INFO project- Implants: The Next Generation

Publication date: 2007

POPULATION REPORTS 1 Implants:Implants: The Next GenerationThe Next Generation Key Points New contraceptive implants are becoming available to family planning programs around the world—the one-rod system Implanon®, the two-rod system Jadelle®, and in some countries Sino-Implant (II)®, also two rods. By 2008 Norplant®, the six-capsule implant system will no longer be available. Like Norplant, the new implants are highly effective at preventing pregnancy, and, like Norplant, they alter women’s bleeding patterns. Their most important advantage over Norplant is easier and quicker insertion and removal. Implants have advantages. • Implants are safe, highly effective, and quickly reversible long-term contraceptives that require little attention after insertion. Clients are satisfi ed with them because they are convenient to use, long-lasting, and highly effective. Con- tinuation rates are high. Programs should consider offering new • implants. The new implants offer the same benefi ts of the older system but are easier to provide. Programs may want to add the new implants to their method mix, and programs currently offering Norplant should plan for transition to a new implant. Competency-based training works best. • It ensures that each provider gets enough training and supervised practice to insert and remove implants correctly. Training also covers counseling, which includes preparing clients to expect bleeding changes. Demand appears high.• Evidence suggests that many more women would choose implants if they could. Initial cost is high but is coming down. • Despite potential demand worldwide, use of implants is low, largely because the implants themselves are costly. Still, when implants are used for several years, they are relatively cost-effective compared with other methods. The prices that donors pay for implants have fallen recently. Strategies to address the high cost of implants must involve donor and government subsidies, expanding registra- tion of a lower- priced implant, and sharing the cost with users. INFO Project Center for Communication Programs How family planning programs and providers can prepare to provide new contraceptive implants Series K, Number 7 Injectables and Implants Population Reports See companion INFO Reports, “Implants: Tools for Providers” October 2007 © 2005 D r. Ph ilip p e Fau ch er/Paris © 2005 D r. Ph ilip p e Fau ch er/Paris 2 POPULATION REPORTS2 New Implants Can Expand Access Contraceptive implants offer women many advantages that can suit their reproductive intentions and that make continued use easy. The most impor- tant improvement that the new implants offer is easier and quicker insertion and removal. With new implants making the method easier to provide, more programs may want to begin offering implants. Box: Which New Implant to Introduce? Family planning programs evaluate a variety of factors when deciding which new implant to introduce, including regulatory approval, cost, and manufac- turer support for service delivery, including training for providers. Spotlight: From Norplant to Jadelle: Smooth Transition in a Dominican Republic Clinic A clinic in the Dominican Republic switched successfully from Norplant to Jadelle. Providers adapted quickly to providing the new implants, and clients, although hesitant at fi rst, are now satisfi ed with Jadelle as an alternative. Preparing to Offer New Implants Good implant services require a competent and well-prepared staff that can perform insertion and removal procedures and can help clients make an informed choice about implants. The best training is competency-based. Providers also help clients by counseling about side effects, screening to make sure clients are eligible to use implants, and answering clients’ questions about insertion and removal procedures. Spotlight: Training Nurses Increases Implant Use in Ghana The Ghana Ministry of Health and EngenderHealth collaborated to train a large group of nurses in implant insertion and removal and in related coun- seling. This effort contributed to a tenfold increase in the number of women using implants in Ghana. Box: Information and Communication Technology Supports Implant Programs A number of organizations have developed useful Information and Communication Technology tools that can help family planning programs introduce and manage contraceptive implants. Meeting Demand for New Implants Requires Supply and Access Worldwide use of implants remains low, but demand exceeds supply. The largest barrier to implant use is the high cost of the method. Manufacturing costs are declining, donors and governments are placing larger orders and negotiating lower prices, and a lower-priced implant has become available. With such efforts to reduce costs, programs are more likely to be able to meet the demand for implants and to offer them to clients at lower prices. Bibliography Note: Italicized reference numbers in the text refer to citations printed on page 19. These were the most helpful in preparing this report. Other citations can be found online at http://www.populationreports.org/k7/ This report was prepared by Deepa Ramchandran, MHS, and Ushma D. Upadhyay, PhD. Research assistance by Lauren Necochea, MPA. Edited by Ward Rinehart. Design by Mark Beisser, Francine Mueller, Linda Sadler, and Rafael Avila. Production by Monica Jiménez. The INFO Project appreciates the assistance of the following reviewers: Maaike Addicks, Vivian Brache, Lee Claypool, Gloria Coe, Carmela Cordero, Juan Díaz, Laneta Dorfl inger, Stephen Goldstein, Peter Hall, David Hubacher, Roy Jacobstein, Barbara Janowitz, Monica Jasis, Robert Lande, Enriquito Lu, Olav Meirik, J.T. Mutihir, Nuriye Ortayli, John Pile, Malcolm Potts, Frank Roijmans, Irving Sivin, John P. Skibiak, J. Joseph Speidel, Vidya Setty, Markus Steiner, John W. Townsend, and Mary Beth Weinberger. Suggested citation: Ramchandran, D. and Upadhyay, U. D. “Implants: The Next Generation.” Population Reports, Series K, No. 7. Baltimore, INFO Project, Johns Hopkins Bloomberg School of Public Health, October 2007. Available online: http://www.populationreports.org/k7/ INFO Project Center for Communication Programs Johns Hopkins Bloomberg School of Public Health 111 Market Place, Suite 310 Baltimore, Maryland 21202 USA 410-659-6300 410-659-6266 (fax) www.infoforhealth.org infoproject@jhuccp.org Jane T. Bertrand, PhD, MBA, Professor and Director, Center for Communication Programs Earle Lawrence, Project Director, INFO Project Population Reports is designed to provide an accurate and authoritative overview of important developments in family planning and related health issues. The opinions expressed herein are those of the authors and do not necessarily refl ect the views of the U.S. Agency for International Development (USAID) or Johns Hopkins University. Published with support from USAID, Global, GH/PRH/PEC, under the terms of Grant No. GPH-A-00-02-00003-00. Cover Photo: As part of a training of trainers in Madagascar, providers prepare to insert Implanon into a woman’s arm. Insertion requires attention to infection prevention procedures, sterile conditions, correct place- ment of implants, and care to minimize tissue damage. 8 CONTENTS 3 6 Tools for Providers • Box: What Clients Should Know About Insertion and Removal, p. 13 • INFO Reports: “Implants: Tools for Providers” • Table 1: Comparing Implants, p. 5 • Table 4: Key Resources for Program Managers and Providers of Implants, p. 16 7 11 9 14 19 POPULATION REPORTS 3 Family planning programs around the world are intro- ducing the new one- or two-rod implant systems Implanon®, Jadelle®, and in some countries Sino-Implant (II)®. By 2008 Norplant®, the six-capsule implant system, fi rst introduced in mid-1980s, will no longer be available. Like Norplant, the new implants are highly effective, and like Norplant, they alter bleeding patterns. Their most important improve- ment over Norplant is easier and quicker insertion and removal. Sino-Implant (II) may also cost much less than other implants. The new implants are recommended for as much as three to fi ve years of use, depending on the make. Thus they are particularly suitable for women who want to space births. Indeed, for many women implants are a convenient method. Once inserted into a woman’s arm, the implants do not require any action by the user. Since implants do not contain estrogen, they do not decrease production of breast milk and thus are suitable for breastfeeding women. They are also a good choice for women who do not want more children but are not ready to opt for sterilization, which is permanent. With new implants making the method easier to provide, more programs may want to begin offering implants. Programs currently offering Norplant will need to consider how to make the transition to the newer implants and to meet possibly greater demand. What Is New About Implants? The new contraceptive implants are small, thin, fl exible plastic rods, each about the size of a matchstick, that release a progestin hormone, either levonorgestrel (Jadelle, Sino- Implant (II)) or etonogestrel (Implanon), into the body. The hormone prevents pregnancy by thickening the cervical mucus, which blocks sperm from meeting an egg, and by disrupting the menstrual cycle, including preventing ovulation—the release of an egg from an ovary. With Implanon the primary mechanism of action is the prevention of ovulation in most cycles. With Jadelle ovulation is prevented in about half of cycles. Implants do not interrupt an existing pregnancy (18, 19, 31, 46, 47, 55, 60, 69, 124). Jadelle and Sino-Implant (II) im- prove on Norplant for delivery of levonorgestrel. Jadelle, devel- oped by the Population Council and produced by Bayer Schering Pharma, shares many features with its predecessor Norplant. Randomized comparative trials show that the two im- plants are almost identical in clinical performance (96, 97, 100, 125). Jadelle is a two-rod system, however, compared with Norplant’s six capsules. Each rod contains 75 mg of levonorgestrel. Jadelle improves on Norplant by offering the same performance but also easier insertion and removal, and fewer complications associated with insertion and removal (94, 96). Clients currently using Norplant can continue to use the method until it is time to get the capsules removed. Norplant is labeled for fi ve years of use, but large studies have found that it is effective for seven years (32, 98). Jadelle is labeled for up to fi ve years of continuous use. The new implants can be inserted and removed very quickly —more quickly than Norplant—but the length of time needed depends on the skill of the provider as well as the number of rods (18, 19, 31, 46, 47, 55, 60). For experienced providers in comparative trials, inserting Jadelle took about an average of 2.5 minutes, compared with 4.8 minutes for Norplant. Removing Jadelle took 5 to 7.5 minutes, compared with 10 to 15 minutes for Norplant (17, 96) (see Table 1, p. 5). The World Health Organization’s (WHO) Model List of Essential Medicines, as published in March 2007, includes a two-rod levonorgestrel-releasing implant (123). This inclusion is likely to create greater awareness of implants at the country level. Many countries base their national essential drugs list on WHO’s Model List. (For more information, see http://www.who.int/medicines/publications/EML15.pdf.) The Chinese two-rod implant system Sino-Implant (II), manu- factured by Shanghai Dahua Pharmaceutical, has been avail- able in China since the mid-1990s and has been registered for use in Indonesia since 2002. Like Jadelle, each rod contains 75 mg of levonorgestrel. Its clinical performance in terms of effec- tiveness and safety is comparable to that of Norplant (25, 57). Insertion and removal times for Sino-Implant (II) are not available at this time. Sino-Implant (II) is labeled for up to four years of continuous use. Implanon provides a one-rod option. Implanon, a single-rod contraceptive implant devel- oped by Organon, contains 68 mg of the progestin etonoges- trel. Safety and effectiveness studies have demonstrated that Implanon is highly effective and that insertion and removal are usually fast and uncomplicated (28, 53). Compared with Norplant, Implanon was New Implants Can Expand Access With new implants making the method easier to provide, more programs may want to begin offering implants. © 2006 D avid Alex and er, Co ur te sy o f P ho to sh ar e 4 POPULATION REPORTS signifi cantly quicker to insert and remove (82). Although complications are rare with both systems, fewer occurred with Implanon removals (67). Experienced providers inserted Implanon in an average of 1.5 minutes and removed the rod in about 2.7 minutes (see Table 1, p. 5). As the in- sertion procedure for Implanon is different from the other implants, training providers in proper insertion is essential (69). Implanon is currently labeled for up to three years of con- tinuous use. WHO is conducting a randomized clinical trial in seven countries to assess the clinical per- formance and contraceptive effi cacy of Jadelle and Implanon. This will be the fi rst large-scale study comparing the second generation of implants (75). Implant Characteristics Important to Women Contraceptive implants offer women many advantages that can suit their reproductive intentions and that make continued use easy (18, 19, 31, 46, 47, 55, 60, 113, 124): Highly-effective. • Implants are one of the most effective methods, comparable to intrauterine devices (IUDs), female sterilization, and vasectomy. Far fewer than one pregnancy per 100 users (fi ve per 10,000) is expected during the fi rst year of using levonorgestrel implants. A small risk of preg- nancy remains beyond the fi rst year of use and continues as long as the woman is using implants. Overall, in fi ve years of Jadelle use, one pregnancy per 100 users can be expected. Similar rates have been found for Sino-Implant (II) (25). In three years of Implanon use, less than one pregnancy per 100 users can be expected (46, 113, 124). Convenient. • Once the implants are in place, no routine follow-up is required, and no action is required of the client until the implants need to be replaced (122, 124). Immediate return to fertility. • Once implants are removed, women can become pregnant as quickly as women who stop using nonhormonal methods. Any side effects resolve immediately after removal.