Dr. Coleman is an assistant professor of pharmacy practice and director of the pharmacoeconomics and outcomes studies group at the University of Connecticut School of Pharmacy.

MD, a 73-year-old woman with a history of hypertension, high cholesterol, and diabetes, goes to her local pharmacy with a letter from her prescription insurance provider. The letter states that one of MD’s current medications, Caduet (amlodipine/atorvastatin) 10 mg/40 mg, will no longer be on the plan’s formulary this coming year and that she has the option of paying for it out-of-pocket or switching to the preferred agent(s), in this case, amlodipine 10 mg and simvastatin 80 mg each once daily. MD’s blood pressure and low-density lipoprotein (LDL) cholesterol have been at target goals for the past 1½ years. She is concerned that her care is going to be adversely affected by the medication switch. MD also tells the pharmacist that her cousin is taking pravastatin, and she is doing well. She asks if it would be possible to start pravastatin instead of simvastatin?

MK is a 76-year-old woman who was recently seen at an outpatient clinic following a fall on icy ground. She was given a bone mineral density scan and was found to have a T-score at the spine of —1.8 and at the hip of –2.6. The physician at the clinic gives her a prescription for alendronate 70 mg by mouth weekly, and she brings the prescription to the pharmacy. The pharmacist reviews MK’s profile and sees that she is also taking simvastatin 40 mg daily, lisinopril 20 mg daily, lansoprazole 30 mg daily, and calcium carbonate 500 mg plus 400 IU of vitamin D, 3 times daily. MK tells the pharmacist that she feels fine and does not understand why she should take this medication. She also asks if it is true that she has to stand up for 2 hours after she takes “bone drugs.”

 What should the pharmacist tell the patient?

Six statins are currently approved for marketing in the United States by the FDA. Although they all share the same mechanism of action for lowering cholesterol, they are not all equally potent reducers of LDL cholesterol levels at FDA-approved doses. According to the insurance provider’s letter, the 40 mg of atorvastatin MD receives in her Caduet will be replaced with an adequate LDL cholesterol—lowering equivalent dose of simvastatin (80 mg). Thus, the pharmacist can tell MD that her LDL cholesterol levels should not be affected by the statin switch. The pharmacist also should explain to MD that although pravastatin’s LDL-lowering efficacy may be sufficient for her cousin, it does not lower LDL cholesterol enough to enable MD to reach her own LDL goal and therefore is not an option. Finally, MD should be reminded that she will still receive her amlodipine, however, not as part of a combination tablet.

Osteoporosis is due to an imbalance of bone formation and resorption and may lead to complications such as fractures. Diagnosis is typically made by measuring the T-score, which compares a patient’s bone mineral density with that of a young healthy person of the same sex. A T-score <—2.5 is diagnostic for having osteoporosis. Based on MK’s T-score at the hip (–2.6), she is considered to have osteoporosis and should receive treatment to prevent fractures. The pharmacist should tell the patient that her alendronate will help to keep her bones strong so that she would be less likely to get a fracture if she were to fall again. Alendronate prevents bone loss and should be taken in addition to calcium and vitamin D. MK should take alendronate in the morning with a full glass of water (~8 ounces) at least 30 minutes before eating, taking other medications, or drinking anything besides water. The patient should remain upright (either sitting or standing) for 30 minutes, not 2 hours. This is to prevent any esophageal irritation that might result from direct contact of alendronate on the esophagus. MK also is taking lansoprazole, which may have a drug interaction with her calcium. Calcium is better absorbed in an acidic stomach environment, but MK likely has reduced calcium absorption due to her acid suppression. She might benefit from switching to a calcium citrate form (plus vitamin D), which does not require as much acidity in the stomach for absorption.

Articles

Case Studies

Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP

PharmaForce, Inc (Columbus, OH) announced the FDA approval for its abbreviated new drug application for betamethasone  sodium phosphate and betamethasone acetate injectable suspension, USP. The product is a generic version of Schering Corporation's Celestone Soluspan, and is indicated for intramuscular use in allergic states, dermatologic diseases, endocrine disorders, gastrointestinal diseases, hematologic disorders, neoplastic diseases, nervous system issues, ophthalmic diseases, renal diseases, respiratory diseases, and rheumatic disorders; intra-articular or soft tissue administration as adjunctive therapy for short-term administration in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, and synovitis of osteoarthritis; intralesional administration in patients with alopecia areata, discoid lupus erythematosus, keloids; and localized hypertrophic infiltrated inflammatory lesions of granuloma annulare, lichen planus, neurodermatitis, and psoriatic plaques, and necrobiosis lipoidica diabeticorum. For more information, visit www.pharmaforceinc.com.

Sagent Pharmaceuticals, Inc (Schaumburg, IL) has launched epirubicin hydrochloride injection. The product, a generic equivalent to Pfizer Oncology's Ellence, is indicated as part of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. Epirubicin hydrochloride injection is latex- and preservative-free, and comes with enhanced labels and packaging that is aimed at reducing medication errors. Epirubicin hydrochloride is an anthracycline cytotoxic agent intended for intravenous administration. It is supplied as a sterile, clear red, ready-to-use solution. The pharmacokinetics of epirubicin hydrochloride injection in pediatric patients have not yet been evaluated. For more information, visit www. sagentpharma.com.

Baxter Healthcare Corporation (Deerfield, IL) recently introduced new, distinctive labeling for midazolam hydrochloride injection to help reduce medication errors. The new labeling features include a patents-pending tear-off label, requiring clinician intervention prior to administration of the drug, something exclusive to Baxter. One of several dozen drugs categorized by the Institute for Safe Medication Practices as a "high-alert medication" due to the significant patient harm possible if used in error, midazolam hydrochloride injection is an anesthetic indicated for preoperative sedation, anxiolysis, and amnesia preoperatively and for diagnostic, therapeutic, or endoscopic procedures; for the induction of general anesthesia prior to the administration of other anesthetic agents; and as a continuous, intravenous infusion for sedation of intubated and mechanically ventilated patients. Visit www.baxter.com for more information.

