Tuesday 26 November 2013

AIMS Ireland AGM: Saturday December 7, 2013

                       AIMS Ireland AGM


When:  Saturday, December 7, 2013
Time:    2:30PM
Where: Teacher's Club, Parnell Square, Dublin (across from Rotunda)

Directions: http://www.clubnamuinteoiri.com/

 Speakers

 

"Daughters of the Revolution, Theatre Workshops" - Kate Harris of 4 Elements Theatre Company

 

AIMSI member, Nuala Hoey is speaking about her personal experience of birthing decisions and positive birth choice.

 

"Neglecting Reproductive Autonomy : A legal analysis of consent during pregnancy and childbirth in Ireland" - Barrister, Mary Kirwan


AIMS Ireland AGM

* 2012-2013 Committee Annual Report
* Proposed Motions and Business
* Election of Committee Roles

AIMS Ireland Members: Proposed Motions and Business


Any proposed motions or business for AIMS Ireland in the upcoming year are to be submitted by email to Chair@aimsireland.com by 5pm, Thursday December 5th.

 Committee Roles


AIMS Ireland need to elect all committee roles at the AGM. We are currently taking nominations.

To be eligible for Committee Roles with AIMSI you must fit the following:

* member of AIMS Ireland
* cannot be a medical professional
* be available and willing to commit to a year in elected position

AIMS Ireland Committee Roles:

Secretary
Treasurer
Membership

Press Officer
Women's Support and Information Aide
Events/Fundraising
** Chair
** Vice Chair

** Chair and Vice Chair may be split as Co-Chair if preferred and agreed with committee


AIMS Ireland are also seeking assistance with non-committee roles in a voluntary capacity with issues such as event planning, fundraising assistance, campaigns, surveys/research, graphic design (infographs), video production, etc. If you have skills you would like to contribute to AIMSI please contact us at info@aimsireland.com


 Membership to AIMS Ireland is €20 for a year. Membership entitles you to membership of a private AIMSI online facebook group and election/vote of committee roles and motions. Membership fees go back into women's support services. Please Join Us!! http://www.aimsireland.com/join/?topic=join

Fundraising/Donations to AIMS Ireland go directly to AIMS Ireland research, support services and campaigns. If you would like to organize an event in the aide of AIMS Ireland, please contact us at info@aimsireland.com

AIMS Ireland receives no outside funding - fundraising, donations, and membership provide our sole financial support and go straight back to campaigns and women's services.

Annual Organizational and Financial Reports from AIMSI for 2012-2013 will be made available at the AGM.

Our amazing Treasurer, Alcarine Power, has recently resigned following 5 amazing years with AIMSI. We are so sad to see her go and will miss her immensely.

 Thank You,

AIMS Ireland Team

Thursday 21 November 2013

AIMSI 3 PQ's regarding Misoprostol Dosage Guidelines & Bimbo Onanuga

QUESTION NOS:  638 to 640
    DÁIL QUESTIONS addressed to the Minister for Health (Dr. James Reilly)
    by Deputy Clare Daly
    for WRITTEN ANSWER on 19/11/2013  

     
     *  To ask the Minister for Health if all 11 recommendations following Health Service Executive investigations following the death of a person (details supplied) including number seven, have been fully implemented in the Rotunda Hospital, Dublin.

                                                                                              - Clare Daly T.D.

    For WRITTEN answer on Tuesday, 19th November, 2013.

    Details Supplied: Bimbo Onanuga

    *  To ask the Minister for Health if the Rotunda Hospital, Dublin, have updated their guidelines on the management of intrauterine death to include lowering the dosage of Misoprostol to reflect recommended standards in RCOG.

                                                                                              - Clare Daly T.D.

    For WRITTEN answer on Tuesday, 19th November, 2013.

    *  To ask the Minister for Health the reason the RCPI/IOG guidelines regarding the use and dosage of misoprostol were not implemented, as per Health Service Executive recommendations.

                                                                                              - Clare Daly T.D.

    For WRITTEN answer on Tuesday, 19th November, 2013.

    Details Supplied: (Note the October 2013 published HSE guidelines remain unchanged and do not reflect what was recommended following the death of Bimbo Onanuga)?


     
    REPLY.
    As I responded to the Deputy in my reply of 13th October last, I have been advised that the circumstances surrounding this patient's death were investigated by the HSE under the National Incident Protocol following which 11 actions were recommended.  I have been informed by the HSE that the Rotunda Hospital has now implemented all 11 recommendations.  

    In relation to the other issues raised by the Deputy, as these are service matters, I have referred them to the HSE for attention and direct reply.

    Thursday 14 November 2013

    Minister for Health James Reilly rejects calls for a HIQA review into the death of Bimbo Onanuga

    AIMS Ireland last week welcomed the verdict of medical misadventure in the Coroner's Court following the inquest into the death of Bimbo Onanuga in the Rotunda in March 2010.

    Bimbo Onanuga died following a medical induction with Misoprostol/Cytotec 29+ weeks into her pregnancy due to the intrauterine death of her baby. Eyewitness accounts describe a catalogue of errors and failures to provide basic care to Bimbo that day.

    Following the coroner's verdict, supporters (academics, medical professionals, oganizations and friends) of Bimbo Onanuga, including AIMS Ireland, called for a HIQA review into the failures of basic care and treatment Ms Onanuga received in the Rotunda Hospital in March 2010.

    AIMS Ireland reported that there were "Echoes of both Savita and Tania McCabe once again at inquest of Bimbo Onanuga today..." More: http://nocountryforpregnantwomen.blogspot.ie/2013/11/a-matter-of-public-interest-aimsi-calls.html

    A HIQA review would be in line with actions taken by the Minister following the death of Savita Halappanavar.

    A PQ (Parliamentary Question) was put into the Dáil to the Minister for Health, James Reilly by Deputy Clare Daly.

    The Minister has rejected calls for a HIQA review - denying an investigation into the systematic failures of care and treatment Bimbo Onanuga received in the Rotunda Hospital in Dublin.

    AIMS Ireland is extremely concerned by the lack of accountability and continued significant efforts to hide the circumstances of Bimbo’s death.

