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The Emergency Contraceptive
Newsletter
ABOUT THIS NEWSLETTER: This newsletter is prepared and distributed as a voluntary activity onbehalf of the American Society for Emergency Contraception and theinternational Consortium for Emergency Contraception. It is distributedelectronically twice each year to anyone who wishes to receive it. Tocontribute a news item, please send it to Charlotte Ellertson(cellertson@popcouncil.org.mx) or to Kelly Blanchard (AmSocEc@aol.com). Annik Sorhaindo (asorhaindo@popcouncil.org.mx) is currently the editor ofthe newsletter. We reserve the right to check and edit items asappropriate. To join or remove your name from the newsletter circulationlist, please write to AmSocEC@aol.com.
ABOUT THE AMERICAN SOCIETY FOR EMERGENCY CONTRACEPTION: The American Society for Emergency Contraception (ASEC) is a voluntary collaboration of organizations that promote the availability of emergencycontraception for women. Founded in 1997, ASEC has four mandates: 1) to serve as a source of information for the media and others who wantinformation on emergency contraception; 2) to serve as a watchdog forinaccurate or biased articles in the press and respond with accurate letters to the editor, and to watch for abuses of reproductive rights related to emergency contraception, and draw attention to these problems; 3) to promulgate policies on emergency contraception and to support anddisseminate the statements and guidelines of other organizations willing to endorse the method; and 4) to link the members of the emergencycontraception field, primarily by sending out (in collaboration with theinternational Consortium on Emergency Contraception) this semi-annualelectronic newsletter on recent events in emergency contraception and byorganizing an annual meeting held on the first Monday in October in New York to share information with researchers, policy makers and the pharmaceutical industry. The next meeting is scheduled for October 2nd, 2000. ASEC is open to industry participation, although it will not endorse onemethod or regimen over others that are also safe and effective. Membership is free, and although the focus is primarily on the United States, international affiliates are welcome. To receive a list of the member organizations, please write to AmSocEC@aol.com. The Executive Director of ASEC is currently Kelly Blanchard, who can be reached at (212) 339-0656. ASEC is managed by a volunteer steering committee consisting of CharlotteEllertson (Population Council), James Trussell (Princeton University),Kirsten Moore (Bass and Howes), Laneta Dorflinger (Family HealthInternational), Allan Rosenfield (Columbia University), Elisa Wells(Consortium for Emergency Contraception) and Jackie Buster-Lawrence (Planned Parenthood Federation of America).
ABOUT THE CONSORTIUM: The Consortium for Emergency Contraception is an innovative collaborationamong eighteen nongovernmental and public sector organizations and a private sector industry partner The Consortium’s immediate objectives include the introduction of a dedicated product for emergency contraception into the public and private sector markets of four developing countries–Indonesia, Kenya, Mexico, and Sri Lanka. The larger goals of the Consortium’s introduction program are to identify and disseminate "best practices" for the delivery of emergency contraceptive services and to demonstrate for the world’s policymakers, health care providers, and pharmaceutical manufacturers the widespread acceptability and need for the method.The Consortium has recently expanded its membership to include:
(*founding members, 1995) The Consortium’s industry partner is Gedeon Richter, one of Europe’s largest pharmaceutical companies. For information about the Consortium, please contact any of the memberorganizations. To obtain Consortium materials, contact the ConsortiumCoordinator, Elisa Wells, 3224 Purdue Street, Anchorage, AK 99508.Phone/fax: (907) 279-2055.E-mail: elisa@alaskalife.net.
PRODUCT NEWS: ****Special Notice**** Free Supplies of NorLevo® Progestin-only EC Available — Request Now Through ASEC ASEC was recently approached HRA Pharma, the company marketing the emergency contraceptive, NorLevo®. NorLevo® is a progestin-only EC product recently approved in France and available directly from pharmacists. Due to the change in labeling required when the product moved from prescription-only status to pharmacist provision - or p status (which happened only one day after the product was approved!)-HRA Pharma had to recall several thousand boxes. They are generously making these supplies available for research or humanitarian purposes through ASEC. This offer is made with the following provisions:
Plan B on the Market in the United States This summer the United States Food and Drug Administration approved itsfirst progestin-only pill developed for emergency contraception, Plan B. The light blue, compact package contains of two 0.75 mg tablets oflevonorgestrel. According to two World Health Organization (WHO) studies,levonorgestrel is highly effective and produces less nausea and vomitingthanthe Yuzpe regimen. Women’s Capital Corporation is the United Statesdistributor for Plan B. Supplies will be sold by prescription in drugstores soon, but in the meantime, are available through Title X clinics and individual EC providers. Physicians wishing to order supplies should call 1-800-330-1271.
