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					Emergency Contraception Update 10/96
LAW AND POLICY WHO ADDS ECPs TO LIST OF ESSENTIAL DRUGS The World Health Organization has added emergency contraceptive pills (ECPs) to its published list of Essential Drugs. The entry covers products containing four tablets of 50 mcg ethinyl estradiol and 250 mcg of levonorgestrel (the standard Yuzpe regimen). National governments use the Essential Drugs list to help guide pharmaceutical procurement for public sector programs. Only five other hormonal contraceptives are currently on the WHO list, which is revised every two years. Products meeting this description are currently manufactured by Schering AG in Berlin and Gedeon Richter in Hungary. (See below). Contact: Peter Hall WHO/HRP CH-1211 Geneva 27 Switzerland Tel 41-22-791-2111 Fax 41-22-791-4171 Internet: hallp@who.ch

US FOOD AND DRUG ADMINISTRATION (FDA) FINDS EMERGENCY CONTRACEPTIVE PILLS SAFE AND EFFECTIVE At a hearing June 28, the US Food and Drug Administration Advisory Committee on Reproductive Health Drugs voted unanimously to find the Yuzpe regimen for emergency contraception safe and effective. The action followed a day-long review of scientific data and testimony by a wide range of medical groups and advocates for women's health. Although the FDA cannot approve a drug for a new indication without an application from the drug's manufacturer, the expected publication of the FDA findings later this year in the official US Federal Register represents a strong FDA endorsement of "off-label" use of six brands of birth control pills currently on the US market. The pill brands are: Ovral, Lo-Ovral, Nordette and Tri-Phasil (marketed by Wyeth-Ayerst) and Levlen and Tri-Levlen (marketed by Berlex, the US subsidiary of Schering AG). FDA officials hope the action will encourage pharmaceutical manufacturers to bring dedicated products for emergency contraception to the US market. At least one company, the Paris-based HRAPharma, has since announced plans to market a new Yuzpe-type product in the United States and elsewhere in 1997. Meanwhile, the FDA action may reduce medical malpractice risks to US health care providers who offer the method now. That and new Practice Patterns on emergency contraception, issued by the American College of Obstetricians and Gynecologists in early October, may lead to expanded US availability.

Contacts: Philip Corfman, MD Supervisory Medical Officer, Reproductive Health Drugs Food and Drug Administration Parklawn Building Room 17B45 Rockville, Maryland 20857 USA Tel. 301-827-4260 Fax 301-827-4267 Internet: corfman@a1@fdacd.gov Stanley Zinberg, MD American College of Obstetricians and Gynecologists 409 12th Street SW Washington, DC 20024-2188 Tel: 1-202-638-5577 Fax: 1-202-484-3993 Internet: szinberg@acog.com

UNHCR SUPPORTS ECPS FOR REFUGEE CAMPS The United Nations High Commissioner for Refugees (UNHCR), in collaboration with the United Nations Population Fund (UNFPA), UNICEF and WHO, has recently defined emergency contraception as part of a Minimum Initial Service Package (MISP) to be provided in the world's refugee camps. In defining essential emergency reproductive health services, the interagency task force guidelines note that: "Sexual and gender-based violence is strongly associated with situations of forced population movement. In this context it is vital that emergency post-coital contraception supplies are available to those women who request this." The document notes that emergency contraception is not a substitute for other contraceptive methods, nor should it be considered abortifacient, since "it inhibits the ovulation and modifies the development of endometrium before implantation." UNHCR, UNFPA and WHO/HRP are already working with humanitarian and emergency relief groups, like the International Rescue Committee, to develop an emergency reproductive health care kit. Meanwhile, emergency contraceptive pills are already provided in refugee camps in Kenya, Ethiopia and Uganda. The pills have been donated to UNFPA by Schering AG, which manufactures a four-pill packet of high-dose combined oral contraceptives, marketed as Tetragynon or PC4. Contact: Daniel Piorotti MD Director Emergency Relief Operations United Nations Population Fund 9 Chemain des Anemone Geneva, Switzerland Tel: 41-22-979-9314 Fax: 41-22-979-9049 Kate Burns

UNHCR Reproductive Health Coordinator CP 2500 CH 1211 Geneva 2 Depo, Switzerland Tel: 41-22-739-8003 Internet: burns@unhcr.ch

CENTER FOR REPRODUCTIVE LAW AND POLICY ANALYZES LEGAL BARRIERS , MODEL LEGISLATION The Center for Reproductive Law and Policy is currently surveying legislation and regulations in various countries which may bear on the provision of emergency contraception. The Center expects to assemble considerable evidence that emergency contraceptives are not generally treated as abortifacients. CRLP will also identify model legislation and regulations which might be replicated in other countries. Contact: Anika Rahman Esq., Director International Programs Center for Reproductive Law and Policy 120 Wall Street New York, New York 10005 USA Tel: 1-212-514-5534 Fax: 1-212-514-5538 Internet: crlpintl@igc.apc.org

