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Appendix F:Proceedings
Abstract of the Scientific Symposium and Business Meetingsof the United States Pharmacopeial Convention of 2000
The 2000Quinquennial Meeting (QM)of the USP Convention was held April 12–16,2000,at the Grand Hyatt in Washington,DC.Attendance at the meeting was the largest in the history of the USP,due in part to the 1995Resolution that increased Convention membership in specific categories.
Scientific Symposium Explores the Changing Health Care Landscape Richard W.Underwood,Managing Director,Space Panoramas,began the full day program with a presentation on The Earth as Seen from Space:The Changing Landscape of the World in Which We Live.Mr.Underwood showed participants numerous photographs of the earth taken from space over the past 40years.The photographs document a significant historical record of changes to the earth,all the result of very rapid growth in the planet's population.Mr.Underwood,through his fascinating illustrations,captured the concept of change from a global standpoint.
George Poste,D.V.M.,Ph.D.,Chief Executive Officer,Health Technology Networks,spoke on Genetics and Computing:The Key Drivers of Radical Change in Health Care.Dr.Poste stated that “the real challenge of the next two decades is how we will move back from understanding the building blocks of life to actually integrate that into an understanding of the complex whole body system in health,physiology and in disease pathology.”He predicted that 10years hence,pharmaceuticals would still be important,but that “the genetic background of the patient into which a drug is put will become increasingly important.”Dr.Poste reiterated that diseases and patients are no longer uniform and that therapies will be tailored to those patients whose genes will characterize them as responders versus nonresponders.Further research will concentrate on how genetic variations affect pharmacodynamics.Furthermore,Dr.Poste predicts that patient medical history data will be contained in a subcutaneous implantable chip,versus the current smart card technology.
Hemant K.Shah,C.F.A.,President,HKS Company,Inc.,spoke on The Changing Landscape of the Pharmaceutical Industry.Mr.Shah outlined how the financial performance of the pharmaceutical industry is unmatched by any other industry,and how U.S.-based companies have a significant advantage over non-U.S.-based companies in that their market capitalization is greater.To continue to deliver the expected return,the industry must come up with billions of dollars more in incremental sales.Mr.Shah predicted several factors that will affect the industry in the future.Innovative new blockbuster drugs with a value in the $2–4billion range will become commonplace,with consumer price tags of $10per day for therapy.According to Shah,managed care will improve its public image and profitability through higher premiums and economic incentives to patients and doctors.Shah believes that Medicare Reform for the industry “while negative in the near future (due to the elderly cash market being the most profitable for industry),will be positive in the long run as it will shift the debate from price to access and thus from industry to the government.”Also,patent expiration cycles will be key as industry will have to continue to consolidate to improve profitability to achieve cost savings from blockbuster drugs going off patent.Lastly,we have not seen the last of mergers and consolidations with the potential for several more in the immediate future.
Charles E.Saunders,M.D.,Chief Medical Officer,Healtheon/WebMD Corporation,spoke on The Changing Landscape of Health Care Delivery.Dr.Saunders stated that the Internet is the most rapidly adopted technology in history.Noting that “43%of Internet searches are for health care issues,”Dr.Saunders believes this reflects consumers'desire for more information.The Internet provides consumers with a layer of anonymity to explore uncomfortable topics such as depression,allergies,bipolar disorders and cancer.Dr.Saunders added that while consumers use of the Internet is up,so is physician use—he documented an 875%increase in physician use from 1997.Dr.Saunders highlighted the following trends to watch:consumerism (for the first time consumers are driving health care change);migration of business to the Internet;new online paradigms for health care delivery;convergence of multimedia and globalization of the Internet;information age and alignment of policy;and a better,more affordable health care system.
During the afternoon session,the Scientific Symposium focused on The Changing Health Care Landscape:Implications for Scientists,Business Decision-Makers,Practitioners,and Patients.Participants heard various reactions to the day's presentation and dialogues to set the stage for the Convention's work.
