Balancing care with compliance: Medicolegal issues for general practitioners treating attention deficit hyperactivity disorder

Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental condition characterised by both strengths and challenges with attention, concentration, hyperactivity and/or impulsivity.¹ ADHD can negatively affect a person’s learning, work and relationships. It often begins in childhood and might continue into adulthood.² It affects over 1 million Australians and is estimated to cost the Australian economy over $20 billion per annum.³

The past 20 years has seen a global increase in diagnosis and treatment rates for ADHD.⁴ Data from the Australian Institute of Health and Welfare shows that the number of people treated climbed 11-fold from 2 patients per 1000 population in 2004–05, to 8 per 1000 population in 2018–19, to 22 per 1000 in 2024–25.⁵ These increases might reflect an increase in the number of ADHD medications available on the Pharmaceutical Benefits Scheme (PBS),⁶ expanded PBS listings for existing medications, and greater community awareness of the symptoms and impact of ADHD.⁷

Psychostimulants have high misuse and dependency potential and long-term health consequences, with some psychiatrists concerned they are being overprescribed.⁸ However, delays in access to ADHD treatment can adversely impact academic and social progress in children and psychosocial functioning in adults.⁹ In response to growing awareness of the symptoms and impact of ADHD and community demand for timely and affordable assessment and treatment, state and territory governments are relaxing psychostimulant prescribing requirements for general practitioners (GPs). This shift in the treatment of ADHD towards primary care will increasingly mean GPs are diagnosing ADHD and initiating and monitoring ADHD treatment. Therefore, they will need to understand and comply with a complex web of legal, regulatory and professional obligations.

Therapeutic Goods Administration licensing and scheduling of ADHD treatments in Australia

Three psychostimulants are currently approved by the Therapeutic Goods Administration (TGA) for use in Australia: dexamphetamine (International Nonproprietary Name [INN]: dexamfetamine), methylphenidate and lisdexamphetamine (INN: lisdexamfetamine). All are classified as Schedule 8 (S8) under the Standard for the Uniform Scheduling of Medicines and Poisons¹⁰ and are strictly regulated because of their high risk of misuse and/or physical and psychological dependence. While other psychostimulants, such as amphetamine (INN: amfetamine) mixture and methamphetamine (INN: metamfetamine), are approved for use by the Food and Drug Administration (FDA) in the US,¹¹ they are not currently approved for use in Australia.

Non-psychostimulant medications commonly used to treat ADHD are classified as Schedule 4 (S4). They include atomoxetine, guanfacine and clonidine. Atomoxetine and guanfacine are approved for use in ADHD treatment. Clonidine is not. Table 1 summarises the classifications of medications used to treat ADHD in Australia.

State and territory prescribing laws and regulations

If an ADHD treatment is approved for use in Australia, GPs must then ensure that they are legally authorised to prescribe it in their state or territory. While there are no requirements for GPs to obtain a permit or approval before prescribing S4 medications used to treat ADHD, there are strict requirements in relation to the prescribing of the S8 psychostimulants (dexamphetamine, methylphenidate and lisdexamphetamine) that can differ substantially across Australian jurisdictions, making it confusing for GPs working across state or territory borders.

In Queensland, the requirements for GPs to prescribe S8 psychostimulants are least restrictive.¹² GPs may lawfully initiate and continue S8 psychostimulant treatment for children and adults with ADHD, provided that certain criteria are met (Table 2). GPs can prescribe without having to apply for an approval/permit/authorisation. In addition, they are not required to undertake further education or to be co-managing the patient with a relevant non-GP specialist (eg paediatrician or psychiatrist).

In Western Australia (WA), GPs may continue (but not initiate) prescribing an S8 psychostimulant under a shared care model without authorisation, provided certain criteria are met¹³ (Table 2).

In New South Wales (NSW) and the Australian Capital Territory (ACT), GPs who have undertaken endorsed education may continue prescribing S8 psychostimulants that were commenced by a relevant non-GP specialist without applying for an approval/permit/authorisation for each individual patient and without ongoing non-GP specialist review, but must check the relevant real-time prescription monitoring database in that jurisdiction (Table 3).^14,15 GPs who have not undertaken endorsed training in those jurisdictions must apply for an approval/permit/authorisation for each individual patient before prescribing. In NSW (and planned for the ACT), GPs who undertake additional training will also be able to initiate S8 psychostimulant prescribing.

