USP: Setting the Standards for Pharmaceutical Quality
USP: Setting the Standards for Pharmaceutical Quality
The U.S. Pharmacopeia (USP), the world's only nongovernmental pharmacopeia, establishes state-of-the-art standards to ensure the quality of medicines, dietary supplements, and other healthcare technologies. These standards are developed by a unique process involving all interested parties and are accepted worldwide. USP also helps to monitor and prevent medication error problems through national reporting programs. USP is a not-for-profit organization that achieves its goals through its scientific staff and the volunteer service of experts representing pharmacy, medicine, and other healthcare professions and sciences. USP's primary areas of service include drug and dietary supplement standards setting, medication error reporting, veterinary medicine, international activities, and drug information.
Roger L. Williams, MD, is Executive Vice President and Chief Executive Officer of the United States Pharmacopeia. He assumed these positions in April 2000.
Dr. Williams received his BA degree at Oberlin College and his medical degree and training in internal medicine at the University of Chicago. He served in the United States Army, both in Korea and at Walter Reed Army Institute of Research, where he conducted antimalarial drug research. In 1977, he completed a clinical pharmacology training program at the University of California, San Francisco, and became a faculty member at the University, a position he retains. In 1989, he spent a year studying an anti-HIV drug at Genelabs as Vice President for Medical Affairs. He joined the Food and Drug Administration (FDA) in 1990 as the Director of the Office of Generic Drugs in the Center for Drug Evaluation and Research. In 1993, he moved to an Associate Director position in the Center, and in 1995 he became Deputy Center Director for Pharmaceutical Science. In this capacity, he had oversight for the Center's Office of New Drug Chemistry, Office of Generic Drugs, Office of Clinical Pharmacology and Biopharmaceutics, and Office of Research and Testing.
Dr. Williams is a fellow of the American Association of Pharmaceutical Scientists, an expert member of the International Pharmaceutical Federation Board of Pharmaceutical Sciences, and has been a member of the World Health Organization Expert Committee on Pharmaceutical Preparations. He has authored or coauthored over 150 reports in the areas of clinical pharmacology and product quality. Dr. Williams is board-certified in internal medicine and clinical pharmacology and is a member of Phi Beta Kappa and Alpha Omega Alpha.
We recently interviewed Dr. Williams to get his perspective on the past, present, and future of USP and to highlight 2 important USP programs that are helping to increase medicine use safety for all.
Bernstein: What do you consider to be USP's greatest contribution to the practice of pharmacy?
Williams: It is difficult to highlight one contribution over the course of USP's 180-year partnership with pharmacy. The overarching contribution, to pharmacy and to healthcare in general, has been USP's assurance of quality standards in medicines -- both today and throughout history. Pharmacists know USP is an organization that can be trusted. USP goes beyond its standards, to the provision of healthcare information and other public health activities.
Bernstein: What is the primary role of the USP?
Williams: USP's primary role is to establish standards that ensure the quality of medicines, dietary supplements, and other healthcare products. These standards are developed by a unique combination of scientific expertise from a cadre of volunteer experts and USP staff, public input, and cooperation with the FDA. The standards are legally enforced under the provisions of the Federal Food, Drug, and Cosmetic Act. USP also helps to monitor and prevent medication error problems through national reporting programs for human and veterinary drugs.
Bernstein: How is the USP of 2001 different from the USP of 20 years ago? How will the USP of 2021 be different from the organization today?
Williams: USP of 2001 is already different from the USP of 2000, let alone USP of 20 years ago. Today we are focusing on our core competencies, with drug and dietary supplement standards setting as the primary core business. We also have defined 7 programs that USP is uniquely qualified to pursue; the Dietary Supplement Quality Demonstration Program and Medication Error Reporting are 2 of those areas. The others include USP's reference standards/publications program, training programs, information programs, veterinary medicine programs, and a USP policy center. To carry out these programs, USP has a membership of more than 400 organizations, a Council of Experts that includes 62 committees and over 600 experts, and a staff of nearly 300.
USP extends its commitment to public health to other countries by working with many important stakeholders focused on medicine and pharmacy.
Bernstein: Recently, the USP Board of Trustees approved a pilot program to oversee ingredient quality for dietary supplements. Tell us about this program and what you hope to accomplish in each of its phases.