TECHNICAL RESOURCES SCIENTIFIC DATABASE ON EMERGENCY CONTRACEPTION ACCESSIBLE SOON ON INTERNET The Special Programme of Research, Development and Research Training in Human Reproduction (WHO/HRP) is assembling all technical papers on emergency contraception written since 1966, including papers in private collections at WHO/HRP. Abstracts will be available on a WHO World Wide Web page later this year, and the full papers for all references in the data base will be available through Internet file transfers or through the mail. The activity is supported by the Consortium for Emergency Contraception. Contact: Paul Van Look MD PhD WHO/HRP CH-1211 Geneva 27 Switzerland Tel 41-22-791-2111 Fax 41-22-791-4171 Internet: vanlookp@who.ch

PRINCETON UNIVERSITY WEB SITE Basic information on emergency contraception is currently available on the World Wide Web at http://opr.princeton.edu/ec/. The site is maintained by Princeton University researcher and leading EC expert, Dr. James Trussell. Trussell reports the EC Web site has had 75,000 "hits" since it was set up in December 1994. The Home Page describes the two proven hormonal regimens for emergency contraception, as well as emergency insertion of the IUD. Links to other pages give "Web surfers" more detailed information and pictures of each method, a state-by-state directory of over 2,000 US health care providers, and answers to commonly asked questions about emergency contraception. Future plans include a Spanish-language version and information from the IPPF worldwide Directory of Hormonal Methods of Contraception which will identify pill brands suitable for emergency contraception by country. Contact: James Trussell MD, Director Office of Population Research Princeton University Princeton, New Jersey 08544 USA Tel: 1-609-258-4810 Fax: 609-258-1418 Internet: trussell@princeton.edu WWW: http://opr.princeton.edu/ec/

CONSORTIUM RESOURCE PACKET REPRINTED/ SOON ON INTERNET To meet greater than expected demand, the Consortium for Emergency Contraception is printing another 5,000 copies of its Resource Packet for Health Care Providers and Programme Managers. The packet contains prototype materials for clients, standardized Medical and Service Delivery Guidelines (extensively reviewed by international experts and endorsed by all Consortium members), a Q & A for decision-makers and community leaders, talking points on controversial issues, a list of scientific references and other useful materials. A 50-page training curriculum is also available on request. Nearly 2,000 copies of the packet and training curriculum have already been distributed as part of an effort to standardize regimens in use around the world. A recent analysis by Family Health International of older guidelines from eight organizations shows that health care providers have gotten conflicting information and, as a result, have given incomplete or inaccurate advice to patients. The Consortium's prototype materials are designed to be adapted locally in a variety of country settings. Small orders can be filled by the Consortium Coordinator or any of the seven Consortium members. (For bulk orders see below). International colleagues are encouraged to reproduce, translate and/or modify the un-copywrited materials to meet their particular needs.

The Western Hemisphere Region of IPPF will produce a Spanish-language version of the Resource Packet in the near future. In late November, the Consortium will put up a Home Page on the World Wide Web with hotlinks to other Internet sources of information on emergency contraception. The Resource Packet, Consortium Updates and other materials and technical resources will be available for downloading. Contact for Bulk Supplies of Resource Packet and Web Page Information: Lenore Jackson PATH 4 Nickerson Street Seattle, Washington 98109 USA Tel: 1-206-285-3500 Fax: 1-206-285-6619 Internet: ljackson@path.org WWW: http://www.path.org/html/cec Contact for Bulk Supplies of Training Manual: Douglas Huber MD Pathfinder International 9 Galen Street, Suite 217 Watertown, Massachusetts 02172 USA Tel: 1-617-924-7200 Fax: 1-617-924-3833 Internet: dhuber@%6381752@mcimail.com Contact for Spanish Language Version: David Andrews, IPPF/WHR 902 Broadway, 10th floor New York, New York 10010 USA Tel: 1-212-995-8800 Fax: 1-212-995-8853 Internet: dandrews@ippfwhr.org

NEW PRODUCTS FOR EMERGENCY CONTRACEPTION SOUTH AFRICA APPROVES PC4 FOR SALE OVER THE COUNTER In September, South African drug regulatory authorities gave the Schering AG local subsidiary marketing approval for PC4. The emergency contraceptive pill, also marketed as Tetragynon, is available by prescription in Germany, Great Britain and a handful of other countries. In South Africa, however, the product has been approved for sale over the counter, raising doubts about when it might actually become available. Schering AG's management in Berlin requires that the product be sold only by prescription to limit possible misuse and, presumably, to limit the company's product liability risks.

The German parent company has strongly opposed efforts by ECP advocates in Great Britain and New Zealand to allow non-prescription distribution of PC4 by pharmacists. As a result, the effort to take emergency contraceptives off prescription is now stalled in both countries. In Norway, Ministry of Health officials, faced with similar company opposition, have threatened to license the product to another company. The likely outcome in South Africa is unclear. But rapidly growing interest in emergency contraception (see Country News below) may prompt Akromed, a former South African subsidiary of Wyeth-Ayerst, to bring out a competitive product. Contacts: Rob Goodall Schering P.O. Box 1685 Randjespark, Midrand South Africa Heinrich Hoeller Akromed P.O. Box 1713 Kelvin, 2054 South Africa

