Pharmacists Are Key Access Point for Patients Amid Alabama Ruling on IVF

According to study findings published in Reproductive Sciences, in vitro fertilization (IVF) is a quickly growing reproduction method for individuals who are faced with infertility, with an estimated nearly 10% of all children conceived through IVF in the near future.¹ Pharmacists have a unique and important role in assisted reproductive technology, which includes IVF. Pharmacists serve as a key access point on educating patients about their medication usage during the IVF process.

Approximately 1 in 6 individuals globally experienced infertility at some stage of their life from 1990 to 2021, according to the World Health Organization. The lifetime prevalence, defined as those who experienced infertility at any time in their life, was estimated to be 17.5% and the period prevalence, defined as individuals who experience infertility at any given interval of time, was approximately 12.6%, according to the study. The lifetime infertility rate in North and South America was approximately 20% and the period infertility rate was 10.4%. Furthermore, there was little difference between high-income and middle- and low-income countries at 17.8% and 16.5% lifetime infertility, respectively, and 12.6% for period infertility in both.²

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According to Apthorp, a fertility prescription service, prescription medicine is necessary at various stages in IVF, and the proper medication must be taken at the correct time.³ Most fertility clinics have a pharmacist who specializes in reproductive health and is well versed in each drug, medication use, and potential adverse events. Their role is to help educate individuals regarding the usage of the medication and address any issues that may arise, including issues with adherence, according to the Apthorp website.^3,4

Drugs for IVF treatment include gonadotropins, which can increase hormones to produce eggs in the body via injection over several days. Prescriptions can also include clomiphene citrate, dopamine agonists, and gonadotropin-releasing hormone analogs, and a missed dose can affect the overall success rate of IVF.⁴

New legal challenges in Alabama, however, are having a drastic effect on IVF in the state. The Alabama Supreme Court has ruled that extrauterine embryos (i.e., embryos created and frozen before implantation in IVF) are considered children under the state’s Wrongful Death of a Minor Act.⁵

This has caused multiple infertility clinics to pause their IVF procedures due to “fear that their patients and doctors could face prosecution or punitive damages,” according to a press release from RESOLVE: The National Infertility Association. This included the University of Alabama at Birmingham, according to the release.⁶

According to Goodwin Procter LLP, the case included 3 couples who received IVF treatment at The Center for Reproductive Medicine, which included the creation of multiple embryos with some being implanted and some remaining in cryogenic storage. In 2020, after an unauthorized individual removed the embryos improperly, they were destroyed, causing the couples to sue the hospital and the IVF clinic under the Wrongful Death of a Minor Act.⁷ Due to the state supreme court ruling, there could be implications for other IVF clinics in Alabama to be held liable for wrongful death of a minor due to the destruction of the extrauterine embryos. There is a potential for other states to make similar rulings.⁷

This ruling has many implications and potential barriers for IVF clinics, personnel, and pharmacies that work with infertility and IVF therapy. According to Goodwin Procter LLP, potential scrutiny could come from regulators in Alabama including audits, investigative authorities, and inquiry into facility security, internal protocols, security measures, and storage.⁷ It is essential for pharmacists, who are more accessible to patients than fertility physicians,³ to be aware of these developments regarding IVF policy Alabama as well as other states. This allows them to be able to answer and ease any questions or concerns from patients who may not be as well versed in these implications and require more assistance to make informed decisions.

References

1. Kushnir VA, Smith GD, Adashi EY. The Future of IVF: The New Normal in Human Reproduction. Reprod Sci. 2022;29(3):849-856. doi:10.1007/s43032-021-00829-3

2. World Health Organization. Infertility prevalence estimates, 1990–2021. 2023. Accessed February 26, 2024. https://iris.who.int/bitstream/handle/10665/366700/9789240068315-eng.pdf?sequence=1

3. Apthorp. IVF Medication: Your Pharmacist’s Role in Assisted Reproductive Technology. Accessed February 26, 2024. https://apthorprx.com/fertility-medication/ivf-medication-your-pharmacists-role-in-assisted-reproductive-technology/#:~:text=A%20pharmacist%20can%20be%20a,safest%20location%20on%20the%20body

4. Apthorp. Fertility Medication and Your Pharmacist: 3 Helpful Questions to Ask. Accessed February 26, 2024. https://apthorprx.com/fertility-medication/fertility-medications-your-pharmacist-3-helpful-questions-to-ask/

5. FindLaw.com. Alabama Code Title 6. Civil Practice § 6-5-391. Updated December 30, 2022. Accessed February 27, 2024. https://codes.findlaw.com/al/title-6-civil-practice/al-code-sect-6-5-391/

6. Statement from RESOLVE on Pause of IVF Procedures at the University of Alabama at Birmingham. News release. February 21, 2024. Accessed February 27, 2024. https://resolve.org/statement-from-resolve-on-pause-of-ivf-procedures-at-the-university-of-alabama-at-birmingham/

7. Lee S, Santos JA, Wetzel M, Brendel AM. Alabama IVF Clinics: Potential Implications of the LePage Case. Goodwin Law. February 23, 2024. Accessed February 27, 2024. https://www.goodwinlaw.com/en/insights/publications/2024/02/alerts-lifesciences-hltc-lepage-implications