325
Vol. 52, No. 6, Special Issue 1992
THERAPEUTIC DRUGS
Dentists, Drugs, and Decisions: Introduction to Part I-Therapeutic Drugs Katherine Kula, MS, DMD, MS, FACD Associate Professor Pediatric Dentistry and Orthodontics University of North Carolina at Chapel Hill School of Dentistry, CB #7450 Chapel Hill, NC 27566-7450
Abstract Numerous dental therapeutic agents ordrugsare available over the counter or with prescription for patient use at home or in a professional office. Knowledge of the processes by which these agents are evaluatedfor safety and efficacy by the FDA and ADA is necessary for dental professionals to make intelligent decisions concerning their use. Several examples of problems with drugkosmetic evaluations are cited. Key Words: dental drugs, FDA, ADA, evaluation, safety, efficacy.
As dental professionals, we are involved in the diagnosis, treatment, and prevention of intraoral and perioral infectionsand disorders. Our time, energy, and resources are committed primarily to two infections, dental canes and periodontitis. However, we also treat traumatic injuries and soft tissue lesions such as herpes, candidiasis, and apthous ulcers, as well as pain from sources such as temporomandibular disorders, dental infections, and surgical procedures. Numerous dental therapeutic agents or drugs are available commercially to prevent, treat, or provide palliative relief for these diseases and disorders. These agents may be either prescription drugs or over-thecounter (OTC) drugs. The prescription drugs can be for professional use or for patient use at home. In addition, other products are used intraorally that are considered cosmetic. There is a wide range of therapeutic agents that a dentist may use: topical, local, and general anesthetics, analgesics, antianxiety agents, antimicrobial agents, astringents, anticholinergics, vasoconstrictors, corticosteroids, hemostatics, and miscellaneous preparations and pharmaceutical aids including calcium hydroxide prep arations, cavity liners, formocreosol, and sweetening agents, among others (1). Preventive agents include dentifrices, mouthwashes, and fluoride compounds. Many of these products have been used effectively for years in dental care. For example, the reported caries reductions J Public Health Dent 1992;52(6)1258
in the children of the United States (2) were partially attributed to the use of fluoride products (3). Other agents are in premarket stages of research and development. These agents include collagen products as well as new-drug delivery systems such as the intraoral fluoride-releasingdevice and tetracycline-filledfibers. The process by which drugs become available to the patient is complex. It depends upon industry to develop, test, and market drugs that are safe and efficacious. The process depends on external evaluation by the federal government to ensure safetyand efficacy.The dentist has the responsibility to know the indications for use, efficacy, side effects, and cost prior to prescribingor recommending therapeutic agents to the patient. Ultimately, patient satisfaction depends on the safety and the efficacy of these products. The result of inappropriate prescription or recommendation of drugs, at best, means that the disease or disorder may subside on its own. At worst, inappropriate prescription or recommendation of drugs means that the disease will become debilitating because of abscess, cellulitis, or extractions or that a life-threatening adverse reaction may occur. Patient satisfactionwith these drugs is critical to the health of both the dental practice and the drug industry. However, thorough evaluation of products by individual dental clinicians is difficult because of the explosion of dental scientific publications and advertisement literature. In addition, the dental professional receives product recommendationsfromotherprofessionals.Access to scientific literature by private practitioners is becoming easier with the use of computers and modems. However, many practitioners do not have the time to read and synthesizenumerous articles.Thus, the dental profession has relied on two major organizations to provide the expertise to evaluate the safety and efficacy of dental therapeutic agents. These organizations are the Food and Drug Administration (FDA) and the American Dental Association (ADA),both of whom work with industry to provide safe and efficaciousdrugs. These organizations periodically provide dental professionals with information concerning various prod-
326
ucts, either through the FDA Medical Bulletin or the A D A Newsletter. Both organizations also provide monographs concerning therapeutic products. However, a source of information some educators have depended on, the annual update of the ADA-approved therapeutic agents that was published in the Journal of the American Dental Association, is no longer available through that source. In contrast, the public generally receives information concerning oral health products from their dentist or hygienist, advertisements, consumer group publications, local newspaper articles, or their friends. The issues of timely and adequate evaluation of safety and efficacy of dental products are important to dental clinicians, manufacturers, and the public because of patient treatment needs and the need for sustained profitability by manufacturers within the United States and internationally. Industries that are not profitable may minimize or discontinue