- Email: [email protected]
The Challenges Before Us
The Challenges Before Us the public interest. APhA has never lost sight of this essential truth. This afternoon, I want to focus on challenges that we all must face in order to bolster our profession and increase its service in the public interest.
Regaining Professional Prerogatives
Address of Outgoing President Philip Sacks Our time has appropriately been described as "the age of anxiety." The anxieties of the nation's professions were heightened earlier this month when President Carter aimed his political guns at law and medicine. In highly publicized speeches, the President challenged lawyers and physicians to examine and improve their professions. He voiced blunt criticism of our systems of justice and health care and the performance of the professions charging that they have little concern for "the little guy." Many observers believe that President Carter's sweeping attacks struck a responsive chord, which revealed deep public dissatisfaction with the professions in the United States. The President was both right and wrong. There is great concern among those who require or would use professional services as to their accessibility and cost. Nonetheless, the public still holds lawyers and physicians in the highest regard as individual practitioners. How can we account for the apparent gap between "doctors and lawyers are no good-but my doctor or lawyer suits .me fine!"? President Carter lays the blame at the feet of the organizational structures of each profession. Lawyers and doctors may be OK, but organized lawyers and doctors aren't. For all professions, the President's recent salvos underline the necessity for a professional association to safeguard the interests of its constituents. But, professional organizations must also have a broader outlook. Some organizations always seem to go overboard and forget that, in the long run, the interests of their members are closely tied to
8
Our profession, under APhA leadership, has compiled an impressive track record since we assembled in Montreal nine years ago. That session in this city set the stage for APhA's efforts to protect and regain several professional prerogatives which are of fundamental importance. That meeting supplied the impetus for APhA's efforts to regain for pharmacists authority and responsibility to select the source of drug products to be dispensed on prescription orders from physicians or other prescribers. At the Washington, DC, meeting following Montreal, we formally kicked off the movement to amend the antisubstitution laws which were in effect in virtually all states. Today, in more than 35 states, pharmacists have the right to engage in drug product selection. This is a creditable record of legislative accomplishment in such a short time span. By the time our association holds its 1980 meeting in Washington, I predict that every state will have amended its antisubstitution law. Working to regain our professional drug product selection prerogatives has been a gruelling struggle. We have faced the well-financed opposition of organized medicine and the drug industry. We have had "support" of consumer organizations which, in some cases, ftas served neither their goals nor ours. No drug product selection law is perfect. Some states have enacted drug selection legislation that is a contradiction in terms. While it purports to give pharmacists professional discretion, it punishes them if they fail to dispense on the basis of drug product cost alone. Last year, the worst drug product selection statute in the country was enacted in the state of New York by an overwhelming vote. This law incorporates unnecessary, expensive and oppressive features which are offensive to pharmacists, physicians and the drug industry alike. In the long run the citizens of New York will lose-and pharmacists will also-because organized pharmacy in that state, instead of protecting the interest of the profession, washed its hands of the whole legislative affair. Confusion has been the order of the day for pharmacists in New York. Just before the April 1 effective date of the statute, the New York State Board of Pharmacy and the state health department gave conflicting rulings to pharmacists. If organized pharmacy in New York had worked with the legislature, a vastly improved drug selection law could have resulted, the public interest could have been truly served, and the profession would have gained respect rather than all of the adverse publicity which has resulted. Recently, PMA president Stetler shed verbal tears for pharmacy based on the New York "cheapest drug" law. He has pointed out-correctly I must add-that under such a law, pharmacists lose, rather than gain, professional prerogatives. Everyone will lose in New York and any other state which grounds its drug product selection law on distrust of the pharmacist. While Mr. Stetler is now discrediting laws such as those enacted in New York, however, he is ignoring the fact that it was the industry itself which created the "pharmacist can't be trusted" atmosphere which prompted legislators to include these price provisions. It was not consumer groups who were responsible for "cheapest drug" provisions. It was ~rug firm lobbyists, including battalions of sales perAmerican Pharmacy Voi.NS18 , No. 8, July 15, 1978 / 384
sonnel, who were telling legislators that pharmacists would line their pockets by dispensing "cheap generic drugs" at inflated prices. Industry itself created the problem, and I am wondering now what industry is prepared to do to help us solve it. One thing is clear to me, and that is that drug product selection can and will work where pharmacists are accorded appropriate respect for their essential contribution to the public health and the welfare of individual patients.
Spotlight on Pharmacy Pharmacists must understand fully that the spotlight has been turned on pharmacy. Our performance will be carefully evaluated to see whether the public interest will be served by our exercise of professional authority under drug product selection laws. Consumer organizations, the news media, politicians and researchers will be reviewing pharmacists' performance to see if our earlier predictions are met. We are being called on to use our expertise to help control raging health care costs. The examination has already begun. Although workable drug product selection laws have been in effect less than five years, surveys are already underway to monitor the accountability of pharmacists. Last month, it was reported that an HEW- sponsored study examining the operation of the Michigan statute concluded that pharmacists were failing miserably to use their drug product selection authority. 1't claimed that the cost of prescribed drugs in the state was reduced by only $300,000 annually while the law had been projected to save consumers more than $13,000,000 per year. Those Michigan statistics will be used to argue that you can't depend on pharmacists to serve the public interest. Of course, the validity of the Michigan study can be debated, and we can question whether the original expectations were realistic. We can offer many good reasons why these laws are being implemented gradually. But, we must understand that pharmacists will be held publicly accountable. Therefore, pharmacists and their professional associations must take the necessary time to educate the public about drug product selection. It is important for us to explain to our patients why we have selected a particular drug product. The public has a right to expect cost savings through the operation of drug product selection laws, but people must be educated to have realistic savings expectations and not rely on frivolous statistical projections. A $300,000 saving in one year should hardly be sneered at. In his remarks challenging the legal and medical professions, President Carter aimed at fostering greater competition among the practitioners in those professions. Pharmacy also has been under attack for an alleged lack of competition.
The Drug Regulation Reform Act of 1978 The Drug Regulation Reform Act of 1978, recently introduced by Senator Kennedy, Congressman Rogers and several co-sponsors, seeks to promote pharmacy competition by requiring pharmacy to post prices of prescription drug products. Comments that we have received about our recent testimony on this bill before Senator Kennedy's subcommittee revealed that pharmacists are reacting strongly to this provision. APhA has also reacted forcefully. Price posting is a gimmick and an ineffective one at that. Ten years of experience with it has exposed price posting American Pharmacy Voi.NS18, No.8, July 15, 1978/385
as only offering the illusion of serving the consumer. Pharmacists know that posted prices are generally ignored by the public, while mandatory price posting places a punitive and discriminatory burden on pharmacists. The frequency of drug product cost increases has made some pharmacists feel they are sign painters rather than professionals. APhA has made its opposition to the price posting requirement well known to Congress. Price posting will never be an effective device to regulate or increase competition within the nation's professions. While pharmacists are up in arms about mandatory price posting, some still may not see the major threat in this bill to their practices and their ability to serve the public. If enacted in its present form, the bill would overturn the entire history of drug regulation, and for the first time give the secretary of HEW and FDA sweeping control over drug prescribing, distribution, and use . The bill would overturn the profession's hard-earned legal victory in the methadone case. For those who have forgotten, APhA spent considerable time and money to win a 1975 court decision preventing the FDA from usurping control of the practice of pharmacy. The courts held the Congress had not given FDA authority to decide which pharmacists may or may not dispense any legend drug. FDA now is determined to get that authority via this bill. APhA is determined that it won't. If this bill is enacted as now drafted, the HEW secretary could dictate what physicians could prescribe and what pharmacists could and could not dispense ampicillin, tetracycline or any other prescription drug product. FDA could restrict the distribution and use of virtually any drug in any way the agency sees fit if the HEW secretary simply makes certain findings. As a practical matter, of course, these findings could be challenged only at great expense and even then, the courts are unlikely to interfere with the medical expertise of the secretary. The secretary of HEW, by the way, usually has been a lawyer or an educator-and in one case even a newspaper