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The FDA ought to change Plan B's label
Abstract
This commentary defends three arguments for changing the label of levonorgestrel-based emergency contraception (LNG EC) so that it no longer supports the possibility of a mechanism of action after fertilization. First, there is no direct scientific evidence confirming any post-fertilization mechanisms. Second, despite the weight of evidence, there is still widespread public misunderstanding over the mechanism of LNG EC. Third, this FDA label is not a value-free claim, but instead it has functioned like a political tool for reducing contraceptive access. The label is laden with anti-abortion values (even though EC is contraception, not abortion), and it imposes these values on potential users, resulting in barriers to access such as with Burwell v. Hobby Lobby. These three arguments together provide scientific, social, and ethical grounds for the FDA to take the initiate in changing Plan B's drug label.
... Evidence shows that contraception (including emergency contraception [EC]) works by preventing pregnancy before fertilization rather than disrupting an existing pregnancy. 1,2 Nonetheless, incorrect representations of contraception as abortifacients (ie, substances that cause the termination of an implanted fertilized egg) are common in the media and in antichoice rhetoric, 3,4 contributing to public misconceptions, driving political debate, and impacting contraceptive access. Misconceptions about how contraception works can be common among healthcare providers too. 5 However, few studies have examined multispecialty physicians' beliefs about contraception's mechanisms of action or the characteristics associated with these beliefs. ...
... Targeted medical education along with updating US Food and Drug Administration labeling to accurately reflect EC's mechanism of action could help reduce contraceptive misconceptions. 2 Providers who understand that contraception works by preventing, not terminating, pregnancy can better support contraceptive care and accurate, evidence-based policies. Match rates for first-year residency positions in obstetrics and gynecology since medical school expansions ...
... Obstetrics and gynecology is one of several specialties in which the number of resident graduates is insufficient to meet the growing women's health needs. 1 In response to a probable impending physician shortage, the Association of American Medical Colleges recommended in 2006 a 30% increase in first-year medical positions. 2 This goal was reached in academic year 2019. 2 The anticipated increase in graduates prompted funding for more residency programs and first-year positions in all medical specialties. The objective of this cross-sectional study was to examine trends in match rates for first-year residency positions in obstetrics and gynecology since medical school expansions. ...
Objectives
Abortion is a safe procedure, but it is not always perceived as such, even among healthcare providers. These misperceptions may hinder physicians’ willingness to participate in abortion care. We documented physicians’ beliefs about abortion safety and associations between these beliefs and physician referral for and participation in abortion care.
Methods
A 2019 survey at Wisconsin's largest and only public medical school assessed practicing physicians’ abortion attitudes, beliefs, and practices (n=893). We conducted bivariate analyses followed by logistic regression to document relationships between physician beliefs about abortion safety and their participation in abortion care.
Results
One in five physicians (22%, n=190) believed that abortion is not at all, a little, or somewhat safe compared with 78% (n=690) of physicians who reported that abortion is very or extremely safe. Findings indicated that medical specialty (obstetrics-gynecology vs. other; B=2.359, p=0.022), exposure to abortion during medical education (B=0.359, p=0.038), and religiosity (B=-0.526, p=0.004) were significantly associated with physicians’ beliefs about the safety of abortion. Providers who believed that abortion was very or extremely safe were more likely than those who did not to refer patients for abortion care (B=1.145, p<0.001). Beliefs about abortion safety were significantly associated with participation in abortion care in bivariate analyses (X²[1]=5.834, p=0.016) but not in regression analysis (B=0.611, p=0.065).
Conclusions
While abortions are associated with extremely few adverse events, a sizable proportion of physicians in our study believed that abortion was not very safe. Results suggest that exposure to abortion during medical education leads to more accurate assessments of abortion safety, underscoring the importance of training in this area.
... Evidence shows that contraception (including emergency contraception [EC]) works by preventing pregnancy before fertilization rather than disrupting an existing pregnancy. 1,2 Nonetheless, incorrect representations of contraception as abortifacients (ie, substances that cause the termination of an implanted fertilized egg) are common in the media and in antichoice rhetoric, 3,4 contributing to public misconceptions, driving political debate, and impacting contraceptive access. Misconceptions about how contraception works can be common among healthcare providers too. 5 However, few studies have examined multispecialty physicians' beliefs about contraception's mechanisms of action or the characteristics associated with these beliefs. ...
