Tag Archives: reproductive health

We are Title X

As providers of women’s healthcare and sexual and reproductive health (SRH) services, we must stay up to date and vigilant about the ongoing attacks that are eroding access and rights to essential healthcare services. Policy changes at the federal and state levels are threatening the very core of the comprehensive, evidence-based reproductive health and family planning services delivered through the Title X program in the United States. At the same time, severe restriction of abortion services has rendered the procedure virtually inaccessible in many states. The consequences of these trends are particularly dire for individuals who are most vulnerable, including those who are low income, uninsured/underinsured, and/or adolescents. Historically, Title X-funded clinics have also been a key source of training and employment for women’s health nurse practitioners (WHNPs). Reducing funding for this program not only threatens our livelihood and the pipeline for preparing future providers of women’s healthcare and SRH care but also, in our view, undermines the health of our patients. Continue reading »

Fears surrounding pregnancy and motherhood among women with cystic fibrosis

Recent advances in science and clinical care have changed the characteristics of the population with cystic fibrosis (CF). Half of patients with CF are now adults who want to achieve milestones that were impossible in the past; for women with CF, this may include motherhood. However, these women may have concerns and fears about getting pregnant, being pregnant, and becoming mothers that go beyond those that otherwise healthy women experience. This qualitative study was conducted to ascertain the reproductive health concerns of a small group of women with CF. Continue reading »

Challenges of preconception and interconception care: Environmental toxic exposures

This article provides healthcare providers with up-to-date information about the impact of a variety of potentially toxic environmental exposures on reproductive health, specifically with respect to preconception care (PC) and interconception care (IC). PC/IC should include education regarding environmental risks and a discussion about ways to minimize a woman’s exposure to environmental toxins in order to optimize both pregnancy and infant outcomes. Continue reading »

Developing and implementing PrEP at your local health center

Pre-exposure prophylaxis (PrEP) is an effective tool in the prevention of HIV acquisition. Advanced practice registered nurses are ideally positioned to introduce and prescribe PrEP, but some may not know how to integrate it into their practice. In this article, the authors describe the logistics of developing and implementing a PrEP program at multiple Planned Parenthood of Illinois (PPIL) health centers. They also discuss the training and support offered to PPIL clinicians during implementation of the program, the evaluation process, and the results. The process from development to implementation and evaluation can be easily adapted to other clinical settings. Continue reading »

Seeing our invisible patients: The importance of providing inclusive sexual and reproductive healthcare to LGBTQ populations

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The author encourages healthcare providers to become more competent and inclusive in caring for patients who identify as lesbian, gay, bisexual, transgender, or gender-queer or non-conforming.

Statement of the problem

Women who identify as lesbian or bisexual (also known as sexual minority women, or SMW), as well as those who were assigned female gender at birth but identify as transgender, gender-queer, or gender non-conforming (TQ), represent subsets of the LGBTQ population. These groups have historically experienced discrimination and stigma in healthcare. As a result, they may be less likely than heterosexual women or cis-gender women (those whose gender identity matches the female sex they were assigned at birth) to seek sexual and reproductive healthcare. Even if they seek this type of care, they may not be properly assessed, managed, or educated if their healthcare providers (HCPs) lack the knowledge and communication skills they need to provide inclusive sexual and reproductive care to SMW and TQ patients. In a video from the National LGBT Education Center, LGBT individuals share some of the experiences, both bad and good, that they have had with HCPs.

Dearth of research

Perpetuating this healthcare disparity is a dearth of research on LGBTQ-specific healthcare needs (with the exception of HIV/AIDS and mental health problems in gay men). Only in the past 5 years have the many health disparities experienced by LGBTQ individuals and the need for LGBTQ-specific research become a topic of conversation on a national level. From 1989 until 2011, 0.5% of studies funded by the National Institutes of Health (NIH), the largest funder of medical research in the world, pertained to LGBTQ health, and of that 0.5%, only 13.5% was allocated to SMW and 0.2% to transgender men.1 In 2011, the CDC identified health disparities related to sexual orientation as one of the main gaps in current health disparities research.2 In the same year, the Institute of Medicine reported the inadequacy of LGBTQ health research, identified challenges in conducting research on these populations, and established recommendations for the NIH, including implementation of a research agenda designed to advance knowledge and understanding of LGBTQ health.3

