Monday, July 31, 2017

Virginia Outbreak Settlement Approved

By Walter F. Roche Jr.

A federal judge has approved the $235,811 settlement of a suit brought by the family of a Virginia victim of the 2012 fungal meningitis outbreak who died on Jan. 6, 2013.
Under the approval by U.S. District Judge Rya Zobel, the two daughters and the spouse of the victim will each get $37,134.
The suit was filed against Insight Imaging and related companies involved in injecting the victim with fungus contaminated steroids.
Just last week the family of another Roanoke area victim filed documents showing a $916,951 settlement of their claim.
In the latest settlement legal fees totaling $94,324 will go the firm of Crandall and Kett, which represented the victim's survivors. An additional $8,674 will go for legal expenses and $21,409 will go to reimburse the federal Medicare program.
The suit was one of hundreds filed in the wake of the 2012 fungal meningitis outbreak which sickened 758 patients, killing 76 of them.
Contact: wfrochejr999@gmail.com

Thursday, July 27, 2017

Infections Reported Following Joint Injections

From The CDC

Morbidity and Mortality Weekly Report (MMWR)

CDCMMWR

Outbreak of Septic Arthritis Associated with Intra-Articular Injections at an Outpatient Practice — New Jersey, 2017

Weekly / July 28, 2017 / 66(29);777–779

Kathleen Ross, MPH¹^,2; Jason Mehr, MPH¹; Barbara Carothers¹; Rebecca Greeley, MPH¹; Isaac Benowitz, MD³; Lisa McHugh, MPH¹; David Henry, MPH⁴; Lisa DiFedele, MPH¹; Eric Adler, MPH¹; Shereen Naqvi⁴; Edward Lifshitz, MD¹; Christina Tan, MD¹; Barbara Montana, MD¹ (View author affiliations)
View suggested citation

Summary

What is already known about this topic?
Single-use medications, including pharmacy bulk packaged (PBP) products, typically lack antimicrobial preservatives and can become contaminated and serve as a source of microorganisms when handled inappropriately. Use of a PBP product as a multiple-dose container outside of pharmacy conditions could contaminate the container and serve as a source of pathogens for multiple patients.
What is added by this report?
In March 2017, an outbreak of 41 cases of septic arthritis associated with intra-articular injections administered at an outpatient practice occurred in New Jersey. A public health investigation identified multiple breaches of recommended infection prevention practices during the preparation and administration of PBP products, which are intended for single-use, in accordance with standards outlined by the United States Pharmacopeial Convention.
What are the implications for public health practice?
No additional septic arthritis cases were identified after infection prevention recommendations were implemented within the practice. The findings from this investigation highlight the need for better adherence to and oversight of basic infection prevention recommendations and sterile compounding standards in outpatient settings.

On March 6, 2017, the New Jersey Department of Health (NJDOH) was notified of three cases of septic arthritis in patients who had received intra-articular injections for osteoarthritic knee pain at a private outpatient practice. The practice voluntarily closed the next day. NJDOH, in conjunction with the local health department and the New Jersey Board of Medical Examiners, conducted an investigation and identified 41 cases of septic arthritis associated with intra-articular injections administered during 250 patient visits at the same practice, including 30 (73%) patients who required surgery. Bacterial cultures of synovial fluid or tissue from 15 (37%) patients were positive; all recovered organisms were oral flora. An infection prevention assessment of the practice identified multiple breaches of recommended infection prevention practices, including inadequate hand hygiene, inappropriate use of pharmacy bulk packaged (PBP) products as multiple-dose containers and handling PBP products outside of required pharmacy conditions, and preparation of syringes up to 4 days in advance of their intended use. No additional septic arthritis cases were identified after infection prevention recommendations were implemented within the practice.

