CSPI Antibiotic-Resistance Project: Comments from CSPI to the CDC regarding antibiotic resistance

American Public Health Association
Center for Science in the Public Interest

August 3, 2000

Office of Health Communication
National Center for Infectious Diseases
Centers for Disease Control and Prevention
Mailstop C-14
1600 Clifton Road
Atlanta, GA 30333

RE: Draft Public Health Action Plan to Combat Antimicrobial Resistance

Dear Sir/Madam:

We would like to comment on some of the Action Items included in the Draft Public Health Action Plan to Combat Antimicrobial Resistance⁽¹⁾ that pertain to the medical use of antimicrobials.⁽²⁾ We commend the interagency task force for identifying numerous measures that could reduce the occurrence of antimicrobial resistance. The scope and depth are unprecedented, and the document should serve as a guide for many years. We enthusiastically support the Plan and hope that the following comments are useful.

The declaration of time lines is helpful. However, the fact that many Action Items would not be initiated for up to five years (e.g., Action Items #37, 65, 83 [a "top priority action item"]) — suggests that some agencies do not recognize the urgency for action. We recommend that all Action Items be initiated within two years.

The introduction of the action plan states: "The plan will be implemented incrementally, as resources and, where needed, new appropriations become available" (page 11). Lack of funding may delay implementing several of the Action Items, such as Action Item #27 (Top Priority), recommending a major educational program. We are concerned that the action plan does not address the need for larger budgets and other specific legislative actions. Many previous reports on antimicrobial resistance⁽³⁾^,⁽⁴⁾^,⁽⁵⁾^,⁽⁶⁾ include a number of such recommendations.

We urge the task force to obtain Administration support for existing legislative proposals⁽⁷⁾ and to request any needed funding. Additionally, we urge the task force to advise specific regulatory actions, when appropriate, in its recommendations. We also suggest that the Department of Justice be included in the task force, particularly to give input regarding federal prisons as model program sites.

Surveillance

Action Item #5 (Top Priority) proposes developing and implementing procedures for monitoring antimicrobial drug use in human medicine, agriculture, and consumer products. We support that, but it is critical that drug-use data be linked with antimicrobial-resistance data. That information is fundamental to analyzing the impact of antimicrobial use on subsequent resistance within communities and is not specified in the action plan (see Recommended New Action Item, below).
Action Item #6 proposes identifying and evaluating methods for collecting and disseminating surveillance data on antimicrobial drug use. We encourage the task force to also include a recommendation to identify and evaluate those sources of drug-use data and databases that could correlate antimicrobial use with diagnosis codes and diagnostic test results, including antimicrobial-resistance testing (see comments on Action Items #17 and #18, below). That information would be particularly valuable to health-care practitioners and public health officials and may allow modification of prescribing habits before resistance develops.
Action Item #17 proposes establishing a centralized, accessible source of antimicrobial-resistance data. Action Item #18 proposes disseminating data on the impact of drug-resistant microorganisms and prevention and control mechanisms to health-care administrators. We suggest revising these Action Items to include data on drug use and diagnoses. As stated above in our comments about Action Item #6, an integrated, centralized data source would be a valuable resource for all health-care practitioners and public health officials. That would also facilitate correlation of drug-use trends with resistance and provide the basis for implementing clinical-practice changes.