• In contrast with injectable contraceptives, the hormone does not remain in the body once the implants are removed. Therefore, any associated side effects will resolve shortly after removal. Complications are few.• Few complications occur as a result of the insertion procedure. Rarely, infections occur at the insertion site. Most of these infections occur within the fi rst two months after insertion. Expulsion of an implant is extremely rare. It most often occurs within the fi rst four months after insertion and is often related either to infec- tion or to incorrect insertion. Removal can sometimes be diffi cult, but this is rarely a problem if the implant was properly inserted and the provider is skilled at removal (124). • Suitable for nearly all women.• Nearly all women can use implants, including women who have or have not had children; are not married; are of any age, including adolescents; have just had an abortion, mis- carriage, or ectopic pregnancy; are breastfeeding (starting as soon as six weeks after child- birth); have anemia; smoke cigarettes (regardless of age); or are infected with HIV or have AIDS, whether or not on antiretroviral (ARV) therapy. It is not certain whether ARV med- ications reduce the effectiveness of implants, but they are thought not to. Use of condoms would make up for any such reduction in the effectiveness of the im- plants. Usually, women who should not use implants include those who are breastfeeding and are less than six weeks since giving birth; have a current blood clot in deep veins of legs or lungs; have unexplained vaginal bleeding that requires evaluation; have breast cancer (currently or in the past); have severe liver disease, infection, or tumor; and currently use antiseizure drugs or rifampicin (121, 124). (For more information on the clinical characteristics of implants, see the companion INFO Reports, “Implants: Tools for Providers”). Continuation rates are high. Women who use implants tend to be satisfi ed, and continuation rates are high. A recent Cochrane Review found that the majority of women using contraceptive implants continued with the method long- term. Over 80% of women were still using their implant at two years (82). In clinical trials and observational studies in a number of countries, continuation rates for implants range between 78% and 96% at one year, and between 50% and about 86% at three years (15, 25, 26, 28, 53, 57, 95, 96) (see Table 2, p. 5). Continuation rates for Norplant and Jadelle are not signifi cantly different (82). While there have been con- cerns that continuation may sometimes refl ect diffi culty fi nding removal services, the majority of implant users How to Use Th is Report Th is report can help family planning program managers to: • Decide how to adopt new implants into their method mix. • Prepare their staff to provide the new implants. • Meet the demand for implants by assuring availability and good-quality services. Providers can use the companion issue of INFO Reports, “Implants: Tools for Providers,” to review the important elements of providing good-quality services to new and continuing users of implants. Th e issue of INFO Reports off ers tools for counseling women and helping women use implants with satisfaction. © 2006 D avid Alex and er, Co ur te sy o f P h ot o sh a re Implants offer many advantages that can suit women and that make continued use easy. POPULATION REPORTS 5 Table 1. Comparing Implants Common Trade Name Formulation Labeled Length of Use Average Insertion Time1 Average Removal Time1 Registration Bulk Public Sector Price2 Implanon®, manu- factured by Organon 1 rod containing 68 mg etonogestrel Up to 3 years 1.5 minutes (69) 2.7 minutes (69) Registered in more than 40 countries. US$19–$25 Norplant®, manu- factured by Bayer Schering Pharma 6 capsules, each containing 36 mg levonorgestrel Up to 5 years 4.8 minutes (17) 10 to 15 minutes (17, 96) Registered in more than 60 countries, but unavailable after 2008. US$23 Jadelle®, manu- factured by Bayer Schering Pharma 2 rods, each containing 75 mg levonorgestrel Up to 5 years 2.5 minutes (17) 5 to 7.5 minutes (17, 96) Registered in more than 50 countries. US$21–$27 Sino-Implant (II)®, manufactured by Shanghai Dahua Pharmaceutical 2 rods, each containing 75 mg levonorgestrel Up to 4 years Data not available Data not available Registered in China and Indonesia. Registration underway in Egypt and other African countries. US$4.50–$7.50 1As measured in clinical trials 2As of September 2007 Table 2. Continuation Rates for New Implants Percentage of Women Keeping Their New Implants for One to Five Years, Selected Studies Authors, Date (Reference Number) Type of Study Implant Country Number of Women Start- ing Implants % Continuing to Use at… 1 Year 2 Years 3 Years 4 Years 5 Years Kiriwat et al., 1998 (53) Pilot project/ observational study Implanon Thailand 100 87 75 72 Flores et al., 2005 (28) Clinical trial Implanon Mexico 417 78 67 61 Chaovisitsaree et al., 2005 (15) Prospective observational study Implanon Thailand 92 92 Sivin et al., 1997 & Sivin et al., 1998 (96, 100) Randomized clinical trial Jadelle 6 countries 600 94 82 71 63 55 Sivin et al., 1998 (95) Clinical trial Jadelle Dominican Republic & United States* 594 83 66 50 37 27 Liu et al., 1999 (57) Prospective observational study Sino-Implant (II) China 315 80 Fan et al., 2004 (25) Randomized clinical trial Sino-Implant (II) China 1,000 96 86 68 Fang et al., 1998 (26) Clinical trial Sino-Implant (II) China 9,934 90 *Some women in this study may also be represented in the six-country Jadelle study in the row above (96, 100) Table 3. Estimated Worldwide Use of Implants Among Women Ages 15–49 (Married or In Union), 2005 Region Any Method Any Modern Method Implants DEVELOPING AREAS 58 52 0.4 Sub-Saharan Africa 21 15 0.2 Near East & North Africa 52 40 0.1 Asia 63 59 0.5 Latin America & Caribbean 71 62 0.1 DEVELOPED AREAS 68 56 0.2 Europe 74 64 0.0 Eastern Europe & Central Asia 63 42 0.0 North America 75 71 0.9 Other Developed* 59 54 <0.10 WORLD 59 53 0.3 *Includes Australia, Israel, Japan, and New Zealand Methodology and data sources: Country usage rates from United Nations, 2005 (115) are weighted by the size of the population of women ages 15–49, obtained from population projections for 2005 by the World Bank (120). % Currently Using POPULATION REPORTS 5 6 POPULATION REPORTS have had no problems getting their implants removed and acceptability studies fi nd that women using the method over many years have been satisfi ed with the implants (96). Use Could Increase if Barriers Overcome Worldwide, the level of implant use is low (see Table 3, p. 5). In spite of over 25 years of development, refi nement, and intro- duction in family planning programs around the world, contra- ceptive implants have failed to gain wide use. The largest bar- rier to implant use is the high cost of the method. As a result, few programs and clinics are able to offer the method and, among those who do, stock-outs are frequent (36, 42, 60, 74). The costs of contraceptive implants, however, have fallen in the past few years and are likely to continue falling. Wholesale prices for bulk orders of Jadelle, Implanon and Sino-Implant (II) have been as low as US$21, US$19, and US$4.50 respectively. Continued support from donors and subsidized prices can make it easier for programs to provide implants. (For more information on cost issues, see p. 14.) There is concern that overall costs of a family planning program will rise if it introduces implants. The cost of implants could be weighed against their potential to reduce unintended preg- nancies, however (47). In a recent assessment using data from Kenya, researchers used a previously published simulation model to estimate the annual number of unintended pregnan- cies with implant use compared with the number of unintend- ed pregnancies with oral contraceptive use. The simple exer- cise estimated that, if 100,000 users of oral contraceptives switched to implants, an estimated 26,000 unintended preg- nancies would be prevented over a fi ve-year period (42). Providing implants requires planning. Because implants are a “provider-dependent” method, introducing or expanding implant services requires that programs have the capacity to deliver the method appropriately. This includes Which New Implant to Introduce? Th e entry of new contraceptive implants and the exit of Norplant leaves family plan- ning programs to decide whether to add one of the new implants to their method mix and if so, which one to introduce— Jadelle, Implanon, or Sino-Implant (II). In- creasing or maintaining the range of meth- ods off ered is important because, when more methods are available, people are more likely to fi nd a method that suits them (89). Where Norplant has been an important method, clients will expect an alternative implant to replace it. Such decisions are often made at the national level, by the ministry of health or national family plan- ning program, or at the program level by program managers. If more than one implant is already in the country, local pro- grams will probably want to decide on one implant to off er. Experience with injectable contraceptives fi nds that carrying multiple types of injectables complicates forecasting, distribution of supplies, training, and ser- vice delivery (44, 56, 85, 92). Programs evaluate a variety of factors in deciding which implant to introduce. First comes regulatory approval. An implant al- ready approved will be fastest to incorporate into programs. If another implant provides comparative advantages, however, starting the process to obtain regulatory approval can be appropriate. If none of the new im- plants has regulatory approval, programs consider the comparative ease of the ap- proval process. Often Jadelle is easiest to approve because it is based on Norplant, which has already received approval in many countries. Currently, both Jadelle and Sino-Implant (II) meet the criteria for a two-rod levenorgestrel-releasing implant in the World Health Organization Model List of Essential Medicines (123). Th is, too, should help speed approval of these implants. At the same time, approval of Implanon may be just as straightforward. Many countries rely on U.S. or European regulatory approval as a guideline (119), and both Jadelle and Implanon have received regulatory approval in the United States and many European countries. Th e second factor programs must consider is cost. Currently, Sino-Implant (II) is the cheapest implant available. At US $4.50- $7 per unit, several African countries are choosing to introduce this implant into their programs (see p. 18). Currently, Implanon is just slightly cheaper than Jadelle on a per-unit basis, but with large bulk orders, the total cost diff erence could be substantial. Programs must consider cost-eff ectiveness within the service delivery system as well. Does the longer, fi ve-year active life of Jadelle make it more cost-eff ective than Implanon, which lasts three years? Any such com- parison would need to incorporate the proportion of users who would actually keep the implants for longer than three years if it were an option. Th ird, programs must consider service de- livery issues, including training and support for providers. For programs that have sub- stantial experience providing Norplant, it may be easiest to shift to Jadelle. Experience in the Dominican Republic (12) and Ghana (78) demonstrates that such a transition is smooth and easy, requiring only brief addi- tional training of providers. Transition to Implanon can be easy, too. Organon, which produces Implanon, provides substantial support in countries introducing Implanon, including training of trainers programs (90). In Tanzania the Ministry of Health and Social Welfare, the ACQUIRE Project, and Organon are collaborating to train providers in Implanon insertion and re- moval. In 2006 and 2007 some 150 pro- viders received training, and some 12,000 women had Implanon inserted (78). Family planning programs will need to consider these factors and others in decid- ing which new implant to off er. A strategic approach to introducing a new method will improve the overall quality of family planning programs in addition to increas- ing users’ contraceptive choices (93, 104). For more information on introducing a new contraceptive method, see the World Health Organization’s Making Decisions About Contraceptive Introduction, available