... Future studies could build on our descriptive research using nationally representative samples and more sophisticated measurement and analysis strategies to determine the origins and patient care impact Targeted medical education along with updating US Food and Drug Administration labeling to accurately reflect EC's mechanism of action could help reduce contraceptive misconceptions. 2 Providers who understand that contraception works by preventing, not terminating, pregnancy can better support contraceptive care and accurate, evidence-based policies. ...
Background
Emergency Hormonal Contraception (EHC) has been underused in Britain and internationally since its introduction. ‘Stigmatisation’ has been identified as one of the barriers to EHC. However, few, if any publications have focussed on the significance of this factor in the British context, the social meanings for women of seeking EHC and the implications for future contraceptive provision and innovation.
Method
In-depth qualitative material from 27 women across two British studies was analysed. The first, in which 11 young women were interviewed in-depth regarding EHC specifically, was supplemented by material from a multi-stage narrative study of 15 women concerning their life history experiences of using contraception more broadly.
Results
Stigmatisation of EHC use is a key barrier and derives from associations with irresponsible behaviour. This irresponsibility exists on a continuum with some behaviours and some women more ir/responsible than others. In addition, despite not being an abortifacient, EHC may be closely aligned with abortion meaning users can be perceived as ‘bad women’ in a similar way to abortion seekers. This stigma can deter participants seeking EHC when they may need it.
Conclusion
Stigma is a powerful barrier to EHC use due to the social significance of responsibility and expectations pertaining to the behaviour of ‘good women.’ Understandings about stigmatisation in the case of EHC should be translated to other aspects of contraceptive service delivery and future innovations, to ensure effective provision of methods and safeguard their uptake.
OBJECTIVE
To analyze the degree of knowledge of Brazilian adolescents regarding emergency contraception (EC) such as correct administration, frequency of use, efficacy, mechanism of action, adverse effects, and complications.
METHODS
Cross-sectional study. Adolescents aged 11-19 years answered a questionnaire containing questions about sexuality, knowledge, and use of EC.
RESULTS
Out of 148 adolescents who were interviewed 8% did not know about the EC. Among the sexually active, 56.7% used EC at least once. The chance of obtaining EC information with friends triples between 15-19 years old [p=0.04; OR=3.18 (1.08-10.53)]. Most used single-dose EC. They said that EC prevents 80% of pregnancy and should be used within 72 hours after unprotected sex. Only 41.2% between 10-14 years old and 82.4% between 15-19 years old know that it prevents fertilization. As reasons for using they cited: rape and unprotected sex in 58.3% of those aged 10-14 years old and 79.6% between 15-19 years old. About side effects, 58.8% of 10-14 years old and 17.6% of those aged ≥15 years old could not answer, but 60.5% between 15-19 years old mentioned nausea and vomiting. A significant portion (17.6-41.2%) believes that EC causes abortion, cancer, infertility, and fetal malformations. Over 80% of the girls agree that it can cause menstrual irregularity.
CONCLUSION
Knowledge regarding EC is not satisfactory, especially regarding its risks, regardless of the age and education of the groups evaluated. Improved knowledge may lead to greater adherence to EC and lead to a reduction in unplanned pregnancies.
In the medical field, conscientious objection is claimed by providers and pharmacists in an attempt to forgo administering select forms of sexual and reproductive healthcare services because they state it goes against their moral integrity. Such claim of conscientious objection may include refusing to administer emergency contraception to an individual with a medical need that is time-sensitive. Conscientious objection is first defined, and then a historical context is provided on the medical field’s involvement with the issue. An explanation of emergency contraception’s physiological effects is provided along with historical context of the use on emergency contraception in terms of United States Law. A comparison is given between the United States and other developed countries in regard to conscientious objection. Once an understanding of conscientious objection and emergency contraception is presented, arguments supporting and contradicting the claim are described. Opinions supporting conscientious objection include the support of moral integrity, religious diversity, and less regulation on government involvement in state law will be offered. Finally, arguments against the effects of conscientious objection with emergency contraception are explained in terms of financial implications and other repercussions for people in lower socioeconomic status groups, especially people of color. Although every clinician has the right and responsibility to treat according to their sense of responsibility or conscience, the ethical consequences of living by one’s conscience are limiting and negatively impact underprivileged groups of people. It is the aim of this article to advocate against the use of provider’s and pharmacist’s right to claim conscientious objection due to the inequitable impact the practice has on people of color and individuals with lower incomes.