Williams: We recently announced the launch of a voluntary pilot program that will form the framework for a national program to assess the quality of dietary supplement ingredients. We believe that this program, the Dietary Supplements Quality Program, will fulfill the need for a certification program for dietary supplements and botanicals and will complement FDA's regulation of dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA). USP is uniquely positioned to undertake this certification role because of its more than 100 years of vitamin standards setting and the current recognition of United States Pharmacopeia and National Formulary (USP-NF) dietary supplement standards in DSHEA.
In the pilot phase of the program, USP is seeking to enroll up to 10 dietary supplement manufacturers to help build the certification program. Ingredients of 2 supplement products for each company will be analyzed for quality. Specifically, the pilot program will include:
We designed the pilot program so that these companies will help us fine-tune and enhance the program's criteria, standards, and procedures for the rollout of the national quality ingredient program.
Upon the completion of the pilot program, which we anticipate will happen later this year, we will launch the national program. Participation in the program will be opened up to all U.S. dietary supplement and botanical product manufacturers. At this time, USP will introduce a proprietary USP certification mark, which will be granted to manufacturers who demonstrate adherence to the criteria, standards, and procedures as developed and established in the pilot program. The companies who participated in the pilot program whose products met USP's specifications will be among the first to use the USP mark.
The mark will be designed to communicate to healthcare practitioners, retail distributors, consumers, and all market stakeholders that USP, an established authority with over 100 years of experience in dietary supplement standards, has provided oversight for a product's ingredient quality by helping to assure that dietary supplements and botanicals:
Our primary goal of the program is to help assure the public that dietary supplements bearing the USP certification mark contain quality ingredients in the amount designated on the product label.
Bernstein: Will the USP program address issues of safety and efficacy?
Williams: USP will address safety and efficacy issues of dietary supplements only as they relate to quality. USP will not address a manufacturer's structure/function or health claims.
Quality safety issues include potential contamination with substances such as heavy metals, pesticides, or pathogenic organisms. USP's program will address the issue of contaminants. USP will not provide a certification mark for dietary supplements that are inferior in quality.
The issue of contaminants is a complex one, since dietary supplement ingredients come from all over the world. USP will require manufacturer testing to include heavy metals, microbial contaminants or pathogens, as required, and foreign substances or chemicals.
Because it is virtually impossible to eliminate all contaminants, USP's quality program will include accepted limits on the amount of contaminants allowed in the substance. As noted above, testing will be performed for only certain contaminants.
Bernstein: Are physicians and pharmacists doing enough to educate patients about the use of dietary supplements? What more could they do?
Williams: Dietary and botanical supplements are a topic in which new information is emerging every day. Physicians, pharmacists, and other healthcare professionals now, more than ever before, need an unbiased source of information to convey to their patients. The USP Dietary Supplement Quality Program will have an educational component about the program.
Bernstein: What resources should the consumer use to better understand dietary supplements?
Williams: USP's Dietary Supplement Quality Demonstration Program will include a consumer education outreach program. The USP Web site also contains information on dietary supplements.
Bernstein: What role does or will USP play in developing standards for products of biotechnologic and ultimately pharmacogenomic origin?
Williams: USP's goal is to provide public standards by which to judge the quality of medications and other articles used in healthcare. This is true whether the articles are botanical, chemical, or biological in origin. As the science develops and matures, USP will provide monographs for these articles just as it has for insulin, hormones, and other complex ingredients and products in the past.
Bernstein: How is the USP working to identify and prevent medication errors in our country's hospitals?
Williams: USP believes that the sharing of experiences and concerns among healthcare professionals is important to reducing medication errors and providing safer, better-quality healthcare. USP operates 2 medication error reporting, tracking, and analysis programs: the Medication Errors Reporting (MER) Program for healthcare professionals to report problems encountered during clinical practice, and the MedMARx Program (pronounced med-marks) for hospitals. MedMARx was launched in 1998.
MedMARx reports and data are used to build comprehensive information databases, improve USP's drug standards, and provide feedback to reporting professionals, product manufacturers, and regulatory agencies.
USP began operating the MER Program in 1991. USP purchased the program from the Institute for Safe Medicine Practices (ISMP) in 1995. The ISMP continues as a cooperating organization in the MER Program.
Bernstein: What is MedMARx and why have USP and the Department of Defense (DOD) recently signed an agreement to implement USP's MedMARx program?
Williams: MedMARx is an anonymous Internet-accessible performance improvement tool developed and launched by USP. The purpose of MedMARx is to allow participating hospitals to report, track, and share medication error data in a standardized format. It is the only national hospital database that aggregates hospital medication error data for dissemination to participants and the public.
