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Emergency Contraception

Product Profile

Emergency Contraception

Potential Lives Saved/Year:

If unmet need for modern methods were fully satisfied, an estimated 53 million unintended pregnancies would be avoided, ~ 90,000 women’s lives would be saved and ~590,000 newborn deaths would be averted¹

 

Read the full case study (PDF)


Problem and Proposed Intervention


Sexually-active women of reproductive age in developing countries experience high rates of unintended pregnancy. According to the Guttmacher Institute, nearly 90 percent of the estimated 208 million pregnancies in 2008 occurred in the developing world. Globally, 86 million pregnancies were unintended; of these, 41 million ended in abortions, 33 million in unplanned birth, and 11 million in miscarriage. When women and couples can access a wide range of contraceptive methods, they are more likely to find a method they like and can use over a period of time, to switch methods when life circumstances change, and to meet their contraceptive intentions. Even among those who currently use contraception, many who would like to have no more children have no access to long-acting and permanent methods. Similarly those who are at risk of HIV/AIDS or other sexually transmitted infections (STIs) too often do not have access to the means for prevention of both infection and pregnancy. Youth, in particular, must overcome significant barriers to access contraception that meets their needs and vulnerability to unprotected sex.  Among investments in public health, those made to ensure access to contraceptive supplies and services are proven to result in significant improvements in the health of women and children. The 603 million women who currently use modern contraception in developing countries, combined with the 215 million women with an unmet need for modern contraception, attest to the need and desire for contraceptive services and related commodities overall.  Three main reproductive health products have long been classified by the Coalition’s Caucus on New Underutilized Methods as being “underutilized:” emergency contraception, female condoms and contraceptive implants.  As a group, the three serve as a bellwether for identifying opportunities for improving access, use and effectiveness of family planning and for meeting Millennium Development Goal 5b—universal access to reproductive health.


  Emergency Contraception (EC) product characteristics:


Drug:

levonorgestrel

Proposed Indication:

avoid pregnancy following unprotected intercourse

Formulation2:

Tablet: 1.5 mg; 750 micrograms (pack of two); 30 micrograms

Dose:

One dose of 1.5 mg, as soon as possible after unprotected sexual intercourse.

Avg. Cost:

Pack of 2(POSTINOR)- US$ 0.25 (UNFPA Price)


Read more below.



Initial Findings from Product Case Study Working Paper

 

* Note: The strengths and challenges outlined below are initial findings from a longer working paper developed to analyze the current global situation of each product.  The findings are presented below to catalyze further thinking and discussion in order to finalize a list of issues and recommendations. The full working paper texts are forthcoming.

 

 

 

Strengths

Challenges

Policy and Regulation

 

 

Global

* EC is included as part of the WHO EML2 [1] and is included in norms, protocols and guidelines issued by global organizations such as the International Federation of Gynecology and Obstetrics (FIGO).

* Inadequate knowledge and information regarding EC in most developing/underdeveloped countries.

National, Regional

* An EC product is registered in most developing and developed countries.

* EC is safe and appropriate for dispensing without a prescription by a pharmacist or drug seller.

* Currently, it is registered as a non-prescription product in over 50 countries, including many lower income countries.

 

* Where a product is not registered, it is generally because of conservative policies and a conflating of EC with abortion (this is the case in Costa Rica, Honduras and the Philippines).

 

Product specification & characteristics

* Because EC is widely used in the developed world (Europe and USA), it is subject to extensive post-marketing surveillance and found to be safe.

* The ideal EC package is a single pill formation which is currently under patent in both developed countries and member states of the African Regional Intellectual Property Organization.

* There are instances of developing countries selling a generic version of the single-pill formulation.

* No cold-chain storage is required and there are few packaging or delivery complications.

* Currently the package, dose and instructions are adequate, but not optimum, due to patent issues.  The majority of the product sold outside of Europe and the US is a two-pill formulation, which is not as easy to use as the one-pill formulation.

Financing, Procurement & Supply

* There are currently over 60 manufacturers of EC.

* 2 manufacturers have received stringent regulatory approval from the U.S. Food and Drug Administration (USFDA) or the European Medicines Agency (EMA); they are products manufactured by Gedeon Richter and HRA Pharma.

* 1 product has received WHO Prequalification (Gedeon Richter’s).

* EC can safely be provided in pharmacy settings without clinical supervision, so it is a good fit for the commercial and social marketing sectors.

* Major donor support for EC in 2010 for Public Sector (Quantity: 3.26 million doses worth US$ 1.2 million).

* Restrictions on access are often due to unnecessary prescription requirements or lack of provision in the public sector.

* Forecasting in particular is difficult with little historical data.

* Current donor support is inadequate.

Service Provision (Rational Use)

* Easy to administer.  Does not require the involvement of a clinician.

* Since EC is still little known by health care providers, there have been examples of countries (such as Kenya and Uganda) that have purchased EC for their public sector services only to see it underutilized as providers did not order it for their clinics.

Demand

* Woman-controlled.

 

* Very low rates of awareness of EC in most developing countries as captured in DHS surveys.  Because many consumers prefer to access EC from the commercial and social marketing sectors, they need to learn about it outside of clinic services to seek it out.  Not enough has been done to raise awareness.





[1]  Guttmacher Institute, International Planned Parenthood Federation, Facts on Satisfying the Need for Contraception in Developing Countries, November 2010. Original source:  World Health Organization (WHO) et al., Trends in Maternal Mortality:1990 to 2008, Geneva: WHO, 2010.
[2]  WHO. WHO Model List of Essential Medicines (March 2011), 17th edition.  Available at:  http://whqlibdoc.who.int/hq/2011/a95053_eng.pdf.  Accessed March 26,2011