Background: Emergency contraception (EC) has the potential to play a vital role in preventing unintended pregnancies after unprotected sexual intercourse or contraceptive failure. Residency training can influence practice behaviors, however, the extent to which EC-related information is taught in training programs remains unknown. This study examined where residents obtain information about EC and whether knowledge differs by resident program characteristics. Materials and Methods: Program coordinators of Obstetrics and Gynecology (OB/GYN) and Family Medicine residency programs (n = 689) were emailed and requested to forward the survey link to residents. The survey included measures of EC education (hours, sources, including lectures, grand rounds), and EC-related knowledge. EC knowledge items assessed the three methods of EC (copper intrauterine device, ulipristal acetate, and oral levonorgestrel), effectiveness, mechanism of action, contraindications, and side effects. t-Tests and analysis of variances were used to compare mean knowledge scores (maximum = 20; higher scores indicating higher knowledge). Results: Among participants (n = 676), 61% were Family Medicine residents, 66% were white, and 72% were female. Overall, 34% received <1 hour of EC education, with OB/GYN residents receiving significantly more hours than Family Medicine residents. OB/GYN residents (mean = 14.40, standard deviation [SD] = 2.69) had a significantly higher mean knowledge score than Family Medicine residents (12.12, SD = 2.63; p < 0.000). Mean knowledge score differences were found by region of residency program, with residents in the Northeast reporting higher knowledge. Conclusions: Overall, residents received very little EC education, with OB/GYN residents receiving more training and having higher knowledge than their Family Medicine counterparts. Additional training is needed to ensure that residents are knowledgeable about this effective method to decrease unintended pregnancies.
Philosophers of science and medicine now aspire to provide useful, socially relevant accounts of mechanism. Existing accounts have forged the path by attending to mechanisms in historical context, scientific practice, the special sciences, and policy. Yet, their primary focus has been on more proximate issues related to therapeutic effectiveness. To take the next step toward social relevance, we must investigate the challenges facing researchers, clinicians, and policy makers involving values and social context. Accordingly, we learn valuable lessons about the connections between mechanistic processes and more fundamental reasons for (or against) medical interventions, particularly moral, ethical, religious, and political concerns about health, agency, and power. This paper uses debates over the controversial morning-after pill (emergency contraception) to gain insight into the deeper reasons for the production and use of mechanistic knowledge throughout biomedical research, clinical practice, and governmental regulation. To practice socially relevant philosophy of science, I argue that we need to account for mechanistic knowledge beyond immediate effectiveness, such as how it can also provide moral guidance, aid ethical categorization in the clinic, and function as a political instrument. Such insights have implications for medical epistemology, including the value-laden dimensions of mechanistic reasoning and the “epistemic friction” of values. Furthermore, there are broader impacts for teaching research ethics and understanding the role of science advisors as political advocates.
There has been much debate regarding levonorgestrel emergency contraception's (LNG-EC's) method of action since 1999 when the Food and Drug Administration first approved its use. Proponents of LNG-EC have argued that they have moral certitude that LNG-EC works via a non-abortifacient mechanism of action, and claim that all the major scientific and medical data consistently support this hypothesis. However, newer medical data serve to undermine the consistency of the non-abortifacient hypothesis and instead support the hypothesis that preovulatory administration of LNG-EC has significant potential to work via abortion. The implications of the newer data have important ramifications for medical personnel, patients, and both Catholic and non-Catholic emergency room protocols. In the future, technology such as the use of early pregnancy factor may have the potential to quantify how frequently preovulatory LNG-EC works via abortion.
Lay Summary: How Plan B (levonorgestrel emergency contraception) works has been vigorously debated ever since the Food and Drug Administration approved it in 1999. Many doctors and researchers claim that it has either no—or at most—an extremely small chance of working via abortion. However, the latest scientific and medical evidence now demonstrates that levonorgestrel emergency contraception theoretically works via abortion quite often. The implications of the newer data have important ramifications for medical personnel, patients, and both Catholic and non-Catholic emergency room rape protocols.
