Norgestrel

How does the new over-the-counter birth control pill, Opill, work to prevent pregnancy? 5 questions answered

Retrieved on: 
Wednesday, July 19, 2023
People, Blood pressure, Vaginal bleeding, Review, Seizure, Insurance, State University of New York, Pregnancy, Headache, Conversation, Thrombus, Bleeding, Thornburgh v. American College of Obstetricians & Gynecologists, Diarrhea, Breast, Pharmacy, Pulmonary embolism, Neoplasm, HIV/AIDS, Progesterone, Binghamton University, Ovulation, Infection, State university system, Woman, Acne, Appetite, Uterus, Hormone, Provisions of the Affordable Care Act, Fatigue, Vomiting, Pharmacist, Food and Drug Administration, Norgestrel, Affordable Care Act, Tuberculosis, Time, Risk, OTC, Vertically transmitted infection, Deep vein thrombosis, Nausea, Growth, American College, FDA, Pulmonary hypertension, Mucus, Safety, Hormonal contraception, Food, Female, Breast cancer, Legislation, Birth control, Pharmaceutical industry

The Food and Drug Administration’s July 13, 2023, approval of the first over-the-counter birth control pill, called Opill, broadens the options for people seeking to prevent pregnancy.

Key Points: 
  • The Food and Drug Administration’s July 13, 2023, approval of the first over-the-counter birth control pill, called Opill, broadens the options for people seeking to prevent pregnancy.
  • When Opill becomes available, presumably in the first quarter of 2024, it will be sold in grocery and convenience stores, in pharmacies and through online retailers.

1. How does Opill work to prevent pregnancy?

    • Opill, like many other progestin-only birth control pills, must be taken at the same time each day to prevent pregnancy.
    • This is because progestin has to stay at a certain level in the body in order to effectively prevent pregnancy.
    • Opill does not prevent sexually transmitted infections, so people looking to further protect themselves should still use some sort of barrier method during intercourse.

2. Is Opill safe to be sold over the counter?

    • The same drug in Opill, norgestrel, has been used safely and effectively for birth control since 1973.
    • In order for a drug to be sold without a prescription in the U.S., it must first be reviewed and approved by the Food and Drug Administration.
    • Several studies have looked at whether women can accurately evaluate their own ability to safely use birth control.

3. Shouldn’t a doctor be involved in choosing birth control?

    • Screenings may include pap test, pelvic examination, clinical breast examination and testing for sexually transmitted diseases.
    • Even before the approval of Opill, people had the option to uncouple their screening examinations from prescription access.
    • In addition, more than 20 states currently allow pharmacists to provide prescription contraceptive based on a self-assessment questionnaire and blood pressure screening.

4.Does Opill have any side effects?

    • Opill does not contain estrogen, as some other hormonal birth control pills do.
    • Estrogen plays a role in menstrual regularity, so people who use Opill may experience more irregular vaginal bleeding.
    • But some individuals who use Opill may have less bleeding or stop bleeding altogether while taking the pills.

5. Will OTC status truly increase accessibility to birth control?

    • The Affordable Care Act currently mandates insurance coverage of certain FDA-approved prescription birth control products, but it does not require coverage of nonprescription options.
    • Lastly, Opill represents only one type of birth control.
    • If 100 women use a birth control that is 91% effective over one year, it is estimated that nine women using that method will become pregnant over that year.

FDA approves first daily over-the-counter birth control pill, Opill – a pharmacist and public health expert explain this new era in contraception

Retrieved on: 
Friday, July 14, 2023
Insurance, Pregnancy, Travel, Vaccination, Pharmacy, Public, Food, Ovulation, Birth, COVID-19, Prescription, Supermarket, American Pharmacists Association, Organization, Abortion, Pharmacist, Patient, Physician, Time, Association, Norgestrel, Knowledge, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Color, Hormonal contraception, Legislation, Birth control, Pharmaceutical industry, Generic drug

Its approval for nonprescription use may spark other manufacturers of prescription-only birth control to follow.

Key Points: 
  • Its approval for nonprescription use may spark other manufacturers of prescription-only birth control to follow.
  • This highlights the importance of pharmacies as destinations for health care and pharmacists as facilitators of contraceptive care.
  • The process begins with a pharmacist consultation to screen patients for eligibility, collect a medical history and measure blood pressure.
  • We see the move toward over-the-counter birth control as an important step toward accessible and equitable reproductive health care for all Americans.

Making birth control more accessible

    • Traditionally, hormonal contraception – also known as birth control, or when taken orally, “the pill” – has only been accessible after a comprehensive medical evaluation by a physician, physician assistant or nurse practitioner.
    • But in 2016, California and Oregon changed their legislation to allow pharmacists to prescribe birth control.
    • However, the move toward over-the-counter birth control is important because it will lessen some of the known barriers to birth control, especially if the products are offered at an affordable price point.
    • Over-the-counter birth control can also reduce access barriers by preventing the need for a scheduled appointment with a primary care physician during work hours, the need for a pharmacist to be present to dispense prescription birth control or the need to travel long distances to access these professionals.

Addressing remaining barriers

    • Even in states where pharmacists are currently allowed to prescribe birth control, over-the-counter hormonal birth control can make a difference.
    • For example, if state policies do not create payment pathways to reimburse pharmacists for their time to counsel and prescribe, pharmacists may choose not to participate in prescribing birth control.
    • Ultimately, a jury found that the pharmacist did not discriminate against the woman by denying to fill her prescription.

Pharmacist ‘conscience clauses’

    • In addition, company policies may require pharmacists with objections to arrange for another pharmacist – who does not have objections – to provide the medication and care requested by the patient.
    • However, some states do not require a system to ensure this patient access as the American Pharmacists Association suggests.
    • Pharmacist conscience clauses are unlikely to interfere with over-the-counter birth control availability at large pharmacy chains, supermarkets and mass merchandisers due to top-down decision-making structures of these organizations.
    • These contraception deserts could be reduced or eliminated altogether now that retailers may sell over-the-counter hormonal birth control at an affordable price.

Pharmacists’ role in providing contraceptive

    • Pharmacists are trained as medication experts and acquire unique knowledge and skills of self-care products and nonprescription medications.
    • In our view, pharmacists can positively contribute to the safe, effective and accessible use of contraception across the country.

FDA Approves First Nonprescription Daily Oral Contraceptive

Retrieved on: 
Thursday, July 13, 2023
Vaginal bleeding, Pregnancy, Headache, Syphilis, Laboratoires Pierre Fabre, Bleeding, HIV, Center for Drug Evaluation and Research, Prenatal care, Condom, Cancer, Gonorrhea, Cramp, Hepatitis B, Perrigo, Appetite, Abdominal pain, Dizziness, AIDS, Wart, Risk, Child, Norgestrel, Genital herpes, Vertically transmitted infection, Nausea, Bloating, Chlamydia, Amenorrhea, Research, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Breast cancer, Birth control, Pharmaceutical industry

Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online.

Key Points: 
  • Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online.
  • "Today's approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States," said Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research.
  • "When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy."
  • Opill also should not be used together with another hormonal birth control product such as another oral contraceptive tablet, a vaginal ring, a contraceptive patch, a contraceptive implant, a contraceptive injection or an IUD (intra-uterine device).

Perrigo Announces U.S. FDA Approval for Opill® OTC Daily Oral Contraceptive

Retrieved on: 
Thursday, July 13, 2023
Pregnancy, Society, Pill, Obstetrics, American College of Obstetricians and Gynecologists, PRGO, Birth, NDAC, Health, Women's health, Woman, American Academy, Adolescence, Perrigo, American Medical Association, Family medicine, Adolescent health, OTC, Norgestrel, American Academy of Family Physicians, Consumer, Reproductive system, American College, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Gynaecology, NYSE, Food, Medicine, Birth control

DUBLIN, July 13, 2023 /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO), a leading provider of Consumer Self-Care Products, announced today that the U.S. Food and Drug Administration (FDA) approved Opill®, a progestin-only daily oral contraceptive, for over-the-counter (OTC) use for all ages.

Key Points: 
  • DUBLIN, July 13, 2023 /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO), a leading provider of Consumer Self-Care Products, announced today that the U.S. Food and Drug Administration (FDA) approved Opill®, a progestin-only daily oral contraceptive, for over-the-counter (OTC) use for all ages.
  • "Today marks a truly momentous day for women's health nationwide," said Perrigo President and Chief Executive Officer Patrick Lockwood-Taylor.
  • "Today's approval is a groundbreaking expansion for women's health in the U.S., and a significant milestone towards addressing a key unmet need for contraceptive access," said Frederique Welgryn, Perrigo Global Vice President for Women's Health.
  • "Perrigo is committed to making Opill®, which is now the most effective method available OTC at preventing pregnancy(1), accessible and affordable to women and people of all ages.

FDA Joint Advisory Committee Votes in Favor of Perrigo's Opill® Daily Oral Contraceptive for OTC Use

Retrieved on: 
Wednesday, May 10, 2023
Pregnancy, Use, Obstetrics, American College of Obstetricians and Gynecologists, LCS, PRGO, Public, Physician, Birth, NDAC, Health, Women's health, Woman, American Academy, Perrigo, ACCESS, American Medical Association, Family medicine, OTC, Norgestrel, American Academy of Family Physicians, Consumer, Reproductive system, American College, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Gynaecology, NYSE, Food, Pharmaceutical industry, Birth control

The joint committee's vote, while not binding, will be considered by the FDA when making its final decision regarding the potential approval of Opill® for OTC use, which is expected later this year.

Key Points: 
  • The joint committee's vote, while not binding, will be considered by the FDA when making its final decision regarding the potential approval of Opill® for OTC use, which is expected later this year.
  • "Today's vote to recommend a switch of Opill® to OTC is a new, groundbreaking chapter in reproductive health.
  • "We are motivated by the millions of people who need easy access to safe and effective contraception.
  • Notably, adherence in the ACCESS study, taking the pill daily, was no different from published data on oral contraception adherence in the prescription setting(1).

NEC Launches Open RAN cloud-native virtualized software suite to extend the NEC Open Networks best of breed ecosystem

Retrieved on: 
Thursday, September 29, 2022
TSE, Software, Safety, Efficiency, 3GPP, Telecommunication, Machine learning, Automation, Service management, Solution, RAN, Norgestrel, Ecosystem, Descriptive ethics, NEC, Rus, Third party, SMO, Network equipment

TOKYO, Sept 29, 2022 - (JCN Newswire) - NEC Corporation (TSE: 6701) introduces its open virtualized RAN software suite to the international market.

Key Points: 
  • TOKYO, Sept 29, 2022 - (JCN Newswire) - NEC Corporation (TSE: 6701) introduces its open virtualized RAN software suite to the international market.
  • NEC's vCU/vDU software suite leverages the company's long history of technological leadership and commitment to improving Open Radio Access Networks (RAN).
  • NEC Open Networks is an ecosystem that provides operators with choice in every category with best-of-breed solutions and services from both NEC and its partners in Open RAN radio units, software, open transport, converged packet core, automation, and orchestration.
  • NEC will continue integrating, commercializing, and deploying multiple ecosystem partners in this vRAN software suite to meet its customers' needs.

Perrigo's HRA Pharma Submits Application to FDA for First-Ever OTC Birth Control Pill

Retrieved on: 
Monday, July 11, 2022
American Academy of Family Physicians, Health, Norgestrel, Assessment, FDA, Rx, COVID-19, Pregnancy, Adult, Thornburgh v. American College of Obstetricians & Gynecologists, Achievement, Terminology, Method, Risk, American College, Industry, Consumer, PRGO, Journal of Women's Health, MBA, Birth, American Medical Association, Coronavirus, NYSE, Marketing, Birth control, Company, Government, Woman, Intention, Multimedia, American Academy, OTC, Indian Medical Association, Acquisition, The New England Journal of Medicine, Sale, ACOG, MPH, U.S. Securities and Exchange Commission, Public health, Innovation, Hormonal contraception, Family medicine, Gynaecology, Pharmaceutical industry, Perrigo, MD

The company has applied for an Rx-to-OTC switch for Opill, a progestin-onlydaily birth control pill (also referred to as a mini pill or non-estrogen pill).

Key Points: 
  • The company has applied for an Rx-to-OTC switch for Opill, a progestin-onlydaily birth control pill (also referred to as a mini pill or non-estrogen pill).
  • "More than 60 years ago, prescription birth control pills in the U.S. empowered women to plan if and when they want to get pregnant.
  • Moving a safe and effective prescription birth control pill to OTC will help even more women and people access contraception without facing unnecessary barriers."
  • Access to a range of methods and ways to access contraception that meet people's needs will increase the likelihood of using effective birth control methods.