    It is astonishing that  given the similarities of failures on record, the Minister has chosen to act, calling for an independent HIQA review into one woman's death, while refusing the other.

    The PQ and Reply:


    QUESTION NO:  22
      DÁIL QUESTION addressed to the Minister for Health (Dr. James Reilly)
      by Deputy Clare Daly
      for ORAL ANSWER on 13/11/2013  

       
       To ask the Minister for Health if he will order a Health Information and Quality Authority investigation into the circumstances of the care of a person (details supplied) in line with the HIQA investigation into the death of Savita Halappanavar.

                                                                                               Clare Daly T.D.

      Details Supplied: An inquest into the death of Ms Bimbo Onanuga concluded on 5 November with a coroner’s verdict of medical misadventure. In the course of treatment in the Rotunda Hospital on 4 March 2010, Ms Onanuga suffered a catastrophic incident and was transferred later that day to the Mater Hospital where she died. The details of her case as laid out in the Coroner’s Court raise fundamental issues about her care and treatment. Will the Minister order a HIQA investigation into the circumstances of Ms Onanuga’s care, in line with the HIQA investigation into the death of Savita Halappanavar.?


       
      REPLY.
      I would like in the first instance to offer my sympathies to the family involved in this very unfortunate case.

      I have been advised that the circumstances surrounding this patient's death were investigated by the HSE under the National Incident Protocol following which 11 actions were recommended.  I have been informed by the HSE that the Rotunda Hospital has now implemented all 11 recommendations.  

      I am advised by my Department's Chief Medical Officer that it is not necessary nor is it appropriate for me to request the Health Information and Quality Authority (HIQA) to undertake investigations in a case such as this which has been adequately investigated under the HSE's incident management procedures.  

      It is important to state that maternal and peri-natal health statistics indicate that Ireland continues to be a very safe country for a woman to give birth and our safety record compares favourably with other developed countries.

      Monday 11 November 2013

      AIMS Ireland calls for a HIQA review into the Death of Bimbo Onanuga and the Catalogue of Sytematic Failures in Basic Care.

      AIMS Ireland last week welcomed the verdict of medical misadventure in the Coroner's Court following the inquest into the death of Bimbo Onanuga in the Rotunda in March 2010.

      Bimbo Onanuga died following a medical induction with Misoprostol/Cytotec 29+ weeks into her pregnancy due to the intrauterine death of her baby. Eyewitness accounts describe a catalogue of errors and failures to provide basic care to Bimbo that day.

      AIMS Ireland are calling for a HIQA review into the death of Bimbo Onanuga

      A Catalogue of Sytematic Failures in Basic Care


      * Despite conflicting reports, Bimbo Onanuga disclosed her full medical history on booking at the Rotunda. Women are encouraged to disclose full histories in order for their care team to pre-empt any complications which may arise following some medical histories. Gynaecological procedures and investigations, abortion, surgery, injury, previous mode of birth, and more are all histories in which can affect the care paths of women.

      * It is the responsibility of maternity providers to ensure individual assessment and appropriate care to women, regardless of her history. It is also the responsibility of maternity providers to inform themselves of women's previous history in order to develop the safest care plan for each woman taking into account her medical history, current pregnancy, her concerns, informed choice, and potential complications.

      * It is the responsibility of care providers to listen to concerns raised by women and their families. AIMS Ireland encourage women and their birth partners to express concerns, unusual sensations or pain, if something doesn't 'feel right', and side affects to their care providers. It is the duty of care providers to listen.

      * It is the responsibility of maternity providers to ensure that all staff are fully trained on how to provide basic clinical observations and record them in a timely fashion.

      Bimbo's failure of basic care

      * Bimbo Onanuga was nearly 30 weeks pregnant and was medically induced with Misoprostal on the Gynaecological ward rather than the labour ward.

      * One of the principal carers for Bimbo Onanuga during the time of her induction on the gynaecological ward of the Rotunda Hospital was a nurse, not a midwife. The necessary clinical skills for diagnosis and treatment of labour, induction, complications, and basic issues such as experience in palpitation of the uterus are outside the scope of practice for a nurse and require the professional skills of a midwife.

      * Bimbo was administered two doses of Misoprostol of 200mcg at three hour intervals - one vaginal and one oral. Recommendations from RCOG state that (I) induction of labour using Misoprostol is not recommended (II) Misoprostol should only be given orally, not internally (III) recommended dosage is 50-100mcg by four hours.

      * Misoprostol is an off-label drug. This means that staff are not required to record adverse outcomes relating to this drug. Misoprostol has been linked to uterine hyperstimulation  and uterine rupture in women with scarred and unscarred uteri. There have been recorded instances of rupture in first time mothers whom were given Misoprostol for induction of labour.

       * Bimbo reported to be in 'constant' pain. It is reported that Bimbo was told as the pain was constant, rather than waves of contractions, she was not in labour. Concerns raised by Abiola that Bimbo was experiencing constant and severe pain were reportedly ignored and midwife Shiela Lynch is reported to have said she was exaggerating. Constant and severe pain is unusual and suggests something is out of the normal progression of induction. This was not recognized as 'abnormal'.

      * Bimbo's partner Abiola reported that Bimbo could not breath or talk. His attempts to raise the alarm were not followed through.

      * On Bimbo's collapse, it was Abiola who first initiated CPR

      * It is reported that on Bimbo's collapse the available machine for measuring blood pressure appeared not to be working. Rather than taking the blood pressure manually, staff spent time attempting to get the machine working again.

       * On Bimbo's collapse the medical team prepared for an emergency Caesarean Section. However the bed was too large to fit through the door of the Gynaecological ward and subsequently, an immediate Caesarean Section was instead performed on her bed on the Gynaecological ward.

      * There are concerns relating to the medical notes the day Bimbo died. Notes were retrospective, out of sequence, were incomplete, and clinical observations were not recorded.

      * Following Bimbo's death investigations were undertaken very quietly through the HSE. At no point was any information made public. Bimbo's death did not receive a full HSE inquiry. Bimbo's death did not receive a public apology. Following 3 PQs, recommendations into HSE investigations into Bimbo's death were released.

