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| A low-cost, safe, and highly effective contraceptive implant | |||
| Number 1 • August 2010 | |||
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Supporting the Global Introduction of Sino-implant (II) The contraceptive implant is a highly effective, safe, long-acting, and popular contraceptive method that has been shown to be acceptable to women worldwide. However, the high cost of this commodity has been a major barrier to its availability in many countries. Sino-implant (II) addresses this problem. As of 2009, this implant cost about 60 percent less than others available, according to the Reproductive Health Supplies Coalition database. Under a current five-year grant awarded to FHI by the Bill & Melinda Gates Foundation, FHI provides technical assistance to support the introduction of Sino-implant (II) in resource-constrained countries. Sino-implant (II)—marketed as Zarin, as Femplant, and under other trade names—is composed of two thin rods, each containing 75 mg of levonorgestrel, the active ingredient. Sino-implant (II) is comparable to Jadelle, in that it provides the same amount of levonorgestrel and has the same mechanism of action. It is currently labeled for four years of use and is distributed with a CE-marked disposable trocar.
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Spotlight on Quality: Sino-implant (II) Meets International Standards
Laboratory Testing: A five-year quality evaluation and monitoring program led by FHI is underway and includes the following components:
FHI's Product Quality and Compliance Division conducts tests on the active ingredient, levonorgestrel; the quality of the final product; and all packaging components. Years 1 and 2 of the evaluation demonstrated that Sino-implant (II) met all of the specifications of the international quality standards used in the evaluation. The third annual assessment is currently underway. Independent Audits and Inspections: The manufacturer is evaluated on an ongoing basis through the following mechanisms:
Explant Analysis: A recent analysis conducted by FHI measured levonorgestrel levels remaining in Sino-implant (II) rods removed from women after various durations of use. (Rods in these cases are referred to as "explants".) The amount of levonorgestrel remaining in the explants was similar to the amount remaining in explant samples of Jadelle (from publicly available data for a three-year period) after the same periods of time had elapsed. Using these data, scientists calculated the release rate of Sino-implant (II) and compared it to the release rate of Jadelle. In this analysis, the levonorgestrel release rate for Sino-implant (II) was similar to that of Jadelle. This finding supports the hypothesis that the two products are bioequivalent for the three years of use that were studied. Clinical Studies: Existing clinical evidence supports the safety and effectiveness of Sino-implant (II). A review of four randomized trials following more than 15,000 women showed Sino-implant (II) to be safe and highly effective. Annual pregnancy rates were below 1 percent. One trial had a two-year follow-up, while three of the trials had five years of follow-up data. Review of the clinical data was conducted by a group of eight leading reproductive health and clinical trial experts at the World Health Organization (WHO), the United States Agency for International Development (USAID), Princeton University, and FHI. The authors concluded that, "Available clinical data, combined with independent laboratory testing and the knowledge that 7 million women have used this method since 1994, support the safety and effectiveness of Sino-implant (II)." (Steiner et al., 2010, abstract). For more information about FHI's Quality Testing program, please email us at sino-implant@fhi.org. FHI's Product Quality and Compliance Division has over 20 years experience testing and ensuring quality of public health commodities for donors and service delivery groups. |
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From the Project Director's Desk: I am often asked what exactly is FHI's role in the global introduction of Sino-implant (II), a low-cost contraceptive implant. With support from the Bill & Melinda Gates Foundation, FHI has five key responsibilities:
FHI does not produce, sell, or distribute Sino-implant (II). Therefore, we do not stand to make a financial profit as global sales of Sino-implant (II) increase. Rather, we play the role of an independent, global coordinator. This work is part of FHI's larger efforts to increase access to affordable and sustainable healthcare provision worldwide. Although contraceptive implants are highly effective, safe, popular, and long-acting, their high cost has been a major barrier in ensuring their availability in resource-constrained settings. Introducing Sino-implant (II), which costs approximately 60 percent less than other implants, into programs in a well-coordinated manner can lead to substantial cost-savings for governments and donors, and to improved public health as use of implants increases. We look forward to continuing to work to achieve these objectives.