HUNGARIAN DRUG REGULATORY AUTHORITIES APPROVE GENERIC VERSION OF PC4; POSTINOR GETS NEW PACKAGE, EC LABEL In August, Hungarian drug regulatory authorities granted the Budapest-based pharmaceutical company, Gedeon Richter, registration for Fertilan, a four-pill package of high-dose combined oral contraceptives. The product is a generic of the Schering AG product, marketed as Tetragynon or PC4 in a number of Western European countries and New Zealand. Hungarian approval paves the way for registration in additional countries should the company decide to market the product more widely. Gedeon Richter already has a postcoital pill, Postinor, on the market throughout Eastern Europe and in some developing countries. The 0.75 mg levonorgestrel tablet, in four-pill and ten-pill packages, has been sold for regular postcoital use. A new product, Postinor-2, will be packaged in a two-pill strip and repositioned in the market as a one-time emergency contraceptive (one tablet to be taken within 72 hours of unprotected intercourse, followed by a second tablet 12 hours later). In a 1994 Hong Kong study, this progestin-only regimen was shown to be as effective as the standard Yuzpe regimen, with much lower side effects. Interim data from a large multi-center trial sponsored by WHO appear to support the findings. (See Research News below). Gedeon Richter has supplied the drugs for both arms of the double-blind WHO study. The Consortium for Emergency Contraception will be supporting model introductions of Postinor-2 in selected countries under a Collaborative Agreement between Gedeon Richter and the Bangkok-based Concept Foundation. Contacts:

Katalin Komandi PhD, Product Development Chemical Works of Gedeon Richter Ltd. H-1475 Budapest, P.O.B. 27 Hungary Tel. 36-1-261-0182 Fax 36-1-260-0349 The Concept Foundation Arwan Building, 8/F 1339 Pacharat 1 Road Bangsue, Bangkok 10800 Thailand Tel: 66-2-587-4787 Fax: 66-2-587-5125

ENDOMETRIOSIS DRUG STUDIED FOR EMERGENCY CONTRACEPTION South-to-South Cooperation in Reproductive Health, based in Brazil, and HRAPharma, a new French pharmaceutical company, are collaborating in the development of gestrinone for use as a single-dose emergency contraceptive. Most experts believe a single-dose regimen would be a major advantage over currently available ECPs. The drug, made by the French pharmaceutical firm Roussel-Uclaf, is marketed in about 40 countries for the treatment of endometriosis. Roussel has transferred certain rights to the drug to South-to-South. Early data from Brazil indicate that 2.5 mg of gestrinone, taken within a few days of unprotected intercourse, may be effective for postcoital pregnancy prevention with minimal side effects. If additional Phase II studies involving 1,500 women confirm these findings, gestrinone might be available for use as an emergency contraceptive in some countries by early 1998. A Phase III trial of 3,000 will be needed for registration in countries like the United States. Meanwhile HRAPharma plans to establish an international ECP franchise by registering a standard Yuzpe-type product in a number of countries in 1997. Contact: Docteur André Ulmann HRAPharma 21, rue Monsieur 75007 Paris, France Tel/fax 33-1-53-62-09-89 Internet: 106342.2424@compuserve.com

NIH LICENSES ANTIPROGESTIN FOR DEVELOPMENT AS EMERGENCY CONTRACEPTIVE

The Contraceptive Development Branch of the US National Institutes of Health (NIH) has arranged for the licensing of CDB2914, an antiprogestin similar to mifepristone (RU486). The agreement will allow development of the compound as a single dose emergency contraceptive pill, as well as for other medical uses. The drug, also known as HRP2000, was developed at the Research Triangle Institute in North Carolina with support from both NIH and WHO/HRP. The licensee is BKB Pharmaceuticals, a new company based in Washington DC, which was interested at one time in the French antiprogestin, mifepristone. Company CEO, Sandra Toro, expects to bring CDB2914 (the drug has no name as yet) to market by the year 2000. NIH-sponsored Phase I studies have just been completed and show high levels of efficacy and no side effects, even at the highest doses tested. The likely ECP dose is 10 mg. In the Phase II study, also funded by NIH, CBD2914 will be compared with the standard Yuzpe regimen. Contacts: Nancy Alexander MD Center for Population Research National Institutes of health 6100 Building, Room 8B13 Bethesda, Maryland 20892-7510 USA Tel: 301-496-1661 Fax: 301-480-1972 Sandra K. Toro, CEO BKB Pharmaceuticals, LLC 5335 Wisconsin Avenue NW, Suite 440 Washington, DC 20015 Tel. 1-202-274-0207 Fax 1-202-244-8257

STUDIES OF MIFEPRISTONE (RU486) FOR EMERGENCY CONTRACEPTION ONGOING A WHO/HRP study comparing the efficacy and side-effects of three different doses of mifepristone for emergency contraception is in the final phase of analysis. Some 80 % of 1717 subjects were treated within 72 hours of unprotected intercourse, and the others were treated between 72 hours and 120 hours. Efficacy appears to be similar for single doses of 10 mg, 50 mg and 600 mg, but drops off after 72 hours. As measured against expected pregnancies, efficacy is preliminarily estimated at between 73-82% -- about the same as for the Yuzpe and levonorgestrel regimens. Incidence of nausea appears to be about 20% and vomiting 2%, probably a little less than with the levonorgestrel regimen. A potentially more important side effect, in terms of acceptability, appears to be the delay in menses. Pending the outcome of efforts to market mifepristone for early abortion in the United States, the Population Council hopes to be involved in the development of the drug for a number of indications, including emergency contraception. The Council has received rights from Roussel-Uclaf for all known indications for the US market.

