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Drug Topics E-News
November 16, 2010
TOP SEARCHES: Diabetes care // Inpatient infections // Performance measures
In this issue
MD-Pharm partnerships
Patient medication decisions
Buprenorphine implants
BP goals for blacks
Drug hotline launch
Warfarin replacement approved
FDA approves trastuzumab
IV acetaminophen approved
Bromfenac approved
Duloxetine helps osteoarthritis
Botox approved for migraine
AF risks linked to BPHs
AEDs increase infertility
Thigh-bone fracture risk
Saquinavir gets new warnings
GnRH agonists risks
Combo therapy for hypertension
More Tylenol recalled
OTC product news
CMS withdraws AMP rule
NASCSA gets PDMP grant
WSU business plan wins
NCPA president installed

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Clinical news

Studies show impact of doctor-pharmacist collaboration
A collaborative effort between physicians and pharmacists appears to result in improved blood pressure control in hypertensive patients, and continued education in cessation counseling may help physicians, according to separate articles published October 11 in the Archives of Internal Medicine, HealthDay News reported. More...

DECISIONS survey study: Americans often make medication decisions without being well-informed
According to the findings of the DECISIONS survey study published in a September/October supplement of Medical Decision Making, Americans frequently find themselves faced with high blood pressure, high cholesterol, and depression medication decisions that they are ill prepared to make. More...
Buprenorphine implants reduce opioid use of opioid-dependent patients
In a new randomized, placebo-controlled clinical trial published in the October 13, 2010 Journal of the American Medical Association, trial investigators demonstrated that the use of buprenorphine implants (Probuphine, Titan Pharmaceuticals) could reduce opioid use over a 24-week study period. More...
Consensus statement lowers BP goals in blacks to manage hypertension
An updated consensus statement on the management of hypertension among African Americans places significant emphasis on a comprehensive assessment and appropriate risk stratification of individual patients with hypertension, stated a report published online October 4 in Hypertension, HealthDay News reported. More...
APP Pharmaceuticals launches drug hotline
APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., launched its new APP Drug Hotline on Wednesday, November 10, 2010. More...

FDA approvals

First warfarin replacement approved
Dabigatran etexilate (Pradaxa, Boehringer Ingelheim) has received FDA approval for the prevention of stroke and blood clots in patients with atrial fibrillation. More...
FDA approves trastuzumab to treat HER2-overexpressing metastatic gastric or gastroesophageal cancer
FDA approved trastuzumab (Herceptin, Genentech) for use in combination with cisplatin and capecitabine or 5-fluorouracil to treat patients with human epidermal growth factor receptor 2-overexpressing metastatic gastric or gastroesophageal junction cancer who have not received prior treatment for metastatic disease. More...
First IV formulation for acetaminophen approved
FDA has approved acetaminophen injection (Ofirmev, Cadence Pharmaceuticals), the first intravenous formulation of acetaminophen for the management of mild-to-moderate pain, moderate-to severe-pain with adjunctive opioid analgesics, and the reduction of fever. More...
FDA approves first once-daily eyedrop for inflammation and pain after cataract surgery
Bromfenac ophthalmic solution (Bromday, ISTA Pharmaceuticals) 0.09% has been granted FDA approval as a once-daily prescription eyedrop for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction. More...
FDA OKs duloxetine hydrochloride to treat chronic musculoskeletal pain
In patients with chronic knee pain due to osteoarthritis, 60 mg to 120 mg of duloxetine hydrochloride, a serotonin-norepinephrine reuptake inhibitor, administered daily, was found to provide both significant pain control and improve physical functioning. More...
FDA approves onabotulinumtoxinA to prevent chronic migraine
FDA has approved onabotulinumtoxinA (Botox, Allergan Inc.) injection to prevent headaches in adult patients with chronic migraine. To prevent chronic migraine, onabotulinumtoxinA is injected about every 12 weeks in multiple sites around the head and neck to try to dull future headache symptoms. More...

Medication safety

Risk of AF in cancer patients grows with IV bisphosphonate therapy
Older cancer patients who receive intravenous bisphosphonate therapy may be at a modestly increased risk for atrial fibrillation, supraventricular tachycardia, and stroke, according to research published online October 12 in the Journal of Clinical Oncology, HealthDay News reported. More...

Infertility risk rises in women on multiple antiepileptic drugs
For women with epilepsy, the risk of infertility increases with each additional antiepileptic drug, and more than one-third may be unable to conceive, according to research published online October 11 in Neurology and reported by HealthDay News. More...

FDA warns about increased risk of thigh-bone fracture with bisphosphonates
FDA is requiring a labeling change and Medication Guide to warn patients and healthcare providers about the possible risk of atypical thigh-bone (femoral) fracture in patients who take bisphosphonates for the prevention and treatment of osteoporosis. More...

