Yvette C. Terrie, RPh

In a few weeks, students and teachers across the country will begin returning to the classroom to start a new school year.

Although back-to-school season is exciting, individuals heading back to the classroom who are prone to allergies often face numerous challenges. Symptoms present with varying degrees of severity and often negatively affect an individual’s quality of life by causing fatigue and sleep disturbances and impairing concentration. Allergy symptoms also often contribute to absences from school and work and a loss of productivity.

For individuals who suffer from seasonal allergies, finding relief from the common symptoms, such as headaches, itchy and watery eyes, nasal congestion, and repetitive sneezing, is a top priority. Unfortunately, the selection of a nonprescription allergy product can be overwhelming, particularly for individuals who have other medical conditions and/or take other medications. Pharmacists can be instrumental in guiding patients in the selection and proper use of nonprescription allergy products and directing them to seek further medical care when warranted. Prior to initiation of pharmacologic therapy, a patient’s medical and medication history should be thoroughly assessed to determine whether self-treatment is appropriate and to prevent contraindications and drug interactions.

During this time of year, ragweed pollen is responsible for most symp- toms associated with fall allergies.

 With 17 species of ragweed pollen, peak levels typically occur in mid-September, affecting an estimated 23 mil- lion individuals in the United States.

Almost 75% of individuals who are allergic to spring plants also expe- rience allergic reactions to ragweed.

 Ragweed pollen can also aggravate asthma symptoms, which can lead to coughing and wheezing.

 Other plant allergens that trigger fall allergy symptoms may include mugwort, sagewood, and tumbleweed.

Other possible causes of fall allergy symptoms include dust mites and mold.

Moreover, the American College of Allergy, Asthma, & Immunology (ACAAI) indicates that some students present with allergy symptoms in the fall because of exposure to allergens in the classroom, such as chalk dust and classroom pets.

A study published in the Annals of Allergy, Asthma & Immunology, the scientific journal of the ACAAI, found that 75% of adults with asthma aged 20 to 40 years and 65% of adults with asthma aged 55 years and older have at least 1 allergy.

Available OTC products for the self-treatment and prevention of mild to moderate allergy symptoms include intranasal corticosteroids (INCS), mast cell stabilizers, ocular and oral antihistamines, and oral and topical decongestants. INCS have been shown to be the most effective treatment for most of the symptoms associated with allergic rhinitis.

 Pharmacists can also be instrumental in recommending dosage forms that are convenient and easy to use, such as long-acting, once-daily formulations and/or orally disintegrating tablets, especially for pediatric patients.

In June, the FDA approved azelastine hydrochloride nasal spray 0.15% (Astepro Allergy; Bayer) as an OTC product for the temporary relief of itchy nose, nasal congestion, runny nose, and sneezing associated with upper respiratory allergies such as hay fever.

 Its recent approval makes it the first steroid-free antihistamine nasal spray for indoor and outdoor allergies available over the counter in the United States.

OTC Astepro Allergy is indicated for use in patients 6 years and older.

 Each nasal spray delivers a volume of 0.137-mL solution containing 205.5
μg of azelastine hydrochloride. The product may be administered as a once- or twice-daily dosage regimen. The OTC formulation includes flexible dosing that provides up to 24-hour relief from itchy nose, nasal congestion, runny nose, and sneezing caused by indoor and outdoor allergies.

Because of the risk of somnolence associated with the use of azelastine, the label for Astepro Allergy warns consumers to avoid alcoholic drinks and to be cautious when driving a motor vehicle or operating machinery.

 Additionally, consumers should avoid sedatives or tranquilizers when using the product.

The 0.15% strength is approved for OTC use, but the 0.1% strength will remain prescription based for perennial and seasonal allergic rhinitis. The manufacturer anticipates that Astepro Allergy will be available at national mass retail locations the first quarter of 2022.

