Proposed revisions to abortion guidance

We, the undersigned medical professionals, believe that the Department of Health and Social Care should consider the below recommendations as it revises guidelines for independent-sector abortion providers following the change in the law to make permanent the previously temporary measure to allow women and girls to take both pills for early medical abortion (EMA) in their own homes up to 10 weeks. The recommendations are workable suggestions for improving the policy framework based on our collective expertise and experience.

The below points are consistent with the content and style of the required standard operating procedures (RSOPs) that currently inform guidance for independent-sector providers of termination of pregnancy services. We are happy to provide further detail on the below upon request.

Suggested provisions for revised abortion guidance:

1. Supervision and post-procedure follow ups

   It is clear from current guidance that there is a gap where routine but essential follow-up care should be. With that in mind, the following points can help to address this omission:

   1. The offer of an in-person appointment should be mandated. 
   2. In instances of women still having possession of the abortion pills but having not taken them, guidelines should set out standard procedures for the safe disposal of unused pills to avoid health risks and negative environmental consequences.
   3. In order to provide better patient care, all providers/clinics should be mandated to maintain accurate digital client records so that GPs and hospitals can access them in the event of assessing complications and following up on treatments as needed.  
   4. Providers should be strongly encouraged, ideally stipulated by regulations, to use a patient’s NHS number for the purpose of recording a telemedical abortion and all medical outcomes.
      1. It is recommended that these records should be either automatically sent to the summary care record or a process put in place for hospitals to quickly access them, ensuring that future medical care is responsive to the patient’s particular personal medical history. 
      2. This would also assist with verifying the age of the woman or girl seeking the pills, especially in instances where there is any uncertainty about the age of the woman or girl in question, and verifying contraindications/cautions/the need for direct medical supervision. 
      3. This would also enable longitudinal research to be conducted in this area, as epidemiologists would be able to investigate home abortion’s linkage with other subsequent health outcomes. This data is currently collected for nearly all other procedures commissioned by the NHS, but not for abortions performed by independent providers. This data is currently collected for all abortions in Scotland. Finland also collects this and has had a computerised abortion registry since 1983 and Denmark has had the same since 1973 - a combined total of 70 years’ data entry - with no breaches of confidentiality.
   5. Patients should be encouraged to report complications and other issues, via a straightforward process through a website or phone line. 
   6. It should be mandated that issues raised here are added to the HSA4 form, or, if that has been completed already, that the provider be mandated to report them to the NHS centrally so that they can be tracked in national statistics and be used to inform better care going forward. 
2. Service provision for children, young people and vulnerable adults
   1. All girls under 18 must be guaranteed a face-to-face appointment prior to being given the abortion pills so that a full assessment can be made to ensure that the pregnancy is not beyond 10 weeks, and to detect or prevent the risks of coercion and/or sexual exploitation.
      1. This is essential as the Children Act 1989 recognises children as being vulnerable in law. 
   2. The age of girls seeking telemedical abortion services should be subject to both verbal and documentary checks, and all vulnerable care-experienced adults up to the age of 25 should receive a guarantee of a face-to-face appointment.
   3. For children under the age of 13, there should be a mandatory requirement to report the incident to the police given anyone under the age of 13 is not legally capable of consenting to sexual activity (under the Sexual Offences Act 2003.)
   4. For children under the age of 18, there should be a safeguarding assessment carried out for each patient, in consultation with experts in child safeguarding, to establish the specific pathways needed for children (particularly given 16 is the legal age of sexual consent.) 
3. Consent
