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The Emergency Contraceptive Newsletter Spring 1999 Vol. 4, No. 1 ABOUT
THIS NEWSLETTER
This
newsletter is prepared and distributed as a voluntary activity on behalf
of the American Society for Emergency Contraception and the
international Consortium for Emergency Contraception. It is distributed
electronically twice each year to anyone who wishes to receive it. To
contribute a news item, please send it to Charlotte Ellertson
(cellertson@mpsnet.com.mx) or to Kelly Blanchard (AmSocEc@aol.com).
Annik Sorhaindo (asorhain@mpsnet.com.mx) is currently the editor of the
newsletter. We reserve the right to check and edit items as appropriate.
To join or remove your name from the newsletter circulation list, 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 option of emergency
contraception for women. Founded in 1997, ASEC has four mandates: 1) to
serve as a source of information for the media and others who want
information on emergency contraception; 2) to serve as a watchdog for
inaccurate 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 and disseminate the statements and guidelines of other
organizations willing to endorse the method; and 4) to link the members
of the emergency contraception field, primarily by sending out (in
collaboration with the international Consortium on Emergency
Contraception) this semi-annual electronic newsletter on recent events
in emergency contraception and by organizing an annual meeting (hosted
on the first Friday in October by Population Council in New York) to
share information with researchers, policy makers and the pharmaceutical
industry. ASEC
is open to industry participation, although it will not endorse one
method 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 Charlotte Ellertson (Population Council), James Trussell
(Princeton University), Kirsten Moore (Bass and Howes), Laneta
Dorflinger (Family Health International), Allen 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 international collaboration
among eight organizations committed to making a dedicated product for
emergency contraception a standard part of reproductive health care
around the world. Member organizations are: The Concept Foundation
(Bangkok); International Planned Parenthood Federation (London); Pacific
Institute for Women's Health (Los Angeles); Pathfinder International
(Boston); Population Council (New York); Population Services
International (Washington, DC); Program for Appropriate Technology in
Health (PATH); and UNDP/UNFPA/WHO/World Bank Special Programme of
Research, Development and Research Training in Human Reproduction
(Geneva). The
Consortium will fulfill its original mandate by mid-1999. At that time,
given the enthusiastic response to emergency contraception around the
world, and the increase in the number of organizations engaged in
introducing this method, the Consortium will welcome new members
interested in working together to ensure a coordinated introduction of
emergency contraception worldwide. For
information about the Consortium, please contact any of the member
organizations. To obtain Consortium materials, contact the Consortium
Coordinator, Elisa Wells, 3224 Purdue Street, Anchorage, AK 99508.
Phone/fax: (907) 279-2055. E-mail: elisa@alaskalife.net. PRODUCT
NEWS FDA
Accepts Women's Capital Corporation's Application for Levonorgestrel
Emergency Contraception In
March, the Women's Capital Corporation (WCC) announced that the FDA had
completed its initial review of the New Drug Application submitted for a
levonorgestrel-only regimen of emergency contraception. WCC announced
that the application would be reviewed within six months or less, making
the target United States approval date July 28, 1999. The WCC hopes to
launch the product immediately after approval. The product consists of
two 0.75 mg tablets of levonorgestrel. The first dose is to be taken
within 72 hours of unprotected sex and the second dose to be taken 12
hours later. Clinical data on approximately 15,700 women who have used
levonorgestrel for emergency contraception were included in the
application. The WCC has been dedicated to bringing the "second
generation" emergency contraception product to the United States
and Canada since 1997. Contact: Gynetics,
Inc. Hopes to Bring Levonorgestrel-only ECPs to the Market within a Year
Following
the introduction of PREVENÔ, a dedicated EC product employing the Yuzpe
regimen, the product's manufacturer, Gynetics, Inc. has been working to
bring a levonorgestrel-only emergency contraception drug to the market.
