Thursday, September 25, 2014

TN Drug Compounder Forged Prescriptions for Diet Drugs, State Charges

By Walter F. Roche Jr.

The owner of a Cleveland, Tenn. drug compounding pharmacy repeatedly forged prescriptions for a diet drug in her son's name, the state Pharmacy Board has charged.
The forgeries, which took place over a nearly four year period, were just one of several charges that led the state board to summarily suspend the license of Robin Terrero and her pharmacy, The Wellness Store Compounding Center.
In a 13-page order made public Thursday, the board spelled out multiple violations noted by a state inspector in three separate August visits to the pharmacy. The inspections, according to the state, were triggered by a complaint alleging multiple violations filed earlier that month.
The pharmacy did not respond to a request for comment.
While state Health Department officials released the suspension orders, they declined to release the inspection report leading to the regulatory action.
The order of summary suspension states that the inspector found that prescriptions, both new and refills, were left lying on an open counter for customers to retrieve. The pharmacy routinely operated when no pharmacist was present, the order states.
Other allegations include the dispensing of prescription drugs compounded from outdated and deteriorated products, preparation of prescriptions by staffers not licensed or trained to do so and failure to maintain sanitary conditions, even for drugs required to be sterile.
According to the complaint Terrero forged prescriptions for a drug called benzphetamine "in the name of her son and dispensed them herself from The Wellness Store."
In addition, the state charged Terrero, the chief pharmacist and owner, was often absent from the store and even when she was present she failed to provide proper supervision for the staff.
The investigator observed that "Terrero also failed to verify prescriptions being dispensed to patients" or to counsel customers on the use of the drugs being dispensed.
  Other charges include dispensing prescription drugs without a valid prescription and allowing unlicensed staffers to take prescription orders by phone.
"Wellness Store's staff routinely and systematically altered records, including the beyond-use dates on dispensing labels and compounding logs, in order to override software safeguards designed to prevent the use or dispensing of expired products," the order states.
Though state health officials say there have been no reports of illness from injectable drugs dispensed by the Cleveland pharmacy, they are urging consumers not to use any unused remaining doses.
The suspension comes on the second anniversary of a fungal meningitis outbreak caused, according to state and federal regulators, by tainted spinal steroids shipped around the country by a now defunct Massachusetts compounder.
Tennessee was one of the hardest hit in the outbreak with 16 patients dying and 153 sickened.  The outbreak triggered changes in both state and federal laws and regulations governing drug compounders.

Wednesday, September 24, 2014

Tennessee Compounding Pharmacy Cited for Unlawful Dispensing, Intentional Falsification

By Walter F. Roche Jr.
A Tennessee compounding pharmacy has been cited for using outdated, deteriorated or otherwise unsafe ingredients and state health officials are warning patients who may have received injectable drugs from the Cleveland druggist not to use them.
The warning applies to products from The Wellness Store Compounding Pharmacy at 3555 Keith St. NW in Cleveland.
In announcing the warning, state health officials said they were not aware of any illnesses caused by drugs sold by the pharmacy and that the volume of drugs produced was small.
"However, this warning is being issued out of an abundance of caution," the agency said in a statement.
Symptoms of possible contamination include pain, swelling or redness at or near the injection site.
The state is asking that any unused medications from the pharmacy be sent to the state for further testing.
Other violations found in an August inspection of the pharmacy include intentional falsification of records, the unsupervised production of compounded drugs and illegal dispensing of controlled substances.
According to the department the licenses for the pharmacy and pharmacist Robin Terrero  were summarily suspended.
The action is one of the first since the enactment of a new law and supporting regulations adopted after Tennessee became one of the hardest hit in the nation from tainted injectable steroids issued by a now defunct Massachusetts drug compounding firm.
Clinics known to have received injectable medications from the Cleveland pharmacy are Associates in Spine and Joint Medicine, Cleveland Medical Associates, Internal Medicine Group and Voytik Center for Orthopedics, all in Cleveland, East Tennessee Vein Clinic in Knoxville, Hollywood Body Spa in Athens, Kennedy Clinic in Ooletewah, Lynn Garden Weight Loss in Kingsport and Premier Weight Management in LaFollete.

Monday, September 22, 2014

Deaths, Infections Increase in 2012 Meningitis Outbreak

By Walter F. Roche Jr.

