Non-physician clinicians can safely provide first trimester medical abortion

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Non-physician clinicians can safely provide first trimester medical abortion Jillian Yarnall,a Yael Swica,b Beverly Winikoff c a Program Research Assistant, Gynuity Health Projects, New York NY, USA. E-mail: [email protected] b Senior Medical Associate, Gynuity Health Projects, New York NY, USA c President, Gynuity Health Projects, New York NY, USA

Abstract: Mid-level clinicians are integral to provision of pregnancy-related care in many settings. Yet midwives and other non-physician clinicians are excluded from training and from providing medical abortion. A substantial body of evidence exists demonstrating that mid-level providers, including nurses and midwives specialized in pregnancy-related care for women, are either already competently involved in providing medical abortions or have the requisite skills to expand their scope of practice to include medical abortion with a short course of additional training. While additional evidence may be needed to show that second trimester medical abortion can be safely and effectively provided by trained mid-level providers, we argue that for first trimester medical abortion the evidence is sufficient for governments to implement, monitor and evaluate programmes that allow mid-level clinicians to offer first trimester medical abortion independently. Because mid-level clinicians often work in rural or remote areas where physicians are scarce or where there are few surgical facilities or equipment, the expansion of the medical abortion provider pool has the potential to greatly improve the reproductive health of women worldwide. ©2009 Reproductive Health Matters. All rights reserved. Keywords: mid-level providers, medical abortion

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HYSICIAN shortages, increasing financial pressures, and poor access to care in rural or remote areas are driving increased use of mid-level providers for both basic and complex health services.1,2 Mid-level providers have different titles in different countries, including physician assistant, advanced practice practitioner or clinician, nurse practitioner, midwife, medex, medical assistant, health officer, or health assistant,2,3 and they vary in training, education, skills and responsibilities.3 In general, mid-level providers diagnose and treat common conditions and refer to higher-level cadres and higher levels of care when necessary.2 Some prescribe and dispense medication,4 perform complicated procedures such as surgery,1,5 or are trained in medical specialities.4 Mid-level providers are essential for provision of medical care in settings with physician shortages, especially in rural areas.2,6,7

The use of mid-level clinicians in medical specialities such as surgery and paediatrics is a recent phenomenon. Non-physician clinicians, however, have long been in involved in providing pregnancy-related care,8,9 routine gynaecological care and family planning.10,11 Such practitioners examine patients, diagnose conditions, perform tests and biopsies, prescribe and administer medicines, and deliver babies.5,10,11 In Indonesia, for example, community midwives manage deliveries, supervise traditional birth attendants and handle emergencies. 9 In Mozambique, maternal and child health nurses coordinate and supervise maternity units and collaborate with surgical technicians to manage women needing caesarean sections.5 Most of these tasks are associated with physician-level skills, and yet in many settings mid-level clinicians are entrusted as the primary providers of these important services. 61

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In low resource settings where physicians are scarce, expansion of the provider pool can increase access to safe abortion services and minimize unsafe abortion, including where abortion is legal.12

Surgical abortion provision by mid-level providers Historically, surgical abortion procedures (D&C, D&E) required specialized skills and were performed primarily by physicians trained in gynaecological surgery. Today, the vast majority of surgical abortions use manual or electric vacuum aspiration (MVA, EVA), which are simple procedures requiring only a basic level of skills.12 As a result, a number of countries permit,6,13,14 and in some cases promote,15–17 independent midlevel clinician provision of first trimester surgical abortion services with MVA in rural and remote areas where there are no physicians.16 In Viet Nam, for example, midwives and assistant doctors have been permitted to perform surgical abortion since its legalization decades ago.18 In Cambodia, the law now permits midwives and medical assistants authorized by the Ministry of Health to provide surgical abortion through 12 weeks' gestation.13 In Bangladesh, menstrual regulation using MVA has been performed by paramedics up to 8 weeks' gestation since the late 1970s.14,19 In Mozambique, maternal-child health nurses provide all aspects of surgical abortion care, including ultrasound, pre-treatment with misoprostol, MVA, follow-up and postabortion counselling.6 To increase service availability in South Africa, a programme was recently introduced to train midwives to provide stand-alone first-trimester surgical abortions at primary care clinics.15,16 Review of the programme found that midwives demonstrated good clinical skills and provided high quality abortion services without physician supervision.15 In two US states, Vermont and Montana, physician assistants have been performing surgical abortions since the 1970s.20–22 Finally, in several low-resource settings, nursemidwives and other trained mid-level providers of reproductive health care successfully manage the complications of unsafe abortion through provision of post-abortion care with MVA.23 Mid-level practitioners provide high quality, safe, surgical abortion care, often without 62

physician supervision.15,24 Equivalence studies comparing mid-level and physician provision of surgical abortion (mostly MVA) in both high- and low-resource settings confirm that trained mid-level clinicians competently perform these procedures at the same standard of care as physicians.18,22,24 Yet, there remains doubt and debate as to whether mid-level clinicians can provide a similarly high level of medical abortion care. This attitude is counter-intuitive, given that performance of surgical abortion requires a higher degree of skill than that required for provision of medical abortion. Most components of medical and surgical abortion are common to both methods, including verification of pregnancy, counselling, management of complications, and referral to higher levels of care where necessary. These steps are routinely performed by mid-level clinicians in relation to surgical abortion worldwide. In this paper, we describe the skill set necessary to provide first trimester medical abortion, offer a rationale for expanding the role of midlevel clinicians to include medical abortion, describe their current role in doing so in a range of developed and developing countries, summarise the ample clinical evidence that shows trained mid-level clinicians can do so safely, including if complications arise, and discuss the barriers to independent provision of medical abortion by mid-level clinicians. To identify literature for this review, we searched PubMed using the following search terms: “advanced practice clinician”, “midwife”, “medical abortion”, “abortion”, “mid-level”, “nurse practitioner” and “physician assistant”. We conducted telephone interviews with physician assistants and nurse practitioners who practise at Planned Parenthood clinics in the United States as well as with physicians who perform abortions in the United States and Viet Nam. We also reviewed materials published by organizations including the World Health Organization (WHO), Ipas, Center for Reproductive Rights and National Abortion Federation.

Skill set for provision of medical abortion In contrast to surgical abortion, first trimester medical abortion requires no surgical skills; it is a safe and effective method of pregnancy termination that involves the use of medications to induce an abortion.25 The gold-standard

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regimen consists of mifepristone (orally) followed one to two days later by misoprostol (by mouth or vagina), and dosage changes according to length of pregnancy.26 Unlike surgical abortion, medical abortion is not a discrete procedure that must be performed in a sterile setting using specialized equipment. 20 First trimester medical abortion can be offered at primary care level by trained physician assistants and nurse practitioners. It is a logical addition to the care provided by midwives, nurse-midwives and other primary care providers.11 Indeed, WHO supports provision of early medical abortion care by skilled mid-level clinicians: “Early medical abortion has been successfully provided by registered medical practitioners (who need not be gynaecologists), trained nurses and supervised paramedical staff… Personnel with experience of providing contraceptives can be trained to provide medical abortion during courses lasting only a few days.”27 (p.88–89) Most mid-level providers of reproductive health care already possess the requisite clinical skills for provision of medical abortion.12 In many settings, midwives or other mid-level clinicians routinely perform bimanual examinations to assess gestational age28,29 and detect and diagnose ectopic pregnancies,28,30 both critical components of medical abortion provision. Where ultrasonography is standard for prenatal care or for pre-abortion screening, mid-level providers typically manage it as well.31,32 Midlevel clinicians are also frequently responsible for abortion counselling, family planning and routine post-abortion care, even if physicians are available.12,31,33 In addition to providing routine prenatal care, skilled mid-level clinicians who manage normal pregnancies and births and obstetric complications must be able to diagnose and sometimes address complex, critical, emergent conditions such as intrauterine fetal death, rupture of membranes prior to term, maternal or fetal distress, obstructed labour, pre-eclampsia and eclampsia, post-partum haemorrhage and neonatal asphyxia.9,28,30 They may also perform and repair episiotomies and vaginal tears, and insert and remove intrauterine devices.11,12,34 Arguably, the provision of medical abortion requires a lower level of skill than what is needed with most of these conditions. Yet mid-level

providers are frequently not permitted to provide medical abortion in the first trimester.

Rationale for expanding the provider pool to include mid-level clinicians Research shows that medical abortion increases access to abortion care in rural and remote regions that do not have the infrastructure to support surgical abortion services.35–37 Provision of abortion services by mid-level clinicians is particularly important when physician shortages and uneven distribution of providers translate into limited access to safe care. For example, in the United States, there is a shortage of trained abortion providers outside urban centres; 97% of non-metropolitan US counties have no abortion provider.20,38 Similarly, in India, abortion providers are clustered in urban centres, which leaves many women without access to care.36 Such situations are often exacerbated by physicianonly laws that prohibit mid-level clinicians from providing abortion.39 Under such circumstances, women with the means often must travel long distances, frequently at great expense. Those without the means must often resort to unsafe abortions, which may result in death or morbidity.40 Training mid-level providers to perform first trimester medical abortion is an important strategy to increase access to safe abortion services where physicians are scarce and where surgical facilities and equipment are difficult to come by. By expanding the pool of abortion providers, more women will be able to access safe abortion services. Furthermore, given the lower skill requirements for medical abortion provision, it is logical to train mid-level clinicians to provide first trimester medical abortion services even in urban centres and high-resource settings where physicians are numerous. This enhances the costeffectiveness of abortion care because the salaries of mid-level clinicians are lower than those of physicians.41,42 Indeed, this is the service model of many Planned Parenthood clinics in the United States (Mid-level practitioners, various Planned Parenthood clinics, personal communications, Nov–Dec 2008).

Current involvement of mid-level clinicians in medical abortion provision The ubiquity of mid-level clinicians in established medical abortion services demonstrates 63

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that physician-level skills are not requisite for its provision. Mid-level clinicians are already involved in or responsible for all steps of medical abortion treatment, although specific practices vary by country and state. In some settings, physicians supervise mid-level clinicians, while in others, mid-level clinicians function autonomously but have access to physician involvement when needed. At full-service institutions, trained mid-level providers routinely manage all aspects of medical abortion under physician supervision, even in countries where physician involvement is mandated. For example, Swedish law states that abortion must be provided by a physician. Immediately after approval and introduction of medical abortion services there, most medical abortions were managed by physicians.8 However, these regulations have been reinterpreted over the years, as the number of medical abortions has grown, to increase the role of mid-level clinicians and minimize physician involvement.33 Midwives have taken over most aspects of care, including pelvic examinations, counselling, assessing abortion completion at the follow-up visit, and in some settings, administering the drugs. At present, physicians in Sweden primarily act in a consultatory and supervisory role.33 The evolution of medical abortion practice from physician-dominated services to increased involvement of mid-level clinicians has also occurred in Great Britain,33,43,44 France,33 Denmark,45 and the United States (US).11,31,46,47 For example, in the US, laws governing medical abortion practice vary by state. Generally, mid-level clinicians can provide most components of medical abortion care,11,31 but only a few states permit them to prescribe and administer the drugs under their own authority.23 Nonetheless, most US physicians now believe that mid-level clinicians are capable of medical abortion provision,46,47 which is borne out in clinical practice. At many Planned Parenthood clinics nationwide, the entire medical abortion process, including physical exam and history, pre-abortion ultrasound, counselling, administration of mifepristone, on-call care, post-abortion follow-up visit, and confirmation of completed abortion, is managed by mid-level providers. Physicians are available for consultation as needed but are primarily responsible for surgical abortion services (Midlevel practitioners, various Planned Parenthood 64

clinics, personal communications, November– December 2008). In Viet Nam, trained midwives handle many aspects of the medical abortion process under physician supervision (Dr NTN Ngoc, personal communication, 14 December 2008). 48 South Africa has recently adapted its abortion policy to permit trained mid-level clinicians to independently provide all aspects of medical abortion care.23 Similarly, in Tunisia, most medical abortion procedures are carried out by midwives without physician involvement.49,50

What if gestational age is beyond 63 days, or the pregnancy is ectopic, or the method fails? Certain aspects of diagnosis and complications associated with medical abortion are sometimes cited as barriers to independent provision by midlevel clinicians. These include under-estimation of gestational age, failure to detect ectopic pregnancy, treatment failure and emergencies. Under-estimation of gestational age Many mid-level clinicians have been trained to assess pregnancy duration accurately, either by a combination of bimanual examination and dating of last menstrual period (LMP) or by ultrasonography. An important component of medical abortion care is correct dating of gestational age, as current standards recommend that the dosage and regimen change as gestation advances, specifically after 9 weeks LMP and again after 13 weeks.51 Under-estimation by several days or a week of gestational age around 63 days may be of little clinical significance as the decline in efficacy after 9 weeks' gestation is gradual.52 Research on medical abortion between 9 and 13 weeks' gestation suggests that it is still effective during this period,53,54 though there may be a slightly higher rate of method failure if the regimen developed for use up to 63 days' LMP (mifepristone with misoprostol orally) is used after that time. Additionally, women may experience heavier bleeding and greater pain53 because the pregnancy is more advanced. There is no indication of an increased rate of major complications, such as haemorrhage or infection.54 If the method fails or the abortion is incomplete, the woman would have MVA, which is the same treatment that she

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would have received if she not had the option of medical abortion. What is more, because some mid-level clinicians also provide MVA, the woman might not need to be referred to another clinician for completion of the abortion. Failure to detect and diagnose ectopic pregnancy Ectopic pregnancy is a potentially life-threatening condition that requires urgent medical attention.55 Any clinician from obstetrician-gynaecologists to mid-level clinicians who provide care for pregnant women must be able to detect and diagnose ectopic pregnancy, counsel women about symptoms, and provide or refer for treatment.29 What if an ectopic pregnancy is missed during pre-abortion screening? An ectopic pregnancy can be missed by a midwife during an initial visit for medical abortion, but it can also be missed during an initial prenatal visit. In both cases, a woman with an ectopic pregnancy would present for medical attention at the acute onset of symptoms.55,56 The medical abortion medications will have no effect on an ectopic pregnancy. They neither treat ectopic pregnancy nor increase the risk of its rupture.29 In practice, the risk of missing an ectopic pregnancy during pre-abortion screening is extremely low. A review of the medical literature shows that ectopic pregnancy is very rarely diagnosed following early medical abortion, with diagnosis present in only 0.02% of procedures, which implies that providers are adequately screening for ectopic pregnancies prior to treatment.56 In fact, abortion care may actually facilitate diagnosis and treatment of ectopic pregnancy, since women who seek abortions are often screened earlier than women who intend to continue their pregnancies.56,57 Furthermore, studies of US women seeking abortion services have found that the rate of ectopic pregnancy is lower among women seeking abortions (1.2–5.9 per 1,000 pregnancies)57,58 than among the general population of pregnant women (19.7 per 1,000 pregnancies).59 Therefore, while ectopic pregnancy is rare, it is even rarer among women who seek abortion services.60 Method failure and emergency management Skilled mid-level providers routinely manage complications associated with pregnancy and childbirth. The conditions are in many cases similar to the complications encountered in medical abortion provision, and the level of skill

required to manage those associated with medical abortion is certainly no higher than that required with most obstetrical emergencies.61 In the event that medical abortion fails, providers must be able to offer a back-up surgical method or refer women to a higher level of care. Mid-level providers trained in aspiration abortion can do a surgical evacuation. Those who are not trained can refer women with failed medical abortions just as they would any pregnant woman who has complications like bleeding or miscarriage. The referral networks required for management of complications associated with medical abortion are the same as those needed for management of spontaneous miscarriage, later abortion, ectopic pregnancy or infections.29

Conclusion Mid-level clinicians should neither be excluded from training nor barred from providing first trimester medical abortion. The skills required to provide first trimester medical abortion fall entirely within the domain of mid-level providers specialized in reproductive health care, and a recent review of the literature found abundant evidence that these clinicians can and are already providing competent medical abortion services.23 The important question then is why many governments and professional bodies have failed to establish evidence-based policies that integrate mid-level clinicians as independent providers of early medical abortion. We suggest several reasons. First, governments that are ambivalent about abortion or lack commitment to provision of abortion services may delay or fail to update obsolete policies to reflect current clinical and scientific realities. Second, governments or the medical establishment may only adopt medical innovations with caution until influential physicians have gained substantial clinical experience with them. For example, in Viet Nam, where medical abortion is a relatively recent technology, mid-level clinicians are permitted to perform aspiration abortions but are barred from providing medical abortion.17 Third, new medical technologies are often lucrative for physicians. Once these technologies can be provided by other cadres of clinicians, reimbursements inevitably decline. Consequently, physicians may have a financial incentive to support policies that limit who can provide medical abortions. 65

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We have shown that there is a substantial body of evidence demonstrating that midlevel providers specialized in pregnancy-related care are either already competently providing medical abortions or have the requisite skills to expand their scope of practice to include medical abortion with a short course of additional training. While additional evidence may

be needed to show that second trimester medical abortion can be safely and effectively provided by trained mid-level providers, we believe that for first trimester abortion the evidence is sufficient for governments to implement, monitor and evaluate programmes that allow mid-level clinicians to offer first trimester medical abortion independently.

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Résumé Les cliniciens de niveau intermédiaire font souvent partie intégrante des soins liés à la grossesse. Pourtant, les sages-femmes et autres cliniciens non médecins sont exclus de la formation et de la pratique de l'avortement médicamenteux. Or, une somme considérable de données montre que les prestataires de niveau intermédiaire, notamment les infirmières et les sages-femmes spécialisées dans les soins liés à la grossesse, sont déjà engagés avec compétence dans les avortements médicamenteux ou possèdent les aptitudes requises pour élargir leur pratique et y inclure l'avortement médicamenteux après

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medical abortion. Women's Health 2008;4(2):5. Shannon C, Brothers LP, Philip NM, et al. Ectopic pregnancy and medical abortion. Obstetrics and Gynecology 2004;104(1): 161–67. Edwards J, Carson SA. New technologies permit safe abortion at less than six weeks' gestation and provide timely detection of ectopic gestation. American Journal of Obstetrics and Gynecology 1997;176(5): 1101–06. Kaali SG, Csakany GM, Szigetvari I, et al. Updated screening protocol for abortion services. Obstetrics and Gynecology 1990;76(1): 136–38. Centers for Disease Control and Prevention. Ectopic Pregnancy United States, 1990–1992. Morbidity and Mortality Weekly Report 1995;44:46–48. Grossman D, Ellertson C, Grimes DA, et al. Routine follow-up visits after first-trimester induced abortion. Obstetrics and Gynecology 2004;103(4):738–45. Taylor D, Hwang AC. Mifepristone for medical abortion. Exploring a new option for nurse practitioners. Journal of Association of Women's Health, Obstetric, and Neonatal Nurses Lifelines 2003/2004;7(6):524–29.

Resumen En muchos lugares, el personal médico de nivel intermedio es fundamental en la atención relacionada con el embarazo. No obstante, las parteras profesionales y otros profesionales de la salud no médicos son excluidos de recibir capacitación y proporcionar servicios de aborto con medicamentos. Existe un considerable conjunto de pruebas que demuestran que los prestadores de servicios de nivel intermedio, como las enfermeras y parteras profesionales especializadas en la atención del embarazo, ya participan competentemente en efectuar procedimientos de aborto con medicamentos o

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cuentan con las habilidades necesarias para realizar abortos con medicamentos si atienden un curso corto de capacitación adicional. Aunque se necesitan más pruebas para demostrar que los profesionales de nivel intermedio capacitados pueden efectuar procedimientos de aborto con medicamentos en el segundo trimestre de manera segura y eficaz, argüimos que para el primer trimestre existe suficiente evidencia para que los gobiernos establezcan, monitoreen y evalúen programas que permitan que los profesionales de la salud de nivel intermedio ofrezcan servicios de aborto con medicamentos de primer trimestre independientemente. Dado que estos profesionales suelen trabajar en zonas rurales o remotas donde los médicos son escasos o donde existen pocos centros o equipos quirúrgicos, al ampliarse el grupo de prestadores de servicios de aborto con medicamentos se podría mejorar notablemente la salud reproductiva de las mujeres del mundo.

ADAM GOULT / SCIENCE PHOTO LIBRARY

une brève formation complémentaire. Si des recherches supplémentaires seront peut-être nécessaires pour montrer que les prestataires de niveau intermédiaire peuvent pratiquer efficacement et en toute sécurité l'avortement médicamenteux du deuxième trimestre, nous estimons qu'il existe suffisamment de preuves pour que les gouvernements appliquent, surveillent et évaluent des programmes qui autoriseront les cliniciens de niveau intermédiaire à proposer de manière indépendante des avortements médicamenteux du premier trimestre. Comme ces cliniciens travaillent souvent dans des zones rurales ou éloignées, où les médecins sont rares ou qui disposent de peu de centres ou d'équipements chirurgicaux, l'expansion du corps de prestataires de l'avortement médicamenteux peut améliorer sensiblement la santé génésique des femmes dans le monde.

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