Studies show that levonorgestrel-only EC regimens are at least as
effective and produce less side effects than Yuzpe. Gynetics hopes to
release its levonorgestrel-only product late this year or early in 2000.
Contact: Increase
in Demand for EC with the Introduction of PREVENÔ In
the three months that the first specially packaged product approved for
emergency contraception in the U.S. has been on the market, 1.3 million
kits have been sold. Sales of PREVENÔ have increased at family planning
clinics, inner-city medical facilities and college health centers. For
example, Penn State University reported a 57% increase in the number of
patients requesting EC since the product's release. The number of
requests have doubled at Planned Parenthood clinics. Planned Parenthood
believes the availability of a dedicated product has raised awareness of
emergency contraception. Contact: Nigeria's
Society for Family Health Works to Increase Access to Postinor 2
The
Society for Family Health (Population Services International's Nigerian
affiliate) has entered into an agreement with Gedeon Richter's Nigerian
distributor, Interscavon, to increase access to Postinor 2. Beginning in
April 1999, Postinor 2 is being phased in to replace Postinor 10 pill
packs, and will be integrated into SFH's existing contraceptive line
including condoms, pills and injectables. PSI is currently seeking
funding to initiate a small promotion and training component, based on
findings from baseline and feasibility studies conducted in 1997-98. In
collaboration with Pathfinder, SFH intends to include EC in training for
approximately 400 providers. Concurrently, SFH plans to sponsor an event
to increase awareness of Postinor 2 and stimulate demand among
retailers, distributors and providers. To address concerns of correct
usage, SFH will develop a product insert to convey dosage and timing
instructions to low literacy audiences. PSI/SFH believe that these
educational materials will be applicable for use in other EC social
marketing programs. Contact: Venezuela
Awaits the Approval of Postinor-2
Apprende
(a division of PROSALUD) has completed the submission of the application
for registration of Postinor 2 in Venezuela. Apprende awaits the
imminent approval of the application in order to launch Postinor 2 as
soon as possible. Apprende, an affiliate of PSI, began its EC program by
training a network of providers, who are now well informed about the
correct use and prescription of EC. With this training, the network has
evolved into an advocacy coalition to support the registration and
ensure that women have access to EC when and where they need it. Contact: Preferential
Public Sector Pricing Negotiated with Gedeon Richter
Consortium
for Emergency Contraception members have negotiated a public sector
pricing agreement with Gedeon Richter, the Hungary-based manufacturer of
Postinor-2. This preferential price is available to public sector
agencies in selected countries worldwide (the agencies need not be
Consortium members). Agencies desiring assistance with Postinor-2
registration and procurement should contact the Consortium Coordinator. Contact: COUNTRY
UPDATES United
States: EC
and Mifepristone Cut from the North Carolina Bill that Would Mandate
Insurance Coverage for Prescription Contraceptives The
North Carolina State Senate recently attached an amendment to the bill
requiring insurers who provide prescription drug plans to cover
prescription contraceptives. The amendment excludes emergency
contraception and mifepristone from being eligible for coverage. The
bill's supporters argue that its intent was only to create equity in
health coverage and not to mandate coverage for what they called potent
drugs. The North Carolina senate previously approved the unamended bill,
but it is still under review in the House committee. Contact: Selected
US Pharmacies Refuse to Dispense EC
Many
pharmacists around the country are refusing to fill prescriptions for
the emergency contraception pill kit, PREVENÔ. Many are still not clear
about the drug's mechanism of action and mistakenly consider it an
abortafacient. Although most pharmacy chains do carry PREVENä, the
second largest pharmacy chain in the United States, Wal-Mart, released a
memo to its pharmacists prohibiting them from stocking, ordering or
dispensing PREVENä. Planned Parenthood of New York City is calling for
a boycott of all Wal-Mart stores until their policy is changed. They are
also asking for help in urging Wal-Mart to change its policy though
letters and emails. Representatives of the Pharmacists' Association
support the right of pharmacists to refuse to fill prescriptions, but
feel there should be a system of referral for customers requesting the
service. Contact: New
Jersey Considers Legislation to Give Pharmacists the Right to Refuse to
Fill Prescriptions for EC
New
Jersey legislators are currently working to create a law that would give
