A Transition Category of Drugs: VVin-VVin-VVin-VVin7 Establishing a third class of drugs could assure the safety of drugs being considered for nonprescription status. by Robert P. Marshall, PharmD
Introduction The 1951 Durham-Humphrey Amendment to the Federal Food, Drug, and Cosmetic Act divided drugs into two classes: prescription and nonprescription.1 Since the 1970s, numerous prescription drugs (e.g., hydrocortisone cream, ibuprofen , fluoride mouthwashes) have been switched to nonprescription status. Industry sources predict that as many as 50 prescription products will be switched within the next three to five years.2 Because the switched products are more potent and effective, and potentially more dangerous than previously marketed nonprescription products , many pharmacists and pharmacy groups have called for the creation of an intermediate drug category. They want something between the restrictive prescription category and the universally available nonprescription category, with products that would be dispensed only by a pharmacist.
Association Activities During the debate preceding passage of the 1951 DurhamHumphrey Amendment, pharmacy organizations disagreed about whether two classes were sufficient to ensure safe and effective use. 3 Some agreed two classes were enough, but others felt that an additional class should be created to include products that would be dispensed only by pharmacists, and still others believed that some medications should be sold only in pharmacies but need not be dispensed only by pharmacists. The debate concerning the need for a third class of drugs has resurfaced on many occasions during the past 40 years. The American Pharmaceutical Association (APhA) House of Delegates,4-6 NARD, and Pharmacists Planning Services, Inc. , AMERICAN PHARMACY
of Sausalito, Calif., have repeatedly called for establishment of a third, transitional class of drugs (see timeline). State pharmacy associations have also been interested in the "transition" category. Since 1972, the California Pharmacists Association (CPhA) has passed four policies favoring the creation of an additional category of drugs. Current policy states that CPhA supports creating a category of drugs to be dispensed by pharmacists, including prescription drugs the Food and Drug Administration (FDA) is considering switching to nonprescription status. In 1992, CPhA sponsored a legislative resolution, introduced by State Assemblyman Bruce Bronzan, that would encourage the U.S. Congress to "authorize the FDA to establish a new transition drug category available through a licensed pharmacist. " The resolution was passed by the California Legislature and forwarded to the Congress, preSident, and FDA. In 1983, Florida adopted legislation sponsored by the Florida Pharmacy Association that created a class of prescription drugs that could be prescribed by pharmacists. The number of products in this class was substantially increased in 1990. Other states, including Rhode Island, Oregon, and Iowa, are also considering legislative or regulatory action on a transition class of drugs. Consumer groups-including the National Consumers League, the Consumer Federation of America, the Consumers Union, the Public Citizens Health Research Group, and the National Council of Senior Citizens-have voiced support for the transition concept as well. They see the transition class as a means of addressing rnisuse of switched drugs by the selfmedicating public. In September 1991, the National Consumers League, a key supporter of the transition category, sponsored the symposium "Transition Class for Drugs: PreOctobe r 1992/ 828
Vol. NS32, No. 10
scription for Change-Global Perspectives," which included presentations on the use of pharmacist-only drug categories in Great Britain, Australia, the Netherlands, and Canada. In general, presenters agreed that a transition category would ilnprove the u.s. dnlg classification system.7
Lack of Adequate Definition