Top

Investigation and Response

On March 6, 2017, Monmouth County Regional Health Commission No. 1 (MCRHC) notified NJDOH that three patients were hospitalized for septic arthritis after receiving intra-articular injections for osteoarthritis pain relief at practice A, a private outpatient facility where procedures were performed by two staff physicians with the aid of two medical assistants. On March 7, practice A voluntarily closed in response to a large number of reports of severe knee pain and swelling. On March 8, NJDOH notified the New Jersey Board of Medical Examiners, which oversees physician licensure, to facilitate and coordinate a joint investigation.
A confirmed case of septic arthritis was defined as any one of the following in a patient who received intra-articular injections at practice A during March 1–6, 2017: 1) isolation of any microorganism from synovial fluid or tissue collected from the injected joint, 2) positive Gram stain of synovial fluid, 3) synovial fluid white blood cell count of >20,000/mm³, and 4) recipient of intravenous antibiotics or surgical debridement for a clinical diagnosis of septic arthritis.
Among 250 patient visits involving knee intra-articular injections at practice A during March 1–6, NJDOH identified 41 confirmed cases (16%) of septic arthritis. Patients had been scheduled over 3 consecutive clinic days (March 1, March 2, and March 6) with no apparent clustering by appointment time; the same physician administered all injections on these 3 days. Information on time of symptom onset was available for 38 (93%) of 41 patients and ranged from zero to 65* days after injection; 35 (92%) of the 38 patients developed symptoms within 48 hours of the procedure. Thirty (73%) of the 41 patients required surgery.
All 41 patients had synovial fluid or knee tissue obtained during surgery collected for culture, and cultures were positive for 15 (37%) patients. Bacteria recovered included Streptococcus mitis-oralis (10 patients), Abiotrophia defectiva (two), Staphylococcus aureus (two), Actinomyces odontolyticus (one), alpha-hemolytic Streptococcus (one), Eikenella corrodens (one), Haemophilus parainfluenzae (one), Neisseria oralis (one), Streptococcus gordonii (one), Streptococcus intermedius-milleri (one), Streptococcus sanguinis (one), and Veillonella (one); five patients had polymicrobial infections. Cultures from 26 (63%) patients were negative. All recovered organisms are commonly found in oral flora (1,2). In addition to bacteria recovered from culture of synovial fluid or tissue, Staphylococcus aureus was isolated from the blood of two patients.
On March 13, MCRHC, NJDOH, and the New Jersey Division of Consumer Affairs representing the New Jersey Board of Medical Examiners conducted an unannounced visit to practice A to inspect the premises, interview staff members, observe infection prevention practices, and review records. Because the practice remained closed to patients at this time, mock procedures were observed during the visit.
Multiple breaches in infection prevention recommendations were identified. Staff members did not have access to a handwashing sink, and alcohol-based hand rub was not available in medication preparation or treatment areas. Staff members, operating under the mistaken belief that PBP products could be used as multiple-dose containers outside of pharmacy conditions (e.g., use of a laminar flow hood, appropriate garbing, staff training, and environmental monitoring), accessed a 50 mL PBP container of contrast material up to 50 times to prepare syringes for multiple patients, with the septum of the container cleaned with alcohol only before the initial draw. Staff members prepared injections in a separate room, away from the patient treatment area; however, pharmacy conditions necessary for batch preparation of syringes and use of PBP products were not in place. In addition, injectable medications were drawn into syringes by medical assistants up to 4 days in advance of procedures, contrary to the recommended practice of administering medication from single-dose vials within 1 hour of preparation (3).
Injections were initiated using a needle and syringe filled with local anesthetic. After injecting the anesthetic, the physician removed the syringe, leaving the needle within the intra-articular space. A second syringe containing contrast material from the PBP container was then attached to the needle hub and used to facilitate fluoroscopic needle placement. This was followed by replacement with a third syringe containing a glucocorticoid or hyaluronic acid–based product. The physician did not wear a face mask during joint injection procedures and used nonsterile gloves to manipulate the needle hub during procedures.
Practice A was advised to immediately stop batch preparation of syringes and use of PBP products for multiple patients and to hire an infection preventionist to assess staff competency and ensure that hand hygiene, standard precautions, and safe injection practices were followed. No additional cases occurred after these measures were implemented.

