Contraception

TOPLINE:

Mepivacaine instillation significantly reduced pain during intrauterine device (IUD) placement in nulliparous women. More than 90% of women in the intervention group reported tolerable pain compared with 80% of those in the placebo group.

METHODOLOGY:

• A multicenter, double-blind, randomized, placebo-controlled trial was conducted in 12 centers in Sweden, which involved 151 nulliparous women aged 18-31 years.
• Participants were randomly assigned to receive either 10 mL of 20 mg/mL mepivacaine or 10 mL of 0.9 mg/mL sodium chloride (placebo) through a hydrosonography catheter 2 minutes before IUD placement.
• Pain scores were measured using a 100-mm visual analog scale (VAS) at baseline, after instillation, during IUD placement, and 10 minutes post placement.
• The primary outcome was the difference in VAS pain scores during IUD placement between the intervention and placebo groups.

TAKEAWAY:

• Mepivacaine instillation resulted in a statistically significant reduction in mean VAS pain scores during IUD placement, with a mean difference of 13.3 mm (95% CI, 5.75-20.87; P < .001).
• After adjusting for provider impact, the mean VAS pain score difference remained significant at 12.2 mm (95% CI, 4.85-19.62; P < .001).
• A higher proportion of women in the mepivacaine group reported tolerable pain during IUD placement (93.3%) than the placebo group (80.3%; P = .021).
• No serious adverse effects were associated with mepivacaine instillation, and there were no cases of uterine perforation in either group.

IN PRACTICE:

“We argue that the pain reduction in our study is clinically important as a greater proportion of women in our intervention group, compared to the placebo group, reported tolerable pain during placement and to a higher extent rated the placement as easier than expected and expressed a willingness to choose IUD as contraception again,” the authors of the study wrote.

SOURCE:

This study was led by Niklas Envall, PhD; Karin Elgemark, MD; and Helena Kopp Kallner, MD, PhD, at the Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet in Stockholm, Sweden. It was published online in American Journal of Obstetrics & Gynecology.

LIMITATIONS:

This study’s limitations included the exclusive focus on one type of IUD (LNG-IUS 52 mg, 4.4 mm), which may limit generalizability to other IUD types. Additionally, only experienced providers participated, which may not reflect settings with less experienced providers. Factors such as anticipated pain and patient anxiety were not systematically assessed, potentially influencing pain perception.

DISCLOSURES:

Envall received personal fees from Bayer for educational activities and honorarium from Medsphere Corp USA for expert opinions on long-acting reversible contraception. Kallner received honoraria for consultancy work and lectures from multiple pharmaceutical companies, including AbbVie, Actavis, Bayer, and others. The study was funded by the Swedish Research Council. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Mepivacaine instillation significantly reduced pain during intrauterine device (IUD) placement in nulliparous women. More than 90% of women in the intervention group reported tolerable pain compared with 80% of those in the placebo group.

METHODOLOGY:

• A multicenter, double-blind, randomized, placebo-controlled trial was conducted in 12 centers in Sweden, which involved 151 nulliparous women aged 18-31 years.
• Participants were randomly assigned to receive either 10 mL of 20 mg/mL mepivacaine or 10 mL of 0.9 mg/mL sodium chloride (placebo) through a hydrosonography catheter 2 minutes before IUD placement.
• Pain scores were measured using a 100-mm visual analog scale (VAS) at baseline, after instillation, during IUD placement, and 10 minutes post placement.
• The primary outcome was the difference in VAS pain scores during IUD placement between the intervention and placebo groups.

TAKEAWAY:

• Mepivacaine instillation resulted in a statistically significant reduction in mean VAS pain scores during IUD placement, with a mean difference of 13.3 mm (95% CI, 5.75-20.87; P < .001).
• After adjusting for provider impact, the mean VAS pain score difference remained significant at 12.2 mm (95% CI, 4.85-19.62; P < .001).
• A higher proportion of women in the mepivacaine group reported tolerable pain during IUD placement (93.3%) than the placebo group (80.3%; P = .021).
• No serious adverse effects were associated with mepivacaine instillation, and there were no cases of uterine perforation in either group.

IN PRACTICE:

“We argue that the pain reduction in our study is clinically important as a greater proportion of women in our intervention group, compared to the placebo group, reported tolerable pain during placement and to a higher extent rated the placement as easier than expected and expressed a willingness to choose IUD as contraception again,” the authors of the study wrote.

SOURCE:

This study was led by Niklas Envall, PhD; Karin Elgemark, MD; and Helena Kopp Kallner, MD, PhD, at the Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet in Stockholm, Sweden. It was published online in American Journal of Obstetrics & Gynecology.

LIMITATIONS:

This study’s limitations included the exclusive focus on one type of IUD (LNG-IUS 52 mg, 4.4 mm), which may limit generalizability to other IUD types. Additionally, only experienced providers participated, which may not reflect settings with less experienced providers. Factors such as anticipated pain and patient anxiety were not systematically assessed, potentially influencing pain perception.

DISCLOSURES:

Envall received personal fees from Bayer for educational activities and honorarium from Medsphere Corp USA for expert opinions on long-acting reversible contraception. Kallner received honoraria for consultancy work and lectures from multiple pharmaceutical companies, including AbbVie, Actavis, Bayer, and others. The study was funded by the Swedish Research Council. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Mepivacaine instillation significantly reduced pain during intrauterine device (IUD) placement in nulliparous women. More than 90% of women in the intervention group reported tolerable pain compared with 80% of those in the placebo group.

METHODOLOGY:

• A multicenter, double-blind, randomized, placebo-controlled trial was conducted in 12 centers in Sweden, which involved 151 nulliparous women aged 18-31 years.
• Participants were randomly assigned to receive either 10 mL of 20 mg/mL mepivacaine or 10 mL of 0.9 mg/mL sodium chloride (placebo) through a hydrosonography catheter 2 minutes before IUD placement.
• Pain scores were measured using a 100-mm visual analog scale (VAS) at baseline, after instillation, during IUD placement, and 10 minutes post placement.
• The primary outcome was the difference in VAS pain scores during IUD placement between the intervention and placebo groups.

TAKEAWAY:

• Mepivacaine instillation resulted in a statistically significant reduction in mean VAS pain scores during IUD placement, with a mean difference of 13.3 mm (95% CI, 5.75-20.87; P < .001).
• After adjusting for provider impact, the mean VAS pain score difference remained significant at 12.2 mm (95% CI, 4.85-19.62; P < .001).
• A higher proportion of women in the mepivacaine group reported tolerable pain during IUD placement (93.3%) than the placebo group (80.3%; P = .021).
• No serious adverse effects were associated with mepivacaine instillation, and there were no cases of uterine perforation in either group.

IN PRACTICE:

“We argue that the pain reduction in our study is clinically important as a greater proportion of women in our intervention group, compared to the placebo group, reported tolerable pain during placement and to a higher extent rated the placement as easier than expected and expressed a willingness to choose IUD as contraception again,” the authors of the study wrote.

SOURCE:

This study was led by Niklas Envall, PhD; Karin Elgemark, MD; and Helena Kopp Kallner, MD, PhD, at the Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet in Stockholm, Sweden. It was published online in American Journal of Obstetrics & Gynecology.

LIMITATIONS:

This study’s limitations included the exclusive focus on one type of IUD (LNG-IUS 52 mg, 4.4 mm), which may limit generalizability to other IUD types. Additionally, only experienced providers participated, which may not reflect settings with less experienced providers. Factors such as anticipated pain and patient anxiety were not systematically assessed, potentially influencing pain perception.

DISCLOSURES:

Envall received personal fees from Bayer for educational activities and honorarium from Medsphere Corp USA for expert opinions on long-acting reversible contraception. Kallner received honoraria for consultancy work and lectures from multiple pharmaceutical companies, including AbbVie, Actavis, Bayer, and others. The study was funded by the Swedish Research Council. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

The use of a levonorgestrel-releasing intrauterine system (LNG-IUS) is associated with an increased risk for breast cancer. An analysis by Danish researchers found 14 extra cases of breast cancer per 10,000 women using this type of an intrauterine device (IUD) vs women not using hormonal contraceptives.

METHODOLOGY:

• The investigators used nationwide registries in Denmark to identify all women aged 15-49 years who were first-time initiators of any LNG-IUS between 2000 and 2019.
• They matched 78,595 new users of LNG-IUS 1:1 with women with the same birth year who were not taking hormonal contraceptives.
• Participants were followed through 2022 or until a diagnosis of breast cancer or another malignancy, pregnancy, the initiation of postmenopausal hormone therapy, emigration, or death.
• The investigators used a Cox proportional hazards model to examine the association between the continuous use of LNG-IUS and breast cancer. Their analysis adjusted for variables such as the duration of previous hormonal contraception, fertility drugs, parity, age at first delivery, polycystic ovarian syndrome, endometriosis, and education.

