Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Monday, July 28, 2014
Fierce Animal Health Top Stories and News Relating to Animal Drugs
Today's Top Stories
Ares to acquire most of America's freestanding veterinary hospitals; Regulator slams Antech's advertisement over heartworm screen; and much more...
- Lohmann deal adds growth to Elanco sales in quick order
- Court stands with FDA on its approach to antibiotics use in farm animals
- North American sales propel growth at Abaxis
- Eco's poultry and swine antibiotic Aivlosin key to revenue growth
- USDA, Nebraska U. researchers find no danger in Merck's Zilmax
Editor's Corner: Top 10 animal health companies of 2013
Also Noted: Spotlight On... In Purina v. Blue Buffalo, how far will manufacturers go? Ares to acquire most of America's freestanding veterinary hospitals; Regulator slams Antech's advertisement over heartworm screen; and much more...
Question of the Day July 28, 2014 In 2004 NECC settled a lawsuit claiming that a compounded shot caused bacterial meningitis. How many other compounding pharmacies have settled cases involving harm caused by their compounded preparations and these cases have gone virtually unnoticed each year?
A 2004 lawsuit filed in upstate New York's Monroe County claimed New England Compounding Center produced a tainted shot that caused William Koch to contract bacterial meningitis at Rochester General Hospital on July 17, 2002. Koch died Feb. 28, 2004, at the age of 83.
The lawsuit said the shot was the source of Koch's meningitis, but did not explain how that determination was made.
Bacterial meningitis is contagious and much more common than the fungal meningitis involved in the current outbreak. Fungal meningitis is more difficult to catch, according to the Centers for Disease Control and Prevention.
The compounding pharmacy reached a settlement with Koch's widow in 2007 before the case went to trial, according to her lawyer Mark S. Nunn. He declined to elaborate Wednesday because the terms were confidential.
"Really all I can say is that the case settled prior to trial," Nunn said.
source found here
Texas medical board charges controversial Houston cancer doctor: Clinic promotes unapproved drugs while knowing most patients were ineligible for the experimental therapy; Note that the Doctor owns the pharmacy and the lab also
Texas medical board charges controversial cancer doctor
Liz Szabo, USA TODAY 11:01 a.m. EDT July 25, 2014
Fans of Houston doctor Stanislaw Burzynski love him for defying the medical establishment and offering alternative therapies to terminally ill patients.
The latest charges against Burzynski by the Texas Medical Board, which has tried and failed to take away his license for more than two decades, paint a very different picture.
Burzynski has long lured patients from around the world to his Texas clinic by promoting his unapproved drugs as safe, effective and available from nobody else. Yet Burzynski knew that most patients were ineligible for the experimental therapy, according to a 200-page complaint that describes problems with the care of 29 patients.
continue to read here
The latest charges against Burzynski by the Texas Medical Board, which has tried and failed to take away his license for more than two decades, paint a very different picture.
Burzynski has long lured patients from around the world to his Texas clinic by promoting his unapproved drugs as safe, effective and available from nobody else. Yet Burzynski knew that most patients were ineligible for the experimental therapy, according to a 200-page complaint that describes problems with the care of 29 patients.
