University of Iowa IACUC Guidelines: Use of Drugs and Chemicals in Laboratory Animals With Useful Flow Chart Submitted by kzobeck on Fri, 02/22/2013 - 14:53

These guidelines describe the requirements regarding the use of drugs and other chemicals administered to laboratory animals at the University of Iowa. The use of drugs falls into one of two usage categories: therapeutic purposes or experimental use. These guidelines apply to both categories of administration. Deviation from these guidelines must be described and justified in an IACUC-approved Animal Protocol. 

The use of non-pharmaceutical grade compounds in animals may be necessary and appropriate, but must be scientifically justified in an IACUC-approved Animal Protocol.

Definitions

• Pharmaceutical grade compound: Drug, biologic, or reagent which is approved by the FDA or for which a chemical purity standard has been established by USP/NF or BP.
• Non-pharmaceutical grade compound:  Any substance which does not meet the above definition of pharmaceutical grade, including:
  • Analytical grade bulk chemical: ~99% purity chemical, Certificate of Analysis typically available
  • Pharmaceutical grade drug compounded with non-pharmaceutical grade vehicle or other substance
• FDA – Food and Drug Administration
• USP/NF – United States Pharmacopeia/National Formulary
• BP – British Pharmacopeia

Drugs Administered for Therapeutic Purposes

• Current standards for the veterinary therapeutic care of research animals state that pharmaceutical grade medications should be used for routine medical treatment
• Examples of therapeutic purposes include:
  • Sedation and anesthesia for surgery or other procedures
  • Relief or treatment of disease or injury  
  • Pain control (analgesia)
  • Euthanasia
• Drugs used for veterinary care, either as part of an IACUC-approved Animal Protocol or an OAR veterinarian-approved treatment plan, should be obtained from a veterinary supply or from a pharmaceutical supplier licensed by the FDA, if available from such sources

Popular pet ointment nixed

Zoetis, the animal health unit of pharmaceutical giant Pfizer, plans to stop making Panolog, a popular ear-and-skin medication for pets.

“We have made the decision to discontinue production of our Panolog ointment and cream products,” Zoetis spokesman Deron Johnson told Examiner.com in a two-sentence statement Feb. 25. “This decision is based on a regular review of our product portfolio and consideration of future API (active pharmaceutical ingredient) supplies; it is not related to the quality or integrity of the finished product currently available on the market.”

More details about the prescription drug’s demise were not immediately available from Zoetis.

Panolog cream and ointment are used to treat skin infections in cats and dogs. The ointment also is used to treat ear infections in pet.

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FDA Doesn't Plan Furloughs; Eyes Training, Contract Cuts If Sequestration Kicks In

FDA does not currently anticipate having to furlough employees if the cuts mandated by sequestration go into effect Friday (March 1), but will likely reduce travel and training, and curtail contracts and outside collaborations.

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Source HealthPolicyNewstand

Sterile compounding lessons to be learned

FEB 27, 2013

Source found at Drug Topics

By: Michelle Sprehe, Digital and Interactive Content Producer

The importance of cleanliness and being proactive were the two most important lessons learned following the New England Compounding Center’s practices that led to the nationwide fungal meningitis outbreak, said sterile compounding expert Eric Kastango, MBA, RPh, FASHP.

"This is probably the most catastrophic event that has happened in my lifetime, as it relates to compounding," Kastango said during a web seminar Feb. 20 sponsored by Pharmacy OneSource.

In October 2012, the FDA issued a 483 form to NECC, detailing the filthy conditions of its main clean rooms, gown rooms, prep rooms, and adjacent rooms, as well as observations of vials of methylprednisolone acetate (preservative free) 80 mg/mL from one of the lots known to be contaminated with fungus.

"It's mind-blowing," Kastango said of FDA's findings. "If you have a person in a clean room, you're going to have micro-organisms."

It was noted that the air-conditioning was turned off at 8 pm to 5:30 am in the clean room, according to personnel who were interviewed during the FDA inspections.

Sequester, Hitting HHS Anti-Fraud Efforts, Could Lead To Smaller Returns

02-27-2013

If the budget sequester kicks in March 1, cuts slated for CMS' anti-fraud, waste and abuse activities will have a multiplying effect as funding reductions in those areas could also reduce the amount of money program integrity activities are able to return to the Medicare trust fund, CMS Center for Program Integrity Director Peter Budetti told lawmakers Wednesday (Feb. 27).