research, development, and marketing of new, improved products that benefit the patient. It became apparent while talking to colleagues in schools and private practice that there is a need for a clearer understanding of these processes and the interaction among industry, the FDA, and the ADA. Knowledge of the processes by which products are evaluated for safety and efficacy should result in better product selection and recommendation by dental professionals. The selection of safeand efficaciousproducts should result in increased patient satisfaction and increased profit for both the dentist and the dental manufacturer. Thus, the purpose of this symposium is to enhance patient treatment by informingdental professionalsof the evaluatory processes for dental therapeutic agents, devices, and materials by the FDA and the ADA and how these processes affect the marketing of these agents. The purpose of the first part of the symposium is to enhance patient treatment by informing the dental clinician and the dental educator of:1) the processes by which the FDA and ADA evaluate the safety and efficacy of dental therapeutic drugs; 2) the effect these processes have on research, development, marketing, and advertising of these products; 3) the ultimate effects these processes have on the availability and cost of dental drugs; 4)the interpretation of the results of drug research; and 5) the legal ramifications of product evaluation, marketing, and usage. Discussion In order to demonstrate the need for the dental professional to understand the processes by which drugs are evaluated, several situations or questions that have occurred over the last few years will be mentioned. We hope these examples will stimulate questions and discussion by the audience. This symposium is a result of these questions. Some products are questioned as to safety or efficacy
Journalof Public Health Dentistry
during their introduction. For example, whitening agents became available to the patient either as professionally applied or as over-the-counteragents. These agents were purported to whiten enamel, thus helping to meet patients’ esthetic needs. However, controversy appeared in the dental literature concerning whether these products were adequately tested for safety and efficacy prior to their marketing. Some of the discussion also centered around whether the products were drugs, thus controlling or improving a physiological condition, or were cosmetics. Recently, the FDA (4)decided that whiteners were drugs and as such were subject to the FDA New Drug Application process. To serve their patients optimally, dentists need to know how the safety and claims of new products are evaluated prior to reaching the market. Periodically, the safety of drugs used for years in dentistry is questioned either by scientists or by the media. For example, the potential mutagenicity of a sedative drug, chloral hydrate, which was used by dentists and physicians for many years for acooperative or uncooperative children undergoing treatment was questioned in a letter to the editor of Science (5). Many pediatric dentists, at least locally, are now reluctant to use this drug, thus adding to the problems of treating these patients in the office. Many of these patients are now referred for treatment under general anesthesia in a hospital setting, thus increasing the cost of care. In addition, the safety of an OTC mouthrinse marketed for many years was questioned recently in the news media (6). The carcinogenic potential of the mouthrinse, which has a high alcohol content (26%),was questioned when the news media received information about an unpublished study on the relationship among cancer, alcohol, and tobacco. Press releases were sent out by the company to prevent potential loss in confidence in the product. Dentists need to understand the process by which therapeutic agentswhich have been used for many years-first came to market and the process by which they are monitored for safety after reaching the market, in order to make intelligent decisions for continuing their use. Practicingdentists may have difficulty staying current with the status and availability of products and their efficacy. Numerous brands of the same or similar prescription products can be available and at distinctly different costs. For example, there are multiple formulations for commercially available fluoride supplements. The listing of the many fluoride supplements (Table 1)shows that not all fluoride supplements are ADA-approved, even though they may be FDA-approved. None of the fluoride-vitamin supplements were ADA-approved prior to the spring of 1991(71, even though many clinical studies documenting efficacy of fluoride supplements used fluoride-vitamin preparations (8). Dentists need to understand the differences between the status of prescription products that are ADA-approved and those
327
Vol. 52, No. 6, SpecialIssue 1992 TABLE 1 ADA Approval Status of CommerciallyAvailable Fluoride Supplements
Type Drops Vitamin drops Tablet Vitamin tablet
Available (n)
Approved (n)
5 26 10 23
5 7 6 7
