Are you monitoring a pregnant patient who had gastric banding or stapling?

There’s a code for that, as of Oct. 1.

Have you seen female genital cutting or mutilation in your practice?

There is a code for that.

Has your patient’s obesity made it difficult to obtain a diagnostic image?

You get the picture.

The new International Diagnostic Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) adds specific codes for these and other disorders.

Cancer codes clinch the case

Specific codes now describe findings that indicate a cancer diagnosis and support appropriate treatment.

Estrogen receptor status

V86.0 Estrogen receptor positive

V86.1 Estrogen receptor negative

The 2007 ICD-9-CM adds a new category: estrogen receptor status. This bit of diagnostic information is an important indicator of the type of treatment to which breast cancer will be responsive. For instance, an estrogen-receptor–positive (ER+) finding means estrogen is causing the tumor to grow. This information in conjunction with a primary diagnosis of malignant neoplasm of the breast (ICD-9-CM codes 174.0–174.9) instantly gives the payer a snapshot of the patient’s condition and supports hormone suppression treatment.

Elevated tumor markers

795.81 Elevated carcinoembryonic antigen [CEA]

795.82 Elevated cancer antigen 125 [CA 125]

795.89 Other abnormal tumor markers

Previously, an elevated CA-125 tumor marker was reported using the unspecified code 790.99 (other nonspecific findings in blood), but with the addition of a new code subcategory, 795.8x, to report elevated tumor-associated and specific antigens, this will no longer be a problem.

Abnormal cervical cytology

795.06 Papanicolaou smear of cervix with cytologic evidence of malignancy

The inclusion term “cytologic evidence of carcinoma” was deleted from code 795.04 (Papanicolaou smear of cervix and cervical HPV). A new code reports this finding, and this new code is now an “excludes” diagnosis under code 233.1 (carcinoma in situ of cervix uteri). Furthermore, code 233.1 has a new inclusion definition: cervical intraepithelial glandular neoplasia.

OB complications

649.xx Other conditions or status of the mother, complicating pregnancy, childbirth, or the puerperium

Preexisting conditions are covered in the new category.

Bariatric surgery and pregnancy

649.2X Bariatric surgery status complicating pregnancy, childbirth, or the puerperium

Until now, if you were monitoring a pregnant woman more closely because of her previous bariatric surgery, your only option was code 648.93 (other current conditions, classifiable elsewhere). The new code is for any intervention required during the pregnancy, if the mother has had obesity surgery such as gastric banding or gastric stapling.

A 5th digit must be appended: 0, unspecified episode of care; 1, delivered with or without mention of antepartum condition; 2, delivered with postpartum condition; 3, antepartum condition or complication; 4, postpartum complication.

Smoking, obesity, epilepsy, and more

649.0 [0–4] Tobacco use disorder

You must clearly indicate that the patient’s current smoking is complicating the management of her pregnancy.

649.1 [0–4] Obesity

A secondary code for type of obesity is required; for instance, 278.01 (morbid obesity).

649.3 [0–4] Coagulation defects

A second code from the 286 category (coagulation defects) must be added to identify the exact condition. If a coagulation defect causes antepartum hemorrhage, the correct code is 641.3x. A coagulation defect that appears only in the postpartum period is coded 666.3x.

649.4 [0–4] Epilepsy

A secondary code identifies the type of epilepsy (345.00–345.91). However, if the patient has eclampsia, use the code 642.6 (eclampsia with convulsions).

649.5 [0, 1, 3] Spotting

This code will be used predominately in early pregnancy when spotting is the chief complaint and there is no evidence of miscarriage. Note that the allowable 5th digits for this code exclude 2 and 4, because spotting is not considered a complication in the postpartum period. If the patient is bleeding heavily, other existing codes would be selected, such as 640.0x (threatened abortion) or 641.1x (hemorrhage from placenta previa).

649.6 [0–4] Uterine size-date discrepancy

This condition, which was formerly included under 646.8x (other specified complications of pregnancy), is used most often when an ultrasound is performed to date the pregnancy, especially when the last monthly period is unknown.

666.1x Other immediate postpartum hemorrhage

This code is revised, and now specifies uterine atony with hemorrhage. Uterine atony without hemorrhage is coded 669.8x.

More specific “other” codes

Several “other”-type codes for gynecologic conditions got more specific. For example, 2 new, more specific, 5-digit codes replace code 616.8 (other specified inflammatory diseases of cervix, vagina, and vulva).

 

616.81 Mucositis (ulcerative) of the cervix, vagina, and vulva

Requires an additional E code to identify the adverse affects of therapy that caused the mucositis, such as antineoplastic or immunosuppressive drugs or radiation therapy.

616.89 Other inflammatory disease of the cervix, vagina, and vulva

Identifies conditions such as a caruncle of the vagina or labium or ulcer of the vagina.

616.84 Cervical stump prolapse

Previously was reported with the code 618.39 (other specified genital prolapse).

629.29 Other types of female genital mutilation

This code includes female genital cutting or mutilation Type IV status, the collective term for other types of mutilation that can include such things as pricking the clitoris with needles, burning or scarring the genitals, and ripping or tearing the vagina.

Code 629.8 (other specified disorders of female genital organs) was deleted and replaced by these 2 new 5-digit codes:

629.81 Habitual aborter without current pregnancy

629.89 Other unspecified disorders of female genital organs

Index changes to ICD-9-CM are also important to note. This year the reference for vaginal intraepithelial neoplasia (VIN I and VIN II) was changed from code 624.8 (other specified noninflammatory disorders of vulva and perineum) to:

624.0 Dystrophy of vulva

New category: Pain control

338 Pain, not elsewhere classified

338.18 Other acute postoperative pain

338.28 Other chronic postoperative pain

338.3 Neoplasm-related pain (acute) (chronic)

Diagnostic coding just got easier if your practice includes insertion of an On-Q device for postoperative pain. A whole new category of codes groups pain into acute and chronic classifications and includes codes for both types of postoperative pain. These new codes would not be used to report generalized pain (780.96) or localized pain by site (eg, pelvic pain, 625.9), or pain disorders attributed to psychological factors. Listed above are some of the new codes in this category that may be of particular interest to ObGyns.

Imaging

Breast calcifications

793.81 Microcalcifications seen on a mammogram

793.89 Other abnormal findings on radiological examination of breast

ICD-9-CM now differentiates microcalcifications. The less-specific code is for findings documented as simply mammographic calcification or mammographic calculus.

Inconclusive imaging due to obesity

793.91 Image test inconclusive due to excess body fat

You must add a second code indicating the patient’s body mass index (BMI).

Other imaging abnormalities

793.99 Other nonspecific abnormal findings on radiological and other examination of body structure

This code could be reported for such things as an abnormal placental finding on ultrasound or an abnormal finding in the skin or subcutaneous tissue, where a more definitive diagnosis is not available.

Urinary symptoms

Additions to your diagnostic arsenal:

788.64 Urinary hesitancy

788.65 Straining on urination

Hyperglycemia

A new inclusion term is added

790.29 Other abnormal glucose

The existing code now includes a diagnosis of hyperglycemia not elsewhere specified.

V-codes for men

V26.34 Testing of male for genetic disease carrier status

V26.35 Encounter for testing of male partner of habitual aborter

V26.39 Other genetic testing of male

Use these new codes to identify the male as the reason for doing the testing—something that has been lacking for years.

Are you monitoring a pregnant patient who had gastric banding or stapling?

There’s a code for that, as of Oct. 1.

Have you seen female genital cutting or mutilation in your practice?

There is a code for that.

Has your patient’s obesity made it difficult to obtain a diagnostic image?

You get the picture.

The new International Diagnostic Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) adds specific codes for these and other disorders.

Cancer codes clinch the case

Specific codes now describe findings that indicate a cancer diagnosis and support appropriate treatment.

