Global Introduction of a Low-Cost Contraceptive Implant
Hormone-releasing subdermal implants are a safe, highly effective, and reversible form of contraception that provides continuous pregnancy protection for 3–5 years depending on the type of implant. Implants are among the most effective forms of contraception available; efficacy is comparable to other long-acting and permanent methods including the intrauterine device (IUD) and sterilization, with annual pregnancy rates less than 1 % for women using these methods (Mansour et al. 2010). However, unlike the IUD or female sterilization which requires a gynecological procedure, implants are inserted under the skin of a woman’s upper arm. Because no regular action is required by the user and no routine resupply or clinical follow-up is needed, implants are widely seen as an ideal method for women with limited access to health services, particularly women in developing countries (Frost and Reich 2008). However, despite the advantages of this method, worldwide use of implants is low: whereas 56 % of married women between the ages of 15 and 49 around the globe use a modern method of contraception, less than 1 % use implants (United Nations 2011).
KeywordsGood Manufacture Practice Melinda Gate Foundation Contraceptive Implant Good Manufacture Practice Guideline Common Technical Document
The authors appreciate the contribution of John Bratt and Katherine Tumlinson to the analysis of direct service delivery costs for contraceptive methods. The authors also want to thank Timothy Mastro, Charles Morrison, Diane Luo, David Asante and David Hubacher for their review of the chapter.
- Adamchak, S. (2010). Sino-implant (II): Year 2 monitoring, learning and evaluation experience. FHI. Unpublished report.Google Scholar
- Barot, S. (2008). Back to basics: The rationale for increased funds for international family planning. Guttmacher Policy Review, 11, 3.Google Scholar
- Bayer HealthCare. (2012, September 26). Bayer joins global initiative for better access to safe and effective contraception. Press release. http://press.healthcare.bayer.com/en/press/news-details-page.php/14732/2012-0429. Accessed Sept 2012.
- Bertrand, J. T., Rice, J., Sullivan, T. M., & Shelton, J. (2000). Skewed method mix: A measure of quality in family planning programs. Chapel Hill: MEASURE Evaluation.Google Scholar
- The Bill & Melinda Gates Foundation. (BMGF). (2013). Innovative partnership reduces cost of Bayer’s long-acting reversible contraceptive implant by more than 50 percent. Press release. February 27, 2013. http://www.gatesfoundation.org/Media-Center/Press-Releases/2013/02/Partnership-Reduces-Cost-Of-Bayers-Reversible-Contraceptive-Implant. Accessed May 2013.
- Brett, T. (2011, May 24). Associate Director of Procurement, MSI. Interview.Google Scholar
- Clinton Health Access Initiative. (2011). Regulatory approvals for ARVs: An analysis of review timelines under the US FDA, WHO PQ, and ERP (Internal report). Received via personal correspondence.Google Scholar
- Engenderhealth. (2009). Respond project. Meeting national goals and people’s needs with LA/PMs: Kenya country assessment. http://www.respond-project.org/pages/index.php
- FHI. (2010). Zarin launch in Sierra Leone. Fact sheet. Unpublished.Google Scholar
- FHI 360 (2009 and 2012). Process capability analysis reports. Unpublished.Google Scholar
- Frost, L. J., & Reich, M. R. (2008). Access: How do good health technologies get to poor people in poor countries? Cambridge: Harvard University Press.Google Scholar
- Harris, G. (2011, June 20). FDA confronts challenge of monitoring imports. Agency head outlines difficulties and risks of food and drug imports. The New York Times, B3. http://www.nytimes.com/2011/06/21/health/policy/21food.html
- Issak, B. (2011, May 18). Head of the Division of Reproductive Health, Kenya Ministry of Health. Interview.Google Scholar
- Jenkins, D., Taylor, D., Owen, D., & Steiner, M. (2010). Evaluation of Sino-implant (II) explants (Final report). Family Health International. Durham, NC, USAGoogle Scholar
- Kenya National Bureau of Statistics (KNBS) and ICF Macro. (2010). Kenya demographic and health survey 2008–09. Calverton: KNBS & ICF Macro.Google Scholar
- Luo, D. (2011, May 24). Independent regulatory consultant. Interview.Google Scholar
- Macartney, J. (2008, September 22). China baby milk scandal spreads as sick toll rises to 13,000. Times Online. http://www.timesonline.co.uk/tol/news/world/asia/article4800458.ece
- Marie Stopes International. (2012). Impact calculator. www.mariestopes.org
- Marie Stopes International (MSI), FHI, Pharm Access Africa, Ltd. (2010). Introducing the contraceptive Sino-implant (II) (Zarin) in Sierra Leone (Final report). Available at: http://www.k4health.org/toolkits/implants/country_experiences/sierraleone
- MSD. (2013). MSD and partners announce agreement to increase access to innovative contraceptive implants Implanon® and Implanon Nxt® in the poorest countries. Press release. May 2013. http://www.rhsupplies.org/fileadmin/user_upload/Announcements/MERCK_EXTERNAL_STATEMENT_FINAL_May_2013__4_.pdf. Accessed May 2013.