that are not. The commercial sources of fluoride supplements and 0.4 percent stannous fluoride gels have changed considerably during the last six years (9,lO) as a result of discontinuation of brands and the marketing of new brands. Most of the changes occurred among products produced by small companies. More 0.4 percent stannous fluoride gels are now ADA-approved (12 of 16 marketed products) than a few years ago. The question is whether all these stannous fluoride products show the same stability, shelf life, and efficacy. In 1985the FDA OTC panel (11)recommended that 0.4 percent stannous fluoride gels become over-the-counter agents rather than remain prescription drugs. However, many dentists are uncertain as to the status of these gels as OTC products vs prescription products. The question is: how is/was the information disseminated concerning the final approval of 0.4 percent stannous fluoride as an OTC product? Evaluation of products also includes cost considerations. The wholesale cost of these products varies considerably. At least a fourfold difference in cost is noted between nationally known brands of fluoride supplements and generics (12). Many patients have prescription plans mandating the substitution of the generic for the nationally known product when available. How does a dentist determine whether all generic prescription products have the same safety and efficacy as the nationally known brands? Consider the products available directly to consumers as over-the-counter (OTC) drugs. The decisions patients make in purchasing oral health products can be monumental. The kinds of oral health products available in drug stores and groceries as over-the-counter products can be impressive, depending on the store. These products include at least 56 topical analgesics for toothaches, cold sores, or canker sores; at least 22 denture adhesives; approximately 14 denture cleansing agents; and at least seven saliva substitutes. In addition, there are whitening agents, temporary restorative materials, mouthrinses, toothpastes, scalers, batterydriven prophy angles, floss, toothbrushes, and breath fresheners. Dentists and dental hygienists are familiar with many of these products and maybe able to answer the questions patients askconcern-
ing the choice of products. However, many dental professionals may be unaware of the variety of products available directly to patients and would be unable to make intelligent recommendations based on their safety, efficacy, and cost. Patients may make arbitrary decisions based on packaging, cost, and availability. To emphasize the difficultypatients and dental professionals may have evaluating OTC products, specific groups of products will be discussed in more detail. For example, mouthrinses may claim antiplaque, anticalculus, anticaries, or wound-healing properties, or claim simply to freshen the breath and clean debris. The ninth edition of theHundbookofNonprescriptionDrugs lists 26 mouthrinse/throat spray products (13) available as over-the-counter drugs. However, many commercially availablemouthrinses are not listed. House-brand rinses, for example, were not included. Some of these products appear td be generic, with containers and coloring similar to well-known products. The cost of some nationally known products can be three times greater than that of the house brand. The question is whether these products are equal in efficacy and safety compared to nationally known products. How will dental professionals and the public determine the differences? The December 10, 1990, issue of the ADA News (14) included a report that the ADA accepted two antiseptic mouthrinses with the same chemical formula as a mouthrinse previously accepted by the ADA. According to the article, the patient may not see the name of the manufacturer on the label. "Both manufacturers will market the rinses under dozens of differentbrand names, depending on whom they're packaging it for.'' Thearticle did not mention how the dental professional or the public could identify these products. An article appearing in Consumer's Research (15) informed consumers of the difference in price between a national brand and one of the new generics. The author told consumers that the approved generic had a company name on the bottle, not on the label. The author did not mention the presence of the ADA seal of approval, nor did he comparedifferences between other generics and nationally known products. Differences between the FDA and the ADA approval processes for OTC products also exist and should be understood. For example, several producers of OTC mouthrinses, of which two were ADA-approved, had to submit data to substantiate their antiplaque and antigingivitis claims when the FDA stated that these claims violated FDA OTC regulations (16). The potential effect that this discrepancy may have on both industry and the consumer should be understood and discussed. Toothpastes, another example, may make fluoride, antiplaque, anticalculus, cosmetic, and desensitizing claims or combinationsof claims. The ADA approved 13 of the 37 toothpastes listed in theHundbookafNonprescription Drugs (13).Fifteen toothpastes found in the ADA list
328
did not appear in the Handbook. Some of this difference could be because one product was listed as a toothpaste and the other as a gel. However, more toothpastes are available over the counter than are found in either source. The dental professional needs to know how differences in claims affect the marketing and evaluatory processes. These are only a few of the questions or concerns that have been raised in the past few years. We hope our speakers will clarify these issues and any others that the audience may raise. The audience should know that some proprietary information may be considered confidential and cannot be discussed specificallyby the speakers.
