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).
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Notes
- 1.
Quotations are from unpublished interview transcripts recorded in a 2008 study of female sex workers in Kenya, from which some results have been published in Sutherland et al. (2011).
- 2.
Costs include commodities, supplies and labor.
- 3.
These GMP inspections were conducted by the Chinese SFDA; NQA, an international assessment group based in the UK; national drug regulatory authorities as part of the product registration process; and international NGOs and procurement organizations such as PSI.
- 4.
Lot release testing refers to the conduct of a series of contingency tests of representative samples from a single manufacturing run of product. Based on the results of these tests, the product is either cleared for distribution or rejected. For additional information on lot release testing, see Table 14.2.
- 5.
These include the United States Pharmacopoeia, British Pharmacopoeia, International Organization for Standardization, and ASTM (formerly the American Society for Testing and Materials).
- 6.
To this end, the Chinese government is in the process of updating their current GMP guidelines; the latest draft was issued in early 2011. The revised version incorporates key concepts from the ICH GMP guidance as well as EU and US GMP regulations, thus strengthening the international credibility of future Chinese inspections.
- 7.
By May 2012, Sino-implant (II) had been registered in Burkina Faso, Cambodia, Chile, Ethiopia, Fiji, Ghana, Jamaica, Kenya, Madagascar, Mali, Malawi, Mongolia, Mozambique, Nepal, Nigeria, Pakistan, Sierra Leone, Uganda, Zambia, and Zanzibar, as well as China and Indonesia.
- 8.
At the outset of the process, Dahua did not have any English speakers on staff. FHI 360 helped navigate the application process, assisted with development of a Common Technical Document dossier, and engaged consultants to conduct mock GMP audits and advise Dahua on preparations. The Common Technical Document was submitted to WHO and accepted for official review in the fall of 2010.
- 9.
The study followed 600 women over a period of 12 months. Results are expected by the end of 2013.
- 10.
FHI 360 does not procure or donate commodities under the initiative. Rather, donors, NGOs and Ministries of Health buy units of Sino-implant (II) for country-level programs.
- 11.
Savings are calculated based on a price of $8 for Sino-implant assuming the alternative is to purchase Jadelle (average unit price for Jadelle was $24 in 2009, $22 in 2010, $19 in 2011 and US$18 in 2012). Prices were calculated using information from the Reproductive Health Supplies Coalition and the RHInterchange: http://rhi.rhsupplies.org/.
- 12.
At the end of 2012, the volume thresholds were reached for Implanon sales which triggered an additional retro-active price reduction to $16.50, according to the Reproductive Health Supplies Coalition (RHSC 2012b).
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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.
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Rademacher, K.H., Vahdat, H.L., Dorflinger, L., Owen, D.H., Steiner, M.J. (2014). Global Introduction of a Low-Cost Contraceptive Implant. In: Kulczycki, A. (eds) Critical Issues in Reproductive Health. The Springer Series on Demographic Methods and Population Analysis, vol 33. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-6722-5_14
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