FDA Grants Gynétics Less Restrictive Labeling for PREVEN™ The United States Food and Drug Administration has given approval toGynétics to change the label on their emergency contraception product,PREVEN™, to a less restrictive one. The previous "Black Box Warning" label cautioned women "...that cigarette smoking increases the risk of serious cardiovascular side effects from use of combination oral contraceptives.This risk increases with age and heavy smoking (15 or more cigarettes a day)and is quite marked in women over 35 years of age Women who use combined oral contraceptives should strongly be advised not to smoke." The new label notes that the warning is given for daily use of cyclical combination oral contraceptives and that is it unknown whether the warning applies to emergency contraception. Gynétics feels this change allows them to communicate better with consumers and medical professionals.
PREVEN™ Goes to Canada Gynétics Inc. has recently announced an agreement to grant Canadianmarketing rights to PREVEN™ to the Roberts Pharmaceutical Corporation forsix-years. The Roberts Pharmaceutical Corporation currently markets women’s healthcare products such as REPLENS, a vaginal moisturizer and ADVANTAGE 24, a nonoxynol-9 spermicidal gel, in Canada. Gynétics hopes this alliance will allow PREVEN™ to have the same impact on unintended pregnancies and abortions in Canada as it has in the United States.
COUNTRY UPDATES: Emergency Contraception in Israel SHILO, a non-profit family planning education and counseling center inJerusalem, is launching a public awareness campaign on the availability and accessibility of emergency contraception. They plan to run weeklyadvertisements in the most widely circulated local newspaper to inform the public about emergency contraception. They hope to dispel the myth that EC is effective only the morning-after, and to provide telephone numbers where women can receive more information. Two years ago, the Israeli Ministry of Health approved prescribing birthcontrol pills for use as emergency contraception. However, most women still do not know this therapy is available, where to get it or how to use it. The current media campaign, sponsored by US/Israel Women to Women, plans to focus on informing young women in their twenties and thirties, who generally are unaware, of emergency contraception. SHILO plans to evaluate the effectiveness of the campaign by the number of phone calls received asking for information and by the number of women who request EC from their counseling service.
Consortium work in Indonesia, Kenya, Mexico and Sri Lanka The Consortium has been implementing Postinor-2 introduction programs in Indonesia, Kenya, Mexico, and Sri Lanka. In each country, a baseline survey of attitudes, knowledge, and practice has guided the local adaptation of materials and the design of model services. Postinor-2 is now registered in Kenya, Mexico, and Sri Lanka and is in process in Indonesia. Introduction of Postinor-2 through clinical outlets is ongoing in Indonesia, Kenya, and Sri Lanka. In Indonesia, EC services are currently available through 22 clinics and are also becoming available through midwives in Central Java and Bali. The Consortium has been working closely with the Indonesia Society of Obstetrics and Gynecology to provide OB/GYNs and other health professionals with information on EC. In Kenya, Postinor-2™ is available through 19 clinics. To accommodate the more conservative service delivery and regulatory climate in Mexico, the Consortium used strategy that is not specific to Postinor-2™. Consortium work in Mexico has helped to increase awareness about emergency contraception in the general population. In addition, in September 1999, Postinor-2™ was approved by the Mexican drug regulatory agency. In Sri Lanka, Postinor-2 has been made available to women through the Family Planning Association of Sri Lanka (FPASL) clinics, general practitioners and pharmacists. FPASL has distributed 7,000 units of Postinor-2 as of June 1999.
Pacific Institute for Woman’s Health (PIWH) Collaborates with Women’s Organizations in Latin America The Pacific Institute for Women’s Health (PIWH) is working with women’s NGOs in Latin America to strengthen their capacity to provide information on EC and make it known and accepted in their communities. In 1998, PIWH surveyed women's groups throughout Latin America and the Caribbean to determine their familiarity with, and interest in, emergency contraception. In 1999, PIWH collaborated with Colectivo de Mujeres Xochilt in Nicaragua, and in Mexico with Organizacion Lilith de Mujeres Independientes and Instituto Mexicano de Investigación de Familia y Población (IMIFAP), to develop materials, conduct workshops, and initiate advocacy.
