.
Full Story >> Off-Label Zyvox Use May Increase Death Risk, FDA Says
Kate Traynor - ASHP -- March 20, 2007
FDA issued an alert last Friday about new study data pointing to an increased risk of death in patients who received linezolid for the treatment of catheter-related bloodstream infections, an off-label use of the drug.
Full Story >> FDA Issues New Safety Information for Erythropoiesis-Stimulating Agents
March 16,2007
The Food and Drug Administration (FDA) notified healthcare professionals of new safety information for erythropoiesis-stimulating agents (ESAs) Aranesp® (darbepoetin alfa), Epogen® (epoetin alfa), and Procrit® (epoetin alfa).
Full Story >> FDA Requests Sedative/Hypnotic Manufacturers to Strengthen Labeling Regarding Potential Risks
March 15, 207
FDA requiring manufacturers for sedative-hypnotic drugs to include stronger language in labeling concerning protenital risks.
Full Story >> Actos® Tablets - Evaluation of Safety Data Showed Increased Incidence of Fractures in Female Patients
March 16, 2007
Takeda and the FDA notified healthcare professionals of recent safety data concerning pioglitazone-containing products.
Full Story >> Notice to Readers: Guidelines for Maintaining and Managing the Vaccine Cold Chain
CDC -- March 15, 2007
Temperatures should be read and documented twice each day, once when the office or clinic opens and once at the end of the day.
Full Story >> Novartis Hypertension Drug Approved
Kate Traynor - American Society of Health-System Pharmacists -- March 14, 2007
FDA approval to market aliskiren, a direct renin inhibitor, for the treatment of hypertension in adults.
Full Story >> AHA statement recommends doctors change approach to prescribing pain relievers for patients with or at risk for heart disease
American Heart Association Scientific Statement -- March 9, 2007
Many doctors should change the way they prescribe pain relievers for chronic pain in patients with or at risk for heart disease.
Full Story >> Bloodstream Infection Rates Differ for Treprostinil (Remodulin)& Epoprostenol (Flolan)
Cheryl A. Thompson - American Society of Health-System Pharmacis -- March 6, 2006
Although the cause is unclear, bloodstream infections seem to occur in patients with pulmonary arterial hypertension more frequently during i.v. treprostinil therapy than with epoprostenol.
Full Story >> Subpoena served at Universal Health Services UHS system in Texas
Vince Galloro -- February 22, 2007
Company that purchased TMC under fauld investigation in South Texas.
Full Story >> Hospitals hire pharmacists for ER
Elise Kleeman -- March 5, 2007
Around the country, emphasis on emergency patient safety is growing. Toward that end, some hospitals are beginning to hire specialized pharmacists to assist the doctors and nurses in the ER.
Full Story >> Drug Innovation on the Decline
Donna Young ASHP -- March 5, 2007
The number of new drugs entering the U.S. market has declined sharply.
Full Story >> Tech-Check-Tech in Hospitals Gets OK in California
Kate Traynor - ASHP -- March 1, 2007
California this year joined a handful of states that allow specially trained pharmacy technicians to check the work of other technicians.
Full Story >> FDA OK's Vyvanse for ADHD Use
Donna Young - American Society of Health-System Pharmacists -- February 28, 2007
Lisdexamfetamine dimesylate, or Vyvanse, has received approval for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ages 6–12 years.
Full Story >> FDA Alerts Consumers to Unsafe, Misrepresented Drugs Purchased Over the Internet
FDA Alert -- February 20, 2007
The Food and Drug Administration (FDA) has become aware that a number of Americans who placed orders for specific drug products over the Internet (Ambien, Xanax, Lexapro, and Ativan), instead received a product that contained haloperidol.
Full Story >> Whistleblowers Tell Congress of Ketek Problems
Donna Young - American Society of Health-System Pharmacists -- February 20, 2007
As Congress addresses concerns about FDA's "apparent mishandling" of telithromycin's 2004 approval and postmarketing safety monitoring.
Full Story >> New Drug and Biological Product Approvals, 2006
Kate Trayor - ASHP -- February 8, 2007
FDA last year cleared for marketing 32 new molecular entities.
Full Story >> Drug Firms Miss Safety-Study Deadlines
Donna Young - American Society of Health-System Pharmacists -- February 8, 2007
Companies have failed to start 71% of postmarketing drug safety and efficacy studies the firms committed to conduct as part of approval decisions for their products. That figure was 34% for makers of biological products.
