Organizational Affairs Reference Committee Report

Organizational Affairs Reference Committee Report

he Organizational Affairs Reference ommitt considered the report of the APhA Policy Committee on Organizational Affairs. It i the consensus of the Reference ommittee that Section 3.2 of the Policy Committee report is not restrictive with respect to the individuals, group or organizations that would be involved in the planning and operation by the As ociation of a national clearinghouse for continuing education. The Reference Committee recommend the adoption of Section 1, 3 and 4 of the report of the APhA Policy Committee on Organizational Affairs, and I so move.

In considering Section 2 of the Policy Committee report, the Reference Committee noted the fact that a number of the recommendations expressed in the Policy Committee report had been incorporated by the American Council on Pharmaoeutical Education in its final Accreditation Standards Revision dated January 28, 1972. Based on testimony heard at the Reference Committee hearing, the Reference Committee concluded that some of the recommendations contained in the Policy Committee report are inappropriate at this time for inclusion in the Accreditation Standards. The Reference Committee recommends the rejection of Section 2 of the report of the APhA Policy Committee on Organizational Affairs, and I so move.

Robert E. Ohrlund

Robert E. Ohrlund, chairman Martin Barr, vice chairman George B. Browning Richard C. Carroll Thomas J. Garrison Casimir H. Srutwa Kathleen A. McGee

[The House adopted the Reference Committee's recommendations as presented except for Section 1 which was rejected.]

Organizational Affairs 1. Uniform Designation for Pharmacists [Entire Section 1 was rejected by the House of Delegates.]

Recommendation: 1.1-The committee recommends that the Association adopt and use the designation "Pharm." following an individual's name to identify that the individual is a pharmacist. 1.2-The committee recommends that the Association urge the use of the designation "Pharm." by pharmacists and that at the discretion of the individual pharmacist, his academic degree be indicated following the uniform designation "Pharm." (eg, Pharm. BS or PharmD). Background: 1.3-The APhA House of Delegates at its 1971 annual meeting rejected a recommendation contained in the report of the APhA Policy Committee on Organizational AfJairs that the 296

designation PD (pharmacy doctor) be adopted as the uniform designation for pharmacists. This proposal failed to receive substantial support from the delegates, not because they did not recognize the desirability of a uniform designation for pharmacists, but because the designation suggested by the committee was considered inappropriate. l.4-Through the years, various designations have been used to indicate that an individual is a pharmacist. While some pharmacists use designations such as RPh or RP following their names, other pharmacists have preferred to use their undergraduate degrees as PhG, PhC, BS, BS Pharm or PharmD or their graduate degrees as MS, PhD and DSc. 1. S-Idea lly , any national standard designation for pharmacists should 'be readily recognized by the public and other health professionals, should be appropriate for use by all pharmacists, regardless of their academic degrees,

Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION

and should apply to an individual, regardless of whether or not he is licensed. The designation should indicate the fact that he is by training a pharmacist. 1.6--The use of the descriptive abbreviations RP or RPh is applicable only to those individuals who are licensed by a board of pharmacy to practice in one or more jurisdictions. There is some question as to the appropriateness of an individual utilizing the designation RP or RPh after his name if he is residing in another jurisdiction in which he is not licensed. 1.7-Webster's Third New International Dictionary of the English Language Unabridged defines a pharmacist as "one skilled in pharmacy: one engaged in the practice of pharmacy." This definition applies both to the individual who has an academic degree in pharmacy and the individual who is licensed to practice pharmacy: The abbreviation "Pharm." following an individual's name could easily be

recognized by the public, as well as members of the health professions, as indicating that the individual is a pharmacist by education and/ or licensure. The public's need to know that an individual is licensed to practice his profession can be satisfied through other mechanisms that would be less confusing than the present practice of referring to an individual as RPh or RP. 1.8-The committee's recommendation that the Association adopt the suffix "Pharm." as the uniform designation for pharmacists could be implemented by utilizing the designation, where appropriate, in the membership records, publications and correspondence of the Association. Other associations and individual pharmacists would be encouraged to utilize this uniform designation for pharmacists.

2. American Council on Pharmaceutical Education Accreditation Standards [Entire Section 2 was rejected by the House of Delegates. See page 281 for alternate motion ad~pted by House.]

Recommendation: 2.1-The committee recommends that the Association support the adoption of the revised accreditation standards proposed by the American Council on Pharmaceutical Education (ACPE) with the inclusion of provisions which would accomplish the following objectivesa. The standards should specifically emphasize that colleges of pharmacy have a responsibility to coordinate continuing education planning and programming with other colleges of pharmacy, state pharmaceutical associations and other health professions. b. The standards should provide that colleges of pharmacy shall strive to develop curricula which will equip graduates of both the baccalaureate degree curriculum and the doctoral degree curriculum with the technical and professional capabilities to assume expanded responsibilities in the clinical use of drugs and related products, to demonstrate competence in the application of pharmaceutical and biomedical sciences to the practical problems of drug therapy, to assume responsibility to focus upon patient-oriented pharmacy practice and to serve as a practitioner education. c. The standards should encourage colleges of pharmacy to make current professional knowledge available to present practitioners through formal nonresident educational programs. Such programs should include provisions for the granting of

doctoral degrees to successful candidates. 2.2-The committee recommends that the Association urge state pharmaceutical associations to seek amendments to state pharmacy practice acts and board of pharmacy regulations which allow candidates for licensure to fulfill the practical experience prerequisite during their college of pharmacy program under curricula developed in accordance with the revised ACPE accreditation standards. 2.3-The committee recommends that the Association endorse the granting of a doctoral degree as the standard professional degree in pharmacy and that the normal period of study for such degree be no longer than five calendar years. 2.4--The committee recommends that the Association oppose anything which would establish the illusion that pharmacists with a baccalaureate degree are "second-class pharmacists" who do not have the capacity to function in other than the traditional dispensing role. Background: 2.S-Accreditation is the recognition accorded to an institution that meets the standards or criteria established by a competent agency or association whose general purpose is to promote and ensure high quality in educational programs. The American Council on Pharmaceutical Education is the accrediting agency in pharmacy. It was established in 1932 and is composed of a total of ten persons-three each from three pharmaceutical organizations-the American Pharmaceutical Association, the National Association of Boards of Pharmacy and the American Association of Colleges of Pharmacy. In addition and representing the lay public is one appointee of the American Council on Education. 2.6-The standards which the ACPE has developed to describe an adequate college of pharmacy are published in the Accreditation Manual, the sixth edition of which is currently official and in use. During the past several months, the A CPE has been in the process of revising the accreditation standards which were last revised in 1960. As part of the revision procedure, the Association, as one of the sponsors of the Council, was invited to submit comments to the revision committee. 2.7-APhA Board of Trustees appointed an ad hoc committee of the Board to review the existing standards and to prepare recommendations for the consideration of the Board of

Trustees. The ad hoc committee report was approved for transmittal to the ACPE revision committee in January 1971. Among the recommendations offered by the APhA Board of Trustees were the followinga. Several areas of specific concern to the profession should be incorporated as part of the standards, including patient orientation in pharmacy practice, externship-internship, length of education and internship period, relationships oj pharmacy to other health care projessions and continuing education. b. The standards should clearly indicate that "A" college should not undertake a graduate or postgraduate program when in the judgment of examiners such programs compromise the quality oj the undergraduate program. c. The standards should provide jor current "add-on" programs leading to the granting oj the PharmD degree. d. Expertness in practice should be included as one oj the indices in evaluating the faculty as a whole. e. The standards should ref/ect the APhA policy that the length of the process oj education and internship leading to licensure should be shortened and that externship learning experiences should be incorporated into the five-year academic programs of the schools. f. There should be an additional standard entitled "continuing education." 2.8-The committee was pleased to note that many of these recommendations were incorporated into the suggested revision of the Accreditation Manual, Section IV, accreditation ~tan­ dards, dated July 7, 1971, which ACPE disseminated for discussion and comment. The committee felt that the revised standards properly ref/ect advancements in pharmacy and pharmaceutical education and wishes to commend the A CPE committee on revision. 2.9-With regard to the responsibility of colleges of pharmacy in the area of continuing education for pharmacists, the committee fully supports the recommendation submitted by the APhA Board of Trustees that Section VII include the statement, "Coordination with other colleges of pharmacy, state pharmaceutical associations and other health professions is essential." 2.10-The committee felt that Section IV of the suggested revision could be interpreted to imply that the pharmacy graduate from a baccalaureate degree curriculum would not be capable of functioning at the level of a fullfledged health professional and that such a program would not prepare the BS graduate for the challenges of evolving patient-oriented roles for the pharmacist. This conclusion is drawn Vol. NS12, No.6, June 1972

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from the narrative in the suggested revision about the doctoral program which statesThe adl'anced program must be designed to produce a professional person clearly able to perform professionally at a higher level than the BS graduate. Such a program should prepare students for the challenges of developing the innovative professional services demanded by a rapidly changing health care delivery system . ... l.Il-The committee recognized the importance of having standards for the doctoral degree programs included in the accreditation standards. At the same time, extreme care must be exercised in order to avoid creating two classes of pharmacists in this country. All pharmacists should have the benefit of a level of education and training which will equip them to provide optimum professional services to the public. As new concepts and bodies of knowledge become available, these should be incorporated into the professional curricula of the colleges. Furthermore, practicing pharmacists should be provided the opportunity through continuing education programs and, where appropriate, through formalized, postgraduate education to acquire this knowledge and these skills. l.U-The suggested revision represents a significant modernization of the educational process for pharmacists by incorporating time for completing the intern training requirement within the professional curriculum. This commendable innovation is in keeping with the policy of the Association that internship requirements for licensure be abandoned in favor of an externship to be gained during the years of formal college training and supervised by the college as part of the educational experience. 2.13-It was pointed out in the pharmaceutical survey of 1948 thatThe degree that should be conferreU upon graduates in pharmacy has been the subject of some discussion in recent years. The degree of bachelor of science of pharmacy now generally awarded to graduates is in keeping with degrees conferred for the completion of other four-year professional prograr:zs such as chemistry, bacteriology, agnculture and engineering. The bachelor's degree does not, however, confer the status that is desired by pharmacists, particularly those who work. i~ rather intimate professional assoCiatIOn with physicians, dentists and members of other health professions who hold professional doctor's degrees. A professional doctor's degree has come to be regarded by many as a needed asset for the pharmacist. 2.14-0ne other recommendation of the pharmaceutical survey was that 298

the four-year curriculum be increased to a six-year program which would result in awarding of a doctor of pharmacy degree. Although some schools adopted a six-year doctor of pharmacy program, the minimum educational requirements became the five-year program leading to the BS degree. l.IS-Presently, the University of Southern California school of pharmacy and the University of California school of pharmacy have adopted a six-year mandatory program leading to the PharmD degree. At least 12 other colleges of pharmacy offer a doctor of pharmacy degree on an optional basis. l.I6--The Association of Graduate Schools in the American Association of Universities and the United States have issued a statement with respect to "The Doctor's Degree in Professional Fields." Among the guiding principles concerning such degrees is the follOWing statementProfessional doctoral degrees should be available only to those who have satisfactorily completed advanced studies that are comparabie in rigor to existing doctoral experiences of high quality as the professional programs leading to the degree of doctor of medicine or the research-oriented programs leading to the doctor of philosophy. For most students, the doctoral degree should represent a period of full-time study of at least seven or eight years beyond high school. 2.17-Since the present five-year academic program for pharmacy does not meet the requirements of the Association of Graduate Schools and the Council of Graduate Schools, it can be anticipated that universities would he reluctant at present to authorize the granting of a doctor of pharmacy degree' for graduates of the present five-year program. l.IS-The Carnegie Foundation for the Advancement of Teaching, as well as other educational and professional leaders, including the American Medical Association, are advocating a reduction to six years the time required for an individual to obtain a medical doctor's degree. Academic and public acceptance of the proposal that pharmacists be awarded a doctor of pharmacy degree for the completion of a five-year program seems more likely in the future in light of these recent developments. Such would particularly be the case as pharmacy curricula change to reflect more emphasis on clinical training. 2.19-The pattern has been established in this country that as the need for expanded and lengthene4 pharmacy curricula became acknowledged, these programs were adopted as the standard for all future pharmacists. In this

Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION

way, the profession has avoided the divisiveness which could result if practitioners were to hold themselves up to the public as being superior to other individuals licensed to practice pharmacy. During the period when some colleges of law were granting juris doctor degrees while other colleges of law were still granting bachelor of laws degrees, the legal profession avoided potential confusion in the mind of the public by means of an ethical prohibitiofz against the use of the title "doctor" by practicing attorneys. It is not too soon to' declare it the policy of this Association to be in favor of the doctoral degree as the basic professional degree for all future pharmacists. l.20-Simultaneously with the question of the doctoral degree as the basic professional degree for future pharmacists, the question of the retroactive granting of the doctorate is raised in the minds of most pharmacists. Unlike the legal profession where the ID degree was granted for essentially the same academic work as the former LLB degree, the PharmD curriculum varies from that of the BS degree program. This precludes the granting of the PharmD retroactively. However some adaptation of the European idea of the external degree could and should be developed to enable pharmacists the opportunity of acquiring the professional doctorate. 2.2l-The external degree concept involves development of appropriate assessment techniques to make possible the granting of degrees to those who are able to demonstrate that they possess the knowledge and abilities equivalent to those of a degree recipient. In his inaugural address as president of the University of the State of New York and Commissioner of Education, on September 15, 1970, Dr. Ewald B. Nyquist proposed the external degree concept to the Board of Regents of the University of the State of New York.