References 1. Coundlon DentalTherapeutics. Accepteddental therapeutics.40th ed. Chicago: American Dental Assodation, 1984. 2. National Institute of Dental Research. Oral health of United States
children: the national survey of dental caries in US schoolchildren: 1986-1987; Bethesda, M D National Institutes Health, 1989; NIH pub no 89-2247. Abernathy JB, 3. Bohannan HM, Graves RC, Disney JA, Stamm JW, Bader JD. Effect of secular decline in caries on the evaluation of preventive dentistry demonstrations. J Public Health Dent 1985;45: 83-9.
Journal of Public Health Dentistry 4. BerryJ.FDAsays whitenersaredrugs.ADANews1991 Oct71,6-7. 5. Smith M. Chloral hydrate warning. Letter to the editor. Science 1990;19359. 6. Jakush J. Council: no reason to back off Listerine. ADA News 1991, May 614. 7. Anonymous. CDT accepts multivitamin with fluoride. ADA News 1991Jun 1724. 8. Driscoll WS. The use of fluoride tablets for the prevention of dental caries. In: Forrester DJ, Schdz EM, eds. International workshop on fluorides and dental caries reductions. Baltimore, MD: School of Dentistry, University of Maryland, 1974:25.96. 9. Chan IT, Wyborny LE, Kula K. Clinical applications of fluorides. In: Hardin JF, ed. Clark’s clinical dentistry. Philadelphia, PA: JB Lippincott, 199&1-25. 10. Kula KS, Wei SH. Fluoride supplements and dietary sources of fluoride. In: Wei SHY, ed.Clinical uses of fluorides. Philadelphia, PA: Lea & Febiger, 1985:57-74. 11. Gilbertson WE. The FDA’s OTC drug review. In: Handbook of nonprescription drugs.Washington, DC American PharmaceuticalAssociation, 19902539. 12. O h BR, ed. Drug facts and comparisons. St. Louis, M O Lippincott, 1990. 13. Baker K. Oral health products. In: Handbook of nonprescription drugs. Washington, DC American Pharmaceutical Association, 1990:653-87. 14. Jakush J. Council accepts two mouthrinses. ADA News 1990 Dec 1&2. 15. Kaye IA. Fresh breath for less. Consumer’s Research 1991;74(2):2930. 16. Jakush J. What’s in a plaque claim? ADA News 1989 Sept 4:9,16.
Vol. 52, No. 6, Special Issue 1992
THERAPEUTIC DRUGS
Dentists, Drugs, and Decisions: Introduction to Part I-Therapeutic Drugs Katherine Kula, MS, DMD, MS, FACD Associate Professor Pediatric Dentistry and Orthodontics University of North Carolina at Chapel Hill School of Dentistry, CB #7450 Chapel Hill, NC 27566-7450
Abstract Numerous dental therapeutic agents ordrugsare available over the counter or with prescription for patient use at home or in a professional office. Knowledge of the processes by which these agents are evaluatedfor safety and efficacy by the FDA and ADA is necessary for dental professionals to make intelligent decisions concerning their use. Several examples of problems with drugkosmetic evaluations are cited. Key Words: dental drugs, FDA, ADA, evaluation, safety, efficacy.
As dental professionals, we are involved in the diagnosis, treatment, and prevention of intraoral and perioral infectionsand disorders. Our time, energy, and resources are committed primarily to two infections, dental canes and periodontitis. However, we also treat traumatic injuries and soft tissue lesions such as herpes, candidiasis, and apthous ulcers, as well as pain from sources such as temporomandibular disorders, dental infections, and surgical procedures. Numerous dental therapeutic agents or drugs are available commercially to prevent, treat, or provide palliative relief for these diseases and disorders. These agents may be either prescription drugs or over-thecounter (OTC) drugs. The prescription drugs can be for professional use or for patient use at home. In addition, other products are used intraorally that are considered cosmetic. There is a wide range of therapeutic agents that a dentist may use: topical, local, and general anesthetics, analgesics, antianxiety agents, antimicrobial agents, astringents, anticholinergics, vasoconstrictors, corticosteroids, hemostatics, and miscellaneous preparations and pharmaceutical aids including calcium hydroxide prep arations, cavity liners, formocreosol, and sweetening agents, among others (1). Preventive agents include dentifrices, mouthwashes, and fluoride compounds. Many of these products have been used effectively for years in dental care. For example, the reported caries reductions J Public Health Dent 1992;52(6)1258
in the children of the United States (2) were partially attributed to the use of fluoride products (3). Other agents are in premarket stages of research and development. These agents include collagen products as well as new-drug delivery systems such as the intraoral fluoride-releasingdevice and tetracycline-filledfibers. The process by which drugs become available to the patient is complex. It depends upon industry to develop, test, and market drugs that are safe and efficacious. The process depends on external evaluation by the federal government to ensure safetyand efficacy.The dentist has the responsibility to know the indications for use, efficacy, side effects, and cost prior to prescribingor recommending therapeutic agents to the patient. Ultimately, patient satisfaction depends on the