Baxa Corporation (Englewood, CO) has introduced its new NeoThrive Enteral Feeding System, paired with a campaign to spread awareness about the dangerous risks of tubing misconnections in neonatal intensive care unit (NICU) facilities. Distinct "Enteral Only" orange coloring and a specialty connector alert health care clinicians against intravenous (IV) line errors in NICU feedings. Further ensuring safety, the NeoThrive System comes complete with NeoThrive Enteral Syringes, which are the first syringes designed for enteral feeding only. Their exclusive nonluer tips prevent them from being joined with standard luer connections, and the NeoThrive Enteral Pump only functions with NeoThrive Enteral Syringes, eliminating the risk of using an IV syringe for enteral feeding. For more information, on the NeoThrive Enteral Feeding System, visit www.baxa.com/ neothrive. 

Health Systems Pharmacy Product News

Health Systems Product News

Researchers have released new guidelines aimed at physicians and women to help recognize signs of bleeding disorders, which often go undiagnosed.

“Too often, women think heavy bleeding is OK because the women in their family—who may also have an undiagnosed bleeding disorder&mdash;have heavy periods as well,” said the study’s lead author Andra James, MD. “We want women who continually experience abnormal reproductive tract bleeding, specifically heavy menstrual bleeding, to be alert to these other signs and approach their physicians about being evaluated.”

The recommendations, which appeared in the July 2009 issue of the 

American Journal of Obstetrics & Gynecology

• Bleeding for >5 minutes with minor wounds

• Excessive or prolonged bleeding after dental extractions

• Hemorrhaging that requires blood transfusions

FAST FACT: The National Osteoporosis Foundation reports that 27.2 million women are estimated to have low bone mass. 

Women may prolong life by taking multivitamins. The study, reported in the June 2009 issue of the American Journal of Clinical Nutrition, found that multivitamins prevent parts of women’s DNA from shortening. The telomeres (the end portion of chromosomes) protect chromosomes from damage. Because telomeres shorten to some extent when cells divide, the researchers hypothesized that stopping this shortening could protect new cells, thereby reducing the effects of aging.

The researchers based their findings on an analysis of 586 women participating in the Sisters Study. The women were asked about their vitamin supplement use over a 12-year span. The scientists also took blood samples and tested DNA. The study results indicated that multivitamin use was linked with longer leukocyte telomeres. 

Osteoporosis Therapy Adherence Helps Avoid Fracture

A CVS Caremark study that analyzed women diagnosed with osteoporosis over a 2-year period found that 87% of women aged 18 and older, who were taking medication to treat the disease, did not experience a fracture during the study’s duration. The study also found that untreated women <65 years of age were 5.7 times more prone to have a fracture, compared with women treated with bisphosphonate, estrogen, or other hormone-related osteoporosis therapy.  

Women entering menopause who notice their brains not working as well should not be alarmed—it is only temporary. The 4-year study involved >2300 women aged 42 to 52.

The study included women who were still menstruating regularly, had completed menopause, or were in perimenopause. The women were given a series of tests to determine cognitive skills. The tests measured memory and how quickly they processed information. The researchers found that when it came to processing speed, all the women, except those in the late perimenopausal stage, improved their scores after repeatedly taking the test. Similar findings were seen with verbal memory tests.

, the researchers concluded that the differences between the women were a matter of some failing to improve as much as others over time. The women with lower scores as they entered menopause did better after it.

An analysis on all original clinical cancer research published in 2006 in 5 major cancer journals showed that women are underrepresented in clinical cancer research. The study, which included >1 million participants, examined 661 prospective studies about types of cancer that affect both men and women at relatively equal rates.

The research indicated that women made up 37% of participants in studies not receiving government funding, compared with 41% of women in government-funded studies. Barriers to clinical participation include lack of information and the perception that the studies will interfere with personal responsibilities. Furthermore, researchers have been told to avoid involving vulnerable populations in their studies (eg, women of childbearing age).

Women's Health Watch

Dr. Holmberg is the pharmacy coordinator at Desert Vista Behavioral Health Center in Mesa, Arizona.

The FDA has approved sanofi-aventis’ Multaq (dronedarone) for adult patients with atrial fibrillation or atrial flutter.

Multaq has been shown to reduce the risk of cardiovascular hospitalizations. It is indicated for patients with paroxysmal or persistent atrial fibrillation or atrial flutter who have recently experienced an episode of atrial fibrillation or atrial flutter and who have cardiovascular risk factors (age >70 years, hypertension, diabetes, previous cerebrovascular accident, left atrial diameter ≥50 mm or left ventricular ejection fraction of <40%) and who are in sinus rhythm or who will be cardioverted.

Atrial fibrillation affects an estimated 2.5 million Americans, and it is currently the leading cause for arrhythmiarelated hospitalization in the United States. Patients with atrial fibrillation have up to 5 times the risk for stroke than patients without atrial fibrillation. Although atrial flutter occurs less frequently, it may eventually become atrial fibrillation.

Multaq’s mechanism of action is currently unknown. It demonstrates antiarrhythmic properties of all 4 Vaughan- Williams classes.

Multaq is dosed as 400 mg twice daily with the morning and evening meals.

Contraindications, Warnings, and Precautions                                                                    

Multaq carries a boxed warning regarding its contraindication in patients with New York Heart Association (NYHA) Class IV heart failure or symptomatic NYHA Class II or III heart failure with a recent decompensation that required hospitalization or referral to a specialist.

Multaq also is contraindicated in patients with second- or third-degree atrioventricular block or sick sinus syndrome, unless its use is in combination with a functioning pacemaker. Multaq is contraindicated in patients with bradycardia <50 beats per minute; concomitant use of a strong cytochrome P (CYP)3A4 inhibitor; concurrent use of medications or herbal products that may prolong the QT interval and may lead to torsade de pointes; QTc Bazett interval ≥500 ms; and severe hepatic impairment. Multaq is Pregnancy Category X and should not be used in patients who are pregnant or breastfeeding.