Susan D.Desmond-Hellman,M.D.,M.PH.,Executive Vice President,Development and Product Operations,and Chief Medical Officer,Genentech,offered the biotechnology industry perspective.Speaking specifically on Herceptin,an anti Her-2monoclonal antibody,Dr.Desmond-Hellman related how this unlabeled monoclonal antibody “could shrink metastatic breast cancer and prolong survival by 25%when given concomitantly with chemotherapy.”Dr.Desmond-Hellman predicted that the thought process on cancer would move from the anatomical to the molecular.She stressed that doctors must encourage patients to enroll in clinical trials and that the challenge of this wondrous drug development process is that of pharmacogenetic economic concerns,and of finding the patients that will benefit most directly from such therapy.
Catherine M.Kunkle,Vice President,National Business Coalition on Health,offered the health care business perspective.Ms.Kunkle discussed the patient protection bill,noting that should this bill pass,employers will rethink their role in providing health insurance,potentially moving to a defined contribution approach.Ms.Kunkle emphasized that participants should hold the system more accountable and to look for standardized contracts and standardized performance guarantees.She predicted that business coalitions will issue requests for proposals to large employer groups and will emphasize patient outcomes.
Robert Graham,M.D.,Executive Vice President,American Academy of Family Physicians,offered the practitioner perspective.Dr.Graham reiterated that the “irreducible basis of the health care transaction is that of the patient—the heart and soul of what medical practice is all about.”Dr.Graham offered the following areas of focus:the current nature of the system is one of fragmentation and differentiation;patient empowerment can rebalance the system;genetic specificity will become increasingly targeted to increase outcomes;and information technology has an enormous potential to change the way we act and practice.He suggested that “technological events on the horizon may be good or full of mischief and that we all must be cautious.”Graham remarked that while Internet communities may provide support to select patients,it is important to remember that fraud is prevalent and to be anticipated.Dr.Graham does believe that communication between the physician and his/her patient will become increasingly electronic.
Grace Powers Monaco,J.D.,Director,Medical Care Ombudsman Program,offered the consumer/patient perspective.Dr.Monaco stated her belief that the family physician is the optimal patient ombudsman and that,regardless of the number of initials after one's name,we are all patients at one time or another and need support.Dr.Monaco also reiterated the importance of advocacy groups being informed when dealing with health issues,stressing the need to link science and medicine.She encouraged physicians to be responsible and to encourage clinical trials.Dr.Monaco also challenged more employers to push health plans to accept independent and outside reviews.Lastly,Dr.Monaco stated that “to have the best educated medical consumers,we must educate our children to be responsible and informed.”
USP Honors Its Board of Trustees with 100th Anniversary Celebration and Bestows Inaugural Beal Award—USPmembers commemorated the 100th Anniversary of its Board of Trustees with a multi-media presentation,honoring Board members,past and present.The video,along with live presentations chronicled the history of the fiduciary body.The presentation highlighted the persistence of USPleadership in trying to establish USPas a non-profit organization,an important step in securing USP's legitimacy and credibility.The significant contributions of seventeen current and former officers and trustees,who were present for the celebration,were recounted for attendees.The finale of the celebration was an appearance by Horatio C.Wood,IV,great-grandson of the individual most responsible for establishing the USP Board of Trustees.
Lester Chafetz,Ph.D.and Ralph Shagraw,Ph.D.(posthumously)received the inaugural Beal Award for distinguished volunteer service.The two were honored for their expertise and commitment as well as their significant contributions to USP's far-reaching impact on public health.
Business Meeting of the United States Pharmacopeial Convention
FDA Commissioner Urges USP Members to Create Agenda of Cooperation and Synergy—Jane E.Henney,M.D.,Commissioner of Food and Drugs,Food and Drug Administration,began her presentation by remarking on the “long and colorful history USPand FDAhave shared,working side-by-side for almost 95years.”Dr.Henney addressed the new challenges that we all can expect,including the increased demand for new standards and more information in areas such as botanicals and biotechnological products.In her remarks,she noted that “improvements in the FDAwill make it a better partner to USP,such as increasing science internally and increasing its scientific leveraging resources externally.”Dr.Henney praised the reciprocal program being put into place to educate employees on each organization's programs and services.In addition,Dr.Henney praised the USPad hoc reviewer program,and stressed that the two organizations must “continually improve and maintain regular contact.”Lastly,Dr.Henney encouraged USPand FDAto “create an agenda that promotes cooperation and synergy worthy of a new century,including the best of our past and the greatest of our desires and dreams.”