Estrogen receptor status

V86.0 Estrogen receptor positive

V86.1 Estrogen receptor negative

The 2007 ICD-9-CM adds a new category: estrogen receptor status. This bit of diagnostic information is an important indicator of the type of treatment to which breast cancer will be responsive. For instance, an estrogen-receptor–positive (ER+) finding means estrogen is causing the tumor to grow. This information in conjunction with a primary diagnosis of malignant neoplasm of the breast (ICD-9-CM codes 174.0–174.9) instantly gives the payer a snapshot of the patient’s condition and supports hormone suppression treatment.

Elevated tumor markers

795.81 Elevated carcinoembryonic antigen [CEA]

795.82 Elevated cancer antigen 125 [CA 125]

795.89 Other abnormal tumor markers

Previously, an elevated CA-125 tumor marker was reported using the unspecified code 790.99 (other nonspecific findings in blood), but with the addition of a new code subcategory, 795.8x, to report elevated tumor-associated and specific antigens, this will no longer be a problem.

Abnormal cervical cytology

795.06 Papanicolaou smear of cervix with cytologic evidence of malignancy

The inclusion term “cytologic evidence of carcinoma” was deleted from code 795.04 (Papanicolaou smear of cervix and cervical HPV). A new code reports this finding, and this new code is now an “excludes” diagnosis under code 233.1 (carcinoma in situ of cervix uteri). Furthermore, code 233.1 has a new inclusion definition: cervical intraepithelial glandular neoplasia.

OB complications

649.xx Other conditions or status of the mother, complicating pregnancy, childbirth, or the puerperium

Preexisting conditions are covered in the new category.

Bariatric surgery and pregnancy

649.2X Bariatric surgery status complicating pregnancy, childbirth, or the puerperium

Until now, if you were monitoring a pregnant woman more closely because of her previous bariatric surgery, your only option was code 648.93 (other current conditions, classifiable elsewhere). The new code is for any intervention required during the pregnancy, if the mother has had obesity surgery such as gastric banding or gastric stapling.

A 5th digit must be appended: 0, unspecified episode of care; 1, delivered with or without mention of antepartum condition; 2, delivered with postpartum condition; 3, antepartum condition or complication; 4, postpartum complication.

Smoking, obesity, epilepsy, and more

649.0 [0–4] Tobacco use disorder

You must clearly indicate that the patient’s current smoking is complicating the management of her pregnancy.

649.1 [0–4] Obesity

A secondary code for type of obesity is required; for instance, 278.01 (morbid obesity).

649.3 [0–4] Coagulation defects

A second code from the 286 category (coagulation defects) must be added to identify the exact condition. If a coagulation defect causes antepartum hemorrhage, the correct code is 641.3x. A coagulation defect that appears only in the postpartum period is coded 666.3x.

649.4 [0–4] Epilepsy

A secondary code identifies the type of epilepsy (345.00–345.91). However, if the patient has eclampsia, use the code 642.6 (eclampsia with convulsions).

649.5 [0, 1, 3] Spotting

This code will be used predominately in early pregnancy when spotting is the chief complaint and there is no evidence of miscarriage. Note that the allowable 5th digits for this code exclude 2 and 4, because spotting is not considered a complication in the postpartum period. If the patient is bleeding heavily, other existing codes would be selected, such as 640.0x (threatened abortion) or 641.1x (hemorrhage from placenta previa).

649.6 [0–4] Uterine size-date discrepancy

This condition, which was formerly included under 646.8x (other specified complications of pregnancy), is used most often when an ultrasound is performed to date the pregnancy, especially when the last monthly period is unknown.

666.1x Other immediate postpartum hemorrhage

This code is revised, and now specifies uterine atony with hemorrhage. Uterine atony without hemorrhage is coded 669.8x.

More specific “other” codes

Several “other”-type codes for gynecologic conditions got more specific. For example, 2 new, more specific, 5-digit codes replace code 616.8 (other specified inflammatory diseases of cervix, vagina, and vulva).

 

616.81 Mucositis (ulcerative) of the cervix, vagina, and vulva

Requires an additional E code to identify the adverse affects of therapy that caused the mucositis, such as antineoplastic or immunosuppressive drugs or radiation therapy.

616.89 Other inflammatory disease of the cervix, vagina, and vulva

Identifies conditions such as a caruncle of the vagina or labium or ulcer of the vagina.

616.84 Cervical stump prolapse

Previously was reported with the code 618.39 (other specified genital prolapse).

629.29 Other types of female genital mutilation

This code includes female genital cutting or mutilation Type IV status, the collective term for other types of mutilation that can include such things as pricking the clitoris with needles, burning or scarring the genitals, and ripping or tearing the vagina.

Code 629.8 (other specified disorders of female genital organs) was deleted and replaced by these 2 new 5-digit codes:

629.81 Habitual aborter without current pregnancy

629.89 Other unspecified disorders of female genital organs

Index changes to ICD-9-CM are also important to note. This year the reference for vaginal intraepithelial neoplasia (VIN I and VIN II) was changed from code 624.8 (other specified noninflammatory disorders of vulva and perineum) to:

624.0 Dystrophy of vulva

New category: Pain control

338 Pain, not elsewhere classified

338.18 Other acute postoperative pain

338.28 Other chronic postoperative pain

338.3 Neoplasm-related pain (acute) (chronic)

Diagnostic coding just got easier if your practice includes insertion of an On-Q device for postoperative pain. A whole new category of codes groups pain into acute and chronic classifications and includes codes for both types of postoperative pain. These new codes would not be used to report generalized pain (780.96) or localized pain by site (eg, pelvic pain, 625.9), or pain disorders attributed to psychological factors. Listed above are some of the new codes in this category that may be of particular interest to ObGyns.

Imaging

Breast calcifications

793.81 Microcalcifications seen on a mammogram

793.89 Other abnormal findings on radiological examination of breast

ICD-9-CM now differentiates microcalcifications. The less-specific code is for findings documented as simply mammographic calcification or mammographic calculus.

Inconclusive imaging due to obesity

793.91 Image test inconclusive due to excess body fat

You must add a second code indicating the patient’s body mass index (BMI).

Other imaging abnormalities

793.99 Other nonspecific abnormal findings on radiological and other examination of body structure

This code could be reported for such things as an abnormal placental finding on ultrasound or an abnormal finding in the skin or subcutaneous tissue, where a more definitive diagnosis is not available.

Urinary symptoms

Additions to your diagnostic arsenal:

788.64 Urinary hesitancy

788.65 Straining on urination

Hyperglycemia

A new inclusion term is added

790.29 Other abnormal glucose

The existing code now includes a diagnosis of hyperglycemia not elsewhere specified.

V-codes for men

V26.34 Testing of male for genetic disease carrier status

V26.35 Encounter for testing of male partner of habitual aborter

V26.39 Other genetic testing of male

Use these new codes to identify the male as the reason for doing the testing—something that has been lacking for years.

Are you monitoring a pregnant patient who had gastric banding or stapling?

There’s a code for that, as of Oct. 1.

Have you seen female genital cutting or mutilation in your practice?

There is a code for that.

Has your patient’s obesity made it difficult to obtain a diagnostic image?

You get the picture.

The new International Diagnostic Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) adds specific codes for these and other disorders.

Cancer codes clinch the case

Specific codes now describe findings that indicate a cancer diagnosis and support appropriate treatment.

Estrogen receptor status

V86.0 Estrogen receptor positive

V86.1 Estrogen receptor negative

The 2007 ICD-9-CM adds a new category: estrogen receptor status. This bit of diagnostic information is an important indicator of the type of treatment to which breast cancer will be responsive. For instance, an estrogen-receptor–positive (ER+) finding means estrogen is causing the tumor to grow. This information in conjunction with a primary diagnosis of malignant neoplasm of the breast (ICD-9-CM codes 174.0–174.9) instantly gives the payer a snapshot of the patient’s condition and supports hormone suppression treatment.

Elevated tumor markers

795.81 Elevated carcinoembryonic antigen [CEA]

795.82 Elevated cancer antigen 125 [CA 125]

795.89 Other abnormal tumor markers

Previously, an elevated CA-125 tumor marker was reported using the unspecified code 790.99 (other nonspecific findings in blood), but with the addition of a new code subcategory, 795.8x, to report elevated tumor-associated and specific antigens, this will no longer be a problem.