Dearth of educational programs

The curricula in most clinical education programs do not include adequate LGBTQ-related content. One study that specifically assessed inclusion of LGBTQ-related content in medical school curricula in the United States and Cana da found, on average, 5 hours of instruction in this area.Although corresponding studies assessing nursing school curricula have not been reported, they would likely reveal similarly discouraging findings. Educating future HCPs, through both classroom instruction and clinical experiences, to care for LGBTQ patients will help increase the number of HCPs who are competent and comfortable in this area.

Ways to provide competent and inclusive healthcare for LGBTQ populations

As a basic foundation in this regard, HCPs must understand the differences among the terms sex assigned at birth, sexual orientation, and gender identity. Sex assigned at birth, also referred to as biological sex, is based objectively on genital appearance, hormones, and chromosomes. Sexual orientation refers to the object of a person’s physical and/or emotional attraction. Gender identity represents how one perceives oneself—as female, as male, or somewhere in between.

Both U.S. society and the healthcare community within it are hetero-normative and cis-normativeinadvertently creating an environment that is a source of implicit discrimination toward LGBTQ populations.In a heteronormative society, heterosexuality is the expected and “normal” sexual orientation. Similarly, in a cis-normative society, being cis-gender—having a gender identity that matches one’s sex assignment at birth—is expected and “normal.” By these definitions, anyone who lives/behaves as anything other than heterosexual or who identifies as anything other than cisgender is considered “abnormal.”

Recognize and aim to overcome health disparities

Although the literature has been sparse, newly emerging studies provide information about the sexual and reproductive health behaviors of young SMW populations. In general, researchers have found that SMW (and/or sexual minority teens), compared with their heterosexual counterparts:

• display a greater number and range of sexually risky behaviors (e.g., younger age at sexual debut, greater number of sex partners, greater use of alcohol or drugs during sexual encounters, greater likelihood of having unprotected sex)6-11;

• with the exception of lesbians11 have higher rates of sexually transmitted infections (STIs)7,8,10;

• have similar rates of unwanted pregnancy and higher rates of abortion6,8,10;

• have lower rates of contraceptive and gynecologic care seeking, including a lesser likelihood of getting Pap tests and the HPV vaccine series12-15;

• have a greater likelihood of being subjected to intimate partner violence (IPV)6-8; and

• may have an elevated risk for breast cancer because of their increased rate of nulliparity, older age at first live birth, and greater rates of obesity and alcohol consumption.16

Fewer studies have addressed the sexual and reproductive health disparities that affect TQ populations, which also include gender non-binary individuals, who reject the assumption that gender is strictly an either/or option of male/female that matches the sex they were assigned at birth.17 Instead, these individuals view gender identity as a spectrum of possibilities. No epidemiologic studies on transgenderism in the U.S. have been published, and demographic studies based on national surveys have been limited because of a lack of questions about gender identity.18

About 0.3% of adults in the U.S. (~1 million persons) are thought to identify as transgender.18 Most of the available literature concerns transgender females (i.e., persons who are assigned the male sex at birth but who identify as female). In studies conducted in countries outside the U.S., the prevalence of transgender males (i.e., persons who are assigned the female sex at birth but who identify as male) has been reported as 1:30,400 to 1:200,000.19

Many transgender individuals have experienced discrimination in healthcare, particularly after disclosing their gender identity to their HCP. Experiences of hostility and/or insensitivity from their own HCP can cause mistrust of HCPs in general.20 This cycle can lead to a lack of utilization of healthcare services, particularly when care is not critical for survival.