In medicine, the vast majority of conscientious objection (CO) is exercised within the reproductive healthcare field – particularly for abortion and contraception. Current laws and practices in various countries around CO in reproductive healthcare show that it is unworkable and frequently abused, with harmful impacts on women's healthcare and rights. CO in medicine is supposedly analogous to CO in the military, but in fact the two have little in common.
This paper argues that CO in reproductive health is not actually Conscientious Objection, but Dishonourable Disobedience (DD) to laws and ethical codes. Healthcare professionals who exercise CO are using their position of trust and authority to impose their personal beliefs on patients, who are completely dependent on them for essential healthcare. Health systems and institutions that prohibit staff from providing abortion or contraception services are being discriminatory by systematically denying healthcare services to a vulnerable population and disregarding conscience rights for abortion providers.
CO in reproductive healthcare should be dealt with like any other failure to perform one's professional duty, through enforcement and disciplinary measures. Counteracting institutional CO may require governmental or even international intervention.
(View follow up articles, response to critics: https://arcc-cdac.academia.edu/JoyceArthur/Follow-up-and-Rebuttals-to-CO-article)
This study aimed to investigate the extent of knowledge and use of emergency contraception among women of reproductive age and to identify barriers existing in Turkey in this context. There is limited research regarding the knowledge and use and barriers to emergency contraception use, since the prepackaged form of hormonal emergency contraception has been available over the counter in Turkey.
This is a descriptive, cross-sectional study of 257 women. Data were collected through face to face interviews with a questionnaire on sociodemographic features, knowledge, use and barriers to emergency contraception.
The rate of unintended pregnancies and abortions was noteworthy in the study, where 36.3% of the subjects revealed previous unintended pregnancies and 62.3% of them had undergone surgical termination or spontaneous loss. Remarkably, 42.1% of the respondents had never heard of emergency contraception. Common barriers to the use of emergency contraception were lack of awareness, misconceptions that the pills are abortion-inducing and unavailable without prescription, and anxiety about harming the fetus. The results indicated differences in practice, although emergency contraception is included in contraception counseling. Sixty percent of the subjects counseled by healthcare professionals stated that they were not informed about emergency contraception; a majority expressed a willingness to receive such information.
Our study has revealed knowledge deficiency on the part of reproductive-aged women about the effective use, safety, mechanism of action, availability without prescription and legal status of emergency contraception. Client barriers were also found, particularly a lack of awareness. Healthcare professionals are in a key position to provide information and to overcome the barriers.
This article is an examination of the FDA hearing on a proposal to permit nonprescription access to the emergency contraceptive pill Plan B. Participants debated the drug's impact on female and young adult sexuality, illustrating how the rhetoric over disciplining pharmaceutical use in the American public is a displaced language for talking about disciplining women's and girls' sexuality. Debate over Plan B also focused on its mechanism of action and whether or not it was abortifacient, revealing a medical technology characterized not only by moral but also by marked scientific ambiguity. The scientific framing of the politics of emergency contraception is testament to the powerful authority of biomedicine to narrate and thus produce ideologies of bodies (individual, embryonic, social, and political), sexuality, and selves. The discourse on access to Plan B in the United States demonstrates how women's bodies are sites of control where the politics of sexuality, discourses on public health, and medical constructions of biological processes intersect.
Among feminist philosophers, there are two lines of argument that sexist values are illegitimate in science, focusing on epistemic or ethical problems. This article supports a third framework, elucidating how value-laden science can enable epistemic oppression. My analysis demonstrates how purported knowledge laden with sexist values can compromise epistemic autonomy and contribute to paternalism and misogyny. I exemplify these epistemic wrongs with a case study of the morning-after pill (emergency contraception) during its 2006 switch to over-the-counter availability and its new drug label from the US Food and Drug Administration that it “may prevent implantation.” Antiabortion science advisers created this label to protect zygotes based on debated value judgments that were later concealed. This zygote-centric knowledge enabled them to shape potential users by instructing “good mothers” that they ought to protect zygotes and punishing “bad mothers” by refusing their requests for the drug. Therefore, I argue that the sexist values and gender norms of antiabortionists that prioritize zygotic health are illegitimate in this context because they cause epistemic injustices and perpetuate epistemic oppression. Furthermore, I advocate against blanket protections for the “right to conscience” and “religious freedom” of healthcare providers because they reinforce the epistemic oppression of women, especially those on the margins.
Content Warning : This article discusses sexual assault and refusals to provide contraception to patients, including survivors.