publisher-rather than a medical expert. APhA is convinced that the practical result of such drug product distribution restriction authority would be a horrendous setback for patients' equal access to the best possible medical care. It would impose needless hardships on individual patients and it would discriminate against physicians, pharmacists and the public. Overregulating the medical and pharmacy professions will not solve any problems relating to misprescribing of drugs. Any such problems can be corrected at their source by other means authorized in this bill instead of by imposing restrictions on drug product distribution. Under the "drug treatment investigation" provision of the bill, the secretary of HEW would gain another device to control who could prescribe, dispense and receive particular drug products. It would legalize what APhA believes are unlawful and discriminatory treatment conditions for' patients and discriminatory prescribing and dispensing privileges for physicians and pharmacists. APhA will forcefully oppose this continued discrimination under the sham "compa~sionate IND" procedure. At least two consumer activist leaders have already expressed concern about the adverse effects of restricted drug distribution on patients. To remedy this concern, the bill should be revised to add affirmative language protecting the rights of pharmacists and equal patient access to pharmaceutical service. Neither the public nor the health professions should be subjected to the whims of any FDA commissioner. APhA and pharmacy have been burned
9
once by arbitrary regulation-it still hurts and the pain will not let us forget it. , As the representative of the profession of pharmacy, APhA has been participating in discussions for nearly a year regarding reform of the current drug regulatory system. We are now working closely with administration officials and congressional leaders in an attempt to resolve our concerns with this legislation. We are extremely pleased that both Senator Kennedy and FDA commissioner Kennedy and their staffs have shown a sincere willingness to receive our recommendations. And, we have already begun to turn our attention to the development of acceptable new language for the bill. Shortly after we delivered our Senate testimony, APhA met with commissioner Kennedy and his staff. Since that meeting we detect some movement by FDA. In a recent meeting with consumer organization representatives, the commissioner is reported to have stated that he is concerned about the limited access for patients caused by the "compassionate IND" ploy. He said "I think what we see in compassionate INDs is a relatively elitist system and I am troubled by that." Several persons at that conference had the impression that FDA's position on restricted distribution is being rethought. That is progress in the right direction for once.
The Equal Rights of All Pharmacists to Dispense APhA members must be informed advocates of the equal right of all pharmacists to dispense. We will call on you to take the time to explain the implications of this legislation to the citizens of your community if their access to vital medicines continues to be threatened. And, we must all be prepared to call on our elected officials to deliver the message for the profession and the public if that becomes necessary. With your help, and that of your patients, APhA will succeed and the profession's delivery of pharmaceutical service will be strengthened by this challenge. I have been stressing that APhA is working hard to prevent Washington from overregulating our professional lives. However, APhA is just as concerned about state action and the action of other organizations that would have a destructive impact on our ability to practice as professionals. As you know, APhA became greatly alarmed about the intention of the United States Pharmacopeia! Convention to continue and expand the dispensing information sections of the USP. Following candid discussions, we persuaded USPC to publish its dispensing information in a separate book outside the official compendium and its supplements, to eliminate any issue as to its mandatory n.ature. Despite this responsible move by USPC, pharmaCists must now be alert to a new threat to their individual professional judgments. In the keynote address at the 1978 NABP meeting in New Orleans last month, NABP president Higley mourned AP.hA's success. He urged state pharmacy boards to adopt stnct regulations requiring the use of dispensing informat~on that will be found in this separate new USPC publication. I am a member of the Illinois State Board of Pharmacy, and I doubt that the boards possess the authority to impose such demands on the profession. But, I can guarantee this-! will be among the first to oppose any such power grab by any board of pharmacy. The public interest is not served by destroying any profession and the professional judgment of its practitioners in the name of regulation.
