New OTC Drugs and Devices 2000: A Selective Review

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New OTe Drugs and Devices 2000: A Selective Review Gail D. Newton, W. Steven Pray, and Nicholas G. Popovich

Objectives: To create a heightened awareness of the issues confronting pharmacists in the self-care arena. To educate pharmacists about newly introduced nonprescription products, devices, and diagnostic products. Data Sources: Recently published governmental, clinical, and pharmaceutical industry literature. Data Synthesis: Several developments during the previous year have important implications for patient self-care. The Food and Drug Administration recommended the withdrawal of phenylpropanolamine from the market and denied proposals to switch lovastatin, pravastatin, and omeprazole to nonprescription status. Widespread use of dietary supplements in the face of insufficient data on their safety and efficacy continued to be a problem in 2000, although there were several encouraging developments. In 2000, new over-the-counter products were introduced for, among other purposes, treating acid-peptic disorders, musculoskeletal injuries, dermatologic disorders, and minor wounds. Numerous nonprescription products, including sophisticated home diagnostic products and accessories, continue to become available on the U.S. market. It is important that the pharmacist become as knowledgeable as possible about these products so he or she can educate patients about their appropriate use.

Conclusion: Patients will continue to place an increasing emphasis on self-care. To assist them, pharmacists must remain up to date on trends and have a balanced understanding of new products. The new nonprescription medications and diagnostic products discussed in this review article represent valuable additions to the growing array of self-care products.

JAm Pharm Assoc. 2001;41:273-82.

Consistent with previous installments in this series of annual reviews of new over-the-counter (OTC) products, the fIrst section of this article highlights the developments or issues arising over the past year that we view as the most significant to patient self-care. The second section describes the OTC medications, diagnostic products, and accessories introduced during the past year that we believe will generate the most questions from, or pose potential problems for, patients.

Received December 8,2000, and in revised form January 17,2001. Accepted for publication January 17,2001. Gail D. Newton, PhD, is associate professor of pharmacy practice; Nicholas G. Popovich, PhD, is professor of pharmacy practice, School of Pharmacy and Pharmacal Sciences, Purdue University, West Lafayette, Ind. W. Steven Pray, PhD, is professor of nonprescription products and devices, School of Pharmacy, Southwestern Oklahoma State University, Weatherford, Okla. Correspondence: Nicholas G. Popovich, PhD, Department of Pharmacy Practice, School of Pharmacy and Pharmacal Sciences, Purdue University,1335 Robert E. Heine Pharmacy Building, West Lafayette, IN 479071335. Fax: 765-494-5966. E-mail: [email protected].

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Self-Care Products: Major Regulatory Actions in 2000 Phenylpropanolamine In October 2000 the Nonprescription Drugs Advisory Committee (NDAC) of the Food and Drug Administration (FDA) met to discuss the safety of phenylpropanolamine (PPA), which has been used in nonprescription weight loss and cough-and-cold products. After reviewing the results of a study by Kernan et aI., I which would not be published in the New England Journal of Medicine until December 21, the committee agreed with the researchers that there was an association between ingestion of PPA and hemorrhagic stroke in women. Kernan et al. 1 determined that, among women using PPA-containing products for weight control and nasal decongestion, risk of hemorrhagic stroke increased within 3 days after starting the medication. Men may also be at risk. Hence NDAC recommended that PPA be withdrawn from the market. In November 2000 FDA took the first steps toward the removal of PPA from all drug products by asking manufacturers to voluntarily discontinue marketing products that contain it as an active ingredient. Even though the risk of hemorrhagic stroke is very low with PPA use, FDA ruled that the conditions for which these products were used were not serious enough to warrant this increased risk.

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Since the FDA announcement, pharmacies have been removing PPA-containing products from their shelves. Manufacturers are now working with FDA to remove PPA from OTC products. It appears that pseudoephedrine will be reformulated into nasal decongestant products that formerly contained PPA. There is no FDA-approved alternative chemical entity to PPA for weight control. However, one can envision unscrupulous advertisers extolling the (thus far unproved) merits of using ephedrine (e.g., huang) as an alternative and further endangering the ephedra, public. Therefore, the situation provides an opportunity for pharmacists to educate patients about PPA and provide guidance on selecting alternative cough-and-cold products and avoiding unapproved OTC weight loss products. No doubt, patients will have questions about this action ("Why was such a drug left on the market for so long if there was a danger?" "Can I continue to use what I have at home?"), and pharmacists must be knowledgeable enough to provide thorough and accurate answers. Pharmacists should advise patients to look for "phenylpropanolamine" in the listing of active ingredients on the labels of any previously purchased OTC products. If the product contains the drug, it should be discarded. If the consumer is unsure, he or she should be advised to bring the product to the pharmacist for verification. Patients using a prescription nasal decongestant or cough-and-cold product should be encouraged to contact the pharmacist to determine whether it contains PPA. If it does, the patient should work with his or her physician and pharmacist to find a suitable therapeutic alternative.

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Cholesterol-Lowering Drugs In July 2000 NDAC, along with FDA's Endocrinologic and Metabolic Drugs Advisory Committee, concluded that there was insufficient evidence that the cholesterol-lowering drugs lovastatin (Mevacor-Merck) and pravastatin (Pravachol-BristolMyers Squibb) could be used safely and effectively on a nonprescription basis. Merck and Bristol-Myers Squibb proposed their respective drugs for nonprescription use by persons with a total cholesterol level of 200 mg/dL to 240 mg/dL and a low-density lipoprotein (LDL) value> 130 mg/dL. As the basis for its proposal, Merck cited the increasingly widespread availability of cholesterol testing' which makes consumer self-medication for lowering cholesterol feasible. The company announced that it planned to support the drug's switch to nonprescription status with an extensive consumer education program. Bristol-Myers Squibb proposed the nonprescription use of Pravachol by patients who have been instructed by their physician to lower their cholesterol levels but are not taking a prescribed cholesterol-lowering medication. The advisory committees unanimously agreed that both drugs demonstrated effectiveness in lowering LDL cholesterol levels. However, they questioned whether the labeling in the manufacturer's proposals was sufficiently clear that consumers could understand when the products were appropriate for self-care. The