Top

Discussion

An investigation of 41 cases of septic arthritis associated with intra-articular injections at an outpatient practice in New Jersey identified multiple breaches of recommended infection prevention practices during the preparation and administration of PBP products, which are intended for use in a pharmacy setting, using standards outlined by the United States Pharmacopeial Convention (USP) (3,4). PBP products are restricted to preparation of admixtures only in a suitable work area as defined by USP, such as in a laminar flow hood, and handled in accordance with sterile compounding standards outlined by the manufacturer and USP (3,4). CDC guidelines call for medications labeled as “single-dose” or “single-use” to be used for only one patient (5,6). Single-use medications, including PBP products, typically lack antimicrobial preservatives and can become contaminated and serve as a source of microorganisms when handled inappropriately (6). Use of a PBP product as a multiple-dose container outside of pharmacy conditions could contaminate the container and serve as a source of pathogens for multiple patients. Because practice A used a single PBP container of contrast material for as many as 50 patients, contamination of only a single container could account for the large number of cases identified in this outbreak.
Proper hand hygiene should be performed before handling any medications. In addition, batch preparation of medication for future administration should be performed in accordance with sterile compounding standards recommended by USP (3).
In this outbreak, all pathogens isolated were oral flora. CDC recommends that health care personnel wear face masks for spinal injection procedures that require injection of material or insertion of a catheter into epidural or subdural spaces (e.g., myelogram, administration of spinal or epidural anesthesia, or intrathecal chemotherapy) (5). Multiple outbreaks have demonstrated the risk for bacterial meningitis associated with droplet transmission of oral flora from health care personnel to patients during spinal injection procedures. The Association for Professionals in Infection Control and Epidemiology recommends the use of a face mask to contain respiratory droplets when preparing and injecting material into an intra-articular space (7). The use of multiple syringes with a single intra-articular needle could serve as a conduit for organisms to enter directly into the joint space if the needle hub is left exposed to potential respiratory droplets. Although this is a potential mechanism for a single case, it is unlikely to explain the large number of cases identified in this outbreak.
No additional septic arthritis cases were identified after infection prevention recommendations were implemented within the practice. The findings from this investigation highlight the need for better adherence to and oversight of basic infection prevention recommendations and sterile compounding standards in outpatient settings (8,9).

Top

Conflict of Interest

No conflicts of interest were reported.

Top

Corresponding author: Kathleen Ross, Kathleen.Ross@

Tuesday, July 25, 2017

Cadden Says Any Forfeiture Should Be Limited

By Walter F. Roche Jr.

The convicted pharmacist and drug executive facing a nine-year jail term says any money forfeiture should be limited to a little under $250,000 and not the $75 million sought by federal prosecutors.
In a 10-page filing in U.S. District Court in Boston, Mass., Barry J. Cadden's lawyers also argued that the court does not even have jurisdiction to order forfeiture because Cadden has filed formal notice that he is appealing his conviction to the 1st Circuit Court of Appeals.
Cadden contends in the filing that the total proceeds from the racketeering activities on which he was convicted were only about $1.4 million, not the $75 million claimed by federal prosecutors.
"The appropriate starting point for the court's forfeiture calculation is the analysis the court undertook for determining the loss amount for the purpose of sentencing," the filing states.
In addition Cadden's lawyer charged that the government ignored a recent U.S. Supreme Court ruling placing limits on some forfeiture orders.
"The government makes no genuine attempt to satisfy the rule of proportionality," the filing continues, noting that Cadden only owned 17.5 percent of the New England Compounding Center, the company blamed for a deadly 2012 fungal meningitis outbreak.
"The NECC enterprise is defunct and Mr. Cadden has no interest in it," the filing states.
Cadden has been ordered to report to the federal Bureau of Prisons on Aug. 7 to begin serving his sentence. He was convicted on March 22 of 57 counts of racketeering, conspiracy and mail fraud.
Cadden has asked to serve his sentence at a federal prison in central Massachusetts.not far from his Wrentham, Mass. home.

