Apr 30 2010
Four of the nation's leading public health officials laid out opportunities and challenges in the diverse area of patient care in the 21st century at the recently concluded U.S. Pharmacopeial Convention's (USP) 2010 Membership Meeting in Washington, D.C., emphasizing the critical nature of partnerships and the evolving role of quality standards to meet modern threats. USP sets standards for the strength, quality and purity of drugs, food ingredients and dietary supplements, and its work touches on the many areas of public health addressed by the speakers.
Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration (FDA); Dr. Michael Maves, chief executive officer of the American Medical Association (AMA); Mr. Thomas Menighan, chief executive officer of the American Pharmacists Association (APhA); and Ms. Jennie Chin Hansen, president of AARP and chief executive officer of the American Geriatrics Society, addressed nearly 500 delegates and observers April 23 at the USP Convention meeting, held once every five years.
Dr. Hamburg noted that the close relationship between FDA and USP stretches back more than a century, beginning with the enactment of the Pure Food and Drug Act in 1906. The two groups share a common public health mission-and have worked collaboratively to address serious issues such as the adulteration of the blood thinner heparin in 2007�. Dr. Hamburg said that this episode underscored one of the most pressing areas for FDA and USP to work together-modernizing public standards in light of new threats brought on by globalization. Dr. Hamburg stated that the heparin episode "can be used as a model for how to move forward proactively to modify monographs in a way that they identify counterfeited or intentionally adulterated products before they enter the healthcare system. Now, we must jointly identify drug ingredients and products that would benefit from an up-to-date monograph-starting with those that have the greatest impact on public health."
Dr. Hamburg said that new approaches are essential to ensuring that the food and medicines consumed by Americans every day are safe and quality-assured, particularly because FDA will not be able to inspect all imported goods as they come over the border. This is an area where partnerships such as those between FDA and USP are key. Dr. Hamburg referred to three joint initiatives in which FDA and USP have agreed to expand efforts to promote the purity, quality and efficacy of current and new drugs. First, physical reference standard candidates that are controlled substances will be jointly assessed. Second, in efforts to combat economic adulteration, FDA and USP will exchange information on hand-held device applications designed to screen drugs for adulteration or contamination and explore ways to integrate the requirements of those new technologies into USP's documentary standards. Third, FDA will assist in the development and modernization of USP monographs, leading to enhanced tests and assays to better assess and characterize drug ingredients and products.
Moreover, the FDA commissioner said, "We also want to work with you to ensure the safety and quality of food and food ingredients for Americans," and, "In the coming years, we would like to share information about ways to help manufacturers make and market safe dietary supplements. We would also work together to develop methods to detect contaminants, including pharmaceuticals, in dietary supplements and foods."
Declaring that, "You have been extremely successful in cultivating your relationships abroad-in the past five years," Dr. Hamburg told USP Convention members and observers, "We are eager to work with you as we interact with our counterpart agencies and industry overseas to help establish science-based standards for the quality of the products that we regulate. We are both integral parts of the international regulatory community, and we look forward to working with you in these new outreach efforts."
AMA's Dr. Maves also began by invoking a historical tone, noting that USP's history mirrors AMA's as both groups were founded by physicians to pursue better health care. He noted five common interests that AMA and USP share. These are: quality standards for drugs (the experience with adulterated heparin serves an important symbol for what can potentially go wrong, he said); Medicare Part D; the naming of drugs under the United States Adopted Names Council (both groups are founding members); dietary supplement quality (doctors have ongoing concerns about dietary supplements and AMA encourages manufacturers to participate in USP's verification program, he noted); and patient safety activities such as the work of USP's Safe Medication Use Expert Committee.
APhA's Mr. Menighan stressed the need for collaboration to meet today's challenges, noting that health care reform has advanced the notion of "team care" for patients. Much of this collaboration can be in the form of information-sharing. Mr. Menighan called on pharmacists to have read/write access to electronic health records, among other activities.
"We have a medication use crisis in this country," he noted. "We tend to throw medications at people with little information." He asserted that through cooperative efforts, this situation could greatly improve. Mr. Menighan also focused on the issue of drug interactions, which first captured the attention of pharmacists in the 1970s. At that time, a list of about 10 drug interactions was developed to protect patients. Today, knowledge about this problem is "literally exploding," representing a major opportunity for doctors, nurses, pharmacists and others to advance public health.
AARP's Ms. Jennie Chin Hansen continued the focus on patients, noting that medications are essential to older Americans. She said that 18 percent of adults 64 and older take ten or more medications. One significant area of concern for AARP is adverse drug events, which are common in elderly patients. Ms. Chin Hansen noted that these pose significant health threats. In the context of health care reform and cost, reduction of these events-and better education of patients-is also a significant opportunity financially. Out of three billion prescriptions a year, 40 percent are not taken properly. As a result, $290 billion is added to health care costs.
While Ms. Chin Hansen noted that USP often plays a "behind the scenes" role, she stressed the impact of its science on patients. She pointed to a number of areas in which AARP and USP can effectively collaborate. One of these areas is biologic medicines. AARP is vested in the issue of biologics given their potential in treating diseases. USP has served to educate AARP and its members about the science of biologics during the last cycle, and Ms. Chin Hansen sees this role continuing. Another area for future collaboration cited by Ms. Chin Hansen is drug information. A low literacy rate in the adult population as well as language differences means that many people may not understand the information they receive about their medications-a serious problem that needs to be addressed.
Source: US Pharmacopeia
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