10
The Effectiveness of Unity Some of you will remember when a young senator from Minnesota who was also a pharmacist teamed up with the influential pharmacist and congressman from North Carolina, Carl T. Durham, to engineer the enactment in 1951 of major amendments to the Federal Food, Drug and Cosmetic Act. Congressman Durham had been a practicing pharmacist for 30 years before his election to the House in 1938, while Hubert H. Humphrey had practiced only four years in his father's pharmacy before leaving to launch his career in politics. As the result of their experience both as pharmacists and lawmakers, Durham and Humphrey knew it was absolutely critical for the profession to speak with one voice to Congress. Both distinguished legislators seldom missed an opportunity to challenge the profession to realize the enormous effectiveness only unity can bring. Whenever he addressed the profession in subsequent years, Senator Humphrey repeated the plea for unity. And, in his public statements as well as in his private conversation, Carl Durham stressed that pharmacy would be much more effective in Washington if crippling organizational divisiveness was eliminated from the profession. America's presidents have always repeated the unity theme in their state of the union messages. In the same way, from the time APhA was established in 1852, a common element has run through our own presidential addresses-pharmacists must pull their profession together into a vibrant and dynamic organization. Today, some in American pharmacy believe that unity is impossible, and they want us to end discussion of the subject, but past failures to reform our organizational structure should not detour us from striving to achieve a united profession. Today many political commentators are telling us that the rapid proliferation of vested interests and pressure groups are tearing our country apart. Ask yourself if this is not a problem facing American pharmacists. A hard core of pharmacists support APhA. Many of them also belong to one or more specialized organizations. Does our profession need all the organizations we now have? Most pharmacists recognize that pharmacy's organizational structure needs to be revamped and revitalized. Will you express your view on the need for unity to the leaders of the pharmacy organizations you support? I am sure you are all familiar with the inspirational passage from Ecclesiastes, which was popularized as a hit song more than ten years ago: "To everything there is a season, And a time to every purpose under heaven; A time to be born, and a time to die; A time to weep and a time to laugh; A time to mourn and a time to dance; A time to keep silence and a time to speak." This is the time to unify our profession. This is th~ time for you to speak. This is the time for you to get involved. This is the time for you to make it happen. This is the time for you to help the profession recapture its sense of common purpose. Hubert Humphrey refused to be silent. He often spoke about the practical benefits to be derived from unity and he did not give up in the face of difficult odds. Do not become discouraged. Pharmacy's specialized organizations will have to respond to their members. During the past year, I have chosen to speak as I am today. As proud as I am of all our rich accomplishments, I am forced to admit that we do not have the manpower, the American Pharmacy Voi.NS18, No.8, July 15, 1978/386
The 1978-1979 APhA Board of Trustees and former board members in Montreal. Standing from left to right: speaker of the house of delegates Ralph S. Levi; trustees Mary Munson Runge, Robert K. Chalmers, and Daniel A. Hussar; vice speaker of the house Earl L. Giacolini; vice chairman of the board Maurice Q. Bedel; outgoing APhA vice president Angele C. D'Angelo; trustee Donald A. Dee; and executive
resources and the espirit de corps that are necessary to meet all of the challenges confronting our profession. I am particularly troubled about the many pharmacists who neglect or refuse to support their national professional society. Unfortunately, many practitioners are turned off by pharmacy's chaotic organizational structure. We can attract those pharmacists, and we will receive their support, when we achieve organizational unity in the profession. It has been a great honor for me to have had the opportunity to lead American pharmacy during the past year. I have worked hard to fulfill the important responsibilities of the APhA presidency. And, I am delighted to report that APhA has been strengthened during my tenure. Today, nearly 60,000 men and women are members of the American Pharmaceutical Association. With the generous support and understanding of my family, I have worked to serve the profession as a roving
American Pharmacy Voi.NS1 ~ · No. 8, July 15, 1978/387
director William S. Apple. Sitting from left to right: treasurer Grover C. Bowles; vice president Charles C. Rabe; trustees Gill T. Hartliep, W. James Bicket and Herbert S. Carlin; chairman of the board William J. Edwards; president Jacob W. Miller: immediate past-president Philip Sacks; and 1976-7] APhA president William F. Appel.
