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• Comment on 'An emergency contraception algorithm based on risk assessment: changes in clinician's practice and patient choices': authors' response
  Rebecca J McKay
  Published on: 13 May 2016
• Comment on 'An emergency contraception algorithm based on risk assessment: changes in clinicians' practice and patients' choices'
  Aisling Baird
  Published on: 13 May 2016

• Published on: 13 May 2016

  Comment on 'An emergency contraception algorithm based on risk assessment: changes in clinician's practice and patient choices': authors' response

  • Rebecca J McKay, Subspecialist Registrar in Sexual and Reproductive Healthcare
  • Other Contributors:
    • Lynne Gilbert

  We thank Drs Baird and Webb for their considered response [1] to our article [2] and for opening up a constructive debate on provision of different methods of emergency contraception (EC).

  We are aware of the evidence regarding the relative efficacies of the three EC methods and that Faculty of Sexual & Reproductive HealthCare (FSRH) guidance [3] is that all women, subject to eligibility, should be offered a...

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  We thank Drs Baird and Webb for their considered response [1] to our article [2] and for opening up a constructive debate on provision of different methods of emergency contraception (EC).

  We are aware of the evidence regarding the relative efficacies of the three EC methods and that Faculty of Sexual & Reproductive HealthCare (FSRH) guidance [3] is that all women, subject to eligibility, should be offered all options from which to make their own informed choice. However, services do work within constraints that inevitably impact on what can be provided and that must be considered in the development of protocols. As we have indicated, our study was a pilot testing a pragmatic approach to method selection and was subject to restrictions requested by our local Medicines Management team. It also pre-dated current FSRH guidance.

  When ulipristal acetate (UPA) was granted a UK licence in May 2009 our Primary Care Trust (PCT) placed it on their 'Red List' of drugs (i.e. not funded). Four years on it is still there, albeit with exceptional use in women presenting between 72 and 120 hours after unprotected sexual intercourse (UPSI) now permitted. Although, as a specialist service we are not constrained by the Red List, we are strongly encouraged to comply where possible to ensure consistency and parity of provision between our service and primary care. Our audit in 2010 of 136 women attending for EC demonstrated that 90% present within 72 hours of UPSI. Complying with the Red List would mean that only 10% of our attenders would be eligible for UPA. The pilot protocol was developed against this restrictive background, and whilst we fully appreciate the fundamental concern of Drs Baird and Webb about using risk assessment in decision-making, if use is restricted there has to be some eligibility criteria.

  Encouragingly, the results from Dr Baird's service demonstrate that when women are provided with free choice they do not all choose UPA. However, the use of this method has increased at the expense of levonorgestrel (LNG) with additional cost implications. [4] We would suggest that for some services this may be a cause for concern.

  Faculty guidance recommends that women should be offered all three EC options from which they can make an informed decision. Whilst there are many factors that may influence this decision, we believe that for most women the principal one against which other factors are considered is the likelihood of pregnancy. No one would argue against an intrauterine device (IUD) being the most effective option. However, it is an invasive procedure that many women are reluctant to pursue. In making their decision and weighing up the 'pros and cons' surely the concern most likely to overcome women's reluctance is how likely they are to become pregnant? We are therefore obliged to discuss the IUD to enable a woman to make that informed choice. Whilst we accept that any method of risk assessment will not give an absolute answer, a relative risk can be provided. Estimates of the probability of conception relative to intercourse on a given cycle day do suggest a definite peak (i.e. a high- risk time), which for women with regular cycles is Day 13. [5] Whilst not perfect, our method of risk assessment did at least permit more widespread use of UPA and hopefully targeted those women at the highest risk of pregnancy and most likely to benefit. The efficacy of hormonal methods of contraception is based on ratios between observed and expected pregnancies and therefore also relies on estimates of the risk of conception.