Sterile Drugs Subject to Recall

Safety

Cantrell Drug Company Issues Voluntary Recall of Select Sterile Drug Products Due to Lack of Sterility Assurance

For Immediate Release

November 18, 2016

Contact

Consumers

Cantrell Drug Company
877-666-5222

Media

David Ball
david@ballcg.com
617-243-9950

Announcement

Little Rock, AK - Cantrell Drug Company is voluntarily recalling certain unexpired sterile drug products due to lack of sterility assurance.
The recalled products, distributed nationwide to health care facilities from May 25 to October 31, 2016, are the following:

Drug Product Name	NDC	Lot Number	Manufacture Date	Beyond Use Date
CALCIUM CHLORIDE 1 G ADDED TO 5% DEXTROSE 50 ML BAG	52533-175-37	169170	10/15/2016	1/5/2017
CALCIUM CHLORIDE 10 G IN 0.9% SODIUM CHLORIDE 500 ML BAG	52533-102-09	168032	9/12/2016	12/11/2016
CALCIUM CHLORIDE 10% INJECTION SOLUTION 10 ML VIAL	n/a	169924	10/26/2016	4/15/2017
FENTANYL CITRATE 10 MCG/ML IN 0.9% SODIUM CHLORIDE 150 ML BAG	52533-024-35	9002	9/6/2016	3/5/2017
FENTANYL CITRATE 10 MCG/ML IN 0.9% SODIUM CHLORIDE 250 ML BAG	52533-024-61	8990	8/31/2016	2/27/2017
FENTANYL CITRATE 2 MCG/ML & BUPIVACAINE HCL 0.125% IN 0.9% SODIUM CHLORIDE 100 ML BAG	52533-080-75	8942	8/23/2016	2/19/2017
FENTANYL CITRATE 2 MCG/ML & BUPIVACAINE HCL 0.125% IN 0.9% SODIUM CHLORIDE 250 ML BAG	52533-080-61	9029	9/12/2016	3/11/2017
FENTANYL CITRATE 2 MCG/ML & BUPIVACAINE HCL 0.125% IN 0.9% SODIUM CHLORIDE 100 ML BAG	52533-080-75	9207	10/19/2016	04/17/2017
GLYCOPYRROLATE 0.2 MG/ML INJECTION SOLUTION 5 ML SYRINGE	52533-028-15	9006	9/7/2016	1/20/2017
GLYCOPYRROLATE 0.2 MG/ML INJECTION SOLUTION 5 ML SYRINGE	52533-028-15	8757	7/18/2016	11/30/2016
GLYCOPYRROLATE 0.2 MG/ML INJECTION SOLUTION 5 ML SYRINGE	52533-028-15	8954	8/24/2016	1/6/2017
GLYCOPYRROLATE 0.2 MG/ML INJECTION SOLUTION 5 ML SYRINGE	52533-028-15	9174	10/11/2016	2/20/2017
HEPARIN SODIUM 0.5 USP UNITS/ML IN 0.45% SODIUM CHLORIDE 2 ML SYRINGE	52533-148-16	9220	10/20/2016	4/18/2017
HEPARIN SODIUM 5,000 USP UNITS ADDED TO 0.9% SODIUM CHLORIDE 1,000 ML BAG	52533-097-24	167081	8/18/2016	2/14/2017
HYDROMORPHONE HCL 0.2 MG/ML IN 0.9% SODIUM CHLORIDE 30 ML SYRINGE	52533-002-03	8742	7/13/2016	1/9/2017
HYDROMORPHONE HCL 1 MG/ML IN 0.9% SODIUM CHLORIDE 30 ML PCA VIAL	52533-006-10	163941	6/21/2016	11/30/2016
HYDROMORPHONE HCL 1 MG/ML IN 0.9% SODIUM CHLORIDE 50 ML SYRINGE	52533-006-04	9016	9/9/2016	3/7/2017
LIDOCAINE HCL 1% INJECTION SOLUTION 10 ML SYRINGE	n/a	165538	7/19/2016	1/8/2017
MIDAZOLAM HCL 1 MG/ML IN 0.9% SODIUM CHLORIDE 50 ML SYRINGE	52533-001-04	169619	10/20/2016	2/7/2017
MORPHINE SULFATE 1 MG/ML IN 0.9% SODIUM CHLORIDE 100 ML BAG	52533-160-75	8625	6/18/2016	12/15/2016
NEOSTIGMINE METHYLSULFATE 1 MG/ML INJECTION SOLUTION 5 ML SYRINGE	52533-046-15	8997	9/2/2016	12/1/2016
NEOSTIGMINE METHYLSULFATE 1 MG/ML INJECTION SOLUTION 5 ML SYRINGE	52533-046-15	9246	10/26/2016	1/23/2017
OXYTOCIN 30 USP UNITS ADDED TO 0.9% SODIUM CHLORIDE 500 ML BAG	52533-056-30	9210	10/19/2016	1/17/2017
PHENYLEPHRINE HCL 100 MCG/ML IN 0.9% SODIUM CHLORIDE 10 ML SYRINGE	52533-171-12	8502	5/25/2016	11/21/2016
PHENYLEPHRINE HCL 100 MCG/ML IN 0.9% SODIUM CHLORIDE 10 ML SYRINGE	52533-171-12	8962	8/25/2016	2/21/2017
ROCURONIUM BROMIDE 10 MG/ML INJECTION SOLUTION 5 ML SYRINGE	52533-064-15	8995	9/1/2016	2/28/2017
ROPIVACAINE HCL 0.25% IN 0.9% SODIUM CHLORIDE 100 ML BAG	52533-185-75	169064	10/20/2016	1/2/2017
SUCCINYLCHOLINE CHLORIDE 20 MG/ML INJECTION SOLUTION 10 ML SYRINGE	52533-067-12	169262	10/11/2016	1/8/2017
SUCCINYLCHOLINE CHLORIDE 20 MG/ML INJECTION SOLUTION 10 ML SYRINGE	52533-067-12	169812	10/24/2016	1/19/2017