continue to read here
Invoking Anti-Fraud Law, Louisiana Doctor Gets Rich--A Whistleblower in Health Care Fraud
Invoking Anti-Fraud Law, Louisiana Doctor Gets Rich
Serial Whistleblower William LaCorte Wins $38 Million; Losing a 'Threadbare' Lawsuit
FDA Import Alerts Modified in the Last Seven Days Several Relating to Unapproved Drugs and API
Import Alert
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IA-12-10
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Detention Without Physical Examination of Cheese Due to Microbiological Contamination
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IA-16-120
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Detention Without Physical Examination of Fish/Fishery Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP
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IA-16-124
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Detention Without Physical Examination Of Aquaculture Seafood Products Due To Unapproved Drugs
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IA-16-125
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DETENTION WITHOUT PHYSICAL EXAMINATION OF REFRIGERATED (NOT FROZEN) RAW FISH AND FISHERY PRODUCTS THAT ARE VACUUM PACKAGED OR MODIFIED ATMOSPHERE PACKAGED OR PACKAGED IN A MATERIAL THAT IS NOT OXYGEN- PERMEABLE DUE TO THE POTENTIAL FOR CLOSTRIDIUM BOTULINUM TOXIN PRODUCTION
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IA-16-39
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Detention Without Physical Examination of Processed Seafood and Analogue Seafood (Surimi) Products for Listeria Monocytogenes
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IA-16-74
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Detention without physical Examination of *** Uneviscerated Fish Or Partially Eviscerated Fish that are either Sat-Cured, Dried, Smoked
Acidified, Pickled, Fermented or Brined
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IA-16-81
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Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella
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IA-21-04
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DETENTION WITHOUT PHYSICAL EXAMINATION OF DRIED, PRESERVED FRUITS FROM INDICATED COUNTRIES/AREAS
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IA-21-05
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Detention Without Physical Examination of Dates from China Due to Filth
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IA-45-02
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Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors
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IA-55-03
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DETENTION WITHOUT PHYSICAL EXAMINATION OF DIFFERENT FORMS OF HEPARIN AND HEPARIN-RELATED PRODUCTS FOR CGMP ISSUES
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IA-55-05
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DWPE of Finished Dosage Drug Products - API's and Inactive Ingredients for Potentially Hazardous Micro Contamination
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IA-60-01
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Tagamet Tablets Cimetidine Tablets (Canada)
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IA-66-40
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Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs
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IA-66-41
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Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
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IA-76-01
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Detention Without Physical Examination Of Medical Instruments from Pakistan 2
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IA-80-04
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Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves
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IA-95-04
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Detention Without Physical Examination Of Laser Pointers, Laser Gunsights, Laser Levels, Laser Light Shows, Laser Pointer Key Chains, & Similar Products That Fail To Comply With Applicable Performance Standards And Reporting Requirements
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IA-99-05
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Detention Without Physical Examination Of Raw Agricultural Products for Pesticides
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IA-99-08
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Detention Without Physical Examination Of Processed Foods for Pesticides
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IA-99-19
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Detention Without Physical Examination Of Food Products Due To The Presence Of Salmonella
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IA-99-20
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Detention Without Physical Examination Of Imported Food Products Due to NLEA Violations
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IA-99-32
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DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS FROM FIRMS REFUSING FDA FOREIGN ESTABLISHMENT INSPECTION
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IA-99-38
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DETENTION WITHOUT PHYSICAL EXAMINATION OF LOW-ACID CANNED FOODS OR ACIDIFIED FOODS DUE TO INADEQUATE PROCESS CONTROL
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Sunday, July 27, 2014
How gaps in regulation of compounding pharmacy set the stage for a multistate fungal meningitis outbreak Journal of American Pharmacists Association (2014)
How gaps in regulation of compounding pharmacy set the stage for a multistate fungal meningitis outbreak
Besu F. Teshome; Kelly R. Reveles; Grace C. Lee; Laurajo Ryan; Christopher R. Frei
J Am Pharm Assoc (2003) 2014;54:441-445. doi:10.1331/JAPhA.2014.14011
Pharmacy Scam Growing Trend in Health Care Fraud
Pharmacy Scam Growing Trend in Health Care Fraud
According to the FBI, health care fraud in the United States costs an estimated $80 billion annually. A Cornell University School of Law overview of health care fraud explains that 10 cents of every dollar spent on health care goes toward paying fraudulent health care claims.
The federal government does not like people dipping into its pocketbook, and thus, it aggressively prosecutes Medicare fraud and Medicaid fraud. A Health Care Fraud and Abuse Control Program (HCFAC) report says that under the program, “Convictions . . . increased by over 27 percent (from 583 to 743) between 2009 and 2011, and the number of defendants facing criminal charges filed by federal prosecutors in 2011 increased by 74 percent (from 821 to 1430) compared with 2008.” The feds are clearly cracking down on health care fraud and abuses of the Medicare system.
