Medical and Health Services Issues
Introduction of Abortion Technologies: A Quality of Care Management Approach Forrest C. Greenslade, Judith Winkler and Ann H. Leonard
mid-1960s of an early Intrauterine Device, the Lippes Loop, into family planning programs in India is often cited for being poorly managed with important negative consequences. The Lippes Loop IUD was viewed at the time as a revolutionary new contraceptive. A single act of acceptance provided years of highly effective contraceptive protection compared to other reversible methods available. Enthusiasm for the method’s benefits was not matched, however, with adequate planning for its introduction. According to Soni, this IUD
The development of antiprogestins and their use for early legally induced abortion have caused considerable heated debate concerning the appropriateness of this new technology for introduction into health care settings around the world. This debate is obviously complicated by broader issues such as abortion itself, women’s rights and reproductive freedom, hormone-related medications, and other controversies. While these issues cannot be completely separated, this paper focuses on the management challenges that surround the introduction of new reproductive health technologies. This problem is central to the availability, accessibility, and applicability of new abortion technologies such as the RU 486Prostaglandin combination. Introduction of new contraceptive and abortion technologies has yielded important lessons that can guide decision-making regarding RU 48 6Prostaglandin. Specifically, these experiences have highlighted the need to concentrate on quality of care concerns in introducing technologies, to ensure new services’ acceptability and, thereby, their effectiveness. My organization, PAS, drawing on over 20 years’ experience in the developing world with manual vacuum aspiration (MVA), has developed a framework for quality of care in abortion. This paper draws on that framework to suggest a management approach to introduction of RU 486Prostaglandin that emphasizes women’s needs and preferences.
was enthusiastically introduced as the vital missing link in the program. Within two years of its introduction 1.7 million IUDs were inserted. But the success and optimism were short-lived as inadequate checks, poor follow-up, genuine side effects and grossly exaggerated rumors led to high termination rates and a 7-year slump in annual insertions. The programme had, quite simply, been rushed through without organizational preparedness to cope with the known side effects.’ Bernard Berelson, then President of the Population Council (developer of the IUD), commented in his 1966 annual address: In the first rush of enthusiasm about a method that was both new and loaded with promise, too much attention was given to speeding the work and too little attention paid to informing women about the difficulties they might expect in the first two months of wearing an IUD....Where initial service had been inadequate, dissatisfied women spread adverse gossip and encouraged others to discontinue ....The quality of service is of critical importance when a new and unfamiliar method is being introduced. In short,
Technology introduction: a management perspective Despite the enormous successes of organized family planning programs over the last several decades, certain efforts to introduce new contraceptive technologies into health care and family planning programs around the world have demonstrated serious shortcomings. Some have met with outright failure. For example, the introduction during the 161
Volume 20: 3 , Fall
important as it is to have a satisfactory method, it is equally important that women be given an adequate understanding of what they can expect.2 In this and other programs, managers and contraceptive developers frequently paid too little attention to women’s perspectives on the new technologies and neglected important aspects such as counseling and monitoring of method use. The resulting difficulties in introducing new technologies, especially in developing countries, eventually led program managers to articulate a new definition of technology introduction-one that encompassed both the contraceptive method itself (hardware) and the service delivery practices (software) needed to promote user satisfaction with the method. Introduction strategies for more recently developed contraceptive technologies such as NORPLANTB implants and the Copper T IUD reflect greater awareness of the interrelation of the method, service delivery systems, and the needs of women using or potentially using the method. These introduction strategies emphasize the need to define the intrinsic biomedical features of each product-including effectiveness, duration, contraindications, method of administration, and side effects-and to evaluate the service delivery requirements dictated by that particular product profile for achieving a high probability of success in satisfying users’ needs. Health systems utilizing
Environment
RiskdBenefits Informed Choice Equitable Access Method’s Biomedical Profile
Patient’s Needs
Figure I: Ethical Issues Concerning Introduction of New Health Care Technologies. Source: Ruth Macklin, “Antiprogestins: Ethical Issues,” paper prepared for the International Symposium on Antiprogestins (Dhaka, Bangladesh: October 1991).
1992
this management approach must establish the management capacity to introduce the new technology by training staff, making the appropriate facilities and supplies available, providing comprehensive information for counseling and instituting recordkeeping and other administrative practices that will maximize the method’s availability and providers’ ability to manage any problems users might experience.3 The interface among the biomedical profile of a method, the service delivery environment, and the needs of patients is increasingly recognized as the focus of bioethical issues raised by the introduction of new health care technologies (figure I ) . Macklin, in a recent presentation on ethical issues to be addressed in introducing antiprogestins into a developing country setting, noted three areas of concern: I ) the assessment of the risks and benefits to the patient, as compared to other available methods; 2) the ability of the patient to make an informed choice of the method; and 3 ) whether patients will have equitable access to the method.4 Clearly, each concern relates as much to the service delivery infrastructure as it does to the method itself. IPAS’ two decades of experience introducing the MVA method into health care systems, especially in developing countries, underscore the influence of the management and policy environment on the quality of abortion care.5 Experience with introduction of both contraceptive and abortion technologies has shown that no one method is the best option for the majority of women. Each method has its advantages and disadvantages. As Spicehandler points out, a woman’s decision to begin a particular contraceptive method involves trade-offs and subjective choices based on diverse factors such as: fertility goals; perceptions by individuals (and across cultures) of what constitutes a tolerable side effect; male/female attitudes toward contraception in general or toward specific methods; preferences regarding ease of use; and potential obstacles to access to services. In recognizing that no one method can meet the different fertility goals, preferences, and requirements of each individual or couple, introduction strategies now embrace a user-oriented rather than a method specific approach. More broadly, in recognizing the diverse needs of couples, the objective of introducing new contraceptive technologies is to ensure better use of family planning services rather than to promote any specific method.6 This experience has led to a management-oriented approach that views the introduction of a new or under-utilized technology as an opportunity to improve the quality of services, not just by the addition of a new method thereby expanding choice, but also by facilitating the upgrading of quality of care provided in general.’ Experience with introduction of MVA has also demonstrated that new abortion technologies can facilitate improvements in quality of care.* 162
Law, Medicine ei. Health Care
A quality of care approach to introducing RU 486/prostaglandin It is appropriate that many questions remain concerning the introduction of antiprogestins into health care systems in different country settings; the evaluation process is only beginning. What is important is that the evaluation follow a woman-centered rather than a method-centered approach that examines the interface between the biomedical profile of the antiprogestin and the elements of quality of care. To guide such an effort, this paper summarizes the method profile of RU 48 6Prostaglandir1, as compared with vacuum aspiration (VA) and dilation and curettage (D&C) (presented in more depth in table I ) and discusses the implications of quality of care for introduction of this new technology.
