Decisions for Norplant programs - surgically implanted contraceptive - includes bibliography

Ann P. McCauley

Norplant is new. After decades of careful development and testing, Norplant implants are taking their place as the newest choice among family planning methods. Family planning programs now face important decisions about whether to offer Norplant and how to offer it in ways that meet clients' needs.

Norplant is already becoming popular. To date the implants are widely available or their use is expanding rapidly in 14 countries, including Indonesia, Thailand, and the US. An estimated 1.8 million women have used the method. Regulatory agencies in 23 countries have approved the product.

What Is New About Norplant?

The unique feature of Norplant is how it is used. Six flexible capsules, each about the size of a paper match, are placed just under the skin of a woman's upper arm. For five years the capsules steadily and slowly release a hormone that prevents pregnancy. Only one woman in every 500 becomes pregnant in the first year of Norplant use--a first-year rate as low as for any temporary family planning method. Over five years, one in every 25 women becomes pregnant. When the capsules are removed, a woman's normal fertility returns quickly. In the meantime, the method is easy to use: the user needs to do nothing more to avoid pregnancy.

Norplant implants are likely to suit some women especially well. Norplant may particularly suit women of all ages who do not want to become pregnant for several years, women who want no more children but do not want or cannot obtain sterilization, women who want the effectiveness of a hormonal method without the side effects of estrogen, women who do not want to worry about remembering a daily pill, and women far from dependable supplies of contraceptives.

Like every other family planning method, Norplant implants also have drawbacks. Like voluntary sterilization and intrauterine devices (IUDs), implants depend on specially trained personnel, who must insert and remove them. Like progestin-only injectables and minipills, they change menstrual patterns in most women. Also, they cost donor organizations and developing-country family planning programs US$23 per set, not including training, salaries, and other service costs for counseling, insertion, and removal. In the US, a set of Norplant capsules costs $350.

Deciding on Norplant

Because Norplant use depends on providers, a program that decides to offer Norplant makes a special commitment to meeting users' needs. These needs include a free and informed choice among methods, including Norplant; mass-media information and face-to-face counseling that help clients understand Norplant and decide whether it will suit them; services that do not create unneeded barriers to using Norplant by requiring unnecessary tests, procedures, or eligibility criteria and yet give adequate attention to clients who want more attention; help on hand when users need advice; and convenient services when they want the capsules removed. Programs must decide whether they can afford the necessary high quality of care, keeping in mind the long run poor care is more costly and more wasteful than good care.

Introducing Norplant

For programs that choose to offer Norplant, a clear consensus on its role is important. Managers in each program need to assess what are the most important characteristics of the new method, who might find Norplant most appealing, and what implants offer compared with other available methods--a planning process known as positioning. The role of Norplant in a program may depend greatly on what other methods, such as voluntary sterilization, IUDs, and oral contraceptives, are available and popular.

Program managers may want to position Norplant for women who want long-term, reversible contraception. At the same time, providers should not withhold Norplant or any other method from any client who can use it. Nor should they pressure any client into choosing it or continuing to use it against her wishes. In the long run programs are seeking successful users of family planning, and the most successful users are satisfied clients.

What Is Norplant?

Norplant(*1) implants are a new contraceptive method. Norplant consists of six flexible capsules, each about the size of a paper pocket match (see photograph, this page). The capsules are inserted under the skin usually on the inside of a woman's upper arm. The implanted capsules prevent pregnancy by releasing the hormone levonorgestrel into the blood stream at a slow, steady rate.

Norplant has many advantages. It is:

* Very effective at preventing pregnancy;

* Approved for five years of use;

* Reversible at any time by having the capsules removed;

* Free from estrogen side effects;

* Easy to use, with nothing to remember each day or at the time of intercourse;

* Convenient because there is no need to obtain supplies periodically.

The chief disadvantages of the method to the user are that she must depend on a health care provider to insert and remove the capsules and that the hormone, a progestin, changes menstrual bleeding patterns.

More than 1.8 million women in 51 countries have used Norplant. Several thousand women have used Norplant in clinical and pre-introduction trials conducted by, or in association with, the Population Council, developer of Norplant (151, 171). Implants are now widely available or their use is rapidly expanding in 14 countries including Indonesia, Thailand, and the United States, where hundreds of thousands of women use Norplant. In nine other countries regulatory agencies have approved Norplant, but it is not yet widely available, and three countries without drug approval processes offer Norplant in family planning programs. In these and other countries family planning officials are assessing Norplant and considering how to introduce it.

Norplant expands the range of family planning choices available to women. As with any method, its unique combination of features will serve some women particularly well. Women who want a long-term, reversible method may especially like Norplant. Women who have had, or are likely to have, difficulties with the intrauterine device (IUD) or the estrogen in combined estrogen-progestin oral contraceptives may want to try Norplant. Also, women who do not want to have a pelvic procedure can choose Norplant as an alternative to an IUD. As with other hormonal methods, Norplant can be used by women of any age and by women who have never been pregnant.

A new family planning method offers an opportunity to serve more people who want to control their fertility. Taking advantage of this opportunity requires: (1) good medical care during insertion, removal, and the management of side effects, (2) thorough, high-quality counseling, and (3) publicity that appeals particularly to women who might want Norplant and that informs them of available services (see pp. 16-17). Program managers must plan all of these activities before they introduce Norplant.

Cost is an issue in deciding how, or whether, to introduce Norplant. Both the costs of introducing the method and of providing the implants are higher than those of most other methods (see p. 15). Introductory costs include training health care providers to insert and remove capsules and to counsel women. Continuing costs include the salaries and infrastructure for the providers and the cost of the implants themselves, as well as continuing training. Each set of implants costs US$23 to nonprofit groups and public organizations in developing countries and to donor agencies. This commodity cost is much higher than the cost of an initial supply of other temporary methods. Because Norplant can be used for as long as five years, however, its cost per year may not be much more than that of some other methods (see Table 1). The cost per year for an individual woman depends on how long she uses Norplant. Some women will decide to have their implants removed before five years of use, and these decisions must be honored. Program managers must be sure that they can afford to introduce and provide Norplant in a way that does not compromise their clients' right to make their own health care decisions.

The Implant Method

Norplant implants combine materials used in other medical products into a new contraceptive delivery system. Norplant consists of a set of six capsules filled with the progestin levonorgestrel, which has been used in oral contraceptives for more than 20 years. The capsules are made of medical-grade Silastic tubing, a material like that used in medical drainage tubes and prosthetic devices since the 1950s. Each capsule is 34 mm long and 2.4 mm in diameter [151]. Through a small incision, the capsules are inserted one by one in a fan-shaped pattern just under the skin.

Each capsule contains 36 mg of levonorgestrel in crystalline form [151, 184]. The six capsules together initially release approximately 85 [mu]g per day, decreasing to 50 [mu]g per day by 9 months of use, to 35 [mu]g per day at 18 months, and then to 30 [mu]g per day during the third, fourth, and fifth years of use [151, 219].

How Norplant works. The levonorgestrel in Norplant prevents pregnancy in several ways. It makes cervical mucus thicker and reduces the amount produced. Sperm have difficulty moving through such thick and meager mucus, and therefore few sperm pass through the cervical canal to reach the uterus [32, 44, 151, 219]. Also, the progestin suppresses ovulation in at least half of menstrual cycles [31]. Recent research suggests that, even when ovulation occurs, endocrine dysfunction would usually prevent fertilization of the egg if sperm were to reach it [72]. The constant low levels of levonorgestrel also may suppress the growth of the endometrial dometrial lining of the uterus, thus preventing implantation [46, 200, 201]. A recent study of one menstrual cycle per woman found no sign of fertilization among 32 Norplant users, but 9 of the 20 women in a control group who wanted to become pregnant produced the glycoprotein human chorionic gonadotropin (hCG), which indicates the presence of a fertilized egg within nine days after conception. Six of these women in fact were pregnant [193]. [TABULAR DATA OMITTED]

Features That Women Most Appreciate

Women who have used Norplant like the fact that the implants are easy to use, effective, and reversible.

Easy to use. Once the implants are put into a woman's arm, she needs to take no further steps to prevent pregnancy for up to five years. Thus Norplant is particularly appropriate for women who do not want to worry about remembering to take a pill every day or to use condoms, spermicide, or a diaphragm at the time of sexual intercourse.

Effective. Norplant is one of the most effective contraceptive methods. The Population Council has compiled annual pregnancy rates and the cumulative 5-year pregnancy rate for 2,670 woman in 13 countries [174, 224]:

Annual Pregnancy Rates and 5-Year Cumulative Pregnancy Rate Among Norplant Users

           No. of Women   Rate per
            Completing       100
    Year       Year       Women
Year 1......  1,954        0.2        or 1 in 500
Year 2......  1,379        0.5        or 1 in 200
Year 3......  1,067        1.2   or about 1 in 80
Year 4......    743        1.6   or about 1 in 60
Year 5.....     476        0.4        or 1 in 250
5-year cumulative.......   3.9        or 1 in 25

The first-year pregnancy rate of 0.2 per 100 women for Norplant is lower than the first-year rates for injectables, oral contraceptives, and most other contraceptive methods [129, 151, 240] (see Table 1). In the first year Norplant is about as effective as the first year of progestin-only injectables, vasectomy, or tubal ligation [154].

Pregnancy rates among Norplant users have been higher among heavier women than among lighter women. In pooled data from Population Council studies, women weighing 70 kg or more had a cumulative pregnancy rate of 7.6 per 100 over five years of use compared with 0.2 per 100 for women who weighted 50 kg or less [151, 219]. During the first two years of Norplant use, pregnancy rates were similar for women of different weights, but the pregnancy rate increased for heavier women after the second year as the daily release of levonorgestrel diminished [219]. It is not known whether the differences in pregnancy rates are due to dosage requirements, genetic factors, metabolic characteristics due to different diets, or other causes [10].

Preliminary data suggest that pregnancy rates may be lower in all women and may differ less by weight with new tubing that has been introduced by the manufacturer, Leiras Oy [219, 224]. By the end of 1992 the Finnish company will produce Norplant implants only with the new tubing.

If a woman wants to continue using Norplant longer than five years, she can have the original capsules removed and a new set inserted. After five years of use the capsules continue to release levonorgestrel but in gradually decreasing amounts;thus the risk of pregnancy increases. All women should have the capsules removed after five years in any case because little is known about the effects of implants left in place longer.

Reversible. The implants may be removed at any time. Within 96 hours there is little progestin left in the blood [45]. Thus a woman's previous level of fertility returns quickly. In a study of 17 Nigerian women who discontinued Norplant, 14 ovulated within four weeks, and all ovulated within seven weeks. Also, cervical mucus gradually increased, and by the seventh week 80% of the women had mucus levels sufficient to facilitate pregnancy [110].

Several small studies show that more than 75% of women who want to become pregnant do so within one year after the implants are removed, a rate similar to those for most other methods [57, 140, 151, 191, 209, 219, 232]. In studies of 260 women of similar age and parity in Indonesia and Chile, pregnancy rates at four months were similar to those of women who had stopped using the IUD and higher than those of women who had stopped using injectable contraceptives, which are known to delay the average return of fertility somewhat beyond when the next injection would have been given [8, 57]. The length of time that a woman has used Norplant does not affect how soon she conceives after the capsules are removed [57, 232]. In the Nigerian study, however, those with regular cycles while using Norplant had more cervical mucus; they also ovulated and became pregnant more quickly after discontinuation [110].