      * Following the PQs, the HSE released a statement expressing its sincere sympathies to the family involved. However, the family were not contacted directly and are unaware of the statement

      * The initial request for an inquest into the death of Bimbo Onanuga was denied by the Coroner ruling she died of natural causes. This was later reviewed and an inquest was granted.


        These are the recommendations from the HSE following investigations into Bimbo Onanuga's death:

      1. The need to identify clinical pathways relating to management of women with an intrauterine death in third trimester to complement existing medical management policy.

      2. The Guidelines for Medical Management of Intrauterine Death should be revised in line with a review of the medical literature.

      3. Details of all patients for Induction of Labour, regardless of place of induction should be centrally documented.

      4. This recommendation cannot be disclosed as it contains personal, private, sensitive and confidential information relating to the individual patient.

      5. Develop a brief operational outline of the Gynaecology Department to assist staff who are sent there on an occasional/intermittent basis.

      6. Due to the complexity of work, there is a need for an updated training needs analysis of all midwifery and nursing staff on the gynaecology ward.

      7. There should be a designated individual with responsibility for coordinating, monitoring and auditing the Basic Life Support attendance and Advanced Life Support Skills attendance, ideally a designated Resuscitation Training Officer.

      8. An Obstetric Early Warning System should be introduced and evaluated.

      9. Install additional phone lines in the ward.

      10. A review of the possibility of emergency call bells or designated phones for emergencies in each room should be carried out and measures taken to address this.

      11. Hospital wide analysis of all doorways in clinical areas to establish the feasibility of moving a bed in a critical event.


      The Rotunda is reported as having changed their guidelines for the management of intrauterine death and fully implementing the 11 HSE guidelines.

      However, it is important to note that guidelines on the HSE/RCPI/IOG websites (revised October 2013) are unchanged and recommend the same management guidelines which were in place the day Bimbo died; Misoprostol dosage and scheduling 200mcg by 3 hours.

      AIMS Ireland call for a full HIQA review into the death of Bimbo Onanuga and review of guidelines for Management of Intrauterine Death to come in line with those of the UK and RCOG

      Wednesday 6 November 2013

      A Matter of Public Interest - AIMSI calls on transparency & accountability following details into death of Bimbo Onanuga. Press Release: Echoes of both Savita and Tania McCabe once again at inquest of Bimbo Onanuga today, according to maternity advocacy group. AIMS Ireland calls for accountability and clinical review following verdict of misadventure as a matter of 'public interest'

      Echoes of both Savita and Tania McCabe once again at inquest of Bimbo Onanuga today, according to maternity advocacy group

       

      AIMS Ireland calls for accountability and clinical review following verdict of medical misadventure


      Press Release:




      (Tuesday, November 5, 2013) The Association for Improvements in the Maternity Services Ireland (AIMS Ireland) today petitioned for accountability, a review into clinical care practices, and national guidelines on the use of the drug misoprostol (cytotec) following the verdict of medical misadventure returned at the inquest into the death of Bimbo Onanuga at the Dublin Coroner’s Court today. Bimbo Onanuga's inquest has once again exposed underlying critical flaws in basic clinical care within an Irish maternity unit, echoing concerns raised following reports into the deaths of both Savita Halapanavar and Tania McCabe.

      The HIQA report into the death of Savita Halapanavar published last month found ‘The most basic means of identifying any patient at risk of clinical deterioration is to observe the patient’s general condition and regularly monitor and track their clinical observations. This should be a basic component of caring for any patient.’ Abiola Adesina, Bimbo Onanuga’s partner, told the inquest yesterday that Bimbo was rolling around and in constant pain following admission to the Rotunda Hospital in March 2010 and that attempts to raise concerns were disregarded as a normal progression of labour. Bimbo, who had a number of risk factors in relation to the intrauterine foetal death, had received misprostol (cytotec) to induce labour.

      Krysia Lynch, Co-Chair of AIMS Ireland, commented "The parallels between Savita, Tania, and now, Bimbo, are staggering. We see once again a catalogue of basic fundamental failures from a lack of documentation to basic clinical observations. Most crucially, we once again see a comprehensive failure by health care providers to listen to women. This is a reoccurring complaint from women contacting AIMS Ireland - they do not feel their concerns are acknowledged or listened to. In a critical medical event, this can be the difference between recovery or death."

      On the issue of the use of the drug cytotec, Lynch added "Misoprostol has been linked to uterine rupture  in women with and without scarred uteri and is not recommended for use in induction. The Royal College of Physicians in Ireland (RCPI) guidelines on cytotec use sit outside those of the Royal College of Obstetricians and Gynaecologists (RCOG) in the UK, which raises a red flag and unanswered questions. AIMS Ireland is calling for full accountability and transparency. We ask the Rotunda, did Bimbo receive the basic care, monitoring and a care plan consistent with her clinical needs? Was she appropriately and effectively monitored given the use of the drug misoprostol? Has the Rotunda taken proper and appropriate steps to update staff about the use of the drug misoprostol? Why do their guidelines continue to sit outside those of the RCOG? We also raise concerns regarding queries to the disclosure of Bimbo's previous termination at the inquest. Our sources have revealed that this history was fully disclosed and this information was available to care providers. From the onset, the Rotunda hospital has made attempts to conceal information relevant to the case - including a litany of errors, mishaps, and failures of basic care to Bimbo. We publicly call on the Rotunda to clarify on these matters. This is a matter of public interest."

      Concluding, Lynch said “We very much welcome this verdict of medical misadventure from the Coroner Brian Farrell. Despite significant efforts to hide the circumstances of Bimbo’s death, the truth is now on public record. After fighting for many years for this inquest and to have her story heard, Bimbo’s family is finally vindicated.”



      ENDS
       
      For further information, contact:
      Krysia Lynch, AIMS Ireland 087 754 3751
      Jene Hinds Kelly, AIMS Ireland 087 681 9095




      UK & Irish guidelines on the use of Cytotec/Misoprostol for medical induction of labour after an intrauterine foetal death (IUFD)

      RCOG Guideline

      The RCOG Green-top Guideline No.55 Late Intrauterine Fetal Death and Stillbirth, published in October 2010 recommends the use of low doses of misoprostol (50 or 100 micrograms depending upon gestational age) when inducing labour:

      “The RCOG is aware that protocols employing much larger doses of misoprostol are still being employed in the UK, with consequent potentially associated adverse effects. Each maternity unit is advised to review their protocol for the management of induction of labour under these circumstances and to adopt the recommended misoprostol dosaging. Currently, misoprostol is only available in the form of a 200 microgram tablet; however the required dosage of 50 or 100 micrograms can be obtained by cutting the tablet or by dilutional methods. Your hospital pharmacist will be able to assist you with this if necessary.”
      http://www.rcog.org.uk/...