UNFPA Provides EC to Countries in Crisis Since 1994, UNFPA has provided emergency contraception to selected countries in crisis through grants of Postinor 1 and 2 from Gedeon Richter and PC4 from Schering. PC4 is included as part of an emergency kit that has been provided in Uganda, Senegal, Madagascar, Eritrea, Rwanda, Lesotho, Guinea Conakry, Tanzania, Albania and Macedonia. Other emergency kits contain combined oral contraceptives and IUDs which both could be used as emergency contraceptives if needed. As UNFPA is currently evaluating the impact of the kits, they have no precise data on the exact number of EC kits distributed, their popularity, or the kits’ effect on the population. In Albania, the climate is highly favorable to the dissemination of emergency contraception, which has recently been explicitly legalized. EC is now officially part of the national reproductive health program. In Angola, a new project called "the starter project" is soon to belaunched. This project consists of the distribution of packages containing a female condom, several male condoms, a sanitary pad and one dose of EC pills. For this project, 10,000 doses of NorLevo® pills and 10,000 female condoms will be donated by pharmaceutical companies. In general, there is not a great demand of EC in crisis areas with highrates of reported rape. Often, the time elapsed between the rape and thepotential prescription of EC is too long. In Kosovo, for example, rapedwomen walked for days before reaching the border, so that EC could not beadministered efficiently. EC will only reduce unwanted pregnancies due torape if women are aware of the treatment, know where it is available, andare able to receive treatment in time.
Five California Nurses Express Their Right to Not to Dispense EC This summer, five nurses quit their jobs at a county-run health clinic in California for refusing to agree to dispense emergency contraception. When the demand for emergency contraception at the clinic increased, the nurses were asked to sign a list of job expectations by the County Health Services Agency. The Agency wanted to avoid the possibility of their nurses imposing their personal views about emergency contraception on the patients. As a result, five nurses quit their jobs. Supporters of emergency contraception believe it is a violation of federal law to refuse to dispense the medication. Some feel the nurses have the right to express their personal beliefs at their jobs, but agree that the women should not be obligated to work in the clinic. Another nurse in the clinic also opposed emergency contraception, but said she believes each woman should have the right to choose.
Emergency Contraception Project in Alaska Alaska has an unintended pregnancy rate of 42% and the highest sexual assault rate in the United States. Concerned women’s health providers have been watching national activity on emergency contraception and the success of Washington State project. In December 1998, the Alaska Emergency Contraception Project was created through a coalition of federal, state, municipal, and tribal members as well as local representatives from Planned Parenthood and PATH. In September 1999, the project mailed out 1500 educational packets to statewide health care providers on emergency contraception. A multi-media "Tool-box" has been professionally prepared and is available upon request. The project also established a speaker’s bureau. Emergency contraception presentations created in Power Point have been designed for four target audiences: medical providers, health care workers, pharmacists, and lay people. These presentations will be available via a local Planned Parenthood website. In November 1999, The coalition plans to hold a multidisciplinary emergency contraception seminar to target both medical providers and pharmacists.
PREVEN™ Supporters Picket Walmart In August of this year, protesters picketed a Central Florida Walmart inresponse to the company’s refusal to dispense the contraceptive kit, PREVEN™;, through their pharmacies. Fourteen protesters held signs reading "Don’t get between me and my MD." The protesters were especially concerned with the organization Pharmacists for Life International, which is currently lobbying several states to create conscience clauses that would allow pharmacists to refuse to prescribe medications with which they have moral, ethical or religious conflicts. Protesters argued that pharmacists should leave the profession if they do not agree with the products they dispense.
Members of the American College of Obstetricians and Gynecologists (ACOG)Criticize Wal-Mart’s Decision Not to Dispense PREVEN™ Following the report that one of America’s largest pharmacy chains, Wal-Mart, had refused to distribute the dedicated product for emergency contraception, PREVEN™, some members of ACOG have expressed their disapproval of the company’s position. The chair of the ACOG Committee for Underserved Women criticized Wal-Mart saying the company has an obligation to ensure that women’s reproductive rights are not limited. Pharmacists have the right to refuse to dispense drugs that they feel are morally objectionable according to the American Pharmaceutical Association. However, some members of ACOG feel pharmacists have an ethical and moral obligation to refer the patient to another provider for emergency contraception.