Full Story >> Health Care Providers Partly To Blame for Antithrombotic Nonadherence
Cheryl A. Thompson - American Society of Health-System Pharmacis -- February 5, 2007
Recipients of drug-eluting coronary artery stents may be prematurely stopping dual antithrombotic therapy because of health care providers' "misguided concerns about excessive procedure-related bleeding.
Full Story >> SSRIs Linked to Bone Fractures in Older Adults
Donna Young - American Society of Health-System Pharmacists -- February 5, 2007
Older adults taking daily doses of a selective serotonin-reuptake inhibitor (SSRI) have a twofold increased risk of fragility fracture.
Full Story >> Direct To Consumer Drug Ads Use Emotional Appeals, Not Facts
Donna Young - American Society of Health-System Pharmacists -- January 31, 2007
Nearly all direct-to-consumer (DTC) television advertisements for prescription drugs are based on emotional appeals rather than facts.
Full Story >> U.S. drug industry takes aim at prescription law
By Julie Masis and Toni Clarke - Reuters -- January 31, 2007
Psychiatrist Marc Sadowsky recalled being shocked when a drug-company salesman challenged him two years ago to explain why he prescribed more of one type of antidepressant than another.
Full Story >> The Institute for Healthcare Improvement lunches 5 Million Lives campaign
Ron Kolar, RPh, MS, FASHP -- January 29, 2007
Based on years of research IHI estimates 15 million instances of medical harm occurs in U.S. hospitals every year.
Full Story >> Stopgap Provisions Issued on Medication Management Standard
Cheryl A. Thompson - American Society of Health-System Pharmacis -- January 25, 2007
The Joint Commission this month announced the onset of temporary provisions aimed at allaying the concerns of emergency department (ED) and radiology practitioners regarding medication management standard 4.10.
Full Story >> U.S. Health Spending Slows
Kate Trayor - American Society of Health-Systems Pharmacists -- January 22, 2007
U.S. spending on health care costs slowed in 2005 to the lowest rate since 1999, a situation driven mainly by a decline in the growth of prescription drug spending.
Full Story >> HIGH-ALERT MEDICATION FEATURE:
ANTICOAGULANT SAFETY TAKES CENTER STAGE IN 2007
Institute for Safe Medication Practices -- January 22, 2007
When used or omitted in error, anticoagulants can cause life-threatening or fatal bleeding or thrombosis. These drugs are among those that will be receiving targeted attention during the coming year from the Joint Commission.
Full Story >> Systematic Review: Opioid Treatment for Chronic Back Pain: Prevalence, Efficacy, and Association with Addiction
Bridget A. Martell, MD, MA; Patrick G. O'Connor, MD, MPH; et.al. -- January 22, 2007
Abstract from Annals of Internal Medicine
Full Story >> Relationship Between Adherence to Evidence-Based Pharmacotherapy and Long-term Mortality After Acute Myocardial Infarction
Jeppe N. Rasmussen, MD; Alice Chong, BSc; David A. Alter, MD, Ph -- January 19, 2007
Abstract discribing the apparent benefit of drug therapy adherence for AMI survivors.
Full Story >> Nation's costs for arthritis rose to $128 Billion
Daniel Yee, Associated Press -- January 19, 2007
Full Story >> Antithrombotic Adherence Essential with Drug-Eluting Stents
Cheryl A. Thompson - American Society of Health-System Pharmacis -- January 16, 2007
The Society for Cardiovascular Angiography and Interventions, representing invasive and interventional cardiologists advises physicians on "practical steps for reducing the risk" of the rare, but serious, complication known as late stent thrombosis.
Full Story >> Cold Remedies Can be Deadly for Infants, CDC Says
Kate Trayor - American Society of Health-Systems Pharmacists -- January 16, 2007
Reports of a small but troubling number of adverse events, including three deaths, prompted the CDC to call for caution when prescribing or administering cough and cold remedies to children age two years or younger.
Full Story >> Call for Comment on Proposed Revisions to Joint Commission Standards
American Society of Health-Systems Pharmacists -- January 9. 2007
The Joint Commission recently released for field review proposed changes to Medication Management Standards MM 4.10 and MM 8.10 for Joint Commission-accredited hospitals.
