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`New Clozapine REMS program changes monitoring, dispensing requirements I Drug Topics
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`Clozapine REMS Program
`
`New Clozapine REMS program changes
`monitoring, dispensing requirements
`
`September 18, 2015
`
`By Julia Talsma, Content Channel Director
`
`FDA announced new requirements for the monitoring, prescribing, and dispensing of
`
`clozapine, an atypical antipsychotic for treatment-resistant schizophrenia, due to the
`
`continued risk of severe neutropenia, which can be life-threatening.
`
`A new Clozapine REMS Program has been established and includes revised prescribing
`
`information for all clozapine products for the safe monitoring of patients for neutropenia and
`
`management of clozapine treatment. The REMS program, which will replace the six
`
`clozapine registries that were established by the manufacturers of the drug, requires
`
`prescribers, pharmacies, and patients to enroll in one centralized place.
`
`Psychiatric pharmacists help optimize patient care
`
`"Centralizing those registries under one REMS program will allow pharmacies, prescribers,
`
`and patients to have one destination for the vital clinical information
`
`needed to safely manage their clozapine therapy," according to Tim
`
`Gentilcore, PharmD, director of Retail Pharmacy, Mission Health
`
`System, Asheville, N.C.
`
`A centralized, shared REMS program is a great improvement
`
`compared with the current system of several different registries
`
`Tim Gentilcore
`
`managed by the individual manufacturers, said Megan Maroney,
`
`PharmD, clinical assistant professor at Ernest Mario College of
`
`Pharmacy and a board-certified clinical pharmacy speCialist in psychiatry at Monmouth
`
`Medical Center, Long Branch, N.J.
`
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`CELGENE EXHIBIT 2058
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`1/4/2016
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`New Clozapine REMS program changes monitoring, dispensing requirements I Drug Topics
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`"When coordinating care for a patient starting on clozapine in the
`
`inpatient setting, one of the challenges I face as a pharmacist, is
`
`ensuring continuity of care into the outpatient setting," Maroney
`
`continued. "If a patient is started on the Mylan brand of clozapine in
`
`the inpatient setting and is originally registered in the Mylan registry,
`
`and then after discharge the patient goes to an outpatient pharmacy
`
`that supplies clozapine manufactured by Teva, the pharmacist will
`
`Megan Maroney
`
`need to obtain the physician's signature and required bloodwork to
`
`enroll them all over again in the TEVA registry. [With the new REMS program], transition
`
`from one provider to another and from one pharmacy to another will be much smoother."
`
`New REMS start date
`
`On October 12, 2015, all clozapine products will only be available through the new
`
`DrugTopic",c!)rn/DrugTopl""App
`
`Clozapine REMS Program. Patients who are currently enrolled in the six separate
`
`registries will be automatically transferred into the new centralized program.
`
`"In order to prescribe and dispense clozapine, prescribers and pharmacies will be required
`
`to be certified in the Clozapine REMS Program according to a specific transition schedule
`
`starting October 12, 2015," FDA wrote in its drug safety communication.
`
`Prescribers and pharmacies can obtain certification online at the Clozapine REMS
`
`Program website, IJWJw.clozapinerems.com, or call for more information about the program,
`
`844-267-8678. Prescribers can designate a representative to enroll patients in the REMS
`
`program and enter the patients' absolute neutrophil counts (AN C). The designated
`
`individual also must enroll in the REMS program and be confirmed by the prescriber.
`
`Pharmacies also must appoint an authorized representative to become certified.
`
`Pharmacies with multiple locations will need to complete staff training and then can enter
`
`each location online.
`
`The REMS program also requires that only prescribers or their designated representatives
`
`can enroll patients in the REMS program. "Unless a pharmacist is a prescriber designee, a
`
`pharmacist is no longer permitted to enroll patients in the Clozapine REMS Program or
`
`view a list of patients on clozapine," according to the document, Wl7at's New witt)
`
`Clozapine: An Overview.
`
`PDA requirement for outpatient pharmacies
`
`Before dispensing clozapine, outpatient pharmacies must obtain a predispense
`
`authorization (PDA) from the REMS Program by December 14, 2015. The PDA is an
`
`electronic code that ensures that the prescriber and pharmacy are certified in the
`
`Clozapine REMS Program and that the patient is enrolled in the program. Also, the PDA
`
`confirms that the ANC is up to date and within the acceptable guidelines to continue
`
`clozapine treatment or the prescriber has authorized the continued treatment of the atypical
`
`antipsychotic.
`
`Inpatient pharmacies are not required to obtain a PDA from the Clozapine REMS Program
`
`before dispensing the drug. However, inpatient pharmacies need to verify patient
`
`enrollment, provider certification, and the patient's ANC and prescriber authorization by
`
`signing into the website, \MMo\I.clozapinerems.com or calling the Clozapine REMS Program
`
`contact center at 844-267-8678. The patient's ANC and prescriber authorization can also
`
`be verified by reviewing the patient's electronic medical record.
`
`Changes to neutropenia monitoring
`
`http://drugtopics.modernmedicine.com/drug-topics/news/new-clozapine-rems-program-changes-monitoring-dispensing-requirements?page=full
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`Page 2 of 4
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`New Clozapine REMS program changes monitoring, dispensing requirements I Drug Topics
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`Patients taking clozapine must now be monitored for neutropenia using absolute neutrophil
`
`count (ANC) only. Monitoring using white blood cell (WBC) counts is no longer acceptable,
`
`FDA stated.
`
`In addition, the ANC thresholds for continued treatment of clozapine are now lower,
`
`allowing more patients to be treated with the drug. For patients in the general population,
`
`clozapine treatment should be interrupted if neutropenia is suspected and the ANC drops
`
`below 1000 celis/ill. For individuals with benign ethnic neutropenia (BEN), clozapine
`
`treatment should be stopped if neutropenia is suspected and the ANC is less than 500
`
`celis/ill.
`
`"The requirements for ANC are being modified so that patients will be able to continue on
`
`clozapine treatment with a lower ANC, a change that will allow continued treatment for a
`
`greater number of patients. In addition, patients with benign ethnic neutropenia (BEN), who
`
`were not eligible for clozapine treatment, will now be able to receive the medicine,"
`
`according to the Agency.
`
`With these new recommendations, FDA stated that prescribers can continue treatment with
`
`clozapine even though the ANC is less than 1000 celis/ill if it is determined that the
`
`benefits of the drug outweigh the risk of severe neutropenia.
`
`"Patients may be re-challenged if the prescriber determines the risk of psychiatric illness is
`
`greater than the risk of severe neutropenia," FDA noted in its drug safety communication.
`
`FDA plans to discontinue the National Non-Rechallenge Master File on October 12, 2015.
`
`This file included patients whose WBC count dropped below 2,000 celiS/ill or had an ANC
`
`less than 1,000 celiS/ilL. All patients that were in the master file will be transferred to the
`
`Clozapine REMS Program.
`
`For more information, visit the Clozapine REMS Program website,
`
`w\lI/w.clozapinerems.com, or call for more information about the program, 844-267-8678.
`
`Clozapine REI,,1S Program
`
`FDA
`
`FDA drug safety
`
`Pharmacy News
`
`Rx Care
`
`schizophrenia
`
`The Latest
`
`Top News
`
`Julia Talsma, Content Channel Director
`
`Julia Talsma is lead editor for Drug Topics magazine.
`
`DmgTopks
`et\fetVs
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