Wal-mart Offers Alternatives to Dispensing PREVEN™ Wal-mart stores recently clarified their position on dispensing PREVEN™. Although the stores will not stock PREVEN™, they will fill prescriptions for high-dose oral contraceptives that can work as emergency contraception. The policy requires that Walmart pharmacists, who will not fill prescriptions for PREVEN™ or high dose oral contraceptives for use as emergency contraception, refer patients elsewhere to fill the prescription.
NEW MATERIALS AND CAMPAIGNS: British Pregnancy Advisory Service (BPAS) Provides EC to Women in Advance Following the WHO study that showed emergency contraception was 50% more effective if taken within 12 hours of having unprotected sex, the British Pregnancy Advisory Service (BPAS) launched a program to provide EC to women in advance of need. The program, started in July, advises women to call a special hotline number and book an appointment with a physician where she will be advised about emergency contraception. After receiving this consultation, she can obtain EC supplies to keep on hand in case of need. The program has become so popular in some areas that BPAS has set up "walk-in" services so that women do not need to make appointments to receive the counseling and ECP supply in advance. Previously, women were only able to receive emergency contraception by prescription after seeing a health professional within three days after unprotected sex. For many women whose physicians or clinics do not provide extended hours or are not open over the weekend, the time constraint created a barrier to access. BPAS has a network of 40 clinics around Britain.
Women in Scotland Receive Free EC Kits in Advance The Lothian Primary Care NHS Trust Family Planning and Well Women Service of Scotland has recently begun a program to provide free emergency contraception kits to women in advance of need. In 1997, researchers found that women were more likely to use the method if they had it on hand at home than if they had to go and see a physician to receive a prescription. Since it must be prescribed within 72 hours of unprotected sex, this policy has created barriers to access for women during weekends and holidays when doctors are not available. In total, approximately 85,000 women ages 16 to 29 will be provided with ECPs to take home for use when needed. This program will continue for two more years and changes in abortion rates will be evaluated at the end.
Planned Parenthood of Connecticut begins "Dial EC" program Beginning in the fall of 1998, Planned Parenthood of Connecticut (PPC) has had an after-hours nurse practitioner on duty for weekends and evenings, taking calls and calling in prescriptions for EC to pharmacies. From September to July, 665 prescriptions were called in to Connecticut pharmacies. Of these calls, 44% of calls were from teenagers ages 14 to 19. Since April, there has been an average of 85 calls per month. Seventy-eight percent of the calls have been over the weekend.
Planned Parenthood of Connecticut (PPC) Brings EC to Rock Concerts Planned Parenthood of Connecticut (PPC) has recently experimented with including a clinician in the medical booths typically found at rock concerts hoping to prescribe EC "in advance of need." Staff found it very difficult to interest young women in purchasing EC before they need it. Most young women felt that if it is available when they did need it, it is not necessary to spend the money ahead of time. PPC also administered quizzes at the concerts to test the knowledge of teens and others in attendance about EC. They found that 78% of the women polled at a recent concert had heard about EC. In addition, 70% of teens under 18 were aware of EC and 79% of women 18-22 had heard about EC. Of EC users, 50% knew it is effective up to 72 hours after unprotected sex.
The American Medical Women’s Association (AMWA) Launches Sex and Sensibility Campaign AMWA has recently launched an emergency contraception public education campaign to provide information to women who are unaware or misinformed about EC called "Sex and Sensibility." The campaign includes an online quiz to inform women of emergency contraception and explain that it is not an abortafacient. Dr. Drew Pinsky from MTV’s Loveline is the campaign spokesperson.