While the Value-Free Ideal of science has suffered compelling criticism, some advocates like Gregor Betz continue to argue that science policy advisors should avoid value judgments by hedging their hypotheses. This approach depends on a mistaken understanding of the relations between facts and values in regulatory science. My case study involves the morning-after pill Plan B and the “Drug Fact” that it “may” prevent implantation. I analyze the operative values, which I call zygote-centrism, responsible for this hedged drug label. Then, I explain my twofold account of value-ladenness, involving the constitutive role of value judgments in science and the social function of facts as political tools. Because this drug fact is ineliminably value-laden in both senses, I conclude that hedged hypotheses are not necessarily value-free. https://philpapers.org/go.pl?id=CHODFV&u=https%3A%2F%2Fphilpapers.org%2Farchive%2FCHODFV.pdf
Objective
The mechanism of action (MOA) of emergency contraceptive pills (ECPs) is frequently mischaracterized. Our objective was to identify how members of the general public understand the mechanisms of ECPs.
Study Design
We recruited a convenience sample from social media for a survey about reproductive health attitudes and analyzed spontaneous descriptions of how ECPs work. We inductively coded responses to create themes and sub-themes, and collapsed sub-themes into three MOA categories based on previous research.
Results
Among 1,443 respondents, 533 mentioned an MOA in their description of ECPs. While nearly half of these responses (49.5%) stated that ECPs prevent pregnancy before fertilization occurs (in accordance with most biomedical ECP research), over 60% described a mechanism related to preventing implantation of a fertilized egg. Nine percent of responses described a post-implantation mechanism that would be considered abortion by mainstream medical standards. Some respondents conveyed significant confusion about the biological processes involved with pregnancy and pregnancy prevention.
Conclusion
Confusion about how ECPs work was common among our sample. The largest group of responses described a mechanism – preventing implantation of a fertilized egg – listed on the FDA-approved ECP labels that does not reflect most relevant biomedical research. Mischaracterizations of ECPs’ mechanisms have been used to limit access to EC. These misunderstandings were common in our sample and may reflect poor quality sex education and public information, and confusion introduced by the FDA-approved labels. Additional research should identify whether public perception of ECPs’ mechanisms influences policy, healthcare provision, and use of ECPs.
Rationale and objectives: Emergency contraceptives pills (ECPs) are described as drugs that work by either inhibiting or delaying ovulation without affecting implantation. In our opinion, as we aim at demonstrating, both EMA documents and the experimental papers indicate that they prevalently inhibit embryo-implantation.
LNG-ECPs: literature: LNG-ECPs never prevent ovulation when are taken in the most fertile days (EMA-EPAR on ellaOne® p. 9, first table). Conversely, they prevent the formation of an adequate corpus luteum. When they are taken pre-ovulatory ovulations occur regularly, but pregnancies do not appear. Taken after ovulation, they seem ineffective in preventing pregnancies.
UPA-ECPs: literature: EllaOne® prevents ovulation only when is taken in the first fertile day. Thereafter, its anti-ovulatory effect drops sharply and becomes insignificant (8%) 36 h before ovulation, in the most fertile days (Brache); its decreasing anti-ovulatory effect cannot explain a consistently high effectiveness in preventing pregnancies (≥80%) that does not decrease depending on which of the 5 d it is taken after unprotected intercourse. Besides, ovulation occurs regularly in 91.7% of women taking ellaOne® weekly, for eight consecutive weeks (EMA-CHMP-Assessment Report ‘EMA/73099/2015’: study HRA2914-554, p. 7). Lastly, Lira-Albarrán administered ellaOne® to women in the most fertile pre-ovulatory days: they had normal ovulation, but their endometrium, evaluated through samples obtained in the implantation window, became inhospitable: the expression of 1183 genes was exactly the opposite of that observed in the receptive pro-gestational endometrium. This agrees with information by EMA-CHMP-Assessment Report ‘EMEA/261787/2009’ (p. 8): after UPA administration ‘the proteins necessary to begin and maintain pregnancy are not synthesized’.
Conclusions: Emergency Contraceptives work prevalently by preventing embryo-implantation. People shall receive correct information.