The MedMARx and the DOD is a natural partnership. We both have strong commitments to reduce and ultimately eliminate medication errors. MedMARx will enable approximately 300 DOD hospitals to view and learn from the data of other facilities. Using MedMARx is more cost-effective for the DOD than if they were to develop their own medication error tracking system. The MedMARx system also will allow the DOD hospitals to view their own medication error information in addition to data from other healthcare facilities enrolled in the program. Access to this data will help identify error-prone medications or therapeutic classes of drugs. MedMARx helps DOD and other participants make drug formulary selection decisions, develop protocols, and develop proactive safety measures for problematic products.
Bernstein: In what ways should pharmacists use USP products and services in their daily practice?
Williams: MedMARx and the Medication Error Reporting Program are the 2 USP "products" that pharmacists can use on a daily basis. MedMARx is available to hospital pharmacists and the MER is available to community and other pharmacy practices. Soon, pharmacists will have the USP certification mark on dietary supplement products that meet USP's quality ingredient standards. This mark indicates that the dietary supplement product is one that pharmacists can recommend with confidence because an authoritative organization has tested its ingredients. In addition, the USP-NF contains many standards that govern pharmacy practice: compounding, beyond-use dates, packaging, storage, and others.
Bernstein: What mechanisms do you have in place to encourage practitioner reporting of medication errors? How does USP facilitate the sharing of this information among practicing physicians, pharmacists, and nurses to help us learn from our mistakes?
Williams: The Medication Error Reporting Program is available to any healthcare provider and is available in several formats. Pharmacists and other healthcare professionals can report medication errors via an "800" telephone number, the Internet, or a printed form.
USP facilitates sharing this information through a quarterly newsletter, the Quality Review, and on its Web site via the PRN News. Both reports highlight pertinent medication error issues or trends in the data collected by USP. USP also issues annual data summaries from the MedMARx program.
Bernstein: What are your 3 wishes for USP during your tenure?
Williams:
The U.S. Pharmacopeia (USP), the world's only nongovernmental pharmacopeia, establishes state-of-the-art standards to ensure the quality of medicines, dietary supplements, and other healthcare technologies. These standards are developed by a unique process involving all interested parties and are accepted worldwide. USP also helps to monitor and prevent medication error problems through national reporting programs. USP is a not-for-profit organization that achieves its goals through its scientific staff and the volunteer service of experts representing pharmacy, medicine, and other healthcare professions and sciences. USP's primary areas of service include drug and dietary supplement standards setting, medication error reporting, veterinary medicine, international activities, and drug information.
Roger L. Williams, MD, is Executive Vice President and Chief Executive Officer of the United States Pharmacopeia. He assumed these positions in April 2000.
Dr. Williams received his BA degree at Oberlin College and his medical degree and training in internal medicine at the University of Chicago. He served in the United States Army, both in Korea and at Walter Reed Army Institute of Research, where he conducted antimalarial drug research. In 1977, he completed a clinical pharmacology training program at the University of California, San Francisco, and became a faculty member at the University, a position he retains. In 1989, he spent a year studying an anti-HIV drug at Genelabs as Vice President for Medical Affairs. He joined the Food and Drug Administration (FDA) in 1990 as the Director of the Office of Generic Drugs in the Center for Drug Evaluation and Research. In 1993, he moved to an Associate Director position in the Center, and in 1995 he became Deputy Center Director for Pharmaceutical Science. In this capacity, he had oversight for the Center's Office of New Drug Chemistry, Office of Generic Drugs, Office of Clinical Pharmacology and Biopharmaceutics, and Office of Research and Testing.
Dr. Williams is a fellow of the American Association of Pharmaceutical Scientists, an expert member of the International Pharmaceutical Federation Board of Pharmaceutical Sciences, and has been a member of the World Health Organization Expert Committee on Pharmaceutical Preparations. He has authored or coauthored over 150 reports in the areas of clinical pharmacology and product quality. Dr. Williams is board-certified in internal medicine and clinical pharmacology and is a member of Phi Beta Kappa and Alpha Omega Alpha.
We recently interviewed Dr. Williams to get his perspective on the past, present, and future of USP and to highlight 2 important USP programs that are helping to increase medicine use safety for all.
Bernstein: What do you consider to be USP's greatest contribution to the practice of pharmacy?
