IACP: IACP AdvanCE Webinar, “Endotoxin Testing and Environmental Monitoring for Your Pharmacy,” presented by William A. Stuart, RPh, Hartley Medical Center Pharmacy, Inc.

 

Register today for the Jan 22 IACP AdvanCE Webinar, “Endotoxin Testing and Environmental Monitoring for Your Pharmacy,” presented by William A. Stuart, RPh, Hartley Medical Center Pharmacy, Inc. This one-hour webinar will provide new technologies for endotoxin testing, how to implement USP <797&...more http://bit.ly/1hTOZLr This program is made possible through an unrestricted educational grant-in-aid from Associates of Cape Cod, Inc.

Patients benefit from specialized medications prepared by community pharmacists By B. Douglas Hoey, RPh, MBA - 09/16/13 04:00 PM ET

While Democrats and Republicans both work on the proper legislative response to the 2012 meningitis outbreak, it's critical that lawmakers preserve patient access to customized cures provided by independent community pharmacists through the centuries-old practice of compounding. New, bipartisan House legislation would do just that.

When manufactured drugs aren't an option, independent community pharmacists prepare or "compound" customized medications for patients in accordance with a prescriber's prescription based on the patient's individual needs and under the supervision of the state board of pharmacy. This important practice is widely recognized as medically necessary.

Federal legislation should strike the right balance so that traditional compounding is not hindered, but preserved, while lawmakers ensure proper oversight to prevent another meningitis outbreak, caused by the New England Compounding Center.

Read more: http://thehill.com/blogs/congress-blog/healthcare/322493-patients-benefit-from-specialized-medications-prepared-by-community-pharmacists#ixzz2f6HYnZ9T 
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Outsourced Medications: How Can You Know They are Safe? Eric S. Kastango, MBA, RPh, FASHP Clinical IQ , LLC O

This is an excellent powerpoint  Eric S. Kastango is an member of the 2010-2015 USP
Compounding Expert Committee although the presentation was done in his individual capacity.  View the powerpoint here

Powerpoint Outline Idaho Pharmacy Law 2013 Jurisprudence Continuing Education Mark Johnston, RPh

here

Navigating the Compounding Pharmacy Regulation Debate May 17, 2013 David Joseph, RPh

| AnazaoHealth Corporation

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Tragic headlines often lead to increased regulation, as policy-makers and regulatory bodies are understandably motived to ensure such incidents will not happen again. We have seen this occur several times throughout the history of the pharmacy business. In fact, the development of the Pure Food and Drug Act (the precursor to the Food and Drug Administration (FDA)) in 1906 was driven by unsanitary conditions observed in food plants and the use of poisonous preservatives and dyes in drugs and remedies. The 1912 Shirley Amendment, which made it illegal to make false claims regarding medications, was driven by Mrs. Winslow’s Soothing Syrup, which contained morphine and killed many infants.
Continue reading "Navigating the Compounding Pharmacy Regulation Debate"

End-preparation Assessments and Tests for Compounded Sterile Preparations Linda F. McElhiney, PharmD, RPh, FIACP, FASHP, FACA

The fungal meningitis tragedy that occurred in the fall of 2012 and the closure of NECC and AmeriDose has raised serious quality and safety concerns for health systems about outsourcing sterile preparations. Outsourcing has become a necessity to obtain sterile products that are currently on backorder. Although there are evaluation tools through the International Academy of Compounding Pharmacists (IACP) and the American Society of Health-System Pharmacists (ASHP) to assist hospital pharmacy leadership in selecting a compounding pharmacy or FDA-registered manufacturer that provides customized compounded preparations, there is still not a 100% guarantee that the contractor is following all of theUnited States Pharmacopeia (USP) standards for sterile compounding.¹Outsourcing sterile compounding can be very expensive and put a financial strain on a hospital pharmacy budget that is already tight. Pharmacy leadership in health systems are now considering the option of insourcing sterile compounding to reduce pharmacy expenses and control how these sterile preparations are compounded.

Many of the parenterals that are on manufacturer backorder, such as electrolytes used to prepare large volume parenterals, are relatively simple to compound. These commercial products are usually just the active ingredient dissolved in sterile water that is adjusted to a certain pH range and then sterilized by filtration and/or steam-autoclaved. It is also relatively easy to find information on the exact quantities of each ingredient through websites such as drugs.com, manufacturer package inserts, professional peer-reviewed journals, and credible compounding resources such as CompoundingToday.com. However, the key to preparing high-quality, safe, sterile preparations is end-preparation assessments and tests.

What are End-preparation Assessments and Tests?

The stated objective in the USP <797> chapter on sterile compounding is to provide and describe the conditions and practices required to safely compound sterile preparations in order to prevent harm and even death to patients receiving these medications. End-preparation assessments and tests ensure that the finished compounded sterile preparations (CSPs) are not contaminated with bacteria, fungus, endotoxins, particulate matter, or unintended chemicals. It also ensures that the patients will receive accurate doses and that the CSPs are compatible with the patients' body fluids, organs, and tissues. End-preparation assessments and tests are the final checks before a CSP should be dispensed and administered to a patient.

Continue reading here

Powerpoint on Lessons Learned from NECC and Dealing With Testing and Sterility from Eric S. Kastango

Lessons to be Learned from the NECC 483
Eric S. Kastango, MBA, RPh, FASHP –President/CEO
Clinical IQ, LLC and CriticialPoint,LLC
Madison, NJ and Gaithersburg, MD


click here to view Powerpoint