3 days ago - NCPA is awaiting response to a letter sent to the Defense Health Agency regarding ESI's egregious recoupment efforts for Tricare compounded prescriptions.
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
Friday, August 14, 2020
FDA alerts health care professionals of risks associated with intraocular use of compounded moxifloxacin
August 12, 2020
Background
Ophthalmologists frequently administer moxifloxacin and other anti-infective agents either topically or intraocularly to reduce the incidence of postoperative endophthalmitis. Endophthalmitis occurs at a low incidence following cataract surgery (estimated to be between 0.012% 1.3%).1 There are currently no FDA-approved drugs for endophthalmitis prophylaxis.
Outsourcing facilities have compounded moxifloxacin drug products from bulk drug substances and repackaged the FDA-approved topical moxifloxacin drugs. Traditional and hospital pharmacies (generally, those that operate under section 503A of the Federal Food, Drug, and Cosmetic Act), as well as individual ophthalmologists have used moxifloxacin ophthalmic solutions, approved for topical administration, as the starting material to prepare moxifloxacin drugs for use during intraocular procedures.
Adverse Events
FDA received case reports of TASS (Toxic Anterior Segment Syndrome) following intraocular administration of compounded drugs using moxifloxacin as a bulk drug substance, as well as reports associated with the intraocular administration of repackaged and/or diluted FDA-approved moxifloxacin drugs. FDA searched the Adverse Event Reporting System (FAERS) database for all reports through December 19, 2019, and identified 29 cases that described TASS associated with intraocular administration of drugs containing moxifloxacin (16 compounded drugs using moxifloxacin as a bulk drug substance, 10 repackaged Moxeza, 2 unspecifieda Vigamox, and 1 unspecifieda Moxeza). The majority of cases (n = 19) reported use of moxifloxacin following cataract surgery and the remaining 10 did not specify the type of ophthalmic surgery.
Of the 29 TASS cases, five reported use of 0.5% moxifloxacin at a volume of 0.5 mL, one reported use of 0.1% moxifloxacin at a volume of 0.1 mL, and the remaining 23 did not report the volume used. Most cases were reported by a health care professional and did not report the use of concomitant intraocular drugs or drugs containing multiple active ingredients.
According to one facility that reported 10 of these cases, TASS developed within one week after intraocular administration of a compounded drug containing moxifloxacin. The report indicated a positive drug-event association, as the TASS events ceased following the discontinuation of the use of moxifloxacin at the facility. When the compounded moxifloxacin drug was reintroduced during subsequent surgical procedures, patients again presented with TASS. While it is not possible to determine if the TASS events were solely due to exposure to intraocular moxifloxacin, the occurrence of additional cases following re-introduction of compounded moxifloxacin use reduces the likelihood of other causes.
a Unspecified means the report did not specify whether the drug was either repackaged/diluted or administered without repackaging/dilution by the ophthalmologist during intraocular surgery.
Discussion
Moxifloxacin topical ophthalmic solutions are FDA approved and marketed under the proprietary names Moxeza and Vigamox. Neither drug is approved for intraocular administration. FDA is aware of multiple literature reports that claim to support the use of intraocular moxifloxacin for the prophylaxis of endophthalmitis, and it is a common practice among ophthalmologists in association with cataract surgery. However, there are no adequate and well controlled studies that demonstrate moxifloxacin’s efficacy for treating endophthalmitis. There also are no adequate and well controlled studies that demonstrate that any anti-infective, topical or intraocular, is effective in reducing the incidence of endophthalmitis.
Moxifloxacin is an anti-infective, which, in a dose dependent manner, kills specific microorganisms. Moxifloxacin, in sufficient concentrations, may also contribute to cellular injury in the human body.2 The concentration that causes human harm is not precisely established, although multiple clinical studies support that intraocular use of moxifloxacin in volumes of 0.3mL or less with concentrations of 0.5% or less is unlikely to cause significant adverse events.3, 4, 5, 6, 7
In addition to selecting the proper concentration and volume, the safety of an intraocularly injected drug is also dependent on the content of the active and inactive ingredients in the formulation. There are two different topical moxifloxacin ophthalmic solutions approved for marketing, Vigamox (moxifloxacin ophthalmic solution) 0.5% and Moxeza (moxifloxacin ophthalmic solution) 0.5%. Although these two drugs contain the same active ingredient with the same concentration, they contain different inactive ingredients. Moxeza contains xanthan gum, which has been linked to causing TASS.8, 9 Intraocular injection of Moxeza, including diluted Moxeza, is likely to cause TASS. Moxeza carries a specific warning that it is for topical ophthalmic use only and should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye. Moxeza should not be used, diluted, repackaged or compounded for intraocular injection.
