Pages

Monday, July 31, 2017

Doctors increasingly face charges for patient overdoses

CNN-16 hours ago
(CNN) Doctors are increasingly being held accountable -- some even facing murder charges -- when their patients overdose on opioid painkillers they ...

Arkansas Lawsuit Faults Makers of Opioids

Arkansas Business Online-18 hours ago
A Sebastian County man who became addicted to opioids sued the drug manufacturers last month in one of the latest lawsuits filed by consumers, state ...

Trump's Opioid Commission Calls for a State of Emergency

The Atlantic-3 hours ago
A government opioid commission chaired by New Jersey Governor Chris Christie has called for President Trump to declare a state of emergency in dealing with ...

Injections from Texas Pharmacy Linked to 43 Eye Injuries

Daily Hornet-9 hours ago
At least 43 people who had cataracts surgery in Texas developed severe eye problems after receiving injections of a drug that was compounded by Guardian 

Injections from Texas Pharmacy Linked to 43 Eye Injuries

Daily Hornet-9 hours ago
At least 43 people who had cataracts surgery in Texas developed severe eye problems after receiving injections of a drug that was compounded by Guardian 

Injections from Texas Pharmacy Linked to 43 Eye Injuries

Daily Hornet-9 hours ago
At least 43 people who had cataracts surgery in Texas developed severe eye problems after receiving injections of a drug that was compounded by Guardian 

Pharmacists fight bid to restore charges over meningitis outbreak

Reuters-4 hours ago
Three pharmacists at a defunct Massachusetts compounding pharmacy are urging a federal appeals court to uphold a judge's decision to toss charges filed ...
A prosecutor on Friday made the government's final pitch to the jury weighing the fate of “pharma bro” Martin Shkreli over securities fraud and conspiracy charges, saying that the former CEO of Retrophin Inc. and Turing Pharmaceuticals is nothing but a con man. Read more »

Friday, July 28, 2017

Pharmacy owner charged over steroids stash

Cyprus Mail-8 hours ago
A 45-year-old pharmacy owner in Paphos was charged in writing on Friday and released after police confiscated hundreds of products believed to be steroids ...

Very High Importance!! Compounded Triamicinolone and Moxifloxacin Product for Intravitreal Injection by Guardian Pharmacy Services: Alert to Health Professionals - Serious Adverse Events Reported

[Posted 07/28/2017]
AUDIENCE: Ophthalmology, Pharmacy, Patient
ISSUE: FDA received adverse event reports on April 5 and June 1, 2017, concerning at least 43 patients who were administered intravitreal (eye) injections of a drug containing triamcinolone (steroid) and moxifloxacin (anti-infective) compounded by Guardian Pharmacy Services in Dallas, Texas. The patients were administered Guardian’s product at the end of a cataract surgery procedure at the PRG Dallas Ambulatory Surgery Center in Dallas, Texas, by physicians affiliated with the Key Whitman Eye Center, and at the Park Central Surgical Center in Dallas, Texas, by physicians affiliated with Tylock-George Eye Care.
According to information received from Park Central, Guardian’s product was injected into the vitreous of the eye at the end of the cataract surgery procedure. The purpose of the injection was to provide post-operative prophylaxis for ocular inflammation and endophthalmitis with the expectation that the patient would not need to use post-operative eye drops. Over the course of several months, patients developed various symptoms, including vision impairment (blurred or decreased vision), poor night vision, loss of color perception, photophobia (light sensitivity), glare, halos, flashing lights, ocular discomfort, pain, loss of balance, headaches, and/or nausea. A number of the symptoms were not exhibited until at least one month postoperatively.
During follow-up examinations of the Park Central patients, physicians observed that the patients had diminished visual function involving both visual acuity and visual fields. Optical coherence tomography testing initially showed macular edema (swelling), which was followed in some cases by retinal degeneration. While the symptoms reportedly improved in some patients over the five-month post-operative period, a number of patients remain with a significant reduction in best-corrected visual acuity and visual fields.
BACKGROUND: Compounded drugs are not reviewed by FDA for safety, effectiveness, or quality.
RECOMMENDATION: Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form 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
[07/28/2017 - Alert to Health Professionals - FDA]
Page Last Updated: 07/28/2017 

Breaking News!! Reps. Upton, Bishop Call For Compounding Report Language To Be Stripped From FDA Funding Bill Inside Health Policy · 25 mins ago

Reps. Upton, Bishop Call For Compounding Report Language To Be Stripped From FDA Funding Bill

Inside Health Policy · 25 mins ago

FBI comments on multi-million dollar compounding pharmacy fraud scheme


FBI comments on multi-million dollar compounding pharmacy fraud scheme
Two people involved in a multi-million-dollar compounding pharmacy healthcare fraud scheme that involves hundreds of additional defendants, ...
FDA Informs Veterinarians about Important Labeling Changes to Critical Care Medications for People
July 2017 Update - The FDA alerts veterinarians and veterinary pharmacologists that the strength of epinephrine might be expressed differently on the labeling on certain human and animal epinephrine products. To avoid dosing errors in animals, the FDA recommends that veterinarians carefully review an epinephrine product’s labeling before administering the drug to determine if strength is expressed as mg/mL or as a ratio. The FDA also recommends that veterinary emergency dosage charts include epinephrine products that are labeled both ways (mg/mL and ratio) to reduce confusion and potential dosing errors.