Pharmacists can assist patients who suffer from allergy symptoms in the selection and proper use of nonprescription products. They can also provide patients with key information about the most efficacious nonpharmacological and pharmacological measures to prevent or reduce allergy symptoms. Masks have been used to reduce transmission of COVID-19, but some study results have shown that masks may also be helpful in reducing allergy symptoms.

During counseling, patients should be advised to use OTC products as recommended and be aware of potential adverse effects.

Patients experiencing severe allergy symptoms should be encouraged to seek further care from their primary health care provider. They can also make recommendations about patient education resources that teach patients about back-to-school allergy plans such as the Allergy & Asthma Network website (https://allergyasthmanetwork.org/health-a-z/covid- 19/covid-19-school-resources-for-managing-asthma-and-allergies/) and the ACAAI website (https://www.aaaai.org/tools-for-the-public/conditions-library/ asthma/back-to-school-with-allergies-and-asthma).

Asthma and Allergy Foundation of America. Allergy Capitals. Fall 2018. Accessed July 25, 2021. https://www.aafa.org/media/2183/ AAFA-2018-Fall-Allergy-Capitals-Report.pdf

Ragweed allergy. American College of Allergy, Asthma, and Immunology. Updated April 23, 2018. Accessed July 25, 2021. https://acaai.org/allergies/types/ragweed-allergy

Nall R. Ragweed allergy: what is it and foods to avoid. Medical News Today. April 13, 2018. Accessed July 25, 2021. https://www.medicalnewstoday.com/articles/321490.php

More D. What to expect during fall allergy season. Verywell Health. September 30, 2020. Accessed July 25, 2021. https://www.verywellhealth.com/fall-allergies-83184

Mold allergy. American Academy of Allergy, Asthma & Immunology. Accessed July 25, 2021. https://www.aaaai.org/conditions-and-treatments/allergies/mold-allergy

Four things you might not know about fall allergies. American College of Allergy, Asthma & Immunology. Accessed July 25, 2021. https://acaai.org/news/four-things-you-might-not-know-about-fall-allergies

Busse PJ, Cohn RD, Salo PM, Zeldin DC. Characteristics of allergic sensitization among asthmatic adults older than 55 years: results from the National Health and Nutrition Examination Survey, 2005-2006. Ann Allergy Asthma Immunol. 2013;110(4):247-252. doi:10.1016/j.anai.2013.01.016

Scolaro K. Disorders related to colds and allergy. In: Krinsky D, Berardi R, Ferreri S, et al. Handbook of Nonprescription Drugs. 19th ed. American Pharmacists Association; 2018.

FDA approves Astepro Allergy nasal spray for over-the-counter use in the United States. News release. Bayer. June 17, 2021. Accessed June 17, 2021. https://www.businesswire.com/news/home/20210617005872/en/FDA-Approves-Astepro%C2%AE-Allergy-Nasal-Spray-for-Over-the-Counter-Use-in-the-United-States

Articles

Pharmacists can be essential resources for patients seeking advice on the selection and use of nonprescription medications.

Help Prevent and Relieve Allergy Symptoms

Most individuals experience a headache from time to time, but for some it is routine, which can affect overall quality of life.

Many patients elect to use OTC analgesics for the self-treatment and management of headaches, but selecting products may be overwhelming, especially for individuals with other comorbidities and/or those taking other medications. An estimated two-thirds of OTC analgesics are used for headaches.

The types of headaches most frequently amenable to self-treatment with OTC analgesics include diagnosed migraines, medication-overuse headaches, sinus headaches, and tension-type headaches, also known as stress headaches (see 

The results of a survey showed that 24% of patients chronically overused OTC analgesics and that just 14.5% were ever advised by a health care professional to limit use of these agents for acute headaches.

 As frontline health care providers, pharmacists are positioned to guide patients in the proper use of these nonprescription analgesics and can encourage them to seek further medical evaluations when warranted if self-treatment is not appropriate, especially for those with recurring or severe headaches or undiagnosed migraines.

Prior to making any recommendations, pharmacists should always screen for possible contraindications, drug interactions, and therapeutic duplications. Pharmacists can also identify those pharmacological agents that may cause or exacerbate headaches, make clinical recommendations accordingly and encourage patients to discuss concerns with their primary care providers.

