ReportWire

Tag: prescription

  • DC residents can now get a COVID-19 shot without a prescription – WTOP News

    [ad_1]

    Emergency legislation signed by D.C. Mayor Muriel Bowser will authorize licensed pharmacies to administer COVID-19 vaccinations without a prescription.

    Emergency legislation signed this week by D.C. Mayor Muriel Bowser will authorize licensed pharmacies to administer COVID-19 vaccinations without a prescription.

    Changes in federal recommendations this year made it a requirement for those who wanted the COVID-19 vaccine to get a prescription first, unless a person was 65 or older or was considered at risk. The Centers for Disease Control’s immunization schedule lists the 2024-25 COVID-19 vaccine, but not the 2025-26 version — leaving the newer shots subject to a prescription requirement.

    That has resulted in several states resorting to implementing their own policies to negate the need for a prescription, which was not required in previous years since the pandemic.

    “D.C. will now match both Maryland and Virginia, so that residents don’t have to travel out of state to be able to get access to the vaccine,” said At-Large Council member Christina Henderson, who chairs the Committee on Health.

    It was her bill that was passed 12-0 by the council and signed by Mayor Bowser.

    Eligible Virginians also now have an easier time getting vaccines due to an order issued by the Virginia Department of Health two weeks ago. Neighboring Maryland will also protect access to vaccines for all of its residents with flu season approaching.

    “The D.C. Department of Insurance Securities and Banking has required that all insurance plans in the District continue to cover all vaccines that were approved as of last December through 2026,” Henderson added.

    Henderson is concerned that the current administration is not focused on proven, health-based practices.

    “I do wish that the federal government would get back on track in terms of truly following the science, as opposed to these associations not correlations that they are seeing in research,” she said.

    She pointed to President Donald Trump’s announcement this week that pregnant women should not take Tylenol because he said — without any supporting scientific evidence — that there is a link between acetaminophen and autism in children. The maker of Tylenol, Kenvue, as well as numerous scientific groups immediately and forcefully rebuked that claim.

    Get breaking news and daily headlines delivered to your email inbox by signing up here.

    © 2025 WTOP. All Rights Reserved. This website is not intended for users located within the European Economic Area.

    [ad_2]

    Alan Etter

    Source link

  • Vaccine chaos: Even some vulnerable seniors can’t get COVID shots amid spiking cases

    [ad_1]

    Seniors in some parts of the country say they are being denied COVID-19 vaccinations amid an ongoing spike in cases, leading to rising frustration over new Trump administration policies that are making it harder to get the shots.

    Matthew D’Amico, 67, of New York City, said a Walgreens declined to administer COVID-19 vaccines to him and his 75-year-old wife on Friday because they didn’t have a prescription. They’re trying to get vaccinated ahead of a trip.

    “I can’t believe we can’t get” the vaccine, D’Amico said in an interview. “I’ve been inoculated a number of times and never had to get a prescription. And it’s just very frustrating that this is where we are.”

    He’s not alone in his exasperation. Under the leadership of the vaccine skeptic Health and Human Services Secretary Robert F. Kennedy Jr., federal agencies have effectively made it more difficult to get vaccinated against COVID-19 this year. The Food and Drug Administration has only “approved” COVID-19 vaccines for those age 65 and up, as well as younger people with underlying health conditions.

    That means across the country, people younger than 65 interested in getting the COVID-19 vaccine must now either consult with a healthcare provider or “attest” to a pharmacy that they have an underlying health condition. It’s a potential hurdle that can make getting the vaccine more difficult and, some health experts worry, prompt even more Americans to eschew getting vaccinated.

    As D’Amico can attest, though, being part of a group for whom the COVID vaccine is “approved” doesn’t necessarily guarantee easy access.

    “For me to go to my primary [healthcare provider] now and get a prescription, it’s just kind of ridiculous,” D’Amico said.

    At least some people younger than 65 are encountering pharmacy staff asking probing questions about their medical conditions.

    That happened Friday at a CVS in Orange County, according to 34-year-old Alex Benson, who takes medication that can suppress his immune system.