Continuation Rates

Continuation rates for Norplant in clinical trials have matched or exceeded rates in clinical trials of the IUD, the other multi-year reversible contraceptive method [3, 126]. The average user in clinical trials has relied on Norplant for about 3.5 years [224]. Rates have varied, however. In five studies around the world, 76% to 90% of users completed one year of use, and 33% to 78% completed five years [219, 224]. Most women who discontinue Norplant for method-related reasons cite the changes in menstrual bleeding patterns that are common with this method. Others have the capsules removed because of headaches, weight gain or loss, hypertension, expulsion of a capsule, acne, hair loss, or hair growth. Norplant users in clinical trials had the capsules removed for other reasons as well. Some wanted to become pregnant, or their husbands objected to implant use. Others were moving, or they were widowed or divorced [7, 14, 107, 187, 190, 219, 230].

Side Effects

The side effects of Norplant resemble those of progestin-only pills (minipills) and progestin-only injectables. Change in bleeding patterns is by far the most common side effect.

Bleeding patterns. In various clinical trials 60% to 100% of women experienced menstrual changes [190, 219, 225]. The changes that women experience vary greatly. They include bleeding on more days per cycle, heavier bleeding, spotting between periods, infrequent or scanty bleeding, and amenorrhea (no bleeding at all).

Women who weigh less may be more likely to experience amenorrhea. For example, in a study of women in the US who weighed an average of 65 kg, 7% were amenorrheic [201]. In contrast, 20% to 30% of women were amenorrheic in a study in Sri Lanka and the Philippines, where women are generally lighter [21]. In a study of 1,000 Norplant users, lighter women in Chile, Sri Lanka, and Thailand had less irregular bleeding and less intermenstrual bleeding than heavier women, but the pattern was reversed among Chinese women, suggesting that dietary, genetic, or other factors may influence bleeding patterns [10]. It is impossible to predict accurately, however, just what pattern an individual woman will experience.

A Norplant user who has regular menstrual periods may be ovulating regularly and therefore face greater risk of pregnancy [54, 58, 201]. In a US study of Norplant use, the cumulative 5-year pregnancy rate was 1.4 per 100 women overall but 17.4 per 100 for women with regular bleeding patterns [201]. Women in the US study were heavier than those in other clinical trials, and heavier women are more likely to ovulate [47]. The women in the study were not using implants made with the new tubing, which is expected to lower pregnancy rates. [TABULAR DATA OMITTED]

Although a woman may experience bleeding at shorter intervals or bleeding on more days, she is likely to lose less blood than if she had a normal menstrual period [219]. In some studies the hemoglobin levels of Norplant users are higher than those of control groups--a beneficial effect for anemic women [64, 73, 151, 201, 219]. Not surprisingly, women whose bleeding decreased while using Norplant were most likely to have higher hemoglobin levels [73].

Other physical effects. Clinical trials comparing Norplant and IUD users find that certain conditions are statistically associated with Norplant (see Table 2). These conditions include headache, nervousness, nausea, dizziness, dermatitis (skin rash), acne, change of appetite, hair loss, increase in facial or body hair, breast tenderness, nausea, and enlarged ovarian follicles [14, 51, 107, 151, 174, 190, 219]. Although women who used Norplant reported these conditions more often than did women who used IUDs, it is not clear how implants might cause them. Acne, hair growth, and hair loss may be due to the androgenic activity of the hormone and are seen in women using oral contraceptives that contain levonorgestrel [26, 51]. Ovarian follicles sometimes become large enough to feel like cysts to a physician doing a pelvic examination. These follicles usually disappear without treatment. Surgery is necessary only on the rare occasions that the follicles twist and rupture, causing pain [174].

Insertion-site complications. If aseptic technique is used during insertion, the implant site seldom becomes infected. Other insertion-site complications also are uncommon. A pooled analysis involving 2,674 first-year users in seven countries found that 0.8% experienced infection, 0.4% experienced expulsion of a capsule, and 4.7% had temporarily irritated skin at the insertion site [104].

Insertion-site complications did not always occur immediately after implantation. Some 35% of infections and 64% of expulsions took place after the first two months of use. Similarly, 36% of skin irritations occurred after 4.5 months or more of use [104].

Some clinics have lower rates of infection at the insertion site than others. The differences suggest that some providers are more careful than others about maintaining aseptic conditions during insertion [24, 78, 104, 105].

Duration of side effects. Side effects, including disruption of bleeding patterns, appear to be most common and most severe during the first year of use, when progestin levels in the blood are highest [186]. In one study 72% of participants had irregular bleeding patterns during the first year, but by the fifth year only 38% had irregular bleeding patterns [201] (see Figure 1). Women who abandon Norplant because of bleeding problems account for part of this decrease, but some women who continue to use Norplant experience decreases in bleeding over time. In a study of 116 women who kept menstrual diaries for five years, the number of bleeding and spotting days decreased each year from a mean of 92 in the first year to 70 in the fifth year [151, 219]. In some women a bleeding pattern becomes established by six to nine months, but that pattern may not be a monthly cycle. The pattern may change little thereafter [24, 122, 219, 247].

One small study suggests that normal menstrual patterns resume after Norplant use. Of 12 Singapore women who discontinued use because of changed menstrual patterns, all reported normal periods one year after removal [209]. The World Health Organization (WHO), Family Health International (FHI), and the Population Council are now conducting a postmarketing study on reversal of side effects after discontinuation as well as other aspects of Norplant use.

Ectopic pregnancy. As with other hormonal contraceptive methods, ectopic pregnancies among Norplant users are a concern in the rare event that conception takes place. Progestin may reduce the motility of the fallopian tubes, slowing the progress of a fertilized egg and increasing the chances of implantation in the tube rather than the uterus [201]. Ectopic pregnancies can rupture tubes and cause internal bleeding and death.

Among Norplant users the rate of ectopic pregnancy is lower than among women who use no contraceptive method. In the US the estimated ectopic pregnancy rate among women who do not use contraception is 6.5 per 1,000 woman-years. The rate may differ substantially in other countries [121,214]. Among Norplant users in clinical trials, the rate of ectopic pregnancies was 1.3 per 1,000 woman-years [151]. By comparison, the estimated ectopic pregnancy rate for unmedicated IUDs is about 1.2 per 1,000 woman-years of use, and the estimated rate for combined oral contraceptives, which prevent ovulation, is 0.4 per 1,000 woman-years [214]. The rate of ectopic pregnancies is low for Norplant users because there are so few pregnancies at all. A higher percentage of the pregnancies that do occur are ectopic, however. In five years of clinical trials, 8 of the 46 pregnancies that occurred, or 17%, were ectopic [219, 224].

Ectopic pregnancy rates among Norplant users may be higher among heavier women and may increase with longer use of Norplant [151, 174]. Health care providers should consider ectopic pregnancy when examining a Norplant user who becomes pregnant or has lower abdominal pain. The possibility of increased ectopic pregnancies with longer use reinforces the need to remove the implants after five years, at least until longer use is studied further.

Physiological Effects

Studies of physiological effects indicate that Norplant is safe. Studies have found no significant changes in liver, kidney, adrenal, or thyroid function in Norplant users [151]. Studies of cholesterol levels have yielded ambiguous results [87, 151]. Although levels of total cholesterol consistently decreased, half of the studies found that the level of high-density lipoproteins (HDL) significantly increased--a beneficial effect--and the other half found that HDL decreased [87, 151, 195, 202, 203, 208]. The results of studies on clotting factors also vary, suggesting that other influences, such as diet, may be involved [151, 195, 205]. Until more is known, the Population Council suggests assuming that clotting factors change as they do in women who use combined estrogen-progestin oral contraceptives. They do not recommend Norplant for women with blood clots in the legs or eyes, which may be evidence of active cardiovascular disease [151]. Such women are at greater risk for complications in pregnancy, however. If they cannot or will not use a reliable nonhormonal method, progestin-only methods such as Norplant are preferable to combined oral contraceptives.

Norplant probably does not heighten the risk of strokes and heart attacks, as has been alleged with oral contraceptives and blamed largely on the estrogen component. Norplant contains no estrogen. Still, lacking long-term epidemiologic studies on circulatory system disease and Norplant use, which are feasible only after a method is widely used, the United States Food and Drug Administration (US FDA) and the Population Council have chosen a conservative approach and suggest that women who have hypertension, an important risk factor for stroke, should use a nonhormonal method unless their blood pressure can be regularly monitored [174]. A study of 600 Norplant users in Indonesia found no change in blood pressure during the first year of use, however [123]. A recent Nigerian study of 117 low-dose pill users and 76 Norplant users found that increases and decreases in blood pressure occurred with about equal frequency and in both groups. The change in either direction was moderate, but the range with Norplant was narrower than with oral contraceptives [65].

Recent studies report that glucose and insulin levels rise slightly when women start Norplant but remain within the normal range. These studies suggest that Norplant may affect carbohydrate metabolism [108, 109, 203, 205, 210, 241]. A woman with diabetes can use Norplant, however, if she or a health care provider can monitor her condition.

The Population Council began work on an implantable contraceptive in 1966. In the 1990s that work is reaching its objective as Norplant, the first implantable contraceptive, wins government approvals around the world and attracts more users. Over the years of development, research focused first on effectiveness and safety and then on Norplant users' opinions, the management of side effects, and program managers' needs. The Population Council has planned the introduction of Norplant to ensure that programs offer the implants with good medical care and counseling that helps women make a free and informed choice among methods.

Several organizations have cooperated in the development of Norplant. The Population Council has developed the implant concept, has conducted and overseen research and development, and is guiding the process of introduction. Wyeth-Ayerst Pharmaceutical Company carried out the toxicology studies on its drug, levonorgestrel, and Leiras Oy designed the equipment used to manufacture the capsules. The United States Agency for International Development (US AID), the International Planned Parenthood Federation (IPPF), the United Nations Population Fund (UNFPA), and governments and private organizations in several countries supported clinical and pre-introduction trials.

As of mid-1992 Norplant has been used in 51 countries and is widely available or rapidly becoming available in 14 (see table on back of "Norplant at a Glance," published with this issue). Norplant is playing different roles in the family planning programs of different countries--roles influenced primarily by the range of other methods available and differing abilities to pay for supplies and services.

History of Development

The development of oral hormonal contraception--the pill--in the 1950s paved the way for implantable methods. First with the combined estrogen-progestin pills and then with the progestin-only pills, researchers learned the dosages of these synthetic steriods required to prevent conception [191]. Of all the progestins, or progesterone-like compounds, tested, levonorgestrel eventually became one of the most widely used in oral contraceptives as well as the progestin chosen for Norplant [93].

The method of delivery, not the active agent, makes Norplant unique among contraceptives. Silastic, a polymerized silicone rubber material, is used in surgical tubing, pacemakers, and prosthetic devices because it is well tolerated by the body. (Unlike the silicone gel in the now-controversial breast implants used for prosthetic and cosmetic purposes [246], Silastic is a solid and does not leach into body tissue or circulation.)