Various proposals for an additional drug category have referred to a "pharmacists only" category, a "third class of drugs ," a "restrictive class of dnlgs" and, most recently, a "transition category of drugs. " An understanding of the nature of such a category, even among pharmaCists, is Major Events in the Discussion of a as varied as the titles given: Transition Class of Drugs • Some have looked on an Year Event intermediate category as a permanent classification, i.e. , 1951 The Durham - Humphrey Amendment to the Federal Food, Drug, and Cosmetic Act creates two categories of drugs: prescription and dnlgs assigned to this categononprescription . ry would remain there in perpetuity. 1964 APhA House of Delegates advocates establishing a third class of drugs that would not require a prescription order but could only be selected directly by • Others believe that the a pharmacist. new category would be a holding category, whereby 1967 APhA House of Delegates calls for dispensing of "exempt narcotics" (predominantly codeine-containing cough and cold products and exclusive sale of a product antidiarrheal products, now Schedule V controlled substances) exclusively by pharmacists for a few by pharmacists. years without negative con1972 Californ ia Pharmacists Association a dopts policy calling for a pharmacistsumer experience would be only class. considered proof that a dnlg should be released for gener1974 FDA first opposes the creation of an additional (third) category of medications. al nonprescription use. • Many pharmacists believe 1975 The first Rx-to-OTC switch is made, changing the classification of the sleepthat the category should aid, diphenhydramine. include only prescription 1982 NARD passes a resolution calling for a "pharmacist legend" category of drugs ~eing considered for drugs. nonprescription status; oth1983 Florida pharmacists receive legislative authority to prescribe certain ers would also include some medications. drugs currently classified as 1984 APhA House of Delegates calls for a new category of drugs to facilitate an nonprescription. Rx-to-OTC switch by: (a) authorizing FDA to designate such drug products The Nonprescription Dnlg to be dispensed without prescription orders, (b) requiring such drug Manufacturers Association products to be dispensed by pharmacists, (c) requiring that drug products (NDMA) , formerly known as remain in this transitional category until FDA determines, within a specified time period that the drug product can be moved into nonprescription status, the Proprietary Association, and (d) requiring that during this time studies be conducted to assess the has led the opposition to creappropriateness of such drug products for nonprescription use. ating an additional class of 1987 APhA House reaffirms the 1984 policy, using the term "transition class." medications. NDMA states it "opposes a third class of 1990 Florida expands the· number of prescription drugs that could be prescribed dnlgs as anticompetitive and by pharmacists; products included are lindane, antihistamine/decongestant products, terfenadine, scopolamine patches, and fluoride products. anti-consumer. " 1 Much of NDMA 's opposition stems 1992 California Pharmacists Association introduces a legislative resolution calling from a concern that a transifor Congress and FDA to investigate a transitional category of drugs. California Legislature passes the resolution and forwards to Congress, tion category would restrict president, and FDA. the sales of nonprescription products and reduce mem1992 Rhode Island legislature considers legislation that would require switched products to be sold by pharmacists for the first two years after the switch. ber companies ' profits. NDMA publications point 1992 FDA responds to Pharmacists Planning Services, Inc., and other citizens out that the present distribupetitions that an " intermediate " class of drugs is not "necessary. " tion system includes more General Accounting Office conducts study of need for a transition class of 1992 than one million retail outdrugs. lets; a policy that requires a
Vol. NS32, No. 10 October 1992/ 8 29
AMERICAN PHARMACY
product to be sold only by a pharmacist would limit its availability to 65,000 u.s. pharmacies. FDA also has consistently opposed an additional category of medications. Administration officials have stated that the current prescription/nonprescription system provides consumers with good access to needed medications while assuring an acceptable level of consumer safety. Both NDMA and FDA have generally opposed a permanent, pharmacist-only third class of dnlgs, rather than the newer concept of a transition category. The Pharmaceutical Manufacturers Association (PMA) has taken no official position on the issue, but representatives of many PMA member companies have been skeptical that an additional drug category would be useful. No productive dialogue has occurred or been seriously attempted between organized pharmacy and the prescription and nonprescription dnlg industry on the proposed transition category. This lack of communication can be blamed, at least in part, on the fact that pharmacy organizations have not fully defmed what they believe the transition category should be, and have consequently not enlisted the support of the nation's pharmacists.