    Besides just protecting himself, he wanted to get vaccinated as he has family members who are at high risk should they get COVID — his mother is immunocompromised, and his mother-in-law had open-heart surgery on Thursday night.

    Benson said an employee asked why he thought he was eligible for the vaccine.

    “They asked me for either a prescription or they wanted to know … why I felt I needed the vaccination,” Benson said. At one point, a staffer offered to call his doctor to get an authorization for the vaccine.

    Benson said he was alarmed by the questions, and started to “feel kind of some desperation to plead my case to the pharmacist.” Another CVS staffer later came over and said further answers weren’t necessary and simply attesting he was eligible was good enough. He eventually got the vaccine.

    Still, he felt the experience was dismaying.

    “I think easy access should be the policy,” Benson said. “I tend not to get too political, but it seems just rather juxtaposed to me that an anti-regulation administration is using regulation in this way. They’re supposed to be removing barriers to healthcare.”

    The vaccine chaos comes as COVID-19 is either increasing or starting to hit its late summer peak. According to data released Friday, there are now 14 states with “very high” levels of coronavirus detected in their wastewater — California, Texas, Florida, North Carolina, Indiana, South Carolina, Alabama, Louisiana, Connecticut, Utah, Nevada, Idaho, Hawaii and Alaska, as well as the District of Columbia.

    Dr. Elizabeth Hudson, the regional physician chief of infectious diseases for Kaiser Permanente Southern California, said data continue to show an increase in coronavirus cases.

    “Over this past week, we’ve seen an increase in the number of outpatient COVID cases, and even a smattering of inpatient cases,” Hudson said. “It appears that we may be nearing the top of the wave, but it may be another two weeks or so until we truly know if we’re there.”

    The rate at which coronavirus lab tests are confirming infection also continues to rise statewide and in the Los Angeles area. For the week ending Aug. 30, California’s COVID test positivity rate was 12.83%, up from 7.05% for the week ending Aug. 2. In L.A. County, the positive test rate was 14.83%, up from 9.33%.

    Other data, however, suggest some areas may have reached their summer COVID peak.

    In Orange County, the COVID positive test rate was 13.1%. That’s below the prior week’s rate of 18%, but still higher than the rate for the week that ended Aug. 2, which was 10.8%.

    In San Francisco, the test positivity rate has been hovering around 9% for the last week of reliable data available. It’s up from 7% a month earlier.

    In addition, wastewater data in L.A. County show coronavirus levels declined slightly from the prior week.

    “It’s too early to know if this decrease in wastewater viral concentrations is the first sign that COVID-19 activity is peaking or is regular variation typical of this data source,” the L.A. County Department of Public Health said.

    COVID hospital admissions in California are increasing — with the latest rate of 3.93 admissions per 100,000 residents, up from 2.38.

    But they remain relatively low statewide and in L.A. County. The number of L.A. County residents seeking care for COVID-related illness, or who have been hospitalized, “is quite a bit lower than during summer surges in 2023 and 2024,” the public health department said.

    A relatively mild summer wave, however, could mean that the annual fall-and-winter COVID wave might be stronger. In July, the state Department of Public Health said that scientists anticipate California would see either a stronger summer COVID wave or a more significant winter wave.

    The current confusion over federal COVID vaccine policy has been exacerbated by the chaos at the U.S. Centers for Disease Control and Prevention, where Kennedy earlier this year fired everyone on the influential Advisory Committee on Immunization Practices, and orchestrated the firing of CDC Director Susan Monarez just 29 days after she was confirmed to the post by the Senate.

    Some of Kennedy’s handpicked replacements on the ACIP have criticized vaccines and spread misinformation, according to the Associated Press. And the new interim CDC director — Jim O’Neill, a Kennedy deputy — is a critic of health regulations and has no training in medicine or healthcare, the AP reported.

    The CDC hasn’t issued its own recommendations on who should get vaccinated, and that inaction has resulted in residents of a number of states needing to get prescriptions from a healthcare provider for at least the next couple of weeks. In some cases, that’s true even for seniors, as D’Amico found out.

