Wednesday, July 11, 2018

Pa. Hospital Hit With Compounding Deficiencies

By Walter F. Roche Jr.

In a scathing report that eerily echoed details of a five-year-old deadly national outbreak, a Pennsylvania hospital has been cited with multiple violations of drug compounding standards placing cancer patients in immediate jeopardy.
The findings by the Pennsylvania Health Department forced the Pottstown Hospital to immediately shutdown its cancer center pharmacy where supposedly sterile drugs were being compounded for administration to cancer patients.
The report concluded that hospital management and staffers "failed to ensure established procedures for hand hygiene and donning protective gear were followed for the compounding of hazardous drugs."
State surveyors observed staffers working under hoods without required protective gear. Numerous violations of the industry standard code known as Chapter 797 were observed.
Officials of Tower Health, the holding company for the hospital did not respond to requests for comment. The hospital did file a corrective action plan with the state in response to some but not all of the deficiencies.
State surveyors also cited the 232 bed Pottstown facility for an array of violations of the federally mandated Life Safety Code. The report states that the main hospital building "exceeds the maximum story height allowed"and several areas lacked the required fire ratings.
Other violations also were noted in several areas other than the cancer center pharmacy.
Staffers failed to follow proper procedures for blood transfusions and mold was observed in an ice machine.
Still other deficiencies included failure to ensure the privacy of patient records and improper cleaning of endoscopy equipment.
IV bags were observed without expiration dates and expired gloves and drugs were also observed in the endoscopy area.
In the clean room where critical procedures were performed gaps were observed on counter tops, floors were damaged and even when microbial sample showed contamination, no action was taken. According to the report there were over 30 incidents of microbial growth without documented follow up.
The facility "failed to ensure environmental microbial samples were evaluated," the lengthy report states.
The descriptions in the report were similar to the court testimony in the recent trials of former officials of the New England Compounding Center, the company blamed for the 2012 fungal meningitis outbreak.
In those trials federal investigators described similar deviations from the 797 standards including the failure to take corrective action when environmental tests showed evidence of contamination in the clean rooms. The two NECC official were found guilty of racketeering, mail fraud and related charges and are now serving prison sentences.
Still other citations included failure to have adequate post anesthesia services for pediatric
surgical patients and failure to maintain proper temperatures in an operating room.
Pottstown was one of five hospitals purchased by Tower Health from Community Health Associates last year for $418 million.
Another hospital purchased from CHA was the Brandywine Hospital in Coatsville, which was also the subject of a recent critical health department report.
That facility was cited for failure to comply with the state Child Protective Services Act. According to the surveyors, hospital staffers watching a monitor observed a visitor touching a child in an appropriate manner but subsequently failed to properly report the incident immediately. Instead, a report was filed three days late, the report states. The incident occurred on Aug. 27, 2017, two months before the purchase.
Brandywine also was cited for failure to properly follow up on patients who had discharged themselves against medical advice.
The surveyors found that Brandywine failed to contact the patients' outpatient therapists.

180 More Checks Go to Outbreak Victims

By Walter F. Roche Jr.

Another 180 checks have been mailed out by the Massachusetts Attorney General's office to victims of the 2012 fungal meningitis outbreak, according to officials of that agency.
Aides to Attorney General Maura Healey said Wednesday the checks totaling $5.325 million were issued Friday to the 180 victims or their survivors.
The fund was established by a $40 million grant from the U.S. Justice Department in response to repeated requests from U.S. Rep. Mike Bishop, a Michigan Republican whose district was especially hard hit by the outbreak.
The outbreak sickened at least 778 patients killing 76 of them. It was caused by steroids heavily contaminated with fungus that were shipped from a now defunct drug compounder, the New England Compounding Center in Framingham, Mass.
The deadline for applying for payments from the fund expired June 30, but it has now been extended yet again to Sept. 30. More than $18 million of the $40 million available was claimed by the Friday deadline.
According to the state agency those receiving the checks were notified in advance and were provided tracking numbers.
Some of the checks were mailed to attorneys representing victims, rather than the victims themselves.

Monday, July 2, 2018

Compounding Outsourcer Recalling Drugs

From the FDA

Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling

Fagron Sterile Services of Wichita KS is voluntarily recalling two (2) lots of Neostigmine Methylsulfate 5mL syringes to the user/hospital/clinic level. The specified product lots are being recalled because of a confirmed customer complaint that some syringe units containing Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL are incorrectly labelled as Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL. Secondary packages are properly labelled as Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL.

Risk Statement: In the event that 5mL rather than the intended 3mL is administered to a patient, adverse events from Neostigmine Methylsulfate overdosage can range from nausea, vomiting, diarrhea, excessive salivation and sweating, increased bronchial secretions, miosis, bradycardia or tachycardia, cardiospasm, bronchospasm, incoordination, muscle cramps, fasciculation, paralysis, to Cholinergic Crisis resulting in death.

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Friday, June 29, 2018

$144.6 Million approved for Outbreak Victims

By Walter F. Roche Jr.