      RCPI Guidelines

      Royal College of Physicians I reland (RCPI) Guideline: #4 Intrapartum fetal heart rate monitoring - Appendix 4:
      http://www.rcpi.ie/article.php?locID=1.5.71.492


      On the day of diagnosis of IUFD
      Mifepristone 200mg PO
      36-48 hours after diagnosis
      24-34 weeks Misoprostol 200mcg PV followed by 200mcg PO 3 hourly x 4 doses
      >34 weeks Misoprostol 100mcg PV followed by 100mcg PO 3 hourly x 4 doses
      A second course may be started after 24 hours and with medical review

      Cytotec (Misoprostol) drug label: http://www.rxlist.com/cytotec-drug.htm

      Cytotec/Misoprostol - Research

      A 2006 Cochrane Review of Misoprostol for induction showed that while oral use of Misoprostol was shown to be an effective induction method, this is not without increased risks. Misoprostol increases risk of uterine hyperstimulation. The uterus may contract too frequently (more than five contractions in 10 minutes), the contractions may last too long (2 minutes or more per contraction), or the uterus may not relax enough between contractions. A casual relationship between uterine rupture and use of Misoprostol in scarred and unscarred uteri is acknowledged, Cochrane notes this requires further investigations but is a cause for concern.




      Unfortunately, it is almost impossible to show true risks of misoprostol in induction of labour, because according to the Cochrane review (2010) - "It is not registered for induction of labour, and has therefore not undergone the systematic testing for appropriate dosage and safety required for registration".

      The 'off label' use makes it a drug that has never been through rigorous clinical trials and it is, by proxy, not subject to reporting of adverse reactions or outcomes.
       
      How many maternal deaths invoving Cytotec have to happen before it is removed from 'off label' use?
       
      We'll never know, because no one records Cytotec as a cause or a factor in these deaths.


      In the inquest of Bimbo Onanuga, Rotunda's Sam Coulter-Smith is on record as saying:


      "Dr Coulter-Smith said there are risks when using misoprostal if there has been previous scarring or perforation of the uterus, but there was nothing in Ms Onanuga's medical notes to indicate such a risk." (RTE news)

      "A post-mortem examination later revealed that there was scarring due to a previous termination of pregnancy. But that knowledge came only in hindsight." (RTE news)

      AIMS Ireland Counter-Points:

      * Undisclosed sources to AIMS Ireland report that Bimbo Onanuga was upfront about her previous termination and report that this information is in her booking notes.

      * The occurrence of uterine hyperstimulation and instances of uterine rupture following Misoprostol have been reported in women with scarred and unscarred uterus.

      From the Cochrane Review 2010:


      "There have been several reports of uterine rupture following misoprostol labour induction with and without previous caesarean section (Bennett 1997; Sciscione 1998; Blanchette 1999; Matthews 1999; Khosla 2002). One unpublished case of uterine rupture occurred in a nulliparous woman following misoprostol use (EM Smith, personal communication). At term plus 12 days she received misoprostol 100 mcg vaginally. After six hours her cervix was found to be 7 cm dilated, and she progressed to full dilatation within a further 70 minutes. Fetal distress was suspected. Ventouse application produced no descent, so delivery was effected by caesarean section. The infant showed no signs of life at birth. After resuscitation, life was sustained for a few hours only. A posterior uterine tear arising from the cervix and spiraling up the posterior aspect of the uterus was discovered and repaired. because such uterine tears are rare in nulliparous women without prolonged labour or syntocinon use, a causal relationship with the use of misoprostol must be considered."

       
       
       
      And:
       
       
      "In a subsequent abstract (Merrell 1996), they described labour inductions with vaginal misoprostol in 345 women with live fetuses and 86 with intrauterine deaths. There was one unexplained maternal death; two uterine ruptures, one of which followed a previous caesarean section; eight caesarean sections for fetal distress and one for uterine hyperstimulation; and 10 perinatal deaths."
       
       
      See More: Vaginal misoprostol for cervical ripening and induction of labour - Cochrane 2010 http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD000941.pub2/full 
       
      Matter of Public Interest
       
      The Rotunda made significant efforts to conceal the circumstances in this case and the initial request into an inquest into Bimbo's death was denied. It was only after constant pressure and support from whistleblowers, advocacy groups, politician Clare Daly who put forward the PQs, and Bimbo's amazing and strong family that the coroner granted an inquest and the lithany of errors and failures of basic clinical care contributing to the circumstances surrounding Bimbo's death began to emerge. It is a matter of public interest that the details of these circumstances are acknowledged.

      AIMSI is currently finalizing a catalogue of these errors to be published later today.
       






       



       
      References:

      RTE News: Medical misadventure ruling at Onanuga inquest http://www.rte.ie/news/2013/1105/484745-inquest-bimbo-onanuga/

      November 5, 2013 - Coroner rules Bimbo Onanuga (pictured above) died by 'medical misadventure'
      Is induction of labour with Cytotec (Misoprostol) worth the risk? 

      AIMS Ireland welcomes the verdict of ‘medical misadventure’ delivered in the Dublin Coroner’s Court in the case of Bimbo Onanuga, who died in the Rotunda Maternity Hospital in March 2010. The term ‘medical misadventure’ means that Bimbo Onanuga died of “an unintended result of an intended action” (RTE TV News, November 5, 2013). The Coroner welcomed changes in practice that had taken place in the Rotunda since Bimbo’s death but he also questioned various medical witnesses on the drug Cytotec (Misoprostol) and its off label use for induction of labour. While the administration of Cytotec will not be recorded as a cause of death in the case of Bimbo - or any other woman or baby who dies after being exposed to this 'off label' drug - it is still worthy of note that the Coroner's inquest focused on its use for induction of labour in Ireland and questioned the safety and efficacy of its 'off label' use.