TAKEAWAY:

• Compared with the nonuse of hormonal contraceptives, the continuous use of LNG-IUS was associated with a hazard ratio for breast cancer of 1.4 (95% CI, 1.2-1.5).
• The use of a levonorgestrel IUD for 5 years or less was associated with a hazard ratio of 1.3 (95% CI, 1.1-1.5). With 5-10 years of use, the hazard ratio was 1.4 (95% CI, 1.1-1.7). And with 10-15 years of use, the hazard ratio was 1.8 (95% CI, 1.2-2.6). A test for trend was not significant, however, and “risk did not increase with duration of use,” the study authors wrote.

IN PRACTICE:

“Women should be aware that most types of hormonal contraceptive are associated with a small increased risk of breast cancer. This study adds another type of hormonal contraceptive to that list,” Amy Berrington de Gonzalez, DPhil, professor of clinical cancer epidemiology at The Institute of Cancer Research in London, England, said in comments on the research. “That has to be considered with the many benefits from hormonal contraceptives.”

Behaviors such as smoking could have differed between the groups in the study, and it has not been established that LNG-IUS use directly causes an increased risk for breast cancer, said Channa Jayasena, PhD, an endocrinologist at Imperial College London.

“Smoking, alcohol and obesity are much more important risk factors for breast cancer than contraceptive medications,” he said. “My advice for women is that breast cancer risk caused by LNG-IUS is not established but warrants a closer look.”
 

SOURCE:

Lina Steinrud Mørch, MSc, PhD, with the Danish Cancer Institute in Copenhagen, Denmark, was the corresponding author of the study. The researchers published their findings in JAMA.

LIMITATIONS: 

Unmeasured confounding was possible, and the lack of a significant dose-response relationship “could indicate low statistical precision or no causal association,” the researchers noted.

DISCLOSURES:

The study was funded by Sundhedsdonationer.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

The use of a levonorgestrel-releasing intrauterine system (LNG-IUS) is associated with an increased risk for breast cancer. An analysis by Danish researchers found 14 extra cases of breast cancer per 10,000 women using this type of an intrauterine device (IUD) vs women not using hormonal contraceptives.

METHODOLOGY:

• The investigators used nationwide registries in Denmark to identify all women aged 15-49 years who were first-time initiators of any LNG-IUS between 2000 and 2019.
• They matched 78,595 new users of LNG-IUS 1:1 with women with the same birth year who were not taking hormonal contraceptives.
• Participants were followed through 2022 or until a diagnosis of breast cancer or another malignancy, pregnancy, the initiation of postmenopausal hormone therapy, emigration, or death.
• The investigators used a Cox proportional hazards model to examine the association between the continuous use of LNG-IUS and breast cancer. Their analysis adjusted for variables such as the duration of previous hormonal contraception, fertility drugs, parity, age at first delivery, polycystic ovarian syndrome, endometriosis, and education.

TAKEAWAY:

• Compared with the nonuse of hormonal contraceptives, the continuous use of LNG-IUS was associated with a hazard ratio for breast cancer of 1.4 (95% CI, 1.2-1.5).
• The use of a levonorgestrel IUD for 5 years or less was associated with a hazard ratio of 1.3 (95% CI, 1.1-1.5). With 5-10 years of use, the hazard ratio was 1.4 (95% CI, 1.1-1.7). And with 10-15 years of use, the hazard ratio was 1.8 (95% CI, 1.2-2.6). A test for trend was not significant, however, and “risk did not increase with duration of use,” the study authors wrote.

IN PRACTICE:

“Women should be aware that most types of hormonal contraceptive are associated with a small increased risk of breast cancer. This study adds another type of hormonal contraceptive to that list,” Amy Berrington de Gonzalez, DPhil, professor of clinical cancer epidemiology at The Institute of Cancer Research in London, England, said in comments on the research. “That has to be considered with the many benefits from hormonal contraceptives.”

Behaviors such as smoking could have differed between the groups in the study, and it has not been established that LNG-IUS use directly causes an increased risk for breast cancer, said Channa Jayasena, PhD, an endocrinologist at Imperial College London.

“Smoking, alcohol and obesity are much more important risk factors for breast cancer than contraceptive medications,” he said. “My advice for women is that breast cancer risk caused by LNG-IUS is not established but warrants a closer look.”
 

SOURCE:

Lina Steinrud Mørch, MSc, PhD, with the Danish Cancer Institute in Copenhagen, Denmark, was the corresponding author of the study. The researchers published their findings in JAMA.

LIMITATIONS: 

Unmeasured confounding was possible, and the lack of a significant dose-response relationship “could indicate low statistical precision or no causal association,” the researchers noted.

DISCLOSURES:

The study was funded by Sundhedsdonationer.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE: 

The use of a levonorgestrel-releasing intrauterine system (LNG-IUS) is associated with an increased risk for breast cancer. An analysis by Danish researchers found 14 extra cases of breast cancer per 10,000 women using this type of an intrauterine device (IUD) vs women not using hormonal contraceptives.

METHODOLOGY:

• The investigators used nationwide registries in Denmark to identify all women aged 15-49 years who were first-time initiators of any LNG-IUS between 2000 and 2019.
• They matched 78,595 new users of LNG-IUS 1:1 with women with the same birth year who were not taking hormonal contraceptives.
• Participants were followed through 2022 or until a diagnosis of breast cancer or another malignancy, pregnancy, the initiation of postmenopausal hormone therapy, emigration, or death.
• The investigators used a Cox proportional hazards model to examine the association between the continuous use of LNG-IUS and breast cancer. Their analysis adjusted for variables such as the duration of previous hormonal contraception, fertility drugs, parity, age at first delivery, polycystic ovarian syndrome, endometriosis, and education.

TAKEAWAY:

• Compared with the nonuse of hormonal contraceptives, the continuous use of LNG-IUS was associated with a hazard ratio for breast cancer of 1.4 (95% CI, 1.2-1.5).
• The use of a levonorgestrel IUD for 5 years or less was associated with a hazard ratio of 1.3 (95% CI, 1.1-1.5). With 5-10 years of use, the hazard ratio was 1.4 (95% CI, 1.1-1.7). And with 10-15 years of use, the hazard ratio was 1.8 (95% CI, 1.2-2.6). A test for trend was not significant, however, and “risk did not increase with duration of use,” the study authors wrote.

IN PRACTICE:

“Women should be aware that most types of hormonal contraceptive are associated with a small increased risk of breast cancer. This study adds another type of hormonal contraceptive to that list,” Amy Berrington de Gonzalez, DPhil, professor of clinical cancer epidemiology at The Institute of Cancer Research in London, England, said in comments on the research. “That has to be considered with the many benefits from hormonal contraceptives.”

Behaviors such as smoking could have differed between the groups in the study, and it has not been established that LNG-IUS use directly causes an increased risk for breast cancer, said Channa Jayasena, PhD, an endocrinologist at Imperial College London.

“Smoking, alcohol and obesity are much more important risk factors for breast cancer than contraceptive medications,” he said. “My advice for women is that breast cancer risk caused by LNG-IUS is not established but warrants a closer look.”
 

SOURCE:

Lina Steinrud Mørch, MSc, PhD, with the Danish Cancer Institute in Copenhagen, Denmark, was the corresponding author of the study. The researchers published their findings in JAMA.

LIMITATIONS: 

Unmeasured confounding was possible, and the lack of a significant dose-response relationship “could indicate low statistical precision or no causal association,” the researchers noted.

DISCLOSURES:

The study was funded by Sundhedsdonationer.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Twice a month, a 40-foot-long truck transformed into a mobile clinic travels the Rio Grande Valley to provide rural Texans with women’s health care, including birth control.

The clinic, called the UniMóvil, is part of the Healthy Mujeres program at the University of Texas Rio Grande Valley School of Medicine in Edinburg.

The United States has about 3000 mobile health programs. But Saul Rivas, an ob.gyn., said he wasn’t aware of any that shared the specific mission of Healthy Mujeres when he helped launch the initiative in 2017. “Mujeres” means “women” in Spanish.

It’s now part of a small but growing number of mobile programs aimed at increasing rural access to women’s health services, including long-acting reversible contraception.

There are two kinds of these highly effective methods: intrauterine devices, known as IUDs, and hormonal implants inserted into the upper arm. These birth control options can be especially difficult to obtain — or have removed — in rural areas.

“Women who want to prevent an unintended pregnancy should have whatever works best for them,” said Kelly Conroy, senior director of mobile and maternal health programs at the University of Arkansas for Medical Sciences, Little Rock.