Despite the lack of research, transgender males do express concerns related to their sexual and reproductive healthcare, particularly with respect to discrimination, lack of validation of their gender identity, physical discomfort during examinations, fertility preservation, and pregnancy. Another fact to keep in mind: Although a person born with a uterus and ovaries may not identify as female, this person may wish to have biological children. In a cross-sectional Web-based survey of transgender males who had been pregnant and delivered a baby, two-thirds of the pregnancies were planned, and pregnancy, delivery, and birth outcomes did not differ according to whether or not the patient had used testosterone prior to pregnancy.21

Avoid faulty assumptions

Not all patients are heterosexual and cis-gender. If a reproductive-aged patient states that she is sexually active, an HCP should not necessarily follow up with the question “What type of birth control are you using?” First, the HCP needs to determine the patient’s sexual orientation; she may not need to practice birth control. Instead of giving patients two gender options—“male” and “female”—on intake forms, the HCP can provide a box labeled “other” that can be filled in with the patient’s stated identity.

These concepts also apply to the way that visit types are labeled in the office. Visits related to contraception care are often termed family planning visits, and those that occur yearly are often termed well-woman exams. The terminology for these visit types can be off-putting to persons, including staff members, who may not use contraceptives for birth control and for those who may not identify as women even though they have female genitalia and reproductive organs. HCPs should aim to create an inclusive office atmosphere so that SMW and TQ patients can build trust in their provider and receive healthcare that meets their needs.

Create an inclusive environment

Providers should not assume that a patient coming into the office for contraceptive care or for a yearly checkup is heterosexual and cis-gender. One of the first things any patient does in an office visit is complete intake and health history forms. Forms are more inclusive when the term partner or spouse is used instead of husband or wife and when transgender and other identitywith a write-in area, are added to the cis-gender options of male and female. HCPs need to ask patients who identify as transgender, gender-queer, or gender non-conforming about their preferred names and which gender pronouns they use (e.g., he, she, they). Preferred names may differ from the legal documentation on their driver’s licenses and insurance cards; HCPs must avoid using a name that the patient no longer uses or that may cause distress. Questions about preferred names and gender pronouns are appropriate and polite, and demonstrate from the outset of the professional relationship that the HCP and the staff acknowledge and validate all their patients’ sexual orientations and gender identities.

Non-discrimination policies need to be posted in check-in areas and/or waiting rooms where they are easily visible. Information about and examples of patient non-discrimination policies are available through the Human Rights Campaign Healthcare Equality Index website. Staff members need to know these policies and adhere to them. After all, the first person with whom a patient has contact in a healthcare setting is usually not the HCP but, rather, the office reception staff. The National LGBT Health Education Center, a program of The Fenway Institute, offers online webinars and video training sessions that can be used to help educate clinical and administrative office staff members.

Follow health screening and preventive health recommendations

Recommendations are implemented for SMW and TQ patients within the same parameters as for heterosexual and cis-gender female patients. Screening for STIs and HIV is based on behaviors and risk factors, not on sexual orientation or gender identity. HCPs need to ask patients about the types of sexual behaviors in which they engage so that the types of STI screenings and the sites of sampling can be determined. HCPs also need to advise patients to catch up on their HPV vaccinations if they have not completed them.

Providers need to ask patients whether they have a partner with whom it would be possible to get pregnant, and whether they are having penetrative vaginal sex with this partner. If so, and if the patient does not desire a pregnancy, HCPs need to discuss and offer all available and appropriate contraceptive options. HCPs need to inform SMW and TQ patients that, even if they are not engaging in what is typically considered heterosexual or cis-normative sex, they could still be at risk for cervical dysplasia or cancer and should undergo cervical cancer screening according to current guideline recommendations. Screening for a history of or current IPV needs to be included.

Clinical breast exams need to be performed and screening mammography recommendations followed, even in patients who have had “top surgery” or a bilateral mastectomy because these individuals may have residual breast tissue. Because this topic may be a sensitive one, HCPs must allow adequate time to communicate openly and compassionately about it.

Enhance competence and understanding

Conferences and webinars on providing healthcare to LGBTQ patients, many with continuing education credit, are available from organizations such as the World Professional Association for Transgender Health, UCSF Center of Excellence for Transgender Health, The Fenway Institute, and Health Professionals Advancing LGBT Equality (formerly the Gay and Lesbian Medical Association). These organizations and others have developed vetted lists of articles, publications, and online training sessions that can be used as resources (Table). For HCPs seeking more intensive education in LGBTQ health, graduate certificate programs are available through institutions such as Drexel University in Philadelphia, The George Washington University in Washington, DC, and New York University in New York City.