Four 'Wins' In the evaluation of this or any other transition model, four "wins" must be present for the concept to be effective: 1. Consumers must be able to obtain an increased number of products for safe self-medication. 2. Pharmaceutical manufacturers must be assured that the sale of their products will not be needlessly restricted. 3. The process of nonprescription product approval by FDA must be shortened, not lengthened. 4. Pharmacists must increase use of their expertise in properly managing drug therapy. /
A Transition Class of Drugs Model FDA and many pharmaceutical companies are aggressively working to transfer up to 50 prescription drugs to nonprescription status within the next few years. Some of these drugs have already entered clinical trials for use in acute, selflimiting diseases; others have not. The process for switching a drug from prescription to nonprescription status i~ regulated by the Office of OTC Drug Evaluation, which was , created within FDA in 1991. If the transition category were to be establish~d as an extension of the clinical research process, pharmaceutical manufacturers could work with FDA and pharmacists practicing in ambulatory settings to conduct clinical trials while dispensing proposed switch products to the self-medicating public. Principles of this transition research would include the following: • Compounds in this category would be provisionally approved by FDA for dispensing by pharmacists and would AMERICAN PHARMACY
be subjected to additional clinical research by sponsoring pharmaceutical companies and practicing pharmacists. • Research trials would be coordinated by the manufacturers and performed by practicing pharmacists who would be reimbursed by the manufacturers. Research data could be collected using systems that capture electronic data; these systems are already in place in most pharmacies. Initial data collected would include patient demographic information, symptoms, other medical conditions, and history of other treatment. Participating pharmacists would conduct followup interviews to determine efficacy of the transition product, untoward effects, and possible interactions with other medical conditions, drugs, or food. • Pharmaceutical companies would be permitted to advertise transition products in a manner similar to current advertising of nonprescription drugs , except that consumers would be informed that transition products are available exclusively from their pharmacist. • In the absence of significant adverse experience with a transition product, the product would be transferred to full nonprescription status within a defmed period of time, e.g. , two to three years. If FDA and the sponsoring pharmaceutical manufacturer determine that the product is not safe enough for nonprescription use, it could be returned to prescription status. If more experience with the drug is deemed necessary to determine safety, the product could remain in the transition category for another specified period of time. It is not anticipated that products would remain in the transition category indefmitely. • The process would be designed to shorten the overall evaluation period for a product to switch from prescription to nonprescription status. • Virtually all candidates for the transition class would be prescription drugs targeted for nonprescription status. In rare instances, FDA could decide to study a current nonprescription drug within the transition status, if general consumer experience raised questions about effective or safe use and more controlled experience was desired. Creation of the transition category as part of the research process could conceivably create a "win" for all affected parties. Consumers could be assured of medications switched expediently, but safely, from prescription to nonprescription status. FDA could receive assistance from well-qualified health professionals in evaluating potential nonprescription drugs. Pharmaceutical manufacturers could enjoy enhanced product sales by virtue of products reaching the general nonprescription market more quickly. Pharmacists could enjoy increased professional fulfillment, and could potentially earn enhanced reimbursement by participating in the research process.
Pitfalls There are, of course, potential pitfalls in the research concept for a transition class of drugs. For example, how would Octo b er 1992/8 30
Vol. NS32, No. 10
FDA and sponsoring pharmaceutical companies assure that practicing pharmacists will participate in research projects? How would FDA assure the reliability of data collected by pharmacists? How would pharmacists be paid for conducting research on use of drugs in the transition category? What measures of safety and efficacy; would be used? How would consumers and other health professionals react to the new category? Although these potential problems may prove troublesome, the concept of a transition category deserves a full investigation by pharmacists and their organizations, the drug industry, the FDA, and the U.S. Congress. Pharmacists who participate in such functions as patient education, pharmacokinetic monitoring, dnlg use review, and drug product selection are already demonstrating the capability of providing high-quality, cost-effective health services. Many pharmacists would willingly embrace the opportunity to help speed the provision of effective nonprescription products to the American public.
Robert P. Marshall, PharmD, is executive vice president, California Pharmacists Association.
Actions Needed by Pharmacy
References
To fully investigate the potential of a transition category of drugs, the following actions should be taken: • Major pharmacy organizations, including APhA, NARD, the National Association of Chain Drug Stores, the American Society of Hospital Pharmacists, and the National COlmcil of State Pharmaceutical Association Executives, should form a task force to accept the responsibility of preparing a white paper fully defIning organized pharmacy's concept of a transition class of drugs. • Leaders of the organizations should meet to develop specific strategies for implementation of the profeSSion's goal. • Designated pharmacy leaders should meet extensively with representatives of the prescription and nonprescription dnlg industry, FDA, Congress, and consumer groups to fully explore the potential for a transition class, and wherever possible, develop coalitions to assist in enacting all necessary legislation and regulations. • Pharmacists should be encouraged and equipped to docunlent current patient counseling activities with nonprescription drugs , and to expand the services provided to consumers of nonprescription products. These activities could conceivably be coordinated by a body appointed or designated by the Joint Comnlission of Pharmacy Practitioners OCPP) , an organization comprised of representatives from all major national pharmacy associations. However, if all JCPp member organizations do not fully support the implementation of a transition class, those organizations that are supportive should proceed with the initiative on their own.
