Introduction of Subcutaneous Depot Medroxyprogesterone Acetate (DMPA-SC) Injectable Contraception at Facility and Community Levels: Pilot Results From 4 Districts of Uganda.

Reproductive Health Uganda (RHU), a local NGO, introduced subcutaneous depot medroxyprogesterone acetate (DMPA-SC, brand name Sayana Press) in 4 districts of Uganda between April 2016 and March 2017. RHU trained public and private facility providers on all family planning methods including DMPA-SC; trained community health workers (known as village health teams, VHTs) to give family planning counseling, provide short-acting methods including DMPA-SC, and make referrals for long-acting and permanent methods; conducted mobile outreach and raised awareness of family planning; and provided family planning commodities. We used a retrospective cross-sectional evaluation design drawing on data from (1) in-depth interviews with 32 facility- and community-based providers; (2) key informant interviews with 7 policy makers and program staff; and (3) family planning program statistics from 4 RHU clinics, 26 mobile outreach sites, and 40 VHTs in 4 study districts. Data collection took place between April and June 2017. Over 12 months, 14,273 units of DMPA-SC were provided in RHU clinics, by mobile outreach teams, and by VHTs. DMPA-SC units were mostly administered in community settings either by VHTs (70%) or at mobile outreach events (26%). A substantial proportion (43%) of DMPA-SC units were administered to young people (<25 years), a significantly higher proportion compared with other methods provided to this age group through the project (P<.001), except condoms. In addition, a greater proportion of DMPA-SC units provided at the community level by VHTs were used by young people (45%) compared with units provided at outreach (36%) or in clinics (35%). Overall, injectables (DMPA-SC and intramuscular DMPA combined) came to represent 43% of all contraceptive methods provided, up from a baseline of 20%. This shift occurred despite significant increases in the volume of all other methods provided (P<.001). Qualitative data revealed various factors that facilitated introduction, including comprehensive training, commodity availability, strong referral links, and early community engagement. RHU's experience supports the viability of community-based delivery of DMPA-SC and identifies opportunities to strengthen this approach. There is further evidence that DMPA-SC may be popular with young people, especially in community settings.

The feasibility of contraceptive injections at the community pharmacy.

PURPOSE: The progestogen-only intramuscular injectable Depo-Provera® (depot medroxyprogesterone acetate) is an effective contraceptive method, but users need to attend a clinic every 12-13 weeks for a repeat injection from a doctor/nurse. This limits convenience of the method and may affect continuation rates. We conducted a pilot study to examine the feasibility and acceptability of users receiving the subcutaneous form of the contraception injection from pharmacists in the community pharmacy setting. MATERIALS AND METHODS: Existing users of Depo-Provera®, who wished to switch to the subcutaneous preparation with the same active ingredient (Sayana Press®) were invited to attend 1 of 11 community pharmacies for up to three repeat injections, given by a pharmacist. Evaluation consisted of (i) self-administered questionnaires of women and (ii) interviews with participating pharmacists, at study exit on their respective experiences. RESULTS: Global unavailability of the product during the study adversely affected recruitment and retention. 50 women were recruited. Only 48 injections were delivered at the pharmacy out of a possible 150 (34%). About 26 participants received no injections at the pharmacy and only seven (14%) participants received all three injections at the pharmacy. Participants reported mixed experiences, with some welcoming the intervention but others experiencing difficulty with pharmacist availability. Pharmacists were enthusiastic about this expansion of their role, and did not view their availability as a barrier to service delivery. CONCLUSIONS: Delivery of the subcutaneous contraceptive injectable from a community pharmacy may be feasible but availability of sufficient numbers of pharmacists trained in this technique is necessary for a robust model of service delivery.

Estimating demand for a new contraceptive method: projections for the introduction of Sayana Press.

OBJECTIVE: To describe a demand estimation exercise conducted in response to an initiative to introduce Sayana Press in Sub-Saharan Africa and South Asia. METHODS: Secondary data sources were used to develop estimates of the number of Sayana Press units needed for countrywide introductions in 12 countries. To estimate uptake, the number of women who had stated an intention to use injectables was calculated. Two sets of assumptions (one conservative, one more ambitious) were used to assess conversion to actual use. RESULTS: Even with the use of very conservative assumptions, and assuming no method switching, Sayana Press was estimated to have the potential to cumulatively reach 3-6million women by 2016. CONCLUSION: This projected uptake in a relatively short period and at the very beginning of an adoption curve suggests that Sayana Press has promise for countries looking to expand their list of contraceptive choices.

Injectable contraceptive sales at licensed chemical seller shops in ghana: access and reported use in rural and periurban communities.

