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Appendix E: Proceedings

Abstract of USP Convention 2005
USP Convention 2005 took place from March 9 to 13, 2005, at the Grand Hyatt in Washington, DC. More than 300 representatives from national and state healthcare professional associations and medical societies, government, the pharmaceutical industry, academia, and international health organizations attended.


Wednesday, 9 March 2005 included registration and a USP Convention orientation session. During the evening, Convention representatives were welcomed to a dessert reception at the Corcoran Gallery of Art in downtown Washington.


Roger L. Williams, M.D., USP executive vice president–CEO, welcomed Convention members to the healthcare symposium: The Future of Healthcare and Healthcare Standards. He introduced the first speaker, Jack C. Chow, M.D., assistant director-general for HIV/AIDS, tuberculosis, and malaria at the World Health Organization (WHO). Dr. Chow noted that one-third of the world population is infected with tuberculosis, and TB is the leading cause of death for those infected with HIV; that 75% of malaria deaths involve African children aged 5 or less; that 38 million people now live with HIV/AIDS; and that cumulative global annual deaths from these three diseases amount to 6 million individuals. Asking “what can we do together as a grand coalition of the caring and committed” to alleviate these scourges, Dr. Chow identified four main goals: develop public health strategies, especially in terms of improving public health infrastructure; energize civil society via coalition building; transform political leadership toward public health issues; and devote more resources—financial, intellectual, and human talent—to solving global public health problems.
Dr. Williams introduced the next speaker, Lucian L. Leape, M.D., adjunct professor of health policy at the Harvard School of Public Health and one of the founders of the National Patient Safety Foundation. Dr. Leape began by noting that the Institute of Medicine published its report on medical errors, To Err Is Human, in 1999. Since then, he stated, practitioners have generally stopped assigning individual or personal blame for medical errors. He added, however, that the healing professions have made only limited progress in improving thinking about poorly designed medical systems and have yet to begin functioning as teams. Airlines have made enormous improvements in safety, he suggested, because the barriers between pilots, crews, and support personnel have been systematically dismantled. He went on to suggest several improvements that can help healthcare practitioners work more effectively as teams: establish Electronic Medical Records, which will require adequate funding to ensure full implementation; begin team medical training with simulation; and full disclosure. Dr. Leape ended his talk with several examples of medical teamwork (e.g., simplifying a central venous catheter protocol and making it a true team effort) and showing how such team efforts can lead to reductions in medical errors.
Uwe E. Reinhardt, Ph.D., professor of economics and public affairs at Princeton University's Woodrow Wilson School of Public and International Affairs spoke about the changing needs in US healthcare. He noted that in constant terms averaged during the past 30 years, the US healthcare expenditures increased 4.5% per year compared with average annual growth of gross domestic product (GDP) of 2%. Observations such as this led some observers to predict in 1993 that by 2000 Americans would be paying 20% of GDP on healthcare. This prediction never materialized, Dr. Reinhardt observed, because of the rise of managed care. Current projections suggest that 18.7% of US GDP will be devoted to healthcare by 2014. As long as GDP rises appropriately, Dr. Reinhardt noted, the US can afford this expenditure. However, 30% of the US population now earns $35,000 or less, and the price of health insurance has increased by double digits since 2000. At the same time, US fiscal policy relies on deficit spending, a situation that Dr. Reinhardt encouraged USP and other public bodies to help change for the public good.
Following a recess, Darrell R. Abernethy, M.D., Ph.D., candidate for USP president, moderated a discussion as the speakers from the morning session took questions from the audience.


President D. Craig Brater, M.D., convened the first business session by asking René H. Bravo, M.D., committee chair, to present the initial report of the Membership Committee. Dr. Bravo introduced the committee members and delivered his report, which was accepted by the membership. Susan de Mars, J.D., secretary of the Convention, presented the Minutes of the 2000 USP Convention and gave the Secretary's report, calling attention to premeeting materials that were distributed to all Convention delegates. Following her presentation Dr. Brater recessed the morning session.