Abnormal cervical cytology

795.06 Papanicolaou smear of cervix with cytologic evidence of malignancy

The inclusion term “cytologic evidence of carcinoma” was deleted from code 795.04 (Papanicolaou smear of cervix and cervical HPV). A new code reports this finding, and this new code is now an “excludes” diagnosis under code 233.1 (carcinoma in situ of cervix uteri). Furthermore, code 233.1 has a new inclusion definition: cervical intraepithelial glandular neoplasia.

OB complications

649.xx Other conditions or status of the mother, complicating pregnancy, childbirth, or the puerperium

Preexisting conditions are covered in the new category.

Bariatric surgery and pregnancy

649.2X Bariatric surgery status complicating pregnancy, childbirth, or the puerperium

Until now, if you were monitoring a pregnant woman more closely because of her previous bariatric surgery, your only option was code 648.93 (other current conditions, classifiable elsewhere). The new code is for any intervention required during the pregnancy, if the mother has had obesity surgery such as gastric banding or gastric stapling.

A 5th digit must be appended: 0, unspecified episode of care; 1, delivered with or without mention of antepartum condition; 2, delivered with postpartum condition; 3, antepartum condition or complication; 4, postpartum complication.

Smoking, obesity, epilepsy, and more

649.0 [0–4] Tobacco use disorder

You must clearly indicate that the patient’s current smoking is complicating the management of her pregnancy.

649.1 [0–4] Obesity

A secondary code for type of obesity is required; for instance, 278.01 (morbid obesity).

649.3 [0–4] Coagulation defects

A second code from the 286 category (coagulation defects) must be added to identify the exact condition. If a coagulation defect causes antepartum hemorrhage, the correct code is 641.3x. A coagulation defect that appears only in the postpartum period is coded 666.3x.

649.4 [0–4] Epilepsy

A secondary code identifies the type of epilepsy (345.00–345.91). However, if the patient has eclampsia, use the code 642.6 (eclampsia with convulsions).

649.5 [0, 1, 3] Spotting

This code will be used predominately in early pregnancy when spotting is the chief complaint and there is no evidence of miscarriage. Note that the allowable 5th digits for this code exclude 2 and 4, because spotting is not considered a complication in the postpartum period. If the patient is bleeding heavily, other existing codes would be selected, such as 640.0x (threatened abortion) or 641.1x (hemorrhage from placenta previa).

649.6 [0–4] Uterine size-date discrepancy

This condition, which was formerly included under 646.8x (other specified complications of pregnancy), is used most often when an ultrasound is performed to date the pregnancy, especially when the last monthly period is unknown.

666.1x Other immediate postpartum hemorrhage

This code is revised, and now specifies uterine atony with hemorrhage. Uterine atony without hemorrhage is coded 669.8x.

More specific “other” codes

Several “other”-type codes for gynecologic conditions got more specific. For example, 2 new, more specific, 5-digit codes replace code 616.8 (other specified inflammatory diseases of cervix, vagina, and vulva).

 

616.81 Mucositis (ulcerative) of the cervix, vagina, and vulva

Requires an additional E code to identify the adverse affects of therapy that caused the mucositis, such as antineoplastic or immunosuppressive drugs or radiation therapy.

616.89 Other inflammatory disease of the cervix, vagina, and vulva

Identifies conditions such as a caruncle of the vagina or labium or ulcer of the vagina.

616.84 Cervical stump prolapse

Previously was reported with the code 618.39 (other specified genital prolapse).

629.29 Other types of female genital mutilation

This code includes female genital cutting or mutilation Type IV status, the collective term for other types of mutilation that can include such things as pricking the clitoris with needles, burning or scarring the genitals, and ripping or tearing the vagina.

Code 629.8 (other specified disorders of female genital organs) was deleted and replaced by these 2 new 5-digit codes:

629.81 Habitual aborter without current pregnancy

629.89 Other unspecified disorders of female genital organs

Index changes to ICD-9-CM are also important to note. This year the reference for vaginal intraepithelial neoplasia (VIN I and VIN II) was changed from code 624.8 (other specified noninflammatory disorders of vulva and perineum) to:

624.0 Dystrophy of vulva

New category: Pain control

338 Pain, not elsewhere classified

338.18 Other acute postoperative pain

338.28 Other chronic postoperative pain

338.3 Neoplasm-related pain (acute) (chronic)

Diagnostic coding just got easier if your practice includes insertion of an On-Q device for postoperative pain. A whole new category of codes groups pain into acute and chronic classifications and includes codes for both types of postoperative pain. These new codes would not be used to report generalized pain (780.96) or localized pain by site (eg, pelvic pain, 625.9), or pain disorders attributed to psychological factors. Listed above are some of the new codes in this category that may be of particular interest to ObGyns.

Imaging

Breast calcifications

793.81 Microcalcifications seen on a mammogram

793.89 Other abnormal findings on radiological examination of breast

ICD-9-CM now differentiates microcalcifications. The less-specific code is for findings documented as simply mammographic calcification or mammographic calculus.

Inconclusive imaging due to obesity

793.91 Image test inconclusive due to excess body fat

You must add a second code indicating the patient’s body mass index (BMI).

Other imaging abnormalities

793.99 Other nonspecific abnormal findings on radiological and other examination of body structure

This code could be reported for such things as an abnormal placental finding on ultrasound or an abnormal finding in the skin or subcutaneous tissue, where a more definitive diagnosis is not available.

Urinary symptoms

Additions to your diagnostic arsenal:

788.64 Urinary hesitancy

788.65 Straining on urination

Hyperglycemia

A new inclusion term is added

790.29 Other abnormal glucose

The existing code now includes a diagnosis of hyperglycemia not elsewhere specified.

V-codes for men

V26.34 Testing of male for genetic disease carrier status

V26.35 Encounter for testing of male partner of habitual aborter

V26.39 Other genetic testing of male

Use these new codes to identify the male as the reason for doing the testing—something that has been lacking for years.

Did benzodiazepines prescribed to patient
with addiction cause delirium?

Maricopa County (AZ) Superior Court

A 40-year-old woman addicted to diazepam sought treatment from a psychiatric nurse who performed a psychological evaluation. The patient claimed that the nurse negligently prescribed benzodiazepines and other medications for anxiety, panic attacks, and depression.

The patient claimed that the prescriptions caused a drug-induced delirium, during which she put a nonlethal amount of the medication on her two minor daughters’ ice cream, then attempted suicide by overdosing with her prescriptions. The patient and her daughters survived.

The patient was charged with two counts of attempted murder and was incarcerated for 18 months while awaiting trail. She was acquitted of the charges but lost custody of her daughters.

The psychiatric nurse argued that the medication prescribed was appropriate and the patient was not in a drug-induced delirium when she tried to kill herself and her daughters. The defense alleged that other factors caused the patient to attempt suicide/homicide, including a pending divorce and financial problems.

• A defense verdict was returned
  

Woman claims she was prescribed narcotics
despite alprazolam addiction

Multnomah County (OR) Superior Court

The patient, age 57, began seeing a psychiatrist in March 1993 for anxiety and panic attacks. She had kicked a 10-year alprazolam addiction and had been drug-free for more than 6 months when she first visited the psychiatrist.

The patient claimed that over the next 11 years she developed an intimate friendship with the psychiatrist. The patient visited the psychiatrist’s office almost weekly—sometimes twice a week—and incurred almost $100,000 in fees. The patient says that the psychiatrist prescribed her narcotics, then sought the drugs from her for his personal use, and was negligent in his treatment.