Congresswomen Morella Invites USP Members to Challenge Congress to Pass Important Medication Error Legislation—The Honorable Constance A.Morella,4th District,U.S.House of Representatives,praised USP,a prominent constituent,for its work in promoting the public health.Congresswoman Morella affirmed her commitment to work with colleagues in Congress “to promote the use of MedMARx and help USPbuild a comprehensive database.”She stated her belief that with passage of appropriate legislation,Congress can improve patient care,improve quality,and reduce errors.Ms.Morella remains confident that if her bill,HR3672Medication Error Prevention Act,cannot pass on its own,then it will be integrated into another bill,such as the current patient privacy legislative proposal.The Congresswoman urged attendees to call and write their legislators to prompt support of the legislation.
AMA Chairman Forecasts Strengthening of USP/AMA Relationship in Shared Areas of Interest—Thomas R.Reardon,M.D.,President,American Medical Association,expressed his support of MedMARx and similar activities that will reduce medical errors.Dr.Reardon offered the AMA's assistance to help further MedMARx and said he is looking forward to working with USPon the medication error issue.Dr.Reardon also identified another shared area of interest herbals and dietary supplements and their regulation.Dr.Reardon expressed his belief that the “advances of the last 50years may pale in comparison to the next 10or 20years,”and he is hopeful that USPand AMAwill strengthen their relationship.
APhA Executive Vice President Recognizes Convenor Role of USP—John A.Gans,Ph.D.,Executive Vice President and CEO,American Pharmaceutical Association,remarked on the rich heritage that APhAshares with USP.Dr.Gans challenged USPmembers to develop new thinking and new resources to attack the $100billion we spend on medication use problems.He stated that “our work is cut out for us if we are to increase the safety of medication use collectively and individually.”Dr.Gans reiterated that physicians,patients and pharmacists,as well as other health care professionals,should collaborate to improve health outcomes.Dr.Gans acknowledged that USP“often plays an important convener role and already has a table set with the appropriate people.”He reiterated that APhAremains “committed to collaboration with USP.”
PhRMA Urges USP Members to Let Expertise Unite Group—Frederick W.Telling,Ph.D.,Corporate Vice President,Pfizer,Inc.,Pharmaceutical Research and Manufacturers of America,encouraged participants “to let expertise unite us,not divide us.”He stressed the need to build a health care delivery system that will allow all professions to offer unique expertise.Dr.Telling spoke of the partnership with PhRMAand USPand how both organizations are achieving progress in the public health arena.He specifically reflected on the expansion of opportunities for industry participation in USP,and the increasing role USPplays in pharmacopeial harmonization.Dr.Telling also spoke on new frontiers such as genomics and biotechnology products,stating that such areas would ultimately “augment the practice of medicine and pharmacy not displace it.”
Actions on Constitution and Bylaws Implement Recommendations from a Five-Year Study on the Committee of Revision—Members actively debated and finally approved proposed amendments to the Constitution and Bylaws,which implemented substantive changes to the structure and processes of USP's scientific body,the Committee of Revision,newly named the Council of Experts.Of particular interest to members were changes in the nomination and election of the Council of Experts and its Expert Committees (previously Subcommittees and Advisory Panels)and ensuring the continued authority of the scientific body to approve and certify revisions to the USP–NF.