3. National Clearinghouse for Continuing Education Recommendation: 3.1-The committee recommends that the Association function as a national clearinghouse for continuing education. 3.2-The committee recommends that the Association develop a continuing education accreditation program in cooperation with colleges of pharmacy, state boards of pharmacy, national affiliated organizations and state pharmaceutical associations. 3.3-The committee recommends that the Association provide services to aid

states in the administration of continuing education relicensure requirements and to facilitate the fulfillment of such requirements by pharmacists. Background: 3.4--0ne of the purposes of the Association set forth in Article II of the Constitution of the American Pharmaceutical Association isTo provide a system of education and training in the art of pharmacy, calculated to produce competent personnel for all phases of the practice of pharmacy in order to provide the greatest protection for the public at large. The public expects that the health professions not only assure that those entering the professions are competent to practice their professions but that, once admitted to practice, the competency of the pract~tioners is maintained. The responsibility of the Association in relation to the education and training of pharmacists must be considered to encompass the continued education of pharmacists as well as the education and training of those seeking to become pharmacists. 3.5-In adopting the report .of the APhA Policy Committee on Professional Affairs, the APhA House of Delegates in 1970 indicated that before it considered " . . . .,the question of mandatDry continuing education for relicensuJ1e, that the Association prepare and distribute a background paper on this subject to the delegates which includes information about rthe experience of other professions which have such a requirement." Such a background paper has not as yet been issued, and thus, the committee did not consider whether to recommend that mandatory continuing education for relicensure be endorsed by the Association at this time. However, the committee did recognize that a growing number of states are adopting such requirements (California and Ohio in addition to Florida and Kansas as previously noted in prior committee reports). As was pointed out in the 1968 report of the APhA Committee on EducationThere is the further complication that unless there is some uniformity and standardization of these (continuing education) programs, reciprocal licensure may be further complicated by this requirement which will vary from state to state. 3.6-Many pharmacists are licensed in more than one of the states that have adopted mandatory continuing education requirements for l1elicensure. This situation points to the need for a national clearinghouse for continuing education programs which would fa-

cilitate the meeting of continuing education requirements by pharmacists, which would facilitate the administration of the programs by the various states and which would insure uniformity in the quality and standards of such continuing education requirements. 3.7-For a number of years, the American Medical Association (AMA) has operated a continuing medical education accr'editation program as a service to the medical profession. Two states have adopted legislation dealing with the mandatory continuing education issue as it relates to the relicensure of physicians (Kansas and New Mexico). Several state medical societies have adopted policies which have the effect of requiring continuing education as a condition of membership (Arizona, Massachusetts, New Mexico, Ohio, Oregon and Pennsylvania). The existence of the AMA continuing education accreditation program assists in the administration of these requirements both from the standpoint of the organizations and agenci'es involved and the individual physician. 3.8-Among the clearinghouse functions to be performed by the Association would be the establishment of criteria for accrediting continuing education programs. Sponsors of continuing education programs desiring listing with the clearinghouse would submit to the· Association requested information about their institution or organization and about the continuing education programs offered by them. Approved programs would be included on the lists of available continuing education programs disseminated to the profession. Such an accreditation program would not constitute the usurpation of the certification function of the various boards of pharmacy or state continuing education authorities. Criteria adopted for continuing education accreditation would reflect the standards of the various boards. Boards of pharmacy with responsibility for the certification of continuing education programs could accept, as meeting their requirements, programs accredited by the Association; or they could continue their own certification program, taking into consideration as one factor the action of the Association with respect to programs submitted to it .for review. The advantages to sponsors of continuing education programs and to the boards of pharmacy of having available a single national clearinghouse for such approval are clear. 3.9-Through the operation of a clearinghouse, the Association could

assist in the smooth functioning of mandatory continuing education requirements through administration services, including a procedure for the coordinated certification of attendance and .participation by pharmacists in continuing education programs listed with the clearinghouse. The advantages of modern computer technology could be applied to the task of providing pharmacists, program sponsors and state boards of pharmacy with attendanoe data necessary for the implementation of mandatory continuing education relicensure requirements. This service would provide an income potential which could underwrite, at least in part, the cost of operation of the clearinghouse. 3.10-A functioning clearinghouse would make it possible for a pharmacist in any part of the country to conveniently obtain information about the availability of continuing education programs which would comply with the requirements of the state or states in which he is licensed. The clearinghouse would eliminate untold duplication of effort on the part of boards of pharmacy and colleges of pharmacy and should make the administration of mandatory continuing education requirements feasible for boards of pharmacy with even the most limited staff resources. 4. Organizational Unity for Pharmacy [See also motion on page 281 for related action.]

Recommendation: 4.1-The committee recommends that the Association work toward the goal of organizational unity for pharmacy with a total commitment. 4.2-The committee recommends that the Association 'express the conviction that its responsibility to the goal of organizational unity goes beyond perpetuating the American Pharmaceutical Association in its present form, or even the American Pharmaceutical Association its,elf. 4.3-The committee recommends that the Association charge every member to accept his responsibility to cause other pharmacy organizations which he presently supports to adopt with equal commitment the goal of organizational unity. Background: 4.4-"Never have so many so clearly recognized a problem for so long, complained about it so much, possessed ,the ability to resolve it and yet permitted it to continue." With these words, APhA President Lloyd M. Parks described the present organizaVol. NS12, No.6, June 1972

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tional problems facing the profession of pharmacy when he spoke before the 1971 annual meeting of the Pennsylvania Pharmaceutical Association on July 26. The broad interest of pharmacists in the subject of organizational unity in pharmacy at this time is evidenced by a number of factors, including the requests received by the Association to submit the issue to the 1971-72 APhA Policy Committee on Organizational Affairs fo.r consideration. 4.S-Jt has been said that pharmacy is over-organized in that the numerous organizations (nearly 30 at the national level alone are listed in the /97/-72 Pharmaceutical Directory) tend to dilute each other's effectiveness and influence in representing pharmacy to the public while confusing their members and encouraging the development of strongly held loyalties. Too much of each organization's resources is spent on interorganizational disputes, with the result that less than the full potential of benefit is returned to the members for their dues dollars. 4.6-Pharmacists spend approximately $4 million annually in dues for membership in pharmaceutical associations at all levels-local, state and national. Last year, the American Medical Association operated on a budget of over $30 million, while the American Dental Association received more than $10 million in income to support their programs and activities. In his report to the APhA House of Delegates at the 1971 annual meeting, APhA Treasurer Grover C. Bowles reported that the Association's income for 1970 amounted to $1.7 million. It is obvious that the profession can ill afford the extravagance of having a mUltiplicity of organizations speaking for the profession at the national level. 4.7-ln his inaugural address at the 1971 APhA Annual Meeting, President Lloyd M. Parks statedWhile we are justifiably proud of Our present organizational structure and the improvements we made in it during the sixties, we recognize the need for further strengthening of not just APhA but of organized pharmacy its~lf. Accordingly, one of the objectives of my presidency will be to bring about a formal and complete review of the profession'S total organizational structure. While APhA is the oldest and today the largest and most effective Associati?~ in the profession, our responsibility goes far beyond perpetuating APhA in its present form, or even APhA itself. 4.8-This past year, the APhA Board of Trustees has pursued the o,bjective 300

of organizational unity in pharmacy as a matter of utmost priority. The committee observed that countless hours were devoted by the Association officers and trustees both collectively and individually this past year in the pursuit of this goal. The committee is in full accord with the decision that this matter should have received the attention it did even with the knowledge that had these same efforts been expended in other areas, the Association may have moved ahead in other areas, while drifting still farther from the stated objective of unity in the profession. 4.9-Several developments occurred since the 1971 annual meeting related to the issue of organizational unity. Among these was the continuation of the meetings of the Ad Hoc Committee of the Board of Directors of the American Society of Hospital Pharmacists (ASHP) and the Board of Trustees of the American Pharmaceutical Association which had been appointed to review the relationship between the two organizations. During the discussions held by this Ad Hoc Committee, it became apparent that the organizational problems confronting the profession today and in the future must be faced with a broad perspective and objective attitude. The respective boards were of the general agreement that the Association and ASHP should consider holding an open conference where interested pharmacy organizations and individuals would have an opportunity to participate in discussions concerning the organizational restructuring of American pharmacy. 4.10-During the fall of 1971, calls for "summit meetings" to discuss the unification of pharmacy were issued by the National Council of State Pharmaceutical Association Executives (NCSPAE) and by the American College of Apothecaries (ACA). Replies by the Association and the ASHP to these invitations stated the feeling that the Association was the proper organization to sponsor such a conference and that a meeting would be called at the appropriate time. 4.11-ln September 1971, the National Association of Retail Druggists (NARD) offered to host a meeting of the Association, ASHP, ACA and NCSPAE representatives on October 8, 1971, just prior to the NARD annual meeting in New OrJ,eans. The conference resulted in agreement between the Association and NARD on three points. The Association accepted the NARD proposal for the executive bodies of the two Associations to meet twice annually. It was

Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION

agreed that NARD and the Association would consider presentation of a joint statement before the House Ways and Means Committee on national health insurance. The NARD accepted an invitation of the Association and ASHP to participate in a meeting to consider the creation of a task force to study the organizational needs of the profession of pharmacy. The committee reviewed the difficulties encountered in attempting to schedule an early date for the joint APhA/ ASHP/NARD meeting, which was mutually acceptable to the three organizations. At the time of the final meeting of the commilJtee, the date of March 3, 1972, had been set for the joint meeting. 4.12-The members of the APhA House of Delegates have positions of leadership and responsibility, not only in the Association but also in other pharmacy organizations. It is the opinion of the committee ·that the delegates have the opportunity and responsibility to translate the dialogue at unity conferences into positive, constructive action at every level of organized pharmacy. The committee believes that the key to sucoessful discussions regarding the design and implementation of an improved organizational structure for pharmacy lies in the adoption of a policy and attitude of commitment to the organizational unity in the profession by every pharmacy organization. The commitment to this objective on the part of every organization should transcend self-interest on the part of the organizations involved. Only by adoption of such a sincere attitude will efforts toward restructuring organized pharmacy be productive. 4.13-Pharmacists everywhere have expressed the desire to see something constructive done about the duplication, opposition and inefficiency which so often characterizes the present organizational structure of American pharmacy. The committee feels that its recommendations (4.1,4.2 and 4.3) offer a challenge and opportunity to each and every pharmacist to become personally involved in the effort to do something about the problem that has been recognized for so long by so many. Mark J. Sullivan, chairman Kathleen A. McGee, vice chairman Rinaldo A. Brusadin Richard C. Carroll Joseph L. Fink III Mary L. Munson Thomas W. Rorrer William F. Schaffer Gale W. Stapp Margaret M. Szymczak Jack G. Watts

Public Affairs Reference Cotntnittee Report

Irving Sprugasci

The Reference CDmmittee considered the report of the Policy Committee on Public Affairs. The Reference Committee recommends adoption of the entire report but believes that the following comments are in order: 1. With regard to Section 1 of the report som~ concern was expressed that the statement, "it is the patient, as the recipient, who shDuld have the final right to accept the drug product selected by the pharmacist," might be interpreted to mean that patients should be able to dictate to prescribers or pharmacists that a particular drug entity or drug product must be dispensed to them. That is not tqe case nor was such implication intended by the PoHcy Committee. The statement referred to merely recognizes that while a patient cannot force the prescribing of a particular drug entity against the prescriber's will or the dispensing of a particular drug product against the pharmacist's will, neither can the prescriber or pharmacist force a particular drug

entity or drug product upon a patient against the patient's will. The Reference Committee wishes to emphasize that the intent of all of the guidelines suggested by the Policy Committee is to increase communication between patients, prescribers and pharmacists to give real meaning to the often-referred to "physician-pharmacist-patient rela tionship."

3. With regard to Section 4 .of the report, it is the understanding of the Reference Committee that reference to a particular pending Senate bill does not preclude support for any similar bill which may bear a different number nor does it bind the Association to support the referenced bill if it is subsequently amended so as to .materially change its present substance.

2. With regard to Section 2 of the report, several speakers before the Reference Committee stated that the recommendations regarding repeal or amendment of state prophylactic laws should not be interpreted as support for distribution of prophylactic devices outside of pharmacies. The Reference Committee concurs and understands that such was not the intent of the Policy Committee. which focused on correcting restrictions which presently prevent pharmacists from performing an important professional function.

With those explanatory comments, Reference Committee recommends the adoption of the entire report of the APhA Policy Committee on Public Affairs, and I so move. Irving Sprugasci, chairman Donald V. Vaught, vice chairman George F. Kramer Tom S. Miya Howard W. Nelson Theodore W. Tober James D. Wagner

[The House adopted the Reference Committee's recommendations as presented.]