      Cytotec (Misoprostol) is a drug that is indicated for use in reducing gastric ulcers. It also has the side effect of producing uterine contractions and after it was approved by the FDA in the USA, it began to be used ‘off label’ for induction of labour in maternity services. This ‘off label’ use of approved medications is supported by the FDA and other similar medicines agencies worldwide as long as this use is based on sound medical evidence. 

      A Cochrane review in 2010 of ‘Vaginal Misoprostol for cervical ripening and induction of labour’ raised serious questions about the evidence that supports ‘off label’ use of misoprostol. This review posits that what is of particular concern in the ‘off label’ use of misoprostol are “several reports of uterine rupture following misoprostol labour induction with and without previous caesarean section”. It also suggests that “in countries in which misoprostol is being used for non-registered obstetric indications, there is a need for health authorities and professional organisations to clarify the medico-legal implications”. In other words, it is of great importance that health authorities, such as the HSE. publish clear guidelines for practitioners to ensure the safety of a drug - particularly one that lacks well designed clinical trials that support efficacy and safety of use. 

      In an article called The Freedom to Birth - The Use of Cytotec to Induce Labour: A Non-Evidence Based Intervention published in the Journal of Perinatal Education (2009) the author, Madeline Oden, discusses the need to be aware of the evidence-based interventions that are used in childbirth. The American College of Obstetricians and Gynecologists (ACOG) makes recommendations that have become the standard of care for labor and birth and Oden expalins that these recommendations sometimes deviate from the evidence-based ones supported by published research. The routine practices of episiotomies, induction, and denying food to the mother during labor without true medical indication have all been shown to be unnecessary interventions and can contribute to a spiraling effect of adverse events up to and including deaths of the mothers and/or infants. The off-label use of Cytotec (misoprostol) to induce labor and soften the cervix is an excellent example of an unnecessary intervention that is not supported by research (Enkin et al., 2000) (see Table) yet is rapidly becoming the standard of care, despite the evidence demonstrating the catastrophic events that can occur when it is used.

      A Mother’s story - Madeline Oden discusses her experience of Cytotec
      In December 2001, my 32-year-old daughter, Tatia Oden French, entered a well-known hospital in Oakland, California, to have her first child. She was in perfect health. The baby was in perfect health. The pregnancy was “unremarkable.” Tatia was almost 2 weeks past the due date, and the doctor wanted to induce her. After much stalling on Tatia's part, she reluctantly agreed to submit to induction. The agent used was Cytotec (misoprostol). None of the medical staff told us anything about Cytotec. When I asked what Cytotec was, I was told it is “the standard of care… we use it all the time.” Tatia said it was “not approved by the FDA [U.S. Food and Drug Administration] for use in labor.” Nothing else was said about the potential side effects, the dangers to the mom and child, or the alternatives. However, phrases such as “You don't want to go home with a dead baby, do you?” were said. The pressure was on. Tatia conceded. She told me to go home and that she would call me, believing it would be a long night. We told each other we loved each other and, having not decided on which specialty she would focus on in medical school, she smiled and said, “Maybe I'll be an OB/GYN.”
      Ten hours after Tatia was induced with Cytotec, both she and her baby girl, Zorah, were dead. When I asked Tatia's doctor what happened, she just said, “It was a very rare adverse effect of Cytotec, but it does happen.” Still not comprehending what had just happened, I heard myself ask the doctor, “Could you at least tell me that you will not use that drug again?” Surprised, she looked at me and said, “No, I cannot promise that.” Finally, my two sons, Tatia's dad, Tatia's husband, and I were allowed into the operating room where Tatia and Zorah were lying perfectly still. We gathered and said a prayer around both of them. When I left the hospital, it was raining and gray and cold. I heard myself say out loud, “That drug is going to go away.”
      After her daughter’s untimely death, Madeline Oden began to campaign for the cessation of the use of Cytotec for the induction of labour. She founded the Tatia Oden French Memorial Foundation in an effort to empower women around the issues of childbirth and pregnancy. The main focus of the foundation is on maternal mortality, ‘off label’ use of drugs, such as Cytotec, and informed consent. The danger of using a drug like Cytotec as an ‘off label’ medication is that no accurate statistics are kept on adverse events when it is used to induce labor. Oden says: “Pregnant women are still being given Cytotec, and some come through unscathed. However, many women and babies are permanently harmed.”
      For more information about The Tatia Oden French Memorial Foundation, log on to the organization's Web site (http://www.tatia.org/)
      For more information on Bimbo Onanuga and the AIMSI campaign to have her case heard at the Coroner’s Court, see http://nocountryforpregnantwomen.blogspot.ie/2013/11/inquest-into-death-of-bimbo-onanuga.html

      Monday 4 November 2013

      Inquest into the death of Bimbo Onanuga - Rotunda Hospital

      Introduction


      In 2010, AIMS Ireland were contacted over the recent death of a woman in the Rotunda hospital in Dublin. We were asked to look into the woman's death and the circumstances in which the woman died due to their concerns regarding the care the woman received. The woman's name was Bimbo Onanuga.

      The following is a summery of events to seek justice for her death.

      Synopsis in Brief - Salome Mbugua CEO -AkiDwA


      Bimbo Onanuga was a Nigerian woman, mother to Nellie who was born with severe cerebral palsy in Limerick Regional Hospital in 2003. Bimbo was Nellie’s fulltime carer. In 2010, Bimbo was pregnant with her second child. On 1 March, 2010, her GP referred Bimbo to the Rotunda Hospital with a suspected intrauterine death. Bimbo was seen in the hospital on the 1 March when the IUD was confirmed. She was told to return to the hospital on Thursday the 4 March for treatment. Bimbo was then over seven months pregnant.  Bimbo began to experience severe pain on the night of the 3 March and was taken to the Rotunda by ambulance.  Throughout that night and into the following day, Thursday the 4 March, Bimbo’s partner, Abiola Adesina, was increasingly alarmed at Bimbo’s deteriorating condition. He attempted repeatedly to raise his concerns with hospital staff, but felt that his warnings were ignored.  Bimbo was transferred in critical condition to the nearby Mater Hospital on the 4th March where she died later that night. 