WHO/HRP is comparing the efficacy and side effects of 10 mg of mifepristone manufactured by Roussel-Uclaf in France with the same dose manufactured in China. The Concept Foundation is conducting an audit of Chinese producers to assess whether or not the Chinese product would meet international quality standards. The unwillingness of Roussel-Uclaf to register the drug in additional countries has increased interest in Chinese, Indian and other sources of supply. WHO/HRP will also start a study in 1997 comparing 10 mg of mifepristone with 10 mg of gestrinone in 800 women. Finally, a large multi-center study is being developed by WHO to compare a single dose of mifepristone with the two-dose levonorgestrel regime. Contacts: Helena von Hertzen, MD, PhD WHO/HRP CH1211 Geneva 27 Switzerland Tel: 41-22-791-2111 Fax: 41-22-791-4171 Internet: vonhertzenh@who.ch Ann Robbins PhD Center for Bio-Medical Research The Population Council 1230 York Avenue New York, New York 10021 Tel: 1-212-327-8717 Fax: 1-212-327-7678 Internet: arobbins@popcouncil.org

RESEARCH ON EXISTING METHODS BIO-MEDICAL RESEARCH TO EXPAND THE YUZPE REGIMEN The Population Council is seeking funds to support a multicenter trial at four sites in the United States and Scotland, designed to refine and expand the Yuzpe regimen. The trial will assess the efficacy of the standard regimen beyond 72 hours after unprotected sex as well as the efficacy of a single dose. The study will also compare the effectiveness of another widely available progestin to see if it might work as well as levonorgestrel does in the Yuzpe regimen. Family Health International (FHI) is fielding a study on the routine prophylactic use of anti-emetics to control the nausea and vomiting often associated with the Yuzpe regime. The USAID-funded study includes a placebo arm and will also examine the timing of symptoms in relation to treatment and the impact of food intake. Contacts: Charlotte Ellertson PhD Population Council One Dag Hammarskjold Plaza

New York, New York 10017 USA Tel: 1-212-339-0607 Fax 1-212-755-6052 Internet: cellertson@popcouncil.org Elizabeth Raymond Family Health International P.O. Box 13950 Research Triangle Park, North Carolina 27709 USA Tel: 1-919-544-0740 Fax: 1-919-544-7261 Internet: eraymond@fhi.org

STUDYING THE IMPACT OF ADVANCE SUPPLIES A number of organizations are studying the efficacy of emergency contraception when it is provided to women in advance of need, including women who rely for fertility control on a male partner's use of condoms. Dr. Anna Glasier, in Edinburgh, hopes to have results next Spring from a 1,000 women study comparing pregnancy rates among women given advance supplies and a control group of clients at the Dean Terrace Family Planning Centre. FHI will study the probability of pregnancy among condom users who get counseling and a packet of emergency contraceptive pills (the Yuzpe regimen) to keep at home in case of need, as compared to the probability of pregnancy among condom users who receive only counseling about the method. Secondary analysis will look at the consistency of condom use, frequency of ECP use and several acceptability issues. A WHO/HRP study on the use of male condoms alone, as compared with use of condoms backed up by levornorgestrel ECPs will enroll 3,000 subjects in two cities in China. The Population Council will test the efficacy of advance supplies at one site in India. (See Population Council contact information above). Contacts: Anna Glasier MD Director of Family Planning and Well Women Services Dean Terrace Centre Edinburgh, Scotland Tel: 44-131-343-6243 Fax: 44-131-332-2931 Elizabeth Raymond PhD Family Health International P.O. Box 13950 Research Triangle Park, North Carolina 27709 USA Tel: 1-919-544-0740 Fax: 1-919-544-7261 Internet: eraymond@fhi.org

Helena von Hertzen MD DDS WHO/HRP CH1211 Geneva 27 Switzerland Tel: 41-22-791-2111 Fax: 41-22-791-4171 Internet: vonhertzenh@who.ch

YUZPE AND LEVONORGESTREL COMPARED IN MULTICENTER WHO/HRP TRIAL WHO/HRP expects its large multicenter trial, comparing the standard Yuzpe regimen with two 0.75 mg doses of levonorgestrel, to run beyond its planned December 31 completion date. The total study will encompass 2200 women at 23 centers. The four Chinese centers and the three Nigerian centers have completed the study, but recruitment has been slow at many sites owing largely to the study's strict recruitment criteria. Centers without an established emergency contraception service have had the greatest enrollment problems. Other study sites are in Australia, Canada, Georgia, Hungary, Mongolia, Panama, Sri Lanka, Sweden, the United Kingdom and the United States. Interim analyses appear to support the results of a 1994 Hong Kong study showing the levonorgestrel regimen has comparable efficacy to the Yuzpe regimen, but much lower side effects. Only about 5% of women vomit, of the approximately 20% who become nauseous (compared to 20% and 50% in the Yuzpe regimen). If interim results continue to be borne out by additional data, levonorgestrel tablets could quickly become the new standard of care in most parts of the world. Contact: Helena von Hertzen, MD, DDS WHO/HRP CH1211 Geneva 27 Switzerland Tel: 41-22-791-2111 Fax: 41-22-791-4171 Internet: vonhertzenh@who.ch