In 1965 Sheldon Segal, then head of the Population Council's biomedical research staff, happened to discuss the properties of Silastic over lunch with a representative of its manufacturer. The conversation concerned an experiment in which a dye from Silastic tubing used in canine pacemakers dispersed and harmlessly disappeared into the animals' systems [93]. This discussion suggested to Segal that a similar slow diffusion of progestin might provide long-term contraception--a conclusion soon confirmed by research [192].

Horacio Croxatto, a Chilean physician then a Fellow at the Population Council, developed the delivery system by creating the capsule [93]. Over time his research team tested various synthetic steroids and various capsules in animals to ascertain their different release rates.

Clinical trials. Multinational blind comparative studies took place in 1974. Researchers tested implants containing eight different progestins in 36 different doese with 1,100 volunteers [93]. These studies gathered information on efficacy, duration of effect, and side effects.

Clinical trials of the three most promising capsule and progestin combinations began in Brazil, Chile, Denmark, the Dominican Republic, Finland, and Jamaica in 1975 [93]. In these trials 1,500 women volunteered to use the implant formulations, which were randomly assigned. The volunteers were asked to keep records of their menstrual patterns and to return for follow-up visits for one year [93, 151]. In 1977 levonorgestrel was chosen as the progestin for the new implants because of its long period of effectiveness and high level of effectiveness, and because extensive toxicity test results were already available [93, 151]. More clinical trials began between 1980 and 1982 in Chile, the Dominican Republic, Finland, Sweden, and the US [151].

Pre-introduction trials. Norplant pre-introduction trials began in 1980 and have taken place in 43 countries in all regions (see table on back of "Norplant at a Glance"). Pre-introduction trials typically involve more women and more service sites than clinical trials. About 40,000 women have participated, although published results are not available for most of these studies. These trials help to design appropriate training and informational materials for providers and users, to acquaint local medical personnel with the method, and to gather country-specific information for local regulatory approval. In addition, this experience with a small program assists managers later with logistics, training, and service delivery on a larger scale [19, 233]. The Population Council has collaborated with FHI, the Program for Appropriate Technology in Health (PATH), and the Association for Voluntary Surgical Contraception (AVSC) in pre-introduction and information efforts.

WHO, FHI, and the Population Council now are collaborating on a postmarketing study of 8,000 Norplant users and 8,000 sterilization or IUD users in Barbados, Chile, China, Colombia, Indonesia, Sri Lanka, and Thailand. Focused on safety, the study will follow up all of the women as they use their contraceptive method for five years. All women who discontinue any time after six months of use also will be followed up. The findings should be able to identify health-related events associated with implant use that occur with a frequency of one per 2,000 women or greater [158, 224].

Regulatory Approvals

By August 1992 Norplant had been approved for marketing in 23 countries and adopted by family planning programs in 3 more countries that have no regulatory approval process. The first country to approve Norplant was Finland, in 1983. This approval permitted Leiras Oy to export the capsules. As manufacturer of Norplant, Leiras Oy prepares the documents for submission to national drug regulatory agencies in all countries except the US. The Population Council, which applied to the US FDA, received regulatory approval for Norplant on December 10, 1990. Most countries require regulatory approval before a drug can be marketed, but manufacturers do not always immediately market the approved product. Thus Norplant is not widely available in all countries where it has been approved.

Leiras Oy and Wyeth-Ayerst Pharmaceutical Company have agreed on Norplant production and distribution. Wyeth-Ayerst produces levonorgestrel and sells it to Leiras Oy. Leiras Oy manufactures all of the implants and sells them to Wyeth-Ayerst, donor agencies, government family planning programs, and pharmaceutical distributors in countries other than the US and Canada. Wyeth-Ayerst markets Norplant in the US and, when approved, in Canada.

As noted (see p. 5), Leiras Oy has changed the Silastic used in making the capsules. This shift required changing the manufacturing equipment used in semi-automated production. Some regulatory bodies including the US FDA had earlier approved the capsules made manually with the new tubing. Leiras Oy must submit a supplement to the approved US FDA application to cover implants produced by the semi-automated process. Most other countries have already certified the implants with the new tubing made by the semi-automated manufacturing process. Supply of Norplant has not been affected by these changes [86, 257].

Norplant in the United States and Europe

Early clinical trials in the US, supported by US AID, involved 400 women and took place in the 1980s in Los Angeles, San Francisco, and New Brunswick, New Jersey [224]. Wyeth-Ayerst began preparing for nationwide introduction in 1988, when the company decided to market Norplant in the US [175]. In the first two years that Norplant was available in the US, about 500,000 women obtained implants. Almost three-quarters were under age 30. About half were married [264].

While the price for implants is US$23 per set for donor agencies and developing-country, not-for-profit family planning programs (see p. 15), in the US the price for a set of Norplant implants is US$350 to both public clinics and private physicians [117, 252]. All contraceptives are more expensive in the US than in developing countries. The US price covers Wyeth's expenses for its training program, promotion and sales of the method, and individual packaging of each implant with all the material required for insertion. Clients pay additional fees for counseling, insertion, removal, and follow-up visits. For example, in Baltimore clinics of the Planned Parenthood Federation charge a total of about $600--$350 for the implants plus $25 for a counseling session, $45 for a physical examination, and $175 for insertion and two follow-up visits [23, 146]. Removal at Planned Parenthood clinics in Baltimore costs the client about $100. Others' fees vary, but total cost can be as high as $1,000 [70]. Despite the costs, some providers in the US have a waiting list for implants because demand exceeds supply [15, 82].

Many US women have health insurance that will pay for Norplant. As of August 1992, 46 of the 58 major health maintenance organizations in the US had decided to reimburse women for at least part of the cost of Norplant insertion [257]. Health maintenance organizations provide all health care to members who pay a periodic fee. Private insurance organizations, such as Blue Cross, also will reimburse in some cases [15, 260]. Medicaid, the government-funded health insurance program for the poor, pays for the implants and a portion of the cost of associated medical services. Some public clinics that provide free or reduced-price services doubt that they will offer Norplant, however. They can serve more clients when they buy less expensive methods [251, 252]. Physicians and nurse-practitioners at clinics can apply for free implants to the new Norplant Foundation established by Wyeth-Ayerst to help low-income women. The foundation has an initial US$2.8 million to provide implants to about 10,000 US women who cannot afford the method and do not qualify for Medicaid [11, 69, 117, 250]. The foundation does not pay service costs. It has recently changed its requirements so that providers no longer must fill out a form for each woman who wants Norplant [68].

In Europe the first countries to approve Norplant were Finland in 1983 and Sweden in 1985. In both countries many contraceptive methods are available. In Finland about 3% of women who use contraceptives currently use Norplant [248]. About 70% of the 20,000 Finnish women who use Norplant received their implants in private clinics, and the rest received their implants in government family planning centers. On average, Norplant insertion costs US$200 to $250. The government has subsidized 60% of these costs in public clinics, but the amount of the subsidy is decreasing [248].

Elsewhere in Europe, Leiras Oy has guided clinical trials in Belgium, Bulgaria, Denmark, France, and Germany. Norplant has been approved in Czechoslovakia and the former USSR, but it is not widely distributed in these areas [118, 248].

Norplant in Three Countries

Indonesia, Thailand, and Colombia are among the first countries where Norplant is widely available. Patterns of use in these countries vary, reflecting differing circumstances.

Indonesia: Widespread Norplant Use

Over one million women in Indonesia have received Norplant through the extensive government family planning program. Indonesia aims to reach zero population growth by 2035-2050 [92]. Achieving this goal requires substantial increases in the number of contraceptive users [127]. At present, 49% of married women use a modern method of contraception. The government family planning program hopes that introducing new methods such as Norplant will attract new clients to family planning [91, 92]. Norplant is a valuable new method in the Indonesian program, particularly because sterilization is not available through the government family planning program. After clinical trials in 1981, the national family planning coordinating board, Badan Koordinasi Keluarga Berentjana Nasional (BKKBN), planned to offer Norplant primarily to women in remote areas where resupply of pills, condoms, or other contraceptives was difficult [123]. That same year, however, the Board of Islamic Religious Leaders issued a statement opposing all forms of sterilization [5]. As a result, government facilities stopped offering voluntary sterilization as part of the official family planing program [18, 127]. By that time BKKBN had begun a campaign to encourage couples to use more effective, long-term methods in place of oral contraceptives and condoms. Therefore they urged women who wanted to delay or end childbearing to use Norplant or IUDs [127]. Islamic leaders have recently stated that sterilization may be used judiciously, but it is not widely available [40].

In 1984 BKKBN, with support from UNFPA, bought 30,000 implant sets and made Norplant available at 87 hospitals and large health centers [97, 247]. UNFPA supplied another 25,000 sets in 1987 and 109,000 sets in 1988 [243]. The Indonesian government also has purchased implant sets with its own funds and with loans from the Asian Development Bank and, since 1990, the World Bank [175, 234].

Since regulatory approval in 1986, the number of new Norplant users has grown each year [92]. Norplant now accounts for 3% of Indonesian contraceptive use [91]. Most Norplant users live in the densely populated areas of rural Java, where providers were first trained. BKKBN has introduced the method in other areas with less dense populations, and 6% to 7% of contraceptive users in some of these areas use Norplant [91].

A variety of Indonesian women like Norplant. In rural Java, where the method was first widely used, most women are Muslim and do not accept sterilization or the pelvic procedure necessary for an IUD [5]. But women in other areas also like implants. In a national survey of 3,000 users conducted by BKKBN, 72% of the women interviewed said that they would recommend implants to others. About 65% of users did not want more children, but 30% definitely desired a future pregnancy [90].

By 1991 Norplant was used in all Indonesian provinces, especially in rural areas [91]. Government programs served 95% of Norplant users--50% at health clinics, 21% at temporary service sites called "safari," 16% through health posts or field workers, and 7% at hospitals. Private pracitioners served 4% [91]. Two-thirds of married women knew about implants, and 60% knew where to obtain them [91].

BKKBN has set a national goal of 300,000 new Norplant users per year [92]. As with goals set for other methods, provincial program managers must decide what portion of the national goal they can meet. Each year they assess past use of Norplant and other methods, estimate the anticipated number of new users, and then request supplies and service support accordingly [100]. Hospitals, clinics, and other centers receive their supplies and their funding according to their expected number of clients. At current international prices, it would cost more than US$8 million each year to supply Norplant capsules for the intended 300,000 new users, most of whom will use public clinics. Indonesia is considering local manufacture in hopes of reducing costs [92, 98].

Indonesian officials are now reassessing their past emphasis on numbers of new users. Health officials have concluded that, although initial acceptance of family planning has been high, continuation rates need to be higher. Therefore family planning services in Indonesia are now emphasizing high-quality service, including better counseling and screening, as well as numbers of new users. Temporary service sites--"safari"--are no longer used to provide implants because program managers found it difficult to screen and counsel women adequately at such sites [92]. Also, offering Norplant only in fixed facilities should hold rates of infection at the insertion site to a minimum and improve record-keeping.

Some 27 regional centers now train physicians to provide Norplant, including insertion and removal. Midwives also are trained to insert Norplant under the supervision of a trained physician, but they may not remove Norplant [34]. In addition, the general family planning curricula in medical and nursing schools cover the implant method. Recently, Indonesia has begun training more physicians in removal techniques because need for removals is growing.