Full Story >> Who Tops List of Most Honest and Ethical Professions?
Gallup's annual list -- January 4, 2007
Nurses top the list.
Full Story >> Most Hospital Performance Measures for Heart Failure Not Linked to Improved Patient Outcomes
Americian Medical Association -- January 4, 2007
Four of five hospital performance measures for heart failure do not appear to accurately reflect the quality of care provided, according to a study in the January 3 issue of JAMA
Full Story >> Safety Concern Widens for Gadolinium Contrast Agents
Cheryl Thompson - ASHP -- January 3, 2007
FDA reported that a debilitating, potentially fatal skin disorder has the potential to occur in patients with moderate to end-stage kidney disease exposed to any gadolinium-containing contrast agent.
Full Story >> Reformulated Decongestants May Be Useless, Experts Say
Robert Cohen - Newhouse News Service -- January 1, 2007
Reformulated over the counter decongestant may not be as affective.
Full Story >> Financial ties found among clinical trials
Denise Gellene - NY Times -- January 1, 2007
More than a third of those overseeing studies report monetary links to pharmaceutical or medical firms.
Full Story >> FDA Approves New Antipsychotic
Kate Traynor - ASHP -- December 26, 2006
FDA and Janssen L.P. announced the approval of paliperidone extended-release tablets for the treatment of schizophrenia.
Full Story >> Rituxan May Lead to Fatal Nerve Disease in Patients with Lupus
Kate Traynor - ASHP -- December 26, 2006
The US Food and Drug Administration (FDA) and Genentech are warning healthcare professionals regarding the risk for progressive multifocal leukoencephalopathy (PML) in patients receiving intravenous rituximab for the management of (SLE).
Full Story >> Celebrex Wins Approval to Treat Arthritis in Children
Donna Young - ASHP -- Decemeber 22, 2006
Celecoxib, or Celebrex, has received approval to be marketed for the relief of the signs and symptoms of juvenile rheumatoid arthritis (JRA) in patients as young as two years.
Full Story >> Don't Give Aprotinin Again Within 12 Months, FDA Says
Cheryl A. Thompson - ASHP -- Decemeber 22, 2006
FDA announced today that it had approved seven changes to the labeling of Bayer Pharmaceuticals Corporation's aprotinin product.
Full Story >> Panel Urges Black-Box Warning for Ketek
Donna Young - ASHP -- Decemeber 22, 2006
Telithromycin, or Ketek, should remain on the U.S. market to treat community-acquired pneumonia, a federal advisory panel said yesterday, but the drug's risks outweigh its benefits in treating its other two approved indications.
Full Story >> Are drug reps your major source of drug information?
Ron Kolar, RPh, MS, FASHP -- December 19, 2006
While company sales reps are important we should never expect them to be the most object source of drug information, after all they are not referred to as information reps.
Full Story >> Study finds Doctors often call in antibiotic prescriptions without exams.
Rita Rubin USA Today -- December 11, 2006
Researchers found that 40 percent of antibiotic prescriptions are phoned in without a physical exam of the patient.
Full Story >> CDC Revises General Recommendations on Immunizations
VHA/Novation News -- December 8,2006
The Centers for Disease Control and Prevention (CDC) has recently revised its general recommendations on immunizations.
Full Story >> FDA Issues Safety Alert on Dolophine
VHA/Novation News -- December 8, 2006
The Food and Drug Administration (FDA) notified healthcare professionals of reports of death and life-threatening adverse events in patients receiving Dolophine (methadone hydrochloride; Roxane Laboratories).
Full Story >> Adverse Drug Events Cause 700,000 Emergency Visits
Donna Young - American Society of Health-System Pharmacists -- November 28, 2006
About 700,000 U.S. residents each year have an adverse drug event (ADE) that leads to an emergency department (ED) visit.
Full Story >> New Overdosage Alert Issued for Effexor
Donna Yound - American Society of Health-Systems Pharmacists -- November 28, 2006
Patients who take excessive amounts of venlafaxine hydrochloride have a higher risk of death, especially if the drug is consumed with alcohol
Full Story >> Pharmacogenomics Technique Predicts Chemotherapy Success
Kate Traynor -- November 20, 2006
An elegant set of experiments led by researchers at the Duke University Institute for Genome Sciences and Policy could be an important step toward bringing genome-guided therapy from the laboratory to the bedside.
