- Email: [email protected]
Over-the-counter psychotropics
Editorial
Over-The-Counter Psychotropics Ju¨rgen Unu¨tzer, M.D., M.P.H. The past 10 years have seen a tremendous rise in the popularity and use of herbal and synthetic compounds that are touted to have beneficial effects on physical and mental well-being and that are available without prescriptions. Some of the more commonly used preparations include St. John’s Wort, Gingko, Kava, and Valerian [1]. These compounds are not only available in retail drugs stores and pharmacies, but they are sold in large quantities by local retailers and supermarket chains in the United States. The use of such nonprescription remedies has been the source of substantial controversy among medical professionals, and important concerns have been raised about the safety and efficacy of such preparations [2]. A recent government alert points out, for example, that potentially dangerous changes in drug effects can occur when commonly used medications such as cyclosporine, digoxin, or warfarin are taken with hypericum, one of the ingredients of St. John’s Wort. Hypericum can also decrease the blood levels of antiretroviral medications that are used in the treatment of HIV infection, thus making these drugs less effective. In addition to these concerns, there is still debate about what component of the hypericum plant represents the active ingredient and how it is best prepared, and little is known about the potency of various commercially available preparations of the plant [3]. In addition to these safety concerns, there is debate about the efficacy of most “over-the-counter psychotropics.” A recent meta analysis [4] suggests that St. John’s Wort may be an effective treatment for mild to moderate depression, and the revised Practice Guideline for the Treatment of Patients with Major Depressive Disorder from the American UCLA Neuropsychiatric Institute, Los Angeles, California. Address reprint requests to: J. Unu¨tzer, M.D., M.P.H., UCLA, NPI Health Services Research Center, UCLA Wilshire Center, 10920 Wilshire Blvd., Suite 300, Los Angeles, CA 90024-6505.
General Hospital Psychiatry 22, 221–223, 2000 © 2000 Elsevier Science Inc. All rights reserved. 655 Avenue of the Americas, New York, NY 10010
Psychiatric Association [3] lists St. John’s Wort as a “whole plant product with antidepressant medication properties.” A recent survey performed by Consumer Reports [5] indicates substantially less improvement in depression from St. John’s Wort than from prescription antidepressants, and a number of well-designed randomized controlled trials are currently underway to compare the efficacy of St. John’s Wort with that of newer antidepressants. There is, however, little to no information on the efficacy of the hundreds of other commercially available products that are touted as having beneficial psychotropic properties. Despite these concerns, practitioners of allopathic medicine have become increasingly aware of and interested in the use of alternative medicine, and many U.S. medical schools have developed formal courses on complementary and alternative medicine. The American public has embraced the use of “alternative” medications with tremendous enthusiasm. In most cases, patients take such compounds on their own, or they may take them in addition to medications prescribed by conventional health care providers, often without telling their providers [6]. This enthusiastic embrace of “alternative” medications suggests that they are either beneficial for the indications for which they are being sold or that they meet some other need that may not be met by available conventional treatments. A number of studies have attempted to address the question why consumers choose “alternative” products or treatments when conventional medical treatments for common mental disorders are available. In this issue, Drs. Van Rijswijk and colleagues [7] present data from 32 primary care practices in the Netherlands describing users of “Over-TheCounter Psychotropics” (OTC-Ps). The total number of OTC-P users (1.7% of the population studied) seems low compared with recent U.S. estimates. The authors point out that OTC-P users had higher
221 ISSN 0163-8343/00/$–see front matter PII S0163-8343(00)00093-1
J. Unu¨tzer
rates of psychological symptoms and distress but not higher levels of somatic symptoms or problems than nonusers. This finding is consistent with other studies that report higher rates of common mental disorders in patients who use complementary and alternative medicine [8,9,10]. Half of the OTC-P users in their study were known to have mental health problems by their primary care providers, and one-third of the OTC-P users had been prescribed a benzodiazepine. More than half of the OTC-P users took a preparation containing Valeriana Officinalis, an herbal substance with supposed anxiolytic properties, which suggests that patients used products that were recommended for potentially appropriate target symptoms. One of the more interesting findings was the fact that even though mood and anxiety disorders were the most commonly diagnosed psychiatric disorders in this sample, no patients had been prescribed an antidepressant medication. The article by Van Rijswijk and colleagues [7] and the concept of OTC-Ps raises two additional questions. How should psychotropic medications be regulated, and should a prescription from a physician be required to use such drugs? From a historical perspective, there have always been substances that were touted as having beneficial effects on the mind. The 20th century has seen increasing regulation of the pharmaceutical industry by national regulatory agencies such as the U.S. Food and Drug Administration (FDA). In this country, herbal and other alternative remedies are marketed as “dietary supplements,” which means that they are not as stringently regulated as medicines. This is concerning because there is no conclusive evidence about the safety or efficacy for most of the psychotropic preparations that are sold over the counter. In Germany, the government regulatory body similar to the U.S. FDA (Commission E), reviews data on the safety and efficacy of herbal remedies and approves or disapproves specific preparations [1]. A different but related question concerns the need for a prescription for compounds with psychotropic properties. It appears that the boundaries between medications that require a prescription and those that are available over the counter are not carved in stone, but they can shift over relatively short periods of time. The best example may be powerful H-2 receptor antagonists such as cimetidine or ranitidine, which have become available over the counter during the past few years. These medications are highly successful treatments of peptic ulcer disease, a common medical problem.