— Dr. Markus Steiner | |
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International Planned Parenthood Federation Approves Global Distribution of Sino-implant (II) In May 2010, the International Planned Parenthood Federation's (IPPF) International Medical Advisory Panel (IMAP) approved the purchase and distribution of Sino-implant (II) by its global network of associated members. IMAP is a body of medical scientists and technical experts with a mandate to formulate and disseminate recommendations to IPPF and other interested parties regarding best practices in sexual and reproductive health care, based on the best available evidence. After reviewing the clinical studies and quality testing results, Sino-implant (II) was approved by the panel at the 56th IMAP meeting. IPPF currently has 151 Member Associations working in 173 countries. IPPF's commodity procurement group, International CONtraceptive & SRH Marketing Ltd. (ICON), is currently working with distributors in countries where Sino-implant (II) is registered to finalize purchase agreements. | |||
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Product Registration and Introduction
WHO Prequalification: In May 2010, the manufacturer of Sino-implant (II), Shanghai Dahua Pharmaceutical Co., Ltd., with support from FHI, submitted a Common Technical Dossier (CTD) to WHO as part of its prequalification application for Sino-implant (II). The CTD is available to partners to support national registration applications. The manufacturer is currently responding to a request for more information from WHO regarding the prequalification application; responses are due September 2010. For more information about registration and product introduction activities, please email us at: sino-implant@fhi.org. | |||
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Research Update Disposable Trocars: An evaluation in Kenya showed that the new disposable trocar for two-rod implants is safe, effective, and easy to use. The disposable trocar will facilitate the provision of implants in resource-constrained settings because it reduces the need for sterilized equipment in the field. All Sino-implant (II) units are now distributed with a disposable trocar bearing the CE Mark. (The CE mark indicates the trocar meets European quality standards of manufacturing.) Steiner M, Boler T, Obhai G, et al. Assessment of a disposable trocar for insertion of contraceptive implants. Contraception 2010;81(2):140–2. Cost recovery in Kenya: A study conducted in 22 facilities throughout Kenya revealed that the median price for implant insertion paid by clients in the public, private for-profit, and private not-for-profit sectors was US$1.30, US$13.30, and US$20.00, respectively. The commodity cost of Sino-implant (II) is approximately 60 percent less than two other widely available implants. Sino-implant (II) has a direct service delivery cost (the cost of the commodity plus supplies and labor for insertion) of approximately US$12.00 in Kenya. Patient fees in both private sectors allow for 100 percent recovery of the direct cost of providing Sino-implant (II). In the public sector, subsidies will continue to be needed. Overall, Sino-implant (II) has the potential to reduce reliance on donor-supplied implants and thereby improve contraceptive security. Tumlinson K, Steiner M, Rademacher K, et al. The promise of affordable implants: is cost recovery possible in Kenya? Contraception. In press.
Tumlinson K, Steiner M, Rademacher K, et al. The promise of affordable implants: is cost recovery possible in Kenya? Contraception. In press. Integration of Sino-implant (II) into an HIV Prevention Trial: The FEM-PrEP (pre-exposure prophylaxis) clinical trial led by FHI is designed to test the safety and effectiveness for HIV prevention of a daily dose of Truvada, a pill that combines two antiretroviral drugs—emtricitabine and tenofovir disoproxil fumarate. Women cannot participate in the trial if they are pregnant or plan to become pregnant. Therefore, one criterion for eligibility is that participants must agree to use a study-approved, nonbarrier method of contraception for the duration of the study. Prior to February 2010, DMPA and COCs were the only two methods offered to women enrolling in the study at the Bondo site in Kenya. After that date, women enrolling in the study at Bondo also had the option of choosing Sino-implant (II). Since February, 26 out of 196 newly enrolled participants (13 percent) chose to receive Sino-implant (II). An assessment of uptake and continuation rates is ongoing. For more information about the FEM-PrEP trial, click here. Support Available for Research: Under the Gates initiative, FHI is able to provide small quantities of Sino-implant (II) for operations research. For more information about this opportunity or for more information about any of our research projects, please email us at: sino-implant@fhi.org. | |||
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Product Brand Information
For information about ordering Sino-implant (II), please contact the distributors: Pharm Access Africa, Ltd. (PAAL) Marie Stopes International | |||
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Resources K4H Implants Toolkit Goes Live! Resources specific to Sino-implant (II), including fact sheets, quality testing summaries, country experiences, and client materials, are also available within the Implants Toolkit. To keep informed about important long-acting and permanent methods of family planning, please join the LA/PM Community of Practice on the Implementing Best Practices (IBP) Knowledge Gateway. Additional Resources
For additional resources in English, French, or Spanish, please email us at: sino-implant@fhi.org. | |||
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Events Learn more about Sino-implant (II) at these upcoming events: The East, Central, and Southern African College of Nursing (ECSACON) 9th Scientific Conference. Lusaka, Zambia. August 23–27, 2010. Global Maternal Health Conference 2010. New Delhi, India. August 30–September 1. Pharmaceutical Sciences 2010 World Congress. New Orleans, Louisiana, USA. November 14–18. We want to hear from you! Please email us your questions or comments at: sino-implant@fhi.org. | |||
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V2 | |||
As the independent global coordinator for Sino-implant (II)'s introduction, FHI's priority is to assess the quality of the product. Quality evaluation efforts involve reviewing existing and new clinical data, facilitating audits and inspections of the manufacturer, and performing rigorous
Country Registrations: As of August 2010, Sino-implant (II) has been approved by national drug regulatory authorities in 11 countries: Burkina Faso (2010), China (1994), Indonesia (2002), Fiji (2010), Kenya (2008), Madagascar (2009), Malawi (2010), Pakistan (2010), Sierra Leone (2008), Uganda (2010), and Zambia (2010). Dossiers are under review in eight other countries, and the submission process is underway in 20 additional countries. 
Comparison of Direct Costs per CYP: A recent assessment looked at direct service delivery costs of Sino-implant (II) relative to other contraceptive methods. Based on varying labor and supply costs for both insertion and removal of methods across 13 countries designated by USAID as tier-one reproductive health priority countries, Sino-implant (II) has a direct cost per couple year of protection (CYP) of approximately US$4. This makes it one of the most affordable methods of reversible contraception, second only to the intrauterine device (IUD). In addition, total direct service delivery costs of Sino-implant (II) are comparable to those of two other popular methods, depot-medroxyprogesterone acetate (DMPA) and combined oral contraceptives (COCs), after just two years of use. In the same 13 countries, the total direct cost of delivering Sino-implant (II) services, averaged over two years, was projected to be US$13.30,
Sino-implant (II) is marketed under a variety of names in different countries. In addition to the manufacturer's name for the product, trade names are registered in countries by distributors and used by service delivery partners. The following is a list of the various names by which this product is known.