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U.S. regulators have put some of the new clozapine risk evaluation and mitigation strategy (REMS) program on temporary hold because of start-up difficulties, including long telephone wait times.
In a Nov. 19 statement, the Food and Drug Administration announced it is temporarily suspending certain aspects of the program because of challenges reported by medical professionals who were trying to meet the original Nov. 15 deadline.
In response, the FDA has conceded that pharmacists can dispense clozapine without a REMS dispense authorization (RDA). Wholesalers can continue to ship clozapine to pharmacies and health care settings without confirming enrollment in the REMS, the FDA also said.
“We encourage pharmacists and prescribers to continue working with the clozapine REMS to complete certification and patient enrollment,” the FDA said in a statement.
In July, the FDA approved modifications to the clozapine REMS strategy. Clozapine is used to treat schizophrenia that is not well controlled with standard antipsychotics. It is also prescribed to patients with recurrent suicidal behavior associated with schizophrenia or schizoaffective disorder.
Although it is highly effective in some patients, it also carries serious risks. Specifically, it can decrease the neutrophil count, which can lead to severe neutropenia, serious infections, and death.
As a result, those taking the drug must undergo regular absolute neutrophil count (ANC) monitoring. Clozapine REMS is intended to maximize the benefits of the drug and minimize risk.
HCP frustration
, including a high call volume and long call wait times for stakeholders.
“We understand that this has caused frustration and has led to patient access issues for clozapine,” the FDA said in a statement.
“Continuity of care, patient access to clozapine, and patient safety are our highest priorities,” the FDA added. “We are working closely with the clozapine REMS program administrators to address these challenges and avoid interruptions in patient care.”
Abrupt discontinuation of clozapine can result in significant complications, the FDA said. The agency urged use of “clinical judgment” with respect to prescribing and dispensing clozapine to patients with an absolute neutrophil count within the acceptable range.
As previously reported by this news organization, the American Psychiatric Association and other national groups in a September letter asked the FDA to delay the implementation of a new REMS program until after Jan. 1, 2022.
A version of this article first appeared on Medscape.com.
U.S. regulators have put some of the new clozapine risk evaluation and mitigation strategy (REMS) program on temporary hold because of start-up difficulties, including long telephone wait times.
In a Nov. 19 statement, the Food and Drug Administration announced it is temporarily suspending certain aspects of the program because of challenges reported by medical professionals who were trying to meet the original Nov. 15 deadline.
In response, the FDA has conceded that pharmacists can dispense clozapine without a REMS dispense authorization (RDA). Wholesalers can continue to ship clozapine to pharmacies and health care settings without confirming enrollment in the REMS, the FDA also said.
“We encourage pharmacists and prescribers to continue working with the clozapine REMS to complete certification and patient enrollment,” the FDA said in a statement.
In July, the FDA approved modifications to the clozapine REMS strategy. Clozapine is used to treat schizophrenia that is not well controlled with standard antipsychotics. It is also prescribed to patients with recurrent suicidal behavior associated with schizophrenia or schizoaffective disorder.
Although it is highly effective in some patients, it also carries serious risks. Specifically, it can decrease the neutrophil count, which can lead to severe neutropenia, serious infections, and death.
As a result, those taking the drug must undergo regular absolute neutrophil count (ANC) monitoring. Clozapine REMS is intended to maximize the benefits of the drug and minimize risk.
HCP frustration
, including a high call volume and long call wait times for stakeholders.
“We understand that this has caused frustration and has led to patient access issues for clozapine,” the FDA said in a statement.
“Continuity of care, patient access to clozapine, and patient safety are our highest priorities,” the FDA added. “We are working closely with the clozapine REMS program administrators to address these challenges and avoid interruptions in patient care.”
Abrupt discontinuation of clozapine can result in significant complications, the FDA said. The agency urged use of “clinical judgment” with respect to prescribing and dispensing clozapine to patients with an absolute neutrophil count within the acceptable range.
As previously reported by this news organization, the American Psychiatric Association and other national groups in a September letter asked the FDA to delay the implementation of a new REMS program until after Jan. 1, 2022.
A version of this article first appeared on Medscape.com.
U.S. regulators have put some of the new clozapine risk evaluation and mitigation strategy (REMS) program on temporary hold because of start-up difficulties, including long telephone wait times.
In a Nov. 19 statement, the Food and Drug Administration announced it is temporarily suspending certain aspects of the program because of challenges reported by medical professionals who were trying to meet the original Nov. 15 deadline.
In response, the FDA has conceded that pharmacists can dispense clozapine without a REMS dispense authorization (RDA). Wholesalers can continue to ship clozapine to pharmacies and health care settings without confirming enrollment in the REMS, the FDA also said.
“We encourage pharmacists and prescribers to continue working with the clozapine REMS to complete certification and patient enrollment,” the FDA said in a statement.
In July, the FDA approved modifications to the clozapine REMS strategy. Clozapine is used to treat schizophrenia that is not well controlled with standard antipsychotics. It is also prescribed to patients with recurrent suicidal behavior associated with schizophrenia or schizoaffective disorder.
Although it is highly effective in some patients, it also carries serious risks. Specifically, it can decrease the neutrophil count, which can lead to severe neutropenia, serious infections, and death.
As a result, those taking the drug must undergo regular absolute neutrophil count (ANC) monitoring. Clozapine REMS is intended to maximize the benefits of the drug and minimize risk.
HCP frustration
, including a high call volume and long call wait times for stakeholders.
“We understand that this has caused frustration and has led to patient access issues for clozapine,” the FDA said in a statement.
“Continuity of care, patient access to clozapine, and patient safety are our highest priorities,” the FDA added. “We are working closely with the clozapine REMS program administrators to address these challenges and avoid interruptions in patient care.”
Abrupt discontinuation of clozapine can result in significant complications, the FDA said. The agency urged use of “clinical judgment” with respect to prescribing and dispensing clozapine to patients with an absolute neutrophil count within the acceptable range.
As previously reported by this news organization, the American Psychiatric Association and other national groups in a September letter asked the FDA to delay the implementation of a new REMS program until after Jan. 1, 2022.
A version of this article first appeared on Medscape.com.