Amid contradictory laws, hospitals in one state were unable to explain policies on emergency abortion care, study finds | CNN



CNN
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Oklahoma’s laws restricting abortions have created a confusing, contradictory environment that may have a chilling effect on health care, new research says.

After the US Supreme Court overturned the right to an abortion last year with the Dobbs v. Jackson Women’s Health Organization decision, several states quickly passed laws that restricted such procedures. A report released Tuesday and described in the medical journal the Lancet finds that the laws in at least one state left workers at many hospitals confused about how to proceed.

When the court made its decision, the Oklahoma law that criminalized abortion in 1910 went back into effect, according to the state’s attorney general. Lawmakers then created multiple overlapping laws that further criminalized abortion and increased penalties for those who performed or assisted in an abortion procedure, according to the new report from Physicians for Human Rights, Oklahoma Call for Reproductive Justice and the Center for Reproductive Rights.

The Oklahoma laws allow abortion in the case of a medical emergency, but one doesn’t define a medical emergency. Another says it allows for the “preservation of life in a medical emergency,” defined as causing “substantial and irreversible body of bodily impairment” – which is not a medical term, experts say.

To understand exactly how well Oklahoma hospitals understood the laws, the researchers used a “secret shopper method,” study co-author Dr. Michele Heisler said.

Researchers posed as prospective patients and called 34 hospitals to ask about the emergency pregnancy care they offered.

Heisler said that when the researchers designed the study, she expected the hospitals to tell the patients that they could get help in an emergency but that a second provider might have to sign off on an abortion or that a doctor would have to get the decision past an “onerous” hospital oversight committee.

“What we weren’t expecting is that there would be so much confusion and contradictory information and really not clear information,” said Heisler, who is medical director at Physicians for Human Rights and a professor of internal medicine and public health at the University of Michigan.

The researchers said that none of the hospitals they contacted in Oklahoma was totally able to articulate clear, consistent policies for emergency obstetric care to potential patients.

Specifically, 65% – 22 of the 34 hospitals – were unable to provide information about policies, procedures or the support provided to doctors when it is clinically necessary to terminate a pregnancy to save the life of a pregnant patient.

In 14 of the 22 cases, hospital representatives provided unclear and/or incomplete answers about whether doctors require approval to perform a medically necessary abortion.

Three of the hospitals said they do not provide abortions at all, even though it remains legal in the case of a medical emergency or to “preserve the life” of the pregnant person. Four others provided information that was factually wrong, the report says.

Four hospitals said they had formal approval processes that clinicians must go through if they have a situation in which it is medically necessary to terminate a pregnancy; they cannot make that decision on their own.

Three hospitals indicated that they have policies for these situations but refused to share any information about them.

“Unfortunately, it is being just left up to individual health systems and clinicians to try to make sense of these laws and provide guidance and support,” Heisler said.

The Oklahoma Hospital Association said it has been in conversations with Oklahoma’s medical licensure boards to seek clarity about the state’s conflicting abortion laws.

The association sent guidance to its members in September to explain what it interpreted as “saving the life of a pregnant woman” and what the laws would mean for a person made pregnant through rape or incest, among other issues. The guidance explains that the state’s criminal laws do not make an exception for these circumstances unless it is to save the life of someone who is pregnant in a medical emergency.

The guidance also warns that a person convicted of “administering, prescribing, advising, or procuring a woman to take any medicine drug or substance, or a person convicted of using or employing any instruction or ‘other means whatever,’ with the intent to procure an abortion, shall be guilty of a felony punishable by two (2) to (5) years imprisonment. From August 27, 2022, forward, a person convicted of performing or attempting to perform an abortion shall be guilty of a felony punishable by a fine not to exceed One Hundred Thousand ($100,000.00) and/or imprisonment not to exceed ten (10) years.”

The guidance says the “persons potentially liable” are the provider, not the pregnant person.

Study co-author Rabia Muqaddam, a senior staff attorney at the Center for Reproductive Rights who is working on multiple cases challenging the abortion bans in Oklahoma, called the overlapping laws a “bizarre” situation.

“Aside from the fact that there are so many of them is that they all conflict,” she said. “All of the laws have inconsistent definitions, which is where a lot of the confusion comes from for health care providers. What’s most dangerous for patients is the fact that the definitions of medical emergency and life-preserving abortions is unclear and inconsistent.”

“If I was the hospital general counsel and I was looking at these laws, I have absolutely no idea what my physician could or could not do in any particular circumstance,” she said.

When there is a lack of clarity and when penalties are involved, “what you get is massive chill.”

“Physicians are terrified. They’re terrified that if they make the wrong decision, they’re going to go to jail. They’re going to lose their license. And at the other end of that is that patients are being seriously harmed,” Muqaddam said.

Sonia M. Suter, a professor of law at George Washington University who was not involved in the new research, said recent abortion laws have created “such a mess.”