Currently, women who receive Norplant in a public clinic pay nothing, while those who obtain Norplant through a private provider pay Rp. 70,000 (US$36) [41]. Indonesia's Blue Circle campaign, which provides participating private physicians and trained midwives with supplies at low cost, will soon offer Norplant.

Because Indonesia has the first large implant program, it is the site of several studies exploring long-term side effects, women's attitudes towards implants, and the planning requirements for a high-quality program. Indonesia is one of the locations in the multinational postmarketing study. BKKBN also is conducting its own internal evaluations of Norplant program needs [92]. Operations research studies are currently underway to review use dynamics, follow-up, and provision of removal services for women who have used their implants for five years [175]. The program also is participating in preliminary field trials of other contraceptive implants such as Implanon (see box, p.7) [92].

Thailand: Limited Use of Norplant

Thai family planning managers expect Norplant to attract new users to their program. The Thai government established the National Family Planning Program (NFPP) in 1970, and the contraceptive prevalence rate grew from 15% in 1969-70 to about 71% in 1987--a level like those in developed countries [27, 114, 138]. When the rate of increase in prevlence slowed in the 1980s, however, NFPP looked to Norplant and injectable contraceptives to attract women who were not using modern contraceptives.

A pre-introduction trial of Norplant began in 1980 with 1,000 volunteers [190]. In 1985 NFPP took the first steps to introduce the method nationally. NFPP held an orientation meeting for the chief medical officers of all 73 provinces, won regulatory approval for Norplant in 1986, prepared informational materials for trainers and general-practice physicians, trained trainers and other physicians in insertion and removal, and obtained implants and trocars [114, 151].

In 1986, 700 physicians were trained, one from every district hospital [27]. They were to serve an expected 10,000 users nationwide [114]. When import duties increased the cost of the implants from the 1986 price of US$13 to $36, however, NFPP bought one-third the number of implants originally planned [139]. Supplies were not adequate to meet demand throughout Thailand [27]. Thus implants were offered only to women in the remote northern hill areas and to Muslim women in the south, as an alternative to sterilization [139].

Training of physicians has expanded steadily [97]. Nurses in some hospitals also have learned insertion, removal, and counseling [95]. Norplant is discussed in medical and nursing school curricula, and some doctors and nurses are learning insertion and removal. For the most part, practicing health care providers learn the procedures and counseling skills informally by observing experienced practitioners.

In 1991 the Thai government bought 40,000 implant sets and made Norplant part of the contraceptive services available at all district hospitals. By mid-1992, 150,000 Thai women had used Norplant [249]. Because physicians have limited time available to do insertions, hospitals with nurses trained in insertion provide more Norplant than hospitals without specially trained nurses [95].

Women pay for the implants according to a sliding scale. Poor women and those in remote areas receive Norplant free of charge; other women pay something, and a few pay as much as US$8 for the implant and insertion [95, 97, 139]. Occasionally, NFPP runs campaigns to promote long-term family planning methods. To attract new users, they offer Norplant, IUDs, and voluntary sterilization without charge for a limited time [76]. NFPP expects Norplant to appeal to about 5% of women who seek contraceptives [139].

Thai couples have many contraceptive options, and NFPP considers Norplant appropriate only for women who want long-term birth spacing or who live in remote areas. The program discourages short-term use of Norplant because of the cost [27]. Women over age 30 with several children are encouraged to choose either IUDs or voluntary sterilization rather than the more expensive implants.

Colombia: Norplant in the Private Sector

In Colombia the private sector has played the largest role in offering Norplant. The family planning association Asociacion Pro-Bienestar de la Familia Colombiana (PROFAMILIA), an affiliate of the International Planned Parenthood Federation (IPPF), provides most contraceptive services, including Norplant. Some private physicians offer implants, too. Use of Norplant has grown gradually since government approval in 1986. The Corporacion Centro Regional de Poblacion (CCRP), a private research institute, began the first pre-introduction Norplant trials at two hospitals of the Ministry of Health [18, 239, 254]. In 1988 and 1989 more trials, involving nearly 3,000 women, began in PROFAMILIA clinics [97]. An additional 1,000 women received implants from PROFAMILIA in 1990 through the postmarketing study. In 1991 about 15,000 women were using Norplant in Colombia, and about 15,000 more are expected to receive implants in 1992 [239].

The first Colombian physicians to offer Norplant, from the Ministry of Health and PROFAMILIA, trained in the Dominican Republic. These physicians informally trained others at PROFAMILIA until 1991. Then 2-day seminars began to train personnel in all 40 PROFAMILIA clinics [239].

In 1987 the Sociedad Medico Farmaceutica (SOMEFA), a society of physicians in private practice, became the distributor of Norplant implants in Colombia [18]. In cooperation with the CCRP and the Fundacion Sante Fe (a private hospital in Bogota), SOMEFA organized training courses in insertion and removal. Since 1990 more than 50 physicians in private practice have attended these courses, and more than 500 health professionals have attended informational seminars in five locations [18]. SOMEFA has distributed over 1,000 implant sets to trained private physicians and expects that each will insert five implants per month [18, 97].

PROFAMILIA currently charges US$30 for Norplant if the client is not involved in a research study. This charge covers the implants, insertion, follow-up, and removal. While the charge is below PROFAMILIA's costs, it is still expensive for many Colombian women [239]. Although PROFAMILIA charges less than cost for all methods, it charges more for implants than for any other method including vasectomy and tubal ligation. Currently, PROFAMILIA is undertaking two studies on the cost of Norplant. One will study the demand for Norplant at different prices; the other will compare the cost components of Norplant and of other methods in part to determine whether Norplant and of other methods in part to determine whether Norplant is more expensive to provide than voluntary sterilization [18, 175].

Deciding on Norplant

In deciding whether to introduce Norplant, providers must assess the benefits and costs of the method. Managers of family planning programs first need to determine how this new method might meet clients' needs. They also must consider the requirements for starting and maintaining the program and how they will pay the costs. Private providers, too, must determine whether their clients will be interested in this new contraceptive method and willing to pay for it. To make such assessments, providers may want to consider:

* How will Norplant help meet women's needs?

* Will implants further program goals?

* How much will Norplant services cost?

* Can the program provide high-quality Norplant services?

* Who can help support Norplant services?

How Will Norplant Help Meet Women's Family Planning Needs?

Family planning clients are best served when they can choose from a variety of methods [35]. Different clients have different needs and preferences, and any client's needs may change over the years that she uses family planning. When a variety of methods is available, clients are more likely to find a method that they like and will continue using.

In clinical trials Norplant's unique combination of features appealed to several different groups of women. Many women were attracted to Norplant because it was effective for five years but also reversible. Others liked the convenience of a method that did not require frequent clinic visits. Still others were interested in trying a new method. In clinical trial sites in Thailand and the US, 50% of new Norplant users had been using oral contraceptives before trying implants. In Thailand another 20% switched from injectables, and 12%, from IUDs [107]. In the US, another 14% had been using condoms, and 14% had been using diaphragms [48].

Couples dissatisfied with other methods also may choose Norplant. Women who do not want to take a daily pill may prefer the ease of implant use. So may couples who dislike using condoms, diaphragms, or spermicides at the time of intercourse. Implants also may appeal to women bothered by estrogen-related side effects of combined oral contraceptives, such as nausea and headaches, and to women who have had difficulties with IUDs.

The range of methods available will influence the appeal of Norplant. When the Indonesian family planning program decided to encourage women to use long-term methods, they offered implants, injectables, and IUDs but not voluntary sterilization (see p. 11). Because IUDs and implants do not need frequent resupply, Indonesian clinics emphasized these two methods [123]. Thus in Indonesia Noplant is often a method for women who want no more children[7]. Similarly, many of the women who chose Norplant in clinical trials in Egypt, the Philippines, and Sri Lanka said that they did not want more children [21,24,71]. By comparison, in Thailand, where sterilization is widely available, women who do not want more children are encouraged to choose sterilization rather than Norplant [179,262].

In Sri Lanka many younger women who used modern contraceptives were interested in using Norplant. As part of the Rural Family Planning Survey in 1985, interviewers told more than 2,000 women about implants and asked whether they would be interested in using them. More than one-third were interested. These women tended to be younger women who wanted to delay pregnancy for several years and who already used some form of modern contraceptive method, either alone or along with a traditional method [236].

Norplant may appeal especially to certain groups of women for geographical or cultural reasons. In Indonesia, Kenya, and Thailand, family planning program managers initially addressed Norplant services to women in remote areas where it is difficult for them to obtain oral contraceptives, condoms, and other family planning supplies [123, 153]. These policies have been modified in Indonesia and Thailand, however, until it becomes possible to ensure good follow-up services for these women. Also, implants may appeal practically to some Muslim women who may not approve of sterilization--or whose husbands or religious leaders may not approve--or who want to avoid the pelvic procedure necessary for an IUD [247,262]. These women, however, may particularly object to the irregular menstrual bleeding that can be a side effect of Norplant because they cannot pray or have sexual intercourse while bleeding.

Once Norplant is more widely used, researchers will be able to develop profiles of women who are likely to be most satisfied with implants. Then providers can use this information to advise women about contraceptive choices, and programs can use it to help design promotional and informational messages and materials (see pp. 16-17). These profiles will differ from one country to another because of religious, cultural, geographic, and programmatic factors. A study found that potential Norplant users in Bangladesh, Haiti, Nepal, and Nigeria differed in average age, education, desire for future pregnancy, and number of children. For example, in Bangladesh and Nepal the women with the least education were most interested in Norplant, but in Haiti the most educated women were most interested [102]. Providers should remember, however, that some women who do not fit the profile may want to use Norplant and may be very satisfied with it. For example, young women who have no children, including unmarried women, may want to use Norplant as much as older women who have all the children they want.

Will Implants Further Program Goals?

Most family planning programs are established to improve the health of women and children and/or to contribute to socioeconomic development by slowing population growth. Thus most programs seek to increase the number of couples using family planning, increase the effectiveness of use, and lengthen the use of effective family planning methods. In the long run this is best done by making readily available the services that people want. By meeting clients' needs, Norplant can help accomplish all three goals. As a new method, Norplant can attract women who have never used an effective method and can serve women who have discontinued other methods. As a highly effective method, Norplant can improve the effectiveness of the overall method mix. As a long-acting, low-maintenance method, Norplant can extend overall continuation rates.

To what extent will Norplant attract women to contraception for the first time? At this point, evidence is slight because Norplant has not yet been widely offered in many countries. The pre-introduction trials did not promote the method to the public but instead found volunteers among women who came into family planning clinics for contraception.

There is some evidence, however, that implants may attract new contraceptive users. In Egypt, word of the new method spread, and women lined up to join the pre-introduction study [261]. In Indonesia a study of 8,681 Norplant clients in 1984 found that 36% had not used any method previously [81]. In Thailand 13% to 20% of women who chose Norplant in clinical trials had never used any contraceptive method before [107,190]. In a study of 550 women at 11 Thai hospitals, 12% of women who chose Norplant had never used a modern contraceptive method before. Most of the women in this last study were young, however, and just beginning to need contraceptives. Nearly all would have chosen another method if Norplant had not been available [96].