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committees recommended additional studies to support approval of these drugs for nonprescription status. They also recommended that Bristol-Myers Squibb support its switch application with additional label comprehension studies and a better definition of the target population for Pravachol. 2

Omeprazole During a joint meeting in October 2000 the FDA's NDAC and Gastrointestinal Drugs Advisory Committees decided that the proposed labeling for Prilosec 1 (the OTC version of omeprazole) was not sufficient to convey the benefits and long-term risks of the drug; therefore, they declined to grant it OTC status. The committees were equally divided as to whether gastroesophageal reflux disease and chronic heartburn are appropriate for OTC treatment. 3

Dietary Supplements Dietary supplements are becoming more numerous in the marketplace and the "structure and function" claims made for them are increasing and becoming more complex. For example, 100% Bovine Colostrum (i.e., IGF-l [insulin-like growth factor]) is being touted by one Internet company (Sam's General Store) as a substance "that contains an amazing complex of immunoglobulins, growth factors, antimicrobial proteins, and carbohydrates, and is beneficial for adults as well as infants." One must wonder how the 500 mg capsules of this product would be orally administered to an infant. Consumers' use of dietary supplements as part of their selfcare regimen for health maintenance is well documented in the professional and consumer literature. Unfortunately, this use is often unsupported by reliable data, because the information source is typically a friend or family member or a questionable site on the Internet. In addition, consumers are frequently reticent to inform their health care providers about the dietary supplements they are taking. There are several reasons for this, including the desire for privacy and the belief that their physician or pharmacist might chastise them for using dietary supplements. Pharmacists must be aware that patients .often fail to volunteer this information. When taking a medication history or attempting to answer a self-care inquiry, pharmacists must specifically ask about use of dietary supplements and alternative therapies. 4 In March 2000 the director of California's Department of Health released a statement urging consumers to immediately stop using five specific herbal products: Diabetes Hypoglucose Capsules, Pearl Hypoglycemic Capsules, Tongyi Tang Diabetes Angel Pearly Hypoglycemic Capsules, Tongyi Tang Diabetes Angel Hypoglycemic Capsules, and Zhen Qi Capsules. The manufacturers claimed these products contained only natural Chinese herbal ingredients for the treatment of diabetes. However, analysis revealed that they contain two prescription drugs (glyburide

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and phenformin). The state's investigation was launched in response to a report that a patient with diabetes suffered several episodes of low blood sugar after taking one of the aforementioned products. 5 Several articles in the scientific/professional literature have documented adverse interactions between herbal products and prescribed medications.6-8 The potential for these hazards underscores the importance of pharmacists educating patients about herbal products and monitoring their use of these products. Pharmacists must listen to patients' concerns and encourage them to discuss any problems encountered with dietary supplements. In their discussions with patients, pharmacists must also identify any drug-drug interactions they suspect might have occurred. To this end, it is essential that pharmacists also take time to report suspected adverse drug reactions from these medications to the Special Nutritionals Adverse Event Monitoring System (SN/AEMS) (http://vm. cfsan.fda.gov/-dms/aems.html). In July 2000 the General Accounting Office (GAO) concluded in a report that FDA regulations and federal law provide limited assurances on the safety of functional foods and dietary supplements. 9 GAO cited as areas of concern a lack of defined safety standards, inadequate labeling, and a lack of FDA oversight. Furthermore, the report criticized FDA for not providing sufficient guidance to in~ustry on the evidence needed to support safety and/or label claims and for not taking action against companies making questionable claims. Among other recommendations, GAO asked the agency to establish clear time frames for addressing these issues. Because many herbal drugs, for example, are not eligible for patent protection, pharmaceutical manufacturers have little, if any, incentive to perform or support research leading to a New Drug Application (NDA). Manufacturers' incentive to support research is further reduced because ingredients fall under the purview of the 1994 Dietary Supplement Health and Education Act (DSHEA) rather than under the more stringent Food and Drugs Act. The federal government is funding research on dietary supplements through grants and projects administered by the National Institutes of Health National Center for Complementary and Alternative Medicine (NCCAM) and carried out by university medical centers. This program is the government's opening salvo in an attempt to answer persistent questions about dietary supplements and their value in disease treatment and health maintenance. As one example of this government-funded research, NIH has allocated $6.6 million for a nine-center trial on dietary supplements containing glucosamine and chondroitin and such products ' role in relieving the pain of osteoarthritis. Approximately 1,000 patients with osteoarthritis will be enrolled in the study. Another example is the creation by NCCAM of two Centers for Dietary Supplement Research that will focus on the health effects of botanicals. The first center will study the health effects of polyphenols from nutritional sources (e.g., grapes, soy, green tea). This research is clinically relevant to heart disease, cancer,

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osteoporosis, and cognitive decline. The second center will identify the active constituents of ginger, tumeric, and Boswellia, all herbs used in Native American medicine for the treatment of inflammatory disease. 10 The White House Commission on Complementary and Alternative Medicine Policy was created in March 2000. This 20member panel will focus on the folLowing items: (1 ) education and training of health care providers in complementary and alternative medicine; (2) coordination of research to increase knowledge about complementary and alternative medicine; (3) provision to health care providers of reliable and useful information that can be readily accessible and understandable to the general public; and (4) guidance on appropriate access to and delivery of complementary and alternative medicine. The commission is expected to release its findings in late 2001 or early 2002. In another encouraging development, in March 2000 the Consumer Healthcare Products Association (CHPA) adopted a voluntary labeling program for dietary supplements. The program specifies when manufacturers must include the following statement on supplement product labels: "If you are pregnant or nursing a baby, ask a health professional" [before using this product].ll Subsequently, CHPA also announced that member companies agreed to use the following statement when marketing products containing St. John's wort: "If you are taking a prescription medicine, ask a health professional."12 Again, however, the question arises as to whether the consumer will read the label warnings and take appropriate action.