Profile of RU 486/prostaglandin While the effectiveness of RU 486 alone in terminating early pregnancy is limited (65 to 90 percent), a regimen of RU 486 plus prostaglandin achieves effectiveness of 95 to 98 percent, approximately comparable to VA and D&C. The current dosage regimen is a single 600 mg
dose (three 200 mg tablets) followed 36 to 48 hours later by a gemeprost vaginal suppository, a sulprostone intramuscular injection or oral misoprostol. RU 486Prostaglandin can be used earlier in pregnancy than VA or D&C. D&C is not recommended for early abortion. Because it is a non-surgical intervention, RU 486Prostaglandin avoids the risks of cervical and uterine trauma of VA or D&C, as well as risks associated with anesthesia, which is often used with D&C. These surgical methods also involve some increased risk of procedure-related infection. Currently labeled contraindications for RU 486Prostaglandin include diabetes, liver or renal insufficiency, adrenal abnormalities, clotting disorders, bronchial asthma, history of heart disease and hypertension, anemia and malnutrition, age over 3 5 and regular smoking. Common side effects include uterine pain and gastrointestinal complaints (nausea, diarrhea, and vomiting), and prolonged bleeding or spotting. Serious but rare complications of RU 4 86Prostaglandin include excessive bleeding and cardiac complications. The most serious complications reported to date are myocardial infarctions, believed to be related to the prostaglandin sulprostone in three women who smoked.
LEGALLY INDUCED ABORTION METHODS: BIOMEDICAL PROFILES E I U 4861
Very effective when administered up to 9 weeks after the first day of the last menstrual period (LMP). Prolonged bleeding and spotting also reported. Rarely, myocardial infarction and cardiac arrhythmia.
Heavy bleeding, uterine pain, and gastrointestinal (GI)problems most commonly reported.
Capability of multiple clinic visits. Back-up to treat complications. VA or D&C available in case of failure to ahort.
VACUUM ASPIRATION Uterine contents evacuated by vacuum through cannula VA) introduced through cervical 0s. Requires minimal cervical dilation, minimal pain control medication.
Very effective throughout first trimester. Less effectivc prior to 7 weeks LMP.
Heavy bleeding most commonly reported. Rarely, uterine and cervical injuries and pelvic infection also reported.
Single visit for abortion procedure. Follow-up visi recommended. Training in VA technique. Back-uE for complications. Clinic or outpatient facility sufficient.
DILATION & CURETTAGE (D&C)
Slightly less effective. Not recommended early in the first trimester.
Heavy bleeding most commonly reported. Uterine and cervical injuries, pelvic infection, and anesthesiarelated complications also reported. Serious complications twice as frequent as with VA.
Single visit for abortion procedure. Follow-up vis recommended. Training in D&C technique. Backup for complications. Anesthesia and hospital stays common.
’ROSTAGLANDIN
Drug action to produce uterine bleeding and contrac i o n . Two drug regimen administered at different times.
SERVICE DELIVERY REQUIREMENTS
Uterine contents removed by scraping of uterine lining with metal curette. Requires more cervical dilation. Requires more pain control than VA.
Sources: Program for Appropriate Technology in Health (PATH), “RU 486 in Developing Countries: Questions Remain,” Outlook, y (Sept. 1991):1-6; World Health Organization, Technical and Managerial Guidelines on Abortion Cure (Geneva: World Health Organization, in press).
Volume 20: 3 , Fall 1992 RU 486Prostaglandin is a clinic-based method. Multiple clinic visits are needed: the first to administer the RU 486, possibly a second (twodays later) to administer the prostaglandin, and another (one to two weeks later) to confirm that pregnancy termination is complete. Administration of RU 486 requires trained health practitioners, and patients need access to surgical procedures when termination is unsuccessful and for treatment of any complications.9
Quality of care concerns for the introduction of RU 486/prostaglandin Decisions related to introducing a new technology by necessity are country-specific, oftentimes even program- or clinic- specific. The appropriateness of new methods such as RU 486Prostaglandin can be judged by evaluating the preparedness of local policy and service delivery infrastructure to assume the specific responsibilities of incorporating it into ongoing programs. With the above biomedical profile for RU 486Prostaglandin in mind, a number of questions should be asked in each program setting. The fundamental issue to be addressed in decision-making concerning new abortion technologies is how the technology will affect the quality of care-the overall safety, effectiveness and appropriateness of health care-provided to women who need it. Drawing on successes and difficulties encountered in
introducing MVA, IPAS staff have adapted Bruce’s quality of care framework for family planning‘” to reflect concerns that are specific to ensuring high-quality abortion care (figure 2). IPAS’ framework, which will be fully described in a forthcoming publication, is a useful tool for focusing questions on those issues most critical in evaluating the impact of the technology on delivery of abortion care.“ The framework helps to demonstrate the dynamic interface among abortion care technologies, service delivery environment, and women’s needs. It can be used to identify specific policy, infrastructure, and management factors that can be barriers for women to high-quality abortion care. In this way the framework provides a set of goals around which strategies may be devised for improving the quality of abortion care for the future. It does not prescribe minimum or optimum standards; rather, it can be used to identify areas in which services are stronger or weaker and to highlight improvements made. Finally, the framework can aid in evaluating the factors that determine the appropriateness of a new or under-utilized technology in a specific country or program setting. The seven elements of IPAS’ quality of care for abortion care framework are shown graphically in figure 2 , described in depth in the attached Appendix, and summarized in the following discussion of their applicability to RU 486Prostaglandin.
Appropriate abortion care technology
Quality of Care Framework
A Information
Figure 2: A Framework for Quality of Care in Abortion Services. Source: Ann H. Leonard and Judith Winkler, “A Quality of Care Framework for Abortion Care,” Advances in Abortion Cure, I (Dec. 1991).