safety and the efficacy of these products. The result of inappropriate prescription or recommendation of drugs, at best, means that the disease or disorder may subside on its own. At worst, inappropriate prescription or recommendation of drugs means that the disease will become debilitating because of abscess, cellulitis, or extractions or that a life-threatening adverse reaction may occur. Patient satisfactionwith these drugs is critical to the health of both the dental practice and the drug industry. However, thorough evaluation of products by individual dental clinicians is difficult because of the explosion of dental scientific publications and advertisement literature. In addition, the dental professional receives product recommendationsfromotherprofessionals.Access to scientific literature by private practitioners is becoming easier with the use of computers and modems. However, many practitioners do not have the time to read and synthesizenumerous articles.Thus, the dental profession has relied on two major organizations to provide the expertise to evaluate the safety and efficacy of dental therapeutic agents. These organizations are the Food and Drug Administration (FDA) and the American Dental Association (ADA),both of whom work with industry to provide safe and efficaciousdrugs. These organizations periodically provide dental professionals with information concerning various prod-
326
ucts, either through the FDA Medical Bulletin or the A D A Newsletter. Both organizations also provide monographs concerning therapeutic products. However, a source of information some educators have depended on, the annual update of the ADA-approved therapeutic agents that was published in the Journal of the American Dental Association, is no longer available through that source. In contrast, the public generally receives information concerning oral health products from their dentist or hygienist, advertisements, consumer group publications, local newspaper articles, or their friends. The issues of timely and adequate evaluation of safety and efficacy of dental products are important to dental clinicians, manufacturers, and the public because of patient treatment needs and the need for sustained profitability by manufacturers within the United States and internationally. Industries that are not profitable may minimize or discontinue research, development, and marketing of new, improved products that benefit the patient. It became apparent while talking to colleagues in schools and private practice that there is a need for a clearer understanding of these processes and the interaction among industry, the FDA, and the ADA. Knowledge of the processes by which products are evaluated for safety and efficacy should result in better product selection and recommendation by dental professionals. The selection of safeand efficaciousproducts should result in increased patient satisfaction and increased profit for both the dentist and the dental manufacturer. Thus, the purpose of this symposium is to enhance patient treatment by informingdental professionalsof the evaluatory processes for dental therapeutic agents, devices, and materials by the FDA and the ADA and how these processes affect the marketing of these agents. The purpose of the first part of the symposium is to enhance patient treatment by informing the dental clinician and the dental educator of:1) the processes by which the FDA and ADA evaluate the safety and efficacy of dental therapeutic drugs; 2) the effect these processes have on research, development, marketing, and advertising of these products; 3) the ultimate effects these processes have on the availability and cost of dental drugs; 4)the interpretation of the results of drug research; and 5) the legal ramifications of product evaluation, marketing, and usage. Discussion In order to demonstrate the need for the dental professional to understand the processes by which drugs are evaluated, several situations or questions that have occurred over the last few years will be mentioned. We hope these examples will stimulate questions and discussion by the audience. This symposium is a result of these questions. Some products are questioned as to safety or efficacy
Journalof Public Health Dentistry
during their introduction. For example, whitening agents became available to the patient either as professionally applied or as over-the-counteragents. These agents were purported to whiten enamel, thus helping to meet patients’ esthetic needs. However, controversy appeared in the dental literature concerning whether these products were adequately tested for safety and efficacy prior to their marketing. Some of the discussion also centered around whether the products were drugs, thus controlling or improving a physiological condition, or were cosmetics. Recently, the FDA (4)decided that whiteners were drugs and as such were subject to the FDA New Drug Application process. To serve their patients optimally, dentists need to know how the safety and claims of new products are evaluated prior to reaching the market. Periodically, the safety of