Reproductive Health Technologies Project (RTHP) Develops EC Campaigns in LA and Philadelphia In response to focus group research, RHTP has developed multi-faceted strategies incorporating both traditional media outlets and community-based outreach. Thus far, each campaign has sparked the interest of the targeted communities In Los Angeles, brochures and posters in Spanish and English have been developed and are being distributed to campaign partners and health educators in the San Fernando Valley, Unicorporated East Los Angeles and Southeast Los Angeles. Several provider briefings have been conducted to engage health care professionals in the campaign. In addition, media kits including the brochure and poster, information about emergency contraception and a press release on the campaign have been distributed to Latino-focused media outlets in Los Angeles. In Philadelphia, radio ads with the theme of "After the Fact; After the Act" have been developed and are currently playing on top urban radio stations. Since the launch of radio ads in Philadelphia, call volume to the Emergency Contraception Hotline has more than doubled. Campaign materials including posters, brochures and postcards are being distributed to over 200 campaign partner organizations. These organizations include hair and nail salons, recreation centers, and residents’ councils in public housing associations. The Family Planning Council and Choice of Philadelphia have funded an additional print run of 30,000 brochures with inserts of local clinics and the Choice Hotline for distribution within their network of clinics. Events throughout the city including participation in Black Women’s Forums, a joint promotional effort with the Power 99 van at a YMCA and community college, and a 1-888-NOT-2-LATE challenge marathon between organizations to generate calls to the Hotline are also planned.
Pharmacists in British Columbia Want to Collaborate with Physicians to Dispense EC Plans are underway in British Columbia to move forward with an emergency contraception program involving pharmacists working in collaborative agreements with physicians. The College of Pharmacists of British Columbia (CPBC), a regulatory organization, and the British Columbia Pharmacy Association (BCPhA), a voluntary group, are working together to launch a pilot program in spring 2000. The CPBC recently surveyed 3,000 pharmacists to gauge the amount of interest in the program and they have begun to identify pharmacists who will attend a "train-the-trainers" session in cooperation with the Washington Pharmacists Association.
PIWH Publishes Booklet "From Secret to Shelf" to Document the Story of EC’s Rise in Popularity The Pacific Institute for Women’s Health (PIWH), in collaboration with the Packard Foundation, has drawn together the story of what it took to move emergency contraception from being "America’s best kept secret" to becoming available at the corner pharmacy. Women’s health activists and philanthropic foundations have been major forces in this achievement. The publication will be available in the Fall 1999.
RESEARCH RESULTS AND UPDATES: Reducing Nausea Associated With Emergency Contraception Family Health International recently fielded a study to determine if treatment with meclizine would reduce the incidence of nausea and vomiting associated with the Yuzpe regimen of emergency contraception. Women were randomized to receive treatment of 50 mg meclizine one hour before the first ECP dose, Yuzpe treatment and placebo, or Yuzpe alone. The risk of nausea and vomiting dropped significantly if women took the Yuzpe regimen following treatment with meclizine (nausea from 64.2% to 47.2% and vomiting from 12.8% to 4.6%). However, meclizine did significantly increase the rate of drowsiness (from 15.6% to 30.6%). The study found no placebo effect. Brand names for meclizine in the US include Bonine and Dramamine II.
A Reminder of the Importance of EC in Times of Rape Many unwanted pregnancies are the result of sexual violence. A study published in the American Journal of Obstetrics and Gynecology in August 1996 found that the rape-related pregnancy rate is 5.0% among women aged 12 to 45. In that study, researchers found that among adult women an estimated 32,101 pregnancies result from rape each year. Such information serves as a reminder to the healthcare community of the value of EC in preventing pregnancies that may result from rape. * Source: American Journal of Obstetrics and Gynecology 1996 August; 175(2):320-4
Provision of EC to Spermicide Users in Ghana Family Health International (FHI) has recently completed a study of two approaches to the provision of EC to spermicide users at four clinics of the Planned Parenthood Association of Ghana. EC had not previously been dispensed at any of these clinics. The objectives of the study were to evaluate EC use and unprotected intercourse after the introduction of EC. At two clinics, women were counseled about EC and invited to obtain them at the clinic when needed, and at the other two clinics, women were given a packet of EC to use at home if needed. Women were asked to keep pictorial coital diaries for eight weeks and to return to the clinic for follow-up at 4 and 8 weeks. A total of 208 women were enrolled. Follow-up ended in spring 1999. Preliminary analysis indicates that women at all clinics used EC after almost all unprotected acts of intercourse and that, considering the high total amount of intercourse in this population, the number of unprotected acts was low at three of the clinics. A final analysis should be available soon.