Conclusion

Healthcare providers who manage the sexual and reproductive health concerns of heterosexual and cisgender women are used to providing sensitive and compassionate care during vulnerable stages throughout the lifespan. They need to expand their knowledge and understanding, and acknowledge their implicit assumptions and biases, if they exist, in order to provide the same quality of care to SMW and TQ patients. These populations are often overlooked or “invisible” in healthcare settings, or they experience discrimination, stigma, and hostility, precluding their full access to and utilization of routine and preventive care.

Nationally representative research is needed to fully reveal the health disparities and risk factors that burden these populations. Curricula must be expanded to prepare future HCPs to adequately address these concerns and provide competent and inclusive sexual and reproductive healthcare. HCPs need to use available evidence, create inclusive office environments, and commit to continuing education that expands knowledge about LGBTQ healthcare needs for themselves and their staff to help make a meaningful difference and have a beneficial effect in caring for these populations.

References

1. Coulter RWS, Kenst KS, Bowen DJ, Scout. Research funded by the National Institutes of Health on the health of lesbian, gay, bisexual, and transgender populations. Am J Public Health. 2014;104(2):e105-e112.

2. CDC. CDC Health Disparities and Inequalities Report – United States, 2011. MMWR Suppl. 2011;60(1):1-2.

3. The National Academies Press. The Health of Lesbian, Gay, Bisexual, and Transgender People: Building a Foundation for Better Understanding. March 31, 2011.

4. Obedin-Maliver J, Goldsmith ES, Stewart L, et al. Lesbian, gay, bisexual, and transgender-related content in undergraduate medical education. JAMA. 2011;306(9):971-977.

5. Morrison S, Dinkel S. Heterosexism and health care: a concept analysis. Nurs Forum. 2012;47(2):123-230.

6. Tornello SL, Riskind RG, Patterson CJ. Sexual orientation and sexual reproductive health among adolescent women in the United States. J Adolesc Health. 2014;54(2):160-168.

7. Oshri A, Handley ED, Sutton TE, et al. Developmental trajectories of substance use among sexual minority girls: associations with sexual victimization and sexual health risk. J Adolesc Health. 2014;55:100-106.

8. McCauley HL, Silverman JG, Decker MR, et al. Sexual and reproductive health indicators and intimate partner violence victimization among female family planning clinic patients who have sex with women and men. J Womens Health (Larchmt). 2015; 24(8):621-628.

9. Matthews AK, Cho YI, Hughes T, et al. The relationships of sexual identity, hazardous drinking, and drinking expectancies with risky sexual behaviors in a community sample of lesbian and bisexual women. J Am Psychiatr Nurses Assoc. 2013;19(5):259-270.

10. Herrick A, Kuhns L, Kinsky S, et al. Demographic, psychosocial, and contextual factors associated with sexual risk behaviors among young sexual minority women. J Am Psychiatr Nurses Assoc. 2013;19(6):345-355.

11. Estrich CG, Gratzer B, Hotton AL. Differences in sexual health, risk behaviors, and substance use among women by sexual identity: Chicago, 2009-2011. Sex Transm Dis. 2014; 41(3):194-199.

12. Lindley LL, Barnett, CL, Brandt HM, et al. STDs among sexually active female college students: does sexual orientation make a difference? Perspect Sex Reprod Health. 2008; 40(4):212-217.

13. Waterman L, Voss J. HPV, cervical cancer risks, and barriers to care for lesbian women. Nurse Pract. 2015; 40(1):46-53.

14. Charlton BM, Corliss HL, Missmer SA, et al. Influence of hormonal contraceptive use and health beliefs on sexual orientation disparities in Papanicolaou test use. Am J Public Health. 2014;104(2):319-325.

15. McRee A-L, Katz ML, Paskett ED, Reiter PL. HPV vaccination among lesbian and bisexual women: findings from a national survey of young adults. Vaccine. 2014;32(37):4736-4742.

16. Clavelle K, King D, Bazzi AR, et al. Breast cancer risk in sexual minority women during routine screening at an urban LGBT health center. Womens Health Issues. 2015;25(4):341-348.