New OTC Drugs and Devices-2000 The following new product reviews were developed in the spirit of professional obligation. The authors are hopeful that the information will assist pharmacists in their interactions and consultations with patients. For each product covered, the Discussion subsection provides background and context, while the Patient InformationlInstructions subsection highlights information that the pharmacist should share with the patient in the course of counseling.

Acid-Peptic Disorders/Combination Heartburn Product Pepcid Complete (Johnson & 10hnsonlMerck Consumer Pharmaceuticals) Active Ingredients: Famotidine 10 mg, calcium carbonate 800 mg, magnesium hydroxide 165 mg Indication: Relief of heartburn associated with acid indigestion and sour stomach Availability: Packages of 5, 15, 25 , and 50 chewable tablets

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Discussion: An estimated 7% of Americans suffer daily episodes of heartburn, and as many as 50% suffer occasional occurrences of heartburn symptoms.13 The variety of nonprescription products available for the relief of minor gastric distress fall into two therapeutic categories: antacids and histamine H2 receptor antagonists (H2RAs). Antacids relieve symptoms by neutralizing gastric acid, resulting in a decrease in gastric pH. Their advantage is that patients often realize relief within minutes of ingestion. Their disadvantage is that, to provide sustained relief, most antacid products must be ingested multiple times throughout the day. In contrast, H2RAs competitively and reversibly block histamine at the H2 receptors in parietal cells. This results in an overall decrease in gastric acid secretion and relief of gastric symptoms. Although they have a slower onset of action than antacids, some products containing H2RAs can provide sustained relief for up to 12 hours. In this context, it is not surprising that the immediate and sustained relief of heartburn often requires a combination of an antacid and an H2RA. Pepcid Complete is the fIrst combination product formulated with calcium carbonate and magnesium hydroxide for rapid alleviation of heartburn and famotidine for sustained relief of symptoms. Patient InformationlInstructions: • The product should not be used in conjunction with other famotidine products or acid reducers. • Patients 12 years of age and older should use one tablet up to twice daily, chewing thoroughly before swallowing. • Patients who are allergic to famotidine or other acid reducers, or who have trouble swallowing, should not use Pepcid Complete. • Discontinue use of the product if stomach pain persists beyond 14 days.

Musculoskeletal Injuries and Disorders/Topical Analgesic (Thermotherapy Device) ThermaCare (Procter & Gamble) Active Ingredients: Iron, charcoal, sodium chloride, water Indication: Topical pain relief Availability: Menstrual cramp relief wraps (three per box); back pain relief wraps (two per box; small-medium or large--extra large sizes) Discussion: Menstrual cramping is thought to be caused by prostaglandin from sloughed uterine lining, which induces uterine contractions. It is severe in 23% of high-school-aged girls. 14 Also, sore muscles and back pain are extremely common in our increasingly sedentary society. Local heat has long been known to be effective for dysmenorrhea when applied to the lower abdomen or for pain when applied to the back or other sore muscles. Unfortunately, the most widely used methods of delivering thermotherapy have signifIcant prob-

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lems: Heating pads require an electrical source and are therefore not portable; hot water bottles deliver inconsistent and rapidly diminishing heat. Until now, it has been diffIcult to treat these discomforts with a consistent and reliable source of heat while at work, during recreation, or when traveling. ThermaCare, a wearable thermotherapy device, is a wrap containing circular heat discs. When the wrap's pouch is opened, room air begins to oxidize the iron, which is an exothermic reaction. I5 Within about 30 minutes, the wrap reaches its maximum temperature. The oxidation reaction produces a low-level and consistent heat for 8 hours. Patient InformationlInstructions: • This product should not be used by patients with diabetes, young children, individuals who are insensitive to heat, or anyone who cannot remove the product by him- or herself. • Patients with poor circulation or patients who want to place heat on the abdomen when pregnant should check with a physician before using the product. • After opening the pouch, immediately position the wrap on the body as directed or wait for it to reach its full temperature. • If the material covering any of the heat discs is tom, discard the entire wrap. • Place the side of the wrap with the darker heat discs next to the skin. • If the wrap still seems too cool after 30 minutes, remove it, fold it up for a few minutes, and reapply. • ThermaCare should be worn for at least 3 hours to obtain therapeutic benefIt. It may be worn during normal activities (e.g., exercise, sports, family outings, manual labor); while sitting or standing for long periods (e.g., while traveling by plane or car); or while performing seasonal activities such as gardening or shoveling snow. • Do not use the product for more than 8 hours in a day or more than 7 consecutive days (4 days for menstrual cramping). If still experiencing discomfort, consult a physician. • Check the skin periodically if it is sensitive to heat, if heat tolerance is reduced, if lying or leaning back against ThermaCare, or if wearing a tight-fItting belt or waistband over the wrap. • Do not use ThermaCare on areas of the body that are insensitive to heat. • Never use ThermaCare in conjunction with medicated creams, ointments, gels, or liniments, on damaged or broken skin, or on any area where bruising or swelling has occurred within the last 48 hours.