pharmacists the legal right to refuse to fill prescriptions based on
religious, moral and ethical beliefs. Support for the law came in
response to the release of PREVENä last year and the expected FDA
approval of mifepristone for medical abortion. Many pharmacists are
refusing to fill prescriptions for PREVENä and want to have the legal
right to refuse to distribute any drug that is not in line with their
personal beliefs. To counter this movement, The ProChoice Resource
Center has recently launched Pharmacists for Choice. They hope this new
organization will provide pharmacists who are willing to dispense EC to
almost every pharmacy in the country. Louisiana
Rejects Conscience Clause Bill
A
Louisiana House committee recently rejected a bill that would have given
pharmacist the right to refuse to fill prescriptions for drugs that are
against their personal or religious beliefs. The bill would have
protected unwilling pharmacists from being required to dispense
medication used for emergency contraception. Representatives opposing
the bill are satisfied that the result prevented creating a new barrier
for women who are need of the therapy. Contact: Pharmacists
Tell Clients to call 1-888-NOT-2-LATE When Unable to Provide Emergency
Contraception Services
The
ProChoice Resource Center recently analyzed The American Pharmaceutical
Association's statement on their emergency contraception policy. The
policy gives pharmacists the right to refuse services, but emphasizes
their obligation to meet their patient's need. It suggests that
pharmacists who do not wish to dispense EC provide other sources of
information to women requesting the therapy. The hotline
1-888-NOT-2-LATE, created and maintained by Princeton University in
conjunction with the Reproductive Health Technologies Project, is given
as an example of one source of information. While it is a positive
compromise, time lost while searching for access to the time-sensitive
drug remains a concern. Contact: Doctors
in Oregon Vote to Allow Pharmacists to Dispense EC Directly
The
Oregon Medical Association House of Delegates recently voted to approve
a resolution that would allow for pharmacists in seven Oregon Counties
to establish a direct-pharmacist program modeled after the Washington
State project. These pharmacists would be required to inform physicians
of the prescription and recommend that women see their physicians. Some
physicians challenged the program arguing that pharmacist are not
trained to provide information on STDs. The House of Delegates reviewed
this concern and ruled that the program is beneficial to women who can
not see their doctors within 72 hours. Contact: Education
for Adolescents on EC through "Dr. Drew"
Co-host
of the popular MTV show LOVELINE, Dr. Drew Pinsky, is sponsoring the
construction of a new website that will include a focus on emergency
contraception. The MTV show and the KROQ radio program, LOVELINE is
popular among the under-thirty crowd. "Dr. Drew" says he hopes
to improve knowledge about EC in this population. Contact: Mexico:
01-800-EN-3-DIAS:
National Hotline and Website Launched in Mexico The
Population Council's Latin America and Caribbean office has launched a
toll-free, 24-hour telephone hotline and developed a corresponding media
campaign to spread information about EC. The hotline can be reached from
anywhere within the Mexican republic by dialing "01-800-
EN-3-DIAS," meaning "in three days." The hotline opened
on February 14 of this year, and has received nearly 1000 calls to date
in spite of the absence of widespread advertising. Once
government approval is obtained, the Population Council plans to launch
a mass media campaign to advertise the hotline. Ads will appear in
subways, in magazines, and on television. The campaign is scheduled to
begin on May 26th with a press conference organized to include over 100
local journalists and mass media personnel. The
Population Council has also established an EC website in Spanish,
www.en3dias.org.mx. Currently the website is set up to provide general
emergency contraception information with examples from Mexican campaigns
and current EC news to a Spanish-speaking audience, and then link
internet users to other sites where more or different EC information is
posted. The website will soon be expanded to cover all countries in
Latin America and the Caribbean. Contact: Pakistan:
PSI
Hopes to Bring a Dedicated EC Product to Pakistan PSI
and its affiliate, Social Marketing Pakistan, have initiated plans to
introduce a dedicated EC product in Green Star clinics. In coordination
with the IPPF affiliate, PSI/SMP currently train providers from its
network of reproductive health clinics that are marketed under the Green
Star logo. This EC pilot project will enable over 2000 Green Star
clinics to inform clients about EC and also make it available to them.