Source HealthPolicyNewstand

Drug Companies Start Buying Off Doctors In Med School Carl Lowe | Feb 28, 201

Medical schools say they are trying to keep drug companies away from medical students. But a survey of medical students and residents shows that pharmaceutical sales reps are still sending medical students gifts, buying them meals and generally trying to bribe them with industry-sponsored educational materials.

“In medical school and residency, as trainees are learning the fundamentals of their profession, there is a need to ensure the education they receive is as unbiased as possible,” warns researcher Dr. Aaron Kesselheim of Brigham and Women’s Hospital in Boston. “However, it is well known that promotional information and gifts from pharmaceutical companies can encourage non-evidence-based prescribing. Though many institutions have tried to insulate trainees from these effects, trainees’ exposure to industry promotion is still quite high.”

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The survey shows that one-third of first-year students and more than half of fourth-year students and residents report receiving industry-sponsored gifts.

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New meningitis cases from tainted medicine still occurring in Michigan; outbreak from Massachusetts company started in October - theoaklandpress.com

New meningitis cases from tainted medicine still occurring in Michigan; outbreak from Massachusetts company started in October - theoaklandpress.com

Did the state drop the ball in protecting residents from the meningitis outbreak?

Did the state drop the ball in protecting residents from the meningitis outbreak?

Dr. Omidi's Blog: WEDNESDAY, FEBRUARY 27, 2013 Controversy in Culpability Surrounding Meningitis Outbreak

Because the fungal meningitis outbreak was so catastrophic in terms of lives lost and pain needlessly suffered, it was only a matter of time before survivors began to seek remuneration from the parties responsible. Not only are the owners of the compounding pharmacy being sued, many of the physicians who administered the tainted shots are also facing litigation.

While it cannot be denied that the blame for the fungal meningitis disaster lays at the feet of a compounding pharmacy that flouted not only governmental regulations, but also basic pharmaceutical practices of health, safety and due diligence, many patients are nonetheless beginning to wonder if the clinics that administered the tainted shots shouldn’t bear some responsibility as well.

The entire matter is extremely delicate. While it is true that the New England Compounding Center was woefully inept at maintaining an environment suitable for the production of an extremely delicate and difficult to manufacture drug, the Massachusetts regulatory boards did little, if anything to oversee or police their practices. The NECC was inspected several times by the FDA as well as state board officials, who issued warnings and concerns that were completely ignored, and yet the regulatory bodies did nothing to follow up on those warnings, leaving thousands of patients in jeopardy.

One of the main reasons compounding pharmacies distribute so many vials of epidural steroid is because many physicians believe in the studies that report of the dangers of using injectable drugs that contain preservatives. While there are many conflicting studies regarding the potential hazards of preservatives in injectable applications, the crux of the objection to the commonly used pharmaceutical preservatives is that they may trigger outbreaks of arachnoiditis, an incurable inflammation of the arachnoid membrane which surrounds the spinal column. This condition is painful, chronic, has debilitating side effects, and requires more or less constant pain management therapy and treatment. Injectable steroids that do not contain preservatives can only be obtained through compounding pharmacies, not FDA regulated drug companies

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Blog found here

Hospira issues 3 recalls as it faces crucial FDA inspection

February 27, 2013 | By Eric Palmer

Sterile injectables maker Hospira ($HSP) is having to recall lots of 5 different products even as FDA inspectors are in one of its plants conducting what the company hopes will be a final inspection that will return the drugmaker to the agency's good graces.
Over the last several days, Hospira recalled three lots of propofol injectable emulsion after reports came to light that some vials had visible particles embedded in the glass. These were found in some retained samples. It is recalling one lot of preservative-free morphine sulfate injection after a customer found either a loose crimp or no crimp on the flip-top vial, which raises the possibility of contamination. It also recalled three lots of diazepam injection, furosemide injection and Quelicin (succinylcholine chloride) injection for the same problem with loose crimping in flip tops.
The company said all of the recalls are voluntary and there have been no reports of patients being affected by any of the recalled products, although in each case there is a chance for serious effects.


Read more: Hospira issues 3 recalls as it faces crucial FDA inspection - FiercePharma http://www.fiercepharma.com/story/hospira-issues-3-recalls-it-faces-crucial-fda-inspection/2013-02-27#ixzz2MAnwvSbt
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