Topical Antiseptics in Healthcare

Clinical Laboratory Science, Summer 2005 by Jackson, Michelle M

Topical antiseptics are essential for infection control. Antiseptic formulations employ a variety of mechanisms, act at various rates and persistence intervals, demonstrate various levels of toxicity, and are more or less likely to trigger resistance. The desired characteristics are considered when selecting antiseptics for hand washing, surgical scrubbing, and patient preoperative skin preparation. The selection process requires evidence of product safety and efficacy. This article explores currently available topical antimicrobial agents used in medical settings.

ABBREVIATIONS: CHG = chlorhexidine gluconate; FDA = Food and Drug Administration; FR = Federal Register; GRASE = generally recognized as safe and effective; MRSA = methicillin resistant Staphylococcus aureus; NDA = new drug application; OTC = over-the-counter; PCMX = chloroxylenol; RASE = recognized as safe and effective; TFM = tentative final monograph; USP = United States Pharmacopeia.

INDEX TERMS: antiseptics; healthcare antiseptic; topical antiseptic.

Clin Lab Sci 2005;18(3):160

LEARNING OBJECTIVES

1. Define transient flora and resident flora and compare the two groups in terms of ease of removal.

2. Describe the FDA regulatory approval process for a drug product.

3. Define the following terms: antimicrobial soap, skin antiseptic, Healthcare personnel handwash, surgical hand scrub, and patient preoperative skin preparation.

4. Identify the types of healthcare topical antiseptic currently available on the market.

5. Identify factors that may influence the antimicrobial action of an antiseptic.

GLOSSARY OF TERMS

* Advisory Review Panels are composed of scientifically qualified members and nonvoting technical liaison members representing consumer and industry interests. These panels are charged with reviewing the ingredients and labeling of marketed OTC drug products to determine whether they could be classified as GRASE for use in self-treatment.

* Food and Drug Administration or the FDA is a federal agency in the Department of Health and Human Services established to regulate the release of new foods, drugs, and health-related products.

* GRASE is a term used to describe nonprescription drug products that are generally recognized as safe and effective.

* Misbranded is to label a drug product falsely or in a misleading way.

* Monograph is a list of therapeutic classes of ingredients that are generally recognized as safe and effective. A manufacturer wanting to market a product containing an ingredient covered under the OTC monograph need not seek the FDA's prior approval.

* NDA is a new drug application which requires that the drugs be proven safe and effective for human use before being marketed.

* OTC drugs are nonprescription drugs that are considered to be safe and effective for consumers to use without professional supervision, provided the required label directions and warnings are followed.

* RASE is a term used to describe prescription drug products that are recognized as safe and effective.

* TFM or tentative final monograph represents FDA's tentative conclusions as a proposed rule. This document offers the first clear signal of FDA's ultimate intentions. After the TFM is published, a period of time is allotted for objections or requests for a public hearing. New data may be submitted during this period.

INTRODUCTION

Topical antiseptics are antimicrobial agents that kill, inhibit, or reduce the number of microorganisms on the skin.1 The human skin is colonized by a wide variety of microorganisms that may provide a protective mechanism to the host but also serve as a source of infection. Organisms that do not cause disease are called the "usual or normal flora". Normal flora on the skin are "transient" or "resident". Transient flora are contracted from the environment or from other people. In most cases, these organisms are not part of the established normal flora.2 Healthcare professionals, for example, acquire microbes including methicillin-resistant Staphylococcus aureus (MRSA) during contact with patients or contaminated surfaces. Although transient organisms are easily removed from the upper layer of the skin along with dirt particles and oil, they may become part of the resident established flora of individuals. Resident flora can be persistently isolated from the hands of most people. These organisms include coagulase-negative staphylococci, Corynebacterium (diptheroids or coryneforms), Pmprionibacterium, and Acinetobacter species.

Topical antiseptics are active against both resident and transient flora on intact skin and are able to reduce microbial numbers on the skin by mechanical removal, chemical action, or both. When selecting an antiseptic for healthcare professionals, the following considerations should be taken into account: efficacy, maximal killing of both transient and resident bacteria, rapidity of antimicrobial action, persistence of activity, ease of use, and lack of skin irritation.3,4

There are many types of topical antiseptics designed for various purposes; each may be used for healthcare, veterinary workers, food-handlers, or public consumers. Topical antimicrobials are considered drugs by the FDA and are regulated as such. This article provides an overview on antiseptics and discusses factors influencing their activity, mechanisms of action, safety, and toxicity. A brief history of the regulatory approval process of these products is also described. The Healthcare Infection Control Practices Advisory Committee provides an in-depth review and guideline for hand antisepsis in healthcare settings.4