Challenges to Contraceptive Coverage in the Affordable Care Act

The Affordable Care Act (ACA) has been one of the most highly debated health care changes in recent years, with millions of people both for and against its legislation.  One of the most controversial topics in the act is the  provision that covers contraceptives for women covered by private insurance companies.  Many would argue that this is a long overdue step, and a basic right to women to control their risk of pregnancy.  Although the act has proven beneficial to many women, there are still a number of barriers to accessing appropriate methods of contraceptives for many women.  A recent article published in JAMA attempted to look at the challenges that still remain and explore potential solutions to these problems so that more women are able to have free access to the contraceptives that are best for them.

Under the ACA, women with privately covered health insurance have the right to access FDA approved methods of contraception, sterilization procedures, and counseling without any patient costs.  Already, it has shown to provide free contraceptives to millions of women who may have otherwise struggled to pay for the expenses themselves. However, this does not apply to medicare covered women, follow-up appointments or services, and management of any side effects from the contraceptive methods.  It also failed to cover emergency contraceptives, like Plan B, or any contraceptive methods for men like condoms and vasectomies.  Also, the new provisions are met with resistance from insurance companies who limit the options available without cost sharing, fail to cover contraceptive use with a medical indication besides preventing pregnancy, and fall short on covering many of the procedures and services that surround contraception use.  To compound the issue, there is remarkable confusion about appropriate billing codes by patients and physicians to ensure care coverage, and obtaining coverage for diagnostic costs and out-of-network care.  The article suggests that changes to the act are needed to better define what is covered and what is not billable under certain health care plans.  Also, attention is needed to ensure that insurance companies are compliant with the new laws and clear about their coverage.

This issue is very complex, and no solution to such a multifaceted problem will be quick or simple.  As future pharmacists, it would be beneficial to investigate the problem, its limitations, and ways to use the role of medication expert to help women navigate the system and get the care that they are entitled to.  Anyone who has worked in a community pharmacy understands the struggles with obtaining coverage from private insurance companies, and can sympathize with the barriers that exist to some women to get contraception that they need at a price they can all afford. I am sure there are ways that professionals from the pharmacy field can contribute to solving the gaps in the ACA contraception coverage, any ideas?

 

Article Link

Politi MC, Sonfield A, Madden T. Addressing Challenges to Implementation of the Contraceptive Coverage Guarantee of the Affordable Care Act. JAMA. Published online February 01, 2016. doi:10.1001/jama.2016.0204.

New Study Links Usage of Tylenol during Pregnancy and Infancy to Asthma in Children

Paracetamol, also known as acetaminophen (APAP), or as many people recognize it, Tylenol®, is the recommended analgesics for pregnant women and for infants. However, recent studies have shown that prenatal and infant exposure to APAP could include a higher risk for that child developing asthma. As the second most chronic child-hood disease, it is important to study what may be causing asthma and how we can prevent it. Using data from the Norwegian Mother and Child Cohort Study, 53,169 children were included in the analysis. The study found modest associations between asthma at 3 years old with prenatal APAP exposure and the use of APAP during infancy. However, maternal and paternal usage of APAP outside of pregnancy did not show any association with asthma development. Because APAP is the most suggested pain reliever in pregnant women and infants, it is important to uncover potential adverse effects of its wide usage. I feel that this study has made the first steps in researching the effects of a commonly used drug that is widely accepted as safe. Do you think we should continue to spend money and time researching drugs that have been determined safe and used so prevalently over the past 60+ years, or focus our time and attention on new and up-coming drugs?

Link

Magnus, Mc., Karlstad, O., Haber, SE., et al. Prenatal and infant paracetamol exposure and development of asthma: the norwegian mother and child cohort study. Int. J. Epidemiol. Published ahead of print: February 9, 2016.

Antidepressants Taken by Pregnant Woman and the Risk of Autism in her Child

Autism spectrum disorder has no known single cause for its occurrence, but it is known to result from some sort of abnormality in the brain. Some studies suggest that it is genetic, however, a gene has not been identified to cause autism. It is also thought that babies may be born susceptible to autism, but there is no trigger that has been identified. One theory of autism is mothers using harmful substances while pregnant.

This study aims to uncover if antidepressants in pregnant mothers constitutes a harmful substance to the baby and therefore causes autism. This is a controversial topic, because the mother is put in a tough spot. The study was register-based of an ongoing population-based cohort in Quebec from January 1, 1998 to December 31, 2009. 145, 456 babies were born during this time. The study classified the different antidepressants into class as well as what trimesters they were used in. The average age of the children studied was 6.24 years old. About 1,054 of these children had a diagnosis of autism, which is about 0.7%. There were 4 boys to every 1 girl diagnosed. 31 infants were exposed to antidepressants during the second or third trimester, and the hazard ratio was 1.87. Specifically, 22 infants were exposed to SSRIs, and this caused the health ratio to be 2.17. It was concluded that antidepressants, especially SSRIs, do increase the risk of having an autistic child if the medication is taken during the second or third trimester. More research is needed to figure out why.