      Under current legislation, maternity hospitals and maternity units are required to report a maternal death to the local coroner’s office, but an inquest is not automatically forthcoming.  Internal inquiries are generally held in hospitals but their contents and findings are not necessarily disclosed to family members. More recently, since 2008, the HSE has instituted a national critical incident review policy, but these reports are not necessarily made public either.  On the basis of the hospital’s report to the Dublin City Coroner, the Coroner determined that there was no necessity to hold an inquest.

      However, Abiola felt there were pressing questions about Bimbo’s care that were never responded to by the hospital and put in repeated requests to the coroner’s office about holding an inquest.  

      The results of the Rotunda’s internal inquiry were not made public and it was only after parliamentary privilege was exercised on the floor of the Dáil by Clare Daly TD in May, 2011, that the HSE disclosed most, although not all recommendations arising from its inquiry into Bimbo’s death. Parts of that report were redacted. The HSE then issued a public apology to Bimbo’s partner and family via a press release but were not in direct contact with them. The family had not heard from the hospital nor the HSE from the time of Bimbo’s death, March 2010, up to the night the questions about the inquiries were answered in the Dáil in May, 2011.
      The Dublin City Coroner has now gathered documentation and determined that an inquest be held and this will happen on the 18th April, 2013.

      Bimbo’s daughter, Nellie, died in December 2010 as a result of complications with her cerebral palsy. Abiola is now in London where Bimbo’s brother also lives.

      The presence of both Abiola and Bimbo’s brother at the forthcoming inquest is vital.  Abiola is owed a full and public hearing about the circumstances of Bimbo’s death. He will have full legal representation at the inquest.

      Full Details Thus Far:


      Correspondence with Rotunda Hospital regarding Maternal Death
      In late April, 2010, AIMSI wrote to the Master of the Rotunda Hospital, Sam Coulter-Smith expressing concern in relation to the death in March, of Bimbo Onanuga, an Irish-Nigerian woman who was seven months pregnant and had been told days earlier that her unborn child had died. AIMSI raised several points of concern, including the responsibility of maternity hospitals to take into account the specific needs of migrant women, and the need for clear and empathic communication with women and their families.  While the response received was not specific to the case, AIMSI was pleased to receive a swift reply from Mr. Coulter-Smith acknowledging the importance of issues raised. AIMSI are aware that Amnesty International has expressed an interest in this case, in light of suggestions that race and ethnicity may have played a role in the care and treatment of Ms. Onanuga. The investigation was ongoing. While we tried to chase Sam Coulter-Smith for more information, we were told that nothing would be released.
       
      Contact with the Coroner's office informed us that as Bimbo had died of 'natural causes' there would be no inquest.
       
      The HSE said there would be not internal inquiry into Bimbo's death.
       
       
       Another Foreign National Maternal Death and an Irish Maternal Death....

      On April 13, 2011 AIMSI were informed that there had been another maternal death in the Rotunda - in March 2011 - and the woman was once again non-national. The details AIMSI received were that she was a Polish woman, went in with pain and had an emergency section at 34 wks. The baby was rushed to NICU and she was later rushed to Mater, where she died. AIMSI were very concerned; if this report proved true, this would be the second maternal death of a non-national woman in a year.Attempts to verify this have been through the Rotunda and the Mater hospital, in which we were told they could neither deny nor verify.
       
      April 28, 2011, AIMSI received further information - that a Polish woman had died 6 weeks previous in the Mater following a perimortum section in Rotunda. Cause of death pulmonary embolism.
       
       On April 28th,  supporters of justice for Bimbo discussed the issues and decided that a  Parliamentary Question (PQ) into the death of Bimbo Onanuga, an un-named Polish woman, and to find out why there was no HSE inquiry for these Rotunda deaths as compared with the response to the death of Monaghan woman in Our Lady of Lourdes.
       
      Parliamentary Questions
       
      On May 9, 2011, AIMSI wrote to TDs Caoimhghin O'Caolain and Clare Daly asking them to support and initiate a PQ on the issue of maternal deaths in Ireland, foreign national maternal death and maternity care, and why some maternal deaths are given full inquiries and others do not.

      AIMSI wrote:

       AIMSI are writing to you asking you to support this PQ and to initiate a PQ on this issue in the Dáil through the People Before Profit party.

      As you are aware, the HSE recently responded and apologised following an inquiry of a maternal death at Our Lady of Lourdes Drogheda - Tanya McCabe. The HSE have also recently responded to media reports of a second maternal death at Our Lady of Lourdes Drogheda, in which they have requested a full internal inquiry into the death.

      AIMS Ireland wants to know why the HSE have not requested a full internal inquiry into the death of a foreign national woman at the Rotunda last year (March 2010). Her name was Bimbo Onanuga and the circumstances of her death are concerning. In fact, the only reason we know about it was that concerned Rotunda staff contacted AIMSI and a small local paper called the African Voice. It was not covered in the mainstream media. You can read more about Bimbo Onanuga's story here: http://www.theafricanvoice.ie/articles/latest.php

      We are extremely concerned with the fact that this death is not having a proper inquiry. These concerns are further intensified by the fact that AIMSI have been contacted to report that a SECOND non-national woman, this time a Polish woman, has died in the Rotunda this past March 2011. Attempts to verify this story with the Master of the Rotunda and the Mater (where the woman was transported to die) have not been fruitful. We have been told that as we do not have the full name of this woman, they can neither confirm nor deny


      On May 13, 2011, Clare Daly responded that she would ask a PQ on these issues.

      On May 19th, Clare Daly contacted AIMSI with the following response:


      QUESTION NO:  152




      DÁIL QUESTION addressed to the Minister for Health and Children (Dr. James Reilly )
      by Deputy Clare Daly
      for WRITTEN ANSWER on 19/05/2011  


       
       *  To ask the Minister for Health and Children the reason the Health Service Executive has not requested a full internal inquiry into the death of a person (details supplied) in 2010.