There have been yet more deaths and illnesses from a 2012 fungal meningitis outbreak but just who those victims are and where they were stricken remains a mystery amidst an ongoing federal criminal investigation.
The increased toll was disclosed in a footnote to an affidavit filed in federal court on Sept. 4. The affidavit was filed to back a move by federal prosecutors to arrest Glenn A. Chin, 46, a former employee of the now defunct Massachusetts drug compounding firm blamed for the outbreak.
The last official count from the U.S. Centers for Disease Control and Prevention showed 751 patients across the country were stricken with infections in the outbreak. Sixty-four patients died.
A CDC official, in response to an inquiry, stated that the agency stopped collecting data from state health departments in October of 2013. After that individual state health departments were left with the responsibility to report any additional cases.
A survey of some 20 state health agencies where cases had been previously reported turned up only a single additional victim. That patient in the state of Virginia boosted the total number of victims in that state to 55. Deaths in that state from the outbreak remained at five.
Calls to other state health agencies including the hardest hit, like Michigan and Tennessee, turned up no additional cases
An FDA spokesman declined to state how many additional cases have been uncovered because the investigation is still ongoing.
The five-page affidavit filed by FDA Special Agent Benedict Celso in Chin's case states, "the total of patients (sickened) has continued to rise as have the total number of patients who died."
Recently filed documents in a massive civil suit stemming from the outbreak give further evidence of a possible undercount.
According to a report prepared by attorneys for victims of the outbreak, four cases have been filed in behalf of four patients who contend they became infected after being treated at three different California health facilities.
Nonetheless the official CDC case report includes no cases from California.
Lynn Janssen, an official of the California Department of Public Health, said her agency was not aware of any illnesses  or deaths in California patients who received injections from medications  distributed by the Massachusetts compounding firm.
Suits have been filed in other states, such as Alabama and Nevada, where no cases have been reported by the CDC.
Another unanswered question is the number of patients who have suffered relapses of fungal meningitis or other infections caused by the fungus tainted methylprednisolone acetate.
According to CDC spokewoman Christine Pearson, five relapse cases have been confirmed. A sixth case, she said, has not been confirmed and is still under investigation.
One person to suffer a relapse was Joan Peay of Nashville, Tenn., who underwent nearly two months of hospital treatment followed by two weeks of rehabilitation for a relapse just over a year ago. The other relapse victims have not been publicly identified.

Friday, September 19, 2014

Judge Moves Meningitis Cases Forward

By Walter F. Roche Jr.

A federal judge helping oversee more than 200 lawsuits filed by victims of a 2012 nationwide fungal meningitis outbreak has issued a series or orders setting a schedule that could move the massive litigation to a quicker conclusion.
The orders issued by U.S. Magistrate Judge Jennifer C. Boal clear the way for victims' lawyers to begin collecting evidence and taking testimony from defendants in the case.
"We're very happy with this," said Nashville, Tenn. attorney Gerard Stranch. "This is what we've wanted for a long time."
Boal issued the orders Thursday in Boston, Mass. following a hearing on the cases which have been consolidated under U.S. District Judge Rya Zobel. Zobel had referred the scheduling issue to Boal.
Stranch said the order means that the defendants in the cases, including the Saint Thomas Outpatient Neurosurgical Center in Nashville, will have to respond to subpoenas for records. Clinic officials will also be required to answer questions under oath in a series of depositions.
Stranch said the plaintiffs in the case also will have to produce new information including profiles of the patients making the claims.
Those profiles will not be required, however, for victims whose cases are involved in a mediation process.
Chris Tardio, one of the lawyers representing the Saint Thomas outpatient center, said he too was pleased with the Boal order, which he added included many provisions they had requested.
 "We are looking forward to demonstrating that, in the setting of complete abandonment of oversight by the U.S. Food and Drug Administration and Massachusetts Board of Pharmacy, our clients had no reason to foresee the Massachusetts pharmacy would send us contaminated medication despite assuring us they followed proper safety procedures."