Treatment with Multaq should be interrupted or discontinued in patients in whom heart failure develops or worsens. Ensure that both potassium and magnesium levels are maintained within normal ranges prior to and during treatment with Multaq. If the QTc Bazett is ≥500 ms, Multaq should be discontinued. Patients may experience an increase in serum creatinine within the first week of treatment with Multaq; this increase does not represent a change in renal function. Women who may become pregnant should use effective contraception during treatment with Multaq.

The most common adverse reactions to Multaq are diarrhea, nausea, abdominal pain, vomiting, and asthenia.

Multaq is metabolized by CYP3A and is a moderate inhibitor of CYP3A and CYP2D6. As a result, concurrent administration of some medications may require extra monitoring or therapeutic adjustments.

Avoid concurrent use of antiarrhythmic agents, CYP3A inducers, and grapefruit juice. If discontinuation of digoxin is not a feasible option, the dose should be halved, and therapy should be monitored appropriately. Treatment with beta-blockers and calcium channel blockers should be initiated at low doses and increased only after tolerability has been confirmed by and electrocardiogram. Administration of 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors should be according to the manufacturer’s recommendation for treatment with a statin and a CYP3A and P-glycoprotein inhibitor. Other substrates of CYP3A with a narrow therapeutic index (sirolimus and tacrolimus) should be monitored carefully with dosage adjustments made as necessary.

Rx Product News Profile

Rx Product News Profile: A closer look at new FDA actions: Multaq

Statins are not being taken by nearly half of the Americans who meet the criteria for these medicines, found a national survey presented at a recent American Heart Association meeting. The findings are based on data from the 2003-2004 National Health and Nutrition Examination Survey. The researchers used the data to identify 777 adults who met the criteria established by the National Cholesterol Education Program for statin therapy. These criteria consider blood levels of low-density lipoprotein cholesterol levels and other risk factors for heart disease, such as high blood pressure and smoking. Of 777 patients, only 428 were taking statins. Overall, 44.9% of individuals who met criteria for cholesterol-lowering drug treatment were untreated. Individuals who reported being informed they had high cholesterol and had a history of heart disease were more apt to take the medications, according to researcher Erica S. Spatz, MD. The major factors linked with being untreated were: • Individuals younger than 50 years of age were twice as likely to be untreated. • Individuals with no health insurance were more than twice as likely to be untreated. • Individuals not having a source of regular medical care were nearly 4 times as likely to be untreated.

Prevent Dementia: Not with Statin Therapy 

Statins do not ward off Alzheimer’s disease or dementia, according to a recent report in the 

. In an earlier review, 2 clinical reports had found an association between statin therapy and a reduction in the frequency of Alzheimer’s disease by as much as 70%. No randomized clinical trials, however, had been performed at this point. In the current study, the researchers identified 2 published trials involving 26,340 participants. One trial compared simvastatin 40 mg with placebo, and the second trial compared pravastatin 40 mg with placebo. The researchers noted no major differences between any of the treatment groups in the percentage of participants classified as cognitively impaired. “In late life, there is good evidence that statins given to people at vascular risk have no effect in preventing Alzheimer’s disease or dementia,” explained Bernadette McGuinness, MD. “Statins cannot be recommended for this purpose therefore.”

New Cholesterol Tests Need Further Scrutiny

Physicians may one day be able to predict which patients will develop heart disease with new tests that measure individual particles of low-density lipoprotein (LDL; “bad”) cholesterol. The researchers noted, however, that the tests still need further analysis. Although several companies have developed more refined tests that measure the size and concentration of individual LDL particles, clinicians believe that smaller LDL particles are more dangerous because they can easily become embedded in artery walls, forming clots that may break off and result in a heart attack or stroke. The researchers looked at data from 24 published studies that found an association between LDL particle concentrations and heart disease. The researchers found that in all the studies, the higher the LDL particle number, the greater the risk for heart disease, despite the levels of other fats, according to a recent issue of the 

Presenting at the American Academy of Neurology’s annual meeting in April, researchers reported that elevated levels of high-density lipoprotein (HDL; “good”) cholesterol may help prevent disabilities related to multiple sclerosis (MS). Because HDL has anti-inflammatory properties, it might benefit patients with the central nervous system disease. The current study, which included 186 patients with MS whose average age was 50 years, analyzed clinical demographic and HDL data. At study onset, nearly 20% of the participants had low HDL levels, whereas nearly 50% had high levels. During the next 6 years, the researchers noted that an association between the level of HDL cholesterol and the level of disability became apparent. The patients with higher scores on the Expanded Disability Severity Scale (EDSS) initially were considerably less prone to have elevated levels of HDL at follow-up. The researchers recommended that patients with MS have their HDL levels checked. If they are low, “consider dietary and medical interventions, such as statins and fish oil supplements, which are known to increase HDL levels.” The investigators concluded that further study of the relationship between HDL levels and disease progression is warranted.

Cholesterol Watch

Mr. McAllister is a health systems consultant based in Chapel Hill, North Carolina.

Biosimilars or follow-on biologics are defined as officially approved new versions of innovator biopharmaceutical products after patent expiration. The use of biotechnology holds great promise for new drug development using new approaches in drug discovery, design, and production, especially for many cancers, Alzheimer’s disease, and a myriad of conditions and diseases that are difficult to treat with drugs currently available. To date, the FDA does not have a pathway for establishing innovator products or establishing therapeutic equivalence of biosimilar products.

As one might imagine, both the Senate (Health, Education, Labor and Pensions Committee amendment) and the House (Energy and Commerce Committee amendment) have received approval from their respective members for creation of a pathway for approval of biosimilars as well as a 12-year period of exclusivity during which the FDA cannot use the innovator’s safety and efficacy data to approve biosimilar products. The challenge to legislators is to approve necessary regulations that protect innovator companies, while maintaining the safety and efficacy of biosimilar products that will increase competition and lower drug costs. Lobbyists on both sides of the issue debate safety and efficacy concerns over biosimilars and the fear that they will hinder innovation if the innovator’s drug is replaced before a positive return on investment is achieved.