Although patients may be involved in health care fraud, the majority of schemes are perpetrated by health care providers. Typically, they bill Medicare or insurance providers for services not rendered, more expensive equipment than provided, and similar types of fraudulent and inflated billing. Sometimes, a health care provider will work in conjunction with a patient to perpetrate a fraud. This is what is happening more frequently in a pharmacy scam that CNBC says is bilking millions of dollars from taxpayers.
Tom O'Donnell, special agent in charge with the Health and Human Services Office of Inspector General (HHS-OIG), says that unscrupulous pharmacy owners
more here
Written by Patrick Quillian
According to the FBI, health care fraud in the United States costs an estimated $80 billion annually. A Cornell University School of Law overview of health care fraud explains that 10 cents of every dollar spent on health care goes toward paying fraudulent health care claims.
The federal government does not like people dipping into its pocketbook, and thus, it aggressively prosecutes Medicare fraud and Medicaid fraud. A Health Care Fraud and Abuse Control Program (HCFAC) report says that under the program, “Convictions . . . increased by over 27 percent (from 583 to 743) between 2009 and 2011, and the number of defendants facing criminal charges filed by federal prosecutors in 2011 increased by 74 percent (from 821 to 1430) compared with 2008.” The feds are clearly cracking down on health care fraud and abuses of the Medicare system.
Although patients may be involved in health care fraud, the majority of schemes are perpetrated by health care providers. Typically, they bill Medicare or insurance providers for services not rendered, more expensive equipment than provided, and similar types of fraudulent and inflated billing. Sometimes, a health care provider will work in conjunction with a patient to perpetrate a fraud. This is what is happening more frequently in a pharmacy scam that CNBC says is bilking millions of dollars from taxpayers.
Tom O'Donnell, special agent in charge with the Health and Human Services Office of Inspector General (HHS-OIG), says that unscrupulous pharmacy owners
more here
Saturday, July 26, 2014
Update on U.S Vladimir Kleyman, who is compounding pharmacist charged with paying referrals/kickbacks to doctor to refer prescriptions for a compounded pain to Prescriptions R US. The pain creame contained several components, including ketamine (a Schedule III non-narcotic), lidocaine, and diclofenac
06/12/2014 | 16 | ORDER TO CONTINUE - Ends of Justice as to VLADIMIR KLEYMAN Time excluded from 7/25/2014 until 8/25/2014.. Signed by Magistrate Judge James B. Clark on 6/12/2014. (mw, ) (Entered: 06/13/2014) |
Pharmacist Charged with Paying More Than $50,000 in Kickbacks to Doctor for Prescription Referrals
U.S. Attorney’s Office January 09, 2014 |
NEWARK—A pharmacist with a compounding pharmacy in Lakewood, New Jersey was arrested today and charged with paying more than $50,000 to a Toms River, New Jersey physician to induce the doctor to make prescription referrals to the pharmacy, U.S. Attorney Paul J. Fishman announced.
Vladimir Kleyman, 42, of Lakewood, New Jersey, the president and pharmacist in charge of Prescriptions R US—a compounding pharmacy in Lakewood—was charged with violating the Anti-Kickback Statute by using a middle-man to provide repeated cash payments—totaling at least tens of thousands of dollars—to a New Jersey physician over the course of several months. Kleyman appeared before U.S. Magistrate Judge James Clark, III in Newark federal court this afternoon.
According to the complaint unsealed today:
Beginning in February 2013, Kleyman provided one of his employees with at least $50,000 in cash or checks to provide bribes to the physician to refer prescriptions for a compounded pain cream to Prescriptions R US. Pharmacy compounding describes the preparation of medication, using different types and dosages of drugs, in order to provide more personalized medications for patients. The compounded pain cream prepared by Prescriptions R US in this case contains several components, including ketamine (a Schedule III non-narcotic), lidocaine, and diclofenac.