After lunch Ms. de Mars introduced Dr. Brater, who devoted his President's Address to international healthcare issues. Dr. Brater is Dean of Indiana University's School of Medicine, which has formed a partnership with Moi University in Eldoret, Kenya. Interspersing his talk with video clips, Dr. Brater said, “Kenya is losing about 700 young people every day [to HIV/AIDS]. That's like two fully packed 747s going down every day, day after day, in the Kenyan society. This is unlike any other epidemic. It's a triple hit. It not only takes the youth away, but it leaves the children without parents and it leaves the elderly without the support systems they counted on in their retirement.” He noted that in 2010, the date of the next USP Convention, Africa will be home to 20 million of the 25 million worldwide AIDS orphans. Dr. Brater movingly pointed out that the US in USP does not mean the organization and its volunteer members should ignore the suffering of the less fortunate in the world—to the contrary, he emphatically suggested, USP standards-setting activities, Global Assistance Initiatives, foreign-language translations of USP–NF, the proposed USP-International compendia, and work with international organizations such as the World Health Organization can all contribute to ameliorating the disparities in healthcare worldwide and promoting good pharmaceutical care for all.
Larry L. Braden, R.Ph., D.Sc., began his Chairman's report by acknowledging each Board member and his or her contributions during the cycle. He reviewed the key activities of the Board, beginning with the 2003–2005 Strategic Plan: Upholding Our Commitment and Securing the Core, which required that the Board's fiduciary responsibilities remain its primary duty throughout the cycle. Staff oversight, particularly working with the new CEO and COO, were also high priorities for the Board. Dr. Braden also reviewed the committee structure adopted by the Board and reviewed the activities of its ad hoc committees, all of which, he pointed out, served to further USP's goal of promoting the public health. Dr. Braden concluded his report by reaffirming USP's commitment to the pharmacy community.
Dr. Williams reported that the cycle had been a “perfect storm ... [that] led to an in-depth rethinking of the way this organization works ...” Dr. Williams described USP as an organization that is moving from good to great. Using an analogy of a bus, he reviewed who is aboard and where the vehicle is going. Convention members, the Board, the Council of Experts, Stakeholder Forum and Project Team members, and staff are all aboard, all striving to develop world-class standards and programs. As part of USP's efforts to move from good to great, Dr. Williams noted, USP now publishes USP–NF annually, is preparing a Spanish edition (and is contemplating editions in other languages), is introducing the Pharmacists' Pharmacopeia, and is exploring the advisability of developing USP-International for drugs not legally marketed in the US. USP also makes available reference standards to laboratories around the world and offers a variety of educational and training courses. Toward the end of the cycle, USP became involved in the development of the Model Guidelines that the Centers for Medicare and Medicaid Services, Department of Health and Human Services, will make available to prescription drug plans for the elaboration of formularies; this work may continue into the next cycle. Also, the Board authorized USP to open a new site in India, which will mark the first time USP has opened a laboratory outside the US. Finally, as the cycle closed USP was making good progress toward the construction of two new buildings on its current site so that all staff will be unified at one location by 2007.
Following these three leadership presentations, Drs. Brater, Braden, and Williams were joined by Mr. John Fowler, chief business officer, Ms. de Mars, chief legal officer, Mr. Brian Hendrix, chief finance and administrative officer, Dr. Eric Sheinin, chief scientific officer, and Mr. William Zeruld, vice president of corporate and international planning and development, for a question and answer session with the Convention membership. Afterwards Dr. Brater introduced parliamentarian Walter Carson, J.D., who was present at all official proceedings for the duration of the Convention. Dr. Brater then introduced Jordan L. Cohen, Ph.D., the chair of the Nominating Committee for Officers and Trustees, who presented the nominees for the 2005–2010 term. His report was accepted unanimously, and Dr. Brater called on Thomas S. Foster, Pharm.D., vice chair of the committee, to present the report of the Nominating Committee for the Council of Experts. One additional nomination was made from the floor, and the report was accepted. Dr. Brater adjourned the session and invited attendees to a reception that evening to meet the officer and trustee candidates.



Dr. Brater convened the Convention and called on Dr. Bravo to present the report of the Membership Committee, which was accepted by the membership. Dr. Brater introduced the first invited speaker, FDA Acting Commissioner Lester Crawford, D.V.M., Ph.D. Dr. Crawford noted the close working relationship between the two organizations: “FDA shares with USP the tradition, the effort, and the responsibility for upholding the highest standards possible for public health.” He went on to discuss the importance of current Good Manufacturing Practices, FDA's Critical Path initiative, its Generics Rule to facilitate approvals, and the agency's Drug Safety Oversight Board.
For the first time, the Biotechnology Industry Organization (BIO) was invited to address the USP Convention. Dr. Brater introduced Mr. Michael J. Werner, Esquire, chief of policy at BIO. Mr. Werner noted that BIO is pleased to continue its work with USP and FDA to ensure the availability of good-quality therapeutic products to meet healthcare needs. He told Convention members that BIO was grateful for the opportunity to participate in USP's efforts to develop the Medicare Model Guidelines. Mr. Werner raised a few questions about USP-International and its possible effects on USP's resources but concluded his presentation by expressing a desire for USP and BIO to maintain a collaborative relationship.