Hospital pharmacists should be quite interested in the proposed regulations, because the vast majority of these drugs are used in organized health care settings. Past experience with biotechnology-derived drugs that have received approval reflect extremely high prices (and sometimes for large patient cohorts) that can have a dramatic impact on a hospital’s drug spend. In addition, hospitals have a tendency to be the primary provider of these expensive products following discharge, because initiating therapy during an inpatient stay almost obliges them for providing continuation of therapy regardless of the patient’s prescription drug benefit plan coverage or his or her ability to pay out of pocket. Sales of biopharmaceuticals exceeded $20 billion in 2003, and some experts predict that sales may exceed $100 billion by 2010.

President Obama and his administration intend to focus health care reform on improving access while reducing costs. Biologic products will surely dramatically increase overall spending on drugs, and hospitals may need to somehow limit access of these products to patients whose insurance (or lack thereof) will not reimburse the hospital.

One of the most hotly debated points related to the proposed reform legislation is the period of exclusivity, which is a 12-year period in both the House and Senate versions of health care reform. It is interesting to note that the Generic Pharmaceutical Association and AARP advocated for a 5- to 7-year exclusivity period, and a Federal Trade Commission report supports their position because biologics usually require a more complicated manufacturing process, thus offering additional protection for the innovator. Despite these recommendations, the Obama administration objected to the shorter protection period.

Pharmacy colleagues with considerably more expertise on this issue have suggested that we need to look at the European Union for guidance on this issue. The European Medicines Agency (similar to the FDA) has a science-based pathway for biosimilar review that has resulted in 20% to 30% lower prices for biosimilars that have achieved a 30% market share.

It is evident that politics is again about to let us down and miss the target espoused by the Obama administration of reducing health care costs. I agree that biopharmaceuticals have the potential for improving health, and we should encourage their development. The pharmaceutical industry needs more self-reflection on this issue, however, to contribute to a more controlled growth of drug costs. What do you think?

Health Systems Pharmacy Editor's Note

Biosimilars and Health Care Reform

Ms. Terrie is a clinical pharmacy writer based in Haymarket, Virginia.

Pharmacists are likely to encounter patients who are at risk or have been diagnosed with gestational diabetes and should be prepared to counsel these patients as well as provide them reassurance in order to successfully manage this condition. Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance of variable severity with onset or first recognition during pregnancy and does not include women who had diabetes prior to conception.

 GDM occurs in an estimated 7% to 9% of pregnant women, representing 200,000 cases annually.

 Gestational diabetes initially becomes apparent after 24 to 28 weeks of pregnancy, but can continue in some women after delivery.

GDM is associated with both maternal and perinatal complications.

 If left untreated, gestational diabetes can pose serious 

health consequences for both the mother and infant.

Women with GDM are at risk for the development of hypertensive disorders, and perhaps the most common complication that can affect the infant is macrosomia, which is defined as an infant weighing more than 9 lb.

 In addition, GDM increases the mother’s risk of preeclampsia, cesarean delivery, and type 2 diabetes in the future. An estimated 50% of women who have GDM will develop type 2 diabetes within 5 to 10 years.

With regard to the infant, GDM also is associated with increased rates of perinatal mortality, birth trauma, hyperbilirubinemia, and neonatal hypoglycemia. Some studies report an association between GDM and increased perinatal mortality rates, but other studies have shown no increased risk.

The American College of Obstetrics and Gynecology (ACOG) recommends screening and treatment of gestational diabetes.

 The ACOG recommends considering screening obese pregnant women for GDM during the first trimester and repeating it later in pregnancy if initial screening is negative.

 It has been demonstrated that good metabolic control maintained throughout pregnancy can reduce maternal and fetal complications in diabetes.

Although any pregnant woman can develop GDM, certain risk factors may increase a woman’s chances of developing GDM (see www.PharmacyTimes. com/CounselingGDM for this list).

American Diabetes Association Standards of Care 

According to the 2009 standards of care from the American Diabetes Association (ADA), women at very high risk for GDM should be screened for diabetes as soon as possible after the confirmation of pregnancy.3,7 In addition, all women with a greater-thanlow risk of GDM, not found to have diabetes early in pregnancy, should undergo GDM testing at 24 to 28 weeks of gestation.

, which does not require GDM screening, is defined as women with all of the following characteristics: younger than 25 years of age; normal weight before pregnancy; member of an ethnic group with a low prevalence of diabetes; no known diabetes in first-degree relatives; no history of abnormal glucose intolerance; and no history of poor obstetrical outcome.

More information on the ADA's standards of care for GDM can be found on the Diabetes Care Web site at http://care.diabetesjournals.org/content/30/Supplement_2/S2512.full.

Results from various studies have concluded that proper treatment has a significant impact on the health of both mother and child. In general, the management and treatment of GDM involves a multifaceted approach, including the incorporation of routine blood glucose monitoring, dietary changes, exercise, and medication, if warranted. In general, GDM can be controlled through a proper diet and exercising regularly, but sometimes a woman with GDM may require treatment with insulin.

Dietary medication, also referred to as medical nutritional therapy, is typically the initial therapy for GDM and, when possible, a dietitian/nutritionist is consulted to design a dietary plan. Whether medication is required, diet is considered to be the mainstay of treating GDM. Once a dietary plan has been determined, it is important for patients to routinely monitor blood glucose to ascertain the effectiveness of the plan. The ADA recommends a diet that adequately meets the needs of the specific patient while restricting carbohydrates to 35% to 40% of daily caloric intake.

If appropriate, moderate exercise also is incorporated in the management of GDM.

 Studies have shown that women who are physically active before and during pregnancy are also less likely to develop GDM.

When diet and exercise fail to maintain desired blood glucose levels, insulin is considered as the standard pharmacologic therapy used in GDM. It is estimated that 15% of women with GDM require the use of insulin.

 Pharmacotherapy also is indicated in the setting of elevated fasting glucose levels, because dietary modification has little effect on these levels.

 It is important that patients are adequately counseled on the proper administration of insulin, whether using syringes or prefilled insulin pens. Key topics to cover during patient counseling include preparing for the shot, including necessary supplies, checking dosage and expiration date before administration, proper injection technique for administering the insulin, disposal after completion of injection, and proper storage of insulin. It is important to ensure that patients understand how to measure blood glucose and know how often they should test throughout the day.