Patients who do not find relief with the use of OTC analgesics should always be referred for further medical evaluation because effective prescription therapies are available that may be beneficial. When counseling patients about the use of OTC analgesics, pharmacists can relay the following information to them

Consult the primary care provider prior to using any of these products if breastfeeding or pregnant or if an individual has a preexisting medical condition or takes other medications.

If appropriate, patients with diagnosed migraines who can predict the onset may benefit from taking an analgesic before the event known to trigger a migraine.

Individuals with a history of hepatic disease should avoid the use of acetaminophen.

Limit dosage of acetaminophen to no more than 4 grams per day to avoid potential liver damage.

Take nonsteroidal anti-inflammatory drugs (NSAIDS) and salicylates with food or milk to avoid gastrointestinal (GI) upset.

In addition, caution patients not to do the following:

administer aspirin or other salicylates to children younger than 15 years who are recovering from chicken pox or have influenza symptoms;

exceed recommended dosages; however, patients should discuss any concerns with a primary care provider;

take aspirin if taking medications for arthritis, diabetes, or gout, unless directed by a primary care provider;

take aspirin or NSAIDS if allergic to aspirin or have asthma or nasal polyps; take acetaminophen if appropriate instead;

take aspirin or NSAIDS if there is a history of GI disorders, heart failure, kidney or liver disease, or ulcers;

take NSAIDS if at high risk for cardiovascular disease or stroke unless under the supervision of a physician;

take NSAIDs or salicylates if taking anticoagulants;

take OTC analgesics for more than 3 days per week unless recommended by a health care provider;

take products containing magnesium salicylate if an individual has renal disease;

use naproxen for those younger than 12 years; and

use these medications if consuming 3 or more alcoholic drinks per day. 

, is a consulting pharmacist and a medical writer in Haymarket, Virginia.

Wilkinson J,Tromp K. Headache. In: Krinsky D,Berardi R, Ferreri S,et al, eds. 

Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care. 19th ed

. American Pharmacists Association;2018. 

Mehuys E, Paemeleire K, Van Hees T, et al. Self-medication of regular headache: a community pharmacy-based survey. 

 2012;19(8):1093-1099. doi:10.1111/j.1468-1331.2012.03681.x 

Headache. JohnsHopkins Medical. Accessed February 15, 2021. http://www.hopkinsmedicine.org/healthlibrary/conditions/adult/nervous_system_disorders/headache_85,p00784/

Silberstein SD. Approach to thepatient with headache. Merck Manuals. Updated April 2020. Accessed February 15,2021. https://www.merckmanuals.com/professional/neurologic-disorders/headache/approach-to-the-patient-with-headache

Prior to making any recommendations, always screen for possible contraindications, drug interactions, and therapeutic duplications.

Help Patients Treat Headaches Safely

The pharmacologic class of drugs known as 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors, also most commonly known as "statins," have made a significant impact on the treatment of hypercholesterolemia and the prevention of coronary diseases. Since their debut more than 16 years ago, this class of drugs has revolutionized the treatment of individuals with an increased risk of hypercholesterolemia. Today there are 8 statins on the market (Table). 

In recent years, statins have proven to be more than just beneficial cardiovascular agents. Research studies have shown that statins can have a positive impact on other disease states. They have become increasingly popular in various studies for the following diseases: 

Various cancers (breast, prostate, colorectal) 

Macular degeneration (age-related maculopathy) 

It is a known fact that diabetics are at an increased risk for developing some form of cardiovascular disease, in particular coronary artery disease and myocardial infarction. Diabetics need to follow established risk management guidelines for hyperglycemia and coronary disease in order to reduce the chances of developing further complications. Older guidelines recommended that individuals with type 2 diabetes and low-density lipoprotein cholesterol levels >100 mg/dL be prescribed statins. 