ambassador during this past year. Since the conclusion of our 1977 meeting in New York, I have tried hard to keep in touch with practicing pharmacists, a necessity for APhA and a personally rewarding experience for me. The future of American pharmacy depends upon their strength and their determination to be progressive about the profession's future. I call upon you to share that outlook. When he received the Hugo H. Schaefer Award at our 1965 Annual Meeting in Detroit, Hubert H. Humphrey, the epitome of the involved, selfless pharmacist, summoned us to move ahead. He challenged us irt declaring: "I know we will succeed one day later if we don't start now. The longest jump is the first step." We have taken the first and many following steps. We have not yet reached our goal but we can and we will if we continue to march forward in the service of the public and our profession. 0
11
Regaining Professional Prerogatives
Address of Outgoing President Philip Sacks Our time has appropriately been described as "the age of anxiety." The anxieties of the nation's professions were heightened earlier this month when President Carter aimed his political guns at law and medicine. In highly publicized speeches, the President challenged lawyers and physicians to examine and improve their professions. He voiced blunt criticism of our systems of justice and health care and the performance of the professions charging that they have little concern for "the little guy." Many observers believe that President Carter's sweeping attacks struck a responsive chord, which revealed deep public dissatisfaction with the professions in the United States. The President was both right and wrong. There is great concern among those who require or would use professional services as to their accessibility and cost. Nonetheless, the public still holds lawyers and physicians in the highest regard as individual practitioners. How can we account for the apparent gap between "doctors and lawyers are no good-but my doctor or lawyer suits .me fine!"? President Carter lays the blame at the feet of the organizational structures of each profession. Lawyers and doctors may be OK, but organized lawyers and doctors aren't. For all professions, the President's recent salvos underline the necessity for a professional association to safeguard the interests of its constituents. But, professional organizations must also have a broader outlook. Some organizations always seem to go overboard and forget that, in the long run, the interests of their members are closely tied to
8
Our profession, under APhA leadership, has compiled an impressive track record since we assembled in Montreal nine years ago. That session in this city set the stage for APhA's efforts to protect and regain several professional prerogatives which are of fundamental importance. That meeting supplied the impetus for APhA's efforts to regain for pharmacists authority and responsibility to select the source of drug products to be dispensed on prescription orders from physicians or other prescribers. At the Washington, DC, meeting following Montreal, we formally kicked off the movement to amend the antisubstitution laws which were in effect in virtually all states. Today, in more than 35 states, pharmacists have the right to engage in drug product selection. This is a creditable record of legislative accomplishment in such a short time span. By the time our association holds its 1980 meeting in Washington, I predict that every state will have amended its antisubstitution law. Working to regain our professional drug product selection prerogatives has been a gruelling struggle. We have faced the well-financed opposition of organized medicine and the drug industry. We have had "support" of consumer organizations which, in some cases, ftas served neither their goals nor ours. No drug product selection law is perfect. Some states have enacted drug selection legislation that is a contradiction in terms. While it purports to give pharmacists professional discretion, it punishes them if they fail to dispense on the basis of drug product cost alone. Last year, the worst drug product selection statute in the country was enacted in the state of New York by an overwhelming vote. This law incorporates unnecessary, expensive and oppressive features which are offensive to pharmacists, physicians and the drug industry alike. In the long run the citizens of New York will lose-and pharmacists will also-because organized pharmacy in that state, instead of protecting the interest of the profession, washed its hands of the whole legislative affair. Confusion has been the order of the day for pharmacists in New York. Just before the April 1 effective date of the statute, the New York State Board of Pharmacy and the state health department gave conflicting rulings to pharmacists. If organized pharmacy in New York had worked with the legislature, a vastly improved drug selection law could have resulted, the public interest could have been truly served, and the profession would have gained respect rather than all of the adverse publicity which has resulted. Recently, PMA president Stetler shed verbal tears for pharmacy based on the New York "cheapest drug" law. He has pointed out-correctly I must add-that under such a law, pharmacists lose, rather than gain, professional prerogatives. Everyone will lose in New York and any other state which grounds its drug product selection law on distrust of the pharmacist. While Mr. Stetler is now discrediting laws such as those enacted in New York, however, he is ignoring the fact that it was the industry itself which created the "pharmacist can't be trusted" atmosphere which prompted legislators to include these price provisions. It was not consumer groups who were responsible for "cheapest drug" provisions. It was ~rug firm lobbyists, including battalions of sales perAmerican Pharmacy Voi.NS18 , No. 8, July 15, 1978 / 384
sonnel, who were telling legislators that pharmacists would line their pockets by dispensing "cheap generic drugs" at inflated prices. Industry itself created the problem, and I am wondering now what industry is prepared to do to help us solve it. One thing is clear to me, and that is that drug product selection can and will work where pharmacists are accorded appropriate respect for their essential contribution to the public health and the welfare of individual patients.