Public Affairs 1. Pha.,macist-Patient Relationship Recommendation: t.t-The committee recommends that the Board of Trustees prepare and distribute as promptly as possible a "White Paper" on the subject of promotion of prescription drugs and professional services to the public. 1.2-The committee recommends that the Association adopt the suggested "Pharmacy Guidelines Governing Relationships Between Pharmacists, Pa-

tients and Prescribers" (Section 1.18) and that these guidelines be supplemented or revised from time to time by the House of Delegates or Board of Trustees as necessary. Background: 1.3-The Association has taken beginning steps toward improving communication between pharmacy and "consumers." However, at the local level, pharmacists still require guidance with regard to their professional

conduct toward patients and also prescribers, particularly in the areas of selection of drug products and the explanation of costs of pharmaceutical service. Patients and prescribers are often confused and misled by unwarranted or unsupportable statements relating to drugs and the profession of pharmacy. 1.4-Virtually all policies of the Association have some effect on patientconsumers. From its founding in 1852, APhA has established a record Vol. NS12, No.6, June 1972

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of service to the public through its leadership by continually seeking improvement in the profession of pharmacy and the performance of pharmaceutical service functions. 1.S-In 1968, for example, the House adopted as policy certain standards of professional conduct for pharmacists concerning instructions to patients regarding proper administration of prescription drugs. In 1969, the APhA Committee on Economic and Social Relations discussed the subject of "price" advertising of prescription drugs in terms of their adverse effect on the public. It called on the Association to inform consumer interest groups concerning the APhA position on this subject. 1.6-In 1970, the APhA Policy Committee on Public Affairs considered specifically the subject of "consumerism" and recommended a policy calling for closer pharmacy liaison with consumer groups at the national and local levels. The sense of the committee's recommendation, which was subsequently adopted by the House, was that pharmacy must initiate more vigorous and more effective efforts to assist consumer understanding of the pharmacist and his role in the health care system. 1.7-The 1971 annual meeting found the APhA Policy Committee on Public Affairs echoing prior calls for action. This time, however, the committee focused on two specific areas of concern and recommended specific activities. The committee's recommendations were again adopted by the House. These recommendations were that the Association should undertake to bring to the attention of the public, as well as the government and other health professions, the adverse effects of promoting prescription drugs to the public by any means. With regard to the question of the cost of pharmaceutical service, the committee recommended that the Association undertake generally to provide the public with facts concerning pharmaceutical service and charges. Specifically, the committee recommendeda. The Association should develop informational materials designed to provide the public with factual information concerning pharmacy practice and charges for pharmaceutical services and that such materials be distributed by the Association, state associations and individual pharmacists. b. The Association should hold a national meeting for consumer groups, government officials, the press and others for the purpose of airing the needs for cost information and problems involved in providing it. 302

Such a meeting should also seek to inform attendees of the nature and scope of pharmaceutical service. 1.8--Shortly after completion of the 1971 annual meeting, staff met with the executive director of the Consumer Federation of America to discuss the consumerism movement generally and to obtain her view with regard to the specific recommendations of the APhA Policy Committee on Public Affairs. Her reaction to the course adopted by the House was generally favorable except that she did not feel a national conference of consumers would be feasible because of the lack of financing available to support the attendance of individual consumer representatives. She pointed out during the discussion, however, that sophisticated leaders among the consumer movement were generally aware that the consumer is often iIIserved"" the "lowest price." She emphasized that the consumer's most important interest lies in obtaining the "best value," recognizing that this frequently requires paying more than the lowest price. 1.9-ln addition to the contact with the Consumer Federation of America, staff had some discussion with officials in the office of President Nixon's Consumer Advisor, Mrs. Virginia Knauer. Interest was expressed in the concept of a national meeting. 1.10-The consumerism issue was also discussed at a meeting of affiliated state association executives in light of the then apparent unfeasibility of a national meeting. The state executives felt it would be beneficial were the Association to sponsor a workshop for pharmacy leaders with the participation of knowledgeable consumer representatives. This workshop was seen as assisting and better preparing state and local pharmacy leaders to participate in consumer-oriented activities at the state ~nd local levels in accordance with the 1970 policy position of the House. l.ll-The specific activities recommended for the Association have not yet been consummated. Nonetheless, preliminary steps have been taken and some affirmative results achieved in terms of gauging reaction to various issues and identifying potential sources of assistance. l.ll-For example, staff has had several discussions with members of the Stern Community Law Firm, a public interest law firm with offices in Washington, D.C., and California, which is ~uppor.ted by foundation funds. Origmally mterested only in the subject of drug promotion and "pricing," its interest has now been expanded to in-

Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION

c1ude the role of the pharmacist as a health care professional. The Stern firm has begun to shift its orientation somewhat from consumer advocacy and litigation to consumer education. It has expressed an interest in working with APhA to develop consumer education projects relating to drugs and pharmacy. 1.13-APhA and pharmacy received very affirmative press reaction with regard to testimony presented in congressional hearings with regard to o-t-c drugs. This testimony made clear the profession's patient orientation and recognition of pharmacists' professional responsibilities with regard to this class of drug products. 1.14-ln this regard, the APhA Handbook of Non-Prescription Drugs was recently widely praised and publicized by the consumer pUblication, Moneysworth, which has purchased outright from the Association several thousand copies for resale to the pUblic. While APhA has never promoted the Handbook for sale to the public, the fact remains that much useful information within the understanding of laymen is contained in the Handbook, and its wide distribution should benefit not only the public but the profession and the Association as well. 1.1S-The foregoing are merely some examples of Association activity faIling within the area of consumer activities. Staff has also regularly responded to consumer correspondence and articles criticizing pharmacy. 1.16-There still clearly exists a substantial degree of concern among pharmacists about the image of pharmacy as a profession and their day-to-day relationship with consumers. Many expressions of such concern have been heard at pharmacy meetings throughout the country. Much correspondence received by the Association from pharmacists reflects a growing sensitivity to these issues, particularly the subject of "the cost of prescription drugs." 1.17-During the past year controversy has forced pharmacists to consider the question-"To whom does the pharmacist owe his primary professional obligation-the physician or the patient?" One of the most serious concerns of pharmacists who have opposed the Association's position on drug product selection has been the feared adverse effects such a position would have on "interprofessional relations." At the organizational level, such an effect is readily apparent in the vocal and continuous criticism by the American Medical Association and other medical organizations directed at APhA and pharmacy. At the same

time, however, on the personal relationship level, the relationship between pharmacists and physicians has apparently never been better. The Association has been made aware of numerous instances in which prescribers have been enthusiastic in their willingness to have pharmacists perform the drug product selection functi~n. This trend is evidenced by the contInual, although slow, expansion of generic prescribing and by the large number of requests by pharmacists for Drug Product Selection Authorization forms prepared by the Association. 1.18-A major problem remains in communicating professional standards and obligations to practicing pharmacists in a way which will cause them to direct their attention to these issues and which will, at the same time, pr~­ vide them some guidance as to their solution in day-to-day practices. As one way of achieving this goal, the committee has developed the following guidelines for pharmacistsPreamble The pharmacist is an independent professional provi?ing health care services to the pubbc and e~­ trusted by society with the responsIbility for the safekeeping, distribution and safe use of drug products. The APhA Code of Ethics sets ethical standards for pharmacists and makes c~ear that the pharmacist's primary obbgation is to the patient. At the same time, pharmacy has alwa~s worke.d closely on an interprofesslOnal baSIS with physicians and other h~alth c~re professionals to provide patients With the highest standards of health care in the interest of public health. The purpose of these guidelines is not to supplant the APhA Code o~ Eth~cs but rather to provide pharmaCists With professional guidance in some common situations they experience in day-today practice.

a. Charges for Pharmaceutical Service Patients have a right to know upon request the cost of pharmaceutical service including the cost of drug produdts, prior to the providing of such service or drug products by the pharmacist. No request for such information should ever be refused when the pharmacist is aware of the service or drug products to be provided. For his part, the pharmacist has a right to know with certainty the nature of the service and the drug products required by the patient. In the case of a written prescription order, the pharmacist has a right to examine the prescription order before quoting costs. This protection fO.r bot? the pharmacist and the patient IS necessary because of frequent inability of the patient to correctly interpret the prescription order and because the cost of different drug products, even of the same generic

class, is subject to wide variation. Neither the patient nor the pharmacist should be penalized because costs of service or drug products are quoted on the basis of incorrect assumptions by either. A pharmacist should explain any refusal to quote costs via the telephone in the above terms. b. Nature of Pharmaceutical Service Pharmacists should undertake to inform patients fully regarding the nature of the pharmaceutical service they provide in addition to dispensing drug products. This service may include patient medication records, consultation, emergency service, delivery and other functiolls. Information regarding the pharmacist's professional training should also be freely provided patients so that they will understand that the pharmacist is not merely someone who "sells drugs." Patients should be encouraged to select a family pharmacist on the basis of the service he provides measured against the cost of that service. The pharmacist's goal should always be to provide the patient the best health care "value" for his expenditures, and both the pharmacist and the patient must understand that value is not measured in terms of "price" alone.

c. Personal Relations Between Pharmacist and Patient The pharmacist owes an obligation to each patient as an individual. He should make every effort to know and respect each patient as such. Further, the pharmacist must personally ensure that the patient understands all relevant information rel!j.ting to drug products prescribed for him. This responsibility cannot be delegated to untrained personnel and cannot be neglected in cases where drug products are delivered to the patient rather than presented to him personally. In the delivery situation, either written instructions or personal communication is dictated. In modem pharmacy practice the pharmacist can be greatly assi~ted in providing patientoriented service by maintaining and using a patient medication record system. Such a system is not only basic to the providing of full pharmaceutical service in the interest of the patient's health but is one of the most effective devices for communicating to the patient the nature of the service performed by the pharmacist.

d. Drug Product Selection It is the pharmacist's responsibility to provide a quality drug product at the lowest possible cost consistent with high quality standards. It is the prescriber's privilege to pr~­ scribe either by brand or genenc name' the drug required by his patient.' Ultimately, however, it is the patient who is obtaining the drug product for his own use, and it is

the patient who is responsible for implementing his own drug therapy. While the law requires a prescription order for the dispensing of certain types of drugs, it is the patient, as the recipient, who should have the final right to accept the drug product selected by the pharmacist. To the extent existing "antisubstitution" laws prevent the patient from exercising this right with the guidance of the pharmacist, they impinge on the patient's basic right to provide himself with health care according to his ability or desire to do so. The pharmacist should assist the patient in making a decision as to the drug product he is acquiring or make that decision himself on behalf of the patient when the patient so desires. The pharmacist must also have the option to refuse to stock particular products if. in his professional judgment, they do not meet acceptable quality or reliability standards, and he cannot be required to dispense a particular product to a particular patient if, in his professional judgment, that dispensing is not in the patient's best interest. Legally and professionally, the pharmacist is required to exercise an independ~nt, professional judgment in performmg pharmaceutical service functions. Blind, unthinking conformity to another's opinion or instructions satisfies neither the pharmacist's legal nor professional obligations. e. The Pharmacist's Obligation to Prescribers Ideally, the pharmacist and the prescriber work with one another on the basis of mutual trust and respect to provide the highest quality health care for patients. The prescriber is an expert in the diagnosis and treatment of disease; the pharmacist is an expert in drugs and drug products. In their relationship, neither should assume that he knows more than the other in his respective area of specialization. As the most highly trained expert on drugs a',ld drug products, the pharmacist should serve as a primary source of drug information for the prescriber. His expertise should be exercised and his advice given fully and freely without fear of prescribers or others. Similarly, the pharmacist should inform the prescriber generally of the drug products he stocks and dispenses and specifically of the drug products he has dispensed to t.he prescriber's patient when such mformation may significantly affect the patient's therapy. In his dealings with prescribers, the pharmacist must always keep uppermost in his mind that each profession owes its primary obligation to the patient. In his relations with patients, the pharmacist must also avoid any unnecessary interference in the relationship between the patient and the prescriber. Vol. NS12, No.6, June 1972

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I

2. State and LoeaI Propbylactic Laws

Recommendation: 2.t-The committee recommends that the Association support the repeal of state and local laws which act to prevent pharmacists from participating with maximum effectiveness in efforts to combat venereal disease by restricting the availability within pharmacies of prophylactic devices and dissemination of information regarding" their use. 2.2-The committee recommends that the Association support the principle that state and local laws controlling the distribution of prophylactic devices should require that open display and advertising of prophylactic devices be accompanied by the distribution of educational materials relating to venereal disease prevention and contro/. 2.3-The committee recommends that the Association call upon all producers of such devices to include in or on their packaging adequate instructions for use so as to better ensure the effectiveness of the devices in the prevention of venereal disease. 2.4-The committee recommends that the Association urge pharmacists, to the extent presently permitted by law, to make more readily available to the public educational materials, prophylactic devices and adequate instructions for use in combating venereal disease. Background: 2.S-ln 1970, the APhA Policy Committee on Public Affairs recommended that venereal disease prevention be given high priority as an APhA public education program, noting....There is no question but that the profession of pharmacy can assume a vital role in eradicating venereal disease. The disease is on the ascendancy in this country with estimates projecting that almost two million people will be infected. This recommendation resulted in part in adoption of venereal disease prevention as the theme for National Pharmacy Week, 1971. 2.6-The recommendation envisioned that the pharmacist, as the most accessible member of the community health team, would have an active role in the prevention of venereal disease by disseminating accurate and frank information to all members of the community. The pharmacist was seen as taking a leadership role in supplying the public with the essential knowledge needed for an educated and rational approach to the prevention of venereal disease. This educational activity would complement and 304

make more effective the pharmacist's role in distributing condoms for venereal disease prevention. 2.7-Despite numerous press, magazine, radio and television campaigns to increase the public's awareness of the problem, there are still many persons, both male and female, who are hesitant to discuss the problem and the prevention of venereal disease. Although the pharmacist is recognized in the community as the source of condoms, many persons are often too embarrassed or too afraid to ask the pharmacist for them or the personal counseling which may be required for their proper use. 2.8-This psychological barrier is often likely created, and at least reinforced, by the fact that condoms are not even as freely accessible as overthe-counter contraceptive products but are usually secreted away in the prescription department of the pharmacy. The entire atmosphere surrounding the distribution of condoms is negative and suggests that the user deserves community disapproval. This total atmosphere is also created or reinforced by laws which prohibit the open display and advertising of condoms. 2.9-ln the committee's view, it is nonproductive to engage in arguments regarding the morals-or lack of them -of the country in considering the problems of venereal disease. The well-documented fact is that sexual activity in today's society is less restrained than in the past, that developments such as "the PilI" and liberalized abortion laws tend to negate prior restrictions relating to sexual activity. One result of these recent influences, as well as a substantial change in society's basic attitude toward sex, is that venereal disease has reached epidemic proportions in many areas of the country. 2.10-A recent estimate has placed the direct government and taxpayer cost of syphilis and gonorrhea at a minimum of $145 milIion a year. An estimated 540,000 persons are infected with syphilis in the United States at the present time. If these are not found and treated, one in 13 may be expected to develop syphilitic heart disease, one in 25 may be expected to become crippled or otherwise physically incapacitated; one in 200 may be expected to become blind from syphilis; and one in 44 may be expected to finish his life in a mental institution with paresis or syphilitic insanity. Together, these diseases are striking one American every 15 seconds-or four cases a minute-with gonorrhea itself accounting for 2,000,000 cases a year. In the interest of public health, all available means should be utilized to

Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION

combat this threat. One weapon is to insure that psychological barriers do not prevent the public from obtaining and correctly using prophylactic devices. 2.11-Today there is a problem of treatment. Penicillin is the drug of choice for both syphilis and gonorrhea. Penicillin is effective against syphilis when caught in time. However, gonorrhea is developing resistance to penicillin. Only 15 years ago 75,000 units of penicillin could clear up a case of gonorrhea. Today, it takes as much as 4,800,000 units of penicillin in females, and even this dosage is not always effective. There is no vaccine available for either syphilis or gonorrhea at this time, although some research successes are being achieved. 2.12-ln the view of most public health experts, prevention is the chief weapon against venereal disease. Dr. William J. Brown, former chief of the Venereal Disease Section of the Center for Disease Control of the United States Public Health Service, the highest-ranking among all medical professionals in the field of venereal disease, has said, "Prevention is the long neglected stepchild in the whole field of venereal disease control." Dr. Warren Ketterer, chief of the Venereal Disease Branch of the California State Public Health Department, has stated, "Prevention, meaning the condom, is the only hope for bringing venereal disease under control." 2.13-As noted, a major obstacle to venereal disease prevention is that a majority of states and many municipalities, by statute or ordinance, prohibit the display or advertising of condoms or their packages in pharmacies and provide penal sanctions for those violating these laws. Some efforts to remove the impediments created by such laws have already been instituted. For example, at the urging of the California Pharmaceutical Association, two bills have been enacted by that state's legislature. Senate Bill 650, introduced by Senator Behr, eliminated the flat prohibition against public display and advertising of condoms by providing that such display and advertising is permissible if accompanied by educational information relating to veneral disease prevention. Senate Bill 1030, also introduced by Senator Behr, provides, for the purpose of eliminating any possible conflict with S.B. 650, that existing prohibitions on the advertising of means for the prevention of conception be removed. 3.