    As of Friday, CVS said people need a prescription to get a COVID-19 vaccine, sometimes depending on their age, in Arizona, Florida, Georgia, Louisiana, Maine, North Carolina, New Mexico, New York, Pennsylvania, Utah, Virginia and West Virginia, as well as the District of Columbia.

    CVS couldn’t even offer the COVID-19 at its pharmacies in Nevada as of Friday; they were only available at the company’s MinuteClinic sites, according to spokesperson Amy Thibault.

    CVS said it expects to offer COVID-19 vaccines without prescriptions at its pharmacies in New Mexico, Nevada, New York and Pennsylvania “soon,” due to recent regulatory changes in each state.

    “Right now, all patients in all states need to attest to being eligible for the vaccine in order to schedule an appointment online,” Thibault said. If an adult says they have no underlying health conditions, but do have a prescription from a healthcare provider for “off-label” use of the vaccine, they can get the shot, Thibault confirmed.

    On Thursday, Hawaii joined California, Washington and Oregon in launching the West Coast Health Alliance: an interstate compact meant to provide science-based immunization guidance as an alternative to the CDC.

    “Together, these states will provide evidence-based immunization guidance rooted in safety, efficacy, and transparency — ensuring residents receive credible information free from political interference,” according to a statement from Gov. Gavin Newsom’s office.

    The statement suggested that the Trump administration was essentially “dismantling” the CDC.

    “The absence of consistent, science-based federal leadership poses a direct threat to our nation’s health security,” the statement said. “To protect the health of our communities, the West Coast Health Alliance will continue to ensure that our public health strategies are based on best available science.”

    It was not immediately clear, however, whether the formation of the West Coast Health Alliance would make it easier for people to get COVID-19 vaccines at the nation’s largest pharmacy retailers, where many people get their shots.

    Mainstream medical groups, such as the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists, are also offering their own recommendations to advise individuals and families on what vaccines they should get.

    [ad_2]

    Rong-Gong Lin II

    Source link

  • Orange County Adopts CDC Initiative to Reduce Fatal & Nonfatal Overdoses

    Orange County Adopts CDC Initiative to Reduce Fatal & Nonfatal Overdoses

    [ad_1]

    In order to address the increasing number of overdose deaths related to prescription opioids and illicit drugs, Orange County has engaged with the Centers for Disease Control and recently was awarded a grant funded by the CDC to implement its Stop Overdose campaigns locally.

    The series of campaigns focuses on four key areas: the dangers of illicitly manufactured fentanyl, the risks and consequences of mixing drugs (polysubstance use), the lifesaving power of naloxone, and the importance of reducing stigma around recovery and treatment options. The messaging highlights drug-use trends and encourages harm-reduction practices.

    “We worked with CDC staff to determine the best messages for our community, and they helped us identify our priorities,” explained Dr. Thomas Hall, director, Orange County Drug-Free Coalition. “The campaigns are based on best-practice marketing strategies, and the messages are simple and direct. Each message has an action associated with the information presented.”

    The connecting feature of the campaigns is the Stop Overdose website, which was launched as a resource library for people who use drugs and their loved ones. Each subpage on the website features campaign messaging, support data and resources for the intended audience – those who use drugs between the ages of 18-34.

    “There’s a big stigma attached to addiction, so we need to get specific messages out to people who use illicit drugs, including that the community offers access to free medicine that reverses opioid overdoses and free treatment,” asserted Megan Giddens, senior program manager, Orange County Drug-Free Office. “This campaign really helps get these messages to its intended audience.”

    Three hundred people die of a drug overdose every day in this country, and the availability of illicit fentanyl significantly increases the likelihood of opioid overdoses and overdose deaths. In our community and across the nation, deaths related to mixing fentanyl with other drugs, such as cocaine and methamphetamines, are most prominent.

    For more about local strategies, programs and resources, visit Orange County Responds.

    “The Drug Enforcement Administration reported 7 out of every 10 pills seized by the agency contain a lethal dose of fentanyl, yet drug users may not know the risk of fentanyl being present,” said Dr. Hall. “Raising awareness of these risks is a priority for Orange County, and the Drug-Free Coalition is committed to expanding harm reduction strategies to reduce drug-related deaths in our community.”

