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.

My Horse Daily Says to Just Say No

Just Say No to (Unapproved) Drugs for Your Horse

February 28, 2013

The recent human meningitis outbreak, caused by the injection of contaminated compounded steroid products prepared by the New England Compounding Center, has put compounding pharmacies into the daily headlines.
But it isn’t just human drugs consumers should be concerned about. Compounding pharmacies prepare drugs for horses, as well. In 2009, a vitamin and mineral supplement prepared by Franck’s Compounding Lab in Ocala, FL included an excessive amount of one ingredient (selenium) that resulted in the death of 21 polo ponies.
In other cases of questionable drug safety, illegal products that claim to be “the same as” name brand drugs are marketed to consumers, sometimes with devastating results. In 2006, a reported six horses died as a result of using an illegal clenbuterol product.
Unfortunately, in these cases, the results of using non U.S. Food and Drug Administration (FDA) approved drugs were tragic. In other instances, while the unapproved and unproven products may not be particularly harmful, they may not contain the labeled amount of active ingredient, or do what they claim to do.
Studies presented at the American Association of Equine Practitioners (AAEP) Convention in prior years have shown a wide range in the pharmaceutical equivalence of compounded drugs when compared to brand name drugs. In 2003, Scott Stanley, PhD, presented findings from a study evaluating compounded versions of the FDA-approved drugs ketoprofen, amikacin and boldenone. In the case of ketoprofen, one compounded preparation contained just one-half of the expected concentration.
With amikacin, some compounded preparations had less drug, between 59 percent and 76 percent of what was stated on the label. Other compounded versions of the drug had more than the stated concentration: 112 percent and 140 percent.
Dr. Stanley conducted similar research on compounded versions of omeprazole, presenting his findings at the 2011 AAEP Convention. The compounded omeprazole products ranged from more than 100 percent to approximately 63 percent of the concentration claimed on the label.
After 60 days, the compounded versions lost potency, with the amount of active ingredient varying from 82 percent to as little as 17 percent.
At the 2012 AAEP Convention, Dr. Stanley presented results from a similar study, this one comparing compounded formulations of clenbuterol with the FDA-approved version. His findings showed the compounded formulations varied from containing as little as 32 percent of the labeled concentration up to more than 316 percent of the labeled concentration.
“What these studies have shown is that compounded versions of equine drugs, in many cases, do not contain the proper concentration of the active ingredient,” says April Knudson, DVM, equine specialist, Merial Large Animal Services. “If they don’t have enough of the active ingredient, it’s a natural conclusion they won’t work as well, if at all. If they have too much of the ingredient, it’s possible there will be a detrimental effect on the horse’s health, depending on the ingredient,” she says.
Additionally, merely containing the same active ingredient as a brand name drug does not guarantee efficacy or safety. The proper formulation is often an essential part of making a safe and efficacious product.
How can horse owners be sure they are getting a product that is safe and will do what it claims on the label? By making sure that product is FDA approved.
Drugs that are approved by the FDA are:

• Tested in the target animal in field trials and in the laboratory.
• Manufactured according to Good Manufacturing Practices, which ensures consistency.
• Manufactured in inspected facilities that meet FDA guidelines.
• Labeled with information that can be scientifically substantiated.
• Advertised in such a way as to not be false or misleading.
• Monitored following approval for adverse events.

Because many of these unapproved drugs are made to look like the approved drugs, horse owners should be wary and do their homework.

Whether a product has been FDA-approved can be determined by checking the searchable database at AnimalDrugs@FDA (http://www.accessdata.fda.gov/scripts/animaldrugsatfda/. Most generic and brand name drugs also feature a number on the label indicating FDA approval. In the case of brand name drugs, look for the six-digit New Animal Drug Application (NADA) and for generics, the Abbreviated New Animal Drug Application (ANADA) number.

“Horse owners have a lot of financial and emotional investment in their horses,” says Dr. Knudson. “Taking some time to research the products available and make educated decisions should help them keep their horses healthy in the long run.”

For more information about the types of products available and the importance of FDA approval, go to equinedrugfacts.com.

Source found here