Why are metabolic monitoring guidelines being ignored?

The vast majority of psychiatrists and psychiatric nurse practitioners in the United States are aware of the following facts:

• The unhealthy lifestyle of persons with chronic psychotic disorders (sedentary living, smoking, poor diet) is conducive to weight gain, metabolic disorders, high cardiovascular risk, and premature mortality. ¹
• Second-generation antipsychotics (SGAs) are associated with metabolic dysregulation, including obesity, diabetes, dyslipidemia, and hypertension.²
• The dramatic increase in diabetes, diabetic ketoacidosis, and death in the late 1990s and early 2000s prompted the FDA in August 2003 to apply a class warning to the labels of all SGAs and require that practitioners monitor metabolic parameters in patients receiving SGAs, before and after initiating therapy.³
• The consensus statement published by the American Psychiatric Association (APA) and American Diabetes Association (ADA) in February 2004 reviewed the metabolic side-effects literature of SGAs and included guidelines for monitoring the metabolic status of patients at baseline and after initiating treatment, including family history of metabolic disorders, body mass index, waist circumference, blood pressure, fasting glucose, and fasting lipids.^4,5
• The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study⁶ confirmed the APA/ADA findings and indicated that 43% of 1,460 outpatients with schizophrenia met criteria for metabolic syndrome⁷ when they enrolled in the study and the prevalence of metabolic syndrome increased over the duration of the study.⁸
• The CATIE study also reported that a substantial proportion of patients with schizophrenia had no access to primary care and never received standard treatment for hyperlipidemia, hypertension, and diabetes,⁹ prompting an angry Current Psychiatry editorial.¹⁰

And now for the grim facts. It is simply shocking that many practitioners are not monitoring the metabolic status of their patients consistently or at all. A recent systematic review and meta-analysis of 48 published studies showed that clinicians who prescribed antipsychotics are not abiding by guidelines to monitor metabolic risk in their seriously ill psychotic patients.¹¹ The inconsistent monitoring was evident not only in the United States but also in Canada, the United Kingdom, Australia, and Spain. Thirty-nine of those studies were conducted on the pattern of monitoring before any guidelines were published and 9 were conducted after monitoring guidelines were published. All of them were equally dismal in their findings.

The most urgent question is why aren’t practitioners monitoring vulnerable, seriously mentally ill patients to protect them from potential iatrogenic harm? If we don’t do it, who will? Wouldn’t we be outraged if a family member was not receiving standard clinical monitoring for a serious medical condition? The language that the FDA inserted in SGA labels specifically states that intervention is required if hyperglycemia emerges during monitoring, including treatment or switch to a metabolically more benign antipsychotic agent. How can an intervention be implemented if the monitoring is not done in a timely manner?

Persons suffering from psychotic disorders such as schizophrenia are compromised mentally and physically. They rely on us to give them proper treatment and follow-up, driven by evidence as well as compassion and commitment. Our guiding principle is to treat while doing no harm. The potential benefit of antipsychotic pharmacotherapy is widely accepted and the potential harm also is well recognized; published guidelines help protect patients via early detection of metabolic dysregulation. There is absolutely no excuse for failing to provide patients who need antipsychotics with consistent, guideline-based monitoring. No excuses. None.

The vast majority of psychiatrists and psychiatric nurse practitioners in the United States are aware of the following facts:

• The unhealthy lifestyle of persons with chronic psychotic disorders (sedentary living, smoking, poor diet) is conducive to weight gain, metabolic disorders, high cardiovascular risk, and premature mortality. ¹
• Second-generation antipsychotics (SGAs) are associated with metabolic dysregulation, including obesity, diabetes, dyslipidemia, and hypertension.²
• The dramatic increase in diabetes, diabetic ketoacidosis, and death in the late 1990s and early 2000s prompted the FDA in August 2003 to apply a class warning to the labels of all SGAs and require that practitioners monitor metabolic parameters in patients receiving SGAs, before and after initiating therapy.³
• The consensus statement published by the American Psychiatric Association (APA) and American Diabetes Association (ADA) in February 2004 reviewed the metabolic side-effects literature of SGAs and included guidelines for monitoring the metabolic status of patients at baseline and after initiating treatment, including family history of metabolic disorders, body mass index, waist circumference, blood pressure, fasting glucose, and fasting lipids.^4,5
• The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study⁶ confirmed the APA/ADA findings and indicated that 43% of 1,460 outpatients with schizophrenia met criteria for metabolic syndrome⁷ when they enrolled in the study and the prevalence of metabolic syndrome increased over the duration of the study.⁸
• The CATIE study also reported that a substantial proportion of patients with schizophrenia had no access to primary care and never received standard treatment for hyperlipidemia, hypertension, and diabetes,⁹ prompting an angry Current Psychiatry editorial.¹⁰

And now for the grim facts. It is simply shocking that many practitioners are not monitoring the metabolic status of their patients consistently or at all. A recent systematic review and meta-analysis of 48 published studies showed that clinicians who prescribed antipsychotics are not abiding by guidelines to monitor metabolic risk in their seriously ill psychotic patients.¹¹ The inconsistent monitoring was evident not only in the United States but also in Canada, the United Kingdom, Australia, and Spain. Thirty-nine of those studies were conducted on the pattern of monitoring before any guidelines were published and 9 were conducted after monitoring guidelines were published. All of them were equally dismal in their findings.