Recently, the American College of Physicians developed guidelines on managing dyslipidemia, particularly hypercholesterolemia, in patients with type 2 diabetes mellitus. The guidelines were derived from a research study consisting of clinical trials involving 50,000 individuals with type 2 diabetes, including those with some form of microvascular complication and with a particular emphasis on premenopausal women. Specifically, the study made the following verbatim recommendations

Lipid-lowering therapy should be used for secondary prevention of cardiovascular mortality and morbidity for all patients (both men and women) with known coronary artery disease and type 2 diabetes

Statins should be used for primary prevention against macrovascular complications in patients (both men and women) with type 2 diabetes and other cardiovascular risk factors

Once lipid-lowering therapy is initiated, patients with type 2 diabetes mellitus should be taking at least moderate doses of a statin

For those patients with type 2 diabetes who are taking statins, routine monitoring of liver function tests or muscle enzymes is not recommended except in specific circumstances

The new guidelines suggest that individuals over 55 years of age with type 2 diabetes and younger individuals with type 2 diabetes who have at least one cardiovascular risk factor should be taking a statin drug.

Whereas the research regarding statin usage in many other disease states appears to be encouraging to many, more research still needs to be done. Overall, statins are relatively safe agents. Although some in the health care industry may see statins as "wonder drugs," it is important to review the side effects associated with these agents to determine their appropriateness for each individual patient when prescribing. 

More information about statins can be found at the National Heart, Lung, and Blood Institute Web site (www.nhlbi.nih.gov) and at the various drug manufacturers' Web sites. 

Ms. Terrie is a clinical pharmacy writer based in Slidell, La.

For a list of references, send a stamped, self-addressed envelope to: References Department, Attn. A. Stahl, Pharmacy Times, 241 Forsgate Drive, Jamesburg, NJ 08831; or send an e-mail request to: astahl@mwc.com.

Statins and Diabetes

Everyone at one time or another has suffered some form of pain from an injury or illness. In most cases, people experience acute pain, which, with effective pain management coupled with the healing process, eventually goes away. Chronic pain is another form of pain, which also occurs as the result of some type of injury or illness but persists even after the apparent healing has occurred. It can last for weeks, months, or years and may not respond to any form of treatment. As a result, an individual's quality of life may be impaired, and the pain may lead to future long-term physical, psychological, and social problems. The pain can occur in any region of the body and can vary from mild to severe. Chronic pain often results in sleep disorders or depressive states in some patients. Although most causes of chronic pain are known, the causes of some pain are never identified, and pain can occur without longterm illness or injury. 

Chronic pain is considered to be the leading cause of disability among individuals in the United States.

 It is very prevalent in approximately 90% of cancer patients and is often considered to be undertreated. According to the American Chronic Pain Association, 86 million individuals in the United States are afflicted with some form of chronic pain.

As stated above, the most prevalent causes of chronic pain are long-term illness (Table 1) and injuries. Other possible factors include damage to the central or peripheral nervous system and vascular conditions. 

Chronic pain can be categorized into 3 classes

Pathophysiologic?pain due to functional changes related to or the result of an illness or injury 

Neuropathic?pain resulting from damage to the nervous system (spinal cord, brain, or peripheral nerves) 

Nociceptive?pain associated with continual tissue damage due to circumstances such as surgery, osteoarthritis, or sports injuries 

Chronic pain may be experienced in the following forms: 

Mild-to-severe episodes of pain that does not subside 

Severe episodes of discomfort, aching, burning, stiffness, or soreness 

Persistent episodes of tingling or radiating pain 

Diagnosis usually is made through review of the patient's medical history, a neurologic examination, and a series of diagnostic tests, which may include the following: 

Imaging tests (eg, magnetic resonance imaging, x-ray, computerized axial tomography scan, bone scan) 

Functional assessment (eg, evaluation of an individual's ability to perform day-to-day activities) 

Pain management for an individual suffering from chronic pain often can be challenging. The goal of pain management is to relieve or decrease the intensity of the pain, enabling the person to function. Several treatment plans may be attempted before adequate pain relief is achieved (Table 2). Patients should be advised to seek aid from their health care provider if their pain persists for more than a month. 

