Monday, April 1, 2013

Dr. David F. Chang Reminds Ophthalmologists of Importance of Compounding Pharmacies David F. Chang interviews Charles Leiter regarding the state of compounding and how pharmacies, such as Leiter’s, maintain high standards of quality when compounding medications.


San Jose, CA (PRWEB) April 01, 2013
In the March 2013 issue of EyeWorld magazine, Dr. David F. Chang interviewed CEO of Leiter’sCompounding Pharmacy, Charles Leiter. As compounding pharmacies continue to reel from the devastating Meningitis outbreak caused by the negligence of New England Compounding Center, Dr. David F. Chang reminds the industry of the importance of quality compounding in “Compounding pharmacies: Let’s not throw the baby out with the bathwater.”
In the op-ed and interview, Dr. Chang discusses what happened in Massachusetts, the state of the industry, the results of the Meningitis outbreak, and the utmost need for quality medication from reliable compounding pharmacies such as Leiter’s.
Dr Chang said, “The disastrous fungal infections caused by contaminated medications from the New England Compounding Center(NECC) have rocked the pharmaceutical compounding industry. As a result of this horrible outbreak, the confidence of many physicians and their patients in compounded medications has been shaken.” Leiter expands, “What happened at NECC was a disaster. They were operating under horrific, unsafe conditions, and they never should have been in business. They’ve unfairly tarnished our entire industry. No responsible doctor should have ever ordered from NECC. The FDA and pharmacy boards should have shut them down years ago, and the owners should never have allowed product to ship.”
Dr. Chang follows by explaining the continued need for high quality medication from compounding pharmacies. He said, “Of course, drug compounding has always filled important and otherwise unmet pharmaceutical needs.” Leiter reiterates this point, saying “The role of compounding drugs is paramount in the U.S. because compounding meets very tangible and very serious medical needs that cannot be met anywhere else.”
As scrutiny intensifies on compounding pharmacies, Chang reminds industry professionals of the compounding pharmacies that are producing quality medications and the distinction of a PCAB accredited pharmacy. “As you will see, there is only a small minority of compounding pharmacies that are accredited, and this is a very important distinction.” Leiter expands on the accreditation and the importance of not distinguishing based on cost. “NECC was not PCAB accredited. The number one rule for doctors when ordering a compounded medication is to verify that the pharmacy is PCAB accredited. Doctors or buyers at their clinics or ASCs should know and trust who they are doing business with and should not procure on the basis of selecting the lowest cost provider.”
Dr. Chang summarizes, “With the increased scrutiny and regulation that are sure to follow in the wake of the fungal meningitis outbreak, we must heed the idiom in this column’s title and preserve patient access to appropriate and properly compounded medications.”
About Dr. David F. Chang:
David F. Chang, MD is clinical professor at the University of California, San Francisco, and the current president of the American Society of Cataract and Refractive Surgery. He is also Chairman of the American Academy of Ophthalmology’s Cataract Preferred Practice Pattern Committee, and is considered a leading expert in cataract surgery. Dr. Chang is the chief medical editor of EyeWorld and was previously co-chief medical editor for Cataract and Refractive Surgery Today.

State Weighs New Regulations for Compounding Pharmacies April 1st, 2013


BOSTON (AP) — Lawmakers are considering changes in how sterile compounding pharmacies are regulated after a deadly nationwide fungal meningitis outbreak that was linked to a steroid distributed by a Massachusetts firm.
The Legislature’s public health committee has scheduled a hearing for Tuesday on several proposals that call for strengthening oversight and licensing of the pharmacies.
Among them is a bill filed by Gov. Deval Patrick that would require compounding pharmacies to obtain a special state license. The bill would also create whistleblower protections for pharmacy workers and enforce new fines and penalties for compounding pharmacies that break the rules.
More than 50 deaths and hundreds of illnesses have been tied to the meningitis outbreak. New England Compounding Center of Framingham shut down operations last fall.
Source found here

Pharmacy Compounding Pharmacy Compounding: FDA Actions

Pharmacy Compounding Pharmacy Compounding: FDA Actions

Meningitis outbreak sparks investigations, lawsuits, fears


Second of two parts
In September, Milda Mattila became unsteady on her legs. Soon, she was unable to walk.
The 87-year-old South Lyon woman had been infected with fungal meningitis through a tainted steroid shot meant to relieve back pain.
"Why did I have to get this?" she asked her family.
That question fills households and hospital rooms as hundreds of people struggle with the physical, emotional and financial scars left in the wake of the national fungal meningitis outbreak that has killed at least 51 people, including 17 Michigan residents. Nationwide, 730 people have fallen ill, including 259 in Michigan.
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California State Board of Pharmacy LEGISLATION AND REGULATION COMMITTEE April 11, 2012


California State Board of Pharmacy
1625 N. Market Blvd, N219, Sacramento, CA 95834 Phone: (916) 574-7900
Fax: (916) 574-8618
www.pharmacy.ca.gov

NOTICE OF MEETING AND AGENDA
STATE AND CONSUMER SERVICES AGENCY DEPARTMENT OF CONSUMER AFFAIRS GOVERNOR EDMUND G. BROWN JR.
California State Board of Pharmacy LEGISLATION AND REGULATION COMMITTEE April 11, 2012
DATE: April 11, 2013
PLACE: Department of Consumer Affairs Headquarters Building II
1747 North Market Blvd., Room 186 Sacramento, CA 95834
This committee meeting is open to the public and is accessible to the physically disabled. A person who needs a disabilityrelated accommodation or modification in order to participate in the meeting may make a request by contacting Laura Hendricks at (916) 5747918, by emailing laura.hendricks@dca.ca.gov or sending a written request to the Board of Pharmacy, 1625 N. Market Blvd., Suite N219, Sacramento, CA 95834. Providing your request at least five business days before the meeting will help to ensure availability of the requested accommodation.
Opportunities are provided to the public to address the committee on each open agenda item. Board members who are not on the committee may attend the meeting as observers. Action may be taken on any item on the agenda.
CONTINUING EDUCATION: Pharmacists and pharmacy technicians who attend the full committee meeting in person may be awarded two hours of Continuing Education (CE) in accordance with the Board’s CE policy. Signin and signout that day is required for the CE credit.
Contact Person: Virginia Herold (916) 5747911
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Call to Order
A. LEGISLATION REPORT
9:00 a.m.
1.
BoardSponsored Legislation for 2013
  1. SB 294 (Emmerson) – Compounded Sterile Drug Products
  2. BoardApproved Proposals for 20132014
  3. Board Proposal – Section 4046 “Correctional Pharmacy” Defined
  4. Omnibus – SB 822, SB 821
Agenda
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Page 1 of 3
Meeting Materials will be available on the board’s Web site at
www.pharmacy.ca.gov by April 9, 2013.

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