PSI/SMP are in discussions with the Gedeon Richter distributor to design
the most appropriate packaging for the dedicated EC product. Contact: Canada:
Society
of Obstetricians and Gynecologists of Canada (SOGC) Petitions for OTC EC
In
a guide released last year, the SGOC outlined recommendations for
contraceptive use for Canadians. The guide includes a chapter and a
consensus statement on emergency contraception that included a provision
for over-the-counter use. The SGOC has recently taken the next step to
OTC by petitioning the Health Protection Branch of the Canadian
government to change the status of emergency contraception from
prescription to non-prescription. Their petition is supported by many
Canadian and world health organizations including the WHO. Although they
realize the change in policy will take time, they are confident that the
Canadian government will support the change. Uganda:
Program
to Introduce Dedicated EC Product to Uganda USAID
has requested that the new Commercial Market Strategies project (CMS)
introduce emergency contraception in Uganda. Under the auspices of CMS,
in March 1999 Population Services International (PSI) conducted a
feasibility study for the launch of an EC social marketing program in
early 2000. Pathfinder International has coordinated several meetings
with the Government, while PSI led focus groups among women of
reproductive age in order to gauge their knowledge and awareness of EC
as well current practice with EC. Based on these findings, PSI will
design a program to introduce a dedicated EC product in clinics. The
product will be supported by a training and promotion program to
heighten awareness and encourage correct prescription and use of EC. In
addition to making EC available and accessible to Ugandan women, PSI is
in discussions with several organizations to design a research agenda to
test the impact of EC social marketing on condom and other contraceptive
use. Contact: RECENT
OR UPCOMING MEETINGS Cairo
Plus Five: Vatican calls Emergency Contraception Abortion and Warns
against Use in Family Planning Programs Following
the Hauge Forum, concerned to assess the progress since Cairo, the
Vatican released a statement cautioning members against implying a right
to abortion while promoting access for women to family planning
services. In this statement, Vatican representatives mistakenly consider
emergency contraception abortion. Family planning advocates responded by
explaining that it has been widely accepted in the medical society that
emergency contraception is not abortifacient and that this
misunderstanding can result in limiting safe family planning options for
women around the world. Contact: Workshop
on Expanding ECP Access to be held in Washington State
PATH
is hosting a three-day workshop to expand emergency contraception access
through collaborative drug efforts. In the past two years, organizations
in Washington state who support EC have been collaborating with health
professionals and state officials to provide a program where women
receive ECPs directly from their pharmacists. The program's success has
sparked an effort to encourage other states to create such agreements.
The workshop is designed to assist health care professionals and
legislators in working together to establish similar programs in other
states. The workshop will be held May 3rd to 5th in Seattle, Washington.