The initial treatment depends on the severity and type of the person's pain. Treatment varies from individual to individual. The use of pharmacologic agents is the most common form of treatment. Most individuals suffering with chronic pain initially resort to nonprescription analgesics. In conjunction with regularly used analgesics (eg, nonopioids, opioids, and opioid agonist/ antagonists), adjunctive therapies may be incorporated into a pain-management plan. 

Nonopioids commonly are used in the initial stages of chronic pain. These agents are a rational choice when the etiology of the chronic pain is associated with an inflammatory response. These agents must be monitored carefully on a consistent basis. Renal and hepatic functions should be routinely monitored, as well as signs of gastrointestinal irritation and the potential for developing ulcers. Pharmacists should inform patients that some of these agents should not be used for more than 10 days unless otherwise directed by their physicians. These nonopioids are as follows: 

Cyclooxygenase-2 inhibitors (celecoxib, rofecoxib, valdecoxib) 

The use of opioids, although effective in most cases of chronic pain, is still somewhat controversial among health care providers. These agents should be reserved for uncontrolled pain and should be used with caution, because they may interfere with cognitive skills and the potential exists for tolerance and addictive effects. Patients should be instructed to adhere to regular follow-ups to monitor progress. Common adverse effects include somnolence, confusion, dry mouth, constipation, and nausea. Patient-controlled analgesia is re-served for severe chronic pain that has been uncontrolled with oral medications. Opioids include: 

Adjunctive analgesic therapy often is utilized (Table 3). For other treatment options, see Table 4. 

The treatment of chronic pain with only analgesics can be successful, but the adverse effects associated with long-term use of these drugs are important factors to consider. Patients need to be made aware that repeated administration of pain medications could result in tolerance and psychological as well as physical dependence. Therefore, the incorporation of other forms of therapy?such as physical, rehabilitation, and nutritional therapies?also should be evaluated. Multidisciplinary treatment plans involving education, medication, physical therapy, and behavioral therapy have demonstrated effectiveness in most pain-management cases. 

Help from pharmacists can be indispensable for individuals afflicted with chronic pain. Pharmacists can serve as educational resources and can refer patients to specialists who may aid in identifying treatment plans that may in some way enhance their quality of life. Although chronic pain cannot always be cured, it can be managed in some cases. Effective pain management often requires both pharmacologic and nonpharmacologic interventions. 

Evaluating and Managing Chronic Pain

Breast cancer is the most prevalent type of cancer affecting women (aside from skin cancer), and it is the second leading cause of cancer-related deaths in women after lung cancer. In 2004, an estimated 215,900 women will be diagnosed with carcinoma of the breast in the United States, and approximately 40,110 will die from the disease. Currently, there are over 2 million women in the United States who have been treated for breast cancer.

 More than 80% of breast cancer cases occur in women over 50 years of age. Although the number of cases of breast cancer appears alarming, there has been a decline in the number of cancer-related deaths, due to early detection, intervention, and the treatment options available. Breast cancer is not limited to just women. Approximately 1500 men annually are afflicted by the disease. 

Treatment options are available for each stage of breast cancer. Surgery is typically the initial line of defense. Depending on the disease stage, however, adjuvant therapies?such as radiation, chemotherapy, hormone/endocrine, or biological?are employed to prevent or delay the possibility of metastasis. 

The management and treatment of breast cancer has progressed in the last few years. Women who have stage I of the disease (negative axillary lymph node dissections and small primaries) usually are treated via surgery alone and have an 80% survival rate.

 In cases where patients have node-positive disease, there is a high risk of recurrence. 

A variety of chemotherapy agents are accessible for the treatment of breast cancer. Carcinoma of the breast may respond to various cytotoxic agents, hormonal therapies, and various other endocrine treatments. Most chemotherapy protocols involve a combination of one or more agents to aggressively treat the breast cancer. Some of the most common chemotherapeutic agents are listed in the Table.