at http://www.who.int/reproductive- health/publications/contraceptive_ introduction/index.htm. POPULATION REPORTS 7 having the equipment and facilities needed to provide implants, staff trained to perform insertions and removals and to counsel both new and continuing clients, as well as a well-functioning logistics system to maintain the supply of implants and other contraceptive methods (60) (see p. 8). Because the new implants are easier to insert and remove than the six-capsule Norplant system, family planning programs that have provided Norplant should be able to switch quickly to providing the new implants. There may be a period of unavoidable overlap as a program continues offering Norplant while introducing newer implants. This overlap could complicate training and counseling. In addition, providing implants with different durations of action requires attention to appropriate counseling for each method and keeping careful records of which implant a woman has. Programs need to take these and other factors into account when deciding which implants they are going to offer and when (see box, p. 6). A clinic in the Dominican Republic serves as an example of switching successfully from Norplant to Jadelle (see Spotlight, below). PROFAMILIA, a private nonprofi t clinic in Santo Domingo, Dominican Republic, had been routinely providing Norplant for 30 years when it successfully switched to Jadelle in 2002. Th e clinic was eager to start providing the new implant because Jadelle is quicker to insert and remove than Norplant, has fewer complications with removal, and is less visible in the arm. During the transition researchers studied the acceptability of Jadelle to clients and providers. Th e clinic off ered both Norplant and Jadelle to all clients at the same subsidized price of about US$30. Th e clinic’s staff learned to provide Jadelle quickly and easily. Initially, some clients were hesitant to use an unfamiliar product. PROFAMILIA has now stopped off ering Norplant, however, and its clients are satisfi ed with Jadelle as an alternative. Th e study fi ndings suggest that, especially where Norplant is well-known and liked, counseling clients about the comparative advantages of the new implants is necessary. Th is counseling led some women to choose Jadelle. Others, however, still preferred Norplant, while it was available. Once PROFAMILIA stopped off ering Norplant, counseling was very eff ective in helping Norplant-seeking clients accept Jadelle. Providers Adapted Quickly and Overwhelmingly Preferred Jadelle Because the PROFAMILIA providers were familiar with Norplant, they needed little training to start off ering Jadelle. Th e staff members attended a one-hour training followed by a question- and-answer session conducted by one of the researchers. Th e researcher discussed the two implants in terms of eff ectiveness, adverse events, continuation and termination rates, mechanism of action, and hormone levels in the blood. Th e researcher also explained insertion and removal procedures but did not perform either a live demonstration or use a model arm. Th e majority of the providers were satisfi ed with this training. One-third would have liked an actual demonstration of insertion and removal as well. Still, none of the providers felt that the lack of a demonstration limited their ability to insert the new implants. A clinic supervisor reported that the staff became comfortable with Jadelle “immediately.” After providing the new implant for 18 months, the providers almost unanimously preferred Jadelle over Norplant. Th ey favored Jadelle because fewer rods made insertion and removal easier. Some Clients Hesitant to Choose an Unfamiliar Product At the PROFAMILIA clinic some women were more comfort- able with the method that was well-known and recommended by friends and family, even when an alternative was available. Since there had been little local promotion of Jadelle, most women were unfamiliar with it. Providers explained to clients that inserting and removing Jadelle is quicker, but that Jadelle needs to be replaced after fi ve years, while studies have shown that Norplant is eff ective for seven years. After hearing this information as well as receiving it on a printed sheet, each client chose the implant that she pre- ferred. Nearly half of the clients chose Norplant. Th e most common reason cited for this choice was that Norplant had been recom- mended by a friend, relative, or provider. More than 40% of the women who chose Norplant mentioned that it is better known. Another 15% mentioned that it is registered in the country. Less than 15% said they preferred Norplant because it lasts longer, which is in fact its only potential clinical advantage over Jadelle. Slightly more than half of the clients chose Jadelle. Th eir most common reason was the fewer number of rods, followed by easier insertion and removal and less visibility in the arm. Because almost half of the clients chose Norplant, the researchers initially concluded that providers should continue to off er it while making the transition to Jadelle. While this might ensure that women are comfortable with their contraceptive options, recent experience suggests that it may not be necessary. PROFAMILIA no longer off ers Norplant. When clients request it, the provider explains the diff erences between Jadelle and Norplant and says that Norplant is no longer available. A clinic supervisor noted that virtually all clients accept Jadelle after receiving this counseling rather than choosing a diff erent contraceptive method or declining contraception altogether. Counseling alone will not persuade every client to choose an unfamiliar product, but it is important to give women complete and comparative information. Inadequate counseling may cause women to avoid a new product for the wrong reason. For example, nearly 9% of those who preferred Norplant chose it for the greater number of capsules, incorrectly reasoning that the additional capsules make it more eff ective. Th orough, clear counseling on the characteristics of new implants is essential to avoid such misperceptions and to help women make well-informed choices. Sources: Brache, 2007 (11); Brache, 2006 (12) SPOTLIGHT From Norplant to Jadelle : Smooth Transition in a Dominican Republic Clinic 8 POPULATION REPORTS Good implant services require a competent and well- prepared staff that can perform insertion and removal procedures and can help clients make an informed choice about implants. Programs can prepare providers to insert and remove implants through competency-based training. Providers can help clients interested in implants by: counseling them about side effects with an emphasis on bleeding changes; screening clients using the World Health Organization (WHO) Medical Eligibility Criteria; describing and answering questions about insertion and removal; and determining whether the client can have implants inserted immediately. Programs should also make sure they can assure women’s access to removal services. Who Can Provide Implants? Many different cadres of health care professionals can safely provide implants if they are thoroughly trained. These include nurses, nurse-midwives, nurse-practitioners, midwives, physicians, and, depending on educational and professional standards in each country, physician’s assistants and associates (16, 60, 124). Training a wide variety of health care professionals spreads awareness of implants and increases access to services (23, 30, 52, 79, 84, 103). Where only physicians can insert and remove implants, access to implants is unnecessarily limited. For example, when implant services were fi rst introduced in Ghana, only doctors had been trained to provide implants. As a result, women seeking implants often encountered long waiting times or found that the doctor was unavailable. EngenderHealth and the Ghana Ministry of Health collaborated to train a large group of nurses in implant insertion and removal and in related counseling. This effort contributed to a tenfold increase in the number of women using implants in Ghana (see Spotlight, p. 9). Competency-Based Training Helps Providers Learn By Doing Competency-based training develops the skills, knowledge, and attitudes required to meet standards of com- petence. Training continues until each trainee is competent to provide implant services, and satisfactory completion of training is based on the achievement of all the specifi ed competencies (108). Competence is defi ned as the point at which the trainee knows the steps in their sequence and can perform the required skill or activity (8). The approach focuses on the success of each trainee, recognizing that different providers need different amounts of practice to reach competence (16, 108). Although insertions and removals of implants are minor surgical procedures, experience in Norplant programs has shown that a formal competency-based training program, using model arms and supervised practice, leads to profi cient and confi dent providers (9, 13, 38). Information and communication technology (ICT) tools can deliver some aspects of competency-based training. Computer-based training offers a new means of self- education (7). Computers enable participants to control the pace and fl ow of their learning. Organon, the maker of Implanon, has developed a number of computer-based ICT training tools. For example, a CD-ROM on insertion and removal techniques not only includes slides presenting relevant technical information, but also offers videos of actual insertions and removals (see box, p. 11). Preparing to Offer New Implants Providers in Indonesia practice inserting Norplant implants in a model arm. Providers later go on to perform actual insertions under supervision until they demonstrate competence. Many different cadres of health care professionals can safely provide implants if they are thoroughly trained. Good implant services require staff competent to insert and remove implants and to counsel clients. © 1 99 2 G ar y B er g th o ld /J H PI EG O , C o u rt es y o f P h o to sh ar e POPULATION REPORTS 9 Between 1998 and 2003 more than 600 nurses in Ghana received training to provide Norplant implants (84, 103). Now more than 88,000 women have used or are using implants (47). Training nurses, as well as some doctors, was crucial to increasing access to implants and reducing waiting times for clients (23). Th e large number of providers trained to provide Norplant will make it easier for Ghana to start providing the new implants. Th e Ghana Health Service collaborated with EngenderHealth, a technical assistance organization, to carry out the training. Th e U.S. Agency for International Development (USAID) provided funding and supplies. Ghana’s previous policies implied that only doctors could insert implants. As a result, women seeking implants often encountered long waits or found that the doctor was unavailable. EngenderHealth staff documented these diffi culties, and this helped to convince policy makers to clarify the guidelines in 1996. Ghana’s national family planning guidelines now explicitly permit nurses to provide implants (23, 103). Th e training was directed to nurses instead of doctors because more nurses were available, nurses were more likely to stay in their communities, and nurses were more motivated to learn insertion and removal procedures. By comparison, doctors tended to have too much to do and were less interested in learning implant procedures (79). Initially, only a few doctor/nurse teams received training each year, starting in 1994. Widespread training of nurses started in 1998, after Ghana clarifi ed its policies (23). By building training capacity within Ghana’s health system, EngenderHealth and the Ghana Ministry of Health sought to assure that the training eff ort would be sustainable. EngenderHealth trained Ghana Health Service staff , who, in turn, trained providers to insert and remove Norplant (23). In addition to teaching technical skills, the Ghana Health Service trained an even larger number—almost 2,800 nurses —in counseling and interpersonal communication skills for all family planning methods, including implants (23). As a result, a national survey found that providers encouraged new clients to ask questions or share concerns about methods during 71% of visits in 2002, compared with 31% of visits in 1993 (41). Th e Ghana Health Service also promoted facilitative supervision, an approach that emphasizes mentoring, joint problem solving, and two-way communication between the supervisor and those being supervised. By playing a supportive, friendly role, supervisors helped providers improve various skills. For example, at fi rst only 25% of providers said that their supervisors examined records and gave feedback, or observed them providing services. After the training this increased to 75% for both indicators (23). One supervisor summarized, “People are now happy to see me and no longer try to hide away…. We sit down and discuss issues. I make suggestions on how staff can solve their problems” (48). Following the training, many more facilities off ered implants, and 88,000 women had implants inserted (47). Th e number of facilities off ering Norplant grew from 23 in 1994 to 168 by 2002 (23). Th e percentage of women of reproductive age using implants across the country increased from 0.1% in 1998 to 1.2% in 2006 (47). Ongoing Challenges Include Staff Turnover