    Giddens agreed the priority is saving lives. “We have high overdose rates in this region, so Stop Overdose is a critical education piece,” she said. “We want to be proactive, and this represents an effective preventive measure.”

    [ad_2]

    Source link

  • Insomnia drugs could lead to driving and cooking while sleeping, FDA warns

    Insomnia drugs could lead to driving and cooking while sleeping, FDA warns

    [ad_1]

    Pretty much everyone has heard of sleepwalking – and some of us even do it from time to time. But sleep cooking and sleep driving?

    Engaging in such activities while not awake – a phenomenon known as complex sleep behaviors – can result from taking prescription insomnia medications, also commonly referred to as Z drugs. These medications include eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Edluar, and Zolpimist).

    Z drugs can improve the quality, though not necessarily the duration, of sleep, according to research. But they can also pose serious risks by leading to bizarre complex sleep behaviors, including driving, cooking and eating while sleeping, the Food and Drug Administration warns.

    The FDA has even had reports of people accidentally overdosing on other medications or shooting themselves while taking Z drugs.

    Upon waking, people may or may not recall their complex sleep behaviors.

    The FDA cautions that people could find themselves enacting complex sleep behaviors even on lower doses or after their first use, and that Z drugs could impair your ability to drive or operate machinery even the next morning.

    The FDA recommends:

    • Discussing the risks of taking a Z drug with your health-care provider
    • Reading the patient medication guide as soon as you fill a prescription for a Z drug
    • Carefully following dosing instructions from your health-care professional
    • Not taking Z drugs with other sleep drugs, including those available over-the-counter
    • Abstaining from alcohol use before and while using Z drugs since together they may be more likely to cause side effects.

    [ad_2]

    Courtenay Harris Bond

    Source link

  • Ozempic overdose? Poison control experts explain why thousands OD'd this year

    Ozempic overdose? Poison control experts explain why thousands OD'd this year

    [ad_1]

    Some of those taking Ozempic or Wegovy are learning that too much of a good thing is never good.

    Semaglutide, the medication prescribed under the brand names Ozempic, for treating Type 2 diabetes, and Wegovy, for weight management, works by mimicking the hormone GLP-1, which is released by the gut after eating. The hormone has several effects in the body, such as stimulating insulin production, slowing gastric emptying and lowering blood sugar.

    It has been hailed for its weight-loss benefits, most conspicuously among celebrities. Oprah Winfrey recently said she uses weight-loss medication and lauded “the fact that there’s a medically approved prescription for managing weight and staying healthier, in my lifetime.” She said it felt “like a gift.”

    But between Jan. 1 and Nov. 30 this year, at least 2,941 Americans reported overdose exposures to semaglutide, according to a recent report from America’s Poison Centers, a national nonprofit representing 55 poison centers in the United States.

    California accounted for about 350 of the reports, or around 12%, according to Raymond Ho, the managing director of the California Poison Control System. Ho said the number roughly corresponds to the proportion of California’s population to the rest of the country.

    The nationwide number of semaglutide overdoses this year is more than double the 1,447 reported in 2022, which was more than double the 607 semaglutide overdoses reported in 2021.

    There were only 364 reported semaglutide overdoses in 2020 and 196 in 2019, less than 10% of the number that occurred so far this year.

    America’s Poison Centers released the data with a disclaimer that the figures likely represent an undercount in the number of cases involving semaglutide, as the center only included those voluntarily reported to poison control centers.

    “It is an alarming trend from a poison center perspective,” Ho said. “We get the usual dosing error calls, and all of a sudden there’s an explosion of people calling much more regularly about this.”

    The use of semaglutide and other GLP-1 imitators has surged in popularity over the last year as a quick and effective way to manage weight loss. More than 4 million prescriptions for semaglutide were issued in the United States in 2020, according to federal data, and usage of the drug has continued to grow since then.

