New OTC Drugs and Devices 1997: A Selective Review

REVIEWS

New OTC Drugs and Devices 1997: A Selective Review Gail D. Nevvton, W. Steven Pray, and Nicholas G. Popovich

Objective: To create a heightened awareness of the proposals for nonprescription product labeling changes being explored by the

Food and Drug Administration and the Nonprescription Drug Manufacturers Association, and to review selected new self-care products that are now available in the United States. Data Sources: Recent clinical and pharmaceutical industry literature. Data Synthesis: The debate continues about what constitutes sufficient labeling information for a nonprescription drug product. However, one fact remains. Numerous nonprescription drug products, including home diagnostic products and accessories, will continue to become available on the U.S. market. It is important that the pharmacist become as knowledgeable as possible about these products, and be capable of educating consumers on their appropriate use. Conclusion: New products cited in this review article are valuable new additions to the selfcare product pool that provides an increasing array of products for consumer use.

JAm Pharm Assoc. 1998;38:199-209.

The use of nonprescription drug products by American consumers continued to escalate over the last year. Notable contributors to this trend have been the extraordinary number of prescription products switched to over-the-counter (OTC) status and the estimated health care savings resulting from the use of OTC products. In fact, since 1995, for example, there have been at least 14 switches, double the number since 1988. 1 In a study conducted by Kline & Company, Inc., for the Nonprescription Drug Manufacturers Association (NDMA), consumer health care savings attributable to self-care with OTC medications jumped from $10.5 billion in 1987 to $20.6 billion in 1997.2 Savings were calculated by comparing the average cost of an OTC medication with the typical cost of visiting a physician, buying a prescription drug, and, for those receiving hourly wages, the income lost while visiting a physician. These estimated savings are impressive and of definite benefit

Received December 24, 1997, and in revised form January 16, 1998. Accepted for publication January 28, 1998. Gail D. Newton, PhD, is associate professor of pharmacy practice and administration, Mylan School of Pharmacy, Duquesne University, Pittsburgh, Pa. W. Steven Pray, PhD, is professor of pharmaceutics, School ofPharmacy, Southwestern Oklahoma State University, Weatherford, Okla. Nicholas G. Popovich, PhD, is professor of pharmacy practice, School of Pharmacy and Pharmacal Sciences, Purdue University, West Lafayette, Ind. Correspondence: Nicholas G. Popovich, PhD, Department of Pharmacy Practice, School of Pharmacy and Pharmacal Sciences, Purdue University, West Lafayette, IN 47907-1335. Fax: (765) 494-0801. E-mail: [email protected]

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to society. However, the question must be asked-what is the amount of health care dollars spent as a result of patient misuse of OTC products (i.e., using an OTC product incorrectly and/or for the wrong indication)? The research assumed that in the absence of a switch product, the patient would consult a physician. In reality, however, in the experience of the authors, a more likely scenario would have the patient selecting an existing OTC product to treat the problem. Events at the time of this writing suggest that prescription-toore switch products will have a similar influence on the extent to which consumers use OTC products during the upcoming year. For example, Nizoral Shampoo (ketoconazole 2% ), was recently approved for the self-treatment of dandruff. In addition, Rogaine Extra Strength for Men (minoxidil 5%) has been approved for the self-treatment of male-pattern baldness. (The latter switch is especially noteworthy because minoxidil 5% was never even available as a prescription product, and therefore is not a switch product per se; the former prescription product was only available as a 2% solution.) Both Nizoral and Rogaine Extra Strength for Men will be critiqued in next year's article following their introduction into the OTC marketplace in early 1998. While prescription-to-OTC switches continue to be greeted enthusiastically by the public, the ability of consumers to choose and use these products safely and effectively is a central issue for pharmacists and pharmacy. In this context, the labeling changes proposed by the Food and Drug Administration (FDA) for OTC products are generating considerable debate. On February 27 1997, FDA proposed a rule aimed at making nonpre cription medication labels more consumer friendly. 3 The 39-page pro-

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po ed rule call for standardized headings and subheadings preented in a pecified order and the use of graphic features intended to aid consumers' comprehension, such as font size (i.e., sixpoint), pacing, and capitalization, among others. The rule would allow manufacturers to simplify the presentation of the labeling information by deleting specific terms that may interfere with clarity. It would increase the number of interchangeable labeling terms that manufacturers can use to make the language more concise and easier to understand (e.g., throw away rather than discard; lung instead of pulmonary). Furthermore, the rule would amend specific language to make warnings on OTC labels more comprehensible to consumers. The proposal provided for a public comment period (by June 27, 1997) and required manufacturers to implement changes within two years of publication of the final rule. In the meantime, FDA has been conducting four consumer surveys to collect information on OTC labels. 4 The surveys relate to "preferences for and comprehension of information contained in different formats and methods of communication." For example, should active ingredient(s) be listed first or last, and should directions for use precede warnings (i.e., Study C [Statement of Identity Comprehension])? It is anticipated that any proposed changes resulting from this research will amount only to "fine tuning" rather than drastic changes resulting from the proposed rule. Indeed, there have been significant differences of opinion between FDA and NDMA with respect to what this research will demonstrate. NDMA, for example, has asked FDA to form a special working group composed of representatives of interested parties to develop research proposals of quality design to study pertinent aspects of OTC labeling. Furthermore, NDMA wants FDA to provide interested parties with access to the survey data at the time the survey results are published in the Federal Register. 5 Philosophically, NDMA believes that to select a product and u e it effectively and safely, all a consumer needs is a comprehenive, well-written label. However, the question remains, how much written information is enough? To intelligently select and u e a product, a consumer must have a reasonable amount of information. This is a particularly challenging problem for smaller package sizes or those with large amounts of required copy. 6 In fact, NDMA has provided FDA additional information on a posible smaller package exemption to the proposed OTC labeling rule. A concern is that if the labeling rule were finalized as proposed, it would not fit the majority of OTC packages (the majority of OTC packages would be too small to contain the required information). Furthermore, if most of the information appears on the packaging, and not on the actual product, it is conceivable that patient would discard the information with the packaging. The issue of the sufficiency of print-based information for consumers' purposes is further complicated by the functional illiteracy level in America. Functional illiteracy, i.e. , the inability to meet personal objectives in a print culture despite schooling, can lead to, for example, an inability to comprehend the information on an OTC product, causing feelings of frustration and powerless-

