Pharmacy Announcements

2008  |  2007  |  2006  |  2005

November 2006

FDA Alert - Ortho-Evra FDA and Ortho-McNeil notified health care professionals of results from two separate studies that evaluated the risk of developing a non-fatal venous thromboembolism (VTE), a serious blood clot, in women using Ortho-Evra compared to women using a different oral contraceptive.

The first study found the risk of VTE to be similar to the risk associated with the use of oral contraceptive pills containing 35 micrograms of ethinyl estradiol and norgestimate.

The second study differs from the first and found an approximate twofold increase in the risk of VTE between users of Ortho-Evra and users of norgestimate-containing oral contraceptives with 35 micrograms of estrogen. The second study supports FDA’s concerns regarding the potential for Ortho-Evra use to increase the risk of blood clots in some women.

Prescribing information for Ortho-Evra continues to recommend that women with concerns or risk factors for thromboembolic disease talk with their health care professionals.

For additional information on this warning, please refer to http://www.fda.gov/medwatch/safety/2006/safety06.htm#Evra.

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CuraScript Update

Effective immediately, providers who utilize CuraScript to obtain the drugs Aranesp, EPO, Leukine, Neulasta, Neupogen, and Procrit must indicate the place of administration on the prescription. Member copayments are determined by this indication of either administration in the provider’s office or self-administration by the patient.

For your convenience, we plan to update the pharmacy prior authorization forms so that this information may be collected and reported with ease. In the meantime, if this information is omitted from the prescription, CuraScript will make a follow-up call to your office.

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September 2006

Abilify (aripiprazole), Clozaril (clozapine), Geodon (ziprasidone), Risperdal (risperidone), Seroquel (quetiapine), and Zyprexa (olanzapine), atypical antipsychotics, do not require prior authorization at the point-of-sale when a second antipsychotic is added to a member's current treatment regimen, as indicated in the online Your Choice and First Choice Pharmacy Benefit Guides. However, a retrospective review will be performed and physicians will be notified of concomitant use.

Currently, Seroquel (quetiapine), does not require prior authorization for total daily doses less than 200mg, as indicated in the online Medical Assistance Your Prescription Drug Program, the Your Choice Pharmacy Benefit Guide, and the First Choice Pharmacy Benefit Guide. However, as of January 2007, prior authorization will be required for total daily doses less than 200mg for members ages 59 and younger.

May 2006

Actos (pioglitazone hydrochloride) and ActoPlus Met (pioglitazone hydrochloride and metformin hydrochloride), indicated to improve glycemic control for type 2 diabetics, are available for our UPMC Health Plan members as preferred brand medications.

March 2006

FDA Alert - Mifeprex (mifepristone)
The Food and Drug Administration notified healthcare professionals of two additional deaths following medical abortion with Mifeprex (mifepristone). The Agency received verbal notification of the deaths in the United States from the manufacturer, Danco Laboratories. At this time we are investigating all circumstances associated with these cases and are not able to confirm the causes of death. However, all providers of medical abortion and their patients need to be aware of the specific circumstances and directions for use of this drug and all risks including sepsis when considering treatment. In particular, physicians and their patients should fully discuss early potential signs and symptoms that may warrant immediate medical evaluation.

For additional information on this warning, please refer to http://www.fda.gov/medwatch/safety/2006/safety06.htm#Mifeprex.


FDA Alert - Tracleer (bosentan)
Actelion and the Food and Drug Adminstration notified healthcare professionals of changes to the prescribing information based on cases of hepatotoxity reported. The notification underscored the need to continue monthly liver function monitoring for the duration of Tracleer treatment and the need to adhere to the recommended dosage adjustment and monitoring guidelines described in the product labeling.

For additional information on this warning, please refer to http://www.fda.gov/medwatch/safety/2006/safety06.htm#Tracleer.

February 2006

Tricor (fenofibrate, micronized), indicated for the treatment of hypercholesterolemia and hypertriglyceridemia, is available for our UPMC Health Plan members as a preferred brand medication.

FDA Alert - Tequin (gatifloxacin)
Bristol-Myers Squibb notified Food and Drug Administration and health care professionals about proposed changes to the prescribing information for Tequin, including an updating of the existing WARNING on hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), and a CONTRAINDICATION for use in diabetic patients. The changes also include information identifying other risk factors for developing low blood sugar and high blood sugar, including advanced age, renal insufficiency, and concomitant glucose-altering medications while taking Tequin. The proposed changes are highlighted in the following "Dear Healthcare Provider" letter issued by BMS. Specific wording of these additions and revisions to the labeling is pending FDA review and approval.

For additional information on this warning, please refer to http://www.fda.gov/medwatch/safety/2006/safety06.htm#Tequin.

To read the "Dear Healthcare Provider" letter mentioned above, please click on the following hyperlink - http://www.fda.gov/medwatch/safety/2006/tequin_DHCP.pdf