Device integrity protects pharmacy personnel
05/01/2001
by Hank Rahe
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Employers in healthcare have a legal requirement to protect their personnel. This responsibility, which includes hospitals, encompasses all areas, from those receiving materials on the dock, to those directly involved in the delivery of medication to the patient.
However, pharmacy personnel who physically handle the injectable product and the caregivers who administer the final dosage form to the patient have a higher risk for potential exposure to potent compounds.
The ability of the containment device to protect personnel from exposure to potent compounds is dependent on the integrity of the device. The number of routes for possible escape of the compound determines the integrity. In the case of the Class II biological safety cabinets, there are three routes of escape: the front face of the cabinet, the HEPA filter and the arms and hands of the pharmacist or technician preparing the product inside the cabinet. Because they are closed environments, barrier/isolators eliminate at least two of these three routes, the front face and the arms or hands.
By eliminating direct contact between personnel and the product during preparation, barrier/isolators reduce the potential for exposure and contamination, making it the device of choice for pharmacies.
The pharmacist prepares the product by converting it from the manufacturer's original container, usually a vial, to a "piggyback" or a syringe. During this preparation, the product is drawn from the container with a syringe and injected into the final delivery package. Up to one microgram of product can be released to the surrounding environment during this manipulation, resulting in an exposure hazard if proper containment is not in place. The release is in the form of a micro aerosol, which becomes airborne—and if the particle size of the aerosol is small enough, it is capable of passing through a HEPA filter. This release is dispersed throughout the containment device.
The next segment is in the administration of the medication to the patient. Primarily, nurses are the personnel responsible for delivering medication to the patient and as such, also are at risk for potential exposure. The risk becomes greater when the nurse connects the potent medication and the intravenous (IV) set. This is usually done by "push" or "piggyback."
In the "push" method, the product is delivered to the nurse in a syringe and injected from the syringe into the IV set which is attached to the patient. (The same aerosols that occur in the pharmacy also occur during this operation.) After the set is hooked up it requires "priming" during which the nurse removes all the air from the set. This is critical to prevent air from entering the patient's blood stream and results in a small amount of the liquid being discharged. In some cases it is discharged into a wastebasket in the patient's room. The difference between the pharmacy and the patient's room is that there are no containment devices in place during the set up and administration of the medication. Therefore, the nurse and any individual in the room such as the patient, visitors or other staff, are at risk of exceeding the exposure limit for the potent compound.
The second potential exposure for nursing personnel occurs when a "piggyback" is connected to the IV set. The exposure potential during this hook up is influenced by the style of the IV set. The newer sets are needle-less and have approximately half the exposure potential of the older style.
In both instances nursing personnel, who routinely perform IV operations, exceed the exposure limits of the potent compounds.
Hank Rahe is director of technology at Contain-Tech in Indianapolis. He has over 30 years' experience in the areas of conventional and advanced aseptic processing. He is the past chairman of the board of the International Society of Pharmaceutical Engineers (ISPE), and is a member of the CleanRooms Editorial Advisory Board.