Week 9 Recommend one FDA-approved drug, one off-label drug, and one nonpharmacological intervention for treating your chosen disorder in older adults or pregnant women.

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Discussion: Prescribing for Older Adults and Pregnant Women

After assessing and diagnosing a patient, PMHNPs must take into consideration special characteristics of the patient before determining an appropriate course of treatment. For pharmacological treatments that are not FDA-approved for a particular use or population, off-label use may be considered when the potential benefits could outweigh the risks.

In this Discussion, you will investigate a specific disorder and determine potential appropriate treatments for when it occurs in an older adult or pregnant woman.

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To Prepare:
  • Choose one of the two following specific populations: either pregnant women or older adults. Then, select a specific disorder from the DSM-5-TR to use.
  • Use the Walden Library to research evidence-based treatments for your selected disorder in your selected population (either older adults or pregnant women). You will need to recommend one FDA-approved drug, one non-FDA-approved “off-label” drug, and one nonpharmacological intervention for treating the disorder in that population.
By Day 3 of Week 9
  • Recommend one FDA-approved drug, one off-label drug, and one nonpharmacological intervention for treating your chosen disorder in older adults or pregnant women.
  • Explain the risk assessment you would use to inform your treatment decision  making. What are the risks and benefits of the FDA-approved medicine? What are the risks and benefits of the off-label drug?
  • Explain whether clinical practice guidelines exist for this disorder, and if so, use them to justify your recommendations. If not, explain what information you would need to take into consideration.
  • Support your reasoning with at least three current, credible scholarly resources, one each on the FDA-approved drug, the off-label, and a nonpharmacological intervention for the disorder.

Read a selection of your colleagues’ responses.

By Day 6 of Week 9

Respond to at least two of your colleagues on 2 different days who selected different disorders. Propose an alternative on-label, off-label, or nonpharmacological treatment for the disorders. Justify your suggestions with at least two references to the literature.

Prescribing for Older Adults and Pregnant Women

Treating bipolar disorder is complex in and of itself due to the difficulties of managing mood stability (Jain et al., 2022). Treating bipolar disorder during pregnancy presents new challenges and controversies regarding whether psychotropic medication is appropriate and, if so, which drugs are the safest. According to some studies, women with bipolar disorder in pregnancy are at an increased risk for adverse outcomes, including premature birth, regardless of psychotropic therapy, making treatment beneficial to them (Betcher et al., 2019). According to other studies, continuing psychotropic treatment is highly discouraged due to maternal and fetal risk (Trifu et al., 2020). The practitioner must carefully perform a risk-benefit analysis and consider essential information before determining the best individual treatment plan for each patient.

FDA-Approved Drug, Off-Label Drug, & Nonpharmacological Intervention

Lamotrigine is an FDA-approved drug for the treatment of bipolar disorder in pregnancy. Lamotrigine is considered a relatively safe alternative to lithium, primarily associated with Ebstein’s anomaly, or valproate, primarily related to neural tube defects (Albertini et al., 2019). Atypical antipsychotics are frequently prescribed “off-label” to manage bipolar disorder. Quetiapine is the most frequently prescribed atypical antipsychotic to treat bipolar disorder in pregnancy. Greater mood stability has been noted with the use of atypical antipsychotics, such as quetiapine, than antiepileptics (Betcher et al., 2019). Psychosocial strategies are a nonpharmacological intervention that can help manage bipolar symptoms in pregnancy. Anxiety and depression symptoms can be reduced through cognitive behavioral therapy (CBT) and behavioral strategies. One behavioral strategy potentially helpful in preventing relapse is eliminating the significant risk factor of sleep deprivation by establishing a regular nighttime routine (Boyce & Buist, 2016).

Risk Assessment

The risk assessment used to inform treatment decision-making would be a risk-benefit analysis for the use of pregnancy psychotropic medications. The risk of a bipolar episode recurrence doubles for patients who discontinue treatment during pregnancy, which often justifies the risks of medication exposure (Betcher et al., 2019). The risks of lamotrigine use in pregnancy include an increased chance of miscarriage, stillbirth, and oral cleft palate (Creeley & Denton, 2019). The benefits of lamotrigine use in pregnancy include an association with a low incidence of congenital malformations (Albertini et al., 2019). The risks of quetiapine use in pregnancy include abnormal fetal growth, preterm birth, and birth by cesarean section (Creeley & Denton, 2019). The benefits of quetiapine use in pregnancy include a significant lack of association between congenital and cardiac malformations (Betcher et al., 2019).

Clinical Practice Guidelines

There are no official clinical practice guidelines existing for the treatment of bipolar disorder in pregnancy. Essential information practitioners must consider before prescribing psychotropic medications in pregnancy includes the risk of untreated illness, infant outcomes, pharmacotherapy-related maternal adverse reactions, and birth complications. The new FDA and Pregnancy and Lactation Labeling Rule (PLLR) have removed pregnancy letter categories A, B, C, D, and X on medications. Currently, prescription drug labeling is presented in a Physician Labeling Rule Format (PLR). The PLR is a comprehensive explanation of the medication’s benefit versus risk to pregnant and nursing mothers (Betcher et al., 2019).


Albertini, E., Ernst, C. L., & Tamaroff, R. S. (2019). Psychopharmacological decision making in

bipolar disorder during pregnancy and lactation: A case-by-case approach to using

current evidence. FOCUS, A Journal of the American Psychiatric Association, 17(3),

249-258. https://doi.org/10.1176/appi.focus.20190007

Betcher, H. K., Montiel, C., & Clark, C. T. (2019). Use of antipsychotic drugs during pregnancy.

Current Treatment Options in Psychiatry, 6(1), 17-31.


Boyce, P., & Buist, A. (2016). Management of bipolar disorder over the perinatal period.

Australian Family Physician, 45(12), 890-893.


Creeley, C. E., & Denton, L. K. (2019). Use of prescribed psychotropics during pregnancy: A

systematic review of pregnancy, neonatal, and childhood outcomes. Brain Sciences, 9(9),

  1. https://doi.org/10.3390/brainsci9090235

Jain, R., Kong, A. M., Gillard, P., & Harrington, A. (2022). Treatment patterns among patients

with bipolar disorder in the United States: A retrospective claims database analysis.

Advances in Therapy, 39(6), 2578-2595. https://doi.org/10.1007/s12325-022-02112-6

Trifu, S. C., Popescu, A., & Marian, M. A. (2020). Affective disorders: A question of continuing

treatment during pregnancy. Experimental and Therapeutic Medicine, 20(4), 3474-3482.



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