Shortage of norethisterone-containing pills in Australia: Advice for GPs

July/August 2020

The Therapeutic Goods Administration (TGA) advises:

Consumers and health professionals are advised that there is a shortage of oral contraceptive pills containing the combination ethinylestradiol and norethisterone.

The affected products are:

  • Brevinor – norethisterone 0.5 mg and ethinylestradiol 35 micrograms
  • Norimin – norethisterone 0.5 mg and ethinylestradiol 35 micrograms
  • Brevinor-1 – norethisterone 1 mg and ethinylestradiol 35 micrograms
  • Norimin-1 – norethisterone 1 mg and ethinylestradiol 35 micrograms.

All four products are sponsored by Pfizer Australia Pty Ltd.

Pfizer has advised the Therapeutic Goods Administration (TGA) the shortage of these products is due to manufacturing issues and is expected to continue until mid-October 2020 and early December 2020, depending on the product. Further information about the shortage is available on the TGA’s Medicine Shortage Reports Database.

Meanwhile, SPHERE (NHMRC Centre of Research Excellence in Sexual and Reproductive Health for Women in Primary Care) have released a statement:

A global shortage of contraceptive pills containing the progestogen contrnorethisterone (NET) has led to shortages in Australia since March 2020. The reason for the shortages, as provided by the manufacturer Pfizer, is ‘’manufacturing delays’’ as the company states it is upgrading engineering on packaging lines and implementing additional packaging lines to rectify the shortages.

At the time of writing, the Therapeutic Goods Administration (TGA) website indicates that the pills will become available in November-December 2020, however, there may be additional COVID-19-related delays.

Updated IMPLANON NXT Procedures Statement

SHINE SA, September 2020

The contraceptive implant (Implanon NXT) is one of the most effective contraceptives available. Along with the hormonal and copper IUDs, it is classified as Long Acting Reversible Contraception (LARC) which are recommended as first-line options for all people choosing to use contraception.

SHINE SA wish to alert clinicians to important updated information about Implanon NXT procedures following an update of the product information in January 2020. These changes have been made to avoid the large blood vessels and nerves within and around the sulcus between biceps and triceps and reflect published research.

RACGP offers new suite of IUD resources

RACGP, 25th August 2020

The newly released suite consists of five intrauterine device (IUD) resources, including a checklist and patient confirmation form, patient pre- and post-insertion checklist, practitioner checklist and disclaimer. Current evidence-based options for pain relief during IUD procedures are provided as an appendix.

Dr Amy Moten, Chair of the RACGP Specific Interests Sexual Health Medicine network, led development of the resources, which she says are designed to provide guidance and support to all Australian practitioners.

Sexual and reproductive health a COVID-19 priority (Statement)

Burnet Institute, 28 May, 2020

Burnet Institute is a member of a consortium of Australian-based non-governmental organisations (NGOs) and academic institutes concerned about the detrimental effects of the COVID-19 pandemic on the sexual and reproductive health and rights of women and girls globally.

The International Sexual and Reproductive Health and Rights Consortium, which includes Save the Children, Family Planning NSW, CARE Australia, The Nossal Institute for Global Health, and Médecins Sans Frontières Australia, is calling on the Australian Government to prioritise the needs of women and girls in its response to COVID-19.

Collectively, the consortium works across 160 countries to champion universal access to sexual and reproductive health and rights.

It’s concerned that women and girls across the globe are struggling to access critical sexual and reproductive health care, citing evidence that COVID-19 lockdowns are likely to cause millions of unplanned pregnancies.

In the Pacific, travel to rural and remote areas have been curtailed, and physical distancing requirements have forced the cancellation of most group training on sexual and reproductive rights.

A recent UNFPA report determined that a six-month lockdown could mean 47 million women and girls globally cannot access contraception, and seven million will become pregnant.

The consortium has issued a joint statement setting out priorities to ensure Australia’s global response to COVID-19 meets the critical needs of all women and girls, including:

  • Recognise and respond to the gendered impacts of the pandemic, and the increased risk to women and girls from gender-based violence and other harmful practices
  • Improve the supply of contraceptives and menstrual health products which are being impacted by the strain and disruption on global supply chains
  • Increase flexibility in delivering sexual and reproductive health services during lockdown using innovative health delivery models such as task-sharing, tele-health and pharmacy distribution
  • Support sexual and reproductive health workers and clinics to continue delivering services sagely with access to personal protective equipment as well as training on how to refer, test or diagnose COVID-19.

 

SEXUAL HEALTH MATTERS: new clinical podcast from SHINE SA

SHINE SA, May 2020

Filled with quality clinical guidance and tips for best practice, SHINE SA’s new Sexual Health Matters – Clinical Podcast delves into the intimate regions of the body and broaches the uncomfortable conversations necessary to ensure client safety and sexual/reproductive well-being.

Through discussion, interview and explanation, experienced sexual health clinicians raise awareness of guidelines, resources, research and emerging trends to ensure that clinicians everywhere can provide excellent sexual and reproductive care to improve client outcomes.

If you have a topic you would like us to cover in future podcasts, email courses@shinesa.org.au to let us know!

U.S. FDA Approves Evofem Biosciences’ Phexxi™, the First Non-Hormonal Prescription Gel for the Prevention of Pregnancy

Evofem Biosciences via PRNewswire, May 22nd 2020 

Evofem Biosciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Phexxi™ (lactic acid, citric acid and potassium bitartrate) vaginal gel for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.

Phexxi is the first non-hormonal, on-demand, vaginal pH regulator contraceptive designed to maintain vaginal pH within the normal range of 3.5 to 4.5 – an acidic environment that is inhospitable to sperm.