The majority of participants had one or more chronic medical conditions, including acne, diabetes, hypertension, multiple sclerosis, systemic lupus, migraines, and arthritis. Medications taken by participants included isotretinoin, antidepressants, anti-inflammatory medications, proton pump inhibitors, and antibiotics. All women had taken medications at some point during adulthood, for either chronic or acute health conditions, and identified as their primary care provider a physician who did not provide obstetric services. A number of participants had previously been pregnant, and some had used medication while pregnant. None of the participants disclosed having personal experience with an abnormal pregnancy outcome. In addition, none of the participants described ever having scheduled an appointment to specifically discuss medication risks or preconception counseling with their HCP. Additional sample characteristics are shown in .
Demographic Characteristics of Focus Group Participants*
Women’s Experiences with Teratogenic Risk Counseling
Sources of information
Women reported receiving information about pregnancy-related risks associated with prescribed medications from a variety of sources.() The most commonly reported sources of information were written materials (e.g., pamphlet inserts) which did not allow women the opportunity to ask questions, clarify content, or explore the relevance of the information. However, a number of women also reported obtaining information from individuals from whom they could engage in a dialogue, ask questions, and receive additional clarification. Commonly cited sources included HCPs, friends or family members.
Sources of Information about Teratogenic Effects of Medications
HCP Approaches to teratogenic risk counseling
Women reported that HCPs used several different approaches to providing teratogenic risk counseling (). Some providers directly cautioned women not to become pregnant while taking a particular medication while others were less direct. One woman described her provider giving direct counseling to avoid pregnancy: “My doctor has been pretty good. I guess, you know, since I’m a female, automatically that pregnancy question comes along every time he does something with me.” Another woman described her doctor’s less direct approach: “If you become pregnant, this medication could harm the baby – [but] they didn’t advise me to not become pregnant while using the medication.” Other women described having had a HCP indirectly tell them not to become pregnant while using a medication, by cautioning the woman to use a “backup” or second method of birth control.
Health Care Provider Approaches to Teratogenic Risk Counseling
A number of women reported never having received any teratogenic risk counseling from a HCP. These women described feeling concerned upon having discovering on their own that a medication could have teratogenic effects on a pregnancy. As one woman said, “I know the medication I’m taking right now causes problems [with a pregnancy] and my doctor has never told me it. I found out by accident, actually, from another person who was taking it. And then I researched it and there it was.”
For women who received information about teratogenic risks of medications, there were varying levels of satisfaction with the information received. While several women indicated that they were satisfied with the teratogenic counseling they received from their HCPs, other women expressed concern that the information they had received was not complete. As one woman expressed, “If they do tell you, they’re vague. Like oh, you know, just take some extra birth control. Tell me why I need to make sure I’m extra safe because what can happen. I want the whole picture all the time. I want to know why…why do I need to be extra careful…what will happen if I do get pregnant? Don’t just say -- Oh, just be careful. Use a second method of birth control.” This implies that in situations where information on the safety of use of a medication during pregnancy is not yet available, HCPs should share with their patients the need for ongoing data collection.
Women’s sense of their providers’ comfort with teratogenic risk counseling also affected their perceptions of the quality of their counseling experiences. Some HCPs were perceived as uncomfortable when introducing the topic of medication-induced birth defects to women: “[My gynecologist] seems like she’s actually kind of uncomfortable talking about it with me, and I’m just kinda like, “Well… you’re giving me this. Like, I need to know what this is.” Women also expressed that impersonal communication styles, or poor bedside manner, at times hindered communication about medication-induced birth defects.
Although women generally indicated that they trusted their HCPs, particularly when they had a long-standing relationship, many still directed follow-up questions to trusted friends or relatives, particularly those who worked in health care. In the words of one woman, “My mom is a nurse…so a lot of times I’ll ask her about different medications…I usually listen to her advice more than anything, or ask friends, but, put her at the top of my list.”
Women’s Preferences for Teratogenic Risk Counseling
Women overwhelmingly expressed the feeling that HCPs should initiate discussions and provide information about teratogenic risks of medications, regardless of a woman’s age, pregnancy intentions, sexual orientation, or level of sexually activity. Although most women acknowledged that patients should play an active role in initiating questions about the safety of medications during pregnancy and providing accurate information about their current sexual activity, pregnancy plans, and contraceptive use, they uniformly expressed the opinion that it is primarily the responsibility of HCPs to proactively provide women with accurate and current information about pregnancy-related risks associated with medication use. This is illustrated by statements such as “If they gonna put you on a medicine, then they should tell you. If they puttin’ you on a medicine or something like that that may harm a fetus, then ask me am I planning pregnancy or just tell me the side effects if I am pregnant because I’m a woman, so you should tell the women the side effects of pregnancy and that medicine.” In the words of another participant, “Even if <someone> doesn’t wanna know– it’s still the doctor’s responsibility to give that information, just like it was the doctor’s responsibility to say, “Hey, you have lung cancer.” Even if you don’t wanna know that” Another common perspective among women in this focus group was expressed by one woman as: “if they’re going to wait for people to say oh, yeah, I’m planning to get pregnant, they’re going to get very little response from that-- because nobody’s planning!”
Women identified seven components of effective teratogenic risk counseling: 1) timely information, 2) data on all potential impacts on a fetus, 3) clear information, 4) repetition of important information, 5) avoiding assumptions about women’s pregnancy intentions, 6) explanations as to why HCPs are asking about sexual activity and pregnancy intentions, and 7) discussion of future consequences for reproductive health ().
Desired components of teratogenic risk counseling
Women also had preferences for how information about teratogenic risks should be communicated. Specifically, women spoke about: 1) a desire for privacy, 2) sufficient time to discuss the topic during a medical visit, 3) HCP bedside manner, and 4) a trusting patient-provider relationship (). Although women wanted timely information about pregnancy-related risks, this desire was tempered by a general concern that a HCP must build a trusting relationship with a patient in order for the patient to have confidence in the counseling she is receiving. Trust in a patient-provider relationship was identified as a critical factor to successful teratogenic risk counseling.
Desired characteristics of teratogenic risk counseling
However, women felt that detailed information about pregnancy-related risks at the time of prescription was necessary to prevent unfavorable outcomes, and they preferred to receive this information regardless of whether the discussion might make either their HCPs or themselves uncomfortable. As one woman said, “I think I’d be more embarrassed if I had to go and have an abortion because I took this medication that was gonna prevent this baby’s kidneys from developing and I didn’t know the full extent of what it would do. I’d rather be embarrassed in the office than embarrassed in a situation like that down the line.”
Despite the above thoughts about the importance of teratogenic risk counseling, none of the women who participated in these focus groups reported having personally considered the possibility of teratogenic effects of a medication when they last filled a prescription. When women were asked what factors they had personally considered when deciding whether to take their current medication, participants described side effects, cost, interactions with other medications, and efficacy as their primary concerns. Only two women identified “interaction with contraception” as a concern, and none of the women suggested effects on a pregnancy or fetus as a concern without prompts from the moderator. This underscores the importance of HCPs introducing the topic of medications’ potential effects on fetal development.