  We are in complete agreement with the comments regarding use of UPA in the under-18s and reiterate that the exclusion of this group from the pilot was a condition requested by Medicines Management and does not indicate an inconsistency in our general approach to this age group. Since November 2012, UPA has been provided under a patient group direction (PGD), which has no age restrictions. We have also modified the protocol to include body mass index (BMI) in our discussion on method selection as there is some evidence that both hormonal methods, but particularly LNG, are less effective with a BMI>25. [6,7]

  In the 8 months following the introduction of the PGD there have been 400 attendances for EC. Methods chosen were LNG 63 %, UPA 24% and IUD 13%. Our use of UPA is therefore slightly higher than the 18.7% reported by Dr Baird [4] when women are given free choice. Whilst there was a fall in IUD usage in eligible women from 15% to 8.7% during the pilot study when UPA was introduced, further staff training prior to introducing the PGD has returned our IUD usage rates to baseline. In the subgroup of patients aged under 18 years (80 patients) usage has been LNG 79%, UPA 17% and IUD 4%.

  The NHS is going through a time of great financial hardship and services are being rationalised in all areas. Our algorithm was developed against a background in which unrestricted use was not permitted in order to promote the copper IUD as the most effective form of postcoital contraception for all eligible women, with UPA second line for those at most risk.

  References

  1. Baird A, Webb A. Comment on 'An emergency contraception algorithm based on risk assessment: changes in clinicians' practice and patients' choices'. J Fam Plann Reprod Health Care 2013; eLetter 18 July 2013. doi:10.1136/jfprhc-2013-100725.

  2. McKay RJ, Gilbert L. An emergency contraception algorithm based on risk assessment: changes in clinicians' practice and patients' choices. J Fam Plann Reprod Health Care 2013;39:201-206.

  3. Faculty of Sexual and Reproductive Healthcare. Emergency Contraception. 2011. http://www.fsrh.org/pdfs/CEUguidanceEmergencyContraception11.pdf [accessed 11 July 2013].

  4. Baird AS. Use of ulipristal acetate, levonorgestrel and the copper -intrauterine device for emergency contraception following the introduction of new FSRH guidelines. J Fam Plann Reprod Health Care 2013; ePub 25 April 2013. doi:10.1136/jfprhc-2012-100467.

  5. Wilcox AJ, Dunson DB, Weinberg CR, et al. Likelihood of conception with a single act of intercourse: providing benchmark rates for assessments of post-coital contraceptives. Contraception 2001;63:211-215.

  6. Moreau C, Trussell J. Results from pooled Phase III studies of ulipristal acetate for emergency contraception. Contraception 2012; 86(6):673-680.

  7. Glasier A, Cameron ST, Blithe D, et al. Can we identify women at risk of pregnancy despite using emergency contraception? Data from randomized trials of ulipristal acetate and levonorgestrel. Contraception 2011;84(4):363-367.

  Conflict of Interest:

  None declared

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  Conflict of Interest:
  None declared.

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• Published on: 13 May 2016

  Comment on 'An emergency contraception algorithm based on risk assessment: changes in clinicians' practice and patients' choices'

  • Aisling Baird, Consultant in Sexual and Reproductive Healthcare
  • Other Contributors:
    • Anne Webb

  Congratulations to Drs McKay and Gilbert on trying to increase access to emergency contraception (EC) intrauterine device (IUD) and on achieving high rates[1]. Even in Liverpool, UK where we pride ourselves on easy, often immediate, IUD access and where we have long been promoting its effectiveness we only achieve around 5%.

  We have some concerns about the algorithm described in this article.[1] The classificatio...

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  Congratulations to Drs McKay and Gilbert on trying to increase access to emergency contraception (EC) intrauterine device (IUD) and on achieving high rates[1]. Even in Liverpool, UK where we pride ourselves on easy, often immediate, IUD access and where we have long been promoting its effectiveness we only achieve around 5%.