Williams: It is difficult to highlight one contribution over the course of USP's 180-year partnership with pharmacy. The overarching contribution, to pharmacy and to healthcare in general, has been USP's assurance of quality standards in medicines -- both today and throughout history. Pharmacists know USP is an organization that can be trusted. USP goes beyond its standards, to the provision of healthcare information and other public health activities.
Bernstein: What is the primary role of the USP?
Williams: USP's primary role is to establish standards that ensure the quality of medicines, dietary supplements, and other healthcare products. These standards are developed by a unique combination of scientific expertise from a cadre of volunteer experts and USP staff, public input, and cooperation with the FDA. The standards are legally enforced under the provisions of the Federal Food, Drug, and Cosmetic Act. USP also helps to monitor and prevent medication error problems through national reporting programs for human and veterinary drugs.
Bernstein: How is the USP of 2001 different from the USP of 20 years ago? How will the USP of 2021 be different from the organization today?
Williams: USP of 2001 is already different from the USP of 2000, let alone USP of 20 years ago. Today we are focusing on our core competencies, with drug and dietary supplement standards setting as the primary core business. We also have defined 7 programs that USP is uniquely qualified to pursue; the Dietary Supplement Quality Demonstration Program and Medication Error Reporting are 2 of those areas. The others include USP's reference standards/publications program, training programs, information programs, veterinary medicine programs, and a USP policy center. To carry out these programs, USP has a membership of more than 400 organizations, a Council of Experts that includes 62 committees and over 600 experts, and a staff of nearly 300.
USP extends its commitment to public health to other countries by working with many important stakeholders focused on medicine and pharmacy.
Bernstein: Recently, the USP Board of Trustees approved a pilot program to oversee ingredient quality for dietary supplements. Tell us about this program and what you hope to accomplish in each of its phases.
Williams: We recently announced the launch of a voluntary pilot program that will form the framework for a national program to assess the quality of dietary supplement ingredients. We believe that this program, the Dietary Supplements Quality Program, will fulfill the need for a certification program for dietary supplements and botanicals and will complement FDA's regulation of dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA). USP is uniquely positioned to undertake this certification role because of its more than 100 years of vitamin standards setting and the current recognition of United States Pharmacopeia and National Formulary (USP-NF) dietary supplement standards in DSHEA.
In the pilot phase of the program, USP is seeking to enroll up to 10 dietary supplement manufacturers to help build the certification program. Ingredients of 2 supplement products for each company will be analyzed for quality. Specifically, the pilot program will include:
Manufacturer testing of ingredient samples, with a review of the test results by USP
Compliance with the principles of good manufacturing practices
Postmarketing product surveillance by USP
We designed the pilot program so that these companies will help us fine-tune and enhance the program's criteria, standards, and procedures for the rollout of the national quality ingredient program.
Upon the completion of the pilot program, which we anticipate will happen later this year, we will launch the national program. Participation in the program will be opened up to all U.S. dietary supplement and botanical product manufacturers. At this time, USP will introduce a proprietary USP certification mark, which will be granted to manufacturers who demonstrate adherence to the criteria, standards, and procedures as developed and established in the pilot program. The companies who participated in the pilot program whose products met USP's specifications will be among the first to use the USP mark.
The mark will be designed to communicate to healthcare practitioners, retail distributors, consumers, and all market stakeholders that USP, an established authority with over 100 years of experience in dietary supplement standards, has provided oversight for a product's ingredient quality by helping to assure that dietary supplements and botanicals:
Contain the declared ingredients on the product label
Contain the amount or strength declared on the product label
Are made under the principles of good manufacturing practices
Our primary goal of the program is to help assure the public that dietary supplements bearing the USP certification mark contain quality ingredients in the amount designated on the product label.
Bernstein: Will the USP program address issues of safety and efficacy?
Williams: USP will address safety and efficacy issues of dietary supplements only as they relate to quality. USP will not address a manufacturer's structure/function or health claims.
Quality safety issues include potential contamination with substances such as heavy metals, pesticides, or pathogenic organisms. USP's program will address the issue of contaminants. USP will not provide a certification mark for dietary supplements that are inferior in quality.
The issue of contaminants is a complex one, since dietary supplement ingredients come from all over the world. USP will require manufacturer testing to include heavy metals, microbial contaminants or pathogens, as required, and foreign substances or chemicals.
Because it is virtually impossible to eliminate all contaminants, USP's quality program will include accepted limits on the amount of contaminants allowed in the substance. As noted above, testing will be performed for only certain contaminants.