A computer-generated document prepared by Kleyman or someone working with him, and purporting to reflect the names of 63 patients for whom prescriptions for the pain cream had been sent by the bribed physician referenced in the complaint, included at least 33 Medicare beneficiaries for whom Prescriptions R US had received reimbursement from Medicare for prescriptions referrals from the bribed physician. In 2013, Prescriptions R US obtained more than $40,000 from Medicare alone in connection with filling prescriptions for the bribed physician referenced in the complaint—separate and apart from additional money Prescriptions R US obtained from other health care insurance providers.
In a series of meetings in November and December 2013, the unidentified employee received more than $50,000 in cash or checks from Kleyman or Kleyman’s spouse—who also works at Prescriptions R US—with the understanding that the bulk of that money would be used to bribe the physician to make prescription referrals to Prescriptions R US.
U.S. Attorney Fishman credited special agents of the FBI, under the direction of Special Agent in Charge Aaron T. Ford; U.S. Department of Health and Human Services, Office of Inspector General, under the direction of Special Agent in Charge Thomas O’Donnell; and IRS–Criminal Investigation, under the direction of Special Agent in Charge Shantelle P. Kitchen, with the ongoing investigation leading to today’s charges.
The government is represented by Assistant U.S. Attorney Jane Yoon and Senior Litigation Counsel Andrew Leven of the U.S. Attorney’s Office Health Care and Government Fraud Unit in Newark.
U.S. Attorney Paul J. Fishman reorganized the health care fraud practice at the New Jersey U.S. Attorney’s Office shortly after taking office, including creating a stand-alone Health Care and Government Fraud Unit to handle both criminal and civil investigations and prosecutions of health care fraud offenses. Since 2010, the office has recovered more than $520 million in health care fraud and government fraud settlements, judgments, fines, restitution, and forfeiture under the False Claims Act; the Food, Drug, and Cosmetic Act; and other statutes.
The charges and allegations contained in the complaint are merely accusations, and the defendant is presumed innocent unless and until proven guilty.
Vladimir Kleyman, 42, of Lakewood, New Jersey, the president and pharmacist in charge of Prescriptions R US—a compounding pharmacy in Lakewood—was charged with violating the Anti-Kickback Statute by using a middle-man to provide repeated cash payments—totaling at least tens of thousands of dollars—to a New Jersey physician over the course of several months. Kleyman appeared before U.S. Magistrate Judge James Clark, III in Newark federal court this afternoon.
According to the complaint unsealed today:
Beginning in February 2013, Kleyman provided one of his employees with at least $50,000 in cash or checks to provide bribes to the physician to refer prescriptions for a compounded pain cream to Prescriptions R US. Pharmacy compounding describes the preparation of medication, using different types and dosages of drugs, in order to provide more personalized medications for patients. The compounded pain cream prepared by Prescriptions R US in this case contains several components, including ketamine (a Schedule III non-narcotic), lidocaine, and diclofenac.
A computer-generated document prepared by Kleyman or someone working with him, and purporting to reflect the names of 63 patients for whom prescriptions for the pain cream had been sent by the bribed physician referenced in the complaint, included at least 33 Medicare beneficiaries for whom Prescriptions R US had received reimbursement from Medicare for prescriptions referrals from the bribed physician. In 2013, Prescriptions R US obtained more than $40,000 from Medicare alone in connection with filling prescriptions for the bribed physician referenced in the complaint—separate and apart from additional money Prescriptions R US obtained from other health care insurance providers.
In a series of meetings in November and December 2013, the unidentified employee received more than $50,000 in cash or checks from Kleyman or Kleyman’s spouse—who also works at Prescriptions R US—with the understanding that the bulk of that money would be used to bribe the physician to make prescription referrals to Prescriptions R US.
U.S. Attorney Fishman credited special agents of the FBI, under the direction of Special Agent in Charge Aaron T. Ford; U.S. Department of Health and Human Services, Office of Inspector General, under the direction of Special Agent in Charge Thomas O’Donnell; and IRS–Criminal Investigation, under the direction of Special Agent in Charge Shantelle P. Kitchen, with the ongoing investigation leading to today’s charges.