and Stock-Outs Training is an ongoing eff ort. In 2003 the trainers began to conduct refresher courses in Norplant removal (84). Depending on the caseload in a particular clinic, providers sometimes do not get enough practice performing removals to maintain their skills. Also, many providers leave the country or stop practicing, taking their new implant skills with them. Between 1996 and 2002 the number of doctors and nurses in Ghana decreased by 17% and 24%, respectively (23). As staff turnover occurs, trainers can educate the new staff , sometimes with on-the-job training, when courses are not possible (51). Ensuring a constant supply of implants is another challenge. Th e Ministry of Health of Ghana recognized the importance of reliable supplies and earmarked a small amount of its budget for Norplant, beyond USAID’s contributions (79). Still, problems with distribution and ordering have led to local shortages. In 1998 there were stock-outs of Norplant in almost every region (23). In 2002, while 17% of the facilities that provide family planning services in Ghana off ered implants, almost one-third of these did not have implants available on the day that they were surveyed (30) (see p. 14). Emerging challenges include funding and training for the transition to one or more of the new implants. Norplant will soon be discontinued, and USAID funding for Ghana’s national family planning program ended in 2004, although some district-level funding continues (51, 79). In 2005 the Ghana Food and Drug Board approved Jadelle (84). Th e trainers received training in Jadelle in early 2007. In several regions trainers are now training providers to off er Jadelle. Th e Ghana Health Service is making plans for the transition to Jadelle in other regions (51). For the short term Ghana has secured funding from other donors to purchase Jadelle, but the need for support will continue (79). Many African Women Will Choose Implants When Available Attempts to introduce implants in Africa have often failed because trained providers, adequate supplies, and awareness of implants have been lacking (79). Levels of use remain low in most of Africa. In countries such as Ethiopia, Kenya, and Tanzania, however, implant use is increasing (14, 42, 78). Th e experience of Ghana and other countries shows that many African women will choose implants when there are trained providers and implants available. SPOTLIGHT Training Nurses Increases Implant Use in Ghana 10 POPULATION REPORTS Training to insert Jadelle, Sino-Implant (II), and Implanon. Training for insertion requires attention to infection preven- tion procedures under sterile conditions, correct placement of implants, and care to minimize tissue damage. The rods are inserted just under the skin of the inner side of the upper arm. With Jadelle, the rods are loaded in a reusable hollow needle, called a trocar. Preloaded disposable inserters are available in a few countries. The clinician injects a local anesthetic into the woman’s arm and makes a small incision—about 3 mm long—using a scalpel or the tip of the trocar. The rods are placed, one at a time, to form the shape of a V opening toward the shoulder. Alternatively, the trocar is used to puncture the skin and insert the rods, without the need for an incision. The procedure should take only a few minutes. Usually, the incision or puncture does not require stitches. A small adhesive bandage and protective gauze bandage are all that are necessary (99). Sino- Implant (II) is inserted in the same way as Jadelle. Implanon comes packaged in a specially designed applicator. The provider identifi es the location for insertion on the inner side of the upper arm. After injecting local anesthetic, the provider uses the pre-loaded applicator to puncture the skin and place the single implant under the skin (67, 69) (see companion INFO Reports, “Implants: Tools for Providers,” pp. 8–9). Gauze or a pressure bandage minimizes bruising. Learning proper placement and removal requires practical, hands-on training. If an implant is not placed properly, removal may be diffi cult. Providers train for insertion on an artifi cial arm and later perform actual insertions under supervision until they can demonstrate competency (73). A study in Indonesia found that providers who were trained to practice on a model arm before performing supervised procedures with clients were more competent at insertions and removals than those who went directly from the classroom to performing actual insertions (10). Providers who are familiar with inserting and removing Norplant adapt quickly to the new implants (12). Providers who are new to providing implants need more training. Training to remove Jadelle, Sino-Implant (II), and Implanon. Most removals are not diffi cult, but removal usually takes longer than insertion. Because the new implants have fewer rods, removing Jadelle, Sino-Implant (II), or Implanon implants takes considerably less time than removing Norplant. There are two most commonly used techniques for removing new implants. With the “pop-out” technique, the provider fi rst feels the site to be sure she can locate the implant(s) underneath the skin. The provider then makes a small incision at the lower (distal) end of the implant, pushes the implant gently towards the incision until the tip is visible, and then removes it with forceps (54, 69, 99). The “U” technique (named after its developer Dr. Untung Praptohardjo) was developed for use when Norplant proved diffi cult to remove and also to make routine removals easier. The technique involves the use of an oval-ring-tipped forceps with an internal diameter of 2.2 mm to reach through a 4-mm incision to fi rmly grasp and remove each of the Norplant capsules. This technique is recommended for removing Jadelle as well (54, 58, 83). Ongoing removal training is essential. Every user of implants should be able to have the implants removed whenever she wishes, including when the end of their recommended lifespan has been reached. To make this possible, there must be suffi cient numbers and broad geographical distribution of providers trained in implant removal. As with training in insertion, training in removal starts with using the model arm, followed by closely supervised practice with actual clients. It can take time to gain clinical experience in removals, however. Early in a program, at least, many more women are having implants inserted than are asking to have them removed (84). Thus, over the years, ongoing training in removal, with refresher courses, is important. Providers can practice removals on anatomical models and watch videos of live removals. If it is not practical to keep up all providers’ skills for implant removal, an alternative is training a core group of providers, giving them continued support and guidance, and referring clients to these providers for removals. Helping Clients Make an Informed Choice Counseling users of implants on what to expect can be as important to the client’s satisfaction as proper insertion and removal techniques (16, 99, 112). If the client is interested in implants, the provider should: Counsel the client about possible side effects, particularly • bleeding changes, Screen the client, using the WHO Medical Eligibility Criteria,• Describe and answer questions about the insertion and • removal procedures (see box, p. 13), and Determine whether she can have the implants inserted • immediately. Counseling clients about side effects. Like some users of all other hormonal contraceptives, some users of implants report side effects such as weight gain, headaches, acne, and mood changes, but bleeding changes are the most common reason that women cite for discontinuing implants (28, 40, 53, © 2005 D r. Ph ilip p e Fau ch er/Paris An Implanon rod is inserted just below the skin of the upper arm. If implants are placed properly, removal usually is not diffi cult. POPULATION REPORTS 11 Information and Communication Technology Supports Implant Programs Family planning programs with access to computers and Internet services can use information and communication technology (ICT) to help them introduce and manage contraceptive implants. ICT Tools Can Help Train Providers in Implant Provision A number of organizations have developed computer-based tools to help train providers in implant provision. Th ese tools help providers develop competence with implant insertion and re- moval, improve their knowledge about the types of implants, and develop counseling techniques to help clients with continued use. Organon. Where Implanon is available, Organon has held training programs to familiarize health care providers with all aspects of its use. Participants have the opportunity to practice insertion and re- moval techniques under professional guidance. In addition, Organon has developed numerous computer-based training materials in English, French, and Arabic. A CD-ROM with a PowerPoint presentation about Implanon gives a detailed scientifi c overview of the method. An accompanying clinician’s manual and product monograph cover these topics in more detail. Another CD-ROM provides an animated display of the anatomy of the arm where the implant should be placed and insertion and removal demonstra- tions, including both correct and incorrect insertions. Videos show actual insertion and removal procedures and how to locate hard- to-fi nd implants with ultrasound (67, 68, 69, 70, 71, 72, 73). For additional information, see http://www.implanon.md. For more information in French, see http://www.contraception.organon.fr. Bayer Schering Pharma. Bayer Schering Pharma works locally with family planning programs around the world, off ering support and technical expertise in providing Jadelle. Th e training programs use a CD-ROM showing both actual and animated insertion and removal procedures. A PowerPoint presentation on Jadelle for trainers and providers gives a detailed scientifi c overview of the method. All trainees receive a Jadelle Insertion Training Kit, which includes a card to help measure exactly where the rods should be placed in the arm, scalpel, trocar, forceps, and other supplies. A training manual and product monograph off ers detailed information on the clinical profi le of the method, bleeding characteristics, and insertion and removal techniques (4). To request materials, contact Bayer Schering Pharma Oy, PO Box 415, FI-20101 Turku, Finland. JHPIEGO. JHPIEGO’s Internet resource collection Reproline contains a section dedicated to Norplant. Th e Norplant Web site off ers information about the method, service delivery guidelines, and a PowerPoint presentation that gives a thorough overview of the method. Th e site also off ers a PowerPoint presentation on man- aging bleeding problems, checklists for providers, and materials for training courses. Th e Norplant materials on the Web site are ready- to-use resources for clinical trainers and resource managers. Th ese resources can be used as visual aids or additional references for training, and they can be modifi ed, adapted, and translated into local languages. Th e Web resources can be used in conjunction with a paper-based learning resource package that contains a refer- ence manual and participant’s and trainer’s handbooks. As of August 2007 JHPIEGO is updating the Web site to refl ect revised medical eligibility criteria as well as recent fi ndings on eff ective- ness. Th ese materials are also available on a CD-ROM (59). See http://www.reproline.jhu.edu/english/1fp/1methods/1ni/ni.htm. Baylor College of Medicine. Th e Baylor College of Medicine provides a free online continuing medical education (CME) course on Implanon. Th e course covers the characteristics of the implant, common myths, and the benefi ts and side eff ects of the method. Th e course is presented in a PowerPoint format and is followed by a post-test (81). See http://www.contraceptiononline.org/slides/ talk_cme_activity.cfm?tk=28&cmepage=cme_info. Forecasting Tool Helps With Decision-Making When countries and family planning programs consider adding contraceptive implants into their method mix, they should assess whether they have the capacity to deliver the method appropriately (60). Th e ACQUIRE Project has developed a planning package of evidence-based tools and approaches. Th e package includes Reality Check, a forecasting tool that helps national and district level staff to project family planning needs and plan realistically to meet them. Projecting contraceptive prevalence rates for each method is essen- tial both to evaluate current eff orts and to make plans for the future. Th is tool can be useful for considering the introduction of new implants. For example, Reality Check could forecast future levels of implant use, commodity needs, and costs of implants at the district and site level. Th is can help program managers assess whether they have the resources to meet the needs forecasted by Reality Check (1, 80, 101, 110). For additional information con- tact the ACQUIRE Project at info-acquire@acquireproject.org. Computer-Based Tools Help Manage Supply To ensure a smooth introduction or transition to new implants, maintaining suffi cient supplies is essential. Pipeline Monitoring and Procurement Planning System (PipeLine), a PC database application developed by USAID through the DELIVER Project at John Snow Inc., generates the information needed to ensure timely receipt of products and to maintain consistent stock