Vol. NS32, No. 10 October 1992/ 831
Conclusion Health care delivery is changing dratnatically. Affordability of and access to health care are being debated by federal, state, and local governments, by consumer groups, by health profeSSionals, and by nearly everyone else in American society. New ideas for improving the effIciency of providing health care are being considered altnost daily. If the nation's pharmacists are gong to help improve and accelerate the selfcare movement, professional phamlacy issues like the transition category of drugs should be explored fully, rather than discarded summarily by those more interested in retaining the status quo. Incorporation of the transition class will come at a high price: the total commitnlent of all American pharmacists to its creation and adoption into the health care system.
1. Fink JL, Marquardt KW, Simonsmeier LM. Drug control law. In: Pharmacy Law Digest. St. Louis: J.B. Lippincott Company, 1987;DC-11 . 2. Issues and Perspectives 1992. Washington, DC: Nonprescription Drug Manufacturers Association; 1992. 3. Sonnedecker G. National organiza~ons. Kremers and Urdang's History of Pharmacy. 4th ed. Madison, Wis: American Institute of the History of Pharmacy, 1986;207. 4. Committee Reports. APhA's reclassification proposal. J Am Pharm Assoc. 1967;NS7:308. 5.1984 A PhA Po licy Actions. Prescription to nonprescription switch. Am Pharm.1984;NS24:452. 6. Martin S. Is a third class of drugs in pharmacy's future? Am Pharm. 1991;NS31 :284-8. 7. The benefits of a pharmacist legend category. NARD J. 1991;113(10):18.
T
APhA Publications
T
The Handbook of Nonprescription Drugs is your most complete reference on OTe drug products. Call 1-800-237-2742 to order your copy! $98 for APhA members Code TIl
AMERICANPHARMACY
Introduction The 1951 Durham-Humphrey Amendment to the Federal Food, Drug, and Cosmetic Act divided drugs into two classes: prescription and nonprescription.1 Since the 1970s, numerous prescription drugs (e.g., hydrocortisone cream, ibuprofen , fluoride mouthwashes) have been switched to nonprescription status. Industry sources predict that as many as 50 prescription products will be switched within the next three to five years.2 Because the switched products are more potent and effective, and potentially more dangerous than previously marketed nonprescription products , many pharmacists and pharmacy groups have called for the creation of an intermediate drug category. They want something between the restrictive prescription category and the universally available nonprescription category, with products that would be dispensed only by a pharmacist.
Association Activities During the debate preceding passage of the 1951 DurhamHumphrey Amendment, pharmacy organizations disagreed about whether two classes were sufficient to ensure safe and effective use. 3 Some agreed two classes were enough, but others felt that an additional class should be created to include products that would be dispensed only by pharmacists, and still others believed that some medications should be sold only in pharmacies but need not be dispensed only by pharmacists. The debate concerning the need for a third class of drugs has resurfaced on many occasions during the past 40 years. The American Pharmaceutical Association (APhA) House of Delegates,4-6 NARD, and Pharmacists Planning Services, Inc. , AMERICAN PHARMACY
of Sausalito, Calif., have repeatedly called for establishment of a third, transitional class of drugs (see timeline). State pharmacy associations have also been interested in the "transition" category. Since 1972, the California Pharmacists Association (CPhA) has passed four policies favoring the creation of an additional category of drugs. Current policy states that CPhA supports creating a category of drugs to be dispensed by pharmacists, including prescription drugs the Food and Drug Administration (FDA) is considering switching to nonprescription status. In 1992, CPhA sponsored a legislative resolution, introduced by State Assemblyman Bruce Bronzan, that would encourage the U.S. Congress to "authorize the FDA to establish a new transition drug category available through a licensed pharmacist. " The resolution was passed by the California Legislature and forwarded to the Congress, preSident, and FDA. In 1983, Florida adopted legislation sponsored by the Florida Pharmacy Association that created a class of prescription drugs that could be prescribed by pharmacists. The number of products in this class was substantially increased in 1990. Other states, including Rhode Island, Oregon, and Iowa, are also considering legislative or regulatory action on a transition class of drugs. Consumer groups-including the National Consumers League, the Consumer Federation of America, the Consumers Union, the Public Citizens Health Research Group, and the National Council of Senior Citizens-have voiced support for the transition concept as well. They see the transition class as a means of addressing rnisuse of switched drugs by the selfmedicating public. In September 1991, the National Consumers League, a key supporter of the transition category, sponsored the symposium "Transition Class for Drugs: PreOctobe r 1992/ 828
Vol. NS32, No. 10
scription for Change-Global Perspectives," which included presentations on the use of pharmacist-only drug categories in Great Britain, Australia, the Netherlands, and Canada. In general, presenters agreed that a transition category would ilnprove the u.s. dnlg classification system.7
