Showing posts with label Show all posts
Showing posts with label Show all posts

Tuesday, October 30, 2012

Florida health department suspends compounding pharmacy

The Florida Department of Health has temporarily suspended compounding operations at a pharmacy, the latest in a growing number of closings since a deadly meningitis outbreak caused by contaminated drugs in a Massachusetts facility.

The Florida pharmacy, based in Boca Raton and called Rejuvi Pharmaceuticals, prepares injectable drugs and medications. The Florida health department said in a statement that it violated "a number" of statutes and rules.

Rejuvi Pharmaceuticals' website says it makes "bio identical hormones" and compounded medications. No other information on its products was available and Rejuvi was not immediately available for a comment.
Compounding pharmacies mix large quantities of prescription drugs, typically for use by doctors and clinics.
Regulators are scrutinizing these pharmacies after thousands of vials of contaminated injectable steroids were shipped from a New England compounding facility, leading to 25 deaths so far from fungal meningitis. Hundreds more patients were sickened from the steroid shots, which were used to treat back and neck pain.

Wednesday, October 24, 2012

October 24, 2012: Tainted Steroid Recall News - List of Customers

The FDA released a comprehensive list of businesses that received products from NECC. Part one of the list is 345 pages. Here is the PDF link via Slideshare:


Our office is investigating this national tragedy - 404-451-7781

Monday, October 22, 2012

10/22/12: Alabama Facilities Added to Tainted Steroid Medications Recipient List

The recent recall of steroid shots being linked to the deadly meningitis outbreak in the U.S. now has
Alabama clinics on alert. This morning there is news that the products may have been shipped to these facilities:

Andalusia Regional Hospital, Andalusia
Northeast Alabama Regional Medical Center, Anniston
Atmore Community Hospital, Atmore
Healthcare Authority for UAB Medical West, Bessemer
Alabama Pain Physicians, Birmingham
Baptist Medical Center-Princeton, Birmingham
Birmingham Surgery Center, Birmingham
Brookwood Medical Center, Birmingham
Children’s Hospital, Birmingham
Ginsburg Dermatology Center, Birmingham
Montclair Dermatology, Birmingham
Premier Plastic Surgery Center-AL, Birmingham
Rousso Facial Plastic Surgery, Birmingham
St. Vincent’s Hospital, Birmingham
St. Vincent’s Hospital Outpatient Surgery, Birmingham
Trinity Medical Center, Birmingham
Veterans Medical Center-GALA, Birmingham
Cullman Regional Medical Center, Cullman
Parkway Medical Center, Decatur
Dothan Surgery Center, Dothan
Flowers Hospital, Dothan
Southeast Alabama Medical Center, Dothan
Southeast Eye Clinic, Dothan
Surgery Center South, Dothan
Medical Center Enterprise, Enterprise
Gulf Health Hospital, Fairhope
South Baldwin Regional Medical Center, Foley
North Alabama Medical Center--Coffee Campus, Florence
DeKalb Regional Medical Center, Fort Payne
Gadsden Regional Medical Center, Gadsden
Marion Regional Medical Center, Hamilton
Huntsville Hospital, Huntsville
Alabama Outpatient Surgery Center, Jasper
Alabama Orthopaedic Clinic, PC, Mobile
Mobile Infirmary, Mobile
Mobile Surgery Center, Mobile
Springhill Medical Center-Cardio, Mobile
Central Alabama Pain Management Center, Montgomery
Jackson Hospital and Clinic, Montgomery
The Surgery Center, Oxford
Bigelow Cosmetic Surgery Center, Scottsboro
Vaughan Regional Medical Center, Selma
Lanier Health Services, Valley
Brookwood Dermatology, Vestavia Hills

Friday, October 19, 2012

10/19: Alabama Meningitis Outbreak News- NECC Steroid Medications

Alabama health officials say two Alabamians are showing symptoms of meningitis after receiving tainted steroid injections. Officials have contacted four of the six additional people who also received the shot.

All six are Alabama residents who were treated in Florida, and thirteen other Alabamians were treated in Florida and Tennessee. The Alabama residents who have contracted meningitis from the contaminated drug have received the medication from outside of the state.

Now, authorities are looking at other medicines from the New England Compounding Center to see if they are safe. Health officials in both Alabama and Florida started contacting health care facilities in their states who have received such medications, but only medicines that were sent to them since January.