A court appointed administrator reported today that some $144.6 million in payments have been approved for victims of the deadly 2012 fungal meningitis outbreak.
In a 64-page annual report filed in U.S. District Court in Boston, Mass. Lynne F. Riley reported that 2,027 claims totaling $95.8 million have been fully or partially approved for payment from a national settlement fund while an additional $48.8 million has been approved from settlements with three clinics where outbreak victims were injected with fungus laden steroids.
The 2012 outbreak sickened some 778 patients and at least 76 of them died. The tainted vials of methylprednisolone acetate were produced at the now defunct New England Compounding Center in Framingham, Mass.
The Riley report does not include payments from a separate settlement fund established for victims who were treated at a Nashville, TN clinic, the Saint Thomas Outpatient Neurosurgical Center. That fund estimated at $20 million is being administered separately.
Riley's report also includes payments over the one year period ending May 31 of this year for lawyers and other professional fees paid from the same settlements. Some $6.2 million was paid including $316,362 in trustee fees and $119,620 to the Duane Morris law firm.
Riley reported that a total of 3,919 payments had been made to victims from the national fund created under the NECC bankruptcy. The report states 283 claims were fully denied, 41 declared invalid and two were withdrawn.
A total of 19 claims were approved totaling $2.6 million from a settlement with High Point Surgery in North Carolina, while 45 payments totaling $12.1 million were paid from a settlement with Inspira Health Network in New Jersey and $34.1 million was paid to 181 claimants from Insight Imaging of Virginia.
According to the report payments to victims from the national fund were made in two installments. Additional payments are expected with the resolution of tax refund issues.
Two NECC officials, Barry Cadden and Glenn Chin, are now serving prison sentences following their conviction on racketeering, mail fraud and related charges. Cadden, NECC's president and part owner, was sentenced to nine years while Chin was sentenced to eight years. They are confined at separate federal prisons in Pennsylvania.
Additional defendants stemming from a two year federal probe of the outbreak are scheduled for trial early in October.

Friday, June 22, 2018

Conigliaro Denied Scrap Metal License

By Walter F. Roche Jr,

The Framingham, Mass. city coucil has voted to deny a scrap metal dealers license to a company headed by one of the founders of a now defunct drug compounding company blamed for a deadly 2012 outbreak of fungal meningitis.
The council voted earlier this week to deny a license to Conigliaro Industries headed by Gregory Conigliaro who is set to go on trial this Fall for his role at the New England Compounding Center, the firm blamed for the outbreak which killed 76 patients in 20 states. More than 700 other patients were sickened after injection with fungus riddled methylprednisolone acetate.
During this week's meeting council members cited Conigliaro's role at NECC where he was a vice president and part owner.
The denial marked the second time the panel turned down the request from Conigliaro. In 2015 a similar request was denied.
At a hearing earlier this year council members and residents expressed concerns about the recycling operation run by Conigliaro's company.
The scrap metal license would have allowed Conigliaro to buy and sell scrap metals.
Conigliaro was one of 14 persons connected to NECC to be indicted in December of 2014 following a two year federal probe of the 2012 fungal meningitis outbreak.
Two of the defendants, Barry J. Cadden and Glenn A. Chin already are serving prison sentences following their conviction by separate juries on racketeering, mail fraud and related charges. They were both cleared of second degree murder charges.
In addition to Conigliaro the defendants in the October trial include nine others charged in the 2014 indictment. All were either employees of NECC or related companies.
State licensing records show Conigliaro was granted a real estate sales license shortly before his indictment.

Friday, June 15, 2018

New Outbreak Suit Filed

AGO — A patient is suing Advanced Pain & Anesthesia Consultants PC, which does business as APAC Centers for Pain Management, and physician Randolph Chang, citing alleged medical negligence.

Leslie Musselwhite filed a complaint June 5 in Cook County Circuit Court, alleging the defendants failed to properly perform a cervical epidural steroid injection (ESI) procedure.

According to the complaint, the plaintiff was administered the injection between June 28, 2012, and Sept. 7, 2012, allegedly resulting in fungal meningitis and causing Musselwhite permanent pain and rendering him disabled.

The plaintiff requests a trial by jury and seeks more than $50,000 plus costs. He is represented by Charles A. Hornewer of Hornewer Law Firm LLC in Chicago.

Cook County Circuit Court case number 2018-L-005820
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Thursday, June 14, 2018

Compounding Outbreak

FDA’s investigation into Guardian’s compounded triamcinolone-moxifloxacin drug product
Update: June 14, 2018

On July 28, 2017, FDA alerted health care professionals of adverse event reports concerning at least 43 patients who were administered intravitreal (eye) injections of a drug containing triamcinolone acetonide (steroid) and moxifloxacin (anti-infective) compounded by Guardian Pharmacy Services in Dallas, Texas. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. As part of its investigation into these adverse events, FDA collected and tested samples of Guardian’s product to identify and quantify the substances contained therein. FDA also prepared and tested in-house samples to assess the impact of autoclaving and sonication, which were used by Guardian during its compounding process, on the stability of the drug product. Below is a description of the test results and the agency’s analysis of those results.

For more information, please visit: Guardian's compounded triamcinolone-moxifloxacin investigation.