RESEARCH ON MECHANISMS OF ACTION Family Health International( FHI) will study the mechanisms of action of the Yuzpe regimen in a study of 20 women over two menstrual cycles. The study will evaluate the effect of the standard ECP treatment on markers of endometrial receptivity. WHO/HRP will study mechanisms of action for levonorgestrel and mifepristone regimens in 60 women, also by looking at receptor markers.

Contacts: Elizabeth Raymond MD Family Health International P.O. Box 13950 Research Triangle Park, North Carolina 27709 USA Tel: 1-919-544-0740 Fax: 1-919-544-7261 Internet: eraymond@fhi.org Helena von Hertzen, MD, DDS WHO/HRP CH1211 Geneva 27 Switzerland Tel: 41-22-791-2111 Fax: 41-22-791-4171 Internet: vonhertzenh@who.ch

COUNTRY NEWS FROM AROUND THE WORLD PUBLICITY CAMPAIGNS BOOST LEVELS OF USE IN UNITED KINGDOM In some parts of the United Kingdom, knowledge of emergency contraception is now almost universal among young women, and use of emergency contraceptive pills has climbed steadily. In Edinburgh, a recent survey indicates that 98 percent of school girls have heard of emergency contraception and one-third report having used it. Sales of PC4 (commercially packaged ECPs) have more than doubled, from about 325,000 packets in 1992, to about 725,000 in 1995. Some providers continue to cut up packets of Ovran (Ovral) for use as emergency contraceptives, so the sales figures for PC4 understate actual use of the method. Observers credit much of the recent increase in knowledge and use in the United Kingdom to a series of national publicity campaigns sponsored by the Family Planning Association and the Health Education Authority, with support from the Brook Advisory Centres (specializing in reproductive health services for young people), the Birth Control Trust, the Royal College of Obstetricians and Gynecologists (RCOG) and other prominent medical and nursing associations. The campaign organizers have distributed information packs containing client brochures, posters, RCOG medical guidelines and other materials to thousands of UK health care providers. Extensive mass media coverage has, at the same time, greatly raised awareness among women of all ages. Contact: Toni Belfield, Director of Information Family Planning Association 2-12 Pentonville Road London N1 9FP, United Kingdom Tel. 44-171-837-5432 Fax 44-171-837-3042

NEW FRENCH ASSOCIATION FOR THE PROMOTION OF EMERGENCY CONTRACEPTION L'Association pour la Promotion des Methodes de Contraception d'Urgence has been formed in France under the direction of Dr. Elisabeth Aubeny, a leading gynecologist at the Hopital Broussais in Paris. The Association brings together physicians, pharmacists, family planning providers and demographers in order to advance research and mobilize the public and private sectors behind efforts to inform women and health care providers and evaluate new methods, such as those based on progestins or antiprogestins. The Association believes wider availability of emergency contraception in France could help reduce the need for abortion. Contact: Docteur Elisabeth Aubeny Hopital Broussais Batiment Maurice Raynaux 96 rue Didot 75014 Paris, France Tel/ Fax: 45-41-13-99

LARGE HMO TESTS EMERGENCY CONTRACEPTIVE SERVICES Kaiser Permanente of Southern California, part of one of the world's largest health maintenance organizations (HMO), and the Pacific Institute for Women's Health have allied to test the acceptability of emergency contraception among Kaiser Permanente's health care providers and clients at eight sites in San Diego County in Southern California. The project's tag line is: Once a secret; now an option". The HMO's pharmacy is repackaging Ovral as a dedicated "product" for use in the demonstration. Advocates of emergency contraception stress its cost-effectiveness in a managed care setting, but express concerns about accessibility. The San Diego project will, among other things, help identify barriers to use that might be unique to managed care settings. A baseline survey of providers was completed in August and provider training began in September. The study will run for 12 months, with a target of 400 clients. Both clients and providers will be interviewed in depth at the end of the project and an effort will be made to assess the impact on levels of unwanted pregnancy and abortion. Contacts: Diana Petitti MD, Director of Research Kaiser Permanente Walnut Center 393 East Walnut Street Pasadena, California 91188 USA Tel: 1-818-564-3460 Fax: 1-818-564-3430 Francine Coeytaux PhD, Marie Harvey PhD and Christy Sherman PhD

Pacific Institute for Women's Health 2999 Overland Avenue, Suite 218 Los Angeles, California 90064 USA Tel: 1-310-842-6828 Fax: 1-310-280-0600 Internet: piwh@aol.com