levels at the national and program level (50). Basic computer skills are all that are required to use PipeLine. For each product, PipeLine tracks rate of consumption, shipments of new products, inventory levels, and inventory changes. Graphic displays help managers to estimate supply requirements. Th e program can predict pipeline problems, including shortfalls, surpluses, or stockouts (50). Th is tool can be useful for planning implant procurements. Th e PipeLine software can be downloaded directly from the DELIVER Project Web site at http://www. deliver.jsi.com. To request a copy of the PipeLine CD-ROM, email deliver_pubs@jsi.com. POPULATION REPORTS 11 12 POPULATION REPORTS 95, 96, 99, 100, 102, 125). A client who knows about possible side effects beforehand is more likely to keep using a method even if side effects occur (36, 118). In Indonesia users of Norplant implants who were more knowledgeable about the method and about potential bleeding changes were more satisfi ed with the method than those who had less knowledge. In the province with the greatest differences in levels of satisfaction, 98% of women with a high level of knowledge about the method were satisfi ed overall compared with 33% of women with a low level of knowledge (109). Similarly, in a Norplant study in Senegal, women who perceived their counseling to be “thorough”—that is, counseling included discussion of side effects and of other contraceptive options—were less likely than other women to discontinue use of implants when bleeding changes did occur (112). Among the various side effects associated with implant use, bleeding changes can be particularly upsetting, especially if providers do not tell women about them and explain them in advance (111, 112). Providers should tell clients that, espe- cially in the fi rst year of using levonorgestrel implants, changes in bleeding patterns can include lighter bleeding and fewer days of bleeding, frequent irregular bleeding, prolonged bleeding or spotting that lasts more than eight days, infre- quent bleeding, or no monthly bleeding. After about a year of use, bleeding changes typically include lighter bleeding and fewer days of bleeding, irregular bleeding, and infrequent bleeding. Users of etonogestrel implants are more likely than levonorgestrel users to experience infrequent or no monthly bleeding (28, 40, 53, 95, 96, 99, 100, 102, 124, 125). Providers can explain that bleeding changes are usually harm- less and not likely to indicate a serious underlying condition. Usually, the bleeding changes gradually diminish. Every client should understand that she is welcome to come back to consult with the provider at any time. If the bleeding changes are not acceptable to the client, she should always have the option of switching to another, more appropriate method (124) (see companion INFO Reports, “Implants: Tools for Providers,” p. 7). Screening clients with the Medical Eligibility Criteria. Before a client can begin using implants, WHO recommends that a provider ask a client about medical conditions that could affect implant use (121). Using a checklist, a provider can ask a woman if she knows she has certain medical conditions— conditions that would make another method preferable (see companion INFO Reports, “Implants: Tools for Providers,” p. 4). A pelvic exam, blood tests, breast examination, and cervical cancer screening are not needed to decide whether a woman can use implants, although they may be helpful for other reasons. They should never be required for implant use. Can a client start implants immediately? A woman can start using implants any day of the menstrual cycle if it is reason- ably certain that she is not pregnant. For example, a client who has regular menstrual cycles can begin implants within seven days after the start of her monthly bleeding (fi ve days for Implanon). If it is more than seven days after the start of her monthly bleeding (more than fi ve days for Implanon), she can have implants inserted if it is reasonably certain for other rea- sons that she is not pregnant—for example, if she has not had intercourse since her last monthly bleeding. She will need to abstain from sex or use a backup method for the fi rst seven days after insertion. Also, if a woman is fully breastfeeding and her monthly bleed- ing has not returned, she can have levonorgestrel implants inserted any time between six weeks and six months after giving birth (124). Organon specifi es that Implanon can be inserted 21 to 28 days after delivery without need for backup. If it is inserted later, a woman should use a backup method for the fi rst seven days after insertion (69). (For more information on when to start implants and a checklist to help assess whether it is reasonably certain a woman is not pregnant, see Family Planning: A Global Handbook for Providers at http://www.fphandbook.org.) Access to Removal Services Is Necessary to Good Quality of Care Access to services for implant removal could strongly infl uence public perceptions of implants. Providers could be considered coercive if women cannot have implants removed when they want (43, 112). While the majority of Norplant users have had no problems get- ting their implants removed, some women have faced barriers. For example, clients have reported high prices charged for removal. One woman in Ghana who could not afford the cost said, “I have been here In Madagascar a woman considers choosing Implanon with the help of a family planning provider. Good counseling includes helping the client decide whether implants are right for her, discussing possible changes in menstrual bleeding, and describing the insertion and removal procedures. © 2005 D r. Ph ilip p e Fau ch er/Paris POPULATION REPORTS 13 What Clients Should Know About Insertion and Removal A client who has chosen implants needs to know what will happen during the insertion and removal procedures. Explaining the following important steps in the procedures tells the client what to expect (67, 69, 99, 124). Insertion: Removal: 1The woman receives an injection of local anesthetic under the skin of her arm to prevent pain while the implants are being inserted. This injection may sting. She stays fully awake throughout the procedure. 1The woman receives an injection of local anesthetic under the skin of her arm to prevent pain while the implants are being removed. This injection may sting. She stays fully awake through- out the procedure. 2.For Jadelle and Sino-Implant (II), the provider makes a small incision and inserts the implants just under the skin. Alternatively, the provider uses the trocar to puncture the skin and insert the implants, without the need for an incision. The woman may feel some pressure or tugging during insertion. With Implanon, there is no incision. The provider uses a special insertion applicator with a needle that punctures the skin and inserts the implant. 2.During removal the provider makes a small incision and uses an instrument (forceps or small tongs) to pull out each implant. The woman might feel some pressure or tugging and slight pain during the procedure and for a few days after. 3.After either procedure the provider closes the incision with an adhesive bandage. Stitches are not needed. The incision is covered with a dry cloth, and the arm is wrapped with gauze. Alternatively, two adhesive bandages can be used, one crossed over the other over the incision. 3.After removal the provider closes the incision with an adhesive bandage. Stitches are usually not needed. An elastic bandage may be placed over the adhesive bandage to apply gentle pressure for two or three days and keep down the swelling. 4.After implant insertion a provider tells the woman when she should return to have the implants replaced or else removed in favor of another method. She may be given a reminder card listing the type of implant she has, the date of insertion, the month and year when the implants will need to be removed or replaced, and where to go if she has problems or questions. 4.If a woman wants new implants immediately after her current implants are removed, they can be placed above or below the site of the pre- vious implants or in the other arm. With Implanon, the incision that was made for removal can also be used to insert the new implant. 5.After insertion she should keep the insertion area dry. She can take off the elastic bandage or gauze after two days and the adhesive bandage after fi ve days. 5.Return to fertility is immediate, so inform the client that if she does not get another implant or use another method, she could get pregnant immediately after removal. 6.After the anesthetic wears off, her arm may be sore for a few days. She also may have swelling and bruising at the insertion site. This is common and will go away without treatment. 7.The contraceptive effect starts within 24 hours. three times, and the nurse told me to bring 50,000 Cedis” (about US$5.75) (30)—a fee that was over fi ve times the minimum daily wage in Ghana in 2003 (116). In an Indonesian study of 3,000 Norplant users in the 1990s, 8% still had their implants beyond their prescribed lifespan of fi ve years. One-fourth of this 8% said that they never had the implants removed because the cost was too great. Among the women who had their implants removed, 9% reported having to make two or more requests (27). In Bangladesh 52% of Norplant users studied in the 1990s had to request removal two or more times. Some women were told that the doctor was too busy or that the implant could not be removed until at least fi ve years of use. In a few cases clients removed the implants by themselves (37). Clinics that offer implants should develop and communicate a clear policy on removal that states the following: When a woman wants her implants removed, she should • be able to have them removed promptly and free of charge, without undue waiting, regardless of where or when the implants were inserted. Every user of implants should be able to have the implants removed whenever she wishes. 14 POPULATION REPORTS A woman should not feel pressured to keep her implants. • They should be removed whatever her reason, whether it is personal or medical. All staff must understand and agree that women must not be pressured or forced to continue using implants. Clinics that do not have staff trained to remove implants should arrange to refer women to convenient services elsewhere. Providers can explain the policies to clients during counseling before they decide on implants. Reminders. Many clients need help to remember when their implants should be removed. In the study of Norplant removals in Indonesia, about 38% of women remembered on their own when the time came to have them removed. Some 13% were reminded by a family member or another user, and 49% were reminded by a family planning worker (27). Clinics can develop systems for notifying users when to have their implants removed or replaced. Follow-up in many situa- tions can be extremely diffi cult, but most programs give clients reminder cards to keep with other important documents. A notation on a client’s records is important, too. Seeing the notation, a provider can remind the client of the date when she visits the clinic for other services (62, 88). If a woman rea- lizes that she has missed the removal date and she is worried, but she has not become pregnant, a provider can reassure her that leaving the implants in place has caused no harm. Meeting Demand for New Implants Requires Supply and Access Throughout the world use of implants remains low, but de- mand exceeds supply. Many women want implants but are unable to obtain them. Women who want implants but can- not get them go on waiting lists or choose another method. Some experts contend that the true demand for implants is unknown because there are not enough supplies and services available to meet demand (42). Currently, few clinics offer implants. For example, in Ghana, only 17% of clinics surveyed by the Demographic and Health Surveys in 2002 offered contraceptive implants, and only 12% had them available on the day of the survey (30). In both Egypt and Kenya 13% of surveyed clinics offered implants. In Egypt 6% of clinics surveyed in 2002 and in Kenya 4% in 2004 actually had them available on the day of the survey (63). Programs that do offer implants often experience shortages. Shortages have been reported in Zambia (39) and Tanzania, and also in Madagascar, where clinics were reported to have run out of implants on the same day that the shipments arrived (105). In Kenya demand for implants continually out-runs supply (20, 42). Many women who want implants must choose other methods, while others prefer to wait—and risk unwanted pregnancy—until implants become available. Some Kenyan service providers keep lists of clients who are waiting for future shipments of implants (42). Word-of-mouth from satisfi ed users has created and sustained demand despite the recurrent stock-outs. A 2007 analysis of the implants market in Kenya concludes that, with an expansion of training in insertion, Kenya could make use of procurements of 200,000 implants per year. This would be an increase of more than fourfold, up from the 47,000 sets procured in 2005 (42). Cost is the largest barrier to access to implants. Many of the reported shortages of implants are due to their cost. In terms of supply cost, after the levonorgestrel-IUD, implants are the most expensive supply method