“You are telling physicians that they have two conflicting obligations,” said Suter, whose scholarship focuses on issues at the intersection of law, medicine and bioethics, with a particular focus on reproductive rights.

There is an obligation to stabilize patients in emergencies that may not always qualify as “life-threatening,” but doctors and hospitals could also risk being sued because the doctors are not following the standard of care, “which you can’t do with how some of these exceptions are worded.”

She said hospitals also don’t know how the laws will be applied. Lawyers typically will instruct institutions to interpret the law as conservatively as possible, and physicians may be equally conservative because they don’t want to risk their licenses or face stiff penalties.

“It’s just devastating for everybody,” Suter said. “It’s just cruel.”

Molly Meegan, general counsel for the American College of Obstetricians and Gynecologists, said state laws to restrict abortion with emergency exceptions are not comprehensive.

“They can’t be applied in a medical situation. They just aren’t practical,” she said. “They have an ethical and personal duty to their patients to do what is best for their patients. It can at times be in direct conflict with whatever the laws are, especially if they’re vague, and most of the ob/gyns throughout the country, including in Oklahoma, are in an impossible situation.”

Meegan and Suter both believe the confusion will lead to the deaths of more women. Those who survive may be left with dire health problems, including losing the ability to have children in the future.

“They already have horrific maternal mortality and infant mortality rates,” Suter said. “It feels like the end of evidence-based medicine.”

According to the US Centers for Disease Control and Prevention, Oklahoma persistently ranks among the states with the worst rates of maternal deaths, even before the new abortion laws went into effect. The state had a maternal mortality rate of 25.2 deaths per 100,000 live births for 2018-20, well above the national average.

For communities of color, the rate is significantly worse, according to the Oklahoma Health Department.

White women had 23.2 maternal deaths per 100,000 live births for 2018-20, the lowest rate overall in Oklahoma. The rates for Black women and Native American women were about twice as high: 49.4 and 44.4, respectively.

Oklahoma is not alone. The 13 states where most abortions are banned generally have some of the highest infant and maternal mortality rates in the country, Heisler said. Even more states could be restricting abortion access soon, the experts believe, with potentially more problems to come.

“The hostile climate many states are creating for the health care field by enacting criminal and other penalties for abortion care is an outcome whose reverberations we are only just beginning to see,” said Kelly Baden, vice president for public policy at the reproductive health nonprofit Guttmacher Institute.

Heisler noted that the researchers don’t blame the hospitals or the doctors for this confusion. Overall, she said, the staffers who talked to the researchers “were wonderful,” despite the circumstances.

“They were empathetic. They said, ‘I completely understand.’ They tried to give answers. They acted in good faith. But really, none of the hospitals were really able to say what we were hoping for, which is to unequivocally state that they would stand behind their clinicians and that clinicians at their facilities would be able to use their best clinical judgment for the individual case and that it would be made as medical decisions should be in collaboration with the patient, taking into account to their needs, their preferences and their values,” she said.

“We are recognizing that hospitals and clinicians are in an untenable situation,” Heisler added.

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Naloxone nasal spray may soon be in your pharmacy. Our medical analyst explains what it is and who can use it | CNN



CNN
 — 

Two advisory committees to the US Food and Drug Administration have voted unanimously to recommend that a nasal spray version of the opioid overdose antidote, naloxone (also called Narcan), be made available over the counter.

If the FDA agrees with this recommendation, naloxone may soon be sold without a prescription in pharmacies and made available in grocery stores, big-box stores, gas stations, and corner stores around the country.

This development comes at a time when opioid overdoses are at a record high, rising more than 15% in one year. Deaths attributed to opioids rose from around 70,000 in 2020 to 80,800 in 2021, according to the US Centers for Disease Control and Prevention. The highly potent and lethal opioid, fentanyl, is implicated in the majority of these deaths.

What is naloxone, and how does it work to save lives from opioid overdose? How do you know if someone is overdosing, and how can bystanders administer the antidote? How can people get access to it now, and what will it mean if the FDA approves it for over-the-counter use? What more needs to be done to reduce overdose deaths?

To guide us through these questions, I spoke with CNN Medical Analyst Dr. Leana Wen, an emergency physician and professor of health policy and management at the George Washington University Milken Institute School of Public Health. She is also the chair of the advisory board for Behavioral Health Group, a network of outpatient opioid treatment and recovery centers around the United States. Previously, she was Baltimore’s health commissioner, where she led the city’s overdose prevention strategy.

CNN: How does naloxone work to save people overdosing on opioids?

Dr. Leana Wen: Naloxone is a medicine that rapidly reverses the effect of an opioid overdose. It is an antagonist to opioids, meaning that it attaches to the opioid receptors in the brain, and in doing so, reverses and blocks the effects of opioids.

Someone who has taken too large of a quantity of opioids can become unconscious and stop breathing. This is deadly — a person can die within minutes after they stop breathing. Naloxone reverses the effect of the opioid overdose and can restore normal breathing within a couple of minutes.