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ness.7 The National Adult Literacy Survey, sponsored by the U.S Department of Education and administered by the Educationa c Testing Service in 1992, reported that 21 to 23 % (i.e., 40 to 4million of the 191 million adults in this country) demonstrate~ skills at the lowest level of prose, document, and quantitative pro. ficiencies (i.e., Level One). 8 Many adults at this level perfonneo 1 simple, routine tasks involving brief, uncomplicated texts and documents, but were unable to make low-level inferences using printed materials and to integrate easily identifiable pieces of information. With the continuing influx of immigrants changing the demo. graphics in the United States, average reading levels have actually dropped from a sixth-grade to a fourth-grade level.* Black, American Indian/Alaska Native, Hispanic, and Asian/Pacific Islander adults were more likely than white adults to perform in the lowest two of five possible literacy levels in the aforementioned survey. Therefore, these groups must be considered at risk for using OTC products unsafely and ineffectively. Another at-risk group is the elderly population, who because of diminished visual acuity and/or literacy level might have problems reading and under· standing OTC product information. Yet, even those who are categorized as literate may have trou· ble comprehending label information, for example, because of technical or medical jargon. Clearly, alternatives to traditional labeling (e.g., pictograms, verbal counseling) must be studied to ensure that all of these populations are able to use OTC medica· tions safely and effectively. 9 Another point of recent controversy is whether the phrase "consult your doctor or pharmacist" should be mandated for inclusion on OTC package labels. The American Medical Association (AMA) has expressed opposition, reasoning that the addi· tional words will confuse the consumer and that pharmacists are not educated to diagnose medical problems. Certainly, the profes· sion of pharmacy is not arguing that pharmacists should diagnose. Rather, the important role of the pharmacist is one of triage, advising the patient or to consult a physician, select an appropri· ate OTC product, use a nondrt!.g approach to solve the problem, or do nothing at all. A second AMA argument against the inclusion of the phrase "or pharmacist" on the label is that it would exclude other knowl· edgeable health care professionals and potentially mandate their mention on the label as well. Yet, it is difficult to understand how a reasonably aware consumer would perceive nurses and dieti· tians, for example, to be as knowledgeable as pharmacists about OTC products. Realistically, and more to the issue, is the medical profession's concern that placing the phrase "or pharmacist" on the label would inadvertently create a "pseudo" third class of drug product that would never be mandated through legislation. However, this is seemingly a "dead" issue in light of the recent U.S. Government Accounting Office report indicating the value of a

* Personal communication. Linda Golodner, National C onsumer League, Washington, D. C.

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pharmacist-controlled clas of OTC product ha yet to be demonstrated. 10 But if the phrase "or pharmaci t" were placed on product labels, more consumers would likely confer with the pharmacist (or the physician) before using an OTC drug product. Thus, one of the primary goals of the profession of pharmacy would be achieved and one would not. That is, pharmacists would help consumers to realize optimal therapeutic outcomes from their ore drug therapy' but would still not be reimbursed for their intervention. Regardless of the font size, pictograms, and wording that are fmally agreed upon for nonprescription drug labels, pharmacists will continue to encourage consumers to ask questions and to assist them in selecting appropriate OTC products. Also, pharmacists should be alert to those individuals (e.g., non-native speakers, elderly patients) who may need additional assistance in understanding and interpreting package information. It is in the spirit of this professional obligation that the followingnew product reviews were developed. The authors are hopeful that this information will assist pharmacists as they provide pharmaceutical care to their patients.

REVIEWS

Simethicone helps gas symptoms through its action as a defrothicant. 12 It reduces the surface tension of gas bubbles in the gastrointestinal tract, allowing the foamy mass to coalesce into one large pocket of gas (the intraluminal pressure remains the same). This larger pocket of gas moves more easily through the gastrointestinal sphincters, including the anal sphincter. Thus, gas is eliminated more rapidly, reducing symptoms of bloating, pressure, and cramping. Patient Information: All dosing directions should be followed exactly. The product should not be used in children under the age of 6 years, unless directed by a physician. Furthermore, parents must not treat diarrhea in children under the age of 3 years without professional advice. Diarrhea that has lasted for more than two days is beyond selftreatment, and the patient should be referred to a physician. This two-day period begins with the first loose stool, not when the nonprescription product is first taken. Fever along with diarrhea indicates the presence of an infectious process and contraindicates self-treatment. Should the stool contain blood or mucus, a physician appointment is prudent. The possibility of dehydration should be kept in mind, and a nonprescription rehydrating solution used if diarrhea persists.

Antidiarrheal Product Asthma Product · lmodium Advanced (McNeil Consumer Products Co.) Indication: Diarrhea when combined with cramps, bloating, and pressure Active Ingredients: Loperamide 2 mg and simethicone 125 mg Availability: Boxes containing 6, 12, or 48 vanilla-mint flavored chewable tablets ' Discussion: Diarrhea is defined as three or more loose, watery stools daily. While diarrhea is deadly in developing countries, it is usually little more than a minor inconvenience in the United States, because offending organisms are less pathogenic here and medical intervention is quicker. U.S. citizens experience approximately two episodes of diarrhea yearly. 11 DiarAnti-Diarrheal/Anti-Gas Controlstfltsympromsof diMrt!H rhea may be acute or chronic; the b/01111"11, _ . ,,., ond aomps patient should only self-treat acute cases. Acute diarrhea may be caused by medical conditions, infectious agents, or may be an adverse effect of medications. The patient may also experience symptoms consistent with trapped gas. Thus, this new combination of nonprescription ingredients (loperamide plus simethicone) relieves the diarrhea along with the cramping, bloating, and sensation of pressure caused by gas in the bowel. Loperamide acts to reduce the number of loose bowel movements through its ability to slow intestinal motility. The patient retains the tool longer, thereby increasing the body's absorption of fluid from the fecal bolus. This reverses the diarrhea by firming the stools.

