This story is republished from Louisville Public Media and the Kentucky Center for Investigative Reporting. Last St. Patrick’s Day, Dr. Jessica Adkins Murphy and her husband were happy to see a positive home pregnancy test because they were trying to grow their family. A couple months later, though, an OB-GYN diagnosed Murphy with a miscarriage.  Murphy, an emergency medicine doctor who lived in Lexington then, consulted with her OB-GYN on treatment options and decided on a two-medication regimen – mifepristone and misoprostol – that helps patients like her pass pregnancy tissue after an early loss.  However, that same medication combo also can induce an abortion, which is illegal in Kentucky. Murphy said her doctor warned her mifepristone, which is subject to special government regulations, might not be available.  “But I said … let’s just try to get it. Because I want to have the best chance possible of not having complications like retained products (of conception), and I want to preserve my fertility,” said Murphy, who detailed her experience to the Kentucky Center for Investigative Reporting.  Murphy went to UK HealthCare’s Good Samaritan Retail Pharmacy, like she would to pick up any other prescription. But the staff told her they could only give her misoprostol. It turned out, Murphy said, the pharmacy didn’t have a certification required by the U.S. Food and Drug Administration.  UK Healthcare’s Good Samaritan Hospital in Lexington. (UK Healthcare) A misoprostol-only treatment is also clinically recommended to treat an early pregnancy loss, but research shows higher efficacy when it’s taken with mifepristone. With mifepristone unavailable at the pharmacy, Murphy took the misoprostol alone, on her doctor’s advice. But the medication didn’t fully treat her miscarriage, which happens to some patients. Weeks later, she was hospitalized with sepsis, a life-threatening complication from the incomplete miscarriage.  “I didn’t get adequate miscarriage care because of this culture of fear that’s been created and because of unnecessary regulations that made it harder to get,” Murphy said. “And this is not how we should be practicing medicine for miscarriage in this century.”  Murphy’s experience highlights the risks women face when a mix of federal regulations, state laws and fear limits access to a miscarriage treatment supported by research and leading medical groups.  KyCIR interviewed more than a dozen people to learn more about mifepristone access for miscarriage care in Kentucky. The consensus: It’s legal to treat an early pregnancy loss with mifepristone, but patients have little chance of getting it from an in-state doctor or pharmacy.  Federal rules require physicians and pharmacies to get special certification to provide mifepristone to patients. And Kentucky’s anti-abortion laws — which threaten criminal prosecution, financial penalties and professional sanctions for violations – make many health care providers reluctant to offer mifepristone for miscarriage care because it’s also an abortion medication.  Dr. Coy Flowers is an OB-GYN and the immediate past chair of Kentucky’s chapter of the American College of Obstetricians and Gynecologists, a leading professional association.  Asked if it’s fair to say mifepristone is borderline inaccessible in the state for miscarriage care, he said, “scratch out the word ‘borderline.’”  Why mifepristone is used to treat miscarriages The FDA approved it in 2000 as an abortion medication, currently authorized for the first 10 weeks of pregnancy. Decades of research show mifepristone is safe and effective.  Doctors prescribe many medicines for unapproved, or off-label, uses. In mifepristone’s case, an off-label use is to prescribe it, along with misoprostol, to treat a miscarriage.  Research1 shows patients’ ability to get medical treatment for miscarriages is affected by anti-abortion laws because the same methods are used to induce abortions.  Dr. Nisha Verma, the American College of Obstetricians and Gynecologists’ senior advisor for reproductive health policy and advocacy, said patients have three standard options if they’ve retained pregnancy tissue after a miscarriage and are in stable condition.  Their options are:  Expectant management, where they wait to see if their body passes the tissue on its own.  Surgical management, where the tissue is removed through a procedure also used to provide abortions.  Medication management, which uses misoprostol alone or in combination with mifepristone. Mifepristone blocks the hormone progesterone, which is vital to continue a pregnancy. Misoprostol, also used to ward off stomach ulcers, causes contractions to help empty the uterus.  Verma said patients often opt for surgery or medication over expectant management.  “This is an emotional experience for a lot of people, and they don’t want to wait to have that unpredictable experience of not knowing when the pregnancy will pass, if it will pass,” she said.  For patients going the medication route, Verma said: “Both regimens are reasonable based on what is available, but the most effective method uses mifepristone and misoprostol.”  The American College of Obstetricians and Gynecologists’ guidance cites a 2018 study that showed the mifepristone-misoprostol regimen succeeded for 83.8% of women experiencing early pregnancy loss in a clinical trial, compared to 67.1% of women who received the misoprostol-only regimen.  The association recommends doctors prescribe the combined regimen if available, Verma said. But that’s the difficult part.  “When someone is going through this process of having a miscarriage, the ideal is to be able to offer the most effective method, but … mifepristone is not available for a lot of places and in a lot of situations,” she said.  