222
Similar to antidepressant medications, they were available only by prescription until recently. In many organizations, they were subject to special formulary restrictions, mostly because of their high price. A similar conversion of commonly used antidepressants such as the selective serotonin reuptake inhibitors (SSRIs) to “over-the-counter medications” could have far-reaching negative and positive consequences on the public health. At this point, access to effective treatments for depression such as antidepressant medications remains a substantial barrier for many depressed patients. The availability of some antidepressant medications over the counter may reduce some of these barriers, particularly among patients for whom financial barriers and concerns about stigma play an important role. It might also cause some depressed persons who are currently self medicating with overthe-counter products of questionable efficacy to use better-understood antidepressant medications with established safety and efficacy profiles. From a safety perspective, the risk of drug– drug interactions with SSRIs may not be more serious than interactions with an over-the-counter medication such as cimetidine, a powerful inhibitor of liver enzymes responsible for the metabolism of such drugs as warfarin, phenytoin, propranolol, nifedipine, tricyclic antidepressants, and theophylline. On the other hand, however, there are valid concerns about the effectiveness and safety of using these medications without the guidance and close follow-up of a prescribing clinician, and there is the potential for overuse or misuse of these agents. Clearly, many questions remain unanswered about the use, the value, and the risks of OTC-Ps. As clinicians and researchers, we should approach this topic with an open mind. We should try to understand why our patients use such over-thecounter preparations and learn about the effects of these commonly used drugs.
References 1. Davidson JRT, Connor KM: Herbs for the Mind. New York, The Guildord Press, 2000 2. Angell M, Kassirer JP: Alternative medicine: the risks of untested and unregulated remedies. N Engl J Med 339:839–841, 1998 3. American Psychiatric Association Practice Guidelines: Practice Guideline for the treatment of patients with major depressive disorder (revision). J Am Psychiatric Association 157(suppl):32, 2000 4. Linde K, Ramirez G, Mulrow CD, Pauls A, Weidenhammer W, Melchart D: St. John’s wort for depres-
Over-The-Counter Psychotropics sion—an overview and meta-analysis of randomised clinical trials. BMJ 313:253–258, 1996 5. The mainstreaming of alternative medicine. Consumer Reports May: 17–25, 2000 6. Elder NC, Gillcrist A, Minz R: Use of alternative health care by family practice patients. Arch Fam Med 6:181–184, 1997 7. Van Rijswijk E, van de Lisdonk E, Zitman FG: Who uses over-the-counter psychotropics? Characteristics, functioning, and health profile. Gen Hosp Psychiatry, 22:236–241, 2000
8. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR, Delbanco TL: Unconventional medicine in the United States. N Engl J Med 328:246–252, 1993 9. Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, Kessler RC: Trends in alternative medicine use in the United States, 1990–1997. JAMA 280:1569–1575, 1998 10. Davidson JR, Rampes H, Eisen M, Fisher P, Smith RD, Malik M: Psychiatric disorders in primary care patients receiving complementary medical treatments. Comprehensive Psychiatry 39:16–20, 1998
223
Over-The-Counter Psychotropics Ju¨rgen Unu¨tzer, M.D., M.P.H. The past 10 years have seen a tremendous rise in the popularity and use of herbal and synthetic compounds that are touted to have beneficial effects on physical and mental well-being and that are available without prescriptions. Some of the more commonly used preparations include St. John’s Wort, Gingko, Kava, and Valerian [1]. These compounds are not only available in retail drugs stores and pharmacies, but they are sold in large quantities by local retailers and supermarket chains in the United States. The use of such nonprescription remedies has been the source of substantial controversy among medical professionals, and important concerns have been raised about the safety and efficacy of such preparations [2]. A recent government alert points out, for example, that potentially dangerous changes in drug effects can occur when commonly used medications such as cyclosporine, digoxin, or warfarin are taken with hypericum, one of the ingredients of St. John’s Wort. Hypericum can also decrease the blood levels of antiretroviral medications that are used in the treatment of HIV infection, thus making these drugs less effective. In addition to these concerns, there is still debate about what component of the hypericum plant represents the active ingredient and how it is best prepared, and little is known about the potency of various commercially available preparations of the plant [3]. In addition to these safety concerns, there is debate about the efficacy of most “over-the-counter psychotropics.” A recent meta analysis [4] suggests that St. John’s Wort may be an effective treatment for mild to moderate depression, and the revised Practice Guideline for the Treatment of Patients with Major Depressive Disorder from the American UCLA Neuropsychiatric Institute, Los Angeles, California. Address reprint requests to: J. Unu¨tzer, M.D., M.P.H., UCLA, NPI Health Services Research Center, UCLA Wilshire Center, 10920 Wilshire Blvd., Suite 300, Los Angeles, CA 90024-6505.