                                                                                                - Clare Daly

      Details Supplied: Bimbo Onanugaw in the Rotunda Hospital in March 2010


       
      REPLY.
      When the case was received by HSE, it was assessed using the Investigation Procedure and Toolkit under the HSE established National Incident Management Protocol

      The level of the investigation was decided by reference to the National Incident Protocol in light of the information on the case received  by HSE.  The case has therefore been investigated under that protocol by the HSE. Factors that contributed to this maternal death were identified in this review. To address these contributory factors and to prevent future harm arising from them 11 actions were recommended.

      The hospital has indicated that 8 of the 11 recommendations have been implemented. Work on the outstanding 3 recommendations is in progress and due for completion shortly.



      QUESTION NO:  153



      DÁIL QUESTION addressed to the Minister for Health and Children (Dr. James Reilly )
      by Deputy Clare Daly
      for WRITTEN ANSWER on 19/05/2011  


       
       *  To ask the Minister for Health and Children if a maternal death of a non-national woman occurred in a hospital (details supplied); and if an investigation is being carried out into the case.

                                                                                                - Clare Daly

      Details Supplied: the Rotunda in March 2011


       
      REPLY.
      I am informed that a non-national patient who attended the Rotunda Hospital collapsed and was transferred to the Mater Hospital. She subsequently passed away in Intensive Care Unit in the Mater Hospital on March 8 of this year. A full adverse incident review by the HSE is currently in progress.

      This PQ reply provoked more questions.

      What are the 11 actions were which were implemented?
      Why were the last 3 that haven't yet been implemented over a year later?
      Can we see this report? Can it be requested through FOI?


      On May 20, 2011, Clare Daly put in a THIRD PQ to request information on the recommendations from the Rotunda following the death of Bimbo Onanuga.



      QUESTION NO:  109
        DÁIL QUESTION addressed to the Minister for Health and Children (Dr. James Reilly )
        by Deputy Clare Daly
        for WRITTEN ANSWER on 26/05/2011  

         
         *  To ask the Minister for Health and Children if he will outline the 11 recommendations made in the investigation into the death of a person (details supplied) and the reason three of the recommendations have not yet been implemented over a year after the death.

                                                                                                  - Clare Daly

        Details Supplied: Bimbo Onanuga in the Rotunda Hospital in March 2010


         
        REPLY.
        This case was investigated under the National Incident Protocol by the HSE, using the Investigation Procedure and Toolkit to identify factors that contributed to this maternal death. To address these contributory factors and to prevent future harm arising from them 11 actions were recommended.
        Recommendations were made in relation to the need to identify clinical pathways for the management of such cases.

        The recommendations are as follows :
        1. The need to identify clinical pathways relating to management of women with an intrauterine death in third trimester to complement existing medical management policy.
        2. The Guidelines for Medical Management of Intrauterine Death should be revised in line with a review of the medical literature.
        3. Details of all patients for Induction of Labour, regardless of place of induction should be centrally documented.
        4. This recommendation cannot be disclosed as it contains personal, private, sensitive and confidential  information relating to the individual patient.
        5. Develop a brief operational outline of the Gynaecology Department to assist staff who are sent there on an occasional/intermittent basis.
        6. Due to the complexity of work, there is a need for an updated training needs analysis of all midwifery and nursing staff on the gynaecology ward.
        7. There should be a designated individual with responsibility for coordinating, monitoring and auditing the Basic Life Support attendance and Advanced     Life Support Skills attendance, ideally a designated Resuscitation Training Officer.
        8. An Obstetric Early Warning System should be introduced and evaluated.
        9. Install additional phone lines in the ward.
        10. A review of the possibility of emergency call bells or designated phones for emergencies in each room should be carried out and measures taken to address this.
        11. Hospital wide analysis of all doorways in clinical areas to establish the feasibility of moving a bed in a critical event. 

        The HSE confirm that all but the 7th recommendation have now been implemented.
        Discussions are underway in the HSE to bring the implementation of this recommendation to conclusion.

        It was now determined that the HSE did undergo an internal inquiry into the death of Bimbo Onanuga, but it had been done extremely quietly. It also appeared that recommendations following the inquiry were not to be published publicly. As this PQ reply did not address the issue of the report into the publication of Bimbo's death and so yet another PQ was initiated by Clare Daly.

        Apology

        On May 27, 2011, the day after the Dáil reports of AIMSI PQs are published and it is reported in Irish Health.com, a HSE statement expressed it sincere sympathies to the family involved. However, the family were not contacted directly and are unaware of the statement.

        Fourth PQ

        June 3, 2011, AIMSI received the following reply.
         
        QUESTION NO:  137
          DÁIL QUESTION addressed to the Minister for Health and Children (Dr. James Reilly )
          by Deputy Clare Daly
          for WRITTEN ANSWER on 02/06/2011  

           
           *  To ask the Minister for Health and Children if he will publish the full report of the investigation into the death of a person (details supplied)..

                                                                                                  - Clare Daly T.D.

          Details Supplied: Bimbo Onanuga at the Rotunda


           
          REPLY.
          The question of publishing the report is a matter for the HSE. I understand that the full report cannot be released as it specifically relates to the patient care and personal circumstances of an individual whose rights must be respected. However, all of the recommendations of the report have been released other than one which relates to the individual patient. Details of these recommendations are included in my reply to you of 26th May 2011 in response to Parliamentary Question 109 .

          QUESTION NO:  106
            DÁIL QUESTION addressed to the Minister for Justice and Equality (Mr. Shatter)
            by Deputy Clare Daly
            for WRITTEN on Thursday, 2nd June, 2011.  

             
             *  To ask the Minister for Justice and Equality if he will implement procedures that require every maternal death, regardless of circumstance, should be submitted to a coroner's inquest.

                                                                        - Clare Daly

               
              REPLY.
                The requirement to report a death to a coroner and whether to subsequently conduct an inquest is set out in sections 17 and 18 of the Coroners Act 1962. Under Coroners'  Rules of Practice, as outlined on the Coroners website www.coroners.ie, maternal deaths relating to childbirth are required to be reported to the coroner. The Coroners Bill 2007, confirms this by providing, inter-alia, in the Third Schedule on Deaths Reportable to Coroner, for the reporting of "any maternal death that occurs during or following pregnancy (up to a period of six weeks post-partum) or that might be related to pregnancy".  