High-quality abortion care depends on the availability of safe, effectivemedical technologies that are acceptable to women and providers and appropriate to specific service delivery settings. Questions that can be used to ascertain the appropriateness of RU 486Prostaglandin include: What niche will this new method fill among other abortion technologies available through the program? Will this particular mode of administration, side effect pattern, or pattern of contraindications be more acceptable to certain groups of women or providers than other methods? Will adding this new method decrease the efficiency of provision of currently available abortion technologies? Is a two-drug regimen too complicated for the health care system? Can the health care system be adapted to accommodate the multiple visit clinic protocol? What impact will leakage of RU 486 or prostaglandin into clandestine use have on women’s health? How will back-up services be organized to handle failed or incomplete terminations or complications? Can RU 486 itself have a role in treatment of incomplete abortion and abortion complications?
Law, Medicine & Health Care
Technical competence To ensure the safety and effectiveness of abortion care, all members of the health care team at all levels of the system need to perform their respective tasks proficiently. Administrative elements that promote technical competence include training; supervision; adherence to standardized protocols for referral, treatment, and infection prevention; and mechanisms for review of complications and deaths related to abortion treatment. Some specific concerns related to technical competence in the delivery of RU 4861 Prostaglandin follow: Because it is a non-surgical intervention, will training of providers be easier than for surgical methods? How will adequate management and supervision be developed to ensure adherence to the protocol, follow-up, and referral for back-up services? Since it is a new method, how will surveillance of the experience be monitored? Can the multiple visit protocol be made simpler to accommodate the women and providers in the setting?
Interactions between women and providershaff High-quality abortion care is characterized by supportive interactions between women and health care providers and staff. Among other elements, responsiveness to women’s expressed concerns is fundamental to establishing conditions conducive to quality of care. How will this non-surgical method affect the relationships among women, providers and staff in the clinic setting? What are the special training and management issues for supportive interactions? Are there specific provider biases with respect to this method or those already available that will affect informed decision-making by women? What can be done to facilitate continuity of care for women, given the multiple visit protocol? v
What broad-based community informational programs are needed to ensure a supportive environment for responsible use? How can supporting informational materials be distributed at the same levels of the health care system that provide the drugs?
Post-abortion family planning and reproductive health care Women’s needs for post-abortion family planning and other reproductive health care should be assessed at the time of abortion care, and effective counseling, referral, or services should be provided as appropriate. What contraceptive methods are appropriate after pregnancy termination with RU 486/Prostaglandin? Given the multiple visit clinical protocol, what is the appropriate time for counseling about contraceptive options? Will the non-surgical nature of this intervention mean that women will be more likely to leave the health system without being counseled or referred for postabortion services?
Equipment, supplies and medication The of essential and appropriate equipment, supplies and medications is central to the provision of safe and effective care. Competent management, including functioning systems for transportation, communication, and referral, are critical to ensuring the availability of these commodities. Can the existing logistics system ensure consistent and reliable availabilityof both RU 486 and prostaglandm? Can the drugs be securely obtained and leakage to clandestine use minimized? Will this non-surgical method result in savings of health resources?
Access to care
All the preceding elements of this framework combine to Information and counseling Women requiring abortion care need comprehensive, comprehensible information and counseling to assist them in expressing their concerns and making decisions and to ensure that they obtain complete and appropriate care that meets their individual needs. What specific information and counseling are required to ensure informed decision-making by women regarding use of RU 486/Prostaglandin? How can adherence to clinical protocols for followup and referral be facilitated?
determine the ease with which women can obtain needed abortion care. Making high-quality care accessible to the largest possible number of women requires that services be effectively and appropriately managed and that women understand how to obtain them. Key factors in achieving this level of accessibility include decentralization of service delivery; operative, efficient referral networks; affordability of services; and linkage of abortion care services to the fullest available array of medical and reproductive health services.
To what degree will legal restrictions on abortion block women’s access to RU 486/Prostaglandin ser-
Volume 20: 3, Fall 1992 vices? Will legal systems that severely limit abortion but permit menstrual regulation facilitate access? Will this medical innovation prompt new legal interpretations with the potential to increase access? How will the introduction of this new technology affect the availability and efficiency of use of current technologies? How can this combination of drugs be provided at a cost that makes them accessible to most women who need them? What financial impact will procurement of this new method have on availability and accessibility of other abortion care services (i.e., impact on women and health system)? How will the high visibility of RU 486 and the controversy surrounding abortion affect women’s access to the new technology? Can introducing RU 48 6Prostaglandin help decentralize service delivery and thereby increase women’s access to abortion care?
Appendix A quality of care framework for abortion care Appropriate Abortion Care Technology The provision of quality abortion care depends on the availability of safe and effective medical technologies. It is essential that the technologies used be: acceptable to women and providers manufactured to high standards consistent with relevant regulatory requirements appropriate to specific service delivery settings.
Technical Competence Technical competence refers to the proficiency with which all members of the health care team at all levels of the system perform the tasks involved in abortion care. ,High levels of competence can be achieved through: training in relevant aspects of care for all staff according to the functions that each staff member fulfills adequate supervision of all staff and functions adherence to protocols for referral and treatment by staff throughout the health care system adherence to standard infection prevention practices to maintain the safety of women, providers, staff, and the community mechanisms for review of all complications and deaths related to abortion treatment throughout all levels of the health care system.
Conclusions The development of antiprogestins as a technology for early abortion is clearly a landmark in reproductive health. The regulatory approval of RU 486 in France, its country of origin, initiated a vigorous debate over the appropriateness and availability of this abortion care technology for introduction around the world-a debate in which RU 486 has become an icon for groups advocating women’s health and reproductive rights on the one hand and groups opposing abortion on the other. Although it is impossible to ignore these compelling ideological issues, it is important to separate them as much as possible from the pragmatic medical and programmatic questions that need to be answered in evaluating the impact of introducing antiprogestins on the quality of care in a specificsetting, In short, it is necessary to distinguish the medicine from the icon. It is appropriate that technological innovations such as antiprogestins serve as focal points for debate over the quality of health care. In many ways the process of innovation is an ever-increasing experiment through the stages of research, development, introduction, and incorporation into health care systems. This crucial stage at which the technology intersects the realities of the service delivery environment requires the broadest perspective with inputs from diverse points of view. Evaluation of the appropriateness of a new or underutilized technology for a specific setting is most effective if the decision-making process is patient-centered rather than method- centered. Many of the issues relevant to medicinal abortifacients such as antiprogestins are as challenging as those for currently available surgical technologies. The question for each locale is-will this technology improve the quality of care in this setting for these women needing abortion care?