- Power, J., French, R., & Cowan, F. (2007). Subdermal implantable contraceptives versus other forms of reversible contraceptives or other implants as effective methods of preventing pregnancy (review). Cochrane Database of Systematic Reviews, 3(3), 1–31.Google Scholar
- Ramchandran, D., & Upadhyay, U. D. (2007). Implants: The next generation. Popul Rep Ser K Injectables Implants, 7, 1–19.Google Scholar
- Reproductive Health Supplies Coalition (RHSC). (2011, June 24). Private and public sectors announce commitments to increase access to contraceptives. Press release. http://www.rhsupplies.org/. Accessed 13 July 2011.
- Reproductive Health Supplies Coalition (RHSC) (2012a, February). Supply Insider. http://www.rhsupplies.org/. Accessed 7 May 2012.
- Reproductive Health Supplies Coalition (RHSC) (2012b, November 19). Coalition-supported initiative triggers more than $15 million in savings. Press release. http://www.rhsupplies.org/. Accessed 20 Nov 2012.
- RHInterchange. http://rhi.rhsupplies.org/rhi/index.do?locale=en_US. Accessed May 2011 and May 2013.
- Sivin, I., Nash, H., & Waldman, S. (2002). Jadelle levonorgestrel rod implants: A summary of scientific data and lessons learned from programmatic experience. New York: The Population Council.Google Scholar
- Statistics Sierra Leone, & ICF Macro. (2009). Sierra Leone demographic and health survey 2008. Calverton: Statistics Sierra Leone (SSL) and ICF Macro. Available at: http://www.measuredhs.com/pubs/pdf/FR225/FR225.pdf
- Story, L. (2007, August 2). Lead paint prompts mattel to recall 967,000 toys. The New York Times. http://www.nytimes.com/2007/08/02/business/02toy.html
- U.S. Agency for International Development (2012, September 26). New partnership expands access to contraception for 27 million women and girls in low-income countries. Press release. http://www.usaid.gov/news-information/press-releases/new-partnership-expands-access-contraception-27-million-women-and. Accessed Sept 2012.
- United Nations Commission on Life-Saving Commodities for Women and Children (2012, September). Commissioners’ report. http://www.everywomaneverychild.org/images/UN_Commission_Report_September_2012_Final.pdf. Accessed Oct 2012.
- United Nations, Department of Economic and Social Affairs, Population Division. (2011). World contraceptive use 2010. New York: United Nations. http://www.un.org/esa/population/publications/wcu2010/Main.html.
- United Nations Population Fund (UNFPA) (2011, April). First invitation to manufacturers of reproductive health medicines to submit an Expression of Interest (EOI) for product evaluation and UNFPA Technical assessment by the Expert Review Panel (ERP) or the Internal Technical Committee. Received through personal correspondence, May 2011.Google Scholar
- US FDA. (2007). Melamine pet food recall of 2007. http://www.fda.gov/animalveterinary/safetyhealth/recallswithdrawals/ucm129575.htm
- World Health Organization. (2010, August). WHO prequalification. http://www.who.int/mediacentre/factsheets/fs278/en/index.html. Accessed Dec 2010.
- World Health Organization. (2012). Prequalification programme. http://apps.who.int/prequal/. Accessed Nov 2012.
- Zhou, C. (2011, June 27) Sales Manager, Shanghai Dahua Pharmaceuticals Co., Ltd. Personal correspondence.Google Scholar