lmodiulll

Advanced Loperrrnode~

plus

c:ommonl)' nt fwNd to u flU

PATENTEOFO,.MIJCA

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DOSER (NEWMED Corporation) Indication: To monitor the number of inhalations used and remaining in metered-dose inhaler (MDI) canisters Availability: Packages contain one disposable device that uses an integral battery that works for up to 13 months Discussion: Approximately 15 million Americans suffer from asthma, including 4.5 million children. Another 5 to 10 million Americans suffer from emphysema and chronic bronchitis. Annually these patients purchase between 75 and 80 million MDis at a cost of about $450 million. 13 The magnitude of these numbers alone underscores the importance of patient education and compliance with inhalation therapy. Pharmacists should instruct patients how to gauge when their inhaler canister requires a refill. This determination is especially critical for bronchodilators used to abort acute exacerbations of symptoms. For example, failure to recognize that an inhaled bronchodilator canister is empty until the time of an attack could have life-threatening consequences for an asthma patient. Until recently, the most accurate method patients could u e to estimate the amount of medication left in inhalers was to keep a record of the actuations used. Patients would then order refill when the total approached the number of actuations indicated on the canister label. However, many patients find this method inconvenient. Thus, it is not surprising that the results of a recent study indicated that only about 10% of patients use this method. 14 Some pharmacists recommend the "float" method to determine when to order refills. This method involves placing the MDI can-

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i ter in a bowl of water. The cani ter will sink when full and float when empty. 15 Although more convenient, this method is much le accurate than written record keeping and might not be applicable to all canister products. In addition, in the study mentioned previou ly, only 10% of patients use this method. Rather, the majority of patients indicated that they judged refill times subjectively by shaking the canister or by looking for changes in the way the medication looked, tasted, or felt when inhaled. 14 These re ults clearly demonstrate the need for an alternative means to estimate when a MDI needs to be replaced. In this context, NEWMED Corporation recently received FDA approval to market DOSER, a small device that can be attached to the top of most MDI canisters. The plastic mouthpiece for certain inhalers (Intal, Tilade, Atrovent, and Alupent) prevents attachment of the device to the canister. However, the device can still be used with these products if the canister is used without the mouthpiece in an extender device that includes a built-in actuator (e.g., Inspir-Ease or Opti-haler). DOSER records the number of times an inhaler is actuated and displays this information in a liquid crystal display (LCD) window. In addition, the device sounds an alarm when a canister is nearly empty. Finally, DOSER tracks how many times the inhaler has been used during the past 30 days. This information may be useful to physicians assessing patient compliance and evaluating the effectiveness of prescribed therapies. A separate DOSER should be used for each type of inhaler. Each device is powered by an integral battery that lasts for up to 13 months. After this time, the entire unit must be replaced. Patient Information: Patients should be advised to read all in tructions thoroughly before using DOSER. To attach DOSER to a canister, it should be pressed slowly but frrmly in the top-center, until a beep signals that the device has been activated. Next, the device should be attached to the top of the inhaler canister and the rubber collar rolled down to secure DOSER in position. The patient hould then follow the package instructions to set the device' internal clock and program the number of inhalations in the cani ter. At this point, DOSER is ready for use. Once the device is attached, the inhaler may be used in the normal manner. A beep confirms that each inhalation is counted and th number of inhalations appearing in the display window decreasby one, while the number of inhalations used increases by one. Patient hould be advised to use DOSER only with new inhaler , not with old or partially filled canisters. Patients should avoid immer ing the device in water and should not attempt to repair DOSER if problems occur. A service representative may be reached u ing the toll-free number (800-941-7735) included in the package instructions.

AirWatch Airway Monitoring System (Enact Health Management System) Indication: Asthma airway monitoring for use in children more than 5 years of age and adults who have a chronic respiratory condition, such as asthma

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Availability: A pocket-sized, electronic spirometer device weigh. ing 3.3 ounces, with three control buttons and an LCD windo~ The monitor has two pieces: the main case and a removable mouthpiece, which swivels between the open and closed positions 1 and contains a built-in sensor. An additional mouthpiece i included with the device. Discussion: Increasingly, physicians specializing in asthma care are recommending objective home monitoring of asthma with aI peak expiratory flow meter, commonly known as a peak flow meter. The peak expiratory flow rate (PEFR-the rate at which air can be forcefully expelled from the lungs) measured by the device helps assess both the response to therapy and deterioration of the patient's condition. The peak flow meter is highly effort-dependent. Typically, PEFR is recorded early each morning and evening at horne and values are entered on a chart or graph. PEFR can be recorded either before using an inhaled bronchodilator or before and after use. One approach to the interpretation of results is for the patient's physician to establish a "target value" or "best value" after clearing up any acute exacerbation. Ideally, this best value will be close to or above the predicted value for the patient based on age, sex, and height. To help patients interpret PEFR results, the values are grouped into color-coded "zones" analogous to a traffic light: green, yellow, and red. The green zone demonstrates all clear; no asthma symptoms are present and the patient may follow the routine treatment plan. The yellow zone signals a need for caution; an acute asthma exacerbation may be present and a temporary increase in medications may be necessary; alternatively, the asthma may not be under sufficient control, and maintenance therapy # may need to be increased. The red zone signals a medical alert and the need for immediate action. The success of the peak flow meter approach depends largely , on patient initiative and willingness to maintain an accurate record of readings and appropriate use of the peak flow meter. Another variable is the accuracy of the manual peak flow meter and the accurate interpretation of the result by the patient. Much like earlier blood glucose test strips, which were compared visually against a color comparison chart on the side label of the product vial, the manual peak flow reading must be visually assessed after measurement. The AirWatch Airway Monitoring System is a portable, pagersized monitor that accurately measures and displays both the PEFR and forced expiratory volume (FEV 1) readings, records the information in its memory, and explains the results to indicate appropriate treatment. A patient can then send the information, via telephone line, to a physician's office. The physician receive by fax a Patient Summary Report, which includes patient background information, 30-day and 6-month FEV 1, and 30-day and 6-rnonth PEFR. Also faxed upon physician request is the patient' Measurement Diary, which provides an ongoing record of airwaY status without requiring the patient to keep a time-consuming, handwritten diary.