   1. Providers should be strongly advised to “actively encourage” women and girls to take up a face-to-face appointment. Ideally, the onus should be on providers to provide face-to-face appointments unless specified otherwise - i.e. in-person consultations should be the effective default.
      1. As a means of incentivising such an approach, providers could be asked to give regular reports to their local Clinical Commissioning Group as to why women in certain categories are not being seen in person, for example. 
   2. There should be clear opportunity for the facilitation of domestic abuse and trafficking disclosures through face-to-face appointments, making clear the benefits of this setting for such disclosures. 
   3. Guidance around consent and information on complications should be reworded to ensure that it includes the latest available data on complications. This includes the problems in current recording and reporting of them, e.g. the greater risk of complications and undetected ectopic pregnancies through lack of ultrasound scans, vulnerability to undetected domestic abuse and coercion through the lack of in-person consultation, and the physical and psychological risks of unintended later-term abortions following misestimation of gestational stage.
      1. Specifically in relation to ruling out ectopic pregnancies, best practice should be for women experiencing symptoms of lower abdominal pain and bleeding to present to A&E for a check via an ultrasound scan or, failing that, a physical examination. This is particularly important given that medical abortion and ruptured ectopic pregnancies have similar symptoms, and it is essential that women should be informed that these may be indistinguishable.
   4. There should be clear procedures for providers seeking consent where there is a question over the age of the patient. Rigorous procedures should be in place to ensure verification of the age of the girl seeking abortion pills, and a requirement to conduct in-person checks if there is any uncertainty about the age of the girl in question. As highlighted in point 1 (d) this would be eased by linking the patient's NHS number with the procedure.
   5. Informed consent provisions should be strengthened so that women are better informed about risks (e.g. ruptured ectopic pregnancies, coercion, late gestation, and others). 
      1. One such example is Rhesus disease, where a Rhesus negative woman develops antibodies (sensitisation) in response to the fetal Rhesus antigen. If the woman’s Rhesus status is not detected from blood tests (due to appointments being virtual), and she is not given anti-D immunoglobulin, then she and her fetus may develop Rhesus disease in future pregnancies. Though the risk of sensitisation is speculated to be low before 10 weeks gestation, the fact that remote consultations cannot accurately determine whether the pregnancy is lower than 10 weeks increases our uncertainty about the risk and clearly poses risks to women at later gestations. 
4. Gestational limits
   1. Given the risk of poor psychological outcomes for patients having abortions later than 10 weeks, providers should actively encourage women and girls to seek a face-to-face appointment in cases of reasonable concern. This is particularly the case for women and girls who may lack adequate emotional and psychological resources to effectively cope with a mid-trimester abortion. 
   2. Thorough investigations of abortion providers that have facilitated abortions beyond the legal time limit following inaccurate gestational estimates must be conducted. 
      1. In instances where this has happened, there should automatically be an investigation by the Care Quality Commission. Referrals to the General Medical Council should be encouraged in these circumstances also.
      2. This should include 
         1. an insistence on in-person checks in future to prevent repeated incidents; 
         2. investigations by the Care Quality Commission into incidents of inaccurate gestational estimate; 
         3. penalities from the Care Quality Commission in case of repeated incidence e.g. loss of ability to practice telemedical abortion. 
   3. Given that data shows that 40% of women do not accurately recall their last menstrual period, guidance should specify that best practice is, in the following order of preference, to: 
      1. Confirm gestation with an ultrasound scan; or
      2. Confirm gestation through a physical examination; 
   4. In respect of Rhesus, there is a specific concern given the increased risk after 10 weeks gestation (see point 3.e. above.) 
   5. For children and young women, providers should be required to determine the stage of a pregnancy by a face-to-face appointment.
       