HIV drug saquinavir to get new safety data on label
New safety information has been added to the label for the HIV antiviral drug saquinavir (Invirase, Genentech), describing potentially life-threatening side effects on heart function when used with ritonavir (Norvir, Abbott Laboratories), another HIV antiviral medication, FDA announced. More...

New label information to advise that GnRH agonists for prostate cancer could increase risk of diabetes and cardiovascular diseases
FDA is asking the manufacturers of gonadotropin-releasing hormone agonists to add new safety information to the Warnings and Precautions section of the drugs' labels about an increased risk of diabetes and certain cardiovascular diseases. More...

Guidance emerges on specific types of combo therapy for hypertension
With single-pill, fixed-dose combinations of antihypertensive agents, as well as triple-therapy, single-pill agents emerging, updated guidance on specific types of combination therapy for hypertension has emerged. More...

McNeil voluntarily recalls more Tylenol
McNeil Consumer Healthcare, a unit of Johnson & Johnson, is voluntarily recalling nearly 128,000 bottles of Tylenol 8-hour caplets after some consumers complained of a musty or moldy odor in the products, the company announced. More...

Product news

OTC Product News
In this section we showcase products and product news that ran up against space limitations or fell outside the parameters of recently featured categories in the print edition. Look for more OTC Product News in upcoming issues of the Drug Topics e-newsletter. More...

Association news

CMS issues final rule to withdraw provisions of "AMP" rule currently blocked by injunction
CMS moved to withdraw provisions of the Medicaid pharmacy reimbursement formula under the AMP model, according to a statement issued by the NACDS and NCPA. More...
NASCSA gets grant to support state prescription drug monitoring programs
The National Association of State Controlled Substances Authorities has received a $200,000 grant from Purdue Pharma LP, which it will distribute to state government agencies that are able to accept private funding specifically for their state prescription-monitoring programs. More...
Washington State University team wins business plan competition
A team of pharmacy students from Washington State University's College of Pharmacy won the 2010 Good Neighbor Pharmacy National Community Pharmacists Association Pruitt-Schutte Student Business Plan Competition. The announcement was made during NCPA's 112th Annual Convention and Trade Exposition in October in Philadelphia. More...
Iowa pharmacist Robert Greenwood begins term as NCPA president
The National Community Pharmacists Association installed Robert Greenwood of Iowa as its new president during the organization's 112th Annual Convention and Trade Exposition, held in October in Philadelphia. More...

Meetings and events

December 5-9 ASHP
Anaheim, CA
Contact:
7272 Wisconsin Avenue
Bethesda, MD 20814
Phone: 301-657-3000

December 7-8, 2010 European Compliance Academy
ECA Certified Pharmaceutical Development Manager Course: Quality by Design in Pharmaceutical Analysis
Heidelberg, Germany
Contact:
CONCEPT HEIDELBERG
P.O. Box 10 17 64
69007 Heidelberg, Germany
Phone: ++49-62 21/84 44-0
Fax: ++49-62 21/84 44 84
[email protected]

December 8-9, 2010 European Compliance Academy
The New FDA/EU Approach to Process Validation
Berlin, Germany
Contact:
Bethesda, MD 20814
CONCEPT HEIDELBERG
P.O. Box 10 17 64
D-69007 Heidelberg, Germany
Phone: +49 (0) 62 21/84 44-0
Fax: +49 (0) 62 21/84 44 34
[email protected]

December 8-9, 2010 European Compliance Academy
Rapid Microbiological Methods Conference
Budapest, Hungary
Contact:
CONCEPT HEIDELBERG
P.O. Box 10 17 64
D-69007 Heidelberg, Germany
Phone: +49 (0) 62 21/84 44-0
Fax: +49 (0) 62 21/84 44 34
[email protected]

February 6-8, 2011 NACDS Regional Chain Conference
Naples, FL
Contact:
P.O. Box 34814
Alexandria, Virginia 22334-0814
703-837-4300

February 13, 2011 19th Annual WILLIAM R. BACON MEMORIAL
Breakfast: 6:30 a.m. - 8:45 a.m.

Palm Springs, California
Contact:
800-333-7535; 760-325-6611

March 9-10, 2011 NACDS RxIMPACT Day on Capitol Hill
Washington, DC
Contact:
P.O. Box 34814
Alexandria, Virginia 22334-0814
[email protected]

March 13-15, 2011 NACDS Supply Chain & Logistics Conference
San Diego, CA
Contact:
P.O. Box 34814
Alexandria, Virginia 22334-0814
703-683-5678

April 30-May 3, 2011 NACDS Annual Meeting
Scottsdale, AZ
Contact:
P.O. Box 34814
Alexandria, Virginia 22334-0814
703-837-4300

June 25-28, 2011 NACDS Marketplace Conference
Boston, MA
Contact:
P.O. Box 34814
Alexandria, Virginia 22334-0814
[email protected]

August 27-30, 2011 NACDS Pharmacy & Technology Conference
Boston, MA
Contact:
P.O. Box 34814
Alexandria, Virginia 22334-0814
703-683-5678

 
 

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