Drug Product Advertising

Recommendation: 3.1-The committee recommends that

the Association seeks to establish, with the cooperation and support of the drug industry, a public education fund to produce educational materials, particularly for broadcast use, whichwould develop public awareness of proper drug use and of the dangers inherent in improper drug use and which would emphasize the necessity for professional consultation for and supervision of drug therapy. .- /3.2-The committee recommends that the Association work to ensure that la1;leling and promotional materials for proprietary drug products direct attention to instructions regarding precautions and proper use of such products and identify the pharmacist as a source of information and advice regarding self-medication. Background:

3.3-ln its 1971 report, the APhA Policy Committee on Public Affairs discussed extensively the subject of promotion of prescription-legend and nonlegend drugs to the public. At that time, the committee recommended -and the House of Delegates adopted as Association policy-a call for preuse clearance of nonlegend drug ,advertising by a government agency or joint government-industry committee. The committee also recommended and the House agreed that, as of that time, the Association should not support a flat ban on nonlegend drug advertising. Also the House adopted the committee's recommendation that the Association should urge voluntary compliance by manufacturers of over-the-counter drugs with advertising guidelines such as those promulgated by the National Association of Broadcasters. 3.4-The committee is extremely gratified to report its observation that significant improvement in the quality of non-prescription drug advertising has occurred during the past year. In the committee's view, some proprietary manufacturers have refocused their advertising campaigns toward providing information and away from purely commercial promotional appeals. 3.5-The committee believes that this healthy development will be greatly enhanced by action of the Television Code Review Board of the National Association of Broadcasters in December 1971. At this time, the Television Code Review Board announced its intention-subject to the approval of the National Association of Broadcasters board of directors-to adopt the following standardIn commercials for over-the-counter (proprietary) drug products, if ingredients are referenced in a manner which relates to product efficacy, di-

recdy or indirectly, the common names or easily understood description of the ingredients must also be referenced. 3.6-ln addition, the Code Review Board took other actions to control the frequency and quality of television advertising generally and of some proprietary products specifically. For instance, the Code Review Board determined that hemorrhoid product advertising would be acceptable subject to claim documentation and maintenance of high taste standards and directed its Code Authority to serve as "central clearance" for this kind of advertising. 3.7-Thus, the committee believes that responsible steps are being taken which would help to achieve Association goals with regard to non-prescription drug advertising stated in 1971. 3.8-At this time, the committee believes that further steps can be taken to help assure that non-prescription drug advertising serves not only the interest of manufacturers of such products but also the public. Specifially, the committee believes that such advertising should refer the public directly to the product's labeling for any applicable warnings and also to the pharmacist as a source of information and advice regarding the use of the product and self-medication generally. 3.9-The committee also believes that both the profession and the drug industry have a responsibility to the public to perform an educational function regarding the inherent dangers of improper drug use and the necessity for professional consultation and supervision of drug therapy. The committee believes that all media can effectively be used for this purpose and further believes that a public education fund supported by the profession and the industry should be developed for this purpose. Such a public educational campaign can be conducted so as to benefit the public by increasing public awareness that "drug abuse" is not merely a crime problem, can benefit the profession by increasing the public's awareness of the pharmacist and his health care role and can benefit the industry by increasing the public's awareness of the industry'S dedication to combating the abuse and misuse of drugs. 4.

Federal Food, Drug _and Cosmetic Act Biological Criteria Amendments

Recommendation:

4.1-The committee recommends that the Association support S.3254 which

would require pharmaceutical manufacturers to disclose all pertinent data relating to a drug product's biological characteristics. Background: 4.2-Senator Gaylord Nelson of Wisconsin introduced S.3254, on February 29, 1972. This bill would require all pharmaceutical manufacturers to include in New Drug Applications a definitive statement as to what, if any, biological characteristics must be exhibited by the drug entity in order that the drug be safe and efficacious.

4.3-The legislation would amend the Federal Food, Drug and Cosmetic Act to require manufacturers to disclose factors such as blood level concentrations, .excretion rates and other biological criteria which are essential to the proper performance of their drug products. This information would be made available to the Food and Drug Administration which must approve the drugs. The legislation would also require that such information be included in the product labeling, thereby making it available to pharmacists and physicians who must dispense and prescribe the drug products. 4.4-S.3254 would help put to rest much of the controversy surrounding drug product selection and the modification of state antisubstitution laws by requiring each manufacturer to define the specific performance criteria essential to the drug. If a manufacturer cannot establish that certain biological characteristics are essential to a drug's effectiveness, he will be obliged to make a declaration to that effect. 4.5-S.3254 would preclude unwarranted claims of drug product superiority. The bill will help prescribers and dispensers to evaluate and compare biological performance of competing drug products on the market. It is also envisioned that patients will be afforded the benefits of cost savings resulting from product selection by the pharmacist. William J. Edwards, chairman James D. Wagner, vice chairman Donald W. Arthur James E. Hodges Warren J. Kingdon Howard W.Nelson David A. Schlichting Isadore Singer Howard Sudit Joe D. Taylor J. Roger Vadheim Vol. NS12, No.6, June 1972

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Professional Affairs Reference Committee Report

The Reference Committee on Profesional Affairs con idered the report of the APhA Policy Committee on Profe ional Affairs. The Reference Committee heard considerable di CllS ion regarding the recommendation contained in Section 1. The Reference Committee is aware of the need to give attention to defining term u ed in contemporary pharmacy practice and, therefore, urges that the A ociation continue in its efforts to arrive at definitions of terms which relate to all aspects of pharmacy practice. The Reference Committee gave seriou con ideration to the discussion raised with regard to the recommendations contained in Section 2. The Reference Committee recognizes that the Food and Drug Administration has proposed regulations restricting the prescribing and dispensing of methadone. Generally, the Reference Committee and others speaking to the subject concur in the FDA efforts to control the distribution and utilization of methadone. In fact, the Committee's recommended policy would be more restrictive than that proposed by FDA.

The Reference Committee wishes to point out, however, that one aspect of the FDA proposal would create an unacceptable precedent for pharmacy practitioners. For the first time, the FDA proposes to have its legally required decision regarding safety for use depend on the channel of distribution of a drug entity rather than its therapeutic purpose. Thus, FDA proposes to permit the use of methadone as an analgesic but only if the drug is dispensed through hospital pharmacies on either an inpatient or outpatient basis. In the view of the Reference Committee, this proposal will create a situation essentially similar to that regarding methotrexate and, as an ASHP representative pointed out in the Reference Committee hearing, a similar situation would also be created in the case of triethylenemelamine, in that it would unreasonably restrict the dispensing of an approved drug by pharmacists. The Reference Committee feels that adoption of the recommendations in Section 2 of the report will make clear the Association's opposition to denying any pharmacy practitioner any professional rights available

to other . pharmacy practitioners. Therefore, the Reference Committee recommends the adoption of Section 1, 2, 3, 4 ,!-nd 6 of the report of the APhA Policy Committee on Professional Affairs, and I so move. It was the consensus of the Association members speaking at the Reference Committee hearing that further study should be given to Section 5. Accordingly, the Reference Committee recommends the referral of Section 5 of the report of the APhA Policy Committee on Professional Affairs back to the Committee for further consideration, and I so move. Wallace S. Klein Jr., chairman Angele C. D'Angelo, vice chairman J. Homer Boutwell Doyle F. Harrell William J. Hod·a pp Maven J. Myers Janet E. Oates

[The House adopted the Reference Comlmittee's recommendations as presented except for Secti,on 5.2 which was referred back to the committee of origin.]

Professional Affairs 1.

Report of the Task Force on the Definition of Clinical Pharmacy, Institutional Pharmacy and Group Practice Recommendation: 1.1-The committee recommends that the APhA House of Delegates receive the report of the Task Force on the Definition of Clinical Pharmacy, Institutional Pharmacy and Group Practice. 306

1.2-The committee recommends that the Association adopt as policy the following statement on "pharmacy practice"-

be considered "clinical" is the assurance of safety and efficacy in the prescribing, administering and use of drugs and related ,articles.

Pha:rmacy practice is defined as that personal health service that assures safety and efficacy in the procuring, storing, prescribing, compounding, dispensing delivering, .administering and use of drugs and related articles. The aspect of pharmacy practice that can

Clinical experience is a part of "pharmacy practice," regardless of environment. However, the environment in which a pharmacist practices may determine some of the functions performed by him and may affect his degree of clinical involvement.

Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION

Most practitioners exercise some degree of clinical involvement in their practice. All practitioners should involve themselves in the clinical functions of pharmacy that will result in increased patient-oriented "pharmacy practice." Because the term "clinical" describes those functions of "pharmacy practice" in which evaluations and sound judgments are made regarding a patient's drug therapy, pharmacy should not be identified as "clinical pharmacy," and pharmacists should not be identified as "clinical pharmacists." While clinical functions of pharmacy practice do not constitute a specialty at this time, continued involvement of the pharmacist in patient-oriented activities may eventually lead to the development and recognition of a specialized area.

Background: 1.3-The following is a report of the Task Force on the Definition of Clinical Pharmacy, Institutional Pharmacy and Group Practicea. During its 1970 session, the APhA House of Delegates adopted the following report of the APhA' Policy Committee on Organizational Affairsl.l-The committee recommends that the Association sponsor a special conference (including representatives of the American Association of Collegcs of Pharmacy, the American Society of Hospital Pharmacists, the APhA Academy of General Practice of Pharmacy and such other organizations as are indicated) to define the terms "clinical pharmacy" and "institutional practice" because of the multitude of definitions which have been used by various pharmaceutical organizations and the pharmaceutical press. 1.2--The committee recommends that, if the special conference reaches a consensus on the definition of these terms, such definitions by widely publicized through official APhA publications, news releases and other methods with appropriate explanatory remarks. b. In implementing this mandate from the House, the APhA Board of Trustees authorized the appointment of a task force consisting of representatives from the organizations mentioned in the committee report to consider the definition of "institutional pharmacy" and "clinical pharmacy." In addition, the Board also required that the task force consider defining the term "group practice." c. The Task Force appointed consisted of two representatives from the APhA Academy of General Practice of Pharmacy, the Student APhA, the American Association of Colleges of Pharmacy, the American

College of Apothecaries, the American Society of Hospital Pharmacists, the National Association of Boards of Pharmacy and the National Association of Retail Druggists. The following were the organizational representatives appointedAPhA Academy of General Practice of Pharmacy W. James Bicket Richard P. Penna Student American Pharmaceutical Association Raymond L. Sattler Ronald L. Williams William F. McGhan American Association of Colleges of Pharmacy Varro E. Tyler Warren E. Weaver American College of Apothecaries Russell A. Benedict American Society of Hospital Pharmacists Herbert S. Carlin Joseph A. Oddis National Association of Boards of Pharmacy Daniel A. Nona Paul G. Grussing National Association of Retail Druggists Nick M. Avellone William E. Woods d. Donald C. Brodie, director, Pharmacy Programs Branch, Special Research and Development Projects Division, National Center for Health Services Research and Development, Department of Health, Education, and Welfare, was invited as an observer. e. The Task Force met on February 3, 1971, and July 14, 1971. In its discussions regarding the definition of "clinical pharmacy," the Task Force was of the opinion that it would be more appropriate and in the best interest of the profession if "pharmacy practice" was defined and a statement issued describing those functions of pharmacy practice that could be considered "clinical." The Task Force wished to place the term "clinical" in perspective for the profession. Concern was expressed by members of the group that pharmacists were identifying themselves as "clinical pharmacists" or describing their practice as "clinical pharmacy" without any appreciation as to what the term means or the confusion it was causing within and outside the profession. f. The following statement on pharmacy practice was agreed upon by the Task ForcePharmacy practice is defined as that personal health service that assures safety and efficacy in the procuring, storing, prescribing, compounding, dispensing, delivering, administering and use of drugs and related articles. The aspect of pharmacy

practice that can be considered "clinical" is the assurance of safety and efficacy in the prescribing, administering and use of drugs and related articles. Clinical experience is a part of "pharmacy practice," regardless of environment. However, the environment in which a pharmacist practices may determine some of the functions performed by him and may affect his degree of clinical involvement. Most practitioners exercise some degree of clinical involvement in their practice. All practitioners should involve themselves in the clinical functions of pharmacy that will result in increased patient-oriented "pharmacy practice." Because the term "clinical" describes those functions of "pharmacy practice" in which evaluations and sound judgments are made regarding a patient's drug therapy, pharmacy should not be identified as "clinical pharmacy," and pharmacists should not be identified as "clinical pharmacists." While clinical functions of pharmacy practice do not constitute a specialty at this time, continued involvement of the pharmacist in patient-oriented activities may eventually lead to the development and recognition of a specialized area. g. In discussing a definition for "institutional pharmacy," the Task Force was of the unanimous opinion that "clinical pharmacy" and "institutional pharmacy" are not synonymous. An editorial published in the American Journal oj Hospital Pharmacy (January 1971) stated: At the same time we disavow any attempt to relate clinical pharmacy to locus of practice by definition, reaffirming our belief that specialties of pharmacy should be identified by function rather than environment, we do not question that environment is extremely important to the manner in which pharmacy is practiced. h. The Task Force reviewed a number of definitions for "institutional pharmacy," but they all centered on the location of practice as their basis. The Task Force was unable to define "institutional pharmacy" along functional lines. i. In discussing a possible definition for "group practice," the Task Force observed that, as it appears today, "group practice" can be described in terms of (1) business arrangement in which practitioners share common expenses such as billing, secretarial and laboratory but remain essentially solo practitioners; and (2) a professional practice arrangement in which practitioners of Vol. NS12, No.6, June 1972