NEW US HOTLINE ON EMERGENCY CONTRACEPTION LOGS OVER 33,000 INQUIRIES In February, the Washington DC-based Reproductive Health Technologies Project launched a toll-free telephone information service on emergency contraception. The Emergency Contraception Hotline has already received over 33,000 calls. Some 4,000 calls were received in 24 hours following a 30-second news item about the Hotline on MTV -- a television program favored by American teenagers. The fully automated service operates 24 hours a day in English and Spanish and provides callers with information about all available methods as well as referral to health care providers in their calling area. Despite fears of attacks from conservative opponents, the Hotline has proved largely non-controversial. Sponsors report a total of only five hostile letters or calls. Contact: Marie Bass Reproductive Health Technologies Project 1818 N Street, NW, Suite 450 Washington, DC 20036 Tel: 1-202-530-2900 Fax: 1-202-530-2901 Internet: mbass@basshowes.com

MEXICAN ORGANIZATIONS LAUNCH PUBLIC EDUCATION EFFORT The US Hotline's success may soon be replicated in Mexico City, where the Population Council will adapt the technology and Spanish language script as part of a larger collaborative effort with MEXFAM and leading universities to educate health care providers and women about emergency contraception. Since oral contraceptives are available over the counter in Mexico, greater awareness among women could by itself result in a rapid increase in access to the method. But the Population Council/MEXFAM project, which is one of four model introduction programs sponsored by the Consortium for Emergency Contraception, also represents the first test of prospects for registering and marketing dedicated products for emergency contraception in the Latin American region. The Pacific Institute for Women's Health is sponsoring a similar demonstration project across the border in San Diego (see above) and will lend its expertise to aspects of the Mexico effort. Contact:

Ana Langer, Regional Director for Latin America The Population Council Apartado Postal 105-152 11560 Mexico, D.F. Mexico Tel: 52-5-280-1725 Fax: 52-5-281-0702 Internet: alangerpc@lanet.apc.org

RAPE VICTIMS IN MEXICO CITY TO GET INFORMATION ON ECPS Although early abortion is legal in Mexico in cases of rape, only 3% of the victims of sexual assault who get pregnant are referred for legal pregnancy termination. Many of these women could have avoided pregnancy if they had known about emergency contraception. Rape crisis intervention centers in Mexico will soon be in a position to provide help. As part of a 12-month demonstration project, staff at four agencies attached to the Attorney General's Office of the Federal District, which specialize in sexual crimes, will be getting counseling materials, training and medical protocols. So will staff at the Support Therapy Center and the Hotline for Victims of Sexual Crimes. Pending approval by the Ministry of Health, referral centers for rape victims may also be set up in selected pharmacies and Ministry of Health centers. Rape victims can already be referred to most drugstores for supplies of oral contraceptives suitable for use as emergency contraceptive pills. Contact: Ricardo Vernon The Population Council Apartado Postal 105-152 11560 Mexico, D.F. Mexico Tel: 52-5-280-1725 Fax: 52-5-281-0702 Internet: rvernon@popcouncil.org

FAMILY PLANNING GROUPS IN ECUADOR PLAN MAJOR DEMONSTRATION PROJECT Five organizations are collaborating in a 12-month operations research project in Ecuador to test alternative approaches to the delivery of emergency contraceptive services. The five partners are: Centro Ecuatoriano para la Promocion y Accion de la Mujer (CEPAM); Centro Obstetrico Familiar (COF), Centro Medico de Orientacion y Planificacion Familiar (CEMOPLAF), the Municipio of Quito, and the International Center for Research on Women (ICRW), which will support the project, with USAID funds, through the INOPOL project. Dividing the responsibilities among them, the organizations will: diagnose the climate for emergency contraception, including attitudes and barriers to access among key groups, such as adolescents

and rape victims; assess the knowledge and attitudes of providers; train staff in the partner organizations; develop and distribute informational materials; and, finally, assess the impact of these interventions within the different service delivery networks. The project expects to adapt materials for clients and providers developed by the Consortium for Emergency Contraception. Contact: Marjorie Macieira or Michael Paolisso International Center for Research on Women 1717 Massachusetts Avenue, NW Washington DC 20036 USA Tel: 1-202-797-0007 Fax: 1-202-797-0020 Internet: mpaolisso@icrw.org

CONSENSUS DOCUMENT EMERGES FROM BRAZIL MEETING In March, 28 specialists, representing a wide range of disciplines (research, law and policy, medicine, ethics, women's rights and communications) gathered in Brazilia to define the appropriate place for emergency contraception in Brazil's reproductive health agenda. The Brazilian Ministry of Health attended and was supportive of the initiative, which was funded by the Population Council as a follow-on to the 1995 consensus meeting in Bellagio. The Brazil consensus document which emerged from the three-day meeting calls on the Ministry to adopt new technical guidelines on emergency contraception and makes recommendations on the choice of methods, target populations, service delivery and access issues, public information and education about the method and research needs. Contact: Charlotte Ellertson, PhD Population Council One Dag Hammarskjold Plaza New York, New York 10017 USA Tel: 1-212-339-0607 Fax 1-212-755-6052 Internet: cellertson@popcouncil.org

MULTI-COUNTRY STUDY LOOKS AT ECP ACCEPTABILITY IN LATIN AMERICA The Mellon Foundation has provided support to WHR/HRP for a multi-country study of ECP acceptability in Latin America. The study will start in Brazil and Chile at the end of 1996. It will include focus groups of women at risk of abortion, adolescents, mothers of adolescents, health care providers and medical educators, elected officials and religious leaders. Results will be used in the Latin American region. Soledad Diaz MD