    Dr. Stephen Petrou, an emergency medicine physician and toxicology fellow with California Poison Control, said there were multiple factors contributing to the increase in overdoses.

    “Not only is there rising social popularity” of the drug, Petrou said, “but there’s also wider FDA indications for use.”

    Semaglutide was patented by the Danish pharmaceutical company Novo Nordisk in 2012 and has been available in the United States since the FDA approved it in 2017. The drug was originally released as Ozempic for Type 2 diabetics to manage blood sugar levels. Moderate weight loss was found to be a common side effect of the drug, and the FDA approved a different formulation of semaglutide, called Wegovy, for that purpose in 2021.

    Ho and Petrou said the different formulations of semaglutide could help explain why it has led to so many more overdoses than other drugs of its class. Both are administered via weekly injections, with Wegovy in single-use pens and Ozempic in needles that can vary in dosage. Standard dosages range from 0.25 mg to 2.4 mg for weekly injections, depending on the prescription.

    “Someone who is unable to get Wegovy can resort to using Ozempic instead, because it is the same medication, but they may start to [adjust] their dose” upward, Petrou said. “That’s when they might encounter problems.”

    Ho and Petrou said the vast majority of semaglutide overdose reports are accidental, either due to patients not waiting a week between doses or by misunderstanding dosing instructions. Unlike the GLP-1 hormone, which is rapidly metabolized by the body, semaglutide and similar medications have much longer half-lives, meaning the medication can build up inside the body if not enough time elapses between doses.

    Furthermore, semaglutide can also be taken orally as a daily pill — sold under the name Rybelsus — but overdoses are rarely reported.

    “We’re not seeing cases of mis-administration or toxicity or overdose with that medication,” Petrou said.

    Ho and Petrou explained the signs of semaglutide overdose can resemble those of hypoglycemia, also known as low blood sugar. Symptoms can begin with increased heart rate, sweating, dizziness and irritability. More serious cases can cause confusion, delirium and coma.

    “If they have hypoglycemia, the good majority of them will have to be admitted to the hospital and monitored and watched closely, because of how long these drugs last,” Ho said.

    Ho encourages everyone who is prescribed semaglutide to thoroughly read the medication’s label and follow the dosing instructions listed.

    “We always say this: The dose makes the poison,” Ho said.

    Anyone who needs emergency poison assistance or has other poisoning-related inquiries can call the national Poison Helpline at (800) 222-1222 or visit the Poison Help website.

    [ad_2]

    Jeremy Childs

    Source link

  • National Survey Reveals Americans Saving $5,000 a Year by Ordering Prescriptions From Canada

    National Survey Reveals Americans Saving $5,000 a Year by Ordering Prescriptions From Canada

    [ad_1]

    93% Say Prescription Drug Costs Are Important to How They’ll Vote in the Next Election, Compared to 84% a Year Ago


    WASHINGTON, October 12, 2023 (Newswire.com)
    –
    Americans choosing to import their prescription medications from licensed Canadian pharmacies report saving $4,920 a year and four times the savings compared to U.S. pharmacies, GoodRx and Amazon Pharmacy, according to survey results and price comparison analysis released today by the Campaign for Personal Prescription Importation (CPPI).

    This national CPPI survey demonstrates a remarkable trend of increasing savings for patients importing medications from Canada over the last five years. It also highlights the importance of personal prescription importation as a means of accessing affordable medication for Americans.

    Key Survey Findings

    • Average annual savings of $4,920 in 2023, as reported by Americans importing prescription medications from Canada, compared to U.S. costs, reveals a major 5-year trend:
      • In 2022, the average annual savings amounted to $3,744
      • In 2021, savings averaged $2,736
      • In 2020, savings averaged $2,940
      • In 2019, savings averaged $2,352
    • Americans importing their prescription medications from Canada reported saving an average of $410 per month, compared to U.S. costs.
    • 99% of respondents would recommend importation to their friends and family members.
    • 93% of respondents say that addressing the high cost of prescription drugs in the U.S. is important to how they will vote in the next election, compared to 84% just one year ago. 