307

varying specialties associate for the purpose of providing health ~are. While the former concept (busmess amlOgement) need not require the latter (practice arrangement), the latter of necessity requires an effective business arrangement in order to function. j. It was the consensus of the Task Force that what most pharmacists describe as "group practice of pharmacy" today is the business arrangement form of "group practice." The Task Force felt that the preferred type of "group practice" is a true interdisciplinary group in which pharmacist, physician, dentist and other health professionals are united in an effective business organization and practice arrangement in which each contributes his own specialized functions in providing quality health care. The Task Force is wen aware, however, that medical practice acts and medical/ethical constraints presently prevent such arrangement from being established. k. In the course of the Task Force's deliberations, the subject of specialties in pharmacy arose on several occasions. As an exercise, the Task Force attempted to identify pharmacy practice areas which could be considered as "specialties." This exercise served to identify for the Task Force the need to identify specialties in terms of the functions associated with the specialty rather than the location where the functions are performed. Furthermore, the Task Force realized that for specialties to exist, they must not only be identified and described, but a formal certifying body officially recognized by the profession must exist to admit those who qualify to the specialty.

l.4-During the committee's discussion of the statement on "pharmacy practice," one member questioned the completeness of the definition of "pharmacy practice" (see minority report) . It was the consensus of the committee, however, that the term "personal health service" included in the definition implies the provision of service to individual patients as well as patients collectively. Furthermore, the committee felt that the functions of manufacturing and analysis are implied in the functions of "compounding." The committee also felt that judgmental activities are involved with each function performed within the context of "pharmacy practice" (judgments and decisions are integral parts of a professional act) and should not be singled out as a separate function performed in the practice of pharmacy. The majority of the committee is of the opinion, therefore, that the definition of "pharmacy practice" as developed by the Task Force included those functions specified in the minority report. 308

Minority Report of Dr. Franz W. Geisz I.S-While there was a unanimous opinion that the statement is generally a good one, there was a minority view that the definition of pharmacy is incomplete. 1.6-Two aspects were considered. One is that even considering present technological advances, there is no need to abandon traditional pharmacist roles, such as manufacturing and analysis. The other is that emphasis should be placed upon the professional aspects of a professional ministering to the needs of his patient as an individual service rather than rendering a personal service to an institution or a mass of patients. 1.7-Therefore, the minority opinion is that the APhA House of Delegates, in its normal review of the statement of the Task Force, consider adding the underlined words to this otherwise excellent statement"Pharmacy practice" is defined as that personal health service that assures judgment, safety and efficacy to a particular patient in the procuring, storing, prescribing, compounding, dispensing, delivering, administering, manufacturing, analysis and use of drugs and related articles. 2. Legal Status of Methadone Recommendation: 2.I-The committee recommends that the Association develop necessary information to encourage those currently engaged in or contemplating methadone programs to place pharmacists in charge of their drug distribution and control systems. 2.2-The committee recommends that the Association seek the withdrawal of Food and Drug Administration approval of methadone for its indications as an analgesic and antitussive. 2.3-The committee recommends that until Food and Drug Administration approval of methadone for its indications as an analgesic and antitussive is withdrawn, the Association urge pharmacists to discourage the prescribing of methadone as an analgesic or antitussive. 2.4-The committee recommends that the Association urge pharmacists receiving prescription orders for methadone to ensure that the drug has been prescribed for a currently acceptable medical use; and, if such ensurance cannot be obtained, the prescription order should not be dispensed. Background: 2.S-At the 1970 annual meeting of the Association, the APhA House of Delegates adopted four recommendations of the APhA Policy Committee on Professional Affairs pertaining to "Methadone in Treatment of Narcotic

Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION

Addiction" (Journal of the American Pharmaceutical Association, NSIO, 6, pp. 355-6, June, 1970). Since that time, a number of developments in this area indicate the prudence of re-examining this issue. 2.6-0n April 2, 1971, the Food and Drug Administration and the Bureau of Narcotics and Dangerous Drugs published in the Federal Register guidelines for conducting programs for the investigation of methadone in the medical management of addicted persons (JAPhA, NSll, 7, 366, July 1970) . It should be noted that these guidelines do not authorize the prescribing by the physician or dispensing by the pharmacist of methadone for maintenance purposes, except in formalized programs reviewed by FDA and given Investigational New Drug status. Therefore, no prescription order for methadone written by a physician in private practice and intended for maintenance purposes is legal, and any pharmacist knowingly dispensing methadone on the basis of such a prescription order is in clear violation of the law. 2.7-The basic concept of maintenance of the addict through use of methadone, ie, replacing use of one addictive substance with use of another, remains controversial on a medical and sociological basis. In addition, many variables exist from program to program, including dose levels; criteria for patient selection; differences in age, sex, drug history; history of criminal activity; employment record; education record; education level; family structure, and general medical and psychiatric status. Although most programs incorporate a variety of allied services, such as general medical evaluation and care,· psychiatric services and a host of different social rehabilitative techniques, they are used in varying combinations and at levels ranging from minimal to all-encompassing. A few programs are even studying a modality of simply providing methadone without any allied services. 2.S-As the use of methadone for addict maintenance purposes has increased, there has been an apparent simultaneous increase in its illicit use. For example, the Bureau of Narcotics and Dangerous Drugs reports that from December 1969 to July 1970, 8,202 dosage units of methadone were seized or purchased, while from July 1970 to January 1971, the number increased to 33,981. Although conclusive statistics are not available, many pharmacy practitioners have noted a significant increase in the number of prescription orders for methadone, allegedly for one of its three legitimate medical uses-analgesic, antitussive or detoxifying agent.

2.9-Since methadone cannot be considered the drug of choice as an analgesic or antitussive, it is probable that many such prescription orders are being written for maintenance purposes and, therefore, are illegal. Since patients possessing such prescription orders can and will have them dispensed in a number of pharmacies, many pharmacists may be unknowingly contributing to the growing illicit use of methadone. Due to the existence of other drugs of equal or superior efficacy for analgesic and antitussive indications and also due to the increased abuse and diversion of the drug, it would appear that the critical point has been reached where the risks involved with its use exceed the benefits. It would seem logical, then, that approval for the drug as an analgesic or antitussive should be removed, limiting its use only to the detoxification or maintenance of addicts. The ultimate effect would be the distribution of the drug only through closely regulated and controlled methadone programs and the virtual elimination of the writing and dispensing of prescription orders allegedly for legitimate medical uses but more likely for maintenance purposes.

cal service program." In making its report on its study of this issue, Reference Committee A commented on the guideline as follows-

2.10-The proper control and accurate adjustment of dosage levels are essential in any methadone maintenance program, so the value of the training and the expertise of the pharmacist in such programs is obvious. Pharmacists, therefore, are urged to participate actively both in the planning and implementation of such programs. However, it is pointed out that pharmacists involved in these programs should be familiar not only with the techniques involved but with the sociological and psychological aspects of addiction and its treatment.

The established position of the Association does not bind, preclude or prevent any pharmacist, as an individual, from participating in any program or from taking any risk that in his judgment is appropriate for him.

Reimbursement for Service in Prepayment Programs Recommendation: 3.1-The committee recommends that the following policy, adopted by the APhA House of Delegates in 1967, be repealed-"Pharmacists should not underwrite the actuarial risk of any pharmaceutical service program." Background: 3.2-In 1967, the APhA House of Delegates adopted the report of the APhA Committee on Social and Economic Relations, a section of which dealt with prepaid pharmaceutical services (Journal of the American Pharmaceutical Association, NS7, 6, 306, June 1967) . Among four recommended guidelines for use in the Association work on prepayment programs was included the following"Pharmacists should not underwrite the actuarial risk of any pharmaceuti3.

It is the Reference Committee's inter-

pretation and understanding that this subsection does not preclude any pharmacist or state association from discussing prepayment plans with any group, whether presently in operation or planned in the future. Further, the Reference Committee and the APhA Committee on Social and Economic Relations wish to emphasize that they have not suggested that the Association interfere with, seek to prevent or seek to eliminate any particular pre-· payment program. 3.3-In spite of the attempt by the Reference Committee to clarify the guideline, confusion as to its intentand, therefore, the Association's policy -continued throughout the ensuing year. In its 1968 report, the APhA Committee on Social and Economic Relations again endeavored to clarify the situation and even stated verbatim the section of the Reference Committee quoted above. To further attempt to clarify the issue, the committee included the following in its report (JAPhA, NS8, 7,362, July 1968)-

3.4-Nonetheless, it has been requested that the Association reassess, change or clarify its position. Such reassessment is deemed necessary by many, due to the phenomenal growth of third-party payment programs in both the private and government sectors, the probable imminence of legislation instituting a national health insurance. program and the current Administration's effort to institute on a wide-scale basis health maintenance organizations (HMOs) or prepaid group health programs. The latter development is of special importance to this discussion, for the method of reimbursement for service is basic to any such plan. 3.5-Historically, pharmaCists have determined their charges for pharmaceutical service by a number of methods, the most common being percentage markup, professional fee or a variation of both. For a number of years, the Association has supported the concept of the professional fee, ie, a flat fee added to the acquisition cost of the medication that includes all overhead expenses beyond the product cost, the pharmacist's compensation and return on education and capital investments. In recent years, however, two additional methods of reimburse-

ment have been advanced-the retainer and capitation systems. Both systems are designed to offer a pharmacist or group of pharmacists payment based on all service provided, not just for the dispensing of prescription orders. Usually, this service is described in a contractual agreement for a specified length of time between the pharmacist or group of pharmacists and the institution or recipients of service. The basic difference between the two systems is that in the retainer system, the fee is contracted irrespective of the specific number of recipients who will use the service, while in a capitation system, the fee is determined on the basis of the number of recipients who will utilize the contracted pharmaceutical service. 3.6-It is pertinent to note that both the retainer and capitation systems by their very nature require the determination of specific fees on the basis of projected utilization and cost of service and, therefore, have an element of actuarial risk involved. They are, in effect, a type of insurance policy bought by the recipient to insure against the costs . of possible high utilization of pharmaceutical service during a specific period of time in the future. Increasing numbers of prepaid group health programs currently in existence are employing the capitation system of reimbursement, and indications are that similar groups created through health maintenance organization legislation will use a similar approach. Clearly, then, pharmacists delivering service in such facilities will be bound to operate under the capitation system, and by virtue of the capitation principle, pharmacists may be faced with the prospect of assuming actuarial risk in order to participate. In this case, pharmacists may assume all of such risk, pass all or part of it on to an insurance carrier through a contractual agreement or enter into an agreement with prescribers that would place a portion of the responsibility for risk on these providers. The latter alternative would also serve as a type of control, since the prescriber would be more motivated to curb over-utilization of drugs. 4. Licensure Recommendation: 4.1-The committee recommends that the Association assist the National Association of Boards of Pharmacy in developing a streamlined procedure for direct licensure in any state. The procedure should provide for a national pharmacy examination and make it possible for a pharmacist who has passed the examination to apply only to the state in which he wishes to be licensed. Vol. NS12, No.6, June 1972

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4.2-The committee recommends that the Association develop techniques and methodologies that could be used in ensuring the continued competency of pharmacy practitioners.

Background: 4.3-ln April 1971, the APhA House of Delegates adopted the following policyThe committee recommends that the Association endorse the use of a national pharmacy examination by all boards of pharmacy. The committee recommends that a candidate who passes the national examination be eligible for licensure in any state after demonstrating to the satisfaction of that state's board of pharmacy that he meets the state's requirements for character qualifications and knowledge of state pharmacy and drug laws. 4.4-ln August 1971, the Department of Health, Education, and Welfare submitted to Congress a Report on Licensure and Related Health Personnel Credentialing. Among the recommendations of that report area. States should be urged to use nationallicensing examinations: b. There should be a two-year moratorium on legislative establishment of new categories of health personnel with defined scopes of functions. c. Professional health organizations and licensing boards should adopt specific requirements to assure the continued competency of health practitioners. 4.5-ln September 1971, the American Dental Association's Task Force on National Health Programs submitted a lengthy report in which the following recommendations were includeda. State boards of dental examiners should assume the responsibility for periodic recertification of persons to determine their right to practice, and such recertification should be based on an evaluation of professional qualifications. b. Regional examinations should be encouraged and tested in all areas of the United States and its territories. c. There should be a uniform national standard for licensure with complete reciprocity between the states, the District of Columbia, the Commonwealth of Puerto Rico and United States territories. d. Graduates of foreign dental schools who qualify for and successfully pass the national board examination of the American Dental Association should be qualified for examination by all boards of dental examiners. 4.6-ln its background statement to these recommendations, ADA's Task 310

Force on National Health Programs statedWt could find no evidence that individual state licensure examinations significantly affect the distribution of dental manpower in the United States, although we are aware of instances in which individual dentists have registered prejudicial complaints after their failure to pass such examinations. We believe that the integrity of state boards of dental examiners should be preserved, but we think state boards should give more attention than they do now to their responsibility for continually evaluating the qualifications of licensed personnel. In our view, the initial licensure of applicants to practice is no more important than is credible recertification. Regional licensure examinations, although rather new in dentistry, appear to be professionally efficient and practical. We believe that the trend toward developing a uniform national standard for dental licensure is laudable and that national reciprocity of dental licensure between the states should be encouraged. Licensure reciprocity between the states should not diminish the integrity of the state boards of dental examiners but rather allow them time to give more attention to monitoring dental personnel currently practicing. 4.7-At its annual meeting, the American Dental Association House of Delegates deleted Task Force recommendation d, and its Reference Committee rejected recommendation c. 4.8-Current reciprocity procedures require a pharmacist desiring to obtain a license to practice in another state to apply to the National Association of Boards of Pharmacy and to the state in which he desires to practice. Application fees must be paid to both groups, and valuable time is consumed in processing and coordinating the application through the agencies. The development of a system utilizing a national pharmacy examination should eliminate the need for dual application, since all persons who successfully completed the national pharmacy examination should automatically be certified in every state and eligible to apply directly for licensure in any state. Minority Report of William J. Hodapp and Howard E. Mossberg

4.9-While there was unanimous agreement concerning the committee recommendations as listed, a minority opinion developed on one additional point. This point is the proposal that every board of pharmacy should have a nonpharmacist representative of the public on the board. 4.10-Some boards of pharmacy presently have nonpharmacist members. As the practice of pharmacy becomes increasingly subject to public scrutiny, the decisions made by boards of phar-

Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION

macy become a matter of public concern. The consumerism movement is focusing attention on all phases of pharmacy practice. Many complaints concerning pharmacy practice occur because of ignorance and/ or lack of understanding of the practice of pharmacy on the part of the public. Lack of trust develops when an affected group believes it has little voice in decisions which affect that group's wellheing. 4.11-Boards of pharmacy have been constituted to license practitioners and regulate practice in order to protect the health of the public. It would be most appropriate then for the public to be represented on these boards and to vote on matters within their area of competence. This representation would serve to reduce the public's feeling on nonrepresentation. The minority opinion, therefore, is that the APhA House of Delegates should consider the addition of the following recommendation to those which were unanimously recommended as policy for the Association-The committee recommends that the Association encourage state pharmaceutical Associations to actively seek the appointment of a nonpharmacist representative of the public to their respective Boards of Pharmacy. [For subsequent action on related motion, see page 281.]