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. The company has not received any reports of adverse events, but is issuing this recall out of an abundance of caution following a recent inspection of the company’s facility.
Cantrell Drug Company will begin notifying its customers by email and phone and is arranging for the return of all recalled products. Consumers who have product subject to the recall should stop using it and contact the company.
“Because patient safety is our top priority, we immediately began addressing the issues raised and are working closely with health officials,” said Dell McCarley, Chairman & CEO of Cantrell Drug Company. “We have received no reports of injury or illness, and it’s important to note that all of our sterile products are tested for sterility before they are shipped. We deeply regret the impact this voluntary recall has on providers and patients, but our culture is one of safety first and we take absolutely no chances.”
To return medication or request assistance related to this recall, contact Cantrell Drug Company at 877-666-5222, Monday through Friday between 9 a.m. and 5 p.m. CST.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

###

Follow FDA

Sunday, July 23, 2017

Approval Sought for Viriginia Victim's Family

By Walter F. Roche Jr.

A federal judge is being asked to approve a settlement of nearly $1 million and approve a distribution plan to heirs in the case of a woman who died after being injected with a steroid contaminated with a deadly fungus.
In papers filed last week, the attorney for the estate of the Virginia victim of the 2012 fungal meningitis outbreak reported that a $916,951.46 settlement was reached in the suit brought by the victim's granddaughter against Insight Health and related parties.
The filing seeks the final approval of the settlement by U.S. District Judge Rya Zobel.
According to the petition the law firm of Crandall and Kett will be paid $366,780 in legal fees, the federal Medicare program will get $84,386 and the Virginia Medicaid program will receive $24,458.
The remaining $416,225, after expenses and other fees, will be split among 12 beneficiaries, but the petition states that the 12 were unable to agree on a distribution plan.
As a result Zobel is being asked to hold a hearing and then make a decision on who gets what. The petition states that some of the so-called statutory beneficiaries have indicated they wish to testify at the hearing.
The petition also notes that the granddaughter who filed the suit is the executor of the estate and she was the grandmother's caretaker when the latter died in late 2013.
The case is one of hundreds stemming from the 2012 fungal meningitis outbreak cause by fungus laden steroids shipped by a Massachusetts drug compounding firm. The cases were consolidated before Zobel.
Victims or their survivors also qualify for payments from a separate fund created under the bankruptcy of the New England Compounding Center, the firm that produced the tainted drugs.
According to the filing all but one of the 12 beneficiaries has been notified, but efforts to locate one son of the victim were unsuccessful. Despite extensive research, the filing states, they were unable to even determine if the son was dead or alive.
Contact: wfrochejr999@gmail.com

Thursday, July 20, 2017

Some Outbreak Victims Payments Delayed to 2021

By Walter F. Roche Jr.