The clinics and physicians are being urged to then notify their patients who might have received them, especially any patients who might have been treated with injections for eye or heart surgeries.

Talk with us if you are concerned that the company that produced these products should be held accountable. Toll Free 855-525-3955

Wednesday, October 17, 2012

Steroid Recall, Ohio: Ohio facilities that received NECC medications

Ohio facilities that received NECC medications from May 21, 2012 to October 3, 2012, include:
Akron Children’s Hospital
Ashland/Mansfield Foot & Ankle Specialists
Contemporary Cosmetic Surgery
Surgcenter Cleveland LLC
Physicians Outpatient Surgery Center
Blue Ash:
Professional Radiology
Vitreo-Retinal Consultants
Eye Centers of Ohio
Ohio Retina Associates
Vitreo Retinal Consultants
Smith Vein Institute
The Christ Hospital Spine Surgery Center

Cincinnati Eye Institute

Cincinnati Pain Management, Cornell Road

Greater Cincinnati Pain Management, Hunt Road

Medical Weight Management Center

Middletown Surgery Center, Franklin

Physicians Healthsource Inc.

Western Hills Interventional Pain

SW Ohio ASC, Middletown
Dublin Pain Clinic
Eye Center of Columbus
Mid-West Allergy Associates Inc.
New You Center for Advanced Medical Aesthetics
Taylor Station
Dayton Vitreo-Retinal Associates
Eye Laser and Surgery Center
Kunesh Eye Center
Samaritan North Surgery Center
Artemis Laser Vein Center
Dublin Physical Medicine
Ortho-Spine Rehab Center Inc.
Timeless Skin Solutions
Fairview Park:
Northcoast Opthalmology
Findlay Surgery Center
Middletown Surgery Center
Scott Gurwin MD
Holzer Clinic
Western Reserve Surgery Center
Eye Surgery Center of Western Ohio
Roman A. Ringel MD
Mansfield Foot and Ankle Specialists
Revision Advanced Surgery Center
BKC Pain Specialists
Marion Pain Clinic
Marysville Surgical Center
Mayfield Heights:
Jason Leedy MD
HMT Dermatology
Middleburg Heights:
Medical Eye Associates Inc.
Mentor Surgery Center
Vitreo Retinal Consultants - Mentor
Surgical Care Center (2165 Mentor Avenue)
Parma Heights:
Northern Ohio Eye Center
Eye Specialists of Ohio
Southern Ohio Medical Center
St. Clairsville:
Khoury Eye Center Inc.
St. Clare Surgery Center
Novus Clinic
Advanced Pain Management
Toledo Clinic Outpatient Surgery Center
George Parras MD
Eye Services LLC
Skin Care Solutions
Insight Surgery & Laser Center LLC

10/17/2012: Steroid Injection Recall - Live Update

From a colleague of mine, this information at the NECC site, the pharmacy that is alleged to be responsible for the tainted steroid and other medication that lead to a nationwide Meningitis outbreak. 

The CDC and FDA are this morning  currently on site at NECC along Mass DPH and various police agencies seizing and impounding all records of the Center. They have been there for several hours and from what we have seen, they are packing up and labeling boxes as they empty out the file drawers. 

Call us at 855-525-3955 if you would like us to investigate any link between an illness you may have and a steroid injection you had. 

Tuesday, October 16, 2012

10/16/12 Steroid Injection Recall News: New Drugs (Cardioplegic Solution) Tied to Meningitis Outbreak

From the FDA, more worrisome news as of yesterday: 

ISSUE: As a result of the ongoing investigation of New England Compounding Center (NECC), a patient with possible meningitis potentially associated with epidural injection of an additional NECC product, triamcinolone acetonide, has been identified through active surveillance and reported to FDA. Triamcinolone acetonide is a type of steroid injectable product made by NECC. The cases of meningitis identified to date have been associated with methylprednisolone acetate, another similar steroid injectable product.
In addition, two transplant patients with Aspergillus fumigatus infection who were administered NECC cardioplegic solution during surgery have been reported. Investigation of these patients is ongoing; and there may be other explanations for their Aspergillus infection. Cardioplegic solution is used to induce cardiac muscle paralysis during open heart surgery to prevent injury to the heart.