Conclusion
FDA recommends that before health care professionals administer moxifloxacin intraocularly, they know its formulation. The agency also alerts compounders, ophthalmologists and other health care professionals of risks associated with the intraocular administration of moxifloxacin drugs that contain more than 0.3 mL of 0.5% moxifloxacin or that contain certain potentially harmful inactive ingredients, such as xanthan gum.8,9 Additionally, FDA cautions health care professionals to carefully consider the concentration and inactive ingredients of any moxifloxacin drug before intraocular administration.
References
- Cao, H., Zhang, L., Li, L., Lo, S. (2013). Risk factors for acute endophthalmitis following cataract surgery: A systematic review and meta-analysis. PLoS ONE 8(8): e71731.
- Miyake, H., Miyazaki, D., Shimizu, Y., et al. (2019). Toxicities of and inflammatory responses to moxifloxacin, cefuroxime, and vancomycin on retinal vascular cells. Sci Rep. 9:9745.
- Arbisser, L.B. (2008). Safety of intracameral moxifloxacin for prophylaxis of endophthalmitis after cataract surgery. J Cataract Refract Surg. 34(7):1114-20.
- Haripriya, A., Chang, D.F., Ravindran, R.D. (2017). Endophthalmitis reduction with intracameral moxifloxacin prophylaxis: Analysis of 600,000 surgeries. Ophthalmology. 124(6):768-775.
- Chang, D.F., Prajna, N.V., Szczotka-Flynn, L.B. et al. (2020). Comparative corneal endothelial cell toxicity of differing intracameral moxifloxacin doses after phacoemulsification. J Cataract Refract Surg. 46(3):355-359.
- Zhou, A.X., Messenger, W.B., Sargent, S., Ambati, B.K. (2016). Safety of undiluted intracameral moxifloxacin without postoperative topical antibiotics in cataract surgery. Int Ophthalmol. 36(4):493-8.
- Lira, R.P.C., Lucena, N.P., Ferreira, K.S.A., dos Santos. B.M.A. (2017) Long-term safety of intracameral moxifloxacin after cataract surgery. J Cataract Refract Surg. 43(1):139-140.
- Braga-Mele, R., Chang, D.F., Henderson, B.A., Mamalis, N., Talley-Rostov, A., Vasavada, A. (2014). Intracameral antibiotics: safety, efficacy, and preparation. J Cataract Refract Surg. 40:2134–2142.
- Park, C.Y., Lee, J.K., Chuck, R.S. (2018) Toxic anterior segment syndrome-an updated review. BMC Ophthalmol. 18(1):276.
The chief executive officer of Central Rexall Drugs Inc., a Louisiana pharmacy used by numerous individuals to defraud New Jersey health benefits programs and other insurers out of more than $50 million for compounded medications, has admitted her guilt
Department of Justice
U.S. Attorney’s Office
District of New Jersey
FOR IMMEDIATE RELEASE
Wednesday, August 12, 2020
Chief Executive Officer Of Louisiana Compounding Pharmacy Used To Defraud State Health Benefits Programs Pleads Guilty
CAMDEN, N.J. – The chief executive officer of Central Rexall Drugs Inc., a Louisiana pharmacy used by numerous individuals to defraud New Jersey health benefits programs and other insurers out of more than $50 million, has admitted her guilt, U.S. Attorney Craig Carpenito announced.
Hayley Taff, 37, of Hammond, Louisiana, pleaded guilty by videoconference before U.S. District Judge Robert B. Kugler to an information charging her with one count of conspiracy to commit healthcare fraud.
According to documents filed in this case and statements made in court:
Central Rexall was a retail pharmacy in Louisiana that prepared compounded medications, which are specialty medications mixed by a pharmacist to meet the specific medical needs of an individual patient. Hayley Taff was Central Rexall’s chief executive officer and 22 percent owner. In 2013, Taff entered into an agreement with two individuals, identified as Individual 1 and Individual 2, to expand the compounding business, with Individual 1 and 2’s company receiving 90 percent of the profits.
Taff and her conspirators learned that certain insurance plans administered by an entity referred to in the information as the “Pharmacy Benefits Administrator” would reimburse thousands of dollars for a one-month supply of certain compounded medications – including pain, scar, antifungal, and libido creams, as well as vitamin combinations. The health plans for New Jersey state and local government and education employees, including teachers, firefighters, municipal police officers, and state troopers, had this insurance coverage.
Taff’s conspirators designed compounded medications and manipulated the ingredients in the medications in order to obtain high insurance reimbursements rather than serve the medical needs of patients. To determine which ingredients and combinations resulted in the high insurance reimbursement, Taff’s conspirators sent the Pharmacy Benefits Administrator false prescription claims to test out different combinations of ingredients, but the prescriptions did not exist. By trial and error use of these false claims, Taff’s conspirators designed compounded medications with combinations of ingredients that were chosen solely based on the amount of money that insurance would pay rather than on the medications’ ability to serve the medical needs of patients. At Taff’s direction, Central Rexall sent compounded medications to patients based solely on financial gain.