The use of oral hypoglycemic agents for the management of GDM has gained popularity over the past few years. Some studies have demonstrated that glyburide is safe to use during pregnancy and that it provides glucose control comparable to that of insulin for women with GDM.

 Due to the relatively small number of patients in these studies, the absolute safety of this agent has not yet been proven, and debate about whether it crosses the placenta also exists.

 In some cases, glyburide is used as an alternative to insulin therapy and sometimes used as first-line therapy.

Metformin may also be another option for managing GDM, particularly for women with polycystic ovarian syndrome. The Metformin in Gestational Diabetes (MiG) trial randomly assigned 751 women with GDM at 20 to 33 weeks of pregnancy to open treatment with metformin (with supplemental insulin if necessary) or to insulin alone.

 The results reported that treatment with metformin when compared with the use of insulin was not associated with increased perinatal complications in women with GDM, and the study participants preferred the metformin.

Several clinical trials are currently investigating the use of metformin in GDM. More information about these trials can be found at www.clinicaltrials. gov/ct2/results?term=metformin+and+gestational+diabetes. Currently, the ACOG and the ADA do not recommend oral hypoglycemic agents as a treatment for GDM due to concerns regarding safety and the need for studies.

Pharmacists are in a pivotal position to remind pregnant women and even those contemplating pregnancy, especially those at greater risk of developing GDM, about the importance of receiving early prenatal care and continuing care throughout their pregnancy. Patients with GDM should be reminded to adhere to the recommended treatment plan for both their overall well-being as well as that of their unborn child.

In general, GDM patients should test their blood glucose levels at least 6 times a day (before each meal and 1 hour after each meal). Patients should also be encouraged to adhere to the recommended dietary plan and, if appropriate, a routine exercise regimen, if approved by an obstetrician. Most patients do not require insulin postpartum, but should have glucose levels monitored and be encouraged to follow up with their physician after delivery. Regular screenings for type 2 diabetes should be encouraged. The Diabetes Prevention Program recommendations to promote weight and decrease the risk of type 2 diabetes include breast-feeding and establishing a diet plan for specific weight loss and an exercise regimen of at least 150 minutes per week.

Patient Counseling

Gestational Diabetes: What Patients Need to Know

Blood Glucose Meters for the Pediatric Population

An estimated 186,300 individuals younger than age 20 throughout the United States have been diagnosed with diabetes. 

 The majority of these patients have type 1 diabetes; however, as the obesity rates in the United States continue to escalate, type 2 diabetes, a condition that primarily occurs in adults over the age of 45, is becoming increasingly prevalent among those in the pediatric population.

 Many children newly diagnosed with diabetes and their families may face unique challenges when dealing with the everyday management of diabetes, including treatments, adapting to dietary changes, and the routine monitoring of blood glucose.

Many questions may also arise when selecting a blood glucose meter for pediatric patients. Pharmacists can be instrumental in assisting and educating both pediatric patients and their parents/caregivers in the selection and use of the various blood glucose meters available.

A variety of at-home blood glucose meters to meet the needs of patients with diabetes, especially those patients in the pediatric population, are currently on the market. Key factors that may be considered when selecting a meter include accuracy of the meter; size of the meter; small sample size required for testing; ease of use and easy-to-follow testing procedure; ability for alternate testing sites; quick testing time and availability of results; ease of portability to allow testing at school and during leisure time; easyto- read numbers on display; memory options; cost of meter and supplies.

 A helpful checklist to assist pediatric patients and their parents/caregivers in selecting a glucose meter is available on the American Diabetes Association (ADA) Web site at www.diabetes.org/ youthzone/choosing-a-bg-meter.jsp.

Throughout childhood and adolescence, a child’s ability to take an active role in the management of diabetes continues to vary and change due to growth and development, along with continual advances in motor skills, cognitive abilities, and maturity.

 Parents/caregivers have a crucial role in the management of diabetes as well.

 Results from various studies have reported that parental involvement is necessary throughout childhood and adolescence to ensure appropriate self-management and metabolic control.

Parents/caregivers should be aware of the signs of hypoglycemia and know what to do in these cases, especially because preschool and early schoolaged children may be unable to identify and self-report episodes of hypoglycemia. 

 Safe management of pediatric patients may often require more frequent blood glucose testing, particularly if a child has not been eating well.

Additional testing during periods of increased physical activity, stress, and illness also is very important.

 The ADA Web site, www.diabetes.org, has various teaching tools for parents, as well as children, to encourage them to get involved in the management of their condition. The Web site explains diabetes, as well as provides useful tips to successfully manage diabetes, including monitoring blood glucose.

In July 2009, Bayer Diabetes Care announced a new blood glucose meter for pediatric patients called the DIDGET, a blood glucose meter that plugs into the gaming systems Nintendo DS and Nintendo DS Lite. When patients consistently monitor their blood glucose levels with the DIDGET, it rewards them with points that they can use to buy in-game items and unlock levels in a game.

 Some of the key features of this glucose meter include

• Small sample size of 0.6 µL of blood required

• In advanced mode, children can identify tests done before/after meals and set a reminder to test after meals

The DIDGET is available in the United Kingdom, but is not yet available in the United States.

When assisting patients in the selection of a glucose meter, it is important that the proper testing protocol is clearly understood and that the patient and/or parent/caregiver is comfortable with using the monitor. Continual reinforcement of the importance of maintaining good glycemic control is crucial to the optimal management of diabetes. Ongoing patient education and patient involvement give pediatric patients and their parents/caregivers the necessary tools to effectively manage their condition throughout their adult lives, as well as help them improve the quality of their lives.

Pharmacists should emphasize the importance of adhering to recommended treatment plans, regular blood glucose monitoring, and establishing healthy eating habits and exercise routines.

Parents/caregivers should ensure that day care providers, school principals, teachers, and nurses are aware of their child’s diabetes and that trained personnel are available if needed. They should also be aware of how often and when the child should test blood glucose. Patients and their parents/caregivers should be reminded to keep a log of their blood glucose readings and discuss these results with their primary health care provider.