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Available only by pre cription (unlike the other products mentioned in this article), thi system allow a more accurate view of me patient's respiratory condition than did previous y tern . The patient's physician register with the AirWatch Network, receive aPIN (Personal Identification Number), and writes the pre cription for AirWatch. Ultimately, the physician establishes the zone funits for the patient, and he or she should give the patient specif' ic instructions for when the reading falls into the red zone. Usually, a written asthma management plan will instruct the patient to notify the physician if the peak flow measures do not rise immediately and stay within the green or yellow zones. The green/yellowboundary can be set up to 80 to 90% of the Personal Best; the yellow/red boundary can be set to 50, 60, or 70% of the Personal 1 Best. The AirWatch package is mailed either to the physician or directly to the patient's home. It includes the instrument, batteries, extra mouthpiece, instructional videotape, and manual. The intent is for the patient to use the system daily and periodically plug into the telephone line at home. Individual patient data are received and stored in the database at the AirWatch Central. r Control charts are then automatically generated and forwarded to !he physician and patient. The AirWatch monitor can store up to 500 measurement pairs ~EFR and FEV 1) in memory, including the time and date of each test. At a usage rate of three test sessions per day, the monitor has enough memory to store up to six months of test results. Patient Information: It is important to emphasize to the patient ---- ~ !hat airway readings should be taken as specified by his or her physician. Because the device is pocket-sized, it can be carried by !he patient during exercise and other daily activities. The patient should understand that the peak flow zone chart on !he monitor's screen indicates airway status in relation to a predetennined target value, which is often referred to as the Personal Best. In addition to reporting zone status at the time of measurement, the monitor's peak flow zone chart also displays the zone tatus for the previous eight measurements. This is valuable in that it demonstrates increasing or decreasing PEFR variability. 1 · After taking as deep a breath as possible, the patient turns on the AirWatch monitor, positions the mouthpiece in the mouth, I and blows with maximum effort for at least two seconds, turning arotor inside the mouthpiece. Through magnetic induction the · Imonitor tracks the rotational speed of the rotor during the first ! second and a half of the blow. Using the speed information and ~ llie known volume per turn, the monitor's internal software deter~ I mines PEFR and PEV 1 . The monitor has a built-in telephone port covered by a rubber plug. This port is identical to a modular household telephone con1 • nector or jack. By connecting the telephone port to a standard telephone line, the monitor can send a copy of its stored measurement diary to AirWatch Central. At the push of a button, the monitor dials a toll-free number, identifies itself to AirWatch Central by its serial number, and transfers the portion of its measurement diary accumulated since its last send call. The entire process takes

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approximately two minute . For tho e intere ted patient , the data tran fer protocol i not compatible with one' personal computer.

Cold, Cough, and Allergy Nasalcrom Nasal Spray (McNeil Consumer Products Co.) Active Ingredient: Cromolyn sodium 4% Indication: To prevent and relieve nasal symptoms of hay fever and other nasal allergies Availability: Solution in 13 mL and 26 mL bottles with a pump unit and actuator Discussion: Allergic rhinitis is the fifth most common chronic condition in the United States. Although it affects people of all ages, the incidence is greatest in children and adolescents. 16 Allergic rhinitis is classified according to the pattern of symptom occurrence. Seasonal allergic rhinitis occurs secondary to weed, grass, or tree pollen present in the air during certain times of the year. In contrast, symptoms of perennial allergic rhinitis can occur year round and can be triggered by a variety of allergens, including dust mites, pet dander, tobacco smoke, and mold spores. 17 The most effective means to prevent symptoms of allergic rhinitis is to avoid exposure to allergens. People with seasonal allergies are often advised to stay indoors and to use air conditioning during allergy season. Those who suffer from perennial symptoms are advised to reduce or eliminate allergen sources in the indoor environment. The specific measures recommended depend on the allergen, but may include regular replacement of heating and air conditioning filters, frequent vacuuming of carpets and upholstery, and eviction of household pets. When non-drug measures fail to control allergic rhinitis symptoms, pharmacotherapy may be necessary. Prescription and nonprescription antihistamines are first -line agents to control allergic rhinitis symptoms. These block the effects of histamine at H 1 receptors (e.g., sneezing, pruritus, and increased vascular permeability and secretions). Antihistamines are most effective for the prevention of symptoms when therapy is initiated prior to allergen exposure and continued throughout the allergy season. One disadvantage that may limit the usefulness of antihistamines is that they reduce symptoms only by 40 to 60%.18 Thi is because they only block the effect of one mediator of the allergic response. In addition, most nonpre cription antihi tamine cause anticholinergic and sedative effects. Newer antihi tamine are less likely to cause these effect , but are only available by prescription. Nasalcrom, a 4% aqueou solution of cromolyn sodium, ha been approved for the self-treatment of allergic rhinitis. Cromolyn sodium inhibits the release of histamine and other mediators from

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rna t cell following allergen expo ure. The product is admini tered topically to the na al mucosa and ha no anticholinergic or sedative effects. Patient Information: Nasalcrom should be sprayed once in each nostril up to six times daily for the relief of allergic rhinitis symptoms. It should be used consistently every day that allergens are present in the environment. To prevent nasal allergy symptoms, therapy should be initiated a week prior to contact with allergens. This concept is very important for the patient to understand as a preventive measure. Patients using the product for the first time should be told that Nasalcrom may take up to two weeks to become fully effective. Because initially they may still experience attacks, an explanation by the pharmacist is important at this point. The use of other allergy medications may be necessary to relieve symptoms until the benefit of the medication becomes apparent. This product should not be used in children younger than 6 years of age or when fever, discolored nasal discharge, sinus pain, and/or wheezing are present. Use should be discontinued if symptoms worsen, new symptoms develop, or if symptoms do not improve within two weeks. In each instance, a physician should be consulted, because new, worsening, or persistent symptoms could be signs of a serious illness.

Contact Lens Product Opti-Free Supraclens (Alcon Laboratories, Inc.) Active Ingredient: Purified pancreatin Indication: For daily removal of protein deposits from any soft contact lens that requires care Availability: 1.5 and 3 mL bottles of solution Discussion: Annual sales of contact lens care products in the United States exceed $900 million and are growing faster than any other category of nonprescription products. This growth has been attributed to the introduction of soft lenses, enhanced comfort (i.e. , gas permeable) hard lenses, and lenses for special vision correction needs (e.g. , bifocal lenses, toric lenses for astigmatism). Because of these advances, it has been predicted that the number of contact lens wearers will be equal to those who wear eyeglas e by the year 2000. !9 The majority of contact lens wearers (85 %) use soft lenses. Until recently , appropriate care of soft lenses involved daily cleaning, rin ing, and di infecting and weekly removal of protein depo it u ing enzymatic tablets. Regular removal of protein depo it i critical to avoid discomfort, reduced visual acuity, and shortened len life. Protein removal is also necessary to prevent the development of giant papillary conjunctivitis. 20 However, many wearers have difficulty remembering to use a protein remover at the end of each week. In addition, even those who use removers regularly may experience problems associated with protein deposits between treatments. 21

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Alcon Laboratories has introduced Opti-Free Supraclen . the first liquid daily protein remover for soft contact lense . Users clean and rinse their lenses daily, as usual. One drop ot protein remover is then placed in each well of the contact len case along with the traditional disinfectant/soaking solution. This system allows simultaneous disinfection and protein removal without weekly treatment with separate vials. A number of studies have demonstrated that this regimen result in cleaner, more comfortable lenses relative to traditional approaches. Study participants also reported that daily protein removal was easier to remember and perform than weekly regimens. 20 •21 Patient Information: This product may be used with any type of contact lens. After rub-and-rinse cleaning, place one drop daily into each well of the lens case containing Opti-Free Expres Multi-Purpose solution, which is used for simultaneous protein removal and disinfection. At minimum, lenses should remain in the solution for four hours, but may be left in overnight without causing lens damage.