17. Green ER, Maurer, L. Teaching Transgender Toolkit: A Facilitator’s Guide to Increasing Knowledge, Decreasing Prejudice and Building Skills. Ithaca, NY: Planned Parenthood of the Southern Finger Lakes; 2015.

18. Stroumsa D. The state of transgender health care: policy, law, and medical frameworks. Am J Public Health. 2014;104(3):e31-e38.

19. World Professional Association for Transgender Health. Standards of Care for the Health of Transsexual, Transgender, and Gender Nonconforming People, Version 7.

20. Bradford J, Reisner SL, Honnold JA, Xavier J. Experiences of transgender- related discrimination and implications for health: results from the Virginia Transgender Health Initiative Study. Am J Public Health. 2013; 103(10):1820-1829.

21. Light AD, Obedin-Maliver J, Sevelius JM, Kerns JL. Transgender men who experienced pregnancy after female-to-male gender transitioning. Obstet Gynecol. 2014;124(6):1120-1127.

Web resources (Table)

E. lgbt.ucsf.edu/lgbt-education-and-training

F. http://transhealth.ucsf.edu/

G. glma.org/index.cfm?fuseaction=Page.viewPage&pageId=534

H. fenwayhealth.org/the-fenway-institute/

I. mazzonicenter.org/training-and-resources

J. straightforequality.org/Healthcare

K. wpath.org/site_page.cfm?pk_association_webpage_menu=2577&pk_association_webpage=6633

L. hrc.org/hei/the-national-lgbt-health-education-center#.VttJLVKzWu4

Drugs in pregnancy, lactation, and reproductive health: Standards for prescribers

In June 2015, the FDA updated its recommendations for the labeling of drugs with respect to their use by pregnant women, lactating women, and females and males of reproductive potential. Healthcare providers caring for these populations, many of whom are taking prescription medications and biologics, need to be alert to these labeling changes.

Between 64% and 94% of pregnant women use a prescribed medication during their gestation.1,2 Among pregnant women who take prescribed medications, 80% do so during the first trimester,3 when fetal organ systems and structures are being formed. For many women who are managing chronic diseases, discontinuing the medications is not an option. In addition, because more than 50% of pregnancies in the United States are unintended,4 a large group of women are exposing their fetus to medications before they even realize that they are pregnant.

For postpartum patients on medications for chronic conditions, the choice to breastfeed their infant may pose a dilemma. Many of these women are advised to bottle-feed their infants instead, even if they are using medications safely taken by lactating women.5 Likewise, women who become ill during the lactation period may be counseled to stop breastfeeding their child if they need to take certain medications. According to the Centers for Disease Control and Prevention, 77% of infants born in the United States in 2010 were breastfed.6 During the same year, breastfeeding rates were 49% at 6 months and 27% at 1 year. Because many breastfeeding mothers are using prescription medications, these statistics translate to hundreds of thousands of infants potentially being exposed to these same medications for prolonged periods of time.

For reproductive-aged women who could become pregnant, counseling with regard to the potential impact of prescription or over-the-counter medications on pregnancy is often lacking. In the case of drugs that are known teratogens, past research indicates that women who had them prescribed, compared with women for whom safer medications were prescribed, did not receive contraceptive counseling in greater numbers.7 The impact of certain drugs on fertility, including chemotherapeutic medications, may not be discussed unless the effects are catastrophic. Finally, there is scant information on the need for reproductive health counseling for men in terms of medication use. Available counseling has often focused on the impact of illicit drugs on male factor infertility.8

Role of the FDA

The thalidomide tragedy, as it developed in the late 1950s and early 1960s in Europe, provided the impetus for tighter regulation of drugs by the FDA in the United States. In 1979, the FDA adopted a labeling system  hat rated drugs for pregnant women using the well-known letter system: A, B, C, D, or X. At the time, the FDA did not provide a risk classification system for drugs taken during lactation. Pregnant women and nursing mothers were considered under the precaution areas of the counseling for medication use.9