The use of cytotoxic agents is recommended for women who have positive nodes. The chemotherapy combination regimens most commonly used to treat breast cancer include the following: 

CAF (FAC): Combination of cyclophosphamide, Adriamycin (doxorubicin), and 5-fluorouracil

 by mouth (PO) daily on days 1 to 14 (given as a single daily dose)

 by intravenous (IV) push on days 1 and 8 

Cycle repeated for 6 cycles every 28 days 

CMF: Combination of cyclophosphamide, methotrexate, and 5-fluorouracil

CAF is often used in women with a high risk of recurrence. Both of the above protocols have been shown to significantly reduce relapse rate and to increase chances of survival. These agents may be very effective for patients in locally advanced disease stages, and they can actually increase chances of survival and/or possibly remission. They are less effective in patients with rapidly growing tumors or in cases of metastasized cancers. 

Other alternative protocols include the following: 

AC: Adriamycin (doxorubicin) and cyclophosphamide

ACT: Adriamycin (doxorubicin), cyclophosphamide, and Taxol (paclitaxel)

FEC: fluorouracil, epirubicin, and cyclophosphamide

In the past few years, oncologists have had several new choices of therapies to combat resistant tumors or cases of advanced cancer. The taxenes and platinum-based agents are 2 very well-known classes. Examples of taxenes include paclitaxel and docetaxel. Oxaliplatin, cisplatin, and carboplatin are members of the platinum-based class, also known as alkylating agents. The most common adverse effects of all the therapies listed above include nausea, vomiting, hair loss, neutropenia, neurotoxicity, thrombocytopenia, fatigue, and diarrhea. 

Paclitaxel is an alkaloid ester derived from the Pacific (or Western) yew tree (

). It is used as an adjuvant therapy for node-positive breast cancer administered subsequently to doxorubicin-containing chemotherapy and for the treatment of metastatic breast cancer after a failure of combination chemotherapy or in relapse within 6 months of adjuvant therapy.

 It is metabolized primarily by the liver P-450 system. This agent usually is administered as 100 mg/m 

 IV over 1 hour every 3 weeks for 4 courses. 

This agent is a synthetic taxene derived from the European yew tree. The mechanism of action is identical to that of paclitaxel. It is approved for the treatment of locally advanced or metastatic breast cancer after the failure of prior chemotherapy. It usually is administered as 60 to 100 mg/m 

Because some breast cancers progress with excess estrogen or progesterone, hormone therapy often is utilized. The goal of therapy is to prevent hormones from aiding the growth of cancer cells. This therapy works primarily by blocking estrogen that causes cell proliferation. These agents frequently are used as adjunctive therapy for women with advanced-stage estrogen-receptor-positive cancer. The hormonal therapy agents fall into the following classes: 

The most commonly used hormone therapy is the antiestrogen tamoxifen. Tamoxifen is a synthetic hormone that has been utilized for more than 25 years to treat breast cancer. It can decrease the chances of some earlystage cancers recurring and can prevent further metastasis. It also is approved as a chemopreventive agent for women who have a high risk of developing breast cancer. It can be beneficial in postmenopausal women when used as monotherapy or in combination with cytotoxic chemotherapy. Experts recommend that women take tamoxifen for 5 years following surgical resection.

Tamoxifen exerts its pharmacologic effect by acting as a competitive partial agonist?inhibitor of estrogen and binds to the estrogen receptors of estrogen-sensitive tumors. Common adverse effects include an increased risk of endometrial cancer, vaginal bleeding and discharge, edema, hot flashes, and nausea. Tamoxifen, although effective, targets all estrogen receptors. 

A generation of agents known as selective estrogen receptor modulators (SERMs) also can act as estrogen blockers. SERMs, such as raloxifene and toremifene, are more specific in targeting breast cancer cells and have a lesser antiestrogenic effect. Although raloxifene and toremifene are not approved for the treatment of breast cancer, a clinical study that began in 1999, known as STAR (Study of Tamoxifen and Raloxifene), is still under way to determine the effectiveness of raloxifene in relation to tamoxifen. 

