Early medical abortion at home - future arrangements: consultation analysis

Risks of the Current Arrangements

The consultation paper sought feedback on the risks associated with the current EMAH arrangements, as well as any possible mitigation measures.

Q3. What risks do you consider are associated with the current arrangements for early medical abortion at home (put in place due to COVID-19)? How could these risks be mitigated?

Overall, 5,181 respondents provided a qualitative response to this question, consisting of 5,112 (99%) individuals and 69 (1%) organisations. It should be noted however, that 2,780 responses were from the Right to Life standard campaign and so provided identical information.

While the question sought feedback about both the risks and possible mitigation measures, most responses focused on identifying and discussing the risks.

Perceived Risks

A long list of perceived risks were identified, which largely mirrored the negative impacts outlined above. These included:

• The lack of direct medical supervision, and having no/delayed access to medical support should there be complications - with risks of serious complications including incomplete abortion, haemorrhaging, infection/sepsis, and death;
• The medication being taken beyond the recommended/legal gestation - both increasing the risk of complications for the woman and the risk of viable babies being born if the medication is taken later in pregnancy;
• The medication not being taken at the correct intervals - again risking complications;
• Ectopic pregnancies, twins or other health issues being missed, which could lead to dangerous complications;
• No way to identify whether patients are being abused/coerced or are victims of human trafficking, including being coerced/forced into having the abortion;
• No way to verify the identity of the patient or that they will be the true recipient of the medication;
• No way to verify where the medication will be taken, whether this is a safe environment, and whether appropriate adult support will be present;
• Some women or girls may not have a safe and private space to conduct the teleconsultation, to receive the medication or pass the pregnancy;
• Practitioners not being as able to establish whether the woman has made a fully informed decision or feels this is their only option despite wishing to continue the pregnancy;
• No evaluation of, or support for, the women's emotional/mental state before, during or after the procedure - it was stated there was a risk of severe issues, such as regret, shame, depression, substance misuse and suicide;
• Increased risk of future health issues for women, including future fertility problems, subsequent premature births, lack of access to anti-D prophylaxis for those who are Rhesus D negative^[3] and the impact on subsequent births, and breast cancer;
• Women will feel rushed into the decision with no information/procedure for them to reconsider, and more limited opportunity to administer reversal medication should they change their mind after taking the first pill; and
• Lack of information and support available/provided on alternative options:

"To go back to the basics of 'first do no harm', providing controlled drugs via a telephone conversation, to an unknown person, of unknown age or ability, with no method of verifying any of the information given, is neglecting our duty of care to pregnant women." (Individual)

A few respondents felt that the current arrangements went against previous guidelines, or allowed these to be avoided. For example, it was highlighted that women needed to be in a safe environment/at home, which they felt could not be ensured under the current arrangements.

Possible Mitigation Measures

Of those who suggested possible mitigation measures, some felt it was important to continue to provide the option of attending a clinic in-person to ensure those who are at risk, or more nervous of the procedure can be supported - it was argued that remote services should not become the only option.

Other suggested mitigation measures for the current EMAH arrangements included:

• Conduct thorough risk assessments and teleconsultations following strict questionnaires or guidance to ensure all relevant information is collected;
• Provide clear guidance to women on how and when to take the medication, and what to expect;
• Ensure women are provided with clear information about when they should contact services for further guidance, if they have any concerns, or experience any complications;
• Conduct routine follow-up checks via teleconsultation, and/or text services, for both medical and emotional purposes;
• Facilitate calls at the point of taking the medication to guide and support them through it;
• Provide teleconsultants with additional training on identifying abuse and how to ensure the woman can talk safely and is not being coerced;
• Provide a full and complete support service: offer information about the practical and emotional effects of abortion; introduce better crisis pregnancy counselling; provide a means to link women to sources of support; and provide information and support for alternatives to abortion;
• Provide a dedicated 24/7 'helpline' to medical professionals and/or psychological support;
• Provide easy access to online and/or in-person options for counselling, both pre- and post-procedure;
• Provide a 'cooling off' period for women to allow them to fully consider their choices before taking the medication; and
• Provide the medication in discrete, unbranded/neutral packaging, and ensure child-proof packaging and storage instructions to ensure children do not mistakenly consume the pills:

"Any medical issues that may arise… can be mitigated by the woman having direct access by telephone to a medical professional who can assess the situation and decide whether or not the woman needs to come into hospital to be seen. This should be no different to any other person who is currently experiencing a medical issue that they are managing at home, it happens successfully all the time." (Individual)

Conversely, many wanted an end to EMAH. Some suggested that the best mitigation against the risks was to return to the previous system, and in particular, to reinstate in-person consultations, with several suggesting that scans should become routine. Others preferred a move to a model where the full procedure would take place within a medical facility, and preferably one capable of dealing with the associated complications. Others wanted an end to all forms of abortion.