Impotence Product Rejoyn Support Sleeve (American MedTech Corporation) Indication: Impotence Composition: Rubber Availability: Single-unit carton containing one penile support sleeve and three covers Discussion: More than 30 million men in the United States experience impotence occasionally. At least half of them are between I 35 and 64 years of age. In at least 20 million of these patients, the problem is chronic. 22 Impotence may be due to physiologic or psychological causes. Of the physiologic causes of impotence, diabetes mellitus is responsible for 40% of cases, and cardiovascular disease for another 30%. Surgery is the cause in 13% of patients, spinal prob· lems in 8%, and miscellaneous endocrinologic problems in anoth· er 6% of cases. Additionally, fatigue, hypercholesterolemia, and use of nicotine and alcohol are causally associated with this prob· lem. Even prolonged intercourse can cause the penis to lose full tumescence. 22 Psychological causes of impotence include job stress, family discord, depression, financial or family worries, or unrelated medical problems. Also, one episode of impotence can create anxiety that the problem will recur. Unfortunately, this can become a self-fulfilling prophecy in which fear of recurrence causes recurrence. Patient Information: Rejoyn is a Class 1 medical device, a flexi· ble sleeve into which the flaccid penis may be inserted before vaginal penetration. The support sleeve should be fitted over the penis and the attached strap fastened comfortably around the scro· tum. Once the patient has determined the comfortable strap 1

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length, the excess may be cut away. A new lubricated cover i placed over the support leeve with each u e. Rejoyn i reu able, after the device ha been thoroughly wa hed and rin ed. If the man does experience an erection while u ing Rejoyn, there i no need to remove the device, a Rejoyn will not interfere with exual activity. The lubricated covers are provided only to increase comfort. They do not prevent pregnancy or sexually transmitted diseases (each cover has a hole at its tip). However, if the couple wishes to do so, they may use a lubricated condom rather than the lubricated cover. If either partner experiences discomfort, or has a preexisting condition such as genital herpes or genital warts, the product should not be used.

First-Aid and Minor Wound Care Product Band-Aid Antibiotic (Johnson & Johnson Consumer Products, Inc.) Indication: First aid for minor cuts, scrapes, and burns Active lngredient(s): The adhesive bandage pad is impregnated with polymyxin B sulfate 10,000 units per gram and bacitracin zinc 500 units per gram in a petrolatum base Availability: Boxes containing 20 bandages Discussion: Minor wounds, such as cuts, scratches, and bums, usually heal without incidefit. However, many patients allow the wound to dry while healing. The dry wound forms a scab, which is the body's attempt to form a protective barrier to the dry environment. Unfortunately, the scab inhibits healing, because epidermal cells must burrow beneath it during the epidermal phase of healing, and a minor wound can take two to three days to heal. On the other hand, healing time is shortened to 18 to 24 hours if the wound is occluded and kept moist. 23 An adhesive bandage accelerates healing by ensuring proper hydration of the skin and preventing evaporation, preventing environmental trauma, and reducing infiltration by opportunistic organisms. Several topical nonprescription ingredients provide disinfection for minor injuries, including antibiotics such as polymyxin B, neomycin, bacitracin, tetracycline, and chlortetracycline. 24 The pad surface of Band-Aid Antibiotic is impregnated with antibiotics. The product provides the dual action of disinfection plus occlusion. An added advantage is that it is neomycin-free. eomycin has been implicated as a patient sensitizer through frequent topical application. Patient Information: Cleanse the skin, then open the bandage as directed and place it over the wound so that the antibioticimpregnated pad contacts the wound itself. A product containing · first-aid antibiotics cannot be used on existing infections, animal bites, sunburn, punctures, or ophthalmic injuries. Obviously, medical care is required if the wound is deep, continues bleeding, or may require stitches. Scrapes with embedded Particles or debris that cannot be flushed away should be seen by

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a phy ician, a hould large wound , or bums that are more serious than a mall reddened area. The patient hould stop using the product if the wound worsens or if a rash or other allergic reaction develops. Band-Aid Antibiotic should not be used longer than one week.

Anti-Migraine Product Excedrin Migraine (Bristol-Myers Squibb) Indication: Migraine headache (new indication) Active Ingredient(s): Acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg Availability: Boxes containing 12 tablets; boxes containing 24, 50, or 100 caplets or tablets; boxes containing 20 or 40 geltabs Discussion: The patient's self-description of migraine may assist the pharmacist in its recognition. The patient may experience an aura that heralds the onset of migraine, and this may consist of visual changes, sensory impressions, and motor symptoms. An example of a visual aura might be weird geometric shapes that seem to dance across the field of vision in an endless line. Other aura symptoms include difficulty in speech and unilateral weakness, paresthesia, or numbness. Often the aura symptoms abruptly cease with onset of headache pain. Pain is intermittent, pulsating, and usually on one side of the head only. 25 Intensity is moderate to severe, with a duration of 4 to 72 hours. Pain is often sufficiently severe to inhibit or preclude normal daily activities. Indeed, the patient often seeks the quiet of a darkened room during an attack. During migraine, the patient may experience nausea, vomiting, photophobia, and phonophobia. The approval of Excedrin Migraine marks the first such FDAapproved label for any specific headache subtype. Ordinary, "regular" strength OTC combination analgesic products do not have this indication. Patient Information: If the current headache is the first or worst one ever experienced, or if the features, symptoms, or severity change, a physician must be consulted. 26 Adult patients may take two tablets with water every 6 hours while symptoms persist, up to a maximum of 8 tablets in any consecutive 24-hour period. Children under the age of 12 years should not use the product without physician consultation. Excedrin Migraine should not be used longer than 48 hours for migraine. Patients with an allergy to aspirin, who have asthma, or stomach problems should not take the product. A history of ulcers or gastrointestinal bleeding problems contraindicates use as well. It should not be used during pregnancy or nursing; use of aspirin during the fmal three months of pregnancy can cause severe problems during childbirth.