In South Australia (SA), GPs who complete additional training may diagnose and make the initial application for an authority to prescribe S8 psychostimulants, whereas in Tasmania, GPs who have completed training may diagnose ADHD and initiate S8 psychostimulant prescribing without an authority.^16,17 In SA and Tasmania, GPs who have not completed training must apply for an authority and comply with other requirements (Table 2).

In Victoria and the Northern Territory (NT), the requirements for S8 psychostimulant prescribing remain the most onerous.^18,19 GPs must obtain an approval/permit/authorisation prior to prescribing for each patient. An approval/permit/authorisation will generally only be issued where there is evidence of paediatrician or psychiatrist involvement. Victoria is rolling out education for GPs, allowing them to diagnose ADHD and initiate treatment without the need for non-GP specialist involvement.²⁰ NT has not proposed any changes to S8 psychostimulant prescribing rules for GPs. Table 2 summarises the salient features of S8 psychostimulant prescribing in each Australian jurisdiction. The Australasian ADHD Professionals Association (AADPA) also has a useful guide.²¹ This is a rapidly changing area, and GPs would be advised to check current requirements in their state or territory.

If GPs are legally authorised to prescribe an S8 ADHD treatment in their jurisdiction, the details on the prescription must also comply with further legal requirements to be valid. These include the name and address of the patient and prescriber, the name, strength, quantity and number of repeats of the medication, directions for use, and the prescriber’s signature. The Australian Digital Health Agency has produced a useful quick reference guide that sets out these requirements.²²

Pharmaceutical Benefits Scheme requirements

Aside from the legal requirements for prescribing ADHD treatments, GPs must also comply with additional PBS requirements if they want the cost of the medication to be subsidised. GPs can prescribe dexamphetamine, methylphenidate and lisdexamphetamine as Authority Required medicines under the PBS and must meet and document specific criteria before supply can be subsidised. These criteria are available on the PBS website²³ and are summarised in Table 4. Essentially, prescribers must comply with restrictions based on dose, maximum amount, maximum repeat, dosage frequencies, and age of the patient at the time of diagnosis and treatment. Non-stimulants (guanfacine or atomoxetine) cannot be initiated by GPs under the PBS, but can be continued where a paediatrician or psychiatrist has commenced PBS-subsidised treatment: (1) as an adjunct to the maximum tolerable dose of a psychostimulant; or (2) where there is a contraindication to, or severe medical risk with, the use of a psychostimulant; or (3) where there has been a severe adverse reaction to, or worsening of a comorbid mood disorder from, the use of a psychostimulant.

Prescribing in accordance with appropriate standards

As ADHD prescribing might be new for many GPs, it is critical for GPs to be familiar with clinical guidelines and to refer to relevant non-GP specialists for review or second opinions when in doubt. Civil liability laws in Australia are clear that the standard of care expected of GPs will be that of a reasonable professional peer.²⁴ The Royal Australian College of General Practitioners (RACGP)²⁵ and AADPA²⁶ have recently released a position statement and clinical guideline. Some of the potential medicolegal risks for GPs might include: providing repeat prescriptions without adequate review; failing to adequately assess treatment response, adverse effects or functional outcomes; and failing to reassess the ongoing clinical need for psychostimulants.

In addition, clonidine is sometimes used ‘off label’ for ADHD treatment. Off label uses are not approved by the TGA. The Australian Health Practitioner Regulation Agency (Ahpra) recommends that prescribers only consider prescribing medicines for unregistered indications when an approved medicine is unavailable or inappropriate, and there is adequate information available to support use and the potential benefits and risks have been identified, evaluated and documented.²⁷ This includes obtaining and documenting informed consent and ensuring the patient understands that intended use is unapproved as well as the associated risks and benefits. The reason for the unapproved use should be documented in the patient’s medical record. More broadly, GPs must ensure patients are properly informed about the intended benefits of treatment, any risks (cardiovascular, psychiatric or dependency) and any alternatives.