This analysis examines the precise moral question whether healthcare professionals and survivors of sexual assault can have moral certitude that in any given case the use of Levonorgestrel [LNG], in its clinical dosage for emergency contraception, constitutes a legitimate act of self-defense by suppressing ovulation, and failing that goal does not remove, destroy, or interfere with the implantation of an embryo. This question is examined first by giving a brief overview of the pharmacological design of LNG and its known mechanisms of action to date. Second, it is argued that reducing the moral question to an interminable exchange of opposing scientific views is not consistent with the Catholic moral tradition on moral certitude. Rather, it is shown that the question pivots on how both scientific and non-scientific factors must be taken into account in reaching moral certitude on the issue. To this end, a brief historical account of the Catholic manualist tradition on moral certitude is provided. Third, this tradition is applied to various aspects of the moral question. The analysis concludes that the opinion in favor of using LNG in any given case as an act of self-defense against the lingering effects of sexual assault is consistent with the Catholic moral tradition on moral certitude.
Objective: To determine the acceptability to women of oral emergency contraception (EC) that works by inhibiting ovulation, preventing implantation or disrupting implantation. Also, to determine the characteristics of women associated with the acceptability of each posited mechanism of action.
Study design: Women completed a self-administered, anonymous questionnaire asking whether they would consider using an EC pill based on each of three hypothetical mechanisms of action: inhibiting ovulation, preventing implantation or disrupting implantation. The questionnaire was distributed among women in Edinburgh, UK: (i) presenting for EC at a community pharmacy, (ii) attending a clinic for insertion of intrauterine contraception (IUC) or (iii) attending a clinic for an induced abortion. Descriptive analyses stratified women according to healthcare setting and personal characteristics. Univariable and multivariable analyses were used to establish factors which may predict acceptability of each EC pill’s mechanism of action.
Results: Four hundred and nineteen out of 458 (91%) women responded to the survey. Overall women reported that EC would be acceptable if it worked by inhibiting ovulation (89%), preventing implantation (83%) or disrupting implantation (75%). Among women seeking abortion, more would accept an EC pill which disrupted implantation, compared to women seeking IUC (OR, 2.19; 95% CI, 1.30-3.69; p = 0.004). Based on multivariable analyses, factors associated with acceptability included previous use of EC, previously holding strong views against abortion and having had a previous abortion.
Conclusion: For each of the posited mechanisms of action, a majority of women surveyed would be willing to consider oral EC to prevent unintended pregnancy.
Implications statement: The scope of the study was limited and further work on the views of women in the wider population is needed. This is important as the development of such drugs to prevent pregnancy is likely to raise political and ethical challenges, particularly in relation to disruption of implantation.
Objective:
To test the effect of current versus 2 experimental label formats on information processing among current and potential over-the-counter (OTC) users.
Methods:
A cross-sectional survey was conducted in a cohort of adults across a metropolitan community, Houston, Texas. Three labels were designed. We placed a chunk of like information together (uses, direction, other information). Label A (control) followed the format of the existing FDA Drug Facts panel format for an antiallergy medication, label B had warnings placed before, while label C had warnings placed after the chunk. The 2 label designs were compared using the information-processing constructs derived from the OTC Label Evaluation Process Model (LEPM).
Results:
A multivariate analysis of covariance and Dunnett's test revealed that the mean scores for constructs of OTC LEPM were significantly better for label C compared to the control and label B ( P < .0001).
Conclusion:
Our label format improved information processing among consumers but only when warning placement was placed at the end in the Drug Facts panel, giving an opportunity for the FDA to consider revising the format of the OTC Drug Facts panel, to improve patient understanding and reciprocally enhance patient safety.
Objectives:
The aim of the study was to evaluate the association between physicians' understanding of the mechanism of action of the emergency contraceptive pill (ECP), their personal use of it, and their practice in informing their patients about the method and in prescribing it.
Methods:
The study was carried out in a sample of 3337 obstetrician-gynaecologists who responded to a mailed questionnaire. Bivariate analysis was used to test the association between physicians' personal use of the ECP, their understanding of its mechanism of action, and their practice in informing their patients about the method and in prescribing it. Multiple Poisson regression analysis was carried out to identify variables independently associated with the two dependent variables.
Results:
Multiple regression analysis showed that the percentage of physicians who had informed their patients about the ECP was significantly lower among those who had needed it themselves but had not used it and among those living in the northeast of Brazil. A significantly higher percentage of female than male physicians had provided information on the ECP. The percentage of physicians who had prescribed the ECP was significantly lower among those who had needed it themselves but had not used it and among those who believed that it caused a mini-abortion. The proportion of physicians who had ever-prescribed the ECP was greater among those who worked exclusively in private practice and among those who worked in a state capital.
