One of the most common forms of drug delivery is parenteral administration, which is typically implemented through the use of a hypodermic syringe. Certain therapeutic and medicinal agents have to be administered via a syringe into the blood stream of a patient. Generally, the therapeutic agents are stored in glass vials capped with a resealable resilient membrane such as, for example, a rubber stopper. The hypodermic syringe is composed generally of a hollow pointed needle, a cylinder defining a reservoir in communication with the needle, and a plunger slidably located within the cylinder at the opposite end from the needle. The plunger is movable to draw into and expel fluid from the reservoir through the needle. The resealable rubber stopper is adapted to receive the needle of the syringe and form a fluid seal around the exterior portion of the needle.
The steps for directly drawing fluid contents from the vial into a syringe are well known. More specifically, prior to inserting the syringe into the vial, the plunger is drawn back to draw air into the syringe until the tip of the plunger reaches the line of the number of units required. The rubber stopper of the vial is wiped with an antiseptic. With the vial maintained in an upright position, the syringe needle is then pushed through the rubber stopper. The plunger is then pressed to expel the air into the vial. The vial and syringe is upturned bottom side up with the needle in the fluid. The syringe plunger is drawn back until it is at the appropriate line for the dose needed.
One problem in the prior art is that when a needle must be inserted into a vial to load the syringe with the fluid, in applications where a plurality of doses are obtained from the same vial, it is very difficult to avoid wasting a portion of the medication. When the fluid reaches a critical level, the user must often maneuver the needle tip below the fluid level to catch the fluid. Otherwise, the vial is typically discarded with a portion of the fluid still present, thus resulting in waste. A further problem is the use of needles to withdraw fluid from a container, which increases the likelihood of accidents involving inadvertent pricking. Another problem in the prior art is that vials filled with medication must be kept or stored within specific temperature ranges such as, for example, room temperature or refrigeration temperature. It is important that the health care provider be provided a readily observable notice as to storage requirements for a vial of medication after dispensing to a syringe.
Yet another problem requiring solution is to provide users of vials containing multiple doses of medication, for example, a way to maintain an indication of the original starting level of the medication or fluid, with the vial upright, before a first dose is withdrawn, to “eyeball” how many doses remain after each dose drawing.
Accordingly, there is a need for a spike assembly that can be operatively engaged to a fluid-containing vial in a manner, which effectively minimizes or eliminates the problems associated with prior art dispensing methods. There is a further need for a spike assembly that enhances the relative ease and promptness of dispensing fluids for drawing into a hypodermic syringe, while substantially minimizing waste and contamination of the fluid, and providing a readily observable notice of storage requirements and/or light sensitivity precautions. There is a further need to design a spike assembly having a removable port adapted to receive a hypodermic needle, which permits compatible use of the spike assembly with syringes outfitted with or without a hypodermic needle.