    CPPI 2023 Survey Data Cross Tabs

    “Savings of nearly $5,000 a year on medications from Canada versus prices four times higher at U.S. pharmacies is often a matter of life and death for patients across America,” says Jack Pfeiffer, CPPI Executive Director. “While state and federal efforts aim to lower prescription drug costs, the truth is we hear from Americans every day who still can’t afford U.S. drug prices. Americans’ only immediate, safe solution to access critically necessary, affordable daily prescriptions is to order from licensed Canadian pharmacies.”

    Federal negotiation of drug prices for Medicare does not provide immediate relief from the astronomical prices that Americans pay for their life-saving medicines. The drugs subject to price negotiation will not be made available at lower cost until 2026 and it is unclear if consumers will see those lower prices. It is unlikely that any of the potential savings from this program will affect the hundreds of millions of Americans who are not eligible for Medicare. Only 10 drugs will be subject to the initial price negotiation. What’s more, the price negotiation is subject to multiple lawsuits and legislative challenges that could prevent lower prices from ever becoming a reality.  

    States have joined the battle to allow for the importation of affordable medicines from Canada. While 10 states have wholesale importation laws on the books, none are operational as none of the state programs have been approved by the Food and Drug Administration. The state plans face U.S. and Canadian regulatory restrictions, as well as legal challenges and opposition to wholesale importation. 

    Meanwhile, millions of Americans import prescription medications from abroad. 89% are over the age of 65 according to the CPPI survey. 91% cite the high cost of prescription drugs in the U.S. as the primary reason for ordering from licensed Canadian pharmacies. They rely on international pharmacies for critical daily prescription medications such as ELIQUIS and XARELTO to treat and prevent blood clots and strokes. 

    Daniel Wendell from California says, “I have had asthma since I was a child and have been on various drugs for its treatment my entire life. Generic versions of my inhaler did not work as well for me. Brand name inhaler prices in the U.S., even from a discount pharmacy, are outrageous — $400/month. I can get the same medicine from Canada for $100/month from a certified Canadian pharmacy.”

    Four Times The Savings

    CPPI price comparisons regularly demonstrate savings of 50% to 90% on commonly prescribed brand-name prescription medications from Canada compared to leading U.S. pharmacies, GoodRx and Amazon Pharmacy. Analysis of these price comparisons shows four times the savings on medications from Canada.  

    How to Find a Safe Pharmacy

    Americans need greater access to safe, reliable, and affordable medications. The importance increases for people with multiple underlying conditions, as 66% of survey respondents who report taking four or more medications can attest.

    • 80% of surveyed Americans who import their prescriptions report being referred by a trusted medical professional, friend, or family member.
    • 80% of survey respondents know how to identify “rogue” pharmacies and are savvy in their search to find an online pharmacy they can trust.
    • 99% of respondents would recommend importation to their friends and family members.

    CPPI recommends searching only certified websites for prescription drugs from licensed Canadian pharmacies. Click here for more information on how to find trusted Canadian pharmacies.

    Survey Methodology

    CPPI conducted this online survey between Nov. 15, 2022, and June 31, 2023. Based on the universe of followers of CPPI, this sample of 1,162 responses represents statistically significant findings with a standard sampling error of plus or minus 5%. All registered trademarks referred to herein belong to their respective owners.

    Source: Campaign for Personal Prescription Importation

    [ad_2]

    Source link

  • Birth Control Isn’t the Only Thing That Just Went Over-the-Counter

    Birth Control Isn’t the Only Thing That Just Went Over-the-Counter

    [ad_1]

    The FDA announced yesterday that it had for the first time approved a daily birth-control pill for over-the-counter sales. That’s a big change; once the product, called Opill, is on the market—which may be as soon as early 2024—Americans will be able to buy daily hormonal birth control without a prescription. That’s historic news, but hidden underneath it is another set of firsts: In the coming months, Americans will also be able to grab an over-the-counter treatment for their heavy periods, cramps, headaches, and even migraines; they’ll have prescription-free access to a drug for endometriosis and polycystic ovary syndrome; and they’ll be able to buy a medication that can mitigate the symptoms of menopause. It’s all in the same, progestin-based pill.