Early in 1996, the FDA determined that the letter system was too simplistic.3 In addition, many drugs were allocated to different risk categories, depending on how the results of safety studies were being interpreted,10 resulting in confusion for healthcare providers (HCPs) and patients alike. The Teratology Society asked the FDA to develop a more comprehensive risk counseling strategy that would encompass all stages of the childbearing process.Changes to the system were proposed in 2008, and multiple public hearings and comment periods ensued. The Pregnancy and Lactation Labeling Rule (PLLR) was adopted and published in December 2014. Immediate compliance with the labeling rule has been required for all prescription drug and biologic products submitted to the FDA after June 30, 2015; phased-in compliance over 3-5 years is required for previously approved prescription drugs and biologics.11

The 2015 Pregnancy and Lactation Labeling Rule.12

The PLLR requires changes to the content and format for information presented in prescription drug labeling in the Physician Labeling Rule format to assist HCPs in assessing benefit versus risk and in subsequent counseling of pregnant women and nursing mothers who need to take medication, thereby enabling them to make informed decisions for themselves and their children. Subsections for pregnancy, lactation, and females and males of reproductive potential are required in the Use in Specific Populations section. Pregnancy letter categories have been removed.

Pregnancy subsection

Specific subheadings required in the pregnancy subsection include contact information for a pregnancy exposure registry for the drug (if one is available), a risk summary, clinical considerations, and available human and animal data. Some subheadings may be excluded if no relevant information is available.

Risk summary

This subheading is always required. If a drug is contraindicated in pregnancy, this fact must be listed first. Statements that describe risks for adverse developmental outcomes based on relevant human data, animal data, and the drug’s pharmacology are required. A cross-reference to additional details in the data subheading is included when applicable. Drugs not absorbed systemically following a particular route of administration include a statement that maternal use is not expected to result in fetal exposure to the drug. Drugs with more than one route of administration must include information related to each route.

Clinical considerations

This subheading provides information to further assist HCPs in prescribing decisions and risk–benefit counseling. When relevant, this subheading includes information about disease-associated maternal and/or embryo/fetal risk, dose adjustments during pregnancy and postpartum, maternal adverse reactions, fetal/neonatal adverse reactions, and labor/delivery. Inclusion of any disease -associated maternal and/or embryo/fetal risks is important for patient counseling and informed decision making. After all, HCPs and patients need to weigh the risks and benefits of not treating a disease/condition in pregnancy (e.g., depression, hyperlipidemia) versus the risks and benefits of taking a given drug during pregnancy.

When pharmacokinetic data support dose adjustment during pregnancy and/or postpartum, a summary of this information is provided. When applicable, cross-referencing to other labeling sections (e.g., Clinical Pharmacology, Dosage and Administration) for additional information is included.

Drug-associated adverse reactions that are unique to pregnancy or that occur with increased frequency or severity in pregnant women are described. When available, information on any clinical interventions to monitor or reduce maternal drug-associated adverse reactions is provided.

The fetal/neonatal adverse reactions described in this subsection are those based on the drug’s pharmacologic activity. The potential severity and reversibility of the adverse reaction, as well as interventions for monitoring and mitigation of the adverse reaction, are included.

If a drug is expected to affect labor or delivery, the labeling must provide available information about the drug’s effects on the mother, the fetus/neonate, and the duration of labor and delivery. An example is the use of an opioid during labor that may cause respiratory depression in the neonate. The labeling information includes the effect of dose, timing, and duration of exposure on the risk to the neonate and the use of naloxone to mitigate the reaction.

Data

Data that provide the scientific basis for the information in the risk summary and clinical consideration subheadings are included. Human and animal data are presented separately. Data regarding adverse developmental outcomes, adverse reactions, and other adverse events related to the drug must be included.

Lactation subsection

This subsection must include a risk summary, applicable clinical considerations, and any available human and animal data. The term lactation refers to the biologic state during which the body produces and excretes milk. The term breastfeeding is used to refer to all human milk, whether received directly from the breast or as expressed milk.