Resolutions Adopted by USP Members Address Critical New Issues for Positive Impact on Public Health—Members adopted 19resolutions at the QMto guide USPin establishing new standards and information systems in biotechnology,therapeutic equivalence,botanicals,medication error prevention,and other areas of emerging significance.Through the resolutions members directed feasibility and advisability studies on a number of activities and encouraged collaboration with other organizations,health care professionals,and regulatory agencies as USPundertakes its work.Six resolutions focused on medication safety,error reporting and prevention in the areas of:compounded drug formulations for special populations;packaging,labeling,and nomenclature standards to support safe and proper medicine use;standardized imprint codes for solid dosage forms;developing standards to minimize errors in prescribing,distribution and delivery systems;expanding error reporting systems to include dietary supplements,herbals,and other products.Eight others addressed USP's continuing role as a leader in compendial standards.They included:applied genomics,methods development and validation of botanicals;therapeutic equivalence;bioequivalence through modern pharmaceutical principles;pharmacopeial education;international harmonization;and veterinary medicine.The remaining adopted resolutions dealt with therapeutic decision support,USPmembership,the frequency of member meetings and strategic planning.The full text of the adopted resolutions is printed subsequently in this text.
Elections of Officers and Trustees and Council of Experts —The individuals elected as Officer and Trustees and chairs of the 62Expert Committees of the Council of Experts are listed elsewhere in this edition of USP–NF.
New Executive Vice President and Chief Executive Officer Assumes Leadership of USP—Roger L.Williams,M.D.,assumed the leadership of USPon the last day of the QM,when Jerome A.Halperin stepped down after 10years in that position.In his remarks,Dr.Williams commented that he looks forward to working closely with the newly elected Board of Trustees,and the USPCmember organizations to achieve USP's mission of promoting the public health.He also reaffirmed USP's commitment to strengthening its relationship with the FDA,the industry and other constituencies through various forums.With his experience as an internist and clinical pharmacologist,Dr.Williams said that he hoped to maintain USP's strengths in the pharmaceutical sciences,and with his medical training,he hoped to strengthen USP's services to physicians,nurses,pharmacists,and other health care practitioners;thus,return to USP's practitioner roots.He told members that assuming leadership of USP,for him,is an historic opportunity and an historic challenge as the new millennium dawns and USPenters its third century.
2000–2005Resolutions
Applied Genomics USP Policy and Strategy—Constitute a broadly based expert body to explore the feasibility and advisability of formulating policies and implementing short-and long-term strategies to ensure that USPis responsive to the impact of applied genomics on drug discovery,drug development,and attendant (customized)therapeutic applications and to the needs of affected communities and constituencies.
Equivalence for Products Containing Complex Active Ingredients—Explore the feasibility and advisability of developing guidance on principles and approaches to assure equivalence of complex active ingredients (including botanicals and dietary supplements)recognizing the special issues associated with agents of biologic/biotechnological origin including their regulatory control.Initiatives should be undertaken in collaboration with appropriate partners.
Equivalence Based on Modern Biopharmaceutics Principles—Assess the feasibility and advisability of developing approaches for the application of modern biopharmaceutic principles in conjunction with appropriate dissolution tests to assure equivalent performance of immediate-and modified-release drug products,taking into account their regulatory control.Initiatives should be undertaken in collaboration with appropriate partners.
Compounded Drug Formulations for Special Populations—Continue to develop and institute,in collaboration with other organizations as appropriate,specific initiatives focused on the development of appropriate compounding guidelines and monographs for commonly prescribed medicines and dosage forms that are not commercially available for use in special populations,notably neonatal,pediatric,geriatric,and terminally ill patients.
Compendial Standards to Support Safe and Proper Medicine Use—Explore the feasibility and advisability of establishing standards for packaging,labeling,nomenclature,and dosage form characteristics for compendial articles to aid in the reduction and prevention of medication errors,and to support safe and proper use of medicines.Initiatives should be undertaken in collaboration with appropriate partners.
Minimizing Health System Errors—Assess the advisability and feasibility of developing a program to monitor,evaluate,and provide standards for new and existing prescribing,distribution,and delivery systems to ensure that drug product quality is maintained and the potential for medication errors is minimized.Initiatives should be undertaken in collaboration with appropriate partners.
Medication Error Reporting Program—Additional Focus—Consider expanding the USP Medication Error Reporting Program to include dietary supplements,infant formulas,medical foods,and herbal preparations in collaboration with appropriate partners.
