Women and R.Ph.s: Partners in management of menopause

May 2, 2004

Pharmacists can help women make informed decisions in today's maze of menopause management

 

Women and R.Ph.s: Partners in management of menopause

Pharmacists can help women make informed decisions in today's maze of menopause management.

Many menopausal women are confused. They want to alleviate or ward off the symptoms of menopause, such as hot flashes, night sweats, vulvar and vaginal atrophy symptoms, and moodiness, while remaining healthy for the long run.

Hormone therapy (HT) is a popular remedy that many of the women who reach menopause [the normal stage of development that occurs after a woman's last menstrual period] use. Estrogen therapy (ET) and estrogen plus progestin, also referred to as HT or estrogen plus progestin (EPT), are two types of hormone therapy

HT data concerns

The use of HT is in question after several national studies have been halted. In 2002, a study examining combination HT was stopped when researchers found that the hormones slightly increased the risk of breast cancer. Then in early March 2004, the National Institutes of Health instructed participants in the estrogen-alone study of the Women's Health Initiative (WHI), a large multicenter trial, to stop taking their study pills and to begin the follow-up phase of the study.

All 11,000 healthy postmenopausal women who had a hysterectomy and who were participants in the estrogen-alone study were informed of the NIH review of the study data. NIH researchers concluded that with an average of seven years of follow-up completed, estrogen alone does not appear to affect (neither increase nor decrease) heart disease, a key issue in this study. At the same time, estrogen alone appears to increase the risk of stroke and decrease the risk of hip fracture. It has not increased the risk of breast cancer during the time period of the study.

"The increased risk of stroke in the estrogen-alone study is similar to what was found in the WHI study of estrogen plus progestin when that trial was stopped in July 2002. In that study, women taking estrogen plus progestin had eight more strokes per year for every 10,000 women than those taking the placebo. The NIH believes that an increased risk of stroke is not acceptable in healthy women in a research study. This is especially true if estrogen alone does not affect (either increase or decrease) heart disease, as appears to be the case in the current study," said Barbara Alving, M.D., director of the WHI and acting director of the National Heart, Lung, and Blood Institute.

According to Alving, enough data have been obtained to assess the overall risks and benefits of the use of estrogen in the trial, which was to be completed in 2005. Formal results will be published in a peer-reviewed journal later this year. The NIH advises women to continue to follow the Food & Drug Administration guidance regarding HT.

The FDA's position

According to the FDA, the agency is assessing the latest results for the estrogen-alone trial of the WHI study to determine whether the data supports additional labeling changes for postmenopausal HT. In addition, the FDA is working closely with manufacturers of postmenopausal hormone therapies to update product labeling so that women along with their health-care providers can make the best possible treatment decisions for their individual needs. Many manufacturers of estrogen and progestin-containing products have already revised the labeling for their products to include warnings about an increased risk of heart disease, heart attacks, strokes, and breast cancer.

The FDA is also working with manufacturers on updating the labeling for estrogen and estrogen with progestin-containing products as information from the WHI and Women's Health Initiative Memory Study (WHIMS) is released and reviewed. The WHIMS is an ancillary study to the WHI. WHIMS was designed to determine the effects of HT on the development and progression of dementia symptoms in postmenopausal women.

For postmenopausal women who either use or are considering using estrogen or estrogen plus progestin hormone therapy, the FDA advises women and their healthcare providers to regularly discuss HT benefits and risks. According to the FDA, when estrogen-containing products are used for relief of postmenopausal symptoms such as hot flashes, they should be used only for moderate to severe symptoms. When these agents are used for treating moderate to severe symptoms of vulvar and vaginal atrophy, the FDA urges healthcare providers to consider the use of topical products first.

Also, when estrogen-containing products are prescribed to treat postmenopausal osteoporosis only, the FDA recommends that they be considered for women at significant risk for osteoporosis and for whom nonestrogen treatments are inappropriate. Finally, the agency recommends that health-care providers use the lowest dosage and the shortest treatment duration needed to achieve treatment goals.

Doctor recommendations

This new information has left many menopausal women in there 50s wondering what treatment is best for them. Women—often in their 30s and 40s—who have experienced premature menopause or menopause as a result of surgery, are also concerned about their course of action. After a woman's ovaries are removed, menopause begins overnight and it is very different from natural menopause. Surgical menopause is often more dramatic, according to Carol Landau, Ph.D., clinical professor, Department of Psychiatry and Human Behavior, Brown Medical School, Providence, R.I.

Pharmacists' role

According to Kathryn Martin, Pharm.D, and president of Glenmere Research, Montebello, N.Y., the biggest challenge lies in helping women wade through the amount of negative information that they are bombarded with in the press. She noted that pharmacists could help woman decide what is right for them and what is safe and appropriate use. Menopausal women often come into the pharmacy with a prescription in hand. "Many women have already seen their physician or nurse practitioner and they come to the pharmacy looking for additional information or reassurance. They may be looking for the pharmacist to confirm what their healthcare provider has already told them. It is very important for pharmacists to be able to provide that," Martin explained.

"If it is a person who has a legitimate need for a prescription estrogen product, the pharmacist should be able to provide that reassurance to them with regard to its safe use," she said.

Martin pointed out that when they buy over-the-counter (OTC) products, women need to understand what they are buying and they need to be clear about the expectations they have for the product. The pharmacist can help them determine what those expectations are and explain that the relief they might receive with OTC products might not be the same as the relief that they might experience with a prescription product, she said. According to Landau, the pharmacist has a crucial role to play in patient education."In my opinion the pharmacist is underutilized in the healthcare team. Pharmacists are in a perfect position to help patients understand the interaction between medications and herbal products."

Many women are afraid to talk to their physicians about alternative remedies, but pharmacists often see the "big picture." They [pharmacists] are likely to know what drugs a woman is using—prescription medications, as well as OTC and herbal products. "They are often more available to discuss side effects and interactions with their pharmacist," Landau said. "Because herbal remedies are not carefully regulated, this is a 'buyer beware' situation. Women need to know that the labeling can be misleading and that issues of standardization and even contamination are problems," Landau added.

Lisa B. Samalonis

THE AUTHOR is a medical writer based in New Jersey.

Getting the word out

The Red Hot Mamas, the nation's leading source for menopause education and support, along with top gynecologists, are traveling to selected U.S. cities (New York City, Tampa, Nashville, Columbia, and Boston) to educate women on how to better manage their menopause. The free educational program, Menopause Management 101, is designed to help women prepare for a smooth and comfortable transition into menopause.

Its mission is to broaden the base of women's knowledge about menopause and empower them to become educated healthcare consumers and active participants in menopause management. Karen Giblin, president and founder of Red Hot Mamas, and a leading physician will speak to women about important issues associated with menopause. For more information: www.primeplususa.com .

Fast menopause facts

• Menopause is diagnosed when a woman hasn't had a period for 12 months or when a blood test indicates it.

• The average age of menopause is 51 years.

• Perimenopause is time before menopause when menstruation becomes irregular. It lasts about four years, depending on the woman.

• Common symptoms of menopause include hot flashes, night sweats, and thinning and dryness of the vaginal wall.

Source: The New Truth About Menopause St. Martin's Press, 2003.

 

Lisa Samalonis. Women and R.Ph.s: Partners in management of menopause. Drug Topics May 2, 2004;148:21s.