Cephalon Receives FDA Approval for Risk Evaluation and Mitigation Strategy for ...
/PRNewswire/ -- Cephalon, Inc. (Nasdaq: CEPH ) announced today that the U.S. Food and Drug Administration (FDA) approved the Risk Evaluation and Mitigation Strategy (REMS) for FENTORA® (fentanyl buccal tablet) [C-II] and ACTIQ® (oral transmucosal fentanyl citrate) [C-II]. Both products are indicated for the management of breakthrough pain in opioid-tolerant patients with cancer. Under this REMS, pharmacies and healthcare professionals who prescribe FENTORA and ACTIQ will enroll by completing an education module and knowledge assessment focused on safety information including appropriate patient selection. Healthcare professionals who prescribe these products will also educate patients as part of the program. Cephalon expects that enrollment in the REMS program will begin in .The goals of the REMS are to ensure proper patient selection, to prevent accidental exposure and inappropriate conversion between fentanyl products, as well as to mitigate the potential risks of misuse, abuse, addiction, and overdose. The newly-approved REMS will replace the existing risk management programs for ACTIQ and FENTORA.
"The FENTORA and ACTIQ REMS demonstrate Cephalon's commitment to patient safety while maintaining access to these medicines for the often debilitating breakthrough pain experienced by many opioid-tolerant patients with cancer," said Dr. , Chief Medical Officer, Cephalon. "The program provides education and systems to support safe use of FENTORA and ACTIQ, preserving availability of the medicines to patients through retail pharmacies and using other systems already familiar to prescribers and pharmacists."
When implemented, the FENTORA and ACTIQ REMS will provide checks and balances within the distribution channel to provide safeguards to help assure dispensing to patients appropriate for the medications. All stakeholders can enroll in the system any time beginning in . There will be a transition period of about six months following launch of the REMS after which no prescription may be dispensed unless the prescriber and pharmacy are enrolled.
Cephalon will provide regular updates to FDA regarding the effectiveness of the REMS. Based on these evaluations, Cephalon plans to open discussions with FDA regarding the Company's pending supplemental New Drug Application for FENTORA as a treatment for opioid-tolerant patients with non-cancer breakthrough pain.
Methadone Dispensing System - News
When implemented, the FENTORA and ACTIQ REMS will provide checks and balances within the distribution channel to provide safeguards to help assure dispensing to patients appropriate for the medications. All stakeholders can enroll in the system any
Vancouver city council will consider today whether to call on the province and other health authorities to investigate methadone dispensing abuses, including fraud and intimidation, in its Downtown Eastside
Schedule II opioid substances, which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone, have the highest potential for abuse and risk of fatal overdose due to respiratory depression. Serious adverse events, including deaths,
Another patient died of “methadone overdose,” and one died of what was a “suspected homicide.” What these women's stories are, precisely how these are connected to their chemical abortions, is not made clear in the report. One RU486 patient died of
The report said the deaths were blamed on sepsis, the use of drugs, methadone overdose, delayed onset of toxic shock-like syndrome, suspected homicide and ruptured ectopic pregnancies. "There were five additional deaths in women from foreign countries
FloridaMD | New Florida Law and The Dispensing Practitioner
By: Sam Pratt, RPh; Terry Isler, RPh and
Amparo Miranda, Pharm. D. Candidate
By law, a person may not dispense drugs unless licensed as a pharmacist or a practitioner authorized to prescribe in compliance with Florida Statutes: chapters 465, 499 and 893. In order to dispense, a practitioner needs to register with his or her professional licensing board as a dispensing practitioner and comply with all the laws and rules applicable to pharmacists and pharmacies. The Department of Health has the authority to inspect any facility where practitioners are dispensing in the same manner as it inspects pharmacies to ensure compliance with all statutes and rules. If a practitioner is found to be dispensing drugs in violation of the law, he or she will face suspension or revocation.
The Legislature has found that prescription drug overdose is a public health epidemic and is responsible for nearly seven deaths daily in Florida. In 2006, Florida physicians purchased more than 85% of the oxycodone purchased by all practitioners in the US and more than 93% of the methadone. Due to this occurrence, on June 3, 2011 Florida Governor, Rick Scott signed bill HB 7095 and became Florida CHAPTER 2011-141. This new law refers to healthcare practitioners dispensing Controlled Substances listed in Schedule II and Schedule III.
Starting July 1 , 2011, practitioners will no longer be authorized to dispense controlled substances in Schedule II and III. However, there are exceptions, these include:
The dispensing of these drugs which are labeled as a drug sample to the practitioner’s own patients in the regular course of practice without payment of a fee. The dispensing in the health care system of the Department of Corrections, the dispensing in connection with the performance of a surgical procedure with the amount dispensed not to exceed a 14-day supply. The dispensing pursuant to an approved clinical trial. The dispensing of methadone where treatment for opiate addiction is provided. The dispensing to a hospice patient.The dispensing of controlled substances in Schedule II and III in violation of this new law will be punishable as a felony of the third degree.
With this new act, dispensing physicians will need to make some adjustments to the way they practice to avoid consequences. Within 10 days of the effectiveness of this act, July 11, 2011, each physician needs to dispose of the controlled substance inventory properly, either by returning them to the wholesale distributor or turning the inventory into a local law enforcement agency and abandoning them. Wholesale distributors are required to purchase inventory of controlled substances if they are in the manufacturer’s original packaging, unopened, and in date, or by meeting contractual terms between the wholesale distributor and the physician, concerning returns. Beginning on the 3 day of the effectiveness of this act, July 4, 2011, local law enforcement agencies will quarantine the inventory of those dispensing practitioners who have been identified as the greatest threat to the public health; those identified by wholesale distributors who purchased more than 2000 unit doses of controlled substances in Schedule II and III per month in the last 6 months. On the 31st day after the effectiveness of this act, August 2, 2011, any remaining inventory of controlled substances listed in Schedule II or Schedule III in practitioners’ offices will be deemed contraband; the Department of Law Enforcement will seize the inventory and destroy it. Also, effective January 1, 2012, each medical physician, osteopathic physician, podiatrist, or dentist who prescribes controlled substances for the treatment of chronic nonmalignant pain must designate himself or herself as a controlled substance prescribing practitioner on the physician practice profile.
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