Int J Gynaecol Obstet 15: 105-110, 1977
Medical Supervision for Contraception: Too Little or Too Much? Allan Rosenfield Center for Population and Family Health and College of Physicians and Surgeons, Columbia University, New York, New York, USA
ABSTRACT Rosenfield, A. (Center for Population and Family Health and College of Physicians and Surgeons, Columbia University, New York, New York, USA). Medical supervision for contraception: too little or too much? Int J Gynaecol Obstet 15: 105-110, 1977 The need to provide medical supervision in contraceptive services is reviewed in the context of the situation existing in developing nations. The author contends that less rather than more medical supervision can be justified if one compares the relatively low incidence of complications from modern contraception with the inordinately high maternal death rates from pregnancy and its complications in these same countries.
INTRODUCTION A complex issue in family planning programs today relates to the safety of contraceptive agents and the need (or lack thereof) to provide medical supervision in contraceptive services in developing countries and in the United States. A difficult ethical question which raises the possibility of double standards arises when one recommends that other countries establish medical practices different from those used in one's own country. To some observers, individuals who recommend the widespread distribution of contraceptives with little or no medical supervision appear at the least callous, if not unethical. While this practice may be justified to some extent on the basis of demographic considerations, i.e., a country's need to solve problems related to excess rates of population growth, this paper will discuss this issue based solely on medical and public health considerations. It will present a review of problems relating to the constraints placed on the delivery of health and family planning care by existing medical standards, with a few specific examples. There are, in my opinion, ethical concerns that lead to the conclusion that many situations exist in which less, rather than more, medical supervision is the appropriate recommendation.
PROBLEMS IMPOSED BY EXISTING MEDICAL STANDARDS In the US medical system, which serves as a model for medical systems in many countries of the developing world, curative services are provided predominantly by physicians. Although programs using auxiliary personnel, such as physicians' assistants, obstetric and pediatric practitioners and Medex, have been developed, their use thus far has been somewhat limited. The American system is doctor-oriented, urban-oriented, medical-centeroriented, episodic, frequently impersonal, and primarily concerned with disease, not health (2). According to Senator Kennedy, "...we do an excellent job of teaching physicians to take care of a few people, and a poor job of educating physicians to take care of most people" (9). Unfortunately, the same system exists in developing countries with more serious effects. Scrimshaw has suggested that factors other than modern medical care have been primarily responsible for the decline in mortality in modern times (20). Nobel Prize winner McFarlane Barrett has stated, "Molecular biology has contributed little, if anything—and nothing at all since 1955—to health care" (26). It seems quite fair to state that while US medicine has been truly innovative in technical and scientific research, it has remained conservative in many important areas affecting public health. Many physicians in developing countries are trained in developed nations and attempt, upon their return home, to establish medical practices modeled closely after the systems that existed in the country in which they studied. Local elite groups interested in model Western systems for "national prestige" often encourage this practice. Thus urban-oriented systems have been developed which, despite vast technical advances, have adversely affected the delivery of health and family planning services in the developing world. In most developed countries, the physician-topopulation ratio ranges from 1:700 to 1:1500 people. In the developing countries, on the other
Int J Gynaecol Obstet 15
106 A. Rosenfield
hand, the ratios range from 1:5000 to 1:20000 or higher. In rural areas, where from 50 to 90% of the people live, the figures are much worse, with ratios as high as 1:100000 or more. For example, in Thailand in 1970, there was one physician per 7000 population. However, over 60% of these physicians were located in the capital city of Bangkok, with a resultant ratio there of 1:1000. In areas outside Bangkok, on the other hand, the ratio was 1:35000. Further, if one excludes the larger urban areas outside Bangkok, the ratio becomes 1:110000 people (14). Similar examples of maldistribution exist in the West, but they are not as severe. It should be apparent that any system of medicine which provides care in a setting in which there is one physician for roughly 1000 people is an inappropriate and unrealistic model for societies where there may be one physician for over 100000 people. Jelliffe and Jelliffe have commented, and quite correctly, that "the health services of the Third World countries have tended to be ill-adapted imports from Europe and North America, with emphases placed on costly curative institutionalized medicine, largely in urban centers and hospitals, manned by highly (and expensively) trained, credential-oriented cadres of orthodox health staff, particularly physicians, attempting similar functions and duties of colleagues in developed countries" (8). Large sums of money are invested in building costly, elaborate, modern edifices which Mahler, the Director General of the World Health Organization (WHO), has described as "disease palaces" (10). These centers are filled with expensive and exotic equipment and provide the most "modern" of services. Unfortunately, inordinate percentages of the national health budgets go into building and maintaining such facilities, and little is left for the urgently needed rural health services. In the past, donor agency support has also favored building the large urban centers, but this, fortunately, is beginning to change. Thus, the current situation is that modern medical care is provided for the minority or the "elite" in most developing countries, and little or no care is provided for the majority of the people. Medical standards in these countries are established along the lines of those in the West and dictate that curative services be provided only by physicians, despite their severely limited numbers. In some countries the only "medical care" that most people receive comes from "injection doctors" and other types of traditional practitioners who are willing to travel to the home and function in a way analogous to the Western general practitioners of the past (6, 13). Morbidity and mortality rates in developing
Int J Gynaecol Obstet 15