GAO looking into improper HHS healthcare tweets

The Hill-19 hours ago
They are doing so at the request of Democrats, who asked the GAO in June to look into whether tweets from HHS supporting the GOP's healthcare bill violated a ...

Health care state of play: What happens next

CNN-39 minutes ago
(CNN) By now, the events related to Republicans' plans for health care early Friday morning have reverberated across Washington. Three GOP senators voted ...


Alaska Senator Lisa Murkowski's health care vote draws White ...

ABC News-15 hours ago
After Alaska Sen. Lisa Murkowski was just one of two Republican senators to vote against proceeding to debate on a health care bill on Tuesday, she received a ...

Celgene to Pay $280 Million to Settle False Claims Act Case

ExpressNewsline-Jul 27, 2017
"Patients deserve to know their doctors are prescribing drugs that are likely to ... compounded this by instructing its sales representatives to hide the drugs' risks

Federal Register :: Drug Products That Present Demonstrable ...

https://www.federalregister.gov/.../drug-products-that-present-demonstrable-difficultie...
6 hours ago - Drug Products That Present Demonstrable Difficulties for Compounding Under the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket.

Thursday, July 27, 2017

Trial evidence proves 'Pharmacy Bro' Martin Shkreli told 'lies upon ...

USA TODAY-18 minutes ago
NEW YORK Martin Shkreli told "lies upon lies upon lies" in related financial scams, then "doubled down" to hide his deceit, a prosecutor said Thursday as ..
Even a 'skinny' Obamacare repeal prospect alarms insurers
As Senate Republicans consider taking up a slimmed-down version of their ACA repeal bill that would preserve health insurance subsidies and Medicaid expansion, several insurers warn it could grievously damage the individual market.  READ MORE

Cantrell Drug Company Issues Voluntary Nationwide Recall of All Sterile Drug Products Due to Lack of Steril

For Immediate Release

July 25, 2017

Contact

Consumers

Cantrell Drug Company
877-666-5222

Media

Greg Turner
 greg@ballcg.com
617-243-9950

Announcement

Cantrell Drug Company is voluntarily recalling all lots of unexpired sterile drug products to the hospital and user level due to lack of sterility assurance.  The recalled products were distributed to health care facilities nationwide, except to the states of Connecticut, Hawaii, South Carolina and Vermont.  To date, Cantrell has not received any reports of adverse events.
The affected products include all lots distributed February 16, 2017, to July 19, 2017, remaining within expiry, and they would be packaged in a syringe or IV bag.  Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
“Cantrell has a longstanding commitment to quality and safety.  We are voluntarily issuing a recall out of an abundance of caution after several issues were identified during a recent inspection of our facility,” said Dell McCarley, Chairman and CEO of Cantrell Drug Company.  “We regret any impact this recall has on our loyal customers and their patients.”
Cantrell Drug Company is notifying its customers by email and phone, and is arranging for the return of all recalled products.  Anyone with product subject to the recall should stop using it and contact the company.  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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Wednesday, July 26, 2017

FDA's Scott Gottlieb says agency will lean on payers, pharmacy ...

FierceHealthcare-11 hours ago
Scott Gottlieb, M.D., commissioner of the Food and Drug Administration, said he wants insurers and pharmacy benefit managers to help curb opioid prescriptions ...

Pharmacy owner released in federal healthcare fraud case; Federal prosecutors allege that the two men submitted nearly $2 million in fraudulent claims to Blue Cross and Blue Shield of Texas for costly pain patches and scar creams, court records show.

Pharmacy owner released in federal healthcare fraud case

Monitor-1 hour ago
McALLEN — The owner of a local Valley pharmacy is back home after a federal ... Espericueta, who owns PeƱitas Family Pharmacy, also known as Riverside ...

They admitted to creating a cream for bogus patients and billing ...

The Sun Herald-6 hours ago
Gerald Jay Schaar, 46, of Biloxi and Jason May, 40, of Lamar County, admitted their roles in a multi-million dollar compounding pharmacy health care fraud ...

Tuesday, July 25, 2017

Cow had 8000% the legal limit of drug in edible tissue

Food Safety News-Jul 23, 2017
Furthermore, the inspection reported that the company offered an animal, for slaughter, for sale as food, that contained a new animal drug that is unsafe, ...