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Dermatologic Disorders

Topical Antifungal

Topical Antiviral

Lamisil AT (Novartis Consumer Health, Inc.) Active Ingredient: Terbinafine hydrochloride 1% Indications: Tinea pedis, tinea cruri , tinea corporis Availability: Cream (12 grams or 24 gram ), solution (30 mL), spray pump (30 mL) Discussion: Superficial fungal infection are among the mo t common skin infections for which pharmacist advice i olicited. Dermatophytic conditions affect about 10% to 20% of people in the United States at any given time. The mo t common are tinea pedis (athlete's foot), which occurs in up to 70% of adult, tinea cruris (jock itch), and tinea corporis (ringworm).19 Patient may contract the fungus by coming into contact with an infected human (anthrophilic spread), a di eased animal (zoop hili c spread), or soil (geophilic spread). One drawback of existing antifungal treatment i the time required for a complete course of therapy: 4 weeks for tinea pedi and corporis and 2 weeks for tinea cruris. Most patients simply treat until the skin looks or feels better, and discontinue the product prematurely, which leads to recurrences. Lamisil AT shortens the time to a complete cure and may lessen the number of recurrences. Lamisil AT contains terbinafine 1%, which can cure tinea cruris, tinea corpori , and some ca e of tinea pedis between the toes in 1 week. 20 The cream al 0 cure athlete's foot on the soles of the feet in 2 weeks. Patient InformationlInstructions: • Parents should consult a physician before allowing children under the age of 12 years to use the product. • Lamisi1 AT relieves the itching, burning, cracking, and caling associated with athlete's foot, jock itch, and ringwonn. • Do not use Lamisil AT to treat vaginal yea t infection or infections in or near the eye. • Infections of the scalp or nails require pre cription therapy in all cases. 21 • Wash the skin with soap and water and dry thoroughly before applying the cream. • If athlete's. foot is on the soles or bottom of the foot, u e the cream, not the dropper or spray. • Apply the product once in the morning and once at night. • Wash the hands after applying the cream. • Do not cover treated skin with a bandage. • When treating athlete's foot, wear shoe that fit comfortably and allow the foot to "breathe." • Change shoes and socks at least once daily. • If the product causes additional irritation or if the condition worsens, stop using Lamisil AT and contact a phy ician. • If Lamisil AT accidentally contacts the eye , rin e them thoroughly with water.

Abreva (Glaxo SrnithKline) Active Ingredient: Docosanol 10% Indication: Treatment of recurrent oral-facial herpes simplex in adults Availability: Cream in 2 gram tubes Discussion: Cold sores or fever blisters are painful, recurrent lesions that occur most often on or near the lips. They are caused by herpes simplex virus type 1 (HSV-l). After the virus enters the body (i.e., primary herpes infection), it migrates to the sensory nerve ganglia. It remains there for the lifetime of the individual and may trigger lesions at any time (i.e., recurrent infection).16 Approximately 90% of the United States population is infected with HSV -1. Most primary infections occur during childhood. Some patients develop immunity after the primary infection, but 20% to 45% experience recurrent infections. Primary triggers for recurrences include ultraviolet radiation, stress, fatigue, chills, windburn, infectious diseases, fever, and trauma secondary to injury or dental work. Regardless of the trigger, cold sores are self-limiting and heal within 10 to 14 days. 17 Until recently, nonprescription products available for the treatment of cold sores only relieved symptoms. These products contain external analgesics, anesthetics, and protectants, alone and in combination, to alleviate the pain, itching, burning, and cracking associated with cold sore lesions. 17 Abreva is the first topical antiviral for the treatment of cold sores to be approved for nonprescription sale. Its approval was due, in part, to its unique mechanism of action, which minimizes the likelihood of viral resistance. Unlike its prescription counterparts, Abreva prevents viral particle fusion with host cell membranes and has no direct viricidal activity. In contrast, prescription products such as acyclovir and penciclovir treat cold sores by inhibiting DNA synthesis of HSV-l, thereby preventing viral replication. Because these products have been associated with viral resistance, their approval for nonprescription use is unlikely.I8 Patient InformationlInstructions: • Patients with known hypersensitivity to any product ingredient should not use Abreva. • Pregnant women should consult a physician before using Abreva. • Apply the product at the first sign of a fever blister or cold sore, then five times daily until the lesion is healed. • Use Abreva only to treat lesions on the lips and face. • Do not apply Abreva near the eyes, as it may cause irritation.

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Minor Wounds and Skin Infections Wound Wash Saline (Blairex Laboratories, Inc.) Active Ingredients: Sterile sodium chloride solution 0.9% Purpose: Cleansing of minor wounds Availability: 90 mL and 210 mL aerosol cans Discussion: Most minor wounds, such as paper cuts and small punctures (splinters), are relatively clean. However, a child who falls down while running may suffer an abrasion wound that is contaminated with gravel, grass, dirt, and other foreign substances. Material in the wound and the fresh bleeding hinder visibility, to the frustration of a parent trying to gauge the nature and extent of the injury. Yet, dressing the wound without fIrst cleansing it can allow the foreign material to granulate into the healing tissues.22 Tap water is often used to clean the wound, but it is not isotonic. Furthermore, because of variations in the effectiveness of sanitation systems, any particular township may not produce tap water that is ideal for cleansing. For these reasons, patients may benefIt from use of Wound Wash Saline. This product is a sterile 0.9% sodium chloride packaged in an aerosol can. The nature of aerosol packaging prevents contamination of the contents of the isotonic, sterile fluid in the can. Hospitals often use sterile saline in plastic bottles for irrigation of wounds. These containers are costly, because they must be discarded 24 hours after fIrst being opened to prevent accumulation of undue levels of bacteria inside them. An advantage of Wound Wash Saline is that it may be used at any time throughout its 2year shelf life. Patient InformationlInstructions: • If the wound is deep or if it was caused by a puncture or an animal bite, seek care from a physician. • Expel a short stream of Wound Wash Saline fluid to clear the nozzle. 23 • Aim the nozzle at the wound and press. The distance may be adjusted to effect full cleansing. The can may be held in any position during use, as it is effective over a 3600 area of movement. • The manufacturer's instructions specify that eqch can is to be used on a single patient only.