Lack of Adequate Definition
Various proposals for an additional drug category have referred to a "pharmacists only" category, a "third class of drugs ," a "restrictive class of dnlgs" and, most recently, a "transition category of drugs. " An understanding of the nature of such a category, even among pharmaCists, is Major Events in the Discussion of a as varied as the titles given: Transition Class of Drugs • Some have looked on an Year Event intermediate category as a permanent classification, i.e. , 1951 The Durham - Humphrey Amendment to the Federal Food, Drug, and Cosmetic Act creates two categories of drugs: prescription and dnlgs assigned to this categononprescription . ry would remain there in perpetuity. 1964 APhA House of Delegates advocates establishing a third class of drugs that would not require a prescription order but could only be selected directly by • Others believe that the a pharmacist. new category would be a holding category, whereby 1967 APhA House of Delegates calls for dispensing of "exempt narcotics" (predominantly codeine-containing cough and cold products and exclusive sale of a product antidiarrheal products, now Schedule V controlled substances) exclusively by pharmacists for a few by pharmacists. years without negative con1972 Californ ia Pharmacists Association a dopts policy calling for a pharmacistsumer experience would be only class. considered proof that a dnlg should be released for gener1974 FDA first opposes the creation of an additional (third) category of medications. al nonprescription use. • Many pharmacists believe 1975 The first Rx-to-OTC switch is made, changing the classification of the sleepthat the category should aid, diphenhydramine. include only prescription 1982 NARD passes a resolution calling for a "pharmacist legend" category of drugs ~eing considered for drugs. nonprescription status; oth1983 Florida pharmacists receive legislative authority to prescribe certain ers would also include some medications. drugs currently classified as 1984 APhA House of Delegates calls for a new category of drugs to facilitate an nonprescription. Rx-to-OTC switch by: (a) authorizing FDA to designate such drug products The Nonprescription Dnlg to be dispensed without prescription orders, (b) requiring such drug Manufacturers Association products to be dispensed by pharmacists, (c) requiring that drug products (NDMA) , formerly known as remain in this transitional category until FDA determines, within a specified time period that the drug product can be moved into nonprescription status, the Proprietary Association, and (d) requiring that during this time studies be conducted to assess the has led the opposition to creappropriateness of such drug products for nonprescription use. ating an additional class of 1987 APhA House reaffirms the 1984 policy, using the term "transition class." medications. NDMA states it "opposes a third class of 1990 Florida expands the· number of prescription drugs that could be prescribed dnlgs as anticompetitive and by pharmacists; products included are lindane, antihistamine/decongestant products, terfenadine, scopolamine patches, and fluoride products. anti-consumer. " 1 Much of NDMA 's opposition stems 1992 California Pharmacists Association introduces a legislative resolution calling from a concern that a transifor Congress and FDA to investigate a transitional category of drugs. California Legislature passes the resolution and forwards to Congress, tion category would restrict president, and FDA. the sales of nonprescription products and reduce mem1992 Rhode Island legislature considers legislation that would require switched products to be sold by pharmacists for the first two years after the switch. ber companies ' profits. NDMA publications point 1992 FDA responds to Pharmacists Planning Services, Inc., and other citizens out that the present distribupetitions that an " intermediate " class of drugs is not "necessary. " tion system includes more General Accounting Office conducts study of need for a transition class of 1992 than one million retail outdrugs. lets; a policy that requires a
Vol. NS32, No. 10 October 1992/ 8 29
AMERICAN PHARMACY
product to be sold only by a pharmacist would limit its availability to 65,000 u.s. pharmacies. FDA also has consistently opposed an additional category of medications. Administration officials have stated that the current prescription/nonprescription system provides consumers with good access to needed medications while assuring an acceptable level of consumer safety. Both NDMA and FDA have generally opposed a permanent, pharmacist-only third class of dnlgs, rather than the newer concept of a transition category. The Pharmaceutical Manufacturers Association (PMA) has taken no official position on the issue, but representatives of many PMA member companies have been skeptical that an additional drug category would be useful. No productive dialogue has occurred or been seriously attempted between organized pharmacy and the prescription and nonprescription dnlg industry on the proposed transition category. This lack of communication can be blamed, at least in part, on the fact that pharmacy organizations have not fully defmed what they believe the transition category should be, and have consequently not enlisted the support of the nation's pharmacists.