The truth about the dangers of dietary supplements

Atlanta Journal Constitution-4 hours ago
Dietary supplements in a variety of forms, including as vitamins, herbs or energy drinks, are often marketed to consumers as a simple solution to boost energy, ...

Queens couple indicted for stealing $3.7 million from pharmacy ...

QNS.com-3 hours ago
According to the indictment, in 2007, Vergara worked as the manager of Gardner's Pharmacy in Williamsburg when the owner, Rafael Abreu, became ill and ...

Qui Tam Litigation/False Claims Act: Fla. Judge Slashes Suit Alleging Tricare False Claims Scam

Fla. Judge Slashes Suit Alleging Tricare False Claims Scam

Law360 (subscription)-4 hours ago
The suit from Brady McFarland, an Arizona-based regional marketing representative for Florida Pharmacy Solutions, a national compounding pharmacy located ...

High Importance!! Must Read! Pharmacist Pleads Guilty to Health Care Fraud Charges for Role in $192 Million Compounded Medication Scheme; Pharmacy Marketer Also Pleads Guilty

Department of Justice
Office of Public Affairs

FOR IMMEDIATE RELEASE
Tuesday, July 25, 2017

Pharmacist Pleads Guilty to Health Care Fraud Charges for Role in $192 Million Compounded Medication Scheme; Pharmacy Marketer Also Pleads Guilty

The Pharmacist in Charge of a Hattiesburg, Mississippi compounding pharmacy pleaded guilty today to health care fraud charges for his role in a scheme that defrauded TRICARE and private insurance companies out of at least $192 million in payments for medically unnecessary compounded medications.
Acting Assistant Attorney General Kenneth A. Blanco of the Justice Department’s Criminal Division, Acting U.S. Attorney Harold Brittain of the Southern District of Mississippi, Special Agent in Charge Christopher Freeze of the FBI’s Jackson Division, Special Agent in Charge Jerome R. McDuffie of the Internal Revenue Service – Criminal Investigation’s New Orleans Field Office and Special Agent John F. Khin of the Defense Criminal Investigative Service Southeast Field Office made the announcement.
May, 40, of Lamar County, Mississippi, pleaded guilty to one count of conspiracy to commit health care fraud and money laundering before U.S. District Judge Keith Starrett of the Southern District of Mississippi. Sentencing has been scheduled for October 17 before Judge Starrett.
As part of his guilty plea, May admitted that he conspired with others to select compounded medication formulas based on profitability, rather than on effectiveness or patient need. He further admitted that he conspired with co-owners of the pharmacy to circumvent fraud prevention measures, such as collecting copayments, so that patients were incentivized to receive, and continue to receive, medically unnecessary medications.  According to plea documents, May dispensed these medically unnecessary compounded medications and caused fraudulent claims to be submitted to TRICARE, a health care program that benefits members of the U.S. armed forces, and other health care benefit programs. Based on these fraudulent claims, May and his co-conspirators received at least $192 million in reimbursements.
In a related case, Gerald Schaar, 46, of Biloxi, Mississippi, pleaded guilty to one count of conspiracy to commit health care fraud for his role in the scheme to defraud TRICARE. According to plea documents, Schaar admitted to soliciting physicians and other medical professionals to write prescriptions without seeing patients for medically unnecessary compounded medications dispensed by the pharmacy. According to the plea documents, Schaar further admitted to conspiring with others to falsify patient records to make it appear as though medical professionals had seen patients prior to the date prescriptions were written, when in reality, no examinations had occurred. As a result of the fraudulent prescriptions obtained by Schaar, and ultimately forwarded to the pharmacy, TRICARE reimbursed approximately $2.3 million in false and fraudulent claims submitted by the pharmacy. Sentencing for Schaar has been scheduled for October 17 before Judge Starrett.
This case was investigated by the FBI Jackson Division's Hattiesburg Resident Agency, the IRS Criminal Investigation, the Defense Criminal Investigative Service, Health and Human Services Office of Inspector General, the Mississippi Bureau of Narcotics, and other government agencies. Trial Attorneys Dustin Davis and Katherine Payerle of the Criminal Division’s Fraud Section and Assistant U.S. Attorney Mary Helen Wall of the Southern District of Mississippi are prosecuting the case.
The Fraud Section leads the Medicare Fraud Strike Force, which is part of a joint initiative between the Department of Justice and HHS to focus their efforts to prevent and deter fraud and enforce current anti-fraud laws around the country. The Medicare Fraud Strike Force operates in nine locations nationwide.  Since its inception in March 2007, the Medicare Fraud Strike Force has charged over 3,500 defendants who collectively have falsely billed the Medicare program for over $12.5 billion. In addition, the HHS Centers for Medicare & Medicaid Services, working in conjunction with the HHS-OIG, are taking steps to increase accountability and decrease the presence of fraudulent providers.
Individuals who believe that they may be a victim in this case should visit the Fraud Section’s Victim Witness website for more information.
Press Release Number: 
17-828