• A $593,000 verdict was returned, which included $200,000 in punitive damages
  

Box 1

Dr. Grant’s observations

Should benzodiazepines or other addictive substances be prescribed to a patient with a history of substance abuse? Little evidence guides clinicians,^1,2 and limited research has examined whether former substance abusers are more likely than other patients to abuse benzodiazepines or if these medications increase the risk of substance abuse relapse.²

A psychiatrist can prescribe medication whenever a medical basis exists. In the first case a patient with anxiety and panic attacks was given benzodiazepines, an appropriate treatment for anxiety disorder.³ But what if the patient has a history of substance abuse? When is prescribing these medications negligent?

The fiduciary relationship between psychiatrist and patient states that the therapist is the patient’s ally and should always act in the patient’s best interest. With limited data, clinicians have no clear rule for a standard of care.

On one hand, benzodiazepine misuse is a problem and these medications must be prescribed cautiously. In 2004 roughly 300,000 Americans reported using prescription sedatives for nonmedical purposes.⁴ Many addiction specialists believe benzodiazepines are contraindicated for patients with current alcohol or drug abuse problems and for those in recovery. In this scenario, the clinician could choose an appropriate alternative to a benzodiazepine such as an antidepressant, buspirone, beta blocker, or anticonvulsant. Explain to the patient that these medications’ clinical effect is slower than that of benzodiazepines. Also consider psychotherapy to address anxiety.

On the other hand, benzodiazepines might be underused because of fear of addiction.⁵ Clinicians must consider whether their prescribing practices are designed to protect themselves or are in the patients’ best interests (Box 1). Of course, when treating a patient with a benzodiazepine addiction, the risk-benefit analysis shifts and abuse concerns may be more appropriate.

In the first case, the patient attempted suicide by overdosing on the prescribed medication. This fact might support the patient’s argument that she was not an appropriate candidate for benzodiazepines and the psychiatric nurse could be held liable—even though in this case she was not. One court found that a psychiatrist writing prescriptions for large amounts of controlled substances to someone addicted to drugs could be held liable for the patient’s suicide.⁶

 

In the second case, a psychiatrist prescribed narcotics to a patient with a history of addiction. The code of medical ethics is clear: A psychiatrist who regularly practices outside his or her area of professional competence should be considered as having acted in an unethical manner.⁷ So if you wish to prescribe narcotics, you must follow internal medicine’s ethical standards (Box 2).

Responsibility of care

Although the nurse in the first case could be liable for her actions, the psychiatrist who supervised the nurse might also be partially responsible. The law assumes that those who work under a physician’s supervision act as his or her agents. Nurses working for a physician are the physician’s agents, and the physician is responsible for a nurse’s acts. This legal principle is respondeat superior, or “let the master reply.”

Generally, the physician’s lack of knowledge about what the nurse prescribes is not a defense for a malpractice claim. In fact, the law requires that the physician know whether his or her agents meet the profession’s standard of care. In cases where a nurse prescribes an inappropriate medication, the psychiatrist can be charged with negligent supervision—that is, failing to provide to the nurse proper guidance and instruction.

Ethical conduct

Relationships with patients. The second case raises several egregious issues in patient care. Although intimate relationships with patients are prohibited, the fact that these cases still come before licensing boards and courts suggests that physicians are not getting the message. Although the report of this case is vague about what “intimate” means, several points are raised:

• Sexual relationships with current or former patients are not allowed.⁷ A patient is vulnerable, and the power differential makes it difficult for the patient to resist the therapist’s requests.
  
• Nonsexual, intimate relationships likely would be seen as a boundary violation, akin to a sexual relationship. In the case presented, the boundary violation is obvious even though the relationship may not have been sexual.
  

Box 2

Inappropriate prescribing. There is no justification for a physician seeking drugs from a patient for personal use, as was reported in the second case. Interestingly, one study found that 17.6% of physicians had used opioids in the past year in an unsupervised fashion.¹⁰

Medical ethics prohibit this behavior and state that psychiatrists should not:⁷

• use the unique position afforded by the psychotherapeutic situation to influence the patient in any way that is not directly relevant to treatment goals
  
• exploit information furnished by patients.
  

In this case, the psychiatrist could face federal and state criminal charges because of his use of a patient’s narcotics and inappropriate prescribing.

State medical boards have varying procedures in place to handle a physician’s substance abuse.

These programs’ goal is to assist recovery, eliminate risk to the public, and allow the physician to return to work. Clinicians should be aware of such programs in their jurisdictions.

Drug brand names

• Alprazolam • Xanax
  
• Buspirone • BuSpar
  
• Diazepam • Valium
  

Did benzodiazepines prescribed to patient
with addiction cause delirium?

Maricopa County (AZ) Superior Court

A 40-year-old woman addicted to diazepam sought treatment from a psychiatric nurse who performed a psychological evaluation. The patient claimed that the nurse negligently prescribed benzodiazepines and other medications for anxiety, panic attacks, and depression.

The patient claimed that the prescriptions caused a drug-induced delirium, during which she put a nonlethal amount of the medication on her two minor daughters’ ice cream, then attempted suicide by overdosing with her prescriptions. The patient and her daughters survived.

The patient was charged with two counts of attempted murder and was incarcerated for 18 months while awaiting trail. She was acquitted of the charges but lost custody of her daughters.

The psychiatric nurse argued that the medication prescribed was appropriate and the patient was not in a drug-induced delirium when she tried to kill herself and her daughters. The defense alleged that other factors caused the patient to attempt suicide/homicide, including a pending divorce and financial problems.

• A defense verdict was returned
  

Woman claims she was prescribed narcotics
despite alprazolam addiction

Multnomah County (OR) Superior Court

The patient, age 57, began seeing a psychiatrist in March 1993 for anxiety and panic attacks. She had kicked a 10-year alprazolam addiction and had been drug-free for more than 6 months when she first visited the psychiatrist.

The patient claimed that over the next 11 years she developed an intimate friendship with the psychiatrist. The patient visited the psychiatrist’s office almost weekly—sometimes twice a week—and incurred almost $100,000 in fees. The patient says that the psychiatrist prescribed her narcotics, then sought the drugs from her for his personal use, and was negligent in his treatment.

• A $593,000 verdict was returned, which included $200,000 in punitive damages
  

Box 1

Dr. Grant’s observations

Should benzodiazepines or other addictive substances be prescribed to a patient with a history of substance abuse? Little evidence guides clinicians,^1,2 and limited research has examined whether former substance abusers are more likely than other patients to abuse benzodiazepines or if these medications increase the risk of substance abuse relapse.²

A psychiatrist can prescribe medication whenever a medical basis exists. In the first case a patient with anxiety and panic attacks was given benzodiazepines, an appropriate treatment for anxiety disorder.³ But what if the patient has a history of substance abuse? When is prescribing these medications negligent?

The fiduciary relationship between psychiatrist and patient states that the therapist is the patient’s ally and should always act in the patient’s best interest. With limited data, clinicians have no clear rule for a standard of care.

On one hand, benzodiazepine misuse is a problem and these medications must be prescribed cautiously. In 2004 roughly 300,000 Americans reported using prescription sedatives for nonmedical purposes.⁴ Many addiction specialists believe benzodiazepines are contraindicated for patients with current alcohol or drug abuse problems and for those in recovery. In this scenario, the clinician could choose an appropriate alternative to a benzodiazepine such as an antidepressant, buspirone, beta blocker, or anticonvulsant. Explain to the patient that these medications’ clinical effect is slower than that of benzodiazepines. Also consider psychotherapy to address anxiety.

On the other hand, benzodiazepines might be underused because of fear of addiction.⁵ Clinicians must consider whether their prescribing practices are designed to protect themselves or are in the patients’ best interests (Box 1). Of course, when treating a patient with a benzodiazepine addiction, the risk-benefit analysis shifts and abuse concerns may be more appropriate.

In the first case, the patient attempted suicide by overdosing on the prescribed medication. This fact might support the patient’s argument that she was not an appropriate candidate for benzodiazepines and the psychiatric nurse could be held liable—even though in this case she was not. One court found that a psychiatrist writing prescriptions for large amounts of controlled substances to someone addicted to drugs could be held liable for the patient’s suicide.⁶

 

In the second case, a psychiatrist prescribed narcotics to a patient with a history of addiction. The code of medical ethics is clear: A psychiatrist who regularly practices outside his or her area of professional competence should be considered as having acted in an unethical manner.⁷ So if you wish to prescribe narcotics, you must follow internal medicine’s ethical standards (Box 2).