First Aid Hurt-Free Tape (Johnson & Johnson) Active Ingredient: Hypoallergenic, latex-free tape Purpose: Secure bandages and dressings to wounds Availability: Package of 5 yards of tape in 1- or 2-inch widths Discussion: Most minor wounds need not be dressed by a health care provider. Hurt.Free"Tape Dressing a wound serves several purposes. 24 An absorbent dressing will wick exudate and any contaminated wound fluids away from the wound and help protect healthy surrounding tissue from further maceration or contamination. The dressSdckrTollSClf, No.ToSIdn

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ing also protects the wound from environmental filth, bacteria, fungi, and other potential contaminants and helps prevent further damage from brushing or scraping the healing tissues against surfaces. The dressing can also accelerate healing by retaining a small amount of healthy moisture in the wound. Some dressings have their own adhesive, but others require a separate tape to secure them to the wound site. 25 Tape has two components: backing and adhesive. The adhesives can cause problems. Patients may develop an allergy to them, and they may tear or damage the skin when they are removed. Hypoallergenic and latex-free, Hurt-Free Tape prevents these problems. It is less irritating to the skin than comparable products and leaves no sticky residue. It will not stick to skin or hair, and will not tear the skin upon removal. 26 Patient InformationlInstructions: • Use the 1-inch-wide tape for smaller body parts, such as the hands and feet, and on children or adults ' with small builds. Use the 2-inch tape on the arms and legs. • Place an appropriate dressing over the wound, then wrap Hurt-Free Tape over the dressing, overlapping layers of tape and wrapping it around the area several times until the dressing is fully secured. • Do not wrap the tape so tightly that circulation to the area is hampered.

Band-Aid Advanced Healing (Johnson & Johnson) Active Ingredient: Hydrocolloid bandage Purpose: Primary dressing for minor skin wounds A vailability: Boxes of 10 regular-sized or 6 large-sized strips Discussion: A scab is a temporary wound barrier consisting of a mixture of fIbrin, blood products, necrotic cells, and exposed cells. Although the scab serves as a barrier, it also delays the proce,ss of wound healing. As healing commences, the scab separates the edges of the wound; thus, healing can only start at the bottom and periphery of the scab. Epithelial cells must form healthy granulation tissue by detouring around and under the scab. Eventually, the scab is loosened by epidermal-ceIl-derived proteases. It was long thought that minor wounds healed better if the scab was left intact, but this is a misconception. 24 It is now understood that prevention of scab formation is preferable, because all surfaces of the wound are actively involved in the healing process. The best way to prevent scabs from forming is by early application of a dressing that allows the minor wound to remain moist. 27 Some dressings are designed to wick fluid away from wounds, but most minor wounds do not produce sufficient exudate for active wicking. Wounds heal more rapidly when moisture level is controlled; yet most minor wound dressings are not designed to actively retain moisture to promote healing. Band-Aid Advanced Healing is composed of a hydrocolloid that has been used in hospitals for decades. Unlike other bandages, Band-Aid Advanced Healing does not have a small absorbent pad in the middle. Rather, the entire strip is composed

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of hypo allergenic polymer and is active in healing. The new product meets the need for moisture retention. The translucent bandage seals the wound completely, preventing contact with environmental filth, bacteria, and external moisture. The body's natural healing fluids are sealed in, but the bandage also absorbs excess fluid and allows it to evaporate. 28 Patient Information/lnstructions: • Position the strip over the wound and leave it in place for several days. • As the strip absorbs moisture, a white gel is formed that 'allows the wearer to see the healing area. • The bandage may be worn while bathing or showering.

Ophthalmic Disorder/Dry Eye GenTeal Lubricant Eye Gel (Ciba Vision) Active Ingredients: Hydroxypropyl methylcellulose 0.3%, carbopol 980, phosphonic acid, purified water, sorbitol, sodium perborate Indication: Dry eye Availability: 10 mL tubes Discussion: There are many causes of dry eye, but the most common is partial or absolute tear deficiency, often caused by lacrimal gland occlusion. Dry air, medications (e.g., antihistamines, anticholinergics), and contact lenses may also cause dry eye. Dry eye may also be a symptom of a serious medical condition such as Sjogren's syndrome or keratoconjunctivitis sicca. 29 Dry eye treatments have come in several dosage forms, each with its own drawbacks. Multidose bottles may contain allergenic or irritating preservatives. Preservative-free dry eye products packaged in unit-of-use containers are expensive. Ophthalmic dry eye ointments containing petrolatum are inconvenient to apply and can cause blurred vision. GenTeal Lubricant Eye Gel contains sodium perborate as a preservative. When placed in the eye, this preservative converts to water and oxygen. 30 The gel vehicle liquifies on contact with the eye, spreading rapidly and yielding relief that lasts long enough that only three to four applications per day are needed. Patient InformationlInstructions: • The product temporarily relieves discomfort due to minor irritation of the eye from exposure to wind, sun, or other irritants. • Instill one to two drops in the affected eye(s) three to four times daily or more frequently if needed. • Hold the tube vertically, allowing a small drop to form and drop into the conjunctival sac. • Do not touch the tip to any surface. • Close the tube immediately after use. • If eye pain, changes in vision, continued redness or irritation of the eye is experienced, or if the condition worsens or persists for more than 72 hours, stop using the product and consult a physician.