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In-Home Testing and Monitoring Products

OVU-TEC Fertility Detector (Gennex Healthcare Technologies)

Indication: To monitor and identify the fertile period within a Home Access (Home Access Health Corporation) Home Access Express (Home Access Health Corporation) Indication: Home testing for HIV -1 Availability: Packages containing one single-use specimen collection kit Discussion: AIDS continues to constitute a national emergency, with more than one million Americans currently infected with HIV-1, and the numbers of cases rising each year. No vaccine or cure exists; thus, avoidance remains the most effective intervention. 27 The cornerstones of prevention are voluntary refusal to engage in high-risk transmission behaviors by those who are infected and testing to detect the disease. Nevertheless, only 20% of those at high risk for HIV infection (e.g., intravenous drug users, male homosexuals, prostitutes) would agree to be tested for AIDS in on~ survey. However, more than twice that number stated that they would use a home test if one were available. 28 The first approved test, Confide, was discontinued because of poor sales. However, a second test was recently approved by FDA and is being marketed in two forms. The Home Access includes a cardboard U.S. mail envelope in which to send the sample. The patient can call for test results in even business days. Home Access Express includes a Federal Expre overnight envelope to transmit the sample, allowing the patient to call for results after only three business days. Patient Information: The patient must follow an extensive set of written directions exactly. Each kit includes a confidential 11digit code, which the purchaser must register by calling a toll-free numb r. The patient cleanses a puncture site on the soft pad of a fing rtip with alcohol before taking the sample. The patient hould re t hi or her hand on a table while piercing the skin using th lancet included in the kit to obtain a drop of whole blood. A circle on the blood specimen collection card must be compi t ly filled with a blood sample to ensure a readable test. The patient hould examine the back of the card to ensure that blood ha oaked through, allow the card to air-dry for 30 minutes, then place it in the pecimen return pouch. It is then sealed in the mailer provided. Patient with hemophilia or bleeding disorders must not use the kit. Lancets hould be used only by the person being tested, and blood from the patient or on the specimen collection card should not contact other individuals. If the blood specimen is not received within 10 days of sampling, the test may not be carried out due to perishability of the sample. Use of the kit in patients younger than 18 years has not been investigated.

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woman's menstrual cycle

Availability: Packages containing one reusable glass slide, a lipstick-sized, illuminated microscope with SOx lens in a durable plastic case, replaceable batteries Discussion: Traditional methods for identifying the time of ovulation in a woman's menstrual cycle include basal thermometry and urine tests for luteinizing hormone (LH). Each has its advantages and disadvantages. Basal thermometry is advantageous in that this method is relatively inexpensive and easy to use. The woman only has to take her temperature every morning with a basal thermometer, which can be reused as often as necessary. However, some women find it inconvenient to measure temperature early in the morning, others have difficulty reading mercury thermometers well enough to detect small changes in temperature, and some women have difficulty recording and interpreting test results. Finally, because an egg is only viable for 24 hours, and because a sharp rise in basal body temperature indicates that ovulation has already occurred, it is particularly important to have intercourse as soon as possible after this temperature change has been detected. In contrast, urine LH tests permit a more precise determination of the time of ovulation. However, these tests are expensive and can only be used once. Furthermore, these tests usually require the collection of urine samples and a series of complex procedural steps. As a result, these products can be messy and difficult to use. Test results, which involve distinguishing among subtle changes in color intensity, can also be difficult to interpret. OVU-TEC is a new device for monitoring female fertility that takes advantage of a phenomenon known as saliva ferning. Specifically, the hormonal changes that occur before, during, and after ovulation have a direct effect on dried saliva patterns. Samples of dried saliva during different stages of the cycle may be easily observed under a microscope. During fertile periods, sample patterns resemble fern leaves or straight lines with railroad track-like cross-hatches. During nonfertile periods, only dotted or bubble-like stn1ctures can be seen. Fern structures appear in samples approximately 3 to 4 days before ovulation and persist until two to three days after ovulation. OVU-TEC is a lipstick-sized, illuminated microscope that enables women to monitor these changes on dried saliva patterns for the purpose of determining the fertile days in a menstrual cycle. It comes with a reusable specimen collection slide and replaceable batteries. Its cost is slightly higher than that of urine LH tests. 29 Patient Information: Women should be advised to read all package instructions before using this device. A saliva sample should be placed on the sample slide and allowed to dry for five to seven minutes. Then the user should place the slide into the device and compare the observed saliva pattern with the pictures in the product labeling. When ferning is present, a woman is most likely in

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to the three major offender , poi on ivy, poi on oak, and poi on umac. Some adult , uch a fore try workers, camp caretaker , and utility line worker , may be virtually incapacitated by evere reactions. If a plant i damaged, it exude a resinous substance containing uru hiol, the primary allergen found in the PDT-90 Personal Drug Testing Service plants. 33 Patients develop erythema, inflammation, and vesicle , and inten e pruritus leading to repeti(Psychemedics Corporation) Indication: Testing a child for drug abuse tive scratching. The scratching provides limited but Availability: Single-unit package containing one test transient relief, which lead to repeated scratching, Discussion: At least 13 million Americans use illegal drugs. 30 ultimately excoriating the skin. Ten million use marijuana and 1.6 million use cocaine. Drug Patients may use nonprescription products to abusers have higher accident rates at work and higher absentee treat poison ivy dermatitis once it has occurred, but rates. In a Canadian study, 8.5% of workplace fatalities involved these are often of little use. Prescription approaches people who were using marijuana at the time. 30 include tapering-dose corticosteroids, which often Adolescent drug abuse is a major unsuspected diagnosis in pedi- allow recrudescence as the corticosteroid blood levatricsY Often, drug abuse in the adolescent is never diagnosed, els fall before the two- to three-week course of the disease abates. only partially diagnosed, or diagnosed too late for proper intervenUntil now, the only preventive steps were avoidance of the tions to affect the course of the addiction. There are several rea- plants or washing the exposed area with soap and water within 10 sons why drug abuse is undetected in so many adolescents. Parents minutes. Both strategies are impractical or impossible when one have a low index of suspicion, miss the early stages, or rely on out- is, for example, hiking in dense woods. However, an organoclay dated tests such as examination for needle tracks or septal erosion chemical known as bentoquatam was found to prevent the skin due to cocaine. Most teenagers exhibit none of these signs, making reaction completely or limit its extent in controlled studies. 32 It is the first poison ivy blocker proven safe and effective. 34 detection difficult. It is vital to detect drug abuse early.