                Fortunately, maternal deaths are exceptionally rare and this State has one of the lowest maternal mortality rates in the world. However, where such deaths occur, they are reported to a coroner and an autopsy would normally be held. It is then a matter for the coroner to decide, having regard to the circumstances of the maternal death, whether an inquest is necessary to determine the circumstances. There may be cases where an inquest would be unnecessary and leaving it to the discretion of the coroner is, therefore, considered to be the most appropriate public policy position.

              Investigations into Cytotec

              In early June, following PQs, some supporters of Bimbo began querying if she had been given cytotec to induce her labour. Cytotec has been shown to be linked with uterine rupture and death. Cytotec is a drug which was developed for the treatment of stomach ulcers and is not approved by the FDA for use in maternity purposes. Cytotec is used in maternity care to induce labour and manage excess bleeding following birth (PPH).

              June 5, 2011, Catherine Reilly writes an article looking further into the death of Bimbo Onanuga and the suspected use of cytotec.

              Inquiry Request

              June 2011 - Bimbo's partner, Abioloa,  writes to the Dublin Coroner's Office to request an inquest into Bimbo's death.

              November 2011 - Rotunda PR responses
               
              November 2011 saw several articles in which the Rotunda PR machine began commenting on the case from the view of overstretched maternity wards to blame for Bimbo's death
               
               
              And an interview with the Sunday Business post with Sam Coulter-Smith provoked the following letter to the editor:
               
              The Association for Improvements in the Maternity Services Ireland (AIMS Ireland) wish to highlight grave concerns re Maternal Death following your article (13.11.11), Dr Sam Coulter-Smith, master of the Rotunda Hospital. In the article, Mr. Coulter-Smith alludes to two maternal deaths of non nationals which occurred in the Rotunda Hospital over a 12 month period. Mr. Coulter-Smith states that investigations were undertaken and that the results were published.

              AIMSI wrote repeatedly to Dr. Sam Coulter Smith requesting information regarding the two incidences. At no point was any information made public. Furthermore neither death was reported in the national media. Neither death received a full HSE inquiry. Neither death received a public apology.

              Eventually, AIMSI were reduced to requesting THREE separate Parliamentary Questions to establish that the deaths had occurred and that there were recommendations associated with the multiple system failures following Bimbo Onanuga’s death and the unnamed East European at the Rotunda Hospital.

              By contrast, following a maternal death of an Irish woman in Our Lady of Lourdes, Drogheda during the same time period; a full HSE inquiry was immediately initiated, an apology to the family by the HSE was immediately given, and a full report of events appeared in all national media outlets

              Is the contrast due to poor management at the Rotunda, or due to the fact that the death of non National women in childbirth does not require the same accountability as the death of an Irish woman?
               
              Inquest Granted - Jan 2013
               
              In January of 2013 word was received that the Dublin City Coroner had granted an inquest into the death of Bimbo Onanuga. The inquest date was set for April 2013.
               


              April 2013 would see THREE inquests into maternal death in Ireland

               
              1. Jennifer Crean.
              2. Savita Hallapanavar.
              3. Bimbo Onanuga.
               
               
              At the Inquest - April 2013
               
              *At inquest, it was determined Bimbo had a uterine rupture due to induction
              *It was confirmed that cytotec was administered.
              *A 'serious doctoring' of notes was discussed
              * key witnesses were not present - those who cared for Bimbo on the day of her death
              *demands have been made that critical witness be subpoenaed - 'we need actual witness'
               
              The inquest was adjourned until July 5, 2013 with the hope to call 'critical' witnesses. '
              Critical witnessess' include doctor, HCP who witnessed death, a nurse, and Bimbo's partner.




              In July, the Inquest was adjourned to resume November 4/5th.
               



              Findings of Relevance for the Inquest for Bimbo Onanuga

              from the HIQA Report on the Death of Savita Halappanavar
              The HIQA report found:
               
              ‘A general lack of provision of basic, fundamental care, for example, not following up on blood tests as identified in the case of Savita Halappanavar’
               
              The HIQA report found:
               
              ‘The most basic means of identifying any patient at risk of clinical deterioration is to observe the patient’s general condition and regularly monitor and track their clinical observations. This should be a basic component of caring for any patient.’



              The HIQA report found:
               
              ‘Patients and members of the public are entitled to expect the highest level of healthcare. When the delivery of care falls below that level, they are entitled to ask why and be assured that measures have been taken to protect them and future patients from harm.’

              ‘It was also noted that there were many areas where maternity service needs were not being fully met at the time of the investigation. This finding reinforces the Authority’s concerns in relation to the inconsistency in the provision of maternity services in Ireland and the need to ensure that all pregnant women have appropriate access to the right level of care and support at any given time.’
               

              Key Questions about Bimbo Onanuga’s Care
                Did Bimbo Onanuga, who had a number of risk factors in relation to the intrauterine fetal death, receive the basic care, monitoring and a care plan consistent with her clinical needs?



              Was she appropriately and effectively monitored given the use of the drug misoprostol?

              Is the Rotunda prepared to fully divulge to the public the steps they have taken since Ms Onanuga’s death to reform care plans and retrain staff, in line with the international evidence on the use of misoprostol and to explain why their guidelines differ from those of the RCOG Greentop 55?
               
              ‘The RCOG is aware that protocols employing much larger doses of misoprostol are still being employed in the UK, with consequent potentially associated adverse effects. Each maternity unit is advised to review their protocol for the management of induction of labour under these circumstances and to adopt the recommended misoprostol dosaging.’ RCOG, 2010
               http://www.rcog.org.uk/womens-health/clinical-guidance/late-intrauterine-fetal-death-and-stillbirth-green-top-55



              You can read more about Bimbo Onanuga's story http://www.theafricanvoice.ie/articles/latest.php
               

              Safety flaws highlighted in maternal death probe http://www.irishhealth.com/article.html?id=19216
               
              ‘They told me she was exaggerating - now she’s gone’ - Rotunda neglected care of Bimbo Onanuga says partner: http://metroeireann.com/article/they-told-me-she-was-exaggerating,2747


              Maternal Death Inquiry - Bimbo Onanuga: http://www.imt.ie/news/latest-news/2013/01/inquest-into-death-at-the-rotunda-is-likely-in-april.html