Interactions Between Women and ProviderslSta f f This element encompasses all of the interactions that women have with the providers and staff when they seek and receive abortion care. These interactions need to be characterized by: respect and support for women and their situations while meeting immediate medical needs non-judgmental attitudes an atmosphere of trust between providerslstaff and women respect for women’s need for confidentiality respect for women’s ability and right to make informed decisionskhoices about their health and fertility absence of provider bias or coercion in provision of care an opportunity for women to express their views, concerns and questions responsiveness to women’s expressed concerns.
Information and Counseling Informing and counseling are fundamental aspects of health care. In abortion care women need: counseling to assist them in making decisions and expressing their concerns information about all aspects of their care, including current condition, treatment plan and follow-up needs information about where and how to get comprehensive reproductive health care that meets their individual needs, including medical follow-up, family planning, prenatal care, treatment for STDs and infertility information about warning symptoms of post- abortion complications and how to obtain appropriate care I 66
Law, Medicine & Health Care
the opportunity to express concerns, ask questions, and receive accurate, understandable answers.
fullest available array of medical and reproductive health services.
Post-Abortion Family Planning and Reproductive Health Care
Source: Ann H. Leonard and Judith Winkler, “A Quality of Care Framework for Abortion Care,” Advances in Abortion Care, I (Dec. 1991).
Post-abortion family planning and reproductive health care refer to the additional services to which women need access when they seek abortion care. It is essential that women’s reproductive health needs be: assessed at the time of abortion care through discussion and counseling, and addressed with provision of services or referral as appropriate delivered in the context of the Quality of Care framework for family planning” made accessible and not limited by administrative or policy barriers.
Equipment, Supplies and Medications The availability of essential and appropriate equipment, supplies and medications is central to the provision of safe and effective care. Correct management of these commodities will help ensure that equipment is in functioning order and that supplies and medications are available as needed. Essential equipment, supplies and medications should: be present at every level of the system, corresponding to the care performed at each level and in quantities sufficient to meet the need be managed through a system for inventory control, resupply, and maintenance include well-funcsioning systems for transportation, communication, and referral include supplies and equipment for essential support services, such as infection prevention, throughout the health care system.
Access to Care Access to care is based, in large part, on the availability of services. All of the foregoing elements of the framework contribute to making abortion care available at points throughout the health care system, but women may still not have access to services for a number of reasons. The goal of high-quality abortion care is not simply that services be available, but that the largest possible number of women are able to benefit from quality care. Meeting this objective requires that services be effectively and appropriately managed and that women understand how to obtain them. To achieve this level of accessibility, services need to have the following characteristics: women understand the full range of services available to them through the health care system women enter the health care system through decentralized service delivery points and receive care at the lowest appropriate level of the networked system, i.e., the primary level if possible services are effectively managed, referral and treatment protocols exist and are followed at each level of the system, and administrative and logistical factors are not obstacles to the timely delivery of high-quality care fees for abortion services are within reach of women’s ability to pay; emergency care is provided regardless of women’s ability to pay care for women is in no way contingent on prior acceptance of contraception abortion care services are integrated with or linked to the
References The authors are grateful to Laura Yordy for graphic design, Katie E. McLaurin, Vicki Henderson and Merrill Wolf for text editing, and jo Fulcher for manuscript preparation. I . Veena Soni, “The Development and Current Organisation of the Family Planning Programme,” in Tim Dyson and Nigel Cook, eds., India’s Demography: Essays on the Contemporary Population (New Delhi: South Asian Publishers Pvt. Ltd., 1984). 2. Bernard Berelson, “Report of the President,” The Population Council Annual Report, 1966 (New York: The Population Council, 1966). 3. Joanne Spicehandler, “Norplants Introduction: A Management Perspective,” in Sheldon J. Segal, Amy 0. Tsui and Susan M. Rogers, eds., Demographic and Programmatic Consequences of Contraceptive Innovations (New York: Plenum Publishing Corporation, 1989), 199-225; Robert J. Lapham and George B. Simmons, eds., Organizing for Effective Family Planning Programs (Washington, DC: National Academy Press, 1987);International Development Research Centre, Choice and Challenge-Global Teamwork in Developing a Contraceptive Implant (Ottawa: International DeveIopment Research Centre, 1990); World Health Organization, Norplants Contraceptive Subdermal Implants (Geneva: World Health Organization,
1990). 4. Ruth Macklin, “Antiprogestins: Ethical Issues,” Paper prepared for the International Symposium on Antiprogestins (Dhaka, Bangladesh: October 1991). Another version of this
paper, focusing on United States issues, is published in this issue of Law, Medicine &Health Care. 5. Katie E. McLaurin, Charlotte E. Hord and Merrill Wolf, “Health Systems’ Role in Abortion Care: the Need for a ProActive Approach,” Issues in Abortion Care, I (1991): 1-34; World Health Organization, Technical and Managerial Guidelines on Abortion Care (Geneva: World Health Organization, in press). 6. Judith Bruce, “Users’ Perspectives on Contraceptive Technology and Delivery Systems-Highlighting Some Feminist Issues,” Technologyin Society, 9 (1987):359-383; Spicehandler, supra note 3 . 7. Karen J. Beattie, Forrest C. Greenslade and Elizabeth R. Spitzer, “Opportunities for Improving the Quality of Care in Family Planning Services through Introduction of New Cont-raceptive Methods,” Paper prepared for the r 18th Annual Meeting of the American Public Health Association (New York: October 1990). 8. Jan Bradley, Nsama Sikazwe and Joan Healy, “Improving Abortion Care in Zambia,” Studies in Family Planning, 22 (Nov./Dec. I 99 I). 9. Program for Appropriate Technology in Health (PATH), “RU 486 in Developing Countries: Questions Remain,” Outlook, 9 (Sept. 1991): 1-6; Program for Appropriate Technology in Health (PATH),Model Program for the lntroduction of RU 486 in Developing Country Settings (Seattle, Washington: PATH, 1991).
Volume 20: 3 , Fall 1992 Care, I (Dec. 1991). 12. Judith Bruce, Fundamental Elements of the Quality of Care: A Simple Framework (New York: The Population Council, 1989).