Michael D. Maves, M.D., executive vice president and CEO of the American Medical Association, reflected on the long association between USP and AMA and identified six areas of keen interest to physicians today: medical liability; Medicare (specifically, payments to physicians are expected to decline by 30% during the next 6–8 years); the need to expand healthcare insurance and access to healthcare; promoting healthy life styles; antitrust relief vis-á-vis managed-care plans; and clinical quality improvement, including voluntary medical error reporting. Dr. Maves also identified areas of common interest and possible collaboration with USP: expanding the Medicare Model Guidelines to include more drug information (e.g., drug interaction information); patient safety (MEDMARX and error reporting); continued work on USAN; and dietary supplement evaluation and information programs.
John A. Gans, Pharm.D., executive vice president and CEO of the American Pharmacists Association, noted that this was his fourth address to a USP Convention. After adumbrating themes he had touched on at previous Conventions, he pointed to the need for enhanced communications among prescribers, pharmacists, and patients. Medical products, he suggested, have become so sophisticated and the medical literature has become so complicated that patients too frequently do not use medications correctly. Electronic prescribing may help patients get correct medicine, he pointed out, but practitioners are becoming aware that computerized prescriber order entry is not a panacea. Practitioners must assume their rightful responsibilities for the use of the technology. Dr. Gans challenged USP to bring pharmacists and physicians together to devise a minimum dataset for prescribing to include the physician and pharmacist of record and to address the environmental and therapeutic issues of 90-day prescribing.
Dr. Brater introduced Caroline Loew, Ph.D., vice president of scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA). Dr. Loew cited the proceedings of a conference USP convened in 1992; at the conference, delegates were invited to imagine the state of the pharmaceutical industry in 2020, which will be USP's 200th anniversary. Dr. Loew suggested that many of these predictions are already upon us, especially in terms of improvements in process knowledge and process analytical technology. She encouraged USP to focus on healthcare information for prescribing, dispensing, and use of medicines; to work with global organizations such as WHO; and to continue to set standards for dietary supplements.
The Generic Pharmaceutical Association, (GPhA) also for the first time, was invited to address the USP Convention, and Bruce L. Downey, J.D., chair and CEO of Barr Pharmaceuticals, spoke on behalf of GPhA. He complimented USP for being a premiere standards-setting organization. He applauded the concept of USP-International because it would contribute to global standards-setting activities. He also praised USP's work with flexible monographs, noting that they are an effective mechanism to facilitate market entry for generic products. He went on to recommend that USP become more active in establishing standards for biological products and in helping clarify the path toward registration of follow-on biologics and biotechnology products.
Dr. Brater introduced Lowell J. Anderson, R.Ph., D.Sc., candidate for treasurer of the Convention, who moderated a speakers' dialog with members. After the dialog, Dr. Brater turned over the podium to Michael A. Moné, R.Ph., J.D., chair of the Constitution and Bylaws Committee, who in turn introduced the members of the committee. Mr. Moné briefly reviewed the major revisions proposed by the committee: creating a Council of the Convention; improving communications between the Board of Trustees and the Council of Experts; imposing term limits on Council of Experts members (effective in 2010); formalizing the process for creating Stakeholder Forums and Project Teams; and clearly delineating the role and responsibilities of the chair of the Council of Experts. Drs. Brater and Williams and Ms. de Mars were on hand to answer questions (as noted, the parliamentarian, Mr. Carson, was present throughout the remainder of the Convention). After discussion of proposed changes to the Constitution and Bylaws, Mr. Moné introduced Marilyn K. Speedie, Ph.D., chair of the Committee on Resolutions, who introduced the members of the committee. Convention attendees provided comments, asked questions, and suggested changes to the proposed Resolutions. Both the Constitution and Bylaws Committee and the Committee on Resolutions met later that day to consider the proposals and concerns they had received from Convention members and to rewrite, to the extent they thought appropriate, the proposed changes to the Constitution and Bylaws or the proposed Resolutions.


