2012 USP Listening Tour: Join In and Be Heard!

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Throughout 2012–2013, the USP Council of the Convention (CoC) is hosting a global Listening Tour. At each stop, we’ll meet with delegates from USP Convention member organization to better understand their perceptions, needs, and expectations.

How Your Input Will Help Advance the USP Mission

Member feedback gathered from the Listening Tour plays a critical role in the development of new Resolutions that help guide USP and advance its mission.

view the process and learn how valuable your input can be

First, We Listen Next, We Evaluate Then, We Respond

First, We Listen

The USP Council of the Convention (CoC)
Listening Tour travels the globe throughout 2012–2013. At each stop, the CoC

  • engages members in discussion on
    USP’s role and future
  • listens to varying perspectives and ideas
  • gathers feedback

Next, We Evaluate

Once the Listening Tour ends, the CoC

Then, We Respond

As the 2015 Convention nears, the CoC

Past Tour Stops & Summaries

What We’ve Heard: Tour Themes

  • Improving the Practice of Medication Decision-Making

    USP should explore whether it has a role in helping to improve the way medicines (and/or foods and dietary supplements) are used. Unbiased information developed through the USP process by and for practitioners could be a significant contribution to a body of knowledge about responsible use that practitioners and patients would value.

    • Some practitioners within USP’s membership believe there can be problems determining which drugs are the right drugs to use, and they suggest that USP may have a role in helping to identify the right drug at the right time.
    • The rationale for turning to USP is its history of work in drug information and its tradition of including practitioners in its standards setting process. This inclusive approach sets the foundation for developing and disseminating a reliable source of information about the responsible use of these products to the practitioner community and patients.
    • Additionally, data collected in post-marketing evaluations of medicines are not easily accessible or understandable. If data were collected and reported in a standardized/consistent fashion, they would be especially useful to prescribers in terms of improving the way medicines are used and which medicines are used. USP may wish to consider how it could contribute some standardization to this environment.
    • Although the World Wide Web has offered enormous opportunities to improve patient health (e.g. electronic health records, e-prescribing, knowledge sharing), it has also created challenges (Internet pharmacy, proliferation of “health information” sites that are questionable/unreliable) that may jeopardize patient safety. USP’s unbiased position in the community and access to practitioners and patients may allow it to address some of these issues using its public standards setting model.
  • Biosimilars

    As biosimilars enter the picture, USP’s standards (monographs and reference materials, as well as general chapters) may play a role in the new regulatory approval pathway. Additionally, USP’s history and ability to work at the interface of practitioner and patient communities may allow it to play an important role in education as these new technologies evolve. Accurate scientific information about biosimilars will be critical. The question then arises: How should USP prepare for this role?

  • Supply Chain and Counterfeits

    Members see a growing challenge in the security of the global supply chains for medicines and foods. Associated with risk points and breaches in the supply chain, members have expressed growing concern about the potential for more counterfeits and substandards to enter the health system. Because of these concerns, USP was encouraged to explore how it could equip the healthcare system and members with tools to combat supply chain breaches and counterfeit and substandard medicines and foods. Specifically, USP was encouraged to explore/expand a series of activities or to address these issues, including: spectral libraries; domestic and international.

    • Supply chain breaches can open the system to counterfeit and/or substandard articles. Once thought to be a developing countries issue, counterfeits and substandards have surfaced in developed countries as well. Counterfeit and substandard medicines will continue to proliferate and USP is positioned well to develop anti-counterfeiting approaches within the US as well as outside the US.
    • USP must make every effort to keep its standards up-to-date, including developing more specific identity tests that cannot be “fooled” by potential contaminants and, where appropriate, tests for known contaminants.
    • USP’s spectral library initiative could help to identify spurious products and, in the process, serve regulatory, industry, practitioner, and ultimately patient communities.
    • US practitioners may not be as aware as they should be of the threat of counterfeits and substandards, and USP should consider ways to educate them.
    • International sourcing of pharmaceuticals, supplements, food ingredients, and drug products will continue to create opportunities for counterfeit and substandard products to enter the supply chain. While USP has been diligent in establishing its presence in major manufacturing countries, it should consider where the next major source (country) may arise and begin relationship development now.
  • Drug Shortages

    Drug shortages is a reoccurring topic of major concern to USP member organizations with shortages affecting virtually every organization and patient population. Members suggested that a root cause analysis could potentially uncover novel approaches (among them possibly providing a global comparator product) to help address the issue. USP’s ability to bring together key stakeholders, coupled with its understanding of global manufacturing and supply chains may allow USP to play a role in helping to address the issue. Further, because of drug shortages, practitioners frequently use substitute medicines with which they are often unfamiliar. Given USP’s standards setting structure and experience, it might be able to assist patients and practitioners by providing useful information on appropriate substitutes.