General Hospital Psychiatry 22, 221–223, 2000 © 2000 Elsevier Science Inc. All rights reserved. 655 Avenue of the Americas, New York, NY 10010
Psychiatric Association [3] lists St. John’s Wort as a “whole plant product with antidepressant medication properties.” A recent survey performed by Consumer Reports [5] indicates substantially less improvement in depression from St. John’s Wort than from prescription antidepressants, and a number of well-designed randomized controlled trials are currently underway to compare the efficacy of St. John’s Wort with that of newer antidepressants. There is, however, little to no information on the efficacy of the hundreds of other commercially available products that are touted as having beneficial psychotropic properties. Despite these concerns, practitioners of allopathic medicine have become increasingly aware of and interested in the use of alternative medicine, and many U.S. medical schools have developed formal courses on complementary and alternative medicine. The American public has embraced the use of “alternative” medications with tremendous enthusiasm. In most cases, patients take such compounds on their own, or they may take them in addition to medications prescribed by conventional health care providers, often without telling their providers [6]. This enthusiastic embrace of “alternative” medications suggests that they are either beneficial for the indications for which they are being sold or that they meet some other need that may not be met by available conventional treatments. A number of studies have attempted to address the question why consumers choose “alternative” products or treatments when conventional medical treatments for common mental disorders are available. In this issue, Drs. Van Rijswijk and colleagues [7] present data from 32 primary care practices in the Netherlands describing users of “Over-TheCounter Psychotropics” (OTC-Ps). The total number of OTC-P users (1.7% of the population studied) seems low compared with recent U.S. estimates. The authors point out that OTC-P users had higher
221 ISSN 0163-8343/00/$–see front matter PII S0163-8343(00)00093-1
J. Unu¨tzer
rates of psychological symptoms and distress but not higher levels of somatic symptoms or problems than nonusers. This finding is consistent with other studies that report higher rates of common mental disorders in patients who use complementary and alternative medicine [8,9,10]. Half of the OTC-P users in their study were known to have mental health problems by their primary care providers, and one-third of the OTC-P users had been prescribed a benzodiazepine. More than half of the OTC-P users took a preparation containing Valeriana Officinalis, an herbal substance with supposed anxiolytic properties, which suggests that patients used products that were recommended for potentially appropriate target symptoms. One of the more interesting findings was the fact that even though mood and anxiety disorders were the most commonly diagnosed psychiatric disorders in this sample, no patients had been prescribed an antidepressant medication. The article by Van Rijswijk and colleagues [7] and the concept of OTC-Ps raises two additional questions. How should psychotropic medications be regulated, and should a prescription from a physician be required to use such drugs? From a historical perspective, there have always been substances that were touted as having beneficial effects on the mind. The 20th century has seen increasing regulation of the pharmaceutical industry by national regulatory agencies such as the U.S. Food and Drug Administration (FDA). In this country, herbal and other alternative remedies are marketed as “dietary supplements,” which means that they are not as stringently regulated as medicines. This is concerning because there is no conclusive evidence about the safety or efficacy for most of the psychotropic preparations that are sold over the counter. In Germany, the government regulatory body similar to the U.S. FDA (Commission E), reviews data on the safety and efficacy of herbal remedies and approves or disapproves specific preparations [1]. A different but related question concerns the need for a prescription for compounds with psychotropic properties. It appears that the boundaries between medications that require a prescription and those that are available over the counter are not carved in stone, but they can shift over relatively short periods of time. The best example may be powerful H-2 receptor antagonists such as cimetidine or ranitidine, which have become available over the counter during the past few years. These medications are highly successful treatments of peptic ulcer disease, a common medical problem.