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Prevention of Hygiene-Related Oral DisordersfTooth Whitener Crest Whitestrips (Procter & Gamble) Active Ingredients: Hydrogen peroxide, glycerin, carbopol 956, sodium hydroxide, sodium acid pyrophosphate, sodium stannate impregnated on thin, flexible strips Purpose: Whitening natural teeth Availability: Boxes of 56 strips-28 for lower teeth, 28 for upper teeth Discussion: Many whitening toothpastes have been marketed to clean unsightly stains on teeth, but they can only clean surface stains. Other products may contain harmful abrasives. 3 ) Crest Whitestrips contain hydrogen peroxide in a unique strip form. 32 The strip increases the effectiveness of the active ingredients by keeping them in contact with teeth for a longer period. Patient InformationlInstructions: • Patients who wear braces and/or are under 16 years of age should not use the product. • Use the product within 4 weeks of purchase. • After brushing the teeth, open the blue pouch labeled "Upper." Peel the backing from the whitening strip. Using a mirror, place the strip on the front upper teeth (with the gel side next to the teeth), aligning the edge of the strip with the gingival line. Press gently to ensure that the strip adheres to all tooth surfaces. Wear the strip for 30 minutes, remove it, and wipe off any remaining gel. • Perform this procedure twice daily for the upper teeth. • To treat the lower teeth, one strip may suffice, but a second strip may be used to enhance the whitening effect. • If both upper and lower teeth are treated at the same time, the strips do not stay in place as well. • Do not eat, drink, smoke, or sleep while the strips are in place. • The whitening effect lasts for at least 6 months. To maintain that level of whitening, use a new box of strips every 6 months. • Use of tobacco, coffee, tea, dark colas and red wine causes teeth to stain faster. • Crest Whitestrips will not whiten caps, crowns, veneers, or fillings. Therefore, if these items were previously matched to the teeth, there may be a noticeable difference between the dental work and the gradually whitening natural tooth surfaces. • Sensitivity of the teeth when using the strips may be eased by using the product only once daily or suspending use for a 2- to 3-day interval. • Users may notice gingival discomfort, which is most often caused by brushing too vigorously or using a medium or hardbristled brush while also using the whitening strips. In this instance, use a soft-bristled brush, and take care to brush gently. • Do not allow the whitening gel to touch fabrics. • Do not allow the material on the strip to touch the eyes.

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Home Diagnostic Testing and Monitoring Devices Alternative Site Blood Glucose Monitoring Products Freestyle Blood Glucose Monitoring System (TheraSense) Purpose: Measurement of blood glucose Availability: 1 meter with case, 10 test strips, 10 sterile lancets, 1 vial of control solution, lancing device, and an 8-month personal logbook. Additional test strips are available in quantities of 50 and 100. AtLast Blood Glucose Monitoring System (Amira) Microlet Vaculance (Bayer) FastTake Test Strips (Lifescan) Purpose: Measurement of blood glucose and/or obtaining a blood sample for blood glucose measurement Availability: The AtLast Blood Glucose Monitoring System contains I meter with protective cover and case, 25 test strips, 25 lancets, 2 lancet holders, a calibration chip, a check strip, and a 12-week logbook. Additional test strips are available in quantities of 50. The Microlet Vaculance package contains 1 lancing device and 10 sterile lancets. FastTake Test Strips are available in packages of 50 and 100. Discussion: As of 1998, approximately 10.5 million people in the United States had received diagnoses of diabetes. Of those, only about 10% had received diagnoses of Type 1 diabetes mellitus. Diabetes is particularly prevalent among African Americans and Mexican Americans. 33 Poor glycemic control contributes to a number of complications in patients with diabetes. Advanced glycosylation end products are known to contribute to renal damage. 34 Poorly controlled diabetes can also lead to cardiovascular complications. Studies have shown that patients with diabetes are two to four times as likely to develop some form of cardiovascular morbidity or death than nondiabetic subjects of the same age. 35 Blood glucose and glycosylated protein testing are integral to reducing the likelihood of diabetic complications. Until recently, patients had to lance their fingertips to obtain blood samples for glucose testing. Because the fingertips contain a large number of sensory nerve endings, this procedure can be quite painful, especially for patients who test multiple times a day. Each of these new devices allows patients to obtain samples from sites other than their fingertips. The Freestyle System permits patients to obtain blood samples from the forearms. It does this through the patented "Nano-SampIe" technology designed to measure a blood sample of only 0.3 microliters (i.e., the size of a pinhead). Older meters require samples between 8 and 15 microliters in size to obtain an accurate

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measurement. 36 The smaller sample size permits sampling from sites that are less sensitive and less highly vascularized than the fingertips. The AtLast System requires a larger sample size of 2 microliters. It permits sampling from the forearm, upper arm, and thigh using a built-in lancing device. A custom-made lancet creates a small break in the skin, then a gentle "press and release" motion draws blood to the skin surface. The meter itself employs precision optics to measure and report the blood glucose level in 15 seconds. The Microlet Vaculance is designed for use with Bayer blood glucose test sensor systems with patented MicroEase sampling (Glucometer Elite, Glucometer Elite XL, and Glucometer DEX). It can be used to obtain blood samples from soft, fleshy, nonvenous areas of the skin that are free of hair, such as the fleshy portion of the palm between the wrist and middle finger, the medial aspect of the forearm, the abdomen, and the outer thigh. After lancing the skin, the device creates a vacuum seal around the sampling site that draws the required amount of blood (2 mL to 4 mL, depending on the meter) to the skin surface. 36 The FastTake System is not in itself a new product, but the test strips it uses are new. The new test strips require a 40% smaller blood sample than the original strip (1.5 rnL instead of 2.5 mL). In addition, the new strips employ capillary action to draw the smaller blood into the strip on contact. This makes it possible to obtain adequate blood samples from soft, fleshy areas of the arms in addition to the fingertips. 37 Patient InformationlInstructions: Freestyle Meter • First, set up the lancing device. To do so, snap off the clear cap, insert a lancet in the white cup, twist off the lancet top, and replace the cap. Next, tum the settings dial on the lancing device to the desired depth level (an initial setting of three is recommended) and set the device aside. • Insert a test strip into the meter. The meter will turn on automatically. • As soon as a code number appears on the meter display, use the "c" button to scroll to the number that matches the number on the test strip vial. • Wait until the "Apply Sample" message appears on the meter display before obtaining a blood sample. • Bring fresh blood to the surface on the top of the forearm by rubbing the test site briefly until it feels warm. • Place the lancing device on the test site and press the release button. • Hold the device on the arm and gradually increase the pressure for several seconds. • When a drop of blood about the size of the head of a pin appears under the clear device cap, lift the device straight up without smearing the sample. • To fill the test strip with blood, hold the meter at a slight angle and touch only one side of the strip to the blood sample. Like a straw, the strip draws in an adequately sized sample. The meter beeps when an adequate sample has been obtained.