5. Pharmacy Manpower Recommendation: S.l-The committee recommends that the Association engage in and/ or support manpower studies which would provide on a continuing b,asis information in the following areasa. Geographical distribution of pharmacy practitioners. b. Age-sex cross tabulation of pharmacy manpower. c. Current and future pharmacy manpower requirements to meet the needs of society. [Section 5.2 referred back to committee of origin by the House of Delegates.]

S.l-The committee recommends that the Association generally limit its recruitment activities until adequate information becomes -available to judge more accurately future manpower requirements. Background: S.3-As of January I, 1970, there were 128,843 pharmacists in active practice in the United States. Of this figure, approximately 106,801 (83 percent) practiced in community pharmacies. Approximately 11,000 prac-

ticed in hospitals, while about 5,000 pharmacists were employed by pharmaceutical manufacturers and wholesalers. About 6,000 pharmacists were involved in teaching, government and association activities. Of the 106,801 pharmacists practicing in the community environment, 45,541 were classified as owners or partners, and 61,260 were classified as employees. 5.4-A frequently used indicator of pharmacy manpower is the pharmacist-to-population ratio. In 1951, this ratio was an average of 68 pharmacists for every 100,000 population. The ratio fell to 61 in 1965 and 1968 but had risen to 63 as of January. 1, 1970. As. would be expected, the ratio is subject to pronounced regional variations. For example, the figure is 89.1 for Massachusetts and 36.4 for Puerto Rico. 5.5-The number of pharmacists graduated from colleges of pharmacy has steadily increasrrl from 3,388 in 1965 to 4,774 in 1970. For the past several years, the American Association of Colleges of Pharmacy-with the support of APhA-has been actively seeking federal support for increasing the enrollments of colleges of pharmacy. The principal reason given is the developing shortage of pharmacist manpower. Recently, the AACP received a federal grant to study existing data on pharmacy manpower and evaluate alternative methods of estimating manpower needs. 5.6-There appears to be a consensus among pharmacy educators that there is a shortage of pharmacists in this country and that this shortage will become more acute in the future. The statements of Christopher A. Rodowskas (The Ohio State University College of Pharmacy) that in 1975, 0.4 to 1.0 billion prescription orders may go undispensed and of T. Donald Rucker (Chief, Drug Studies Branch, Division of Health Insurance Studies, HEW) that by the same year a shortage of 71,000 pharmacists may exist are often quoted to support this consensus. 5.7-In 1970, the APhA House of Delegates adopted as policy a recommendation of the APhA Policy Committee on Professional Affairs that. . . . the Association endorse the use of properly supervised supportive personnel in pharmacy practice as a positive step toward improving the quality and quantity of pharmaceutical service provided by the profession. 5.8-In its background to this recommendation, the committee emphasized that in the face of increasing demand for his service, the pharmacist must seek methods of increasing his efficiency as a practitioner.

5.9-While the numb~r of pharmacy school graduates is projected to increase, it is anticipated that this increase ,will be balanced by the increase in population, so that the pharmacistto-population ratio will remain essentially stable for the immediate future. In the meantime, some voices proclaiming the shortage of pharmacy manpower are being sounded ever louder, while increasing reports of rising rates of pharmacist unemployment appear. During its discussion on supportive personnel in 1970, the APhA Policy Committee on Professional Affairs addressed itself to a critical issue which bears directly on manpower, that is, the professional activities which pharmacists perform and the amount of time that pharmacists spend each day engaged in these activities. 5.10-There appear to be a number of questions which the profession should considera. Are pharmacists who practice in areas of low pharmacist-to-population ratio devoting more of their time to professional activitie"s than pharmacists who practice in areas of high ratios? b. In terms of new roles which pharmacists can perform, what should be an optimum pharmacist-to-population ratio? c. What are the techniques which can be utilized to make pharmacists' practices more efficient? d. Is our present system of data collection and analysis of pharmacy manpower adequate? How can it be improved? e. Are we doing a service to the profession and the public by attempting to maintain the pharmacist-topopUlation ratio at its present level? f. Do we have a sound basis for proclaiming that there is a "shortage" of pharmacy manpower? 5.11-In view of these questions, the committee recognizes the urgent need for sound and in-depth studies of the pharmacy manpower issue. The committee also recognizes the need for systems that will provide on a continuing basis data on the current status of pharmacy manpower in order to document effectively projected manpower requirements. 5.12-The committee believes that as demands and practice patterns change,

manpower requirements also will change. It is necessary, therefore, for the profession to maintain a constant watch on the demands of the public and other health professionals for pharmaceutical service as well as the changing nature of the pharmacist's role in providing his service so that accurate assessments of manpower needs can be made. Concurrently, the profession should continually investigate roles for pharmacists in those health care areas in which their training and education can be most effectively utilized to meet general health manpower needs. 5.13-The profession and schools of pharmacy have performed excellently in developing effective student recruitment programs. The committee feels that it may be time to reconsider the continuance of these programs at their current levels (with the exception of minority recruitment activities). The education of a pharmacist involves a considerable investment on the part of the college, the student and society. The profession p.as a responsibility to assure that those who decide to make the personal commitment to become pharmacists have the opportunity to practice their chosen profession in a way which takes full advantage of the investment they-and society-have made in their education. The committee feels unequivocally that there may be a possibility of the profession's facing an over-supply of pharmacy manpower and urges the profession to give serious consideration to this possibility. The current over-supply of teachers and scientists with PhD degrees has been identified as a direct result of the massive education and government efforts in tp.e 50's and early 60's to recruit teachers and scientists. 5.14-The committee is fully cognizant of the forces affecting schools of pharmacy to increase their enrollment. Recently enacted governmental programs to assist health educational institutions make funds available only to those schools that enlarge their student enrollment. The committee feels, however, that the key here is the quality of the education received and not the quantity of students that are enrolled in a given school. 6. I.abeling of Methotrexate

Recommendation: 6.1-The committee recommends that the Association seek deletion of the warning statement in the labeling of methotrexate which indicates that Vol. NS 12, No.6, June 1972

311

pharmaci t hould dispen e the drug nl y to phy ician and never to patient . 6.2- he committee recommends that the A ociation oppose any type of product labeling which would prohibit pharmaci ts from dispensing to a patient any drug which is generally availble for approved medical uses. Background: 6.3- Methotrexate, Lederle Laboratorie ' brand of 4-amino-Nlo-methyl pteroyl glutamic acid, is an antifolic acid metabolite promoted by the manufacturer for its action on certain types of cancer, particularly leukemia and choriocarcinoma. However, risks involved in use of the drug are many, and side effects listed in the drug's labeling include oral erythema, ulceration and hemorrhage, gastrointestinal ulceration and hemorrhage, chills and fever, hem otologic depression, liver atrophy, necrosis, cirrhosis, fatty changes and periportal fibrosis.

6.4- Methotrexate was approved by the Food and Drug Administration as an anticancer drug in 1959, but in clinical trials prior to that date and subsequent to its approval as an anticancer agent, it was noted that the drug al 0 produced dramatic results in controlling the dermatological disorder, psoriasis. Due to published reports of thi new indication, its use has become widespread in the treatment of psoriasis. A 1966 poll by the University of California school of medicine in San Francisco and at the Staub Clinic in Honolulu showed that 56 of 64 institutions that train dermatologists in this country had treated 3,178 patients with the drug for severe psoriasis. This widespread use for psoriasis arose in spite of the fact that the drug had not been approved for this use by FDA, although the manufacturer had applied for such approval in 1964 and again in 1967. On November 1, 1971, ~DA approved the New Drug Applicahon for the drug for use in "severe recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy." 6.S-Apparently due to the toxicity of the drug, the FDA originally required the following warning statement in its labelingCaut.i~n: Pharmacists dispense only to physlcl~ns , never to patients. Dispense only . ~th full statement of warnings.

PhYSICIanS should give the drug personally to patients and should not dispense more than six or seven days supply at one time. 312

6.6- At a later date, FDA decided to no longer require the warning statement, but the manufacturer nevertheless retained it, obviously as a measure of self-protection in the case of possible civil liability suits arising from use of the drug. (A Maryland woman and her father were awarded $600,000 in a medical malpractice suit which charged a prominent dermatologist for use of the drug in treating her psoriasis and which resulted in the development of aplastic anemia.) FDA has recently indicated that it again intends to require the cautionary statement in labeling. 6.7-The unique and unrequired statement in the labeling puts the pharmacy practitioner in an untenable situation for, in the opinion of the Association's legal division, a pharmacist who dispenses this drug directly to the patient increases his risk of civil liability in the event of an adverse reaction-. The practical effect of the label warning could be to shift the burden of proof required in a negligence action. Instead of requiring the patient to prove the pharmacist negligent, the presence of the warning could require the pharmacist to prove that he was not negligent in dispensing it contrary to the stated warning. Therefore, the Association has on several occasions advised pharmacists to heed the warning label of the manufacturer.

6.S-Besides the increased liability to the pharmacist, there are other issues which arise in regard to this labeling. Its potency or toxicity notwithstanding, there is p.o apparent reason or rationale, either from a professional or public health standpoint, to consider this drug differently from other drugs that are used in therapy. As a general rule, pharmacists would routinely dispense drugs only to phys~cians in those cases in which there are special problems or techniques involved in administration (eg, radioisotopes, intravenous solutions, vaccines, etc.). In the case of methotrexate, it is obvious that ~hi.s is l!0t a .factor. To the contrary, It IS qUIte eVIdent that the patient will self-administer the drug since the caution statement specifically refers to dispensing a six- or seven-day supply. Therefore, therapeutic problems associated with methotrexate bear no relationship to the person who physically transfers the drug to the patient. Rather, the essential problem with methotrexate therapy is achieving adequate and appropriate supervision of the patient by the medical practitioner.

Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION

There is no assurance that the patient will be properly supervised if the physician dispenses the drug, and similarly, there is no assurance that he will not be properly supervised if the pharmacist dispenses the drug. Moreover, in the hospital setting, patient supervision is usually considered to be at its highest level. In this environment, the attending physician orders members of the hospital team to carry out his specific requests. In most cases involving extremely potent drugs, the usual sequence of events is for the pharmacist to interpret the order and dispense the drug to the registered nurse in the nursing ward, and she, in turn, administers the drug at the prescribed intervals. Only in rare instances, where the patient may have an immediate acute reaction to a drug, does the physician personally administer a drug to a patient. Therefore, it is evident that the question of who dispenses the drug becomes irrelevant when discussing the problems involved in methotrexate therapy. 6.9-The committee wishes to emphasize that whep dispensing drugs requiring special techniques and means of administration, pharmacists provide additional assuraQce that provisions for the proper administration of these drugs have been made.

Donald O. Fedder, chairman Doyle F. Harrell, vice chairman Paul B. 'C ardin Richard H. Deardorff Franz W. Geisz Willia:m J. Hodapp James B. Leedy Gregory B. Little Charles M. Loftin Howard E. Mossberg

Tel~er Ly':e Lehman (left) checks tally of votzng wzth APhA Assistant Executive Director James D. Hawkins.

Report of the Committee on Nominations

The right to vote for the officers and Trustees of the Association is the privilege of every active member of the American Pharmaceutical Association. The mail ballot election procedure is one of the strengths of our national professional society. Our democratic nomination and election procedure depends on the willing support of a considerable number of individuals. First, there are those members who make a concerted effort to identify willing and qualified candidates and then submit these names to the Committee on Nominations. Next, there are the pharmacists who agree to have their names considered as possible candidates, and then finally, there are the members who agree to have their names submitted to the membership for election. The willing and active involvement of members at each of these levels makes our system of selecting our leadership function in the best interest of our Association. As members of the House of Delegates, you bear an additional responsibility for the nominations and election procedure. You must act upon the report of the Committee on Nominations appointed by the speaker of the House. In doing so, you elect the speaker and vice speaker of the House to serve you for the coming year. If your Committee on Nominations has done a good job, as I feel we have, then you have an easy job of fulfilling your responsibility. As we conclude our work here this afternoon and return home, do not neglect the responsibility you have for assuring the future leadership of the Association. Be constantly alert for potential candidates and do not hesitate to recommend them for committee appointments or as candidates for office. Last January 4, 1972, Speaker Philip Sacks announced his intention to appoint the Committee on Nominations not later than April 1, 1972 and to direct that the committee convene prior to the Annual

Meeting. A deadline of March 15, 1972 was established for the submission of recommendations for the consideration of the Committee on Nominations. In his charge to the Committee on Nominations, Speaker Sacks stated, "Perhaps the most basic precedent for your committee to follow is that each candidate nominated for an office must be qualified to serve in that office." It is the responsibility of the committee to determine who are the best . qualified candidates from among those whose names have been suggested by members in response to the official call for nominations which was published in the January 15, 1972, issue of the APhA Newsletter. It is not the responsibility of the committee to originate nominations. I am particularly pleased with the work of the Committee on Nomina-

tions this year. In response to the call for nominations, over 100 individuals were suggested for the various offices of the Association. It is a credit to the degree of interest of the membership that of this number only 16 requested that their names not be considered by the Committee on Nominations. All of those who indicated a willingness to be a candidate were considered by the committee when it met on April 13, 1972, in Washington, D.C.