Conclusions:
The misconception that emergency contraception could cause a mini-abortion was associated with its denial to potential users, while physicians' personal experience of needing to use it favoured the likelihood of their informing potential users about it and prescribing it.
Background:
Recent studies have identified that levonorgestrel administered orally in emergency contraception (LNG-EC) is only efficacious when taken before ovulation. However, the drug does not consistently prevent follicular rupture or impair sperm function.
Objective:
The present systematic review is performed to analyze and more precisely define the extent to which pre-fertilization mechanisms of action may explain the drug's efficacy in pregnancy avoidance. We also examine the available evidence to determine if pre-ovulatory drug administration may be associated with post-fertilization effects.
Conclusion:
The mechanism of action of LNG-EC is reviewed. The drug has no ability to alter sperm function at doses used in vivo and has limited ability to suppress ovulation. Our analysis estimates that the drug's ovulatory inhibition potential could prevent less than 15 percent of potential conceptions, thus making a pre-fertilization mechanism of action significantly less likely than previously thought. Luteal effects (such as decreased progesterone, altered glycodelin levels, and shortened luteal phase) present in the literature may suggest a pre-ovulatory induced post-fertilization drug effect.
Lay summary:
Plan B is the most widely used emergency contraceptive available. It is important for patients and physicians to clearly understand the drug's mechanism of action (MOA). The drug was originally thought to work by preventing fertilization. Recent research has cast doubt on this. Our review of the research suggests that it could act in a pre-fertilization capacity, and we estimate that it could prevent ovulation in only 15 percent or less of cases. The drug has no ability to alter sperm function and limited ability to suppress ovulation. Further, data suggest that when administered pre-ovulation, it may have a post-fertilization MOA.
Purpose:
The purpose of this study was to ascertain the knowledge level of nurse practitioner (NP) students about emergency contraception (EC), and to explore attitudes about EC that may intersect with willingness to prescribe EC.
Data sources:
Four hundred and sixty-seven NP students completed a 30-item web-based survey using Vovici survey software.
Conclusions:
Students who reported formal content on EC in their program of study showed significantly better mean knowledge scores (t= 5.279, df = 459, p < .001). Gaps in NP students' knowledge of EC mechanisms of action, understanding of indications and contraindications were apparent. Younger students (F(3,457) = 4.994, p < .002), those newer to nursing (F(4,456) = 6.641, p < .0005), and women's health NP students (F(4,445) = 3.488, p < .008), demonstrated significantly better knowledge. Attitudes regarding EC appeared to be tied to the respondent's knowledge about EC.
Implications for practice:
Knowledge is an important factor in informing NP practice decisions. Clinicians need accurate, evidence-based knowledge to provide health education and counseling to reproductive age women if unintended pregnancies are to be reduced.
Objective To identify knowledge of and attitudes towards emergency contraception (EC) in women from five European countries. Methods In an internet-based survey, sexually active women aged 16 to 46 years from France, Germany, Italy, Spain, and the UK were asked about their use of and opinions on EC. Results Overall, 7170 women completed the survey. Thirty percent reported having had unprotected sexual intercourse during the previous 12 months (population at risk). Twenty-four percent of the population at-risk reported using EC. The most common reasons given for not using EC were: not perceiving themselves to be at risk of pregnancy; and not thinking about EC as an option. A third of respondents indicated they did not know how EC works, with several misconceptions about EC noted e.g., leading to infertility, similar to abortion. Seventy-nine percent of women agreed that EC is a responsible choice to prevent unwanted pregnancy, but nearly a third of women who used EC felt uncomfortable or judged when obtaining it. Conclusions EC is underutilised by three-quarters of the women surveyed. Women do not recognise they may be at risk of pregnancy when contraception fails. There are still several misbeliefs about EC indicating a need for better education of the public.