Dr. Brater convened the session by asking Dr. Bravo to present the report of the Membership Committee, and the report was accepted. Dr. Brater announced the morning's business was to review and vote on the previously proposed and published amendments to the USP Constitution and Bylaws. He introduced the Committee of Tellers, who were in the room to assist with the vote. Dr. Brater then called on Mr. Moné, who suggested that the proposed amendments to the Constitution be reviewed and then be voted en bloc and that the proposed amendments to the Bylaws be treated similarly. Mr. Moné then reviewed the proposed amendments to the Constitution and called for a voice vote on each, whereupon he declared the Constitution, with changes, passed. A similar process was used for the Bylaws, and the Bylaws were accordingly amended. Two additional amendments were presented from the floor, which, according to the Constitution and Bylaws had to be considered by the Board, who would report on them to Convention members the following morning. Mr. Moné turned over the podium to Dr. Speedie, who presented the Resolutions the Convention would be voting on the next day, copies of which had been distributed to Convention members.
Dr. Brater introduced USP treasurer Jean Paul Gagnon, Ph.D., who reported that USP's financial results were “stellar,” but he added the important observation that “financial results are merely quantitative measures of broader organizational successes, including the superb science, management, outreach, and oversight that support this great institution.” Following the Treasurer's report, Dr. Brater called on Dr. Williams and other USP staff to give the Report of the Chair of the Council of Experts.
Dr. Williams began his report of the Council of Experts by stating that 62 chairs were elected at the beginning of the cycle; the total number of volunteers at the end of the cycle was 619. In a departure from previous organizational approaches in previous cycles, Dr. Williams had formed the Council of Experts initially into four groups: Noncomplex Actives and Excipients; Complex Actives; General Policies and Requirements; and Information Expert Committees; later the Dietary Supplements Multidisciplinary Coordinating Committee was added. Dr. Williams asked Dr. Sheinin to speak about the standards-setting work of the Council of Experts. Dr. Sheinin reviewed the structure and activities of these committees and pointed out that USP–NF is now published annually and is available in three formats: hard copy, CD, and Internet. USP–NF contains more than 180 General Chapters and more than 4000 monographs, but based on the number of drugs approved by FDA, the compendia are missing approximately 2000 monographs. Further, between 800 and 1200 monographs are outdated or need to be revised. Dr. Sheinin spoke about his department's aggressive monograph commissioning campaign, as well as other publishing activities such as the Spanish translation of USP–NF, the launch in 2005 of the Pharmacists' Pharmacopeia, and the new Annual Scientific Meeting, which will largely supplant open conferences. The new cycle will be a dynamic one for the Department of Standards Development, he said.
Dr. Sheinin introduced Mr. Zeruld, who reminded Convention members that USP had ended its publishing agreement with Thompson and no longer was involved in developing content for USP-DI. USP's recognition in the Medicare Modernization Act of 2003 provided an excellent opportunity for the Information Expert Committees to elaborate a set of model guidelines under which prescription drug providers could develop formularies. The model guidelines, he explained, consist of a list of categories and classes that prescription drug providers can use to develop formularies. Mr. Zeruld reviewed the intense work involved in developing the model guidelines, and gave credit and thanks to the volunteers who helped bring the process to a successful conclusion.
He turned over the podium to Ms. Diane Cousins, R.Ph., vice president, Center for the Advancement of Patient Safety. She noted that USP has operated medication error reporting systems for 15 years, but only during the 2000–2005 cycle had such activity been formally incorporated into USP's standards-setting activities through the Safe Medication Use Expert Committee. This Expert Committee and its working groups have made valuable recommendations for revisions to existing standards. Ms. Cousins highlighted a few: standards to avoid mix-ups of medical gases; revised labeling of single-dose and multidose vials; and restricting printing on ferrules and overseals of injectable drugs to cautionary statements only.
Ms. Cousins returned the podium to Dr. Williams, who commended USP staff for their work during the cycle. He also spoke about the accomplishments of the Stakeholder Forums and Project Teams during the 2000–2005 cycle, thanking USP's volunteer community for their many hours of service.
That evening members enjoyed the closing reception at the Library of Congress. Joseph G. Valentino, J.D., recently retired, was honored for his more than 30 years of service to USP.



Dr. Brater convened the final session of the Convention and asked Dr. Bravo for the final report of the Membership Committee, which was accepted. Dr. Brater then reported that the two amendments to the Constitution offered from the floor at Saturday's session both concerned membership in USP Convention. He asked the chair of the board, Dr. Braden, to report on the Board's recommendation, which was to refer the matter to the Membership Committee (a similar situation arose at the previous Convention, recalled Dr. Brater, and the matter was thus disposed). Accordingly, on behalf of the Board, Dr. Braden moved that each of these amendments be referred to the Membership Committee, and the motions passed.