Another filing in the case by attorneys for the plaintiffs shows that of the 212 cases now before Zobel, 118 were filed in behalf of Tennessee patients. Ninety-one of the cases involve patients of the Saint Thomas outpatient center, while the remaining 27 were treated at two clinics.
Other cases include 39 from Virginia, seven from Ohio and four from California.  Two of those California claims were filed by patients of an Encino outpatient facility. Twenty-three claims have been filed in behalf of New Jersey patients, but 13 of that total are involved in mediation.
Only six suits before Zobel come from Michigan patients, but dozens of others remain in state courts.
Michigan had the most victims, according to data compiled by the U.S. Centers for Disease Control and Prevention.
According to the CDC, 751 patients were sickened in the outbreak, while 64 died. There were 264 victims in Michigan with 19 deaths, while Tennessee reported 153 sickened and 16 dead. Virginia had 54 sickened and five dead while New Jersey listed 51 sickened but no deaths.
Lawyers involved in the case predict that actual trials are not likely to take place until 2016, nearly four years after the outbreak was discovered.

Thursday, September 11, 2014

Drug Compounding Probe "Active and Ongoing"

By Walter F. Roche Jr.

The chief federal prosecutor in a probe of a deadly fungal meningitis outbreak has written to victims across the country assuring them that the investigation is "very active and ongoing" and a recent arrest does not signal the end of the inquiry.

U.S. Attorney Carmen M. Ortiz signed the Sept. 8 two page letter sent to the victims, including Joan Peay, a Nashville resident who has suffered two bouts of fungal meningitis.

Peay received the Ortiz letter Thursday, the same day Glenn A. Chin, 46, was arraigned in U.S. District Court in Boston on a mail fraud charge. Chin, who entered a not guilty plea and was released on bond, was a supervising pharmacist for the now shuttered New England Compounding Center, the firm blamed for the 2012 outbreak that killed 64 patients and sickened 751.

In the letter, Ortiz wrote that Chin's arrest came because federal officials learned of his plans leave the country. The suburban Boston resident was arrested at Logan International Airport as he was preparing to board a flight to China.

"The federal criminal investigation of Mr. Chin and others remains very active ongoing," Ortiz stated in the letter, adding that the arrest "does not signify the end of the investigation."

In a five-page indictment filed earlier this week, a grand jury charged that Chin not only personally compounded tainted steroids, but supervised others who he instructed to certify that the drugs were sterile and fit for injection into patients.

State and federal officials eventually concluded thousands of vials of the NECC steroids were tainted with fungus due to unsanitary conditions at its Massachusetts facility, where Chin was in charge of sterility.

The letter also notified victims that they can  monitor the progress in the case on-line or by phone by utilizing a unique sign-on and password to a victims service center.

Peay said she was pleased to learn that the investigation is continuing and that she already had signed up to get continuing updates..

Peay was administered doses of the steroid, methylprednisolone acetate, at the Saint Thomas Outpatient Neurosurgical Center. She has been hospitalized on multiple occasions for the fungal meningitis she subsequently contracted.

Wednesday, September 10, 2014

Formal Indictment in Drug Compounding Case Gives New Details, Not Guilty Plea Entered

UPDATE: Glenn A. Chin entered a not guilty plea Thursday in a one count indictment charging him with mail fraud.
By Walter F. Roche Jr.
A formal one count indictment was issued today by a federal grand jury in Boston giving new details on the charges being leveled against a supervising pharmacist for the firm blamed for a nationwide fungal meningitis outbreak.
The five-page indictment spells out the charges against Glenn A. Chin, 46, who was in charge of maintaining sterility in special clean rooms at the New England Compounding Center, the now defunct firm blamed for the fatal outbreak.
The indictment states that Chin engaged in a scheme to defraud NECC's customers to enrich himself and NECC "by selling for a profit preservative free methylprednisolone acetate labeled as injectable."
Chin, the indictment states, failed to properly clean and maintain and oversee proper cleaning and maintenance of the NECC clean room.
He was charged with one count of mail fraud.
Chin was arrested last week as he was preparing to board a plane headed to China.  He had been scheduled to appear tomorrow at a show cause hearing on the original arrest warrant, but that session has now been canceled. Instead Chin will be formally arraigned on the grand jury charges in a 10 a.m. hearing.
According to the indictment, Chin was first employed as a pharmacist at NECC in 2004 and was promoted to a supervisory position in January of 2010.
In the new post, the court filing states, Chin was "overseeing all aspects of NECC's clean room."
The 2012 outbreak caused some 751 patients across the country to be sickened. Sixty-four died including 19 in Michigan, 16 in Tennessee  and 11 in Indiana.
The indictment states that in addition to personally compounding a lot of the fungus tainted drugs, Chin "instructed pharmacy technicians to fraudulently complete cleaning logs...purporting to show that the NECC clean room was properly cleaned and maintained."