Recent Study on EC in India Shows Wide Acceptance In a recent study on increasing access to emergency contraception in India, researchers found that 50% of women interviewed would like EC to be available over-the-counter. Currently, EC is only available through private medical practitioners. The study was conducted in Andhra, Pradesh, Orissa and New Delhi and found that the major barriers to emergency contraception use in India were lack of knowledge, awareness, availability and concern about possible side effects. Supporters want to promote EC through the government family planning programs and are planning to target policy makers, providers and clients through EC campaigns.
Study on EC Use Among Condom Users in India Family Health International has recently taken part in a study on EC among condom users in India. This randomized clinical trial is ongoing at three family welfare clinics affiliated with the Institute for Research and Reproduction in Mumbai, India. The objective of the study is to compare use of EC and condoms and attitudes toward EC in two groups of women who rely on condoms as their primary contraceptive method. One group is given a supply of condoms and a regimen of EC at their initial clinic visit and are told to return for another supply if needed. The second group is given condoms and provided with counseling about EC and are told to return to the clinic if the need for EC arises. Each woman is followed for 3 months. The study was initiated in January 1999, and as of August 1999, has enrolled 130 women. Participant enrollment (200 women) will be completed in early 2000.
Many American Women Still Have Not Heard of EC Even with the recent release of two dedicated products and large ad campaigns for emergency contraception in the United States, many American women are still not aware of the method. A recent survey by the Henry J. Kaiser Family Foundation found that 90% of OB/GYNs say they do not regularly discuss emergency contraception with patients. As a result, only 11% of women are aware of EC and only 1% have ever used it. Many women are confused about the nature of EC; either women are not aware that ECs are simply larger doses of regular oral contraceptives or women mistake ECs for the abortion pill, RU 486. Increased use of EC could greatly reduce the number of unintended pregnancies and the need for abortion in the United States.
RECENT OR UPCOMING MEETINGS: ASEC Annual Meeting Moves to First Monday in October At the recent 5th annual ASEC meeting in October, members agreed, at the request of the Consortium on EC, to move the annual meeting from the first Friday in October to the first Monday in October. The change allows the two day Consortium meeting to follow the ASEC meeting without the interruption of a weekend. The 6th annual ASEC meeting will be held in New York on October 2nd, 2000. Notes and an official list of attendees at the 5th annual meeting are available from Joe Harris of the Population Council.
****Special Notice**** At the recent ASEC meeting, a petition to the Mexican Ministry of Health was circulated. The petition urges the government to bring family planning options in Mexico into line with those internationally. Individuals who wish to add their names to the petition should send an email to the coordinator of the Consortium for EC, who has agreed to compile the names. The text of the petition is as follows: TO THE HONORABLE MINISTER
OF HEALTH MEXICO New York City, October 1st, 1999 We the undersigned individuals, joined together in a collaborativeinternational effort to promote the accessibility and appropriate use ofemergency contraception around the world, wish to express to yourinstitution and you personally our support for your endeavors to giveMexican citizens a revised Official Norm for Family Planning Services inline with the latest international medical standards. As interdisciplinary professionals deeply involved in reproductive healthissues, we want to reiterate that hormonal emergency contraception is asafe, effective, simple and widely accepted method to prevent unwantedpregnancies. Emergency contraception does not act as an abortifacient as it cannot interrupt an established pregnancy. On the contrary, it is apreventive method that, when used properly, can help women avoid resorting to unsafe abortions. We strongly believe that this method should be made available to women worldwide as one of the contraceptive options to which they are entitled. If you would like to add your name to the list please contact Elisa Wells at: Elisa Wells Correction: In the Spring 1999 newsletter an error was made in the piece titled, "Society for Obstetricians and Gynecologists of Canada (SOGC) Petitions for OTC EC." We incorrectly stated that the petition was supported by the WHO. Also in that newsletter, the piece titled, "The Sooner the Better: Yuzpe and Levo-only Regimens of EC are Most Effective Within 12 Hours of Unprotected Sex," said pregnancy risk doubled when treatment was given 61 and 72 hours after unprotected intercourse relative to the risk when the pills were taken within the first hours. The statement should read, "when the first dose was delayed by 12 hours the odds of pregnancy increased by almost 50%." |
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