Most women who switch to Norplant from other methods will be switching to more effective contraception. For the first year of use Norplant is more effective than oral contraceptives, condoms, spermicides, and Natural Family Planning, and over five years Norplant is as effective as the most effective IUD [154].

In clinical trials Norplant continuation rates have been about the same as or better than the clinical trial rates for the IUD and better than the rates for other temporary methods (see Table 1). As with all other methods, the best way to improve continuation rates is to satisfy clients. In an Indonesian study 75% of those who were given the method that they preferred continued use for at least one year. In contrast, after one year only 15% of those who did not get the method they wanted were still using the method that they had received [144].

How Much Will Norplant Cost?

Cost is a major consideration with Norplant. The cost of the implant itself and the cost of introducing the method make implants more expensive than other methods. The implants cost nonprofit and government programs in developing countries US$23 per set. In addition, medical professionals must be specially trained to insert and remove the implants. As with other new methods, there are also start-up costs for training other personnel and for communication.

Much of the program cost for supplies, training, and service delivery is up-front cost--that is, cost incurred before a woman begins using implants. Voluntary sterilization, too, has high up-front costs. Therefore the cost per couple-year of contraception provided by both methods decreases as length of use increases.

Thus length of use--and client satisfaction, which determines length of use--are crucial to cost-effectiveness. To compare the costs of implants and other methods, planners should average the costs for supplies and services over the years of use. In clinical trials the average length of use for implants was 3.5 years [224], and the implants can be used for as long as five years. In terms of the cost of the commodity alone, Norplant costs somewhat more than a 3.5- to 5-year supply of oral contraceptives, condoms, or injectables and costs far more than an IUD over the period (see Table 1).

A study in the Dominican Republic found that the full service cost per couple-year of protection was greater for Norplant than for the IUD or female sterilization. Researchers at the Asociacion Pro-Bienestar de la Familia (PROFAMILIA), the family planning association, considered the costs of personnel and materials for each office visit, the average number of client visits for each method, and the duration of visits. They assumed that Norplant users would continue with the method for an average of 3.5 years, as did IUD users, and that sterilized women receive on average 16 years of contraceptive protection. They calculated that in 1993 the PROFAMILIA clinic would incur costs of US$15 for an IUD, $16 for female sterilization, and $30 for Norplant for each couple-year of protection [12].

Norplant may increase the costs of a family planning organization if women switch from less expensive methods or if they switch from private medical facilities to publicly funded ones in order to obtain Norplant. The study of 550 new Norplant users in 11 Thai hospitals found that 97% of the women would have used another method if implants had not been available. Also, 19% of the women had been buying contraceptives from pharmacies or private clinics but came to a government-funded hospital for Norplant [96]. In Thailand the great majority of women who want to control their fertility are using family planning. Where more of the demand for family planning goes unmet, Norplant might attract more new users to family planning a fewer from private sources of contraceptives.

Norplant price. How is the price of Norplant implants determined? The Population Council and Leiras Oy concluded a licensing agreement in 1983. The agreement establishes a formula for setting the price of implants for developing-country nonprofit organizations. Leiras Oy periodically recalculates its price based on its manufacturing and distribution costs, which include labor, materials, factory overhead and depreciation, insurance, and dissemination of information [165]. According to the formula, the price for nonprofit organizations cannot be greater than a fixed margin over these costs. This price is available to donor agencies and various organizations in developing countries--governments, government agencies, private nonprofit agencies offering family planning, and other groups offering family planning services at or below cost or without charge. Over the years the price of the implants has risen as Leiras Oy has begun charging purchasers for the full costs of production [118]. The price was US$13 in 1986, $18 from 1987 to 1989, and has been $23 since 1990 [243]. Prices in the commercial sector in developed and developing countries are not controlled [168]. In the US, a set of capsules costs $350.

The current price of US$23 for nonprofit organizations in developing countries covers only the implant set. There are additional costs for shipping, and a trocar that can be resharpened and used for about 50 insertions costs US$6. Including freight and insurance against damage in transit, the International Planned Parenthood Federation (IPPF) charges US$28.58 to its affiliated family planning associations for an implant set not including the trocar [194].

By the end of 1992 Leiras Oy expects to replace the manual process of making implants with a semi-automated process that will increase production. Eventually, increased sales may help to reduce the price, but Leiras Oy first must recover US$23 million spent on developing the manufacturing process and on applications for regulatory approval [168].

Indonesia and China plan to manufacture their own implants in hopes of reducing costs. Indonesia is negotiating with Leiras Oy for a local manufacturing agreement, and China is developing its own implant [75]. Local production of other contraceptive supplies has lowered their prices to family planning programs and users [241].

Projecting total commodity cost. Experience is too limited to offer much help in predicting demand for Norplant. In Finland, where a wide variety of methods is available, 3% of contraceptive users have chosen Norplant. Laneta Dorflinger has used this rate to project commodity costs for various countries. She has estimated the number of insertions each year needed to supply 3% of the projected number of users of modern contraceptives in 1995. Her analysis assumes a rate of population growth, number of women of reproductive age, and estimated prevalence of modern contraceptives based on data from the US Bureau of the Census. This analysis also assumes a discontinuation rate of 15% per year for Norplant. In Kenya, for example, there are projected to be 4.3 million women of reproductive age in 1995, with 28% using modern contraceptives. If 3% of these women used implants, 9,935 implants would have to be inserted each year, at a commodity cost of about US$228,500 per year for the implants only. In Mexico 63,990 annual insertions would be needed to supply implants for 3% of the women who use contraception. The commodity cost would be about US$1.5 million [60]. Of course, analysts must adjust such cost projections to local conditions, making their own estimates of the expected level of Norplant use.

Can the Program Provide High-Quality Norplant Services?

Program managers may see Norplant as a new method that will benefit clients, but they also must assess their ability to provide high-quality services [116]. Judith Bruce has identified six elements that are fundamental to the quality of all family planning care [35]. These six elements apply to Norplant services:

Choice of methods. Clients have different contraceptive preferences and needs. High-quality family planning services offer a choice of contraceptives and provide a reliable supply of all of the methods that they offer. When Norplant is introduced as an additional choice, women should still be told about other methods and encouraged to choose the method that they prefer.

Information given to clients. Providers should give clients accurate information about all available methods and more detailed information about the method that they choose--all in ways that clients understand and find relevant to their needs. When Norplant is introduced, providers should already know and be able to explain how the method works, how it is used, its advantages and disadvantages, the possible side effects, and the insertion and removal procedures (see p. 23). Providers also should be able to help women decide whether Norplant suits their needs and how to take a relevant medical history. Clients must also know where to come for care, the signs that indicate that they should return to the clinic, the schedule of follow-up visits, the date for implant removal, and where to go for removal (see p. 24).

Technical competence. Providers should be competent in performing all necessary medical procedures. Before Norplant is introduced, medical personnel must be trained to insert and remove implants, and support personnel must be trained to maintain aseptic conditions and to handle supplies. Appropriate providers must be prepared to counsel clients about choosing and using Norplant. Sufficient numbers of trained staff must be ready as the program grows and as previously trained staff are reassigned. Systems of supervision and record-keeping should be ready.

Interpersonal relations. Clinic personnel should see their job as helping clients to use family planning. They should have training in understanding the clients' point of view and in communicating with clients in a helpful, friendly manner. If clinic personnel have this attitude and these skills, they can easily offer Norplant in a positive way. Providers should be rewarded for their ability to satisfy clients' needs.

Mechanisms to encourage continuity. Clinics should be prepared to offer clients family planning advice and care over many years. Clients need help with their initial method, and later they may need more information and support if they decide to switch methods. Programs that introduce Norplant need to help women who experience side effects and to conduct routine follow-up visits (see p. 24 and p. 29). Managers must establish an adequate system for implant removal and strategy for reminding women that implants must be removed after five years (see p. 26 and p. 29). Women who no longer want to use implants need help choosing another method.

Appropriate constellation of services. Clients may prefer that family planning services be offered along with other kinds of services. For example, in some places women may prefer a single service site that offers both family planning and complete maternal and child health services. In other places women may want family planning services offered at job-training sites. Program managers should find out what kinds of services clients would like to receive in combination with family planning and where such services should be offered. In Kenya, for example, Norplant and other family planning methods are offered at clinics set up near market-places because that is most convenient for women. Norplant services can be offered wherever technical competence and asceptic conditions can be assured (see p. 28).

With these elements of high-quality care in mind, program managers must assess their program's readiness to add Norplant to the methods already offered. Both the Population Council and WHO provide detailed checklists of the factors that managers should consider when deciding whether to introduce Norplant [164, 258]. In making their decision, managers can base their estimates for the cost of training, clinic space, and personnel time on their program's costs for similar expenditures in the past.

Managers must be sure that they can provide their clients with good services before they introduce Norplant. Some family planning programs may decide that they do not have the funds, personnel, or facilities to offer adequate Norplant services now. Others may choose to offer Norplant in only a few locations because of limited resources. Such decisions are consistent with the desire to provide family planning in a manner that serves clients well and uses program resources efficiently. In clinical trials, where high-quality education, counseling, and medical services have prepared women to use Norplant and have given them the best of care, Norplant has been popular. This suggests that Norplant will be popular when the quality of care is good. If clients are satisfied with the care that they receive, they will keep coming back when they need family planning, and they will tell others about their good experiences. Thus managers must be prepared for the costs of offering a popular new method and good services to assure that clients' needs are met, which in turn will attract more users. In contrast, if the quality of care is poor, many people will not use the services, and others will soon discontinue use. If clients are dissatisfied, the money spent on supplies and training will be wasted.

Who Can Help Support Norplant Services?

Donor agencies--particularly the United States Agency for International Development (US AID) and, to a lesser extent, the United Nations Population Fund (UNFPA)--provide most of the contraceptives distributed by family planning programs in developing countries. To date, donor agencies have not supplied Norplant implants in large quantities or funded large training programs because few national family planning programs yet offer Norplant. Most donor support has been for research and introduction activities.

US AID. Since 1981 US AID has helped to support Norplant research and development. This support has primarily been through the activities of the Population Council and also through Family Health International (FHI), the Association for Voluntary Surgical Contraception (AVSC), and other Corporating Agencies. US AID is focusing its assistance on 17 large countries, but other countries also may request assistance for Norplant activities, particularly training and technical assistance [37]. US AID's Norplant strategy is based on the following principles, set forth in 1990:

* S&T/POP [The US AID Office of Population] will work with designated CAs [Cooperating Agencies] to develop country-specific approaches for Norplant introduction in priority countries.

* To ensure the best use of limited resources, designated CAs will take the lead in training and service delivery, and collaborate with other agencies in conducting related activities.

* Program activities will be those for which A.I.D. has a comparative advantage, such as counseling, training, quality of care, and operations research as they relate to service delivery. The focus of programming will depend in part on the stage of Norplant activity that has already taken place.

* Programs wil gradually be phased in with emphasis on providing quality services.

* Widespread promotional activities will not be encouraged since Norplant is a provider-and quality-dependent method and demand for Norplant is expected to exceed AID's ability to supply it.