Standardized Imprint Codes for Solid Oral Dosage Forms—USPshould explore the advisability and feasibility of developing and promoting standardized imprint coding for all solid oral dosage forms,after a date to be determined by the USP Board of Trustees in cooperation with appropriate partners,to aid practitioners'and consumers'ability to readily identify and safely use medications.
Methods Development and Validation for Botanical Ingredients—USPis encouraged to work collaboratively with the Food and Drug Administration,academia,and other organizations to develop guidelines for prioritizing and conducting methods research on botanical ingredients by:
Standards and Information for Veterinary Medicine—Evaluate the advisability and feasibility of initiatives focused on the development of drug compounding guidelines and drug information monographs to aid veterinarians and pharmacists in the extra-label use of medications,particularly as these products impact food animal medication practices.Initiatives should be undertaken in collaboration with other organizations as appropriate.
International Harmonization—USPis encouraged,in consultation with the Food and Drug Administration,to expand on-going harmonization with the European and Japanese Pharmacopoeias,and the pharmacopoeias of the Americas.This initiative should include intensified cooperation with the International Conference on Harmonisation for the Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)to harmonize standards and analytical procedures for drug substances,excipients,and,as appropriate,drug products.
Enhance Communications with the Food and Drug Administration to Ensure Efficient Standards Development—USPis encouraged to explore ways of improving communication and sharing information between USPand the Food and Drug Administration to promote the efficient adoption of public standards for products regulated by the Agency.
Education and Training Programs—Establish education and training programs to support the appropriate use of U.S.Pharmacopeiaand National Formulary(USP-NF)standards and compendial methods.Initiatives should be undertaken in collaboration with appropriate partners.
Therapeutic Decision Support—USPshould explore the advisability and feasibility of developing,validating,and disseminating evidence-based therapeutic decision support information that focuses on improving prescribing and the use of medicines.Initiatives should be undertaken in collaboration with other organizations as appropriate.
Guidelines for Schools—Handling Medications—Facilitate and contribute to the development of a rational school medicines policy,including guidelines for student,faculty,and staff medicine education;for acquisition,transport,storage,administration,use,and disposal of medicines;for protection of privacy;and for record-keeping in primary and secondary schools.Initiatives should be undertaken in collaboration with appropriate partners.
Expand Health Professionals'Use of the United States Pharmacopeiaand the National Formulary—The USPis encouraged to expand the distribution of standards in the USP–NFto include practicing pharmacists and colleges/schools of pharmacy,and other practitioners and students in the health professions and increase the visibility and accessibility of USPin the educational system.
Membership—Guidance to the USPC Board of Trustees (and Standing Membership Committee)—In designating organizations as eligible to appoint a member to the USP Convention for the 2000-2005term,the Board of Trustees (and Standing Membership Committee)shall consider:
Ensuring full representation,as provided for in the USPC Constitution and Bylaws,from Consumer Organizations and Individuals Representing Public Interests.
Increasing the representation of health professions'student organizations and the biotechnology,pharmaceutical,and dietary supplements industries,and healthcare informatics communities.
Revisiting the policy of the two-tiered (“Constitutionally named”and “Invited”)membership system to determine whether it meets the Convention's current and projected needs.
Establishing written policies and criteria for the extension of invitations to new organizations and removal of an “Invited”or “Constitutionally named”organization for which a member has not been appointed.
USP Convention Meetings—The Board of Trustees,in cooperation with the Council of Experts and members of the USP Convention,shall explore the feasibility and advisability of increasing the frequency of meetings of the USP Convention.
USP Strategic Planning Process—The following Strategic Planning Process shall be adopted by the USP Convention:
The Board of Trustees shall monitor progress on the Strategic Plan within the context of long-range planning,annual budgets and operating plans,and also shall consider,as appropriate,new goals or strategies.
Annually,the USPC President shall advise and seek comment from Convention members and the Council of Experts as to progress on meeting the goals and strategies of the Strategic Plan utilizing electronic and print media.
The Board of Trustees shall formally consider the Strategic Plan.
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