her fertile period and capable of becoming pregnant. Women who do not become pregnant after having intercour e during the indicated period should be advi ed to con ult a phy ician for further evaluation.

r

l

PDT-90 allows the concerned parent to confidentially obtain a reliable hair analysis to determine marijuana, cocaine, crack cocaine, opiates, methamphetamine, and/or PCP use. Urine tests only provide drug abuse information over the past three days, whereas hair analysis detects abuse over the past three months. Patient Information: Ideally, the parent should obtain the cooperation of the child when using this product, for reasons of trust and communication. Surreptitiously obtaining a sample from a 1 \ hairbrush involves the possibility of choosing the hair of a friend to whom the brush was loaned. The parent should lift a full sample of nonbraided hair from the crown. A 0.5-inch lock of hair that is one strand deep should be cut from the area just next to the 1 scalp. The sample is placed in a foil wrap enclosed in the hair sample collection package. The hair is mailed in the mailer pro, vided. After five business days, the parent may call and provide I the confidential number to discover the results of the test.

Poison Ivy, Poison Oak, and Poison Sumac Product I lvyBiock Suspension (EnviroDerm Pharmaceuticals, Inc.) Indication: Prevention of poison ivy dermatitis Active Ingredient: Bentoquatam (quaternium-18 bentonite) 5% Availability: 4-ounce bottles of suspension D~cussion: Poison ivy dermatitis has been referred to as the "only true dermatological emergency." Allergic contact dermatitis to Plants of the Toxicodendron genus affects many millions of Americans each year.32 At least 50 to 70% of adults suffer from allergy

Yo!. 38, No. 2 March/April 1998

Patient Information: The bottle should be shaken well before each use. IvyBlock should be applied at least 15 minutes prior to possible plant contact. Sufficient product should be applied to leave a smooth wet film on the skin; a visible coating appears over the area of application. The product should be applied every four hours, or more often if the coating is no longer visible. IvyBlock may be removed with soap and water. The product should not be used on patients under the age of 6 years or on patients with an allergy to the ingredients (inactive ingredients include diisopropyl adipate, bentonite, benzyl alcohol, and methylparaben). Again, it is used for prevention, and not for the treatment of poison ivy and/or associated dermatitis conditions. Therefore, patients with existing dermatitis to poison ivy, oak, or sumac should not use IvyBlock. Because of its alcohol content, the patient should stay away from frre or flame during application and until the product has dried on the skin.

Sunscreen and Suntan Product Coppertone Bug and Sun Lotion (Schering-Plough HealthCare Products) Active Ingredient: 10% N, N-diethyl-m-toluamide, ethylhexyl p-methoxycinnamate, ox ybenzone, 2ethylhexyl salicylate, homosalate Indication: To protect the skin from overexposure to the sun and to repel insects Availability: SPF 30 formula for children and SPF 15 formula for adults in 120 mL bottles Discussion: Individuals who take part in outdoor

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recreational or occupational activities are at risk for sunburn and insect bites or stings. In many acute instances, these problems result only in temporary, minor discomfort. However, the longterm health consequences of sunburn (e.g., skin cancer) and the diseases that can be transmitted by insect bites (e.g., Lyme disease) can be quite serious. Until recently; consumers who desired protection from sunburn and insect bites had to apply separate sunscreen and insect repellent products. Coppertone Bug and Sun offers the combined protection of a sunscreen with 10% N, N-diethyl-m-toluamide (DEET), the most common active ingredient in insect repellents. Available in SPF 30 and SPF 15 formulations, this product is waterproof, hypoallergenic, and PABA-free. Acceptance of Coppertone Bug and Sun may be higher than single-entity formulations because consumers need only apply one product instead of two. Patient Information: The product should be shaken well before use. Before exposure to sun or insects, a sufficient amount should be evenly applied to cover the exposed area of skin. It should not be applied underneath clothing because percutaneous absorption could predispose the patient to possible toxicity of the central nervous system. Frequent reapplication and saturation is unnecessary for effectiveness, and the patient should be warned to avoid overuse. However, the product should be reapplied after swimming or excessive sweating. The lotion should not be applied near the eyes or lips or to the hands of small children. The palms should be wiped clean after application. The product should not be applied over cuts, wounds, or irritated skin. Patients should consult a physician before using the product on children younger than 6 months. In all patients, if rash or irritation develops, the product should be discontinued and a physician consulted. Patients should be warned to avoid product contact with plastic and fabrics such as acetate, rayon, and Dynel. The product may damage some plastics (e.g., eyeglass/sunglass frames), furniture fi ni he , painted surfaces, and linoleum. It will not damage nylon, otton, wool, or polyester.

ment of vaginal yeast infections because these agents achieve mycologic and clinical cures with minimal systemic side effects. A number of these antifungal agents have become available on a nonprescription basis in recent years. However, depending on the product, these require nightly application for three or seven days. With three- or seven-dose products, many women prematurely stop treatment when their symptoms subside. Failure to complete the full course of therapy may result in persistence of the infection and recurrence of symptoms. 36 Vagistat-1 was recently approved as the first and only 1-dose medication for the self-treatment ·of vaginal yeast infections. The safety and efficacy of tioconazole are well-established and comparable to miconazole, the active ingredient in three- and sevendose nonprescription treatments. 37 This product is advantageous because of the convenience of the one-dose regimen. As a resul~ compliance is not an issue. Patient Information: The prefilled applicator of ointment should be inserted into the vagina, preferably at bedtime. A feminine napkin may be worn overnight to protect the underclothing/nightclothes and bed linens from staining. Women should be advised to avoid sexual intercourse for three days following treatment. Most patients will experience symptomatic relief within a day. However, complete resolution of symptoms may take up to seven days. The most common side effects of V agistat-1 are itching and burning. If symptoms persist beyond seven days or burning and itching become severe, women should be advised to contact a physician. The patient should be advised against using a portion of Vagistat-1 to treat associated external vaginal itching. Using some of the product for this purpose may result in an insufficient dose administered intravaginally. In this instance, a woman should be advised to use a three-day dual pack of another vaginal product. As with most vaginal antifungal ointments, the base in V agistat-1 may weaken rubber or latex products such as condoms or vaginal contraceptive diaphragms. Thus, women should avoid using such products for three days following treatment. The use of douches, feminine hygiene sprays, tampons, and vaginal spermicides should also be avoided during treatment.

