Formulary Watch |

Rebif (Interferon beta-1a)

New biologic: Second interferon beta-1a product for relapsing multiple sclerosis

FDA Actions in Brief

as reported April 1, 2002

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(as reported April 1, 2002)

New ACC/AHA guidelines reshape drug therapy for acute coronary syndromes

Prompted by a flurry of new evidence, two leading cardiology groups have revised their guidelines for the management of acute coronary syndromes just 18 months after the last revision.

Biologics new and old may offer long-term management option for psoriasis

An array of both existing and investigational biologic agents are showing efficacy in clearing psoriasis and may prove useful for long-term psoriasis management. So suggests a collection of studies presented at the 60th annual meeting of the American Academy of Dermatology, held recently in New Orleans.

Elimination of third-generation cephalosporins improves VRE infection rate control

Three-year data have confirmed the effectiveness of a strategy that eliminated all third-generation cephalosporins from a formulary as a means to control the emergence of vancomycin-resistant enterococcus (VRE).

Physician receptivity to use of formulary-loaded PDAs is high, study finds

Providing formulary information on PDA devices improves formulary compliance and is gaining in physician acceptance as well. These were the findings of a 4-month pilot program involving 104 Connecticut-based physicians conducted by ePocrates and AdvancePCS.

Don't stop statins in inpatients with ACS

Stopping statins after the onset of symptoms completely negates the drugs'protective effect in hospitalized patients with acute coronary syndromes(ACS). So concludes a new subgroup analysis of the PRISM trial.

Reference pricing does not compromise outcomes of ACE inhibitor therapy

Concerns about possible unintended consequences of reference pricing-atleast when applied to ACE inhibitors-appear to be unfounded, according toa new analysis of Canadian data.

ARB outperforms beta blocker for event prevention in hypertensives

For the first time, a beta blocker has been surpassed by another classof antihypertensive drug for the prevention of cardiovascular events inpatients with hypertension.

Applying multiattribute utility technology to the formulary evaluation process (PDF)

Seldom are the attributes of drugs under formulary consideration conveniently measured on the same scale, and if they are, they typically do not carry the same weight in a decision. Fortunately, application of Multiattribute Utility Technology (MAUT) provides a way to incorporate several valued attributes of disparate weights into a unitary measure for the purpose of evaluating options. This month's column presents the core elements of MAUT and explores its use in the drug evaluation process through a mock formulary committee example.

Rosuvastatin: A new HMG0CoA reductase inhibitor for hypercholesterolemia (PDF)

Rosuvastatin is an investigational HMG-CoA reductase inhibitor expected to gain FDA approval later this year for treatment of hypercholesterolemia. It has significantly exceeded atorvastatin, pravastatin, and simvastatin in reducing LDL cholesterol in clinical trials. This Focus article reviews those trials as well as rosuvastatin's pharmacologic and safety profiles in an effort to delineate its likely role in cholesterol-reducing therapy.

Why physicians start or stop prescribing a drug: Literature review and formulary implications (PDF)

These authors report on their literature search of studies assessing the impact of factors influencing the diffusion of new drug therapies and physicians' adoption and eventual relinquishment of those therapies. They specifically explore how their finds can help better align physician prescribing with formulary objectives.

Health plans can substantially boost their use of generics, study concludes

Optimal management can raise health plans' generic utilization rates from the current average of 34.5% to 51%. So concludes a new study from Stanley Wallack, PhD, and other researchers from Brandeis University.

Other FDA actions

FDA actions in brief as reported March 1, 2002

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as reported March 1, 2002

Zithromax (Azithromycin for oral suspension), Pfizer

New dosage regimen: Single-dose and 3-day regimens for acute otitis media

Eligard 7.5 mg (Leuprolide acetate 7.5 mg for subcutaneous injection), Atrix/Sanofi-Synthelabo

New formulation: Monthly SC injection form of GnRH agonist for advanced prostate cancer

Gleevec (Imatinib mesylate capsules), Novartis

New indication: Oral cancer drug approved to treat rare gastrointestinal tumors

Enbrel (Etanercept), Immunex/Wyeth-Ayerst

New indication: Biologic cleared for psoriatic arthritis

Clarinex (Desloratadine tablets)

New indication: Broader allergy indication, new hives indication for nonsedating antihistamine

Orfadin (Nitisinone capsules), Rare Disease Therapeutics

NME: Orphan drug for rare pediatric liver disease

Neulasta (Pegfilgrastim), Amgen

New biologic: Pegylated form of filgrastim requiring less-frequent administration

Arixtra (Fondaparinux sodium injection), Organon/Sanofi-Synthelabo

New biologic: Factor Xa inhibitor for reducing risk of blood clotsafter orthopedic surgeries

Adding query screen to Pyxis machines: Simple strategy drastically improves ADE capture rate

A simple enhancement to Pyxis drug dispensing machines can drastically improve adverse drug event (ADE) capture.

Evaluating CPOE systems: Key comparative criteria you'll need to consider

If your organization hasn't yet selected a computerized provider order entry system (CPOE), it will likely benefit from the checklist of features and functionality criteria presented by Richard Diefes, MS.

Expanded role for the P & T Committee: Gaining patient consent for off-label drug use

What's your institution's policy for handling the following situation: A physician wishes to prescribe an FDA-approved drug for an off-label indication for which there is little literature support.

Physician credentialing: A tool for taking drug management to the next level

New Orleans-When faced with ensuring the appropriate use of high-risk, high-cost drugs, physician credentialing may be another option worth considering.

Federal, state efforts to expand drug coverage may challenge evidence-based formulary practices

The Bush administration's $2 trillion budget proposal for fiscal year 2003 includes $190 billion to improve Medicare, almost half of that aimed to help seniors buy medicines.

Automatic IV to PO conversion process provides greatest gains for hospital, patient

Hartford Hospital, Hartford, CT-Although the economic advantages of IV to oral (PO) antibiotic conversion programs have been documented in numerous studies, most of these programs require physician contact to encourage the switch.