Survey Investigates Attitudes on High-Risk CSPs Daniel Weiss, Senior Editor Published Online: Friday, March 1, 2013

The Institute for Safe Medication Practices surveyed hospital pharmacists and other practitioners about issues including who should be responsible for ensuring the safety of high-risk compounded sterile preparations.

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A survey carried out by the Institute for Safe Medication Practices in November and December 2012 addressed a range of issues regarding the preparation, oversight, and use of high-risk compounded sterile preparations (CSPs). The survey yielded responses from 412 hospital practitioners, primarily pharmacists but also including pharmacy technicians, nurses, and physicians. In the wake of the recent fungal meningitis outbreak caused by contaminated steroids, there is a great deal of concern over how to ensure compliance with sterility standards in pharmacies.
 
High-risk CSPs were defined as preparations in which non-sterile ingredients or devices play a role in preparation, necessitating sterilization before use. More than 1 in 10 respondents reported that contamination of CSPs had occurred in their facility in the last year, although there was some disparity in this regard between pharmacist respondents (11%) and pharmacy technicians (29%).  Just 50% of pharmacists and 38% of technicians expressed confidence that contamination had not occurred in their facility in the last year. In addition, almost 74% of all respondents said that contamination could occur in their facility.
 
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BREAKING NEWS: Contaminants in fertility drug called harmless

By Kay Lazar

 |  GLOBE STAFF   

  MARCH 01, 2013

Particles found floating in ­vials of a fertility drug that was recalled last week by a Waltham speciality pharmacy have been identified as apparently harmless pieces of the vial’s rubber stopper.

Laboratory results given to the Globe late Thursday by ­Village Fertility Pharmacy, which commissioned the ­report, concluded: “The ­vials contained numerous particles that contain polyisobutene with substantial amounts of talc and silica. This composition is typical of rubber stopper formulations.

Continue reading the Boston Globe article

Tufts Center for the Study of Drug Development: Study on the Structural Roots of Drug Shortages and The Shortages Effects on Kids

Pharm Exec recently asked the Tufts Center for the Study of Drug Development (TCSDD) to summarize new survey research—partly commissioned by a grant from Amgen—that documents the scope of the threat and identifies the structural roots of the shortages. In a larger sense, the study underscores how effective management of the drug supply chain is emerging as something much more than an engineering feat: instead it’s a societal obligation.

TCSDD developed a two-part methodology that entailed building a database of current drug shortages and conducting interviews with experience hospital pharmacists to gather first-hand knowledge of how drug shortages are managed and the challenges that they pose. Tufts CSDD staff gathered publicly available data on 240 drug shortages occurring between 2001 and February 2012, from lists maintained by the ASHP and the FDA.

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Rebuttal to "Just Say No To (Unapproved) Drugs for Horses"--Why You Can't Just Say No to Compounded Preparations

by Sue Tuck Richmond

Last night I posted an article entitled " Just Say Not to (Unapproved) Drugs for Horses."  Some might questions why I would post this, but as I have stated before I try to present all views on the blog and not just advocate one position.  After thinking about this article overnight, I felt the need to post a response to it. In the legal world we call this playing devil's advocate--presenting or arguing the other side.  And, I woke  up feeling the need to present  the other side of the argument.  First, I must state a disclaimer.  I am not an expert at all on drugs for horses nor do I pretend to be.  However, I feel certain that there are drugs or medicines that must be compounded for the treatment of horses, thus again making compounding essential and necessary in the veterinary world.  I will leave it to the readers who are experts about horse medications to tell the readers when the essential and necessary times are.  It is true that animals have died from bad compounds.  This can be blamed on a lack of enforcement of the rules and regulations, a lack of proper testing, lack of stopping those who cut corners and use substandard powders, don't have sterile rooms, and really don't care whether their preparations are any good or not.  Ultimately it is about allowing bad compounders to remain in business and compete against the good compounders, who are following the rules and regulations--who are doing the testing, who do have clean, sterile rooms, who don't cut corners or use substandard powders, who do care and take ever step to make sure their preparations are what they say they are.  It is easy for a manufacturer of FDA approved drugs to say "just say no." However, just saying no to unapproved drugs for horses or any animals cannot be the answer as this article suggests.