10.Judith Bruce, Fundamental Elements of the Quality of Care: A Simple Framework (New York: The Population Council, 1989). 11. Ann H. Leonard and Judith Winkler, “A Quality of Care Framework for Abortion Care,” Advances in Abortion
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Introduction of Abortion Technologies: A Quality of Care Management Approach Forrest C. Greenslade, Judith Winkler and Ann H. Leonard
mid-1960s of an early Intrauterine Device, the Lippes Loop, into family planning programs in India is often cited for being poorly managed with important negative consequences. The Lippes Loop IUD was viewed at the time as a revolutionary new contraceptive. A single act of acceptance provided years of highly effective contraceptive protection compared to other reversible methods available. Enthusiasm for the method’s benefits was not matched, however, with adequate planning for its introduction. According to Soni, this IUD
The development of antiprogestins and their use for early legally induced abortion have caused considerable heated debate concerning the appropriateness of this new technology for introduction into health care settings around the world. This debate is obviously complicated by broader issues such as abortion itself, women’s rights and reproductive freedom, hormone-related medications, and other controversies. While these issues cannot be completely separated, this paper focuses on the management challenges that surround the introduction of new reproductive health technologies. This problem is central to the availability, accessibility, and applicability of new abortion technologies such as the RU 486Prostaglandin combination. Introduction of new contraceptive and abortion technologies has yielded important lessons that can guide decision-making regarding RU 48 6Prostaglandin. Specifically, these experiences have highlighted the need to concentrate on quality of care concerns in introducing technologies, to ensure new services’ acceptability and, thereby, their effectiveness. My organization, PAS, drawing on over 20 years’ experience in the developing world with manual vacuum aspiration (MVA), has developed a framework for quality of care in abortion. This paper draws on that framework to suggest a management approach to introduction of RU 486Prostaglandin that emphasizes women’s needs and preferences.
was enthusiastically introduced as the vital missing link in the program. Within two years of its introduction 1.7 million IUDs were inserted. But the success and optimism were short-lived as inadequate checks, poor follow-up, genuine side effects and grossly exaggerated rumors led to high termination rates and a 7-year slump in annual insertions. The programme had, quite simply, been rushed through without organizational preparedness to cope with the known side effects.’ Bernard Berelson, then President of the Population Council (developer of the IUD), commented in his 1966 annual address: In the first rush of enthusiasm about a method that was both new and loaded with promise, too much attention was given to speeding the work and too little attention paid to informing women about the difficulties they might expect in the first two months of wearing an IUD....Where initial service had been inadequate, dissatisfied women spread adverse gossip and encouraged others to discontinue ....The quality of service is of critical importance when a new and unfamiliar method is being introduced. In short,
Technology introduction: a management perspective Despite the enormous successes of organized family planning programs over the last several decades, certain efforts to introduce new contraceptive technologies into health care and family planning programs around the world have demonstrated serious shortcomings. Some have met with outright failure. For example, the introduction during the 161
Volume 20: 3 , Fall
important as it is to have a satisfactory method, it is equally important that women be given an adequate understanding of what they can expect.2 In this and other programs, managers and contraceptive developers frequently paid too little attention to women’s perspectives on the new technologies and neglected important aspects such as counseling and monitoring of method use. The resulting difficulties in introducing new technologies, especially in developing countries, eventually led program managers to articulate a new definition of technology introduction-one that encompassed both the contraceptive method itself (hardware) and the service delivery practices (software) needed to promote user satisfaction with the method. Introduction strategies for more recently developed contraceptive technologies such as NORPLANTB implants and the Copper T IUD reflect greater awareness of the interrelation of the method, service delivery systems, and the needs of women using or potentially using the method. These introduction strategies emphasize the need to define the intrinsic biomedical features of each product-including effectiveness, duration, contraindications, method of administration, and side effects-and to evaluate the service delivery requirements dictated by that particular product profile for achieving a high probability of success in satisfying users’ needs. Health systems utilizing
Environment
RiskdBenefits Informed Choice Equitable Access Method’s Biomedical Profile
Patient’s Needs
Figure I: Ethical Issues Concerning Introduction of New Health Care Technologies. Source: Ruth Macklin, “Antiprogestins: Ethical Issues,” paper prepared for the International Symposium on Antiprogestins (Dhaka, Bangladesh: October 1991).
1992
this management approach must establish the management capacity to introduce the new technology by training staff, making the appropriate facilities and supplies available, providing comprehensive information for counseling and instituting recordkeeping and other administrative practices that will maximize the method’s availability and providers’ ability to manage any problems users might experience.3 The interface among the biomedical profile of a method, the service delivery environment, and the needs of patients is increasingly recognized as the focus of bioethical issues raised by the introduction of new health care technologies (figure I ) . Macklin, in a recent presentation on ethical issues to be addressed in introducing antiprogestins into a developing country setting, noted three areas of concern: I ) the assessment of the risks and benefits to the patient, as compared to other available methods; 2) the ability of the patient to make an informed choice of the method; and 3 ) whether patients will have equitable access to the method.4 Clearly, each concern relates as much to the service delivery infrastructure as it does to the method itself. IPAS’ two decades of experience introducing the MVA method into health care systems, especially in developing countries, underscore the influence of the management and policy environment on the quality of abortion care.5 Experience with introduction of both contraceptive and abortion technologies has shown that no one method is the best option for the majority of women. Each method has its advantages and disadvantages. As Spicehandler points out, a woman’s decision to begin a particular contraceptive method involves trade-offs and subjective choices based on diverse factors such as: fertility goals; perceptions by individuals (and across cultures) of what constitutes a tolerable side effect; male/female attitudes toward contraception in general or toward specific methods; preferences regarding ease of use; and potential obstacles to access to services. In recognizing that no one method can meet the different fertility goals, preferences, and requirements of each individual or couple, introduction strategies now embrace a user-oriented rather than a method specific approach. More broadly, in recognizing the diverse needs of couples, the objective of introducing new contraceptive technologies is to ensure better use of family planning services rather than to promote any specific method.6 This experience has led to a management-oriented approach that views the introduction of a new or under-utilized technology as an opportunity to improve the quality of services, not just by the addition of a new method thereby expanding choice, but also by facilitating the upgrading of quality of care provided in general.’ Experience with introduction of MVA has also demonstrated that new abortion technologies can facilitate improvements in quality of care.* 162
Law, Medicine ei. Health Care
A quality of care approach to introducing RU 486/prostaglandin It is appropriate that many questions remain concerning the introduction of antiprogestins into health care systems in different country settings; the evaluation process is only beginning. What is important is that the evaluation follow a woman-centered rather than a method-centered approach that examines the interface between the biomedical profile of the antiprogestin and the elements of quality of care. To guide such an effort, this paper summarizes the method profile of RU 48 6Prostaglandir1, as compared with vacuum aspiration (VA) and dilation and curettage (D&C) (presented in more depth in table I ) and discusses the implications of quality of care for introduction of this new technology.
