If you discover expired vaccine, remove it from the refrigerator or freezer so that it is not inadvertently given to a patient. Stand-alone units can vary in size from compact, under-the-counter not dormitory style to large, stand-alone, pharmaceutical grade units. Q: Where do facilities fall short with compliance when it comes to best-practices for multidose vials? Glycol-encased probes provide a more accurate reading of actual vaccine vial temperatures when placed in the same area where the vaccine is stored. Contact information can be found here:. You would be surprised at the number of people who, just like you, do a careful job of recording temperatures, but then they fail to act on them when the temperatures go out of range. The 28-day time frame is based on the fact that manufacturers are required by law to test the effectiveness of the bacteriostatic agent used in the multi-dose vial for a period of 28 days.
There are various requirements for the use of vaccines after reconstitution. For example, the package insert for some inactivated influenza vaccine indicates once the stopper of the multidose vial has been pierced, the vial must be discarded within 28 days. This should be done even if there is a temperature alarm. I was surprised when she told me that the policy is the manufacturers exp. It may be something quite fixable e.
This will ensure that you are following the intended specifications. Lyophilized freeze-dried vaccine must be used within a specified time frame after it has been reconstituted. How often does the 28-day rule apply? One morning, our refrigerator thermometer registered 32° F. Our office is committed to assuring appropriate storage for our vaccines. It appears that the 28-day recommendation will prevail along with ensuring vials are accessed, stored, and utilized properly. Recommended temperatures are between 2°C and 8°C 36°F and 46°F for the refrigerator and between -50°C and -15°C -58°F and +5°F for the freezer.
Digital data loggers are electronic devices that may be programmed to record temperatures at intervals throughout the day. The expiration date is based on the assumption that the vaccine has been properly handled and that it has not become contaminated. Cyanocobalamin is usually given monthly for several patients as well as DepoMedro,Depo Testosterone and in procedures Lidocaine for local anesthesia-these of course should be used only when a sterile needle and syringe is used each time of drawing up. Do you trust everyone who went into that before you? Difficult: I almost never have enough time to look after my health, I have too much work to do. Perforated bins may allow for better air circulation around the vaccine, thus helping to maintain correct temperature. This documentation will provide a strict policy and appease surveyors. Your multidose vial may have an expiration date on the label, but that does not take into consideration the date the vial is first used, which is when the 28-day rule takes effect.
Resources Where can I get the most up-to-date information about vaccine storage and handling? By Kirk on Multi-dose labeled vials were labeled as such for pharmacy preparations and not for clinical use. We have encouraged our clinicians to make these products single patient use or to at least discard at the end of the day. Always discard if the sterility of the vial is in question. Since that time, if I have not opened the vial myself I refuse to use it. Therefore, The Joint Commission requires a 28-day expiration date for multi-dose vials from the date of opening or puncture, unless otherwise specified by the manufacturer. Weekly Reader Poll How difficult is it for you to maintain a healthy lifestyle with your current workload? Is the top shelf of a pharmacy-grade storage unit acceptable for vaccine storage if there is a fan directly above it? It appears that the 28 day recommendation will prevail along with assuring vials are accessed, stored and utilized properly. They should also never be put into staff pockets and carried around with them.
It would be helpful to have one evidence-based recommendation for discarding used multidose vials that healthcare personnel and surveyors can both utilize. A: Only use them when single dose vials are not an option. This type of unit has severe temperature control and stability issues. On the other hand, they can cause multiple complications if staff members are not following very precise procedures. I agree about feeling uncomfortable using the same vial others have used. Some models have an alarm that can be set to ring at a specified temperature. This page was reviewed on September 21, 2018.
For some vaccines, the manufacturer specifies that once the multidose vial has been entered or the rubber stopper punctured, the vaccine must be used within a certain number of days. All multi- dose vials should be labeled with the open and expiration date, which is 28 days from the date opened, unless the manufacturers expiration date occurs sooner. Can we use the freezer portion to store staff food? In this instance, it would be best to check with the manufacturer to see if the top shelf is appropriate for storage in your unit. Moderate: I can manage to get sometime in the week to focus on my health, though it can be a time crunch. Multi-dose vials are good for 30 days in the fridge after being entered. We recommend that you remove the vegetable bins and put bottles of water in that space to help maintain a constant temperature in your refrigerator.
By otropogo on In Canada, as of this writing August 2016 the 28 day expiry after opening a multi-use vial is not generally known by physicians or even endocrinologists. My suspicion is that this rule is intended primarily to sell more product, with greater revenues for manufacturers and pharmacies. In general, the unit must be large enough to store the year's largest vaccine inventory without crowding and to store water bottles in a refrigerator and frozen coolant packs in a freezer to stabilize the temperatures and minimize fluctuations. I asked our Pharm D to clarify the expiration situation. Luebbert has added a slide on safe injection practices to her orientation training. If the expired dose is not a live vaccine, the dose should be repeated as soon as possible.