Why mifepristone isn’t available at Kentucky retail pharmacies  When Murphy couldn’t get mifepristone at a pharmacy to treat her miscarriage, she said her OB-GYN figured out she could hand the medication directly to Murphy in the clinic. But the soonest appointment was two weeks out.  “My OB said she’d try to find a different time to come in. But she’s a surgeon. Like, she’s doing surgeries four out of five days of the week. And that’s common for OBs,” Murphy told KyCIR.  Consulting with her doctor, Murphy took the misoprostol alone, rather than wait. But that didn’t complete the miscarriage. She stayed in touch with her doctor. She was about to begin a fellowship at Harvard Medical School in Boston and planned to see a new OB-GYN after she made the move north.  But a few weeks later on the drive to Boston, she started having abdominal pain.  “With every, like, state line that I crossed, it was just getting more unbearable,” she said. “And I spiked a fever in upstate New York, and I couldn’t even walk because it was so painful. So my husband and I just sped to an ER there.”  A doctor diagnosed a life-threatening condition called sepsis – a complication from the incomplete miscarriage and a related infection. Murphy needed surgery, immediately.  “I just was in shock,” Murphy said. “My U-Haul is in the parking lot, my dog is in a hotel room and I’m in an OR (operating room) because I couldn’t get adequate treatment.”  A longstanding barrier to accessing mifepristone is a federal drug safety program that applies to very few medications. It’s called a Risk Evaluation and Mitigation Strategy, or REMS, instituted by the FDA.  FDA officials say REMS programs support patient safety, but prominent medical professional groups like the American College of Obstetricians and Gynecologists want the REMS regulations entirely removed for mifepristone, saying they unnecessarily restrict patients’ access to a useful and safe medication.  The FDA’s REMS for mifepristone requires health care providers get specially certified to prescribe mifepristone, while retail pharmacies need similar certification to dispense the prescribed medication to patients. Murphy said the UK pharmacy she visited wasn’t certified under the FDA program.  UK HealthCare officials want to change that by getting REMS certification for certain retail pharmacies, spokesperson Allison Perry told KyCIR in October.  “In prenatal care at UK, this medication would only be used for care in the case of a miscarriage, nonviable pregnancy or when the mother’s life is in danger, consistent with the law,” Perry said via email.  Murphy once worked for UK HealthCare and welcomed its move to get certified. She said she doesn’t blame UK or its staff for her difficulty getting mifepristone because broader, structural barriers are the problem. She spoke to KyCIR in her personal capacity, not as a former employee.  “I know they could face allegations of, you know, misusing mifepristone or using it for abortion,” she said. “So, I just appreciate that they have gone above and beyond in doing that.”  However, KyCIR learned UK’s application for certification to dispense mifepristone may not succeed. And in mid-January, UK HealthCare’s spokesperson told KyCIR the planned application to certify its Good Samaritan and Chandler Hospital retail pharmacies is on hold. The spokesperson said UK is waiting for the Kentucky Cabinet for Health and Family Services to provide clarification on state laws regarding outpatient use of mifepristone for miscarriage treatment.  Manufacturers for mifepristone, Danco Laboratories and GenBioPro, handle certifications for the FDA REMS program. Officials at both companies indicated a Kentucky anti-abortion law, 2022’s House Bill 3, likely prevents retail pharmacies from getting certified under the FDA REMS program.  “Because of this bill, I do not expect that any authorized distributors of mifepristone would be willing to certify a retail pharmacy in Kentucky,” Abby Long, a spokesperson for Danco Laboratories, told KyCIR via email.  She said no pharmacies have tried to get certified through the company. Long also cited two other decades-old Kentucky statutes as a barrier.  “Kentucky requires that only physicians can provide abortions,” she said via email. “This has the net effect of preventing pharmacies from being able to fill prescriptions for mifepristone, even if they are being used off-label for treating early pregnancy loss.”  However, a spokesperson for the Kentucky Pharmacists Association told KyCIR pharmacists can dispense a prescription for mifepristone to treat a miscarriage. The association cited a provision enacted under 2022’s anti-abortion House Bill 3 as permitting this. The Kentucky Board of Pharmacy’s executive director, Christopher Harlow, cited the same provision in an email to KyCIR.  Long, with Danco, said the manufacturer will provide the drug to certified providers as state law permits.  House Bill 3 was blocked by a federal court in Kentucky but took effect later in 2022 when the U.S. Supreme Court overturned the federal right to an abortion. Confusion about how anti-abortion laws affect access to treatments also used for miscarriage care is common, experts told KyCIR.  Former Kentucky Attorney General Daniel Cameron said in 2022 that Kentucky’s near-total abortion ban doesn’t apply to miscarriage treatment. But such guidance typically isn’t enough to reassure health care providers, according to Adrienne Ghorashi of Temple University’s Center for Public Health Law Research.  She pointed to practical barriers to providing mifepristone, like federal and state regulations, plus the chilling effect of anti-abortion laws that threaten criminal and financial penalties. “Those things all end up affecting access,” she said. “Even if legally, that is something that should be OK.”  