I think this is such a hard decision for a mother that suffers from depression, because she needs to decide if she can handle her mental health without medication for the sake of her child. Relapse into depression may also be harmful for her baby though. The percentage of babies born with autism was relatively small, however, I would not want to take that risk with my baby. Would you choose to suffer depression or take your chances with your baby? Are there other treatment options for depression that would not harm the baby?

Boukhris T, Sheehy O, Mottron L, Bérard A. Antidepressant Use During Pregnancy and the Risk of Autism Spectrum Disorder in Children. JAMA Pediatr. 2016;170(2):117-124. doi:10.1001/jamapediatrics.2015.3356.

The Pharmacist’s Role in Preventing Infant Mortality in the United States

Although a very advanced country, the United States has one of the worst infant mortality rates amongst the industrialized countries of the world. Infant mortality is defined as a child who is born alive but dies within its first year of life. The three main causes in the U.S. of infant mortality are congenital malformations, deformations, and chromosomal abnormalities. When including infant injuries and maternal complications with pregnancy, these problems account for 60% of all infant mortalities. Luckily, there is something pharmacists can do to help improve mother and infant health through all stages of pregnancy.

Improving healthcare access has proven to be a positive factor for infant mortality throughout all living environments and income levels. Because pharmacists are one of the most accessible healthcare providers, we can intervene and educate future parents. Whether it is a planned pregnancy or unplanned, pharmacists are able to promote healthy lifestyles for the preconception period, pregnancy, and the postpartum period of a woman’s life. With free resources such as the Affordable Care Act that provide patient education, pharmacists can reach out to women promote a healthy lifestyle in the preconception period.

Pharmacists can also be available to help expecting mothers with their disease states, figuring out ways to monitor the disease without using medications that may harm the fetus. The pharmacist should obtain an extensive medication list, current and past, including herbal supplements and over-the-counter medications to best identify potential hazards for the mom and the child. It is then important in the postpartum period to educate the mother on vaccines the infant can receive to avoid common illnesses. In addition, pharmacists should emphasize the importance of the mother’s health postpartum, as there will be many changes in her body and life during this time.

Finally, and in my opinion most importantly, pharmacists can educate on contraceptives. Over half of the pregnancies in the United States are unplanned pregnancies, with half of the couples with unintended pregnancies stating they used a form of contraception in the month prior to conception. Educating on the proper use of contraception forms could help to lower the unplanned pregnancies, and in turn lower infant mortality rate. It only takes a five minute explanation from a pharmacist to help teach how to avoid an unplanned pregnancy, and the more pharmacists educate, the more the public will turn to them with further questions.

http://www.japha.org/article/S1544-3191(15)00013-8/fulltext

Mager, Natalie A. “Preventing Infant Mortality: Pharmacists’ Call to Action.” Journal of the American Pharmacists Association. Elsevier Inc. 2016. Web. 8 February 2016.

The Use of Oral Contraceptives in Pregnant Women and the Prevalence of Birth Defects

Oral contraceptives are the most common form of birth control around the world. Although they have a high rate of success, women who miss doses or take medications that decrease the effectiveness of birth control may be at an increased risk for pregnancy. Women are advised to discontinue oral contraceptives prior to trying to conceive, but what if a woman becomes pregnant while still taking the medication? Researchers in Denmark sought out to answer this question. The purpose of this study was to discover whether the use of oral contraceptives during the onset of pregnancy was correlated with a significantly elevated risk of birth defects. This prospective cohort study was conducted in Denmark, and included data on the use of oral contraceptives and 880,694 live births from January 1st, 1997 to March 31st, 2011.

The study looked at four groups of women: those who had never taken oral contraceptives (21% of women), those who quit taking oral contraceptives at least 3 months before pregnancy onset (69% of women), those who took oral contraceptives from 0-3 months before pregnancy onset (8% of women), and those who took oral contraceptives after the onset of pregnancy (1% of women). The results of the study looked at the number of major birth defects that were present per 1,000 live births per group of women. These numbers were 25.1, 25.0, 24.9, and 24.8, respectively. The research concluded that there is no significant risk of birth defects in women who were exposed to oral contraceptives after the onset of pregnancy, versus women who had never used oral contraceptives or who had discontinued use greater than three months prior to the onset of pregnancy.

I think this study is important because the results offers relief to women who may have become pregnant as a result of missing a dose of their oral contraceptive, and they’ve been continuing their medication up until they realize that they are pregnant. The results tell them that their child is not more likely to have a major birth defect. It is definitely reassuring to let the expecting mother know that they haven’t put their unborn child at risk. This is also an important teaching point for pharmacists who counsel women who are taking oral contraceptives. I think an interesting point to explore would be if other forms of contraception that are used during the onset of pregnancy are associated with the risks of birth defects.