Pharmacists can also remind patients that a host of resources are available to assist them in managing their diabetes. For more information on diabetes and children, please visit the following Web sites:

• American Diabetes Association: www.diabetes.org

• Children with Diabetes Foundation: www.cwdfoundation.org

• National Institute of Diabetes and Digestive and Kidney Diseases: www2.niddk.nih.gov

OTC Focus

Blood Glucose Monitors for the Pediatric Population

	Ms. Terrie is a clinical pharmacy writer based in Haymarket, Virginia.

	It is well understood that individuals with diabetes can develop various foot complications. Foot problems in patients with diabetes can be attributed to such factors as neuropathy, poor circulation, and decreased resistance to infection, as well as foot injuries or foot deformities.

	Through early intervention and treat ment of foot problems, however, many diabetes patients may be able to prevent or deter serious complications, underscoring the need to educate patients about the importance of preventive foot care.

	As many as 1 in every 4 patients with diabetes will develop a foot ulcer in their lifetime.

 The leading cause of foot ulcers is peripheral neuropathy. 

 Repeated pressure on the sole of the foot is another contributing factor. 1 If left untreated, the foot ulcer can become infected and cause further complications, which may eventually lead to a lowerlimb amputation.

	According to the American Diabetes Association (ADA), amputation and foot ulceration are the most common consequences of diabetic neuropathy and are considered to be the main causes of morbidity and disability in people with diabetes.

 In addition, the most prevalent cause of diabetesrelated hospitalizations is foot wounds.

 Statistics from the ADA reveal that >60% of nontraumatic lowerlimb amputations are among individuals with diabetes.

	In general, patients with diabetes also are considered to have a 30-fold higher risk over their lifetime of having a lowerextremity amputation, when compared with individuals without diabetes. Studies have shown that diabetes patients who smoke also have a higher risk of developing foot ulcers, because smoking may damage and constrict blood vessels.

 Other risk factors include poor blood glucose control, male sex, having diabetes for >10 years, and a history of ophthalmic, renal, and cardiovascular problems.

	Because neuropathy can cause a decrease in an individual’s ability to feel sensations, an irritation or injury to the foot can go undetected for a period of time if feet are not examined daily. In addition, having diabetes may increase an individual’s risk of developing other foot complications including 

	• Nail disorders such as fungal infections

	• Charcot foot (a softening of the bones in the foot due to significant neuropathy)

	Individuals with diabetes have at least a 10fold greater risk of being hospitalized for soft tissue and bone infections of the foot than individuals without diabetes.2 These alarming statistics underscore the need to identify those individuals at risk for foot complications, as well as the need to educate patients about the importance of appropriate foot care regimens to prevent and reduce complications. Table 1 offers suggestions for diabetes patients and their caregivers on prevention. The ADA’s 2009 standards guideline (Table 2) also outlines key recommendations for foot examinations, screening, and referral.

	1. Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. 

	2. Lavery LA, Armstrong DG, Wunderlich RP, Mohler MJ, Wendel CS, Lipsky BA. Risk factors for foot infections in individuals with diabetes. 

	3. Abbate SL. Expanded ABCs of diabetes. 

	4. American Diabetes Association. Standards of medical care in diabetes—2009. 

	5. Armstrong, D. and Lavery, L. Diabetic foot ulcers: prevention, diagnosis, and classification. 

	6. Complications of Diabetes in the United States. American Diabetes Association Web site. www.diabetes.org/diabetes-statistics/complications.jsp. Accessed September 23, 2009.

	7. Smoking. American Diabetes Association Web site. www.diabetes.org/type-1-diabetes/smoking.jsp. Accessed September 23, 2009.

	8. Diabetes foot care. Medline Plus Web site. www.nlm.nih.gov/medlineplus/ency/article/003937.htm. Accessed September 23, 2009.

	9. Foot Complications. American Diabetes Association Web site. www.diabetes.org/type-1-diabetes/foot-complications.jsp. Accessed September 23, 2009.

	10. Diabetic Complications and Amputation Prevention. The American College of Foot and Ankle Surgeons Web site. www.footphysicians.com/footankleinfo/diabetic-amputations.htm. Accessed September 23, 2009.

	11. National Institute of Diabetes and Digestive and Kidney Disease. Diabetes-Related Amputations on the Rise; Daily Foot Care Can Help Reverse Trend [press release]. www2.niddk.nih.gov/News/SearchNews/11_01_2000.htm. Accessed September 23, 2009.

Health Systems Pharmacy

2-Minute Consultation: Preventive Foot Care for Diabetes Patients

 New research has shown that gastroesophageal reflux disease (GERD) patients face several sleep-related issues. In 2 studies published in 

, investigators discovered that GERD, along with some of its patients, never sleeps.

One study pointed to a sort of catch-22 between GERD and sleep problems— trouble sleeping can cause or worsen GERD, and GERD can cause or worsen sleep problems. The researchers pointed out that a previous clinical trial showed sleep issues being resolved after GERD therapy, underlining the connection.

A second study explored the effect of nighttime GERD symptoms on sleep, and the resulting significant economic burden on the health care system caused by increased visits to clinicians, in addition to a reduction in healthrelated quality of life. By surveying 11,685 GERD patients, the researchers found that 88.9% experienced symptoms at night; 68.3% had sleep difficulties; 49.1% had a hard time falling asleep; and 58.3% had difficulty remaining asleep.

Receptor-Mimic Probiotics May Block Disease

Newly developed bacteria could help prevent intestinal infections from escalating to disease. Called receptor-mimic probiotics, these bacteria were first designed by scientists from the University at Adelaide in Australia in order to halt diseases brought on by various strains of Escherichia coli. From there, they went on to develop comparable receptor-mimic probiotics to combat cholera and travelers’ diarrhea. The bacteria that cause infections in the gut also manufacture toxins that cause damage to tissue by binding to intestinal receptors. Receptor-mimic probiotics have the potential to bind toxins in the intestine, which would stop the toxins from attaching to the receptors and causing disease. The scientists’ project is ongoing, but they presented their data thus far at the Society for General Microbiology’s meeting at Heriot-Watt University in Edinburgh, Scotland. 