Spotlight on Pharmacy Pharmacists must understand fully that the spotlight has been turned on pharmacy. Our performance will be carefully evaluated to see whether the public interest will be served by our exercise of professional authority under drug product selection laws. Consumer organizations, the news media, politicians and researchers will be reviewing pharmacists' performance to see if our earlier predictions are met. We are being called on to use our expertise to help control raging health care costs. The examination has already begun. Although workable drug product selection laws have been in effect less than five years, surveys are already underway to monitor the accountability of pharmacists. Last month, it was reported that an HEW- sponsored study examining the operation of the Michigan statute concluded that pharmacists were failing miserably to use their drug product selection authority. 1't claimed that the cost of prescribed drugs in the state was reduced by only $300,000 annually while the law had been projected to save consumers more than $13,000,000 per year. Those Michigan statistics will be used to argue that you can't depend on pharmacists to serve the public interest. Of course, the validity of the Michigan study can be debated, and we can question whether the original expectations were realistic. We can offer many good reasons why these laws are being implemented gradually. But, we must understand that pharmacists will be held publicly accountable. Therefore, pharmacists and their professional associations must take the necessary time to educate the public about drug product selection. It is important for us to explain to our patients why we have selected a particular drug product. The public has a right to expect cost savings through the operation of drug product selection laws, but people must be educated to have realistic savings expectations and not rely on frivolous statistical projections. A $300,000 saving in one year should hardly be sneered at. In his remarks challenging the legal and medical professions, President Carter aimed at fostering greater competition among the practitioners in those professions. Pharmacy also has been under attack for an alleged lack of competition.
The Drug Regulation Reform Act of 1978 The Drug Regulation Reform Act of 1978, recently introduced by Senator Kennedy, Congressman Rogers and several co-sponsors, seeks to promote pharmacy competition by requiring pharmacy to post prices of prescription drug products. Comments that we have received about our recent testimony on this bill before Senator Kennedy's subcommittee revealed that pharmacists are reacting strongly to this provision. APhA has also reacted forcefully. Price posting is a gimmick and an ineffective one at that. Ten years of experience with it has exposed price posting American Pharmacy Voi.NS18, No.8, July 15, 1978/385
as only offering the illusion of serving the consumer. Pharmacists know that posted prices are generally ignored by the public, while mandatory price posting places a punitive and discriminatory burden on pharmacists. The frequency of drug product cost increases has made some pharmacists feel they are sign painters rather than professionals. APhA has made its opposition to the price posting requirement well known to Congress. Price posting will never be an effective device to regulate or increase competition within the nation's professions. While pharmacists are up in arms about mandatory price posting, some still may not see the major threat in this bill to their practices and their ability to serve the public. If enacted in its present form, the bill would overturn the entire history of drug regulation, and for the first time give the secretary of HEW and FDA sweeping control over drug prescribing, distribution, and use . The bill would overturn the profession's hard-earned legal victory in the methadone case. For those who have forgotten, APhA spent considerable time and money to win a 1975 court decision preventing the FDA from usurping control of the practice of pharmacy. The courts held the Congress had not given FDA authority to decide which pharmacists may or may not dispense any legend drug. FDA now is determined to get that authority via this bill. APhA is determined that it won't. If this bill is enacted as now drafted, the HEW secretary could dictate what physicians could prescribe and what pharmacists could and could not dispense ampicillin, tetracycline or any other prescription drug product. FDA could restrict the distribution and use of virtually any drug in any way the agency sees fit if the HEW secretary simply makes certain findings. As a practical matter, of course, these findings could be challenged only at great expense and even then, the courts are unlikely to interfere with the medical expertise of the secretary. The secretary of HEW, by the way, usually has been a lawyer or an educator-and in one case even a newspaper