222
Similar to antidepressant medications, they were available only by prescription until recently. In many organizations, they were subject to special formulary restrictions, mostly because of their high price. A similar conversion of commonly used antidepressants such as the selective serotonin reuptake inhibitors (SSRIs) to “over-the-counter medications” could have far-reaching negative and positive consequences on the public health. At this point, access to effective treatments for depression such as antidepressant medications remains a substantial barrier for many depressed patients. The availability of some antidepressant medications over the counter may reduce some of these barriers, particularly among patients for whom financial barriers and concerns about stigma play an important role. It might also cause some depressed persons who are currently self medicating with overthe-counter products of questionable efficacy to use better-understood antidepressant medications with established safety and efficacy profiles. From a safety perspective, the risk of drug– drug interactions with SSRIs may not be more serious than interactions with an over-the-counter medication such as cimetidine, a powerful inhibitor of liver enzymes responsible for the metabolism of such drugs as warfarin, phenytoin, propranolol, nifedipine, tricyclic antidepressants, and theophylline. On the other hand, however, there are valid concerns about the effectiveness and safety of using these medications without the guidance and close follow-up of a prescribing clinician, and there is the potential for overuse or misuse of these agents. Clearly, many questions remain unanswered about the use, the value, and the risks of OTC-Ps. As clinicians and researchers, we should approach this topic with an open mind. We should try to understand why our patients use such over-thecounter preparations and learn about the effects of these commonly used drugs.
References 1. Davidson JRT, Connor KM: Herbs for the Mind. New York, The Guildord Press, 2000 2. Angell M, Kassirer JP: Alternative medicine: the risks of untested and unregulated remedies. N Engl J Med 339:839–841, 1998 3. American Psychiatric Association Practice Guidelines: Practice Guideline for the treatment of patients with major depressive disorder (revision). J Am Psychiatric Association 157(suppl):32, 2000 4. Linde K, Ramirez G, Mulrow CD, Pauls A, Weidenhammer W, Melchart D: St. John’s wort for depres-
Over-The-Counter Psychotropics sion—an overview and meta-analysis of randomised clinical trials. BMJ 313:253–258, 1996 5. The mainstreaming of alternative medicine. Consumer Reports May: 17–25, 2000 6. Elder NC, Gillcrist A, Minz R: Use of alternative health care by family practice patients. Arch Fam Med 6:181–184, 1997 7. Van Rijswijk E, van de Lisdonk E, Zitman FG: Who uses over-the-counter psychotropics? Characteristics, functioning, and health profile. Gen Hosp Psychiatry, 22:236–241, 2000
8. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR, Delbanco TL: Unconventional medicine in the United States. N Engl J Med 328:246–252, 1993 9. Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, Kessler RC: Trends in alternative medicine use in the United States, 1990–1997. JAMA 280:1569–1575, 1998 10. Davidson JR, Rampes H, Eisen M, Fisher P, Smith RD, Malik M: Psychiatric disorders in primary care patients receiving complementary medical treatments. Comprehensive Psychiatry 39:16–20, 1998
223