Dealing with fraudulent or stolen prescriptions

Another commonly encountered issue in general practice is dealing with suspected forged or stolen prescriptions for S8 medicines, including psychostimulants. It is an offence for an individual to make or use a false or stolen prescription to unlawfully obtain restricted medicines.²⁸ Examples of forged prescriptions might include computer-generated prescriptions with manual alterations, computer- generated prescriptions with fraudulent phone numbers, and prescriptions of obviously excessive quantities.²⁹ Suppliers (but not prescribers) of S8 medicines can face penalties for failing to take reasonable steps to verify the identity of a prescriber of a suspected false prescription or failing to report a suspected false prescription.³⁰ For GPs, Australian privacy laws could permit voluntary disclosure of limited information about a suspected fraudulent prescription to a law enforcement agency if they reasonably suspect that unlawful activity has occurred and that disclosure is necessary for law enforcement activities.³¹ In addition, GPs might be contacted by pharmacists seeking confirmation about the details of suspected fraudulent psychostimulant prescriptions. Australian privacy laws may also permit disclosure of information without patient consent if directly related to the primary purpose for which the information was collected (ie it is reasonably necessary for the ongoing treatment of a patient),³² or to lessen or prevent a serious risk to public health or safety.³³

Telehealth prescribing

The use of telehealth has been shown to improve the access, assessment, outcomes and experiences of some children with ADHD and their parents,³⁴ and for adults with ADHD.³⁵ However, prescribing via telehealth raises additional medicolegal considerations. First, the Medical Board of Australia’s telehealth guidelines³⁶ recommend that practitioners carefully consider in each clinical situation whether the lack of in-person assessment and physical examination will allow the practitioner to meet the appropriate standard of care. The guidelines also discourage ‘asynchronous requests for medication communicated by text, email, live-chat or online that do not take place in the context of a real-time continuous consultation and are based on the patient completing a health questionnaire, when the practitioner has never spoken with the patient’.

Second, GPs prescribing psychostimulants via telehealth need to be satisfied that this medium facilitates adequate verification of the patient’s identity and assessment of the therapeutic need for and risks of psychostimulant prescribing. For example, in Victoria³⁷ and WA,³⁸ GPs must verify the identity of the patient before prescribing an S8 medication. This might be more difficult online, where there is no prior in-person therapeutic relationship. Moreover, because of the potential for misuse, dependence and diversion, most jurisdictions prevent S8 psychostimulant prescribing to patients who are drug-dependent (Table 2). Therefore, GPs need to consider whether a brief virtual assessment is sufficient to obtain any collateral history and understand a patient’s mental and substance use history, and the concomitant risks of dependence, misuse or diversion. The Medical Board of Australia is currently focusing regulatory attention on emerging models of telehealth- based prescribing.³⁹

Third, GPs physically located in one Australian jurisdiction but prescribing for patients located in another Australian jurisdiction may have to comply with the requirements for prescribing in their jurisdiction, the patient’s jurisdiction, or both. For example, in Queensland, GPs outside Queensland who write prescriptions must be authorised to prescribe in their home jurisdictions and must comply with any legislative requirements of that jurisdiction. Additionally, for a prescription to be dispensed in Queensland, a prescriber (whether inside or outside Queensland) must ensure that the prescription meets the requirements of a lawful prescription under Queensland law.⁴⁰ The situation might be different for other combinations of jurisdictions and GPs are urged to contact their medical defence organisation for advice.

Fitness to drive

ADHD can be associated with higher rates of impaired driving, traffic violations, licence revocations⁴¹ and collisions.⁴² While some studies have found that prescribed psychostimulants have negative effects on driving, most studies show a reduction in driving risks.⁴³ Assessing fitness to drive in patients with ADHD who are taking psychostimulants is complex. However, ADHD and/or the use of psychostimulants only requires reporting to driver licensing authorities if they result in impairment of behaviour, cognitive ability or perception, or any impairment of insight into the above, which are required for safe driving. While GPs only have mandatory legal obligations to report impaired drivers in SA⁴⁴ and the NT⁴⁵ (or for heavy vehicle licence holders in the ACT),⁴⁶ they might have ethical and professional obligations elsewhere. As mentioned above, privacy laws across Australian jurisdictions permit this type of disclosure without consent if reasonably necessary to lessen or prevent a serious risk to the life, health or safety of any individual or to public health or safety, which is a clinical question for the GP to assess. It is recommended that if a driver is being assessed for fitness to drive, their use of prescribed psychostimulants for treating ADHD be documented in any report provided to the driver licensing authority, irrespective of the outcome of the fitness assessment.⁴⁷

