Multi-dose pens, such as those used to inject medications such as insulin, must also follow these guidelines.
Manual: Home Care. Chapter: Medication Management MM. Was this response helpful? Yes No. Comments If you have additional standards-related questions regarding this topic, please use the Standards Online Submission Form.
Additional hospital resources. Hospital Breakfast Briefings. Get the standards. Webinar Series Continue your learning with a deeper dive into our standards, chapter by-chapter, individually or as a team. Explore our webinars. Patients on injection therapy for erectile dysfunction, testosterone therapy, and other injectable medicines use multi-dose vials of sterile medicine. A multi-dose vial is a container a patient punctures with a needle multiple times over a period of time.
Pharmaceuticals need to satisfy two main objectives: They need to be safe and they need to be effective. Effectiveness has nothing to do with safety. Saying a product still works does not mean it is still safe.
An old car without seatbelts and airbags may be effective for getting you from one place to another, but it is not as safe as a newer car with seatbelts and airbags.
Both cars are effective, only one is safe. Sterility means lack of contamination from infectious agents including germs. A product is either sterile or it is not.
A product that does not contain germs is safe in the context of a discussion about sterility. Rigorous standards must be met during the production of injectable pharmaceuticals to minimize the likelihood of germs in the product. These standards include a special production room containing carefully filtered, particle-free air, production personnel dressed in sterile suits with no exposed skin, and many other safety precautions.
Even with these precautions in place, all products are sterilized before being dispensed to the patient. At the very end of the production process a sterility test is performed to further demonstrate all of the rigorous processes worked as intended.
Though some production steps may seem redundant, they are necessary to ensure the product is sterile and therefore safe to use. A sterile product will not cause infection in a patient. Because sterility and safety are so important, even more tests and rigorous precautions are taken in the production of injectable pharmaceuticals. Preservatives are added and challenge tests are done where test vials are purposely contaminated in the laboratory to test the ability of the preservative to keep the product germ free.
Additionally, metals that contaminate their contents can be aspirated and injected through several routes. Moreover, the Exogenous contaminations by glass and metals can reach several sites in the organism. Finally, they trigger organic reactions that may give rise to injuries. Single-dose vials: In short, whenever possible, use a single-dose vial for each patient, to reduce cross-contamination between patients.
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