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As we've mentioned previously, prescription compounding has gotten a lot of attention due to microbiological contamination. Last year, a fungal meningitis outbreak--originating from epidural steroid injections from a compounding pharmacy in New England--killed 63 and sickened 749 others. This August, 15 patients at 2 hospitals have developed bacterial bloodstream infections after receiving calcium gluconate injections. The injections were supplied by Specialty Compounding in Cedar Park, Texas, and a recall has been issued. This new outbreak has reignited and intensified concerns.
In response to the Texas compounding issue, The American Society of Health-System Pharmacists (ASHP) Chief Executive Officer Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), stated:
“Patient harm of this sort should never happen. ASHP will continue to push for passage of bipartisan legislation that will close regulatory gaps in the oversight of sterile compounding and ensure that patients are not harmed by the medications that are intended to help them.”
The ASHP has voiced its support of the Pharmaceutical Quality, Security, and Accountability Act (S. 959), which aims to establish a new category, "compounding manufacturer," that must register with the FDA and abide by all FDA regulations.
It is our position and experience that when created ethically, in accordance with proper procedures, and with certified and appropriate tools, compounding can produce effective and safe medications for people in need.
Resources for safe and effective compounding are available. The Institute for Safe Medication Practices (ISMP) published the Proceedings from the ISMP Sterile Preparation Compounding Safety Summit: Guidelines for SAFE Preparation of Sterile Compounds, available online.
The ASHP Foundation has also released an Outsourcing Sterile Products Preparation: Contractor Assessment Tool. This resource leads the user through questions regarding regulatory compliance and safety measures. It could serve not only as a contractor assessment tool but also as a self-assessment tool for the compounding pharmacy itself.
At the root of it, however, is choosing the right tools and using them properly. Many of our pill counters have important compounding features to keep your products safe and effective. Look for recipe making features that detail ingredients, including the weights of each ingredient, and memory storage for later use and accuracy. Onscreen instructions are especially useful when training new pharmacists.
To find out more about additional safety features built into our line of pill counters and scales, contact us today.