Showing posts with label Michigan. Show all posts
Showing posts with label Michigan. Show all posts

Thursday, September 26, 2013

Quoted from NABP--Michigan Lawmakers Consider Bill to Strengthen Compounding Regulations



A series of bills have been introduced to the Michigan Legislature that would include several provisions intended to strengthen the regulation of compounding in the state. The bills would require: 
  • an on-site “pharmacist-in-charge” at every compounding facility,
  • detailed records for all sterile compounded products,
  • criminal background checks for new pharmacy owners, or those licensed before October 1, 2008, and
  • at least one biannual inspection for each facility.
As of September 6, 2013, Centers for Disease Control and Prevention (CDC) traced 264 cases and 19 deaths in the state of Michigan to the 2012 outbreak of fungal meningitis linked to contaminatedpain medications compounded at the New England Compounding Center in Massachusetts. These numbers led Michigan’s Attorney General, Bill Schuette, one of the bill’s backers, to call Michigan the “epicenter” of the outbreak. More information is available in a Detroit News article and in a Detroit Free Press article.

Wednesday, September 18, 2013

State officials plan to announce compounding pharmacy legislation September 19, 2013


By Ann Zaniewski

Detroit Free Press Staff Writer

Michigan Attorney General Bill Schuette plans to announce legislation today aimed at tightening regulations of compounding pharmacies in the state hit hardest by a national fungal meningitis outbreak.
The public health crisis that erupted last September was linked to tainted steroids prepared by the New England Compounding Center, a compounding pharmacy in Massachusetts. Hundreds of people were sickened by tainted shots, and more than 60 have died.
“Michigan was at the epicenter of this health emergency, and hundreds of families are still wrestling with the aftermath of devastating illnesses and deaths caused by steroid injections tainted with fungal meningitis,” Joy Yearout, a spokeswoman for Schuette, said Wednesday.
continue to read here

Friday, August 2, 2013

University of Michigan College of Pharmacy Presents CEU Including The Changing Landscape of Pharmacy Compounding David Brushwood, RPh, JD Professor of Pharmaceutical Outcomes & Policy The University of Florida College of Pharmacy Gainesville, Florida

Annual Pharmacy Lectures
Program Schedule

Date: Friday, October 4, 2013
Location: Weber's Inn, 3050 Jackson Ave., Ann Arbor, MI 48103
Time: 8:15 AM to 4:30 PM
Cost: $95 / person
7:45 am              Registration and continental breakfast (included in registration fee)
8:15 am              Welcome and program introduction
8:30 am              Morning lectures

Managing the Fungal Outbreak: Pharmacists' View from the Front Lines
Robert Loveland, BSPharm, PharmD
Outpatient Pharmacy Manager
St. Joseph Mercy Hospital
Ann Arbor, Michigan

Nina E. West, PharmD
Clinical Pharmacy Manager
St. Joseph Mercy Hospital
Ann Arbor, Michigan

Kimberlyn M. Dang, PharmD
Generalist Pharmacist
University of Michigan Health System

Wednesday, March 27, 2013

Meningitis Outbreak: Michigan Attorney General Launches Investigation into Contaminated Steroids


Following the death of 17 Michigan residents who contracted meningitis from contaminated steroids, the states attorney general said on Tuesday he is launching a criminal investigation into a Massachusetts pharmaceutical company linked to the deadly outbreak of meningitis.
Bill Schuette filed a request with the Michigan Court of Appeals for a rare, four-county grand jury to conduct a confidential probe into the New England Compounding Center (NECC) that produced tainted steroids which left 51 people dead nationwide and 730 sick.
Continue reading here

Tuesday, January 29, 2013

Michigan Introduces Bill Dealing With Pharmacies


SENATE BILL No. 92



January 29, 2013, Introduced by Senators GREEN, JONES, PROOS and HANSEN and referred to the Committee on Health Policy

  A bill to amend 1978 PA 368, entitled

"Public health code,"

by amending sections 16333, 17705, 17707, 17711, 17721, and 17731

(MCL 333.16333, 333.17705, 333.17707, 333.17711, 333.17721, and

333.17731), section 16333 as added by 1993 PA 80, section 17705

as amended by 1986 PA 304, section 17707 as amended by 1990 PA

333, sections 17711 and 17721 as amended by 2006 PA 390, and

section 17731 as amended by 1994 PA 234, and by adding sections

17735, 17736, and 17744a.