Instituto Chileno de Medicina Reproductiva J.V. Lastarria 29 Depto 101, Casilla 6006 Santiago, Chile Tel: 56-2-633-6204 Fax 56-2-633-6204

KENYA CONSORTIUM FOR EMERGENCY CONTRACEPTION LAUNCHED Officials from the Ministry of Health and the OB/GYN Department of Kenyatta University joined representatives of more than a dozen non-governmental organizations for the official launch of the Kenya Consortium for Emergency Contraception. The Consortium, members of which have been meeting since early June, will soon sponsor a model introduction of emergency contraceptive pills at twelve sites in the Nairobi City area. A baseline survey of attitudes and practice (see below) was completed in September; training for health care providers is scheduled to begin in late November or early December. Drug regulatory authorities are expected to approve the Gedeon Richter product, Postinor-2, in time for the start of the introductory trials. Postinor was registered for postcoital contraception in Kenya in 1992. The project is one of four model introductions supported by the international Consortium for Emergency Contraception. Kenya staff for Pathfinder International, PATH and other partners in the international Consortium are assisting the effort. The coalition of Kenyan organizations and agencies includes; The University of Nairobi Department of Obstetrics and Gynecology; Ministry of Health Division of Family Health, Nairobi City Council; Kenyatta National Hospital, High Risk Clinic; Kenyatta University; Ergerton University; Family Planning Association of Kenya; Mkomani Clinic Society; Reproductive Health Services and Population Health Services. Contact: Nelson Keyonzo, Country Representative Pathfinder International P.O. Box 48147 Nairobi, Kenya Tel. 254-2-224-154 Fax 254-2-214-890 Internet: nkeyonzo%6381752@mcimail.com

KENYA SURVEY SHOWS HIGH LEVELS OF APPROVAL BUT LOW LEVELS OF KNOWLEDGE FOR ECPS In September, the Population Council conducted interviews on emergency contraception with key Kenyan policymakers, 68 health care providers, and 282 clients at ten family planning clinics in Nairobi, in order to determine current levels of knowledge, attitudes and practice. Focus groups were also conducted with male and female students at two leading Kenyan universities. These studies will be repeated following an 18-month model introduction to

determine the impact of a dedicated product and public education effort (see Kenya Consortium above) on attitudes and levels of appropriate use. The baseline data show widespread approval for the concept of an emergency contraceptive pill, but little knowledge or use of the method. Policymakers were uniformly positive about introducing the method in Kenya, although they expressed concern about opposition from some quarters. Health care providers also overwhelmingly approved the concept, but only 35 % had knowledge of existing regimens, and only 5% currently offer the method to clients who have had unprotected intercourse. Knowledge among women is very low. Only 11% had ever heard of emergency contraception and most had no knowledge of existing methods. Over 60 % of the family planning clients surveyed thought there was nothing a woman could do to avoid pregnancy after a contraceptive accident or unprotected intercourse. But 80 % approved of emergency contraceptive pills after being told about the method. Most thought Kenyan women would pay for the method if they were convinced that it was safe and effective. For additional information about the survey, contact: Ester Muia, MD The Population Council Multichoice Towers, Upper Hill P.O. Box 17643 Nairobi, Kenya Tel: 254-2-716-958 Fax: 254-2-713-479 Internet: emuia@popcouncil.org

ZAMBIAN GOVERNMENT MANDATES USE OF EMERGENCY CONTRACEPTION Reacting in part to a needs assessment conducted recently with WHO/HRP, the Zambian government has mandated the provision of emergency contraceptive pills at all levels of the health system. The move is part of a larger effort to reduce the incidence of abortion. The British Overseas Development Agency (ODA) has purchased 50,000 packets of PC4 for use in the Zambian national program -- the first such purchase by a major donor agency. The supplies will be used in an introductory study sponsored by WHO/HRP in selected areas of the country and designed to expand the range of contraceptive methods available. Contact: Peter Hall WHO/HRP CH-1211 Geneva 27 Switzerland Tel: 41-22-791-2111 Fax: 41-22-791-4171 Internet: hallp@who.ch

INTRODUCTORY STUDY IN SOUTH AFRICA EXPANDS ACCESS TO BARRIER METHODS AND EMERGENCY CONTRACEPTION An introductory study involving emergency contraception in three South African provinces (Gauteng, North-West and Northern Province) was recently launched with support from WHR/HRP. Like the Zambia project, this one is part of an effort to broaden available contraceptive choices, in particular to increase use of barrier methods which provide some protection against STD transmission. Tandem provision of barrier methods and emergency contraception is considered a potentially attractive alternative to dual method use among couples at risk of both STDs and unwanted pregnancy. The study will examine user attitudes and current practice as well as service delivery requirements. Materials from the Consortium for Emergency Contraception may be adapted for use in the project. Contact: Helen Rees MD or Elizabeth Cravey Reproductive Health Research Baragwath Hospital, Soweto P.O. Bertsham 2013 JHB, South Africa Tel: 27-11-407-7441 or 407-6780 Fax: 27-11-403-3214