Bernstein: Are physicians and pharmacists doing enough to educate patients about the use of dietary supplements? What more could they do?
Williams: Dietary and botanical supplements are a topic in which new information is emerging every day. Physicians, pharmacists, and other healthcare professionals now, more than ever before, need an unbiased source of information to convey to their patients. The USP Dietary Supplement Quality Program will have an educational component about the program.
Bernstein: What resources should the consumer use to better understand dietary supplements?
Williams: USP's Dietary Supplement Quality Demonstration Program will include a consumer education outreach program. The USP Web site also contains information on dietary supplements.
Bernstein: What role does or will USP play in developing standards for products of biotechnologic and ultimately pharmacogenomic origin?
Williams: USP's goal is to provide public standards by which to judge the quality of medications and other articles used in healthcare. This is true whether the articles are botanical, chemical, or biological in origin. As the science develops and matures, USP will provide monographs for these articles just as it has for insulin, hormones, and other complex ingredients and products in the past.
Bernstein: How is the USP working to identify and prevent medication errors in our country's hospitals?
Williams: USP believes that the sharing of experiences and concerns among healthcare professionals is important to reducing medication errors and providing safer, better-quality healthcare. USP operates 2 medication error reporting, tracking, and analysis programs: the Medication Errors Reporting (MER) Program for healthcare professionals to report problems encountered during clinical practice, and the MedMARx Program (pronounced med-marks) for hospitals. MedMARx was launched in 1998.
MedMARx reports and data are used to build comprehensive information databases, improve USP's drug standards, and provide feedback to reporting professionals, product manufacturers, and regulatory agencies.
USP began operating the MER Program in 1991. USP purchased the program from the Institute for Safe Medicine Practices (ISMP) in 1995. The ISMP continues as a cooperating organization in the MER Program.
Bernstein: What is MedMARx and why have USP and the Department of Defense (DOD) recently signed an agreement to implement USP's MedMARx program?
Williams: MedMARx is an anonymous Internet-accessible performance improvement tool developed and launched by USP. The purpose of MedMARx is to allow participating hospitals to report, track, and share medication error data in a standardized format. It is the only national hospital database that aggregates hospital medication error data for dissemination to participants and the public.
The MedMARx and the DOD is a natural partnership. We both have strong commitments to reduce and ultimately eliminate medication errors. MedMARx will enable approximately 300 DOD hospitals to view and learn from the data of other facilities. Using MedMARx is more cost-effective for the DOD than if they were to develop their own medication error tracking system. The MedMARx system also will allow the DOD hospitals to view their own medication error information in addition to data from other healthcare facilities enrolled in the program. Access to this data will help identify error-prone medications or therapeutic classes of drugs. MedMARx helps DOD and other participants make drug formulary selection decisions, develop protocols, and develop proactive safety measures for problematic products.
Bernstein: In what ways should pharmacists use USP products and services in their daily practice?
Williams: MedMARx and the Medication Error Reporting Program are the 2 USP "products" that pharmacists can use on a daily basis. MedMARx is available to hospital pharmacists and the MER is available to community and other pharmacy practices. Soon, pharmacists will have the USP certification mark on dietary supplement products that meet USP's quality ingredient standards. This mark indicates that the dietary supplement product is one that pharmacists can recommend with confidence because an authoritative organization has tested its ingredients. In addition, the USP-NF contains many standards that govern pharmacy practice: compounding, beyond-use dates, packaging, storage, and others.
Bernstein: What mechanisms do you have in place to encourage practitioner reporting of medication errors? How does USP facilitate the sharing of this information among practicing physicians, pharmacists, and nurses to help us learn from our mistakes?
Williams: The Medication Error Reporting Program is available to any healthcare provider and is available in several formats. Pharmacists and other healthcare professionals can report medication errors via an "800" telephone number, the Internet, or a printed form.
USP facilitates sharing this information through a quarterly newsletter, the Quality Review, and on its Web site via the PRN News. Both reports highlight pertinent medication error issues or trends in the data collected by USP. USP also issues annual data summaries from the MedMARx program.
Bernstein: What are your 3 wishes for USP during your tenure?
Williams:
To lead USP as a key contributor into the many healthcare challenges and opportunities that will characterize the 21st century.
To bring a focused science and public health vision for USP's public health programs and standards setting activities.
To expand USP's public health programs and standard setting activities to the benefit of practitioners and patients/consumers around the world.