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Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, March 2017

Scheduling medicines and poisons

17 May 2017

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1.3. Ulipristal

1. Advisory Committee on Medicines Scheduling (ACMS #20)

1.3. Ulipristal

Referred scheduling proposal

An application was submitted to amend the Schedule 3 entry for ulipristal by including 'ulipristal for emergency post-coital contraception' in Appendix H.

Current scheduling status and relevant scheduling history

Ulipristal is currently listed in Schedules 3 and 4 of the Poisons Standard.

Schedule 4

ULIPRISTAL except when included in Schedule 3.

Schedule 3

ULIPRISTAL for emergency post-coital contraception.

Scheduling application

This was a general application. The applicant's proposed amendments to the Poisons Standard are as follows:

Appendix H - Proposed New Entry

ULIPRISTAL for emergency post-coital contraception

Index - Proposed Amendment

ULIPRISTAL

Schedule 4
Schedule 3
Appendix H

The applicant's reasons for the request are:

  • Emergency contraception (EC) gives women a simple, safe and convenient option to avoid an unintended pregnancy if used within a few days of UPSI. However, while sales of EC in Australia are approaching 650,000 units per year (IMS October 2015 - September 2016), knowledge about the availability and use of EC remains low.
  • The applicant refers to a 2011 study surveying 632 Australian women aged 16 - 35 that concluded that although Australian women have a high level of awareness of EC, their inadequate knowledge limits its potential to assist in reducing unintended pregnancy and abortion rates: "A media campaign could be an effective means of disseminating information about the pharmacy availability, time frame for effective use and safety of EC".
  • The applicant refers to a 2008 study surveying 627 Australian university students regarding knowledge and attitudes about emergency contraception and their understanding of the risk for pregnancy that concluded that "EC needs to be better understood by all members of the community as a back-up contraceptive method after unprotected sexual intercourse to reduce the number of terminations of pregnancy after unprotected sexual intercourse to reduce the number of terminations of pregnancy and unwanted pregnancies" and "Allowing EC to be advertised via the mass media has the greatest potential to improve general community knowledge about EC".
  • The applicant also refers to US and UK European studies that found media campaigns increased community awareness and education about this method of contraception and increased contact with EC hotlines and did not invoke any special controversy.
  • The applicant estimates approximately 200 000 unplanned pregnancies and 80 000 terminations in Australia a year in 2005. Two thirds of women presenting for abortions in Australia reported contraception use at time of conception. The applicant's data shows the number of abortions decreased slightly since EC became available, but its availability has not had a significant impact.
  • The applicant states that under the TG Act, 'Unless a substance is included in Appendix H, members of the community cannot be given any product-specific information including via company websites, display material in pharmacies or even via training material for pharmacy assistants.'
  • The applicant proposes to determine the media used by women of reproductive age to obtain information on contraception options, including EC and identify the sources of information for the different age groups and how women in each age group prefer to receive this information. This will be used to develop appropriate, targeted and responsible direct-to-consumer advertising and informational material specific to ulipristal that supports and complements the role of pharmacists in assisting women facing the possibility of unintended pregnancy. This could include a dedicated web site, consumer leaflets for distribution through pharmacies, doctors' surgeries, family planning centres etc. and social media as well as the more traditional print and broadcast media.
  • The applicant proposes involving professional pharmacy bodies in campaigns to educate women on the use of EC in general and ulipristal in particular with the aim of reducing the number of unwanted pregnancies and abortions (with education and training material covering the condition, the role and benefit of the product as EC, pharmacist involvement). The applicant requests a 12 month delay for implementation from the Schedule 3 implementation date to allow pharmacists to become familiar with the use of ulipristal as Schedule 3.
  • Ulipristal is advertised in 25 EU countries. Branded advertising is allowed in 13 of those countries with 'category' (emergency contraception) advertising in the other 12 countries.
  • Consumer surveys have shown that knowledge of the availability, safety and effects of EC is poor among Australian women and that this may act as a barrier to its use (Hobbs 2011, Calabretto 2008). Specific, targeted, responsible advertising that reinforces the important role of pharmacists has considerable potential to reverse this situation with a significant reduction in unwanted pregnancies and consequent abortions. This would have important direct and indirect benefits for public health and in avoiding the social and economic costs of abortions.