  We have some concerns about the algorithm described in this article.[1] The classification of level of risks is not based on what is known about variability of ovulation timing. The chance of pregnancy is greater than 10% from Day 6 to Day 21 of the cycle, and by the fifth week women still have a 4-6% chance of ovulating[2]. Contrary to previous teaching, only 10% of women with a 28-day cycle will ovulate 14 days before their next bleed[2]. Previous correspondence shows that when hormonal assessments were carried out, women confident of the date of their last menstrual period (LMP) and cycle length were not where they thought they were in their cycle,[3] as Drs McKay and Gilbert hint in their article. So, calculations based only on LMP and cycle length are not accurate enough to inform an individual patient not wishing an unplanned pregnancy. The pregnancies recorded during the pilot study,[1] in women not assessed as high risk who had levonorgestrel (LNG) EC, support the above.

  Regarding IUD eligibility, it is only necessary to elucidate pre-insertion the possibility of an implanted pregnancy, should there have been any unprotected sexual intercourse (UPSI) more than 5 days prior to presentation. The method Drs McKay and Gilbert have used is useful when there have been many episodes of UPSI but before a pregnancy test would be positive. It is restrictive, but can reassure the IUD fitter that there will not be an implanted pregnancy. It does not determine the date of ovulation of the current cycle; it just estimates the earliest possible date.

  Evidence-based practice suggests that wherever women are in their cycle, if all UPSI was within 72 hours, the IUD is the most effective, and ulipristal acetate (UPA) has the edge on LNG, because of its action during the luteinising (LH) surge (closer to ovulation: the highest risk time of the cycle). For UPSI between 72 and 120 hours the IUD is the most effective, UPA is licensed and LNG has neither been shown to have an effect after 96 hours nor is it licensed. Only if there is UPSI more than 120 hours previously is it necessary to consider implantation with all the caveats above.

  However, the Faculty of Sexual & Reproductive Healthcare does not rank the methods with regards to choice, it states: "Health professionals should discuss individual need to ... [EC] and inform women about the different methods with regard to efficacy, adverse effects, interactions, medical eligibility and need for individual contraceptive precautions."[4] It is for the woman then to make an informed choice and other factors may come into play, as previous work has shown,[5] and there is no evidence of a wholesale move towards UPA when free choice is introduced. The offer of an IUD to women seeking EC has been UK standard practice for over 30 years; however, the introduction of an algorithm seems to have been helpful within Drs McKay and Gilbert's service.

  Restricting UPA to those aged over 18 years appears to imply that women aged under 18 years are less deserving of protection against unplanned pregnancy. The studies on UPA did include some 16- and 17-year- olds, and subsequent studies have shown that adolescents are no different to adults.[6] If the authors were being consistent then they would not prescribe most contraceptives to teenagers as they are seldom included in most studies. We would argue that it is precisely the young, fertile woman presenting for EC who needs the most effective method, and though an IUD is possible these individuals are often the ones most reluctant to accept it. The FSRH guidance explicitly supports the use of UPA in under-18s.

  References

  1. McKay RJ, Gilbert L. An emergency contraception algorithm based on risk assessment: changes in clinicians' practice and patients' choices. J Fam Plann Reprod Health Care 2013 ;39:201-206.

  2. Wilcox A J, Dunson D, Baird DD. The timing of the "fertile window" in the menstrual cycle: day specific estimates from a prospective study. BMJ 2000;321:1259-1262.

  3. Webb A, McGough P, Melvin L. Pitfalls of adapting emergency contraception CEU guidance. J Fam Plann Reprod Health Care 2012;38:270.

  4. Faculty of Sexual and Reproductive Healthcare. Emergency Contraception. 2011. http://www.fsrh.org/pdfs/CEUguidanceEmergencyContraception11.pdf [accessed 11 July 2013].

  5. Baird AS. Use of ulipristal acetate, levonorgestrel and the copper -intrauterine device for emergency contraception following the introduction of new FSRH guidelines. J Fam Plann Reprod Health Care 2013; 25 April 2013. doi: 10.1136/jfprhc-2012-100467.

  6. Glasier A. EllaOne, a clinical update. Presentation at the First Global Conference on Contraception, Reproductive and Sexual Health, 24 May 2013, Copenhagen, Denmark.

  Conflict of Interest:

  None declared

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  Conflict of Interest:
  None declared.

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