NEW YORK, Nov. 17 /PRNewswire/ -- The new dual-label Plan B(R) (levonorgestrel) emergency contraceptive arrives in pharmacies this week. To help patients, pharmacists, and healthcare providers understand how this unprecedented product status - Rx and Over-the-Counter (OTC) - will work, Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., will launch the CARE (Convenient Access Responsible Education) Program, a comprehensive education program for healthcare professionals and consumers.
Approved on August 24, 2006, the new dual-label Plan B(R) is an OTC product for consumers 18 years of age and older and prescription only for women 17 and younger. It is marketed as a single package, which allows for a prescription label to be adhered to the package when dispensed to women age 17 and younger.
"We are pleased with the FDA's historic decision, which gives women more timely access to Plan B(R) emergency contraception," said Amy Niemann, Vice President of Marketing-Proprietary Products at Duramed Pharmaceuticals, Inc. "We are committed to educating consumers on the facts about Plan B(R), as well as how they can purchase the product depending on their age."
Over-the-Counter, but Behind-the-Counter
"For consumers 18 and older, Plan B(R) is available over-the-counter, but it must be kept behind-the-counter," said Kathleen Besinque, PharmD., MSEd, FASHP, Associate Professor of Clinical Pharmacy at USC School of Pharmacy, Los Angeles, CA. "Consumers simply go straight to the pharmacy counter, ask a pharmacy staff member for help, show them a government issued ID, and get Plan B(R). Consumers should read the enclosed patient information before taking Plan B(R)."
Since some people may be embarrassed or afraid to ask the pharmacist for emergency contraception, especially in a crowded pharmacy, Besinque offers some tips for consumers to help alleviate any concerns:
-- Hand the pharmacist a slip of paper with the request for Plan B(R)
-- Ask to speak to the pharmacist privately in the consultation area
-- Call the pharmacist to ask questions on the phone rather than in
person and tell them that you are coming in to pick it up
For Women 17 and Younger
For women 17 and younger, Plan B(R) is still available with a prescription from a healthcare provider. Another growing option in some states where legislation has been passed and regulations implemented is pharmacy access, which enables women to get Plan B(R) directly from certified pharmacists at participating pharmacies without going to a healthcare provider first for a prescription. Nine states currently have these programs in place, including Alaska, California, Hawaii, New Mexico, Maine, Massachusetts, New Hampshire, Vermont, and Washington.
Dispelling the Myths
Even after all the news, many women still are confused about what Plan B(R) is, what it isn't, how to use it and now, how to get it.
"Women need to understand that Plan B(R) is meant as a backup contraceptive," said Tina Raine, MD, MPH, Associate Professor of OB/GYN and Reproductive Sciences at UCSF, San Francisco General Hospital. "Plan B(R) contains the same safe hormone used in birth control pills, just in a higher dose. Women also need to realize that it needs to be taken as soon as possible after unprotected sex or contraceptive failure."
How Plan B(R) Works
Consisting of two tablets of 0.75 mg levonorgestrel, Plan B(R) works similar to other oral contraceptives - by preventing ovulation or fertilization; it may also inhibit implantation. Once implantation occurs, Plan B(R) is not effective. Importantly, Plan B(R) will not work if a woman is already pregnant. And there is no evidence that it will harm a pregnant woman or a developing fetus.
Plan B(R) should be taken within three days (72 hours) of intercourse, ideally within the first 24 hours after unprotected sex. When taken as directed, Plan B(R) has been shown to reduce the risk of pregnancy by up to 89 percent.
Plan B(R) does not protect against the AIDS virus (HIV) or other sexually transmitted infections. Common side effects associated with the use of Plan B(R) included nausea, abdominal pain, menstrual changes, dizziness, breast tenderness, and vomiting. Please see full prescribing information. For more information, please visit http://www.go2planb.com or call 800-330-1271.
About Duramed Pharmaceuticals, Inc.
Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., focuses its product development and marketing activities primarily in the women's healthcare category. Since its formation in 2001, the Company's proprietary products subsidiary has steadily grown to over 400 employees, including its Women's Healthcare and Specialty Products Force. Duramed has 20 products in its portfolio, primarily focused on women's healthcare products, with particular emphasis on developing and marketing products that serve the reproductive and menopausal needs of women. During fiscal 2006, Duramed added five products to its proprietary portfolio, including four women's healthcare products. These include the SEASONIQUE(TM) extended-regimen oral contraceptive; Mircette(R) oral contraceptive; ENJUVIA(TM) hormone therapy; and the ParaGard(R) IUC.
Sue Patton or Maren Smagala
Communications Strategies, Inc.
Carol A. Cox
Barr Pharmaceuticals, Inc.
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Duramed Pharmaceuticals, Inc.