TANZANIA ECP PROJECT PART OF CAMPAIGN TO REDUCE UNSAFE ABORTION In August, 30 participants from the Ministry of Health, UMATI (the IPPF affiliate in Tanzania), other non-governmental organizations and private sector representatives attended a contraceptive technology update seminar conducted by specialists, Dr. Pramilla Senanayake, Assistant Secretary General of IPPF and Dr. Miriama Barry of the IPPF Africa Regional office. The wide-range of participants, including lawyers, OB/GYNs, women activists, university peer counselors, and members of parliament support greater availability of ECPs and are expected to play a part in UMATI's planned launch early next year of emergency contraceptive services. The program will be part of a broader national effort to reduce the incidence of unsafe abortion. A baseline survey is currently underway and, following the adaptation of materials from the Consortium for Emergency Contraception, provider and peer counselor training will begin in February or March of next year. Service delivery will begin in March and will be evaluated beginning next December, with results to be available early in 1998.

PHARMACISTS IN VIETNAM A MAJOR SOURCE OF ECPS Experience in Vietnam suggests that pharmacists can play a major role in the provision of emergency contraceptive services and counseling, but that most need training. Assessments made recently by the Population Council, Pathfinder International and other agencies show high levels of ECP pharmacy sales, combined with considerable misuse of the method. The

Population Council assessment, for example, found that some pharmacists were selling a four-pill packet of Postinor (labeled for postcoital use up to four times a month) as a weekly oral contraceptive. Postinor and combined oral contraceptives are available over the counter in Vietnam. A recently completed Pathfinder multi-site training program for 300 pharmacists demonstrates the impact of modest investments in training. The percentage of pharmacists responding correctly to questions regarding appropriate use, timing, and (lack of) contraindications increased from 13-40% to 90-96%%. Follow-up evaluations, using "mystery clients," indicate that most trained pharmacists are now providing women with the information they need to make safe, effective use of emergency contraception, although some confusion over effectiveness rates remains. Many pharmacists are also not advising women about regular methods of contraception -- a problem Pathfinder hopes to correct in future training sessions. The information package developed for the project includes a manual for trainers, a shorter manual for providers to keep on hand, counter-top flipcharts and pamphlets for clients and preprinted envelopes with instructions for dispensing ECPs. The training program in Vietnam also served as a pretest for the training manual being distributed by the Consortium for Emergency Contraception. Contact: Katherine L. Bourne, Resident Advisor Pathfinder International No. 2, C11 Giang Vo Hanoi, Vietnam Tel: 84-4-8-460807 Fax: 84-4-8-460806 Internet: kbourne%6381752@mcimail.com

INDONESIA PLANS LARGE-SCALE MODEL INTRODUCTION In late August, some 30 Indonesian health and family planning leaders met at the National Family Planning Coordinating Board (BKKBN) to discuss possible plans for a model introduction program at 12 sites in six provinces. The project is supported by the Consortium for Emergency Contraception. The Indonesian Planned Parenthood Association will provide most of the sites, but a broad range of government, professional and family planning organizations are likely to be involved in some aspect of the program, including the Indonesian Society of Obstetricians and Gynecologists. A baseline study by WHO/HRP is tentatively scheduled before the end of the year, with materials adaptation and training to take place shortly thereafter. Services will start next year as soon as Postinor-2, or another dedicated product is registered and available in the country. Contact: Does Sampoerno MD, Resident Advisor Pathfinder International

Permata Plaza, Building 10th Floor Jakarta 10350, Indonesia Tel: 62-21-390-3304 Fax: 62-21-390-3302 Internet: dsampoer%6381752@mcimail.com

FAMILY PLANNING ASSOCIATION OF SRI LANKA TESTS DEDICATED PRODUCT Concern over an estimated 250,000 illegal abortions each year in Sri Lanka has created substantial momentum behind efforts to make emergency contraception more accessible in Sri Lanka. Some health care providers and women already know about the method as a result of the Family Planning Association's education efforts over the last four years. But usage is still relatively low: only 140 to 150 clients a year request emergency contraception at the Association's main Colombo clinic. Moreover, the current practice of cutting up monthly packets of pills has led to confusion about the regimen. Dr. Sriani Basnayake, Medical Director, reports that clients counseled over the phone have mistakenly taken two doses of the placebo iron tablets packaged with some oral contraceptives for use in the pill-free week. Leading practitioners believe that the planned introduction of a Postinor-2, under the sponsorship of the Consortium for Emergency Contraception, will help ensure safe and effective use. Contacts: Daya Abeywickrema, Executive Director Family Planning Association of Sri Lanka P.O. Box 365 37/27 Bullers Lane Colombo 7, Sri Lanka Tel: 94-1-584-153 or 584-157 Fax: 94-1-580-915 Pramilla Senanayake MD, Assistant Secretary General Carlos Huezo, Medical Director International Planned Parenthood Federation Regent's College, Inner Circle Regent's Park, London NW1 4NS United Kingdom Tel: 44-171-487-7864 Fax: 44-171-487-7865 Internet: psenanay@ippf.attmail.com chuezo@ippf@attmail.com


				
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