Final payments to victims of a national fungal meningitis outbreak may be delayed until March of 2021, an attorney told a federal judge today.
Michael Gottfried, the attorney for the post confirmation officer in the bankruptcy of the New England Compounding Center, said the delay was necessary because the IRS has four years to challenge tax refunds granted to NECC's former owners.
He told U.S.District Judge Rya Zobel that a total of $12 million in tax refunds collected by NECC's former owners has been earmarked for a national settlement fund for outbreak victims and is now being held in an escrow account.
Calling the $12 million a significant asset, Gottfriend said, "The hope would be that the IRS would not challenge."
Though Gottfried said the delay was "not a surprise to anyone," Zobel responded "It is to me."
According to a motion filed by Gottfried in behalf Paul D. Moore, the post confirmation officer, about $180 million has been collected under the NECC bankruptcy plan for eventual distribution to creditors and outbreak victims.
The 2012 outbreak was caused by steroids contaminated with fungus that were shipped from NECC to health care providers in 20 states. The outbreak sickened 758 patients, killing 76 of them.
About $85.7 million from the settlement fund has been distributed, according to a report submitted to Zobel earlier this week.
Victims can expect to receive a second payment in 30 to 45 days, according to the report and court testimony. However, final payments totaling $12 million, cannot be released until 2021, Gottfried told the court.
During the same court session Gottfried and Thomas Sobol, who heads a committee representing plaintiffs in the NECC bankruptcy, argued over bills totaling a little over $200,000 which Moore wants paid from the national settlement fund.
Sobol argued that the money should not be released because Moore "has decided to not tell us what he is doing."
Gottfried responded stating that under the bankruptcy plan Moore does not need approval from the court or anyone else.
"We think that the court should order the trustee (of the settlement fund) not to pay the funds requested," Sobol stated.
Following further argument, Zobel said she would defer to the bankruptcy court judge who already has scheduled a hearing for early next month.
Zobel also was given a status report on civil cases filed against a Maryland clinic where many outbreak victims were injected with tainted steroids. Some of those cases are being handled in Maryland state courts, while others remain before Zobel.
Zobel set an initial Feb. 26 trial date for the first case remaining in her court.
Ben Gastel, a Nashville Tenn. lawyer, reported that efforts to mediate a settlement of cases filed against a Crossville, Tenn. were continuing.
Contact: wfrochejr999@gmail.com

Wednesday, July 19, 2017

Trustee Reports on Outbreak Victims' Payments

By Walter F. Roche Jr.

The trustee overseeing a national settlement fund for victims of a deadly fungal meningitis outbreak says 2,026 patients have now been fully or partially approved for payment.
Lynne F. Riley filed the report today in U.S. District Court in Boston, Mass. She reported that a total of $85.77 million has been approved for distribution and initial checks have been sent out for 1,711 claimants.
The settlement fund was created under the bankruptcy of the New England Compounding Center, the company blamed for the deadly 2012 fungal meningitis outbreak.
According to federal court records, 76 patients died after being injected with fungus tainted steroids shipped from MECC's Framingham, Mass. headquarters. A total of 758 patients were sickened, many of them suffering fungal meningitis.
Riley's report was filed in advance of a hearing tomorrow before U.S. District Judge Rya Zobel, who has been overseeing the hundreds of civil cases stemming from the outbreak.
Her reports states that 2,352 claims were filed with Epiq, the company hired to process claims. She said 284 claims were finally denied.
In addition to the 1,711 checks mailed to victims from the national settlement fund, Riley reported that checks were mailed for 214 victims who filed claims against the health providers who injected them with the fungus laden steroids.
Victims are expected to get a second check approximately equal to the initial payment and Riley said those second payments are expected to be issued in about 45 days.
In prior reports she also stated that a third set of payments is likely to be issued depending on anticipated tax refunds that are earmarked for the national settlement fund.
Contact: wfrochejr999@gmail.com