The school is launching a mobile women’s health and contraception program in rural parts of the state in October.

Rural areas have disproportionately fewer doctors, including ob.gyns., than urban areas. And rural providers may not be able to afford to stock long-acting birth control devices or may not be trained in administering them, program leaders say.

Mobile clinics help shrink that gap in rural care, but they can be challenging to operate, said Elizabeth Jones, a senior director at the National Family Planning & Reproductive Health Association.

Money is the greatest obstacle, Jones said. The Texas program costs up to $400,000 a year. A 2020 study of 173 mobile clinics found they cost an average of more than $630,000 a year. Mobile dental programs were the most expensive, averaging more than $1 million.

While many programs launch with the help of grants, they can be difficult to sustain, especially with over a decade of decreased or stagnant funding to Title X, a federal money stream that helps low-income people receive family planning services.

For example, a mobile contraception program serving rural Pennsylvania lasted less than 3 years before closing in 2023. It shut down after losing federal funding, said a spokesperson for the clinic that ran it.

Rural mobile programs aren’t as efficient or profitable as brick-and-mortar clinics. That’s because staff members may have to make hours-long trips to reach towns where they’ll probably see fewer patients than they would at a traditional site, Jones said.

She said organizations that can’t afford mobile programs can consider setting up “pop-up clinics” at existing health and community sites in rural areas.

Maria Briones is a patient who has benefited from the Healthy Mujeres program in southern Texas. The 41-year-old day care worker was concerned because she wasn’t getting her menstrual period with her IUD.

She considered going to Mexico to have the device removed because few doctors take her insurance on the US side of the Rio Grande Valley.

But Briones learned that the UniMóvil was visiting a small Texas city about 20 minutes from her home. She told the staff there that she doesn’t want more kids but was worried about the IUD.

Briones decided to keep the device after learning it’s safe and normal not to have periods while using an IUD. She won’t get billed for her appointment with the mobile clinic, even though the university health system doesn’t take her insurance.

“They have a lot of patience, and they answered all the questions that I had,” Briones said.

IUDs and hormonal implants are highly effective and can last up to 10 years. But they’re also expensive — devices can cost more than $1,000 without insurance — and inserting an IUD can be painful.

Patient-rights advocates are also concerned that some providers pressure people to use these devices.

They say ethical birth control programs aim to empower patients to choose the contraceptive method — if any — that is best for them, instead of promoting long-acting methods in an attempt to lower birth and poverty rates. They point to the history of eugenics-inspired sterilization and even more recent incidents.

For example, an investigation by Time magazine found doctors are more likely to push Black, Latina, young, and low-income women than other patients to use long-acting birth control — and to refuse to remove the devices.

Rivas said Healthy Mujeres staffers are trained on this issue.

“Our goal isn’t necessarily to place IUDs and implants,” he said. It’s to “provide education and help patients make the best decisions for themselves.”

David Wise, a spokesperson for the University of Arkansas for Medical Sciences, said staff members with the university’s mobile program will ask patients if they want to get pregnant in the next year, and will support their choice. The Arkansas and Texas programs also remove IUDs and hormonal arm implants if patients aren’t happy with them.

The Arkansas initiative will visit 14 rural counties with four vehicles the size of food trucks that were used in previous mobile health efforts. Staffing and equipment will be covered by a 2-year, $431,000 grant from an anonymous donor, Wise said.

In addition to contraception, faculty and medical residents staffing the vehicles will offer women’s health screenings, vaccinations, prenatal care, and testing and treatment for sexually transmitted infections.

Rivas said the Texas program was inspired by a study that found that, 6 months after giving birth, 34% of surveyed Texas mothers said long-acting contraception is their preferred birth control option — but only 13% were using that method.

“We started thinking about ways to address that gap,” Rivas said.

Healthy Mujeres, which is funded through multiple grants, started with a focus on contraception. It later expanded to services such as pregnancy ultrasounds, cervical cancer screenings, and testing for sexually transmitted infections.

While the Texas and Arkansas programs can bill insurance, they also have funding to help uninsured and underinsured patients afford their services. Both use community health workers — called promotoras in largely Spanish-speaking communities like the Rio Grande Valley — to connect patients with food, transportation, additional medical services, and other needs.

They partner with organizations that locals trust, such as food pantries and community colleges, which let the mobile units set up in their parking lots. And to further increase the availability of long-acting contraception in rural areas, the universities are training their students and local providers on how to insert, remove, and get reimbursed for the devices.

One difference between the programs is dictated by state laws. The Arkansas program can provide birth control to minors without a parent or guardian’s consent. But in Texas, most minors need consent before receiving health care, including contraception.

Advocates say these initiatives might help lower the rates of unintended and teen pregnancies in both states, which are higher than the national average.

Rivas and Conroy said their programs haven’t received much pushback. But Rivas said some churches that had asked the UniMóvil to visit their congregations changed their minds after learning the services included birth control.

Catherine Phillips, director of the Respect Life Office at Arkansas’ Catholic diocese, said the diocese supports efforts to achieve health care equity and she’s personally interested in mobile programs that visit rural areas such as where she lives.

But Phillips said the Arkansas program’s focus on birth control, especially long-acting methods, violates the teachings of the Catholic Church. Offering these services to minors without parental consent “makes it more egregious,” she said.

Jones said that, while these programs have hefty costs and other challenges, they also have benefits that can’t be measured in numbers.

“Building community trust and making an impact in the communities most impacted by health inequities — that’s invaluable,” she said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Twice a month, a 40-foot-long truck transformed into a mobile clinic travels the Rio Grande Valley to provide rural Texans with women’s health care, including birth control.

The clinic, called the UniMóvil, is part of the Healthy Mujeres program at the University of Texas Rio Grande Valley School of Medicine in Edinburg.

The United States has about 3000 mobile health programs. But Saul Rivas, an ob.gyn., said he wasn’t aware of any that shared the specific mission of Healthy Mujeres when he helped launch the initiative in 2017. “Mujeres” means “women” in Spanish.

It’s now part of a small but growing number of mobile programs aimed at increasing rural access to women’s health services, including long-acting reversible contraception.

There are two kinds of these highly effective methods: intrauterine devices, known as IUDs, and hormonal implants inserted into the upper arm. These birth control options can be especially difficult to obtain — or have removed — in rural areas.

“Women who want to prevent an unintended pregnancy should have whatever works best for them,” said Kelly Conroy, senior director of mobile and maternal health programs at the University of Arkansas for Medical Sciences, Little Rock.

The school is launching a mobile women’s health and contraception program in rural parts of the state in October.

Rural areas have disproportionately fewer doctors, including ob.gyns., than urban areas. And rural providers may not be able to afford to stock long-acting birth control devices or may not be trained in administering them, program leaders say.

Mobile clinics help shrink that gap in rural care, but they can be challenging to operate, said Elizabeth Jones, a senior director at the National Family Planning & Reproductive Health Association.

Money is the greatest obstacle, Jones said. The Texas program costs up to $400,000 a year. A 2020 study of 173 mobile clinics found they cost an average of more than $630,000 a year. Mobile dental programs were the most expensive, averaging more than $1 million.

While many programs launch with the help of grants, they can be difficult to sustain, especially with over a decade of decreased or stagnant funding to Title X, a federal money stream that helps low-income people receive family planning services.

For example, a mobile contraception program serving rural Pennsylvania lasted less than 3 years before closing in 2023. It shut down after losing federal funding, said a spokesperson for the clinic that ran it.

Rural mobile programs aren’t as efficient or profitable as brick-and-mortar clinics. That’s because staff members may have to make hours-long trips to reach towns where they’ll probably see fewer patients than they would at a traditional site, Jones said.

She said organizations that can’t afford mobile programs can consider setting up “pop-up clinics” at existing health and community sites in rural areas.

Maria Briones is a patient who has benefited from the Healthy Mujeres program in southern Texas. The 41-year-old day care worker was concerned because she wasn’t getting her menstrual period with her IUD.

She considered going to Mexico to have the device removed because few doctors take her insurance on the US side of the Rio Grande Valley.

But Briones learned that the UniMóvil was visiting a small Texas city about 20 minutes from her home. She told the staff there that she doesn’t want more kids but was worried about the IUD.

Briones decided to keep the device after learning it’s safe and normal not to have periods while using an IUD. She won’t get billed for her appointment with the mobile clinic, even though the university health system doesn’t take her insurance.

“They have a lot of patience, and they answered all the questions that I had,” Briones said.

IUDs and hormonal implants are highly effective and can last up to 10 years. But they’re also expensive — devices can cost more than $1,000 without insurance — and inserting an IUD can be painful.