THE PEOPLE OF THE STATE OF MICHIGAN ENACT:

 1        Sec. 16333. Fees for a person licensed or seeking licensure

 2  to engage in the practice of pharmacy or other practices

 3  regulated under part 177 are as follows:

Tuesday, December 4, 2012

Michigan News Briefs: Hune renews call to suspend pharmacy's license

1:36 AM, Dec. 4, 2012'

State Sen. Joe Hune, R-Hamburg Township, on Monday renewed his call for suspending the Michigan license of a Massachusetts compounding pharmacy linked to a national fungal meningitis outbreak.
Hune, for a second time, called on the Michigan Department of Community Health to suspend New England Compounding Center's Michigan license following news of 10 more Michigan cases of meningitis-related infections linked to contaminated steroids produced at the facility.
"I once again demand
the license be revoked. I would like to see the de-partment investigate this wrongdoing so we can prosecute to the fullest extent of the law," Hune said in a statement.
The department on Monday announced that there are 201 cases and 13 deaths in Michigan tied to the infections, The Associated Press reported.
Additional cases of infection were announced Monday afternoon, bringing the state total up from 188 infections in a count last week.
Four of the deaths were of Livingston County residents, the state reported. Three of the Michigan deaths are being counted
as Indiana cases because that is where treatment occurred in those cases.
Hune in recent weeks first called for suspending the Massachusetts company's Michigan license. An October order of summary suspension filed by Gov. Rick Snyder and Attorney General Bill Schuette awaits the signature of the state Bureau of Health Professions director.
If signed, the order will suspend the New England Compounding Center's Michigan license and force the company to cease its operations in Michigan, Hune said.
Continue reading here

Tuesday, November 27, 2012

Malpractice bills spawn rift over meningitis settlement

Nov. 27, 2012  

An attorney for meningitis victims worries that lame-duck Michigan legislators will enact a series of medical malpractice bills that would make it harder for clients to recover damages.
Supporters of the legislation say the bills won't impact meningitis cases.
The bills would expand immunity for medical professionals and place limits on damages plaintiffs could receive.
"Any changes to malpractice standards will make it more difficult for steroid patients to bring a case," said Marc Lipton, who is representing Howell meningitis victim Brenda Bansale.
The bills have awaited action by the Senate Insurance Committee for several months.
State Sen. Joe Hune, the committee chairman, said the bills "wouldn't involve the meningitis cases."
"We've been meeting with trial lawyers and members of the medical profession," said Hune, R-Hamburg Township. "Hopefully, we'll be coming to some kind of consensus."
At least two of four bills could be released as soon as today with floor debate and a potential vote coming as soon as Thursday, Hune said.
A spokeswoman for Senate Majority Leader Randy Richardville, R-Monroe, said it was hoped they would all come to the floor before the Senate adjourns for the year.
"There is a desire to see it happen," Richardville spokeswoman Amber McCann said. "There's a laundry list of items awaiting action, and medical malpractice is on that list."
Of the four bills, S.B. 1116 would exempt medical professionals from liability if they acted with "reasonable good faith" based on medical practices and patients' best interest.
While this is considered the centerpiece of malpractice reform, Hune said the bill "probably wouldn't be released" from committee today.
Another bill, S.B. 1115, would place limits on damages issued for the loss of household services. That bill caused a particular concern for Lipton.
"My client has been disabled for three months. That means she doesn't do things that she normally does like cooking, cleaning and balancing the checkbook. There's an economic value to that," Lipton said.
Among the other bills, S.B. 1117, tightens requirements for expert witnesses in malpractice cases while S.B. 1118 limits the time frame for interest on damages.
A fifth bill, dealing with emergency room cases, has yet to be debated by the committee.
Bansale is among those seeking damages from New England Compounding Pharmacy Inc. Health officials believe the contaminated steroids were mixed at the now-closed Massachusetts facility. Congress is debating whether to expand the U.S. Food and Drug Administration's ability to regulate similar facilities.
Michigan law restricts victims of defective FDA-approved drugs from suing drug manufacturers, though legal professionals believe the compounding facility can be sued because its products are exempt from FDA review.
Hune earlier joined Gov. Rick Snyder and Attorney General Bill Schuette in calling for the Bureau of Health Professionals to suspend the compounding pharmacy's license, which would prevent it from marketing any more products in Michigan.
The Michigan Department of Community Health has linked four deaths in Livingston County to the meningitis outbreak. In all, the department says 178 cases, including 10 deaths, have been connected to the outbreak in Michigan.
Contact Daily Press & Argus reporter Wayne Peal at (517) 548-7081 or at wpeal@gannett.com.
Source found here