Profile of RU 486/prostaglandin While the effectiveness of RU 486 alone in terminating early pregnancy is limited (65 to 90 percent), a regimen of RU 486 plus prostaglandin achieves effectiveness of 95 to 98 percent, approximately comparable to VA and D&C. The current dosage regimen is a single 600 mg
dose (three 200 mg tablets) followed 36 to 48 hours later by a gemeprost vaginal suppository, a sulprostone intramuscular injection or oral misoprostol. RU 486Prostaglandin can be used earlier in pregnancy than VA or D&C. D&C is not recommended for early abortion. Because it is a non-surgical intervention, RU 486Prostaglandin avoids the risks of cervical and uterine trauma of VA or D&C, as well as risks associated with anesthesia, which is often used with D&C. These surgical methods also involve some increased risk of procedure-related infection. Currently labeled contraindications for RU 486Prostaglandin include diabetes, liver or renal insufficiency, adrenal abnormalities, clotting disorders, bronchial asthma, history of heart disease and hypertension, anemia and malnutrition, age over 3 5 and regular smoking. Common side effects include uterine pain and gastrointestinal complaints (nausea, diarrhea, and vomiting), and prolonged bleeding or spotting. Serious but rare complications of RU 4 86Prostaglandin include excessive bleeding and cardiac complications. The most serious complications reported to date are myocardial infarctions, believed to be related to the prostaglandin sulprostone in three women who smoked.
LEGALLY INDUCED ABORTION METHODS: BIOMEDICAL PROFILES E I U 4861
Very effective when administered up to 9 weeks after the first day of the last menstrual period (LMP). Prolonged bleeding and spotting also reported. Rarely, myocardial infarction and cardiac arrhythmia.
Heavy bleeding, uterine pain, and gastrointestinal (GI)problems most commonly reported.
Capability of multiple clinic visits. Back-up to treat complications. VA or D&C available in case of failure to ahort.
VACUUM ASPIRATION Uterine contents evacuated by vacuum through cannula VA) introduced through cervical 0s. Requires minimal cervical dilation, minimal pain control medication.
Very effective throughout first trimester. Less effectivc prior to 7 weeks LMP.
Heavy bleeding most commonly reported. Rarely, uterine and cervical injuries and pelvic infection also reported.
Single visit for abortion procedure. Follow-up visi recommended. Training in VA technique. Back-uE for complications. Clinic or outpatient facility sufficient.
DILATION & CURETTAGE (D&C)
Slightly less effective. Not recommended early in the first trimester.
Heavy bleeding most commonly reported. Uterine and cervical injuries, pelvic infection, and anesthesiarelated complications also reported. Serious complications twice as frequent as with VA.
Single visit for abortion procedure. Follow-up vis recommended. Training in D&C technique. Backup for complications. Anesthesia and hospital stays common.
’ROSTAGLANDIN
Drug action to produce uterine bleeding and contrac i o n . Two drug regimen administered at different times.
SERVICE DELIVERY REQUIREMENTS
Uterine contents removed by scraping of uterine lining with metal curette. Requires more cervical dilation. Requires more pain control than VA.
Sources: Program for Appropriate Technology in Health (PATH), “RU 486 in Developing Countries: Questions Remain,” Outlook, y (Sept. 1991):1-6; World Health Organization, Technical and Managerial Guidelines on Abortion Cure (Geneva: World Health Organization, in press).
Volume 20: 3 , Fall 1992 RU 486Prostaglandin is a clinic-based method. Multiple clinic visits are needed: the first to administer the RU 486, possibly a second (twodays later) to administer the prostaglandin, and another (one to two weeks later) to confirm that pregnancy termination is complete. Administration of RU 486 requires trained health practitioners, and patients need access to surgical procedures when termination is unsuccessful and for treatment of any complications.9
Quality of care concerns for the introduction of RU 486/prostaglandin Decisions related to introducing a new technology by necessity are country-specific, oftentimes even program- or clinic- specific. The appropriateness of new methods such as RU 486Prostaglandin can be judged by evaluating the preparedness of local policy and service delivery infrastructure to assume the specific responsibilities of incorporating it into ongoing programs. With the above biomedical profile for RU 486Prostaglandin in mind, a number of questions should be asked in each program setting. The fundamental issue to be addressed in decision-making concerning new abortion technologies is how the technology will affect the quality of care-the overall safety, effectiveness and appropriateness of health care-provided to women who need it. Drawing on successes and difficulties encountered in
introducing MVA, IPAS staff have adapted Bruce’s quality of care framework for family planning‘” to reflect concerns that are specific to ensuring high-quality abortion care (figure 2). IPAS’ framework, which will be fully described in a forthcoming publication, is a useful tool for focusing questions on those issues most critical in evaluating the impact of the technology on delivery of abortion care.“ The framework helps to demonstrate the dynamic interface among abortion care technologies, service delivery environment, and women’s needs. It can be used to identify specific policy, infrastructure, and management factors that can be barriers for women to high-quality abortion care. In this way the framework provides a set of goals around which strategies may be devised for improving the quality of abortion care for the future. It does not prescribe minimum or optimum standards; rather, it can be used to identify areas in which services are stronger or weaker and to highlight improvements made. Finally, the framework can aid in evaluating the factors that determine the appropriateness of a new or under-utilized technology in a specific country or program setting. The seven elements of IPAS’ quality of care for abortion care framework are shown graphically in figure 2 , described in depth in the attached Appendix, and summarized in the following discussion of their applicability to RU 486Prostaglandin.
Appropriate abortion care technology
Quality of Care Framework
A Information
Figure 2: A Framework for Quality of Care in Abortion Services. Source: Ann H. Leonard and Judith Winkler, “A Quality of Care Framework for Abortion Care,” Advances in Abortion Cure, I (Dec. 1991).
