Pilot study with randomised control of dual site theta burst transcranial magnetic stimulation (TMS) for methamphetamine use disorder: a protocol for the TARTAN study.

BACKGROUND: Transcranial magnetic stimulation (TMS) (including the theta burst stimulation (TBS) form of TMS used in this study) is a non-invasive means to stimulate nerve cells in superficial areas of the brain. In recent years, there has been a growth in the application of TMS to investigate the modulation of neural networks involved in substance use disorders. This study examines the feasibility of novel TMS protocols for the treatment of methamphetamine (MA) use disorder in an ambulatory drug and alcohol treatment setting. METHODS: Thirty participants meeting the criteria for moderate to severe MA use disorder will be recruited in community drug and alcohol treatment settings and randomised to receive active TMS or sham (control) intervention. The treatment is intermittent TBS (iTBS) applied to the left dorsolateral prefrontal cortex (DLPFC), then continuous TBS (cTBS) to the left orbitofrontal cortex (OFC). Twelve sessions are administered over 4 weeks with opt-in weekly standardized cognitive behaviour therapy (CBT) counselling and a neuroimaging sub-study offered to participants. Primary outcomes are feasibility measures including recruitment, retention and acceptability of the intervention. Secondary outcomes include monitoring of safety and preliminary efficacy data including changes in substance use, cravings (cue reactivity) and cognition (response inhibition). DISCUSSION: This study examines shorter TBS protocols of TMS for MA use disorder in real-world drug and alcohol outpatient settings where withdrawal and abstinence from MA, or other substances, are not eligibility requirements. TMS is a relatively affordable treatment and staff of ambulatory health settings can be trained to administer TMS. It is a potentially scalable and translatable treatment for existing drug and alcohol clinical settings. TMS has the potential to provide a much-needed adjuvant treatment to existing psychosocial interventions for MA use disorder. A limitation of this protocol is that the feasibility of follow-up is only examined at the end of treatment (4 weeks). TRIAL REGISTRATION: Australia New Zealand Clinical Trial Registry ACTRN12622000762752. Registered on May 27, 2022, and retrospectively registered (first participant enrolled) on May 23, 2022, with protocol version 7 on February 24, 2023.

Unmet need for postpartum long-acting reversible contraception in women with substance use disorders and/or socioeconomic disadvantage.

BACKGROUND: In Australia, it is estimated that 30% of pregnancies are unintended and 25% of pregnancies end in abortion. Unintended pregnancy can be particularly problematic for women with substance use disorders (SUD) and/or socioeconomic disadvantage. Long-acting reversible contraception (LARC) including progestogen implants and intrauterine devices (IUD) are safe, affordable and extremely effective in decreasing rates of unintended pregnancy, yet are currently underutilised in Australia. AIMS: To determine the current rate of unintended pregnancy, contraception counselling and postpartum LARC use in women who attend an antenatal clinic for SUD and/or socioeconomic disadvantage in pregnancy. We hypothesise that there is an unmet need for contraception in this population. MATERIALS AND METHODS: We conducted a retrospective audit of women who birthed in a tertiary hospital in 2018 with SUD and/or additional social support needs. We recorded the rate of unintended pregnancy, the occurrence of antenatal and postpartum contraception counselling and the rate of immediate postpartum LARC uptake through review of our electronic medical database. RESULTS: Of the 210 women in our study population, we identified a high proportion of unintended pregnancies (64%), a low rate of antenatal (11%) and postpartum (35%) contraception counselling, and a low uptake of immediate postpartum LARC use (3.3%), confirming an unmet need for contraception. CONCLUSIONS: Further intervention is required to enhance the access to immediate postpartum LARC and reduce the risk and health burden of unintended pregnancy.

Challenges in maintaining treatment services for people who use drugs during the COVID-19 pandemic.

