Download Rx FACTS October 2003

Rx FACTS
October 2003
Volume 3, Number 10
CLINICAL UPDATES:
False Rumors of Recalled Influenza Vaccine: The FDA and CDC have addressed rumors concerning a recalled
“contaminated” lot of flu vaccine. The October 17, 2003 edition of the CDC Health Advisory stated: “No contamination of any flu
vaccine has been identified anywhere in the U.S. and the FDA has not recalled any lot of flu vaccine. Flu vaccine is routinely
tested for safety, purity and potency.”
Approximately 114,000 people in the U.S. are hospitalized each year due to the flu and 3 percent die. For more information
regarding influenza, visit the CDC web site at: http://www.cdc.gov/nip/Flu and the September 2003 issue of Rx Facts.
Serious Health Risks Created by Importation of Unapproved Drugs: FDA and Customs and Border Patrol
(CBP) conducted spot examinations (“blitzes”) of mail shipments of foreign drugs. These spot examinations revealed that
shipments often contain dangerous, unapproved or counterfeit drugs. The blitzes were performed to help the FDA and CBP
target, identify and stop counterfeit drugs from entering the United States via mail. The examinations took place over a 3-day
period this summer in Miami, New York City, San Francisco and Carson, California.
Many of the drugs obtained from the blitzes resemble FDA approved drugs but upon further examination, these medications
were labeled “of unknown quality or origin.” Eighty-eight percent of the packages examined contained unapproved drugs.
Some of the imported drugs include:
Imported Drug Name
Roaccutane
Taro-warfarin
Dilantin
Synthroid
Glucophage
Ketoconazole
Viagra
Zocor
Lipitor
Pravachol
Dipyrone
Clenbuterol
Diazepam
Xanax
Codeine
Valium
Anabolic Steriod
Concern with Entrance into U.S. Market
Unapproved version.
Removed from U.S Market in 1977 due to reported fatalities from development of
severe blood disorders following administration of the drug.
Not approved for human use. Banned from Olympic Committee – labeled as a
performance-enhancing drug.
Controlled substances.
Other drugs found in the spot examinations had inadequate labeling or were inappropriately packaged. Drugs were imported
from countries such as Thailand, Canada, Philippines, Mexico, Costa Rica, Ireland and Japan.
For more information regarding drug importation, visit www.fda.gov
NEW DRUG APPROVALS:
DRUG /
APPROVAL DATE
INDICATIONS / COMMENTS
Seasonale 
(levonorgestrel (0.15mg)
and ethinyl estradiol
(30 mcg)
Indication: Extended cycle birth control pill for the prevention of pregnancy.
Clinical Studies: When taken as directed, Seasonale demonstrated equivalent efficacy for pregnancy
prevention compared to standard 28-day cycle oral contraceptives.
September 5, 2003
Claim to fame: First oral contraceptive to reduce monthly periods to just 4 times a year.
Available: End of October
2003
Adverse Effects: Although Seasonale users have fewer scheduled menstrual cycles, the data from clinical
trials show that many women, especially in the first few cycles of use, had more unplanned bleeding and
spotting between the expected menstrual periods than women taking a conventional 28-day cycle oral
contraceptive.
Tablets containing the
active hormones are
taken for 12 weeks
(84 days) followed by one
week (7 days) of placebo
tablets.
Levora, Levlen and
Portia, all 28 day cycle
packs, represent the
same chemical as
Seasonale (91 day cycle).
Cautions: Use of Seasonale provides women with an additional 9 weeks per year hormonal exposure than
conventional monthly oral contraceptives containing similar strength synthetic estrogens and progestins.
While this added exposure may pose an additional risk of thrombotic and thromboembolic disease, studies to
date with Seasonale have not suggested an increased risk of these disorders. The convenience of fewer
menses (4 vs. 13 per year) should be weighed against the inconvenience of increased intermenstrual
bleeding/spotting.
Cost(per tablet): Seasonale $1.32
Levora $1.10
Portia
$1.10
FLRx Coverage Criteria for Seasonale: Tier 3
Generic Options: Levora and Portia (same chemical entity as Seasonale).
Tier 2: Levlen (same chemical entity as Seasonale).
Wellbutrin XL
(buproprion)
Dosages: 150 mg and
300 mg. The usual target
dose is 300 mg once
daily.
See attached Orange Contraceptive Classification List for further information.
Indication: Wellbutrin XL is indicated for the treatment of major depressive disorder in patients 18 and older.
Dosing: This new version is a once daily formulation, not to be confused with Wellbutrin SR which is dosed
twice daily
Clinical Studies: The approval of Wellbutrin XL was based on bioequivalence to Wellbutrin tablets
(immediate-release formulation of bupropion). Wellbutrin XL has also been proven bioequivalent to
Wellbutrin SR tablets (sustained-release formulation of bupropion). Per the package insert, “There have
been no independent clinical trials demonstrating the antidepressant effectiveness of Wellbutrin XL.”
Cost: Wellbutrin XL 300 mg daily = $3.84
Wellbutrin SR 150 mg twice daily = $4.02 (300 mg total daily dose)
FLRx Coverage Criteria: Currently pending.