Arguments in Favour of the Current Arrangements

Those in favour of EMAH argued that there was no greater risk from the current arrangements compared to the previous system. They noted that, under the previous arrangements, the risks of mis-timed administration of the pills existed as patients were given the second pill to take at home, and medical/physical complications and emotional distress from the procedure would remain the same as the patient simply took the first pill in the clinic and was then sent home to pass the pregnancy:

"I do not see any increased risks, as 24/7 service access is available if required. I consider the current arrangements less risky, as travel/contact/fear of stigma may all be reduced." (Individual)

Respondents argued that abortion was a low risk procedure which was best managed as medical care plans being established through collaboration between a woman and her clinical team. They felt that women's needs and wishes should be at the heart of reproductive healthcare, with several noting that the current arrangements had been found to be an acceptable model for most service users. They also argued that abortion should be regulated in the same manner as other medical treatments, i.e. that clinical risk should be managed by guidelines and regulation, not legislation. It was suggested that legal requirements which would not enable providers to tailor care to the needs and circumstances of individual women would result in some women being unable to access safe, legal abortion care:

"Abortion, especially early abortion, is low-risk. It should be managed between the person requiring care and their medical team, and should have as few barriers in their way as possible." (Individual)

Many respondents from this cohort argued that the evidence showed that the occurrence of risks were rare and that high levels of safeguards and mitigation measures were already in place. Specific points made to support EMAH included:

• Low risk of complications - It was noted that evidence showed there was no greater instance of significant adverse events due to EMAH compared to the previous arrangements. Further, it was highlighted that providers had developed 24-hour advice lines and set out written information with the medications, often alongside the provision of pain management and oral contraception;
• Low risk of wrong gestation or inaccurate administering of the medication - Robust screening processes were said to be in place, with clear, consistent, verbal and written information provided to women. Respondents cited evidence which showed that the current arrangements were facilitating earlier abortions, and that women administering the medication beyond the recommended/legal limit was rare. They also highlighted that patient feedback showed that most women had felt that the procedure was straightforward, that they had enough information to take the medicines themselves, and had not been concerned about safety. Further, it was noted that self-managed abortions had been shown to be safe and effective up to 24 weeks:

"When human error does occur, it may be found that a pregnancy is further along than was initially believed. However, the most significant risk is not a clinical one, as it is highly unlikely that there would be medically significant consequences." (Organisation, Healthcare Provider)

• Low risk of ectopic pregnancies - Instances of undiagnosed ectopic pregnancies were noted to be rare. Respondents highlighted one study that had noted that treatment with mifepristone and misoprostol will have no effect on an underlying ectopic pregnancy, and so there was no clinical reason to require women seeking abortion to have an ultrasound prior to treatment. They also noted that, as women were not required to undergo routine scanning for ectopic pregnancies before continuing with a pregnancy, it would be inconsistent and inequitable to make this mandatory for those seeking an abortion. Rather, they highlighted that the earlier the woman was assessed and conducted the procedure there was an increased likelihood of ectopic pregnancies being identified earlier than traditional pathways. Onward referrals were also routinely provided to early pregnancy units for those at risk of ectopic pregnancies for diagnosis and management;
• No requirement for a scan - It was suggested that clinical guidelines were clear that routine scanning (for either dating gestation or identifying ectopic pregnancies) in every single case was unnecessary, and indeed, there was no law requiring women to have a scan before an abortion;
• Identifying abuse/coercion - Staff had been trained to identify abuse and other areas of vulnerability, and were highly alert to, and dealt flexibly with, such situations. Indeed, they argued that service providers had reported that women who access their services were routinely asked whether they feel safe at home and domestic abuse was regularly disclosed to staff. It was suggested that some women felt more comfortable disclosing abuse from their own home. It was also felt that the existing system of telemedicine, with in-person care where necessary, provided the best options for women who were victim-survivors of sexual violence or domestic abuse, particularly where leaving home for in-person appointments could be unsafe. Further, it was noted that providers made referrals to social services and the police, and worked closely with local charities to support such women;
• In-person service remains available - In-person appointments were still available where needed or preferred, emergency care was also provided as required, and the telemedicine approach did not exclude women from seeking emergency and/or follow-up care from other sources if required;
• Continual learning - It was noted that the Scottish Abortion Care Providers were considering how all learning from the delivery of telemedical services could be incorporated into the future provision of care; and
• Avoiding unregulated approaches - It was proposed that women might be more likely to continue with an unwanted pregnancy or turn to unregulated providers (who operate outwith the protection of the Abortion Act) if they cannot get to a clinic and the telemedicine approach is not available.

Several suggested that the only risk was the temporary nature of the arrangements. They felt that EMAH was a common, safe and effective procedure, which improved access. As such, they argued that the arrangements should become permanent:

"Evidence shows that telemedicine services are safe and effective, that they improve access (most likely for those in vulnerable situations), and that they are acceptable to the vast majority of service user; so… restricting access to abortion for the sake of it would represent a real risk to the health and wellbeing of women and pregnant people across Scotland… regulations should allow telemedicine to become a permanent feature of abortion care provision." (Organisation, Women's or Abortion Support Group)