    The FDA’s approval only covers Opill’s use as a form of birth control, but doctors have been prescribing pills that contain progestin for noncontraceptive needs for years. For the most part, the intervention works much better when the pills include both progestin and estrogen. Adding that second hormone to the mix amplifies all of progestin’s beneficial effects, plus helps control hormonal acne. It also leaves more wiggle room in terms of timing: Progestin-only pills—sometimes called a minipill—have a much shorter half-life in the body, so if you don’t take them during the same three-hour window each day, they’re much less reliable at preventing pregnancy, says Anne-Marie Amies Oelschlager, the chief of pediatric and adolescent gynecology at Seattle Children’s. (Some women are prescribed progestin-only pills because they are particularly susceptible to certain risks associated with estrogen.)

    As a result, an over-the-counter progestin-only pill is far from the best way of treating these conditions, experts told me. “While I suppose that it could be used off-label, I would be hesitant to do that if someone was otherwise able to obtain a prescription for a combined oral contraceptive,” Erin Fleurant, a family-planning fellow at Northwestern Medicine, told me. And if progestin by itself really were the right approach, then an IUD, implant, or injection might be a more effective way to deliver the drug.

    From July 1939: The responsibilities of birth control

    Despite the fact that progestin on its own would not usually be a doctor’s first choice—“I generally don’t prescribe it,” Veronica Ades, the vice chair of ob/gyn at Jacobi Medical Center, told me—the drug can have meaningful benefits when taken on its own. Amies Oelschlager told me that she prescribes it to suppress patients’ periods, especially if they’re experiencing pain or heavy bleeding. Even low-dose pills (like Opill) can be helpful for controlling period- and perimenopause-related migraines, as well as mood swings from premenstrual syndrome or premenstrual dysphoric disorder.

    Progestin pills can also be used to treat endometrial hyperplasia, an abnormal thickening of the uterine lining (a.k.a. the endometrium) that can develop into cancer. Same for endometriosis, a condition that may affect up to 11 percent of American women in which endometrial tissue grows outside the uterus. Patients with PCOS produce unusually high levels of male sex hormones and, Ades said, generally have too much estrogen in their body relative to progesterone (the naturally occurring analogue of progestin). Progestin pills can help strike a healthier balance.

    Right now, patients have few options to get relief from any of those symptoms without a doctor’s help. Until Opill hits the market, the best non-prescription way to treat PCOS is with healthy eating and exercise, Amies Oelschlager told me. For heavy periods, the best option patients can buy without a prescription is an NSAID like ibuprofen. “As far as an over-the-counter, daily hormonal medication, this is the first in the United States,” she said.

    Perhaps the best circumstances for off-label use of Opill will be as a stopgap. If someone starts having abnormal bleeding or period pain but can’t get an appointment or travel to a doctor for several weeks, they could buy themselves some progestin-only pills for the interim. Opill could also be a backup plan for patients who are already taking birth-control pills for a non-birth-control purpose but can’t make it to their doctor to renew their prescription, or can’t get their prescription filled at a pharmacy.

    Read: A vaccine for birth control?

    Still, Ades cautioned that even stopgap use might not be wise for endometriosis patients, for whom switching medications could disrupt a delicate balance of hormones and “create a cascade of problems.” Fleurant warned that some of the symptoms that progestin pills could help alleviate may also be associated with very serious conditions that need a different treatment plan. “Say someone was 45 years old and having irregular bleeding and also had a lot of other risk factors for uterine cancer. I wouldn’t want them to pick up this pill and think that that was going to cure everything,” she said. Instead, they should be seen by a health-care provider.

    For most women who need to be on birth control, a single-hormone drug like Opill is not the most reliable option; but starting next year, it could well be the most convenient. That same trade-off, between effectiveness and access, affects other uses of progestin, too.