Social science studies of bioethics demonstrate that ethics are highly contextual, functioning differently across local settings as actors make daily decisions "on the ground." Sociological studies that demonstrate the key role organizations play in shaping ethical decision-making have disproportionately focused on physicians and nurses working in hospital settings where they contend with life and death issues. This study broadens our understanding of the contexts of ethical decision-making by empirically examining understudied healthcare professionals - pharmacists - working in two organizational settings, retail and hospital, where they act as gatekeepers to regulated goods and services as they contend with ethical issues ranging from the serious to the mundane. This study asks: How do organizations shape pharmacists' identification, negotiation, and resolution of ethical challenges; in other words, how do organizations shape pharmacists' gatekeeping processes? Based on 95 semi-structured interviews with U.S. pharmacists practicing in retail and hospital pharmacies conducted between September 2009 and May 2011, this research finds that organizations influence ethical decision-making by shaping how pharmacists construct four gatekeeping processes: medical, legal, fiscal, and moral. Each gatekeeping process manifests differently across organizations due to how these settings structure inter-professional power dynamics, proximity to patients, and means of accessing information. Findings suggest new directions for theorizing about ethical decision-making in medical contexts by drawing attention to new ethical actors, new organizational settings, an expanded definition of ethical challenges, and a broader conceptualization of gatekeeping.
This paper addresses the likely impact on women of being denied emergency contraception (EC) by pharmacists who conscientiously refuse to provide it. A common view-defended by Elizabeth Fenton and Loren Lomasky, among others-is that these refusals inconvenience rather than harm women so long as the women can easily get EC somewhere else close by. I argue from a feminist perspective that the refusals harm women even when they can easily get EC somewhere else close by.
The August 24, 2006, decision by the US Food and Drug Administration (FDA) to approve over-the-counter (OTC) sales of the emergency contraceptive Plan B—1.5 mg of levonorgestrel taken after unprotected sexual intercourse—was a major development in a long and contentious regulatory process. Since the drug is more effective the sooner it is used, the delay in obtaining it imposed by its prior prescription-only status limited its effectiveness.In the interest of making Plan B available more quickly when needed, the distributor (Women's Capital Corp, Washington, DC) applied to the FDA in April 2003 for approval of OTC status. In December 2003, a joint FDA advisory committee voted 23-4 in favor of approval. It did so on the basis of evidence that the drug is both effective and safe and that it met all FDA criteria for OTC availability. The committee also took into account the likelihood that improved access could prevent at least some of the 3.1 million unintended pregnancies (including the 25 000 that result from rape)1,2—and, hence, some of the more than 1 million elective abortions—that occur in the United States every year.1 Although the FDA almost always accepts its advisory committees' recommendations, in the case of Plan B it twice refused to grant approval of OTC status; the current approval decision came nearly 3 years from the time of the committee vote.
The debate over emergency contraceptive pill access in the United States revolves around speculations about Americans' sexual lives. The recently released internal U.S. Food and Drug Administration (FDA) memo that expresses fears that adolescents will form "sex-based cults" around emergency contraceptive pills echoes arguments made against the nonprescription switch at the 2003 FDA hearings. In these hearings, opponents argued that nonprescription access would lead to adolescent promiscuity and disease transmission and that adult predators would use the drug to facilitate the sexual abuse of young women. In contrast, proponents of expanded access to emergency contraceptive pills overwhelmingly portrayed their model user as a responsible adult who experiences a torn condom during consensual sex. These imaginations of American sexuality are tied to competing models of the role of medical providers in women's sexual decision making. Opponents of the nonprescription switch argued that women need a learned intermediary, not only to determine their need for emergency contraception, but also to educate them about proper sexual behavior and protect them from abuse. Proponents advocated putting more responsibility for sexual health decision making in the hands of women, not doctors, and complained about the moralizing scrutiny of medical providers. In the absence of nonprescription access to emergency contraception, advance prescription of emergency contraceptive pills can ensure that contraceptive education is not tied to a specific sexual act and therefore not perceived as a judgment about women's sexual decisions. However, advance prescription does not help women who lack access to health care or women who make sexual and contraceptive decisions without consulting physicians.
Definition of term pregnancy
Bulletin No. 152: Emergency contraception
Diferenças regionais de conhecimento, opinião e uso de contraceptivo de emergência entre universitários brasileiros de cursos da área de saúde
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Is Plan B an abortifacient? The National Catholic
- Npg Austriaco
Diferenças regionais de conhecimento, opinião e uso de contraceptivo de emergência entre universitários brasileiros de cursos da área de saúde.
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- Vitalle MS de S
- Maranhão H de S
- Canuto MHA
- Pires MM de S
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