Responsibility of care

Although the nurse in the first case could be liable for her actions, the psychiatrist who supervised the nurse might also be partially responsible. The law assumes that those who work under a physician’s supervision act as his or her agents. Nurses working for a physician are the physician’s agents, and the physician is responsible for a nurse’s acts. This legal principle is respondeat superior, or “let the master reply.”

Generally, the physician’s lack of knowledge about what the nurse prescribes is not a defense for a malpractice claim. In fact, the law requires that the physician know whether his or her agents meet the profession’s standard of care. In cases where a nurse prescribes an inappropriate medication, the psychiatrist can be charged with negligent supervision—that is, failing to provide to the nurse proper guidance and instruction.

Ethical conduct

Relationships with patients. The second case raises several egregious issues in patient care. Although intimate relationships with patients are prohibited, the fact that these cases still come before licensing boards and courts suggests that physicians are not getting the message. Although the report of this case is vague about what “intimate” means, several points are raised:

• Sexual relationships with current or former patients are not allowed.⁷ A patient is vulnerable, and the power differential makes it difficult for the patient to resist the therapist’s requests.
  
• Nonsexual, intimate relationships likely would be seen as a boundary violation, akin to a sexual relationship. In the case presented, the boundary violation is obvious even though the relationship may not have been sexual.
  

Box 2

Inappropriate prescribing. There is no justification for a physician seeking drugs from a patient for personal use, as was reported in the second case. Interestingly, one study found that 17.6% of physicians had used opioids in the past year in an unsupervised fashion.¹⁰

Medical ethics prohibit this behavior and state that psychiatrists should not:⁷

• use the unique position afforded by the psychotherapeutic situation to influence the patient in any way that is not directly relevant to treatment goals
  
• exploit information furnished by patients.
  

In this case, the psychiatrist could face federal and state criminal charges because of his use of a patient’s narcotics and inappropriate prescribing.

State medical boards have varying procedures in place to handle a physician’s substance abuse.

These programs’ goal is to assist recovery, eliminate risk to the public, and allow the physician to return to work. Clinicians should be aware of such programs in their jurisdictions.

Drug brand names

• Alprazolam • Xanax
  
• Buspirone • BuSpar
  
• Diazepam • Valium
  

Did benzodiazepines prescribed to patient
with addiction cause delirium?

Maricopa County (AZ) Superior Court

A 40-year-old woman addicted to diazepam sought treatment from a psychiatric nurse who performed a psychological evaluation. The patient claimed that the nurse negligently prescribed benzodiazepines and other medications for anxiety, panic attacks, and depression.

The patient claimed that the prescriptions caused a drug-induced delirium, during which she put a nonlethal amount of the medication on her two minor daughters’ ice cream, then attempted suicide by overdosing with her prescriptions. The patient and her daughters survived.

The patient was charged with two counts of attempted murder and was incarcerated for 18 months while awaiting trail. She was acquitted of the charges but lost custody of her daughters.

The psychiatric nurse argued that the medication prescribed was appropriate and the patient was not in a drug-induced delirium when she tried to kill herself and her daughters. The defense alleged that other factors caused the patient to attempt suicide/homicide, including a pending divorce and financial problems.

• A defense verdict was returned
  

Woman claims she was prescribed narcotics
despite alprazolam addiction

Multnomah County (OR) Superior Court

The patient, age 57, began seeing a psychiatrist in March 1993 for anxiety and panic attacks. She had kicked a 10-year alprazolam addiction and had been drug-free for more than 6 months when she first visited the psychiatrist.

The patient claimed that over the next 11 years she developed an intimate friendship with the psychiatrist. The patient visited the psychiatrist’s office almost weekly—sometimes twice a week—and incurred almost $100,000 in fees. The patient says that the psychiatrist prescribed her narcotics, then sought the drugs from her for his personal use, and was negligent in his treatment.

• A $593,000 verdict was returned, which included $200,000 in punitive damages
  

Box 1

Dr. Grant’s observations

Should benzodiazepines or other addictive substances be prescribed to a patient with a history of substance abuse? Little evidence guides clinicians,^1,2 and limited research has examined whether former substance abusers are more likely than other patients to abuse benzodiazepines or if these medications increase the risk of substance abuse relapse.²

A psychiatrist can prescribe medication whenever a medical basis exists. In the first case a patient with anxiety and panic attacks was given benzodiazepines, an appropriate treatment for anxiety disorder.³ But what if the patient has a history of substance abuse? When is prescribing these medications negligent?

The fiduciary relationship between psychiatrist and patient states that the therapist is the patient’s ally and should always act in the patient’s best interest. With limited data, clinicians have no clear rule for a standard of care.

On one hand, benzodiazepine misuse is a problem and these medications must be prescribed cautiously. In 2004 roughly 300,000 Americans reported using prescription sedatives for nonmedical purposes.⁴ Many addiction specialists believe benzodiazepines are contraindicated for patients with current alcohol or drug abuse problems and for those in recovery. In this scenario, the clinician could choose an appropriate alternative to a benzodiazepine such as an antidepressant, buspirone, beta blocker, or anticonvulsant. Explain to the patient that these medications’ clinical effect is slower than that of benzodiazepines. Also consider psychotherapy to address anxiety.

On the other hand, benzodiazepines might be underused because of fear of addiction.⁵ Clinicians must consider whether their prescribing practices are designed to protect themselves or are in the patients’ best interests (Box 1). Of course, when treating a patient with a benzodiazepine addiction, the risk-benefit analysis shifts and abuse concerns may be more appropriate.

In the first case, the patient attempted suicide by overdosing on the prescribed medication. This fact might support the patient’s argument that she was not an appropriate candidate for benzodiazepines and the psychiatric nurse could be held liable—even though in this case she was not. One court found that a psychiatrist writing prescriptions for large amounts of controlled substances to someone addicted to drugs could be held liable for the patient’s suicide.⁶

 

In the second case, a psychiatrist prescribed narcotics to a patient with a history of addiction. The code of medical ethics is clear: A psychiatrist who regularly practices outside his or her area of professional competence should be considered as having acted in an unethical manner.⁷ So if you wish to prescribe narcotics, you must follow internal medicine’s ethical standards (Box 2).

Responsibility of care

Although the nurse in the first case could be liable for her actions, the psychiatrist who supervised the nurse might also be partially responsible. The law assumes that those who work under a physician’s supervision act as his or her agents. Nurses working for a physician are the physician’s agents, and the physician is responsible for a nurse’s acts. This legal principle is respondeat superior, or “let the master reply.”

Generally, the physician’s lack of knowledge about what the nurse prescribes is not a defense for a malpractice claim. In fact, the law requires that the physician know whether his or her agents meet the profession’s standard of care. In cases where a nurse prescribes an inappropriate medication, the psychiatrist can be charged with negligent supervision—that is, failing to provide to the nurse proper guidance and instruction.

Ethical conduct

Relationships with patients. The second case raises several egregious issues in patient care. Although intimate relationships with patients are prohibited, the fact that these cases still come before licensing boards and courts suggests that physicians are not getting the message. Although the report of this case is vague about what “intimate” means, several points are raised:

• Sexual relationships with current or former patients are not allowed.⁷ A patient is vulnerable, and the power differential makes it difficult for the patient to resist the therapist’s requests.
  
• Nonsexual, intimate relationships likely would be seen as a boundary violation, akin to a sexual relationship. In the case presented, the boundary violation is obvious even though the relationship may not have been sexual.
  

Box 2

Inappropriate prescribing. There is no justification for a physician seeking drugs from a patient for personal use, as was reported in the second case. Interestingly, one study found that 17.6% of physicians had used opioids in the past year in an unsupervised fashion.¹⁰

Medical ethics prohibit this behavior and state that psychiatrists should not:⁷

• use the unique position afforded by the psychotherapeutic situation to influence the patient in any way that is not directly relevant to treatment goals
  
• exploit information furnished by patients.
  