CONTEXT: Most women in Ghana obtain oral contraceptives and condoms from shops run by licensed chemical sellers, but such shops are not legally permitted to sell the country's most widely used method, the injectable. Allowing shops to sell the injectable could increase access to and use of the method. METHODS: In 2012-2013, semistructured telephone interviews were conducted among convenience samples of 94 licensed chemical seller shop operators in two districts who were trained to sell the injectable and of 298 women who purchased the method from these shops. Follow-up interviews were conducted with 92 clients approximately three months after their initial injectable purchase. RESULTS: Ninety-seven percent of shop operators reported selling the injectable, and 94% felt sufficiently trained to provide family planning methods and services. Virtually all sellers (99%) referred clients to a hospital or health facility for injection; none provided injections themselves. Fifty-six percent of injectable clients were new family planning users. Of those who completed a follow-up interview, 79% had purchased the injectable again from a shop. Virtually all clients (97%) reported getting their injection at the health facility to which they were referred by the seller. Women cited trust, convenience and commodities being in stock as key reasons for purchasing from a shop. CONCLUSION: Licensed chemical seller shop operators can safely sell the injectable and refer clients to health facilities for screening, counseling and injection.

Operational assessments of Sayana® Press provision in Senegal and Uganda.

OBJECTIVE: Sayana® Press (SP) is a unique injectable contraceptive (depot medroxyprogesterone acetate, or DMPA) administered subcutaneously in the Uniject(TM) injection system.(1) SP simplifies the injection process; it requires no assembly of components and is easily disposable. This new technology appears to be well suited for community-based delivery of injectable contraception. The study objective was to evaluate SP management and administration in low-resource settings, focusing on how the delivery logistics, administration time, storage and waste-management requirements compare to the traditional intramuscular DMPA injectable (DMPA IM). STUDY DESIGN: We conducted 58 semistructured interviews with clinic providers and community health workers in Senegal and Uganda to identify the merits, challenges and appeal of SP relative to DMPA IM. RESULTS: Providers identified logistical challenges with the management and administration of DMPA IM, including stock outs, transportation, storage constraints, and, in a few instances, waste disposal. Most providers (between 63% and 88%, depending on the logistics issue) do not expect SP to either aggravate or solve those problems. Some envisioned that SP could facilitate supply management (5%), storage (11%) and waste disposal (22%). The all-in-one packaging of SP was perceived to reduce the incidence of mismatched supplies (syringes and vials), and its smaller size was expected to ease space constraints and reduce the frequency of safety box incineration. CONCLUSION: Adding SP to the method mix is unlikely to have a profound impact on clinic operations but may lessen logistical problems related to supply, storage and waste management. IMPLICATIONS: Community health workers and clinic providers who administer SP may see some modest improvements in service delivery logistics. Particularly in settings where service delivery logistical challenges are more pronounced, offering SP may facilitate injectable contraceptive delivery.

Suspect online sellers and contraceptive access.

BACKGROUND: Issues surrounding contraception access have been a national focus. During this debate, adolescent and adult women may seek these products online. Due to safety concerns, including potential counterfeit forms, we wished to assess whether online "no prescription" contraceptives were available. STUDY DESIGN: We assessed online availability of reversible, prescription contraceptive methods resulting in <10 undesired pregnancies/year, i.e., Depo-Provera shot; oral contraceptives; NuvaRing; Ortho Evra patch; Paragard and Mirena IUDs; and Implanon/Nexplanon implants. Using Google search "buy ITEM no prescription," we reviewed the first five result pages for "no prescription" vendors. Searches were conducted 1/3/2012-2/20/2012. RESULTS: All contraceptives were available as "no prescription" products. Furthermore, IUDs were advertised as "over-the-counter" and YouTube videos provided "how to" videos, including a cartoon version. We also found that illicit online pharmacy marketing is shifting from direct search engine access to social media (Facebook, Twitter, Slidehare, flickr). CONCLUSION: Online contraceptive sales represent patient safety risks and a parallel system of high-risk product access absent professional guidance. Providers should educate patients, while policy makers employ legal strategies to address these systemic risks.

Scaling up community provision of injectables through the public sector in Uganda.

This case study presents service monitoring data and programmatic lessons from scaling up Uganda's community-based distribution of depot medroxyprogesterone acetate (DMPA, marketed as Depo-Provera) to the public sector in two districts. We describe the process and identify implementation opportunities and challenges, including modifications to the service model. Analysis of monitoring data indicates that the number of women initiating DMPA with a community health worker (CHW) was 56 percent higher than the number of new DMPA acceptors served by clinics. Including continuing DMPA users, about three of every four DMPA clients chose CHWs as their service delivery point. CHW provision appears to be the preferred method of delivery for new DMPA users in this study, and may appeal even more to continuing clients. Lessons from scaling up in Uganda's public sector include recognizing the needs for ongoing assessment of support, a process to gain community "ownership," and spontaneous innovations to supplement CHW supervision.