From the WSJ: 

The Food and Drug Administration said Monday that two additional drugs may be linked to the multistate fungal meningitis outbreak stemming from steroid injections made by a compounding pharmacy in Massachusetts.
The FDA said that a cooling solution made by NECC called cardioplegia, used in heart surgery, and a second injected steroid called triamcinolone acetonide now may be involved in the outbreak. That finding is based on its investigation, along with inquiries by the Centers for Disease Control and Prevention and by state health departments.
The triamcinolone injection made by the New England Compounding Center was linked to one case of possible meningitis

Monday, October 15, 2012

10/15: Steroid Recall Co-founder Gregory Conigliaro had background in recycling

The pharmacy linked to the nation's deadly outbreak of meningitis is owned by two brothers-in-law who brought different but complementary skills to the venture: One's a pharmacist, the other a risk-taking businessman who made his mark recycling old computers, fishing rope and mattresses.

Now the New England Compounding Center and its practices are under scrutiny as investigators try to determine how a steroid solution supplied by the pharmacy apparently became contaminated with a fungus. The drug has sickened nearly 200 people in 12 states, killing 15. Most of the patients had received spinal injections of the steroid for back pain.
NECC was founded in 1998 by Barry Cadden and Gregory Conigliaro as a compounding pharmacy, a laboratory that custom-mixes solution, creams and other medicines in dosages and forms that often are unavailable from pharmaceutical companies.

Cadden, who is married to Conigliaro's sister, Lisa, had the medical know-how behind NECC, earning a pharmacy degree from the University of Rhode Island. In a 2002 newsletter, he wrote that compounding had rebounded, after falling off when pharmaceutical companies began manufacturing drugs in the 1950s and '60s, and could help patients with painful conditions that demand "novel approaches.

Wednesday, October 10, 2012

10/10/12: Meningitis/Steroid Injection Recall News -Doctors Rethink Use of Custom Pharmacies

An interesting read from the WSJ:

The outbreak of a rare form of meningitis is prompting some doctors to rethink their use of a specialized type of pharmacy that created steroid injections tied to 119 illnesses and 12 deaths.
MedStar Health, a health-care provider that includes Georgetown University and Washington Hospital Center in Washington, D.C., said it is reconsidering its currently limited use of compounding pharmacies, which create alternative versions of medicines, such as liquid forms of pills.

More at the source:

What is a compounding pharmacy?

Compounding is the practice of preparing drugs in new forms. For example, if a drug manufacturer only provides a drug as a tablet, a compounding pharmacist might make a medicated lollipop that contains the drug. Patients who have difficulty swallowing the tablet may prefer to suck the medicated lollipop instead.
Another form of compounding is by mixing different strengths (g,mg,mcg) of capsules or tablets to yield the desired amount of medication indicated by the physician, physician assistant, Nurse Practitioner, or clinical pharmacist practitioner. This form of compounding is found at community or hospital pharmacies or in-home administration therapy.

What does the FDA have to say about compounding pharmacies?

The FDA views traditional pharmacy compounding as the combining, mixing, or altering of ingredients to create a customized medication for an individual patient in response to a licensed practitioner’s prescription.1 In its simplest form, it may involve taking an approved drug substance and making a new formulation to meet the medical needs of a specific patient. For example, it may involve formulating the product without a dye or preservative in response to a patient allergy. Or it might involve making a suspension or suppository dosage form for a child or elderly patient who has difficulty swallowing a tablet or a capsule. These traditional forms of pharmacy compounding are an important component of our pharmaceutical armamentarium.

Although these products technically may be considered unapproved new drugs because they differ from the approved formulation of the drug, FDA has exercised enforcement discretion to allow these legitimate forms of pharmacy compounding, which are regulated under state laws governing the practice of pharmacy.

Although compounding was widespread when the FD&C Act was first enacted in 1938, there were no provisions specifically dedicated to compounding, as distinguished from manufacturing of drugs. After the 1962 amendments to the Act expanded the universe of drugs that require FDA pre-market approval to include drugs that are not already generally recognized by experts as effective, courts have interpreted expansively the Act’s provisions to require pre-market approval of virtually all prescription drugs. It is widely recognized, however, that compounded drugs could not meet the approval requirements, in part because they traditionally are made in small amounts for individual patients according to a prescription. In addition, it is usually not feasible to study them in clinical trials to establish their safety and efficacy or prepare new drug applications for all of the different types of compounded products that might be prescribed.