Four 'Wins' In the evaluation of this or any other transition model, four "wins" must be present for the concept to be effective: 1. Consumers must be able to obtain an increased number of products for safe self-medication. 2. Pharmaceutical manufacturers must be assured that the sale of their products will not be needlessly restricted. 3. The process of nonprescription product approval by FDA must be shortened, not lengthened. 4. Pharmacists must increase use of their expertise in properly managing drug therapy. /
A Transition Class of Drugs Model FDA and many pharmaceutical companies are aggressively working to transfer up to 50 prescription drugs to nonprescription status within the next few years. Some of these drugs have already entered clinical trials for use in acute, selflimiting diseases; others have not. The process for switching a drug from prescription to nonprescription status i~ regulated by the Office of OTC Drug Evaluation, which was , created within FDA in 1991. If the transition category were to be establish~d as an extension of the clinical research process, pharmaceutical manufacturers could work with FDA and pharmacists practicing in ambulatory settings to conduct clinical trials while dispensing proposed switch products to the self-medicating public. Principles of this transition research would include the following: • Compounds in this category would be provisionally approved by FDA for dispensing by pharmacists and would AMERICAN PHARMACY
be subjected to additional clinical research by sponsoring pharmaceutical companies and practicing pharmacists. • Research trials would be coordinated by the manufacturers and performed by practicing pharmacists who would be reimbursed by the manufacturers. Research data could be collected using systems that capture electronic data; these systems are already in place in most pharmacies. Initial data collected would include patient demographic information, symptoms, other medical conditions, and history of other treatment. Participating pharmacists would conduct followup interviews to determine efficacy of the transition product, untoward effects, and possible interactions with other medical conditions, drugs, or food. • Pharmaceutical companies would be permitted to advertise transition products in a manner similar to current advertising of nonprescription drugs , except that consumers would be informed that transition products are available exclusively from their pharmacist. • In the absence of significant adverse experience with a transition product, the product would be transferred to full nonprescription status within a defmed period of time, e.g. , two to three years. If FDA and the sponsoring pharmaceutical manufacturer determine that the product is not safe enough for nonprescription use, it could be returned to prescription status. If more experience with the drug is deemed necessary to determine safety, the product could remain in the transition category for another specified period of time. It is not anticipated that products would remain in the transition category indefmitely. • The process would be designed to shorten the overall evaluation period for a product to switch from prescription to nonprescription status. • Virtually all candidates for the transition class would be prescription drugs targeted for nonprescription status. In rare instances, FDA could decide to study a current nonprescription drug within the transition status, if general consumer experience raised questions about effective or safe use and more controlled experience was desired. Creation of the transition category as part of the research process could conceivably create a "win" for all affected parties. Consumers could be assured of medications switched expediently, but safely, from prescription to nonprescription status. FDA could receive assistance from well-qualified health professionals in evaluating potential nonprescription drugs. Pharmaceutical manufacturers could enjoy enhanced product sales by virtue of products reaching the general nonprescription market more quickly. Pharmacists could enjoy increased professional fulfillment, and could potentially earn enhanced reimbursement by participating in the research process.