drugs used for years in dentistry is questioned either by scientists or by the media. For example, the potential mutagenicity of a sedative drug, chloral hydrate, which was used by dentists and physicians for many years for acooperative or uncooperative children undergoing treatment was questioned in a letter to the editor of Science (5). Many pediatric dentists, at least locally, are now reluctant to use this drug, thus adding to the problems of treating these patients in the office. Many of these patients are now referred for treatment under general anesthesia in a hospital setting, thus increasing the cost of care. In addition, the safety of an OTC mouthrinse marketed for many years was questioned recently in the news media (6). The carcinogenic potential of the mouthrinse, which has a high alcohol content (26%),was questioned when the news media received information about an unpublished study on the relationship among cancer, alcohol, and tobacco. Press releases were sent out by the company to prevent potential loss in confidence in the product. Dentists need to understand the process by which therapeutic agentswhich have been used for many years-first came to market and the process by which they are monitored for safety after reaching the market, in order to make intelligent decisions for continuing their use. Practicingdentists may have difficulty staying current with the status and availability of products and their efficacy. Numerous brands of the same or similar prescription products can be available and at distinctly different costs. For example, there are multiple formulations for commercially available fluoride supplements. The listing of the many fluoride supplements (Table 1)shows that not all fluoride supplements are ADA-approved, even though they may be FDA-approved. None of the fluoride-vitamin supplements were ADA-approved prior to the spring of 1991(71, even though many clinical studies documenting efficacy of fluoride supplements used fluoride-vitamin preparations (8). Dentists need to understand the differences between the status of prescription products that are ADA-approved and those
327
Vol. 52, No. 6, SpecialIssue 1992 TABLE 1 ADA Approval Status of CommerciallyAvailable Fluoride Supplements
Type Drops Vitamin drops Tablet Vitamin tablet
Available (n)
Approved (n)
5 26 10 23
5 7 6 7
that are not. The commercial sources of fluoride supplements and 0.4 percent stannous fluoride gels have changed considerably during the last six years (9,lO) as a result of discontinuation of brands and the marketing of new brands. Most of the changes occurred among products produced by small companies. More 0.4 percent stannous fluoride gels are now ADA-approved (12 of 16 marketed products) than a few years ago. The question is whether all these stannous fluoride products show the same stability, shelf life, and efficacy. In 1985the FDA OTC panel (11)recommended that 0.4 percent stannous fluoride gels become over-the-counter agents rather than remain prescription drugs. However, many dentists are uncertain as to the status of these gels as OTC products vs prescription products. The question is: how is/was the information disseminated concerning the final approval of 0.4 percent stannous fluoride as an OTC product? Evaluation of products also includes cost considerations. The wholesale cost of these products varies considerably. At least a fourfold difference in cost is noted between nationally known brands of fluoride supplements and generics (12). Many patients have prescription plans mandating the substitution of the generic for the nationally known product when available. How does a dentist determine whether all generic prescription products have the same safety and efficacy as the nationally known brands? Consider the products available directly to consumers as over-the-counter (OTC) drugs. The decisions patients make in purchasing oral health products can be monumental. The kinds of oral health products available in drug stores and groceries as over-the-counter products can be impressive, depending on the store. These products include at least 56 topical analgesics for toothaches, cold sores, or canker sores; at least 22 denture adhesives; approximately 14 denture cleansing agents; and at least seven saliva substitutes. In addition, there are whitening agents, temporary restorative materials, mouthrinses, toothpastes, scalers, batterydriven prophy angles, floss, toothbrushes, and breath fresheners. Dentists and dental hygienists are familiar with many of these products and maybe able to answer the questions patients askconcern-
