To Protect Access To Medication Abortion In The US, Make The Misoprostol-Only Regimen A Reality

According to the US Supreme Court Dobbs v. Jackson Women’s Health Organization Decision overruled at the end of June Roe v. calf, the United States joins 126 countries around the world that have restrictive frameworks on access to abortion. As of September 9, all or most abortions are already illegal in 12 states, two others were legal just six weeks ago, and 10 others are inaccessible. At least 10 other state-level bans are either underway or temporarily blocked. Together, these laws mean that many pregnant women do not have access to this vital health service. And despite limited legal, legislative, or administrative ability to respond to new restrictions, the Biden administration has made protecting medical abortion — the use of pills to terminate a pregnancy — one of its top priorities.

To achieve this goal, US health officials, medical institutions, pharmaceutical companies, and advocates must work to support, register, and approve a misoprostol-only regimen for medical abortion before 13 weeks of gestation. Equally important, they must also allow the drug to be prescribed by pharmacists and dispensed at any pharmacy, especially in states where abortion-on-demand is available.

These steps may sound unprecedented, but in reality they align with international standards for existing clinical practices. The latest World Health Organization (WHO) abortion guidelines recommend misoprostol-only therapy for termination of pregnancy before 13 weeks due to the drug’s high efficacy and excellent safety profile. Surveys conducted in Africa, Asia and Latin America show that pregnant women regularly use pharmacy-prescribed and dispensed misoprostol-only therapy in both restrictive and non-restrictive settings.

Advantages of a one-drug regimen for medical abortion

Currently, the Food and Drug Administration (FDA) has only approved combination therapy of misoprostol with the progesterone blocker mifepristone for medical abortion. Federal guidelines now allow delivery of the drugs through the mail; However, 19 states still require them to be delivered and administered in person. Additionally, many states severely restrict the latter drug’s availability by requiring prescriptions from clinicians licensed by the drug’s manufacturer — a relatively small group. While experts argue that personal filing and administration policies are both unjustified and overly onerous, they face active legal challenges for these reasons, they are unlikely to be lifted in the near future. Additionally, mifepristone is expensive to use, with uninsured patients paying an average of more than $500 for a medical abortion. (A single mifepristone pill costs about $90, with the rest of the cost coming from clinic visits, testing, and other processes.)

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In contrast, the standard price of a misoprostol pill in the US is $2 to $5, or $8 to $20 for a full dose. The misoprostol regimen is also simpler. The current procedure involves a 200 mg oral dose of mifepristone followed by four 200 mg misoprostol tablets taken 24-48 hours later buccally (i.e. in the cheek), sublingually or vaginally. The pure misoprostol alternative only requires the administration of the misoprostol pills.

These circumstances make misoprostol a more attractive option. It’s easier, cheaper, less stressful, just as safe and just as effective. It is used for medical abortions in many parts of the world and for this reason in particular it has been recognized by the WHO as an essential medicine since 2005.

Adoption of a misoprostol-only regimen as an alternative to medical abortion, and making it more widely accessible than the current mifepristone-plus-misoprostol regimen, would expand choice and improve access to safe, self-administered, and reliable early medical abortion in the face of ongoing medical abortion attacks on and restrictions on abortion rights.

Step 1: Approve a misoprostol-only regimen for medical abortions

Currently, the FDA has only approved misoprostol for the treatment of stomach ulcers. The first step in expanding access to medical abortion is for the FDA to approve misoprostol for terminating pregnancies. The drug has 10 major manufacturers, some combinations of which must submit a new drug application to the FDA in order to get misoprostol approved as a standalone abortion drug.

This is extremely achievable. Misoprostol-only therapy has been used internationally for decades. There are already a wealth of high-quality studies on the effectiveness of misoprostol alone in abortion, including large-sample randomized controlled trials from reputable institutions. A recent meta-analysis of 42 studies (and more than 13,500 participants combined) showed that self-treatment of misoprostol alone exhibits a high level of efficacy, with 93 percent to 99 percent of participants reporting complete termination of pregnancy without the need for surgical intervention. Side effects are usually limited to cramping and bleeding, with more serious complications (such as more bleeding eventually requiring surgery to complete the abortion) being easily recognized at home and occurring in less than 0.2 percent of cases .

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The increasing use of medical abortions and the safety and effectiveness of misoprostol-only therapy demonstrate that the drug can be widely used in the United States. This large potential market of consumers desiring medical abortions should provide ample motivation for manufacturers to take the necessary steps.

Step 2: Allow pharmacists to prescribe and dispense the misoprostol-only regimen

The misoprostol-only regimen, like the combined mifepristone-plus-misoprostol regimen, can be easily taken at home. Given the safety and effectiveness of medical abortions, the WHO recommends this option for medical abortions rather than taking the pills in a hospital or clinic to reduce the burden on healthcare systems. Home use is supported by simple, reliable gestational age self-assessment tools along with simple instructions. There is ample data showing that home self-administration has the same safety profile as in-clinic administration under physician supervision.

With this in mind, achieving the Biden administration’s goal for accessible medical abortion requires misoprostol to be both prescription and dispensing at every pharmacy. These measures would make medical abortion more available and accessible in a number of ways.

First, it would mitigate the impact of abortion bans and restrictive state-level laws. For example, a pregnant person living in Indiana — the first state to outright ban abortion after the Dobbs ruling — who was seeking a medical abortion could travel to Illinois, where on-demand abortion is available, and purchase a safe, effective one Abortion drugs in a pharmacy without having to face the delays, costs, and other challenges associated with navigating our unnecessarily over-medicated healthcare system.

Second, pharmacy-based prescribing would reduce the burdens associated with seeking abortion treatment, even in states with the strongest protections against abortion. Pharmacies are the first port of call for many Americans, and visits to pharmacies are far more common than visits to family doctors, particularly in underserved and rural areas. Pharmacist-prescribed medical abortions would result in less travel, less expense, and less time away from work or family.

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Finally, allowing pharmacies to dispense misoprostol for home use is a smaller change than it seems. This would be consistent with both standard medical practice in dozens of countries and how the drug is currently administered as part of mifepristone-plus-misoprostol combination therapy. In less restrictive states, patients are already self-administering the drugs at home. Pharmacy prescriptions for misoprostol would work as prescriptions for many other drugs currently do, including birth control, naloxone, and drugs for HIV prevention, smoking cessation, and travel.

Pharmacists would need to be trained on treatment indications, side effects and risks, patient instruction, and the legality and acceptability of over-the-counter abortifacients. Information would need to be freely available from government sources (alongside existing guidance from organizations such as Planned Parenthood and local advocacy groups), including public health campaigns in multiple languages ​​and with pictorial guidance. These processes are all relatively commonplace and easy to implement.

Adapting to a post-Roe America

Policymakers and advocates must brace themselves for years or even decades of restrictions on reproductive health care without federal protections for abortion rights. Despite these circumstances, our health policy around abortion must find ways to ensure the widest possible access and choice of care without relying on the possibility of eventual federal protection.

To that end, advancing misoprostol-only therapy for medical abortion would have a huge impact on access to care, particularly for pregnant people who are forced to cross state borders to receive treatment. The effort will require the commitment and ambition of the private sector, the input of advocates and activists, and the advice of experts from medical professional associations, all brought together by the Biden administration’s determination to achieve its goals. If our nation is truly committed to protecting access to abortion in the US, it should seek the misoprostol-only regimen.

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