Max W. Eggleston, chairman W. James Bicket . J. Homer Boutwell Donald O. Fedder Norman Garfiukel Howard E. Mossberg Rupert Salisbury Charles A. Schreiber Louis M. Sesti

The committee submits the following nominationsFor President:

George D. Denmark (Pocasset, Massachusetts) Victor H. Morgenroth (Baltimore, Maryland)

For vice president: George S. Inman Joe D. Taylor

(Greenville, South Carolina) (Glasgow, Kentucky)

For Board of Trustees: (1) William F. Appel Jack D. Smit

(Minneapolis, Minnesota) (Davenport, Iowa)

(2)

Charles M. Loftin Philip Sacks

(Mobile, Alabama) (Wilmette, Illinois)

(3)

Kenneth F. Finger Joseph V. Swintosky

(Gainesville, Florida) (Lexington, Kentucky)

For Judicial Board: (1)

Edward L. Baker, Jr. (Arlington, Texas) Lucien W. Watson, Jr.(Marianna, Florida)

(2)

August G. Danti John W. Webb

(Monroe, Louisiana) (Framingham, Massachusetts)

For speaker House of Delegates:

Jacob W. Miller

(Topeka, Kansas)

For vice speaker, House of Delegates:

Joseph E. McSoley

(Indianapolis, Indiana) Vol. NS12, No.6, June 1972

313

Roster APhA House of Delegates

Speaker-Philip Sacks, Norridge, IL Vice Speaker-George S. Inman, Greenville, SC

Delegates

Judicial Board·· George W. Grider·, Danville, KY Kenneth S. Griswold, Albany, NY George A. Harris, Arlington Heights, IL Jack A. Karlin, Parma, OH Donald J. Wernik, Metuchen, NJ

Erik H. Jensen, Kalamazoo, MI Harry B. Kostenbauder, Lexington, KY Thomas J. Macek, Rockville, MD Arnold D. Marcus, Hillside, NJ Tom S. Miya, Lafayette, IN Maven J. Myers, Philadelphia, PA George H. Schneller, Philadelphia, PA

APhA Board of Trustees·· William F. Appel, Minneapolis, MN William S. Apple, Falls Church, VA Edward L. Baker, Jr., Arlington, TX W. James Bicket, Zion, IL Grover C. Bowles, Memphis, TN Charles F. Dahl, Viroqua, WI George D. Denmark, Pocasset, MA Max W. Eggleston, Waverly, IA Jack S. Heard, San Rafael, CA George S. Inman, Greenville, SC Jacob W. Miller, Topeka, KS John H. Neumann, Aurora, IL Lloyd M. Parks, Columbus, OH Philip Sacks, Norridge, IL Warren E. Weaver, Richmond, VA William R. Whitten, Fort Worth, TX

IAPhA Past Presidents.· George F. Archambault, Bethesda, MD Grover C. Bowles·, Memphis, TN Joseph B. Burt, Lincoln, NE Sylvester H. Dretzka, Milwaukee, WI Max W. Eggleston·, Waverly, IA Charles H. Evans, Warrenton, GA Robert P. Fischelis, Ada, OH Louis J. Fischl, Oakland, CA Donald E. Francke, Washington, DC Robert J. Gillespie, St. Joseph, MI Henry H. Gregg, Minneapolis, MN George W. Grider, Danville, KY Wm. B. Hennessy, Grosse Pt. Woods, MI Glenn L. Jenkins, Lafayette, IN Ernest Little, Danville, VT John A. MacCartney, Grosse Pt. Woods, MI George A. Moulton, Fort Myers, FL J. Curtis Nottingham, Williamsburg, VA Newell W. Stewart, Phpenix, AZ Linwood F. Tice, Philadelphia, PA William R. Whitten·, Fort Worth, TX

APhA Past Speakers, House of Delegates •• M~ry Louise Andersen, Wilmington, DE

APhA President-elect· Clifton J. Latiolais, Columbus, OH

Academy of General Practice of Pharmacy Robert R. Anderson, New Brighton, MN Donald W. Arthur, Buffalo, NY William R. Bacon, Mill Valley, CA Robert L. Barnett, Louisville, KY Rita C. Bloomfield, Passaic, NJ Herbert G. Brandt, Kutztown, PA Doris Y. Cornell, Renton, WA Gary R. Cornell, Renton, WA Richard C. Carroll, Palos Park, IL Angele C. D'Angelo, East Rockaway, NY Gregory R. D'Angelo, East Rockaway, NY Robert L. Day, San Francisco, CA Vincent J. DeGaetano, Bronx, NY Luann K. Dodini, Palatine, I L Thomas W. Dunphy, Lexington , KY William J. Edwards, Galveston, TX Donald O. Fedder, Baltimore, MD Francis C. Fitch, Delphi, IN Thomas H. Holland, Danville, VA Arthur G. Jacob, Louisville, KY David J. Krigstein, Wilmington, DE Paul W. Lofholm, Kentfield, CA David M. Maksomski, Newburgh; NY Edward J. Martin, Sprihgfield, MO James M. McCoy, Edmonds, WA Joseph E. McSoley, Indianapolis, IN C. Albert Olson, Bountiful, UT Lazarus A. Pahigian, North Andover, MA Stephanie J. Radford, Seattle, WA James R. Ramseth, Renton, WA William H. Randall, Lillington, NC Harold J. Reiss, Buffalo, NY Morris H. Rosen, Pine Bluff, AR Milton Smith, St. Paul; MN Robert L. Snively, Georgetown, DE William P. Taggart, Galesburg, IL

Clifton J, Latiolais, Columbus, OH W. Byron Rumford, Washington, DC Charles A. Schreiber, Tell City, IN

Student APhA James R. Boyd, Norman, OK Peter J. Forni, Sausalito, CA Lynn Harrelson, Lexington, KY J. Craig Hostetler, Washington, DC Jerald R. Jackman, Salt Lake City, UT Janet E. Oates, Little ROCk, AR Lawrence E. Patterson, Los Angeles, CA Stephen W. Schondelmeyer, Kansas City, MO ' Christine A. Sczupak, Buffalo, NY

APhA Military ,S ection Boris J. Osheroff, Silver Spring, MD Theodore W. Tober, Bethesda, MD

New York APhA Chapter Frank J. Pokorny, New York, NY

Puget Sound APhA Chapter Lawrence A. Lemchen, Bellevue, WA

City of Washington APhA Chapter Vernon O. Trygstad, Washington, DC Henry L. Verhulst, Bethesda, MD '

American College of Apothecaries Leonard Grossman, Jamaica Plains, MA Delton C. Huffman Jr., Memphis, TN M. Donald Pritchard, Buffalo, NY Victor A. Morgenroth, Baltimore, MD

Academy of Pharmaceutical Sciences ·Oelegate is entitled to listing, in accord. ance with the bylaws. but is voting in another capacity 'at the annual meeting. ' ··Oelegate ex'officio with vote.

314

Chester J. Cavallito, Ne\y York, NY Gilbert S. Banker, Lafayette, IN James T. Doluisio, Lexington, KY David E. Guttman," Philadelphia, PA William I. Higuchi, Ann Arbor, MI

Journal of the AMERICAN PHARMACE!JTICAL ASSOCIATION

American Society of Hospital Pharmacists 'R. David Anderson, Waynesboro, VA R. Paul Baumgartner Jr., Williamson, WV

Donald F. Beste Jr., New Haven, CT Vincent F. Bouchard, Pittsburgh, PA Herbert S. Carlin, la Grange, Il John A. Ebel, Tallahassee, Fl Fred M. Eckel, Chapel Hill, NC Herbert l. Flack, Philadelphia, PA Thomas J. Garrison, Kansas City, MO Harold N. Godwin, Kansas City, KS Martin Goldstein, Pittsburgh, PA Willard l. Harrison, Richmond, VA Wendell T. Hill Jr., Detroit, MI William H. Hotaling III, Schenectady, NY Louis P. Jeffrey, Providence, RI Charles M. King Jr., Birmingham, Al Samuel Kohan, Englewood, CO Robert l. lantos, Gainesville, Fl Carl D. lyons, Tulsa, OK Sister Mary Matthew, Red Bud, Il William J. Mueller, Haslett, MI Joseph A. Oddis, Bethesda, MD Eleanor M. Pendergast, Salem, MA Robert l. Ravin, Ann Arbor, MI Milton W. Skolaut, Durham, NC Joseph E. Smith, Philadelphia, PA Robert E. Snyder, Baltimore, MD Dan B. Thomas, Irving, TX Harvey A. K. Whitney Jr., Cincinnati, OH Bradford P. Wirth, Syracuse, NY David Zilz, Madison, WI

Connecticut Pharmaceutical Association lester H. Ableman, New london Francis B. Cole, West Hartford

Kansas Pharmaceutical Association George F. Kramer, Ottawa Howard A. Mossberg, lawrence Hubert M. Snell, Wichita

Delaware Pharmaceutical Society Kathleen A. McGee, Wilmington Robert l. Snively, Georgetown

Kentucky Pharmaceutical Association Robert J. lichtefeld, Frankfort Richard H. Rolfsen, Covington Joe D. Taylor, Glasgow

District of Columbia Pharmaceutical Association Chauncey I. Cooper, Washington, DC Kenneth E. Hanson, Washington, DC

Lousiana State Pharmaceutical Association James A. Mosley, Boissier City William P. O'Brien, New Orleans

Florida Pharmaceutical Association Bernard J. Cimino, Tampa John W. Davies, Orlando W. Harold Donahue, Ocala Carl l. Jones, Tallahassee leonard W. Kohn, West Palm Beach William Nestor, West Palm Beach B. Samuel Rogers, Jacksonville Sidney Simkowitz, Miami Beach Mark J. Sullivan, Tallahassee Gilbert Weise, Jacksonville

Maine Pharmaceutical Association

Maryland Pharmaceutical Association Mary W. Connelly, Baltimore Nathan I. Gruz, Baltimore James E. Hodges, Baltimore Nathan Schwartz, Annapolis Henry G. Seidman, Baltimore

Alabama Pharmaceutical Association James T. Davis, Columbiana Sam Hardin, Montgomery Charles M. loftin, Mobile William C. Spires, Dothan

Alaska Pharmaceutical Association lester E. Elkins, Petersburg Myrle A. Myers, Anchorage

Arizona Pharmaceutical Association Glen E. Crandall, Phoenix James A. Toomey, Phoenix

Georgia Pharmaceutical Association Thomas J. Miller, Atlanta Armon B. Neel Jr., Griffin

Betty J. Bell, lihue Omel l. Turk, Honolulu

Idaho State Ph
Illinois Pharmaceutical Association

Stanley G. Mittelstaedt, little Rock Walter J. Morrison, little Rock

Edmond P. Barcus, Oak lawn John l. Barlow, Sullivan Roger W. Cain, Chicago Aaron Finn, Chicago Norman Garfinkel, Oak Park J. Thomas Gulick, Danville John Hegarty, Champaign Harland E. lee, Evanston Henri R. Manasse Jr. la Grange Howard A. Mirsky, Chicago Donald V. Vaught, Riverdale George l. Webster, Wilmette Irwin S. Thornton, Chicago, Il

Richard H. Avanzino, Sacramento Jerry E. Beisner, Oakland Edward S. Brady, Huntington Beach Carl G. Britto, Fremont Charles D. Brown, Santa Barbara Alexander F. Demetro, San Jose Terry E. Dozier, Redondo Beach Robert D. Gibson, San Francisco Alex Golbuff, Ventura Jere E. Goyan, San Francisco Charles K. Jewell, Glendale Robert C. Johnson, Sacramento Robert levin, San Francisco Robert lewinter, San Diego Maynard E. lutts, Palo Alto Mary l. Munson, EI Cerrito George H. Pennebaker, Sacramento Dean D. Reavie, Newport Beach Irving Sprugasci, San Jose James D. Wagner, National City Philip H. Waxman, Menlo Park Chester D. Yee, Redwood City

Colorado Pharmaceutical Association Charles l. Cummings, Denver John M. James, Pueblo

Arnold S. Feldman, Hyde Park BurtonA. Nelson, New Bedford

Hawaii Pharmaceutical Association

Arkansas Pharmaceutical Association

California Pharmaceutical Association

Massachusetts State Pharmaceutical Association

Michigan State Pharmaceutical Association R. Thomas Cook, lansing Maurice Q. Bectel, Muskegon Bruce C. Field, laingsburg Herman Fishman, Okemos H. Thomas Goss, Flint Metta l. Henderson, Battle Creek Kenneth Huckendubler, Kalamazoo Robert K. Krotzer, Mt. Clemens B. William lewis, Detroit Howard W. Nelson, Detroit Donald W. Newman, Ironwood Richard A. Ohvall, Big Rapids Frank Pawlus, Birmingham Walter V. Scott, Ann Arbor Louis M. Sesti, lansing Mary Van Noorloos, Mattawan Roger A. Van Wyke, Dimondale Mitchell F. Wieczorek, St. Clair

Minnesota State Pharmaceutical Association Donald A. Dee, St. Paul Frank E. DiGangi, Minneapolis

Indiana Pharmaceutical Association F. Kenneth Deal, Hammond Richard H. Deardorff, Mishawaka Bill D. Jobe, lafayette lyell E. lehman, Elkhart Merritt l. Skinner, Plymouth Benjamin A. Smith, Indianapolis Ralph W. Thornburg, Syracuse

Mississippi State Pharmaceutical Association J. Homer Boutwell, Hattiesburg Dewey D. Garner, Oxford