The impact of COVID-19 across health services, including treatment services for people who use drugs, is emerging but likely to have a high impact. Treatment services for people who use drugs provide essential treatment services including opiate agonist treatment and needle syringe programmes alongside other important treatment programmes across all substance types including withdrawal and counselling services. Drug and alcohol hospital consultation-liaison clinicians support emergency departments and other services provided in hospital settings in efficiently managing patients who use drugs and present with other health problems.COVID-19 will impact on staff availability for work due to illness. Patients may require home isolation and quarantine periods. Ensuring ongoing supply of opiate treatment during these periods will require significant changes to how treatment is provided. The use of monthly depot buprenorphine as well as moving from a framework of supervised dosing will be required for patients on sublingual buprenorphine and methadone. Ensuring ready access to take-home naloxone for patients is crucial to reduce overdose risks. Delivery of methadone and buprenorphine to the homes of people with confirmed COVID-19 infections is likely to need to occur to support home isolation.People who use drugs are likely to be more vulnerable during the COVID-19 epidemic, due to poorer health literacy and stigma and discrimination towards this group. People who use drugs may prioritise drug use above other health concerns. Adequate supply of clean injecting equipment is important to prevent outbreaks of blood-borne viruses. Opiate users may misinterpret SARS-CoV2 symptoms as opiate withdrawal and manage this by using opioids. Ensuring people who use drugs have access to drug treatment as well as access to screening and testing for SARS-CoV2 where this is indicated is important.

Wrongful life claims: dignity, disability and "a line in the sand".

A recent High Court decision held that children born with disabilities not caused by medical intervention, but not diagnosed antenatally, could not claim general damages for their pain and suffering, nor special damages for the needs created by their disabilities and their loss of earning capacity.

Pandemics, antiviral stockpiles and biosecurity in Australia: what about the generic option?

In view of the possibility of a human pandemic of avian influenza, a first-line strategy for many countries is stockpiling of antiviral neuraminidase inhibitors (oseltamivir [Tamiflu] and zanamivir [Relenza]), which can reduce mortality, morbidity and influenza transmission. However, global supply of the antivirals is controlled by the European-based patent owners, Roche and GlaxoSmithKline. This prevents competition in the manufacturing and distribution of antivirals and has reduced global supply capacity and affordability. The Australian Government has acknowledged that, in the event of a pandemic, its own stockpile of antivirals will be limited and reserved for those on a confidential rationing list. Pharmacies are running out of stocks, limiting opportunities for individuals to secure supplies privately. Compulsory licensing provisions, permitted under domestic patent law, would allow Australian generic manufacturers to start producing antivirals locally or import them from generic producers at affordable prices. Australia also has an opportunity and a responsibility to promote compulsory licensing and generic antiviral production in the Asian region, to ensure our neighbours can establish pandemic stockpiles in a timely and affordable manner.

Private health insurance and regional Australia.

Since 1996, an increasing proportion of federal government expenditure has been directed into Australia's healthcare system via private health insurance (PHI) subsidies, in preference to Medicare and the direct funding of public health services. A central rationale for this policy shift is to increase the use of private hospital services and thereby reduce pressure on public inpatient facilities. However, the impact of this reform process on regional Australia has not been addressed. An analysis of previously unpublished Australian Bureau of Statistics data shows that regional Australians have substantially lower levels of private health fund membership. As a result, regional areas appear to be receiving substantially less federal government health funding, compared with cities, than if these funds were allocated on a per-capita basis. We postulate that the lower level of membership in regional areas is mainly due to the limited availability of private inpatient facilities, making PHI less attractive to rural Australians. We conclude that PHI as a vehicle for mainstream federal health financing has potential structural failures that disadvantage regional Australians.

Will the Australia-United States Free Trade Agreement undermine the Pharmaceutical Benefits Scheme?

The Australia-United States Free Trade Agreement (AUSFTA) contains major concessions to the US pharmaceutical industry that may undermine the egalitarian principles and operation of the Pharmaceutical Benefits Scheme (PBS) and substantially increase the costs of medicinal drugs to Australian consumers. AUSFTA's approach to the PBS excessively emphasises the need to reward manufacturers of "innovative" new pharmaceuticals, instead of emphasising consumers' need for equitable and affordable access to necessary medicines (the first principle of our National Medicines Policy). Several features of AUSFTA may bring pressure to bear on the Pharmaceutical Benefits Advisory Committee (PBAC) to list "innovative" drugs that the committee initially rejected because the evidence for cost-effectiveness was not compelling. Intellectual property provisions of AUSFTA are likely to delay the entry of PBS cost-reducing generic products when pharmaceutical patents expire. We support the many concerned health and consumer organisations who have asked the Senate either not to pass the enabling legislation, or to delay its passage until a fairer deal in terms of public health can be obtained.