Prescribing for the pregnant patient
ABSTRACTPrescribing in pregnancy can be challenging for providers facing insufficient information about drug safety, overestimation of the risk of medications by both the patient and the care provider, and increasing litigation costs. This article provides key concepts to consider when prescribing for a pregnant patient and offers practical advice for choosing the safest possible drug treatments.
KEY POINTS
- There is no protective physiologic barrier between the maternal and fetal environments.
- The gestational stage may determine the effect of a medication on the fetus.
- The physiologic changes of pregnancy affect the pharmacokinetics of medications.
- Sole reliance on the US Food and Drug Administration’s pregnancy safety category may be inadequate.
- Key questions: Is the problem self-limited or amenable to nonpharmacologic management? How do the patient’s (and provider’s) presumptions affect decisions about this medication in pregnancy? How does pregnancy affect the problem, and how does the problem affect pregnancy?
RESOURCES TO ASSESS MEDICATION SAFETY IN PREGNANCY
The FDA has proposed changes in the labeling of medications related to pregnancy and lactation.2 The proposed changes would eliminate the current categories and instead require a summary of the risks, the effects of the drug on the fetus, and clinical considerations for use during pregnancy. In addition, labeling would include a description of the medication’s effects on milk production, the amount of drug present in milk, and possible effects on the infant.
Until such changes are in place, what other resources can a busy clinician turn to for support?
The official drug labeling (or the package insert), also published in the Physicians’ Desk Reference, is one source of information, but it rarely provides up-to-date information about teratogenic risks in human pregnancies.
Several online databases review, summarize, and periodically update information from the peer-reviewed medical literature.3–7 The REPRORISK system4–7 maintained by Micromedex (Greenwood Village, CO) provides access to several databases that contain information about a wide range of individual medications: REPROTEXT, REPROTOX,5 Shepard’s Catalog of Teratogenic Agents,7 and the Teratogen Information System (TERIS).4 Online access and a smartphone “app” for these databases are available for a subscription fee. Summaries for individual medications can be ordered directly from TERIS, also for a fee. Several other resources are available in textbook format.8–10
In addition, health care providers can obtain information from or can refer pregnant and breastfeeding patients to a teratology information service for information and counseling about medication exposures. MotherToBaby,11 a service of the nonprofit Organization of Teratology Information Specialists, provides fact sheets, free phone consultation, risk assessment, and counseling by trained teratogen information specialists about environmental exposures, including prescription and over-the-counter medications and dietary and herbal supplements. Counselors from these services gather and synthesize information about exposures from the databases mentioned above, from the peer-reviewed medical literature, from drug manufacturers, and from other sources.
With the advent of electronic medical records and computerized provider order entry, clinical decision support systems hold promise as an additional resource for safe prescribing in pregnancy.
Fortunately, the list of teratogenic medications that are absolutely contraindicated in pregnancy remains small (Table 2).12,13
THE FOUR-QUESTION APPROACH TO CARING FOR THE PREGNANT PATIENT
Is the symptom self-limited or amenable to nonpharmacologic management?
It has been said that we live in a culture where every symptom warrants a pill. If this is true, there can be no better time for reevaluating this practice than during pregnancy.
Many of the medications most commonly used in pregnancy are for upper-respiratory-tract infections, headache, or psychological distress. Pregnancy is the ideal time to educate patients about the limited effectiveness of most cough-and-cold remedies and the inappropriateness of antibiotics for colds and viral bronchitis. It is also an ideal time for a trial of lifestyle modifications, relaxation, and biofeedback for a chronic headache problem. For cases of mild to moderate depression, it may be worth considering treatment with psychotherapy rather than medications.
Offering patients the option of no treatment or nonpharmacologic treatment for self-limited symptoms is an option worth considering.