Provision of injectable contraceptives in Ethiopia through community-based reproductive health agents.

OBJECTIVE: To determine whether community-based health workers in a rural region of Ethiopia can provide injectable contraceptives to women with similar levels of safety, effectiveness and acceptability as health extension workers (HEWs). METHODS: This was a prospective non-randomized community intervention trial designed to test the provision of injectable contraceptives by community-based reproductive health agents (CBRHAs). Effectiveness, safety, acceptability and continuation rates were the outcomes of interest. The outcomes observed when injectable contraceptives were administered by HEWs in health posts and when they were administered by CBRHAs were compared by means of χ(2) tests for association among categorical variables and t-tests for independent samples to determine differences between group means. FINDINGS: A total of 1062 women participated in the study. Compared with health post clients, the clients of CBRHAs were, on average, slightly older, less likely to be married and less educated, and they had significantly more living children. Women seeking services from CBRHAs were also significantly more likely to be using injectable contraceptives for the first time; health post clients were more likely to have used them in the past. In addition, clients of CBRHAs were less likely to discontinue using injectable contraceptives over three injection cycles than health post clients. CONCLUSION: Receiving injectable contraceptives from CBRHAs proved as safe and acceptable to this sample of Ethiopian women as receiving them in health posts from HEWs. These findings add to the growing body of evidence supporting the development, introduction and scale up of programmes to train community-based health workers such as CBRHAs to safely administer injectable contraceptives.

How commonly do US abortion clinics offer contraceptive services?

BACKGROUND: About half of US women having abortions have already had at least one prior abortion. Facilitating access to contraception may help these women avoid subsequent unintended pregnancies. Information is needed to document the availability of contraceptive services in abortion care settings in the United States. STUDY DESIGN: Data for this cross-sectional mixed-methods study were collected between December 2008 and September 2009 and come from two sources: 15 semistructured telephone interviews and 173 structured questionnaires administered to a nationally representative sample of eligible facilities. Respondents were administrators at large (400+ abortions per year), nonhospital facilities that provide abortion services in the United States. RESULTS: Virtually all (96%) abortion clinics incorporate contraceptive education into abortion care, and the three most common methods reported to be distributed are the birth control pill (99%), the vaginal ring (61%) and Depo-Provera (58%). Almost one-third reported being able to offer post-abortion intrauterine device insertion. Most facilities (82%) accept some form of insurance for either contraceptive or abortion services, and those with a broader family planning focus are significantly more likely to do so. Administrators at the majority of facilities (56%) report that patients most commonly do not pay additional fees for contraceptive services because they are included in the cost of abortion services. CONCLUSION: Although almost all large, non-hospital abortion providers in the United States are able to provide some level of contraceptive care to their abortion patients, the degree to which they are able to do so is influenced by a wide range of factors.

A study of the capability of manufacturers of generic hormonal contraceptives in lower- and middle-income countries.

PURPOSE: Studies were undertaken to assess the capability, competence and capacity of manufacturers of oral and injectable hormonal contraceptives in lower- and middle-income countries. METHODS: A qualitative study on 41 companies, which comprised in-depth interviews and facility observations, was undertaken. Also an in-depth quantitative study of 14 companies was undertaken, of which 3 have not been included in the first study. Following review of a questionnaire and other documentation, a visit was undertaken to each factory to assess staff competence, manufacturing facilities, manufacturing processes, quality management, worker safety and environmental protection. RESULTS: Of the 44 companies from 15 countries, less than 30% would meet the current Good Manufacturing Practice requirements of the World Health Organization (WHO), the Pharmaceutical Inspection Cooperation Scheme or any stringent regulatory authority; a further 20% could comply with investment and improvements in quality management. Few companies are able to develop adequate registration dossiers. CONCLUSION: There is a limited number of companies that are capable of manufacturing high-quality generic products and which can provide a complete registration dossier for use outside their home markets. It is essential that, in the future, procurement agencies only use suppliers that are prequalified by WHO for the procurement of hormonal contraceptives.

Gynecologists' attitudes towards hormone therapy in the post "Women's Health Initiative" study era.