Contact: EC
Consortium Welcomes New Members to September Meeting
Starting
in September 1999, the Consortium will welcome new members who share the
Consortium's overall goal of expanding access to and safe and
appropriate use of emergency contraception worldwide, with emphasis on
developing countries. Membership is limited to non-commercial
organizations. Key functions of the new Consortium will include: ·
Advocating for expanded access to EC ·
·
Setting medical and service delivery standards for EC ·
·
Facilitating registration and procurement of a dedicated product
for EC [Note: While expanding access to a dedicated product has
historically been one focus of the Consortium, activities of members
organizations are in no way limited to use of such a product.] ·
The
first meeting of the expanded Consortium membership will be held
September 29-30, 1999 in New York. Agencies interested in joining the
Consortium should request an application form from the Consortium
Coordinator. Contact: ASEC's
5th Annual Emergency Contraception Meeting in New York City
On
October 1st 1999, ASEC will host the 5th annual Emergency Contraception
Meeting in New York. For notes and a list of attendees from last year's
meeting please contact Joe Harris at the Population Council. Contact: NEW
MATERIALS Family
Health International Produces Module for Educating Health Professionals
About EC Family
Health International (FHI) has designed a presentation including slides,
a narrative, handouts and reprints of significant studies, to educate
health care professional about ECPs. The module is targeted to inform
physicians, nurses, medical students, program managers and policy-makers
on counseling methods, program issues and procedures regarding the use
of ECPs. It is available in English but is also currently being prepared
in French and Spanish. Contact: Association
of Reproductive Health Professionals Hopes to Raise Awareness of EC
Through "Train-the Trainers" Program
With
help from the David and Lucile Packard Foundation, the Planned
Parenthood Federation of America and the Reproductive Health
Technologies Project, the Association of Reproductive Health
Professionals (ARHP) is sponsoring a program to educate health care
providers on emergency contraception. The program titled,
"train-the-trainers", consists of a curriculum that offers a
variety of workshops aimed at raising awareness of the clinical and
legal issues surrounding EC. Contact: Translated
EC Consortium Materials now Available Many
of the Consortium's information and advocacy materials, including
medical and service delivery guidelines, prototype client materials, and
guidance on training and introduction strategies, are now available
on-line (at http://www.path.org/cec.htm) in English, French, and
Portuguese. Spanish materials will be posted in May 1999. Contact: Client
Materials on EC for Diverse Audiences on the World Wide Web
PATH
has produced a booklet containing two sets of materials: a brochure
called Emergency Contraception: It's Not Too Late To Prevent Pregnancy
and instructions for use of emergency contraceptive pills. The brochure
is designed to increase people's awareness and provide a simple
explanation of emergency contraception, how it is used, possible side
effects, and where to get it. The information sheets are individual
instruction sheets that provide simply written, detailed information on
different brands of oral contraceptives that can be used for emergency
contraception, when and how to take the pills, the correct doses, and
possible side effects. The brochures and instructions for use are
prototype materials designed to be photocopied directly from the master
copy. They can also be adapted as needed. No permission is needed to
copy or adapt them. Each set of materials is available in thirteen
different languages, including Amharic, Arabic, Cambodian, Chinese,
English, Haitian-Creole, Korean, Laotian, Portuguese, Russian, Somali,
Spanish, and Vietnamese. Contact: RESEARCH
RESULTS AND UPDATES Emergency
Contraception and Post-Exposure Prophylaxis Suggested as a Part of
Post-Rape Counseling In
the March issue of American Journal of Medicine, guidelines were issued
for treatment of victims of sexual assault. The guidelines suggested
that in addition to traditional counseling, victims should be provided
with post-exposure prophylaxis (PEP) for HIV and emergency
contraception. Although PEP entails many important differences from EC,
several issues raised by it are similar to those confronted by EC. For
this reason, supporters of PEP represent another group of advocates for
increasing awareness and availability of EC for victims of sexual
assault and for women who have experienced a contraceptive failure. Contact: Recent
Survey Shows Lack of EC Knowledge among NYC Pharmacists
Volunteers
to the Planned Parenthood of New York City recently called 100 NYC
pharmacists (from each borough of New York City) with questions about
emergency contraception. Thirty-seven pharmacists called had no
knowledge of EC. Of the sixty-two of those pharmacists who had some