publisher-rather than a medical expert. APhA is convinced that the practical result of such drug product distribution restriction authority would be a horrendous setback for patients' equal access to the best possible medical care. It would impose needless hardships on individual patients and it would discriminate against physicians, pharmacists and the public. Overregulating the medical and pharmacy professions will not solve any problems relating to misprescribing of drugs. Any such problems can be corrected at their source by other means authorized in this bill instead of by imposing restrictions on drug product distribution. Under the "drug treatment investigation" provision of the bill, the secretary of HEW would gain another device to control who could prescribe, dispense and receive particular drug products. It would legalize what APhA believes are unlawful and discriminatory treatment conditions for' patients and discriminatory prescribing and dispensing privileges for physicians and pharmacists. APhA will forcefully oppose this continued discrimination under the sham "compa~sionate IND" procedure. At least two consumer activist leaders have already expressed concern about the adverse effects of restricted drug distribution on patients. To remedy this concern, the bill should be revised to add affirmative language protecting the rights of pharmacists and equal patient access to pharmaceutical service. Neither the public nor the health professions should be subjected to the whims of any FDA commissioner. APhA and pharmacy have been burned
9
once by arbitrary regulation-it still hurts and the pain will not let us forget it. , As the representative of the profession of pharmacy, APhA has been participating in discussions for nearly a year regarding reform of the current drug regulatory system. We are now working closely with administration officials and congressional leaders in an attempt to resolve our concerns with this legislation. We are extremely pleased that both Senator Kennedy and FDA commissioner Kennedy and their staffs have shown a sincere willingness to receive our recommendations. And, we have already begun to turn our attention to the development of acceptable new language for the bill. Shortly after we delivered our Senate testimony, APhA met with commissioner Kennedy and his staff. Since that meeting we detect some movement by FDA. In a recent meeting with consumer organization representatives, the commissioner is reported to have stated that he is concerned about the limited access for patients caused by the "compassionate IND" ploy. He said "I think what we see in compassionate INDs is a relatively elitist system and I am troubled by that." Several persons at that conference had the impression that FDA's position on restricted distribution is being rethought. That is progress in the right direction for once.
The Equal Rights of All Pharmacists to Dispense APhA members must be informed advocates of the equal right of all pharmacists to dispense. We will call on you to take the time to explain the implications of this legislation to the citizens of your community if their access to vital medicines continues to be threatened. And, we must all be prepared to call on our elected officials to deliver the message for the profession and the public if that becomes necessary. With your help, and that of your patients, APhA will succeed and the profession's delivery of pharmaceutical service will be strengthened by this challenge. I have been stressing that APhA is working hard to prevent Washington from overregulating our professional lives. However, APhA is just as concerned about state action and the action of other organizations that would have a destructive impact on our ability to practice as professionals. As you know, APhA became greatly alarmed about the intention of the United States Pharmacopeia! Convention to continue and expand the dispensing information sections of the USP. Following candid discussions, we persuaded USPC to publish its dispensing information in a separate book outside the official compendium and its supplements, to eliminate any issue as to its mandatory n.ature. Despite this responsible move by USPC, pharmaCists must now be alert to a new threat to their individual professional judgments. In the keynote address at the 1978 NABP meeting in New Orleans last month, NABP president Higley mourned AP.hA's success. He urged state pharmacy boards to adopt stnct regulations requiring the use of dispensing informat~on that will be found in this separate new USPC publication. I am a member of the Illinois State Board of Pharmacy, and I doubt that the boards possess the authority to impose such demands on the profession. But, I can guarantee this-! will be among the first to oppose any such power grab by any board of pharmacy. The public interest is not served by destroying any profession and the professional judgment of its practitioners in the name of regulation.