ing the choice of products. However, many dental professionals may be unaware of the variety of products available directly to patients and would be unable to make intelligent recommendations based on their safety, efficacy, and cost. Patients may make arbitrary decisions based on packaging, cost, and availability. To emphasize the difficultypatients and dental professionals may have evaluating OTC products, specific groups of products will be discussed in more detail. For example, mouthrinses may claim antiplaque, anticalculus, anticaries, or wound-healing properties, or claim simply to freshen the breath and clean debris. The ninth edition of theHundbookofNonprescriptionDrugs lists 26 mouthrinse/throat spray products (13) available as over-the-counter drugs. However, many commercially availablemouthrinses are not listed. House-brand rinses, for example, were not included. Some of these products appear td be generic, with containers and coloring similar to well-known products. The cost of some nationally known products can be three times greater than that of the house brand. The question is whether these products are equal in efficacy and safety compared to nationally known products. How will dental professionals and the public determine the differences? The December 10, 1990, issue of the ADA News (14) included a report that the ADA accepted two antiseptic mouthrinses with the same chemical formula as a mouthrinse previously accepted by the ADA. According to the article, the patient may not see the name of the manufacturer on the label. "Both manufacturers will market the rinses under dozens of differentbrand names, depending on whom they're packaging it for.'' Thearticle did not mention how the dental professional or the public could identify these products. An article appearing in Consumer's Research (15) informed consumers of the difference in price between a national brand and one of the new generics. The author told consumers that the approved generic had a company name on the bottle, not on the label. The author did not mention the presence of the ADA seal of approval, nor did he comparedifferences between other generics and nationally known products. Differences between the FDA and the ADA approval processes for OTC products also exist and should be understood. For example, several producers of OTC mouthrinses, of which two were ADA-approved, had to submit data to substantiate their antiplaque and antigingivitis claims when the FDA stated that these claims violated FDA OTC regulations (16). The potential effect that this discrepancy may have on both industry and the consumer should be understood and discussed. Toothpastes, another example, may make fluoride, antiplaque, anticalculus, cosmetic, and desensitizing claims or combinationsof claims. The ADA approved 13 of the 37 toothpastes listed in theHundbookafNonprescription Drugs (13).Fifteen toothpastes found in the ADA list
328
did not appear in the Handbook. Some of this difference could be because one product was listed as a toothpaste and the other as a gel. However, more toothpastes are available over the counter than are found in either source. The dental professional needs to know how differences in claims affect the marketing and evaluatory processes. These are only a few of the questions or concerns that have been raised in the past few years. We hope our speakers will clarify these issues and any others that the audience may raise. The audience should know that some proprietary information may be considered confidential and cannot be discussed specificallyby the speakers.
References 1. Coundlon DentalTherapeutics. Accepteddental therapeutics.40th ed. Chicago: American Dental Assodation, 1984. 2. National Institute of Dental Research. Oral health of United States
children: the national survey of dental caries in US schoolchildren: 1986-1987; Bethesda, M D National Institutes Health, 1989; NIH pub no 89-2247. Abernathy JB, 3. Bohannan HM, Graves RC, Disney JA, Stamm JW, Bader JD. Effect of secular decline in caries on the evaluation of preventive dentistry demonstrations. J Public Health Dent 1985;45: 83-9.
Journal of Public Health Dentistry 4. BerryJ.FDAsays whitenersaredrugs.ADANews1991 Oct71,6-7. 5. Smith M. Chloral hydrate warning. Letter to the editor. Science 1990;19359. 6. Jakush J. Council: no reason to back off Listerine. ADA News 1991, May 614. 7. Anonymous. CDT accepts multivitamin with fluoride. ADA News 1991Jun 1724. 8. Driscoll WS. The use of fluoride tablets for the prevention of dental caries. In: Forrester DJ, Schdz EM, eds. International workshop on fluorides and dental caries reductions. Baltimore, MD: School of Dentistry, University of Maryland, 1974:25.96. 9. Chan IT, Wyborny LE, Kula K. Clinical applications of fluorides. In: Hardin JF, ed. Clark’s clinical dentistry. Philadelphia, PA: JB Lippincott, 199&1-25. 10. Kula KS, Wei SH. Fluoride supplements and dietary sources of fluoride. In: Wei SHY, ed.Clinical uses of fluorides. Philadelphia, PA: Lea & Febiger, 1985:57-74. 11. Gilbertson WE. The FDA’s OTC drug review. In: Handbook of nonprescription drugs.Washington, DC American PharmaceuticalAssociation, 19902539. 12. O h BR, ed. Drug facts and comparisons. St. Louis, M O Lippincott, 1990. 13. Baker K. Oral health products. In: Handbook of nonprescription drugs. Washington, DC American Pharmaceutical Association, 1990:653-87. 14. Jakush J. Council accepts two mouthrinses. ADA News 1990 Dec 1&2. 15. Kaye IA. Fresh breath for less. Consumer’s Research 1991;74(2):2930. 16. Jakush J. What’s in a plaque claim? ADA News 1989 Sept 4:9,16.
