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This month we would like to know...
What is your current feeling/strategy or that of your health system regarding the handling of Risk Evaluation and Mitigation Strategies (REMS) for your patients?
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We don’t do anything extra. We rely on the “dispenser” to do all the education. |
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| b) |
We provide additional counseling/education to patients receiving REMS medications either through pharmacy case/care management or nursing case/care management. |
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| c) |
A medication guide or currently available communication plan is not enough. FDA will need to come up with a better plan. |
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| d) |
It seems like a Band-Aid to meet legislation needs, but it is not enough. |
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Vote in our survey, and see what other P&T committee members have to say.
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| CLINICAL NEWS |
Denosumab effective in reducing skeletal-related events
Amgen of Thousand Oaks, Calif., the maker of denosumab (Prolia) announced at a global conference last month the results of 2 integrated analyses of head-to-head pivotal phase 3 trials comparing the drug to zoledronic acid (Zometa, Novartis Pharmaceuticals), the current standard of care in the prevention of skeletal-related events in patients with advanced malignancies involving bone. More... |
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Studies show impact of physician-pharmacist collaboration
A collaborative effort between physicians and pharmacists appears to result in improved blood pressure control in hypertensive patients, and continued education in smoking cessation counseling may help physicians, according to two articles published Oct. 11, 2010 in the Archives of Internal Medicine, HealthDay News reported. More... |
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Consensus statement lowers BP goals in blacks to manage hypertension
An updated consensus statement on the management of hypertension among blacks places a major emphasis on a comprehensive assessment and appropriate risk stratification of individual patients with hypertension, according to a report published online Oct. 4, 2010 in Hypertension, HealthDay News reported. More... |
Head-to-head hypertension study shows olmesartan superior to losartan
New study results show that patients treated with olmesartan medoxomil (Benicar) 40 mg once daily experienced significantly greater blood pressure reductions and higher goal attainment rates than patients treated with losartan potassium (Cozaar) 100 mg once daily, after 8 weeks. More... |
| THERAPY UPDATE |
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... |
| 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. It is the first replacement for warfarin to win FDA approval. Warfarin was approved in 1954. 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... |
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 trastuzumab to treat HER2-overexpressing metastatic gastric or gastroesophageal cancer
On Oct. 20, 2010, 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... |
FDA OKs duloxetine hydrochloride to treat chronic musculoskeletal pain
FDA has cleared duloxetine hydrochloride (Cymbalta, Eli Lilly and Co.) to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain, giving patients with such conditions another treatment option. 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. More... |
| MEDICATION SAFTEY AND RELIABILITY |
FDA warns of increased risk of death in patients administered tigecycline compared to other antibiotics
In the beginning of September, FDA released a safety announcement reminding healthcare providers of an increased mortality risk associated with the use of the intravenous antibiotic tigecycline (Tygacil) compared to that of other drugs used to treat similar serious infections. More...
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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. More...
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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 mesylate (Invirase, Genentech), describing potentially life-threatening side effects on the heart when used with ritonavir (Norvir, Abbott Laboratories), another HIV antiviral medication, according to FDA. More...
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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 Oct. 11, 2010 in Neurology, HealthDay News reported. More...
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Risk of AF in cancer patients grows with intravenous 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 Oct. 12, 2010 in the Journal of Clinical Oncology, HealthDay News reported. More...
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FDA issues complete response letter for lorcaserin
FDA has issued a complete response letter for lorcaserin’s (Arena and Eisai) New Drug Application. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in some patients who are obese—or patients who are overweight—and have at least 1 weight-related co-morbid condition. More...
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| KEY TOPICS |
FDA APPROVALS
New biologic: Alpha-1-proteinase inhibitor (human) for injection (Glassia): A new chronic augmentation and maintenance therapy for emphysema due to alpha-1-antitrypsin deficiency
Dutasteride and tamsulosin (Jalyn): A combination of dutasteride, a 5α-reductase inhibitor, and tamsulosin, an alpha-adrenergic antagonist for the treatment of symptomatic benign prostatic hyperplasia
FDA Actions in Brief September/October 2010 (Gilenya, Prolia, Krystexxa, Faslodex, Protopam Chloride, Ozurdex, Suboxone Film, Saphris, Tekamlo, Beyaz) |
IN THE PIPELINE
FDA Pipeline Preview, September/October 2010 (Luveniq, Motavizumab, Ceftaroline fosamil, Dabigatran etexilate, Lorcaserin, Oxymorphone, Ipilimumab, Cladribine tablets, Iluvien, Vandetanib, ARC-4558, Tideglusib, ACE-031, PSI-7977, AMT-080, CPP-115, Darinaparsin, 2B3-101, XOMA 052) |
MEDICATION SAFETY
Some antiretroviral drugs used to treat HIV associated with an elevated risk of myocardial infarction |
POLICY NEWS
Risk management, drug safety raise challenges for sponsors and healthcare providers |
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