Dr. Brater then called on Dr. Speedie, on behalf of the Resolutions Committee to deliver the Final Report of the Committee on Resolutions. Two Resolutions proposed from the floor failed to receive a two-thirds vote approving their consideration by the Convention. The complete list of adopted Resolutions follows this summary of the Proceedings.
Dr. Brater then announced the names of the newly-elected officers and trustees, and Dr. Williams announced the names of the new Council of Experts (both are listed elsewhere in this volume of USP–NF). Dr. Brater administered the oath of office to the new Board and passed the gavel to Dr. Abernethy, the new President of the Convention. Dr. Abernethy thanked the Convention for his election and pledged his commitment to implement the Resolutions the membership had adopted He concluded the meeting with a traditional open forum and adjourned the Convention at midday.

2005–2010 Resolutions
1. Public Monographs and Reference Materials
USP resolves to work with appropriate stakeholders to contribute to the public health and patient care by eliminating barriers to expanding and updating public monographs in USP–NF and, if needed, developing reference materials for all legally marketed therapeutic products in the US.
2. Integrity and Safety of Therapeutic Products
USP resolves to work with stakeholders to continue to develop packaging, shipping, distribution, and storage standards and practices that ensure the integrity and safety of all therapeutic products through the distribution and dispensing system. USP further resolves to support educational and allied activities, at all levels of distribution, dispensing, and administration (manufacturer through patient) concerning the integrity and safety of therapeutic products.
3. New Science and Technology
USP resolves to work with appropriate stakeholders to track emerging sciences and technologies, and when appropriate, to develop information, best practices, and standards that have direct applications to the public health and patient care.
4. Compounding Standards and Education
USP resolves to expand its work with appropriate parties involved in compounding, including practitioners, FDA, state boards of pharmacy, and other regulatory authorities, to support and disseminate information about science-based compounding practice.
5. Standards for Nomenclature and Labeling
USP resolves to collaborate with appropriate partners to continue to establish standards for labeling and nomenclature that support the safe and proper use of therapeutic products, including but not limited to the following initiatives that:
  • Provide references for the identification of multi-ingredient products.
  • Address recurring medication errors, particularly in the area of look-alike/sound-alike names, labeling, and packaging.
  • Reduce medication errors, particularly in the area of look-alike/sound-alike names, by encouraging the use, in the practice setting, of only the generic names for new single active-ingredient products marketed after 1 January 2006.
  • Encourage the uniform use of USP–NF dosage form nomenclature.
6. USP International Presence
USP resolves to continue to work with international governmental and nongovernmental bodies to increase the impact of its public health programs internationally. Furthermore, USP resolves to provide assistance to improve regulatory mechanisms and to build capacity to monitor drug quality for countries that lack appropriate resources.
7. International Harmonization
USP resolves to continue its efforts to harmonize compendial standards with the Pharmacopeial Discussion Group (PDG) and other pharmacopeias.
8. Drug Information Programs
USP resolves to work with interested parties to develop information programs concerning therapeutic products for special patient populations in need of targeted information.
9. Promoting Safe Medication Use and Disposal
USP resolves to work with appropriate constituencies to continue to develop programs to promote safe medication use and disposal.
10. Evidence-Based Methodologies and Algorithms for Decision Support Used in E-Prescribing and Pharmacy Computer Systems
USP resolves to work with appropriate stakeholders to continue to develop evidence-based methodologies and algorithms for decision support in areas such as drug–drug interactions, and to expand efforts to other alerts and recommendations for use in e-prescribing technologies and pharmacy computer systems. Furthermore, USP resolves to explore the feasibility and advisability of extending this approach to other information domains in the interest of the public health and patient care.
11. USP Convention
Using the recommendations of the Resolution 18 Committee to the Board of Trustees, USP charges the Council of the Convention, as an ongoing responsibility, to review the purpose, role, and composition of the Convention membership and examine the voting procedures used during the Convention.
12. Expanded Outreach
USP resolves to expand its efforts to engage stakeholders, who are affected by USP standards, but have not been fully involved in USP processes, including but not limited to groups concerned with Human Biologics, Animal Health, Biotechnology, and Device Manufacturers, in USP committees and programs.
13. Organizational Outreach
USP resolves to expand its efforts to engage pharmacy and other healthcare practitioner organizations in discussions related to USP's public health program activities. Efforts should be made to continue this dialogue on a regular, periodic basis to help build understanding among all organizations.