The most urgent question is why aren’t practitioners monitoring vulnerable, seriously mentally ill patients to protect them from potential iatrogenic harm? If we don’t do it, who will? Wouldn’t we be outraged if a family member was not receiving standard clinical monitoring for a serious medical condition? The language that the FDA inserted in SGA labels specifically states that intervention is required if hyperglycemia emerges during monitoring, including treatment or switch to a metabolically more benign antipsychotic agent. How can an intervention be implemented if the monitoring is not done in a timely manner?

Persons suffering from psychotic disorders such as schizophrenia are compromised mentally and physically. They rely on us to give them proper treatment and follow-up, driven by evidence as well as compassion and commitment. Our guiding principle is to treat while doing no harm. The potential benefit of antipsychotic pharmacotherapy is widely accepted and the potential harm also is well recognized; published guidelines help protect patients via early detection of metabolic dysregulation. There is absolutely no excuse for failing to provide patients who need antipsychotics with consistent, guideline-based monitoring. No excuses. None.

The vast majority of psychiatrists and psychiatric nurse practitioners in the United States are aware of the following facts:

• The unhealthy lifestyle of persons with chronic psychotic disorders (sedentary living, smoking, poor diet) is conducive to weight gain, metabolic disorders, high cardiovascular risk, and premature mortality. ¹
• Second-generation antipsychotics (SGAs) are associated with metabolic dysregulation, including obesity, diabetes, dyslipidemia, and hypertension.²
• The dramatic increase in diabetes, diabetic ketoacidosis, and death in the late 1990s and early 2000s prompted the FDA in August 2003 to apply a class warning to the labels of all SGAs and require that practitioners monitor metabolic parameters in patients receiving SGAs, before and after initiating therapy.³
• The consensus statement published by the American Psychiatric Association (APA) and American Diabetes Association (ADA) in February 2004 reviewed the metabolic side-effects literature of SGAs and included guidelines for monitoring the metabolic status of patients at baseline and after initiating treatment, including family history of metabolic disorders, body mass index, waist circumference, blood pressure, fasting glucose, and fasting lipids.^4,5
• The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study⁶ confirmed the APA/ADA findings and indicated that 43% of 1,460 outpatients with schizophrenia met criteria for metabolic syndrome⁷ when they enrolled in the study and the prevalence of metabolic syndrome increased over the duration of the study.⁸
• The CATIE study also reported that a substantial proportion of patients with schizophrenia had no access to primary care and never received standard treatment for hyperlipidemia, hypertension, and diabetes,⁹ prompting an angry Current Psychiatry editorial.¹⁰

And now for the grim facts. It is simply shocking that many practitioners are not monitoring the metabolic status of their patients consistently or at all. A recent systematic review and meta-analysis of 48 published studies showed that clinicians who prescribed antipsychotics are not abiding by guidelines to monitor metabolic risk in their seriously ill psychotic patients.¹¹ The inconsistent monitoring was evident not only in the United States but also in Canada, the United Kingdom, Australia, and Spain. Thirty-nine of those studies were conducted on the pattern of monitoring before any guidelines were published and 9 were conducted after monitoring guidelines were published. All of them were equally dismal in their findings.

The most urgent question is why aren’t practitioners monitoring vulnerable, seriously mentally ill patients to protect them from potential iatrogenic harm? If we don’t do it, who will? Wouldn’t we be outraged if a family member was not receiving standard clinical monitoring for a serious medical condition? The language that the FDA inserted in SGA labels specifically states that intervention is required if hyperglycemia emerges during monitoring, including treatment or switch to a metabolically more benign antipsychotic agent. How can an intervention be implemented if the monitoring is not done in a timely manner?

Persons suffering from psychotic disorders such as schizophrenia are compromised mentally and physically. They rely on us to give them proper treatment and follow-up, driven by evidence as well as compassion and commitment. Our guiding principle is to treat while doing no harm. The potential benefit of antipsychotic pharmacotherapy is widely accepted and the potential harm also is well recognized; published guidelines help protect patients via early detection of metabolic dysregulation. There is absolutely no excuse for failing to provide patients who need antipsychotics with consistent, guideline-based monitoring. No excuses. None.