of family planning, currently up to US$27 per set. Equipment for insertion, program costs of training and retaining providers with insertion and removal skills, and the time involved in insertion and removal also con- tribute to the high costs of implants (60). By comparison, copper- bearing IUDs, which last for at least 10 years, are available to the public sector for about US$0.21 to US$0.27 apiece (114). The relatively high initial per-unit cost of implants has pre- vented widespread provision of implants in resource-poor countries. Donors have limited their purchases because of the high price (87, 105). Fortunately, manufacturing costs are declining, donors and governments are placing larger orders and negotiating lower prices, and a lower-priced implant has become available— priced as low as US$4.50 per set. With such efforts to reduce costs, programs are more likely to be able to meet the demand for implants and to offer them to clients at lower prices. Programs Estimate Implants Needed A smooth transition to offering new implants requires suffi - cient supplies on hand. National family planning programs estimate the number of implants needed based on forecasted consumer demand, on one hand, and, on the other, the capacity of the program to provide clients with implants (87). In practice, it is often challenging to estimate requirements for implants accurately when they are new to the program. Accurate estimates of the need for implants enable programs to place timely orders to manufacturers, donors, or procure- True demand for implants is unknown because not enough supplies and services are available. POPULATION REPORTS 15 ment agents. The most accurate forecasts of consumer demand use several types of information. Usual information includes numbers of new and returning clients, recent trends in use and projected increases as implants become more available and changes in local population due to migration. The estimates of consumer demand, however, must be adjusted for program capacity, including the number of providers trained to offer implants (or any plans to train providers to offer them), the number of facilities that can provide implants, the availability of supplies required for insertion and removal (such as anesthetic, trocars, forceps), and in-country capacity to manage the distribution of implants, among other factors (87). Because implants are relatively new to some programs, forecasting may require other ways to assess consumer demand. Clinics could keep track of requests for implants, for example. Also, the number of clients requesting long- term methods would suggest potential interest in implants. Logistics staff could periodically speak with providers about their perceptions of the demand. (Key resources for ensuring reliable implant supplies are listed in Table 4 p. 16.) Once implants start to arrive, at the national level donors can meet periodically to review quantities of implants ordered and ensure that total quantities will meet the need without overstocking. At service sites logistics offi cers should review stock levels and trends in use each month and place orders as needed to maintain stock (24, 87, 91). At the central warehouse many countries have computerized systems, such as Pipeline Monitoring and Procurement Planning System, to help with forecasting (45, 91) (see box, p. 11). Warehouses must also keep track of supplies and ensure that the facilities are adequate to ensure quality. Storage requirements for implants are similar to those for other contraceptive supplies, such as oral contraceptives. Implants must be stored in a dry place at room temperature, about 15 to 30°C (59 to 86°F), and away from direct sunlight. Generally, implants are labeled for a shelf-life of fi ve years. Countries often purchase a portion of the implants required directly from the manufacturers (11, 64). For example, in late 2007 Ethiopia’s Ministry of Health is in the process of placing an order for 160,000 sets of implants, and Tanzania’s Ministry of Health is ordering 50,000 sets (106). Many thousands more are needed, however. For the remaining quantities needed, countries submit requests to donor agencies. Donors base their purchases from the manu- facturers on the total number of implant sets requested by all countries, taking budgetary considerations and current inven- tory into account. USAID usually can purchase and supply to countries only a portion of the estimated annual requirement of implants, plus some reserve for emergency orders (87). Donor Commitment Essential for Ensuring Supplies The availability of implants to users depends on affordability. The majority of women in low-resource settings would be unable to pay the full cost of implants and implant insertion. Some governments, such as the Dominican Republic’s, do not purchase implants due to their high cost. They make implants available in governmental clinics only when they receive donations of supplies (11). Donor support and fi nancial commitment from national ministries of health will be essential to meet the rising demand for implants. Donors (and national family planning programs) must be able to purchase implants at the lowest possible price. The 2007 price for Implanon is about US$19 to US$25 (90) and for Jadelle is US$21 to US$27 (5). The Population Council devel- oped Jadelle, largely with U.S. government funding, and then licensed it to Leiras Oy. Leiras Oy was taken over by Schering AG in 1996 and merged with Bayer in 2006. The resulting licensing company, Bayer Schering Pharma, is now making Manufacturing costs are declining, donors and governments are placing larger orders and negotiating lower prices, and a lower- priced implant has become available. Looking for information on other methods? www.iudtoolkit.org www.injectablestoolkit.org www.implantstoolkit.org www.infoforhealth.org/condoms Family planning method toolkits with up-to-date information, best practices, resources, and tools to help improve services. Coming soon. .and Condoms Questions & Answers. Visit www.infoforhealth.org for new resources on family planning methods. 16 POPULATION REPORTS Table 4: Key Resources for Program Managers and Providers of Implants Resource Availability Preparing to Introduce Implants Title: The WHO Strategic Approach to Strengthening Sexual and Reproductive Health Policies and Programmes Organization and Date: World Health Organization (WHO) (2007) Description: An overview of the three stages of the WHO Strategic Approach: conducting strategic assessments, testing pilot interventions, and scaling-up. Includes guidance for programs looking to introduce new contraceptive methods, such as implants. PDF available online at: http://www.who.int/reproductive- health/strategic_approach/index.htm For more information, contact: Peter Fajans, MD MPH, Scientist Department of Reproductive Health and Research World Health Organization 1211 Geneva 27, Switzerland Tel: +41-22-791-4137 Fax: +41-22-791-4171 E-mail: fajansp@who.int Ensuring Reliable Supplies Title: Pocket Guide to Managing Contraceptive Supplies Organization and Date: U.S. Centers for Disease Control and Prevention (2000) Description: A quick reference guide for staff who manage contraceptive supplies and logistics for a variety of methods including implants. Includes logistics formulas and principles. PDF available online at: http:// www.cdc.gov/reproductivehealth/ Products&Pubs/PocketGuide.htm To request print copies, contact: U.S. Centers for Disease Control and Prevention Division of Reproductive Health, MS K-22, 4770 Buford Hwy., NE Atlanta, GA 30341, USA E-mail: jtj2@cdc.gov Title: PipeLine Software Tool Organization: John Snow, Inc. (JSI) Description: A computer-based tool to help program managers monitor stock and plan procurement through forecasting, maintaining consistent stock levels, and preventing stock-outs. Tool available online at: http://www.infoforhealth.org/short_ url/?PipeLine To request the PipeLine CD, contact: John Snow, Inc./DELIVER Project 1616 N. Fort Myer Drive, 11th Floor Arlington, VA 22209, USA E-mail: deliver_pubs@jsi.com Web site: www.jsi.com Title: UNFPA Procurement Services Organization: United Nations Population Fund (UNFPA) Description: UNFPA is the largest public sector procurer of contraceptives. UNFPA accepts standard orders of US$6,000 or more, and also accepts emergency procurement orders. For more information, contact: UNFPA Procurement Services Section Midtermolen 3, P.O. Box 2530 2100 Copenhagen, Denmark Web site: http://www.unfpa.org/ procurement/index.htm Developing Technical Guidelines Title: Medical Eligibility Criteria for Contraceptive Use Organization and Date: WHO (2004) Description: A guide for the safe use of 19 methods, including implants, for women and men with known medical conditions. PDF available online at: http://www.who.int/reproductive- health/publications/mec/ To request print copies, contact: WHO/Department of Reproductive Health and Research 1211 Geneva 27, Switzerland E-mail: rhrpublications@who.int Title: Selected Practice Recommendations for Contraceptive Use Organization and Date: WHO (2004) Description: Evidence-based guidelines answering important questions on the use of major contraceptive methods, including implants. A companion to WHO’s Medical Eligibility Criteria for Contraceptive Use. PDF available online at: http://www.who.int/reproductive- health/publications/spr/index.htm To request print copies, contact: WHO/Department of Reproductive Health and Research 1211 Geneva 27, Switzerland E-mail: rhrpublications@who.int Helping Clients Make an Informed Choice Title: Decision-Making Tool for Family Planning Clients and Providers Organization and Date: WHO and the INFO Project, Johns Hopkins Bloomberg School of Public Health Center for Communication Programs (2005) Description: An evidence-based counseling resource for providers to help clients make informed choices about family planning. In- corporates WHO guidance from the Medical Eligibility Criteria and Selected Practice Rec- ommendations. Includes counseling help for new and continuing users of implants. PDF available online at: http:// www.who.int/reproductive-health/ family_planning/counselling.htm To request print copies, contact: Orders Center for Communication Programs Johns Hopkins Bloomberg School of Public Health 111 Market Place, Suite 310 Baltimore, MD 21202, USA E-mail: orders@jhuccp.org Title: Family Planning: A Global Handbook for Providers Organization and Date: WHO and the INFO Project, Center for Communication Programs, Johns Hopkins Bloomberg School of Public Health (2005) Description: A technical guide for providing family planning methods, including implants. Available online at: http://www.fphandbook.org To request print copies, contact: Orders Center for Communication Programs Johns Hopkins Bloomberg School of Public Health 111 Market Place, Suite 310 Baltimore, MD 21202, USA E-mail: orders@jhuccp.org Training to Provide Implants Title: Implanon Training Materials Organization: Organon International Description: Tools for training providers from the makers of Implanon. These include: Implanon clinician’s manual; Implanon product monograph; Implanon scientifi c information (CD-ROM); Implanon insertion, localization and removal techniques (CD-ROM); and Implanon guide de formation (CD-ROM in French). To request materials, contact: Organon International Institutional Affairs and Family Planning Department Postbus 20 5340 BH Oss, The Netherlands Tel: +31-412-66-2068 Title: Jadelle Training Materials Organization: Bayer Schering Pharma Description: Tools for training providers from the makers of Jadelle. These in- clude: Jadelle product monograph, Jadelle training manual, Jadelle insertion and removal video (CD-ROM). Also, a training kit for insertion and removal con- taining a model arm, instruments for in- sertion and removal, a leafl et for providers describing insertion and removal, and a reminder card for the client. To request materials, contact: Bayer Schering Pharma PO Box 415 FI-20101 Turku Finland Tel: +358-0207-785-21 Title: Norplant Implants Course for Nurse-Midwives: Trainers’ Notebook Organization and Date: Uganda Ministry of Health, United States Agency for International Development (USAID), Delivery of Improved Services for Health (DISH), Regional Centre for the Quality of Health Care of the Makerere University Medical School, JHPIEGO (2000) Description: This Norplant training manual includes a course guide and tips for trainers and a course guide for participants. Also, trainers’ checklists for evaluating participants’ counseling and clinical skills, including infection preven- tion practices and insertion and removal. PDF available online at: http://www.ugandadish.org/ norplanttrainer.pdf Title: Norplant® Implants Guidelines for Family Planning Service Programs: A Problem-Solving Reference Manual Organization: JHPIEGO Description: This Norplant manual is a course guide for trainers. Also includes notebooks and handbooks for participants. Available in English and French. To request print copies, contact: JHPIEGO 1615 Thames Street Baltimore, MD 21231-3492, USA Tel: +1-410-537-1800 Fax: +1-410-537-1473 E-mail: orders@jhpiego.net Title: Inserting and Removing Subdermal Contraceptive Implants: Training Guidance for Nurses Organization: Royal College of Nursing (2007) Description: Information on how to acquire the clinical skills for inserting and removing implants. Includes