Ambulatory Care Drug Database System ..

Guidance on Search Criteria. NOTE: The Ambulatory Care Drug Database made the switch to a Multum-based system of drug classification with the 2006 data year.

Critical Care Intravenous Infusion Drug Handbook

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  • NOTE: The Ambulatory Care Drug Database made the switch to a Multum-based system of drug classification with the 2006 data year. As we work more with this system, we are identifying some issues which may affect data users. Specifically, in developing the new online drug database application, we discovered that Multum assigns certain drug characteristics differently than NCHS had done in the past. This was first noticed with aspirin, which Multum classifies as a prescription drug. The reason for this appears to be that there are certain strengths of aspirin that are only available by prescription, and Multum appears to code up to the highest level rather than differentiating prescription and non-prescription forms of drugs. This was also noticed with the DEA Status variable. Some drugs, such as codeine, may have multiple DEA statuses, depending on their dosage and route of administration. Multum codes such drugs up to their highest DEA status. Beginning with the 2008 drug data, we have worked with Multum to reclassify drugs within our own database to reflect multiple statuses. We wish to bring such issues to the attention of our data users so that they can be aware of any seeming contradictions with regard to these characteristics.

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    Based on the recommendations of NDAC at its March 23, 2005, meeting, we are continuing to propose the use of bacterial log reductions as a means of demonstrating that health care antiseptics are GRAE (Ref. 8). The 1994 TFM also proposed final formulation testing for health care personnel hand washes (59 FR 31402 at 31448), surgical hand scrubs (59 FR 31402 at 31445), and patient preoperative skin preparations (59 FR 31402 at 31450). We do not discuss final formulation testing here because we are not proposing that any of the active ingredients are GRAS/GRAE. Although these proposed test methods are intended to evaluate the effectiveness of antiseptic final formulations, this type of clinical simulation testing when adequately controlled also can be used to demonstrate that an active ingredient is GRAE for use in a health care antiseptic product. Based on our experience with the approval of NDA antiseptic products and input from the March 2005 NDAC, we recommend that the bacterial log reduction studies used to demonstrate that an active ingredient is GRAE for use in health care antiseptic drug products include the following:

  • Reports of the persistence of low levels of some antiseptic active ingredients in the environment (Refs. 89, 90, and 91) signal the need to better understand the impact of all antiseptics, including health care antiseptic drug products. Although it is important to consider the relative contribution of the use of health care antiseptic products to any possible environmental impact, it is also important to consider the benefits of these products. Hospital-acquired infections can result in prolonged hospital stays, additional medical treatment, adverse clinical outcomes, and increased health care costs. The use of health care antiseptics is considered an important component of the multifaceted approach that hospitals use to keep hospital acquired infection rates low (Refs. 21 and 23). Furthermore, in situations where there is extensive use of antibiotics, exposure to antibiotics, rather than exposure to antiseptics, plays a dominant role in emerging antibiotic resistance. This makes it difficult to determine whether antiseptics play a significant role in the development of antimicrobial resistance in the hospital setting. Despite this, the use of antiseptics in health care settings may also contribute to the selection of bacterial genera and species that are less susceptible to both antiseptics and antibiotics. We are requesting additional data and information to address this issue. Section VII.C describes the data that will help establish a better understanding of the interactions between antiseptic active ingredients and bacterial resistance mechanisms in health care antiseptic products and will provide the information needed to perform an adequate risk assessment for these health care product uses. FDA recognizes that the science of evaluating the potential of compounds to cause bacterial resistance is evolving and acknowledges the possibility that alternative data different from that listed in section VII.C may be identified as an appropriate substitute for evaluating resistance.

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Studies evaluating the impact of antiseptic active ingredients on the antiseptic and antibiotic susceptibilities of each of the following types of organisms could help support a GRAS determination for antiseptic active ingredients intended for use in OTC health care antiseptic drug products: