Hormonal contraception

Navigating Birth Control: Expert Advice from Dr. Bana Kashani, OB-GYN

Retrieved on: 
Friday, March 29, 2024

In a rapidly evolving landscape of reproductive health, navigating the variety of birth control options can be overwhelming.

Key Points: 
  • In a rapidly evolving landscape of reproductive health, navigating the variety of birth control options can be overwhelming.
  • “When choosing a birth control method, it's essential to consider factors such as efficacy, convenience, side effects, and personal preferences.
  • Dr. Kashani sheds light on various birth control methods in the following Q&A:
    What are the different types of birth control methods available?
  • There is limited evidence to suggest that using birth control methods for an extended period negatively impacts fertility.

Daré Bioscience Announces Commencement of Phase 3 Study of Ovaprene®, an Investigational Hormone-Free Monthly Intravaginal Contraceptive

Retrieved on: 
Monday, December 4, 2023

SAN DIEGO, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced commencement of the Company’s pivotal Phase 3 clinical study of Ovaprene, an investigational hormone-free monthly intravaginal contraceptive.

Key Points: 
  • SAN DIEGO, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced commencement of the Company’s pivotal Phase 3 clinical study of Ovaprene, an investigational hormone-free monthly intravaginal contraceptive.
  • The multi-center, single arm, non-comparative, pivotal Phase 3 clinical study of Ovaprene will evaluate its effectiveness as a contraceptive along with its safety and usability.
  • If successful, Daré expects the pivotal study to support marketing approvals of Ovaprene in the U.S. and other countries.
  • The agreement gives Daré access to the contraceptive clinical trial expertise of the NICHD clinical trial network while also sharing the costs of the Phase 3 pivotal study with the NICHD.

Rite Aid Pharmacists Now Have Prescriptive Authority for Hormonal Contraceptives in Five States

Retrieved on: 
Tuesday, November 28, 2023

Rite Aid Corporation (OTC: RADCQ) today announced that customers in California, Maryland, New Hampshire, Nevada and Oregon can now receive prescribed hormonal contraceptives by their local Rite Aid pharmacist at most store locations after completing an in-person private consultation.

Key Points: 
  • Rite Aid Corporation (OTC: RADCQ) today announced that customers in California, Maryland, New Hampshire, Nevada and Oregon can now receive prescribed hormonal contraceptives by their local Rite Aid pharmacist at most store locations after completing an in-person private consultation.
  • Pharmacists in these states have gained the authority to prescribe hormonal contraceptives depending on each state’s laws and regulations.
  • Rite Aid has created an internal Board of Pharmacy-approved ACPE Accredited CPE course to certify our pharmacists to prescribe hormonal contraception in select states.
  • Rite Aid has expansion plans for prescribing and dispensing hormonal contraception in additional states as regulations permit.

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

Retrieved on: 
Wednesday, July 19, 2023

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

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.

Expanded Care Options at B.C. Pharmacies: Pharmacists Empowered to Treat 21 Minor Ailments with New Prescribing Powers

Retrieved on: 
Thursday, June 1, 2023

pharmacists now have prescribing abilities for common ailments and hormonal contraception, which previously required visiting a doctor or nurse practitioner.

Key Points: 
  • pharmacists now have prescribing abilities for common ailments and hormonal contraception, which previously required visiting a doctor or nurse practitioner.
  • “Engaging pharmacists for the treatment of minor ailments is not only about convenience, but also a matter of improving patient care and expanding primary healthcare capacity.
  • would have to see a doctor or nurse practitioner to obtain prescription treatment for minor ailments.
  • “Assessing symptoms, evaluating medication needs, and offering patients recommendations to treat minor ailments are part of the care provided every day by pharmacists in our communities.

Evofem Biosciences to Explore Strategic Alternatives to Maximize Shareholder Value

Retrieved on: 
Thursday, February 23, 2023

SAN DIEGO, Feb. 23, 2023 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFM), announced today that its Board of Directors has unanimously approved a comprehensive strategic process to explore and evaluate strategic alternatives to maximize shareholder value.

Key Points: 
  • SAN DIEGO, Feb. 23, 2023 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFM), announced today that its Board of Directors has unanimously approved a comprehensive strategic process to explore and evaluate strategic alternatives to maximize shareholder value.
  • Evofem is the provider of Phexxi, the first and only FDA-approved hormone-free, woman-controlled contraceptive gel that women use on demand.
  • Potential strategic alternatives to be explored or evaluated as part of this process may include, but are not limited to, a merger, reverse merger, other business combination, sales of assets, licensing or other strategic transactions involving the Company.
  • Evofem does not expect to disclose developments with respect to this process unless until the evaluation of strategic alternatives has been completed or the Board of Directors has concluded disclosure is appropriate or legally required.

Nurse Practitioner Sues CVS for Revoking Longstanding Religious Accommodation for Prescribing Contraception

Retrieved on: 
Wednesday, January 11, 2023

WASHINGTON, Jan. 11, 2023 /PRNewswire/ -- First Liberty Institute and the law firm Boyden Gray & Associates today filed a federal lawsuit against CVS Pharmacy on behalf of Robyn Strader, a nurse practitioner in Texas.  CVS terminated Strader's employment because she sought a religious accommodation from prescribing any medication that could intentionally end the development or life of an unborn child, an accommodation CVS had granted for the previous six years.  

Key Points: 
  • CVS terminated Strader's employment because she sought a religious accommodation from prescribing any medication that could intentionally end the development or life of an unborn child, an accommodation CVS had granted for the previous six years.
  • "It is illegal to issue a blanket revocation of all religious accommodations when it is so easy for CVS to accommodate its employees.
  • No one should have to choose between her faith and her job, especially where it would be easy to continue a longstanding religious accommodation.
  • For six and a half years she operated under a religious accommodation not to prescribe hormonal contraception.

LOONI LAUNCHES WELLNESS SOLUTIONS TO SUPPORT AND IMPROVE MENSTRUAL HEALTH

Retrieved on: 
Wednesday, August 10, 2022

NEW YORK, Aug. 10, 2022 /PRNewswire/ -- Looni, the new women's health company, is pleased to announce the launch of its first menstrual-health product, Balance Beam Mood Complex, available online at looni.co.

Key Points: 
  • "We identified a strong need for research-backed solutions and education in the menstrual wellness space, alongside a team that was not afraid to tackle outdated taboos," says Looni co-founder Chelsea Leyland.
  • "After more than 70 years of pharmaceutical solutions that do not address the root causes of menstrual discomforts, today's women deserve better, more thoughtful solutions.
  • Looni believes in menstrual literacy and autonomythe menstrual cycle is a valuable guide to our overall health and wellbeing and Looni provides the tools and knowledge for people to become intimate with their natural rhythms.
  • Looni has created a suite of products targeting menstrual discomfort, such as mood instability and breast tenderness.

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

Retrieved on: 
Monday, July 11, 2022

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.