FDA over-the-counter decision for emergency contraception

2004 ◽  
Author(s):  
Sarah Benatar
Keyword(s):  
Emergency Contraception ◽  
Over The Counter

scholarly journals Future Pharmacists’ Opinions on the Facilitation of Self-Care with Over-the-Counter Products and Whether This Should Remain a Core Role

Pharmacy ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 132
Author(s):  
Lezley-Anne Hanna ◽  
Alana Murphy ◽  
Maurice Hall ◽  
Rebecca Craig
Keyword(s):  
Emergency Contraception ◽  
Self Care ◽  
Pharmacy Students ◽  
Single Institution ◽  
Self Medication ◽  
Over The Counter ◽  
Otc Medicines ◽  
Practice Methods ◽  
Identifiable Data

Background: The aim was to investigate pharmacy students’ views on the role of the pharmacist in facilitating self-care with over-the-counter (OTC) medicines, particularly in light of new roles, and establish personal practice. Methods: Final year pharmacy students at Queen’s University Belfast were invited to participate. Data were collected via a pre-piloted questionnaire, distributed at a compulsory class (only non-identifiable data were requested). Descriptive statistics were performed, and non-parametric tests were employed for inferential statistical analysis (responses by gender). Results: The response rate was 87.6% (78/89); 34.6% (27/78) males and 65.4% (51/78) females. Over a third [34.6% (27/78)] reported using OTC medicines about once a month. All appreciated the importance of an evidence-based approach to optimize patient care. Most [(96.2% (75/78)] deemed OTC consultations should remain a fundamental responsibility of pharmacists and 69.2% (54/78) thought OTC consultations have the potential to be as complex as independent pharmacist prescribing. Females felt more confident recommending OTC emergency contraception than males (p = 0.002 for levonorgestrel and p = 0.011 for ulipristal acetate). Many [61.5% (48/78)] considered more medicines should not be deregulated from prescription-only status. Conclusions: Data from this single institution suggests that enabling self-medication is an important part of practice but there were confidence issues around deregulations.

scholarly journals Regulatory standards and processes for over-the-counter availability of hormonal contraception and drugs for medical abortion in five countries in the Eastern Mediterranean Region

2021 ◽  
Vol 19 (S1) ◽  
Author(s):  
Anne Ammerdorffer ◽  
Mark Laws ◽  
Arinze Awiligwe ◽  
Florence Erb ◽  
Wallada Im-Amornphong ◽  
...  
Keyword(s):  
Reproductive Health ◽  
Health System ◽  
Emergency Contraception ◽  
Sexual And Reproductive Health ◽  
Self Care ◽  
Medical Abortion ◽  
Health System Strengthening ◽  
World Health ◽  
Over The Counter ◽  
Regulatory Status

AbstractThe World Health Organization 2019 WHO consolidated guideline on self-care interventions for health: sexual and reproductive health and rights includes recommendations on self-administration of injectable contraception, over-the-counter (OTC) oral contraception and self-management of medical abortion. A review of the regulatory status of these two self-care interventions can highlight processes required to ensure that the quality of the medicines and safety of individuals are safeguarded in the introduction and scale-up in countries. This review outlines the legal regulatory status of prescription-only medicine (POM) and OTC contraceptives, including emergency contraception, and drugs for medical abortion in Egypt, Jordan, Lebanon, Morocco and Tunisia using information obtained from internet searches, regulatory information databases and personal contacts. In addition, the review examines whether the national medicines regulatory authorities have documented procedures available to allow for a change in status from a POM to OTC to allow for increased accessibility, availability and uptake of self-care interventions recommended by WHO. Egypt, Jordan and Lebanon have a documented national OTC list available. The only contraceptive product mentioned in the OTC lists across all five countries is ellaOne (ulipristal acetate for emergency contraception), which is publicly registered in Lebanon. None of the five countries has an official documented procedure to apply for the change of POM to OTC. Informal procedures exist, such as the ability to apply to the national medicines regulatory authority for OTC status if the product has OTC status in the original country of manufacture. However, many of these procedures are not officially documented, highlighting the need for establishing sound, affordable and effective regulation of medical products as an important part of health system strengthening. From a public health perspective, it would be advantageous for licensed products to be available OTC. This is particularly the case for settings where the health system is under-resourced or over-stretched due to health emergencies. Readiness of national regulatory guidelines and OTC procedures could lead to increased access, availability and usage of essential self-care interventions for sexual and reproductive health and rights.

scholarly journals Accessing emergency contraception pills from pharmacies: the experience of young women in London

2020 ◽  
pp. bmjsrh-2019-200339
Author(s):  
Gillian Turnbull ◽  
Rachel H Scott ◽  
Sue Mann ◽  
Kaye Wellings
Keyword(s):  
Young Women ◽  
Emergency Contraception ◽  
Information Needs ◽  
Community Settings ◽  
Pharmacy Staff ◽  
Over The Counter ◽  
Women’S Perceptions ◽  
Depth Interviews ◽  
Prevention Of Recurrence

IntroductionOver-the-counter provision of emergency contraception pills (ECP) has increased since deregulation of progestogen-only formulations and is now the most common public health service provided by UK pharmacists. Important questions relate to women’s perceptions of their experience of receiving ECPs from pharmacists.MethodsQualitative study: in-depth interviews with young women reporting ECP use, recruited from clinic (10); pharmacy (6) and community settings (5) in London.ResultsKey advantages of pharmacy provision were ease and speed of access and convenience. Disadvantages included a less personal service, inadequate attention to information needs and to prevention of recurrence of ECP need, and unsupportive attitudes of pharmacy staff. Suggested service improvements included increasing privacy, providing more contraceptive advice, adopting a more empathetic approach and signposting follow-up services.ConclusionPharmacies are important in the choice of settings from which ECPs can be obtained and many aspects of pharmacy provision are appreciated by young women. There is scope to further enhance pharmacists’ role.

Over-the-counter access to emergency contraception for teens

Contraception ◽  
2008 ◽  
Vol 77 (4) ◽  
pp. 230-233 ◽  
Author(s):  
Cynthia C. Harper ◽  
Deborah C. Weiss ◽  
J. Joseph Speidel ◽  
Tina Raine-Bennett
Keyword(s):  
Emergency Contraception ◽  
Over The Counter

Bringing emergency contraception over the counter: experiences of nonprescription users in France, Norway, Sweden and Portugal

Contraception ◽  
2003 ◽  
Vol 68 (2) ◽  
pp. 117-124 ◽  
Author(s):  
Erin Gainer ◽  
Jennifer Blum ◽  
Else-Lydia Toverud ◽  
Nuno Portugal ◽  
Tanja Tyden ◽  
...  
Keyword(s):  
Emergency Contraception ◽  
Over The Counter
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