Aminoglutethimide is an adrenal steroid inhibitor used primarily in treating metastatic breast cancer in postmenopausal women whose tumors have significant levels of estrogen receptors. It is usually administered with hydrocortisone to decrease the incidence of adrenal insufficiency. 

Newer agents approved by the FDA for the treatment of metastatic breast cancer include anastrozole and letrozole, which are classified as nonsteroidal inhibitors, and exemestane, which is a steroidal hormonal agent. These agents exert their therapeutic effect by inhibiting aromatase, an enzyme that is a primary source of estrogen production in many tissue areas, including the breast. They are approved as firstline therapy, and they can be used in women whose tumors have progressed and have not responded well to tamoxifen treatment. They significantly lower serum estradiol concentrations and have no detectable effect on the formation of adrenal corticosteroids or aldosterone. Common adverse effects include vasodilation, an increased risk of osteoporosis, arthralgia, hot flashes, and headache. 

Gonadotropin-Releasing Hormone (GnRH) Agonists

Goserelin and leuprolide are classified as synthetic peptide analogues of GnRH, and they are sometimes used as palliative treatments in advanced breast cancer. These agents are similar in structure to luteinizing hormone?releasing hormone (LH-RH). They cause the endocrine system to act as if sufficient LH-RH is present, thus preventing further synthesis of estrogen, which in turn reduces the hormones needed by the breast tumors to continuing growing. 

Approximately 25% to 30% of individuals with breast cancer have tumors that cause an excess of human epidermal growth factor receptor 2 protein (HER-2/neu protein), which stimulates cancer cells to grow at an aggressive rate and to become resistant to some of the standard treatment options available. These individuals may receive trastuzumab. Trastuzumab is a monoclonal antibody that binds to the extracellular domain of the HER-2, and it mediates antibody-dependent cellular cytotoxicity against cells, which overproduce HER-2.

 This drug is administered via IV infusion. The initial dosage is usually 4 mg/kg over 90 minutes, and the maintenance dose is 2 mg/kg by IV infusion. The most common adverse effects include leukopenia, diarrhea, anemia, fever, and chills. 

Although the incidence of breast cancer has increased, the number of deaths related to this type of cancer is declining, due to early screening and medical advances in therapy. Many treatment options have become available to patients in the past 2 decades. Various other treatment options are currently being researched. For health care professionals, the best line of defense in combating breast cancer is patient education and encouraging patients to follow the recommended screening guidelines. 

For a list of references, send a stamped, self-addressed envelope to: References Department, Attn. D. Ryan, Pharmacy Times, 241 Forsgate Drive, Jamesburg, NJ 08831; or send an e-mail request to: dryan@mwc.com.

Carcinoma of the Breast: A Review of Pharmacologic Treatment

Polycystic ovary syndrome (PCOS) is one of the most common causes of infertility and the likely cause of many menstrual disorders. Many women are not even aware that they have this condition. PCOS is associated with increased risk of endometrial and ovarian cancer, cardiovascular disease, hypertension, and type 2 diabetes. 

PCOS is an endocrine disorder that occurs in approximately 7% to 10% of premenopausal females and results in the ovarian production of high amounts of androgens (male hormones), in particular testosterone.

 The increased androgen levels prohibit the follicles of the ovaries from producing a mature oocyte. Lack of oocyte production causes the follicles to form cysts. Because ovulation does not occur, enlargement of ovaries tends to occur. Polycystic ovaries are usually 2 to 5 times larger than normal ovaries. Approximately 50% to 70% of females with PCOS have insulin resistance (IR).

In 1990, the National Institutes of Health proposed that the criteria (listed in Table 1) for diagnosing PCOS should be features of hyperandrogenism with chronic anovulation after identifiable causes have been excluded. 