10
The Effectiveness of Unity Some of you will remember when a young senator from Minnesota who was also a pharmacist teamed up with the influential pharmacist and congressman from North Carolina, Carl T. Durham, to engineer the enactment in 1951 of major amendments to the Federal Food, Drug and Cosmetic Act. Congressman Durham had been a practicing pharmacist for 30 years before his election to the House in 1938, while Hubert H. Humphrey had practiced only four years in his father's pharmacy before leaving to launch his career in politics. As the result of their experience both as pharmacists and lawmakers, Durham and Humphrey knew it was absolutely critical for the profession to speak with one voice to Congress. Both distinguished legislators seldom missed an opportunity to challenge the profession to realize the enormous effectiveness only unity can bring. Whenever he addressed the profession in subsequent years, Senator Humphrey repeated the plea for unity. And, in his public statements as well as in his private conversation, Carl Durham stressed that pharmacy would be much more effective in Washington if crippling organizational divisiveness was eliminated from the profession. America's presidents have always repeated the unity theme in their state of the union messages. In the same way, from the time APhA was established in 1852, a common element has run through our own presidential addresses-pharmacists must pull their profession together into a vibrant and dynamic organization. Today, some in American pharmacy believe that unity is impossible, and they want us to end discussion of the subject, but past failures to reform our organizational structure should not detour us from striving to achieve a united profession. Today many political commentators are telling us that the rapid proliferation of vested interests and pressure groups are tearing our country apart. Ask yourself if this is not a problem facing American pharmacists. A hard core of pharmacists support APhA. Many of them also belong to one or more specialized organizations. Does our profession need all the organizations we now have? Most pharmacists recognize that pharmacy's organizational structure needs to be revamped and revitalized. Will you express your view on the need for unity to the leaders of the pharmacy organizations you support? I am sure you are all familiar with the inspirational passage from Ecclesiastes, which was popularized as a hit song more than ten years ago: "To everything there is a season, And a time to every purpose under heaven; A time to be born, and a time to die; A time to weep and a time to laugh; A time to mourn and a time to dance; A time to keep silence and a time to speak." This is the time to unify our profession. This is th~ time for you to speak. This is the time for you to get involved. This is the time for you to make it happen. This is the time for you to help the profession recapture its sense of common purpose. Hubert Humphrey refused to be silent. He often spoke about the practical benefits to be derived from unity and he did not give up in the face of difficult odds. Do not become discouraged. Pharmacy's specialized organizations will have to respond to their members. During the past year, I have chosen to speak as I am today. As proud as I am of all our rich accomplishments, I am forced to admit that we do not have the manpower, the American Pharmacy Voi.NS18, No.8, July 15, 1978/386
The 1978-1979 APhA Board of Trustees and former board members in Montreal. Standing from left to right: speaker of the house of delegates Ralph S. Levi; trustees Mary Munson Runge, Robert K. Chalmers, and Daniel A. Hussar; vice speaker of the house Earl L. Giacolini; vice chairman of the board Maurice Q. Bedel; outgoing APhA vice president Angele C. D'Angelo; trustee Donald A. Dee; and executive
resources and the espirit de corps that are necessary to meet all of the challenges confronting our profession. I am particularly troubled about the many pharmacists who neglect or refuse to support their national professional society. Unfortunately, many practitioners are turned off by pharmacy's chaotic organizational structure. We can attract those pharmacists, and we will receive their support, when we achieve organizational unity in the profession. It has been a great honor for me to have had the opportunity to lead American pharmacy during the past year. I have worked hard to fulfill the important responsibilities of the APhA presidency. And, I am delighted to report that APhA has been strengthened during my tenure. Today, nearly 60,000 men and women are members of the American Pharmaceutical Association. With the generous support and understanding of my family, I have worked to serve the profession as a roving
American Pharmacy Voi.NS1 ~ · No. 8, July 15, 1978/387
director William S. Apple. Sitting from left to right: treasurer Grover C. Bowles; vice president Charles C. Rabe; trustees Gill T. Hartliep, W. James Bicket and Herbert S. Carlin; chairman of the board William J. Edwards; president Jacob W. Miller: immediate past-president Philip Sacks; and 1976-7] APhA president William F. Appel.
ambassador during this past year. Since the conclusion of our 1977 meeting in New York, I have tried hard to keep in touch with practicing pharmacists, a necessity for APhA and a personally rewarding experience for me. The future of American pharmacy depends upon their strength and their determination to be progressive about the profession's future. I call upon you to share that outlook. When he received the Hugo H. Schaefer Award at our 1965 Annual Meeting in Detroit, Hubert H. Humphrey, the epitome of the involved, selfless pharmacist, summoned us to move ahead. He challenged us irt declaring: "I know we will succeed one day later if we don't start now. The longest jump is the first step." We have taken the first and many following steps. We have not yet reached our goal but we can and we will if we continue to march forward in the service of the public and our profession. 0
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