With a strong pipeline of biologics and new drugs for the treatment of skin diseases, parenteral drugs are becoming increasingly useful tools in the therapeutic arsenal of dermatologists.
Familiarizing themselves with this factor in high quality patient care is essential for dermatologists who frequently use these medications or who have administrative roles related to them. Pamella Ochoa, PharmD, gave a comprehensive presentation on this topic at the National Infusion Center Association’s 2022 conference.1
Ochoa began by reviewing regulations and guidelines for the preparation of parenteral drugs. These include National Infusion Center Association (NICA) standards, manufacturer’s insertion instructions, chapter of the United States Pharmacopeia (USP) and respective state boards of pharmacy.
These agencies help ensure the highest standards of pharmacy practice, Ochoa said. However, despite regulatory vigilance, contamination is a concern as it is one of the most serious adverse events associated with parenteral drug preparation. Factors that contribute to contamination include type of preparation, type of container, operator influences, environment, and aseptic techniques.
Ochoa has identified techniques to minimize environmental contamination. She recommended making sure that the temperature is appropriate in the room and that the medicines are well stored. She also noted that the air should be as clean as possible, as the air can sometimes contain particles of dust, skin cells, lint, or paper.
A controlled environment is essential to minimize this problem. To create a controlled environment, Ochoa said a designated medication preparation area should be set up away from traffic, construction, or any other particulate-generating area1. The area should be clean, dry and clear, and should be shaped from a non-porous surface. Nearby sinks should be equipped with splash guards. These areas should be free of food, vermin and any other source of contamination.
In the next part of the presentation, Ochoa reviewed aseptic drug preparation techniques that use a syringe and vial. This is of particular importance to practicing dermatologists because a popular local anesthetic (lidocaine) is prepared in this way.
She pointed out that when using a drug in a vial, the critical site is the tip of the vial. This area should be cleaned with an alcohol swab and allowed to dry for an additional 10 seconds.
To reduce the risk of microbial contamination, Ochoa said gloves should be worn when obtaining medication from a vial; aseptic techniques and hand hygiene should be used to protect critical sites during preparation, preparation time should be kept to a minimum, and all preparations should be used within one hour. Ochoa highlighted the differences between stability and date beyond use (BUD). An important point is that the stability is assigned by the manufacturer and the BUD is assigned for each preparation.
In summary, Ochoa pointed out that infections caused by microbial contamination can be prevented by using proper techniques. Infections resulting from contaminated preparations can be serious. There have been documented cases of fungal infections of the blood and meninges that have made several patients sick.2.3 Finally, she noted, all personnel involved in the preparation of parenteral drugs are responsible for the sterility of the drug and the safety of the patient.
1. 2019-06-19-NICA-Minimum-Standards-for-In-Office-Infusion.pdf. Accessed June 14, 2022. https://infusioncenter.org/wp-content/uploads/2019/06/2019-06-19-NICA-Minimum-Standards-for-In-Office-Infusion.pdf
2. Vasque AM. Notes from the field: Blood fungal infections associated with compound intravenous medication in an outpatient oncology clinic – New York, 2016. MMWR Morb Mortal Wkly Rep. 2016;65. doi:10.15585/mmwr.mm6545a6
3. Multistate outbreak of fungal meningitis and other infections – Number of cases | HAY | CDC. Published May 15, 2019. Accessed June 14, 2022. https://www.cdc.gov/hai/outbreaks/meningitis-map-large.html