* [The US AID Office of Population] does not see commodity supply as its primary role and intends to collaborate with other agencies for this purpose. Moderate quantities of Norplant may be procured for assistance to priority programs [244).

Before US FDA approval in December 1990, US AID supported the supply of Norplant only to research programs. US AID did not supply country programs with Norplant until it was approved by the US FDA. In 1992 US AID is filling requests for 29,600 implant sets from 12 countries and has received one request for 3,000 sets in 1993. Plans beyond 1993 will depend on the growth of Norplant use [86].

UNFPA. Since 1986 UNFPA has supported the Population Council's clinical trials and pre-introduction studies in more than 20 countries [89,242]. Also, in Indonesia UNFPA supported a program that provided training and supplies for several months including Norplant [137]. UNFPA provided Indonesia with 164,000 implant sets, the largest number supplied to any country [243]. Anticipating future requests to fund Norplant clinical and pre-introduction trials, UNFPA has developed the following guidelines:

* All Norplant trials require national government approval.

* All projects should be developed with an experienced executing agency such as the Population Council, FHI, or WHO.

* The executing agency will supervise all activities and procurements.

* All programs will include wide dissemination of information in the Ministry of Health, other ministries, medical and nursing associations, women's groups, relevant nongovernmental organizations, and other groups.

* All programs should conduct user-attitude surveys [89, 185). in the Ministry of

UNFPA supports the Population Council's efforts to introduce Norplant and to develop Norplant II (see p. 7). Activities will include introductory trials, research on clients follow-up and cost-effectiveness, and preparation of materials for policy-makers, program managers, and donors [242].

World Bank. The World Bank has made loans to Bangladesh, Indonesia, and Kenya for programs that include Norplant. In Kenya the World Bank is lending funds for a program to provide several family planning methods, and FINNIDA, the Finnish development assistance agency, is funding the portion of the program that provides Norplant training and supplies [85]. The 1992-97 World Bank loan to Indonesia for family planning and safe motherhood includes funds for Norplant as part of efforts to widen the variety of family planning methods offered [234]. In Bangladesh the World Bank is part of a consortium of donors that will fund family planning and other health services (see p. 22).

IPPF. In 1985 the International Medical Advisory Panel of the International Planned Parenthood Federation (IPPF) approved Norplant and recommended that it be added to the IPPF list of commodities [88]. IPPF makes grants to affiliated family planning associations worldwide and subtracts the cost of commodities from the total grant. Between 1985 and 1987 IPPF received requests for Norplant from 35 countries but supplied implants only to 12 countries that met criteria set to ensure quality of care [88]. These criteria are:

* At least one doctor trained in insertion and removal procedures, trained counselors, and a system for client follow-up;

* Government registration or else government approval to import implants for clinical trials and training [88].

More recently, the number of sets requested has been small. Requests peaked at over 8,000 sets in 1988 but in 1990 through 1992 averaged about 2,400 annually [88,133]. IPPF officials attribute the decline in requests to increases in the price of the implants and the fact that other family planning commodities are cheaper [88,194]. Some IPPF affiliates receive implants from sources other than IPPF.

Donor coordination. Coordination among donor organizations would improve the continuity of services--a key factor in Norplant programs. For example, when a program plans to introduce implants, one donor might fund training, a second might buy supplies, and a third might provide long-term evaluation. Without assurance that other sources of funding are available to sustain all elements of the program, each donor is reluctant to become involved [99].

In Bangladesh the government has worked with a consortium of donor agencies to develop a coordinated plan for improving health services to develop a coordinated plan for improving health services including family planning [143]. Each donor agency identified the most appropriate areas for its participation. For example, US AID has experience in providing resources for training, and the World Bank is able to support the purchase of supplies. In all, 17 donor agencies have agreed to the cooperative program.

In the Bangladesh agreement funds for Norplant are available as part of the amount allocated to clinical trials and the introduction of new technologies. The government of Bangladesh can spend part of these funds on Norplant training and supplies, but the proportion is not fixed. Future demand for each method will determine how much will be spent on each commodity. The original agreement estimated that 20,000 to 30,000 Norplant sets will be needed each year [235).

The concept of a consortium of donors to fund family planning activities, introduced in Bangladesh, is now being applied in Nepal. Within this agreement Norplant would again be offered as part of a much larger program. In 1991 US AID hosted a preliminary meeting of international donors who might be involved in family planning programs in Nepal and elsewhere; more meetings are planned. For organizations such as the World Bank, cooperation is easiest to administer on a country-by-country basis. Other organizations such as US AID may prefer to set global cooperative strategies [131,132]. Similarly, UNFPA has urged a centralized system for procurement and distribution of contraceptive supplies [241].

Client Fees

Programs may spread the cost of Norplant by charging users some fee. Volunteer family planning organizations, such as family planning associations, have long charged modest fees for services and supplies [113]. The must be based on an analysis of what clients are willing and able to pay [125].

Clearly, some women are willing to pay for Norplant. In Thailand some women pay as much as US$8 for their implants, depending on ability to pay [96]. In Sri Lanka nearly 85% of the women who were interested in implants were willing to pay US$3 [236]. Still, price affects choice of methods. In the Dominican Republic researchers observed that some women who preferred Norplant chose the IUD instead because of its lower price. Because the commodity cost of Norplant accounts for so much of the total price, the Dominican researchers noted that the price of Norplant to users would have to increase greatly if donors stopped supplying the implants [12]. In Colombia researchers are studying whether women will pay more for Norplant if prices start low and gradually increase or if they begin at a reasonable but higher level [239].

Planning To Introduce Norplant

Once program managers have decided that their clients will benefit from Norplant and that their program can supply the necessary high-quality services, they must prepare for introduction. For example, managers must consider:

* How big should the initial program be, and how fast should it grow?

* How will people learn about Norplant?

* What does Norplant counseling involve?

* How should removal services be organized?

* How should Norplant providers be trained and supervised?

* Where should services be offered?

* What record-keeping and follow-up are required?

The Population Council, the Johns Hopkins Programs for International Education in Reproductive Health (JHPIEGO), WHO, and other organizations provide detailed information for managers who are planning Norplant introduction (see box, p. 27). Program planners can request these publications for more information on these topics and others.

How Big, How Fast?

Program managers face decisions about how to introduce Norplant services and how quickly to expand them. In the Dominican Republic, for example, the program is small. The family planning association PROFAMILIA carried out clinical trials in Santo Domingo and Santiago. Since pre-introduction trials ended in 1986, PROFAMILIA has continued to offer Norplant. The staff from the pre-introduction trials, now very experienced, continue to provide counseling, insertions, and removals. Although women pay only part of PROFAMILIA's costs, Norplant is still their highest-priced contraceptive option [12, 33]. Few women can afford implants, and so the number of insertions remains small. More women might choose Norplant if the price were lower [12]. Before Norplant was available in the US, Dominican immigrants requested Norplant at some New York clinics where services are free. These clinics had a waiting list of 500 women by the time Norplant became available [130].

In a larger program in Bangladesh, the Ministry of Health plans to provide implants to 20,000 to 30,000 women each year. Pre-introduction trials started in 1985 under the direction of the Bangladesh Fertility Research Program (BFRP), now the Bangladesh Institute of Research for Promotion of Essential and Reproductive Health and Technologies (BIRPERHT). At first only a few clinics offered Norplant, and BFRP planned gradual growth to 12 and then 30 additional sites. The Ministry of Health, however, now plans a large program to provide long-term methods, including Norplant, nationwide, supported by a consortium of donors (see p. 20).

Program managers need to decide how they can best establish Norplant services that offer both high-quality medical care and thorough counseling, and how quickly they can meet clients' demand for implants. What are the relative advantages of large and small programs and of those that grow quickly or slowly?

In small programs and in those that grow gradually, it is easier to ensure that clients receive high-quality service. Supervisors can monitor newly trained personnel more closely. Training enough providers is easier if the clientele grows gradually. Thorough counseling is easier, too, and women may be able to learn about the method from experienced users. Thus they may make better-informed choices about implants. All of these factors--high-quality medical service, easier management, and thorough counseling--lead to satisfied users.

Large programs and those that grow quickly also have a rationale. Many national programs need to increase contraceptive use in order to lower high birthrates that endanger women's health and impede socio-economic development. In such places policy-makers may want to expand family planning services rapidly, and they may see implants as a valuable part of that effort. Such efforts will be undercut, however, if clients receive poor treatment or are pressured into using a particular method.

Large programs may be necessary to provide removals and offer on-going service to Norplant users, especially if much of the population is mobile. If services are not available nationwide, Norplant users may move where local health care providers cannot serve them. Indeed, in some countries governments are committed to offering the same medical services everywhere. Thus it may be against government policy or politically impractical to offer implants in only a limited number of locations.

The pace at which Norplant services expand must ensure thorough counseling and screening, safe insertions, proper handling of side effects, and adequate access to removal at any time. In most places this will require starting small and growing gradually, learning from experience and adapting the program as it develops. The quality of services depends greatly on how many well-trained providers are available, and training many providers well takes time. Programs that have an existing infrastructure for family planning services with established counceling, conditions for asepsis, follow-up procedures, and communication programs will be able to offer clients this new method more quickly. In any case, a program that chooses to introduce Norplant widely and quickly must be particularly attentive to maintaining high-quality care.

How Will People Learn About Norplant?

People need to hear about this new method and to learn the facts about it. To help them do so, program managers first need to understand how clients learn about contraceptive methods and then to use this information to communicate with clients. Because women usually first hear about implants and other methods from current users or from medical personnel not involved with implants, these groups need accurate information about the new method.

Women are most influenced in their family planning choices by what they hear outside clinics. Interviewed in Egyptian health centers, 57% of Norplant users listed their relatives, neighbors, and friends as their most important source of information about Norplant [62]. In the US as well, women who chose Norplant were more often influenced by friends and family members than by clinic personnel [51].

Thus satisfied users of a particular family planning method often are influential sources of positive information. In Thailand one-third of women who chose implants in clinical trials did so because they had talked with Norplant users [107]. Satisfied users also can influence continuation rates. Researchers in the Dominican Republic noted that the earliest users of Norplant were more likely to discontinue because of side effects than women who chose the method several years later. The researchers attributed this change to users' sharing information and supporting each other as well as to counselors' learning more about Norplant and giving clients better information [13] Satisfied user--for example, nurses who use family planning--are particularly credible as providers and counselors.

Conversely, dissatisfied users can discredit a method very quickly. In several countries poor service delivery, especially refusal to remove the implants before five years of use, has caused public opposition to the implant method.

Mass-media television publicity, as well as favorable opinion among users, can attract potential clients, particularly to a new method such as Norplant. In Brazil researchers studied 100 women who chose Norplant and 100 who chose IUDs at the same clinic. They found that 80% of the Norplant users and all of the IUD users had learned about their chosen method before coming to the clinic. Half of the women who chose Norplant--a new method--had heard about it on television. About one-third had heard about the method from friends, relatives, or other women. Of the women who chose the IUD--a well-known method--9% had heard of it on television, and 74% had learned of it from friends, relatives, or other women. Although most women had heard of their method before coming to the clinic, a great majority said that clinic counseling answered questions about the method that they chose [80].

Women also learn about family planning methods from local leaders and community organizations. Government officials, women's health care advocates, religious leaders, and others with a consistituency among the public need information about Norplant. Often, they can help design services, too.

