Advertisement

Global Introduction of a Low-Cost Contraceptive Implant

  • Kate H. Rademacher
  • Heather L. Vahdat
  • Laneta Dorflinger
  • Derek H. Owen
  • Markus J. Steiner
Chapter
Part of the The Springer Series on Demographic Methods and Population Analysis book series (PSDE, volume 33)

Abstract

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).

Keywords

Good Manufacture Practice Melinda Gate Foundation Contraceptive Implant Good Manufacture Practice Guideline Common Technical Document 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgments

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.

References

  1. Adamchak, S. (2010). Sino-implant (II): Year 2 monitoring, learning and evaluation experience. FHI. Unpublished report.Google Scholar
  2. Adams, K., & Beal, M. W. (2009). Implanon: A review of the literature with recommendations for clinical management. Journal of Midwifery & Women’s Health, 54(2), 142–149.CrossRefGoogle Scholar
  3. Barot, S. (2008). Back to basics: The rationale for increased funds for international family planning. Guttmacher Policy Review, 11, 3.Google Scholar
  4. 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.
  5. 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
  6. 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.
  7. Brett, T. (2011, May 24). Associate Director of Procurement, MSI. Interview.Google Scholar
  8. 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
  9. Coukell, A. J., & Balfour, J. A. (1998). Levonorgestrel subdermal implants: A review of contraceptive efficacy and acceptability. Drugs, 55(6), 861–887.PubMedCrossRefGoogle Scholar
  10. d’Arcangues, C. (2007). Worldwide use of intrauterine devices for contraception. Contraception, 75, S2–S7.PubMedCrossRefGoogle Scholar
  11. 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
  12. FHI. (2010). Zarin launch in Sierra Leone. Fact sheet. Unpublished.Google Scholar
  13. FHI 360 (2009 and 2012). Process capability analysis reports. Unpublished.Google Scholar
  14. Ford, N., Calmy, A., & Mills, E. J. (2011). The first decade of antiretroviral therapy in Africa. Globalization and Health, 7, 33.PubMedCrossRefGoogle Scholar
  15. 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
  16. Gross, O. (2006). WHO program for prequalification of antiretroviral, antimalarial and antituberculosis drugs. Médecine Tropicale, 66(6), 549–551.PubMedGoogle Scholar
  17. Hall, P., Oehlera, J., Woo, P., et al. (2007). A study of the capability of manufacturers of generic hormonal contraceptives in lower- and middle-income countries. Contraception, 75, 311–317.PubMedCrossRefGoogle Scholar
  18. 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
  19. Hohmann, H., & Creinin, M. D. (2007). The contraceptive implant. Clinical Obstetrics and Gynecology, 50(4), 907–917.PubMedCrossRefGoogle Scholar
  20. Hubacher, D., & Dorflinger, L. (2012). Avoiding controversy in international provision of subdermal contraceptive implants. Contraception, 85(5), 432–433.PubMedCrossRefGoogle Scholar
  21. Hubacher, D., Kimani, J., Steiner, M., et al. (2007). Contraceptive implants in Kenya: Current status and future prospects. Contraception, 75(6), 468–473.PubMedCrossRefGoogle Scholar
  22. Issak, B. (2011, May 18). Head of the Division of Reproductive Health, Kenya Ministry of Health. Interview.Google Scholar
  23. Jenkins, D., Taylor, D., Owen, D., & Steiner, M. (2010). Evaluation of Sino-implant (II) explants (Final report). Family Health International. Durham, NC, USAGoogle Scholar
  24. Kenya National Bureau of Statistics (KNBS) and ICF Macro. (2010). Kenya demographic and health survey 2008–09. Calverton: KNBS & ICF Macro.Google Scholar
  25. Luo, D. (2011, May 24). Independent regulatory consultant. Interview.Google Scholar
  26. 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
  27. Mansour, D., Inki, P., & Gemzell-Danielsson, K. (2010). Efficacy of contraceptive methods: A review of the literature. The European Journal of Contraception & Reproductive Health Care, 15(1), 4–16.CrossRefGoogle Scholar