In this case, the psychiatrist could face federal and state criminal charges because of his use of a patient’s narcotics and inappropriate prescribing.

State medical boards have varying procedures in place to handle a physician’s substance abuse.

These programs’ goal is to assist recovery, eliminate risk to the public, and allow the physician to return to work. Clinicians should be aware of such programs in their jurisdictions.

Drug brand names

• Alprazolam • Xanax
  
• Buspirone • BuSpar
  
• Diazepam • Valium
  

In August the FDA called for new warnings on stimulants used for attention-deficit/hyperactivity disorder (ADHD). Amphetamines now carry black box warnings that say, “Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events.” Amphetamines and methylphenidates used for ADHD include expanded information about cardiovascular risks at usual dosages for patients with heart conditions.

To examine the clinical implications of these warnings, Current Psychiatry hosted a conversation between ADHD experts Anthony Rostain, MD, MA, and Lenard Adler, MD.

Dr. Rostain: Changes to warnings on ADHD medications have many psychiatrists looking for guidance on using stimulants. Can you give us some background and discuss the labeling changes?

Dr. Adler: Stimulants have been used for more than 40 years as ADHD treatments, and they’ve been shown to be highly effective. The FDA, which monitors issues of cardiovascular safety and stimulants in an ongoing way, examined specific isolated cases and changed some of the warnings as a result.

Dr. Rostain: What should practicing psychiatrists be concerned about if they’re thinking of prescribing stimulants for an ADHD patient?

Dr. Adler: The take-home point is that stimulants—because of the way they work—have been known to have minor effects of increasing blood pressure and pulse (Box 1).^1-3 Clinicians have known about issues regarding stimulant use by patients with pre-existing cardiovascular conditions, but now the warnings are more formal for the methylphenidate and amphetamine products.

Dr. Rostain: An FDA committee recommended black box warnings on all stimulants used for ADHD, but the FDA decided instead to clarify warnings in prescription information for some medications. What was the FDA process?

Dr. Adler: The discussion was internal at the FDA, so I can’t say what their thinking was. The black box warning on amphetamines notes two issues. One is the potential for abuse and diversion, and the other warns of potential for sudden death and serious cardiovascular effects if the drug is misused. A warning has also been placed on all methylphenidate products regarding cardiovascular risk for patients with pre-existing cardiovascular conditions, but it is not a black box warning.

Box 1

Dr. Rostain: How were the warnings clarified?

Dr. Adler: The FDA has changed the language. Now physicians are warned that sudden death can occur at usual doses in patients with a pre-existing structural cardiac abnormality or other serious heart problem. So, stimulants generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.

 

Dr. Rostain: What about adults?

Dr. Adler: The language is the same for adults. Adults have a greater likelihood than children of having a history of serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other cardiac problems. Adults with such abnormalities generally should not be treated with stimulant drugs.

Dr. Rostain: What’s the impact for clinicians?

Dr. Adler: Clinicians have known that stimulants should not be used in patients with significant pre-existing cardiovascular conditions. That generally includes structural abnormalities such as serious heart murmurs and abnormalities of the electro-conduction of the impulse through the heart. When patients present with a history of cardiac abnormalities, clinicians should speak to the pediatrician, primary care physician (PCP), or cardiologist, go over the risk factors, and decide whether these medications can be prescribed for the patient.

Dr. Rostain: Should psychiatrists perform screening tests before prescribing stimulants? When should they consult with a specialist?

Dr. Adler: There is no recommendation in the prescribing information. But clearly a clinician should determine whether a patient has structural cardiac abnormalities or serious heart problems. That means taking a history about heart murmur, syncope, or other serious heart problems. Also, you want to know if the patient is hypertensive. The burden is on the prescribing clinician.

Dr. Rostain: Suppose you have a patient with hypertension or a history of a heart condition, should that patient first be evaluated by a cardiologist? What about a screening ECG?

Dr. Adler: There are no specific recommendations. If clinicians have questions about prescribing the medication, they should consult with the patient’s PCP or cardiologist.

Dr. Rostain: Let’s say the patient has some heart issues, but the PCP or pediatrician gives the goahead to prescribe stimulants. What sort of monitoring do you recommend?

Dr. Adler: I can’t answer that directly. Clearly, you’re going to want to partner with the PCP to establish a plan of how to carefully monitor this patient. FDA guidelines recommend ongoing blood pressure monitoring, especially if the patient is hypertensive, but do not specify how often.

Dr. Rostain: What alternatives do psychiatrists have when treating ADHD in patients in whom stimulants may pose some risk?

Dr. Adler: The only approved nonstimulant ADHD medication is atomoxetine, the labeling of which carries language about possible effects on blood pressure. The FDA warning about structural cardiac abnormalities has not been extended to atomoxetine, but blood pressure needs to be monitored. Whether our medical colleagues feel comfortable using a nonstimulant in patients with structural cardiac abnormalities has not been determined.

Dr. Rostain: In the absence of guidelines in the new warnings on stimulants, are there any studies to help clinicians with treatment and monitoring?

Dr. Adler: There’s very little data. A group at Massachusetts General Hospital has been studying the effects of ADHD medication on adults with hypertension (Box 2).⁴ That’s a different issue than a structural cardiac abnormality, but at least we have some data. This group found that you can safely give stimulants to hypertensive patients by partnering with medical colleagues and monitoring the patient carefully. Antihypertensive dosages may need to be adjusted during psychostimulant treatment.

Dr. Rostain: How do you choose a medication if your patient has a structural heart abnormality?

Dr. Adler: Again, we don’t have a lot of data. The decision would depend on the cardiac abnormality and the consulting physician’s comfort level. Keep in mind that psychostimulants have a short duration of effect, so the effects of the medication can dissipate fairly quickly. Again, the decision to medicate a patient with pre-existing cardiac abnormalities must be done with medical guidance.

Box 2

 

Dr. Rostain: So are you saying clinicians should make decisions about prescribing stimulants for patients with ADHD on a case-by-case basis?

Dr. Adler: Exactly.

Dr. Rostain: What about children and adolescents who have unknown structural heart defects? A lot of parents are concerned about reports of sudden cardiac death in young athletes, such as when playing soccer or basketball. Is there any way for practitioners to protect children with ADHD from an unexpected event?

Dr. Adler: In general, stimulants are safe medications, but we don’t have guidelines to help us determine who will need an ECG and who will not. Children are less likely to have had an ECG in the past than an adult, so it’s important to do a history, obtain input from the pediatrician or PCP, and clearly review the risks and benefits of medication therapy with the patient’s family.

Dr. Rostain: What would you advise clinicians to tell parents of children with ADHD or adult patients who have concerns about the new labeling on stimulants?

Dr. Adler: It would be a shame if patients were not receiving treatment for ADHD because of unfounded medical concerns. When these medications are used appropriately, they have dramatic and positive affects on ADHD.

ADHD is common and highly impairing. Deciding not to treat it has serious consequences in terms of divorce, separation, underperformance in school and on the job, unemployment, smoking, substance use, and issues with motor vehicle accidents and driving.

The goal of treatment is for our patients to get better, and ADHD is highly treatable with medication. But we must be cognizant of the warnings and prescribe medications appropriately. The message is that we’ve got to work collaboratively with our partners in medicine and, in the absence of guidelines, use good common sense.

Related resources

• Wilens TE, Hammerness PG, Biederman J, et al. Blood pressure changes associated with medication treatment of adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry 2005;66:253-9.

