After failures, DPH seeks 30 new staffers to boost inspection ability By Andy Metzger | State House News Service March 01, 2013

FITCHBURG — Interim Commissioner of Public Health Lauren Smith said Thursday that when she took over the depart­ment, following a deadly meningitis outbreak and the closure of a crime lab that shook confidence in the regulators, she engaged in a “frank and brutally honest introspection” with her staff.
One result of that introspection is a proposed $32 million budget increase at DPH, bringing the total amount to $549 million, which would allow for increased inspections and oversight of health care, hazardous material, and substance abuse facilities. That would fund 30 new ­positions and send $1 million to the Board of Registration in Pharmacy, Smith said.
“The public in general goes through its business, its daily life and appropriately assumes that the services, the restaurants, the beaches, the mammography machines, or everywhere it goes, that someone has looked at that, and someone has made sure that it’s OK,” said Smith. “Our role, as I see it, is to make sure that the public’s assumption that those things are well taken care of is actually true.”
The public’s confidence in pharmacies was shaken last year as hundreds fell ill around the country with ailments, includ­ing fungal meningitis, from tainted steroids produced at the New England Compounding Center in Framingham. That outbreak, which has sickened 714 and killed 48 by this week, led to changes within DPH, including unannounced inspections at the state’s 40 sterile compounding pharmacies. Many of those ­revealed that the alleged lack of proper protocols at the Framingham pharmacy was not unique.
Continue reading here

Obstetrics & Gynecology News - Qualitative and quantitative measures of various compounded formulations of 17-hydroxyprogesterone caproate |4471506

Obstetrics & Gynecology News - Qualitative and quantitative measures of various compounded formulations of 17-hydroxyprogesterone caproate |4471506

Government Regulations Hinder Quality Control and Harm Consumers

The tragic case of the tainted medication produced by New England Compounding Center, which resulted in at least twenty-five deaths and hundreds sickened, highlights a little-recognized danger inherent in government regulation. As David Brown reported:

“[Purchasing pharmaceuticals from compounding pharmacies is] like buying your electricity from a different supplier. It looks like you’re getting the same stuff, but evidently you’re not,” says a physician at one of the seven outpatient treatment centers in Maryland that received methylprednisolone from a contaminated lot from the New England Compounding Center. A pain specialist, he’s been using compounding pharmacies [which produce customized drugs] “for at least five years, closer to 10.” He spoke on the condition of anonymity on the advice of his lawyer.

He’s never really thought of compounding pharmacies as different, less regulated, under-the-radar enterprises.

“From our perspective, they look like any of our other vendors,” he said. “They’re licensed and inspected; they have nice, pretty Web sites and sales teams and inspections. They look no different from Upjohn.”

This doctor operated under the assumption that government regulators assured all product integrity, creating in his mind a false sense of security. If there were no government regulation, how would his thinking have differed? Where would physicians and patients turn for information on medications and drug manufacturers? As Stella Daily Zawistowski explains in “How the FDA Violates rights and Hinders Health”:

Continue reading here

FDA sends warning letter to Philly dye company, Abbey Color, about water problems in drug products POSTED: Wednesday, February 27, 2013, 11:47 AM

David Sell

Abbey Color, Inc., an industrial dye manufacturer in the Kensington section of Philadelphia, was sent a warning letter by the U.S. Food and Drug Administration that said the company failed to ensure adequate purity of the water used in drug products including those for eye exams.

Fluorescein is a sterile liquid dye used in eye exams that look at blood flow in the retina and choroid, the two layers in the back of the eye.

Eye drops are put directly in the eye to dilate pupils. With the patient's chin resting in the camera's chin rest, pictures are taken of the eye. Then the fluorescein dye is injected into a vein, usually near the elbow. A second set of pictures is taken as the dye moves through the blood vessels in the back of the eye.

The warning letter said the FDA inspected the facility on East Tioga Street from March 13-23, 2012. The company's reply to the FDA observations was not acceptable, the agency said.

"Your firm uses water in the final purification step of Fluorescein USP, an API [active pharmaceutical ingredient] intended for use in sterile drug products," the letter said. "However, your firm failed to demonstrate that your purified water system can consistently produce water that is suitable for use in the manufacture of this API.

"This is a repeat observation from the July 21-August 8, 2010 inspection. In your response to observations made at the 2010 inspection, your firm promised actions it would take to assure reliable water quality. However, those changes were inadequate, as you continued to get periodic out-of-specification (OOS) endotoxin and total organic carbon (TOC) test results."

continue reading here

Kansas Adopting New Rules and Regulations, Hiring and Training Inspector, Additional Inspections for Holders of Nonresident Permit in Another State

Compounding Issues
Last year’s deadly outbreak of fungal meningitis linked to
spinal injections of a pain-relieving steroid product produced
by the New England Compounding Center in Massachusetts
raised serious questions about the oversight of compounding
pharmacies and the appropriate role for federal and state
regulators. The Kansas State Board of Pharmacy and Kansas
Department of Health and Environment participated in a Food
and Drug Administration (FDA) intergovernmental meeting on
December 19, 2012. There was discussion on whether the states
had the resources to provide oversight of pharmacy compounding
and whether there was a way to rebalance federal and state
participation in the regulation of pharmacy compounding that
would better protect the public health.
The Board is very concerned about whether federal preemptions
will be enacted that could possibly undermine the
Board’s authority by removing its oversight in this area. The
Board has implemented a plan that includes the adoption of
rules and regulations for compounding. The regulations have
been approved by the Department of Administration and are
currently at the Office of the Attorney General for review. The
Board has asked the Office of the Attorney General to expedite
these regulations. The inspectors are going to receive additional
training related to compounding, and the Board is going to
work with the National Association of Boards of Pharmacy®
and other states to share its limited resources. The Board has
also requested that Board staff seek approval for hiring an
additional pharmacist inspector.
If you hold a nonresident permit in another state, be advised
that your pharmacy may get an additional inspection from the
state in which you are licensed. Make sure that you know the
laws of each state that you are registered in related to office use
because many states do not allow this practice. The Board will
cooperate with any state that wants an additional inspection of
your premises.
It is the Board’s goal to address the compounding issues in
order to adequately protect the public’s health, welfare, and
safety.
Source Kansas Board of Pharmacy March 2013 Newsletter

Treat a Veterinarian Prescription Exactly as You Would a Physician Prescription in Kansas

If you are filling veterinary prescriptions and you have questions or concerns about the drug prescribed, it is important to contact the veterinarian for clarification. Lowering or raising the dosage or substituting medication may seriously compromise an animal’s health. Do not make changes to veterinary prescriptions without first contacting the prescriber because drugs affect animals much differently than humans. After contacting the veterinarian, clarification or any changes made to the original prescription should be documented on the back of the original prescription.

Source found at Kansas Board of Pharmacy March 2013 Newsletter

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.

---

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.
 
continue reading here

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.

Continue reading here   

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.