Informing other health workers. Health care personnel who are not providing implants themselves nonetheless need to know about Norplant [233]. Many women ask questions of family or friends who work in health care. In Brazil, for example, 20% of the women who came for Norplant or IUDs had talked about the method that they wanted with health care personnel outside the clinic [80]. Some women ask questions about Norplant when consulting physicians for unrelated reasons. In several cases such physicians misinformed and frightened women because they themselves knew little about the method and were suspicious. In other cases physicians gave women inappropriate care for side effects [262]. Health care providers need accurate information about the method including where women should go to obtain implants and to have them removed. Programs can inform health care providers about Norplant by sending them information in special mailings and by including information in journals or newsletters, in in-service education programs, in professional meetings, and in television or other mass media that reach professionals. Conferences and brochures for medical personnel not providing Norplant were part of introduction activities in Egypt and Colombia, for example [111].

What Does Norplant Counseling Involve?

As with all family planning decisions, a woman's choice of Norplant should be an informed choice, freely made. That is, she must know the full range of methods available to her and their characteristics, and she must be allowed to make her own decisions, based on her own needs. The provider must ensure that she has the information and makes her decision without pressure from the provider or from anyone else [42, 172]. At the same time, the provider helps the client to recognize her own needs and wants as she makes her decision (see Population Reports, Counseling Guide, J-36, December 1989).

When counseling accomplishes this, the result is greater initial use of contraception as well as longer continuation of use (see Population Reports, Counseling Makes a Difference, J-35, November 1987). In the Dominican Republic, as noted, investigators found that, as providers became more confident in counseling, women were less worried about side effects and used Norplant for longer periods [13].

Initial counseling can support women's continued use of Norplant in two ways: [1] By informing women beforehand of the method's features and possible side effects, counseling helps to screen out women likely to be dissatisfied with the method and to abandon it early. [2] For those who choose the method, counseling prepares them for the side effects that they may experience so that they are not frightened if side effects occur.

Telling clients about methods. Clients choosing among family planning methods need to learn the basic features of all available methods. For implants, this includes what they look like and the need for insertion and removal. Women who are seriously considering implants and women who have chosen them need more information, of course. Essential information for both groups is outlined in the "Guide to Norplant Counseling," published with this issue of Population Reports. More detailed information can be found in various publications listed in the box on p.27.

Counseling should emphasize that Norplant is effective for five years and must then be removed, but it can be removed sooner. It should cover the side effects that women might experience. Providers can spend less time on information that women need to hear but not remember, such as how the method works.

Women are asked to understand a great deal of information when they come for counseling. Showing as well as telling can help clients remember. For example, when counseling about menstrual changes with Norplant, some providers in the US show clients calendars marked with possible menstrual patterns, and they point out which patterns are normal for Norplant users as well as which patterns indicate that the Norplant user should return for a check-up [51]. Printed material, designed for clients to take home, can be helpful. So can repeating essential information at follow-up visits.

Helping women decide about Norplant. The central step in the counseling process is helping the client choose a family planning method [115]. This step has two aspects: [1] helping a woman decide which method fits her needs and [2] assessing whether the method that she wants is medically appropriate for her--that is, medical screening. For both aspects, the provider asks the client questions, and they discusses the answers (see the "Guide to Norplant Counseling").

Questions that help a woman decide if a method suits her needs draw her attention to the features of the method, both positive and negative. For example, a provider might first ask a woman whether and when she wants to have children in the future. If the client wants to delay pregnancy for several years, the provider can suggest Norplant as one of several choices that might be appropriate. The provider should point out that Norplant is effective for up to five years but allows the woman to become pregnant after the capsules are removed. Asking about a woman's experience with contraceptives also can be helpful. For example, if a woman was bothered by irregular bleeding with another hormonal method, Norplant may not be the best choice for her. But for a woman who often forgot pills or does not want to take pills, Norplant might be a good choice.

The risk of sexually transmitted diseases (STDs), including AIDS, is crucial to every choice of contraceptive methods. Providers should always remind clients that Norplant and most other methods do not protect against STDs. Providers should politely ask each woman if she has more than one sexual partner or thinks that her sexual partner has any other sexual partners. If so, she needs encouragement and help to try to persuade him to use condoms at every act of coitus outside marriage. She can use Norplant at the same time for highly effective contraception.

Questions that assess whether a method is medically appropriate ask about symptoms and previous diagnoses. These screening questions should focus on conditions relevant to the contraceptive method and not on general health matters. For Norplant, questions should address whether the client:

* Is pregnant;

* Has active liver disease, as evidenced by jaundice;

* Has cancer of the breast or reproductive organs; or

* Has active cardiovascular disease (see the "Guide to Norplant Counseling").

If questioning reveals that a client has symptoms or a diagnosis of these conditions, or if there is uncertainty, she should be referred to a doctor or nurse for diagnosis and, possibly, treatment before she uses Norplant. The provider conducting the counseling should discuss nonhormonal methods with such a client, should help her choose another method at least for the meantime, and should make sure that she has an ample supply of condoms or spermicide when she leaves.

Prospective Norplant users also should be asked about diabetes, hypertension, migraine headaches, and epilepsy. Clinical studies have not suggested, however, that Norplant use will aggravate diabetes, high blood pressure, or migraine headaches, or will increase the risk of stroke. Still, a number of organizations advise that Norplant users with these conditions may need to be monitored or to monitor themselves [174, 259]. They should be referred to a nurse or doctor to decide on this. The recommendation for monitoring is based on findings in some studies that combined estrogen-progestin oral contraceptive altered carbohydrate metabolism or blood pressure or increased the risk of stroke. Also, clinical trials excluded women with diabetes or high blood pressure, and therefore the effects of Norplants on these women have not been studied. As for epilepsy, women who take seizure medication should know that some medications used to treat epilepsy make hormonal contraceptives such as Norplant less effective. They may prefer a nonhormonal method.

Where referrals or monitoring of these conditions is not possible, providers must decide what course of action best protects a client's health, based on the availability of other family planning methods and the client's willingness to use a nonhormonal methods such as condoms, spermicides, voluntary sterilization, or an IUD. If she will not use a nonhormonal method, progestin-only method such as Norplant is preferable to one containing estrogen [94[. Leaving a woman without any contraception may be exposing her to pregnancy. Pregnancy, especially frequent pregnancy, can endanger a woman's health. It is particularly dangerous for women with conditions such as cardiovascular disease, diabetes, and cancer. In setting up Norplant services, program managers should take care not to establish strict criteria that arbitrarily exclude certain women. Instead, providers should make balanced recommendations, taking account of an individual woman's situation (see box, p. 21).

Explaining how to use Norplant. When a woman chooses Norplant, the provider should explain how the capsules are inserted and removed. The provider also should tell the client that she should have the capsules removed after five years but can have them removed at any time sooner. Also, the provider should review common side effects, particularly bleeding changes, so that the client is not alarmed if they occur. Furthermore, the client needs to know the signs of ectopic pregnancy, infection at the insertion site, and cerebrovascular problems that call for her return to a Norplant provider. (See the "Guide to Norplant Counseling.")

Counseling returning clients about side effects. Providers need to recognize Norplant side effects and know how to manage them. When a woman reports a problem, the provider should determine, if possible, whether it is due to Norplant or to some other cause, and what course of action to follow. Both JHPIEGO and the Program for International Training in Health (INTRAH) provide check lists for diagnosing the causes of common conditions experienced by Norplant users [94, 97] (see box, p. 27).

The most common Norplant side effects are menstrual changes--spotting, amenorrhea, or frequent, prolonged, or heavy bleeding (see p. 5). For the great majority of clients whose bleeding changes pose no health risk, counseling may be what is needed. Some women simply want an explanation. Others fear for their health. In these cases, the provider can assure the client that these changes are common and pose no health risk. If the woman is not reassured, she may want to choose another method. Some women find that the bleeding interferes with their religious obligations or their sexual relations with their husbands. When women have doubts about continuing Norplant use, the provider should help them weigh the advantages and disadvantages of switching to another method.

Who can counsel? Various program staff may be responsible for counseling. In most places nurses counsel women in groups at the clinic and then counsel them individually. In Indonesia the family planning field worker does much of the preliminary counseling about the range of methods [253]. Physicians in private practice may counsel clients themselves. Whoever has the chief responsibility for counseling, almost all health care providers counsel clients, informally or formally, at some time, and therefore they need training in counseling skills and talking sympathetically with clients [97].

What Do Insertions Involve?

To set up services, managers must understand what Norplant insertion requires. In brief, to insert an implant, the provider anesthetizes an area of the skin on the inside of the woman's upper arm. The provider then makes a 2 mm incision, either with a special trocar, if it is sharp [49, 53], or with a scalpel, and uses the trocar to insert the capsules just under the skin. The trocar is marked to indicate how far it should be placed under the skin to insert each capsule. The provider places the capsules in a fan shape, radiating out from the incision. Using a paper or plastic template to mark the pattern of the implants on the woman's skin helps to insure correct placement of the anesthetic and the implants [82] (see photos above). Placing the capsules just under the skin, not deeply, helps to assure that they can be removed easily later [233]. When all six capsules are in place, the provider closes the incision with an adhesive bandage--no stitches are needed--and places compresses and gauze over the entire area. Insertion usually takes 8 to 10 minutes [6]. The Population Council, JHPIEGO, INTRAH, and WHO have published complete instructions for insertion and removal [94, 97, 149, 258].

Insertion and removal of implants are minor surgical procedures. The Population Council and Leiras Oy developed the techniques for insertion and removal [149]. As experience with Norplant grows, practitioners are suggesting modifications of these techniques [49, 51, 97]. Most of the equipment for insertion and removal is commonly used in health centers. Leiras Oy provides the specially marked trocar. Norplant insertion and removal kits supplied by US AID contain all the necessary equipment [37].

Avoiding infection. Providers should wash their hands and use gloves that have been soaked in a 0.5% chlorine solution for 10 minutes or boiled in water for 20 minutes. Equipment should be sterilized. Where sterilization is not possible, high-level disinfection can be done by boiling instruments for 20 minutes or by soaking them in chemical disinfectants [97, 149, 258]. If the health care provider wears gloves and avoids cuts with instruments that have blood on them, he or she should be safe from any infection borne in clients' blood, such as AIDS or hepatitis B.

Timing of insertion. To ensure that clients are not pregnant, their implants should be inserted during or within a few days after a menstrual period, or after abortion, unless other information indicates that they are not pregnant. Norplant is effective within 24 hours. Women who are breastfeeding are advised to use a barrier method of contraception [97, 150]. Still, women can safely use Norplant after the first six weeks of breastfeeding, and research may establish that even earlier use is possible [2, 55, 56, 147, 188, 189, 196, 256].

How Should Removal Services Be Organized?

Program managers must understand the procedure involved in removing implants. To remove the capsules, the provider finds them by feeling them, injects local anesthetic under the capsules, and makes one 4 mm incision near where the insertion incision was made. With fingers, the provider pushes against the skin, moving one capsule at a time toward the incision and then, with mosquito forceps, pulls out the capsule. Any fibrous tissue around the capsule must be scraped away with gauze or a scalpel as the capsule is removed. After all of the capsules are removed, the provider places an adhesive bandage and compresses over the incision site [97, 149].