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• Do not press the strip hard against the arm or scrape blood • Lance the side of a fInger or a soft, fleshy area of the arm that with the flat end of the strip. is free of visible veins or excess hair. When using a sample site • The meter will beep two times and display the results when the on the arm, hold the lancing device frrmly against the skin for test is complete (average time is 15 seconds after the sample is a few seconds before and after lancing the skin to bring an obtained). adequate sample to the surface. AtLast Meter • Touch the blood sample to the top, white edge of the test strip • To prepare the AtLast meter, unscrew the lancet holder from until the blood has completely fIlled the confmnation window. the meter and insert an uncapped lancet, metal tip fIrst, into the • Test results are displayed in 15 seconds. holder until it stops. • Screw the lancet holder back on the meter until it snaps into place. • The package contains both a blue and gray lancet holder. The Multi-Test Blood Chemistry Monitor gray holder permits the lancet to penetrate more deeply into the skin and need only be used if the patient fails to get a blood BioScanner 2000 (Polymer Technology sample of adequate size using the blue holder. Systems) • After loading the lancet device, insert the short end of the test Purpose: Measurement of blood glucose, strip into the meter so that the test tip points outward. total cholesterol, high density lipoprotein • To engage the lancet, pull the knob on the end opposite the test cholesterol (HDL-C), and ketone strip until it clicks. Availability: The BioScanner packaging tube contains one meter with case, a lanc• Press the gray start button. • To obtain a blood sample, place the bottom of the meter on the ing device, lancets, literature about the forearm, upper arm, or thigh. product, a user guide, and AAA batteries. • Press the entire unit against the sample site until it clicks and Strips are sold separately in a variety of hold it in this position for about 3 seconds. quantities: glucose strips are available in quan• Keeping the meter pressed to the skin, release the pressure by tities of 25, 50, and 100; cholesterol, HDL-C, and ketone strips allowing the meter to slide up fully so that it rests lightly on are available in quantities of 6, 50, and 100. Each vial of strips includes a corresponding, color-coded memory chip. the skin and hold the meter briefly in this position. Discussion: Diabetes and heart disease are "silent killers" that • Slowly repeat this process of press and release four more times affect more than 200 million Americans. Since 1900, heart disease at the same site to obtain an adequate blood sample. • To perform the test, lift the meter from the skin, taking care has been the leading cause of death in the United States, costing the health care system more than $326.6 billion annually.38 Risk of not to smear the droplet of blood that has formed. • Holding the meter at an angle, gently touch the test tip to the heart disease or stroke is two to four times greater for people with outer edge of the blood droplet until the meter beeps. In about diabetes than for the average person. 39 Of people receiving diag15 seconds, the meter will beep again and display the results of noses of type 2 diabetes, 50% are not aware of their risk until after their fIrst heart attack or stroke. For most of the patients with type the test. 2 diabetes, an average of 7 to 10 years elapses from the time that Microlet Vaculance • To obtain a blood sample with the Microlet Vaculance, heart disease develops to its diagnosis. 40 The most important way that patients with diabetes can reduce remove the end cap from the device, insert a lancet into the their risk of diabetic complications and heart disease is by achievholder, twist off the lancet protector, and replace the end cap. ing and maintaining good glycemic control through diet and exer• Position the device fIrmly on the lancing site (i.e., so that the entire edge of the end cap is in contact with the skin) and cise. Patients can use the Bioscanner 2000 to monitor glycemic control by measuring blood glucose levels. The meter also meadepress the plunger until it stops. • Maintaining pressure between the end cap and the skin, slowly sures blood ketones. Ketones are byproducts of fat metabolism release the plunger to create a vacuum under the end cap. This that appear in the blood of patients with elevated blood sugar and signal the potential development of life-threatening ketoacidosis. vacuum draws blood to the skin surface. The Bioscanner 2000 also permits patients at risk for the devel• When an adequate amount of blood has formed on the skin, of heart disease, such as those with diabetes, to monitor opment press the plunger three-quarters of the way down to release the blood levels of total cholesterol and HDL-C. Given that elevated vacuum. cholesterol levels are a treatable risk factor for heart disease, regu• Remove the device from the skin. lar monitoring should lead to early detection and treatment before FastTake System the development of complications such as heart attack and stroke. • Insert a test strip into the meter. Patient InformationJInstructions: • Match the code number on the test vial with the meter display • Insert the memory chip corresponding to the desired te t into by pressing the " C" button on the meter until the appropriate the meter and tum on the meter. number appears.

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• Wash and dry hands thoroughly, and lance the side of one finger to obtain a blood sample. • Apply enough blood to cover the testing area of a strip. • The strip may be inserted into the meter either before or after the blood sample has been applied. • The meter displays the test results in approximately 1 minute.

Conclusion We anticipate that the trend toward self-care will continue, or even increase. Pharmacists must make the commitment to remain up to date on trends and new products in order to give patients comprehensive and balanced information. The new nonprescription medications and diagnostic products cited in this review represent valuable additions to the increasing array of self-care products. Drs. Pray and Popovich have a long-standing consulting relationship with Procter & Gamble Healthcare. Dr. Newton declares no conflicts of interest or financial interests in any product or service mentioned in this article, including grants, employment, gifts, stock holdings, and honoraria.