Altered Microbiome Found in GERD Patients

Communities of microbial cells, or microbiomes, remain mostly uncharted territory in terms of research, but investigators at New York University’s Langone Medical Center have uncovered a link between an altered esophageal microbiome and gastroesophageal reflux disease (GERD). Examining bacteria from the esophagi of 34 GERD and healthy patients, the researchers discovered a high concentration of Streptococcus in healthy patients, and a high level of Gram-negative bacteria making up an altered microbiome in GERD patients, especially those with Barrett’s esophagus or esophagitis. The findings were published in the August 1, 2009, issue of 

Your Gut and Your Heart: PPIs Okay with Thienopyridines

Recent research has revealed that proton pump inhibitors (PPIs) do not interfere with the efficacy of thienopyridines. The news comes from an analysis of 2 randomized trials that sought to determine whether PPIs indeed thwarted the effectiveness of thienopyridines like clopidogrel or prasugrel, as reported in a March study that left some alarm in its wake, due to the high incidence of PPIs being prescribed in combination with thienopyridines. The research was published in the September 1, 2009, online edition of 

 Patients with a history of sexual abuse are more likely to experience gastrointestinal disorders than those in the general population. 

Mind or Matter for Care-Seeking Upper GI Patients?

Patients with upper gastrointestinal (GI) symptoms have a higher rate of psychological symptoms than others, but it remains unclear whether these are associated with GI symptoms or were simply the impetus to seek out health care. A recent study, published in 

 (September 9, 2009), explored a potential link between psychosocial problems and GI symptoms and found that patients with upper GI symptoms visited their primary care physicians twice as frequently as those in a control group (8.6 vs 4.4 times per year). In addition, patients with upper GI symptoms also complained more of other types of health problems than controls and took more medications. The researchers concluded that an equivocal relationship existed between upper GI symptoms and psychological problems, possibly pointing to general increased health care demands.

GERD Watch

 Bayer Diabetes Care (Tarrytown, NY), a division of Bayer HealthCare LLC

 The A1CNow SELFCHECK is now available without a prescription, enabling patients with diabetes to measure their A1C level at home in between visits to their health care provider. The monitor provides results within 5 minutes, has an easy-to-use design, and delivers a lab-accurate indication of average blood sugar levels over the past 3 months. A1CNow SELFCHECK complements the health care provider—administered A1C test but is not intended to replace it or routine blood glucose testing. The suggested retail price for the 2-test kit is $29.99.

 The Mentholatum Company (Orchard Park, NY)

 The ROHTO Eye Drops Line has launched ROHTO Hydra, specifically formulated to lubricate and provide long-lasting moisture for dry, irritated eyes with the closest hydration to natural tears. All products in the ROHTO Hydra line contain the lubricant hypromellose and offer a special cooling sensation. ROHTO Cool is a general-purpose eye drop for redness relief; ROHTO Ice relieves redness and soothes itch, irritation, and burn; and ROHTO Arctic revives strained, overworked eyes and relieves redness. Each product comes in a 0.4-oz bottle and retails for $8.99.

 Bariatric Advantage (Irvine, CA), a division of Catalina Lifesciences Inc

 The Chewy Bite line of sugar-free, very low-calorie products provides targeted nutrition for patients who have had weight-loss surgery. Calcium Citrate Chews provide 250 mg calcium citrate per chew with 125 IU of vitamin D3 and come in chocolate or lemon flavors; Omega 3 Essential Fatty Acids provide a combined 160 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) per each berry-flavored chew. Chocolate-flavored Calcium Carbonate Chews provide 500 mg of calcium carbonate and 200 IU of vitamin D3 for weight-loss surgery patients who have undergone a restrictive-only procedure such as gastric banding, as well as those preparing for surgery.

 The Centrum Ultra line of multivitamins is specially formulated for women and men to help ensure that, along with a healthy diet, they are getting recommended amounts of key vitamins and minerals each day based on their sex and age. The line includes Centrum Ultra for Women and Centrum Ultra for Men and 2 products specially formulated to meet the needs of individuals aged ≥50: Centrum Silver Ultra for Women and Centrum Silver Ultra for Men. The products are available in 100- and 200-count bottles, with a suggested retail price of $11.99 and $19.99, respectively.

 Natrol DHA 500 Super Strength contains 500 mg of docosahexaenoic acid (DHA), an essential fatty acid that is vital for a healthy brain. Ongoing research suggests that DHA plays a role in healthy brain development and the maintenance of brain and memory function, as well as in supporting cellular, cognitive, and eye health throughout an individual’s lifespan. The product is formulated for once-daily dosing with a suggested retail price of $15.99 for 30 softgels.

 Teva Pharmaceuticals Inc (North Wales, PA)

 The FDA has extended OTC access to the emergency contraceptive Plan B One-Step (levonorgestrel 1.5 mg) to patients 17 years of age and older with government-issued proof-of-age identification. Plan B One-Step can help women prevent an unintended pregnancy with 1 pill in 1 dose when taken as directed within 72 hours of unprotected sex or contraceptive failure. Plan B One-Step should be taken as soon as possible after unprotected sex. Women younger than 17 still require a prescription to obtain Plan B One-Step.

 GelStat Sleep is a dietary supplement, taken 15 minutes before bedtime, to improve sleep health. It combines 3 all-natural ingredients: L-5 hydroxytryptophan is a natural relaxant from the seeds of the Griffonia simplicifolia tree that works as a natural relaxant; valerian root extract is an herb that may help with grogginess upon waking; and melatonin is a natural hormone that aids in falling asleep more quickly. The product comes in bottles of 30 quick-dissolving tablets for a suggested retail price of $19.99.

 Neosporin Lip Health Daily Hydration Therapy features a patented combination of essential lipids and antioxidants to repair and nourish lips, improve lip tone, reduce dryness, and make lips less prone to chapping. The product has been shown to restore visibly healthier lips in 3 days and lock in moisture. Peptides, vitamins, and emollients help to nourish and strengthen lips, and an SPF 20 protects lips from sunburn. The 0.35-oz (10-g) tube retails for $4.99.

