Thanks to a robust pipeline for biologics and novel drugs aimed at treating skin diseases, parenteral medications are becoming increasingly useful tools in the dermatologist’s armamentarium.
It is critical for dermatologists who frequently use these medications or who have administrative roles related to them to be familiar with this factor in high-quality patient care. Pamella Ochoa, PharmD, gave a comprehensive presentation on this topic at the 2022 National Infusion Center Association Conference.1
Ochoa began by reviewing the regulations and guidance regarding the preparation of parenteral medications. These include the National Infusion Center Association (NICA) standards, manufacturer insert instructions, United States Pharmacopeia (USP) Chapter <797>, and the 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 since it is one of the most serious adverse events associated with parenteral medication preparation. Factors that contribute to contamination include preparation type, container type, operator influences, environment, and aseptic techniques.
Ochoa identified techniques to minimize environmental contamination. She recommended making sure the temperature is appropriate in the room and that the medications are stored properly. She also noted that the air needs to be as pure as possible, since air sometimes can contain particulate matter from dust, skin cells, lint, or paper.
A controlled environment is key to minimizing this issue. 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 areas1. The area should be clean, dry, and uncluttered, and should be fashioned from a non-porous surface. Nearby sinks should be fitted with splashguards. These areas should be void of food, vermin, and any other sources of contamination.
In the next part of the presentation, Ochoa reviewed aseptic techniques for the preparation of medications which uses a syringe and a vial. This has special importance for practicing dermatologists because a popular local anesthetic (lidocaine) is prepared in this manner.
She stressed that when using a medication in a vial, the critical site is the tip of the vial. This area should be cleansed with an alcohol swab and allowed to dry for 10 more seconds.
To reduce microbial contamination risk, Ochoa said gloves must 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 minimized, and all preparations should be used within an hour. Ochoa stressed the differences between stability versus beyond use date (BUD). One important point is that stability is assigned by the manufacturer and BUD is assigned for each preparation.
In summary, Ochoa pointed out that infections that are 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 bloodstream and meningeal infections that have led to multiple patients becoming sick.2.3 Finally, she noted, all personnel involved in preparing parenteral medications are responsible for the sterility of the medication 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. Vasquez AM. Notes from the Field: Fungal Bloodstream Infections Associated with a Compounded Intravenous Medication at an Outpatient Oncology Clinic — New York City, 2016. MMWR Morb Mortal Wkly Rep† 2016;65. doi:10.15585/mmwr.mm6545a6
3. Multistate Outbreak of Fungal Meningitis and Other Infections – Case Count | HAI | CDC. Published May 15, 2019. Accessed June 14, 2022. https://www.cdc.gov/hai/outbreaks/meningitis-map-large.html