14. Pray WS. Menstrual discomfort. In: Nonprescription Product Therapeutics. 1st ed. Baltimore, Md: Lippincott Williams & Wilkins; 1999. 15. ThermaCare Therapeutic Heat Wraps [trade package]. Cincinnati, Ohio: Procter & Gamble; 2000. 16. Pray WS. Oral problems. In: Nonprescription Product Therapeutics. 1st ed. Baltimore, Md: Lippincott Williams & Wilkins; 1999. 17. Nonprescription Drug Therapy. Facts and Comparisons. St. Louis, Mo; 1999:635. 18. Palacioz K. New drug: Docosanol 10% cream (Abreva). Pharmacist's Letter Detail Document 161102, Stockton, Calif: Pharmacist's letter; November, 2000. 19. Pray WS. Fungal skin infections. In: Nonprescription Product Therapeutics. 1st ed. Baltimore, Md: Lippincott Williams & Wilkins; 1999. 20. Lamisil AT Cream, Spray Pump, and Solution Dropper [trade packages]. Summit, NJ: Novartis Consumer Health, Inc; 2000. 21. Gupta AK, Nolting S, de Prost V, et al. The use of itraconazole to treat cutaneous fungal infections in children. Dermatology. 1999;199(3):248-252. 22. Rodeheaver GT. Pressure ulcer debridement and cleansing: a review of current literature. Ostomy Wound Manage. 1999;45(1ASuppl): S8~.

23. Wound Wash Saline [trade package]. Columbus, Ind: Blairex Laboratories, Inc; 2000. 24. Pray WS. Minor wounds. In: Nonprescription Product Therapeutics. 1st ed. Baltimore, Md: Lippincott Williams & Wilkins; 1999. 25. Foster L, Moore P. Acute surgical wound care. 3: fitting the dressing to the wound. Br J Nurs. 1999;8(4):200-202, 204, 206. 26. First Aid Hurt-Free Tape [trade package]. Skillman, NJ: Johnson & Johnson Consumer Products Company; 2000.

References 1. Kernan WN, Viscoli CM, Brass LM, et al. Phenylpropanolamine and the risk of hemorrhagic stroke. N Engl J Med. 2000;343:1826-32. 2. Consumer Healthcare Products Association. Cholesterol-lowering drugs not ready for switch ... yet. Executive Newsletter. 2000;16-00;1. 3. Consumer Healthcare Products Association. NDAC votes on PPA and Prilosec. Executive Newsletter. 2000;23-00:1. 4. Consumer Healthcare Products Association. What do we really know about dietary supplement consumers? Executive Newsletter. 2000;-2200:3. 5. Consumer Healthcare Products Association. California wars consumers, certain herbal products contain prescription medicines .. Executive Newsletter. 2000;5-00:7.

6. Johne A, Brockmoller J, Bauer F, et al. Pharmacokinetic interaction of digoxin with an herbal extract from St. John's wort (Hypericum perforatum). Clin Pharmacol Ther. 1999;664:338-45.

7. Fugh-Berman A. Herb-drug interactions. Lancet. 2000;355(9198):134-8. 8. Fowler JB, German TC. The essence of herbal products for the hospital pharmacist. Pharm Prac News. 2000;28:28-33. 9. Food safety: Improvements Needed in Overseeing the Safety of Dietary Supplements and Functional Foods. Washington, DC: Govern-

ment Accounting Office; 2000. 10. Consumer Healthcare Products Association. NIH awards Purdue and Arizona grants to research botanicals. Executive Newsletter. 2000; 21-00:6. 11. Consumer Healthcare Products Association. Leading dietary supplement manufacturers develop voluntary labeling to aid consumers. Executive Newsletter. 2000;7-00: 1. 12. Consumer Healthcare Products Association. CHPA establishes voluntary labeling program for St. John's wort products. Executive Newsletter.2000;10-00:1.

13. Pray WS. Gastric distress. Nonprescription Product Therapeutics. 1st ed. Baltimore, Md: Lippincott Williams & Wilkins; 1999.

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27. Bolton LL, Monte K, Pirone LA. Moisture and healing: beyond the jargon. Ostomy Wound Manage. 2000;46 (in suppl): S51~2. 28. Band-Aid Advanced Healing [trade packagel. Skillman, NJ: Johnson & Johnson Consumer Products Company; 2000. 29. Pray WS. Ophthalmic conditions. In: Nonprescription Product Therapeutics. 1st ed. Baltimore, Md: Lippincott Williams & Wilkins; 1999. 30. GenTeal Lubricant Eye Gel [trade package]. Duluth, Ga: Ciba Vision; 2000. 31 . Pray WS. Plaque-induced diseases: caries and gingivitis. In: Nonprescription Product Therapeutics. 1st ed. Baltimore, Md: Lippincott Williams & Wilkins; 1999. 32. Crest Whitestrips [trade package]. Cincinnati, Ohio: Procter & Gamble; 2000. 33. Harris M. Diabetes in America: epidemiology and scope of the problem. Diabetes Care. 1998;21{suppI3):11C-14C. 34. Makita Z, Bucala R, Rayfield E, et al. Reactive glycosylation end products in diabetic uremia and treatment of renal failure. Lancet. 1994;343:1519-22. 35. Kilhovd B, Berg T, Birkeland K, et al. Serum levels of advanced glycation end products are increased in patients with type 2 diabetes and coronary heart disease. Diabetes Care. 1999;22:1543-48. 36. Ables JC, New technology for patients with diabetes. Pharmacist's Letter Detail Document 160406, Stockton, Calif: Pharmacists Letter; April 2000. 37. Lifescan introduces new test strip that makes blood sugar testing less painful for many with diabetes [press releasel. Newtown, Pa: Lifescan; June 10,2000. 38. Cardiovascular disease cost. American Heart Association; Available at: women.americanheart.org/physicians/index. Accessed February 12, 2001. 39. American Diabetes Association. The dangerous toll of diabetes. Available at: http://diabetes.org/ada/facats.asp#toll. Accessed February 12, 2001 . 40. Diabetes Mellitus statistics. American Heart Association. Available at: http//women.americanheart.org/physicians.org. Accessed February 12, 2001.

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