DID YOU KNOW:
50% of Patients Non-Compliant with Prescription Directions from Physicians
The World Health Organization reported approximately 50% of people are non-compliant in taking their prescription
medications. Doctors believe this may explain why some drugs do well in clinical trials but are not as effective once they are
approved. The percentage of non-compliance appears to be the same across income and education demographics. Reasons
include fear of side effects and not understanding doctor’s orders.
Rx Facts is written and published by Mona Chitre, Pharm.D. CGP, and Joel Owerbach, Pharm.D. of FLRx Pharmacy Management.
Rx Facts is provided as an informational service. Grants or funding are not solicited for this service from the pharmaceutical industry. Providers are directed to
specific reference sources or drug package inserts for detailed information on drug dosing and monitoring.
Comments or questions are welcome by fax: 877-812-5306 • phone: 877-777-2737 • e-mail: [email protected]
2003 Oral Contraceptive Classification List (October 2003)
MONOPHASIC COMBINATIONS
Chemical Ingredients
Desogestrel - ethinyl estradiol 0.15-0.03 mg
Drospirenone - ethinyl estradiol 3.0-0.3 mg
Ethynodiol - ethinyl estradiol 1-0.035 mg
Ethynodiol - ethinyl estradiol 1-0.05 mg
Levonorgestrel - ethinyl estradiol 0.1-0.02 mg
Levonorgestrel - ethinyl estradiol 0.15-0.03 mg
Norethindrone - ethinyl estradiol 0.4-0.035 mg
Norethindrone - ethinyl estradiol 0.4-0.050 mg
Norethindrone 0.35 mg
Norethindrone - ethinyl estradiol 0.5-0.035 mg – or Norethindrone – mestranol 1-0.05 mg – or Norethindrone - ethinyl estradiol 1-0.035 mg
Norethindrone - ethinyl estradiol 1-0.020 mg
Norethindrone - ethinyl estradiol – 1.5-0.030 mg
Norethindrone - ethinyl estradiol – FE 1.5-0.030 or 1.0-0.020 mg
Tier 1
Apri
Zovia 1/35
Zovia 1/50E
Aviane, Lessina
Levora, Portia
Tier 2
Ortho-Cept
Yasmin
Levlite
Levlen
Camila, Nora Be, Errin, Jovilette
Necon 0.5/35, Nortrel 0.5/35
Necon 1/50
Necon 1/35, Nortrel 1/35
Microgestin 1/20, Junel 1/20
Microgestin 1.5/30, Junel 1.5/30
Microgestin 1.5/30 FE, Junel FE
Microgestin 1/20 FE, Junel FE
Cryselle, Low-Ogestrel
Sprintec
Ogestrel
Ortho Micronor
Modicon
Ortho-Novum 1/35
Ortho-Novum 1/50
Chemical Ingredients
Desogestrel (0.1, 0.125, 0.15 mg) - ethinyl estradiol 0.25mg
Tier 1
Tier 2
Desogestrel (0.15 mg) - ethinyl estradiol (0.020,0.010 mg)
Kariva
Trivora, Enpresse
Tri-Levelen
Necon 10/11
Necon 7/7/7
Ortho-Novum 10/11
Ortho-Novum 7/7/7
Norgestrel - ethinyl estradiol 0.3-0.03 mg
Norgestimate - ethinyl estradiol 0.25-35 mg
Norgestrel - ethinyl estradiol 0.5-0.05mg
Tier 3
Desogen
Demulen 1/35
Demulen 1/50
Alesse
Nordette, Seasonale
Ovcon 35
Ovcon 50
Nor-QD
Brevicon
Norinyl 1/50
Norinyl 1/35
Loestrin 1/20
Loestrin 1.5/30
Loestrin 1/20 FE
Losetrin 1.5/30 FE
Lo/Ovral
Ortho Cyclen
Ovral
MULTIPHASIC COMBINATIONS
Levonorgestrel (0.05, 0.075, 0.125 mg) - ethinyl estradiol
(0.030, 0.040, 0.030 mg)
Norethindrone (0.5,1.0 mg) - ethinyl estradiol (0.035 mg)
Norethindrone (0.5,0.75, 1.0 mg) - ethinyl estradiol (0.035 mg)
Norethindrone (0.5,1.0, 0.5 mg) - ethinyl estradiol (0.035 mg)
Norethindrone (1.0 mg) - ethinyl estradiol (0.020, 0.030, 0.035 mg )
Norgestimate (0.18, 0.215, 0.25 mg) - ethinyl estradiol (0.035 mg)
Norelgestromin (6.0mg) – ethinyl estradiol (0.75mg) Transdermal
System (Weekly Patch)
Norgestimate (0.18, 0.215, 0.025 mg) - ethinyl estradiol (0.035 mg)
Tier 3
Cyclessa
Mircette
Triphasil
Tri-Norinyl
Estrostep
Ortho Tri-Cyclen
Ortho Evra
Ortho Tri- Cyclen LO
Please note: The generic market frequently changes; new generics are released to the market and established generics may become unavailable or discontinued.
Rx Facts is written and published by Mona Chitre, Pharm.D. CGP, and Joel Owerbach, Pharm.D. of FLRx Pharmacy Management.
Rx Facts is provided as an informational service. Grants or funding are not solicited for this service from the pharmaceutical industry. Providers are directed to specific reference sources or drug package inserts for
detailed information on drug dosing and monitoring.
Comments or questions are welcome by fax: 877-812-5306 • phone: 877-777-2737 • e-mail: [email protected]