When the Pharmacy Benefits Administrator stopped covering one combination, Central Rexall would develop a compounded medication with a different combination of ingredients based solely on the insurance reimbursement and without considering the medical necessity or effectiveness of the new combination. Central Rexall then would send that new compounded medication to patients, even though the new combination of ingredients was not medically equivalent to the combination originally prescribed for the patients and without telling the patients or their doctor about the differences.
Taff admitted that during the conspiracy, Central Rexall stopped being concerned about the health of its compounded medication patients or the medical necessity of its compounded medications. Instead, she admitted, Central Rexall devoted itself solely to making money.
At Taff’s direction, Central Rexall also stopped requiring that patients make copayments in order to receive medications, even though Central Rexall told the Pharmacy Benefits Administrator that it was collecting copayments. Taff admitted that Central Rexall continued shipping medications to individuals who had not paid their copayments because Central Rexall was making so much money on its medications.
Taff and her conspirators caused numerous fraudulent insurance claims for compounded medications that were not medically necessary. The Pharmacy Benefits Administrator paid Central Rexall over $50 million for compounded medications shipped to New Jersey. Taff received $1,553,616 from Central Rexall during the conspiracy.
Taff faces a maximum of 10 years in prison and a $250,000 fine, or twice the gain or loss from the offense. As part of the plea agreement, Taff must pay restitution of $51,670,251 and forfeiture of $1,553,616. Sentencing for is scheduled for Dec. 1, 2020.
U.S. Attorney Carpenito credited agents of the FBI’s Atlantic City Resident Agency, under the direction of Acting Special Agent in Charge Joe Denahan in Newark; IRS – Criminal Investigation, under the direction of Special Agent in Charge Michael Montanez in Newark; and the U.S. Department of Labor, Office of Inspector General, New York Region, under the direction of Special Agent in Charge Michael C. Mikulka, with the investigation leading to the guilty plea. He also thanked the Division of Pensions and Financial Transactions in the State Attorney General’s Office, under the direction of Attorney General Gurbir S. Grewal and Division Chief Aimee Nason, for its assistance in the investigation.
The government is represented by Assistant U.S. Attorneys R. David Walk Jr. and Christina O. Hud of the U.S. Attorney’s Office in Camden and Assistant U.S. Attorney Barbara Ward, Senior Trial Counsel of the Asset Recovery and Money Laundering Unit.
Defense counsel: J. Garrison Jordan Esq., Hammond, Louisiana
Attachment(s):
Topic(s):
Health Care Fraud
Component(s):
Press Release Number:
20-252
The Food and Drug Administration (FDA) has issued the final guidance titled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.” The guidance is intended for responsible parties, submitters of certain applications and submissions to FDA, and FDA staff.
This guidance document describes the current thinking of FDA regarding civil money penalties under section 303(f)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). That section authorizes FDA to assess civil money penalties against responsible parties and/or submitters of certain applications and submissions to FDA regarding drug products, biological products, and device products (hereafter, “submitters”) who violate applicable FD&C Act prohibitions relating to requirements under section 402(j) of the Public Health Service Act (PHS Act),1 including its implementing regulations in 42 CFR part 11, to submit registration and/or results information to the ClinicalTrials.gov data bank and/or certain certifications to FDA.
The guidance document addresses the following questions:
• How do the Centers intend to identify whether responsible parties have failed to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank or submitted false or misleading information to the data bank, or whether submitters have failed to submit to FDA the certification required by section 402(j)(5)(B)2 of the PHS Act or knowingly submitted a false certification to FDA?
• Under what circumstances may a Center decide to seek civil money penalties against a responsible party or submitter?
• What procedures apply when a Center seeks civil money penalties?
• What civil money penalty amounts may be assessed for (1) failing to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank, (2) submitting false or misleading information to the data bank, (3) failing to submit the required certification to FDA, or (4) knowingly submitting a false certification to FDA?
This guidance is now available on FDA’s website at https://www.fda.gov/
1 42 U.S.C. 282(j)
2 42 U.S.C. 282(j)(5)(B)
Tuesday, August 11, 2020
Coronavirus (COVID-19) Update: Daily Roundup August 11, 2020
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| 08/04/2020 | 07/21/2020 | New Life International | Center for Veterinary Medicine | Unapproved Chloroquine Phosphate Product |
| 08/10/2020 | 08/07/2020 | H-Lab Life | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||
| 08/07/2020 | 08/06/2020 | Canadian Chaga | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 08/11/2020 | 08/04/2020 | Soluciones Cosmeticas, SA de CV | Center for Drug Evaluation and Research | CDER | CGMP/Adulterated/Unapproved/Misbranded |
| 08/11/2020 | 07/31/2020 | Davis Ventures, Inc dba The Green Herb and New Genesis Health | Division of Human and Animal Food Operations West IV | CGMP/Dietary Supplement/Adulterated/Misbranded |
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