Full Story >> Pain Management Research Goes Beyond the Obvious
Cheryl A. Thompson - ASHP -- November 14, 2006
The next big advance in managing patients' pain may well come from a class of drugs that lack analgesic effects.
Full Story >> Outcomes Similar with First- and Second-Generation Antipsychotics
Julie Sedlinger, Pharm.D. - ASHP -- November 14, 2006
Older agents are just as good as newer ones for improving quality of life in schizophrenia patients, reports a British study that compared first- and second-generation antipsychotic agents over a one-year course of therapy.
Full Story >> In medicine, evidence can be confusing
Rita Rubin USA Today -- November 14, 2006
For years, doctors urged post-menopausal women to take estrogen to protect their hearts. But in 2002, a study of 16,000 women found that those on estrogen plus progestin actually had more heart attacks than those on a placebo.
Full Story >> Med Schools Warn of Drug Sales Pitches
David B. Caruso - Associated Press -- November 7, 2006
Medical schools in several states are boosting programs that teach doctors and students to challenge the sales pitches of drug companies and avoid being dazzled by them.
Full Story >> CDC’s Advisory Committee Recommends “Shingles” Vaccination
CDC - Advisory Committee -- November 7, 2006
The Advisory Committee on Immunization Practices (ACIP), a federal panel of immunization experts, has recommended people age 60 and older receive a new vaccine to prevent herpes zoster, or shingles.
Full Story >> Newest drugs not always the best
Rita Rubin USA Today -- October 31, 2006
Increasingly, critics of the FDA and of the drug industry are advising doctors and patients to avoid the newest drugs when there are older, equally effective drugs.
Full Story >> FDA approves new in class Januvia (Sitagliptin) for treatment of diabetes.
VHA/Novation News -- October 31, 2006
Januvia for use in addition to diet and exercise to improve blood sugar levels in patients with type 2 diabetes, alone or in combination with metformin or a PPAR.
Full Story >> Adverse Drug Events Cause 700,000 Emergency Visits
Donna Young-ASHP News -- October 17, 2006
About 700,000 U.S. residents each year have an adverse drug event that leads to an emergency department visit, according to a report in the October 18 issue of the Journal of the American Medical Association.
Full Story >> First-in-Class Diabetes Drug Approved
Kate Traynor- ASHP News -- October 17, 2006
FDA and Merck recently announced the approval of sitagliptin phosphate oral tablets (Januvia)—the first in a new class of drugs to help patients with diabetes mellitus control their blood sugar.
Full Story >> Special Medication Considerations Necessary After Bariatric Surgery
American Society of Health-Systems Pharmacists -- October 8, 2006
Patients Need Special Medication and Nutritional Considerations
Full Story >> New Bismuth Product OK'd to Treat GI Disease
Cheryl A. Thompson - ASHP -- October 8, 2006
A three-ingredient capsule containing a new salt of bismuth has been approved for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease.
Full Story >> FDA Issues New Trasylol Alert
Donna Young ASHP
FDA issued a public health advisory late Friday advising surgeons who use aprotinin injection, or Trasylol, for patients undergoing heart surgery to consider limiting use of the product while the agency evaluates a new safety study.
Full Story >> Physicians Fail to Educate Patients About New Prescriptions
Donna Young ASHP
Physicians often fail to explain critical details to patients about the use of newly prescribed drugs, researchers reported in the September 25 issue of Archives of Internal Medicine.
Full Story >> Colorectal Cancer Treatment Approved
Kate Trayor - ASHP
FDA announced Wednesday that it has approved the marketing of Amgen's Vectibix, or panitumumab, as a second-line therapy for metastatic colorectal cancer
Full Story >> New Pseudoephedrine Restrictions
Texas Pharmacy Association HOTline -- September 25, 2006
Pharmacies must restrict the sales of all dosage forms of Pseudoephedrine, Ephedrine, Norpseudoephedrine, and Phenylpropanolamine, in order to comply with new requirements established by the federal Patriot Act.
Full Story >> Projection of Diabetes Burden Through 2050
American Diabetes Association - Abstract -- September 12, 2006
If recent trends in diabetes prevalence rates continue linearly over the next 50 years, future changes in the size and demographic characteristics of the U.S. population will lead to dramatic increases in the number of Americans with diagnosed diabetes.