  28. Marie Stopes International. (2012). Impact calculator. www.mariestopes.org
  29. 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
  30. Mavranezouli, I. (2009). Health economics of contraception. Best Practice & Research. Clinical Obstetrics & Gynaecology, 23(2), 187–198.CrossRefGoogle Scholar
  31. Milistein, J., Costa, A., Jadhav, S., & Dhere, R. (2009). Reaching international GMP standards for vaccine production: Challenges for developing countries. Expert Review of Vaccines, 8(5), 559–566.CrossRefGoogle Scholar
  32. 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.
  33. Neukom, J., Chilambwe, J., Mkandawire, J., et al. (2011). Dedicated providers of long-acting reversible contraception: New approach in Zambia. Contraception, 83(5), 447–452.PubMedCrossRefGoogle Scholar
  34. 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
  35. Ramchandran, D., & Upadhyay, U. D. (2007). Implants: The next generation. Popul Rep Ser K Injectables Implants, 7, 1–19.Google Scholar
  36. 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.
  37. Reproductive Health Supplies Coalition (RHSC) (2012a, February). Supply Insider. http://www.rhsupplies.org/. Accessed 7 May 2012.
  38. 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.
  39. RHInterchange. http://rhi.rhsupplies.org/rhi/index.do?locale=en_US. Accessed May 2011 and May 2013.
  40. 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
  41. 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
  42. Steiner, M. J., Lopez, L. M., Grimes, D. A., et al. (2010). Sino-implant (II) – A levonorgestrel-releasing two-rod implant: Systematic review of the randomized controlled trials. Contraception, 81, 197–201.PubMedCrossRefGoogle Scholar
  43. 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
  44. Sullivan, T. M., Bertrand, J. T., Rice, J., & Shelton, J. D. (2006). Skewed contraceptive mix: Why it happens, why it matters. Journal of BiosocialScience, 38, 501–521.CrossRefGoogle Scholar
  45. Sutherland, E. G., Alaii, J., Tsui, S., et al. (2011). Contraceptive needs of female sex workers in Kenya – A cross-sectional study. The European Journal of Contraception & Reproductive Health Care, 16(3), 173–182.CrossRefGoogle Scholar
  46. Tumlinson, K., Steiner, M., Rademacher, K., et al. (2011). The promise of affordable implants: Is cost recovery possible in Kenya? Contraception, 83, 88–93.PubMedCrossRefGoogle Scholar
  47. 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.
  48. 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.
  49. 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.
  50. 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
  51. Waning, B., Kaplan, W., King, A. C., et al. (2009). Global strategies to reduce the price of antiretroviral medicines: Evidence from transactional databases. Bulletin of the World Health Organization, 87(7), 520–528.PubMedCrossRefGoogle Scholar
  52. Wirtz, V. J., Forsythe, S., Valencia-Mendoza, A., et al. (2009). Factors influencing global antiretroviral procurement prices. BMC Public Health, 9(Suppl 1), S6.PubMedCrossRefGoogle Scholar
  53. World Health Organization. (2010, August). WHO prequalification. http://www.who.int/mediacentre/factsheets/fs278/en/index.html. Accessed Dec 2010.
  54. World Health Organization. (2012). Prequalification programme. http://apps.who.int/prequal/. Accessed Nov 2012.
  55. Zhou, C. (2011, June 27) Sales Manager, Shanghai Dahua Pharmaceuticals Co., Ltd. Personal correspondence.Google Scholar

Copyright information

© Springer Science+Business Media Dordrecht 2014

Authors and Affiliations

  • Kate H. Rademacher
    • 1
  • Heather L. Vahdat
    • 2
  • Laneta Dorflinger
    • 3
  • Derek H. Owen
    • 4
  • Markus J. Steiner
    • 4
  1. 1.Program SciencesFHI 360DurhamUSA
  2. 2.Social and Behavioral Health SciencesFHI 360DurhamUSA
  3. 3.Global Health, Population and NutritionFHI 360DurhamUSA
  4. 4.Clinical SciencesFHI 360DurhamUSA

Personalised recommendations