CNN: What are the different versions of naloxone? Does it work against illicit drugs like heroin and fentanyl as well as prescription drugs?

Wen: Naloxone comes in two main forms. There is the nasal spray version, with one manufacturer calling its product Narcan Nasal Spray. This version is sprayed into the nostril, similar to some allergy medications.

Naloxone also comes as a liquid. This form can be injected either intravenously through an IV, if a patient already has an IV inserted, or intramuscularly, usually as a shot through the quadriceps muscle in the leg.

Several years ago, there was another version of naloxone that was in an autoinjector, similar to an EpiPen that’s given to people with life-threatening allergic reactions. In 2019, the manufacturer made a business decision to stop making that version available to the public. (An autoinjector is still approved for use by the military and for chemical incident responders.)

The nasal spray, intravenous and intramuscular versions all work very well, and they all work against various versions of opioids. That includes not only heroin and fentanyl but also common opioid medications like oxycodone, hydrocodone, codeine and morphine. It’s important to note that one dose may not be enough, depending on how potent and how much opioid was taken. Often, several doses are needed to revive someone.

CNN: How do you know if someone is overdosing, and how can bystanders administer the antidote?

Wen: Signs of overdose include being unable to be awakened, breathing slowly or not breathing at all, and fingernails and lips taking on a blue or purple color while the skin becomes pale and clammy to the touch. Their pupils are often described as “pinpoint,” or very small.

Someone can overdose from taking too much of an opioid by accident. This often happens when fentanyl, an extremely potent opioid, is mixed with whatever the person is taking without their knowledge. Also, if an opioid is mixed with alcohol or benzodiazepines or other opioids, they can also become unresponsive. And there are instances when someone may not realize they are taking opioids, but the pill they obtained is contaminated with fentanyl.

If someone is overdosing, you or someone who is with you must call 911 immediately. In the meantime, administer naloxone. Naloxone reverses an overdose for up to about 90 minutes, but opioids can stay in the system for longer, so it’s still important for the person to receive medical attention after receiving the drug. Depending on the opioid the person took, they may need to be monitored in the hospital for hours after in case naloxone wears off while the opioid continues to have an effect.

If you have the nasal spray version, insert the tip of the device into the nostril and squeeze. Another spray may be given in the other nostril in two to three minutes if the patient remains unresponsive, and another one in another two to three minutes until either the patient responds or emergency help arrives. If you are trained to perform CPR, and the person isn’t breathing, you should administer CPR as well, in between giving naloxone.

CNN: Is naloxone safe to use? What if you’re not sure if someone is overdosing from opioids?

Wen: Yes, naloxone is extremely safe. If someone is not on opioids and is unresponsive, say, because they drank too much alcohol or has had a stroke, naloxone will have no adverse effect for them. That’s why emergency medical personnel routinely administer naloxone to patients who are found to be unresponsive; there is no harm to people who are unresponsive from non-opioid-related reasons.

If someone overdosed on opioids, naloxone reversal will send them into withdrawal. This could be unpleasant for the individual and could lead to vomiting, agitation, shivering, tearing up and having a runny nose. These aren’t desirable side effects, of course, but in cases when naloxone must be given, the alternative is death.

CNN: How can people get access to naloxone now? What will it mean if the FDA approves it for over-the-counter use?

Wen: As an emergency physician, I’ve given naloxone many times. First responders like paramedics and emergency medical technicians also routinely administer naloxone. When I served as Baltimore’s health commissioner, I felt strongly that everyone should be able to save someone else’s life.

Nonmedical personnel may already obtain and carry naloxone with them, but specific requirements and regulations vary by the state. Health departments and some community nonprofit groups have low-priced or free naloxone that they distribute to community members. Often, the naloxone is distributed to individuals who use drugs, because they are most likely to be around others who are overdosing. Also, their family members can use naloxone to revive them.

If the FDA approves the nasal spray naloxone for over-the-counter use, that means it will be more accessible. People should be able to purchase the spray from pharmacies, grocery stores, gas stations and perhaps even vending machines.

The problem is cost. We don’t yet know how the over-the-counter naloxone spray will be priced, and whether and how much insurance companies cover it will probably vary.

CNN: What more needs to be done to reduce overdose deaths?

Wen: Naloxone access is an important step. Someone who is overdosing has no chance for a better tomorrow if they are dead today. I would encourage everyone with a family member who is on opioids for chronic pain or has an opioid addiction to carry naloxone with them, so that they could save their loved one’s life.

Longer-term, a person who has an opioid use disorder needs treatment with a combination of medications and psychosocial supports. Much more needs to be done to expand treatment access, as well as to reduce the supply of illicitly manufactured drugs like fentanyl that are worsening the overdose crisis.

Finally, I want to remind everyone of 988, a new 24/7 phone and chat hotline that provides suicide counseling, crisis supports and referral for people in need of mental health and addiction support.

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