Full Story >> DEA Proposes 90-Day Prescriptions for Schedule II Controlled Substances
Donna Young ASHP -- September 11, 2006
The Drug Enforcement Administration (DEA) this week proposed a rule to allow physicians, when medically appropriate, to prescribe up to a 90-day supply of Schedule II controlled substances during a single office visit.
Full Story >> Ibuprofen May Hinder Aspirin's Cardioprotective Effects
Donna Young ASHP -- September 11, 2006
Although it is safe to use ibuprofen and aspirin together, ibuprofen 400 mg may interfere with the antiplatelet effect of aspirin 81 mg, potentially rendering the aspirin less effective when used for the prevention of stroke or heart attack.
Full Story >> Involving pharmacists directly with patient care in hospitals decreases medication errors
Hospital Pharmacy Regulation Report -- August 2006
A team from the University of Iowa (UI) and Department of Veterans Affairs (VA) reviewed 36 studies that were published between 1985 and 2005 in English-language, peer-reviewed journals and found that when hospital pharmacists become involved directly wit
Full Story >> Medication storage tops list of noncompliant standards
Hospital Pharmacy Regulation Report -- August 2006
Of the JCAHO’s medication-related standards, medication storage was the one that hospitals had the most difficulty complying with in the past year, according to a JCAHO surveyor speaking at the American Society of Health-System Pharmacists’ Summer Meeting
Full Story >> VA chief: Electronic prescriptions lead to nearly 100% accuracy
R. James Nicholson -- August 22, 2006
Electronic prescription systems are crucial to preventing medication errors, said R. James Nicholson, secretary of the U.S. Department of Veteran Affairs.
Full Story >> Acetaminophen's Maximum Dosage Yields Unexpected Result
Cheryl A. Thompson- ASHP -- 15 August 2006
The widespread belief that adults can safely consume 4 g/day of acetaminophen was questioned in early July when researchers reported an association between this dosage and elevated alanine aminotransferase levels.
Full Story >> Conflicts of interest between device makers and physicians.
Mark Taylor - Modern Healthcare -- August 14, 2006
Government investigators probing relationships between physicians, devicemakers may soon train sights on hospitals
Full Story >> FDA MedWatch - FDA Warns Three Firms To Stop Mass Producing Unapproved Inhalation Drugs
FDA News -- August 10, 2006
The FDA notified consumers and healthcare professionals that RoTech Healthcare, Inc., CCS Medical, and Reliant Pharmacy Services, are manufacturing, and distributing nationwide, unapproved compounded inhalation drugs. These drugs, compounded by pharmacist
Full Story >> European Study: All NSAIDs Raise Heart Attack Risk
Donna Young-ASHP -- August 3, 2006
All nonsteroidal antiinflammatory drugs (NSAIDs) elevate the risk of a first myocardial infarction (MI), according to a study in the European Heart Journal.
Full Story >> New Warnings Added to Telithromycin Labeling
Kate Traynor - ASHP -- August 7, 2006
FDA announced that the labeling (PDF) for telithromycin has been updated to warn prescribers and patients that the drug has been linked to rare cases of liver failure and death.
Full Story >> 2007 National Patient Safety Goals
Ron Kolar, RPh, MS, FASHP -- August 7, 2006
JCAHO sets patient safety goals for acute access hospitals for 2007.
Full Story >> ABSTRACT - American Society of Clinical Oncology Guideline for Antiemetics in Oncology: Update 2006
American Society of Clinical Oncology -- July 31, 2006
Full Story >> FDA: Regulations Will Clarify Pedigree Requirements
Donna Young ASHP -- July 28, 2006
When FDA on December 1 lifts a six-year stay on a rule that requires wholesalers to forward to buyers a pedigree—a drug product's complete sales history—regulators are hoping the action will help protect the U.S. supply chain from counterfeit drugs.
Full Story >> Drug Risks and Benefits Poorly Communicated, Experts Contend
Donna Young ASHP -- July 28, 2006
Regulators and pharmaceutical makers need to be transparent, direct, forthcoming, and willing to acknowledge scientific and medical uncertainties about risks associated with drug products, said Dennis Paustenbach, president of ChemRisk, a San Francisco h
Full Story >> Liver Damage due to Telithromycin
American Society of Health-Systems Pharmacists -- June 30, 2006
Telithromycin (Ketek) marketed by Sanofi Aventis is associated with rare but potentially deadly liver damage.
