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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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