forms to record training experience. Developed for use in the United Kingdom according to local guidelines, but could be adapted for use in other countries. PDF available online at: http://www.rcn.org.uk/ publications/pdf/Inserting RemovingContraceptive Implants.pdf Resource Availability Helping Clients Make an Informed Choice (Continued) 16 POPULATION REPORTS POPULATION REPORTS 17 Jadelle more widely available at a lower price than before. Bayer Schering Pharma submitted the winning competitive bid to supply USAID with Jadelle in 2007, at US$21 per unit. USAID makes the implants that it buys available to a variety of sectors. In 2007 USAID donated 74% of its implants to ministries of health, 24% to non-governmental organizations, and 2% to contraceptive social marketing organizations. In 2006 and 2007 Ethiopia, Rwanda, and Haiti received the largest amounts of implants from USAID (87). Other large donor organizations also make bulk purchases of implants at discounted prices. In 2006 the International Planned Parenthood Federation (IPPF), the United Nations Population Fund (UNFPA), and USAID combined purchased about 270,000 sets of implants, a mix of Jadelle, Implanon, and Norplant, at an average price of US$28 per unit (see Web Table 1). Average prices have come down for 2007 (86, 105). Cost-Effectiveness Studies Show Long-Term Returns While the initial price of implants is high, they can be cost- effective when used for a number of years. For example, at the cost of US$27 for Jadelle, if a woman continues to use the im- plant for a full fi ve years, the cost of the implants divided by the number of pill cycles needed for the same number of years would be US$0.42. This is within the range of the cost of a cycle of oral contraceptive pills for which UNFPA pays US$0.16–US$0.63 per cycle. Also, over the long term, making implants available may reduce workload on the health system, and thus costs, because implants have higher continuation rates and are more effective than most other methods (47). Several detailed analyses have concluded that in the long run implants are relatively less expensive than shorter term methods such as pills and injectables, particularly when such factors as staff time, facility costs (such as consultation space), and equipment are taken into account (21, 66). A study in Mali found that, when implants are used for several years, they are comparable in cost to other methods. The study examined several actual costs including providers’ time and costs of sup- plies and equipment. Researchers concluded that after four years of contraceptive use the cost of providing a couple with a year of contraceptive protection was similar for Norplant, oral contraceptives, IUDs, and injectables (21). Another study, done in a clinic in Turkey, compared the costs of Norplant with the costs of oral contraceptives, taking into account the costs of supplies and staff time spent in counseling and follow-up visits, and actual continuation rates. The analysis estimated the total costs for one month of Norplant use at US$1.04 and one month of oral contraceptives use at US$1.58 (76). A modeling study in the United Kingdom (UK) comparing the levonorgestrel IUD, medroxyprogesterone acetate (DMPA), and Implanon, examined health care resources from the National Health Service’s perspective. The study found that the levonorgestrel IUD was the most cost-effective long-term method in terms of unintended pregnancies prevented, but Implanon was more cost-effective than DMPA, primarily because of the additional pregnancies that implants avert (117). Another UK modeling study found that Implanon was the most cost-effective in terms of unintended pregnancies avoided (and avoiding the costs associated with birth, miscar- riage, and abortion) when compared with Norplant and a levon- orgestrel IUD, DMPA, and oral contraceptives. This model used perfect-use effectiveness rates (how well the method protects against pregnancy when used consistently and correctly) and national discontinuation rates for each method (77). The cost-effectiveness of implants and other long-acting methods rises with length of use. Experience in both clinical trials and actual program use shows that most users of the new implants keep them for at least three years. Review of continuation data for Implanon, Jadelle, and Sino-Implant (II) from eight studies in a wide range of countries fi nds that 78% to 96% of users keep their implants for at least one year, and 50% to 86% keep their implants for at least three years (see Table 2, p. 5). (Implanon is intended for only three years of use.) In a multi-country study of Jadelle, over 55% of users con- tinued using the implant up to the maximum fi ve years (96). Implant services can be kept more cost-effective by avoiding routine follow-up visits, which provide no additional health benefi ts (61). No routine return visit is required until it is time to remove the implants (122). Of course, the client should be clearly invited to return any time she wishes, for any question or problem or any other reason (124). Reducing Costs Will Improve Access Why are implants so much more expensive than other contra- ceptive methods? First, both Jadelle and Implanon are owned by private pharmaceutical companies. The manufacturers try to recover expenditures for research and marketing as well as to make a profi t before patents expire and they face potential price competition from other manufacturers. Second, the manufacturing technology is particularly costly and complex. The manufacturer must have skills in handling both polymers to make the rods and small quantities of steroids. Production processes must be carefully controlled to ensure the right release rate. Costs could probably come down with the devel- opment of better technology and further research into making the production process cheaper (34). Third, manufacturing costs per unit depend on volume. Compared with orders for other contraceptives, current orders for implants are small. Implants could become cheaper as orders increase (6). Generic (nonexclusive) production of implants could reduce prices dramatically (33). Sino-Implant (II), developed by an academic collaboration and purchased by a company in Strategies for providing lower-cost implants include registration of Sino-Implant (II). 18 POPULATION REPORTS China, is an example. The patent on Jadelle has expired, and therefore generic versions are legally possible. In the U.S. the patent on Implanon expires on September 29, 2009. There may be one or two other companies looking into producing generic implants. If experience with the production of other hormonal contraceptives is a guide, however, most companies would fi nd it hard to meet acceptable quality assurance cri- teria (34, 35). Over the long term, manufacturers in the global south can be encouraged to raise their quality standards and consider making generic implants, as they commonly do other contraceptives (33). In the short term, implant prices already are falling as donors negotiate better prices for larger quantities. Manufacturers’ prices generally decline over time in any case. The strategies for providing lower-cost implants in the near future include pursuing registration of Sino- Implant (II), the cheapest implant available. Sino-Implant (II) is cheaper. Efforts are underway to increase the availability of Sino-Implant (II), which now has a wholesale price of about US$4.50. Manufactured by Shanghai Dahua Pharmaceutical, this implant has been available in China since 1997. It has been exported to and used in Indonesia since 2002. To date, Shanghai Dahua Pharmaceutical has distributed 5.3 million units of Sino-Implant (II). The company is manufacturing the implants in a new facility that adheres to industry quality standards (107). This implant is well-suited for widespread international registration because of its low price and because it is a “two-rod levonorgestrel-releasing implant,” as listed in the March 2007 edition of the WHO Model List of Essential Medicines (123). Family Health International (FHI) is working with local part- ners throughout Africa to ensure that Sino-Implant (II) meets regulatory standards for safety and quality—testing the rods as well as obtaining a second evaluation from an independent U.S.-based laboratory. FHI will help local partners register the implants with national drug regulatory authorities in Egypt and several other countries. As part of this initiative, FHI has negotiated price ceilings for the public and non-profi t sectors once national drug regulatory authorities have approved the product (107). Are clients willing to pay? While many women attending public clinics are accustomed to receiving family planning services free of charge, some women are willing to pay for good-quality family planning services, including a wider range of contraceptive choices that includes implants. Most private non-profi t family planning clinics already recover at least some of the costs of services directly from consumers (2, 29). Some programs make services more affordable through cross-subsidy, charging more than the program’s costs to provide less expensive services such as condoms or pills, to subsidize more expensive services such as implant insertion, and thus allow lower prices. Other strategies include sliding- scale fees—charging clients fees based on their ability to pay. Sliding-scale fees are more successful in middle-income countries, where some consumers can afford to pay higher prices, than in the poorest countries (3). Private clinics in Kenya charge the equivalent of US$30 and in the Dominican Republic, US$54 for implant insertion. The charges cover the costs of the implants and operational costs of providing the implants, including staffi ng (11, 42). In Nigeria, where the implants are subsidized by the government, clients pay the equivalent of about US$15 for Implanon (64). Still, the relatively high price of implants compared with other contraceptive methods is one of the main reasons for low use that were cited by program staff in Jos, Nigeria (65). Studies that ask prospective and current contraceptive users how much they would be willing to pay for contraceptive methods (known as “willingness-to-pay studies”) can be helpful in setting an initial consumer price for new implants (2, 29). Once an initial price is decided, program managers might conduct brief, small-scale pricing trials in a few service delivery points to ensure that the price is reasonable. In Guatemala USAID and the Population Council conducted a willingness-to-pay survey before introducing Norplant in clinics of the Asociación Pro-Bienestar de la Familia de Guate- mala (APROFAM). Information from this survey was used to set the price of the product at 90 Quetzales, or almost US$12 (2). Although some clients may be able to pay something, in reality most women will be unable to pay the full cost of implants and will require at least some subsidy. In Kenya A technician at the Dahua Pharmaceutical plant in Shanghai, China, assembles Sino-Implant (II) rods. The company is manufacturing the implants in a new facility, which adheres to industry quality standards. By 2007 Dahua Pharma- ceutical had distributed 5.3 million units of Sino-Implant (II), mostly in China. © 2006 M arku s Stein er/Fam ily H ealth In tern atio n al POPULATION REPORTS 19 the insertion fee charged at many public facilities amounts to US$7, but less or nothing at all if a client cannot pay the usual fee. Efforts there to create a true private-sector market for implants, without donor support, have failed because the product has been too expensive to date (42). Some programs have especially subsidized implants in an effort to encourage their use. When Norplant was introduced in Thailand in 1991, just over half of women received them at no charge. Because the national family planning program wanted to increase contraceptive use, the implants were highly subsidized, and the maximum price charged for Norplant amounted to US$8 (49). Because Egypt’s ministry of health wanted to support the introduction of Norplant, it shifted from charging the equivalent of about US$3.50 to charging no fee at all. Demand for Norplant insertions at all ministry health facilities increased substantially (22). In the face of limited resources for reproductive health, increasing subsidies likely means cuts elsewhere. Programs will have to examine their priorities and decide how much to subsidize implants over other reproductive health services. The new contraceptive implants hold substantial promise and are likely to broaden the appeal of the method. They are an important option in the range of long-acting methods. As family planning programs begin introducing the new implants or making the transition from Norplant, demand can be expected to rise. To meet the demand, programs will need to rely on donor and government subsidies, greater availability of lower-priced implants, and sharing the cost with users. Such strategies to improve access at lower cost will be key to the success of this contraceptive method. Bibliography This bibliography includes citations to the materials most helpful in the preparation of this report. In the text, reference numbers for these citations appear in italic. The com- plete bibliography can be found on the INFO Web site at: http://www.populationreports. org/k7/. The links included in this biblio- graphy are up-to-date as of publication. 