Removals take longer than insertions, and they are more likely to be difficult. They should be done in a clinic setting. In an Indonesian study of removals, the mean time required was about 22 minutes [6]. Occasionally, removals can take an hour or even longer [83, 107]. Rarely, the provider may need to ask the client to return for a second visit if removal is so difficult that her arm becomes swollen [166]. Removals are more likely to be difficult if the provider is not skillful, the implants are deep in the arm, or fibrous encapsulation is extensive. The woman's arm may be painful and bruised after removal [111].

When to remove the implants. The capsules should be removed after five years of use or whenever a woman wants them removed for whatever reason. In addition, providers may recommend removal for such medical reasons as pregnancy; signs of possible cardiovascular disease; possible anemia related to heavy bleeding; implant expulsion, which will require replacement with sterile capsules; severe infection or abscess at the insertion site; and cancer of the breast or reproductive organs. In clinical trials some Norplant users asked providers to remove their implants for conditions, such as irregular bleeding or mild weight gain, that did not impair their health. Initial counseling should try to screen out women who think that they could not tolerate such side effects. Good counseling also may help a woman who has chosen Norplant but now wants it removed. In some cases it may be the husband who needs reassurance, and he should join the counseling session. The provider can listen to the woman and her husband, provide reassuring information, and discuss their options, of which removal of the implants is one.

Other women will request removal because they want to become pregnant or they are moving to an area without Norplant services. Again, initial counseling and screening can minimize the number of such women who choose Norplant. People's circumstances change unpredictably, however, and women cannot be denied removal just because they change their minds or their situations change.

Access to removal. After counseling, some women still will want Norplant removed, and they should be accommodated. In focus-group discussions, however, some users report difficulty persuading health care providers to remove implants [262]. Health care providers have given various reasons for refusing or delaying removals. Removals require time and aseptic conditions, and clinic staff may not be able to perform them whenever a woman comes in [233]. In other cases providers may not feel confident of their ability to perform removals [262]. In still other cases providers have disagreed with women who complained that their side effects were so severe as to require removal. Clinic personnel also have refused removal because implants are expensive, and they thought that women had had sufficient warning about side effects before they chose implants.

Access to removal is a necessary part of high-quality service, however. Women should not be forced to continue using implants if they no longer want them. Such a policy is intrinsically unethical, and word of such a policy will discourage women from trying the method.

As Norplant becomes available, managers must plan for removals by ensuring that facilities and trained personnel are ready when needed. Program managers also must ensure the following six conditions:

* During initial counseling providers must tell women: (1) where to go for removal; (2) that removal is necessary after five years of use but can be done sooner at their request; and (3) that they must return to the clinic if they are moving from the area. Staff should remove the implants if the woman is moving to an area without implant services.

* Clinics designated as removal facilities must allocate time, space, equipment, and personnel to removals.

* Staff must know either how to remove implants or where to refer women.

* Staff must agree that women can have their implants removed on request.

* Staff trained in implant insertion, removal, and counseling should not be transferred elsewhere until other trained staff are available.

* Clinics should have established back-up procedures for difficult removals.

Organizing removal services. Removal services can be organized in several ways. All clients requesting removal might be referred to a central facility; a team of trained providers could travel to service sites on specified days; or many providers could be trained to remove implants at many sites. In deciding how to organize removal services, managers must consider the convenience of clients and how best to train providers and to maintain good medical services. A new program will generate few requests for removal and thus will offer few chances for providers to perform or observe the procedure. A centralized facility for removals or a traveling team with a specific schedule would be suitable for a new program. These skilled providers could schedule removals so that trainees would be able to observe the procedure and perform removals under supervision. Centralized facilities should be conveniently located, however, within easy reach of most clients.

As the number of Norplant users increases, demand for removal services will grow. At that point, most providers could be trained in the removal procedure. Removal services should not be spread so thinly, however, that providers do not perform enough procedures to maintain their skills.

How should Norplant Providers Be Trained and Supervised?

Health care personnel need different kinds of information about Norplant. Those who are not involved in implant services need a general introduction to the method so that they can answer questions and refer clients (see p. 23). If implants are to be widely available, information about Norplant should be part of all preservice family planning education. In Thailand and Indonesia all physicians, nurses, and midwives receive a general introduction to Norplant and other family planning methods while they are in school [75].

Personnel directly involved in implant procedures and counseling need special training and practice to develop skills. In-service training is necessary to supply trained personnel to an expanding program. In clinical trials the personnel who inserted implants were trained at Population Council centers in Indonesia, Egypt, and the Dominican Republic [25]. These providers, primarily physicians, in turn trained people in their own countries. Other countries planning to introduce Norplant need a similar core group of trained and experienced providers. The group can continue to train other providers as the program expands [9]. Some can receive further instruction and become trainers, perhaps using their clinics as training sites. A high-quality program depends on well-trained providers, and managers should encourage good training by recognizing and rewarding good trainers [134].

Formal training must continue as programs grow. As implants become more widely available, more clinic staff will learn both medical procedures and counseling informally, by watching experienced personnel work. This informal training-by-observation is not reliable and must be supplemented with formal training [9].

Training for removals presents special problems because, when implants are first offered, few women request removal [233]. A trainer may demonstrate a removal, but trainees may have no opportunity to perform one until months or even years later. Strategies to help ensure high-quality removals include referring all women to a central facility for removals, providing trained practitioners with a videotape of the procedure, having a trainer go out to clinics on request, encouraging practice on model training arms or animal tissue such as chicken breasts, and retaining clinic personnel later as the need for removals grows [134, 233, 252].

In Indonesia, Thailand, and elsewhere, nurses and midwives, as well as as physicians, have performed Norplant insertions and removals. Two Indonesian studies compared insertions and and removals performed by physicians with those per-performed by nurses and midwives [6, 212]. They found no significant differences between the two groups in the length of these procedures or in insertion-site infection rates. In the US, physicians, nurse practitioners, and nurse-midwives are being trained [252]. When nurses and midwives offer Norplant, more women can receive implants, and the cost may be lower. In many countries Norplant will be widely available only if nurses and midwives provide the method.

Supervision. Good initial training is necessary but not sufficient to ensure continued high-quality service. In addition, managers must continually supervise staff. Supervision should cover clinic services, clinic management, and interaction between client and provider [98]. Different personnel may have responsibility for supervising each of these areas. Initially, trainers might supervise services, especially clinical care. Program managers must develop service standards [100]. Manuals prepared by JHPIEGO and WHO suggest standards for evaluating services [97, 258] (see box, p.27).

Supervision of Norplant services will be most effective as part of a good overall supervisory system. When a good supervision process is in place, Norplant services can be reviewed as all other services are reviewed [98]. Separate supervision of Norplant services may be necessary if there is no general system or as the new method is introduced.

Regular supervision helps maintain high-quality service. Researchers in Ecuador concluded that insertions seemed deceptively easy to some clinic staff. Eventually, overconfidence led to carelessness and cases of infection at the insertion site. With periodic supervision, the situation was corrected [126].

Where Should Services Be Offered?

In general, any facility that can offer voluntary sterilization or IUDs also can offer implant insertions and removals [36]. The room must be clean and equipped with sterile or high-level disinfected supplies [7,97]. In addition, a service site should have the personnel and the space to counsel clients, including a place for client and provider totalk privately. Service points also need adequate record-keeping capabilities.

More service sites will make Norplant more available, but quality of care must be maintained as services expand. In Kenya 83% of women live in rural areas [103]. To serve them, clinics offering vaccinations, child health services, and several contraceptive methods have been set up in rural marketplaces [66]. Although these clinics lack on-site facilities for sterilizing equipment, a physician has devised a way to offer Norplant insertions there without sacrificing the quality of care [153]. Every Monday several presterilized packets, each containing the equipment and supplies for one insertion, are delivered to each clinic where there is a trained provider. On the following Monday the packets of instruments that have been used and any that remain unused are taken back to Nairobi for autoclaving. New packets are left. There were no cases of infection at the insertion site in a study of the first 300 insertions performed at these marketplace clinics [153]. In Indonesia thousands of women received implants and IUDs in temporary outreach facilities set up in urban and rural markets, neighborhoods, or fairgrounds. These programs reached many women who were not using modern birth control methods [181]. In 1990 more than half of the women who received Norplant were served in such clinics [92]. Temporary clinics can present special problems, however. BKKBN and the Ministry of Health have recently discontinued Norplant insertions in temporary clinics because of concern about the ability to maintain asepsis, to screen clients adequately, and to keep records [92, 253].

What Record-Keeping and Follow-Up?

What records must be kept about Norplant users? Initially, clinic staff need to record the name of each implant recipient and when her implants need to be removed after five years of use. At any follow-up visits, any complications or side effects should be noted. When her implants are removed, that, too, should be recorded.

In addition to helping serve individual clients, record-keeping helps program managers evaluate the use of implants. Records on infections at the insertion site and removals for pre-existing conditions such as pregnancy help managers to assess the quality of medical procedures and screening. Also, managers need continuation rates to determine the cost of the program per couple-year of protection from pregnancy.

Organizations involved in Norplant introduction suggest follow-up visits about one month after insertion and once a year thereafter [94, 97, 176, 198, 258]. At the first visit the provider should make sure that there is no infection around the area of the implants, answer the client's questions, and again discuss possible side effects, the need for removal after five years, and the availability of removal whenever the user wishes. At the client's annual visits, the provider should answer the client's questions and screen the client for conditions that might require removal of implants or monitoring of the client [94, 97]. Women with diabetes or high blood pressure may require more frequent follow-up visits to monitor their condition (see p. 24). AVSC has developed a prototype client record form for keeping track of the client's health for the full five years of implant use. The form is a record of the client's name and address, medical history, and physical condition. It can be updated on each follow-up visit [17].

How will Norplant users recall when to have their implants removed? If women come in for a yearly check-up, both they and the program are more likely to remember removal after five years. Most programs also give women some written statement of the date for removing implants. In Indonesia and Nepal, for example, program clients have family planning cards, and Norplant users' cards show the removal date [28, 66]. In Finland and elsewhere the provider attaches a reminder card to the woman's file and gives her one to keep. In other programs the provider writes the removal date on the information booklet that the woman receives [151].

Keeping track of women who have received implants has been difficult [7, 24, 122, 187, 262]. Programs may choose to emphasize the client's responsibility to return for implant removal. To assist her memory, she could be given a colored card that states the date to return. Each year's card would be a different color. Radio announcements, clinic posters, or other means would tell women that this is the year for women with a particular colored card to have their implants removed [20, 37]. In some countries, particularly if the population is mobile, broadcast announcements can remind women to have their implants removed.

New Method, New Opportunity

Introducing a new family planning method such as Norplant is an opportunity for program managers to improve clients' satisfaction and thus program performance. Pre-introduction trials have shown that women like the method if it is offered with good medical care and counseling and if they can have the implants removed when they choose. If a program provides high-quality services and publicity that positions the method to meet clients' needs, Norplant may become a popular new family planning method.

(*1)NORPLANT is the registered trademark of The Population Council for lavenorgestrel subdermal implants.

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ADDENDUM

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