Full Story >> More Surgical Site Infections can be Prevented
American Society of Health-Systems Pharmacists -- June 28, 2006
Giving appropriate antibiotic therapy one hour or less before surgical incision, and discontinuation of prophylactic therapy in the first 24 hours after surgery decreases srugical site infections.
Full Story >> June Medication Management Rounds
Ron Kolar, RPh, MS, FASP -- July 4, 2006
Attendance increased at 2nd monthly "Medication Management Rounds"
Full Story >> Ads, Labeling to Undergo Scrutiny for Ambiguous Abbreviations by the FDA
ASHP Cheryl A. Thompson -- 6-20-2006
FDA launched a national education campaign to eliminate the use of ambiguous medial notations by the pharmaceutical industry.
Full Story >> Quadrivalent Human Papillomavirus Recombinant Vacine
(Gardasil)
Merck Webpage -- 6-9-2006
New vaccine to prevent cervical cancer approved by FDA
Full Story >> More resources don't necessary mean better health care some doctors say.
Ronald Kotulak -- 6-8-2006
Althought it might seem locgical that areas with the most medical resources should offer the best health care, a nationwide survey of physicians has found primary-care physicians disagree.
Full Story >> Change in Reported Critical Vancomycin Trough Levels (Increased from 10 to 15mcg/ml)
John Kanell, Pharm.D. -- May 22, 2006
Full Story >> Novolog / Regular insulin option added to "Adult Sliding Scale Orders"
John Kanell, Pharm.D. -- May 22, 2006
Full Story >> New "Medication Managment Rounds" begin to help staff involved in the medication management process keep informed.
Ron Kolar, RPh, MS, FASP -- May 19, 2006
Full Story >> Old drug effective against multidrug-resistant stains of Acinetobacter & Psudomonas
ASHP Cheryl A. Thompson -- April 10, 2006
Full Story >> Study: Heart Attack Risk is Similar for Celebrex, Vioxx
ASHP Donna Young -- March 2, 2006
Full Story >> Exanta (ximelagtran) removed from worldwide market
Ron Kolar, RPh, MS, FASHP -- March 8, 2006
AstraZeneca removes warfarin withdraws warfaring like anticoagulant from market.
Full Story >> USP says medication errors in Radiology are the worst.
ASHP Cheryl A. Thompson -- February 24, 2006
Nation focused on Radiology errors
Full Story >> Drug Administration Causes Problems in ICU's
ASHP Cheryl A. Thompson -- February 24, 2006
9 percent of harmful errors involved IV pumps
Full Story >> Coreg, Protonix Shortage Update
Ron Kolar, RPh, MS, FASP -- February 3, 2006
Critical Drug Shortage Eases
Full Story >> New Look-Alike and Sound-Alike Drug List
Ron Kolar, RPh, MS, FASHP -- February 3, 2006
Medication Safety Alert
Full Story >> Oral use of Cetacaine (Benzocaine) Spray may cause methemoglobinemia
FDA Public Health Advisory -- February 8, 2006
Full Story >> Pregabalin (Lyrica)approved
Ron Kolar, RPh, MS, FASHP -- January 26, 2006
New Formulary Drug
Full Story >> New Drug Surveillance Policy
Ron Kolar, RPh, MS, FASHP -- January
New Med Management Policy
Full Story >> Texas issues new Schedule II presciptions
The new prescription will be used in addition to the traditional triplicate prescription.
Full Story >> Research suggests that beta-blocker use by patients with hypertension may increase risk of cardiovascular events, death.
ASHP Daily Briefing -- 375
Full Story >> U.S. FTC reports 14 deals to delay generics in '07
By Diane Bartz
Brand name pharmaceutical companies struck 14 deals that led to delayed sale of cheaper generic drugs in the 2007 fiscal year, the U.S. Federal Trade Commission said.
Full Story >> Fluorouracil error ends tragically, but application of lessons learned will save lives
223
The August 2006 death of a Canadian woman with cancer who received four days' worth of fluorouracil in four hours was reviewed by the Institute for Safe Medication Practices, which also offered six "safe practice recommendations."
Full Story >> |