    • Drug shortages are affecting virtually every member organization and patient population. While the Prescription Drug User Fee Act (PDUFA) legislation may help in some ways, a root cause analysis could potentially uncover novel approaches to address the issue. USP’s ability to bring together key stakeholders through its diverse membership, coupled with its understanding of global manufacturing and supply chain issues, could create the right environment to conduct such a root cause analysis. USP’s guidance would be beneficial to assure continued quality of medicines.
    • Global supply of generic medicines raises the issue of where one would find a “global comparator product”. If USP could assist in this effort, it might mitigate some of the shortage issues and potentially create a “short cut” for a globally accepted standard. This contribution would advance the ability of pharmacopeias to harmonize, expand access, and at the same time add another deterrent to counterfeiting and substandard medicines.
    • Because of drug shortages, practitioners have to use substitute medicines with which they are often unfamiliar. Dosing issues and drug interactions when using these substitutes adds to the complexity of drug therapy and disease management for healthcare providers. Could USP assist patients and practitioners by providing useful information on potential substitutes?
    • The connection between drug shortages and compounding was also noted. Health care facilities and practitioners frequently turn to compounders when drugs are no longer commercially available, which in turn highlights the importance of USP standards in ensuring high quality compounding, as discussed below.
  • Compounding Standards for Practitioners and Patients

    Members encouraged USP to continue its efforts in the area of standards for compounding practice and preparations. During the Listening Tour, this recommendation was often associated with drug shortages, where there may be a need to compound drugs that are not available from manufacturers. In light of the subsequent health crisis involving fungal contamination of compounded sterile injections, this topic was extracted for focused attention.

    • Chapters <797> and <795> provide important standards for compounding and positions USP in an important role to help practitioners and patients. In addition, the availability of standards for compounded preparations for drugs in short supply would assist the practitioner and patient communities.
    • USP must continue its efforts to offer education to all practitioners involved in compounding.
  • Diagnostics

    Biologics and diagnostics will work together to create miracles in personalized medicine; however, practitioners will need guidance about what are good diagnostics and good biologics. USP could focus on reference materials for diagnostics that would ensure true measurement so that there is confidence that the right specialized medicine is developed for each patient.

  • Maintaining and Enhancing USP's Position in Global Public Health

    Also during the Listening Tour, members identified USP strengths—unique characteristics and capabilities—that set it apart from other public health organizations. Members also encouraged USP to use its best efforts to promote its value to the global public health community. Noting USP’s unique character, members saw USP as having a myriad of tactics, interactions, and opportunities available to enhance its image among its members.

    USP's Strengths

    • USP is a non-governmental, scientific standards development organization that is financially independent. This status allows it to operate throughout the world without political pressure or influence and to take up issues that the U.S. and other governments cannot.
    • USP’s international reputation and recognition are great strengths, and add to USP’s worldwide credibility and influence. And, because USP approaches issues collaboratively, it has enhanced its position as a global standards-setting leader.
    • USP is the only organization that brings together those that discover, manufacture, distribute, prescribe, dispense and administer medicines and this is a hallmark of the organization. It combines the science and practice of multiple disciplines. USP has maintained its heritage by continuing to include the practitioner community–users of medicines, dietary supplements, and food ingredients–as part of its quality standards-setting process. This tradition and culture of inclusivity is a great strength.
    • The USP Convention itself is a great strength—it is an organization of associations—a model that is unusual in the world. Equally unusual is the diversity, expertise, and number of USP expert volunteers and scientific staff. These assets, combined with the public nature of USP, create an organization that is unlike any in the world.

    USP as Convener

    • Beyond its core competencies, USP is often looked to by its member organizations as a neutral convener—a place where divergent groups can discuss/accomplish things no one group could do alone. Members expressed interest in USP’s facilitating stakeholder and expert discussions/activities in the following areas.
      • Healthcare professionals have a mandate to work together collaboratively; however, communication among these groups is often difficult or non-existent. USP has the ability to convene these health professionals to to advance collaborative practice, patient care, and potentially improve the healthcare system.
      • Many challenges will arise, at times unpredictably, related to ensuring the quality (and responsible use) of medicines and foods. USP should consider expanding its current role to become a “think tank” for identifying and creating policy and/or options to deal with potential drug and food issues, including a macro-economic analysis. USP could present approaches in the form of white papers that demonstrate where it might fill gaps that exist in a broad range of health-related issues.

    Raising Awareness about USP to Members and the Public

    • Some members believe that patients and practitioners don’t know enough about USP and its value to them. Awareness campaigns in these communities using a broad range of tactics (including constituent specific web pages, partnering with member organizations, and taking USP “on the road”) would be greatly beneficial.
    • USP’s standards are good, but states don’t always adopt compounding standards or other practitioner-related standards USP develops. We must find a way to share the value of these standards better with states and encourage adoption.

Resources