Narrator: Welcome to the FDA Drug Safety Podcast from the Division of Drug Information. On November 13, 2013, the FDA issued a Drug Safety Communication requesting label and packaging changes to enhance the safe use of certain over-the-counter (or OTC) topical antiseptic products.
Sarah Kim, a pharmacist in the division, will provide you with additional information about this communication.
Dr. Kim: This request is the result of our ongoing evaluation of infrequent but continuing reports of infections resulting from antiseptic products labeled for preoperative or preinjection skin preparation. When used properly, topical antiseptics are safe and effective products to reduce the number of bacteria on patients’ skin prior to surgery or injections. However, most often, contamination of topical antiseptics occurs when organisms are introduced into the product by users. Therefore, health care professionals and patients should follow all label directions to decrease the chances of infection.
To further reduce the risk of infection with improper topical antiseptic use and the possibility of these products becoming contaminated with bacteria during use, we are requesting that manufacturers package antiseptics indicated for preoperative or preinjection skin preparation in single-use containers. The antiseptics in these single-use containers should be applied only one time to one patient. We also recommend that health care professionals and patients do not dilute antiseptic products after opening them. Applicators and any unused solution should be discarded after the single application.
In order to provide users with important information about contamination that may occur during the manufacturing process, we are also asking manufacturers to voluntarily revise the product labels for topical antiseptics to indicate whether the drug is manufactured as a sterile or nonsterile product. We believe this will assist health care professionals in making informed decisions about using these products. Topical antiseptics are not required to be manufactured as sterile and so may become contaminated with bacteria during manufacturing. Labeling stating a product is sterile means it was treated with a process during manufacturing to eliminate all potential microorganisms.
However, even topical antiseptics manufactured with a sterile process, can become contaminated if proper care is not taken when using them. Health care professionals and patients should follow all label directions to decrease the chances of infection. The term nonsterile on the product label means it was not sterilized during manufacturing; it does not mean the product contains harmful bacteria. All topical antiseptics are required to be manufactured under FDA’s Current Good Manufacturing Practice regulations, which contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.
All topical antiseptic products should always be used according to the directions on the label. Health care professionals should consider these topical antiseptics as a possible source of infection when trying to determine the cause of postoperative or postinjection infections. In past years, outbreaks associated with the use of contaminated topical antiseptics have led to some product recalls. Reported outcomes ranged from localized infections at injection sites to more widespread infections resulting in death.
We are continuing to evaluate this safety issue and will take additional actions as needed. As part of our evaluation, we held a public meeting on December 12, 2012, to gather comments on how to address microbial contamination of antiseptic drug products indicated for preoperative or preinjection skin preparation. The New England Journal of Medicine also published an article we wrote to raise awareness of potential contamination of these products.
At this time FDA recommends that Health Care Professionals be aware of the following:
OTC topical antiseptics are not required to be manufactured as sterile drug products and may become contaminated with bacteria during manufacture or use.
When used properly, topical antiseptics are safe and effective products for patient preoperative or preinjection skin preparation.
To reduce the chances of patient infection, ensure these products are used according to the directions on the label.
Preoperative or preinjection topical antiseptics packaged in single-use containers should only be applied at one time to one patient. Applicators and any unused solution should be discarded after that application.
Topical antiseptic products should not be diluted after opening.
All topical antiseptics are required to be manufactured under Current Good Manufacturing Practice regulations, which require manufacturers to have appropriate procedures in place to prevent the presence of objectionable microorganisms in drug products that are not manufactured as sterile.
Consider topical antiseptics as a possible source of infection when trying to determine the cause of postoperative or postinjection infections.
Report adverse events involving topical antiseptics to the FDA MedWatch program at www.fda.gov/medwatch.
Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication including the complete data summary, facts about topical antiseptic products, and a link to a prepared list of questions and answers can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at firstname.lastname@example.org.
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FDA Drug Safety Podcast: FDA requests label changes and single-use packaging for some over-the-counter topical antiseptic products to decrease risk of infection - mp3(MP3 - 5.5MB) [ARCHIVED] FDA Drug Safety Communication: FDA requests label changes and single-use packaging for some over-the-counter topical antiseptic products to decrease risk of infection