12. BRACHE, V., FAUNDES, A., ALVAREZ, F., and GARCIA, A.G. Transition from Norplant to Jadelle in a clinic with extensive experience providing contraceptive implants. Contraception 73(4): 364-367. Apr. 2006. 15. CHAOVISITSAREE, S., PIYAMONGKOL, W., PONGSATHA, S., MORAKOTE, N., NOIUM, S., and SOONTHORNLIMSIRI, N. One year study of Implanon on the adverse events and discontinuation. Journal of the Medical Association of Thailand 88(3): 314-317. Mar. 2005. 16. CHIKAMATA, D.M. and MILLER, S. Health services at the clinic level and implantable contraceptives for women. Contraception 65(1): 97-106. Jan. 2002. 17. CRAVIOTO, M.D.C., ALVARADO, G., CANTO-DE-CETINA, T., BASSOL, S., OROPEZA, G., SANTOS-YUNG, R., VALENCIA, J., PALMA, Y., FUZIWARA, J.L., NAVARRETE, T., GARZA-FLORES, J., and PEREZ-PALACIOS, G. A multicenter comparative study on the effi cacy, safety, and acceptability of the contraceptive subdermal implants Norplant and Norplant-II. Contraception 55(6): 359-367. Jun. 1997. 19. CROXATTO, H.B. Mechanisms that explain the contraceptive action of progestin implants for women. Contraception 65(1): 21-27. Jan. 2002. 21. DOUCOURE, A., TANDIA, D., SANGARE, M., and KATZ, L. Programmatic evaluation of Norplant introduction in Mali. Bamako, Mali, Division Sante Familiale et Communautaire, Sep. 1995. 47 p. 25. FAN, H., HAN, L., JIANG, J., WU, M., and CHEN, B. A multicenter comparative clinical study of sino-levonorgestrel-releasing impants-No. I and No. II with Norplant. Journal of Reproduction and Contraception 15(2): 101-107. 2004. 26. FANG, K., GUAN, Y., and FAN, H. [A multicentre study of 2 types of Sino-Implant (expanded application) (two year follow-up)]. Chinese Journal of Family Planning 6(1): 11-14, 47. 1998. 27. FISHER, A.A., PRIHARTONO, J., TULADHAR, J., and HOESNI, R.H. An assessment of Norplant removal in Indonesia. Studies in Family Planning 28(4): 308-316. Dec. 1997. 28. FLORES, J.B., BALDERAS, M.L., BONILLA, M.C., and VAZQUEZ- ESTRADA, L. Clinical experience and acceptability of the etono- gestrel subdermal contraceptive implant. International Journal of Gynaecology and Obstetrics 90(3): 228-233. Sep. 2005. 29. FOREIT, J.R. and FOREIT, K.G. The reliability and validity of willingness to pay surveys for reproductive health pricing decisions in developing countries. Health Policy 63(1): 37-47. Jan. 2003. 32. GU, S., SIVIN, I., DU, M., ZHANG, L., YING, L., MENG, F., WU, S., WANG, P., GAO, Y., HE, X., and ET AL. Effectiveness of Norplant implants through seven years: A large-scale study in China. Contraception 52(2): 99-103. Aug. 1995. 33. HALL, P. What has been achieved, what have been the constraints and what are the future priorities for pharma- ceutical product-related R&D to the reproductive health needs of developing countries? Commission on Intellectual Property Rights, Innovation and Public Health, 2006. 63 p. (Available: http://www.who.int/intellectualproperty/studies/ reproductive_health/en/) 37. HARDEE, K., BARKAT E, K., KAMAL, G.M., RAHMAN, A.P.M.S., and MCMAHAN, J. Contraceptive implant users and their access to removal services in Bangladesh. International Family Planning Perspectives 20(2): 59-65. Jun. 1994. 42. HUBACHER, D., KIMANI, J., STEINER, M.J., SOLOMON, M., and NDUGGA, M.B. Contraceptive implants in Kenya: Current status and future prospects. Contraception 75(6): 468-473. Jun. 2007. 47. JACOBSTEIN, R. and PILE, J.M. Hormonal implants: New, improved, and potentially popular. ACQUIRE Technical Update, New York, The ACQUIRE Project/EngenderHealth, 2007. 2 p. 57. LIU, X., MAO, J., CHEN, X., WANG, Z., JIN, Y., WU, X., LI, H., ZHANG, J., ZHU, H., and SU, Z. The safety of Sino-Implant— 3-year clinical observation. Reproduction and Contraception 10(4): 234-241. 1999. 62. MILLER, K., MILLER, R., ASKEW, I., HORN, M.C., and NDHLOVU, L. Clinic-based family planning and reproductive health services in Africa: Findings from situation analysis studies. New York, The Population Council, 1998. 255 p. (Available: http://www.popcouncil.org/pdfs/Cbfp.pdf ) 65. MUTIHIR, J.T., GUFUL, F., and UJAH, I.A. Norplant acceptors in Jos, Nigeria. Annals of African Medicine 5(1): 20-23. 2006. 68. ORGANON. Implanon® insertion, localization and removal techniques. CD-ROM. 2002. 69. ORGANON. Implanon® product monograph. 2005. 84 p. 74. ORTAYLI, N. Users’ perspectives on implantable contracep- tives for women. Contraception 65(1): 107-111. Jan. 2002. 80. PILE, J., WILTSHIRE, J., KAKANDE, H., and SMITH, A. Recent trends in contraceptive prevalence and projections of contraceptive use: Implications for Uganda and ACQUIRE. [Unpublished PowerPoint presentation, obtained through personal communication with John Pile and Alyson Smith.] New York, EngenderHealth, The ACQUIRE Project, 24 p. 82. POWER, J., FRENCH, R., and COWAN, F. Subdermal implantable contraceptives versus other forms of reversible contraceptives or other implants as effective methods of preventing pregnancy. Cochrane Database of Systematic Review (3): CD001326. 2007. 86. REPRODUCTIVE HEALTH SUPPLIES COALITION. RHInter- change. (Available: <http://rhi.rhsupplies.org/rhi/index.do). 87. RILLING, M. (U.S. Agency for International Development) [USAID Procurements of Implants] Personal communication, Jul. 23, 2007. 93. SIMMONS, R., HALL, P., DIAZ, J., DIAZ, M., FAJANS, P., and SATIA, J. The strategic approach to contraceptive introduction. Studies in Family Planning 28(2): 79-94. Jun. 1997. 95. SIVIN, I., ALVAREZ, F., MISHELL, D.R., JR., DARNEY, P., WAN, L., BRACHE, V., LACARRA, M., KLAISLE, C., and STERN, J. Contra- ception with two levonorgestrel rod implants. A 5-year study in the United States and Dominican Republic. Contraception 58(5): 275-282. Nov. 1998. 96. SIVIN, I., CAMPODONICO, I., KIRIWAT, O., HOLMA, P., DIAZ, S., WAN, L., BISWAS, A., VIEGAS, O., EL DIN ABDALLA, K., ANANT, M.P., PAVEZ, M., and STERN, J. The performance of levonorgestrel rod and Norplant contraceptive implants: A 5 year randomized study. Human Reproduction 13(12): 3371- 3378. Dec. 1998. 97. SIVIN, I., LAHTEENMAKI, P., RANTA, S., DARNEY, P., KLAISLE, C., WAN, L., MISHELL, D.R., JR., LACARRA, M., VIEGAS, O.A., BILHAREUS, P., KOETSAWANG, S., PIYA-ANANT, M., DIAZ, S., PAVEZ, M., ALVAREZ, F., BRACHE, V., LAGUARDIA, K., NASH, H., and STERN, J. Levonorgestrel concentrations during use of levonorgestrel rod (LNG ROD) implants. Contraception 55(2): 81-85. Feb. 1997. 98. SIVIN, I., MISHELL, D.R., JR., DIAZ, S., BISWAS, A., ALVAREZ, F., DARNEY, P., HOLMA, P., WAN, L., BRACHE, V., KIRIWAT, O., ABDALLA, K., CAMPODONICO, I., PASQUALE, S., PAVEZ, M., and SCHECHTER, J. Prolonged effectiveness of Norplant® capsule implants: A 7-year study. Contraception 61(3): 187- 194. Mar. 2000. 99. SIVIN, I., NASH, H., and WALDMAN, S. Jadelle® levonorgestrel rod implants: A summary of scientifi c data and lessons learned from programmatic experience. New York, Population Council, 2002. 48 p. (Available: http://list.popcouncil.org/pdfs/jadelle_ monograph.pdf ) 100. SIVIN, I., VIEGAS, O., CAMPODONICO, I., DIAZ, S., PAVEZ, M., WAN, L., KOETSAWANG, S., KIRIWAT, O., ANANT, M.P., HOLMA, P., EL DIN ABDALLA, K., and STERN, J. Clinical performance of a new two-rod levonorgestrel contraceptive implant: A three- year randomized study with Norplant implants as controls. Contraception 55(2): 73-80. Feb. 1997. 104. SPICEHANDLER, J. and SIMMONS, R. Contraceptive intro- duction reconsidered: A review and conceptual framework. Geneva, World Health Organization, 1994. (Available: http:// www.who.int/reproductive-health/publications/HRP_ITT_ 94_1/contraceptive_introduction_reconsidered_review_ conceptual_framework.pdf ) 105. SPIELER, J. (United States Agency for International Development) [USAID purchasing of implants] Personal communication, Jun. 21, 2007. 107. STEINER, M.J. (Family Health International) [Sino- Implant (II) registrations in Africa] Personal communication, Jun.-Jul. 2007. 121. WORLD HEALTH ORGANIZATION (WHO). Medical eligi- bility criteria. WHO, 2004. 156 p. (Available: http://www.who. int/reproductive-health/publications/mec/) 122. WORLD HEALTH ORGANIZATION (WHO). Selected practice recommendations for contraceptive use. 2nd ed. Geneva, WHO, Department of Reproductive Health and Research, 2004. 170 p. (Available: http://www.who.int/ reproductive-health/publications/spr/) 124. WORLD HEALTH ORGANIZATION DEPARTMENT OF REPRO- DUCTIVE HEALTH AND RESEARCH (WHO/RHR) and JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH/CENTER FOR COMMUNICATION PROGRAMS (CCP). Family planning: A global handbook for providers. Baltimore and Geneva, CCP and WHO, 2007. (Available: http://www.fphandbook.org) 125. ZHENG, S.R., ZHENG, H.M., QIAN, S.Z., SANG, G.W., and KAPER, R.F. A randomized multicenter study comparing the effi cacy and bleeding pattern of a single-rod (Implanon) and a six-capsule (Norplant) hormonal contraceptive implant. Contraception 60(1): 1-8. Jul. 1999. ISSN 0887-0241 POPULATION REPORTS Population Reports are free in any quantity to developing countries. In USA and other developed countries, multiple copies are US$2.00 each; full set of reports in print, $35.00; with binder, $40.00. Send payment in US$ with order. Population Reports in print in English are listed below. Many are also available in French, Portuguese, and Spanish, as indicated by abbreviations after each title on the order form below. TO ORDER, please complete the form below. (PRINT or TYPE clearly.) Mail to: Orders, INFO Project, Center for Communication Programs, Johns Hopkins Bloomberg School of Public Health 111 Market Place, Suite 310, Baltimore, MD 21202, USA Fax: (410) 659-6266 E-mail: Orders@jhuccp.org Web site: http://www.jhuccp.org/orders Family name Given name Organization Address E-mail address Population Reports in Print 1. ‰ Send — copies of each future issue of Population Reports. ‰ I am already on the Population Reports mailing list. ‰ Send me a binder (in developed countries, US$7.00) 2. Language: ‰ English ‰ French ‰ Portuguese ‰ Spanish. ORAL CONTRACEPTIVES –– Series A — A-9 Oral Contraceptives––An Update [2000] (F, S) — A-10 Helping Women Use the Pill [2000] (F, S) INTRAUTERINE DEVICES––Series B — B-7 New Attention to the IUD [2006] (F, S) BARRIER METHODS––Series H — H-9 Closing the Condom Gap [1999] (F, P, S) FAMILY PLANNING PROGRAMS––Series J — J-39 Paying for Family Planning [1991] (F, S) — J-42 Helping the News Media Cover Family Planning [1995] (F, S) — J-43 Meeting Unmet Need: New Strategies [1996] (F, S) — J-45 People Who Move: New Reproductive Health Focus [1997] (F, S) — J-46 Reproductive Health: New Perspectives on Men’s Participation [1998] (F, S) — J-49 Why Family Planning Matters [1999] (F, S) — J-50 Informed Choice in Family Planning: Helping People Decide [2001] (F, P, S) — J-51 Family Planning Logistics: Strengthening the Supply Chain [2002] (F, S) — J-52 Performance Improvement [2002] (F, S) — J-53 Coping with Crises: How Providers Can Meet Reproductive Health Needs in Crisis Situations [2005] (F, S) — J-54 When Contraceptives Change Monthly Bleeding [2006] (with supplement: Key Facts About the Menstrual Cycle) (S) — J-55 Developing a Continuing-Client Strategy (with supplement: Measuring Success of a Continuing-Client Strategy) INJECTABLES AND IMPLANTS––Series K — K-4 Guide: Guide to Norplant Counseling [1992] (F, S) — K-5 Guide: Guide to Counseling on Injectables [1995] (F, P, S) — K-5 Fact Sheet: DMPA at a Glance [1995] (F, P, S) — K-6 Expanding Services for Injectables [2006] (with supplement: Injectable Contraceptives: Tools for Providers) — K-7 Implants: The Next Generation [2007] (with supplement: Implants: Tools for Providers) ISSUES IN WORLD HEALTH––Series L — L-10 Wall chart: Family Planning After Postabortion Treatment [1997] (F, P, S) — L-11 Ending Violence Against Women [1999] (F, P, S) — L-12 Youth and HIV/AIDS: Can We Avoid Catastrophe? [2001] (F, P, S) — L-13 Birth Spacing: Three to Five Saves Lives [2002] (F, S) — L-14 Better Breastfeeding, Healthier Lives [2006] (F, S) (with supplement: Breastfeeding Questions Answered: A Guide For Providers) (F, S) — L-15 Family Planning Choices for Women With HIV [2007] (with supplement: Women and HIV: Questions Answered) SPECIAL TOPICS––Series M — M-13 Winning the Food Race [1997] (F, S) — M-14 Solutions for a Water-Short World [1998] (F, S) — M-15 Population and the Environment: The Global Challenge [2000] (F, S) — M-16 Meeting the Urban Challenge [2002] (F, S) — M-17 New Survey Findings: The Reproductive Revolution Continues [2003] (F, S) — M-18 Men’s Surveys: New Findings [2004] (F, S) — M-19 New Contraceptive Choices [2005] (F, S) MAXIMIZING ACCESS AND QUALITY––Series Q — Q-1 Improving Client-Provider Interaction [2003] (F, S) — Q-2 Organizing Work Better [2004] (F, S) POPLINE Please send details on the following products/services: ‰ POPLINE: The world’s largest bibliographic database on population, family planning, and related health issues, is available on CD-ROM (free of charge to developing countries) and on the Internet, at no charge, at: http://www.popline.org ‰ Document Delivery: Receive full-text copies of POPLINE documents by mail or by e-mail. Special topic CD-ROMS: ‰ International Family Planning Perspectives CD-ROM ‰ New Survey Findings CD-ROM Searches: POPLINE searches can be requested by sending an e-mail to popline@jhuccp.org or by mail or fax (see above for address and fax number). �

View the publication

You are currently offline. Some pages or content may fail to load.