That is a question that most patients probably never thought much about until recently. But due to the highly publicized issues with contaminated products being shipped out of the New England Compounding Center (NECC) in Massachussets, patients are more aware than ever of the potential problems with the medications they are putting into their bodies.
In this particular case, NECC was creating big batches of products and shipping them to multiple providers across many states. Unfortunately, if the original batch is contaminated, it can adversely effect many people. The latest tally from the Centers for Disease Control and Prevention lists 386 cases of fungal meningitis and 28 deaths linked to injections of NECC compounded products. Those are sobering numbers, to be sure.
So, how do you know if your compounded medicine is safe? Well, here at Infusion Solutions, we follow the highest industry standards to ensure sterility and accuracy of the products that we provide to patients. These guidelines are published in the United States Pharmacopia, and are known in home infusion parlance as USP 797. This is a national standard for the processing, testing, and verification of any compounded sterile preparation produced for administration to patients. We are also accredited through Healthcare Quality Association on Accreditation (HQAA), which further mandates policies that mirror USP 797. And being licensed in the state of Washington, we are monitored and inspected regularly by the Washington State Board of Pharmacy to ensure compliance with all of the above regulations.
If pharmacies or doctor’s offices do not take the time and energy to safely compound medications, or if they do not have the proper infrastructure (such as a sterile clean room), then they are exposing their patients to a certain level of risk. You may want to ask your health care providers just what their policies are as it relates to compounding medications. What they tell you will go a long way toward answering the question about wether the medication is safe or not.
One other difference between Infusion Solutions and big compounding facilities like NECC is that we mix sterile medications for specific patients, in accordance with patient-specific prescriptions from the patient’s physician. The medications that are prepared by Infusion Solutions are labeled for individual patient use, and shipped or delivered directly to the patient. There are built in redundancies to check and double-check the accuracy of the medications we compound; thus, there is little chance for error in this scenario.
Suffice it to say, everyone in the health care world now has a heightened sense of awareness of the role that compounding pharmacies play in the well being of patients. Infusion Solutions does not take that responsibility lightly. We will go above and beyond to ensure patient safety by continuing to follow USP 797 guidelines. When pharmacists and pharmacy technicians follow the laws and regulations governing their practice, and adhere to the professional standards that have been outlined, then the public is protected and the end result is a sterile and accurate compounded product.