High-quality abortion care depends on the availability of safe, effectivemedical technologies that are acceptable to women and providers and appropriate to specific service delivery settings. Questions that can be used to ascertain the appropriateness of RU 486Prostaglandin include: What niche will this new method fill among other abortion technologies available through the program? Will this particular mode of administration, side effect pattern, or pattern of contraindications be more acceptable to certain groups of women or providers than other methods? Will adding this new method decrease the efficiency of provision of currently available abortion technologies? Is a two-drug regimen too complicated for the health care system? Can the health care system be adapted to accommodate the multiple visit clinic protocol? What impact will leakage of RU 486 or prostaglandin into clandestine use have on women’s health? How will back-up services be organized to handle failed or incomplete terminations or complications? Can RU 486 itself have a role in treatment of incomplete abortion and abortion complications?
Law, Medicine & Health Care
Technical competence To ensure the safety and effectiveness of abortion care, all members of the health care team at all levels of the system need to perform their respective tasks proficiently. Administrative elements that promote technical competence include training; supervision; adherence to standardized protocols for referral, treatment, and infection prevention; and mechanisms for review of complications and deaths related to abortion treatment. Some specific concerns related to technical competence in the delivery of RU 4861 Prostaglandin follow: Because it is a non-surgical intervention, will training of providers be easier than for surgical methods? How will adequate management and supervision be developed to ensure adherence to the protocol, follow-up, and referral for back-up services? Since it is a new method, how will surveillance of the experience be monitored? Can the multiple visit protocol be made simpler to accommodate the women and providers in the setting?
Interactions between women and providershaff High-quality abortion care is characterized by supportive interactions between women and health care providers and staff. Among other elements, responsiveness to women’s expressed concerns is fundamental to establishing conditions conducive to quality of care. How will this non-surgical method affect the relationships among women, providers and staff in the clinic setting? What are the special training and management issues for supportive interactions? Are there specific provider biases with respect to this method or those already available that will affect informed decision-making by women? What can be done to facilitate continuity of care for women, given the multiple visit protocol? v
What broad-based community informational programs are needed to ensure a supportive environment for responsible use? How can supporting informational materials be distributed at the same levels of the health care system that provide the drugs?
Post-abortion family planning and reproductive health care Women’s needs for post-abortion family planning and other reproductive health care should be assessed at the time of abortion care, and effective counseling, referral, or services should be provided as appropriate. What contraceptive methods are appropriate after pregnancy termination with RU 486/Prostaglandin? Given the multiple visit clinical protocol, what is the appropriate time for counseling about contraceptive options? Will the non-surgical nature of this intervention mean that women will be more likely to leave the health system without being counseled or referred for postabortion services?
Equipment, supplies and medication The of essential and appropriate equipment, supplies and medications is central to the provision of safe and effective care. Competent management, including functioning systems for transportation, communication, and referral, are critical to ensuring the availability of these commodities. Can the existing logistics system ensure consistent and reliable availabilityof both RU 486 and prostaglandm? Can the drugs be securely obtained and leakage to clandestine use minimized? Will this non-surgical method result in savings of health resources?
Access to care
All the preceding elements of this framework combine to Information and counseling Women requiring abortion care need comprehensive, comprehensible information and counseling to assist them in expressing their concerns and making decisions and to ensure that they obtain complete and appropriate care that meets their individual needs. What specific information and counseling are required to ensure informed decision-making by women regarding use of RU 486/Prostaglandin? How can adherence to clinical protocols for followup and referral be facilitated?
determine the ease with which women can obtain needed abortion care. Making high-quality care accessible to the largest possible number of women requires that services be effectively and appropriately managed and that women understand how to obtain them. Key factors in achieving this level of accessibility include decentralization of service delivery; operative, efficient referral networks; affordability of services; and linkage of abortion care services to the fullest available array of medical and reproductive health services.
To what degree will legal restrictions on abortion block women’s access to RU 486/Prostaglandin ser-
Volume 20: 3, Fall 1992 vices? Will legal systems that severely limit abortion but permit menstrual regulation facilitate access? Will this medical innovation prompt new legal interpretations with the potential to increase access? How will the introduction of this new technology affect the availability and efficiency of use of current technologies? How can this combination of drugs be provided at a cost that makes them accessible to most women who need them? What financial impact will procurement of this new method have on availability and accessibility of other abortion care services (i.e., impact on women and health system)? How will the high visibility of RU 486 and the controversy surrounding abortion affect women’s access to the new technology? Can introducing RU 48 6Prostaglandin help decentralize service delivery and thereby increase women’s access to abortion care?
Appendix A quality of care framework for abortion care Appropriate Abortion Care Technology The provision of quality abortion care depends on the availability of safe and effective medical technologies. It is essential that the technologies used be: acceptable to women and providers manufactured to high standards consistent with relevant regulatory requirements appropriate to specific service delivery settings.
Technical Competence Technical competence refers to the proficiency with which all members of the health care team at all levels of the system perform the tasks involved in abortion care. ,High levels of competence can be achieved through: training in relevant aspects of care for all staff according to the functions that each staff member fulfills adequate supervision of all staff and functions adherence to protocols for referral and treatment by staff throughout the health care system adherence to standard infection prevention practices to maintain the safety of women, providers, staff, and the community mechanisms for review of all complications and deaths related to abortion treatment throughout all levels of the health care system.
Conclusions The development of antiprogestins as a technology for early abortion is clearly a landmark in reproductive health. The regulatory approval of RU 486 in France, its country of origin, initiated a vigorous debate over the appropriateness and availability of this abortion care technology for introduction around the world-a debate in which RU 486 has become an icon for groups advocating women’s health and reproductive rights on the one hand and groups opposing abortion on the other. Although it is impossible to ignore these compelling ideological issues, it is important to separate them as much as possible from the pragmatic medical and programmatic questions that need to be answered in evaluating the impact of introducing antiprogestins on the quality of care in a specificsetting, In short, it is necessary to distinguish the medicine from the icon. It is appropriate that technological innovations such as antiprogestins serve as focal points for debate over the quality of health care. In many ways the process of innovation is an ever-increasing experiment through the stages of research, development, introduction, and incorporation into health care systems. This crucial stage at which the technology intersects the realities of the service delivery environment requires the broadest perspective with inputs from diverse points of view. Evaluation of the appropriateness of a new or underutilized technology for a specific setting is most effective if the decision-making process is patient-centered rather than method- centered. Many of the issues relevant to medicinal abortifacients such as antiprogestins are as challenging as those for currently available surgical technologies. The question for each locale is-will this technology improve the quality of care in this setting for these women needing abortion care?