OBJECTIVE: To assess the impact of the Women's Health Initiative (WHI) study on gynecologists' attitudes regarding hormone therapy (HT). METHODS: Questionnaires were mailed to a random sample of Lebanese gynecologists (n=178). The questionnaires solicited practice patterns of HT for postmenopausal women and information provided while counseling before and after the WHI study. Descriptive statistical methods were used to evaluate the responses. RESULTS: Questionnaires were returned by 140 physicians (78.7%), 93.6% of whom were aware of the WHI study. More than 90% of respondents routinely offered HT prior to the study. Of the 85.6% who used a combination of oral estrogen and progesterone (E/P), 40.0% used conjugated equine estrogen (CEE) and medroxyprogesterone acetate (MPA). Around 67% of gynecologists reported a change in their therapeutic approach after the study. The main changes were: not offering CEE+MPA (27.3%), prescribing CEE+MPA to a select group of patients (37.5%), using other forms of HT (56.8%), or abandoning any form of HT (6.8%). Other practice modifications included a shift to the use of tibolone (18.2%) or alternative therapies (29.5%). Whereas 76.2% of physicians counseled their patients about a decreased risk of cardiovascular events with HT prior to WHI study, only 34.1% continued to do so after the study (p<0.001). The percentage of gynecologists that inform their patients of an increased risk of breast cancer on HT rose from 45.2 to 73.2% (p=0.018). Almost 51% of gynecologists allow their patients to participate in decision making regarding the type of HT, 42.4% would choose for their patients after counseling, while 6.8% of physicians do not counsel their patients in order not to confuse them. CONCLUSION: In a representative sample of Lebanese gynecologists, there was a significant change in physicians' attitudes towards HT following the publication of the WHI study.

Counting the costs: comparing depot medroxyprogesterone acetate and norethisterone oenanthate utilisation patterns in South Africa.

BACKGROUND: In South Africa, where health care resources are limited, it is important to ensure that drugs provision and use is rational. The Essential Drug List includes depot medroxyprogesterone acetate (DMPA) and norethisterone oenanthate (NET-EN) as injectable progestagen-only contraceptives (IPCs), and both products are extensively used. OBJECTIVES AND METHODS: Utilisation patterns of the injectable contraceptive products DMPA and NET-EN are compared in the context of current knowledge of the safety and efficacy of these agents. Utilisation patterns were analysed by means of a Pareto (ABC) analysis of IPCs issued from 4 South African provincial pharmaceutical depots over 3 financial years. A case study from rural KwaZulu-Natal, South Africa, is used to examine utilisation patterns and self-reported side effects experienced by 187 women using IPCs. RESULTS: IPCs accounted for a substantial share of total state expenditure on drugs. While more DMPA than NET-EN was issued, NET-EN distribution from 2 depots increased over the 3-year period. Since DMPA was cheaper, if all NET-EN clients in the 1999/2000 financial year (annualised) had used DMPA, the 4 depots could have saved 4.95 million South African Rands on product acquisition costs alone. The KZN case study showed slightly more NET-EN (54%) than DMPA (46%) use; no significant differences in self-reported side effects; and that younger women were more likely to use NET-EN than DMPA (p = 0.0001). CONCLUSIONS: Providing IPCs on the basis of age is not appropriate or cost effective. Rational use of these products should include consideration of the cost of prescribing one over another.

New once-a-month injectable contraceptives, with particular reference to Cyclofem/Cyclo-Provera.

Once-a-month injectable contraceptives containing a progestogen and an estrogen have been developed that disrupt vaginal bleeding patterns less than the widely used progestogen-only preparations. Pharmacokinetic studies were undertaken of dosages and ratios of the progestogens and the respective estrogens. In Phase III clinical trials, annual pregnancy rates were below 0.4% for Mesigyna (norethisterone enanthate/estradiol valerate, Schering AG, Berlin, Germany) and below 0.2% for Cyclofem (MPA/E2C) (medroxyprogesterone acetate/estradiol cypionate, Aplicaciones Farmaceuticas, SA, Mexico and PT Tunggal, Indonesia). More than two-thirds of women had predictable, regular cycles, and discontinuation due to bleeding-related problems occurred less than half as often as with progestogen-only injectables. With MPA/E2C, return to fertility is similar to that observed with other hormonal or intrauterine methods, and both products have little effect on lipids or hemostasis. Introductory trials of MPA/E2C in 12000 women with 100000 woman-months of experience confirmed the high efficacy of the product in routine use. The use of MPA/E2C in a non-reusable injection device, Uniject (Becton Dickinson, Franklin Lakes, NJ) is discussed. Once-a-month hormonal contraceptives have been shown to provide a safe contraceptive option for all women and an alternative for women who wish to use injectable formulations that cause less disruption in vaginal bleeding and minimal side effects.