Dealing with parental disagreement

The final issue for GPs to consider is how to manage parental disagreement about the treatment of children with ADHD. This issue has been addressed in a previous article in AJGP.⁴⁸ In summary, GPs should first consider whether the child is ‘Gillick competent’ and has capacity to make their own decision about treatment. In Australia, the common law allows individuals aged under 18 years to consent to medical treatment if they have ‘sufficient understanding and intelligence’ to enable them to ‘fully understand’ what is proposed.⁴⁹ South Australian law allows children aged over 16 years to consent to treatment, but children aged under 16 years may only consent if two medical practitioners agree that the child understands the nature, consequences and risks of treatment that is in the best interests of the child’s health and wellbeing.⁵⁰ The level of maturity required to provide consent will vary with the nature, complexity and risks of the proposed medical treatment. Where a child’s Gillick competence is being relied on to determine the outcome of a parental dispute about treatment, it would be prudent to obtain a specialist psychiatric opinion about the child’s capacity to consent.

Where a child is deemed not to be Gillick competent, Australian Family Law⁵¹ presumes that both parents (whether married, cohabiting, separated or divorced) are entitled to consent to treatment. Either parent can consent. Consent is not required from both parents. Where treatment is commenced with the consent of one parent and the GP later learns that the other parent no longer consents, treatment may still be lawfully provided with the consent of only one parent. However, this situation could prompt a complaint from the non-consenting parent. Requests from one parent to cease treatment that has commenced is also challenging and decisions should ultimately be made that are in the best interests of the child. It is prudent for GPs to seek advice from their medical defence organisation.

Where a parent has engaged in family violence or abuse of that child⁵² or where parenting orders remove parental responsibility from one parent, that parent may not be permitted to consent to treatment on behalf of their child.⁵³ These situations can be complex and emotionally challenging for all involved. If the parents are unable to reach an agreement, then courts might intervene and order a particular course of action.⁵⁴ If this occurs, or if parenting orders exist, the GP should request and file a copy in the child’s medical record and, again, seek advice from their medical defence organisation about how best to give effect to them.

Conclusion

As ADHD management and prescribing increasingly extends into primary care, GPs will need to understand and navigate complex and changing legal, regulatory and ethical issues. While many GPs believe GP-led care is the best approach to improving ADHD diagnosis and management,⁵⁵ sufficient resources need to be invested in general practice education, training, support and guidelines to ensure GPs have the tools to safely and effectively diagnose and manage ADHD. In addition, the RACGP has called for nationally consistent legislation through amendment and harmonisation of state and territory laws to enable GPs to initiate, modify and continue psychostimulant medications for adults and children with ADHD across all jurisdictions.⁵⁶ In response, Australia’s health ministers recently announced the National Advisory Group on Drugs and Poisons Legislation Reform to plot a path towards consistent medicines laws.⁵⁷ GPs will need to keep abreast of legal requirements and emerging clinical evidence in this evolving field.

Key points

• GPs must comply with rapidly changing state and territory requirements before they can lawfully prescribe S8 psychostimulants. These requirements can differ substantially between Australian jurisdictions and are separate and additional to the requirements for a valid prescription and PBS subsidisation.
• GPs new to ADHD prescribing should follow available clinical guidelines and involve relevant non-GP specialists in the care of patients as required.
• Ideally, GPs should only prescribe TGA-unapproved ADHD medicines when an approved medicine is unavailable or inappropriate, and the use of the unapproved medicine is evidence-based – patients should be informed that the medicine is unapproved.
• Before prescribing psychostimulants via telehealth, GPs should consider whether an online consultation is sufficient to assess the patient’s identity, any prescribing risks and whether the medication is clinically justified.
• Where parents disagree about ADHD treatment, the first step is to consider the best interests of the child and whether the child is Gillick competent and can decide for themselves. Where a child is not Gillick competent, the law presumes that both parents have equal say about their child’s treatment, unless there is a court or parenting order to the contrary, or if there are reasonable grounds for suspecting that a parent has engaged in family violence or abuse of that child.
• Additional legal issues can arise when assessing fitness to drive or if GPs believe that patients have forged or stolen S8 prescriptions.
• The medicolegal issues surrounding ADHD treatment can be complex and GPs should contact their medical defence organisation when in doubt.