Vaginal and Menstrual Product Vagistat-1

Conclusion

(Bri tol-Myer Squibb Co.) Active Ingredient: Tioconazole 6.5% Indication: For the treatment of vaginal yeast infections in women who have been previously diagnosed with such an infection and have the same symptoms again Availability: Boxes containing one applicator prefilled with 4.6 grams of ointment Discussion: Approximately 75 % of all l-O
The trend toward more and more new self-care products presents a significant challenge to the practicing pharmacist to remain current and capable of helping consumers with product selection. Coupled with the increasing burden of ensuring that the correct prescription product gets to the right patient, counseling patients on self care may be a distinct challenge. However, the pharmacist must rise to this chal· lenge whenever possible, not only to meet his or her obligations to the patient, but also to demonstrate the value of pharmacist advice and counsel to the consuming public. The profession cannot abrogate the important responsibility of ensuring that these nonprescription prod· ucts, devices, and diagnostic products are used safely and effectively.

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References 1. Nordenberg T. Now available without a prescription. FDA Consumer. 1996;30:6-11. 2. OTC drugs saved consumers $20 billion in 1996. NOMA Executive Newsletter. 1997; 10-97: 1. 3. Federal Register. February 27, 1997;62: 9023. · 4. FDA planning four OTC label consumer surveys. NOMA Executive Newsletter. 1997;12-97:1 . 5. NOMA asks FDA to rethink label studies. NOMA Executive Newsletter, 1997;21-97:2. 6. FDA wa nts more info on smaller package exemption. NOMA Executive Newsletter. 1997;26-97:7.

7. Beverstock C, Bhola HS, Newman A. Adult literacy in Indiana. Indiana Educati on Policy Center Bulletin; March 1993;PB-B17:1 . 8. Kirsch IS, Jungeblut A, Jenkins L, et al. Adult literacy in America (Executive Summary). Washington, DC: Education Information Branch, Office of Education Research and Improvement; 1993. U.S. Department of Education publication 065-000-00588-3. 9. Sansgi ry SS, Cady PS, Patil S. Readability of over-the-counter medication labels. JAm Pharm Assoc. 1997;NS37(5):522-8. 10. Nonprescription drugs: value of a pharmacist-controlled class has yet to be demonstrated (Chapter report, Washington, D.C.: U.S. Government Acouting Office; August 24, 1995, GAO/PEMD-95-12). 11. Pray WS. Relief from acute and chronic diarrhea. US Pharmacist. ' 1993;1 8(6):24. 12. Pray WS. Counseling the patient with intestinal gas. US Pharmacist. 1991;1 6(10):16. 13. Brickates EV. Inhaler device to be sold through Wai-Mart. Boston Business Journal. 1997;17(15):201. 14. Ogren RA, Baldwin JL, Simon RA. How patients determine when to I replace their metered-dose inhalers. Ann Allergy Asthma lmmunol. 1995;75(6 pt 1):485-9. ) 15. Smith, DL. Understanding Prescription Drugs, rev. ed. New York, NY: Consumer Health Information Corporation; 1987:35-6. 16. Austen KF. Diseases of immediate type hypersensitivity. In: lsselbacher KJ, Braunwald E, Wilson JD, et al. eds. Harrison's Principles of Internal Medicine. 13th ed. New York: McGraw-Hill; 1994:1630-8. 17. Tietze KJ. Cough, cold and allergy products. In: Handbook of Nonprescription Drugs. 11th ed. Washington, DC: American Pharmaceutical Association; 1996:136-8.

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18. Sutherland DC. Drug treatment for allergic rhinitis: A clinical immunologist's view. Rhinology. 1992;14(suppl): 72-fJ. 19. Engle JP. Contact lens products. In : Handbook of Nonprescription Drugs. 11th ed. Washington, DC: American Pharmaceutical Association; 1996:465. 20. Levy B. Current trends in contact lens care. Ophthalmol Clin North Am. 1993;6:531- 41 . 21. White E. Alcon's Opti-Free SupraCiens Daily Protein Remover. Optometry Today. 1996; November/December: 55. 22. Kligman EW. Office evaluation of sexual function and compliants. Clin Geriatr Med. 1991;7:15-39. 23. Moy LS. Management of acute wounds. Derm Clin. 1993;11:759. 24. Farley D. Help for cuts, scrapes and burns . FDA Consumer. 1996;30(4):13. 25. Skaer TL. Clinical presentation of migraine. Clin Ther. 1996;18:229. 26. Rubino FA. Initial evaluation of headache. J FlaMed Assoc. 1997;84:20. 27. Frank AP, Wandell MG, Headings MD, et al. Anonymous HIV testing using home collection and telemedicine counseling. Arch Intern Med. 1997;157:309. 28. Kubic M. New ways to prevent and treat AIDS. FDA Consumer. 1992;31(1 ):6. 29. Drug Topics Redbook. Montvale, NJ: Medical Economics Company, Inc.; 1997:583. 30. Floren AE. Urine drug testing and the family physician. Am Fam Physician. 1994;49: 1441. 31. Macdonald Dl. Diagnosis and treatment of adolescent substance abuse. Curr Prob Pediatr. 1989;19:395. 32. Marks JG Jr, Fowler JF, Scheretz EF, et al. Prevention of poison ivy and poison oak allergic contact dermatitis by quaternium-18 bentonite. J Am Acad Dermatol. 1995;33(2 Pt 1):212. 33. Stehlin lB. Outsmarting poison ivy and its cousins. FDA Consumer. 1996;30(7):25. 34. First drug to protect against poison ivy. FDA Consumer. 1996;30(9):2. 35. Shimp LA, Fleming CM. Vaginal and menstrual products. In: Handbook of Nonprescription Drugs. 11th ed. Washington, DC: American Pharmaceutical Association; 1996:92. 36. Faro S. Vaginitis: Diagnosis and management. lnt J Fertil Menopausal Stud. 1996;41 (2): 115-23. 37. "Vagistat-1: First one dose OTC yeast infection treatment now available." New York, NY: Bristol-Myers Squibb Company; May 12, 1997. News release.

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