Charlton BM, Mølgaard-Nielsen D, Svanström H, et al. Maternal use of oral contraceptives and risk of birth defects in Denmark: prospective, nationwide cohort study. BMJ. 2016;352:h6712. (Published 06 January 2016).

 

Effects of Oral Fluconazole Exposure in Pregnant Women

The purpose of this study was to research the possible correlation between pregnant women in contact with fluconazole and the occurrence of miscarriages and stillbirths. Fluconazole is a medication that is used to treat vaginal candidiasis. Typically, this medication is used topically, however an oral formulation can be used in certain cases. Pregnant women have a higher risk of contracting these yeast infections, and therefore may end up being prescribed an oral formulation of fluconazole.

The authors of this article conducted a retrospective cohort study of all pregnancies in Denmark between January 1, 1997 to December 31, 2013 that resulted in either a single live birth, stillbirth, miscarriage, or other form of abortion.  The study looked at pregnant women who were exposed to fluconazole between the gestational weeks of 7 weeks to birth. Specifically, the study was broken down into two two subcategories: pregnant women exposed to fluconazole between gestational week 7 and week 23, and pregnant women exposed to fluconazole between gestational week 7 to birth. Gestational week 23 was an important marker, because a pregnancy loss after this week was considered a stillbirth. The different doses of fluconazole that were prescribed to these women were also taken into account and were assessed in the study. Additionally, topical formulations of fluconazole prescribed to pregnant women were also compared to the prevalence of spontaneous abortions and stillbirths.

In total, 1,495,663 pregnancies were included in this study. Steps were taken to match pregnancies of women who were unexposed to fluconazole versus those who were exposed to fluconazole during their pregnancy. The women were matched via an algorithm based on factors such as their age and the gestational age, and only matches with a standardized difference of 10% or less were considered viable. The study concluded that women who took an oral formulation of fluconazole while pregnant had a higher risk of having a spontaneous abortion between gestational week 7 through week 22 compared to women who had used a topical formulation of fluconazole or had been unexposed. There was no significantly increased risk of a pregnancy ending in a stillbirth as a result of an exposure to oral fluconazole, although the rarity of this event could have resulted in inaccurate representation. The authors of this study recognize that there are additional factors that they could not necessarily account for. For example, they could not count spontaneous abortions that occurred prior to gestational week 6, because “many vary early pregnancy loss are not recognized clinically.” The authors also mention that severe cases of vaginal candidiasis could possibly result in pregnancy loss, so these losses may not have been due to the use of fluconazole.

Although the authors admit that more research should be done on this matter, the evidence presented in this study is enough to convince me that oral fluconazole should not be prescribed to pregnant women. Research like this is important because further studies can hopefully help to prevent the loss of pregnancies. It is also interesting to see how different formulations of the same medication can have different effects: the oral formulation had a significant increased risk of miscarriage, while the topical formulation was not associated with any higher risk that a women who had been unexposed to oral fluconazole.

Mølgaard-Nielsen D, Svanström H, Melbye M, et al. Association Between Use of Oral Fluconazole During Pregnancy and Risk of Spontaneous Abortion and Stillbirth. JAMA. doi:10.1001/jama.2015.17844 (published 5 January 2016)

Potential Risks to Mother and Fetus with Use of Psychotropic Medications

Chisolm and Payne conducted a literature review to summarize the known and unknown risks of using psychotropic drugs during pregnancy. 15% of pregnant women have a psychiatric illness and 10% to 13% of fetuses are exposed to a psychotropic medication. Studies showed that many women relapsed if their medications were discontinued during pregnancy. It was found that most classes of psychotropic drugs are relatively safe to the fetus during pregnancy. A risk-benefit analysis should be conducted to determine if the risks associated with the drug or untreated psychiatric disorder are worse.

CYP1A2 enzymes are down-regulated in pregnant women so medications such as olanzapine and clozapine require a lower dose. Additionally, these medications have an increased risk for maternal weight gain, increased infant birth weight, and gestational diabetes, so ultrasound monitoring of fetal size may be beneficial in late pregnancy. High potency first generation antipsychotics are recommended over low potency first generation antipsychotics to minimize maternal anticholinergic, hypotensive, and antihistamine effects. Second generation antipsychotics are no safer than first generation antipsychotics and may have an increased risk of high infant birth weight and hypoglycemia.

There is still an inadequate amount of literature on the safety of antipsychotic use in pregnant women. Focus should be emphasized on drug management during pregnancy, including before and after delivery. The psychotropic medications should not be suddenly discontinued, and a comprehensive treatment plan should be developed for women to ensure quality and safe care to the mother and developing fetus.

BMJ. doi: http://dx.doi.org/10.1136/bmj.h5918 (published 20 Jan. 2016).

There is still not enough evidence to completely decide which antipsychotics are safe during pregnancy. What other medications could potentially be safe during pregnancy but are often discontinued due to a lack of research? And why?