The government is represented by Assistant U.S. Attorney Jane Yoon and Senior Litigation Counsel Andrew Leven of the U.S. Attorney’s Office Health Care and Government Fraud Unit in Newark.
U.S. Attorney Paul J. Fishman reorganized the health care fraud practice at the New Jersey U.S. Attorney’s Office shortly after taking office, including creating a stand-alone Health Care and Government Fraud Unit to handle both criminal and civil investigations and prosecutions of health care fraud offenses. Since 2010, the office has recovered more than $520 million in health care fraud and government fraud settlements, judgments, fines, restitution, and forfeiture under the False Claims Act; the Food, Drug, and Cosmetic Act; and other statutes.
The charges and allegations contained in the complaint are merely accusations, and the defendant is presumed innocent unless and until proven guilty.
This content has been reproduced from its original source.
Second Question of the Day July 26, 2014 Is the compounding industry crashing like the stock market has in the past? Between the DQSA, less insurance companies and PBMs willing to reimbused, the on going civil and criminal litigation, all the issues the FDA is finding during the inspections, and the amount of recalls since NECC how much more can the industry survive before it decides to change the way it does business?
JAMA Extemporaneous Formulation or Compounding of Corticosteroids for Topical Usage
A number of extemporaneous corticosteroid preparations have been suggested in the literature. Unfortunately, this compounding of the corticosteroid and base is sometimes done without regard to the ultimate activity and stability of the product. A representative prescription filled by six pharmacies was compared with commercially formulated material. None of the six prescriptions was generally acceptable from the standpoint of pharmaceutical compounding, and all were inactive when tested in vasoconstriction studies.
more information found here
more information found here
DrugMonkey: Your Pharmacist May Hate You: Once Again, Real Life Takes Away My Material. I Al...
Your Pharmacist May Hate You: Once Again, Real Life Takes Away My Material. I Al...: Those of you who've picked up a copy of my awesome first book no doubt remember how I opened it with reminiscences of how I used to moc...
FDA takes on another compounder
FDA Takes on Another Compounder for GMP Violations
July 23, 2014
The FDA released its fourth warning letter in two days against a compounding pharmacy, this time chiding a large compounder for a mixture of quality violations at its four facilities. Read More
Must read! Study shows compounded oral liquids for perdiatric patients poses a significant risk to patient safety!
Variability in compounding of oral liquids for pediatric patients: A patient safety concern
Janis M. Rood; Melanie J. Engels; Scott L. Ciarkowski; Larry D. Wagenknecht; Chris J. Dickinson; James G. Stevenson
J Am Pharm Assoc (2003) 2014;54:383-389. doi:10.1331/JAPhA.2014.13074
Objective To determine the degree in variation of oral liquid pediatric compounding practices in Michigan pharmacies.
Design Cross-sectional survey study.
Setting All types of inpatient and outpatient pharmacies across the state of Michigan, excluding nuclear pharmacies and long-term care facilities.
Participants 244 Michigan pharmacies.
Intervention An online survey tool was used to assess the current compounding practices of 147 oral liquid pediatric medications. The survey was e-mailed or faxed to hospitals, chain pharmacies, and independent pharmacies. Pharmacists were also mailed a follow-up postcard, and the Michigan Pharmacists Association publicized the project through its journal and annual meeting.
Main outcome measures Pharmacy demographics; number of compounding pharmacies; number of medications compounded; awareness of compounding errors; results of compounding errors; and number of concentrations compounded per medication.
Results The majority of respondents were from outpatient pharmacies, but inpatient and other types of pharmacies were also represented. The majority of participating pharmacies compound fewer than five oral liquid medications per week. Awareness of errors was low overall, with no errors believed to result in permanent harm or death. The number of concentrations compounded per medication ranged from 1 to 9, with the majority of pharmacies compounding more than 3 concentrations per medication.
Conclusion There is a considerable degree of variation in current oral pediatric liquid compounding practices in Michigan pharmacies. This variability poses a significant risk to patient safety.
more information found here
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