Drug brand names

• Atomoxetine • Strattera
• Bupropion • Wellbutrin
• Desipramine • Norpramin
• Methylphenidate • Concerta, Ritalin
• Mixed amphetamine salts • Adderall
• Pemoline • Cylert

Disclosures

Dr. Adler is a consultant to and receives grant/research support from Abbott Laboratories, Cephalon, Cortex Pharmaceuticals, Eli Lilly and Company, New River Pharmaceuticals, Novartis Pharmaceuticals Corp., Ortho-McNeil, Pfizer, and Shire. He also receives grant/research support from Bristol-Myers Squibb and Merck and Co., and is a speaker for Eli Lilly and Company.

Dr. Rostain is a consultant to Shire and a speaker for Eli Lilly and Company and Ortho-McNeil.

In August the FDA called for new warnings on stimulants used for attention-deficit/hyperactivity disorder (ADHD). Amphetamines now carry black box warnings that say, “Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events.” Amphetamines and methylphenidates used for ADHD include expanded information about cardiovascular risks at usual dosages for patients with heart conditions.

To examine the clinical implications of these warnings, Current Psychiatry hosted a conversation between ADHD experts Anthony Rostain, MD, MA, and Lenard Adler, MD.

Dr. Rostain: Changes to warnings on ADHD medications have many psychiatrists looking for guidance on using stimulants. Can you give us some background and discuss the labeling changes?

Dr. Adler: Stimulants have been used for more than 40 years as ADHD treatments, and they’ve been shown to be highly effective. The FDA, which monitors issues of cardiovascular safety and stimulants in an ongoing way, examined specific isolated cases and changed some of the warnings as a result.

Dr. Rostain: What should practicing psychiatrists be concerned about if they’re thinking of prescribing stimulants for an ADHD patient?

Dr. Adler: The take-home point is that stimulants—because of the way they work—have been known to have minor effects of increasing blood pressure and pulse (Box 1).^1-3 Clinicians have known about issues regarding stimulant use by patients with pre-existing cardiovascular conditions, but now the warnings are more formal for the methylphenidate and amphetamine products.

Dr. Rostain: An FDA committee recommended black box warnings on all stimulants used for ADHD, but the FDA decided instead to clarify warnings in prescription information for some medications. What was the FDA process?

Dr. Adler: The discussion was internal at the FDA, so I can’t say what their thinking was. The black box warning on amphetamines notes two issues. One is the potential for abuse and diversion, and the other warns of potential for sudden death and serious cardiovascular effects if the drug is misused. A warning has also been placed on all methylphenidate products regarding cardiovascular risk for patients with pre-existing cardiovascular conditions, but it is not a black box warning.

Box 1

Dr. Rostain: How were the warnings clarified?

Dr. Adler: The FDA has changed the language. Now physicians are warned that sudden death can occur at usual doses in patients with a pre-existing structural cardiac abnormality or other serious heart problem. So, stimulants generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.

 

Dr. Rostain: What about adults?

Dr. Adler: The language is the same for adults. Adults have a greater likelihood than children of having a history of serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other cardiac problems. Adults with such abnormalities generally should not be treated with stimulant drugs.

Dr. Rostain: What’s the impact for clinicians?

Dr. Adler: Clinicians have known that stimulants should not be used in patients with significant pre-existing cardiovascular conditions. That generally includes structural abnormalities such as serious heart murmurs and abnormalities of the electro-conduction of the impulse through the heart. When patients present with a history of cardiac abnormalities, clinicians should speak to the pediatrician, primary care physician (PCP), or cardiologist, go over the risk factors, and decide whether these medications can be prescribed for the patient.

Dr. Rostain: Should psychiatrists perform screening tests before prescribing stimulants? When should they consult with a specialist?

Dr. Adler: There is no recommendation in the prescribing information. But clearly a clinician should determine whether a patient has structural cardiac abnormalities or serious heart problems. That means taking a history about heart murmur, syncope, or other serious heart problems. Also, you want to know if the patient is hypertensive. The burden is on the prescribing clinician.

Dr. Rostain: Suppose you have a patient with hypertension or a history of a heart condition, should that patient first be evaluated by a cardiologist? What about a screening ECG?

Dr. Adler: There are no specific recommendations. If clinicians have questions about prescribing the medication, they should consult with the patient’s PCP or cardiologist.

Dr. Rostain: Let’s say the patient has some heart issues, but the PCP or pediatrician gives the goahead to prescribe stimulants. What sort of monitoring do you recommend?

Dr. Adler: I can’t answer that directly. Clearly, you’re going to want to partner with the PCP to establish a plan of how to carefully monitor this patient. FDA guidelines recommend ongoing blood pressure monitoring, especially if the patient is hypertensive, but do not specify how often.

Dr. Rostain: What alternatives do psychiatrists have when treating ADHD in patients in whom stimulants may pose some risk?

Dr. Adler: The only approved nonstimulant ADHD medication is atomoxetine, the labeling of which carries language about possible effects on blood pressure. The FDA warning about structural cardiac abnormalities has not been extended to atomoxetine, but blood pressure needs to be monitored. Whether our medical colleagues feel comfortable using a nonstimulant in patients with structural cardiac abnormalities has not been determined.

Dr. Rostain: In the absence of guidelines in the new warnings on stimulants, are there any studies to help clinicians with treatment and monitoring?

Dr. Adler: There’s very little data. A group at Massachusetts General Hospital has been studying the effects of ADHD medication on adults with hypertension (Box 2).⁴ That’s a different issue than a structural cardiac abnormality, but at least we have some data. This group found that you can safely give stimulants to hypertensive patients by partnering with medical colleagues and monitoring the patient carefully. Antihypertensive dosages may need to be adjusted during psychostimulant treatment.

Dr. Rostain: How do you choose a medication if your patient has a structural heart abnormality?

Dr. Adler: Again, we don’t have a lot of data. The decision would depend on the cardiac abnormality and the consulting physician’s comfort level. Keep in mind that psychostimulants have a short duration of effect, so the effects of the medication can dissipate fairly quickly. Again, the decision to medicate a patient with pre-existing cardiac abnormalities must be done with medical guidance.

Box 2

 

Dr. Rostain: So are you saying clinicians should make decisions about prescribing stimulants for patients with ADHD on a case-by-case basis?

Dr. Adler: Exactly.

Dr. Rostain: What about children and adolescents who have unknown structural heart defects? A lot of parents are concerned about reports of sudden cardiac death in young athletes, such as when playing soccer or basketball. Is there any way for practitioners to protect children with ADHD from an unexpected event?

Dr. Adler: In general, stimulants are safe medications, but we don’t have guidelines to help us determine who will need an ECG and who will not. Children are less likely to have had an ECG in the past than an adult, so it’s important to do a history, obtain input from the pediatrician or PCP, and clearly review the risks and benefits of medication therapy with the patient’s family.

Dr. Rostain: What would you advise clinicians to tell parents of children with ADHD or adult patients who have concerns about the new labeling on stimulants?

Dr. Adler: It would be a shame if patients were not receiving treatment for ADHD because of unfounded medical concerns. When these medications are used appropriately, they have dramatic and positive affects on ADHD.

ADHD is common and highly impairing. Deciding not to treat it has serious consequences in terms of divorce, separation, underperformance in school and on the job, unemployment, smoking, substance use, and issues with motor vehicle accidents and driving.

The goal of treatment is for our patients to get better, and ADHD is highly treatable with medication. But we must be cognizant of the warnings and prescribe medications appropriately. The message is that we’ve got to work collaboratively with our partners in medicine and, in the absence of guidelines, use good common sense.

Related resources

• Wilens TE, Hammerness PG, Biederman J, et al. Blood pressure changes associated with medication treatment of adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry 2005;66:253-9.

Drug brand names

• Atomoxetine • Strattera
• Bupropion • Wellbutrin
• Desipramine • Norpramin
• Methylphenidate • Concerta, Ritalin
• Mixed amphetamine salts • Adderall
• Pemoline • Cylert

Disclosures

Dr. Adler is a consultant to and receives grant/research support from Abbott Laboratories, Cephalon, Cortex Pharmaceuticals, Eli Lilly and Company, New River Pharmaceuticals, Novartis Pharmaceuticals Corp., Ortho-McNeil, Pfizer, and Shire. He also receives grant/research support from Bristol-Myers Squibb and Merck and Co., and is a speaker for Eli Lilly and Company.