  • The advertising of ulipristal is unlikely to lead to inappropriate patterns of medication use: as pharmacists are involved in every sale, the pack contains a single tablet to be taken as soon as possible after UPSI, so potential for inappropriate or incorrect use is low and all forms of advertising will emphasize the important role of pharmacists in advising women on the correct and appropriate use of ulipristal.
  • The sponsor for ulipristal will lodge an application to change the label to the TGA to amend the label for the existing ulipristal acetate 30 mg tablet blister pack to match the requirements for schedule 3 medicines (adding a 'pharmacist only medicine' signal heading plus indications & directions for use) and in line with this proposes to comply with advertising of therapeutic goods in Australia must comply with the Therapeutic Goods Advertising Code (TGAC). Section 6(3)(e) of the Code requires the inclusion of words to the effect of: "YOUR PHARMACIST'S ADVICE IS REQUIRED" in all advertisements for schedule 3 medicines. This message will be a key feature in all advertising material.
  • Pharmacists remain involved in sale of Schedule 3 medicines and the CMI will reflect the involvement of pharmacists in counselling consumers.
  • Experience with the non-prescription use of levonorgestrel EC since 2003 provides reassuring evidence that pharmacy access has not created any particular indirect risk. Studies that have examined the use of EC when provided directly at the pharmacy or given in advance of need, have shown that, compared to prescription provision, direct access:
    • Does not increase sexual risk taking behaviour in adolescents (Ekstrand 2008, Harper 2008, Raine 2012).
    • Does not lead to increased frequency of unprotected intercourse (Marston 2005, Moreau 2006).
    • Does not lead to decreased use of effective methods of contraception (Marston 2005, Raine 2005, Ziebland 2005, Moreau 2006, Ekstrand 2008, Moreau 2008) and women's EC experience is actually described as a motivating factor leading to more consistent use of regular contraception (Gainer 2003).
    • Does not lead to increased rates of sexually transmitted infections (Raymond 2006, Raine 2005).
  • The applicant states that ulipristal does not have an abortifacient action.
  • The applicant proposes to work with pharmacy organisations to provide pharmacists educational materials in relation to ulipristal to meet legal and professional obligations and supports them in that role.
  • The applicant proposes to discuss parameters for advertising with pharmacy organisations to ensure advertising and educational material will be framed to increase awareness of the availability of EC through pharmacists and to complement the pharmacist's role in ensuring the 'quality use' of ulipristal.
  • While nearly 70 per cent of Australian women of reproductive age are using some form of contraception (Richters 2003), the uptake of the most effective forms of contraception, long-acting reversible contraception, remains low (Garrett 2015), leaving many women at an increased risk of an unplanned pregnancy.
  • Women have expressed that the availability of emergency contraceptive pills over the counter is advantageous because it gives them more control over their contraception (Hobbs 2009).
  • The need for more information about fertility and contraception, particularly emergency contraception, has been highlighted by both women and healthcare professionals across a number of studies. Young women have expressed the need for more information and education about emergency contraception, as there is little information available to them (Hobbs 2009). Not only is there a need for more information, but both women and healthcare professionals have expressed the need for more inclusive and easier to access contraceptive information, including easy-to-understand wording, and information in audio and video formats (Garrett 2015).
  • Women may be receiving conflicting, out-dated, inaccurate and anecdotal information, rather than evidence-based, current information.
  • Women have reported frustration that healthcare providers had not informed them of alternatives to the contraceptive pill and many felt that they were unable to make informed choices about contraception because of limited understanding of their available options and how they work (Garrett 2015).
  • Poor knowledge about emergency contraception has been linked to its non-use.
  • When women take responsibility for their healthcare and seek EC from a pharmacy, they report being concerned about a lack of privacy within the pharmacy, resulting in feelings of awkwardness and embarrassment (Hobbs 2011). These women reported that they want the pharmacists' role to be limited and their experience at the pharmacy to be as short as possible (Hobbs 2009).
  • Consumers want to exercise more control in the management of their own health, particularly in this personal and sensitive areas. Responsible, targeted advertising could start to address this issue while increasing community knowledge of the availability of this simple, safe and effective option for preventing unwanted pregnancy and at the same time supporting and enhancing the role of pharmacists in helping women through this difficult time.
  • Ulipristal is a safe and effective medicine for the prevention of unwanted pregnancy.
  • The ability to advertise ulipristal and make educational information available to consumers will significantly improve public awareness and knowledge of this simple, safe, effective and convenient option for Australian women to prevent unwanted pregnancies. This increased awareness has the potential to significantly reduce the number of abortions with consequent benefits for public health.
Australian regulatory information