The Kentucky Cabinet for Health and Family Services set up an Abortion-Inducing Drug Certification Program under House Bill 3. The program requires state registration of doctors and pharmacies to provide abortion medication in addition to the FDA REMS certification. KyCIR asked if the program applies to mifepristone if it’s used to treat a miscarriage.  A cabinet spokesperson did not directly answer the question via email, but did indicate the law could be interpreted as not applying to mifepristone prescriptions that are only for miscarriage treatment.  For now at least, it appears no Kentucky retail pharmacies have federal certification to fill mifepristone prescriptions. So if a patient prescribed mifepristone for their miscarriage can’t pick it up at a pharmacy, where else can they go?  Another option is to get it directly from the doctor who wrote the prescription. But doctors and abortion rights experts expect that rarely happens.  ‘Target on their back’  For many years, doctors had to hand mifepristone directly to patients under FDA rules, said Kirsten Moore, director of the EMAA Project, an advocacy group that pushes for expanding access to abortion medication.  “You had to be both the doctor and the pharmacist, and pre-purchase the medication and have it in your clinic to hand over to a patient,” she said. “But that burden … really limited the pool of prescribers.” That’s still an option, but the FDA also changed the rules over the past few years, saying pharmacies could dispense the medication and it could be mailed to patients. With no Kentucky retail pharmacies certified to dispense mifepristone, that leaves patients relying on their doctors to supply the medication.  But reproductive rights advocates and doctors say few physicians are probably willing to do that.  A big reason, they say, is the chilling effect created by anti-abortion laws. Kentucky’s main abortion ban says anyone, except for the pregnant woman herself, can be charged with a Class D felony for providing an illegal abortion.  Flowers, the Kentucky OB-GYN, said OB-GYNs like himself have been harassed or threatened with physical harm by some extreme opponents to abortion. And now state abortion bans threaten criminal penalties.  “You’re asking OB-GYNs to put an even bigger target on their back,” he said. He said very few doctors he knows want to put themselves, their family or their staff at risk.  Flowers and others said health care workers and institutions’ reticence to prescribe mifepristone for miscarriage care is compounded by the need to jump through regulatory hoops to provide the medication  “OB-GYNs are just trying to take care of patients every single day in their offices who come in and find themselves sometimes in really undesirable, tragic circumstances,” he said.  A victim of Kentucky  Like Murphy, Dr. Melissa Puffenbarger of Lexington also had trouble getting mifepristone after she had a miscarriage last year, while she and her husband were trying to have their second child. Puffenbarger told KyCIR she already was on “a long journey of recurrent miscarriage and infertility” by then.  Dr. Melissa Puffenbarger Surgical management of prior miscarriages caused scarring that affected her fertility, which Puffenbarger said is a rare complication. Because of her medical history, she tried medication management this time.  “I remember she (the OB-GYN) wrote me the prescription for mifepristone and misoprostol and said, ‘Mifepristone can be tricky to get,’” Puffenbarger told KyCIR. “And I in no way blame my obstetrician at all, for anything. But I wonder if even obstetricians know how to get their patients mifepristone.”  Puffenbarger works at UK HealthCare and tried to pick up mifepristone and misoprostol from a retail pharmacy at her workplace, where she sends prescriptions for her own patients. But they didn’t have mifepristone. Puffenbarger spoke to KyCIR in her personal capacity, not as an employee.  “I very much wanted the more effective regimen, the mifepristone plus misoprostol,” she said. “Allowing pregnant patients the opportunity to make their own choices really matters.”  She took misoprostol alone. Given her past difficulties recovering from miscarriages, she quickly followed up with her doctor and learned it hadn’t worked. Instead of taking a second dose of misoprostol, she had a dilation and curettage procedure to complete the miscarriage.  She said circumstances aligned for her to get quick follow-up evaluation and treatment, but she worries for other patients, like those living in rural areas where obstetric care often isn’t available closeby.  “This is where we run into the dangers of politicians interfering with medical care when they lack expertise and they don’t understand the nuances that each individual patient may have that affects their care and their medical decision making,” she said. Puffenbarger said she isn’t a victim of the local health care system. “I’m a victim of living in Kentucky,” she told KyCIR.  Moving forward, she and her husband are continuing their family-planning journey through in-vitro fertilization.  Murphy wants the Kentucky General Assembly to help patients get reliable access to mifepristone for miscarriage care through in-state doctors and pharmacies.  She said abortion-related policy debates are often polarized and politicized.  “But when it comes to this, I just really feel like there is an opportunity for bipartisan cooperation in favor of harm reduction,” she said.  Months after she recovered from her emergency surgery and made it to Boston, Murphy said she’s still angry about what happened to her, and trying to stay that way.  “I don’t want to be OK with the fact that this happened to me,” she said. “Because I’m really not OK with the fact that it’s going to continue happening to women, especially in Kentucky, due to completely man-made barriers to care.” The post Kentuckians can’t get an effective medicine for miscarriage because it’s also used for abortion appeared first on The Lexington Times.