knowledge of EC, 26 did not recognize the term "emergency
contraception" until further prompted. About two-thirds of the
pharmacists gave some incorrect information about EC. Eleven pharmacists
said the method was illegal or not available. Four said EC was abortion
and only twelve correctly identified the time frame in which EC must be
taken. The PPNYC plans a campaign to increase education and awareness of
EC among pharmacists. The PPNYC will take three approaches to educating
this population: provide educational materials to each pharmacy polled
in the survey; partner with professional trade associations to offer
education opportunities for its members; contact pharmacy schools in New
York and to offer educational workshops and seminars. Contact: Mifepristone
Effective for EC in Range of Doses February's
Lancet contains the results of a WHO study reporting that mifepristone
is equally effective in preventing pregnancy when taken in doses of 600
mg, 50 mg or 10 mg. The drug can be taken up to 120 hours after
unprotected intercourse. The study took place at family planning clinics
in six countries. Over 1700 women participated in this randomized
double-blind trial. The failure rate for each group was about 1.2% and
the women experienced no major side effects except a dose-related delay
in next menses. Contact: The
Sooner the Better: Yuzpe and Levo-only Regimens of EC Are Most Effective
Within 12 hours of Unprotected Sex
A
research letter from WHO published in February's Lancet reports that
emergency contraception works better the sooner it begins after
unprotected sex. The study found that with both levonorgestrel-only and
Yuzpe regimens when treatment was given between 61 and 72 hours
following intercourse rather than 12 hours after, pregnancy rates more
than doubled. Contact: US
Catholic Hospitals Turn Away Women Seeking EC
Washington
DC-based Catholics for a Free Choice conducted a telephone survey of 589
Catholic-run hospitals asking the question, "Can I get emergency
contraception?" Eighty-two percent of those hospitals said they do
not provide women with emergency contraception even if the woman had
been raped. More disturbing is that fully one-third of hospitals
surveyed refuse to refer women to other facilities even upon request. A
further 47% withhold the telephone numbers of the referred sites, even
though they do refer when requested. The results of this survey and many
others aimed at accessing the availability of emergency contraception in
Catholic-run hospitals are detailed in Caution: Catholic Health
Restrictions May be Hazardous to Your Health. The report was released in
March of this year and includes information on the EC policies of
Catholic-run hospitals in every state in the U.S. Contact: Research
in Zambia to Assess the Quality of EC Services
Two
studies underway in Zambia are testing the quality of the country's EC
services. The first study compares distributing EC directly with
providing a pre-printed prescription that could be filled as needed.
Researchers are comparing the strategies' effectiveness in communicating
appropriate information, facilitating timely access and limiting the use
of pills for emergencies only. Preliminary findings suggest that both
strategies are effective in conveying information on EC. Although,
providing pills directly seem to enhance access, there is concern that
this strategy may encourage women to abandon their regular contraceptive
methods. The second study compared use of Postinor-2 with PC-4.
Researchers are finding that women experience less vomiting and nausea
with Postinor-2 Contact: Reaching
Diverse Communities with Information on Emergency Contraception
PATH
recently initiated a pilot to train medical and social service providers
serving diverse communities. The project includes special training for
pharmacists who counsel diverse client populations on EC and ongoing
contraception. The two-year project will coordinate efforts with
community health and social service agencies and state agencies in an
effort to reduce unintended pregnancy by three per cent each year. The
project will also coordinate with the federal Department of Health and
Human Services, Region X, to help ensure the materials and approach will
be used in Alaska, Idaho and Oregon. In addition, PATH will collaborate
with agencies in other states including the Massachusetts State
Department of Health, Planned Parenthood of New York, the Academy for
Educational Development's Adolescent project in Harlem, New York and
Planned Parenthood in Washington, DC. Project outcomes will include:
increased awareness of EC in diverse communities through the development
of media and promotional materials; EC training curriculum designed for
private and public medical and social service providers; establishment
of a core of master trainers; training sessions conducted with a range
of providers, and training in interpersonal communication and counseling
skills for pharmacists. Contact: |
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