Prevention and Control

Action Item #25 proposes evaluating the relationship between prescribing behavior and antimicrobial marketing and promotional practices; the proposed time line is three to five years. We support that proposal and urge the task force to move the time line forward to one to two years. Additionally, we suggest evaluating if any relationship exists between hospitals’ internal policies regarding pharmaceutical companies’ promotional practices and the individual hospital formularies. Continuing advertisements and promotions for antimicrobials, especially broad-spectrum antimicrobials, may influence health-care practitioners’ prescribing practices, thus affecting antimicrobial-resistance development.
Action Item #26 proposes assisting health-care systems analyze how the availability of antimicrobial-resistance data influences prescriber behavior, health outcomes, and cost; the proposed time line is three to five years. We urge the task force to move the time line forward to one to two years. Analyzing the impact of data availability on prescriber behavior is critical. Currently, most prescribers do not have access to data on local patterns of antimicrobial resistance and the effects of their (and other local prescribers’) prescribing habits on drug resistance. That data would be beneficial for prescribers in choosing an appropriate antimicrobial.
Action Item #27 (Top Priority) proposes developing a public-health education strategy to promote judicious antimicrobial use. Education of health-care practitioners and patients is fundamental to reducing antimicrobial use. We suggest that the task force specify that the public-health education strategy will be an on-going and repetitive campaign to reinforce the principles of judicious antimicrobial use.
Action Item #29 (Top Priority) addresses the development of clinical guidelines for judicious antimicrobial use (time line: initiated). We request that the task force include recommendations for monitoring implementation and adherence to these guidelines. Guidelines will only be effective if health-care practitioners use them. Furthermore, Action Item #66 (Top Priority) addresses demonstration projects to evaluate comprehensive programs that use multiple interventions to promote judicious drug use and reduce infection rates. Action Item #69 proposes encouraging national accrediting agencies to include accreditation standards that promote efforts to prevent and control antimicrobial resistance. Judicious use guidelines should be included in both Action Items.
Action Item #30 proposes exploring ways to integrate judicious-use information into antimicrobial package inserts and promotional materials. The task force should recommend inclusion of patient-package inserts with all antimicrobials, either by FDA direction⁽⁸⁾ or private sector implementation.⁽⁹⁾ Each insert should advise patients that antimicrobial use, and especially mis-use, contributes to the spread of antimicrobial resistance. Currently, distribution of patient-package inserts varies with individual pharmacies, and no special consideration is given to antimicrobials.
Action Item #31 proposes articulating factors supporting the current prescription requirement for systemic antimicrobials; the proposed time line is three to five years. If systemic antimicrobials are made available over-the-counter, the potential for public misuse would be enormous. The recent FDA hearings (June 28-29, 2000) to evaluate discontinuing the prescription requirement for more medications emphasizes the importance of this Action Item. Since the FDA is actively reviewing this matter, we urge the task force to recommend immediate initiation of this Action Item.
Action Item #33 recommends convening an advisory panel for drugs of last resort; the proposed time line is one to two years. This panel will be beneficial in ensuring those drugs are correctly used and only used as a last resort. We urge the task force to recommend the immediate establishment of the advisory panel. In the past year, antimicrobials from two new drug classes were approved by the FDA: quinupristin-dalfopristin (Synercid, a streptogramin) and linezolid (Zyvox, an oxazolidinone). They are approved for treatment of vancomycin-resistant Enterococcus infections, as well as other indications. In order to maintain their efficacy, it is important that they be used judiciously from the beginning. That is critical because it is unlikely that any new classes of antimicrobials will be approved in the next one to two years. Panel members should include infectious disease experts, pharmacology experts, and public health officials.
Action Item #34 proposes convening a working group to examine the impact of federal reimbursement policies for home parenteral antimicrobial treatment on judicious antimicrobial use. We suggest that the task force recommend input from patients and health-care practitioners.
Action Item #37 proposes identifying diagnostic testing barriers; the proposed time line is three to five years. Availability and accuracy of point-of-care diagnostic testing is essential for health-care practitioners to determine when antimicrobials are needed. Even if clinical guidelines are available, they may be difficult to follow if diagnostic testing is not available. We urge the task force to move the time line forward. We also encourage the task force to recommend reimbursement for rapid diagnostic tests by health-insurance carriers and other organizations. That would encourage health-care practitioners to perform those tests.
Action Item #40 proposes promoting increased direct examination of specimens as a point-of-care diagnostic test. Currently, the Clinical Laboratory Improvement Amendment regulations impede some health-care practitioners from performing available point-of-care tests, such as rapid strep tests and Gram stains. We encourage the task force to recommend specific legislative and regulatory changes to allow health-care practitioners and facilities to perform those tests, thus allowing them to make more appropriate prescription choices.
Action Item #44 proposes evaluating the cost-effectiveness and impact on patient care and drug resistance of medical devices that incorporate anti-infective compounds to prevent infection. We request that the task force add a recommendation for long-term resistance surveillance. It is possible that resistance to the incorporated anti-infective compounds may occur. Available surveillance data would assist health-care practitioners to decide when to use these devices and if they need to alternate products (incorporating different antimicrobials) on a routine basis.
Action Item #46 proposes evaluating consumer products utilizing antimicrobials, antiseptics, or disinfectants (e.g., soaps, cutting boards, baby toys). The American Medical Association recently requested an expedited review of the use of antibacterial compounds in consumer products.⁽¹⁰⁾ Resistance to anti-infective compounds used in consumer products has been documented,⁽¹¹⁾ but it is unclear whether it poses a significant risk. We agree with the need for further evaluation.
Action Item #49 proposes public education about using irradiation to reduce bacterial contamination of food. Considering that the inability to directly test the safety of irradiated foods has led to consumer concerns that have impeded the use of irradiation, the task force should recommend concentrated efforts to develop more sensitive tests to evaluate the safety of irradiated foods.
Action Item #51 proposes identifying vaccines useful in reducing drug-resistant infections and evaluating methods to improve coverage with these vaccines. Vaccines are an essential tool for reducing infectious diseases. We suggest that the task force add a recommendation to evaluate broadening vaccination recommendations. For example, Streptococcus pneumoniae (pneumococcal) vaccination is currently not recommended for persons less than 65 years of age without co-morbid conditions. However, elderly patients may not develop sufficient immunity after vaccination.⁽¹²⁾ Therefore, vaccination at an earlier age may help reduce the incidence of pneumococcal pneumonia.
Action Item #65 proposes establishing an ongoing mechanism for obtaining external input on antimicrobial-resistance issues; the proposed time line is three to five years. It is logical to have a broad committee review federal efforts to combat antimicrobial resistance. However, we urge the immediate establishment of an advisory committee. The committee certainly should include medical and agricultural experts, public health officials, and consumer representatives. The federal government would benefit from input during the continual and dynamic process of battling antimicrobial resistance.
Action Item #67 proposes utilizing federal health-care systems as model systems for antimicrobial resistance surveillance and prevention and control activities; the proposed time line is three to five years. The task force should initiate the Action Item immediately due to recent Congressional action "[urging] the VA to use its south Florida facilities to implement and evaluate innovative antimicrobial-use practices . . ."⁽¹³⁾ In addition, the Department of Justice provides health care within its prisons and those should be included as model system sites.
Action Item #69 proposes encouraging national accrediting agencies to include accreditation standards that promote efforts to prevent and control antimicrobial resistance. As stated in our comments on Action Item #29, we urge the task force to recommend monitoring practice-guideline implementation and use in the accreditation standards.

Research

Action Item #72 proposes working with the appropriate peer-review structures to ensure that the requisite expertise is applied to the review process to facilitate funding of quality antimicrobial research. The pharmaceutical companies are bearing an excessive proportion of the burden for funding antimicrobial research. We urge the task force to recommend allocating NIH funds for this research and identifying other funding sources.

Product Development

Action Item #85 addresses streamlining the regulatory process to bring to the market products that would help reduce resistance levels. We suggest that the task force also recommend streamlining the process for novel products.