Monday, September 8, 2014

Pharmacist Charged in Meningitis Outbreak Files Emergency Motion

By Walter F. Roche Jr.
Lawyers for the pharmacist charged in the 2012 fatal fungal meningitis outbreak have filed an emergency motion to force a federal agent to appear at a show cause hearing later this week.
The motion filed Monday in U.S. District Court in Boston seeks an order compelling Food and Drug Administration Special Agent Benedict Celso to appear at the hearing scheduled for Thursday.
It was Celso's affidavit that led to last week's arrest of Glenn A. Chin, 46, the supervising pharmacist for the now defunct New England Compounding Center.
The Framingham, Mass. firm has been blamed by state and federal officials for the fungal meningitis outbreak that sickened more than 750 patients and killed at least 64.
In the motion filed, Paul W. Shaw, one of Chin's lawyers said Celso was "a necessary and material witness" for the hearing.
He wrote that because of the short time frame, they were unable to comply with the usual requirements for issuing a subpoena to an FDA employee.
The motion states that Celso's presence is necessary because of the "various conclusionary assertions made in the affidavit."
In the affidavit made public last week, Celso charged that Chin was personally responsible for overseeing the production of a spinal steroid that was tainted with fungus and led to the deaths and illnesses recorded during the outbreak.
Chin was charged with a single count of mail fraud for his role in the shipping of the drugs and the certification that the drugs met federal purity and sterility standards.
Chin was arrested last week at Boston's Logan International Airport as he was preparing to board a plane for China.

Thursday, September 4, 2014

First Arrest In Drug Compounding Probe

By Walter F. Roche Jr.

Federal authorities have made the first arrest in the probe of the Massachusetts drug compounding firm blamed for the deaths of at least 64 patients.
Arrested at Boston's Logan International Airport Thursday was Glenn A. Chin, 46, one of the pharmacists who worked at the New England Compounding Center, the now shuttered drug compounding firm blamed for the deaths and illnesses suffered by over 750 patients. The record breaking outbreak of fungal meningitis became public in September of 2012.
Chin a resident of Canton, a Boston suburb, was charged with one count of mail fraud. Federal officials said they made the arrest when they learned Chin was trying to flee the country.
An affidavit filed by a federal agent in the Chin case states that the number of victims is actually higher than the the official count issued nearly a year ago by the federal Centers for Disease Control and Prevention.
Noting that the CDC stopped revising its count in 2013, U.S. Food and Drug Administration Special Agent Benedict Celso wrote in a footnote that based on his personal knowledge, "the total number of patients (sickened) has continued to increase as have the total number of patients who have died."
The affidavit specifically cites multiple cases of victims in Michigan and Tennessee. Six Tennessee victims are mentioned while 217 patients at a Michigan clinic were stricken.
According to the complaint Chin caused contaminated vials of a spinal steroid, methylprednisolone acetate, to be issued and shipped in interstate commerce with the certification that it was injectable, when in fact, it was contaminated with a lethal fungus.
According to the complaint and a U.S. Justice Department press release, Chin was a supervising pharmacist for NECC.
The affidavit states that Chin supervised four other pharmacists who performed sterile drug compounding and that he was personally involved in preparing some of the vials of steroids later injected into unsuspecting patients.
He also supervised technicians and staffers and instructed them "to mislabel medication" and to "fraudulently complete cleaning logs."
The affidavit states that Chin was responsible for labels stating the steroids were injectable, "meaning that the medication was sterile and fit for human use."
The affidavit states that among the unsafe practices Chin oversaw were "improper sterilization and improper testing of supposedly sterile medication."
There have been recent indications that the lengthy federal probe was stepping up as FBI agents questioned some of the victims of the nationwide outbreak. Those victims included Joan Peay of Nashville who was sickened in the initial outbreak and suffered a lengthy relapse a year later.
Peay said she was glad to learn of Chin's arrest and added that she hoped federal authorities are also keeping a close eye on other NECC officials.
If convicted on the charge, Chin could face a jail term of up to 20 years and a fine of up to $250,000. He was arraigned Thursday in U.S. District Court in Boston and will remain under home confinement pending further court action.