 New Ultra Probiotic Complex has been clinically studied to improve regularity, boost immune health, and reduce bloating and stomach discomfort. Ultra Probiotic Complex 25 daily formula delivers 25 million cultures per serving to help maintain natural resistance and overall digestive health. Ultra Probiotic Complex 50 provides 50 billion live cultures. This higher potency is beneficial when used during or after antibiotic use, digestive upset, or traveling.

OTC Product News

Every day, amid strenuous studying and an all-around busy schedule, Somer Smith finds time to help someone. “My day is not complete unless I know that one person is breathing easier because of something that I did for them,” said Smith. “The Lord has laid a burden on my heart to help those in need.” This drive, paired with the gratification that comes with lightening others’ loads, has led Smith toward a pharmacy career. It also helped to make her the Walmart/ Pharmacy Times October RESPy winner.

A third-year student at Auburn University Harrison School of Pharmacy, Smith’s pharmacy passion was sparked during her teens. Her grandfather, an Alzheimer’s patient, lived in a care facility near Smith’s high school. As she sat with him during her daily visits, Smith observed the difference she was able to make in his life, as well as the host of medications he took. “To this day, I think about the times that I spent with my grandfather,” Smith said. “They serve as daily motivations for me to not only succeed in school, but to master the profession so that I might be able to help someone else’s grandfather or family member.”

Since then, Smith has worked as a pharmacy technician, going on to intern at Baptist East Hospital in Montgomery, Alabama, and USA Children’s and Women’s Hospital in Mobile, where she stresses the importance of counseling patients. “To us, the patient may be just one more sick person to heal and get out the door,” said Smith. “But, to the patient, their health is everything. It is their livelihood, their ability to work, their ability to take care of their family, feed their family, or care for a child.” Smith also has volunteered performing blood pressure and cholesterol checks throughout her community.

All the while, she has maintained top-notch academic standing, winning scholarships and memberships in several honor societies. Smith’s studies are rounded out by a number of extracurricular activities, including student government, the Academic Honesty Committee, pre-pharmacy club, Christian Pharmacists Fellowship International, and American Pharmacists Association (APhA) Academy of Student Pharmacists, among others.

Smith also represented her school as an APhA delegate at the national conference in San Antonio, Texas, this year. “I believe the greatest battle in the field of pharmacy that we must fight is one with lack of awareness,” said Smith.

Smith’s deep caring for others is evidenced by her fervent devotion to feeding the hungry. “The burden of the hungry is something I carry with me each and every day,” she said. “I can’t eat a meal without thinking about the hungry.” Along with chairing Auburn University’s committee of 19 to combat world hunger, Smith organized a 62-mile walk to the state capital to raise awareness of world hunger. She and 4 other students made the arduous trek, and despite suffering injuries along the way, it was prayer and the inner cadence of “feeding the world, one step at a time” that kept Smith going. “As for the walk, the end result was a brand new pair of shoes that had to be thrown away, a few less toenails, blistered feet, and a whole lot of attention to world hunger—I’ll call it a success!”

Perhaps in tribute to her grandfather, Smith has carved out time to play piano regularly at a retirement home in her area. Bringing a smile to the patients is yet another example of her dedication to others. “It was extremely rewarding, because… I have a passion for children and the elderly.”

Following her passion, Smith is planning a pediatric residency upon graduating. “Ultimately, I would love to work as a clinical pharmacist, or in some type of an advanced diagnostic team traveling across the country,” said Smith. “I can say all of this, but ultimately, I am going to go wherever God leads me.”

Auburn University’s James I. Harrison Sr School of Pharmacy, located in Auburn, Alabama, and established in 1885, is the only public pharmacy school in Alabama and the only in-state institution offering a graduate program in Pharmaceutical Sciences. Also offering postgraduate and continuing education, the school receives 2 to 3 applications for each admission seat in the professional program each year. 

The RESPy (Respect, Excellence, and Service in Pharmacy) award is pre- sented to the student who has made a difference in his or her community by demonstrating excellence in pharmaceutical care. For more information, please visit www.PharmacyTimes.com.

RESPy Awards

RESPy Winner Led by Spiritual Beliefs to Help Others

John Burke, commander of the Warren County, Ohio, drug task force and retired commander of the Cincinnati Police Pharmaceutical Diversion Squad, is a 40-year veteran of law enforcement. Cmdr Burke also is the current president of the National Association of Drug Diversion Investigators. For information, he can be reached by e-mail at burke@choice.net, via the Web site www.rxdiversion.com, or by phone at 513-336-0070.

I had the pleasure of attending a press conference recently in Lexington, Kentucky, that was held to mark the beginning of a statewide prescription drug task force. Kentucky Attorney General Jack Conway had organized the effort involving enforcement officers from his office and many others from around the state.

October 2009

Case Studies

Health Systems Product News

Women's Health Watch

Rx Product News Profile: A closer look at new FDA actions: Multaq

Cholesterol Watch

Biosimilars and Health Care Reform

Gestational Diabetes: What Patients Need to Know

Blood Glucose Monitors for the Pediatric Population

2-Minute Consultation: Preventive Foot Care for Diabetes Patients

GERD Watch

OTC Product News

RESPy Winner Led by Spiritual Beliefs to Help Others

DRUG DIVERSION & ABUSE: Kentucky Takes Steps to Reduce Pill Abuse

Can You Read These Rxs?

Pharmacy Technology News

Clinical Trials

Outlook: Obesity Epidemic

Generic Product News

Tech Product News

Rx Product News

Insulin and Medication Errors

From the Publisher: Diabetes Care and the Pharmacist

Pharmacy Law: Liability for Prescriptions from an Internet Physician

A Pharmacist's Guide to OTC Therapy: OTC Products and the Diabetic Patient

News Capsules

Electronic Prescribing-Potential Areas of Weakness

Celebrating 25 Years of Savings and Looking Ahead

LADA: A Little Known Type of Diabetes

So Why Are You a Pharmacist?

The Effect of Hepatic Disease on Drug Interactions

Diabetes Watch

DIABETES PRODUCTS

Coagulation Counseling

Asthma Watch