It is important to note that having 1 or more of the characteristics of PCOS does not indicate that an individual has PCOS. Various diagnostic tests?such as physical examinations, ultrasonography, and blood tests?are performed to confirm whether the condition exists and to assess the severity of the condition. In some cases, the patients are asymptomatic and discover PCOS upon an attempt to conceive or after seeking medical attention for irregular or missed menstrual cycles. Approximately 5% to 30% of women have some characteristic of PCOS.

Complications of PCOS include reproductive, cardiovascular, and metabolic complications.

Reproductive complications include the following: 

Cardiovascular complications are as follows: 

The following metabolic complications may occur: 

The focus of PCOS treatment is on restoring regular menstrual cycles, relieving symptoms, and preventing or decreasing future complications related to having this disorder, such as cardiovascular disease, diabetes, and cancer. Various treatments are available for treating PCOS, and treatment must be individualized, based on the severity of the condition and its clinical presentation. 

 These agents are effective in decreasing the luteinizing-hormone (LH) levels, thus regulating the menstrual cycle. They also assist in reducing acne and hirsutism. 

 Agents such as medroxyprogesterone or norethindrone aid in decreasing serum levels of LH and regulating menstrual cycles. 

These agents help to decrease elevated androgen levels and to treat hirsutism and alopecia. Spironolactone is the most commonly prescribed antiandrogen for treating hirsutism. 

For PCOS patients who want to conceive, clomiphene citrate is typically prescribed to stimulate ovulation. If not successful, other fertility agents can be utilized. 

Treating Insulin Resistance Associated with PCOS

Insulin-sensitizing agents (Table 2) are typically prescribed to treat non?insulin-dependent diabetes (type 2 diabetes), but these agents have been shown to be beneficial in treating IR, most commonly found in women with PCOS. Although the use of these agents in PCOS is not FDA-approved, studies suggest that in some cases there is a significant decrease in free testosterone levels and in some instances women have ovulated without the use of fertility agents.

 These insulin-sensitizing agents aid the body's sensitivity to insulin and therefore help to normalize the hormonal abnormalities associated with PCOS. 

In July 1998, the results of a study, published in the 

, suggested that women with PCOS had increased rates of ovulation when placed on agents that lower insulin levels.

 Metformin (Bristol-Myers Squibb) was the first agent to be prescribed for IR, and it is commonly used in treating PCOS patients who have insulin resistance. Metformin belongs to the biguanide drug class. 

In 1999, 2 new agents were approved: pioglitazone (Takeda) and rosiglitazone (GlaxoSmithKline). These antidiabetic agents are commonly used for IR in PCOS patients, although this indication has not been approved by the FDA. The use of these agents in some patients with PCOS has been shown to result in a return of the ovulation function. 

Rosiglitazone is metabolized with no unchanged drug excreted in the urine. Therapy with this agent should not be initiated in patients who have clinical evidence of liver disease or increased serum transaminase levels. This agent can cause edema, which may exacerbate or cause congestive heart failure. Patients should, therefore, be observed for signs of heart failure. This drug may be taken without regard to meals. There are no documented cases of drug interactions. 

In October 2002, GlaxoSmithKline Pharmaceuticals announced FDA approval of the combination of rosiglitazone maleate and metformin HCl (Avandamet).

 This drug combines the 2 leading agents currently used for type 2 diabetes in 1 pill. It furnishes 2 distinct but integral mechanisms of action to regulate diabetes. This agent also is not an approved treatment for PCOS, but, like other thiazolidinediones, it may result in ovulation in some premenopausal anovulatory patients. Avandamet should not be prescribed for patients with any type of renal or hepatic abnormalities or congestive heart failure. A small population of patients may develop lactic acidosis. The most common adverse effects include diarrhea, nausea, and mild weight gain. 

PCOS is often underdiagnosed, but with the growing trend toward the recognition of this disorder, more women are being diagnosed and treated. It is imperative that all health care professionals (including pharmacists) be aware of this disorder and realize that, if left untreated, PCOS can cause multiple long-term complications for the vast affected patient population. 

Polycystic Ovary Syndrome Association: www.pcosupport.org

National Women's Health Information Center: www.4woman.gov/faq/pcos.htm