Interactions Between Women and ProviderslSta f f This element encompasses all of the interactions that women have with the providers and staff when they seek and receive abortion care. These interactions need to be characterized by: respect and support for women and their situations while meeting immediate medical needs non-judgmental attitudes an atmosphere of trust between providerslstaff and women respect for women’s need for confidentiality respect for women’s ability and right to make informed decisionskhoices about their health and fertility absence of provider bias or coercion in provision of care an opportunity for women to express their views, concerns and questions responsiveness to women’s expressed concerns.
Information and Counseling Informing and counseling are fundamental aspects of health care. In abortion care women need: counseling to assist them in making decisions and expressing their concerns information about all aspects of their care, including current condition, treatment plan and follow-up needs information about where and how to get comprehensive reproductive health care that meets their individual needs, including medical follow-up, family planning, prenatal care, treatment for STDs and infertility information about warning symptoms of post- abortion complications and how to obtain appropriate care I 66
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the opportunity to express concerns, ask questions, and receive accurate, understandable answers.
fullest available array of medical and reproductive health services.
Post-Abortion Family Planning and Reproductive Health Care
Source: Ann H. Leonard and Judith Winkler, “A Quality of Care Framework for Abortion Care,” Advances in Abortion Care, I (Dec. 1991).
Post-abortion family planning and reproductive health care refer to the additional services to which women need access when they seek abortion care. It is essential that women’s reproductive health needs be: assessed at the time of abortion care through discussion and counseling, and addressed with provision of services or referral as appropriate delivered in the context of the Quality of Care framework for family planning” made accessible and not limited by administrative or policy barriers.
Equipment, Supplies and Medications The availability of essential and appropriate equipment, supplies and medications is central to the provision of safe and effective care. Correct management of these commodities will help ensure that equipment is in functioning order and that supplies and medications are available as needed. Essential equipment, supplies and medications should: be present at every level of the system, corresponding to the care performed at each level and in quantities sufficient to meet the need be managed through a system for inventory control, resupply, and maintenance include well-funcsioning systems for transportation, communication, and referral include supplies and equipment for essential support services, such as infection prevention, throughout the health care system.
Access to Care Access to care is based, in large part, on the availability of services. All of the foregoing elements of the framework contribute to making abortion care available at points throughout the health care system, but women may still not have access to services for a number of reasons. The goal of high-quality abortion care is not simply that services be available, but that the largest possible number of women are able to benefit from quality care. Meeting this objective requires that services be effectively and appropriately managed and that women understand how to obtain them. To achieve this level of accessibility, services need to have the following characteristics: women understand the full range of services available to them through the health care system women enter the health care system through decentralized service delivery points and receive care at the lowest appropriate level of the networked system, i.e., the primary level if possible services are effectively managed, referral and treatment protocols exist and are followed at each level of the system, and administrative and logistical factors are not obstacles to the timely delivery of high-quality care fees for abortion services are within reach of women’s ability to pay; emergency care is provided regardless of women’s ability to pay care for women is in no way contingent on prior acceptance of contraception abortion care services are integrated with or linked to the
References The authors are grateful to Laura Yordy for graphic design, Katie E. McLaurin, Vicki Henderson and Merrill Wolf for text editing, and jo Fulcher for manuscript preparation. I . Veena Soni, “The Development and Current Organisation of the Family Planning Programme,” in Tim Dyson and Nigel Cook, eds., India’s Demography: Essays on the Contemporary Population (New Delhi: South Asian Publishers Pvt. Ltd., 1984). 2. Bernard Berelson, “Report of the President,” The Population Council Annual Report, 1966 (New York: The Population Council, 1966). 3. Joanne Spicehandler, “Norplants Introduction: A Management Perspective,” in Sheldon J. Segal, Amy 0. Tsui and Susan M. Rogers, eds., Demographic and Programmatic Consequences of Contraceptive Innovations (New York: Plenum Publishing Corporation, 1989), 199-225; Robert J. Lapham and George B. Simmons, eds., Organizing for Effective Family Planning Programs (Washington, DC: National Academy Press, 1987);International Development Research Centre, Choice and Challenge-Global Teamwork in Developing a Contraceptive Implant (Ottawa: International DeveIopment Research Centre, 1990); World Health Organization, Norplants Contraceptive Subdermal Implants (Geneva: World Health Organization,
1990). 4. Ruth Macklin, “Antiprogestins: Ethical Issues,” Paper prepared for the International Symposium on Antiprogestins (Dhaka, Bangladesh: October 1991). Another version of this
paper, focusing on United States issues, is published in this issue of Law, Medicine &Health Care. 5. Katie E. McLaurin, Charlotte E. Hord and Merrill Wolf, “Health Systems’ Role in Abortion Care: the Need for a ProActive Approach,” Issues in Abortion Care, I (1991): 1-34; World Health Organization, Technical and Managerial Guidelines on Abortion Care (Geneva: World Health Organization, in press). 6. Judith Bruce, “Users’ Perspectives on Contraceptive Technology and Delivery Systems-Highlighting Some Feminist Issues,” Technologyin Society, 9 (1987):359-383; Spicehandler, supra note 3 . 7. Karen J. Beattie, Forrest C. Greenslade and Elizabeth R. Spitzer, “Opportunities for Improving the Quality of Care in Family Planning Services through Introduction of New Cont-raceptive Methods,” Paper prepared for the r 18th Annual Meeting of the American Public Health Association (New York: October 1990). 8. Jan Bradley, Nsama Sikazwe and Joan Healy, “Improving Abortion Care in Zambia,” Studies in Family Planning, 22 (Nov./Dec. I 99 I). 9. Program for Appropriate Technology in Health (PATH), “RU 486 in Developing Countries: Questions Remain,” Outlook, 9 (Sept. 1991): 1-6; Program for Appropriate Technology in Health (PATH),Model Program for the lntroduction of RU 486 in Developing Country Settings (Seattle, Washington: PATH, 1991).
Volume 20: 3 , Fall 1992 Care, I (Dec. 1991). 12. Judith Bruce, Fundamental Elements of the Quality of Care: A Simple Framework (New York: The Population Council, 1989).
10.Judith Bruce, Fundamental Elements of the Quality of Care: A Simple Framework (New York: The Population Council, 1989). 11. Ann H. Leonard and Judith Winkler, “A Quality of Care Framework for Abortion Care,” Advances in Abortion
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