    [ad_2]

    Rachel Gutman-Wei

    Source link

  • FDA Says Retail Pharmacies Can Now Offer Abortion Pills

    FDA Says Retail Pharmacies Can Now Offer Abortion Pills

    [ad_1]

    By Cara Murez 

    HealthDay Reporter

    WEDNESDAY, Jan. 4, 2023 (HealthDay News) – The U.S. Food and Drug Administration finalized a regulatory change on Tuesday that allows retail pharmacies to offer abortion pills.

    Before now, patients could only get this two-drug medication through clinics, doctors and a handful of mail-order pharmacies.

    Two companies that make the medication, Danco Laboratories and GenBioPro, announced the news after they were notified by the FDA of the change.

    “At a time when people across the country are struggling to obtain abortion care services, this modification is critically important to expanding access to medication abortion services and will provide healthcare providers with an additional method for providing their patients with a safe and effective option for ending early pregnancy,” Danco said in a statement.

    “Today’s FDA announcement expands access to medications that are essential for reproductive autonomy and is a step in the right direction that is especially needed to increase access to abortion care,” GenBioPro CEO Evan Masingill, which makes the generic version of mifepristone, told the New York Times.

    Mifepristone is the first pill used in the abortion regimen, followed by misoprostol, which already had fewer restrictions. While mifepristone blocks a hormone the body needs for a pregnancy to develop, taking misoprostol about 24 to 48 hours later causes contractions.

    Misoprostol is also used to treat many other medical conditions. Mifepristone is only approved for abortion, but it is also used to treat some miscarriages. Dozens of organizations, including medical groups, have petitioned the FDA to make the drug easier to access for miscarriages, the Times reported.

    Patients will still need a doctor’s prescription to access the drugs, and pharmacies must follow certain rules to dispense the medication.

    Abortion pills are used in more than half of U.S. pregnancy terminations, a recent report showed. They are now in even higher demand because of abortion restrictions enacted by states after the U.S. Supreme Court overturned Roe v. Wade last June.

    The American College of Obstetricians and Gynecologists applauded the move.

    “Allowing for brick-and-mortar pharmacies to join mail-order pharmacies in dispensing mifepristone for reproductive health indications will further improve access for patients,” the group said in a statement. “ACOG has long advocated that mifepristone be made available in retail pharmacies, just like other prescription drugs, to allow more patients access to abortion care without clinically unnecessary hurdles. This change will empower patients who choose medication abortion to have the option of going to a pharmacy for immediate care rather than waiting for a mail order, if that is right for them.”

    “Although the FDA’s announcement today will not solve access issues for every person seeking abortion care, it will allow more patients who need mifepristone for medication abortion additional options to secure this vital drug,” the group added.

    Now it’s up to pharmacies to decide whether to offer them.

    They would need to designate an employee to ensure compliance, which could be a barrier, the Times reported. Abortion bans or restrictions in some states would also make it illegal or difficult to offer the pills, the Times reported. Even where the pills are legal, pharmacies may face customer demand and public pressure.

    A Danco official said the company expected smaller, independent pharmacies to offer the drug first. Bigger chains would need to implement the companies’ requirements that keep confidential the names of providers who prescribe the drugs, the Times reported.

    That might look like CVS or Walgreens not being able to list a doctor’s name in a companywide database but instead restricting that information to the specific store, the Danco official, who spoke on the condition of anonymity because of the company’s concerns about threats from abortion opponents, told the Times.

    Some prescribers may be more likely to prescribe the drug if they didn’t have to stock it themselves, the Danco official added.

    “For some people, this is going to be a huge improvement on their ability to access the drug and be able to even consider this as a choice for themselves,” the Danco official said. “For other people, not necessarily. Maybe they don’t want to go into their small mom-and-pop pharmacy. They’d rather receive it from a mail order where there’s just no interaction that way.”

    The federal government has taken various steps to expand access to abortion pills since the Supreme Court decision, including a move that made it possible for telemedicine abortion services to conduct medical consultations with patients by video, phone or online questionnaires, the Times reported.

    Health providers will still need to be certified to show they have the knowledge and ability to treat abortion patients.

    More information

    The U.S. Food and Drug Administration has more on abortion pills.

     

     

    SOURCE: New York Times

    [ad_2]

    Source link