Patient-rights advocates are also concerned that some providers pressure people to use these devices.

They say ethical birth control programs aim to empower patients to choose the contraceptive method — if any — that is best for them, instead of promoting long-acting methods in an attempt to lower birth and poverty rates. They point to the history of eugenics-inspired sterilization and even more recent incidents.

For example, an investigation by Time magazine found doctors are more likely to push Black, Latina, young, and low-income women than other patients to use long-acting birth control — and to refuse to remove the devices.

Rivas said Healthy Mujeres staffers are trained on this issue.

“Our goal isn’t necessarily to place IUDs and implants,” he said. It’s to “provide education and help patients make the best decisions for themselves.”

David Wise, a spokesperson for the University of Arkansas for Medical Sciences, said staff members with the university’s mobile program will ask patients if they want to get pregnant in the next year, and will support their choice. The Arkansas and Texas programs also remove IUDs and hormonal arm implants if patients aren’t happy with them.

The Arkansas initiative will visit 14 rural counties with four vehicles the size of food trucks that were used in previous mobile health efforts. Staffing and equipment will be covered by a 2-year, $431,000 grant from an anonymous donor, Wise said.

In addition to contraception, faculty and medical residents staffing the vehicles will offer women’s health screenings, vaccinations, prenatal care, and testing and treatment for sexually transmitted infections.

Rivas said the Texas program was inspired by a study that found that, 6 months after giving birth, 34% of surveyed Texas mothers said long-acting contraception is their preferred birth control option — but only 13% were using that method.

“We started thinking about ways to address that gap,” Rivas said.

Healthy Mujeres, which is funded through multiple grants, started with a focus on contraception. It later expanded to services such as pregnancy ultrasounds, cervical cancer screenings, and testing for sexually transmitted infections.

While the Texas and Arkansas programs can bill insurance, they also have funding to help uninsured and underinsured patients afford their services. Both use community health workers — called promotoras in largely Spanish-speaking communities like the Rio Grande Valley — to connect patients with food, transportation, additional medical services, and other needs.

They partner with organizations that locals trust, such as food pantries and community colleges, which let the mobile units set up in their parking lots. And to further increase the availability of long-acting contraception in rural areas, the universities are training their students and local providers on how to insert, remove, and get reimbursed for the devices.

One difference between the programs is dictated by state laws. The Arkansas program can provide birth control to minors without a parent or guardian’s consent. But in Texas, most minors need consent before receiving health care, including contraception.

Advocates say these initiatives might help lower the rates of unintended and teen pregnancies in both states, which are higher than the national average.

Rivas and Conroy said their programs haven’t received much pushback. But Rivas said some churches that had asked the UniMóvil to visit their congregations changed their minds after learning the services included birth control.

Catherine Phillips, director of the Respect Life Office at Arkansas’ Catholic diocese, said the diocese supports efforts to achieve health care equity and she’s personally interested in mobile programs that visit rural areas such as where she lives.

But Phillips said the Arkansas program’s focus on birth control, especially long-acting methods, violates the teachings of the Catholic Church. Offering these services to minors without parental consent “makes it more egregious,” she said.

Jones said that, while these programs have hefty costs and other challenges, they also have benefits that can’t be measured in numbers.

“Building community trust and making an impact in the communities most impacted by health inequities — that’s invaluable,” she said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Twice a month, a 40-foot-long truck transformed into a mobile clinic travels the Rio Grande Valley to provide rural Texans with women’s health care, including birth control.

The clinic, called the UniMóvil, is part of the Healthy Mujeres program at the University of Texas Rio Grande Valley School of Medicine in Edinburg.

The United States has about 3000 mobile health programs. But Saul Rivas, an ob.gyn., said he wasn’t aware of any that shared the specific mission of Healthy Mujeres when he helped launch the initiative in 2017. “Mujeres” means “women” in Spanish.

It’s now part of a small but growing number of mobile programs aimed at increasing rural access to women’s health services, including long-acting reversible contraception.

There are two kinds of these highly effective methods: intrauterine devices, known as IUDs, and hormonal implants inserted into the upper arm. These birth control options can be especially difficult to obtain — or have removed — in rural areas.

“Women who want to prevent an unintended pregnancy should have whatever works best for them,” said Kelly Conroy, senior director of mobile and maternal health programs at the University of Arkansas for Medical Sciences, Little Rock.

The school is launching a mobile women’s health and contraception program in rural parts of the state in October.

Rural areas have disproportionately fewer doctors, including ob.gyns., than urban areas. And rural providers may not be able to afford to stock long-acting birth control devices or may not be trained in administering them, program leaders say.

Mobile clinics help shrink that gap in rural care, but they can be challenging to operate, said Elizabeth Jones, a senior director at the National Family Planning & Reproductive Health Association.

Money is the greatest obstacle, Jones said. The Texas program costs up to $400,000 a year. A 2020 study of 173 mobile clinics found they cost an average of more than $630,000 a year. Mobile dental programs were the most expensive, averaging more than $1 million.

While many programs launch with the help of grants, they can be difficult to sustain, especially with over a decade of decreased or stagnant funding to Title X, a federal money stream that helps low-income people receive family planning services.

For example, a mobile contraception program serving rural Pennsylvania lasted less than 3 years before closing in 2023. It shut down after losing federal funding, said a spokesperson for the clinic that ran it.

Rural mobile programs aren’t as efficient or profitable as brick-and-mortar clinics. That’s because staff members may have to make hours-long trips to reach towns where they’ll probably see fewer patients than they would at a traditional site, Jones said.

She said organizations that can’t afford mobile programs can consider setting up “pop-up clinics” at existing health and community sites in rural areas.

Maria Briones is a patient who has benefited from the Healthy Mujeres program in southern Texas. The 41-year-old day care worker was concerned because she wasn’t getting her menstrual period with her IUD.

She considered going to Mexico to have the device removed because few doctors take her insurance on the US side of the Rio Grande Valley.

But Briones learned that the UniMóvil was visiting a small Texas city about 20 minutes from her home. She told the staff there that she doesn’t want more kids but was worried about the IUD.

Briones decided to keep the device after learning it’s safe and normal not to have periods while using an IUD. She won’t get billed for her appointment with the mobile clinic, even though the university health system doesn’t take her insurance.

“They have a lot of patience, and they answered all the questions that I had,” Briones said.

IUDs and hormonal implants are highly effective and can last up to 10 years. But they’re also expensive — devices can cost more than $1,000 without insurance — and inserting an IUD can be painful.

Patient-rights advocates are also concerned that some providers pressure people to use these devices.

They say ethical birth control programs aim to empower patients to choose the contraceptive method — if any — that is best for them, instead of promoting long-acting methods in an attempt to lower birth and poverty rates. They point to the history of eugenics-inspired sterilization and even more recent incidents.

For example, an investigation by Time magazine found doctors are more likely to push Black, Latina, young, and low-income women than other patients to use long-acting birth control — and to refuse to remove the devices.

Rivas said Healthy Mujeres staffers are trained on this issue.

“Our goal isn’t necessarily to place IUDs and implants,” he said. It’s to “provide education and help patients make the best decisions for themselves.”

David Wise, a spokesperson for the University of Arkansas for Medical Sciences, said staff members with the university’s mobile program will ask patients if they want to get pregnant in the next year, and will support their choice. The Arkansas and Texas programs also remove IUDs and hormonal arm implants if patients aren’t happy with them.

The Arkansas initiative will visit 14 rural counties with four vehicles the size of food trucks that were used in previous mobile health efforts. Staffing and equipment will be covered by a 2-year, $431,000 grant from an anonymous donor, Wise said.

In addition to contraception, faculty and medical residents staffing the vehicles will offer women’s health screenings, vaccinations, prenatal care, and testing and treatment for sexually transmitted infections.

Rivas said the Texas program was inspired by a study that found that, 6 months after giving birth, 34% of surveyed Texas mothers said long-acting contraception is their preferred birth control option — but only 13% were using that method.

“We started thinking about ways to address that gap,” Rivas said.

Healthy Mujeres, which is funded through multiple grants, started with a focus on contraception. It later expanded to services such as pregnancy ultrasounds, cervical cancer screenings, and testing for sexually transmitted infections.

While the Texas and Arkansas programs can bill insurance, they also have funding to help uninsured and underinsured patients afford their services. Both use community health workers — called promotoras in largely Spanish-speaking communities like the Rio Grande Valley — to connect patients with food, transportation, additional medical services, and other needs.

They partner with organizations that locals trust, such as food pantries and community colleges, which let the mobile units set up in their parking lots. And to further increase the availability of long-acting contraception in rural areas, the universities are training their students and local providers on how to insert, remove, and get reimbursed for the devices.