Pitfalls There are, of course, potential pitfalls in the research concept for a transition class of drugs. For example, how would Octo b er 1992/8 30
Vol. NS32, No. 10
FDA and sponsoring pharmaceutical companies assure that practicing pharmacists will participate in research projects? How would FDA assure the reliability of data collected by pharmacists? How would pharmacists be paid for conducting research on use of drugs in the transition category? What measures of safety and efficacy; would be used? How would consumers and other health professionals react to the new category? Although these potential problems may prove troublesome, the concept of a transition category deserves a full investigation by pharmacists and their organizations, the drug industry, the FDA, and the U.S. Congress. Pharmacists who participate in such functions as patient education, pharmacokinetic monitoring, dnlg use review, and drug product selection are already demonstrating the capability of providing high-quality, cost-effective health services. Many pharmacists would willingly embrace the opportunity to help speed the provision of effective nonprescription products to the American public.
Robert P. Marshall, PharmD, is executive vice president, California Pharmacists Association.
Actions Needed by Pharmacy
References
To fully investigate the potential of a transition category of drugs, the following actions should be taken: • Major pharmacy organizations, including APhA, NARD, the National Association of Chain Drug Stores, the American Society of Hospital Pharmacists, and the National COlmcil of State Pharmaceutical Association Executives, should form a task force to accept the responsibility of preparing a white paper fully defIning organized pharmacy's concept of a transition class of drugs. • Leaders of the organizations should meet to develop specific strategies for implementation of the profeSSion's goal. • Designated pharmacy leaders should meet extensively with representatives of the prescription and nonprescription dnlg industry, FDA, Congress, and consumer groups to fully explore the potential for a transition class, and wherever possible, develop coalitions to assist in enacting all necessary legislation and regulations. • Pharmacists should be encouraged and equipped to docunlent current patient counseling activities with nonprescription drugs , and to expand the services provided to consumers of nonprescription products. These activities could conceivably be coordinated by a body appointed or designated by the Joint Comnlission of Pharmacy Practitioners OCPP) , an organization comprised of representatives from all major national pharmacy associations. However, if all JCPp member organizations do not fully support the implementation of a transition class, those organizations that are supportive should proceed with the initiative on their own.
Vol. NS32, No. 10 October 1992/ 831
Conclusion Health care delivery is changing dratnatically. Affordability of and access to health care are being debated by federal, state, and local governments, by consumer groups, by health profeSSionals, and by nearly everyone else in American society. New ideas for improving the effIciency of providing health care are being considered altnost daily. If the nation's pharmacists are gong to help improve and accelerate the selfcare movement, professional phamlacy issues like the transition category of drugs should be explored fully, rather than discarded summarily by those more interested in retaining the status quo. Incorporation of the transition class will come at a high price: the total commitnlent of all American pharmacists to its creation and adoption into the health care system.
1. Fink JL, Marquardt KW, Simonsmeier LM. Drug control law. In: Pharmacy Law Digest. St. Louis: J.B. Lippincott Company, 1987;DC-11 . 2. Issues and Perspectives 1992. Washington, DC: Nonprescription Drug Manufacturers Association; 1992. 3. Sonnedecker G. National organiza~ons. Kremers and Urdang's History of Pharmacy. 4th ed. Madison, Wis: American Institute of the History of Pharmacy, 1986;207. 4. Committee Reports. APhA's reclassification proposal. J Am Pharm Assoc. 1967;NS7:308. 5.1984 A PhA Po licy Actions. Prescription to nonprescription switch. Am Pharm.1984;NS24:452. 6. Martin S. Is a third class of drugs in pharmacy's future? Am Pharm. 1991;NS31 :284-8. 7. The benefits of a pharmacist legend category. NARD J. 1991;113(10):18.
T
APhA Publications
T
The Handbook of Nonprescription Drugs is your most complete reference on OTe drug products. Call 1-800-237-2742 to order your copy! $98 for APhA members Code TIl
AMERICANPHARMACY