Missouri Pharmaceutical Association Iowa Pharmaceutical Association Gary N. Boeke, Cresco Rollin C. Bridge, Lamoni Allan K. Fann, Atlantic Gill T. Hartleip, Marshalltown Robert E. Ohrlund, Storm lake Arlan D. Van Norman, Swea City

Charles C. Rabe, St. louis larry l. Slater, Kansas City

Montana State Pharmaceutical Association Robert F. lenz, Butte Robert l. Van Horne, Missoula Vol. NSI2, No.6, June 1972

315

Nebraska Pharmaceutical Association William J. Carroll, Nebraska City John A. Duffy, St. Paul

South Carolina Pharmaceutical Association Carl T. Bougness, Columbia Howard Sudit, Charleston Ralph M. Wilkie, Greenville

Subject Index to Committee Reports

Nevada State Pharmaceutical Association William L. Locke, Reno New Hampshire Pharmaceutical Association Kenneth S. Fortier, Concord Grace E. Hannan, Concord

South Dakota Pharmaceutical Association Robert W. Ehrke, Rapid City Wiley D. Vogt, Mitchell

New Mexico Pharmaceutical Association Joe M. Andrews, Lovington Tom N. Cammack, Hobbs Pharmaceutical Society of the State of New York Salvatore J. Rubino, New York Lester I. Smith, Levittown

Advertising, 304 American Council on Pharmaceutical Education, 297

Tennessee Pharmaceutical Association Seldon D. Feurt, Memphis H. Nestor Stewart, McMinnville

New Jersey Pharmaceutical Association Joseph G. D'Amico, Trenton Roy A. Bowers, New Brunswick Marvin Charen, Kendall Park Leo Dubrow, Newark Nicholas Giannotto, Newark Attilio R. Granito, Tenafly Michaellannarone, East Orange Marjorie Lowe, Flemington John H. McCoubrie Jr., Salem Richard D. Peckman, Maplewood Andrew J. Preston, Boonton Isadore Singer, Spotswood

A

Texas Pharmaceutical Association Susan Bartlemay, Dallas Harry B. Day, Harlingen Charles E. Dierdorf, EI Paso Pat Fryar, Odessa Doyle F. Harrell, Fort Worth Robert C. Keppler, Dallas Bradley A. McMain, Houston Joe B. Park, Dallas Hazel M. Pipkin, Bryan John R. Rains, Dallas Kenneth E. Tiemann, Austin Timothy L. Vordenbaumen, San Antonio George C. Webb, McKinney J. L. Wren Jr., Fort Worth

Utah Pharmaceutical Association

c Charges for Pharmaceutical Service, 303 Clinical Pharmacy, 306 Consumerism, 301 Continuing Education, 298

D-E Drug Product Selection, 303 Education, Pharmaceutical, 297

F-G FDA Biological Criteria Amendments, 305 Group Practice, 306

Henry R. Gardner, Provo J. Harvey Madsen, Vernal

I Institutional Pharmacy, 306

Vermont Pharmaceutical Association North Carolina Pharmaceutical Association Joseph C. Estes Jr., Reidsville Jack G. Watts, Burlington

Francis E. Donovan, Fair Haven Evan D. MacEwan, St. Albans Virginia Pharmaceutical Association

North Dakota Pharmaceutical Association AI Doerr, Bismarck Philip N. Haakenson, Fargo Ohio State Pharmaceutical Association

Robert C. Adams, Winchester Thomas E. Allen, Richmond Robert E. Christopher Jr., Blacksburg Keith D. Kellum, Richmond Gunther K. Kessler, Fairfax Charles I. Rector, Fredericksburg Thomas W. Rorrer, Waynesboro

Lowell E. Briner, Massillon Rupert Salisbury, Columbus Oklahoma Pharmaceutical Association Walter P. Scheffe, Enid Wallace A. Taylor, Oklahoma City Oregon State Pharmaceutical Association Herman Forslund, Corvallis Charles O. Wilson, Corvallis Pennsylvania Pharmaceutical Association Joseph A. Bianculli, Pittsburgh Morris E. Blatman, Harrisburg Daniel A. Hussar, Philadelphia Larue Lunger, Lafayette Hili Bruce D. Martin, Pittsburgh Gloria R. Sabatini, Philadelphia Colegio De Farmaceuticos De Puerto Rico Rhode Island Pharmaceutical Association Richard A. Yacino, Cumberland Heber W. Youngken Jr., Kingston

316

Washington State Pharmaceutical Association . I

Michael L. Kemp, Shelton Richard C. Larson, Cowiche

West Virginia Pharmaceutical Association Raphael O. Bachmann, Morgantown D. Stephen Crawford, Elkins

Wisconsin Pharmaceutical Association Paul B. Cardin, Platteville W. Allen Daniels, Madison John L. Gunsolley, Eau Claire Joseph J. Gwidt, Tigerton David D. Harmon, Milwaukee Richard G. Henry, Madison Raymond H. Jahn, Wauwatosa Lyle F. Rasmussen, Baldwin

Wyoming Pharmaceutical Association Jackson K. Lewis, Cheyenne Marilyn H. Mitchell, Casper

Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION

L-M Licensure, 309 Methadone, 308 Methotrexate, 300

N-O National Clearinghouse for Continuing Education, 298 Organizational Unity, 300

p Pharmaceutical Service, 303 Public Affairs, 303 Pharmacist· Patient Relationship, 301 Pharmacy Manpower,310 Pharmacy Practice, Definition, 306 Prepayment Programs, 309 Prohylactic Laws, 304 Public Education, Drug Use, 301 Public Education, VD, 304

R-S Recruitment, Pharmacy Students, 310 Reimbursement for Service, 309 Self-Medication, 304

u-v Uniform Designation for Pharmacists, 296 Venereal Disease Prevention, 304

APhA Publications and Services The American Pharmaceutical Association has available a variety of educational and informational materials. items, use the coupon on the back of this page. Prices for bulk orders are available on request.

Publications APhA Newsletter-a biweekly newsletter of Association activities and views. Sent only to members as part of dues. Guidelines for Biopharmaceutical Studies in Man-provides a comprehensive discussion of the general principles and important considerations involved in planning and executing human studies designed to test the biological performance of drug products. It also deals with appropriate methods of pharmacokinetic and statistical analysis of the resultant data. The guidelines were prepared in response to a need for a critical analysis and evaluation of current concepts related to drug product testing by means of blood and urine drug level determinations. 1-10 copies, $2 each; 11-49 copies, $1.75 each; 50-99 copies, $1.25 each. Handbook of Non-Prescription Drugs, 1971 Edition-here in one book are the newest facts and figures health professionals need to better serve the self-medicating public. The Handbook contains completely revised and updated texts and tables of home remedies with hundreds of new formulas. Each of the 31 chapters is devoted to a specific class of o-t-c drugs. There is both a product index and a manufacturers' index. Single copy, $6.50. Journal of the American Pharmaceutical Associationannual subscription (foreign and domestic) $10, sent to members as part of their membership dues. Journal of Pharmaceutical Sciences-annual subscription (foreign and domestic): industrial and governmental institution, $50; educational institutions, $30; individual personal use, $20. Association members may elect to receive this Journal as part of $40 annual membership dues. Journal Back Issues-complete volumes of both the Journal of Pharmaceutical Sciences and the Journal of the American Pharmaceutical Association from date of first publication through 1969 are available on 35 mm positive microfilm from University Microfilms, Inc., 300 North Zeeb Road, Ann Arbor, MI. 48106. Single issues from January 1967, subject to availability, can be ordered from the APhA Order Desk as follows: J. Pharm. Sci., $3 each; JAPhA, $1 each. (Foreign orders add 15¢ per copy postage.) National Formulary-an official compendium of drug standards with r'ecognized status under federal and state food and drug laws. NF XIII, $15, official from September 1, 1970, available from Mack Publishing Company, 20th and Northampton Streets, Easton, P A 18042. Supplements to NF sent without charge to purchasers of book who return request card. Previous NF editions III, IV, V, VI, VIII, IX, and XII, $5 each. AvailabLe from APhA. Nursing Home Standards_ .. A Tragic Dilemma in Ame'rican Health-this publication examines in depth nursing home pharmaceutical service standards and other patient

To order

care regulations-nationally, regionally and by staJte. Included are administrative, environmental health and fire safety construction standards under federal Medicare and state licensure programs. Also noted is the tragic absence of minimum standards in some areas. In addition to narrative analysis and interpretation, summary tables of federal and state standards are presented. Single copy, $2.50. 1971 Pediatric Dosage Handbook: Usual ,Doses for Infants and Children-this 119-page booklet was compiled by Harry C. Shirkey, B.S. (Pharm.), MD, to provide health care professionals with the most current information available concerning children's dosages. In addition to using a tabular format, the Handbook is well indexed for quick and easy reference use. 1-10 copies, $2 each; 11100 copies, $1.50 each; over 100 copies, $1.25 each. Pharmaceutical Directory-useful, compact and comprehensive directory of national and state pharmaceutical association officers; state boards of pharmacy; international and foreign national associations; colleges of pharmacy; pharmaceutical fraternities, sororities and honor societies; and national, regional, state and local pharmaceutical journals. Single copy, $2. Pharmaceutical Services in the Nursing Home-a guidebook designed for use by both the pharmaCiist and the nursing home administrator so that each might better understand the scope of the other's responsibilities in the rapidly expanding field of nursing homes. Prepared by a joint committee of the American Pharmaceutical Association, the American Society of Hospital Pharmacists and the American Nursing Home Association. Single copy free. Professional Equilibrium and Compounding Accuracya 16-page booklet of the five reprints discussing the factors related to compounding accuracy-the prescription balance, how to test the balance, how to weigh accurately and how to measure accurately; used extensively in pharmacy schools. Single copy, 25¢. Safer and More Effective Drugs-a symposium edited by Samuel W. Goldstein, APhA Academy of Pharmaceutical Sciences. This book is an informative reference source for today and years ahead. Attention is focused on molecular considerations in synthesis of new compounds and modification of known compounds and on formulation and control parameters of dosage forms. $3 each, hard cover; $1.75 each, paperbound. Suggested Antidotes-a 32-page antidote manual designed to assist pharmacists and others in handling emergencies resulting from accidental poisonings. Provides a quick alphabetical reference to 450 common and potentially poisonous drugs, chemicals and hous,ehold products. Single copy, 25¢. Tableting Specification Manual; IPT Standard Specifications for Tableting Tools-summary of Committee on Tableting Specifications, Industrial Pharmaceutical Technology Section, Academy of Pharmaceutical Sciences. The Vol. N,512, No.6, June 1972

317

Committee, with the cooperation of tool suppliers, worked out a satisfactory set of dimensional specifications and tolerances for punches and dies used in rotary tablet machines. These data have been compiled in a 38-'Page booklet. Single copy, $5.

Services and Materials Drug Abuse Information Kit-display and text materials to assist the pharmacist in his drug abuse informational and educational activities. Contains pertinent speeches, radio spots, editorial, ad mat repros, streamer and poster items and APhA's outstanding booklet, Drug Abuse Education . .. A Guide for the Professions. $3. Health Education Center Service-your professional investment for the future based on proven results on a national experimental study. Each subscribing member receives automatic bimonthly shipments of health literature screened by an expert board of literature review, a counter-type literature rack and educational material. $50 per year. Locked Up Poisons Prevent Tragedy-8-1h by II-inch folder telling patrons how to store potentially dangerous substances to prevent accidental poisoning; can be used for package inserts, bill stuffers, etc. Sample folder and reproduction proofs, $1. Miscellaneous Public Address-Printed addresses ready for presentation on various subjects including drug abuse, careers in pharmacy, pharmacy history and other health topics. Single copies free. Complete list available on request. Poison Prevention Labels and Posters-sheets of 10 various-sized labels with "striking snake" design, reading "Warning-Keep Out of Reach of Children." Accompanying window or counter poster draws attention to free labels available from pharmacists for use on potentially hazardous substances. Excellent public relations aid. Set of 100 sheets of labels, 1 poster, $5; 250 sheets of labels, 2 posters, $10. Prescription Analysis Record Form-useful and accurate economic data on your professional fee can be determined by using one of these record kits. • Kit A provides a three-month supply for a pharmacy dispensing not more than 100 prescription orders daily, with full data on prescription records. $5 per kit.

• Kit B provides the same three-month supply for a pharmacy dispensing not more than 100 prescription orders daily but with a condensed daily prescription record for only economic data. $3 per kit. 10 Minutes for 10 Pills-tells the patient why it takes time to complete his prescription order. Excellent for package stuffers, patrons' information display. Sample folder and reproduction proofs, $1.

Slide Talks Drug Abuse Education Slide Resource Kit-a resource kit of 165 slides, almost all in color, to be used by drug abuse educators to illustrate their own addresses and discussions. It is not a "canned" presentation. Slides are divided into eight sections-history, propaganda, drugs of abuse, effects on the body, government, rehabilitation and treatment, education materials, programs and councils. Each slide has a caption card so the speaker can adapt it to his presentation. Return postage is only charge. The Dentist, The Pharmacist, and Oral Health-a slide program designed for presentation to combined pharmacy/ dentistry groups, health professional gatherings and consumer organizations. Consists of 78 color slides with script and descriptive leaflets for distribution. Featured are various oral hygiene products and illustrations of the manner in which pharmacists and dentists work together for better patient oral health. Return postage is only charge. The Pharmacist as a Health Educator-a set of 36 color slides and accompanying script for presentation to pharmacists or other professional health workers describing the APhA Health Education Center Service and related programs. Return postage is only charge.

Miscellaneous APhA Code of Ethics Plaque-designed for display purposes and printed on parchment in two colors, the APhA Code of Ethics approved August 1969 is available as an attractive 9" X 12" laminated wall plaque. $3 each. APhA Decal-a three-inch diameter decal of the official APhA shield. Colors are pharmacy green and white with the word "PHARMACIST" in white. Adhesive backing for easy application to any smooth surface. Available to APhA members only. $1 for 3 decals; $3 for 10 decals.

-------------------------------------------------------Order Desk American Pharmaceutical Association 2215 Constitution Avenue, N.w. Washington, DC 20037 Plea~e send me the items indicated below. Payment of $ - - - is enclosed. totaling less than $20 must be accompanied by payment.)

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(Note:

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Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION