Key Words: Self Medication, Abortion Pill, Women Health, Medical Abortion, Unsafe abortion.

Research Article Self Medication of Abortion Pill: Women s Health in Jeopardy Rajal V Thaker *, Kruti J Deliwala**, Parul T Shah*** *Associate Professor, **Assistant Professor, ***Professor Department of Obstetrics & Gynaecology, Smt NHL Municipal Medical College, Ahmedabad Abstract Background: Federation of Obstetrics and Gynaecological Societies of India (FOGSI) recommends close monitoring of distribution of drugs that are used for medical abortion and that the medical profession and pharmaceutical industry should exercise due diligence in the promotion and usage of drugs that are used for medical abortion. Despite this, it has been perceived by the society that, medical abortions are extremely safe option even in hands of untrained personnel, leading to its over the counter dispensing and possibly increase in unsupervised terminations and life threatening complications. Objective: To study consequences of self medication of Abortion pill on women s health Study Design: Retrospective Observational Study Duration of Study: One Year: August 2012 to July 2013 Material and Methods: After due permission from authority, data was collected from patients who had come for follow-up and treatment after self medication (purchased over the counter by self/family member without medical guidance/supervision) for Medical method of Medical Termination of Pregnancy (MTP). Results: Data was collected in 37 patients, who had history of self medication of abortion pill. More than half, 20 (54%) women were in age group of 20-29 years and married women were 35 (94.5%). Uneducated women were 12 (32.4%). Majority 33(89.1%) of women had complaint of bleeding per vaginum. On Ultrasonography (USG), 26(70.2%) women had incomplete abortion, 4 (10.8%) women had intrauterine gestational sac with cardiac activity, 2(5.4%) women had complete abortion and 1(2.7%) woman had missed abortion. Surgical curettage was performed in 28(75.6%) women. In 2(5.4%) women, there was complete abortion after oxytocin and misoprostol. One woman (2.7%) wanted to continue the pregnancy. Laparotomy was performed in 2 (5.4%) women having ectopic pregnancy and in 1(2.7%) woman who had perforation of uterus while undergoing surgical curettage at private hospital. Moderate and severe anaemia was found in 21(56.7%) and 5(13.5%) women respectively. Blood and blood products were required in 6(16.2 %) women. Septicemia was present in 3(8.1%) women and 2(5.4%) women were presented with shock on admission. Maternal death occurred in one (2.7) woman. Conclusion: Health care and health protection is every woman s reproductive right. Every woman must be counseled regarding advantages, drawbacks, risks and limitations of different methods of abortion. Awareness on contraceptives is must for all. The chemist also needs to be aware about the MTP Act and consequence of medicines that are taken without medical supervision. The Government must stop the over the counter sell of drugs that are used for medical abortion and provision should be made to make these drugs available directly from hospital/ practitioner who are qualified under the MTP Act. Training on various regimes and advancement is also required for the medical practitioners. Key Words: Self Medication, Abortion Pill, Women Health, Medical Abortion, Unsafe abortion. Introduction The World Health Organization (WHO) 1 recommendations on medical abortion are restricted to early first trimester (up to 63 s since the first of the last menstrual period LMP). Antiprogesterone drugs such as Mifepristone (RU 486), prostaglandins like Misoprostol have been approved by the United States Food & Drug Administration (USFDA) for medical abortion. 2 As per Medical Termination of Pregnancy (MTP) Act of India 3, this method can only be administered by Gynaecologists and Registered Medical Practitioners (RMP) recognized for performing MTPs up to 49 s since the first of LMP. Federation of Obstetrics and Gynaecological Societies of India 4 (FOGSI) recommends close monitoring of distribution of these drugs and that the medical profession and pharmaceutical industry should exercise due diligence in the promotion and usage of drugs that are used for medical abortion. Despite this, it has been perceived by the society that, medical abortions are extremely safe option even in hands of untrained personnel, leading to its over the counter dispensing and possibly increase in unsupervised terminations and life threatening complications 5. Present study highlights the consequences of self medication of these abortion pills. The term self medication is applied when patient, her husband, her NHL Journal of Medical Sciences/Jan 2014/Vol 3/Issue 1 26

relative or her friend has brought the abortion pill (for patient) over the counter without medical guidance/supervision/prescription. Material and Methods: After due permission from authority, data was collected from patients who had come for follow-up and treatment after self medication for medical method of MTP. From August 2012 to July 2013, the data of each patient was collected in a proforma and analysis was done. Results: Data of 37 women was collected, who had history of self medication of abortion pill. Majority of women 26(70.2%) bought the abortion pill by herself going to the pharmacy and in 11(29.7%) women; their husband went to the pharmacy to buy the abortion pill. Demographic details are shown in Table I. More than half, 20 (54%) women were in age group of 20-29 years and majority 35 (94.5%) women were married. Uneducated women were 12 (32.4%). Out of all women, more than half women 19 (51.3%) were gravida three or more. The Table II shows the duration before the Abortion pill taken. Majority of women 9(24.3%) had taken the Abortion pill before 6-10 s before coming to our hospital. As shown in the Table III, 19(51.3%) women took the abortion pill within 6 weeks from their LMP. Table IV shows presenting symptom and its duration. Majority 33(89.1%) of women had complaint of bleeding per vaginum and 28 (75.6%) women had history of passing of products of conception. Table V shows the details of management and outcome. On Ultrasonography (USG), 26(70.2%) women had incomplete abortion, 4 (10.8%) women had intrauterine gestational sac with cardiac activity, 2(5.4%) women had complete abortion and 1(2.7%) woman had missed abortion. Surgical curettage was performed in 28(75.6%) women. In 2(5.4%) women, there was complete abortion after oxytocin and misoprostol. The risk of teratogenesis was explained to 1(2.7%) woman, who wanted to continue her pregnancy. Ectopic pregnancy was found in 2(5.4%) women and laparotomy was performed in both. No pregnancy was found in 1(2.7%) woman. In the present study, 6(16.2%) women were referred from other hospitals. Out of them, 3(8.1%) women were referred after surgical curettage done at private hospital. Out of them, 2(5.4%) women had developed complication while undergoing surgical curettage at private hospital and 1(2.7%) woman was referred for correction of anaemia. As shown in Table VI, more than half women 21(56.7%) had moderate anaemia and 5(13.5%) had severe anaemia. Blood and blood products like 15 Pack Cell Volume (PCV), 6 Fresh Frozen Plasma (FFP) and 6 Platelet Rich Concentrate (PRC) were required in 6(16.2%) women. Shock was present in 2(5.4%) women on admission. Septicemia was present in 3(8.1%) women and out of them maternal death occurred in 1(2.7%) woman. This woman had history of abortion pill taken before 24 s and had bleeding per vaginum for 22 s, she went to a private clinic and collapsed while undergoing surgical curettage and then she was referred to our hospital and later she died at Medical Intensive Care Unit (MICU). Post mortem suggested changes due to septicemia. Table I Demographic Details: (N =37) Age in years Number % <19 01 2.7 20-29 20 54 30-39 14 37.8 40-49 02 5.4 Marital Status Married 35 94.5 Unmarried 02 5.4 Education Nil 12 32.4 Primary 13 35.1 Secondary 08 21.6 Higher Secondary 02 5.4 College 02 5.4 Gravida 1 04 10.8 2 14 37.8 3 or more 19 51.3 Table II Duration of Abortion Pill taken Before Admission to Hospital: Abortion pill taken before No % 0-5 s 07 18.9 6-10 s 09 24.3 11-15 s 02 5.4 16-20 s 04 10.8 21-25 s 02 5.4 26-30 s 07 18.9 11 /2 month 01 2.7 2 month 01 2.7 21 /2 month 01 2.7 3 month 02 5.4 6m month 01 2.7 NHL Journal of Medical Sciences/Jan 2014/Vol 3/Issue 1 27

Table III Number of s/weeks from Last Menstrual Period (LMP): Number of s from LMP No % 4 weeks 33 s 01 2.7 5 weeks 35 s 02 5.4 6 weeks 42 s 16 43.2 8 weeks 56 s 14 37.8 10 weeks 70 s 03 8.1 14 weeks 98 s 01 2.7 Discussion: WHO 6 defines unsafe abortion as not provided through approved facilities and/or person. The facility and person may vary as per country norms. Of the 210 million pregnancies which occur each year worldwide, about 46 million (22%) end in induced abortion. Nearly half of induced abortions are unsafe and ninety five percent of these occur in developing countries. In India, when the MTP act 3 was passed, it was assumed that unsafe and illegal abortions would not take place and so morbidity/mortality associated with it would be prevented. But even after four decades, there are unsafe abortions. In India, the annual estimates of abortion vary from 3.9 to 6 million with some projections claiming upwards of 12 million. Even a conservative 3.9 million annual abortions resulted in 70 million abortions in initial 18 years since 1971 compared to official reported figures of 6.3 million abortions a gross underestimate, suggesting that a majority of abortions are either not reported or taken place illegally 4. As per WHO 1, medical methods of abortion have been proven to be safe and effective when practiced under medical supervision. Medical abortion accounted for 17% of all nonhospital abortions and it has a definite impact on reproductive freedom as it gives the woman more freedom and privacy and has become more common in both legal and illegal procedures. The guidelines 7 for medical abortion in India have been prepared by WHO-CCR in human reproduction, All India Institute of Medical Sciences, in collaboration with Ministry of Health & Family Welfare, Government of India and Indian Council of Medical Research to assist all those who provide medical abortion services under the MTP Act and ensure safe usage for early medical abortion in India. Medical abortion is offered only to those patients, who are ready for minimum three follow- up visits, can understand the instructions, ready for surgical procedure if failure or excessive bleeding occurs, good family support and easy access to appropriate healthcare facility. Counseling, careful history taking and clinical examination is must. Pregnancy confirmation for its gestational age and location is also very important and where available, urine test for pregnancy and an USG examination for confirmation of intra uterine pregnancy along with the exact gestational age should be done in all cases. Laboratory tests such as haemoglobin level, blood group and rhesus (Rh) typing, and screening for hepatitis, human immunodeficiency virus (HIV), and sexually Transmissible Infections (STIs), may be offered on the basis of individual risk factors or available resources. Patient selection is very important and contraindications for use of medical abortion must be ruled out. After taking formal consent, the recommended protocol is oral 200 mg of Mifepristone on first. After 36-48 hours 800 microgram ( պ gm) of vaginal Misoprostol or 400 պ gm of oral Misoprostol is given. The tablets are to be taken under medical supervision. The patient is asked to report immediately if excessive bleeding, pain, fainting or any problem occurs. Average blood loss in medical abortion may be more than that in surgical abortion. On third visit at 15 th, clinical history and pelvic examination should be done to ensure that there are no complications and abortion is complete. USG is required if history and examination do not confirm expulsion of products of conception. If woman is still having irregular bleeding, surgical curettage may be required. Despite this recommendation, it has been perceived by the society that, medical abortions are extremely safe option even in hands of untrained personnel, literally leading to its over the counter dispensing and possibly increase in unsupervised terminations and life threatening complications. Abortion pills are freely prescribed by many unqualified agencies such as dais, practitioners of indigenous systems of medicine, chemists, relatives etc. NHL Journal of Medical Sciences/Jan 2014/Vol 3/Issue 1 28

Table IV Major complaints: Symptoms 1 1-5 Excessive Bleeding Per Vagina 6-10 11-15 16-20 21-25 26-30 2 mths 3 mths 6mths Total 01 10 12 01 01 01 03 01 02 01 33 (89.1%) Passing of 14 07 02 01 01 02 01 28 products of (75.6%) conception Pain in 01 04 02 07 abdomen (18.9%) Giddiness 08 06 14 (37.8%) Fainting 02 02 (5.4%) Table V Management and Outcome: Ultrasonography (USG) findings No % Management No % Incomplete Abortion 26 70.2 Surgical curettage Inj Oxytocin, tab Misoprostol 24 02 64.8 5.4 Missed Abortion 01 2.7 Surgical curettage 01 2.7 Live pregnancy 04 10.8 Surgical curettage Continuation of pregnancy 03 01 8.1 2.7 Complete Abortion (referred after surgical curettage at other hospital) 02 5.4 Correction of Anaemia MICU admission Ectopic Pregnancy 02 5.4 Laparotomy 02 5.4 Perforation 01 2.7 Laparotomy 01 2.7 No Pregnancy 01 2.7 No treatment 01 2.7 01 01 2.7 2.7 In present study, 26(70.2%) women bought the abortion pill by self and in 11(29.7%) women; their husband went to the pharmacy to buy the abortion pill. Only RMPs as prescribed by the MTP Act are authorized to prescribe Mifepristone with Misoprostol for medical abortion [Definition 2(d) of section 2 and MTP rule 3] who are having access to a place approved by the Government under section 4 (b) and rule 4 (1), for surgical and emergency backup when such a back-up is indicated. Thus, when there is a self medication of abortion pill, it is an illegal and unsafe abortion as it is not provided through approved facilities and/or person. The medicine is prescribed either by patient or her relative/friend/husband/chemist who is not a medical personnel authorized as per law, the place from which it was prescribed/dispended is a chemist shop that is also not an approved place as per MTP law. As per law, no consent is taken and no records are kept. Patient is not examined to ascertain the site and weeks of gestation and contraindications are not ruled out, putting the women s health in jeopardy. Table VI Complications* Complications No % Moderate Anaemia 21 56.7 Severe Anaemia 05 13.5 Shock 02 5.4 Septicemia 03 8.1 Maternal Death 01 2.7 * More than one complication was present in some of the women NHL Journal of Medical Sciences/Jan 2014/Vol 3/Issue 1 29

The preliminary data 8 of a study, unsuccessful prior drug use among women seeking first trimester abortion shows that, a considerable demand for over the counter drugs for abortion and women are poorly informed about the protocol for medical abortion. When there is a self medication, women may take the abortion pill whatever may be the gestational age and are not aware of possibility of serious life threatening condition like ectopic pregnancy. Hence, there are more complications when the drugs are taken without medical supervision. In present study, true drug failure was present in 4(10.8%) women where USG revealed intrauterine pregnancy with gestational age of 7 weeks, 9 weeks, 11 weeks and 14 weeks along with cardiac activity. Out of them 3(8.1%) women opted for surgical curettage and 1(2.7%) woman wanted to continue the pregnancy. Risk of teratogenesis was explained to her. When the drug is given under medical supervision, < 1 % of women can have true drug failure 1. In present study, surgical curettage was required in 28(75.6%) women which is a very high proportion compared to other studies where medical abortions were advised under medical supervision. A study by Deshpande et al 9, complete abortion occurred in 99.1% having < 49 s of amenorrhoea. Other studies 10, 11 have reported rates of 2 10% which require surgical abortion. In present study, there were 2(5.4%) women were reported having ectopic pregnancy who came to the hospital with chief compliant of fainting. Emergency laparotomy was performed in both. Yet another woman who had taken the abortion pill at about 14 weeks of gestation had a bout of excessive bleeding. Hence, she went to a private clinic where surgical evacuation was performed. Patient was then referred to our hospital in shock and USG revealed perforation of uterus. Laparotomy was performed and perforation was sutured. In present study, because unsupervised medication and erratic drug schedule, many women had excessive bleeding per vaginum. In our country where 59% of pregnant women are anaemic and prevalence of mild (26 %), moderate (31%) & severe (2%) anaemia is greater among pregnant women 12, such bleeding added fuel to fire. In present study, moderate and severe anaemia was present in 21(56.7%) women and 5(13.5%) women respectively. Blood and blood products were required in 6(16.2 %) women. In a study 13 of 80,000 patients over 18 months, 13 patients required blood transfusion that is 0.01%, when the drugs were given under medical supervision. In a study by Deshpande S et al 9, no women required a blood transfusion when drugs are given under medical supervision. Haemorrhage requiring transfusions occur in only about 1 in 1000 cases of medical abortions 14 when the drugs are given under medical supervision. Another complication that was found in our study was septicemia. In present study, 3(8.1%) women had septicemia. Out of them, 2(5.4%) women responded to higher antibiotics and maternal death occurred in 1(2.7%) women. Postmortem suggested changes of septicemia. According to WHO 15, 47 000 women die from complications of unsafe abortion each year. Deaths due to unsafe abortion remain close to 13% of all maternal deaths. According to the Consortium on National Consensus for Medical Abortion in India 16, every year 20,000 women die every year due to abortion related complications. Most abortion-related maternal deaths are attributable to illegal abortions. In countries where the women have access to safe abortion services, their likelihood of dying as a result of an abortion is no more than one per 2,00,000 procedures 17. Thus, present study highlights the complications of self medications of abortion pill. There is a higher proportion of failure, incomplete abortion, and haemorrhage leading to anaemia, ectopic pregnancy and septicemia leading to maternal death. Such complications of unsafe abortion have negative influence on women s future reproductive life and it places a significant financial burden on public health care system. Effect of maternal death is reflected in the family, as children lose their mother. Hence, medical abortions are safe when carried out under medical supervision. But, when it is practiced without medical supervision, morbidity and mortality are manifold. Conclusion: Health care and health protection is every woman s reproductive right. Every woman must be counseled regarding advantages, drawbacks, risks and limitations of different methods of abortion. Prevention of unwanted pregnancy is the best way to prevent unsafe abortion. Hence, awareness on contraceptives and emergency contraceptives is must for all. News papers, hoardings, radio and television can play a very important role in creating awareness in society. The chemist also needs to be aware about the MTP Act and consequence of medicines that are taken without medical supervision. The Government must stop over the counter sell of drugs that are used for medical abortion and provision should be made to make these drugs available directly from hospital/ NHL Journal of Medical Sciences/Jan 2014/Vol 3/Issue 1 30

practitioner who are qualified under the MTP Act. Training on various regimes and advancement is also required for the medical practitioners. Acknowledgement: I sincerely thank Dr S T Malhan, Superintendent, Sheth V S General Hospital for granting permission to publish the data References: 1. International Consensus Conference on Non-surgical (Medical) Abortion in Early First Trimester on Issues Related to Regimens and Service Delivery (2006). Frequently asked clinical questions about medical abortion. Geneva: World Health Organization. ISBN 92-4-159484-5. http://whqlibdoc.who.int/publications/2006/92415948 45_eng.pdf 2. Ellertson C, Waldman SN. The Mifepristone- Misoprostol regimen for early medical abortion. Curr Women Health Rep. 2001; 1:184-90. 3. http://gujhealth.gov.in/adfwh-download.htm 4. http://www.fogsi.org/index.php?option=com_content &view=article&id=97&itemid=16 5. Geeta G, Ashutosh G, Shahshi K et al. A study of Septic Abortions: trends in a tertiary hospital. J Obstet Gynecol India.2005; 55(3): 257-260. 6. WHO: The prevention and management of unsafe abortions: Report of technical working group. Geneva, 1992 7. http://ebookbrowsee.net/guidelines-for-medicalabortion-in-india-doc-d134818684 8. http://www.psi.org.in/psiindia/urlfiles/nationalmeeti ngofmaconsortium.pdf 9. Deshpande S, Yelikar K, Deshmukh A Kanade K. Comparative study of medical abortion by Mifepristone with vaginal Misoprostol in women < 49 s versus 50-63 s of amenorrhoea. J of Obst & Gyn of India. 60(5);2010: 403-407 10. Trupin S R, Moreno C. Medical Abortion: Overview & Management. Medscape Womens Health 2001; 6: 4. 11. www.popcouncil.orgrhpdev/mifeprex/patient%5fagre ement.html 12. NFHS 3 National Family Health Survey: http://www.nfhsindia.org 13. Hausknecht R. Mifepristone & Misoprostol for early medical abortion: 18 months experience in United States. Contraception 2003; 67: 463-5 14. Grimes DA. Medical abortions in early pregnancy: A review of the evidence. Obstet Gynecol1997;89: 790-96 15. http://www.who.int/reproductivehealth/topics/unsafe_ abortion/magnitude/en/ 16. India - ICMA International Consortium for Medical Abortion. m.icma.md/country/in/ 17. http://www.guttmacher.org/pubs/fb_induced_abortion. html NHL Journal of Medical Sciences/Jan 2014/Vol 3/Issue 1 31