Risk summary

This subheading is always required. If a drug is contraindicated during breastfeeding (e.g., radioisotopes), this fact must be stated first. Drugs not absorbed systemically by the mother following a particular route of administration must include a statement that maternal use is not expected to result in the child’s exposure to the drug during breastfeeding. Drugs with more than one route of administration must include information related to each route. For drugs absorbed systemically, available information on whether the drug and/or its active metabolites are present in human milk, effects of the drug on the breastfed child, and effects of the drug on milk production and/or excretion must be included. If a drug and/or its active metabolites are present in human milk, detailed information on actual or estimated infant daily dose based on exclusive breastfeeding  must be provided. The risk summary must acknowledge when data are lacking.

Clinical considerations

A description of ways to minimize exposure of the breastfed child to systemically absorbed drugs that are used intermittently, in a single dose, or short term must be included. This description may include information on timing of administration of the drug relative to feeding, pumping sessions, or expressing for discarding. Specified time periods are based on the half-life of the drug and/or its active metabolite(s). Information on monitoring for adverse reactions must be included if available.

Data

As with the pregnancy subheading, data on which the risk summary and clinical considerations are based for lactation and breastfeeding are provided.

Females and males of reproductive potential subsection

This subsection is included if there are human or animal study data of potential drug-associated effects on fertility and/or pre-implantation loss. Recommendations for pregnancy testing and/or contraception may be based on concerns for adverse developmental outcomes if the drug is taken during pregnancy.

Relevance to practice

Healthcare providers can use the information provided in the new labeling to be better informed and enhance discussions about the benefits and risks of specific drugs with women who are pregnant or lactating or with patients of reproductive potential. The information contained in the PLLR may or may not be the same as that included in patient drug information.

Providers can utilize websites, mobile apps, and reference texts to focus counseling or answer patients’ questions (Table). These resources may be especially useful until the PLLR changes are fully implemented, as well as for supplemental information. As always, HCPs can consult with pharmacists regarding the pharmacokinetics and pharmacodynamics of a drug.

Kathleen M. Mahoney is a perinatal clinical nurse specialist at Robert Wood Johnson University Hospital in New Brunswick, New Jersey. The author states that she does not have a financial interest in or other relationship with any commercial product named in this article.

References

1. Ramoz LL, Patel-Shori NM. Recent changes in pregnancy and lactation labeling: retirement of risk categories. Pharmacotherapy. 2014;34(4):389-395.

2. Fantasia H, Harris A. Changes to pregnancy and lactation risk labeling for prescription drugs. Nurs Womens Health. 2015;19(3):266-270.

3. Mazur-Amirshahi M, Samiee-Zafarghandy S, Gray G, Van den Anker JN. Trends in pregnancy labeling and data quality for US-approved pharmaceuticals. Am J Obstet Gynecol. 2014;211(6):690e1-11.

4. Guttmacher Institute. Unintended Pregnancy in the United States. March 2016.

5. Saha MR, Ryan K, Amir LH. Postpartum women’s use of medicines and breastfeeding practices: a systemic review. Int Breastfeed J. 2015;10(28):1-10.

6. Centers for Disease Control and Prevention. Breastfeeding Report Card, 2013.

7. Schwartz EB, Postlethwaite DA, Hung YY, Armstrong MA. Documentation of contraception and pregnancy when prescribing potentially teratogenic medications for reproductive age women. Ann Intern Med. 2007;147(6): 370-376.

8. Fronczak CM, Kim ED, Barqawi AB. The insults of illicit drug use on male fertility. J Androl. 2012;33(4):515- 528.

9. Mosley JF 2nd, Smith LL, Dezan MD. An overview of upcoming changes in pregnancy and lactation labeling information. Pharm Pract (Granada). 2015;13(2):605.

10. Addis A, Sharabi S, Bonati M. Risk classification systems for drug use during pregnancy: are they a reliable source of information? Drug Saf. 2000;23(3):245-253.

11. Food and Drug Administration. Pregnancy and Lactation Labeling (Drugs) Final Rule. December 3, 2014.

12. Food and Drug Administration. Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products — Content and Format. Washington, DC: Food and Drug Administration; 2015.

Web resources

A. reprotox.org

B. toxnet.nlm.nih.gov/newtoxnet/lactmed.htm

C. mothertobaby.org/fact-sheets-parent