One difference between the programs is dictated by state laws. The Arkansas program can provide birth control to minors without a parent or guardian’s consent. But in Texas, most minors need consent before receiving health care, including contraception.

Advocates say these initiatives might help lower the rates of unintended and teen pregnancies in both states, which are higher than the national average.

Rivas and Conroy said their programs haven’t received much pushback. But Rivas said some churches that had asked the UniMóvil to visit their congregations changed their minds after learning the services included birth control.

Catherine Phillips, director of the Respect Life Office at Arkansas’ Catholic diocese, said the diocese supports efforts to achieve health care equity and she’s personally interested in mobile programs that visit rural areas such as where she lives.

But Phillips said the Arkansas program’s focus on birth control, especially long-acting methods, violates the teachings of the Catholic Church. Offering these services to minors without parental consent “makes it more egregious,” she said.

Jones said that, while these programs have hefty costs and other challenges, they also have benefits that can’t be measured in numbers.

“Building community trust and making an impact in the communities most impacted by health inequities — that’s invaluable,” she said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Research on pain management during placement of intrauterine devices (IUD) is lacking, but most studies so far indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) are not effective, according to a poster presented at Pain Week 2024 in Las Vegas.

Roughly 79% of the 14 studies included in the systematic review found NSAIDs — one of the most common drugs clinicians advise patients to take before placement — did not diminish discomfort.

“We’re challenging the current practice of using just NSAIDs as a first-line of treatment,” said Kevin Rowland, PhD, professor and chair of biomedical sciences at Tilman J. Fertitta Family College of Medicine in Houston, who helped conduct the meta-analysis. “We need additional measures.”

Some studies found the drugs offered virtually no improvement for patients, while the biggest drop in pain shown in one study was about 40%. The range of pain levels women reported while using NSAIDs was between 1.8 and 7.3 on the visual analog scale (VAS), with an average score of 4.25.

The review included 10 types of NSAIDs and dosages administered to patients before the procedure. One intramuscular NSAID was included while the remaining were oral. All studies were peer-reviewed, used the VAS pain scale, and were not limited to any specific population.

The findings highlight a longstanding but unresolved problem in reproductive health: An overall lack of effective pain management strategies for gynecologic procedures.

“We went into this having a pretty good idea of what we were going to find because [the lack of NSAID efficacy] has been shown before, it’s been talked about before, and we’re just not listening as a medical community,” said Isabella D. Martingano, an MD candidate at Tilman J. Fertitta Family College of Medicine, who led the review.

The research also points to a lack of robust studies on pain during IUD placement, said Emma Lakey, a coauthor and medical student at Tilman J. Fertitta Family College of Medicine.

“We were only able to review 14 studies, which was enough to go off of, but considering we were looking for trials about pain control for a procedure that helps prevent pregnancy, that’s just not enough research,” Ms. Lakey said.

Discomfort associated with IUD placement ranges from mild to severe, can last for over a week, and includes cramping, bleeding, lightheadedness, nausea, and fainting. Some research suggests that providers may underestimate the level of pain the procedures cause.

“Unfortunately, the pain associated with IUD insertion and removal has been underplayed for a long time and many practitioners in the field likely haven’t counseled patients fully on what the procedure will feel like,” said Jennifer Chin, MD, an ob.gyn. and assistant professor of obstetrics and gynecology at the University of Washington in Seattle.

NSAIDs are not mentioned in the recently expanded guidelines on IUD placement from the US Centers for Disease Control and Prevention (CDC). The CDC recommends lidocaine paracervical blocks, gels, sprays, and creams, plus counseling women about pain ahead of the procedures.

IUDs are one of the most effective forms of birth control, with a failure rate below 1%.

Yet hearing about painful placement keeps many women from seeking out an IUD or replacing an existing device, Dr. Rowland said. The review adds to the body of evidence that current strategies are not working and that more research is needed, he said.

According to Dr. Chin, making IUDs more accessible means taking a more personalized approach to pain management while understanding that what may be a painless procedure for one patient may be excruciating for another.

Dr. Chin offers a range of options for her patients, including NSAIDs, lorazepam for anxiety, paracervical blocks, lidocaine jelly and spray, intravenous sedation, and general anesthesia. She also talks to her patients through the procedure and provides guided imagery and meditation.

“We should always make sure we’re prioritizing the patients and providing evidence-based, compassionate, and individualized care,” said Dr. Chin. “Each patient comes to us in a particular context and with a specific set of experiences and history that will make a difference in how we’re best able to take care of them.”

The authors reported no disclosures and no sources of funding. Dr. Chin reported no disclosures.
 

A version of this article first appeared on Medscape.com.

Research on pain management during placement of intrauterine devices (IUD) is lacking, but most studies so far indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) are not effective, according to a poster presented at Pain Week 2024 in Las Vegas.

Roughly 79% of the 14 studies included in the systematic review found NSAIDs — one of the most common drugs clinicians advise patients to take before placement — did not diminish discomfort.

“We’re challenging the current practice of using just NSAIDs as a first-line of treatment,” said Kevin Rowland, PhD, professor and chair of biomedical sciences at Tilman J. Fertitta Family College of Medicine in Houston, who helped conduct the meta-analysis. “We need additional measures.”

Some studies found the drugs offered virtually no improvement for patients, while the biggest drop in pain shown in one study was about 40%. The range of pain levels women reported while using NSAIDs was between 1.8 and 7.3 on the visual analog scale (VAS), with an average score of 4.25.

The review included 10 types of NSAIDs and dosages administered to patients before the procedure. One intramuscular NSAID was included while the remaining were oral. All studies were peer-reviewed, used the VAS pain scale, and were not limited to any specific population.

The findings highlight a longstanding but unresolved problem in reproductive health: An overall lack of effective pain management strategies for gynecologic procedures.

“We went into this having a pretty good idea of what we were going to find because [the lack of NSAID efficacy] has been shown before, it’s been talked about before, and we’re just not listening as a medical community,” said Isabella D. Martingano, an MD candidate at Tilman J. Fertitta Family College of Medicine, who led the review.

The research also points to a lack of robust studies on pain during IUD placement, said Emma Lakey, a coauthor and medical student at Tilman J. Fertitta Family College of Medicine.

“We were only able to review 14 studies, which was enough to go off of, but considering we were looking for trials about pain control for a procedure that helps prevent pregnancy, that’s just not enough research,” Ms. Lakey said.

Discomfort associated with IUD placement ranges from mild to severe, can last for over a week, and includes cramping, bleeding, lightheadedness, nausea, and fainting. Some research suggests that providers may underestimate the level of pain the procedures cause.

“Unfortunately, the pain associated with IUD insertion and removal has been underplayed for a long time and many practitioners in the field likely haven’t counseled patients fully on what the procedure will feel like,” said Jennifer Chin, MD, an ob.gyn. and assistant professor of obstetrics and gynecology at the University of Washington in Seattle.

NSAIDs are not mentioned in the recently expanded guidelines on IUD placement from the US Centers for Disease Control and Prevention (CDC). The CDC recommends lidocaine paracervical blocks, gels, sprays, and creams, plus counseling women about pain ahead of the procedures.

IUDs are one of the most effective forms of birth control, with a failure rate below 1%.

Yet hearing about painful placement keeps many women from seeking out an IUD or replacing an existing device, Dr. Rowland said. The review adds to the body of evidence that current strategies are not working and that more research is needed, he said.

According to Dr. Chin, making IUDs more accessible means taking a more personalized approach to pain management while understanding that what may be a painless procedure for one patient may be excruciating for another.

Dr. Chin offers a range of options for her patients, including NSAIDs, lorazepam for anxiety, paracervical blocks, lidocaine jelly and spray, intravenous sedation, and general anesthesia. She also talks to her patients through the procedure and provides guided imagery and meditation.

“We should always make sure we’re prioritizing the patients and providing evidence-based, compassionate, and individualized care,” said Dr. Chin. “Each patient comes to us in a particular context and with a specific set of experiences and history that will make a difference in how we’re best able to take care of them.”

The authors reported no disclosures and no sources of funding. Dr. Chin reported no disclosures.
 

A version of this article first appeared on Medscape.com.

Research on pain management during placement of intrauterine devices (IUD) is lacking, but most studies so far indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) are not effective, according to a poster presented at Pain Week 2024 in Las Vegas.

Roughly 79% of the 14 studies included in the systematic review found NSAIDs — one of the most common drugs clinicians advise patients to take before placement — did not diminish discomfort.

“We’re challenging the current practice of using just NSAIDs as a first-line of treatment,” said Kevin Rowland, PhD, professor and chair of biomedical sciences at Tilman J. Fertitta Family College of Medicine in Houston, who helped conduct the meta-analysis. “We need additional measures.”

Some studies found the drugs offered virtually no improvement for patients, while the biggest drop in pain shown in one study was about 40%. The range of pain levels women reported while using NSAIDs was between 1.8 and 7.3 on the visual analog scale (VAS), with an average score of 4.25.

The review included 10 types of NSAIDs and dosages administered to patients before the procedure. One intramuscular NSAID was included while the remaining were oral. All studies were peer-reviewed, used the VAS pain scale, and were not limited to any specific population.

The findings highlight a longstanding but unresolved problem in reproductive health: An overall lack of effective pain management strategies for gynecologic procedures.

“We went into this having a pretty good idea of what we were going to find because [the lack of NSAID efficacy] has been shown before, it’s been talked about before, and we’re just not listening as a medical community,” said Isabella D. Martingano, an MD candidate at Tilman J. Fertitta Family College of Medicine, who led the review.

The research also points to a lack of robust studies on pain during IUD placement, said Emma Lakey, a coauthor and medical student at Tilman J. Fertitta Family College of Medicine.

“We were only able to review 14 studies, which was enough to go off of, but considering we were looking for trials about pain control for a procedure that helps prevent pregnancy, that’s just not enough research,” Ms. Lakey said.

Discomfort associated with IUD placement ranges from mild to severe, can last for over a week, and includes cramping, bleeding, lightheadedness, nausea, and fainting. Some research suggests that providers may underestimate the level of pain the procedures cause.

“Unfortunately, the pain associated with IUD insertion and removal has been underplayed for a long time and many practitioners in the field likely haven’t counseled patients fully on what the procedure will feel like,” said Jennifer Chin, MD, an ob.gyn. and assistant professor of obstetrics and gynecology at the University of Washington in Seattle.

NSAIDs are not mentioned in the recently expanded guidelines on IUD placement from the US Centers for Disease Control and Prevention (CDC). The CDC recommends lidocaine paracervical blocks, gels, sprays, and creams, plus counseling women about pain ahead of the procedures.

IUDs are one of the most effective forms of birth control, with a failure rate below 1%.

Yet hearing about painful placement keeps many women from seeking out an IUD or replacing an existing device, Dr. Rowland said. The review adds to the body of evidence that current strategies are not working and that more research is needed, he said.

According to Dr. Chin, making IUDs more accessible means taking a more personalized approach to pain management while understanding that what may be a painless procedure for one patient may be excruciating for another.

Dr. Chin offers a range of options for her patients, including NSAIDs, lorazepam for anxiety, paracervical blocks, lidocaine jelly and spray, intravenous sedation, and general anesthesia. She also talks to her patients through the procedure and provides guided imagery and meditation.

“We should always make sure we’re prioritizing the patients and providing evidence-based, compassionate, and individualized care,” said Dr. Chin. “Each patient comes to us in a particular context and with a specific set of experiences and history that will make a difference in how we’re best able to take care of them.”

The authors reported no disclosures and no sources of funding. Dr. Chin reported no disclosures.
 

A version of this article first appeared on Medscape.com.

After years of debate and disagreement, could an improved, more user-friendly version of iPLEDGE be on the horizon?

iPLEDGE, the Food and Drug Administration (FDA)–required Risk Evaluation and Mitigation Strategy (REMS) program launched in 2010, aims to manage the risks for the teratogenic acne drug isotretinoin and prevent fetal exposure. But it’s been dogged by issues and controversy, causing difficulties for patients and prescribers.

Late in 2023, there seemed to be a reason for optimism that improvements were coming. On November 30, 2023, the FDA informed isotretinoin manufacturers — known as the Isotretinoin Products Manufacturing Group (IPMG) — that they had 6 months to make five changes to the existing iPLEDGE REMS, addressing the controversies and potentially reducing glitches in the program and minimizing the burden of the program on patients, prescribers, and pharmacies — while maintaining safe use of the drug — and to submit their proposal by May 30, 2024.

The timeline for when an improved program might be in place remains unclear.

An FDA spokesperson, without confirming that the submission was submitted on time, recently said the review timeline once such a submission is received is generally 6 months.
 

‘Radio Silence’

No official FDA announcement has been made about the timeline, nor has information been forthcoming from the IPMG, and the silence has been frustrating for John S. Barbieri, MD, MBA, assistant professor of dermatology at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, both in Boston, Massachusetts. He chairs the American Academy of Dermatology Association’s IPLEDGE Work Group, which works with both the FDA and IPMG.

Brigham and Women&#039;s Hospital

He began writing about issues with iPLEDGE about 4 years ago, when he and colleagues suggested, among other changes, simplifying the iPLEDGE contraception requirements in a paper published in the Journal of the American Academy of Dermatology.

In an interview, Dr. Barbieri expressed frustration about the lack of information on the status of the iPLEDGE changes. “We’ve been given no timeline [beyond the FDA’s May 30 deadline for the IPMG to respond] of what might happen when. We’ve asked what was submitted. No one will share it with us or tell us anything about it. It’s just radio silence.”

Dr. Barbieri is also frustrated at the lack of response from IPMG. Despite repeated requests to the group to include the dermatologists in the discussions, IPMG has repeatedly declined the help, he said.

IPMG appears to have no dedicated website. No response had been received to an email sent to an address attributed to the group asking if it would share the submission to the FDA.

Currently, isotretinoin, originally marketed as Accutane, is marketed under such brand names as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane.

Asked for specific information on the proposed changes, an FDA spokesperson said in an August 19 email that “the submission to the FDA from the isotretinoin manufacturers will be a major modification, and the review timeline is generally 6 months. Once approved, the isotretinoin manufacturers will need additional time to implement the changes.”

The spokesperson declined to provide additional information on the status of the IPMG proposal, to share the proposal itself, or to estimate the implementation period.


 

Reason for Hope?

In response to the comment that the review generally takes 6 months, Dr. Barbieri said it doesn’t give him much hope, adding that “any delay of implementing these reforms is a missed opportunity to improve the care of patients with acne.” He is also hopeful that the FDA will invite some public comment during the review period “so that stakeholders can share their feedback about the proposal to help guide FDA decision-making and ensure effective implementation.”
 

From Meeting to Mandate

The FDA order for the changes followed a joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee in March 2023 about the program requirements. It included feedback from patients and dermatologists and recommendations for changes, with a goal of reducing the burden of the program on patients, pharmacies, and prescribers without compromising patient safety.

The Five Requested Changes

In the November 30 letter, the FDA requested the following from the IPMG:

• Remove the requirement that pregnancy tests be performed in a specially certified lab (such as a Clinical Laboratory Improvement Amendments lab). This would enable the tests to be done in a clinic setting rather than sending patients to a separate lab.
• Allow prescribers the option of letting patients use home pregnancy tests during and after treatment, with steps in place to minimize falsification.
• Remove the waiting period requirement, known as the “19-day lockout,” for patients if they don’t obtain the isotretinoin from the pharmacy within the first 7-day prescription window. Before initiation of isotretinoin, a repeat confirmatory test must be done in a medical setting without any required waiting period.
• Revise the pregnancy registry requirement, removing the objective to document the outcome and associated collection of data for each pregnancy.
• Revise the requirement for prescribers to document patient counseling for those who can’t become pregnant from monthly counseling to counseling at enrollment only. Before each prescription is dispensed, the authorization must verify patient enrollment and prescriber certification. (In December 2021, a new, gender-neutral approach, approved by the FDA, was launched. It places potential patients into two risk categories — those who can become pregnant and those who cannot. Previously, there were three such categories: Females of reproductive potential, females not of reproductive potential, and males.)

Perspective on the Requested Changes

Of the requested changes, “really the most important is eliminating the request for monthly counseling for patients who cannot become pregnant,” Dr. Barbieri said. Because of that requirement, all patients need to have monthly visits with a dermatologist to get the medication refills, “and that creates a logistical barrier,” plus reducing time available for dermatologists to care for other patients with other dermatologic issues.

As for missing the 7-day prescription window, Dr. Barbieri said, in his experience, “it’s almost never the patient’s fault; it’s almost always an insurance problem.”

Dr. Barbieri reported no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

After years of debate and disagreement, could an improved, more user-friendly version of iPLEDGE be on the horizon?

iPLEDGE, the Food and Drug Administration (FDA)–required Risk Evaluation and Mitigation Strategy (REMS) program launched in 2010, aims to manage the risks for the teratogenic acne drug isotretinoin and prevent fetal exposure. But it’s been dogged by issues and controversy, causing difficulties for patients and prescribers.

Late in 2023, there seemed to be a reason for optimism that improvements were coming. On November 30, 2023, the FDA informed isotretinoin manufacturers — known as the Isotretinoin Products Manufacturing Group (IPMG) — that they had 6 months to make five changes to the existing iPLEDGE REMS, addressing the controversies and potentially reducing glitches in the program and minimizing the burden of the program on patients, prescribers, and pharmacies — while maintaining safe use of the drug — and to submit their proposal by May 30, 2024.

The timeline for when an improved program might be in place remains unclear.

An FDA spokesperson, without confirming that the submission was submitted on time, recently said the review timeline once such a submission is received is generally 6 months.
 

‘Radio Silence’

No official FDA announcement has been made about the timeline, nor has information been forthcoming from the IPMG, and the silence has been frustrating for John S. Barbieri, MD, MBA, assistant professor of dermatology at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, both in Boston, Massachusetts. He chairs the American Academy of Dermatology Association’s IPLEDGE Work Group, which works with both the FDA and IPMG.

Brigham and Women&#039;s Hospital

He began writing about issues with iPLEDGE about 4 years ago, when he and colleagues suggested, among other changes, simplifying the iPLEDGE contraception requirements in a paper published in the Journal of the American Academy of Dermatology.

In an interview, Dr. Barbieri expressed frustration about the lack of information on the status of the iPLEDGE changes. “We’ve been given no timeline [beyond the FDA’s May 30 deadline for the IPMG to respond] of what might happen when. We’ve asked what was submitted. No one will share it with us or tell us anything about it. It’s just radio silence.”

Dr. Barbieri is also frustrated at the lack of response from IPMG. Despite repeated requests to the group to include the dermatologists in the discussions, IPMG has repeatedly declined the help, he said.

IPMG appears to have no dedicated website. No response had been received to an email sent to an address attributed to the group asking if it would share the submission to the FDA.

Currently, isotretinoin, originally marketed as Accutane, is marketed under such brand names as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane.

Asked for specific information on the proposed changes, an FDA spokesperson said in an August 19 email that “the submission to the FDA from the isotretinoin manufacturers will be a major modification, and the review timeline is generally 6 months. Once approved, the isotretinoin manufacturers will need additional time to implement the changes.”

The spokesperson declined to provide additional information on the status of the IPMG proposal, to share the proposal itself, or to estimate the implementation period.


 

Reason for Hope?

In response to the comment that the review generally takes 6 months, Dr. Barbieri said it doesn’t give him much hope, adding that “any delay of implementing these reforms is a missed opportunity to improve the care of patients with acne.” He is also hopeful that the FDA will invite some public comment during the review period “so that stakeholders can share their feedback about the proposal to help guide FDA decision-making and ensure effective implementation.”
 

From Meeting to Mandate

The FDA order for the changes followed a joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee in March 2023 about the program requirements. It included feedback from patients and dermatologists and recommendations for changes, with a goal of reducing the burden of the program on patients, pharmacies, and prescribers without compromising patient safety.

The Five Requested Changes

In the November 30 letter, the FDA requested the following from the IPMG:

• Remove the requirement that pregnancy tests be performed in a specially certified lab (such as a Clinical Laboratory Improvement Amendments lab). This would enable the tests to be done in a clinic setting rather than sending patients to a separate lab.
• Allow prescribers the option of letting patients use home pregnancy tests during and after treatment, with steps in place to minimize falsification.
• Remove the waiting period requirement, known as the “19-day lockout,” for patients if they don’t obtain the isotretinoin from the pharmacy within the first 7-day prescription window. Before initiation of isotretinoin, a repeat confirmatory test must be done in a medical setting without any required waiting period.
• Revise the pregnancy registry requirement, removing the objective to document the outcome and associated collection of data for each pregnancy.
• Revise the requirement for prescribers to document patient counseling for those who can’t become pregnant from monthly counseling to counseling at enrollment only. Before each prescription is dispensed, the authorization must verify patient enrollment and prescriber certification. (In December 2021, a new, gender-neutral approach, approved by the FDA, was launched. It places potential patients into two risk categories — those who can become pregnant and those who cannot. Previously, there were three such categories: Females of reproductive potential, females not of reproductive potential, and males.)

Perspective on the Requested Changes

Of the requested changes, “really the most important is eliminating the request for monthly counseling for patients who cannot become pregnant,” Dr. Barbieri said. Because of that requirement, all patients need to have monthly visits with a dermatologist to get the medication refills, “and that creates a logistical barrier,” plus reducing time available for dermatologists to care for other patients with other dermatologic issues.

As for missing the 7-day prescription window, Dr. Barbieri said, in his experience, “it’s almost never the patient’s fault; it’s almost always an insurance problem.”

Dr. Barbieri reported no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

After years of debate and disagreement, could an improved, more user-friendly version of iPLEDGE be on the horizon?

iPLEDGE, the Food and Drug Administration (FDA)–required Risk Evaluation and Mitigation Strategy (REMS) program launched in 2010, aims to manage the risks for the teratogenic acne drug isotretinoin and prevent fetal exposure. But it’s been dogged by issues and controversy, causing difficulties for patients and prescribers.

Late in 2023, there seemed to be a reason for optimism that improvements were coming. On November 30, 2023, the FDA informed isotretinoin manufacturers — known as the Isotretinoin Products Manufacturing Group (IPMG) — that they had 6 months to make five changes to the existing iPLEDGE REMS, addressing the controversies and potentially reducing glitches in the program and minimizing the burden of the program on patients, prescribers, and pharmacies — while maintaining safe use of the drug — and to submit their proposal by May 30, 2024.

The timeline for when an improved program might be in place remains unclear.

An FDA spokesperson, without confirming that the submission was submitted on time, recently said the review timeline once such a submission is received is generally 6 months.
 

‘Radio Silence’

No official FDA announcement has been made about the timeline, nor has information been forthcoming from the IPMG, and the silence has been frustrating for John S. Barbieri, MD, MBA, assistant professor of dermatology at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, both in Boston, Massachusetts. He chairs the American Academy of Dermatology Association’s IPLEDGE Work Group, which works with both the FDA and IPMG.

Brigham and Women&#039;s Hospital

He began writing about issues with iPLEDGE about 4 years ago, when he and colleagues suggested, among other changes, simplifying the iPLEDGE contraception requirements in a paper published in the Journal of the American Academy of Dermatology.

In an interview, Dr. Barbieri expressed frustration about the lack of information on the status of the iPLEDGE changes. “We’ve been given no timeline [beyond the FDA’s May 30 deadline for the IPMG to respond] of what might happen when. We’ve asked what was submitted. No one will share it with us or tell us anything about it. It’s just radio silence.”

Dr. Barbieri is also frustrated at the lack of response from IPMG. Despite repeated requests to the group to include the dermatologists in the discussions, IPMG has repeatedly declined the help, he said.

IPMG appears to have no dedicated website. No response had been received to an email sent to an address attributed to the group asking if it would share the submission to the FDA.

Currently, isotretinoin, originally marketed as Accutane, is marketed under such brand names as Absorica, Absorica LD, Claravis, Amnesteem, Myorisan, and Zenatane.

Asked for specific information on the proposed changes, an FDA spokesperson said in an August 19 email that “the submission to the FDA from the isotretinoin manufacturers will be a major modification, and the review timeline is generally 6 months. Once approved, the isotretinoin manufacturers will need additional time to implement the changes.”

The spokesperson declined to provide additional information on the status of the IPMG proposal, to share the proposal itself, or to estimate the implementation period.


 

Reason for Hope?

In response to the comment that the review generally takes 6 months, Dr. Barbieri said it doesn’t give him much hope, adding that “any delay of implementing these reforms is a missed opportunity to improve the care of patients with acne.” He is also hopeful that the FDA will invite some public comment during the review period “so that stakeholders can share their feedback about the proposal to help guide FDA decision-making and ensure effective implementation.”
 

From Meeting to Mandate

The FDA order for the changes followed a joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee in March 2023 about the program requirements. It included feedback from patients and dermatologists and recommendations for changes, with a goal of reducing the burden of the program on patients, pharmacies, and prescribers without compromising patient safety.

The Five Requested Changes

In the November 30 letter, the FDA requested the following from the IPMG:

• Remove the requirement that pregnancy tests be performed in a specially certified lab (such as a Clinical Laboratory Improvement Amendments lab). This would enable the tests to be done in a clinic setting rather than sending patients to a separate lab.
• Allow prescribers the option of letting patients use home pregnancy tests during and after treatment, with steps in place to minimize falsification.
• Remove the waiting period requirement, known as the “19-day lockout,” for patients if they don’t obtain the isotretinoin from the pharmacy within the first 7-day prescription window. Before initiation of isotretinoin, a repeat confirmatory test must be done in a medical setting without any required waiting period.
• Revise the pregnancy registry requirement, removing the objective to document the outcome and associated collection of data for each pregnancy.
• Revise the requirement for prescribers to document patient counseling for those who can’t become pregnant from monthly counseling to counseling at enrollment only. Before each prescription is dispensed, the authorization must verify patient enrollment and prescriber certification. (In December 2021, a new, gender-neutral approach, approved by the FDA, was launched. It places potential patients into two risk categories — those who can become pregnant and those who cannot. Previously, there were three such categories: Females of reproductive potential, females not of reproductive potential, and males.)

Perspective on the Requested Changes

Of the requested changes, “really the most important is eliminating the request for monthly counseling for patients who cannot become pregnant,” Dr. Barbieri said. Because of that requirement, all patients need to have monthly visits with a dermatologist to get the medication refills, “and that creates a logistical barrier,” plus reducing time available for dermatologists to care for other patients with other dermatologic issues.

As for missing the 7-day prescription window, Dr. Barbieri said, in his experience, “it’s almost never the patient’s fault; it’s almost always an insurance problem.”

Dr. Barbieri reported no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

Federal Health Care Data Trends is a special supplement to Federal Practitioner, showcasing the latest research in health care for veterans and active-duty military members via compelling infographics. Click below to view highlights from the issue: 

• VA Overview
• Dermatology
• Depression and PTSD
• Diabetes
• Cardiology
• Arthritis
• Traumatic Brain Injury (TBI)
• Women's Health
• Substance Use Disorder
• Transgender and Gender-Diverse Care
• Respiratory Health
• Age-Related Macular Degeneration (AMD)
• Parkinson Disease
• Amyotrophic Lateral Sclerosis (ALS)

Federal Health Care Data Trends is a special supplement to Federal Practitioner, showcasing the latest research in health care for veterans and active-duty military members via compelling infographics. Click below to view highlights from the issue: 

• VA Overview
• Dermatology
• Depression and PTSD
• Diabetes
• Cardiology
• Arthritis
• Traumatic Brain Injury (TBI)
• Women's Health
• Substance Use Disorder
• Transgender and Gender-Diverse Care
• Respiratory Health
• Age-Related Macular Degeneration (AMD)
• Parkinson Disease
• Amyotrophic Lateral Sclerosis (ALS)

Federal Health Care Data Trends is a special supplement to Federal Practitioner, showcasing the latest research in health care for veterans and active-duty military members via compelling infographics. Click below to view highlights from the issue: 

• VA Overview
• Dermatology
• Depression and PTSD
• Diabetes
• Cardiology
• Arthritis
• Traumatic Brain Injury (TBI)
• Women's Health
• Substance Use Disorder
• Transgender and Gender-Diverse Care
• Respiratory Health
• Age-Related Macular Degeneration (AMD)
• Parkinson Disease
• Amyotrophic Lateral Sclerosis (ALS)

TOPLINE:

A study found significant associations between melasma and several comorbidities, including hypertension and hormonal contraception use, which were the most common.

METHODOLOGY:

• Melasma predominantly affects young women of color and often worsens in hyperestrogen states; understanding the association with comorbidities can improve surveillance and treatment strategies.
• Researchers evaluated 41,283 patients with melasma (mean age, 48.8 years; 93% women) from the TriNetX database and an equal number of matched control individuals.
• The main outcome was comorbidities including allergic rhinitis, atopic dermatitis, anticonvulsants, diabetes, hormonal contraceptives, hypothyroidism, hypertension, lupus, rosacea, skin cancer, and malignancy.

TAKEAWAY:

• Among those with melasma, 25% had hypertension and 24% used hormonal contraception, the two most commonly associated risk factors identified.
• Rosacea (odds ratio [OR], 5.1), atopic dermatitis (OR, 3.3), lupus (OR, 2.5), history of skin cancer (OR, 2.5), and history of internal malignancy (OR, 2.1) were associated with the highest risk of developing melasma (P < .01 for all).
• Asian (OR, 2.0; P < .01) and “other/unknown” races (OR, 1.7; P < .01) and Hispanic ethnicity (OR, 1.3; P < .01) were also significantly associated with melasma, while the odds were slightly lower among White, Black/African American, and “not Hispanic” groups (ORs, 0.8; P < .01 for all groups).

IN PRACTICE:

“Understanding the potential associations between these risk factors and melasma will better improve the management and monitoring of the most susceptible patients,” the authors wrote.

SOURCE:

The study, led by Ajay N. Sharma, MD, MBA, of the Department of Dermatology at the University of California, Irvine, was published online in Journal of Drugs in Dermatology.

LIMITATIONS:

The study limitations included the retrospective design, potential misclassification of diagnoses, and the inability to establish causality.

DISCLOSURES:

The study did not disclose any funding sources. The authors declared no conflicts of interest.

A version of this article first appeared on Medscape.com.

TOPLINE:

A study found significant associations between melasma and several comorbidities, including hypertension and hormonal contraception use, which were the most common.

METHODOLOGY:

• Melasma predominantly affects young women of color and often worsens in hyperestrogen states; understanding the association with comorbidities can improve surveillance and treatment strategies.
• Researchers evaluated 41,283 patients with melasma (mean age, 48.8 years; 93% women) from the TriNetX database and an equal number of matched control individuals.
• The main outcome was comorbidities including allergic rhinitis, atopic dermatitis, anticonvulsants, diabetes, hormonal contraceptives, hypothyroidism, hypertension, lupus, rosacea, skin cancer, and malignancy.

TAKEAWAY:

• Among those with melasma, 25% had hypertension and 24% used hormonal contraception, the two most commonly associated risk factors identified.
• Rosacea (odds ratio [OR], 5.1), atopic dermatitis (OR, 3.3), lupus (OR, 2.5), history of skin cancer (OR, 2.5), and history of internal malignancy (OR, 2.1) were associated with the highest risk of developing melasma (P < .01 for all).
• Asian (OR, 2.0; P < .01) and “other/unknown” races (OR, 1.7; P < .01) and Hispanic ethnicity (OR, 1.3; P < .01) were also significantly associated with melasma, while the odds were slightly lower among White, Black/African American, and “not Hispanic” groups (ORs, 0.8; P < .01 for all groups).

IN PRACTICE:

“Understanding the potential associations between these risk factors and melasma will better improve the management and monitoring of the most susceptible patients,” the authors wrote.

SOURCE:

The study, led by Ajay N. Sharma, MD, MBA, of the Department of Dermatology at the University of California, Irvine, was published online in Journal of Drugs in Dermatology.

LIMITATIONS:

The study limitations included the retrospective design, potential misclassification of diagnoses, and the inability to establish causality.

DISCLOSURES:

The study did not disclose any funding sources. The authors declared no conflicts of interest.

A version of this article first appeared on Medscape.com.

TOPLINE:

A study found significant associations between melasma and several comorbidities, including hypertension and hormonal contraception use, which were the most common.

METHODOLOGY:

• Melasma predominantly affects young women of color and often worsens in hyperestrogen states; understanding the association with comorbidities can improve surveillance and treatment strategies.
• Researchers evaluated 41,283 patients with melasma (mean age, 48.8 years; 93% women) from the TriNetX database and an equal number of matched control individuals.
• The main outcome was comorbidities including allergic rhinitis, atopic dermatitis, anticonvulsants, diabetes, hormonal contraceptives, hypothyroidism, hypertension, lupus, rosacea, skin cancer, and malignancy.

TAKEAWAY:

• Among those with melasma, 25% had hypertension and 24% used hormonal contraception, the two most commonly associated risk factors identified.
• Rosacea (odds ratio [OR], 5.1), atopic dermatitis (OR, 3.3), lupus (OR, 2.5), history of skin cancer (OR, 2.5), and history of internal malignancy (OR, 2.1) were associated with the highest risk of developing melasma (P < .01 for all).
• Asian (OR, 2.0; P < .01) and “other/unknown” races (OR, 1.7; P < .01) and Hispanic ethnicity (OR, 1.3; P < .01) were also significantly associated with melasma, while the odds were slightly lower among White, Black/African American, and “not Hispanic” groups (ORs, 0.8; P < .01 for all groups).

IN PRACTICE:

“Understanding the potential associations between these risk factors and melasma will better improve the management and monitoring of the most susceptible patients,” the authors wrote.

SOURCE:

The study, led by Ajay N. Sharma, MD, MBA, of the Department of Dermatology at the University of California, Irvine, was published online in Journal of Drugs in Dermatology.

LIMITATIONS:

The study limitations included the retrospective design, potential misclassification of diagnoses, and the inability to establish causality.

DISCLOSURES:

The study did not disclose any funding sources. The authors declared no conflicts of interest.

A version of this article first appeared on Medscape.com.