societies are strikingly higher than those in the West. In 1953, a UNICEF/WHO Committee on Health Policy noted that "probably three-fourths of the world's population drinks unsafe water, disposes of human excreta recklessly, prepares milk and food dangerously, are constantly exposed to insect and rodent enemies, and live in unfit dwellings" (24). Thirteen years later, in 1966, it was noted that infant mortality rates in the developing world were 3-10 times higher than those in the developed world and that preschool mortality rates were 30-50 times higher, with 40% of the total mortality occurring among children less than 5 years of age (3). The most common causes of death in these children were malnutrition, diarrhea, and respiratory disease, all of which were preventable. These reports, written 24 and 11 years ago, describe conditions which still exist today in much of the developing world and in many Western slums as well. NONPHYSICIAN PRACTITIONERS IN FAMILY PLANNING Innovations and modifications in the way health care is delivered are possible. Members of the health team can be trained to carry out activities previously reserved to the physicians. For example, they can suture wounds, treat common ailments, and carry out simple surgical procedures. While such approaches appear to be based on "standards" lower than those established in the Western system, they have proved effective in many countries. Among the most dramatic examples of this can be seen in the People's Republic of China. Chairman Mao's leading principles concerning health care include "put prevention first", "serve the people", "combine rural and urban public health measures with medical practice", "unite Chinese traditional therapy with Western scientific knowledge", and "in health and medical care put the stress on rural areas" (21, 22). At one end of the health-care spectrum is the widely discussed "barefoot doctor", usually a farmer given a short, 1-3 month initial training course followed by intermittent refresher courses. He or she is the first level provider in the village rural areas and is supported by a variety of more highly trained categories of health personnel and more sophisticated facilities. At the other end of the spectrum are urban tertiary medical centers staffed by specialists. Innovative approaches to the delivery of health care have also been developed in Cuba, Vietnam, Tanzania, and elsewhere. Some of the models were developed in Africa during the late colonial period when the system there was already moving toward
Medical supervisión for contraception
the practical use of medical assistants and other categories of personnel. Perhaps it is an oversimplification, but it is my belief that any repetitive procedure can be taught to any individual of average dexterity. Four years of medical school followed by several years of further training are not necessary prerequisites to training individuals to do such family planning procedures as IUD insertion, vasectomy, tubal ligation, or even first trimester abortion. The West has introduced a mentality that suggests that only a physician can provide such services. Major educational activities in China are aimed at the démystification of the physician (21), who is seen as a member of the health team with training which enables him to take care of certain complications rather than as a god-like figure with super powers. IUD insertion In the field of family planning, extensive experience in the developed and developing countries attests to the ability of nurses and nurse-midwives to insert IUDs (16). In almost all of the studies evaluating the use of such personnel, their performance has been equal to that of physicians, both in terms of side effects and complications. Moreover, in most studies, continuation rates have been somewhat higher when the IUD was inserted by paramedical personnel. It is often automatically assumed that anyone who has graduated from medical school is competent and knowledgeable in the technique of pelvic examination, and therefore, IUD training courses for physicians are usually very brief. At the same time, it is assumed that paramedical personnel are not particularly qualified, and therefore, the training is more rigorous. In actual fact, however, unless a physician is performing pelvic examinations on a regular basis, the individual is only slightly better prepared by previous medical education than is a layperson. Expertise with pelvic examinations is based simply on practice; didactic lectures cannot help one identify the positions of normal organs and abnormal pathology. As a result of these circumstances, physicians are often ill-trained in this technique, while paramedical personnel usually are well prepared. Further, paramedical personnel are often more sympathetic towards the patient and provide more patient-oriented care. There is even evidence to suggest that paramedical personnel performing pelvic examinations on a regular basis are more effective than physicians who do them only intermittently (16). A dramatic example of the use of personnel other than physicians to carry out repetitive procedures in Bangladesh was recently described. In an
107
integrated rural development project, a highlymotivated, British-trained Bangladesh surgeon carefully prepared laywomen to perform "minilap" interval female sterilization with a postoperative complication rate lower than that found in a control series of cases performed by physicians. Two of these women are illiterate. This, better than any other available example, illustrates that an effective training program can indeed prepare a whole range of personnel to safely carry out procedures that are generally limited to the physician by "Western standards". Oral contraception Despite the many reports concerning a wide range of complications secondary to their use, oral contraceptives continue to be widely used throughout the world. Over 50 million women are estimated to have used the pill in 1976. The reported and documented complications include hypertension, jaundice, cholecystitis and cholelithiasis (gall bladder disease), and increases in serum triglycerides, cholesterol, Cortisol, and insulin levels. Fortunately, almost all of these changes are reversible (1, 5). The complications of greatest concern are thromboembolic and cardiovascular diseases. Data from studies in the United Kingdom and the US show a thromboembolic attack rate of perhaps 50-60 cases per 100000 users, with death rates ranging from one to three per 100000 (19, 25). The risk of death among users is estimated to be approximately eight times that of nonusers, and, in the case of cerebral thrombosis, approximately six times that of nonusers. The ability to predict candidates for these complications from a screening procedure, however, is at best difficult and frequently impossible. In an ideal screening system, one would take a complete past, present, and family medical history, conduct a detailed physical examination, including a pelvic examination, and carry out several routine laboratory tests to rule out the various contraindications. In actual practice, however, even in the West, much less takes place. In a study carried out in London in which family planning acceptors were questioned at some time after acceptance, surprisingly large numbers of women claimed that they had not been questioned about a history of thrombophlebitis, that a blood pressure had not been taken, and that a breast examination had not been carried out (Table I). While it is possible that some of the women who stated that these procedures had not been done had simply forgotten (the study did not cross-check against medical records), it is clear that even under supposedly ideal settings, many women receive oral contraceptives without the proper checks. Int J Gynaecol Obstet
15
108 A. Rosenfield
Table I. Patient screening prior to oral contraceptive use, London, England General Practitioners
FPA Family Planning Clinics
Table I I . Questionnaire for personnel prescribing oral contraceptives Check the following (where appropriate)
by history and by examination:
YES
NO
Yellow skin or yellow eyes Not questioned about history of thrombophlebitis
34%
20%
Blood pressure not taken
81%
43%
Breast exam not done
85%
31%
Mass in the breast
Severe chest pain or headaches
From: Cartwright, A : Parents and Family Planning Services, Routledge and Paul, L o n d o n , 1970. (Based on questionnaire administered t o acceptors at some point after acceptance.)
In 1968, Thailand initiated a national family planning program. By 1969 there were slightly over 300 facilities throughout the country where couples could receive family planning services in clinics located in urban hospitals and in the small number of rural health centers (less than 200) with a physician in residence (7). Auxiliary midwives have 10 years of basic education followed by an 18-month training program in public health nursing and midwifery. In an attempt to evaluate the effectiveness and safety of the use of these auxiliary midwives to prescribe the pill, a special study was initiated in 1969 (18). While pelvic examinations are usually performed in the US before the pill is prescribed, a strong medical case can be made for omitting them in national programs (15), particularly when cervical cancer screening facilities are not available. Cervical cancer screening is expensive and, therefore, is available in only the large urban medical centers in developing countries. Further, since the diagnosis of ovarian or endometrial cancer at the time of a routine pelvic examination is most uncommon, any proposed gain would be more than offset by the large numbers of rural women who would not receive oral contraceptive services if pelvic examinations were required. A simple checklist (Table II) was developed for the auxiliary midwives to use in identifying patients with contraindications. Four provinces were chosen as the study area, and 13 nearby provinces served as the control. The areas were similar in terms of personnel and facilities. In the study area, there was a dramatic increase in the numbers of acceptors, no increase in side effects or complications after 1 year, and a surprisingly high continuation rate (higher than the rate for women in a comparable area receiving the pill from physicians) (18). In 1970, the government of Thailand accepted the bit J Gynaecol Obstet 15
Varicose veins or severe leg swelling
Increased menstrual or intermenstrual bleeding Bleeding after sexual intercourse High blood pressure (Yes = systolic above 160 or diastolic above 1 1 0 ) . . . . From: Rosenfield, A G & Limcharoen, C: Auxiliary midwife prescription of oral contraceptives. A m J Obstet Gynecol 174:942, 1972.
results of this study and allowed all midwives who had received basic training to prescribe the pill. There was a dramatic increase in the number of pill acceptors throughout the country, from roughly 8000 acceptors per month to over 30000 per month. To date, there has been no reported increase in complication rates. Largely because of this particular change, the Thai program has been dramatically successful, with well over 300000 new acceptors of the pill each year. These pill acceptors, plus the large number of sterilization and IUD acceptors, have resulted in family planning prevalence rates, as of 1976, in the range of 30% for the country and definite evidence of an age-specific fertility decline (12). This is a high prevalence rate in comparison to most developing countries (11) and represents a dramatic increase from 1968 when the prevalence rate was estimated at less than 15%. JUSTIFICATION FOR CHANGING THE "STANDARD" The mortality rate due to thromboembolic disease in developed countries ranges from one to three per 100000 users, a rate which increases in women over the age of 35 who are also heavy smokers (19, 23, 25). These mortality rates, which are quite low, are roughly the same as mortality rates due to thromboembolic disease in postpartum women. Maternal mortality rates are significantly higher in developing than in developed countries (250 to 1000 deaths per 100000 live births in the former, as compared to 25 per 100000 live births in the latter) (1). Moreover, maternal mortality rates are highest among high parity, older women, exactly those women who would be prime targets in family planning programs.
Medical supervision for contraception
Tables III and IV compare contraceptive and maternal mortality risks in hypothetical groups of a million women each in developed and developing countries (12). In developed countries, the use of contraception results in fewer deaths than would be the case if women used no contraception. In developing countries, the same data show a dramatic difference between deaths caused by pregnancy and those caused by contraception. Even condom and diaphragm users are at higher risk than pill or IUD users because of the relatively high rate of failure with more traditional methods which results in a number of deaths secondary to unwanted pregnancies.
Table I I I . Contraceptive and maternal mortality per 1000000 women at risk by level of health care in developed countries (maternal mortality: 250 per 1 0 0 0 0 0 0 pregnancies per year)
Pregnancies in any year
No Contraception
Condom/ Diaphragm
IUD
Oral Contraceptives
600000
150000
35000
20000
Deaths due to Pregnancy Method
150 0
38 0
9 10
5 30
Total deaths
150
38
19
35
From:Atkinson, L, Castadot, A G, Cuadros, A & Rosenfield, A G: Oral contraceptives: consideration of safety in nonclinical distribut i o n . Stud Fam Plann 5 : 2 4 2 , 1974.
Table I V . Contraceptive and maternal mortality per 1 0 0 0 0 0 0 women at risk by level of health care in developing countries (maternal mortality: 5 000 per 1 000 000 pregnancies per year) No Contraception
Condom/ Diaphragm
IUD
400 000
112 000
22 000
26 000
Deaths due to Pregnancy Method
2 000 0
560 0
110 10
130 30
Total deaths
2 000
560
120
160
Pregnancies in any year
Oral Contraceptives
From: Atkinson, L, Castadot, A G, Cuadros, A & Rosenfield, A G: Oral contraceptives: consideration of safety in nonclinical distribution. Stud Fam Plann 5 : 2 4 2 , 1974.
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In any discussion of oral contraception, it is cardinal to remember that in conditions in which the use of oral contraception would be contraindicated, pregnancy would be even more contraindicated. In other words, a patient who has hypertension will be at a greater risk from the pregnancy than from the use of oral contraception. In many rural areas motivation is often not high enough to sustain continued use of traditional methods such as coitus interruptus or condoms. There are thus few alternatives to the use of oral contraceptives. Clinical services for either sterilization or IUD insertion usually are not readily accessible, so that the choice really does become one between the use of oral contraceptives and the risk of pregnancy. Thus, it is my opinion as an obstetrician that one can more than justify the widespread practice of oral contraception as the most effective preventive measure available to bring about a significant reduction in maternal and infant morbidity and mortality. The development of a broad maternal and child health care program represents a major investment in terms of funding, training, personnel recruitment, and construction of facilities. It is inevitably a long-range, multiyear program. The widespread distribution of contraceptives utilizing some of the more modern approaches such as community-based distribution, on the other hand, is something that can be accomplished rapidly and effectively in many diverse settings. Given the benefits of avoiding an unwanted pregnancy, even the omission of the oral contraceptive checklist mentioned earlier still leaves one significantly on the positive side in terms of risk/benefit. For similar reasons, I firmly believe that personnel other than physicians can and should be trained in the techniques of vasectomy, postpartum and interval tubal ligation, provision of injectable hormonal contraceptives and, where legally and culturally acceptable, the carrying out of menstrual regulation or early first trimester abortion procedures. Using arguments such as those presented in this paper, I believe that one can more than justify, on ethical grounds, the development of an entirely new set of medical standards: one that calls for much less medical supervision than has been the case in our Western system. I believe that the present systems as implemented under the influence of the West in the developing countries are themselves unethical in that they result in the denial of care for the majority of the population. Thus, I suggest that less medical supervision is required and that this will lead to both better care and to far fewer deaths. Since many of these arguments also apply in the US, we need to reevaluate our standards of care here as well.
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110 A. Rosenfield
REFERENCES 1. Atkinson, L, Castadot, A G, Cuadros, A & Rosenfield, A G: Oral contraceptives: consideration of safety in nonclinical distribution. Stud Fam Plann 5:242, 1974. 2. Beeson, P B: Some good features of the British national health service. J Med Educ 40:43, 1974. 3. Brown, R E: Medical problems of the developing countries. Science 153:271, 1966. 4. Chowdhury, S & Chowdhury, Z: Tubectomy by paraprofessional surgeons in rural Bangladesh. Lancet 2.567, 1975. 5. Connell, E B: The pill revisited. Fam Plann Perspect 7:62, 1975. 6. Cunningham, C F: Thai "injection doctors": antibiotic mediators. Soc Sci Med 4:1, 1970. 7. Hemachudha, C & Rosenfield, A G: National health services and family planning: Thailand, a case study. Am J Public Health «5:864, 1975. 8. Jelliffe, D B & Jelliffe, E F P: Nutrition programs for preschool children. Am J Clin Nutr 25:595, 1972. 9. Kennedy, E M: The challenge of health professions education in the seventies. J Med Educ 48:3, 1973. 10. Mahler, H T: Keynote address. Paper presented at the International Health Conference, National Council for International Health, Reston, Virginia, October 1974. 11. Nortman, D: Population and family planning programs: a factbook. Rep Popul Fam Plann (in press). 12. Prachuabmoh, V: Personal communication, 1976. 13. Riley, J N & Sermsri, S: The variegated Thai medical system as a context for birth control services (forthcoming). 14. Rosenfield, A G: Auxiliaries and family planning. Lancet -7:443, 1972. 15. Rosenfield, A G: Family planning: an expanded role for paramedical personnel. Am J Obstet Gynecol ¿¿0:1030, 1971. 16. Rosenfield, A G: The IUD in family planning programs: programmatic issues. In Analysis of Intrauterine Contraception (éd. F Hefnawi & S J Segal), p. 37. American Elsevier, New York, 1975.
Int J Gynaecol Obstet 15
17. Rosenfield, A G: State of the art in contraceptive technology and its application. Paper presented at the International Conference on Science and Survival, Philippines, September 1976. 18. Rosenfield, A G & Limcharoen, C: Auxiliary midwife prescription of oral contraceptives. Am J Obstet Gynecol ¿¿4:942, 1972. 19. Sartwell, P E, Masi, A T, Arthes, F G, Greene, G R & Smith, H E: Thromboembolism and oral contraceptives: an epidemiologic case-control study. Am J Epidemiol 50:365, 1969. 20. Scrimshaw, N S: Myths and realities in international health planning. Am J Public Health £4:792, 1974. 21. Sidel, V W & Sidel, R: The delivery of medical care in China. Sci Am 230:19, 1974. 22. Snow, E: Report from China, population care and control. New Repub 6M1S):20, 1971. 23. Tietze, C, Bongaarts, J & Schearer, B: Mortality associated with the control of fertility. Fam Plann Perspect 5:6. 1976. 24. UNICEF/WHO Joint Committee on Health Policy, 6th session. May 1953. 25. Vessey, M P & Doll, R: Investigation of relation between use of oral contraceptives and thromboembolic disease. Br Med J 2:199, 1968. 26. Wright, R D: The immorality of excellence in health care. Va Q Rev 50:175, 1974.
Address for reprints: Allan Rosenfield Obstetrics-Gynecology and Public Health College of Physicians and Surgeons Columbia University New York, New York 10025 USA
Medical Supervision for Contraception: Too Little or Too Much? Allan Rosenfield Center for Population and Family Health and College of Physicians and Surgeons, Columbia University, New York, New York, USA
ABSTRACT Rosenfield, A. (Center for Population and Family Health and College of Physicians and Surgeons, Columbia University, New York, New York, USA). Medical supervision for contraception: too little or too much? Int J Gynaecol Obstet 15: 105-110, 1977 The need to provide medical supervision in contraceptive services is reviewed in the context of the situation existing in developing nations. The author contends that less rather than more medical supervision can be justified if one compares the relatively low incidence of complications from modern contraception with the inordinately high maternal death rates from pregnancy and its complications in these same countries.
INTRODUCTION A complex issue in family planning programs today relates to the safety of contraceptive agents and the need (or lack thereof) to provide medical supervision in contraceptive services in developing countries and in the United States. A difficult ethical question which raises the possibility of double standards arises when one recommends that other countries establish medical practices different from those used in one's own country. To some observers, individuals who recommend the widespread distribution of contraceptives with little or no medical supervision appear at the least callous, if not unethical. While this practice may be justified to some extent on the basis of demographic considerations, i.e., a country's need to solve problems related to excess rates of population growth, this paper will discuss this issue based solely on medical and public health considerations. It will present a review of problems relating to the constraints placed on the delivery of health and family planning care by existing medical standards, with a few specific examples. There are, in my opinion, ethical concerns that lead to the conclusion that many situations exist in which less, rather than more, medical supervision is the appropriate recommendation.
PROBLEMS IMPOSED BY EXISTING MEDICAL STANDARDS In the US medical system, which serves as a model for medical systems in many countries of the developing world, curative services are provided predominantly by physicians. Although programs using auxiliary personnel, such as physicians' assistants, obstetric and pediatric practitioners and Medex, have been developed, their use thus far has been somewhat limited. The American system is doctor-oriented, urban-oriented, medical-centeroriented, episodic, frequently impersonal, and primarily concerned with disease, not health (2). According to Senator Kennedy, "...we do an excellent job of teaching physicians to take care of a few people, and a poor job of educating physicians to take care of most people" (9). Unfortunately, the same system exists in developing countries with more serious effects. Scrimshaw has suggested that factors other than modern medical care have been primarily responsible for the decline in mortality in modern times (20). Nobel Prize winner McFarlane Barrett has stated, "Molecular biology has contributed little, if anything—and nothing at all since 1955—to health care" (26). It seems quite fair to state that while US medicine has been truly innovative in technical and scientific research, it has remained conservative in many important areas affecting public health. Many physicians in developing countries are trained in developed nations and attempt, upon their return home, to establish medical practices modeled closely after the systems that existed in the country in which they studied. Local elite groups interested in model Western systems for "national prestige" often encourage this practice. Thus urban-oriented systems have been developed which, despite vast technical advances, have adversely affected the delivery of health and family planning services in the developing world. In most developed countries, the physician-topopulation ratio ranges from 1:700 to 1:1500 people. In the developing countries, on the other
Int J Gynaecol Obstet 15
106 A. Rosenfield
hand, the ratios range from 1:5000 to 1:20000 or higher. In rural areas, where from 50 to 90% of the people live, the figures are much worse, with ratios as high as 1:100000 or more. For example, in Thailand in 1970, there was one physician per 7000 population. However, over 60% of these physicians were located in the capital city of Bangkok, with a resultant ratio there of 1:1000. In areas outside Bangkok, on the other hand, the ratio was 1:35000. Further, if one excludes the larger urban areas outside Bangkok, the ratio becomes 1:110000 people (14). Similar examples of maldistribution exist in the West, but they are not as severe. It should be apparent that any system of medicine which provides care in a setting in which there is one physician for roughly 1000 people is an inappropriate and unrealistic model for societies where there may be one physician for over 100000 people. Jelliffe and Jelliffe have commented, and quite correctly, that "the health services of the Third World countries have tended to be ill-adapted imports from Europe and North America, with emphases placed on costly curative institutionalized medicine, largely in urban centers and hospitals, manned by highly (and expensively) trained, credential-oriented cadres of orthodox health staff, particularly physicians, attempting similar functions and duties of colleagues in developed countries" (8). Large sums of money are invested in building costly, elaborate, modern edifices which Mahler, the Director General of the World Health Organization (WHO), has described as "disease palaces" (10). These centers are filled with expensive and exotic equipment and provide the most "modern" of services. Unfortunately, inordinate percentages of the national health budgets go into building and maintaining such facilities, and little is left for the urgently needed rural health services. In the past, donor agency support has also favored building the large urban centers, but this, fortunately, is beginning to change. Thus, the current situation is that modern medical care is provided for the minority or the "elite" in most developing countries, and little or no care is provided for the majority of the people. Medical standards in these countries are established along the lines of those in the West and dictate that curative services be provided only by physicians, despite their severely limited numbers. In some countries the only "medical care" that most people receive comes from "injection doctors" and other types of traditional practitioners who are willing to travel to the home and function in a way analogous to the Western general practitioners of the past (6, 13). Morbidity and mortality rates in developing
Int J Gynaecol Obstet 15
societies are strikingly higher than those in the West. In 1953, a UNICEF/WHO Committee on Health Policy noted that "probably three-fourths of the world's population drinks unsafe water, disposes of human excreta recklessly, prepares milk and food dangerously, are constantly exposed to insect and rodent enemies, and live in unfit dwellings" (24). Thirteen years later, in 1966, it was noted that infant mortality rates in the developing world were 3-10 times higher than those in the developed world and that preschool mortality rates were 30-50 times higher, with 40% of the total mortality occurring among children less than 5 years of age (3). The most common causes of death in these children were malnutrition, diarrhea, and respiratory disease, all of which were preventable. These reports, written 24 and 11 years ago, describe conditions which still exist today in much of the developing world and in many Western slums as well. NONPHYSICIAN PRACTITIONERS IN FAMILY PLANNING Innovations and modifications in the way health care is delivered are possible. Members of the health team can be trained to carry out activities previously reserved to the physicians. For example, they can suture wounds, treat common ailments, and carry out simple surgical procedures. While such approaches appear to be based on "standards" lower than those established in the Western system, they have proved effective in many countries. Among the most dramatic examples of this can be seen in the People's Republic of China. Chairman Mao's leading principles concerning health care include "put prevention first", "serve the people", "combine rural and urban public health measures with medical practice", "unite Chinese traditional therapy with Western scientific knowledge", and "in health and medical care put the stress on rural areas" (21, 22). At one end of the health-care spectrum is the widely discussed "barefoot doctor", usually a farmer given a short, 1-3 month initial training course followed by intermittent refresher courses. He or she is the first level provider in the village rural areas and is supported by a variety of more highly trained categories of health personnel and more sophisticated facilities. At the other end of the spectrum are urban tertiary medical centers staffed by specialists. Innovative approaches to the delivery of health care have also been developed in Cuba, Vietnam, Tanzania, and elsewhere. Some of the models were developed in Africa during the late colonial period when the system there was already moving toward
Medical supervisión for contraception
the practical use of medical assistants and other categories of personnel. Perhaps it is an oversimplification, but it is my belief that any repetitive procedure can be taught to any individual of average dexterity. Four years of medical school followed by several years of further training are not necessary prerequisites to training individuals to do such family planning procedures as IUD insertion, vasectomy, tubal ligation, or even first trimester abortion. The West has introduced a mentality that suggests that only a physician can provide such services. Major educational activities in China are aimed at the démystification of the physician (21), who is seen as a member of the health team with training which enables him to take care of certain complications rather than as a god-like figure with super powers. IUD insertion In the field of family planning, extensive experience in the developed and developing countries attests to the ability of nurses and nurse-midwives to insert IUDs (16). In almost all of the studies evaluating the use of such personnel, their performance has been equal to that of physicians, both in terms of side effects and complications. Moreover, in most studies, continuation rates have been somewhat higher when the IUD was inserted by paramedical personnel. It is often automatically assumed that anyone who has graduated from medical school is competent and knowledgeable in the technique of pelvic examination, and therefore, IUD training courses for physicians are usually very brief. At the same time, it is assumed that paramedical personnel are not particularly qualified, and therefore, the training is more rigorous. In actual fact, however, unless a physician is performing pelvic examinations on a regular basis, the individual is only slightly better prepared by previous medical education than is a layperson. Expertise with pelvic examinations is based simply on practice; didactic lectures cannot help one identify the positions of normal organs and abnormal pathology. As a result of these circumstances, physicians are often ill-trained in this technique, while paramedical personnel usually are well prepared. Further, paramedical personnel are often more sympathetic towards the patient and provide more patient-oriented care. There is even evidence to suggest that paramedical personnel performing pelvic examinations on a regular basis are more effective than physicians who do them only intermittently (16). A dramatic example of the use of personnel other than physicians to carry out repetitive procedures in Bangladesh was recently described. In an
107
integrated rural development project, a highlymotivated, British-trained Bangladesh surgeon carefully prepared laywomen to perform "minilap" interval female sterilization with a postoperative complication rate lower than that found in a control series of cases performed by physicians. Two of these women are illiterate. This, better than any other available example, illustrates that an effective training program can indeed prepare a whole range of personnel to safely carry out procedures that are generally limited to the physician by "Western standards". Oral contraception Despite the many reports concerning a wide range of complications secondary to their use, oral contraceptives continue to be widely used throughout the world. Over 50 million women are estimated to have used the pill in 1976. The reported and documented complications include hypertension, jaundice, cholecystitis and cholelithiasis (gall bladder disease), and increases in serum triglycerides, cholesterol, Cortisol, and insulin levels. Fortunately, almost all of these changes are reversible (1, 5). The complications of greatest concern are thromboembolic and cardiovascular diseases. Data from studies in the United Kingdom and the US show a thromboembolic attack rate of perhaps 50-60 cases per 100000 users, with death rates ranging from one to three per 100000 (19, 25). The risk of death among users is estimated to be approximately eight times that of nonusers, and, in the case of cerebral thrombosis, approximately six times that of nonusers. The ability to predict candidates for these complications from a screening procedure, however, is at best difficult and frequently impossible. In an ideal screening system, one would take a complete past, present, and family medical history, conduct a detailed physical examination, including a pelvic examination, and carry out several routine laboratory tests to rule out the various contraindications. In actual practice, however, even in the West, much less takes place. In a study carried out in London in which family planning acceptors were questioned at some time after acceptance, surprisingly large numbers of women claimed that they had not been questioned about a history of thrombophlebitis, that a blood pressure had not been taken, and that a breast examination had not been carried out (Table I). While it is possible that some of the women who stated that these procedures had not been done had simply forgotten (the study did not cross-check against medical records), it is clear that even under supposedly ideal settings, many women receive oral contraceptives without the proper checks. Int J Gynaecol Obstet
15
108 A. Rosenfield
Table I. Patient screening prior to oral contraceptive use, London, England General Practitioners
FPA Family Planning Clinics
Table I I . Questionnaire for personnel prescribing oral contraceptives Check the following (where appropriate)
by history and by examination:
YES
NO
Yellow skin or yellow eyes Not questioned about history of thrombophlebitis
34%
20%
Blood pressure not taken
81%
43%
Breast exam not done
85%
31%
Mass in the breast
Severe chest pain or headaches
From: Cartwright, A : Parents and Family Planning Services, Routledge and Paul, L o n d o n , 1970. (Based on questionnaire administered t o acceptors at some point after acceptance.)
In 1968, Thailand initiated a national family planning program. By 1969 there were slightly over 300 facilities throughout the country where couples could receive family planning services in clinics located in urban hospitals and in the small number of rural health centers (less than 200) with a physician in residence (7). Auxiliary midwives have 10 years of basic education followed by an 18-month training program in public health nursing and midwifery. In an attempt to evaluate the effectiveness and safety of the use of these auxiliary midwives to prescribe the pill, a special study was initiated in 1969 (18). While pelvic examinations are usually performed in the US before the pill is prescribed, a strong medical case can be made for omitting them in national programs (15), particularly when cervical cancer screening facilities are not available. Cervical cancer screening is expensive and, therefore, is available in only the large urban medical centers in developing countries. Further, since the diagnosis of ovarian or endometrial cancer at the time of a routine pelvic examination is most uncommon, any proposed gain would be more than offset by the large numbers of rural women who would not receive oral contraceptive services if pelvic examinations were required. A simple checklist (Table II) was developed for the auxiliary midwives to use in identifying patients with contraindications. Four provinces were chosen as the study area, and 13 nearby provinces served as the control. The areas were similar in terms of personnel and facilities. In the study area, there was a dramatic increase in the numbers of acceptors, no increase in side effects or complications after 1 year, and a surprisingly high continuation rate (higher than the rate for women in a comparable area receiving the pill from physicians) (18). In 1970, the government of Thailand accepted the bit J Gynaecol Obstet 15
Varicose veins or severe leg swelling
Increased menstrual or intermenstrual bleeding Bleeding after sexual intercourse High blood pressure (Yes = systolic above 160 or diastolic above 1 1 0 ) . . . . From: Rosenfield, A G & Limcharoen, C: Auxiliary midwife prescription of oral contraceptives. A m J Obstet Gynecol 174:942, 1972.
results of this study and allowed all midwives who had received basic training to prescribe the pill. There was a dramatic increase in the number of pill acceptors throughout the country, from roughly 8000 acceptors per month to over 30000 per month. To date, there has been no reported increase in complication rates. Largely because of this particular change, the Thai program has been dramatically successful, with well over 300000 new acceptors of the pill each year. These pill acceptors, plus the large number of sterilization and IUD acceptors, have resulted in family planning prevalence rates, as of 1976, in the range of 30% for the country and definite evidence of an age-specific fertility decline (12). This is a high prevalence rate in comparison to most developing countries (11) and represents a dramatic increase from 1968 when the prevalence rate was estimated at less than 15%. JUSTIFICATION FOR CHANGING THE "STANDARD" The mortality rate due to thromboembolic disease in developed countries ranges from one to three per 100000 users, a rate which increases in women over the age of 35 who are also heavy smokers (19, 23, 25). These mortality rates, which are quite low, are roughly the same as mortality rates due to thromboembolic disease in postpartum women. Maternal mortality rates are significantly higher in developing than in developed countries (250 to 1000 deaths per 100000 live births in the former, as compared to 25 per 100000 live births in the latter) (1). Moreover, maternal mortality rates are highest among high parity, older women, exactly those women who would be prime targets in family planning programs.
Medical supervision for contraception
Tables III and IV compare contraceptive and maternal mortality risks in hypothetical groups of a million women each in developed and developing countries (12). In developed countries, the use of contraception results in fewer deaths than would be the case if women used no contraception. In developing countries, the same data show a dramatic difference between deaths caused by pregnancy and those caused by contraception. Even condom and diaphragm users are at higher risk than pill or IUD users because of the relatively high rate of failure with more traditional methods which results in a number of deaths secondary to unwanted pregnancies.
Table I I I . Contraceptive and maternal mortality per 1000000 women at risk by level of health care in developed countries (maternal mortality: 250 per 1 0 0 0 0 0 0 pregnancies per year)
Pregnancies in any year
No Contraception
Condom/ Diaphragm
IUD
Oral Contraceptives
600000
150000
35000
20000
Deaths due to Pregnancy Method
150 0
38 0
9 10
5 30
Total deaths
150
38
19
35
From:Atkinson, L, Castadot, A G, Cuadros, A & Rosenfield, A G: Oral contraceptives: consideration of safety in nonclinical distribut i o n . Stud Fam Plann 5 : 2 4 2 , 1974.
Table I V . Contraceptive and maternal mortality per 1 0 0 0 0 0 0 women at risk by level of health care in developing countries (maternal mortality: 5 000 per 1 000 000 pregnancies per year) No Contraception
Condom/ Diaphragm
IUD
400 000
112 000
22 000
26 000
Deaths due to Pregnancy Method
2 000 0
560 0
110 10
130 30
Total deaths
2 000
560
120
160
Pregnancies in any year
Oral Contraceptives
From: Atkinson, L, Castadot, A G, Cuadros, A & Rosenfield, A G: Oral contraceptives: consideration of safety in nonclinical distribution. Stud Fam Plann 5 : 2 4 2 , 1974.
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In any discussion of oral contraception, it is cardinal to remember that in conditions in which the use of oral contraception would be contraindicated, pregnancy would be even more contraindicated. In other words, a patient who has hypertension will be at a greater risk from the pregnancy than from the use of oral contraception. In many rural areas motivation is often not high enough to sustain continued use of traditional methods such as coitus interruptus or condoms. There are thus few alternatives to the use of oral contraceptives. Clinical services for either sterilization or IUD insertion usually are not readily accessible, so that the choice really does become one between the use of oral contraceptives and the risk of pregnancy. Thus, it is my opinion as an obstetrician that one can more than justify the widespread practice of oral contraception as the most effective preventive measure available to bring about a significant reduction in maternal and infant morbidity and mortality. The development of a broad maternal and child health care program represents a major investment in terms of funding, training, personnel recruitment, and construction of facilities. It is inevitably a long-range, multiyear program. The widespread distribution of contraceptives utilizing some of the more modern approaches such as community-based distribution, on the other hand, is something that can be accomplished rapidly and effectively in many diverse settings. Given the benefits of avoiding an unwanted pregnancy, even the omission of the oral contraceptive checklist mentioned earlier still leaves one significantly on the positive side in terms of risk/benefit. For similar reasons, I firmly believe that personnel other than physicians can and should be trained in the techniques of vasectomy, postpartum and interval tubal ligation, provision of injectable hormonal contraceptives and, where legally and culturally acceptable, the carrying out of menstrual regulation or early first trimester abortion procedures. Using arguments such as those presented in this paper, I believe that one can more than justify, on ethical grounds, the development of an entirely new set of medical standards: one that calls for much less medical supervision than has been the case in our Western system. I believe that the present systems as implemented under the influence of the West in the developing countries are themselves unethical in that they result in the denial of care for the majority of the population. Thus, I suggest that less medical supervision is required and that this will lead to both better care and to far fewer deaths. Since many of these arguments also apply in the US, we need to reevaluate our standards of care here as well.
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110 A. Rosenfield
REFERENCES 1. Atkinson, L, Castadot, A G, Cuadros, A & Rosenfield, A G: Oral contraceptives: consideration of safety in nonclinical distribution. Stud Fam Plann 5:242, 1974. 2. Beeson, P B: Some good features of the British national health service. J Med Educ 40:43, 1974. 3. Brown, R E: Medical problems of the developing countries. Science 153:271, 1966. 4. Chowdhury, S & Chowdhury, Z: Tubectomy by paraprofessional surgeons in rural Bangladesh. Lancet 2.567, 1975. 5. Connell, E B: The pill revisited. Fam Plann Perspect 7:62, 1975. 6. Cunningham, C F: Thai "injection doctors": antibiotic mediators. Soc Sci Med 4:1, 1970. 7. Hemachudha, C & Rosenfield, A G: National health services and family planning: Thailand, a case study. Am J Public Health «5:864, 1975. 8. Jelliffe, D B & Jelliffe, E F P: Nutrition programs for preschool children. Am J Clin Nutr 25:595, 1972. 9. Kennedy, E M: The challenge of health professions education in the seventies. J Med Educ 48:3, 1973. 10. Mahler, H T: Keynote address. Paper presented at the International Health Conference, National Council for International Health, Reston, Virginia, October 1974. 11. Nortman, D: Population and family planning programs: a factbook. Rep Popul Fam Plann (in press). 12. Prachuabmoh, V: Personal communication, 1976. 13. Riley, J N & Sermsri, S: The variegated Thai medical system as a context for birth control services (forthcoming). 14. Rosenfield, A G: Auxiliaries and family planning. Lancet -7:443, 1972. 15. Rosenfield, A G: Family planning: an expanded role for paramedical personnel. Am J Obstet Gynecol ¿¿0:1030, 1971. 16. Rosenfield, A G: The IUD in family planning programs: programmatic issues. In Analysis of Intrauterine Contraception (éd. F Hefnawi & S J Segal), p. 37. American Elsevier, New York, 1975.
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17. Rosenfield, A G: State of the art in contraceptive technology and its application. Paper presented at the International Conference on Science and Survival, Philippines, September 1976. 18. Rosenfield, A G & Limcharoen, C: Auxiliary midwife prescription of oral contraceptives. Am J Obstet Gynecol ¿¿4:942, 1972. 19. Sartwell, P E, Masi, A T, Arthes, F G, Greene, G R & Smith, H E: Thromboembolism and oral contraceptives: an epidemiologic case-control study. Am J Epidemiol 50:365, 1969. 20. Scrimshaw, N S: Myths and realities in international health planning. Am J Public Health £4:792, 1974. 21. Sidel, V W & Sidel, R: The delivery of medical care in China. Sci Am 230:19, 1974. 22. Snow, E: Report from China, population care and control. New Repub 6M1S):20, 1971. 23. Tietze, C, Bongaarts, J & Schearer, B: Mortality associated with the control of fertility. Fam Plann Perspect 5:6. 1976. 24. UNICEF/WHO Joint Committee on Health Policy, 6th session. May 1953. 25. Vessey, M P & Doll, R: Investigation of relation between use of oral contraceptives and thromboembolic disease. Br Med J 2:199, 1968. 26. Wright, R D: The immorality of excellence in health care. Va Q Rev 50:175, 1974.
Address for reprints: Allan Rosenfield Obstetrics-Gynecology and Public Health College of Physicians and Surgeons Columbia University New York, New York 10025 USA