Dr. Rostain is a consultant to Shire and a speaker for Eli Lilly and Company and Ortho-McNeil.

In August the FDA called for new warnings on stimulants used for attention-deficit/hyperactivity disorder (ADHD). Amphetamines now carry black box warnings that say, “Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events.” Amphetamines and methylphenidates used for ADHD include expanded information about cardiovascular risks at usual dosages for patients with heart conditions.

To examine the clinical implications of these warnings, Current Psychiatry hosted a conversation between ADHD experts Anthony Rostain, MD, MA, and Lenard Adler, MD.

Dr. Rostain: Changes to warnings on ADHD medications have many psychiatrists looking for guidance on using stimulants. Can you give us some background and discuss the labeling changes?

Dr. Adler: Stimulants have been used for more than 40 years as ADHD treatments, and they’ve been shown to be highly effective. The FDA, which monitors issues of cardiovascular safety and stimulants in an ongoing way, examined specific isolated cases and changed some of the warnings as a result.

Dr. Rostain: What should practicing psychiatrists be concerned about if they’re thinking of prescribing stimulants for an ADHD patient?

Dr. Adler: The take-home point is that stimulants—because of the way they work—have been known to have minor effects of increasing blood pressure and pulse (Box 1).^1-3 Clinicians have known about issues regarding stimulant use by patients with pre-existing cardiovascular conditions, but now the warnings are more formal for the methylphenidate and amphetamine products.

Dr. Rostain: An FDA committee recommended black box warnings on all stimulants used for ADHD, but the FDA decided instead to clarify warnings in prescription information for some medications. What was the FDA process?

Dr. Adler: The discussion was internal at the FDA, so I can’t say what their thinking was. The black box warning on amphetamines notes two issues. One is the potential for abuse and diversion, and the other warns of potential for sudden death and serious cardiovascular effects if the drug is misused. A warning has also been placed on all methylphenidate products regarding cardiovascular risk for patients with pre-existing cardiovascular conditions, but it is not a black box warning.

Box 1

Dr. Rostain: How were the warnings clarified?

Dr. Adler: The FDA has changed the language. Now physicians are warned that sudden death can occur at usual doses in patients with a pre-existing structural cardiac abnormality or other serious heart problem. So, stimulants generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.

 

Dr. Rostain: What about adults?

Dr. Adler: The language is the same for adults. Adults have a greater likelihood than children of having a history of serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other cardiac problems. Adults with such abnormalities generally should not be treated with stimulant drugs.

Dr. Rostain: What’s the impact for clinicians?

Dr. Adler: Clinicians have known that stimulants should not be used in patients with significant pre-existing cardiovascular conditions. That generally includes structural abnormalities such as serious heart murmurs and abnormalities of the electro-conduction of the impulse through the heart. When patients present with a history of cardiac abnormalities, clinicians should speak to the pediatrician, primary care physician (PCP), or cardiologist, go over the risk factors, and decide whether these medications can be prescribed for the patient.

Dr. Rostain: Should psychiatrists perform screening tests before prescribing stimulants? When should they consult with a specialist?

Dr. Adler: There is no recommendation in the prescribing information. But clearly a clinician should determine whether a patient has structural cardiac abnormalities or serious heart problems. That means taking a history about heart murmur, syncope, or other serious heart problems. Also, you want to know if the patient is hypertensive. The burden is on the prescribing clinician.

Dr. Rostain: Suppose you have a patient with hypertension or a history of a heart condition, should that patient first be evaluated by a cardiologist? What about a screening ECG?

Dr. Adler: There are no specific recommendations. If clinicians have questions about prescribing the medication, they should consult with the patient’s PCP or cardiologist.

Dr. Rostain: Let’s say the patient has some heart issues, but the PCP or pediatrician gives the goahead to prescribe stimulants. What sort of monitoring do you recommend?

Dr. Adler: I can’t answer that directly. Clearly, you’re going to want to partner with the PCP to establish a plan of how to carefully monitor this patient. FDA guidelines recommend ongoing blood pressure monitoring, especially if the patient is hypertensive, but do not specify how often.

Dr. Rostain: What alternatives do psychiatrists have when treating ADHD in patients in whom stimulants may pose some risk?

Dr. Adler: The only approved nonstimulant ADHD medication is atomoxetine, the labeling of which carries language about possible effects on blood pressure. The FDA warning about structural cardiac abnormalities has not been extended to atomoxetine, but blood pressure needs to be monitored. Whether our medical colleagues feel comfortable using a nonstimulant in patients with structural cardiac abnormalities has not been determined.

Dr. Rostain: In the absence of guidelines in the new warnings on stimulants, are there any studies to help clinicians with treatment and monitoring?

Dr. Adler: There’s very little data. A group at Massachusetts General Hospital has been studying the effects of ADHD medication on adults with hypertension (Box 2).⁴ That’s a different issue than a structural cardiac abnormality, but at least we have some data. This group found that you can safely give stimulants to hypertensive patients by partnering with medical colleagues and monitoring the patient carefully. Antihypertensive dosages may need to be adjusted during psychostimulant treatment.

Dr. Rostain: How do you choose a medication if your patient has a structural heart abnormality?

Dr. Adler: Again, we don’t have a lot of data. The decision would depend on the cardiac abnormality and the consulting physician’s comfort level. Keep in mind that psychostimulants have a short duration of effect, so the effects of the medication can dissipate fairly quickly. Again, the decision to medicate a patient with pre-existing cardiac abnormalities must be done with medical guidance.

Box 2

 

Dr. Rostain: So are you saying clinicians should make decisions about prescribing stimulants for patients with ADHD on a case-by-case basis?

Dr. Adler: Exactly.

Dr. Rostain: What about children and adolescents who have unknown structural heart defects? A lot of parents are concerned about reports of sudden cardiac death in young athletes, such as when playing soccer or basketball. Is there any way for practitioners to protect children with ADHD from an unexpected event?

Dr. Adler: In general, stimulants are safe medications, but we don’t have guidelines to help us determine who will need an ECG and who will not. Children are less likely to have had an ECG in the past than an adult, so it’s important to do a history, obtain input from the pediatrician or PCP, and clearly review the risks and benefits of medication therapy with the patient’s family.

Dr. Rostain: What would you advise clinicians to tell parents of children with ADHD or adult patients who have concerns about the new labeling on stimulants?

Dr. Adler: It would be a shame if patients were not receiving treatment for ADHD because of unfounded medical concerns. When these medications are used appropriately, they have dramatic and positive affects on ADHD.

ADHD is common and highly impairing. Deciding not to treat it has serious consequences in terms of divorce, separation, underperformance in school and on the job, unemployment, smoking, substance use, and issues with motor vehicle accidents and driving.

The goal of treatment is for our patients to get better, and ADHD is highly treatable with medication. But we must be cognizant of the warnings and prescribe medications appropriately. The message is that we’ve got to work collaboratively with our partners in medicine and, in the absence of guidelines, use good common sense.

Related resources

• Wilens TE, Hammerness PG, Biederman J, et al. Blood pressure changes associated with medication treatment of adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry 2005;66:253-9.

Drug brand names

• Atomoxetine • Strattera
• Bupropion • Wellbutrin
• Desipramine • Norpramin
• Methylphenidate • Concerta, Ritalin
• Mixed amphetamine salts • Adderall
• Pemoline • Cylert

Disclosures

Dr. Adler is a consultant to and receives grant/research support from Abbott Laboratories, Cephalon, Cortex Pharmaceuticals, Eli Lilly and Company, New River Pharmaceuticals, Novartis Pharmaceuticals Corp., Ortho-McNeil, Pfizer, and Shire. He also receives grant/research support from Bristol-Myers Squibb and Merck and Co., and is a speaker for Eli Lilly and Company.

Dr. Rostain is a consultant to Shire and a speaker for Eli Lilly and Company and Ortho-McNeil.