5. Professional guidelines
   1. A Code of Practice should be developed in consultation with medical professionals.
      1. This could be similar to the Code of Practice for the Mental Capacity Act 2005 which “explains how the Act will operate on a day-to-day basis and offers examples of best practice to carers and practitioners.”
   2. Greater oversight of providers should be established to mitigate any power imbalance between health commissioners and providers.
   3. There should also be greater provisions for whistleblowers.
   4. Regulations should be introduced that require all healthcare organisations to ensure that their public-facing documents and statements are rigorously fact-checked and peer-reviewed with breaches dealt with by an official censure mechanism, including for any potential statements that could be construed as misleading.
   5. The setting of healthcare standards should be established according to the best evidence from an independent review of the policy. Any potential conflicts of interest in such a review and standard-setting process should be effectively managed.
   6. There should be a requirement for charity commission safeguarding guidance to be robustly applied, in line with standards expected by the NHS.
       
6. Information for women
   1. Better information should be provided for women specifically around instructions for safe use of the pills. 
      1. It is essential that providers properly inform women about the process of taking both pills, so that they are aware that, if the second pill, the misoprostol, is not taken, there remains a chance (estimated to be 20%¹) that their baby will survive. A detailed understanding of the process is essential so that women are fully informed of the risks and consequences of the process of a medical abortion. 
      2. Providers should be required to inform women about the potential need for surgery in the instances, statistically common, where complications occur as a result of the abortion not being completed (estimated by studies to be as high as 6%)². 
         1. This process, known as Evacuation of Retained Products of Conception (ERPC) and carried out in the case of a failed abortion, is regarded as emergency surgery, and so women should be informed of the risks involved.
   2. Women should be informed that the treatment failure rate for telemedical abortion is significantly higher than currently presented and likely to be around 6% based on the manufacturers’ summaries of product characteristics for the two main treatments used by abortion providers and the evidence previously provided by Marie Stopes Australia.³
       
7. Sexually transmitted infections
   1. Recommended best practice is that the woman is seen in person to be screened for chlamydia (given this is a part of the existing HSA4 form, Question 8).
       
8. Counselling:
   1. It is strongly recommended that women have counselling or time for reflection before the abortion, especially in the case of certain risk factors associated with abortion. This would not be a change to the current NICE guidance, which specifies that counselling is not compulsory, but instead actively encourage women and girls to take up the option. 
   2. Women and girls in vulnerable groups should be especially strongly encouraged to receive pre-abortion counselling. 
9. Disposal of pregnancy remains
   1. There should be guidance around the supervision of the disposal of pregnancy remains by women from vulnerable groups following at-home abortions.
       
10. Performance standards and audit
    1. Abortion providers should be thoroughly audited on a regular basis in a stringent manner.
    2. This should involve CQC inspections on a regular basis.
    3. Likewise an independent auditing process would help to hold providers to account and highlight areas where mistakes occur and lessons could be learned. 
    4. The HSA4 form could be improved by placing a duty on clinicians to put a specific ICD-10 code down as the reason for performing the abortion. For ground (d), this should specify the disability by ICD-10 code. 
       1. Including the code on the HSA4 form would improve data collection and better ensure the patient gets the right treatment in future through effective clinical classification of their historic medical treatments. 
11. Patient feedback and complaints
    1. Patients should be strongly encouraged to send post-treatment surveys. This is vital for patients to feel confident that concerns raised will be followed up as necessary. 
    2. Though filling out the surveys would not be mandatory for patients, it could be mandated that providers have to send them centrally to the DHSC for the purposes of accurate data collection. 
       1. This would follow a similar model to the contractual obligation for GPs to collect data from the NHS Friends and Family Test. 
       2. The surveys would not automatically be linked to a patient (for reasons for anonymity) but the patient could be given the opportunity to opt in to linking their name/NHS number to the survey form if they were happy to be contacted in the event of a serious concern or complaint. This would best ensure any complaints are best dealt with in a sensitive and timely fashion. 
       3. Forms sent, with or without the patient ID, should be linked to the specific abortion provider. 
    3. When serious issues are raised, it should be mandatory that surveys and complaints are sent to the Care Quality Commission.
    4. Provision should be made for survey and complaint forms to be sent by freepost to remove any barriers to their sending.
    5. For the sake of independence, the feedback and complaint forms should be sent to the Department of Health and Social Care, so that they can raise potential issues with providers.    
        
12. Risk management
    1. It should clearly be stipulated in the regulations that each death of a live infant, born unexpectedly as a result of an intended early medical abortion, must be reviewed via the Child Death Review process. 
       1. This is essential in order to provide support for families and staff, as well as to maximise learning opportunities for providers.
    2. The regulations must also set out a process for classifying unintended late abortions from under-18s as Never Events as defined by NHSE, so requiring investigation under the Serious Incident framework.
    3. Regulations should be introduced that make providers responsible in law for doing all they can to ensure that home abortions for under 18s do not occur beyond 10 weeks, and introduce tough procedures for those who have been found to have not done enough to mitigate this risk.