Ulipristal acetate was included in the ARTG on 6 March 2015.

International regulations

Ulipristal was first approved in the EU in May 2009, where it is not subject to medical prescription and has marketing authorisation with the requirement of periodic safety update reports.

Ulipristal is approved as prescription emergency contraception in New Zealand, Canada and the USA. It was approved in the USA in August 2010. In Canada, ulipristal is marketed by two companies, XXXX in 30 mg tablet form and XXXX in 5 mg tablet form.

Substance summary

Figure 1.3: Structure of ulipristal acetate

Figure 1.3: Structure of ulipristal acetate

Ulipristal acetate (chemical name: 17α-acetoxy-11β -(4-N,N-dimethylaminophenyl)-19-norpregna-4,9-diene-3,20-dione) is an orally-active synthetic selective progesterone receptor modulator that acts via high affinity binding to the human progesterone receptor. When used for emergency contraception the mechanism of action is inhibition or delay of ovulation via suppression of the luteinizing hormone surge.

Ulipristal is indicated for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.

Pre-meeting public submissions

Fourteen (14) submissions were received.

Thirteen (13) submissions supported the scheduling proposal. Main points:

  • Ulipristal acetate provides increased efficacy and a longer window of opportunity to prevent unwanted pregnancy compared to other available emergency contraception.
  • An increased uptake of emergency contraception has the potential to prevent unplanned pregnancies, contributing to the reduction of direct and indirect costs to the health care system.
  • There would be a direct reproductive health benefit for women by enabling them to avoid unplanned pregnancies.
  • Some women have misconceptions about its use, especially the time period of its effective use. It is also not widely understood by pharmacists and other practitioners.
  • The likelihood of "inappropriate use" would be minimised with comprehensive training with the pharmacy sector and education with women.
  • EC is extremely safe, even when used repeatedly. Compared with the potential health risks of pregnancy, taking ECPs to prevent unintended pregnancy is much safer.
  • The pack contains a single tablet so the potential for inappropriate or incorrect use is very low.
  • Ulipristal will remain in Schedule 3 meaning a pharmacist must be personally involved in every sale.
  • There should also be an expansion of the list of health professionals to include remote area nurses, midwives and nurse practitioners to supply the ulipristal acetate to women in remote and isolated areas.
  • Direct to consumer marketing will not only promote UPA, but importantly it will also serve to raise awareness of emergency contraception more generally in the community.
  • All forms of advertising will emphasise the important role of pharmacists in advising women on the correct and appropriate use.
  • A UK advertising campaign on emergency ulipristal was shown to be worthwhile.

Two (2) submissions did not support the scheduling proposal. Main points:

  • There may be an increase in requests for the medicine from third parties with advertising.
  • An Appendix H listing would not be in the public interest.
  • Short period of experience as Schedule 3 medicine.

The public submissions will be made available on the TGA website.

Summary ofACMS advice to the delegates

The committee advised that the Schedule 3 entry for ulipristal be amended by including 'ulipristal for emergency post-coital contraception' in Appendix H, as follows:

Schedule 3

ULIPRISTAL for emergency post-coital contraception.

Appendix H - New Entry

ULIPRISTAL for emergency post-coital contraception.

Index - Amend Entry

ULIPRISTAL

Schedule 4
Schedule 3
Appendix H

The committee also recommended an implementation date of 1 February 2018.

Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included (a) risks and benefits of the use of a substance (b) the purpose for which a substance is to be used and the and extent of use; (c) the toxicity of a substance; (e) the potential for abuse of a substance; and (f) any other matters that the Secretary considers necessary to protect public health.

The reasons for the advice comprised the following:

  • Public health is likely to be improved, since increased community knowledge may improve access to this product, which will likely reduce the incidence of unplanned pregnancies.
  • Low toxicity and low potential for abuse, since only available as single dose tablet.
  • Risk of misuse may be mitigated through need for pharmacist counselling and supply. Ulipristal is not an abortifacient therefore risk of 'abuse' is minimal.
  • Listing in Appendix H is supported by the majority of clinical stakeholders. Concerns raised by pharmacists may be mitigated through.
  • A delayed start date will give some lead time for pharmacists to gain experience with the relatively new Schedule 3 listing.
Delegate's considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal
  • ACMS advice
  • Public submissions received
  • Section 52E of theTherapeutic Goods Act 1989
  • Scheduling Policy Framework(SPF 2015)
  • Other relevant information
Delegate's interim decision

The delegate's interim decision is to amend the Schedule 3 entry for ulipristal by including ‘ulipristal for emergency post-coital contraception' in Appendix H. The proposed Schedule entry is as follows:

Schedule 3

ULIPRISTAL for emergency post-coital contraception.

Appendix H - New Entry

ULIPRISTAL for emergency post-coital contraception.

Index - Amend Entry

ULIPRISTAL

Schedule 4
Schedule 3
Appendix H

The proposed implementation date is 1 February 2018 to allow sufficient time for experience to be gained with the relatively new Schedule 3 listing prior to advertising.

The delegate considered the relevant matters under section 52E (1) of theTherapeutic Goods Act 1989: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (e) the potential for abuse of a substance; and (f) any other matters that the Secretary considers necessary to protect public health.

The reasons for the interim decision are the following:

  • The delegate acknowledges the committee's advice.
  • Public health is likely to be improved, since increased community knowledge may improve access to this product, which will likely reduce the incidence of unplanned pregnancies.
  • Low toxicity and low potential for abuse, since only available as single dose tablet.
  • Risk of misuse may be mitigated through need for pharmacist counselling and supply. Ulipristal is not an abortifacient therefore risk of 'abuse' is minimal.
  • Listing in Appendix H is supported by the majority of clinical stakeholders. Concerns raised by pharmacists may be mitigated through.
  • A delayed start date will give some lead time for pharmacists to gain experience with the relatively new Schedule 3 listing.

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